roche hitachi 911 user manual

BM/HITACHI 911

Copyright © Boehringer Mannheim GmbH 1993

Main Table of Contents

PREFACE

P.1 Overview......................................................................................................P · 1P.2 Purpose And Scope of Manual ..................................................................P · 2P.3 Facility Specifications ................................................................................P · 3

CHAPTER 1: INTRODUCTION

1.1 Overview...................................................................................................... 1 · 11.2 Control System ........................................................................................... 1 · 41.3 Sampling System...................................................................................... 1 · 181.4 Reagent System........................................................................................ 1 · 221.5 Photometric Measuring System .............................................................. 1 · 261.6 Cell Rinse System..................................................................................... 1 · 301.7 ISE System ................................................................................................ 1 · 311.8 Operational Modes ................................................................................... 1 · 331.9 Operational Flow....................................................................................... 1 · 351.10 Instrument Specifications ........................................................................ 1 · 37

CHAPTER 2: OPERATIONS

Part A - Operating Instructions

2.1 Daily Operating Check ............................................................................... 2 · 12.2 Daily Start-Up .............................................................................................. 2 · 52.3 Calibration ................................................................................................... 2 · 92.4 Control Test Selection.............................................................................. 2 · 112.5 Routine Patient Test Selection Without Bar Code Reader .................... 2 · 132.6 Routine Patient Test Selection With Bar Code Reader.......................... 2 · 152.7 Initiate Run ................................................................................................ 2 · 172.8 Stat Test Selection .................................................................................... 2 · 202.9 Measurement of Additional Routine Samples ........................................ 2 · 222.10 Rerun Sample Processing ....................................................................... 2 · 242.11 Within-Run Recalibration ......................................................................... 2 · 272.12 Data Editing ............................................................................................... 2 · 282.13 Quality Control Procedures ..................................................................... 2 · 292.14 QC File Maintenance................................................................................. 2 · 302.15 Patient Reports ......................................................................................... 2 · 32


Part B - CRT Screen Displays

2.16 Overview.................................................................................................... 2 · 332.17 Operation Monitor ..................................................................................... 2 · 362.18 Routine Job - - Menu ................................................................................ 2 · 402.19 Routine Job - - Reagent Status ................................................................ 2 · 412.20 Routine Job - - Calibration Test Selection .............................................. 2 · 492.21 Routine Job - - Patient Test Selection Without Bar Code Reader ........ 2 · 532.22 Routine Job - - Patient Test Selection With Bar Code Reader .............. 2 · 582.23 Routine Job - - Start Conditions .............................................................. 2 · 622.24 Routine Job - - Real Time Data Monitor .................................................. 2 · 682.25 Routine Job - - Data Review .................................................................... 2 · 702.26 Routine Job - - Rerun Samples ................................................................ 2 · 762.27 Routine Job - - Status Setting .................................................................. 2 · 802.28 Stat Reception .......................................................................................... 2 · 832.29 Stat Test Selection .................................................................................... 2 · 842.30 Quality Control Job - - Menu .................................................................... 2 · 892.31 Quality Control Job - - Real Time QC....................................................... 2 · 902.32 Quality Control Job - - Individual QC Monitor ......................................... 2 · 932.33 Quality Control Job - - Individual QC List ................................................ 2 · 962.34 Quality Control Job - - Individual QC Chart............................................. 2 · 992.35 Quality Control Job - - Cumulative QC Monitor .................................... 2 · 1012.36 Quality Control Job - - Cumulative QC List ........................................... 2 · 1042.37 Quality Control Job - - Cumulative QC Chart ........................................ 2 · 1062.38 Data Monitor Job - - Menu ...................................................................... 2 · 1082.39 Data Monitor Job - - Reaction Monitor .................................................. 2 · 1092.40 Data Monitor Job - - Calibration Trace .................................................. 2 · 1122.41 Data Monitor Job - - Calibration List ...................................................... 2 · 1142.42 Data Monitor Job - - ISE Calibration Monitor ........................................ 2 · 1162.43 Data Monitor Job - - Working Curve ...................................................... 2 · 1182.44 Parameter Job - - Menu .......................................................................... 2 · 1202.45 Parameter Job - - Chemistry Parameters .............................................. 2 · 1212.46 Parameter Job - - Profiling ..................................................................... 2 · 1362.47 Parameter Job - - Calculated Test ......................................................... 2 · 1382.48 Parameter Job - - Print Order ................................................................. 2 · 1432.49 Parameter Job - - Report Format ........................................................... 2 · 1452.50 Parameter Job - - Control Test Selection .............................................. 2 · 1512.51 Parameter Job - - Control Value Setting ............................................... 2 · 1532.52 Parameter Job - - Special Wash Programming .................................... 2 · 1552.53 Parameter Job - - System Parameters ................................................... 2 · 1592.54 Parameter Job - - Channel Assignment ................................................ 2 · 1672.55 Maintenance Job - - Menu ...................................................................... 2 · 170


2.56 Maintenance Job - - Analyzer Maintenance .......................................... 2 · 1712.57 Maintenance Job - - Mechanisms Check .............................................. 2 · 1752.58 Maintenance Job - - Support Functions ............................................... 2 · 1782.59 Maintenance Job - - Working Information ............................................. 2 · 181

Part C - Reports

2.60 Overview.................................................................................................. 2 · 1852.61 Reagent Status ....................................................................................... 2 · 1862.62 Requisition List - - Without Bar Code Reader....................................... 2 · 1882.63 Requisition List - - With Bar Code Reader ............................................ 2 · 1902.64 Calibrator Load List ................................................................................ 2 · 1922.65 Rerun List ................................................................................................ 2 · 1942.66 Calibration Monitor ................................................................................. 2 · 1962.67 Individual QC Monitor ............................................................................. 2 · 1992.68 Individual QC List.................................................................................... 2 · 2012.69 Cumulative QC Monitor .......................................................................... 2 · 2032.70 Cumulative QC List ................................................................................. 2 · 2052.71 Reaction Monitor .................................................................................... 2 · 2072.72 Patient Reports - - Report Format.......................................................... 2 · 2102.73 Patient Reports - - Short Format ............................................................ 2 · 2132.74 Calibration Trace .................................................................................... 2 · 2152.75 Profiling List ............................................................................................ 2 · 2172.76 Photometer Check.................................................................................. 2 · 2192.77 Cell Blank ................................................................................................ 2 · 2212.78 Bar Code Reader Check ........................................................................ 2 · 2232.79 ISE Check................................................................................................ 2 · 2252.80 Printer Check .......................................................................................... 2 · 2272.81 Daily Alarm Trace .................................................................................... 2 · 2282.82 Cumulative Alarm Trace ......................................................................... 2 · 2302.83 Host Communication Log ...................................................................... 2 · 2322.84 Floppy Disk Check ................................................................................. 2 · 2332.85 Memory Check ........................................................................................ 2 · 2342.86 Precision Check...................................................................................... 2 · 2352.87 Maintenance Report ............................................................................... 2 · 2372.88 Cumulative Operations Report .............................................................. 2 · 2382.89 Original Absorbance............................................................................... 2 · 240


CHAPTER 3: MAINTENANCE

Part A - Scheduled Maintenance

3.1 Maintenance Procedures Overview .......................................................... 3 · 13.2 Working Information ................................................................................... 3 · 23.3 Reaction System Wash .............................................................................. 3 · 43.4 Empty Waste Solution Reservoir .............................................................. 3 · 53.5 ISE Maintenance ......................................................................................... 3 · 63.6 Clean DI Water Reservoir ........................................................................... 3 · 83.7 Check Reaction Cell Condition ................................................................. 3 · 93.8 Clean and Adjust Reaction System Components ................................. 3 · 113.9 Replace Reaction Cells and Clean Reaction Bath ................................. 3 · 163.10 Clean Sample and Reagent Disk Compartments ................................... 3 · 213.11 Clean Refrigerator Condenser Filter ....................................................... 3 · 273.12 Clean Inlet Water Filter ............................................................................. 3 · 283.13 Replace ISE Pinch Valve Tubing ............................................................. 3 · 303.14 Replace Pipettor Seals ............................................................................. 3 · 33

Part B - Unscheduled Maintenance

3.15 Floppy Disk Replacement ........................................................................ 3 · 453.16 System Software Installation ................................................................... 3 · 503.17 Clean Cell Rinse Unit ................................................................................ 3 · 533.18 Replace Photometer Lamp ...................................................................... 3 · 563.19 Clean ISE Reagent Flowpath ................................................................... 3 · 623.20 Replace ISE Measuring Cartridge (Na+, K+, Cl-) ....................................... 3 · 653.21 Replace ISE Reference Cartridge ............................................................ 3 · 703.22 Check/Refill Multiclean Solution .............................................................. 3 · 763.23 Replace Sample Probe ............................................................................. 3 · 793.24 Replace Reagent Probes ......................................................................... 3 · 933.25 Replace Stirring Paddle ......................................................................... 3 · 1083.26 Load Continuous-Form Paper ............................................................... 3 · 1113.27 Replace Printer Ribbon Cassette .......................................................... 3 · 116


CHAPTER 4: TROUBLESHOOTING

4.1 Troubleshooting Procedures .................................................................... 4 · 14.2 Troubleshooting Conditions That Occur At Power Up............................ 4 · 34.3 Chemistry Troubleshooting ....................................................................... 4 · 44.4 Instrument Troubleshooting .................................................................... 4 · 124.5 Data Alarms ............................................................................................... 4 · 134.6 Instrument Alarms .................................................................................... 4 · 21

CHAPTER 5: THEORY

Part A - Instrument Theory

5.1 Overview...................................................................................................... 5 · 15.2 Cell Rinse And Blanking ............................................................................ 5 · 55.3 Begin Operation .......................................................................................... 5 · 85.4 Sample Aspiration and Dispense ............................................................ 5 · 145.5 Sample Predilution ................................................................................... 5 · 185.6 Reagent Aspiration and Dispense .......................................................... 5 · 225.7 Sampling End............................................................................................ 5 · 295.8 ISE System Components ......................................................................... 5 · 30

Part B - Chemistry Theory

5.9 Overview.................................................................................................... 5 · 405.10 Assay Techniques .................................................................................... 5 · 435.11 1-Point Endpoint Assay ........................................................................... 5 · 465.12 2-Point Rate Assay ................................................................................... 5 · 485.13 2-Point Endpoint Assay ........................................................................... 5 · 515.14 3-Point Endpoint Assay ........................................................................... 5 · 545.15 1-Point Endpoint and Rate Assay ........................................................... 5 · 565.16 Rate A Assay ............................................................................................. 5 · 585.17 Rate B Assay - - Mode 1 ........................................................................... 5 · 615.18 Rate B Assay - - Mode 2 ........................................................................... 5 · 645.19 Summary of Assay Techniques .............................................................. 5 · 665.20 Calibration Overview ................................................................................ 5 · 675.21 1-Point Linear Calibration ........................................................................ 5 · 71

5.22 2-Point Linear Calibration ........................................................................ 5 · 735.23 Multipoint Linear Calibration .................................................................... 5 · 755.24 Non-Linear Logit-log 3P Calibration ........................................................ 5 · 775.25 Non-Linear Logit-log 4P Calibration ........................................................ 5 · 795.26 Non-Linear Logit-log 5P Calibration ........................................................ 5 · 815.27 Non-Linear Exponential Calibration ........................................................ 5 · 835.28 Non-Linear Spline Calibration ................................................................. 5 · 855.29 Isozyme P Calibration .............................................................................. 5 · 875.30 Isozyme Q Calibration .............................................................................. 5 · 895.31 ISE Calibration .......................................................................................... 5 · 915.32 Result Integrity Checks ............................................................................ 5 · 955.33 Serum Index Function .............................................................................. 5 · 985.34 Real Time QC Evaluation ....................................................................... 5 · 1035.35 Reagent Labelling ................................................................................... 5 · 110


PREFACE

P.1 Overview......................................................................................................P · 1

P.1.1 Introduction.......................................................................................................................... P · 1P.1.2 Precautions Against Potential Hazards ............................................................................. P · 1

P.2 Purpose And Scope of Manual ..................................................................P · 2

P.2.1 Introduction.......................................................................................................................... P · 2P.2.2 Use of Manual ...................................................................................................................... P · 2P.2.3 Manual Outline .................................................................................................................... P · 2P.2.4 Manual Numbering System ................................................................................................ P · 2P.2.5 Manual Revisions ................................................................................................................ P · 2

P.3 Facility Specifications ................................................................................P · 3

P.3.1 Introduction.......................................................................................................................... P · 3P.3.2 Electrical Requirements...................................................................................................... P · 3P.3.3 Water .................................................................................................................................... P · 3P.3.4 Drain ..................................................................................................................................... P · 3P.3.5 Temperature and Humidity ................................................................................................ P · 3P.3.6 Instrument ............................................................................................................................ P · 3

PREFACE

Contents

PREFACE

Contents

P • 1

P.1 Overview

P.1.1 Introduction

The Boehringer Mannheim/Hitachi 911 Analyzer is afully automated, discrete, computerized chemistryanalyzer. It is intended for in vitro quantitative orqualitative determination of a wide range of analytesin various body fluids.

Packaged with your analyzer, you will receive:

• Accessory Box• ISE Accessory Parts Case• Installation Kit

After your instrument is installed, the followingconsumable materials should be ordered asnecessary from Boehringer Mannheim:

• Bar-CodedReagents• Printer Paper• Printer Ribbon• Reaction Cells• Hitergent• Sample Cups• Pipettor Seals• Photometer Lamps• Probes• ISE Cartridges• Multiclean• ISE Cleaning Solution

P.1.2 Precautions Against PotentialHazards

Chemical

The operator is responsible for taking all necessaryprecautions against hazards associated with the useof clinical laboratory chemicals. Specificrecommendations for each reagent used on the

analyzer are found on the package insert for eachchemistry. Material Safety Data Sheets (MSDS) areavailable for Boehringer Mannheim reagents.

Please ensure that all samples have beenallowed to coagulate completely and aresubsequently centrifuged correctly!Samples containing fibrin clots may block thesample probe and lead to incorrect sampling.

If you are using blood-collection tubescontaining a gel (e.g. Vacutainer SST) pleasefollow the manufacturers recommendation.

Immediately remove any reagent spillage from theinstrument.

Electrical

As with any electronic equipment, electrical shockcan occur. Use extreme caution when workingaround the instrument. Avoid contact with anyelectrical wire or components. DO NOT attempt towork in any electronic compartment with the poweron. ALWAYS turn the MAIN circuit breaker off andunplug the instrument from the power source beforeworking where contact with electrical wires, terminalstrips, motors, or other electrical components ispossible.

Should one of the instrument circuit breakers or fuses"blow", DO NOT attempt to operate the analyzerbefore calling Boehringer Mannheim CustomerTechnical Support.

Mechanical

As with any mechanical system, there are certainprecautions to take when operating the instrument.DO NOT wear loose garments or jewelry that couldcatch in mechanisms such as the sample probeassembly. Whenever possible, operate theinstrument with the main cover down. DO NOTattempt mechanical repair unless the instrument is inStand-by or OFF.

P.1 Overview

PREFACE

P • 2

P.2 Purpose And Scope ofManual

P.2.1 Introduction

This Operator�s Manual is an instructional aid in theperformance of tasks related to the operation andgeneral maintenance of this instrument. The manualcontains detailed descriptions of instrument featuresand specifications. It also contains general theory ofoperation, function and use of controls, emergencyprocedures and maintenance procedures.

P.2.2 Use of Manual

This manual is arranged in a progressive sequence foreasy study and reference. Do not operate theinstrument until thoroughly familiar with theinformation in this manual. The key to goodperformance is good preparation by thoroughlystudying the information contained in this manual.

P.2.3 Manual Outline

The manual contains the following sections:

Main Table of ContentsPrefaceChapter 1 - - IntroductionChapter 2 - - Operation

Part A - -Operating InstructionsPart B - - CRT Job ScreensPart C - - Reports

Chapter 3 - - MaintenanceChapter 4 - - TroubleshootingChapter 5 - - Theory

P.2.4 Manual Numbering System

The manual numbering system provides easylocation of information. The pages, paragraphs,pictorials, tables and the table of contents areestablished in a manner helpful to the user. Thegeneral table of contents at the beginning of themanual, along with individual table of contents foreach chapter, provide points of quick correlation incross referencing. Pictorials are repeated asnecessary to minimize page flipping and referencesare made between sections to point out specificinformation.

P.2.5 Manual Revisions

The arrangement of the manual facilitates easyupdating and revision. Page revision packages areissued from time to time for user insertion into themanual.

P.2 Purpose And Scope of Manual

PREFACE

P • 3

P.3 Facility Specifications

P.3.1 Introduction

Installation of the instrument is performed by aBoehringer Mannheim representative. The customeris responsible for providing the necessary facilities asspecified in Section P.3.6.

P.3.2 Electrical Requirements

The analyzer must be wired for 115 ± 10% VAC,30 amp, 60 Hz. A separate, instrument-dedicatedcircuit must be provided.

P.3.3 Water

The instrument requires 15-30 liters of bacteria-freedeionized water per hour during operation, with aminimum resistance of 1.5 megohm. The water flowrate to the instrument must be at least 80 liters perhour during operation with a minimum pressure of 15psi and a maximum pressure of 25 psi. This flow rate(not to be confused with actual water consumption)permits the deionized water reservoir to fill quicklywhen necessary.

P.3.4 Drain

Although the instrument is equipped with a 10-literwaste water container, it is preferable that a floor drainbe provided. It should be capable of carrying 30 litersof waste water per hour during maximum operation.The drain cannot be more than 10 cm above the floorlevel.

P.3.5 Temperature and Humidity

The instrument generates approximately 6700 Btu/hour. There must be adequate ventilation in the areaof the instrument to maintain a temperature range from15 to 32 °C. Room temperature variation within anyspecific day should not exceed ±2 °C. The top of theinstrument must not be in direct sunlight or in the pathof forced air flow. Free air flow must be allowed aroundall sides of the instrument.

Relative environmental (humidity) range: 45 - 85%without condensation.

P.3.6 Instrument

The dimensions of the analytical unit areapproximately 99 cm wide × 74 cm deep × 112 cmhigh. The dimensions of the control unit areapproximately 61 cm wide × 74 cm deep × 122 cmhigh. Clearance on all sides should be 91 cmminimum after installation. The instrument requires aminimum door width of 122 cm and a turning radius of127 cm. The analytical unit weighs approximately 410kg. The weight is evenly distributed on four levelingfeet. The operational unit weighs approximately 50 kg.Access to normal laboratory facilities such as sink,refrigerator, and storage space is essential. No fumehood or external exhaust system is required.


PREFACE

P • 4


PREFACE

NOTES

1. INTRODUCTION

Contents

1. INTRODUCTION

1.1 Overview...................................................................................................... 1 · 1

1.1.1 Name and Intended Use ..................................................................................................... 1 · 11.1.2 Analyzer Characteristics ..................................................................................................... 1 · 21.1.3 Analyzer Operational Systems ........................................................................................... 1 · 21.1.4 Analytical Unit Operating Principle ................................................................................... 1 · 3

1.2 Control System ........................................................................................... 1 · 4

1.2.1 Introduction.......................................................................................................................... 1 · 41.2.2 CRT Job Screens ................................................................................................................. 1 · 41.2.3 Keyboard Description.......................................................................................................... 1 · 41.2.4 Analyzer Control Keys .......................................................................................................1 · 111.2.5 Job Menu Selection Keys ..................................................................................................1 · 111.2.6 Screen Navigation Keys.....................................................................................................1 · 131.2.7 Data Entry Keys ..................................................................................................................1 · 141.2.8 Printer Control Keys ...........................................................................................................1 · 151.2.9 Buz. Off Key ........................................................................................................................1 · 161.2.10 Control Processing Unit .....................................................................................................1 · 161.2.11 Floppy Disk Drives ..............................................................................................................1 · 161.2.12 Printer .................................................................................................................................1 · 161.2.13 Host Interface......................................................................................................................1 · 161.2.14 Data Storage .......................................................................................................................1 · 17

1.3 Sampling System...................................................................................... 1 · 18

1.3.1 Introduction.........................................................................................................................1 · 181.3.2 Sample Disk ........................................................................................................................1 · 191.3.3 Sample Probe.....................................................................................................................1 · 191.3.4 Sample Probe Arm.............................................................................................................1 · 201.3.5 Sample Pipettor .................................................................................................................1 · 201.3.6 Sample Probe Rinse Station .............................................................................................1 · 201.3.7 Sampling System Flowpath ..............................................................................................1 · 201.3.8 Sample Container Sizes ....................................................................................................1 · 21

1. INTRODUCTION

Contents

1.4 Reagent System........................................................................................ 1 · 22

1.4.1 Introduction .........................................................................................................................1 · 221.4.2 Reagent Disks ..................................................................................................................... 1 · 221.4.3 Reagent Probes .................................................................................................................. 1 · 231.4.4 Reagent Probe Arms ..........................................................................................................1 · 231.4.5 Reagent Pipettors ...............................................................................................................1 · 241.4.6 Reagent Probe Rinse Stations ..........................................................................................1 · 241.4.7 Stirring Units ....................................................................................................................... 1 · 241.4.8 Reagent Flowpath ..............................................................................................................1 · 25

1.5 Photometric Measuring System .............................................................. 1 · 26

1.5.1 Introduction .........................................................................................................................1 · 261.5.2 Reaction Disk ......................................................................................................................1 · 261.5.3 Reaction Bath ..................................................................................................................... 1 · 271.5.4 Hitergent .............................................................................................................................1 · 271.5.5 Photometer ................................................................................................................ .........1 · 28

1.6 Cell Rinse System..................................................................................... 1 · 30

1.6.1 Cell Rinse Unit ....................................................................................................................1 · 301.6.2 Water Supply ......................................................................................................................1 · 301.6.3 Vacuum System .................................................................................................................. 1 · 30

1.7 ISE System ................................................................................................ 1 · 31

1.7.1 Introduction .........................................................................................................................1 · 311.7.2 ISE Calibration....................................................................................................................1 · 321.7.3 ISE Sample Aspiration .......................................................................................................1 · 321.7.4 Sample Dispense and Dilution ..........................................................................................1 · 321.7.5 ISE Measurement Flowpath .............................................................................................. 1 · 321.7.6 Rinse.................................................................................................................................... 1 · 321.7.7 Internal Reference Solution .............................................................................................. 1 · 32

1.8 Operational Modes ................................................................................... 1 · 33

1.8.1 Introduction.........................................................................................................................1 · 331.8.2 Initialization ........................................................................................................................1 · 331.8.3 Stand-by ..............................................................................................................................1 · 331.8.4 Parameter Check ...............................................................................................................1 · 331.8.5 Reset....................................................................................................................................1 · 331.8.6 Operate ...............................................................................................................................1 · 331.8.7 Sampling Stop ............................................................................................................. .......1 · 341.8.8 Probe Wash ........................................................................................................................1 · 341.8.9 Stop .....................................................................................................................................1 · 341.8.10 Sleep ...................................................................................................................................1 · 341.8.11 Wake Up..............................................................................................................................1 · 341.8.12 Stat Stand-by ......................................................................................................................1 · 341.8.13 Stat Operation ....................................................................................................................1 · 341.8.14 Check...................................................................................................................................1 · 34

1.9 Operational Flow....................................................................................... 1 · 35

1.9.1 Daily Check .........................................................................................................................1 · 351.9.2 Power Up/Start Up..............................................................................................................1 · 351.9.3 Calibrators and Controls ....................................................................................................1 · 351.9.4 Patient Test Selection ........................................................................................................1 · 351.9.5 Start Conditions Screen .....................................................................................................1 · 351.9.6 Begin Operation .................................................................................................................1 · 351.9.7 Results .................................................................................................................................1 · 351.9.8 Additional Runs ..................................................................................................................1 · 351.9.9 Daily Maintenance .............................................................................................................1 · 36

1.10 Instrument Specifications ........................................................................ 1 · 37

1.10.1 Introduction.........................................................................................................................1 · 371.10.2 Dimensions .........................................................................................................................1 · 371.10.3 Electrical .............................................................................................................................1 · 371.10.4 Interface ..............................................................................................................................1 · 371.10.5 Test Modes ..........................................................................................................................1 · 371.10.6 Control System ...................................................................................................................1 · 371.10.7 ISE System ..........................................................................................................................1 · 371.10.8 Sampling System ...............................................................................................................1 · 381.10.9 Reagent System .................................................................................................................1 · 381.10.10 Measuring System (photometric) ......................................................................................1 · 381.10.11 Miscellaneous .....................................................................................................................1 · 38

1. INTRODUCTION

Contents

1. INTRODUCTION

Contents

1 • 1

1.1 Overview

1.1.1 Name and Intended Use

1 Analytical Unit

The Boehringer Mannheim/Hitachi 911 Analyzer isshown in Figure 1-1. The analyzer is used to reporttest results on various body fluid samples for a widerange of analytes. This analyzer:

• is fully automated• is discrete• is computerized• uses serum, urine, plasma, and CSF sample types• performs in vitro quantitative and qualitative tests

on a wide range of analytes• performs potentiometric and photometric assays.

1. INTRODUCTION

1.1 Overview

2 Control Unit

The 911 analyzer is composed of two hardware units:the analytical unit and the control unit .

The analytical unit includes:

• the ISE system• photometric measuring systems• Central Processing Unit (CPU).

The control unit includes:

• the monitor (CRT)• keyboard• printer.

Figure 1-1: 911 Analyzer

➀

➁

STATOPERATION

MONITOR ROUTINE QC MONITOR PARAM. MAINTE. GUIDANCEPAGECONTINUE

PAGEBACK

PAGEFORWARD

PRINTSTOP

COPY BUZ OFF

CAPSLOCK

START STOPSAMPLINGSTOP

STOP

7A

8B

9C

4D

5E

6F

1G

2H

3I

0J

.K

_L

C ENTER

BACKSPACE

!

1

@

2

#

3

$

4

%

5

"

6

&

7

*

8

(

9

)

10

-

11

+

12

,

ISEQ

13

W

14

E

15

R

16

T

17

Y

18

U

19

I

20

O

21

P

22

/

23

=

24A

25

S

26

D

27

F

28

G

29

H

30

J

31

K

32

L

33

;

34

:

35

Z

37

X

38

C

39

V

40

B

41

N

42

M

43

<

46

SHIFT ,

44

.

45

ENTER

?

36

SHIFT>

S.INDEX

CAPSLOCK

1 • 2

1.1.2 Analyzer Characteristics

Analyzer characteristics include:

• true stat results availability

• ready to use 24 hours per day

• sample bar code capability

• reagent bar code capability

• 360 tests/hour throughput (photometric)

• 720 tests/hour throughput with ISEs (K+, Na+,and Cl-)

• micro sample cup - - reduced sample evaporation,good for pediatric samples

• automated maintenance functions

• data reduction, nonlinear chemistries:- three parameter logit-log- four parameter logit-log- five parameter logit-log- five parameter exponential- cubic spline

• automatic calibration

• automatic sample blanking

• automatic sample dilution capabilities

• QC capabilities for 8 control levels

• refrigerated storage for 64 reagent containers

• refrigerated storage for 8 controls and 17calibrators

• automatic evaluation of within-run control results

• bidirectional host interface capability

• automatic rerun capability

• endpoint, kinetic, and isoenzyme chemistries

• micro (3-50 microliter) sample sizes.

• 46 programmable tests

1.1.3 Analyzer Operational Systems

The analyzer uses several operational systems toperform required functions. These systems include:

• Control System• Sampling System• Reagent System• Reaction Bath System• Cell Rinse System• Photometric Measuring System• ISE System.

The Control System consists of the control unit (CRT,keyboard, and printer) that is a free-standing hardwaremodule, external to the analytical unit and the CPU,which is located in the analyzer unit. This system isdiscussed in Section 1.2.

The remaining systems are all part of the analyticalunit and are discussed in detail, beginning withSection 1.3. Additional information about themechanical operation of the anlyzer is given in Chapter5, Part A.

1. INTRODUCTION

1.1 Overview

1 • 3

1.1.4 Analytical Unit OperatingPrinciple

Figure 1-2 gives an operational overview of thephotometric portion of the instrument. The generalsequence of events illustrated is:

• The sample disk rotates the appropriate sample tothe sample probe (1).

• The sample probe aspirates sample for testing (2).

• If ISEs are selected, the sample is delivered intothe ISE dilution vessel (3) .

• If photometric chemistries are selected, thesample is delivered into a reaction cell on thereaction disk (4) .

Figure 1-2: Operational Overview

1 Sample Disk2 Sample Probe3 ISE Dilution Vessel4 Reaction Disk/Incubation Bath

• After the sample is placed into the reaction cell,the reagent probes add up to four differentreagents in separate dispense cycles (5).

• Stirring paddles mix the sample after theaddition of each reagent (6).

• Incubation occurs as cells are immersed in theincubation bath below the reaction disk. Reactioncells rotate through the photometer lightpath anda measurement is taken (7).

• The cell rinse unit removes reaction productwaste and cleans reaction cells for reuse (8).

5 Reagent Probes6 Stirring Paddles7 Photometer8 Cell Rinse Unit

1. INTRODUCTION

1.1 Overview

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

1312

1110

98

76

54

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂

➇

➆➅

➄

➅

➄➃

➁

➀

1 • 4

1.2 Control System

1.2.1 Introduction

The control system is used to control all instrumentfunctions. Components include the computer (locatedon the analytical unit), keyboard, CRT, and printer(located on the control unit). An interface port for ahost computer is available for use, if desired. This portis located on the back left side of the analytical unit.

1.2.2 CRT Job Screens

The CRT is used to:

• display information from the computer memory• monitor the instrument status• monitor instrument functions.

Each CRT screen displays information relating to aspecific instrument function. For example, theCHEMISTRY PARAMETERS screen containsinformation necessary for the instrument to perform aspecific chemical analysis and the REAGENTSTATUS screen displays information about eachreagent on board the analyzer.

Similar CRT screens are grouped into Job SelectionMenus. For example, screens used regularly duringroutine patient processing are grouped together in theROUTINE JOB MENU. To view the ROUTINE JOBMENU, press the ROUTINE key.

In some cases, an individual CRT screen may not be

listed in a Job Menu. The STAT screen is anexample. To view the STAT TEST SELECTIONscreen, press the STAT key.

1.2.3 Keyboard Description

The keyboard is used to call up CRT screens and toenter information. The keyboard is divided into fivefunctional parts:

• Analyzer Control Keys• Job Menu Selection Keys• Screen Navigation Keys• Data Entry Keys• Printer Control Keys

Figure 1-5 on page 1-9 shows the 911 keyboard layout.

1. INTRODUCTION

1.2 Control System

1.2 Control System1. INTRODUCTION

1 • 5

Figure 1-3: 911 Job Menu Keys

911 Job Menu Keys

1 • 6

NOTES

1. INTRODUCTION

1.2 Control System

1 • 7

1. INTRODUCTION

1.2 Control System

911 Software Flow Chart

Figure 1-4: Software Flowchart

12345678

Reagent StatusCalibration Test SelectionPatient Test SelectionStart ConditionsReal Time Data MonitorData ReviewRerun SamplesStatus Setting

Routine Job Menu

QC Job Menu

1234567

Real Time QCIndividual QC MonitorIndividual QC ListIndividual QC ChartCumulative QC MonitorCumulative QC ListCumulative QC Chart

Data Monitor Job Menu

12345

Parameter Job Menu

Reaction MonitorCalibration TraceCalibration ListISE Calibration MonitorWorking Curve

123456789

10

Chemistry ParametersProfilingCalculated TestsPrint OrderReport FormatControl Test SelectionControl Value SettingSpecial Wash ProgrammingSystem ParametersChannel Assignment

Maintenance Job Menu

Operation Monitor

STAT

1234

Analyzer MaintenanceMechanisms CheckSupport FunctionWorking Information

1STAT ReceptionSTAT Test Selection

1 • 8

1. INTRODUCTION

1.2 Control System

NOTES

1.2 Control System1. INTRODUCTION

1 • 9

Figure 1-5: 911 Keyboard Layout

911 Keyboard Layout1 Analyzer Control Keys:Start: Press this key to begin processingsamples.Sampling Stop: Press this key to stop sampling,but continue processing any samples alreadydispensed.Stop: Press this key to terminate sampleprocessing, maintenance, or test functions.

2 Job Menu Selection Keys:Press these keys to display the different jobmenus. These menus are shown in Figure 1-3.STATOperation MonitorRoutine JobQC JobData Monitor JobParameter JobMaintenance Job

3 Screen Navigation Keys:Guidance: Press this key to display the secondpage of certain screens.Page Continue: Press this key to display the restof a list of information contained on a screen.Page Back: Press this key to move to the previousscreen in the job menu.Page Forward: Press this key to move to the nextscreen in the job menu.

4 Cursor Control: Press these keys to move fromfield to field within a screen.

Data Entry Keys:5 Alpha: Use these keys to enter data and make

test selections.6 Numeric: Use these keys to enter numeric data

and make profile selections.7 Enter: Press this key to enter data that has been

typed into the computer.8 Cancel: Press this key to cancel data entry errors.

Printer Control Keys:9 Copy: Press this key to copy the CRT screen

display.

10 Buzzer Off Key:Press this key to silence the audible alarm. Pressthe key a second time to clear any alarmmessages listed on the OPERATION MONITORdisplay.

1 • 10

1. INTRODUCTION

1.2 Control System

NOTES

1 • 11

1. INTRODUCTION

1.2 Control System

1.2.4 Analyzer Control Keys

The analyzer control keys enable you to start and stopthe analyzer.

Start Key

Press START to place the instrument into theOperate mode. Always check operating conditionson the START CONDITIONS screen before pressingSTART. The green light above the START keyilluminates when the key is pressed.

Sampling Stop Key

Press SAMPLING STOP to instruct the instrument tostop sampling at the end of the current instrumentsampling cycle. When this key is pressed, only thesampling function stops. All other functions related toprocessing tests continue until results print out. TheSAMPLING STOP key is used during somemaintenance functions to move various mechanicalcomponents to different positions. When theinstrument is in the S. Stop mode, the yellow lightabove the SAMPLING STOP key is illuminated.

Stop Key

The STOP key performs four functions:

• stops all test processing functions at the end of thecurrent mechanical cycle

• ends test program functions• terminates batch transfer of results to the host

computer from the DATA REVIEW screen

• terminates probe adjustments from theMECHANISMS CHECK screen.

When the STOP key is pressed, the red light above theSTOP key is illuminated.

1.2.5 Job Menu Selection Keys

Job menu selection keys enable you to view each jobmenu. The keys are marked with job-specific iconsand the key name is written on the keyboard directlyabove the key.

STAT Key

Press the STAT key to display the STAT TESTSELECTION screen. This screen is used for enteringStat sample information. The STAT TESTSELECTION screen can be accessed from anyoperational mode.

Operation Monitor Key

Press the OPERATION MONITOR key to display theOPERATION MONITOR screen. No entries are madefrom this screen. It is used to monitor the followinginformation:

• analyzer status• mode selected for routine and stat reruns• print mode selected• host communication status• incubator bath temperature• sample number and ID number of specimen

currently being sampled

START STOPSAMPLINGSTOP

1 • 12

• sampling status of specimens on sample disk• alarm status.

Routine Job Menu Key

Press the ROUTINE key to display the ROUTINE JOBMENU screen. The ROUTINE JOB MENU allows youto select screens to:

• verify remaining reagent volumes, expiration dates,and position on disk

• request patient test selection• view calibration time-out status and program

calibrations• request rerun sample test selection• specify analyzer starting conditions prior to

sample processing• execute sleep mode, automatic wake-up time, and

Stat Reception mode.

QC Job Menu Key

Press the QC key to display the QC JOB MENU. TheQC JOB MENU allows you to select screens thatshow:

• control data evaluated with operator-defined multi-rule Shewhart analysis

• daily QC data for a specified control performed fora specified test

• daily QC data listed for a specified control• daily QC data graphed for a specified controlon a

specified test• cumulative QC data for a specified control

performed for a specified test• cumulative QC data listed for a specified control• cumulative QC data graphed for a specified control

on a specified test• edit control files.

Data Monitor Job Menu Key

Press the MONITOR key to display the DATAMONITOR JOB MENU. The DATA MONITOR JOBMENU enables you to select screens to:

• view absorbance changes vs. time for recentreactions

• edit patient files• view calibration data for photometric chemistries• view calibration curves for multipoint linear and

photometric non-linear chemistries and ISEs• monitor the 30 most recent calibrations for each

test• view ISE calibration data.

Parameter Job Menu Key

Press the PARAM. key to display the PARAMETERJOB MENU. The PARAMETER JOB MENU enablesyou to select screens to:

• manually define test names• manually assign photometric and ISE test

parameters• manually assign short test names• define testing profiles• define calculated and compensated test

parameters• define result print orders• customize patient report formats• program probe and cell wash functions• read the Parameter disk into memory and assign

chemistries to test keys• request control test selections• define control value settings• program analyzer default settings.

1. INTRODUCTION

1.2 Control System

1 • 13

Maintenance Job Menu Key

Press the MAINTE. key to display theMAINTENANCE JOB MENU. The MAINTENANCEJOB MENU enables you to select screens to:

• perform various maintenance functions as listed onthe menu

• copy or format floppy disks• perform precision checks of the instrument• diagnose mechanical malfunctions• perform correlation analysis.

1.2.6 Screen Navigation Keys

Screen Navigation keys are used to move between jobmenu screens, change pages within a screen, getadditional information within a screen, and move thecursor from field to field.

Guidance Key

Press GUIDANCE to display the second page ofinformation for a particular screen such as REAGENTSTATUS or CHEMISTRY PARAMETERS. The lightabove the GUIDANCE key illuminates whenadditional information may be displayed. In addition,the guidance icon ( )appears in the upper right-hand corner of the CRT when the Guidance key isactive.

Page Continue Key

The PAGE CONTINUE key is used to scroll through alist of information too large to be displayed on onescreen. Some examples include CALIBRATIONTEST SELECTION and RERUN SAMPLES. The lightabove the PAGE CONTINUE key illuminates whenadditional information may be displayed. In addition,the page continue icon ( )appears in the upper right-hand corner of the CRT when the PAGE CONTINUEkey is active.

When the SHIFT key is pressed along with PAGECONTINUE, the cap locks light illuminates. This takesyou to the end of the list. Pressing PAGE CONTINUEwhile the cap locks light is on scrolls you through thelist from end to beginning. The page continue icon ( )appears as a double arrow when this feature isavailable for a screen.

Page Forward and Page Back Keys

Press the PAGE FORWARD key to:

• move to the next CRT screen within a job

For example, after checking the reagent volumeson REAGENT STATUS, press the PAGEFORWARD key to enter patient test selections onthe PATIENT TEST SELECTION screen.

• select the first screen from a job menu.

For example, press PAGE FORWARD to selectthe REAGENT STATUS screen from the ROUTINEJOB MENU.

1. INTRODUCTION

1.2 Control System

1 • 14

Press the PAGE BACK key to:

• go back to the previous CRT screen within a job

For example, press PAGE BACK to return to theREAGENT STATUS screen from theCALIBRATION TEST SELECTION screen.

• select the last screen from a job menu.

For example, press PAGE BACK to displaySTART CONDITIONS from the ROUTINE JOBMENU.

Cursor Control Keys

The Cursor Control keys are used to move the cursorfrom one entry field to another within a screen. TheCursor Control keys can move the cursor to the rightand left or up and down.

1.2.7 Data Entry Keys

The alphabet and number keys are the primary dataentry keys. They enable you to enter data into entryfields.

Alphabet Keypad

The alphabet keypad has two different functions:entering alpha characters and programming tests bytest key.

Press the appropriate alphabet keys to enter data.The alphabet keys enter lowercase letters when usedalone. When the SHIFT key is pressed, these keysenter uppercase letters. The CAPS LOCK lightilluminates when SHIFT is pressed.

The alphabet keys have a test key number printed onthe front edge of each key. This number correspondsto the test key assignment made on the CHANNELASSIGNMENT screen for a specific test.

When tests are selected for a patient sample on thePATIENT TEST SELECTION screen, the numberedalphabet key corresponding to the desired test ispressed. The selected test is highlighted on thekeyboard matrix that appears on the lower portion ofthe PATIENT TEST SELECTION screen. Pressing thenumbered alphabet key a second time deselects thetest, and removes the appropriate highlightingfrom the keyboard matrix.

Press the BACKSPACE key to delete entries from afield, character by character.

Number Keypad

The number keypad has two different functions:entering numerical data and selecting test profiles.

The number keys allow you to enter numerical data, aswell as mathematical operators and decimals. TheSHIFT key has no affect on the number keys.

The number keys have a letter printed on the front edgeof each key. This letter corresponds to a test profileassigned on the PROFILING SCREEN.

1. INTRODUCTION

1.2 Control System

1 • 15

When a profile is selected for a patient sample on thePATIENT TEST SELECTION screen, the number keycorresponding to the desired profile is pressed. Theselected profile test are highlighted on the keyboardmatrix that appears on the lower portion of thePATIENT TEST SELECTION screen. Pressing thenumber key a second time deselects the profile testsand removes the highlighting from the keyboardmatrix.

Enter Key

Pressing either ENTER key indicates the end of yourdata entry, and registers the data with the control unitand analytical unit for calculations or operations.

Cancel Key

When unacceptable information has been entered, anerror prompt is issued at the bottom of the CRT screen.No other entry may be performed until the CANCELkey is pressed to clear the input error.

The CANCEL key is used to clear one of three typesof input errors:

• when incorrect information has been typed, but theENTER key has not yet been pressed, theCANCEL key deletes the current entry.

• when incorrect information has been typed, and theENTER key has been pressed, the CANCEL keyclears the error prompt and moves the cursor backto the previous entry field.

• when correct information has been typed, theENTER key has been pressed, but the requestedtask cannot be performed until the analyzer is in

Stand-by mode, the CANCEL key clears the errorprompt.

If incorrect information is entered and accepted, it canbe corrected by moving the cursor back to thespecified field and entering the correct information.The following input mesage alarms will appearthroughout the software to explain why an entry is notaccepted:

• Stand-by Status Required for Entry• Data Entered is not in Specified Limit• Input Error• Password Required for Data Entry:Enter

Password• Data Processing• Calculation in Process

1.2.8 Printer Control Key

The printer control key is used to print hard copyversions of CRT screens.

Copy Key

Press COPY to print a copy of the display currentlyshown on the CRT.

1. INTRODUCTION

1.2 Control System

ENTER

C

1 • 16

1.2.9 Buz. Off Key

Buz. Off Key (Buzzer Off)

1 An audible alarm sounds to alert you of the alarmcondition. Press BUZ. OFF once to silence theaudible alarm.

2 Press the BUZZER OFF key twice to clearinstrument alarms from the OPERATIONMONITOR screen.

1.2.10 Central Processing Unit

The central processing unit (CPU) monitors allanalyzer functions and operation modes, calculatesresults from raw absorbance data, and storesinformation. Two floppy disk drives are used.Generally, drive 1 is used for system program andparameter storage, drive 2 for data storage. The CPUis located in the analytical unit.

1.2.11 Floppy Disks

The system disk contains all necessary programminginformation for the instrument to function as achemistry analyzer. When the instrument ON/OFFswitch is turned ON, all instrument operatingparameters are automatically read from the systemdisk into computer memory.

The data disk records test results for a maximum of800 routine samples, 800 routine rerun samples, and200 stat rerun samples. When this disk becomes full,it can be removed from the instrument and saved tomaintain a record of test results. If this type of recordis not desired, the disk can be cleared of all data andreused.

The application disk contains the chemistryparameter information for each Boehringer Mannheimreagent. This information is read into instrumentmemory and then written onto the system disk. Theparameter disk eliminates the need formanual entry of chemistry parameters.

1.2.12 Printer

The instrument uses an 80-column, graphics-capable,dot matrix printer. Patient results can be printed in 8-1/2 × 11 inch report format or short format, which usesless paper.

1.2.13 Host Interface

The instrument can be bidirectionally interfaced with ahost computer.

1. INTRODUCTION

1.2 Control System

1 • 17

1.2.14 Data Storage

The table below outlines where different types of dataare stored in the 911 system.

1. INTRODUCTION

1.2 Control System

DATA STORAGE

Information Storage Location

Tests ResultsRoutineStat

(800 samples)(200 samples)

Data DiskData Disk

Test Selection C-RAM

Individual QC C-RAM

Cumulative QC C-RAM

Reaction Monitor

Routine/STATCalibrationQC

(360 tests)(80 tests)(80 tests)

RAMRAMRAM

Alarms C-RAM

Host Communication C-RAM

Calibration Results System Disk

Chemistry Parameters System Disk

Calibration Trace C-RAM

Cell Blank Results C-RAM

Passwords C-RAM

1 • 18

1.3 Sampling System

1.3.1 Introduction

The Sampling System consists of a sample disk,sample pipettor, sample probe, and a sampleprobe rinse station. The sample probe is mountedon a robotic sample probe arm that moves the probefrom its home position to its aspirate and dispensepositions. Each of these components is explained indetail in the following sections.

1.3.2 Sample Disk

The sample disk (shown in Figure 1-6) sits on a motor-driven turntable. Three concentric rings of samplepositions are arranged as follows:

Outer Ring: 50 positions for ROUTINE samplesand barcoded Stats

Middle Ring: 3 positions for WASH solution(W1-W3)20 positions for STAT samples(E51-E71)17 positions for room temperatureCALIBRATORS (S1-S17)

Inner Ring: 17 positions for refrigeratedCALIBRATORS (S18-S34)8 positions for refrigeratedCONTROLS (C1-C8)

The middle and outer rings form the outer portion of thesample disk and are removable. The inner ring isseated in a refrigerated compartment. This ring iscovered to ensure the refrigerated compartmenttemperature is maintained. The inner ring can also beremoved. Blank, calibrator, and control materials areplaced in dedicated positions on the inner disk rings.

1. INTRODUCTION

1.3 Sampling System

Routine and stat patient samples are placed inpositions on the middle and outer rings as definedwhen making test selections.

The sample disk rotates to bring the desired samplecup into position next to the sample probe (thesampling station) for specimen sampling.

Figure 1-6: Sample Disk

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

S30S29

S28

S27

S26

S25

S24

S23

S22

S21

S20S19 S18

C8

C7

C6

C5

C4

C3

C2

C1

S34

S 33

S 32S31

E65

S15

E64

S14

E63

S13

E62

S12

E

61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E

51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

1 • 19

1.3.3 Sample Probe

The sample probe (shown in Photograph 1-1) carriessample from the sample disk to a reaction cell or ISEdilution vessel. The sample probe is mounted on thesample probe arm and also acts as the liquid-levelsensor. Sensing the level of the liquid reducesexposure of the outer probe walls to specimen andalso alerts you to insufficient sample volumes. This,along with the internal and external probe wash,minimizes any chance of cross contaminationbetween samples.

1.3.4 Sample Probe Arm

The motor-driven sample probe arm moves thesample probe from its home position to the aspirationposition at the sample disk, and then lowers the probeinto the sample. Once the sample probe detectssample via liquid level detection (capacitance),the sample probe arm stops, and sample is aspirated.

After sample has been aspirated, the probe is movedto the reaction disk or the ISE dilution vessel. Thesample probe arm lowers the probe into the reactioncell or ISE dilution vessel at the sample dispenseposition. Sample is dispensed while the beveledsample probe tip is in contact with the bottom of thereaction cell or dilution vessel. This ensures that aprecise volume of sample is deposited into the bottomof the cell or dilution vessel even when using a lowdispense volume. The sample probe is spring-mounted on the arm to avoid damage to the probe,reaction cell, or dilution vessel.

Photograph 1-1: Sample Probe

1. INTRODUCTION

1.3 Sampling System

1 • 20

1.3.5 Sample Pipettor

The sample pipettor, shown in Photograph 1-2, is apositive-displacement pipettor, positioned behind theleft front cover of the instrument. The pipettor, and theplastic tubing that connects it to the sample probe,are filled with degassed, deionized water.

The pipettor motor retracts the plunger within thechamber of the pipettor, and sample is aspirated intothe tip of the sample probe.

1.3.6 Sample Probe Rinse Station

The sample probe rinse station is located between thesample disk and reaction disk. When sampling iscompleted for a particular sample, the sample probearm moves back into position above the rinse station.Water is flushed inside the probe and onto the outersurface of the probe tip before aspirating the nextsample. This rinse removes excess sample adheringto the inside or outside of the probe.

1.3.7 Sampling System Flowpath

Figure 1-7 diagrams the sampling system flowpath.

Figure 1-7: Sampling System Flowpath Diagram

Photograph 1-2: Sample Pipettor

1. INTRODUCTION

1.3 Sampling System

DI water tank

Pump

Degasser

Filter

Solenoidvalve

Sample syringe

Sample

Sample probe(also serving as liquidlevel sensor)

S.V

1 • 21

1.3.8 Sample Container Sizes

The table below lists the various size samplecontainers that can be used on the 911 system. Thedifferent tube sizes can be used in the same run.Sample and micro cups can be used in the same run.

• Standard 2.0 mL Hitachi Sample Cup• Micro 1.5 mL Hitachi Sample Cup• Standard 2.0 mL Hitachi Sample Cup on Primary

Sample Tube• Micro Hitachi Sample Cup on Primary Sample

Tube• 16 mm x 100 mm Primary Sample Tube• 13 mm x 100 mm Primary Sample Tube• 16 mm x 75 mm Primary Sample Tube• 13 mm x 75 mm Primary Sample Tube

1. INTRODUCTION

1.3 Sampling System

1 • 22

1.4 Reagent System

1.4.1 Introduction

The Reagent System consists of two reagent disks,two reagent pipettors that aspirate reagent intocorresponding reagent probes, and two reagentprobe rinse stations.

1.4.2 Reagent Disks

Reagent containers are stored on the instrument intwo identical reagent disks, labelled R1 and R2. Asshown in Figure 1-8, each reagent disk contains 33positions. Position 33 on each disk is used for thereaction bath detergent, Hitergent. This allows for 32reagents on each disk. The reagent compartmentsare refrigerated.

Each reagent disk has a locking cover that helpsprevent evaporation of reagents. A cutaway section ineach cover allows the reagent probe access toaspirate reagent.

When the instrument is ready to add reagent to areaction cell, the appropriate reagent disk rotates,bringing the required reagent container into position atthe reagent aspiration station.

Figure 1-8: Reagent Disk

1. INTRODUCTION

1.4 Reagent System

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

1 • 23

1.4.3 Reagent Probes

The reagent probes (R1 and R2) carry reagent from thereagent disks to the reaction cells. The reagentprobes are mounted to reagent probe arms. Thereagent probes also act as liquid level sensors,signaling the computer when the reagent probe tip isimmersed in reagent (or if no reagent is present). Thesecond reagent probe is used to add additionalreagent to the reaction cell at various dispense times,depending on the reaction.

1.4.4 Reagent Probe Arms

The reagent probes are mounted on motor-drivenreagent probe arms. After the reagent container is inposition at the reagent aspiration station, the reagentprobe arm moves the reagent probe from its homeposition to the reagent disk and lowers the probe intothe reagent container. After the reagent probe detectsreagent, the instrument stops lowering the probe, andreagent is aspirated.

After reagent has been aspirated, the probe movesfrom the reagent container to the reaction disk, wherereagent is dispensed into a reaction cell containingpatient sample. Unlike the sample probe, the reagentprobes are not lowered into the reaction cell. Reagentis dispensed from the top of the reaction cell.

Photograph 1-3: Reagent Probes

Photograph 1-4: Reagent Needles

1. INTRODUCTION

1.4 Reagent System

1 • 24

1.4.5 Reagent Pipettors

The reagent pipettors (shown in Photograph 1-5) arepositive-displacement pipettors, positioned behindthe left front cover of the instrument. The pipettors, andthe plastic tubing connecting them to the reagentprobes, are filled with degassed, deionized water.

When the reagent probe tips are immersed in reagent,the reagent pipettor motors retract the plungers withinthe chamber of the pipettors,and reagent is aspirated into the reagent probes.

After the reagent probes are in position above thereaction disk, the pipettor motors are reversed, andreagent is dispensed into the reaction cell. Followingreagent dispense, the reagent probes are moved to thereagent probe rinse stations.

1.4.6 Reagent Probe Rinse Stations

Reagent probe rinse stations are located between thereaction disk and the reagent disks. After eachreagent dispense, water is flushed through the probesand onto their outside surfaces.

1.4.7 Stirring Units

The stirring units (shown in Photograph 1-6) consistof two slender stirring paddles, the motors that spinthe paddles, and the motor that moves the stirringpaddles to and from the reaction disk.

Following the addition of each reagent to a reactioncell, the reaction disk pauses with that reaction cell inposition next to the stirring units. The stirring unitsmove from their home position to the reaction disk,and the stirring paddles are lowered into the reactioncells. After the paddles are fully lowered into the cells,the stirring motors are briefly activated to mix thecontents of the reaction cells. The stirring units thenare lifted from the reaction cells, and returned to theiroriginal positions where they are thoroughly rinsedwith deionized water.

Photograph 1-5: Reagent Pipettors

Photograph 1-6: Stirring Units

1. INTRODUCTION

1.4 Reagent System

1 • 25

1.4.8 Reagent Flowpath

Figure 1-9 diagrams the reagent system flowpath.

Figure 1-9: Reagent System Flowpath Diagram

1. INTRODUCTION

1.4 Reagent System

DI water tank

Pump

Degasser

Filter

Solenoidvalve

Reagent pipetting syringe

Sample probe(also serving as liquidlevel sensor)

S.V

Reagent bottle

1 • 26

1.5 Photometric MeasuringSystem

1.5.1 Introduction

All photometric tests are measured by thephotometer. The photometer is located adjacent tothe reaction disk. The photometric measuringsystem detects color or turbidity change produced bychemical reactions between reagents and the analyteof interest in the sample while in the reaction cells.The photometric measuring system is capable ofbichromatic photometry of endpoint, kinetic,ultraviolet, and visible light chemistry determinations.

Figure 1-10: Photometric Measuring System

1 Sample Probe2 Reagent Probes3 Stirring Units

1.5.2 Reaction Disk

The reaction disk is a large rotatable disk holding 120reusable plastic reaction cells (cuvettes) uprightaround the outside perimeter of the disk. These cellsare immersed in an incubated reaction bath. Thismaintains the cells at 37 °C, an optimal temperaturefor the chemical reactions occurring in the cells. Thereaction disk rotates to transport the cells to allreaction processing stations including the photometerlightpath.

The components listed below in Figure 1-10 arepositioned around the reaction disk and are necessaryfor photometric reaction processing:

4 Photometer5 Cell Rinse Unit

1. INTRODUCTION

1.5 Photometric Measuring System

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂

➂

➄

➃

➁

➁

➀

1 • 27

1.5.3 Reaction Bath

The circular reaction bath, positioned beneath thereaction disk, maintains the reaction mixtures in thereaction cells at a temperature of 37 °C. Water in thereaction bath is circulated by a pump through arefrigeration unit and heater where it is cooled orheated, as necessary, to maintain temperature (± 0.1°C). The DI water storage tank contains water that isheated to the temperature of the reaction bath. Thisensures a consistent supply of heated water for therinsing processes.

Two glass windows (inner and outer) are positioned inopposite walls of the incubation bath. These windowspermit light from the photometer lamp to pass throughthe reaction bath water, and through the reaction cellsin the bath. The light beam emerges from the outerwindow of the reaction bath and enters the instrumentphotometer.

Figure 1-11: Reaction Bath

A liquid level sensor detects the water level of the bath.Deionized water is automatically added to the reactionbath, as determined by the liquid level sensor, tocompensate for evaporation. This occurs even inStand-by. In addition, the entire incubation bath watervolume is automatically replaced with fresh deionizedwater each time the instrument is powered up andduring Wake-UpTM.

Figure 1-11 shows a cutaway view of the reaction bathunit:

1. INTRODUCTION


Photometer

Cooling Unit

Pump

SolenoidValve

Cooling Tube

Windows

Reaction Cells

Reaction Disk

Reaction Bath

Lamp

Heater

1 • 28

1.5.4 Hitergent

Hitergent is a non-ionic, bacteriostatic detergentautomatically added to the reaction bath by thereagent probes whenever the water is exchanged. Itacts as a surfactant to minimize the formation ofbubbles that could potentially interfere with thephotometer readings.

1.5.5 Photometer

The photometer is positioned so that absorbancereadings of each reaction cell are taken as the reactiondisk is turning. This arrangement enables theinstrument to read the absorbance of each reactioncell as frequently as once every 20 seconds.

The photometer lamp is positioned beneath the centerof the reaction disk, within the ring of the reactionbath, as shown in Photograph 1-7. The lamp isencased in a constant-temperature water jacket ,which helps to maintain a constant energy output fromthe lamp, and also extends the lamp life.

After the reaction mixture is stirred and incubated, theabsorbance of the reaction mixture is measured bythe photometer, and the results are calculated fromthose readings. Photograph 1-7: Photometer Position

1. INTRODUCTION


1 • 29

Instrument parameter information for each assay isprogrammed into the instrument computer. Thecomputer uses the parameter informationprogrammed to select the wavelengths and the timesat which a reaction mixture�s absorbance is read andto calculate results.

The instrument computer keeps track of which test isbeing performed in each reaction cell. It also knowswhen each reaction cell passes through thephotometer light path. The computer uses thistracking ability and the programmed read instructionsto obtain test results.

1. INTRODUCTION


Boehringer Mannheim/Hitachi Photometric System

The light from the photometer lamp passes through thefollowing structures in sequence:

1) Inner reaction bath window2) Reaction bath water3) Reaction cell and its contents4) Reaction bath water5) Outer reaction bath window6) Photometer.

When the light beam enters the photometer, it strikesa diffraction grating. This separates the light into itsconstituent wavelengths, and reflects them onto afixed array of 12 photodetectors. Each photodetectoris permanently positioned to detect light at a differentwavelength. Figure 1-12 shows a cutaway of thephotometer light path.

Figure 1-12: Photomer Light Path

The above system has no moving parts; thus,accuracy and precision are improved.

MonochromaticWavelenghts

of Light

Cuvette

LensLens

Polychromatic Light

PhotometerLamp

(Water cooled -increases

stability and life)

Polychromatic Light

Less Percentage

AbsorbedDiffraction

Grating

Array ofPhotodetectors

(3 of 12 for clarity)

Wavelengthsfocused onto

seperatephotodetectors.

Ability to measuresimultaneously

at severalwavelenghts.

(e.g. Bichromatics)

1 • 30

1.6 Cell Rinse System

1.6.1 Cell Rinse Unit

As shown in Photograph 1-8, the reaction cell rinseunit consists of a series of nozzles mounted above oneside of the reaction disk. The nozzles are connectedto vacuum lines and deionized water supply lines. Thereaction cell rinse unit performs the followingfunctions:

• removes reaction mixture waste from reaction cells• rinses reaction cells with Multiclean• rinses reaction cells with DI water• aspirates rinse water from reaction cells• dispenses deionized water into reaction cells for

photometric cell blanking• aspirates water from reaction cells after

photometric cell blanking• dries inside walls of reaction cells prior to sample

dispense.

These functions occur as part of the instrument’sroutine operation. Each reaction cell is thoroughlycleaned after final absorbance measurement of areaction mixture. The reaction cell integrity ischecked prior to reusing the cell for additional patientsamples.

1.6.2 Water Supply

The reaction cell rinse unit, shown in Photograph1-8, uses the deionized water supply and the internalvacuum system. The deionized water supply systemconsists of the deionized water reservoir, located inthe rear of the analyzer, and a series of pumps andelectronic valves. Water is supplied to the reaction cellrinse unit directly from the deionized water reservoir.Water is automatically added to the reservoir whennecessary.

Water from this source is also supplied to the probeand stirring unit rinse baths and to the reaction bath.

Photograph 1-8: Cell Rinse Unit

1.6.3 Vaccum System

The vacuum system consists of a vacuum pump,vacuum reservoir, and sample waste container. Thevacuum system is used by the reaction cell rinse unitto aspirate reaction mixture waste and reaction cellrinse water. Reaction mixture waste drains into thereaction waste container. Reaction cell rinse water isremoved from the instrument through the main drainline. The vacuum system is located in the rear of theanalyzer and should be accessed only by yourBoehringer Mannheim representative.

1. INTRODUCTION

1.6 Cell Rinse System

1 • 31

1.7 ISE System

1.7.1 Introduction

Figure 1-13: ISE Flowpath

1. INTRODUCTION

1.7 ISE System

DilutionVessel

SIPSyringe

ISSyringe

DILSyringe

Drain

Drain

Sipper

Degasser

RefK Na Cl

PinchValve

LS2 LS1

IS(600 mL)

DIL(300 mL)

REF(300 mL)

Pre

heat

er (

IS)

Pre

heat

er (

DIL

)

Pre

heat

er (

RE

F)

Vacuum

37 °C WaterForPreheat

ISE Unit

➊

➐

➍ ➌ ➋

➎ ➏

➑

1 • 32

The ISE (Ion Selective Electrode) System providesthe instrument with an electronic method for assayingsodium, potassium, and chloride samples. As shownin Figure 1-13, the ISE unit consists of: a sampledilution vessel positioned above and to the left of thesample disk (1); three pipettors (diluent dispense (2)),internal reference dispense (3), and sipper (4); atemperature controlled measuring assembly (threemeasuring cartridges (5), and a reference cartridge(6)); a vacuum system (to remove waste) (7); and adegasser for KCl reagent and diluent (8). ISE reagentsare stored on top of the analyzer, to the rear of thereaction disk.

1.7.2 ISE Calibration

Electrolyte calibration is based on a 3-pointmeasurement. This establishes that an acceptableslope is generated when known samples (aqueousstandards) are analyzed with a serum-basedcalibrator to compensate for aqueous-protein matrixdifferences.

1.7.3 ISE Sample Aspiration

When electrolytes are requested, sample (15 µL) isaspirated by the sample probe, and the probe movesto the ISE dilution vessel.

1.7.4 Sample Dispense and Dilution

Sample is dispensed, then ISE diluent (450 µL) ispipetted into the ISE dilution vessel. The ISE unitdilutes the sample 1:31. The diluted sample flowsthrough the K+, Na+, and Cl- cartridges and stops sothat an electrical voltage can be measured. Thediluted sample is transported through the ISEmeasuring cartridges by the "sipper" syringe orpipettor.

1.7.5 ISE Measurement Flowpath

The diluted sample stops inside the three (sodium,potassium, and chloride) measuring cartridges. Afterequilibration, the electrical potential in the cartridgesis measured. This potential is compared to thepotential generated in a reference cartridge and thesignals are sent to a computer for calculation andconversion to the result units indicative of the amountof electrolyte in the sample. After measurement, thediluted sample is drawn from the cartridges throughthe sipper syringe to the waste container.

1.7.6 Rinse

After the residual sample is aspirated through thevacuum nozzle, the inside of the dilution vessel isrinsed with the internal reference solution.

1.7.7 Internal Reference Solution

Before each sample measurement, the internalreference solution is aspirated into the measurementflowpath and a single-point calibration is performed. Ifthis calibration does not compare to the previouscalibration within certain specifications, an alarm isissued.

1. INTRODUCTION

1.7 ISE System

1 • 33

1.8 Operational Modes

1.8.1 Introduction

While the instrument is ON, it is in one of severaloperational states, or modes. The current operationalmode appears at the upper left corner of the CRT, andit reflects instrument activity. It is important toconsider the operational mode of the instrumentbecause certain functions may only be performedwhile the instrument is in a specific mode. Forexample, while the instrument is in the Operate mode,maintenance functions cannot be requested.

An overview of the functions occurring in each mode isprovided in the following sections.

1.8.2 Initialization

The Initialization mode begins when the instrument ispowered ON. During this period, system parameterinformation is automatically read into computermemory from the System disk, and variousmechanisms are synchronized and readied to performfunctions as instructed by the operator. DuringInitialization:

• incubation bath water is exchanged• Hitergent is added to the bath• an air purge is performed• reagent registration takes place.

Computer-directed functions cannot be requestedduring the Initialization mode.

When instrument parameters have been read intoinstrument memory, the prompt JOB STATUS KEY?appears on the CRT display, the instrumentcompletes the initialization process and enters theStand-by mode.

1.8.3 Stand-by

Stand-by is defined as a waiting mode; the instrumentis ready to perform functions, as requested. This is theusual mode of the instrument, when not in Operate.

1.8.4 Parameter Check

Parameter Check is a momentary state which occurswhen the START key is pressed to place theinstrument into Operate. During this time, theinstrument computer checks internal parameters toensure that no abnormal conditions exist.

1.8.5 Reset

Immediately following Parameter Check, theinstrument enters Reset, during which it resets allmechanisms to verify proper alignment andsynchronization prior to entering Operate. This stateis transitional and lasts less than one minute.

1.8.6 Operate

The Operate mode the state during which theinstrument processes samples. This includes thetime after the instrument has passed throughParameter Check and Reset, when the instrument ispreparing reaction cells for sample dispense. After theinstrument has sampled and dispensed all specimensprogrammed by the operator, it automatically leavesthe Operate mode and enters the Sampling Stopmode.

1. INTRODUCTION


1 • 34

1.8.7 Sampling Stop

Sampling Stop is the time period after the instrumenthas sampled and dispensed all specimensprogrammed, and before all reaction processing iscompleted. When the instrument enters this mode, aNO MORE SAMPLES TO PROCESS alarm is issued.You may instruct the instrument to enter this state bypressing the SAMPLING STOP key. This can bedone to stop sampling without terminating the reactionprocessing already in progress.

The Sampling Stop mode is terminated after all resultshave been printed and all reaction cells have beencleaned by the cell rinse unit. At that time, theinstrument enters the Probe Wash mode.

1.8.8 Probe Wash

While the analyzer is performing the probe washfollowing the end of a run, the status line displaysProbe Wash. The analyzer goes immediately to theStop mode after the probe wash is completed.

1.8.9 Stop

When the instrument completes all sampleprocessing and cell cleaning, it enters the Stop mode.This mode is transitional, and remains in effect forless than one minute. Following the Stop mode, theinstrument enters Stand-by.

1.8.10 Sleep

The instrument is put in the Sleep mode from theSTATUS SETTING screen. This mode is similar topower OFF—except that the CPU remains on.

1.8.11 Wake Up

When the time programmed from the STATUSSETTING screen for the instrument to resume dailyactivities or "wake up" arrives, the instrument entersthe Wake Up mode. In this mode the instrumentperforms the same functions as during Initialization(except program loading from the system disk) andthen enters Stand-by.

1.8.12 Stat Stand-by

When the Stat Reception Mode is requested from theSTATUS SETTING screen, the analyzer prepares 12pre-blanked reaction cells so that they are ready forimmediate use. The analyzer automatically updatesthe ISE calibration by running the internal standardonce every 10 minutes. In this way the analyzer canprocess stat samples without the time delayassociated with the reset that occurs prior to routinesample processing. After Stat Reception has beenrequested, the analyzer remains in the Stat Stand-bymode until a stat sample run is initiated. The analyzerthen returns to Stat Stand-by when the stat samplerun is completed. The analyzer remains in StatStand-by until Stat Reception is cancelled, it isplaced in the Sleep mode, or is powered OFF.

1.8.13 Stat Operation

The analyzer enters this mode after a stat sample isrequested from the Stat Stand-by mode. Whenprocessing is complete, the analyzer returns to theStat Stand-by mode.

1.8.14 Check

This mode indicates that a maintenance function isbeing performed.

1. INTRODUCTION


1 • 35

1.9 Operational Flow

1.9.1 Daily Check

The Daily Check entails procedures performed beforeapplying power to the instrument. If the instrument isused 24 hours a day, these procedures should beperformed once every day, preferably before the bulkof daily processing.

• Has bath exchange been performed?• Is the water supply on (from external supply)?• Is the Hitergent supply sufficient?• Is the Multiclean supply sufficient?• Are the system and data disks in drives?• Is paper supply adequate?• Is sample waste container empty?

1.9.2 Power Up/Start Up

• If not already ON, place on/off switch in "on"position

• Check the REAGENT STATUS screen forsufficient reagent volume and outdated reagents

• Perform data clear (if desired)• Perform patient test selection clear (if desired)

1.9.3 Calibrators and Controls

• Print calibration load list• Select additional tests to be calibrated, if desired• Select additional controls, if desired (Note:

controls are automatically performed followingcalibration)

• Load calibrators and controls on sample disk• Load System Cleaning Solution in "W1" and "W2"

positions on sample disk

1.9.4 Patient Test Selection

• Select tests if they are not downloaded from a hostcomputer

• Load patient samples onto sample disk

1.9.5 Start Conditions Screen

• Specify start sample number• Request Start-up calibration, if desired• Verify operating conditions in remaining fields

1.9.6 Begin Operation

• OPERATION MONITOR screen: no alarmmessages

• Press START key

1.9.7 Results

• Results are test dependent due to variableincubation times and available when completed byviewing the REAL TIME DATA MONITOR screen.

• Results are printed and transferred to host when alltests for that sample are completed.

1.9.8 Additional Runs

• Samples may be added anytime during the run.• Additional runs may be performed, as necessary.

1. INTRODUCTION


1 • 36

1.9.9 Daily Maintenance

Daily maintenance should be performed once every24 hours. For procedural instructions, refer toChapter 3, Maintenance.

1. INTRODUCTION


1 • 37

1.10 Instrument Specifications

1.10.1 Introduction

The following specifications apply to the BoehringerMannheim/Hitachi 911 Analyzer.

1.10.2 Dimensions

1.10.3 Electrical

100/115/127/220/230/240 V AC ± 10%, 50/60 HzPower Consumption: 2kVA max. (actual: 1,9 kVA)Heat Generated: 6700 Btu/hour; 1670 Kcal/hRush Current: 420 A for 10 msec max.Leakage Current: 0,5 mA max. (actual: 0,06 mA)

1.10.4 Interface

ASCII, serial, asynchronous, EIA/RS 232Ccompatible, bidirectional (standard)

1.10.5 Test Modes

MonochromaticBichromaticEndpointEndpoint with sample blankingKineticKinetic with sample blankingSimultaneous endpoint and kineticSimultaneous double endpoint and double kinetic

1.10.6 Control System

Central Processing Unit (CPU):68A09 8 Bit Microprocessor

Floppy Disk:3.5 inchDrive 1 (bottom): System ProgramDrive 2 (top): Data Storage, Application disk

1.10.7 ISE System

Sample volume:15 µL

Throughput:180 samples/hour (ISE only)

Measurement range (Serum):Sodium: 80 - 180 mmol/LPotassium: 1.5 - 10.0 mmol/LChloride: 60 - 140 mmol/L

1. INTRODUCTION


Analyzer Unit Control Unit

Weight 310 kg 50 kg

Width 102 cm 48 cm

Depth 77 cm 65 cm

Height 117 cm 126 cm

1 • 38

1.10.8 Sampling System

Sample volume per test:3 to 50 µL (2 to 50 µL with predilution)

Sampling rate:Once every 10 seconds for photometric chemistries;once every 20 seconds for ISEs

Throughput rate:Tests/hour- photometric 360- ISEs included 720

Bar Code Reader Formats:Codabar, Interleaf 2 of 5, Code 39, Code 128

1.10.9 Reagent System

Total reaction volume/test:250 to 500 µL

Reagent dispense volume:25 to 350 µL per reagent (in 1 µL increments)

Reagent storage:Two compartments (12 °C or less) 32 positions each,for reagent. Each reagent compartment has anadditional position #33 for Hitergent.

1.10.10 Measuring System(photometric)

Light source:Tungsten-halogen lamp

Detector:Gradient photometer with discrete photodiodes infixed array

Wavelengths: 12 fixed; 340 ± 2 nm, 376, 415, 450,

480, 505, 546, 570, 600, 660, 700, and 800 nm ±5 nmLightpath:0.6 cm ±0.02 cm

Photometric linearity:2.500 absorbance at all wavelengths

1.10.11 Miscellaneous

Water Requirement:20 - 30 liters of bacteria-free water per hour duringoperation.Minimum resistance: 1.5 megohmFlow: 80 - 100 liters per hourPressure: 15 - 25 psi

Incubation Bath:Circulating incubation bath 37 °C ±0.1 °C

Reaction Cells (cuvettes):120 semi-disposable cuvettes

WARNINGThe sealed refrigeration system contains CFC 12which is believed to be an ozone damaging substance.Refer all work on cooling system to a suitable qualifiedengineer.

1. INTRODUCTION


2. OPERATIONS

Contents

2. OPERATIONSPART A - OPERATING INSTRUCTIONS

2.1 Daily Operating Check ............................................................................... 2 · 1

2.1.1 Introduction.......................................................................................................................... 2 · 12.1.2 Check Hitergent Supply ...................................................................................................... 2 · 12.1.3 Check Waste Solution Reservoir........................................................................................ 2 · 22.1.4 Check Detergent Bottle ....................................................................................................... 2 · 22.1.5 Check Paper Supply ........................................................................................................... 2 · 22.1.6 Check Floppy Disk Placement............................................................................................ 2 · 32.1.7 Check Water Supply ........................................................................................................... 2 · 32.1.8 Main Circuit Breaker ........................................................................................................... 2 · 32.1.9 Power ON ............................................................................................................................. 2 · 4

2.2 Daily Start-Up .............................................................................................. 2 · 5

2.2.1 Introduction.......................................................................................................................... 2 · 52.2.2 Operational Precautions ..................................................................................................... 2 · 52.2.3 Initialization Mode .............................................................................................................. 2 · 52.2.4 Reconstitute Calibrators and Controls ............................................................................... 2 · 62.2.5 Reagent Status Check ......................................................................................................... 2 · 62.2.6 Photometer Check............................................................................................................... 2 · 72.2.7 Test Specific Information .................................................................................................... 2 · 82.2.8 Demographic Considerations ............................................................................................. 2 · 8

2.3 Calibration ................................................................................................... 2 · 9

2.3.1 Overview .............................................................................................................................. 2 · 92.3.2 Calibration Procedure ........................................................................................................ 2 · 9

2.4 Control Test Selection.............................................................................. 2 · 11

2.4.1 Introduction.........................................................................................................................2 · 112.4.2 Procedure ...........................................................................................................................2 · 11

2. OPERATIONS

Contents

2.5.1 Introduction .........................................................................................................................2 · 132.5.2 Procedure ...........................................................................................................................2 · 132.5.3 Example of Requisition List ............................................................................................... 2 · 14

2.6 Routine Patient Test Selection With Bar Code Reader .......................... 2 · 15

2.6.1 Introduction .........................................................................................................................2 · 152.6.2 Manual Entry ....................................................................................................................... 2 · 152.6.3 Real Time Downloading From Host Computer ................................................................ 2 · 16

2.7 Initiate Run ................................................................................................ 2 · 17

2.7.1 Introduction .........................................................................................................................2 · 172.7.2 Procedure ...........................................................................................................................2 · 17

2.8 Stat Test Selection .................................................................................... 2 · 20


2.9 Measurement of Additional Routine Samples ........................................ 2 · 22

2.9.1 Introduction .........................................................................................................................2 · 222.9.2 Procedure without Bar Code Reader ............................................................................... 2 · 222.9.3 Procedure with Bar Code Reader .....................................................................................2 · 22

2.10 Rerun Sample Processing ....................................................................... 2 · 24


2.5 Routine Patient Test Selection Without Bar Code Reader .................... 2 · 13

2. OPERATIONS

Contents

2.11 Within-Run Recalibration ......................................................................... 2 · 27

2.11.1 Introduction.........................................................................................................................2 · 272.11.2 Procedure ...........................................................................................................................2 · 272.11.3 Rerun Calibration ...............................................................................................................2 · 27

2.12 Data Editing ............................................................................................... 2 · 28


2.13 Quality Control Procedures ..................................................................... 2 · 29

2.13.1 Daily QC Results .................................................................................................................2 · 29

2.14 QC File Maintenance................................................................................. 2 · 30


2.15 Patient Reports ......................................................................................... 2 · 32

2.15.1 Real Time Printout of Patient Results...............................................................................2 · 322.15.2 Edit Patient Reports ...........................................................................................................2 · 32

PART B - CRT SCREEN DISPLAYS

2.16 Overview.................................................................................................... 2 · 33

2.16.1 Introduction .........................................................................................................................2 · 332.16.2 Entry Fields .........................................................................................................................2 · 332.16.3 Field and Prompt Explanations ........................................................................................2 · 332.16.4 Entry Prompts ..................................................................................................................... 2 · 332.16.5 How to Clear Entry Errors ..................................................................................................2 · 332.16.6 Screen Configuration .........................................................................................................2 · 342.16.7 Initialization Screen ........................................................................................................... 2 · 35

2.17 Operation Monitor ..................................................................................... 2 · 36

2.17.1 Introduction .........................................................................................................................2 · 362.17.2 Displaying OPERATION MONITOR - - Page 1 ................................................................... 2 · 362.17.3 Example of OPERATION MONITOR - - Page 1 ..................................................................2 · 362.17.4 OPERATION MONITOR Fields and Prompts - - Page 1 ....................................................2 · 362.17.5 Displaying OPERATION MONITOR - - Page 2 ................................................................... 2 · 382.17.6 Example of OPERATION MONITOR - - Page 2 ..................................................................2 · 382.17.7 OPERATION MONITOR Fields and Prompts - - Page 2 ....................................................2 · 39

2.18 Routine Job - - Menu ................................................................................ 2 · 40

2.18.1 Introduction .........................................................................................................................2 · 402.18.2 Displaying the ROUTINE JOB MENU .................................................................................2 · 402.18.3 Example of the ROUTINE JOB MENU ................................................................................2 · 402.18.4 ROUTINE JOB MENU Fields and Prompts .........................................................................2 · 40

2.19 Routine Job - - Reagent Status ................................................................ 2 · 41

2.19.1 Introduction .........................................................................................................................2 · 412.19.2 Displaying the REAGENT STATUS Screen - - Page 1 ...................................................... 2 · 412.19.3 Example of the REAGENT STATUS Screen - - Page 1 .....................................................2 · 412.19.4 REAGENT STATUS Screen Fields and Prompts - - Page 1 ..............................................2 · 422.19.5 Displaying the REAGENT STATUS Screen - - Page 2 ...................................................... 2 · 452.19.6 Example of the REAGENT STATUS Screen - - Page 2 .....................................................2 · 452.19.7 REAGENT STATUS Screen Fields and Prompts - - Page 2 ..............................................2 · 45

2. OPERATIONS

Contents

2. OPERATIONS

Contents

2.20 Routine Job - - Calibration Test Selection .............................................. 2 · 49

2.20.1 Introduction.........................................................................................................................2 · 492.20.2 Displaying the CALIBRATION TEST SELECTION Screen - - Page 1 ...............................2 · 492.20.3 Example of the CALIBRATION TEST SELECTION Screen - - Page 1 ..............................2 · 492.20.4 CALIBRATION TEST SELECTION Screen Fields and Prompts - - Page 1 .......................2 · 502.20.5 Displaying the CALIBRATION TEST SELECTION Screen - - Page 2 ...............................2 · 512.20.6 Example of the CALIBRATION TEST SELECTION Screen - - Page 2 ..............................2 · 512.20.7 CALIBRATION TEST SELECTION Screen Fields and Prompts - - Page 2 .......................2 · 51

2.21 Routine Job - - Patient Test Selection Without Bar Code Reader ........ 2 · 53

2.21.1 Introduction.........................................................................................................................2 · 532.21.2 Displaying the PATIENT TEST SELECTION Screen Without Bar Code Reader .............2 · 532.21.3 Example of the PATIENT TEST SELECTION Screen Without Bar Code Reader ...........2 · 532.21.4 PATIENT TEST SELECTION Without Bar Code Reader Fields and Prompts .................2 · 53

2.22 Routine Job - - Patient Test Selection With Bar Code Reader .............. 2 · 58

2.22.1 Introduction.........................................................................................................................2 · 582.22.2 Displaying the PATIENT TEST SELECTION Sreen With Bar Code Reader ....................2 · 582.22.3 Example of the PATIENT TEST SELECTION Screen With Bar Code Reader .................2 · 582.22.4 PATIENT TEST SELECTION With Bar Code Reader Fields and Prompts .......................2 · 58

2.23 Routine Job - - Start Conditions .............................................................. 2 · 62

2.23.1 Introduction.........................................................................................................................2 · 622.23.2 Displaying the START CONDITIONS Screen ....................................................................2 · 622.23.3 Example of the START CONDITIONS Screen ...................................................................2 · 622.23.4 START CONDITIONS Screen Fields and Prompts ............................................................2 · 63

2.24 Routine Job - - Real Time Data Monitor .................................................. 2 · 68

2.24.1 Introduction.........................................................................................................................2 · 682.24.2 Displaying the REAL TIME DATA MONITOR Screen ........................................................2 · 682.24.3 Example of the REAL TIME DATA MONITOR Screen .......................................................2 · 682.24.4 REAL TIME DATA MONITOR Screen Fields and Prompts ................................................2 · 68

2. OPERATIONS

Contents

2.25 Routine Job - - Data Review .................................................................... 2 · 70

2.25.1 Introduction .........................................................................................................................2 · 702.25.2 Displaying the DATA REVIEW Screen - - Page 1 .............................................................2 · 702.25.3 Example of the DATA REVIEW Screen - - Page 1 ............................................................2 · 702.25.4 DATA REVIEW Screen Fields and Prompts - - Page 1 .....................................................2 · 712.25.5 Displaying the DATA REVIEW Screen - - Page 2 .............................................................2 · 712.25.6 Example of the DATA REVIEW Screen - - Page 2 ............................................................2 · 722.25.7 DATA REVIEW Screen Fields and Prompts - - Page 2 .....................................................2 · 72

2.26 Routine Job - - Rerun Samples ................................................................ 2 · 76

2.26.1 Introduction .........................................................................................................................2 · 762.26.2 Displaying the RERUN SAMPLES Screen - - Page 1 ........................................................2 · 762.26.3 Example of the RERUN SAMPLES Screen - - Page 1 ...................................................... 2 · 762.26.4 RERUN SAMPLES Screen Fields and Prompts - - Page 1 ...............................................2 · 772.26.5 Displaying the RERUN SAMPLES Screen - - Page 2 ........................................................2 · 782.26.6 Example of the RERUN SAMPLES Screen - - Page 2 ...................................................... 2 · 782.26.7 RERUN SAMPLES Screen Fields and Prompts - - Page 2 ...............................................2 · 79

2.27 Routine Job - - Status Setting .................................................................. 2 · 80

2.27.1 Introduction .........................................................................................................................2 · 802.27.2 Displaying the STATUS SETTING Screen .........................................................................2 · 802.27.3 Example of the STATUS SETTING Screen .......................................................................2 · 802.27.4 STATUS SETTING Screen Fields and Prompts ................................................................ 2 · 80

2.28 Stat Reception .......................................................................................... 2 · 83

2.28.1 Introduction .........................................................................................................................2 · 832.28.2 Displaying the STAT RECEPTION Screen .........................................................................2 · 832.28.3 Example of the STAT RECEPTION Screen .......................................................................2 · 832.28.4 Explanation of the STAT RECEPTION Screen ..................................................................2 · 83

2.29 Stat Test Selection .................................................................................... 2 · 84

2.29.1 Introduction .........................................................................................................................2 · 842.29.2 Displaying the STAT TEST SELECTION Screen - - Page 1 ..............................................2 · 842.29.3 Example of the STAT TEST SELECTION Screen - - Page 1 ............................................ 2 · 842.29.4 STAT TEST SELECTION Screen Fields and Prompts - - Page 1 .....................................2 · 852.29.5 Displaying the STAT TEST SELECTION Screen - - Page 2 ..............................................2 · 86

2.29.6 Example of the STAT TEST SELECTION Screen - - Page 2 ............................................2 · 872.29.7 STAT TEST SELECTION Screen Fields and Prompts - - Page 2 .....................................2 · 87

2.30 Quality Control Job - - Menu .................................................................... 2 · 89

2.30.1 Introduction.........................................................................................................................2 · 892.30.2 Displaying the QC JOB MENU ............................................................................................2 · 892.30.3 Example of the QC JOB MENU ..........................................................................................2 · 892.30.4 QC JOB MENU Fields and Prompts ...................................................................................2 · 89

2.31 Quality Control Job - - Real Time QC....................................................... 2 · 90

2.31.1 Introduction.........................................................................................................................2 · 902.31.2 Displaying the REAL TIME QC Screen ..............................................................................2 · 902.31.3 Example of the REAL TIME QC Screen ............................................................................2 · 902.31.4 REAL TIME QC Screen Fields and Prompts .....................................................................2 · 91

2.32 Quality Control Job - - Individual QC Monitor ......................................... 2 · 93

2.32.1 Introduction.........................................................................................................................2 · 932.32.2 Displaying the INDIVIDUAL QC MONITOR Screen ...........................................................2 · 932.32.3 Example of the INDIVIDUAL QC MONITOR Screen..........................................................2 · 932.32.4 INDIVIDUAL QC MONITOR Screen Fields and Prompts...................................................2 · 93

2.33 Quality Control Job - - Individual QC List ................................................ 2 · 96

2.33.1 Introduction.........................................................................................................................2 · 962.33.2 Displaying the INDIVIDUAL QC LIST Screen ....................................................................2 · 962.33.3 Example of the INDIVIDUAL QC LIST Screen ..................................................................2 · 962.33.4 INDIVIDUAL QC LIST Screen Fields and Prompts ...........................................................2 · 96

2.34 Quality Control Job - - Individual QC Chart............................................. 2 · 99

2.34.1 Introduction.........................................................................................................................2 · 992.34.2 Displaying the INDIVIDUAL QC CHART Screen ................................................................2 · 992.34.3 Example of the INDIVIDUAL QC CHART Screen ..............................................................2 · 992.34.4 INDIVIDUAL QC CHART Screen Fields and Prompts .......................................................2 · 99

2. OPERATIONS

Contents

2.35 Quality Control Job - - Cumulative QC Monitor .................................... 2 · 101

2.35.1 Introduction ....................................................................................................................... 2 · 1012.35.2 Displaying the CUMULATIVE QC MONITOR Screen .......................................................2 · 1012.35.3 Example of the CUMULATIVE QC MONITOR Screen .....................................................2 · 1012.35.4 CUMULATIVE QC MONITOR Screen Fields and Prompts ..............................................2 · 101

2.36 Quality Control Job - - Cumulative QC List ........................................... 2 · 104

2.36.1 Introduction ....................................................................................................................... 2 · 1042.36.2 Displaying the CUMULATIVE QC LIST Screen ...............................................................2 · 1042.36.3 Example of the CUMULATIVE QC LIST Screen.............................................................. 2 · 1042.36.4 CUMULATIVE QC LIST Screen Fields and Prompts .......................................................2 · 104

2.37 Quality Control Job - - Cumulative QC Chart ........................................ 2 · 106

2.37.1 Introduction ....................................................................................................................... 2 · 1062.37.2 Displaying the CUMULATIVE QC CHART Screen ........................................................... 2 · 1062.37.3 Example of the CUMULATIVE QC CHART Screen ..........................................................2 · 1062.37.4 CUMULATIVE QC CHART Screen Fields and Prompts ...................................................2 · 106

2.38 Data Monitor Job - - Menu ...................................................................... 2 · 108

2.38.1 Introduction ....................................................................................................................... 2 · 1082.38.2 Displaying the DATA MONITOR JOB MENU ....................................................................2 · 1082.38.3 Example of the DATA MONITOR JOB MENU ..................................................................2 · 1082.38.4 DATA MONITOR JOB MENU Fields and Prompts ........................................................... 2 · 108

2.39 Data Monitor Job - - Reaction Monitor .................................................. 2 · 109

2.39.1 Introduction ....................................................................................................................... 2 · 1092.39.2 Displaying the REACTION MONITOR Screen ..................................................................2 · 1092.39.3 Example of the REACTION MONITOR Screen ................................................................ 2 · 1102.39.4 REACTION MONITOR Screen Fields and Prompts ......................................................... 2 · 110

2. OPERATIONS

Contents

2.40 Data Monitor Job - - Calibration Trace .................................................. 2 · 112

2.40.1 Introduction....................................................................................................................... 2 · 1122.40.2 Displaying the CALIBRATION TRACE Screen ................................................................ 2 · 1122.40.3 Example of the CALIBRATION TRACE Screen ............................................................... 2 · 1122.40.4 CALIBRATION TRACE Screen Fields and Prompts ........................................................ 2 · 112

2.41 Data Monitor Job - - Calibration List ...................................................... 2 · 114

2.41.1 Introduction....................................................................................................................... 2 · 1142.41.2 Displaying the CALIBRATION LIST Screen .................................................................... 2 · 1142.41.3 Example of the CALIBRATION LIST Screen ................................................................... 2 · 1142.41.4 CALIBRATION LIST Screen Fields and Prompts ............................................................ 2 · 114

2.42 Data Monitor Job - - ISE Calibration Monitor ........................................ 2 · 116

2.42.1 Introduction....................................................................................................................... 2 · 1162.42.2 Displaying the ISE CALIBRATION MONITOR Screen ..................................................... 2 · 1162.42.3 Example of the ISE CALIBRATION MONITOR Screen ................................................... 2 · 1162.42.4 ISE CALIBRATION MONITOR Screen Fields and Prompts ............................................ 2 · 116

2.43 Data Monitor Job - - Working Curve ...................................................... 2 · 118

2.43.1 Introduction....................................................................................................................... 2 · 1182.43.2 Displaying the WORKING CURVE Screen....................................................................... 2 · 1182.43.3 Example of the WORKING CURVE Screen ..................................................................... 2 · 1182.43.4 WORKING CURVE Screen Fields and Prompts .............................................................. 2 · 118

2.44 Parameter Job - - Menu .......................................................................... 2 · 120

2.44.1 Introduction....................................................................................................................... 2 · 1202.44.2 Displaying the PARAMETER JOB MENU ......................................................................... 2 · 1202.44.3 Example of the PARAMETER JOB MENU ........................................................................ 2 · 1202.44.4 PARAMETER JOB MENU Fields and Prompts ................................................................. 2 · 120

2. OPERATIONS

Contents

2.45 Parameter Job - - Chemistry Parameters .............................................. 2 · 121

2.45.1 Introduction ....................................................................................................................... 2 · 1212.45.2 Displaying the CHEMISTRY PARAMETERS Screen - - Page 1....................................... 2 · 1212.45.3 Example of the CHEMISTRY PARAMETERS Screen - - Page 1 ..................................... 2 · 1222.45.4 CHEMISTRY PARAMETERS Screen Fields and Prompts - - Page 1 ..............................2 · 1222.45.5 Displaying the CHEMISTRY PARAMETERS Screen - - Page 2....................................... 2 · 1272.45.6 Example of the CHEMISTRY PARAMETERS Screen - - Page 2 ..................................... 2 · 1282.45.7 CHEMISTRY PARAMETERS Screen Fields and Prompts - - Page 2 ..............................2 · 128

2.46 Parameter Job - - Profiling ..................................................................... 2 · 136

2.46.1 Introduction ....................................................................................................................... 2 · 1362.46.2 Displaying the PROFILING Screen .................................................................................. 2 · 1362.46.3 Example of the PROFILING Screen ................................................................................ 2 · 1362.46.4 PROFILING Screen Fields and Prompts .........................................................................2 · 136

2.47 Parameter Job - - Calculated Test ......................................................... 2 · 138

2.47.1 Introduction ....................................................................................................................... 2 · 1382.47.2 Displaying the CALCULATED TEST Screen ....................................................................2 · 1382.47.3 Example of the CALCULATED TEST Screen ..................................................................2 · 1382.47.4 CALCULATED TEST Screen Fields and Prompts ........................................................... 2 · 138

2.48 Parameter Job - - Print Order ................................................................. 2 · 143

2.48.1 Introduction ....................................................................................................................... 2 · 1432.48.2 Displaying the PRINT ORDER Screen ............................................................................. 2 · 1432.48.3 Example of the PRINT ORDER Screen ........................................................................... 2 · 1432.48.4 PRINT ORDER Screen Fields and Prompts..................................................................... 2 · 143

2.49 Parameter Job - - Report Format ........................................................... 2 · 145

2.49.1 Introduction ....................................................................................................................... 2 · 1452.49.2 Displaying the REPORT FORMAT Screen .......................................................................2 · 1452.49.3 Example of the REPORT FORMAT Screen ..................................................................... 2 · 1452.49.4 REPORT FORMAT Screen Fields and Prompts .............................................................. 2 · 145

2. OPERATIONS

Contents

2.50 Parameter Job - - Control Test Selection .............................................. 2 · 151

2.50.1 Introduction....................................................................................................................... 2 · 1512.50.2 Displaying the CONTROL TEST SELECTION Screen ..................................................... 2 · 1512.50.3 Example of the CONTROL TEST SELECTION Screen .................................................... 2 · 1512.50.4 CONTROL TEST SELECTION Screen Fields and Prompts ............................................. 2 · 151

2.51 Parameter Job - - Control Value Setting ............................................... 2 · 153

2.51.1 Introduction....................................................................................................................... 2 · 1532.51.2 Displaying the CONTROL VALUE SETTING Screen ....................................................... 2 · 1532.51.3 Example of the CONTROL VALUE SETTING Screen...................................................... 2 · 1532.51.4 CONTROL VALUE SETTING Screen Fields and Prompts............................................... 2 · 153

2.52 Parameter Job - - Special Wash Programming .................................... 2 · 155

2.52.1 Introduction....................................................................................................................... 2 · 1552.52.2 Displaying the SPECIAL WASH PROGRAMMING Screen .............................................. 2 · 1552.52.3 Example of the SPECIAL WASH PROGRAMMING Screen ............................................ 2 · 1552.52.4 SPECIAL WASH PROGRAMMING Screen Fields and Prompts ..................................... 2 · 155

2.53 Parameter Job - - System Parameters................................................... 2 · 159

2.53.1 Introduction....................................................................................................................... 2 · 1592.53.2 Displaying the SYSTEM PARAMETERS Screen - - Page 1 ............................................ 2 · 1592.53.3 Example of the SYSTEM PARAMETERS Screen - - Page 1 ........................................... 2 · 1592.53.4 SYSTEM PARAMETERS Screen Fields and Prompts - - Page 1 .................................... 2 · 1602.53.5 Displaying the SYSTEM PARAMETERS Screen - - Page 2 ............................................ 2 · 1632.53.6 Example of the SYSTEM PARAMETERS Screen - - Page 2 ........................................... 2 · 1632.53.7 SYSTEM PARAMETERS Screen Fields and Prompts - - Page 2 .................................... 2 · 164

2.54 Parameter Job - - Channel Assignment ................................................ 2 · 167

2.54.1 Introduction....................................................................................................................... 2 · 1672.54.2 Displaying the CHANNEL ASSIGNMENT Screen - - Page 1 ........................................... 2 · 1672.54.3 Example of the CHANNEL ASSIGNMENT Screen - - Page 1 ......................................... 2 · 1672.54.4 CHANNEL ASSIGNMENT Screen Fields and Prompts - - Page 1 .................................. 2 · 1682.54.5 Displaying the CHANNEL ASSIGNMENT Screen - - Page 2 ........................................... 2 · 1682.54.6 Example of the CHANNEL ASSIGNMENT Screen - - Page 2 ......................................... 2 · 1692.54.7 CHANNEL ASSIGNMENT Screen Fields and Prompts - - Page 2 .................................. 2 · 169

2. OPERATIONS

Contents

2.55 Maintenance Job - - Menu ...................................................................... 2 · 170

2.55.1 Introduction ....................................................................................................................... 2 · 1702.55.2 Displaying the MAINTENANCE JOB MENU ...................................................................... 2 · 1702.55.3 Example of the MAINTENANCE JOB MENU ....................................................................2 · 1702.55.4 MAINTENANCE JOB MENU Fields and Prompts .............................................................2 · 170

2.56 Maintenance Job - - Analyzer Maintenance .......................................... 2 · 171

2.56.1 Introduction ....................................................................................................................... 2 · 1712.56.2 Displaying the ANALYZER MAINTENANCE Screen ......................................................... 2 · 1712.56.3 Example of the ANALYZER MAINTENANCE Screen .......................................................2 · 1712.56.4 ANALYZER MAINTENANCE Screen Fields and Prompts ................................................2 · 172

2.57 Maintenance Job - - Mechanisms Check .............................................. 2 · 175

2.57.1 Introduction ....................................................................................................................... 2 · 1752.57.2 Displaying the MECHANISMS CHECK Screen ................................................................ 2 · 1752.57.3 Example of the MECHANISMS CHECK Screen ...............................................................2 · 1752.57.4 MECHANISMS CHECK Screen Fields and Prompts ........................................................2 · 176

2.58 Maintenance Job - - Support Functions ............................................... 2 · 178

2.58.1 Introduction ....................................................................................................................... 2 · 1782.58.2 Displaying the SUPPORT FUNCTIONS Screen ...............................................................2 · 1782.58.3 Example of the SUPPORT FUNCTIONS Screen .............................................................2 · 1782.58.4 SUPPORT FUNCTIONS Screen Fields and Prompts ...................................................... 2 · 179

2.59 Maintenance Job - - Working Information ............................................. 2 · 181

2.59.1 Introduction ....................................................................................................................... 2 · 1812.59.2 Displaying the WORKING INFORMATION Screen ..........................................................2 · 1812.59.3 Example of the WORKING INFORMATION Screen ........................................................2 · 1812.59.4 WORKING INFORMATION Screen Fields and Prompts ................................................. 2 · 181

2. OPERATIONS

Contents

PART C - REPORTS

2.60 Overview.................................................................................................. 2 · 185

2.60.1 Section Contents .............................................................................................................. 2 · 1852.60.2 Report Table ..................................................................................................................... 2 · 185

2.61 Reagent Status ....................................................................................... 2 · 186

2.61.1 Introduction....................................................................................................................... 2 · 1862.61.2 Printing the Reagent Status Report ................................................................................ 2 · 1862.61.3 Example of the Reagent Status Report .......................................................................... 2 · 1862.61.4 Explanation of the Reagent Status Report ..................................................................... 2 · 187

2.62 Requisition List - - Without Bar Code Reader....................................... 2 · 188

2.62.1 Introduction....................................................................................................................... 2 · 1882.62.2 Printing the Requisition List - - Without Bar Code Reader ........................................... 2 · 1882.62.3 Example of the Requisition List - - Without Bar Code Reader ..................................... 2 · 1882.62.4 Explanation of the Requisition List - - Without Bar Code Reader ................................ 2 · 189

2.63 Requisition List - - With Bar Code Reader ............................................ 2 · 190

2.63.1 Introduction....................................................................................................................... 2 · 1902.63.2 Printing the Requisition List - - With Bar Code Reader................................................. 2 · 1902.63.3 Example of the Requisition List - - With Bar Code Reader ........................................... 2 · 1902.63.4 Explanation of the Requisition List - - With Bar Code Reader ..................................... 2 · 191

2.64 Calibrator Load List ................................................................................ 2 · 192

2.64.1 Introduction....................................................................................................................... 2 · 1922.64.2 Printing the Calibrator Load List..................................................................................... 2 · 1922.64.3 Example of the Calibrator Load List............................................................................... 2 · 1922.64.4 Explanation of the Calibrator Load List ......................................................................... 2 · 192

2. OPERATIONS

Contents

2.65 Rerun List ................................................................................................ 2 · 194

2.65.1 Introduction ....................................................................................................................... 2 · 1942.65.2 Printing the Rerun List .....................................................................................................2 · 1942.65.3 Example of the Rerun List ............................................................................................... 2 · 1942.65.4 Explanation of the Rerun List .......................................................................................... 2 · 194

2.66 Calibration Monitor ................................................................................. 2 · 196

2.66.1 Introduction ....................................................................................................................... 2 · 1962.66.2 Printing the Calibration Monitor Report .........................................................................2 · 1962.66.3 Example of the Calibration Monitor Report ................................................................... 2 · 1962.66.4 Explanation of the Calibration Monitor Report .............................................................. 2 · 196

2.67 Individual QC Monitor ............................................................................. 2 · 199

2.67.1 Introduction ....................................................................................................................... 2 · 1992.67.2 Printing the Individual QC Monitor Report ..................................................................... 2 · 1992.67.3 Example of the Individual QC Monitor Report ...............................................................2 · 1992.67.4 Explanation of the Individual QC Monitor Report ..........................................................2 · 199

2.68 Individual QC List .................................................................................... 2 · 201

2.68.1 Introduction ....................................................................................................................... 2 · 2012.68.2 Printing the Individual QC List Report ............................................................................2 · 2012.68.3 Example of the Individual QC List Report ...................................................................... 2 · 2012.68.4 Explanation of the Individual QC List Report ................................................................ 2 · 201

2.69 Cumulative QC Monitor .......................................................................... 2 · 203

2.69.1 Introduction ....................................................................................................................... 2 · 2032.69.2 Printing the Cumulative QC Monitor Report ..................................................................2 · 2032.69.3 Example of the Cumulative QC Monitor Report ............................................................2 · 2032.69.4 Explanation of the Cumulative QC Monitor Report .......................................................2 · 203

2. OPERATIONS

Contents

2.70 Cumulative QC List ................................................................................. 2 · 205

2.70.1 Introduction....................................................................................................................... 2 · 2052.70.2 Printing the Cumulative QC List Report ......................................................................... 2 · 2052.70.3 Example of the Cumulative QC List Report ................................................................... 2 · 2052.70.4 Explanation of the Cumulative QC List Report .............................................................. 2 · 205

2.71 Reaction Monitor .................................................................................... 2 · 207

2.71.1 Introduction....................................................................................................................... 2 · 2072.71.2 Printing the Reaction Monitor Report ............................................................................. 2 · 2072.71.3 Example of the Reaction Monitor Report ....................................................................... 2 · 2072.71.4 Explanation of the Reaction Monitor Report.................................................................. 2 · 207

2.72 Patient Reports - - Report Format.......................................................... 2 · 210

2.72.1 Introduction....................................................................................................................... 2 · 2102.72.2 Printing the Patient Reports - - Report Format .............................................................. 2 · 2102.72.3 Example of the Patient Reports - - Report Format ........................................................ 2 · 2102.72.4 Explanation of the Patient Reports - - Report Format ................................................... 2 · 211

2.73 Patient Reports - - Short Format ............................................................ 2 · 213

2.73.1 Introduction....................................................................................................................... 2 · 2132.73.2 Printing the Patient Reports - - Short Format ................................................................ 2 · 2132.73.3 Example of the Patient Reports - - Short Format........................................................... 2 · 2132.73.4 Explanation of the Patient Reports - - Short Format ..................................................... 2 · 214

2.74 Calibration Trace .................................................................................... 2 · 215

2.74.1 Introduction....................................................................................................................... 2 · 2152.74.2 Printing the Calibration Trace Report ............................................................................ 2 · 2152.74.3 Example of the Calibration Trace Report ...................................................................... 2 · 2152.74.4 Explanation of the Calibration Trace Report ................................................................. 2 · 215

2. OPERATIONS

Contents

2.75 Profiling List ............................................................................................ 2 · 217

2.75.1 Introduction ....................................................................................................................... 2 · 2172.75.2 Printing the Profiling List Report .................................................................................... 2 · 2172.75.3 Example of the Profiling List Report ..............................................................................2 · 2172.75.4 Explanation of the Profiling List Report .........................................................................2 · 217

2.76 Photometer Check .................................................................................. 2 · 219

2.76.1 Introduction ....................................................................................................................... 2 · 2192.76.2 Printing the Photometer Check Report .......................................................................... 2 · 2192.76.3 Example of the Photometer Check Report..................................................................... 2 · 2192.76.4 Explanation of the Photometer Check Report ...............................................................2 · 219

2.77 Cell Blank ................................................................................................ 2 · 221

2.77.1 Introduction ....................................................................................................................... 2 · 2212.77.2 Printing the Cell Blank Report ........................................................................................2 · 2212.77.3 Example of the Cell Blank Report .................................................................................. 2 · 2212.77.4 Explanation of the Cell Blank Report ............................................................................. 2 · 222

2.78 Bar Code Reader Check ........................................................................ 2 · 223

2.78.1 Introduction ....................................................................................................................... 2 · 2232.78.2 Printing the Bar Code Reader Check Report ................................................................. 2 · 2232.78.3 Example of the Bar Code Reader Check Report ........................................................... 2 · 2232.78.4 Explanation of the Bar Code Reader Check Report ...................................................... 2 · 223

2.79 ISE Check ................................................................................................ 2 · 225

2.79.1 Introduction ....................................................................................................................... 2 · 2252.79.2 Printing the ISE Check Report ......................................................................................... 2 · 2252.79.3 Example of the ISE Check Report ...................................................................................2 · 2252.79.4 Explanation of the ISE Check Report ............................................................................. 2 · 225

2. OPERATIONS

Contents

2.80 Printer Check .......................................................................................... 2 · 227

2.80.1 Introduction....................................................................................................................... 2 · 2272.80.2 Printing the Printer Check Report ................................................................................... 2 · 2272.80.3 Example of the Printer Check Report ............................................................................. 2 · 2272.80.4 Explanation of the Printer Check Report ....................................................................... 2 · 227

2.81 Daily Alarm Trace .................................................................................... 2 · 228

2.81.1 Introduction....................................................................................................................... 2 · 2282.81.2 Printing the Daily Alarm Trace Report ........................................................................... 2 · 2282.81.3 Example of the Daily Alarm Trace Report ..................................................................... 2 · 2282.81.4 Explanation of the Daily Alarm Trace Report ................................................................ 2 · 228

2.82 Cumulative Alarm Trace ......................................................................... 2 · 230

2.82.1 Introduction....................................................................................................................... 2 · 2302.82.2 Printing the Cumulative Alarm Trace Report ................................................................ 2 · 2302.82.3 Example of the Cumulative Alarm Trace Report........................................................... 2 · 2302.82.4 Explanation of the Cumulative Alarm Trace Report ..................................................... 2 · 230

2.83 Host Communication Log ...................................................................... 2 · 232

2.83.1 Introduction....................................................................................................................... 2 · 2322.83.2 Printing the Host Communication Log Report ............................................................... 2 · 2322.83.3 Example of the Host Communication Log Report ......................................................... 2 · 2322.83.4 Explanation of the Host Communication Log Report .................................................... 2 · 232

2.84 Floppy Disk Check ................................................................................. 2 · 233

2.84.1 Introduction....................................................................................................................... 2 · 2332.84.2 Printing the Floppy Disk Check Report ........................................................................... 2 · 2332.84.3 Example of the Floppy Disk Check Report ..................................................................... 2 · 2332.84.4 Explanation of the Floppy Disk Check Report ............................................................... 2 · 233

2. OPERATIONS

Contents

2.85 Memory Check ........................................................................................ 2 · 234

2.85.1 Introduction ....................................................................................................................... 2 · 2342.85.2 Printing the Memory Check Report .................................................................................2 · 2342.85.3 Example of the Memory Check Report ........................................................................... 2 · 2342.85.4 Explanation of the Memory Check Report ..................................................................... 2 · 234

2.86 Precision Check...................................................................................... 2 · 235

2.86.1 Introduction ....................................................................................................................... 2 · 2352.86.2 Printing the Precision Check Report ..............................................................................2 · 2352.86.3 Example of the Precision Check Report .........................................................................2 · 2352.86.4 Explanation of the Precision Check Report ................................................................... 2 · 235

2.87 Maintenance Report ............................................................................... 2 · 237

2.87.1 Introduction ....................................................................................................................... 2 · 2372.87.2 Printing the Maintenance Report .................................................................................... 2 · 2372.87.3 Example of the Maintenance Report ..............................................................................2 · 2372.87.4 Explanation of the Maintenance Report .........................................................................2 · 237

2.88 Cumulative Operations Report .............................................................. 2 · 238

2.88.1 Introduction ....................................................................................................................... 2 · 2382.88.2 Printing the Cumulative Operations Report ................................................................... 2 · 2382.88.3 Example of the Cumulative Operations Report .............................................................2 · 2382.88.4 Explanation of the Cumulative Operations Report ........................................................2 · 238

2.89 Original Absorbance............................................................................... 2 · 240

2.89.1 Introduction ....................................................................................................................... 2 · 2402.89.2 Printing the Original Absorbance Report .......................................................................2 · 2402.89.3 Example of the Original Absorbance Report ................................................................. 2 · 2402.89.4 Explanation of the Original Absorbance Report ............................................................2 · 240

2. OPERATIONS

Contents

2 • 1

2.1 Daily Operating Check

2.1.1 Introduction

The following procedures are performed before theinstrument is powered ON. If the instrument is alreadyON, these procedures can be performed any timeduring a 24-hour period. These procedures are mosteffective, however, when performed before the firstmajor run of the day.

2.1.2 Check Hitergent Supply

Hitergent is located in position 33 on each reactiondisk, as shown in Photograph 2-1. The reagent probesautomatically dispense a total of 6 mL of Hitergent intothe incubation bath during a bath exchange.

Hitergent helps to:

• prevent air bubbles from adhering to the reactioncells

• improve electrical conductivity to make detectionof incubation bath water level easier

• reduce bacteria development.

The alarm Replace Low Hitergent is issued when thebottle needs to be replaced.


2. OPERATING INSTRUCTIONS

Photograph 2-1:Hitergent Supply

PART A

2 • 2

2.1.3 Check Waste Solution Reservoir

The waste solution reservoir is located in the rear of theanalytical unit, as shown in Photograph 2-2. This fiveliter bottle collects concentrated waste. The analyzerissues the alarm Empty Waste Reservoir when thewaste solution reaches a predetermined level. If thiswaste solution reservoir is full, dispose of contentsaccording to your facility�s protocol for biohazardouswaste disposal.

It is not necessary to check the waste solutionreservoir when a waste drain connection is provided.

2.1.4 Check Detergent Bottle

The NaOH detergent bottle is located in the front of theinstrument, as shown in Photograph 2-3. Thisdetergent, Multiclean, is used for rinsing reactioncells. The bottle contains enough detergent for aboutone week of operation, depending on your laboratory�sthroughput.

No instrument alarm is issued when the detergentbottle is empty.

2.1.5 Check Paper Supply

Check remaining paper in the instrument printer andreplace, if necessary. Make sure the printer powerswitch is turned ON.

If your instrument is used on an around-the-clockbasis and is already powered ON, proceed to Section2.2, Daily Start-Up. If the instrument has not beenpowered ON, continue with the Check Floppy DiskPlacement procedure below.



Photograph 2-2:Waste Solution Reservoir

Photograph 2-3:Multiclean

2 • 3

2.1.6 Check Floppy DiskPlacement

The system disk and the data disk must be fullyinserted in the appropriate disk drives prior topowering ON the instrument. The system disk shouldbe in the bottom drive (#1), which is located behind theright front panel. The data disk should be in the topdrive (#2). Under normal conditions, it is notnecessary to remove either disk from its respectivedisk drive, even when the instrument is OFF. If thefloppy disks are not in their drives, insert each into itsrespective drive and push on the disk, as shown inPhotograph 2-4. If the disks need to be removed,press in on the release button located on the bottomright of each drive.

2.1.7 Check Water Supply

Make sure that the external water supply valve isturned ON.

2.1.8 Main Circuit Breaker

The main circuit breaker, shown in Photograph 2-5, ispositioned on the right side instrument cover. Thisbreaker, which controls power supplied to the reagentrefrigerator, must be in the ON position wheneverreagents are stored on the instrument.



Photograph 2-4:Floppy Disk Drives

Photograph 2-5:Main Circuit Breaker

2 • 4

2.1.9 Power ON

The ON/OFF SWITCH is positioned to the right of thetop floppy, disk drive 2, as shown in Photograph 2-6.Place this switch in the ON position to supply powerto the instrument systems. Even with the power OFF,the refrigeration units remain on for reagent storage.



Photograph 2-6:ON/OFF Switch

2 • 5

2.2 Daily Start-Up

2.2.1 Introduction

The automated activation procedures require minimaloperator involvement. The following paragraphspresent these procedures in the most time-efficientsequence. Do not omit any of the describedprocedures from your daily routine.

2.2.2 Operational Precautions

While the analyzer is in operation, make sure theseprecautions are followed:

• Keep the top cover of the analyzer closed.

• Do not replace samples while the sample disk isrotating.

• Avoid touching the sample probe, reagent probes,stirring paddles, and other moving parts.

• Do not remove or replace the cover over the sampledisk inner ring.

• Do not remove or replace the reagent disk covers.

• Do not place reagent or sample containers on thecover of the analyzer.

2.2.3 Initialization Mode

The Initialization mode is indicated by the status linedisplayed at the top of the CRT. During Initialization,several functions occur automatically. Thesefunctions are as follows:

• Reads information from the system disk intomemory

• Reaction bath water exchange

• Air Purge of sample and reagent pipettor pathway

• Mechanical reset

• ISE prime

• Reagent bar code registration.

While these procedures are being performedautomatically by the instrument, calibrators andcontrol products can be prepared. A brief explanationof the above procedures is given below.

· Reads System Disk

Information from the floppy system disk is read intoinstrument memory.

· Reaction Bath Water Exchange

The reaction bath water is exchanged during theInitialization mode. Hitergent (6 mL) is addedautomatically to the water bath when it fills. Thisexchange replenishes evaporated water and bringsthe concentration of Hitergent to a specified level. Thebath exchange also minimizes contamination of theoptimally-heated water.


2.2 Daily Start-Up

2 • 6

· Air Purge (Sample and Reagent Pipettor)

This procedure ensures that no air is in the tubingbetween the probes and their respective pipettors. Airin the pipettor lines can result in imprecise pipetting.This procedure replaces the water in the line withfreshly degassed water and takes approximately oneminute to complete. This procedure does not purgethe ISE System pipettors.

· Reagent Bar Code Registration

All Boehringer Mannheim reagent bottles used withthe Boehringer Mannheim/Hitachi 911 Analyzer arelabeled with a bar code that contains informationconcerning the reagent. All reagent bar codes frombottles on both reagent disks are read during theInitialization mode. Information on up to 200 bottles isstored in CRAM and accessed through the REAGENTSTATUS screen.

· Mechanical Reset

All mechanical parts including the sample probe,reagent probes, sample disk, reagent disks, reactiondisk and stirrers are reset to their home positions.

· ISE Prime

An ISE prime is performed. This clears the air from theISE pipetting system.

2.2.4 Reconstitute Calibrators andControls

Reconstitute all calibrator and control materialsaccording to the instructions provided with each boxof materials. Required calibration or control materialscan be obtained from Boehringer Mannheim.

Additional controls may be run at the discretion of theoperator. The instrument computer can track up toeight different quality control materials.

Quality control products are used to verify calibrationas well as the precision and accuracy of theinstrument. Controls should be performed after everycalibration, or at least once every 24 hours, whichevercomes first. Additional control runs should beestablished by your laboratory, based upon your ownneeds.

2.2.5 Reagent Status Check

1 If the instrument has just been turned ON, proceedwhen the analyzer status line reaches Stand-by.

2 Press ROUTINE to display the ROUTINE JOBMENU. Press 1 ENTER to display the REAGENTSTATUS screen shown in Figure 2-1.

3 Reagent bar codes are read automatically duringthe Initialization mode, and REAGENT STATUSscreen updates accordingly. This is called reagentregistration. As Figure 2-1 illustrates, a forwardslash through a reagent test key on the CRT�skeyboard matrix indicates that not all reagents areon board the analyzer for that test. A back slashindicates that the test has been masked on theSTART CONDITIONS screen.

2.2 Daily Start-Up


Not all reagentson board

Masked fromSTART CONDITIONS

2 • 7

Figure 2-1: REAGENT STATUSScreen - - Keyboard Matrix

4 Press the GUIDANCE key to view page 2 of theREAGENT STATUS screen. Bottle-specificinformation for each reagent on board the analyzeris listed on this page, as shown in Figure 2-2, andincludes the number of tests available for eachreagent. This number is calculated from thevolumes remaining in each reagent container.Determine whether sufficient reagent is availablefor the number of tests in the chemistry calibrationand the scheduled run. Press the PAGECONTINUE key to view a complete list ofreagents. (Press the SHIFT key and PAGECONTINUE to go to the end of the list.) For Diluentand Washsolution the remaining volume in ml isindicated.

Figure 2-2: REAGENT STATUS Screen - - List

5 To print a copy of the Reagent Status report, movethe cursor to the Print field. Press 1 ENTER toprint the report. Proceed to Photometer Check,Section 2.2.6.

NOTEWhen the analyzer is in Stand-by and the lid isremoved and replaced on the reagent disks, theanalyzer automatically performs a reagent registrationto verify current reagent placements.

2.2.6 Photometer Check

A photometer check procedure verifies that thephotometer lamp output remains at an acceptablelevel. This procedure assumes that the following havebeen performed correctly:

• reaction cells replaced every month

• reaction bath windows cleaned monthly


2.2 Daily Start-Up

37.0 Stand-by 12/01/92 12:20

1 Reagent Status

Choose 1:Read Reagent Barcodes 2:Read Barcodes & Check Level : ENTER

RegistrationManual Set

CancelPrint

Hitergent Disk 1

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L

CK LD AST ALT ALP A GGT AMYL T.BIL D.BIL BUN GLU CO2

CA TRIG UA ALB/P TP PHOS CREA CHOL MG

MON. CHEM6 CHEM7

ALL

ISE Int. Ref.ISE DilISE KCl

2

[ ][ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ][ ]

[ ] 80 mL[ ] 80 mL[ ] mL[ ] mL[ ] mL

Y e sY e s3 7 02 3 02 7 0

THEO

37.0 Stand-by 12/01/92 12:20

1 Reagent Status



CancelPrint

Hitergent Disk 1


2

[ ][ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ][ ]

[ ] 80 mL[ ] 80 mL[ ] mL[ ] mL[ ] mL

Y e sY e s3 7 02 3 02 7 0

Assay Type Pos. Tests Size Stab. Exp.W Lot No. App Code

00311000740007400115001150011500115003110003600036003110001800018

049902051986051986070151070151070151070151049902070148048796049902048795070147

LMSLLSSLLLLLL

DilR1R3R1R1R3R3DilR1R3DilR1R3

1121122112112

7205

173126327337

278

93/5293/4393/4394/3894/3894/3894/3893/5294/1793/2193/5292/2593/12

66

131366

27

27

CK

LD

AST

ALT

79120130340

7079

21099079

240990

mL

mL

mL

* Manual Setting ! Over-Ride Manual Setting ? App Code Not Found

2 • 8

• Hitergent supply maintained

• proper reaction bath water level.

To perform a photometer check:

1 Press MAINTENANCE to display theMAINTENANCE JOB menu.

2 Press 1 ENTER to display the ANALYZERMAINTENANCE screen.

3 Move the cursor to the Photometer Check field.

4 Press 1 (Start) ENTER to initiate a photometercheck.

During this procedure, the instrument computerperforms a check of the photometer and light path,which takes approximately one minute. Take this timeto prepare calibrators, controls, or reagents, asneeded.

Figure 2-3: Photometer Check Report

2.2 Daily Start-Up


Compare the current data values, as shown in Figure2-3, with the previous data values. These valuesshould show a consistent, gradual increase. Basedupon this gradual increase, when any photometercheck value exceeds 13000, the photometer lampmust be replaced. A sudden increase from one day tothe next may indicate something other than aphotometer lamp problem (example: no Hitergent inbath).

2.2.7 Test Specific Information

Information specific to a particular chemistry test canbe found in the BM chemistry application sheet forthat method.

2.2.8 Demographic Considerations

Expected values or patient reference intervals areaffected by age, sex, diet, geographical location, andother factors. Each laboratory should establish itsown ranges for each method based upon the specificpatient population of the area.

PHOTOMETER CHECK 01/06/93 14:39

----------PREVIOUS DATA---------- ----------CURRENT DATA----------

2ND WL PRIM. WL 2ND WL PRIM. WL

340376415450480505546570600660700800

340376415450480505546570600660700800

NMNMNMNMNMNMNMNMNMNMNMNM


882487038742865886198617866886348604860385998684

882487038743865786208619866786338604860385998685

889087398754866986388627866886228583857585628612

889387418756867086418628867086258585857885648614

2 • 9

2.3 Calibration

2.3.1 Overview

To ensure proper operation of your 911 analyzer, eachBoehringer Mannheim assay must be calibrated atthe interval specified on its application sheet. Formost BM chemistries, these calibration intervals areprogrammed as part of the Chemistry Parameters.The 911 automatically updates calibrations at therequired time when the proper calibrators are placedon the sample disk. In addition, you may programtests to be calibrated in a Start Up or Repeatcalibration mode.

For most BM chemistries, calibrations necessarydue to a bottle change or lot change of reagent arecarried out automatically when the proper calibratorsare placed on the sample disk.

2.3.2 Calibration Procedure

Press ROUTINE, followed by 2 ENTER, to display theCALIBRATION TEST SELECTION screen shown inFigure 2-4.

Figure 2-4: CALIBRATION TESTSELECTION - - page 1

Press the GUIDANCE key to view the calibration TimeOut Status information.

Figure 2-5: CALIBRATION TESTSELECTION - - page 2

To print the calibrator load list:

1 Move the cursor to the second entry of theCalibration List field.

2 Enter the time interval (in hours) for which you wanta time out calibrator load list printed. Return thecursor to the first entry of the Calibration List fieldand press 3 ENTER. The load list of all calibratorsneeded for scheduled calibrations during thespecified time interval prints out.

3 Use this list to verify that all needed calibrators areon board the analyzer in the proper positions.


2.3 Calibration

37.0 Stand-by 12/01/92 12:20

2 Calibration Test Selection

Choose 1:Start Up 2:Repeat Calibration : ENTER

ModeTypeTests

Calibrator List

:Blank:2 Point

:Span:Full

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

[ ][ ][ - ]

[ ] [ 8] Hour

37.0 Stand-by 12/01/92 12:20



ModeTypeTests

Calibrator List

:Blank:2 Point

:Span:Full

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

[ ][ ][ - ]

[ ] [ 8] Hour

11121314151617181920

GLUCO2CATRIGUAALB/PTPPHOSCREACHOL

Blank 2 point Full SpanTime Out Status (Hour)

0/

0/

145/0/

973/

0/

3

24

16824

999

24

1/

0/

24

24

2 • 10

To manually program test selections for calibration,follow the procedure below:

1 Move the cursor to the Mode field and press 1ENTER to specify START UP Calibration.

2 Move the cursor to the Type field and select thecalibration type for each test.

• Press 1 ENTER for BLANK calibration.

• Press 2 ENTER for SPAN calibration.

• Press 3 ENTER for 2 POINT calibration.

• Press 4 ENTER for FULL calibration.

3 Move the cursor to the Tests field. Press theappropriate test selection key for each test that isto be calibrated with the selected calibration type.The test key highlights in reverse video whenselected. If a selection is made inadvertently,press the test selection key again to deselect thetest. After all tests for a particular calibration typeare selected, press ENTER.

4 The analyzer automatically increments to the nextcalibration type and is ready for test selections tobe entered. After the tests for each calibrationtype are selected, the appropriate icon appears inthe lower right corner of each test key image.

5 Move the cursor to the second entry of theCalibration List field and enter the time outinterval. Press 1 (Start Up) or 2 (Repeat) ENTERto obtain a calibrator load list. This printout lists allprogrammed calibrators, plus any calibrationsscheduled to time out within the specified interval.This printout also indicates the proper sample diskposition for each calibrator.


2.3 Calibration

2 • 11

2.4 Control Test Selection

2.4.1 Introduction

Controls must be run at least once during each 24-hourtime period and following calibration. If a channel iscalibrated more frequently than every 24 hours,controls must be run at least once after eachcalibration.

NOTEThe BM/Hitachi 911 System automatically runscontrols selected from the CONTROL TESTSELECTION screen immediately following acalibration. Control tests are normally programmedduring parameter set-up of the instrument and do notneed to be selected each day. The remainder of thissection outlines the control test selection procedure.

2.4.2 Procedure

1 Press PARAMETER, followed by 6 ENTER, todisplay the CONTROL TEST SELECTION screen.

2 Move the cursor to the Control field and press 1(Input control no. 1 - 8) ENTER. This displays testselections for the first control level. If previous testselections for the selected control level are storedin memory, those tests are highlighted in reversevideo (white) on the keyboard matrix.

3 Move the cursor to the Tests field. Press theappropriate test or profile keys to assign tests tothe control selected in the field above, then pressENTER. Test selections can be checked on thekeyboard matrix. All selected tests arehighlighted in reverse video. The control listed inthe Control field automatically increments by onewhen ENTER is pressed.

Controls and control intervals are selectedindividually for each test.

Figure 2-6: CONTROL TEST SELECTION

4 Repeat test selection in step 3 for each control inuse (up to eight levels).

If an operator programmed calibration is desired:Proceed to step 5 for Start up calibration and proceedto Section 2.11 for a Repeat calibration.

5 To initiate a Start Up Calibration, press ROUTINE,followed by 4 ENTER to display the STARTCONDITIONS screen. Move the cursor to theStart Up Calibration field.

6 Press 1 (On) ENTER to request a Start Upcalibration. The analyzer defaults to Off in this fieldif you do not make a selection.



37.0 Stand-by 12/01/92 12:20

6 Control Test Selection

Select Tests via Keyboard (A -L) : ENTER

ControlTestsS.Type

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

[ PTN-81 ][ - ]

Serum

2 • 12



After these control test selections are entered, theappropriate controls are run when the analyzerexecutes an automatic calibration, assuming acontrol interval > 0 has been assigned in chemistryparameters for all applicable tests. Stat tests areincluded when counting down the control interval. QCtest selections are stored in CRAM.

Figure 2-7: START CONDITIONS

37.0 Stand-by 12/01/92 12:20

4 Start Conditions

Input Sample No. 1 to 800 : ENTER ( Have you cleared data ? )

Start Sample No.Start Up CalibrationRepeat CalibrationRoutine Rerun ModeStat Rerun ModeManual Masking

Host CommunicationISE MaintenancePrint FormatCalibration PrintClear ResultsDefault Sample Cup

[ ] : [ 0] [ 1][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]

1OffOffOffAutomatic-

Off

ReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

2 • 13

2.5 Routine Patient Test Selection Without Bar Code Reader

2.5.1 Introduction

Routine patient test selections can be made when theinstrument is in Stand-by, Stop, Operate, or SampleStop. An example of the PATIENT TEST SELECTIONscreen is shown in Figure 2-8. As the tests areselected, the test key for each test highlights inreverse video on the keyboard matrix. When thesample number of a patient with previously definedtests is entered, the test selections are highlighted onthe keyboard matrix.

Use the following procedure to enter routine patienttest selections when a bar code reader is not used.

2.5.2 Procedure

1 Press ROUTINE, then 3 ENTER to display thePATIENT TEST SELECTION screen.

2 Previous test selections are stored in C-RAM andare not automatically cleared�even if the analyzeris powered OFF and back ON. Clearing theprevious test selections from the internal memoryensures no test selection errors occur by mixingpreviously selected tests with currently selectedtests.

Move the cursor to the Clear field. Press 1 ENTER.The prompt �Are You Sure?� appears. Press 1Continue ENTER.

Figure 2-8: PATIENT TEST SELECTION - - without BarCode Reader

3 The cursor advances to the Sample No. field. Ifyou want to change the Run Type or Sample Cupfields from the default settings, move the cursor tothe appropriate field. Select the proper run typeand press ENTER. Select the proper sample cupand press ENTER.

4 With the cursor in the Sample No. field, enter thefirst sequence number (sample number), sampledisk number, and sample position number. Forexample:

• press 1 ENTER (sequence number for storageon the data disk)

• press 0 ENTER (sample disk number)

• press 1 ENTER (sample position number on thesample tray).

NOTEDO NOT use the same sequence number twice on onedata disk. ALWAYS use the next available sequencenumber.



37.0 Stand-by 12/01/92 12:20

3 Patient Test Selection

Select Tests via Keyboard : ENTER

Run TypeSample CupSample No.ID NumberSample Vol.Tests

Repeat FunctionDisplay Sample No.Print ListClear

[ ][ ][ ] - [ ][ ]

Draw Date/Time

Sex/AgeNAMELOCATIONPHYSICIANPATIENT IDDRAWN BY:

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD Cup

16142Normal

[ ][ ][ ] [ ] [ ][ ][ ][ ]

RECORD SPACE : 785

[ ] / [ ] / [ ] [ ] : [ ]

[ ] [ ] [ ][ ][ ][ ][ ][ ]

12 01 92 12 20

F 67 YWILMOTH, M.O.P.SMITH, J. B.102-23-5656MJM

2 • 14

5 The cursor advances to the ID Number field. Typethe patient ID number, if required, and pressENTER. If a patient ID number is not required, movethe cursor to the Sample Vol. field.

6 With the cursor in the Sample Vol. field, specifya volume level (normal volume, decreased volume,or increased volume), then press ENTER.

7 With the cursor in the Tests field, select therequired tests for the sample. Press the test and/or profile keys that correspond to desired testitems. The corresponding test key shown on thekeyboard matrix highlights in reverse video when aselection is made. An arrow indicating increasedor decreased sample volume appears inappropriate test keys on the keyboard matrix. Ifdemographic information is desired, proceed tostep 8. If no demographic information is needed,proceed to step 9.

8 Draw Date/Time:Sex/Age:Name:Location:Physician:Patient ID:Drawn By:

Use these fields to enter demographic informationabout each sample. The Name, Location,Physician, Patient ID, and Drawn By fields areall comment fields with user-definable titles. Youranalyzer may display different titles for thesefields. Refer to Section 2.53 to assign names tothese fields.

9 After all tests are selected and neededdemographic information is programmed, pressENTER. The sequence number (sample number)increments automatically.

10 The Repeat function for batch programming. It isavailable only after test selections are made for thefirst sample in the batch.

11 To view a visual check of programming, enter thesequence number in the Display Sample No.field.



12 Advance the cursor to Print List. Type thesequence number of the first specimen in the run(first sample number entered), then press ENTER.

13 Type the sequence number of the last specimen inthe run (last sequence number entered), thenpress ENTER. The Requisition List, as shown inSection 2.5.3 on the following page, prints. This listshows the tests selected for each specimen andthe total number of times each test has beenselected.

14 After the instrument enters Stand-by or SampleStop, proceed to Section 2.7, Initiate Run.

2.5.3 Example of Requistion List

An example of the Requisition List is shown below.

Figure 2-9: Requisition List

REQUISITION LIST 09/25/91 12:20

S.NO. POS. ID 5 10 15 20 25 30 35 40 45N001*N002N003N004N005N006N007N008N009N010N011N012N013N014

0-010-020-030-040-050-060-070-080-090-100-110-120-130-14

12345678901231234567890346747584372564723478098723484758943627846347839012837547589327035987082345798487455870950289309834090940783820938704745837409285047070298314904347039842798234

TEST COUNT

CHANNEL TEST COUNT CHANNEL TEST COUNT CHANNEL TEST COUNT

123456789

1011121314151617

CKLDASTALTALPGGTAMYLT.BILD.BILBUNGLUBICARCATRIGURICALBTP

110

111313

813

1741

1045100

1819202122232425262728293031323334

PHOSCREATCHOLMG

1100

353637383940414243444546ISE

S.IND

LIPASCK-MBHDL

NAKCL

000

0000

*--**+-*-I-+--D--+-----+-----+-----+-----+-----+-----+

*--**+-*---+-----+--D--+-----+-----+-----+-----+-----+

--*-*+-*-**+--D--+-----+-----+-----+-----+-----+-----+

*-**I+-*D-*+-*I--+-----+-----+-----+-----+-----+-----+

--***+*--ID+-I***+---I-+-----+-----+-----+-----+-----+

*-***+**---+-*-I-+-----+-----+-----+-----+-----+-----+

*-***+**---+-*-D-+-----+-----+-----+-----+-----+-----+

*-***+**---+-*---+-----+-----+-----+-----+-----+-----+

*-**-+-*--D+-*-I-+-----+-----+-----+-----+-----+-----+

*-***+**-*-+-*---+-----+-----+-----+-----+-----+-----+

---**+**-I-+-*-D-+-----+-----+-----+-----+-----+-----+

*-***+-*---+-----+-----+-----+-----+-----+-----+-----+

*-***+**---+-*---+-----+-----+-----+-----+-----+-----+

*-***+**-**+**---+-----+-----+-----+-----+-----+-----+

LEGEND

* - normal sample volumeI - increased sample volumeD - decreased sample volume

2 • 15

2.6 Routine Patient Test Selection With Bar Code Reader

2.6.1 Introduction

With the bar code reader in use, patient testselections can be either entered manually ordownloaded from a host computer. An example of thePATIENT TEST SELECTION screen is shown inFigure 2-10. As tests are selected, the correspondingtest key is highlighted in reverse video on thekeyboard matrix. After the sample number of a patientwith previously defined tests is entered, the testselection is highlighted on the keyboard matrix.

Use the following procedure to manually enter patienttest selections.

2.6.2 Manual Entry

1 Press ROUTINE, then 3 ENTER to display thePATIENT TEST SELECTION screen as shown inFigure 2-10.

2 Previous test selections are stored in C-RAM andare not automatically cleared�even if the analyzeris powered OFF and back ON. Clearing theprevious test selections from the internal memoryensures no test selection errors occur by mixingpreviously selected tests with currently selectedtests.

Move the cursor to the Clear field. Press 1 ENTER.The prompt �Are You Sure?� appears. Press 1(Continue) ENTER.

Figure 2-10: PATIENT TEST SELECTIONS�with BarCode Reader

3 To change the Run Type or Sample Cup fieldsfrom the default settings, move the cursor to theappropriate field. Select either the run type or thesample cup and press ENTER.

4 Move the cursor to the ID Number field and typethe bar code label ID number; then press ENTER.

5 With the cursor in the Sample Volume field,specify a volume level, (normal volume, decreasedvolume, or increased volume); then press ENTER.

6 With the cursor in the Tests field, select therequired tests for the sample. Press the test and/or profile keys that correspond to the desired testitems. The corresponding test key shown on thekeyboard matrix is highlighted in reverse videowhen a selection is made. An arrow indicatingincreased or decreased sample volume appears inthe appropriate test keys on the keyboard matrix.Refer to Section 2.19 for details about keyboardmatrix highlighting. If demographic information isdesired, proceed to step 7. If no demographicinformation is needed, proceed to step 8.

7 Draw Date/Time:Sex/Age:



37.0 Stand-by 12/01/92 12:20


Input Sample ID Number (Maximum 13 Characters) : ENTER

Run TypeSample Cup

ID NumberSample Vol.Tests

Display ID No.Print ListClear

[ ][ ] - [ ][ ]

Draw Date/Time


1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD on Tube

16142Normal

[ ][ ]

[ ][ ][ ]

[ ] / [ ] / [ ] [ ] : [ ]

[ ] [ ] [ ][ ][ ][ ][ ][ ]

12 01 92 12 20


2 • 16



Name:Location:Physician:Patient ID:Drawn By:

Use these fields to enter demographicinformation about each sample. The Name,Location , Physician , Patient ID and Drawn Byfields are all comment fields with user-definabletitles. Your analyzer may display different titlesfor these fields.

8 After all tests are selected and the necessarydemographic information is entered, pressENTER.

9 To test additional samples, repeat steps 3through 8.

2.6.3 Real Time Downloading fromHost Computer

No entries are necessary on this screen when in realtime bi-directional communication with a hostcomputer.

To initiate real time communication, press ROUTINE,followed by 4 ENTER, to display the STARTCONDITIONS screen. Move the cursor to the HostCommunication field. Press 1 ENTER to turn on hostcommunication. On the OPERATION MONITORscreen, the Communication field indicates whetherthe analyzer is on-line or off-line with the host. Pleaserefer to the 911 Host Interface document for details onthe communication protocol.

2 • 17

2.7 Initate Run

2.7.1 Introduction

This section describes how to initiate a run. PressROUTINE, 4 ENTER to display the STARTCONDITIONS screen, as shown in Figure 2-11. Thisenables you to check operating conditions prior tobeginning the run.

Figure 2-11: START CONDITIONS

2.7.2 Procedure

Any of the entry fields described below may alreadycontain the desired information. If so, advance thecursor to the next field that requires an entry.

1 Start Sample No. : Enter the sequence number ofthe specimen to be sampled first. The first samplenumber (sequence number) may be 1 to 800, asindicated by the prompt at the bottom of thescreen.

Before setting the Start Sample Number to alower number you must clear existing data fromthe data disk. The instrument must be in Stand-by or Sampling Stop to change the Start SampleNumber to a lower number. If you store thepatient data on a data disk, you must replace thedata disk with a new data disk when the disk is full.Refer to step 10 of this procedure to check datadisk storage.

2 Start Up Calibration : Automatic calibration willoccur no matter what is specified in this field. If youwant the scheduled run to begin with a start upcalibration, press 1 and ENTER. After start upcalibration is completed, this field automaticallydefaults back to Off. The analyzer must be inStand-by to make entries in this field.

To begin a scheduled run without a start upcalibration, press 0 ENTER.

3 Repeat Calibration : To begin the scheduled runwith Repeat Calibration, press 1 (ON) ENTER.After Repeat Calibration is completed, this fieldautomatically defaults back to Off. The analyzercan be in any mode to make entries in this field.

4 Routine Rerun Mode : To automatically processreruns at the end of the run, press 1 (PerformAutomatic Rerun) ENTER. If reruns are not to beprocessed automatically, press 0 (No Reruns)ENTER.

5 Stat Rerun Mode : If Stat reruns are to beprocessed automatically press 1 (PerformAutomatic Rerun) ENTER. Stat reruns areprocessed immediately, not at the end of the run.If Stat reruns are not to be processedautomatically, press 0 (No Reruns) ENTER.


2.7 Initate Run

37.0 Stand-by 12/01/92 12:20

4 Start Conditions




[ ] : [ 0] [ 1][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]


Off

ReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

2 • 18

remains inactivated until you �unmask� it throughthis field. Masked channels are indicated by aback slash through the test key on the keyboardmatrix as illustrated in Figure 2-11 on the previouspage.

When a test is masked, it does not calibrate, runcontrols or patient samples. You can mask a testfrom any mode.

7 Host Communication: Use this field to selectcommunication with a host computer. Press 1ENTER to turn on host communication or 0 ENTERto turn OFF host communication. The analyzermust be in Stand-by to make entries in this field.

8 ISE Maintenance: This field defaults to Off. Toinitiate end of run ISE maintenance, make suresystem cleaning solution is in the �W2� cupposition on the sample disk. Press 1 (ON) ENTER.You can be in any mode to initiate ISEmaintenance.

9 Print Format: Press 1 ENTER to print out thereport in the Short format. To print out reports in theREPORT format, press 2 ENTER. If you do notwant reports to print out automatically, press 0ENTER. In this case, the results can be printed outcollectively from the ROUTINE JOB, DATAREVIEW screen.

10 Calibration Print: Press 1 ENTER to print out thecalibration report automatically. If you do not wanta printed calibration report, press 0 ENTER. BM

recommends leaving this field Yes at all times.You cannot reprint a calibration report.

Before You Start the Analysis:

• If you store all specimen results on the datadisk for later retrieval, you must ensure thateach sequence number is used only once onany data disk. To ensure this, replace the datadisk when the sequence number reaches 800.

• If you do not want to retrieve results, you mayclear the data disk. In this case, you mustensure that no more than 800 routinespecimens are run.

WARNINGWhen the STAT sequence number reaches 200, clearall STAT results from the data disk before you requestmore STATs. This prevents an accidental merge of theold data on the data disk with the new data.

11 Clear Results: This procedure clears all routine,and Stat results, as well as all daily QC results. Ifyou do not want to clear your daily QC, clear theroutine, and STAT results individually.

To clear the data disk, advance the cursor to ClearResults, then:

• Press 4 ENTER (All). (Or press the key thatcorresponds to the type of data to be cleared:1: Routine 2: Stat, 3: Control.)

• When you clear all results, the start samplenumber of Stat and control samples are resetto 1. You also may select a range of sampledata to clear. Type in the beginning samplenumber and press ENTER. Type in the endingsample number and press ENTER. Ranges forroutine samples are 1-800, Stat samples are 1-200, and control samples are 1-8.

• The CRT displays the message "Are YouSure?".

• Press 1 (Continue) ENTER.


2.7 Initate Run

IF... THEN...

you want to mask achannel

press the combination oftest and profile keys thatreflects the channel thatyou want to inactivate;then press ENTER.

you want to unmaska channel

press the correspondingtest key ; then pressENTER.

2 • 19


2.7 Initate Run

12 Place all patient samples, controls, and calibratorsin their appropriate positions on the sample disk.(Refer to the Calibration Load List and RequisitionList for positions.) Place sample cups that containSystem Cleaning Solution in the �W1� and �W2�positions on the sample disk.

13 Press OPERATION MONITOR. If any alarms arelisted, correct the alarm condition beforecontinuing. Verify incubation temperature (37 °C ±0.1 °C).

14 Press START.

2 • 20

2.8 Stat Test Selection

2.8.1 Introduction

Use the procedure outlined below to place Statsamples on the analyzer for processing when theanalyzer is in the OPERATE mode. If the analyzer isin any other mode, refer to Section 2.29 for theprocessing of Stat samples. Stat tests are includedwhen counting down the control interval.

2.8.2 Procedure

1 Press STAT to display the STAT TESTSELECTION screen, as shown in Figure 2-12.

Figure 2-12: STAT TEST SELECTION - - page 1

Figure 2-13: STAT TEST SELECTION - - page 2

2 Check the Pos. Status matrix on the screen forany position not highlighted in red. Positions nothighlighted in red are currently available for STATprocessing. Positions 51 through 70 on the middletrack are reserved for dedicated use of STATsamples when the bar code reader is not in use.Positions 1-50 are always highlighted in red whenthe bar code reader is not in use. When the barcode reader is on, all 70 positions may be used forSTAT samples.

3 Run Type: This field defaults to the chosensetting, usually SERUM. If another sample classis used, specify the appropriate class and pressENTER.

4 Sample Cup: This field defaults to STD Cup. Ifanother sample cup size is used, specify theappropriate size and press ENTER.

5 Sample Pos.: Enter the position numbercorresponding to the STAT sample and pressENTER.

6 ID Number: Type in the ID number, if required, andpress ENTER.



37.0 Stand-by 3/18/93 12:20

Stat Test Selection


Run TypeSample Cup

Sample Pos.ID NumberSample Vol.Tests

Pos. Status

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD Cup

61

Normal

THEO

C-18 C-12

LIVER HEART

[ ][ ]

[ ]

[ ][ - ]

1. Put the Sample on the Sample Disk.

3. Press START Key.2. Input S. Position and Select Tests.

12651

22752

32853

42954

53055

63156

73257

83358

93459

103560

113661

123762

133863

143964

154065

164166

174267

184368

194469

204570

2146

2247

2348

2449

2550

0 0 Occupied

37.0 Stand-by 3/18/93 12:20

Stat Test Selection


Run TypeSample Cup


Pos. Status

Draw Date / TimeSex / AgeNAMELOCATIONPHYSICIANPATIENT IDDRAWN BY:

[ 03 ] / [ 18 ] / [ 93 ] [11] : [50][M] [ 63 ] [ Y ][Smith, John ][ER-9 ][GRAHAM, J D ] [405-12-8162 ][DJB

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD Cup

61

Normal

THEO

C-18 C-12

LIVER HEART

[ ][ ]

[ ]

[ ][ - ]



12651

22752

32853

42954

53055

63156

73257

83358

93459

103560

113661

123762

133863

143964

154065

164166

174267

184368

194469

204570

2146

2247

2348

2449

2550

0 0 Occupied

2 • 21



7 Sample Volume: Sample Volume defaults toNormal. If an increase or decrease in SampleVolume is desired, specify the appropriate entryand press ENTER.

8 Tests: Press the test or profile keys to make testselections. Selected tests are highlighted inreverse video in the keyboard matrix on the screen.If demographic information must be entered,proceed to step 8. Press ENTER after all testselections are made. Check the keyboard matrixfor masked tests or tests with insufficient reagenton board.

9 If demographic data for the sample must beentered, press GUIDANCE and make theappropriate entries for the following fields:

Draw Date/Time:Sex/Age:Name:Location:Physician:Patient ID:Drawn By:

After test selections are entered, the cursor remainsin the Tests entry field. Move the cursor to the SamplePos. entry field and follow step 5 to enter the nextSTAT sample request.

Return to the OPERATION MONITOR screen after allentries are complete. The analyzer interrupts routinesamples and processes STATs at its earliestconvenience (2 cycles or 20 seconds later). Routinesample measurements are automatically continuedwhen Stat sampling is completed.

2 • 22

2.9 Measurement of AdditionalSamples

2.9.1 Introduction

The procedure for measuring additional routine samplevaries, depending on whether you are using thesample bar code reader.

2.9.2 Procedure without Bar CodeReader

1 When the analyzer is in the Operation mode,press ROUTINE 3 ENTER to display the PATIENTTEST SELECTION screen. If the next samplenumber is not known, use the Display SampleNo. field to determine the correct number. Type ina number that is close to the last sample numberentered and press ENTER repeatedly until thesample number with position 0 and no testselections is found. Use this sample number tobegin processing additional samples.

2 Run Type:Sample Cup:Select the correct sample class and cup size, ifdifferent from the defaults, and press ENTER.

3 Sample No.: Type in the next sequence numberand press ENTER. Type in the correct disk numberand press ENTER. Type in the position numberand press ENTER.

4 ID Number: Type in the ID number, if necessary,and press ENTER.

5 Sample Volume: Select the desired samplevolume and press ENTER.

6 Tests: Press the TEST or PROFILE key thatcorresponds to the required tests and pressENTER. If demographic information is desired,move the cursor to the comment fields beforepressing ENTER . The sample numberautomatically increments by one to enable you toprogram several samples. You may also use theRepeat function for test selection.

7 Place the additional samples in the properpositions on the sample disk.

8 Return to the OPERATION MONITOR screen.

If the analyzer is in either the S. Stop, Stop, or Stand-by modes, follow these steps to process additionalsamples:

1 Check START CONDITIONS for the next availablesample number.

2 Follow steps 1 through 7 listed above.

3 Press OPERATION MONITOR.

4 Press START.

2.9.3 Procedure with Bar CodeReader

1 When the analyzer is in the Operation mode,press ROUTINE 3 ENTER to select the PATIENTTEST SELECTION screen.

2 Run Type:Sample Cup:Select the correct sample class and cup size, ifdifferent from the defaults, and press ENTER.

3 ID Number: Type in the ID number and pressENTER.

4 Sample Volume: Select the desired samplevolume and press ENTER.


2.9 Measurement of Additional Samples

2 • 23

5 Tests: Press the TEST or PROFILE key thatcorresponds to the required tests and pressENTER. To enter demographic information, movethe cursor to the comment fields and enter theappropriate information prior to pressing ENTER.

6 Place the additional samples on the sample disk inpositions that have not passed the sample barcode reader. If the analyzer has already registereda zero bar code, you must wait for Sampling Stopto process additional samples. Once the analyzeris in the Sampling Stop mode you can placeadditional samples and proceed with step 7.

7 Return to the OPERATION MONITOR screen.

If the analyzer is in either the S. Stop, Stop, or Stand-by modes, follow these steps to process additionalsamples:

1 Follow steps 1 through 6 listed above.

2 Press ROUTINE JOB 4 ENTER to call up theSTART CONDITIONS screen. Type in the correctstart sample number in the Start Sample No.field.


4 Press START.


2.9 Measurement of Additional Samples

2 • 24

2.10 Rerun Sample Processing

2.10.1 Introduction

Selecting Automatic in the RERUN MODE field on theSTART CONDITIONS screen processes rerunsautomatically. If automatic rerun is not selected andyou want to process reruns, or if you want to edit thererun list, use the following procedure. This procedureis performed after a routine run is completed. You donot need to rearrange the sample positions for rerunmeasurement. Occurrence of a data alarmautomatically places the relevant test item on thererun list.

2.10.2 Procedure

1 Press ROUTINE 7 ENTER to view the first pageof the RERUN SAMPLES screen. This screen isshown in Figure 2-14.

2 Rerun List: Type in the first sample number andpress ENTER. This displays a list of all samplesscheduled for rerun. Press PAGE CONTINUE toview additional rerun samples on the CRT.

3 Print: Type in the first and last sample numbersrepresenting the rerun range from the displayedsample list. To make this entry, type the firstsample number and press ENTER, then type thelast sample number and press ENTER. Use theprinted list to check the rerun sample numbers,decreased or increased sample volume, and otherinformation. Press GUIDANCE to view individualrerun sample information.

4 The second page of the RERUN SAMPLESscreen (see Figure 2-15 on the following page)displays individual rerun sample information. Typein the number of the sample you want to view in theSample NO. field. Press ENTER to display theresults for the first run and automatic rerun, if

selected. The original tests requested that have adata flag are highlighted in reverse video in thekeyboard matrix on the screen. An up or downarrow on the test key indicates selection ofincreased or decreased sample volume.

5 ID Number:Sample Cup:S. Type: These three fields are automatically filledin with the information entered for the selectedsample number during Patient Test Selection. TheS. Type field cannot be edited.

6 Name:Location:Physician:Patient ID:Drawn By: These fields are automatically filled inwith the information entered for the selectedsample number during Patient Test Selection. Allfields may be edited.

7 Sample Vol.: Specify decreased or increasedsample volume, if needed, then press ENTER.

8 Tests: To delete or add a rerun test selection,select or deselect the appropriate test key.Selected rerun tests are highlighted in reversevideo in the keyboard matrix on the screen.



2 • 25



Figure 2-14: RERUN SAMPLES - - page 1

Figure 2-15: RERUN SAMPLES - - page 2

9 Press GUIDANCE to return to the previous screen.You can view the edited rerun list or request aprinted list of the edited rerun samples at this time.

10 Press ROUTINE 4 ENTER to display the STARTCONDITIONS screen. Move the cursor to theRoutine Rerun Mode field and press 2 ENTER toselect rerun only. After the rerun processing iscompleted, this field defaults back to Off.

11 Move the cursor to the Start Sample No. field andenter the first rerun sample number.

12 Press OPERATION MONITOR followed bySTART to initiate rerun processing.

After the samples listed on the RERUN SAMPLESscreen are rerun and this screen is recalled, enter thefirst sample number from the original run in the RerunList entry field to display rerun samples again.Within-range samples are displayed in reverse videoat the bottom of the screen. Out-of-range samples aredisplayed in regular type, preceded by a questionmark, indicating further action is needed by theoperator.

1 To clear rerun test selection information, move thecursor to the Clear field, then:

• Press 1 ENTER to remove all rerun testselection information.

• Press 2 ENTER to remove only test selectioninformation that did not generate a data flagupon rerun (those samples displayed in reversevideo).

2 Before you attempt to rerun these samples again,check the cause of the data alarm and take theappropriate troubleshooting steps.

37.0 Sample Stop 12/01/92 12:20

7 Rerun Samples

Input Sample No. 1 to 800 : ENTER

Rerun ListClearPrint

[ ] [ ][ ][ ] - [ ]

S.No. Pos. ID No. Date Time Name LOCATION

ICU-12ICU-8O.P.O.P.OUTPATIENTS317-2ICU-7

7:217:227:157:288:236:305:45

0- 10- 20- 30- 60- 70- 80-10

0599101614212841355

01008269628053

DOBBINS, KSMITH, JJAMES, BVOGT, MILDREDWILMOTH, MHOBBS, JPULAKSI, WM

123678

10

12/0112/0112/0112/0112/0112/0112/01

RoutineAlarm

1 059910

nnn Rerun Finishednnn Rerun Failed?

??

?

37.0 Stand-by 12/01/92 12:20

7 Rerun Samples


Sample No.ID NumberSample CupSample Vol.TestsS.Type

NAMELOCATIONPHYSICIANPATIENT IDDRAWN BY:

[ ][ ][ ][ ][ - ]Serum

Alarm

DOBBINS, KICU-12GRAHAM , J D123-56-9847DJB

[ ][ ] [ ][ ][ ]

1st Rerun 1st Rerun 1st Rerun

810111319

TBILIBUNGLUCA

10.3143.8466$10.7

47484956

NaKCL

UN / CR

138.04.70

105.014

1059910

STD on TubeNormal

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

2 • 26



Both the first run result and the rerun result are storedon the data disk. Upon completion of a successfulrerun, replace the first run result with the rerun result.

IF... THEN...

you do not want tomake changes and thesamples are in theiroriginal position on thesample disk

no other entries arenecessary on thisscreen.

you want to place onlyrerun samples on thesample disk (forinstruments with barcode reader)

no other entries arenecessary. Simplyremove the rerunsamples from theiroriginal positions andreposition them forbatch processing.

you want to place onlyrerun samples on thesample disk (forinstruments without barcode reader)

place samples in newpositions on sampledisk. Move the cursorto the SAMPLE NO.entry field and enter thesequence number. Theoriginal tray numberand cup position aredisplayed. Enter thecorrect tray number andcup position.

2 • 27

2.11 Within-Run Recalibration

2.11.1 Introduction

If any test fails calibration, or if the controls runfollowing calibration are out of range, the test can berecalibrated while the instrument is in the Operatemode.

When an assay calibration fails, subsequent patientand QC results are calculated from the lastsuccessful calibration for that assay. All of thesepatient results are flagged. The patient report will havea CALIB! alarm and the DATA REVIEW and REALTIME DATA MONITOR screens will display �!� to flagthe results until a successful calibration iscompleted.

Do not confuse this alarm with the CALIB alert on theCalibration Monitor report. The CALIB on theCalibration Monitor report indicates that the lastcalibration was different from the previous calibration.As long as the QC results calculated from thecalibration with the CALIB alert on the CalibrationMonitor report are within range, then the calibration isfine.

2.11.2 Procedure

Within-run recalibration is performed as follows:

1 Before requesting recalibration, determine whythe original calibration failed for the specified test.If necessary, consult Chapter 4, Troubleshooting,to determine the nature of the problem.

2 After the situation responsible for the failedcalibration is corrected, press ROUTINE, then 2ENTER to display the CALIBRATION TESTSELECTION screen.

3 Mode: Press 2 (Repeat Calib.) ENTER. Verifythat the 911 has automatically programmed thetest for a Repeat Calibration. If the test is notprogrammed, proceed with step 4. If the test isprogrammed, proceed with step 6.

4 Type: Select the necessary calibration method(Blank, 2 Point, Full, or Span).

5 Tests: Press the test selection key to select theappropriate tests. Selected tests are highlighted inreverse video.

6 Make certain that sample cups containingsufficient quantities of the required calibrators andcontrols are in their assigned positions on thesample disk.

7 Press ROUTINE 4 ENTER to call up the STARTCONDITIONS screen.

8 Repeat Calibration: Press 1 (On) ENTER. Thecalibrators are sampled immediately following thespecimen for which the instrument is currentlyblanking cells.

2.11.3 Rerun Calibration

If a rerun calibration is requested, controls are runimmediately following for those tests that wererecalibrated, provided the appropriate control testselections are made and the control interval onCHEMISTRY PARAMETERS is > 0.

2.11 Within-Run Recalibration


2 • 28

2.12 Data Editing

2.12.1 Introduction

Use the following procedure to add, edit, or deleteresults via the DATA REVIEW screen.

2.12.2 Procedure

1 Press ROUTINE 6 ENTER to display page 1 of theDATA REVIEW screen, as shown in Figure 2-16.This page displays a list of the samples accordingto type and either sample number or ID number,depending on whether the bar code reader is used.

2 Move the cursor to the Run field and press 1ENTER for routine samples or 2 ENTER for Statsamples.

3 Move the cursor to the List field and enter thedesired sequence number.

4 Press GUIDANCE to display page 2 of the DATAREVIEW screen, as shown in Figure 2-17.

5 Move the cursor to the Edit Result field. Press 1ENTER to edit a first run result. Press 2 ENTER toedit a rerun result. Press the test key thatcorresponds to the test to be edited. Enter thecorrect result, or press the space bar to delete theexisting result.

6 When all editing is complete, move the cursor tothe fourth entry of this field. Press 1 ENTER to savethe previously edited data to the data disk. Press2 ENTER to replace all original results with thererun results and save to the data disk. The promptline displays �Are You Sure?�. Press 1 (Continue)ENTER.

2.12 Data Editing


37.0 Operation 12/01/92 12:20

6 Data Review


RunList Print

Data Transfer[ ] [ ] [ ] - [ ][ ] [ ] - [ ]

[ ][ ] [ ]


ICU-12ICU-9O.P.PACU-10O.P.O.P.OUTPATIENTS317-2S323-1ICU-7T412-1OUTPATIENTN403-4OUTPATIENT

8:278:288:308:318:338:348:348:358:378:388:418:438:438:44

0-010-020-030-040-050-060-070-080-090-100-110-120-130-14

059910161421284

25313010571355

0100826962071948053690

63340019616858

DOBBINS, KSMITH, JJAMES, BTOLBERT, UKNIGHT, RVOGT, MILDREDWILMOTH, MHOBBS, JFRICKENSCHMIDT, OPULAKSI, WMDONAGHUE, PJOHNSON, PHOLLINGSWORTH, MKOVAK, K

123456789

1011121314

12/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/01

Routine

Rtn.1 0599910

Figure 2-16: DATA REVIEW - - page 1

37.0 Washing Probe 12/01/92 12:20

6 Data Review


RunListS. Type SerumDraw Date / TimeSex / AgeNAMELOCATIONPHYSICIANPATIENT IDDRAWN BY:

Edit ResultPrintData Transfer

[ ] [ ] [ ] [ ][ ] [ ] [ ] - [ ][ ] [ ] - [ ]

[ ][ ] [ ]

Routine

Rtn.1 059910

Alarm

12 01 92 11 50 M 36 YDOBBINS, KICU-12GRAHAM , J D123-56-9847DJB

[ ] / [ ] / [ ] [ ] : [ ][ ] [ ] [ ][ ][ ] [ ][ ][ ]


123456789

10

11121314151617181920

21222324252627282930

CKLDASTALTALP / AGGTAMYLTBILIDBILIBUN

GLUCO2CATRIGUAALB / PTPPHOSCREACHOL

MG

REF

10.3

143.8

466$

10.7

10.2

Figure 2-17: DATA REVIEW - - page 2

2 • 29

2.13 Quality ControlProcedures

2.13.1 Daily QC Results

Daily quality control results can be viewed through theREAL TIME QC, INDIVIDUAL QC MONITOR,INDIVIDUAL QC LIST, AND INDIVIDUAL QC CHARTscreens.

During routine operation, the instrument comparespaired (X) and (Y) control values against the mean andSD entered for each control on the REAL TIME QCscreen. The instrument uses specific guidelines(modified Westgard Rules or Multi-Rule Shewhart)selected by the operator (explained in Section 5.34) toevaluate each set of control results.

Each set of control results is either acceptable orexhibits a random, system, or indeterminate error. Ifa random, systematic, or indeterminate alarm isissued, an alarm message appears on theOPERATION MONITOR screen, and the appropriatedata alarm appears next to the affected test on theresult printout and on the INDIVIDUAL QC MONITORscreen.

The REAL TIME QC screen judges quality controlresults by a multi-rule Shewhart method. Random,systematic, or indeterminate QC errors are flagged onthe REAL TIME QC screen. In addition, an audiblealarm is issued when an error of this type is detected.Consult these screens during a chemistry run toensure that patient results are properly controlled.

2.13 Quality Control Procedures


2 • 30

2.14 QC File Maintenance

2.14.1 Introduction

Daily and cumulative values for a maximum of eightlevels of controls can be stored in the instrument byperforming the following steps:

1 Evaluate daily QC values for all tests and deletethose that are to be excluded from cumulative QC.Daily QC values should not be deleted without avalid reason. You can delete daily QC values inone of four ways:

• QC Job, REAL TIME QC screen, Data Rejectfield. See Section 2.31

• QC Job, INDIVIDUAL QC MONITOR screen,Delete field. See Section 2.32

• QC Job, INDIVIDUAL QC LIST screen, ResultEdit field. See Section 2.33

• Routine Job, START CONDITIONS screen,Clear Results field. See Section 2.23

2 Accumulate daily values into cumulative QC, usingthe Individual QC List.

2.14.2 Procedure

To delete daily QC values using the REAL TIME QCscreen and the Data Reject field, as well asaccumulate daily QC values, perform the followingsteps:

1 Press QC, followed by ENTER, to display theREAL TIME QC screen, as shown in Figure 2-18.

2 Move the cursor to the Test field. Type the channelnumber or press the test key for the test to beviewed.

3 Move the cursor to the Data Reject field. Press 1to delete random errors, 2 to delete systematicerrors, or 3 to delete QC errors, followed by ENTER.

This deletes all random, system or QC errors. Youcannot selectively delete points here.

4 Repeat steps 2 - 4 for all tests.

5 Press QC, followed by 3 ENTER, to display theINDIVIDUAL QC LIST screen, as shown in Figure2-19.

6 Move the cursor to the Control field and press 1ENTER to accumulate values for control level 1.

7 Move the cursor to the Accumulate field and press1 ENTER. The message "Are You Sure?" isdisplayed. Press 1 (Continue) ENTER.

8 Repeat steps 6 and 7 for the remainder of thecontrols. In step 6, enter the number (2-8) thatrepresents the level of control you areaccumulating.

When the data is accumulated, the REAL TIMEQC and INDIVIDUAL QC LIST are cleared. The QCdata on INDIVIDUAL QC MONITOR appears inreverse video to indicate it has been accumulated.Data points on INDIVIDUAL QC CHART appearsas "#" to indicate it has been accumulated.



2 • 31



37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test

ControlS. TypeTarget MeanTarget SD

( * )(@)( # )(+ )

1010

Normal DataRandom ErrorSystem ErrorQC Error

0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3

@, #, + Data Reject [ ]

Rules Enabled [ ] - [ 1]

1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

*

#

Figure 2-18: REAL TIME QC

37.0 Stand-by 12/01/92 12:20

3 Individual QC List

Input Control No. 1 to 8 : ENTER

ControlS.Type

Accumulate

PrintDelete

Reprint QC Report

Transfer to Host

[ ]Serum

[ ]

[ ][ ]

3.21.90.40.6

0.001.092.4

1.670.330.100.190.320.110.0512.45.17

0.2340.42

2.575.491.681.340.005.313.175.353.932.704.034.274.373.016.133.433.790.39

7511

0.02.4

64.30.70.20.50.70.30.125

11.10.500.6

124.634.623.844.71.30

20.5475.6

31.248.403.704.727.502.521.66

202.4150.586.168

108.20

106.0-30.0-20.0-34.0-1.01-17.7-71.0-25.0-7.40-3.30-4.1-6.8-

2.30-1.56-

184.0-143.9-5.82-

106.2-

148.042.028.050.01.4123.785.033.08.804.304.97.6

2.901.96

214.0155.96.62

120.2

23478

10111213151617181920474849

555335555555555552

LDASTALTAMYLTBILIBUNGLUCO"CAUAALB/PTPPHOSCREACHOL

PTN-81

[ ] [ ] - [ ]

[ ] - [ ]

Ch Test N Mean 2SD Limits SD CV(%) Range

NaKCl

Figure 2-19: INDIVIDUAL QC LIST

2 • 32

2.15 Patient Reports

2.15.1 Real Time Printout of PatientResults

You can direct the instrument to print or not to printpatient results as they become available. Real Timeprinting of patient results is controlled through theSTART CONDITIONS screen. If you request thatresults be printed, the instrument can be directed toprint results in report format (chartable report) or shortformat (condensed report).

The report format is defined by the operator through theREPORT FORMAT screen, which is located in thePARAMETER JOB.

All test results are stored on the data disk. If theinstrument is directed not to print results in real time,you can print patient reports at a later time through theDATA REVIEW screen.

You can edit rerun test results into the original patientfile and print the complete report through the DATAREVIEW screen.

You can edit test results obtained on a separateinstrument into the patient file and print the completereport through the DATA REVIEW screen.

2.15.2 Edit Patient Reports

Use the DATA REVIEW screen to edit patientreports.

2.15 Patient Reports


2 • 33

2.16 Overview

2.16.1 Introduction

Part B of Chapter 2 outlines the CRT screens on youranalyzer. An example and a brief description of eachscreen are included. For screens used to processroutine samples, operating procedures are found inPart A of this chapter, Operating Instructions. Non-routine procedures, or procedures required for initialanalyzer set-up, are included in Part B.

Before discussing specific screens and how to usethem, some general instructions are necessary.These instructions apply to all 911 Analyzer CRTscreens. The screen representations shown in thischapter and throughout this manual are for illustrativepurposes only. The data shown may not accuratlyreflect normal, day-to-day operation of the analyzer.

2.16.2 Entry Fields

Entry fields are areas where you enter information. Anentry field is active when the cursor is shown in the field(in reverse video), and the appropriate entry promptsare displayed. Some data may not reflect normal day-to-day operation of the analyzer. You can move thecursor to activate the entry fields by pressing the arrowkeys, which are the four keys located to the left of thenumeric keypad.

2.16.3 Field and Prompt Explanations

Throughout the remainder of this chapter each entryfield and related screen prompts are listed in thefollowing format:

Entry Field Name [ ] Highlightedarea indicates

Related Screen Prompts position ofcursor.

2.16.4 Entry Prompts

At the bottom of each screen is an entry prompt. Inthis area, the software instructs you as to what typeof information to enter, and what format to use whenentering that information. This information is specificto the entry field where the cursor is positioned. Asyou type your entry, it appears in the entry field.Before you press ENTER, look at the entry to be sureit is correct. NOTE: ENTER must be pressed after theentry is completed to process each keyboard entry.

If the message INPUT ERROR appears at the bottomof the screen, an entry error has occurred.

2.16.5 How to Clear Entry Errors

There are two types of entry errors:

Input errors occur when the instrument status doesnot permit the desired entry. (Example: trying toenter 7 when only 1 - 6 is allowed.)

To correct input errors:

1 Press the CANCEL key to clear.

2 Re-enter the appropriate information after theinstrument has reached the appropriate status.

2.16 Overview

2. CRT SCREEN DISPLAY

PART B

2 • 34

Typing errors are not recognized by the instrumentunless they also result in an input format error. Theymay be corrected by the following procedure:

1 Move the cursor to the field containing the error andpress C to cancel the error.

2 Enter (type) the correct information, according tothe entry prompt.

3 Press ENTER.

2.16.6 Screen Configuration

Figure 2-20 is an example of the 911 screenconfiguration.

Figure 2-20: 911 CRT Screen Configuration

2.16 Overview


Alarm Status(Highlighted inyellow)

Alarm 37° Operation 06/25/92 12:20

Input Number From List to Access Desired Function : ENTER

Routine

Processing Status Date Time

Incubation BathTemperature

Operational Mode

Guidance and Page Continue IconPrompt Line

Contents ofScreen

Item Description

Alarm Status notifies the operator of aninstrument alarm condition.

Incubation Bath indicates temperature ofthe incubation bath water.

Operational Mode(all modes are definedin Section 1.8)

indicates the operationalmode of the instrument.These modes include:Initialization, Stand-by,Parameter Check, Reset,Operation, Sampling Stop,Stop, Sleep, Wake-Up,Stat Stand-by, Check, andProbe Wash.

Processing Status indicates the processingstatus of the instrument.These include: Routine,Stat, and Name ofMaintenance Functionbeing performed.

Date indicates the current date.

Time indicates the current time.

Guidance and PageContinue Icons

indicate the Guidance orPage Continue keys areactive.

Contents of Screen contain information toperform the function.

Prompt Line lists all possible selectionsfor entry field where thecursor is located.

2 • 35

2.16.7 Initialization Screen

After the ON switch is in the ON position, the analyzerenters the Initialization mode and the following screenappears. Press any job selection key to beginoperation. Figure 2-21 is an example of theINITIALIZATION screen.

Figure 2-21: Initialization Screen

NOTEFor reference only. Screen may not appear exactly asshown.

2.16 Overview


Initialization 06/25/92 12:20

HITACHI AUTOMATIC ANALYZER

COPYRIGHT (C) HITACHI, LTD, 1991, 1992

SYSTEM FD VERSION : 7076020-04-08DATA FD VERSION : 7076001-00-01

Press Any Job Selection Key ?

2 • 36

2.17 Operation Monitor

2.17.1 Introduction

Use the OPERATION MONITOR screen to viewinformation about current instrument conditions. TheOPERATION MONITOR screen has two pages. Asampling grid displays the processing status of eachsample in the outer and middle rings of the sampledisk on page 1. Alarms are also listed on page 1.Page 2 displays additional operating information. Theoperator cannot make any keyboard entries fromeither page of the OPERATION MONITOR screen.

2.17.2 Displaying OPERATIONMONITOR - - Page 1

Press the OPERATION MONITOR key to displaypage 1 of the OPERATION MONITOR screen.

2.17.3 Example of OPERATIONMONITOR - - Page 1

Figure 2-22 is an example of page 1 of theOPERATION MONITOR screen.

Figure 2-22: OPERATION MONITOR Screen - - Page 1

2.17.4 OPERATION MONITOR Fieldsand Prompts - - Page 1

Each OPERATION MONITOR screen - - Page1 fieldand prompt is explained below.

SAMPLING GRID

The sampling grid displays the status of each samplein the outer and middle rings of the sample disk. Thecontents in these spaces are cleared when the diskis changed or when START is pressed from Stand-byto begin a new run.

Different letters and highlighting appear in thenumbered boxes of the grid to indicate samplingstatus. The legend on the screen provides anexplanation. A description of the legend is given in thetable below.



37.0 Stand-by 12/01/92 12:20

Operation Monitor

Alarm MessageStirrer 2:Execute Mech. Check

LevelSTOP

Code02-006

Time10:20

51 2 3 4 5 6 7 8 9 60 1 2 3 4 5 6 7 8 9

1 2 3 4 5 6 7 8 9

1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 1 2 3 4 5

70

E E E E E

R:R. Finished

E:S. Finished

R:Routine

E:Stat

R:R. Finished

E:S. Finished

R:N. Rerun

E:S. Rerun

26 7 8 9 30 1 2 3 4 5 6 7 8 9 40

10 20

50

R R R R RR R R R R

Currently Sampling

OuterRing

MiddleRing

S.No.

R52

Pos.

42

ID

1234567890123

Test

AMYL

2 • 37

Currently Sampling

When the analyzer is in the Operate mode, this linedisplays information about the test currently beingsampled. When the analyzer is in the Stand-by orSampling Stop mode, information about the lastsample processed is displayed.

When sampling is complete, the No More Samples toProcess alarm is issued and sounds the buzzer untilyou press the BUZZ. OFF key. The status linedisplays Sampling Stop. After all data has printed outand the automatic wash functions are complete, thestatus line briefly changes to Stop and then returns toStand-by.

S. No.

This field displays the current sample number. Onthis line, the current sample number is preceded by aletter indicating the type of sample.

R = Routine Sample (followed bysample number 1 - 800)

RR = Routine Sample Rerun (followedby sample number 1 - 800)

E = Stat Sample (followed by samplenumber 1 - 200)

ER = Stat Sample Rerun (followed bysample number 1 - 200)

C = Quality Control number (1 - 8)followed by sequence number (1 - 30)

S = Calibrator number (1 - 6)followed by times run (1 - 3)

Pos.

This field displays the position of the test currentlybeing sampled.The first number indicates the disknumber; the second number indicates the diskposition.

ID

This field displays the ID number of the sample beingtested.

Test

This field displays the name of the test currently beingsampled. Only one test name is displayed in the 1-test mode. For serum-indexed samples without othertests selected, S. IND is displayed. For ISEsampling, ISE is displayed.



Sampling Grid Legend

R = Routine · Routine (normal) sampling inprocess (no highlighting)

R = R. finished · Routine sampling withoutrerun test selections complete; resultsprinted (white highlighting)

R = R. Rerun · Routine sampling completewith rerun test selections; resultsprinted or sampling of routine rerun inprocess (yellow highlighting)

R = R. Rerun finished · Routine rerunsampling complete; results printed(gray highlighting)

E = Stat · Stat (emergency) sampling inprocess (no highlighting)

E = Stat finished · Stat sampling withoutrerun test selections complete; resultsprinted (white highlighting)

E = S. Rerun · Stat sampling complete withrerun test selections; results printed orsampling of Stat rerun sample inprocess (yellow highlighting)

E = S. Rerun finished · Stat rerun samplecomplete; results printed (grayhighlighting)

2 • 38

Alarm Message

The descriptive names of instrument alarms that haveoccurred since powering ON the instrument, startinga chemistry run, or clearing the alarm display aredisplayed here. The 10 most recent alarms aredisplayed (first in, first out). To clear the alarmmessages, press the BUZ. OFF key twice. Refer toChapter 4, Troubleshooting, for more information oneach alarm.

NOTEAfter the condition causing the alarm is corrected, thealarm listed is cleared from the screen when the BUZ.OFF key is pressed twice, the START key is pressed,or power to the instrument is interrupted. Alarms canbe retrieved from the Alarm Log (Cumulative or Daily)Reports.

Level

The alarm level (Warning, Sampling Stop, Stop,Emergency Stop) for each alarm is displayed in thiscolumn.

Code

The Class and Code numbers for each alarm are listedin these columns to assist in looking up alarmremedies in the operator�s manual.

Time

The time each alarm occurred is listed in this column.

2.17.5 Displaying OPERATIONMONITOR - - Page 2

To view page 2 of the OPERATION MONITOR screen,press OPERATION MONITOR followed byGUIDANCE.

2.17.6 Example of OPERATIONMONITOR - - Page 2

Figure 2-23 is an example of page 2 of theOPERATION MONITOR screen.

Figure 2-23: OPERATION MONITOR Screen - - Page 2



37.0 Stand-by 12/01/92 12:20

Operation Monitor

Routine Rerun ModeStat Rerun ModePrint ModeHost Communication

Routine

: Off: Automatic: Report: Off-Line

2 • 39

2.17.7 OPERATION MONITOR Fieldsand Prompts - - Page 2

Each OPERATION MONITOR screen - - Page 2 fieldand prompt is explained below.

Routine Rerun Mode

This field displays the mode selected for reruns ofroutine samples. Mode options such as Automatic,Rerun Only, or No. are displayed.

Stat Rerun Mode

This field displays the selected mode for reruns of Statsamples. One of two mode options is displayed: AutoRerun or No.

Print Mode

This field displays the print format chosen for printingpatient results. One of these format choices isdisplayed: Short, Report, or No Print.

Host Communication

This field displays the current host communicationstatus, which is either Offline or Online.



2 • 40

2.18 Routine Job - - Menu

2.18.1 Introduction

Use the ROUTINE JOB MENU to access screens thatare used during routine sample processing.Procedures for the initial set-up of the displays aregiven in the following sections. Procedures for routinedisplay programming are given in Section A of thischapter, Operating Instructions.

2.18.2 Displaying the Routine JobMenu

Press the ROUTINE key to display the ROUTINE JOBMENU.

2.18.3 Example of the Routine JOBMENU

Figure 2-24 is an example of the ROUTINE JOBMENU.

Figure 2-24: ROUTINE JOB MENU

2.18.4 ROUTINE JOB MENUFields andPrompts

Each Routine Job Menu field and prompt is explainedbelow.

Function No. [ ]

Input Number From List to Access Desired Function:ENTER

To choose a screen from the menu, enter the screennumber and press ENTER. The selected screenappears on the CRT.

2.18 Routine Job - - Menu


37.0 Stand-by 12/01/92 12:20

Routine Job Menu

Input Number from List to Access Desired Function : ENTER

1

2

3

4

5

6

7

8

Reagent Status

Calibration Test Selection

Patient Test Selection

Start Conditions

Real Time Data Monitor

Data Review

Rerun Samples

Status Setting

Function No. [ ]

2 • 41

2.19 Routine Job - - ReagentStatus

2.19.1 Introduction

The REAGENT STATUS screen allows the operator tosee what information was obtained by the analyzerwhen the reagent bar codes were last registered(reagent registration). This screen has real-timedisplay capabilities and updates each time a reagentregistration is performed.

The REAGENT STATUS screen has two pages. Page1 has a keyboard matrix on the lower portion of thescreen. Page 2 lists all of the reagents registered bythe reagent bar code reader.

2.19.2 Displaying the REAGENTSTATUS Screen - - Page 1

Press ROUTINE to display the ROUTINE JOB MENU.Press 1 ENTER to display page 1 of the REAGENTSTATUS screen.

2.19.3 Example of the REAGENTSTATUS Screen - - Page 1

Figure 2-25 is an example of page 1 of the REAGENTSTATUS screen.

Figure 2-25: REAGENT STATUS Screen - - Page 1

2.19 Routine Job - - Reagent Status


1ENTER

37.0 Stand-by 12/01/92 12:20

1 Reagent Status



CancelPrint

Hitergent Disk 1

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL


2

[ ][ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ][ ]

[ ] 80 mL[ ] 80 mL[ ] mL[ ] mL[ ] mL

Y e sY e s3 7 02 3 02 7 0

THEO

2 • 42

When a required reagent or diluent for a specificchemistry or wash solution (for a probe wash) is notpresent on the analyzer, the corresponding test key onthe keyboard matrix is highlighted with a slash.

NOTEThe keyboard matrix indicator for an operator initiatedmasking is a reverse slash, as shown:

The test key is highlighted with a slash when:

• the reagent bottle is not present on the analyzer

• the reagent bar code reader cannot read the barcode

• less than 10 tests remain in the bottle at thebeginning of a run.

When the test key is highlighted with a slash, theanalyzer automatically masks that chemistry and willnot process any tests selected for that chemistry.

2.19.4 REAGENT STATUS ScreenFields and Prompts - - Page 1

Each REAGENT STATUS screen field and prompt isexplained below.

Registration [ ]

Choose 1: Read Reagent Barcodes 2: Read Barcodes& Check Level : ENTER

Use this field to specify the type of reagentregistration carried out by the analyzer. A bar coderegistration occurs automatically when: the reagentdisk lid is removed and replaced, the analyzer ispowered ON, or the analyzer performs Wake-UpTM.Choosing 1: Read Reagent Barcodes instructs the

analyzer to read the reagent bottle bar codes only.This takes 1.5 minutes. Choosing 2: Read Barcodes& Check Level registers both the contents of the barcode and the reagent volume. This takes 2.5 minute.The reagent volume is measured by the reagent probethrough liquid level detection. The analyzerautomatically updates the reagent level when thereagent probe enters the bottle for the first time. Enterthe proper choice and press ENTER.

Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Use the manual set fields to manually enterinformation from a reagent bar code. This may beused in the event that a bar code cannot be registeredby the bar code reader or a minimal bar code must beentered.

Three types of reagent bar code labels may be enteredmanually:

• Full bar code—Contains all 21 digits of the bar codeinformation.

• Partial bar code—Contains partial bar codeinformation.

• Minimal bar code—Contains no information aboutthe reagent, but allows the bottle to be placed onthe analyzer (for open system applications).

Depending on the type of bar code label, differentmanual set fields are used to enter the information.Fields 1, 2, and 3 are entered for full or partial barcodes. All fields, with the exception of Field 3, areused for minimal bar codes. (Remember to physicallyplace the reagent bottle in the same position on theanalyzer that is programmed during manual entry.)



2 • 43

Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Input Disk No. 1 or 2 of Reagent : ENTER

Use this field to specify the reagent disk number (1 or2) where the manually-entered reagent bottle islocated. Use this field when entering information forfull, partial, and minimal bar-coded reagents. Enterthe appropriate disk number and press ENTER.

Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Input Position No. 1 to 32 of Reagent : ENTER

Use this field to specify the position number (1 - 32)on the reagent disk where the manually-enteredreagent bottle is located. Use this field when enteringinformation for full, partial, and minimal bar-codedreagents. Enter the appropriate disk position andpress ENTER.

Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Input 21 digit Barcode Number : ENTER

Use this field to specify the reagent bottle bar code (upto 21 numeric characters) for the manually-enteredreagent. Use this field when entering information forfull or partial bar code entries. This field is not usedfor minimal bar code entries. Enter the bar code digitsand press ENTER.

Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Input Bottle Code No. 00001 to 00400 : ENTER

Use this field to specify the bottle code (00001 -00400) for the manually-entered reagent. The bottlecode links the reagent bottle to the test parametersand corresponds to the application code. Use thisfield when entering information for minimal bar codeentries. This field is not used for full or partial bar codelabels. Enter the bottle code and press ENTER.



Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Choose Reagent Type 1:R1 2:R2 3:R3 4:R45:Diluent 6:Wash : ENTER

Use this field to specify the reagent type of themanually-entered reagent, and when enteringinformation for minimal bar-coded reagents. Thisfield is not used for full or partial bar code labels. Validreagent types include: R1, R2, R3, R4, Diluent, andWash. R1 indicates that the reagent is dispensed 10seconds after sample dispense. R2 indicates that thereagent is dispensed 1.5 minutes after sampledispense. R3 indicates that the reagent is dispensed5 minutes after sample dispense. R4 indicates thatthe reagent is dispensed 10 seconds after sampledispense. Enter the number corresponding to theappropriate reagent type, as shown above, and pressENTER.

Manual Set [ ] [ ] [ ][ ] [ ] [ ]

Choose Bottle Size 1:Small (20mL) 2:Medium (50mL)3:Large (100mL) : ENTER

Use this field to specify the bottle size (S, M, or L) ofthe manually-entered reagent. Use this field whenentering information for minimal bar code entries. Thisfield is not used for full or partial bar code labels. Enterthe number corresponding to the correct bottle size,as shown above, and press ENTER.

Cancel [ ] [ ]

Use this field to cancel manually-entered reagentinformation. Manually-entered information isautomatically cancelled when a full bar coded reagentbottle is placed on the reagent disk in the positionspecified during the manual entry. A previously-entered manual registration must be deleted beforeusing the same disk and position number for anothermanual registration entry.

2 • 44

Hitergent Disk 1 [ ]2 [ ]

Input 1:Activate 0:Inactivate : ENTER

Press 1 ENTER to request Hitergent bar coderegistration for reagent disk 2. The remaining volumein the Hitergent bottle on reagent disk 2 is shown tothe right of this field. Press 2 ENTER to cancelHitergent bar code registration for reagent disk 2.

ISE Int. Ref. [ ]

Input Total Volume of Reagents (mL) : ENTER

Use this field to enter the volume of the ISE internalstandard solution (0 - 999). When a new bottle isplaced on the analyzer, enter the volume in mL andpress ENTER. This volume is automatically counteddown as the solution is used during primes oroperation.

ISE Dil. [ ]


Use this field to enter the volume of the ISE diluentsolution (0 - 999). When a new bottle is placed on theanalyzer, enter the volume in mL and press ENTER.This volume is automatically counted down as thesolution is used during primes or operation.

ISE KCl [ ]


Use this field to enter the volume of the ISE KCLsolution (0 - 999). When a new bottle is placed on theanalyzer, enter the volume in mL and press ENTER.This volume is automatically counted down as thesolution is used during primes or operation.



Cancel [ ] [ ]

Input Disk No 1 or 2 of Reagent : ENTER

Use this field to select the reagent disk (1 - 2) fromwhich the manual entry is deleted. Enter the disknumber and press ENTER.

Cancel Reagent [ ] [ ]

Input Position No. 1 to 32 of Reagent : ENTER

Use this field to select the reagent disk positionnumber (1 - 32) from which the manual entry is deleted.Enter the position number and press ENTER.

Print [ ]

Input 1:To Print Report : ENTER

Use this field to print the REAGENT STATUS reportfrom Stand-by. Press 1 ENTER to request a printedcopy.


Use these fields to instruct the analyzer to register theHitergent bar code in position 33 on either reagentdisk during reagent bar code registration.


Input 1:Activate 0:Inactivate : ENTER

Press 1 ENTER to request Hitergent bar coderegistration for reagent disk 1. The remaining volumein the Hitergent bottle on reagent disk 1 is shown tothe right of this field. Press 0 ENTER to cancelHitergent bar code registration for reagent disk 1.

2 • 45

2.19.5 Displaying the REAGENTSTATUS Screen - - Page 2

On page 2 of the REAGENT STATUS screen, a list ofall of the reagents registered by the reagent bar codereaders replaces the keyboard matrix. Differentcharacters and colors are used to highlight thisdisplay and give additional information.

Press ROUTINE to display the ROUTINE JOB MENU.Press 1 ENTER to display page 1 of the REAGENTSTATUS screen. Press GUIDANCE to display page2 of the REAGENT STATUS screen.

Press PAGE CONTINUE to scroll through additionalinformation on page 2.

Press SHIFT and PAGE CONTINUE to move to theend of the list of information on page 2. The Cap Locklight stays lit. Press PAGE CONTINUE to scrollthrough the list from the end to beginning.



2.19.6 Example of the REAGENTSTATUS Screen - - Page 2

Figure 2-26 is an example of page 2 of the REAGENTSTATUS screen.

Figure 2-26: REAGENT STATUS Screen - - Page 2

2.19.7 REAGENT STATUS ScreenFields and Prompts - - Page 2

The following information is listed on page 2 of theREAGENT STATUS screen, replacing the keyboardmatrix. These fields do not allow any entries by theoperator. The entry fields at the top of the screenremain the same as those on page 1 of the REAGENTSTATUS screen.

Assay

This column displays the short name of the testreagents currently in the reagent disks. The namesare displayed in channel order. Question marks (?)appear in this field in the following instances:

• When a reagent bar code is registered by the barcode reader and no parameters have been enteredfor that reagent.

1ENTER

SHIFT

37.0 Stand-by 12/01/92 12:20

1 Reagent Status



CancelPrint

Hitergent Disk 1


2

[ ][ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ][ ]

[ ] 80 mL[ ] 80 mL[ ] mL[ ] mL[ ] mL

Y e sY e s3 7 02 3 02 7 0

Assay Type Pos. Tests Size Stab. Exp.W Lot No. App Code

00311000740007400115001150011500115003110003600036003110001800018

049902051986051986070151070151070151070151049902070148048796049902048795070147

LMSLLSSLLLLLL

DilR1R3R1R1R3R3DilR1R3DilR1R3

1121122112112

7205

173126327337

278

93/5293/4393/4394/3894/3894/3894/3893/5294/1793/2193/5292/2593/12

66

131366

27

27

CK

LD

AST

ALT

79120130340

7079

21099079

240990

mL

mL

mL

* Manual Setting ! Over-Ride Manual Setting ? App Code Not Found

2 • 46

• When a minimal bar code is located on a reagentdisk and no information has been manuallyentered.

• When a minimal bar code is located on a reagentdisk in a position that has full bar codeinformation manually entered.

Type

This column displays the type of reagent in the bottleson the reagent disks. There are six reagent types:DIL, R1, R2, R3, R4, and W. R1 indicates that thereagent is dispensed 10 seconds after sampledispense. R2 indicates that the reagent is dispensed1.5 minutes after sample dispense. R3 indicates thatthe reagent is dispensed 5 minutes after sampledispense. T4 indicates that the reagent is dispensed10 minutes after sample dispense. The reagent type ishighlighted with yellow when there are fewer testsremaining in the reagent bottle than are specified in theReagent Check Level field on the SYSTEMPARAMETERS screen. The reagent type ishighlighted in red when there are fewer than 10 testsremaining in the bottle. For a diluent or wash, the typeis highlighted in yellow when > 10 mL of reagentremain, red when < 1 mL of reagent remains. If areagent is not physically in the reagent disk or if the barcode fails to register, only Type is displayed and thesubsequent items are blank. If either of thesesituations occur, the analyzer automatically masksthe test. The keyboard matrix on page 1 of theREAGENT STATUS screen is highlighted with a slashfor that test.

NOTEChanging the Data Mode field on the CHEMISTRYPARAMETERS screen from On Board to Manual willdelete the test from this list. Only active channels aredisplayed.

Pos.

This column displays the disk number and the diskposition number where each reagent is located. Thefirst digit indicates the disk number and the secondtwo digits indicate the position number. An asterisk (*)following the position column indicates bar codeinformation has been manually entered. Anexclamation point (!) following the position columnindicates full bar code information registered by thereagent bar code reader has replaced manually-entered reagent information. The manually-enteredtest is automatically masked in this case because theanalyzer does not know where the reagentis located.

When multiple bottles of reagent are registered for anytype, the disk number for the smallest position numberis displayed first. Disk numbers and position numbersare displayed in numerical order for each type. If thereagent type has not been placed in the appropriatereagent disk, the reagent disk number is highlighted inyellow and the Check (R1 or R2) Position and AppCode alarms appear on the OPERATION MONITORscreen.

Tests

This column displays the number of tests remainingfor each reagent. If the bar code is not registered, thecolumn remains blank until a level registration isperformed or the bottle is used for the first time. Whenthe number of remaining tests is less than 10, the testis highlighted in red. If the number of tests remainingis greater than 1000, then 990 will be displayed. Thenumber is truncated to the lowest ten. If the numberof tests remaining is 29, for example, then the numberdisplayed will be 20. If the number of remaining testsfalls below 10 during a run, the analyzer continues toperform that test, but the test is masked at thebeginning of the next run if the number of testsremaining reaches zero and a second bottle ofreagent is not on board. If a second bottle of reagentis on board, automatic changeover occures. TheTests column is highlighted in red when the bottle isempty.



2 • 47

NOTEIf the type of reagent is DIL or W, the Tests columndisplays the mL of diluent or wash solution remaining,not number of tests remaining.

Size

This column displays the bottle size for each reagent:S (20 mL), M (50 mL), or L (100 mL). This informationappears for all bar code types.

Stab.

This column displays the remaining working solutionstability in days for each reagent as programmed onthe CHEMISTRY PARAMETERS screen. When a fullbar code label is used, the working solution stabilityis displayed. If partial bar code information or minimalbar code information is entered, the space remainsblank. The working solution stability is counted downby the analyzer�s internal clock. When the workingsolution stability is zero (0), the Stab. column ishighlighted in red. Working solution stability istracked only when a bottle number is assigned to thereagent bottle. If CHEMISTRY PARAMETERS isprogrammed as 0, then the display remains blank.

Exp. Wk

This column displays the expiration week for the lot ofreagent. The first two digits indicate the year ofexpiration and the second two digits indicate the weekof expiration (93 - 52). When the reagent has expired,the date is highlighted in red.

Lot No.

This column displays the lot number for each reagent.This information appears for partial and full bar codesonly.

App Code

This column displays the application code for eachreagent. For all BM reagents, the bottle codecorresponds to the application code for the reagent.This code links the reagent to the chemistryparameters needed to perform the test and calculateresults. For a complete list of all BM assignedapplication codes, refer to the BM/Hitachi 911Application Sheets.

NOTEThe analyzer does not automatically mask a test whenthe reagent expires. All information on the REAGENTSTATUS screen is stored in C-RAM.

NOTEISE reagents are flagged for Reagent Volume Shortalarms. The names are highlighted in red or yellowaccording to the amount of reagent remaining. TheReagent Check Level field on page 2 of theSYSTEM PARAMETERS screen must be set to Yesfor this highlighting to occur.



Reagent Yellow Red

ISE Internal Standard < 50 mL 0 mL

ISE Diluent < 30 mL 0 mL

ISE KCL < 30 mL 0 mL

2 • 48



Reagent Status Screen Legend

IF... THEN...

TYPE is yellow prepare more reagent and placeon 911 (tests remaining < RgtCheck Level)

TYPE is red prepare more reagent and placeon 911 (tests remaining < 10)

POS is yellow place highlighted reagent intoproper disk (R1 DISK = R1, R4,DIL, WASH; R2 DISK = R2, R3,WASH; channel will remainmasked until problem corrected)

POS is * verify that reagent marked with *is in designated position (thisindicates a manual set reagent -for details refer to page 16)

POS is ! verify that the manual setreagent is not required for thisrun (! indicates that a full labelreagent has been placed in aposition previously assigned to amanually set reagent)

EXP.WK is red prepare fresh reagent and placein proper disk on 911, as reagentis expired

STAB is red perpare fresh reagent and placein proper disk on 911, as workingreagent has expired

TESTS is ? verify proper reagent,parameters, and channelassignment (? indicates reagentbottle label was read by bar coderead, but no test is assigned tothis bottle)

2 • 49

2.20 Routine Job - - CalibrationTest Selection

2.20.1 Introduction

The CALIBRATION TEST SELECTION screen isused to designate which tests are to be calibratedduring start-up or repeat calibration. Automaticcalibration, or time out, is carried out according to theCHEMISTRY PARAMETERS, no matter what isselected on this screen.

The CALIBRATION TEST SELECTION screen hastwo pages. Page 1 is used to enter calibration testselections. Page 2 lists the Time-Out calibrationstatus and request the Calibrator Load List.

The time out calibration internal clock for a specificassay is automatically reset when a successfulcalibration is performed. The time out calibrationinternal clock of any assay is not reset when acalibration fails. As a result, failed calibrations willautomatically be reinitiated at the beginning of thenext run when the run is started for the Stand-bymode. In the event of a failed calibration, the analyzerreverts to the last succesful calibration to evaluatepatient data.

2.20.2 Displaying the CALIBRATIONTEST SELECTION Screen Page 1

Press ROUTINE to display the ROUTINE JOBMENU. Press 2 ENTER to display page 1 ofthe CALIBRATION TEST SELECTION screen.

2.20.3 Example of the CALIBRATIONTEST SELECTION Screen - -

Page 1

Figure 2-27 is an example of the CALIBRATION TESTSELECTION screen, page 1.Each CALIBRATION TEST SELECTION field andprompt is explained below.

Figure 2-27: CALIBRATION TEST SELECTIONScreen - - Page 1

2.20 Routine Job - - Calibration Test Selection


2ENTER

37.0 Stand-by 12/01/92 12:20



ModeTypeTests

Calibrator List

:Blank:2 Point

:Span:Full

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46 S.IND

ISE A B C

D E F

G H I

J K L

CK LD AST ALT ALP A GGT AMY L T.BIL D.BIL BUN GLU CO2


MON. CHEM6 CHEM7

ALL

[ ][ ][ - ]

[ ] [ 8] Hour

2 • 50

2.20.4 CALIBRATION TESTSELECTION Screen Fields andPrompts - - Page 1

Mode [ ]

Choose 1: Start Up 2: Repeat Calibration : ENTER

Use this field to select the mode of calibration for whichyou want to make test selections. Two modes ofcalibration can be selected.

Press 1 Start up ENTER to select a start-upcalibration.

• Start-Up Calibration: Test selections for thiscalibration are stored in C-RAM. The tests remainprogrammed until you de-select them. A Start-Upcalibration is initiated from Stand-by only. All QCtest selections are performed following a Start-Upcalibration. Selecting prior to stat or routinesampling a Start-Up calibration from StartConditions with no tests selected will initiateprocessing of controls.

Press 2 Repeat Calibration ENTER to select a repeatcalibration.

• Repeat Calibration: Initiate this mode forimmediate calibration or recalibration of a testwhile the instrument is in any operational mode.QC test selections are performed for only thosetests that were calibrated. A test is automaticallyprogrammed for repeat calibration when acalibration fails and is removed from the repeatcalibration list once a successful calibration isperformed.

Type [ ]

Choose Calibration Type 1 : Blank 2 : Span 3 : 2Point4 : Full : ENTER

Use this field to select the calibration type. For all BMchemistries, the recommended calibration type ormethod is included as part of the chemistryparameters. There are four calibration types:

• BLANK uses the blank (STD (1)) only. For ISEs,this runs the compensator.

• 2 POINT uses the blank calibrator and the spancalibrator. For ISEs, this runs the low and highcalibrators only.

• FULL uses all programmed calibrators includingthe blank. Because ≥ three standards can beused, this type is for multipoint calibrations. Fullcalibration must be selected to run thecompensator, low, and high ISE calibration.

• SPAN uses one specified calibrator other than theblank. Span calibration cannot be selected forISEs.

Chemistry calibration may require a blank only(generally fixed K-factor assays), blank and calibrator(mostly endpoint assays), or blank and multiplestandards (generally nonlinear assays). Select theappropriate calibration type and press ENTER.

Tests [ ]


Use this field to select the tests to be calibrated withthe specified calibration type. Press the appropriatetest or profile key, followed by ENTER. The keyboardmatrix will highlight the selected keys in reversevideo. An icon designating the type of calibrationselected also appears in the highlighted test keys.



2 • 51

2.20.5 Displaying the CALIBRATIONTEST SELECTION Screen - Page 2

On page 2 of the CALIBRATION TEST SELECTIONscreen, a list of the tests and their time outcalibrations is displayed. Up to 10 tests can bedisplayed at one time.

Press ROUTINE to display the ROUTINE JOB MENU.Press 2 ENTER to display page 1 of the CALIBRATIONTEST SELECTION screen. Press GUIDANCE todisplay page 2 of the screen.

Press PAGE CONTINUE to view additional tests thatare scheduled for automatic calibration.

Press SHIFT and PAGE CONTINUE to move to theend of the list of information on page 2. The Cap Locklight stays on. Press the PAGE CONTINUE key toscroll through the list from the end to the beginning.

2.20.6 Example of the CALIBRATIONTEST SELECTION Screen - Page 2

Figure 2-28 is an example of the CALIBRATIONTEST SELECTION screen, page 2.

Figure 2-28: CALIBRATION TEST SELECTIONScreen - - Page 2

2.20.7 CALIBRATION TESTSELECTION Screen Fields andPrompts - - Page 2

Calibrator List[ ] [ ] Hour

Use these fields to obtain a list of the calibratorsneeded for the specified calibration mode. Thecalibrator list also gives the sample disk position eachcalibrator should occupy. The first field selects thecalibration mode; the second field specifies the timeinterval in hours for which the list is printed.



2ENTER

SHIFT

37.0 Stand-by 12/01/92 12:20



ModeTypeTests

Calibrator List

:Blank:2 Point

:Span:Full

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

[ ][ ][ - ]

[ ] [ 8] Hour

11121314151617181920

GLUCO2CATRIGUAALB/PTPPHOSCREACHOL

Blank 2 point Full SpanTime Out Status (Hour)

0/

0/

145/0/

973/

0/

3

24

16824

999

24

1/

0/

24

24

2 • 52




Choose 1 : Start Up 2 : Repeat 3 : Time Out 4 : MasterList : ENTER

Separate lists for start up, repeat, or time outcalibration can be selected. Press 1 ENTER for astart-up calibration list, 2 ENTER for a repeatcalibration list, and 3 ENTER for a time out calibrationlist. Time out calibrations do not appear on the screenwhen a start-up calibration is selected, but will print onthe load list.

Press 4 ENTER to request a master calibration loadlist. This list shows placement of all calibrators thathave chemistry parameters programmed in theanalyzer, regardless of the test selection or time outstatus specified on this screen.


Input Time Interval 0 To 24 Hours : ENTER

Use this field to specify the time interval, in hours, forwhich the load list is active. If a load list is requestedfor the next eight hours, for example, thelist will include all calibrators required by the analyzerin that time period.

If a repeat calibration load list is requested for the nexteight hours, the calibrators appearing on the list arethose needed for the next eight hours, including testswhose calibration will time out within eight hours. Inaddition, those repeat calibrations that were eithermanually entered by the operator, or automaticallyprogrammed by the analyzer due to a failed Automaticor Start-up Calibration appear on the list.

The following information is listed on page 2 of theCALIBRATION TEST SELECTION screen. Thesefields do not allow any entries by the operator. Theentry fields to the left of the screen remain the sameas those on page 1 of the screen.

Time Out Status (Hour)

Blank 2 Point Full Span1Test name xx/xx xx/xx xx/xx xx/xx

The name of each test is listed along with eachcalibration type. Information is present in a columnwhen that calibration type has been specified on theCHEMISTRY PARAMETER screen.

The first number in each column displays the numberof hours remaining until the calibration times out. Thesecond number in each column displays thecalibration frequency.

The first number is shaded yellow if less than one hourremain before calibration time-out. The first number isshaded red at time out. The test will be calibrated thenext time the analyzer is started or during the correntrun.

Most BM chemistries have parameters that definewhen auto calibration should occur based on time out,bottle change, or lot change. This information isincluded on the parameter disk.

2 • 53

2.21 Routine Job Patient TestSelection Without BarCode Reader

2.21.1 Introduction

The PATIENT TEST SELECTION screen is used toprogram test selections and demographic data forroutine sample analysis. Test selection are stored inC-RAM. If previous test selection information appearson the screen, clear the previous test selections.

This screen is not routinely used if you are interfacedto a host computer that downloads patient testselections. The PATIENT TEST SELECTION screenvaries slightly, depending on whether you are usingthe sample bar code reader. This section discussesusing the PATIENT TEST SELECTION screenwithout the bar code reader.

2.21.2 Displaying PATIENT TESTSELECTION Without Bar CodeReader

Press ROUTINE to display the ROUTINE JOB MENU.Press 3 ENTER to display the PATIENT TESTSELECTION Screen.

2.21.3 Example of the PATIENT TESTSELECTION Screen Without

Bar Code Reader

Figure 2-29 is an example of the PATIENT TESTSELECTION screen.

Figure 2-29: PATIENT TEST SELECTION Screen

2.21.4 PATIENT TEST SELECTION Without Bar Code Reade r Fields and Prompts

Run Type [ ]

Choose 1:Serum/Plasma 2 :Urine 3 :Other : ENTER

Use this field to select the type of sample. Enter thenumber that corresponds to the sample type andpress ENTER. The different sample types are operatordefined from the SYSTEM PARAMETERS screen.The CHEMISTRY PARAMETERS screen will indicatewhether choice 1 is S or U.

2.21 Routine Job - - Patient Test Selection Without Bar CodeReader


3ENTER

37.0 Stand-by 12/01/92 12:20



Run TypeSample CupSample No.ID NumberSample Vol.Tests

Repeat FunctionDisplay Sample No.Print ListClear

[ ][ ][ ] - [ ][ ]

Draw Date/Time


1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46 S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD Cup

16142Normal

[ ][ ][ ] [ ] [ ][ ][ ][ ]

RECORD SPACE : 785

[ ] / [ ] / [ ] [ ] : [ ]

[ ] [ ] [ ][ ][ ][ ][ ][ ]

12 01 92 12 20


2 • 54

Sample Cup [ ]

Choose 1 :STD Cup 2 :Micro 3 :STD on Tube 4 :Microon Tube 5 :Tube : ENTER

Use this field to select the size of the sample cupbeing used. Five different sample cup selections canbe made. Press 1 STD Cup ENTER for a normalsample cup. Press 2 Micro ENTER for a micro samplecup. Press 3 STD on Tube ENTER for a normalsample cup on a primary collection tube. Press 4Micro on Tube ENTER for a micro sample cup on aprimary collection tube. Press 5 Tube ENTER for aprimary collection tube.

Sample No. [ ] [ ] [ ]

Use these fields to specify the Sequence Number,Sample Disk Number and Sample Disk PositionNumber for each sample.

Sample No. [ ] [ ] [ ]


Use this field to enter the sequence number for thesample. All routine specimens are analyzed innumerical order, by sequence number. Results arestored on the data disk by sequence number. Testscan be selected, and results can be stored for amaximum of 800 routine patients on one data disk.

When a sequence number is entered, informationstored in memory for that sequence number appearson the CRT, and stored test selection information ishighlighted on the keyboard matrix at the bottom of thedisplay. Enter the appropriate sequence number andpress ENTER.

Sample No. [ ] [ ] [ ]

Input Disk No. 0 to 9 : ENTER

Use this field to enter the sample disk number wherethe sample is located. Up to 10 sample disks,numbered 0 through 9, can be recognized by theinstrument. The number entered in this field identifiesthe disk where the sample is located. One sampledisk can be used for both sample cup sizes, primarycollection tubes, or sample cups on primarycollection tubes. Enter the appropriate sample disknumber and press ENTER.

Sample No. [ ] [ ] [ ]

Input Position No. 1 to 50 (0 : Initiates SamplingStop) : ENTER

Use this field to enter the sample disk positionnumber where the sample is located. The numberentered in this field tells the instrument where to findthe specimen on the sample disk. Each sample diskhas 50 routine sample positions.

Entering a sample position number of zero instructsthe analyzer to stop sampling when the sequencenumber is reached.

WARNINGIf more than 800 specimens are run in sequencewithout clearing or replacing the data disk, theinstrument will write over old patient files. If the datadisk is used to store patient results, the samesequence number should never be re-used on thesame data disk.



2 • 55

The following precautions must be observed:

ID Number. [ ]

Input Sample ID Number (Maximum 13Characters) : ENTER

Use this field to assign an alphanumeric identificationnumber of up to 13 characters for each specimen.This entry is not necessary with the bar code readerturned off and the field may be skipped.

Sample Vol. [ ]

Choose 1 :Normal 2 :Decreased 3 :Increased SampleVolume : ENTER

Use this field to select sample volume size. Normal,Decreased, or Increased may be selected. This fielddefaults to normal sample volume. Choose theappropriate sample size and press ENTER.

More than one sample size may be selected fordifferent tests on the same sample. Specify thesample size in this field. Specify the tests for thatsample size in the Tests field and press ENTER. Thesample number will increment by one. Move the

cursor back to the Sample No. field and re-enter thesample number. Select another sample size andmake test selections for the second sample size.Press ENTER. Repeat if a third sample size isrequired.

Tests [ ]


Use this field to select tests or profiles to beperformed on the sample. It is best to enter alldemographic information before making testselections. Demographic information can beentered later. When the cursor is in this field, the testand profile selection keys are active. When one ofthese keys is pressed, the key that corresponds tothe selected test is highlighted in reverse video onthe keyboard matrix. If the key is pressed a secondtime, the test is deselected and the highlighting turnsoff.

The profile selection keys are the numeric keyslocated to the right of the test selection keys. Whena profile selection key is pressed, the key ishighlighted in reverse video on the keyboard matrix andall tests assigned to that profile also are highlighted.When the key is pressed a second time, thehighlighting turns off and the tests are no longerselected.

Press all test selection and/or profile selection keysfor the sample and ENTER. The sample numberincrements by one automatically following each entry.

After tests are selected, the keyboard matrixhighlights the appropriate keys. If an increasedsample volume was chosen, an up arrow ( ↑ ) isdisplayed in the highlighted key. If a decreasedsample volume was chosen, a down arrow ( ↓ ) isdisplayed in the highlighted key.



IF... THEN...

the Data Disk is used tostore patient results

use each sequencenumber once on aData Disk replace theData Disk afterexceeding 800 patientfiles.

the Data Disk is notused to store patientresults

use each sequencenumber once on aData Disk clear theData Disk afterexceeding 800 files.oruse each sequencenumber once per dayclear the Data Disk atthe beginning of eachday.

2 • 56

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Use these fields to identify the date and time thesample was drawn. If a Draw Date/Time is notentered, this field defaults to the date and time thesample number was entered. The order of these fieldsis defined from the SYSTEM PARAMETERS screen.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Input Month (1 to 12) : ENTER

Use this field to enter the month the sample was taken.Enter the month and press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Input Day (1 to 31) : ENTER

Use this field to enter the day the sample was taken.Enter the day; press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Input Year (0 to 99) : ENTER

Use this field to enter the year the sample was taken.Enter the year; press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Input Hour (0 to 23) : ENTER

Use this field to enter the hour the sample was taken.Enter the hour and press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Input Minute (0 to 59) : ENTER

Use this field to enter the minute the sample wastaken. Enter the minute and press ENTER.



Sex/Age [ ] [ ] [ ]

Use these fields to identify the sex and age of thepatient from which the sample was taken for normalranges that are specific to sex and age.

Sex/Age [ ] [ ] [ ]

Choose 1:Male 2:Female : ENTER

Use this field to enter the sex of the patient from whichthe sample was taken. Press 1 Male or 2 Female;press ENTER.

Sex/Age [ ] [ ] [ ]

Input Number : ENTER

Use this field to indicate the numerical age of thepatient. Enter the numerical age and press ENTER.

Sex/Age [ ] [ ] [ ]

Choose Age Interval 1:Days 2:Months 3:Years :ENTER

Use this field to indicate the age interval in days,months or years. Enter the correct interval and pressENTER.

Name [ ]Input Maximum of 30 Characters : ENTER

Location [ ]Input Maximum of 25 Characters : ENTER

Physician [ ]Input Maximum of 20 Characters : ENTER

Patient ID [ ]Input Maximum of 15 Characters : ENTER

Drawn By [ ]Input Maximum of 10 Characters : ENTER

2 • 57

Use these fields to enter demographic informationconcerning the patient sample. These field names areuser definable on the SYSTEM PARAMETERSscreen. You can remove the demographic inputfields from the PATIENT TEST SELECTION screenusing the SYSTEM PARAMETERS screen.

Repeat Function [ ]


Use this field to assign the same test selections toseveral samples run in sequence. Follow thisprocedure:

• Enter test selections for the first sample.

• Move the cursor to the Sample No. field and re-enter the sequence number for which testselections have been made.

• Move the cursor to the Repeat Function field.

• Enter the sequence number of the last sample ranwith these test selections, then press ENTER.

Identical test selections are programmed for allsequence numbers between the original sequencenumber and the sequence number entered in theRepeat Function field, inclusive.

Display Sample No. [ ]


Use this field for visual verification of programming orto retrieve information on a patient sample. Enter thesequence number, then press ENTER. The sequencenumber, disk number, and position number and alldemographic data appear on the screen. Testselections are highlighted on the bottom of thescreen. To increment by one through sequencenumbers, press ENTER.

Print List [ ] - [ ]

Input Sample No. 1 to 800 : ENTERInput Sample No. 1 to 800 : ENTER

Use these fields to enter the range of sequencenumbers you would like printed on the Requisition List.The Requisition List gives the sequence number, disknumber, and position number, along with testselections, for all requested samples. Enter the firstsequence number, press ENTER. Enter the lastsequence number, press ENTER.

Clear [ ]

Input 1:To Clear : ENTER (Have you cleared data?)Are You Sure? 1:Continue 0:Cancel : ENTER

Use this field to clear all test selection information fromC-RAM at least once per day, if beginning each daywith sequence number 1.

• Press 1 To Clear ENTER

• The CRT prompt line displays: Are You Sure?

• Press 1 Continue ENTER or 0 Cancel ENTER.

Wait until completion of the clear function beforeattempting the next keyboard entry.



2 • 58

2.22 Routine Job Patient TestSelection With Bar CodeReader

2.22.1 Introduction

The PATIENT TEST SELECTION screen is used toprogram test selections and demographic data forroutine sample analysis. Test selection are stored inC-RAM. If previous test selection information appearson the screen, clear previous test selections.

This screen is not routinely used if you are interfacedto a host computer that downloads patient testselections. Keyboard test selections will overrideselections downloaded from the host computer. ThePATIENT TEST SELECTION screen varies slightly,depending on whether you are using the sample barcode reader. This section discusses the PATIENTTEST SELECTION screen using the sample bar codereader.

2.22.2 Displaying PATIENT TESTSELECTION With Ba r CodeReader

Press ROUTINE 3 ENTER to display the PATIENTTEST SELECTION screen.

2.22.3 Example of the PATIEN T TESTSELECTION Screen With BarCode Reader

Figure 2-30 is an example of the PATIENT TESTSELECTION screen.

Figure 2-30: PATIENT TEST SELECTION Screen

2.22.4 PATIENT TEST SELECTIONWith Bar Code Reader Fields

and Prompts

Run Type [ ]

Choose 1 :Serum/Plasma 2 :Urine 3 :Other : ENTER

Use this field to select the type of sample. Enter thenumber that corresponds to the sample type andpress ENTER. The different sample types are operatordefined from the SYSTEM PARAMETERS screen.The CHEMISTRY PARAMETERS screen will indicatewhether choice 1 is S or R.

2.22 Routine Job - - Patient Test Selection With Bar Code Reader


1ENTER

37.0 Stand-by 12/01/92 12:20


Input Sample ID Number (Maximum 13 Characters) : ENTER

Run TypeSample Cup

ID NumberSample Vol.Tests

Display ID No.Print ListClear

[ ][ ] - [ ][ ]

Draw Date/Time


1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46 S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD on Tube

16142Normal

[ ][ ]

[ ][ ][ ]

[ ] / [ ] / [ ] [ ] : [ ]

[ ] [ ] [ ][ ][ ][ ][ ][ ]

12 01 92 12 20


RECORD SPACE : 785

2 • 59

Tests [ ]


Use this field to select tests or profiles to be performedon the sample. It is best to enter all demographicinformation before making test selections.Demographic information can be entered prior toprinting results. When the cursor is in this field, thetest and profile selection keys are active. When oneof these keys is pressed, the key that corresponds tothe selected test is highlighted in reverse video on thekeyboard matrix. If the key is pressed a second time,the test is deselected and the highlighting turns off.

The profile selection keys are the numeric keys,located to the right of the test selection keys. Whena profile selection key is pressed, the key ishighlighted in reverse video in the keyboard matrix andall of the tests assigned to that profile also arehighlighted. When the key is pressed a second time,the highlighting turns off and the tests are no longerselected.

Press all test selection and/or profile selection keysfor the sample and press ENTER.

After tests are selected, the keyboard matrixhighlights the appropriate keys. If an increasedsample volume was chosen, an up arrow () isdisplayed in the highlighted key. If a decreasedsample volume was chosen, a down arrow () isdisplayed in the highlighted key.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Use these fields to identify the date and time thesample was drawn. If a Draw Date/Time is not entered,the date and time the ID number was entered isdisplayed. The order of these fields is defined from theSYSTEM PARAMETERS screen.



Sample Cup [ ]

Choose 1 :STD Cup 2 :Micro 3 :STD on Tube 4 :Microon Tube 5 :Tube : ENTER


ID Number. [ ]


Use this field to assign a bar code identificationnumber of up to 13 characters for each specimen, if itis not downloaded from a host computer. Enter the IDnumber and press ENTER.

Sample Vol. [ ]

Choose 1 :Normal 2 :Decreased 3 :Increased SampleVolume : ENTER

Use this field to select sample volume size. Normal,Decreased, or Increased may be selected. This fielddefaults to normal sample volume. Choose theappropriate sample size and press ENTER.

More than one sample size may be selected fordifferent tests on the same sample. Specify thesample size in this field. Specify the tests for thatsample size in the Tests field and press ENTER. Movethe cursor back to the ID Number field and re-enter thesample number. Select another sample size andmake test selections for the second sample size.Press ENTER. Repeat if a third sample size isrequired.

2 • 60

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]



Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]


Use this field to enter the day the sample was taken.Enter the day and press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]


Use this field to enter the year the sample was taken.Enter the year and press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]



Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]



Sex/Age [ ] [ ] [ ]

Use these fields to identify the sex and age of thepatient from which the sample was taken for normalranges that are specific to sex and age.



Sex/Age [ ] [ ] [ ]

Choose 1 :Male 2 :Female : ENTER

Use this field to enter the sex of the patient from whichthe sample was taken. Press 1 Male or 2 FemaleENTER.

Sex/Age [ ] [ ] [ ]



Sex/Age [ ] [ ] [ ]


Use this field to indicate the age interval in days,months or years. Enter the correct interval and pressENTER.





Drawn By [ ]Input Maximum of 10 Characters : ENTER

Use these fields to enter demographic informationconcerning the patient sample. These field names areuser definable on the SYSTEM PARAMETERSscreen. You can remove the demographic input fieldsfrom the PATIENT TEST SELECTION screen usingthe SYSTEM PARAMETERS screen.

2 • 61

Display ID No. [ ]

Input Sample ID Number (Maximum 13 Characters) :ENTER

Use this field to retrieve information on a patientsample. Enter the ID number, then press ENTER. TheID number and all demographic data appear on thescreen. Test selections are highlighted on the bottomof the screen. To increment to the next ID numbers,press ENTER. Enter 0 to display the first bar codeprogrammed.


Input Sample ID No. (Maximum 13 Characters) :ENTER

Use these fields to enter the range of ID numbers youwould like printed on the Requisition List. TheRequisition List gives the ID number along with testselections for all requested samples. Enter the firstID number, then press ENTER. Enter the last numberof samples to be included on the list, then pressENTER. An example of the Requisition List report isshown in Section 2.63.

WARNINGIf more than 800 specimens are run in sequencewithout clearing or replacing the data disk, theinstrument will write over old patient files. If the datadisk is used to store patient results, the samesequence number should never be re-used on thesame data disk.

Clear [ ]

Input 1:To Clear : ENTER (Have you cleared data?)Are You Sure? 1:Continue 0:Cancel : ENTER

Use this field to clear all test selection information fromC-RAM. Clear all test selection information at leastonce per day.

• Press 1 To Clear ENTER.

• The CRT prompt line displays: Are You Sure?

• Press 1 Continue ENTER or 0 Cancel ENTER.

Wait until completion of the clear function beforeattempting the next keyboard entry.



2 • 62

2.23.3 Example of the STARTCONDITIONS Screen

There are three different configurations of the StartSample No . field on the START CONDITIONSscreen. The configuration depends on the status of thesample bar code reader and host computercommunication. Figure 2-31 shows the STARTCONDITIONS screen as it appears under the followingconditions:

• Without Bar Code Reader and Without HostCommunication

• Without Bar Code Reader and With HostCommunication specified as Results Only

Figure 2-31: START CONDITIONS Screen

2.23 Routine Job - - Start Conditions


2.23 Routine Job - - StartConditions

2.23.1 Introduction

Use this screen to establish run conditions at the startof analysis and to implement ISE Maintenance.Always verify that the correct information is listed onSTART CONDITIONS before pressing START. TheStart Sample N o. configuration on this screendepends on the status of the bar code reader and hostcommunication. Examples of the STARTCONDITIONS display with different Start Sample N o.configurations are illustrated in this section.

2.23.2 Displaying the STARTCONDITIONS Screen

Press ROUTINE 4 ENTER to display theSTART CONDITIONS screen.

4ENTER

37.0 Stand-by 12/01/92 12:20

4 Start Conditions




[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]


OffOffReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46 S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

2 • 63

Figure 2-32 shows the START CONDITIONS screenas it appears under the following conditions:

• With Bar Code Reader and With or Without HostCommunication

• With Bar Code Reader and With HostCommunication specified as Results Only


Figure 2-33 shows the START CONDITIONS screenas it appears under the following conditions:

• Without Bar Code Reader and With HostCommunication


2.23.4 START CONDITIONS ScreenFields and Prompts

Each START CONDITIONS field and prompt isexplained below.

Start Sample No. [ ] : [ ] [ ] - [ ] [ ]

Use this field to enter the sequence number of the firstroutine specimen to be sampled after START ispressed. Up to five entries can be made in this field,depending on your system�s configuration. When theinstrument is in Stand-by, the number that appears inthis field is the next available sequence number fortest selection.



37.0 Stand-by 12/01/92 12:20

4 Start Conditions




[ ] : [ 0] [ 1][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]


OffOffReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

37.0 Stand-by 12/01/92 12:20

4 Start Conditions




[ ] : [ 0] [ 1] - [ ] [ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]


OffOffReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

2 • 64

Start Sample No. [ ]

Input Sample No. 1 to 800 : ENTER (Have you cleareddata?)

This field is displayed for instruments that are notconnected to a host computer and not equipped witha bar code reader. Refer to Figure 2-31.

Enter the sequence number of the first specimen, thenpress ENTER. (The remaining fields under STARTSAMPLE NO. are not shown unless the instrument isconnected to a host computer.)

Start Sample No. [ ] : [ ] [ ]

Input Sample No. 1 To 800 : ENTER (Have You ClearedData?)Input Disk No. 0 To 9 : ENTERInput Position No. 1 To 50 : ENTER

This field is displayed for instruments that areconnected or not connected to a host computer andequipped with a bar code reader. Refer toFigure 2-32.

• Enter the sequence number of the first specimen infield 1, then press ENTER.

• Enter the number of the first sample disk in field 2,then press ENTER.

• Enter the position number of the first specimen infield 3, then press ENTER.

Start Sample No. [ ] : [ ] [ ] - [ ] [ ]

Input Sample No. 1 To 800 : ENTER (Have you cleareddata?)Input Disk No. 0 To 9 : ENTERInput Position No. 1 To 50 : ENTERInput Disk No. 0 to 9 : ENTERInput Position No. 1 To 50 : ENTER

This field is displayed for instruments that areconnected to a host computer with two-waycommunication and not equipped with a bar codereader. Refer to Figure 2-33. Five fields must beentered:

• Enter the sequence number of the first specimen infield 1, then press ENTER.

• Enter the number of the first sample disk in field 2,then press ENTER.

• Enter the position number of the first specimen infield 3, then press ENTER.

• Enter the number of the last sample disk in field 4,then press ENTER.

• Enter the position number of the last specimen infield 5, then press ENTER.

For example, if the specimens to be sampled beginwith sequence number 1, on sample disk number 1,sample position number 2, and end with sample disknumber 9, sample position number 50, the StartSample No. will read:

[ 1] : [1] [ 2] - [9] [50]

NOTEAn INPUT ERROR alarm is issued if the start disknumber/position is not equal to or less than the stopdisk number/position number.



2 • 65

Routine Rerun Mode [ ]

Choose 1 :Perform Automatic Rerun 2 :Initiate RerunOnly 0 :No Reruns : ENTER

Use this field to determine how routine rerun samplesare processed. The analyzer must be in Stand-by tomake a selection in this field. Press 1 PerformAutomatic Rerun ENTER to request that rerunsamples be automatically rerun at the end of a routinerun.

When automatic rerun is requested, the analyzer doesnot go into the Sampling Stop mode after the sampleshave been pipetted. The analyzer goes into the Rerunmode until all results have been calculated. After thelast result has been printed, the analyzer remains inSampling Stop if no reruns are required. If any rerunsare required, they are initiated at the end of the originalrun. If more than 50 samples are included in a singlerun, the automatic rerun is performed on the currentsample disk before continuing to the next disk.

Press 2 Initiate Rerun Only ENTER to request a runconsisting of only rerun samples from a previousroutine run. Only those samples listed on the RerunSamples display will be run. You must set the StartSample No. back to the sample number the rerun willbegin with. Press 0 No Rerun ENTER to request norerun samples be performed in the current run.

Stat Rerun Mode [ ]

Choose 1 :Perform Automatic Rerun 0 :NoReruns : ENTER

Use this field to determine how Stat rerun samples areprocessed. The analyzer must be in Stand-by to makea selection in this field. Press 1 Perform AutomaticRerun ENTER to request that rerun samples beautomatically rerun. Press 0 No Reruns to requestthat no stats be rerun.



Start Up Calibration [ ]

Choose 1 :On 0 :Off : ENTER

Use this field to instruct the instrument to begin thescheduled run with a start up calibration. Press 1 OnENTER to initiate a start up calibration in addition tothe automatic calibrations. This entry is made inStand-by only. After the calibration is completed, thisfield defaults back to Off.

Every time the instrument performs a start upcalibration all controls programmed on the CONTROLTEST SELECTION screen also are performed. Unlessthe control interval on the CHEMISTRYPARAMETERS screen is set to zero with a zerocontrol interval, the control will not be run. Aftersampling for controls, the instrument samples the firstspecimen displayed in the Start Sample No. field.

When operating the analyzer with automaticcalibration programmed correctly, a start upcalibration is only necessary for tests using partial orminimal reagent bar codes.

Repeat Calibration [ ]

Choose 1 :On 0 :Off : ENTER

Use this field to initiate a repeat calibration. Repeatcalibration can be initiated from any operational mode.Specify which test(s) need to be calibrated from theCALIBRATION TEST SELECTION screen.

Press 1 On ENTER to initiate the repeat calibration.After the repeat calibration is complete, the fielddefaults to Off. Controls are run only on therecalibrated tests.

NOTEThe control interval affects only the repeat calibraton.

2 • 66

Print Format [ ]

Choose 1:Short Format 2:Report Format 0:CancelReal Time Print : ENTER

Use this field to choose the format for printing patientresults. Results can be printed in a short format orreport (long) format. The instrument can also beinstructed to store results on the data disk withoutprinting them by selecting 0 Cancel Real Time PrintENTER.

Calibration Print [ ]

Choose 1:On 0:Off : ENTER

Use this field to instruct the analyzer to printcalibration results. Press 1 On ENTER to printcalibration results in real time. Press 0 Off ENTER tocancel printing. If you choose not to print results in thisfield, you will not get a hard copy of the calibrationreport. CALIBRATION RESULTS CANNOT BEREPRINTED LATER.

Clear Results [ ] : [ ] - [ ]

Use these fields to clear any type of results from thedata disk and QC stored in C RAM. This field is usedto clear results only and not test selections.


Choose 1:Clear Routine Sample Results 2:Stats3:Controls 4:All : ENTER

Use this field to specify which type of results you wantcleared from the data disk. Press the appropriatetype of sample followed by ENTER to clear results.


Input Sample No. to Clear : Routine 1-800/Stat 1-200/Control 1-8 : ENTER

Use this field to enter the first result number to becleared. Enter the sample number and press ENTER.Clear Results [ ] : [ ] - [ ]



Manual Masking [ ]


Use this field to mask, or “turn off,” specific chemistrychannels. Any channel that is masked remainsinactive until it is unmasked or “turned on” through thisfield. Press the test selection key(s) that correspondsto the tests to be masked, and press ENTER. Youcannot use a profile key to mask tests. After a test isselected to be masked, a back slash appears throughthe key that corresponds to that test on the keyboardmatrix at the bottom of the START CONDITIONSscreen.

Host Communication [ ]


Use this field to specify communication with a hostcomputer. Press 1 On ENTER to opencommunication with the host computer. Press 0 OffENTER to close communication with the hostcomputer.

ISE Maintenance [ ]

Choose 1:Initiate ISE Maintenance at end of Run 0:No: ENTER

Use this field to specify washing of the ISE SampleFlowpath. Press 1 (Yes) ENTER. Choosing this washinstructs the analyzer to pipette NaOH from the W2cup on the sample disk to the ISE port 15 times. Thiswill occur at the end of the run before the instrumentgoes into Stand-by and adds approximately fiveminutes to the cycle time. You should calibrate priorto running patient samples, at least once every 24hours.

2 • 67

Input Sample No. to Clear: Routine 1-800/Stat 1-200/Control 1-8 : ENTER

Are You Sure? 1:Continue 0:Cancel : ENTER

Use this field to enter the last result number to becleared. Valid data clearing ranges for each type ofresults are listed below:

When data is cleared within a specified range, the

sequence number for stat samples is reset to the firstsequence number specified in the data clear. Thesequence number of control samples is reset to 1only when the full range of 1 - 8 is selected. Whendata is cleared with ALL specified, the sequencenumber of stat and control samples is reset to 1.

Enter the sample number and press ENTER. TheCRT prompt line displays Are You Sure?. Press 1ENTER.

Default Sample Cup [ ]

Choose 1:STD Cup 2:Micro 3:Std. on Tube 4:Microon Tube 5:Tube : ENTER

Use this field to select the size of the sample cupbeing used as default in Patient Test Selection.



SAMPLE TYPE INPUT RANGE(sequence number)

NORMAL 1-800

Stat 1-200

CONTROL 1-8

2 • 68

2.24 Routine Job - - Real TimeData Monitor

2.24.1 Introduction

REAL TIME DATA MONITOR enables you to viewresults from samples currently being processed.Routine, stat, and rerun and controls sample data canbe viewed. When all results are finished, allinformation is printed and is accessible through theDATA REVIEW screen, the REAL TIME DATAMONITOR screen clears.

2.24.2 Displaying REAL TIM E DATAMONITOR

Press ROUTINE to display the ROUTINE JOB MENU.Press 5 ENTER to display the REAL TIME DATAMONITOR screen.

2.24.3 Example of the REAL TIMEDATA MONITOR Screen

Figure 2-34 is an example of the REAL TIME DATAMONITOR screen.

Figure 2-34: REAL TIME DATA MONITOR Screen

2.24.4 REAL TIME DATA MONITORFields and Prompts

Each REAL TIME DATA MONITOR screen field andprompt is explained below.

Sample [ ] [ ]

Use these fields to identity the sample for which youwant to monitor results. The remainder of theinformation on this screen does not allow operatorentry.

2.24 Routine Job - - Real Time Data Monitor


5ENTER

37.0 Operation 12/01/92 12:20

5 Real Time Data Monitor

Input Position No. 1 to 70 , 71 to 78 for Controls : ENTER

Sample

S.No.Pos.IDS.Type

[ ] - [ ]

Alarm Routine


12 / 01 /92 11:45M 38 YDOE, JOHNER-10GETTLE, D

DJB

Test Data Test Data Test Data Test Data

123456789

10111213

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CA

TRIGUAALB/PTPPHOSCREACHOL

14151617181920212223242526

27282930313233343536373839

40414243444546474849505152

THEO

NaKCl

LIPHEMOICTER

403

78.8476

11.2

5.35.0

152.55.42

111.3

110-20

18019Serum

Stat 20

$

2 • 69

Sample [ ] [ ]

Choose 1 :Routine 2 :Routine Rerun 3 :Stat 4 :StatRerun 5 :Control : ENTER

Use this field to select the sample type you wantdisplayed. Press the number that corresponds to thesample type and ENTER.

Enter the position number in the second field andpress ENTER. (See chart below.) For routine orroutine rerun samples, enter 1 to 50. For controlsamples, enter 1-8. For stat or stat rerun samples,enter 51 to 70. If your analyzer is using the sample barcode reader, enter 1 to 50 and addionally 51-70 forsamples without barcodelabel. After the sample typeand position number have been entered, thedemographic information is displayed. As test resultsare calculated, the results appear on the screen.

This screen clears when all results have beencalculated. If only one test is ordered on a sample, itwill not appear on this display.

2.24 Routine Job - - Real Time Data Monitor


Type of Sample Enter

Routine 1-50

R. Rerun 1-50

Stat 1-70,71-78 for controls - -positions 1-8 on disk

Stat Rerun 1-70,71-78 for controls - -positions 1-8 on disk

Control 1-8

2 • 70

2.25 Routine Job - Data Review

2.25.1 Introduction

Use DATA REVIEW to delete, edit, print, or batchupload patient results to a host computer. Theanalyzer does not have to be in Stand-by to edit orreprint results. The DATA REVIEW screen variesslightly, depending on whether you are using thesample bar code reader.

The DATA REVIEW screen has two pages. Page 1lists up to 15 samples at a time, giving overviewinformation. Page 2 lists all test results for a specificsample.

2.25.2 Displaying the DATA REVIEWScreen - - Page 1

Press the ROUTINE key to display the ROUTINE JOBMENU. Press 6 ENTER to display page 1 of the DATAREVIEW screen.

Press PAGE CONTINUE to scroll through informationfor additional samples.

Press SHIFT and PAGE CONTINUE to move to theend of the list of samples on the page. The Cap Locklight stays on. Press the PAGE CONTINUE key toscroll through the list of samples from the end to thebeginning.

2.25.3 Example of the DATA REVIEWScreen - - Page 1

Figure 2-35 is an example of page 1 of the DATAREVIEW screen.

Figure 2-35: DATA REVIEW - - Page 1

2.25 Routine Job - - Data Review


6

SHIFT

ENTER

37.0 Operation 12/01/92 12:20

6 Data Review


RunList Print

Data Transfer[ ] [ ] [ ] - [ ][ ] [ ] - [ ]

[ ][ ] [ ]


ICU-12ICU-9O.P.PACU-10O.P.O.P.OUTPATIENTS317-2S323-1ICU-7T412-1OUTPATIENTN403-4OUTPATIENT

8:278:288:308:318:338:348:348:358:378:388:418:438:438:44

0-010-020-030-040-050-060-070-080-090-100-110-120-130-14

059910161421284

25313010571355

0100826962071948053690

63340019616858

DOBBINS, KSMITH, JJAMES, BTOLBERT, UKNIGHT, RVOGT, MILDREDWILMOTH, MHOBBS, JFRICKENSCHMIDT, OPULAKSI, WMDONAGHUE, PJOHNSON, PHOLLINGSWORTH, MKOVAK, K

123456789

1011121314

12/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/0112/01

Routine

Rtn.1 0599910

2 • 71

2.25.4 DATA REVIEW Screen Fieldsand Prompts - - Page 1

Each DATA REVIEW screen field and prompt isexplained below.

Run [ ]

Choose 1:Routine Samples 2:Stats : ENTER

Use this field to select the run type to be edited. Press1 ENTER to edit routine results or 2 ENTER to edit Statresults.

List [ ] [ ]

Use these fields to identify the first sample to belisted. Analyzers that are not using the sample barcode reader display only Field 1. Analyzers that areusing the bar code reader display Field 1 and Field 2.

List [ ] [ ]


Use this field to enter the sample number of the firstsample to be listed. Use the following ranges for thedifferent sample types.

List [ ] [ ]


Use this field to enter the sample ID number of the firstsample to be listed. Up to 13 characters can be used

(only when the bar code reader is on.)

The Sample List displays the following informationfor 15 samples starting with the sample numberspecified: S. No., Pos., ID No., Date, Time , and thefirst two comment lines, which are specified inSystem Parameters, on the lower portion of thedisplay. Press PAGE CONTINUE to displayadditional samples. Note: The demographicinformation displayed is for the sample numberentered in the List field.

2.25.5 Displaying the DATA REVIEWScreen - - Page 2

Press ROUTINE to display the ROUTINE JOB MENU.Press 6 ENTER to display page 1 of the DATAREVIEW screen. Press GUIDANCE to display page2 of the DATA REVIEW screen.

Press PAGE CONTINUE to scroll through additionalinformation on page 2.

Press SHIFT and PAGE CONTINUE to move to theend of the list of information on page 2. The Cap Locklight remains on. Press PAGE CONTINUE to scrollthrough the list from the end to the beginning.




ROUTINE 1-800

Stat 1-200

6ENTER

SHIFT

2 • 72

2.25.6 Example the of DATA REVIEWScreen - - Page 2

Figure 2-36 is an example of page 2 of the DATAREVIEW screen.

Figure 2-36: DATA REVIEW - - Page 2

LEGEND* = Edited resultData Flags are highlighted in red.

2.25.7 DATA REVIEW Screen Fieldsand Prompts - - Page 2

Run [ ]

Choose 1 :Routine Sample 2 :Stat : ENTER

Use this field to select the run type to be edited. Press1 ENTER to edit routine results or 2 ENTER to edit statresults.

Data [ ] [ ]

Use these fields to identify the first sample to be listed.Analyzers that are not using the sample bar codereader display Field 1. Analyzers that are using thebar code reader display Field 1 and Field 2. After aselection is made in one of these fields, thedemographic information for that sample is displayed.

The bottom of the screen displays the first 30 testsand results run on this sample. Press PAGECONTINUE to display the remainder of the tests andresults run on the sample. This list gives the testname, first run result, and rerun result. Any data flagspresent will be displayed immediately following theresult using a symbol.

Data [ ] [ ]


Use this field to enter the sample number of the firstsample to be listed. Use the following ranges for thedifferent sample types. Enter the sample number andpress ENTER.

Data [ ] [ ]


Use this field to enter the sample ID number of the firstsample to be listed. Up to 13 characters can be used(only if the bar code reader is on.) You can search forboth routine and stat samples by ID number.




ROUTINE 1-800

Stat 1-200

37.0 Washing Probe 12/01/92 12:20

6 Data Review


RunListS. Type SerumDraw Date / TimeSex / AgeNAMELOCATIONPHYSICIANPATIENT IDDRAWN BY:

Edit ResultPrintData Transfer

[ ] [ ] [ ] [ ][ ] [ ] [ ] - [ ][ ] [ ] - [ ]

[ ][ ] [ ]

Routine

Rtn.1 059910

Alarm

12 01 92 11 50 M 36 YDOBBINS, KICU-12GRAHAM , J D123-56-9847DJB

[ ] / [ ] / [ ] [ ] : [ ][ ] [ ] [ ][ ][ ] [ ][ ][ ]


123456789

10

11121314151617181920

21222324252627282930

CKLDASTALTALP / AGGTAMYLTBILIDBILIBUN

GLUCO2CATRIGUAALB / PTPPHOSCREACHOL

MG

REF

10.3

143.8

466$

10.7

10.2

2 • 73

This field automatically displays the sample typeentered on the PATIENT TEST SELECTIONSscreen.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

These fields automatically display the informationentered or downloaded to the PATIENT TESTSELECTIONS screen for the sample requested in theData S. No. field. All five of these fields may be editedfrom this screen.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

The month the sample was drawn appears in thisfield.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

The day the sample was drawn appears in this field.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

The year the sample was drawn appears in this field.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

The hour the sample was drawn appears in this field.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

The minute the sample was drawn appears in thisfield.

Sex/Age [ ] [ ] [ ]

These fields automatically display the informationentered or downloaded to PATIENT TESTSELECTIONS screen for the sample requested in theData S. No. field. All three of these fields may beedited from this screen.



Edit Result [ ] [ ] [ ] [ ]

When one or several tests of a given sample have beenrerun, the rerun results may be incorporated into theoriginal results for that sequence number. Testresults also can be edited in this entry field.

You have the option of marking data that has beenedited on the DATA REVIEW screen. A new field,Edited Flag , is available on page 2 of the SYSTEMPARAMETERS screen. If this option is activiated,edited data will be marked with an "*" both on the DATAREVIEW screen and when downloaded to a host. Inaddition, the word EDITED will print along with anyedited results on reports printed in the short format.Precision check and correlation calculations for edited

The following information is displayed:

Sex/Age [ ] [ ] [ ]

The sex of the patient appears in this field.

Sex/Age [ ] [ ] [ ]

The numerical age of the patient appears in this field.

Sex/Age [ ] [ ] [ ]

The age interval of the patient in days, months, oryears appears in this field.

Name [ ]Comment [ ]Physician [ ]Patient ID [ ]Location [ ]

These fields automatically display the informationentered or downloaded to the PATIENT TESTSELECTIONS screen for the sample requested in theData field. All five of these fields may be edited fromthis screen. Your analyzer may not display allcomment fields, depending on how the SYSTEMPARAMETERS are set up.

2 • 74

items will not be performed. These items will betreated as results marked with a data alarm.

Edit Result [ ] [ ] [ ] [ ]

Choose 1 :Edit 1st Result 2 :Edit Rerun Result :ENTER

Use this field to choose whether you are editing a firstrun result or a rerun result. Press 1 Edit 1st ResultENTER to edit a first run result for the sample numberselected in the Data S. No. field.

Edit Result [ ] [ ] [ ] [ ]


Enter the number of the appropriate test code. Toselect the test by pressing the test key only, the testmust be displayed on the list at the bottom of thescreen. If the test is one of the 30 displayed on thescreen, press the appropriate test key. If the test isshown on the screen, press PAGE CONTINUE todisplay the remaining tests. You then can press thetest key.

Edit Result [ ] [ ] [ ] [ ]

Input New Data or Space bar to Delete : ENTER

Enter the edited result in this field and press ENTER.To delete the result entirely, press the SPACE BARfollowed by ENTER. You will see the result in the firstcolumn or rerun column, depending on which resultyou chose to edit, on the bottom of the displaychanged to the edited result. The cursorautomatically moves back to the second field to allowadditional edits to the same sample. When editing ofa specific sample is complete, advance the cursor tofield 4. If you do not go to field 4 and save the changesmade in this field, the changes will not be written toyour data disk.

Edit Result [ ] [ ] [ ] [ ]

Choose 1 :To Save 1st Result to Disk 2 :To Replace1st Result & Save : ENTERAre You Sure? 1 :Continue 0 :Cancel : ENTER

Use this field to save edits made to the first runresults. Press 1 To Save 1st Result to Disk ENTERto save the results listed in the first column on thisscreen. This saves edited results to the data disk.Press 2 To Replace 1st Result and Save ENTER. Theprompt line reads Are You Sure?. Press 1 ContinueENTER to replace all of the results in the first columnwith the corresponding results in the rerun column.This also saves the edited results to the data disk.You will see the first column’s results replaced withthe rerun column’s results on the screen. No entriesare needed in the first three fields when this is chosen.

Print [ ] [ ] [ ] - [ ]

Use these fields to print test results stored on the datadisk. You must select the run type in the Run fieldprior to entering printing information.

Print [ ] [ ] [ ] - [ ]

Choose 1 :Short Format 2 :Report Format : ENTER

Use this field to specify the printout format. Choose theproper format and press ENTER.

Print [ ] [ ] [ ] - [ ]

Choose 1 :Print All 2 :Print Edited List : ENTER

Use this field to select which reports to print. Press 1Print All ENTER to print all patient reports. Press 1Print Edited List ENTER to print only those patientreports that have been edited.



2 • 75

Print [ ] [ ] [ ] - [ ]


Use this field to enter the sample number for the firstreport in the range you want to print. Enter the correctsample number and press ENTER.

Print [ ] [ ] [ ] - [ ]


Use this field to enter the sample number for the lastreport in the range you want to print. Enter the correctsample number and press ENTER.

Wait until the requested operation is complete beforeattempting the next keyboard entry.

Data Transfer [ ] [ ] - [ ]

Use these fields to send patient files to a hostcomputer in the batch mode. To make an entry in thisfield, Yes must be specified in the HostCommunication Field on the STARTCONDITIONS screen and the analyzer must be inStand-by. If Real Time data transfer is selected on theSYSTEM PARAMETERS screen, no input is neededin this field unless the host crashes and then cansend. You must select a run type in the Run field priorto transferring data.


Choose 1 :Transfer All 2 :Transfer Edited Reports0 :Cancel : ENTER

Use this field to select which results to send to the hostcomputer. Press 1 Transfer All ENTER to send allresults to the host computer. Press 2 Transfer EditedReports ENTER to send all results to the hostcomputer. Press 0 Cancel ENTER to cancel transferof results to the host computer.



Use this field to enter the sample number for the firstresults in the range you want to transfer to the hostcomputer. Enter the correct sample number andpress ENTER.



Use this field to enter the sample number for the lastresults in the range you want to transfer to the hostcomputer. Enter the correct sample number andpress ENTER.

NOTEOnly data stored on the data disk in the first column willbe batch uploaded to the host. Results in the reruncolumn are not updated.



2 • 76

2.26 Routine Job - - RerunSamples

2.26.1 Introduction

The RERUN SAMPLES screen enables you to viewand edit the rerun list. Tests with data flags areautomatically placed on the rerun list. The RERUNSAMPLES screen varies slightly, depending onwhether you are using the sample bar code reader. Ifa test is not run due to masking of the reagent, thistest is not automatically put on the rerun list.

The RERUN SAMPLES screen has two pages. Page1 lists up to 15 samples at a time that have been placedon the rerun list. Page 2 lists all of the first run andrerun test results for an individual sample.

2.26.2 Displaying the RERUNSAMPLES Screen - - Page 1

Press ROUTINE to display the ROUTINE JOB MENU.Press 7 ENTER to display page 1 of the RERUNSAMPLES screen.

Press PAGE CONTINUE to scroll through additionalsamples on the rerun list.

2.26.3 Example of the RERUNSAMPLES Screen - - Page 1

Figure 2-37 is an example of page 1 of the RERUNSAMPLES screen.

Figure 2-37: RERUN SAMPLES - - Page 1

2.26 Routine Job - - Rerun Samples


7ENTER

37.0 Sample Stop 12/01/92 12:20

7 Rerun Samples


Rerun ListClearPrint

[ ] [ ][ ][ ] - [ ]


ICU-12ICU-8O.P.O.P.OUTPATIENTS317-2ICU-7

7:217:227:157:288:236:305:45

0- 10- 20- 30- 60- 70- 80-10

0599101614212841355

01008269628053

DOBBINS, KSMITH, JJAMES, BVOGT, MILDREDWILMOTH, MHOBBS, JPULAKSI, WM

123678

10

12/0112/0112/0112/0112/0112/0112/01

RoutineAlarm

1 059910

nnn Rerun Finishednnn Rerun Failed?

??

?

2 • 77

2.26.4 RERUN SAMPLES Screen Fields and Prompt - - Page 1

Each RERUN SAMPLES field and prompt isexplained below.

Rerun List [ ] [ ]

Use these fields to identify the first sample to be listedon the rerun list. Analyzers that are not using thesample bar code reader display Field 1. Analyzersthat are using the bar code reader display Field 1 andField 2.

Any samples that were flagged with DATA flags (otherthan H or L) on a specific test will be displayed on thelower portion of the screen. Only 15 samples can bedisplayed at a time. Press PAGE CONTINUE todisplay additional rerun samples.

The rerun list includes the Sample Number, Position,ID number, Date and Time the sample was processedand the first two lines of demographic information. Ifthe rerun result did not contain a data flag, then thesample number column will be highlighted in reversevideo. Any rerun results that still contain a data flagafter the rerun tests have been performed are flaggedwith a question mark (?) before the sample number.

Rerun List [ ] [ ]

Input First Sample No. 1 to 800 : ENTER

Use this field to enter the sample number of the firstsample to be listed. Only routine rerun samples areautomatically placed on this rerun list.

Rerun List [ ] [ ]


Use this field to enter the sample ID number of the firstsample to be listed. Up to 13 characters can be used(only if the bar code reader is on.) Only routine rerunsamples are automatically placed on this rerun list.

Clear [ ]

Choose 1 :Clear All Reruns 2 :Clear Shaded RerunResults Only : ENTERAre You Sure? 1 :Continue 2 :Cancel : ENTER

Use this field to clear samples from the rerun list.Executing the clear function removes rerun testselection information only. It does not remove rerunresults (data) stored on the data disk. Press 1 ENTERto clear all samples from the rerun list. Press 2ENTER to clear only samples that did not contain adata flag following the rerun. These are samples thatare highlighted in reverse video on the rerun list. TheRerun List is also cleared when doing a Patient TestSelection clear.


Use these fields to enter the sample numbers for therange of samples you want to print on the Rerun List.



Use this field to enter the sequence number for the firstsample in the range you want to print. Enter thecorrect sequence number and press ENTER.



Use this field to enter the sequence number for the lastsample in the range you want to print. Enter thecorrect sequence number and press ENTER.



2 • 78

2.26.5 Displaying the RERUNSAMPLES Screen - - Page 2

Press the ROUTINE key to display the ROUTINE JOBMENU. Press 7 ENTER to display page 1 of theRERUN SAMPLES screen. Press the GUIDANCEkey to display page 2 of the RERUN SAMPLESscreen. The second screen displays the tests to bererun for the specific sample number indicated inreverse video. Test results also are shown. Thisscreen allows you to add or delete tests to the rerunlist for a specific sample and change the samplevolume for a rerun sample. Patients can be edited ontothe rerun list as long as the sample has already beenrun once.

Press PAGE CONTINUE to view additional results forthe sample being viewed.



2.26.6 Example of the RERUNSAMPLES Screen - - Page 2

An example of page 2 of the RERUN SAMPLESscreen is shown in Figure 2-38.

Figure 2-38: RERUN SAMPLES - - Page 2

LEGEND

Data flags.......................................... redDecreased SV................................... ↑Increased SV .................................... ↓Masked - - no reagent .......................Masked - - from SC ...........................Test selected for rerun....................... reverse video

7ENTER

37.0 Stand-by 12/01/92 12:20

7 Rerun Samples


Sample No.ID NumberSample CupSample Vol.TestsS.Type


[ ][ ][ ][ ][ - ]Serum

Alarm

DOBBINS, KICU-12GRAHAM , J D123-56-9847DJB

[ ][ ] [ ][ ][ ]


810111319

TBILIBUNGLUCA

10.3143.8466$10.7

47484956

NaKCL

UN / CR

138.04.70

105.014

1059910

STD on TubeNormal

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

2 • 79

2.26.7 RERUN SAMPLES Screen Fields and Prompts - - Page 2

Sample. No. [ ] [ ] [ ]

Use these fields to identify the first sample to beedited. Analyzers that are not using the sample barcode reader display and use fields 1, 2, and 3 tosearch for samples. Analyzers that are using the barcode reader display and use Field 1 only or the ID fieldonly to search for samples. After a selection is madein one of these fields, the demographic information forthat sample is displayed.

In addition, the bottom of the screen displays the first15 tests run on this sample. Press PAGE CONTINUEto display the remainder of the tests run on the sample.This list gives the test name, first run results and rerunresults. Any data flags present will be displayedimmediately following the result using a symbol.

Sample. No. [ ] [ ] [ ]


Use this field to enter the sequence number to beedited. Only routine rerun samples may be edited fromthis screen. Enter the sequence number and pressENTER. You must use this field if you are not usingthe sample bar code reader. You may use this field ifyou are using the sample bar code reader.

Sample. No. [ ] [ ] [ ]

Input Disk No. 1 to 9 : ENTER

Use this field to enter the sample disk number of thefirst sample to be edited. Enter the sample disknumber and press ENTER. You must use this field ifyou are not using the sample bar code reader.

Sample. No. [ ] [ ] [ ]

Input Position No. 1 to 50 (0 :Initiates SamplingStop) : ENTER

Use this field to enter the sample disk positionnumber of the first sample to be edited. Enter thesample disk number and press ENTER. You mustuse this field if you are not using the sample bar codereader.

ID Number [ ]

Input Sample ID Number (Max 13 Characters) :ENTER

Use this field to enter the sample ID number for thefirst sample to be edited. Enter the ID number andpress ENTER. You must use this field (or the firstSample No. field) if you are using the sample bar codereader.

After the information for the sample number hasbeen entered, the remaining fields will display theinformation entered for that sample during patienttest selection.

Sample Cup NameSample Volume LocationTests PhysicianS. Type Patient ID

Drawn by

All of the fields listed above, excluding S. Type, maybe edited from this screen. Use the Tests field to edittest selections for reruns. The first run results andrerun results are displayed for up to 15 tests. PressPAGE CONTINUE to view additional results. Theselected rerun tests will highlight in reverse video onthe keyboard matrix. Increased or decreased samplevolume is selected via the Sample Volume field.



2 • 80

2.27 Routine Job Status Setting

2.27.1 Introduction

The STATUS SETTING screen enables you to selectthe automatic Wake-UpTM function. The automaticWake-Up function instructs the analyzer to go throughthe same procedures as the Initialization Mode(except program loading from the system disk) at aspecified time. This reduces start-up time. DuringWake-Up execution, the lamp turns on, the monitorscreen brightens, and all mechanical parts reset. Inaddition, reagent registration, water bath exchange,ISE prime, and an air purge are automaticallyperformed. Upon completion of the Wake-Up function,the instrument goes to Stand-by and remains on theSTATUS SETTING screen. You also can select Statreception execution from this screen.

2.27.2 Displaying the STATUSSETTING Screen

Press the ROUTINE key followed by 8 ENTER todisplay previously entered information.

2.27.3 Example of the STATUSSETTING Screen

Figure 2-39 is an example of the STATUS SETTINGscreen.

Figure 2-39: STATUS SETTING

2.27.4 STATUS SETTING ScreenFieldsand Prompts

Each STATUS SETTING field and prompt is explainedbelow.

Sleep Mode Wake-Up [ ] / [ ] [ ] : [ ]

Use these fields to specify the date and time you wantthe analyzer to wake up.


Input Month (1 To 12) : ENTER

Use this field to specify the month you want theanalyzer to wake up. Enter the month (1-12) and pressENTER.

2.27 Routine Job - - Status Setting


8ENTER

37.0 Stand-by 12/01/92 12:20

8 Status Setting

Sleep Mode STAT Reception

Wake-UpExecute

[12] / [02] [07] : [00][ Off ]

Execute [ No ]


2 • 81


Input Day (1 To 31) : ENTER

Use this field to specify the day you want the analyzerto wake up. Enter the day (1 - 31) and press ENTER.


Input Hour (0 To 23) : ENTER

Use this field to specify the hour you want theanalyzer to wake up. Enter the hour (0-23) and pressENTER.


Input Minute (0 To 59) : ENTER

Use this field to specify the minute you want theanalyzer to wake up. Enter the minute (0-59) andpress ENTER.

Sleep Mode Execute [ ]

Choose 1 :On 0 :Off : ENTERAre You Sure? 1 :Continue 0 :Cancel : ENTER

Use this field to request the automatic Wake-Upfunction be performed at the time specified in theWake Up field. The analyzer must be put into theSleep mode in order to perform the Wake-Up function.Press 1 Execute Sleep Function ENTER. The CRTprompt line displays Are You Sure?. Press 1Continue ENTER to put the analyzer in Sleep mode.Input in this field is allowed during the followingmaintenance operations initiated from ANALYZERMAINTENANCE: Wash Cells, Wash ISE, Wash All,Cell Blank, or ISE Prime.

When the analyzer is in the Sleep mode the CPUremains on. The lamp goes off, the monitor dims, andall mechanisms turn off. This saves lamp life, timereading the System disk and life of mechanical parts.The power ON to Stand-by time is reduced from 10 to6 minutes. All other functions revert to a power offstatus. An example of the STATUS SETTING screenas it appears when the analyzer is in the Sleep modeis shown in Figure 2-40.

The analyzer remains in the Sleep mode until it is timeto perform the Wake-Up function.

Figure 2-40: STATUS SETTING - - Sleep Mode

To wake up the analyzer, move the cursor to theSleep Mode Execute field and press 0 Off.

Stat ReceptionExecute [ ]

Choose 1 :Stat Reception Mode 0 :Cancel : ENTERAre You Sure? 1 :Continue 0 :Cancel : ENTER

Use this field to select the Stat Reception mode. Thisis an alternative to running in routine operation. Thismode minimizes the user time for processingstat samples. In the Stat Reception mode, the



37.0 Sleeping 12/01/92 12:20

8 Status Setting

Alarm Message Level Code Time

Sleep Mode

Wake-UpExecute

[12] / [02] [07] : [00][On]

STAT Reception

Execute [No ]

Z . . . Z . . . Z . . . Z

Input Month ( 1 to 12 ) : ENTER

2 • 82

analyzer blanks 12 reaction cells so that they areready for immediate use. The ISE calibration isautomatically updated by running the InternalStandard periodically. Every 10 minutes the analyzerperforms a one point calibration. It also limitsoperation to Stat samples only. If samples arerequested on the ROUTINE PATIENT SCREEN Fromthe Stat Reception mode, routine samples will not beperformed.

Press 1 Stat Reception Mode ENTER. The CRTprompt line will display Are You Sure?. Press 1Continue ENTER. The analyzer will be in the StatReception mode in 4.5 minutes. To take the analyzerout of the Stat Reception mode, press 0 CancelENTER. The CRT prompt line will display Are YouSure?. Press 1 Continue ENTER.

NOTEFrom the Stat Reception mode, you:1. cannot perform maintenance.2. cannot do Start Up or Repeat Calibration.3. cannot perform QC during auto calibration.4. cannot run routines.5. have room only for 200 stats on the data disk.



2 • 83

2.28 Stat Reception


2.28 Stat Reception

2.28.1 Introduction

The STAT RECEPTION display indicates that theanalyzer is ready to process stat samples.

2.28.2 Displaying the STATRECEPTION Screen

This screen appears 4.5 minutes after Yes is enteredin the Stat Reception field on the STATUS SETTINGscreen.

2.28.3 Example of the STATRECEPTION Screen

Figure 2-41 is an example of the STAT RECEPTIONscreen.

Figure 2-41: STAT RECEPTION Screen

2.28.4 Explanation of the STATRECEPTION Screen

There are no active fields on the STAT RECEPTIONscreen. Press the STAT key to display the STATTEST SELECTION screen.

37.0 Stat Stand-by 12/01/92 12:20

Stat Reception

Alarm Message Level Code Time

Ready For Stat

Press Stat Key

Routine Samples can not be Performedin The Stat Reception Mode.

2 • 84




2.29.1 Introduction

The STAT TEST SELECTION screen enables you toenter Stat test selections. The analyzer does nothave to be in Stand-by to make Stat test selections.

The STAT TEST SELECTION screen has two pages.Page 1 is used to make test selections and page 2 isused to add demographic information.

2.29.2 Displaying the STAT TESTSELECTION Screen - - Page 1

Press the STAT key to display the STAT TESTSELECTION screen.

2.29.3 Example of the STAT TESTSELECTION Screen Page 1

Figure 2-42 is an example of page 1 of the STAT TESTSELECTION screen.

Figure 2-42: STAT TEST SELECTIONScreen - - Page 1

37.0 Stand-by 3/18/93 12:20

Stat Test Selection


Run TypeSample Cup


Pos. Status

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD Cup

61

Normal

THEO

C-18 C-12

LIVER HEART

[ ][ ]

[ ][ ][ ][ - ]



12651

22752

32853

42954

53055

63156

73257

83358

93459

103560

113661

123762

133863

143964

154065

164166

174267

184368

194469

204570

2146

2247

2348

2449

2550

0 0 Occupied

2 • 85

2.29.4 STAT TEST SELECTION ScreenFields and Prompts Page 1

Each STAT TEST SELECTION field and prompt isexplained below.

CAUTIONIf a stat was programmed to a specific position, but notactually run, press GUIDANCE to view thedemographic information. If demographic informationwas entered for the sample that was not processed,this information must be cleared before the positionnumber can be used again.

Run Type [ ]

Choose 1 :Serum/Plasma 2 :Urine 3 :Other : ENTER

Use this field to select the type of sample. Choose thenumber that corresponds to the sample type andpress ENTER. The classes are definedon the SYSTEM PARAMETERS screen. This fielddefaults to Serum/Plasma.

Sample Cup [ ]

Choose 1 :STD Cup 2 :Micro 3 :STD on tube 4 :Microon tube 5 :Tube : ENTER


Sample Pos. [ ]

Input Position No. 51 to 70 for STATS : ENTERInput Position No. 71 to 78 for Controls : ENTER

Use this field to assign a sample disk positionnumber. For analyzers that are not using the samplebar code reader, positions 51 through 70 may beused. For analyzers that are using the sample barcode reader, positions 1 through 70 may be used.

The Position Status grid on the screen will highlight aposition number in red if a sample is already occupyingthat position. Choose a position number that is nothighlighted in red. For controls, 71-78 correspond todisk positions C1-C8. QC that is ran as a stat will notbe included in the QC data.

Enter the position number and press ENTER.

ID Number [ ]

Input ID Number (Maximum 13 Characters) : ENTER

Use this field to assign a bar code identificationnumber of up to 13 characters for each specimen, if itis not downloaded from a host computer. Enter the IDnumber and press ENTER. Entry in this field is notnecessary if you are not using the sample bar codereader. If you place the sample in the outer ring withthe bar code reader in use, the analyzer reads the barcode reader.

Sample Vol. [ ]

Choose 1 : Normal 2 : Decreased 3 : Increased SampleVolume : ENTER

Use this field to select sample volume size. Normal,decreased, or increased may be selected. This fielddefaults to normal sample volume. Choose theappropriate sample size and press ENTER.

More than one sample size may be selected fordifferent tests on the same sample. Specify thesample size in the Sample Vol. field. Specify thetests for that sample size in the Tests field and press



2 • 86

ENTER. The sample number will increment by one.Move the cursor back to the Sample No. field and re-enter the sample number. Select another samplesize and make test selections for the second samplesize. Press ENTER. Repeat if a third sample size isrequired.

Tests [ ]


Use this field to select tests or profiles to be performedon the sample. It is best to enter all demographicinformation before making test selections.Demographic information can be entered prior toprinting the results. When the cursor is in this field,the test and profile selection keys are active. Whenone of these keys is pressed, the key thatcorresponds to the selected test is highlighted inreverse video on the keyboard matrix. If the key ispressed a second time, the test is deselected and thehighlighting turns off.

The profile selection keys are the numeric keyslocated to the right of the test selection keys. Whena profile selection key is pressed the key is highlightedin reverse video on the keyboard matrix and all of thetests assigned to that profile also are highlighted.When the key is pressed a second time, thehighlighting turns off and the tests are no longerselected.

Press all test selection and/or profile selection keysfor the sample and press ENTER. The sample positionnumber increments by one automatically followingeach entry.

After tests are selected, the keyboard matrixhighlights the appropriate keys. If an Increasedsample volume was chosen, an up arrow ( ) isdisplayed in the highlighted key. If a decreasedsample volume was chosen, a down arrow ( ) isdisplayed in the highlighted key.

Continue with additional stat test selections. Pressthe START key after all of the stat samples have beenpositioned on the sample disk. Use page 2 of theSTAT TEST SELECTION screen to enterdemographic information for each stat sample. Referto the following section.

NOTEIf you are interfaced to the host and have Activeselected for Com. Config. in the SYSTEMPARAMETERS screen, the stat samples can beplaced in the outer ring. The 911 reads the bar codeinformations and queries the host for the testselection. The operator needs only to enter a sampleposition number.

2.29.5 Displaying the STAT TESTSELECTION Screen Page 2

Press STAT to display page 1 of the STAT TESTSELECTION screen. Press GUIDANCE to displaypage 2 of the STAT TEST SELECTION screen. Thefields for entering demographic information for statsamples will appear.



2 • 87

2.29.6 Example of the STAT TESTSELECTION Screen - - Page 2

Figure 2-43 is an example of page 2 of the STAT TESTSELECTION screen.

Figure 2-43: STAT TEST SELECTIONScreen - - Page 2

2.29.7 STAT TEST SELECTION ScreenFields and Prompts - - Page 2

Use the following fields to enter demographicinformation for stat samples. To display the testselection information before entering the demographicinformation, move the cursor to the Position field andenter the sample disk position number.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]

Use these fields to identify the date and time thesample was drawn. The order of these fields is definedfrom the SYSTEM PARAMETERS screen.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]



Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]


Use this field to enter the day the sample was taken.Enter the day and press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]


Use this field to enter the year the sample was taken.Enter the year and press ENTER.

Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]



Draw Date/Time [ ] / [ ] / [ ] [ ] : [ ]



If a Draw Date/Time is not entered, the date and timethe sample position number is entered is displayed.

Sex/Age [ ] [ ] [ ]

Use these fields to identify the sex and age of thepatient from which the sample was taken.



37.0 Stand-by 3/18/93 12:20

Stat Test Selection


Run TypeSample Cup


Pos. Status


[ 03 ] / [ 18 ] / [ 93 ] [11] : [50][M] [ 63 ] [ Y ][Smith, John ][ER-9 ][GRAHAM, J D ] [405-12-8162 ][DJB

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

SerumSTD Cup

61

Normal

THEO

C-18 C-12

LIVER HEART

[ ][ ]

[ ][ ][ ][ - ]



12651

22752

32853

42954

53055

63156

73257

83358

93459

103560

113661

123762

133863

143964

154065

164166

174267

184368

194469

204570

2146

2247

2348

2449

2550

0 0 Occupied

2 • 88

Sex/Age [ ] [ ] [ ]

Choose 1 : Male 2 : Female : ENTER

Use this field to enter the sex of the patient from whichthe sample was taken. Press 1 Male or 2 FemaleENTER.

Sex/Age [ ] [ ] [ ]



Sex/Age [ ] [ ] [ ]

Choose Age Interval 1 : Days 2 : Months 3 : Years :ENTER

Use this field to indicate the age interval in days,months, or years. Enter the correct interval and pressENTER.





Drawn by: [ ]Input Maximum of 10 Characters : ENTER

Use these fields to enter demographic informationconcerning the patient sample. These field names areuser definable on the SYSTEM PARAMETERSscreen. You can remove the demographic input fieldsfrom the PATIENT TEST SELECTION screen usingthe SYSTEM PARAMETERS screen.

Stat sequence numbers range from 1 to 200. When200 is exceeded, the next Stat sequence number is1 and new information will be written over old files. Forthis reason, stats should be cleared daily (DataClear, START CONDITIONS), or when 200 samplesare processed.



2 • 89

2.30 Quality Control Job Menu

2.30.1 Introduction

Use the QUALITY CONTROL (QC) JOB MENU toaccess screens that are used to view, evaluate, andprint out daily and cumulative QC results. Proceduresfor the initial set-up of these screens are given in thefollowing sections.

2.30.2 Displaying the QC JOB MENU

Press QC to display the QC JOB MENU.

2.30.3 Example of the QC JOB MENU

Figure 2-44 is an example of the QC JOB MENU.

Figure 2-44: Quality Control Job Menu

2.30.4 QC JOB MENU Fields andPrompts

Function No. [ ]

Input Number From List To Access DesiredFunction : ENTER


2.30 Quality Control Job - - Menu


37.0 Stand-by 12/01/92 12:20

QC Job Menu


1

2

3

4

5

6

7

Real Time QC

Individual QC Monitor

Individual QC List

Individual QC Chart

Cumulative QC Monitor

Cumulative QC List

Cumulative QC Chart

Function No. [ ]

2 • 90

2.31 Quality Control Job RealTime QC

2.31.1 Introduction

REAL TIME QC displays a twin plot graph of dailyquality control data. All QC dataare checked by a multi-rule Shewhart method. Whena random, systematic, or indeterminate QC error isdetected, an alarm is issued. Using this displayenables you to demonstrate that all reported resultsare properly controlled. All daily QC results are storedin C-RAM.

The REAL TIME QC display must be programmed withtwo controls for each chemistry assay. Each timethese controls are run, the results are comparedagainst their respective mean (X) and standarddeviation (SD) as programmed from the CONTROLVALUE SETTING screen. Refer to Section 2.51 formore information.

Each pair of control values (X) and (Y) is plotted on theREAL TIME QC graph. You must select the rules forjudging QC results. If no rules are selected in the RuleSelect Entry field, no Random, Systematic, orIndeterminate errors are displayed.

2.31.2 Displaying the REAL TIME QCScreen

Press QC to display the QC JOB MENU. Press1 ENTER to display the REAL TIME QC screen.

2.31.3 Example of the REAL TIME QCScreen

Figure 2-45 is an example of the REAL TIME QCscreen.

Figure 2-45: Real Time QC Screen

2.31 Quality Control Job - - Real Time QC


1ENTER

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

1010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

*

#

2 • 91

2.31.4 REAL TIME QC Screen Fieldsand Prompts

Each REAL TIME QC field and prompt is explainedbelow.

NOTEUse the COPY key for a graphical printout of thisscreen.

Test [ ]


Enter the test code (1 - 49) of the test for which youwant to view controls, then press ENTER. If controlshave been defined previously for the requested test,these control results will automatically be plotted onthe graph. To define controls or change controls forviewing, move the cursor to the Control (X) or Control(Y) field and enter the appropriate information.

Control (X) [ ]

Input Control No. 1 To 8 : ENTER

Enter the ID No. (1 - 8) of the control to be plotted onthe X axis and press ENTER.

The class, target mean, and target SD values areautomatically displayed. These values are specifiedon the CONTROL VALUE SETTING screen.

Control (Y) [ ]

Input Control No. 1 To 8 : ENTER

Enter the ID No. (1-8) of the control to be plotted on theY axis and press ENTER. Control Y must be a differentID No. (1-8) than Control X.

The class, target mean, and t arget SD values areautomatically displayed. These values are specifiedon the CONTROL VALUE SETTING screen.

Normal Data (*)

This field lists the number of data points that have noQC errors. This field is for display only. No operatorentry is permitted.

Random Err. Data (@)

This field lists the number of data points that haverandom errors. This field is for display only. Nooperator entry is permitted.

System Err. Data (#)

This field lists the number of data points that havesystem errors. This field is for display only. Nooperator entry is permitted.

QC Err. Data (+)

This field lists the number of data points that have QCerrors. This field is for display only. No operator entryis permitted.

NOTEResults with any data alarms other than system,random, or QC errors will not be plotted.


Select Points to be Rejected 1 : Random 2 : System3 : QC 4 : All Points : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

Use this field to clear random, system, and/or QC errordata from the displayed graph:

Press: 1 ENTER to clear random error data.Press: 2 ENTER to clear system error data.Press: 3 ENTER to clear QC error data.Press: 4 ENTER to clear all error data.

Are You Sure? is displayed on the prompt line. Press1 Continue ENTER to clear the data. This procedureclears the results for both Control (X) and Control (Y).



2 • 92

Rules Enabled [ ] - [ ]

Use these fields to select the rules used for QCevaluation.


Select Rule: 1 : 1-2S 2 : 1-3S 3 : 2-2S 4 : R-4S5 : 4-1S 6 : 10X 7 : 1-2.5S : ENTER

REAL TIME QC is evaluated by a multi-rule Shewhart-type method using the Westgard algorithm. Thisalgorithm applies the set of rules selected above. Apair of controls for each chemistry being processed iscompared against a known SD and mean. In somecases, only one of the controls (X or Y) may fail thetest applied by the rule. When a control sample failsa test, a data alarm is issued and the graph displaysa symbol that corresponds to the type of QC errordetected.

Enter the number that corresponds to the rule selectedand press ENTER. Repeat for additional rules.


Input Run size 1 to 10 for R-4S Rule : ENTER

Use this field to specify the number of sequential QCvalues to be used by the R-4S Rule. Enter the run sizeand press ENTER.



2 • 93

2.32 Quality Control Job - -Individual QC Monitor

2.32.1 Introduction

The INDIVIDUAL QC MONITOR screen displays ahistorical listing of the last 30 sequence numbers ofmeasured control values for each test. This screenalso is used to edit non-accumulated control data.Both real time control values and control values thathave already been accumulated are displayed. Whenthe Sample Number is highlighted in reverse video,this indicates the data have already beenaccumulated. This display retains the last 30 values,whether Real Time or Accumulated, (first in, first out).

2.32.2 Displaying the INDIVIDUAL QCMONITOR Screen

Press the QC key to display the QC JOB MENU.Press 2 ENTER to display the INDIVIDUALQC MONITOR.

Data for up to 20 points (sequence numbers) can beviewed at one time. Press PAGE CONTINUE todisplay the remaining data.

2.32.3 Example of the INDIVIDUAL QCMONITOR Screen

Figure 2-46 is an example of the INDIVIDUAL QCMONITOR screen.

Figure 2-46: INDIVIDUAL QC MONITOR Screen

2.32.4 INDIVIDUAL QC MONITORScreen Fields and Prompts

Each INDIVIDUAL QC MONITOR screen field andprompt is explained below.

Control [ ]


Use this field to select the level of control for whichdata is displayed. Enter the control (ID) number(1 - 8) and ENTER.

S. Type

This automatically displays the sample type definedfor this control on the CONTROL VALUE SETTINGscreen. No operator entry is permitted.

2.32 Quality Control Job - - Individual QC Monitor


2ENTER

37.0 Stand-by 12/01/92 12:20

2 Individual QC Monitor


-5.3-4.7-4.7-5.1-0.1-4.50.21.4

-3.11.30.74.8

-0.22.5

-4.68-4.15-4.15-4.51-0.09-3.980.181.24

-2.741.150.624.24

-0.182.21

15:118:04

23:0415:118:04

22:1115:049:19

14:018:198:04

10:269:47

14:23

119118117116115114113111108106105104103102

11/2411/2411/2311/2311/2311/2211/2211/2211/1811/1811/1811/1711/1711/16

107.9108.5108.5108.1113.1108.7113.4114.5110.1114.5113.9118.0113.0115.7

ControlS.TypeTest

Result Editing[ ] [ ] [ ]

Print [ ]

Target MeanTarget SD

[ ]Serum

[ C1 ]

PTN-81

S.No. Date Time Result Deviation %Error

113.23.5

S.No. AccumulatedDev. >2SD

#

+

2 • 94

Test [ ]

Select Tests via keyboard : ENTER

Use this field to select the test for which data isdisplayed. Enter the number that corresponds to thetest (1 - 49) and press ENTER. Data for up to 20sequence numbers may be displayed at one time. Toview additional data, press PAGE CONTINUE.

The QC data displayed contains six columns with theinformation listed below. None of these columnspermit operator entry.

S.No.

This column displays the sequence number of eachcontrol data point.

Date

This column displays the date the control wasperformed.

Time

This column displays the time the control wasperformed.

Result

This column displays the measured value for thatcontrol run.

Deviation

This column displays the deviation from the meanvalue. The deviation is displayed in reverse video if itis > 2 SD.

Deviation is calculated by:measured value - preset mean value = deviation

% Error

This column displays the percent error.

Percent error is calculated by:

deviation x 100 = percent errorpreset mean value

If a QC data alarm has occurred, it is listedimmediately following the result value using a symbol.

Result Editing [ ] [ ] [ ]

Use these three fields to edit non-accumulated controldata.


Input Sample No. to be Edited : ENTER

Use this field to specify the control sequence numberyou want to edit. Enter the control sequence number(101 - 830) and press ENTER.


Input New Data or Spacebar to Delete : ENTER

Use this field to input the new data or delete data.Enter the new data (up to six digits) and press ENTER.Press the SPACE BAR followed by ENTER to deletedata.


Input 1 : To Save Changes : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

Use this field to save the changes previously made tothe control data or changes will not be stored. Press1 To Save Changes ENTER. The CRT will display Areyou Sure?. Press 1 Continue ENTER. Press 0Cancel ENTER to cancel the changes.



2 • 95

Print [ ]

Choose 1 : Print All Reports 2 : Print onlyUnaccumulated Reports : ENTER

Use this field to print a copy of the individual QCmonitor data. Press 1 ENTER to request a printout.Press 2 ENTER to print only unaccumulated reports.An example of the printout is shown in Section 2.67.

Target Mean

This field displays the target mean entered on theCONTROL VALUE SETTING screen for the selectedcontrol level. No operator entry is permitted in thisfield.

Target SD

This field displays the target SD entered on theCONTROL VALUE SETTING screen for the selectedcontrol level. No operator entry is permitted in thisfield.

NOTEIndividual QC data is stored in C-RAM. To clear thisdisplay at the start or end of any day, the �delete� (all)function may be used. Accumulating automaticallyclears individual QC.



2 • 96

2.33 Quality Control Job - -Individual QC List

2.33.1 Introduction

INDIVIDUAL QC LIST displays information on controldata for a selected control level that has not beenaccumulated. This screen also is used to accumulatecontrol data.

Data that were displayed with any data flag other thanHigh, Low, Random error, System error, or QC erroralarm are not included in statistical calculations suchas standard deviation and percent coefficient ofvariation.

2.33.2 Displaying the INDIVIDUAL QCLIST Screen

Press the QC key to display the QC JOB MENU.Press 3 ENTER to display the INDIVIDUAL QC LISTscreen.

Up to 20 tests can be viewed at one time. Press PAGECONTINUE to view additional tests.

2.33.3 Example of the INDIVIDUAL QCLIST Screen

Figure 2-47 is an example of the INDIVIDUAL QCLIST screen.

Figure 2-47: INDIVIDUAL QC LIST Screen

2.33.4 INDIVIDUAL QC LIST ScreenFields and Prompts

Each INDIVIDUAL QC LIST screen field and prompt isexplained below.

Control [ ]


Use this field to select the level of control for which datais displayed. Enter the control (ID) number (1 - 8)ENTER. The daily results of all measured tests for thecontrol level selected are displayed.

The QC data displayed contains eight columns withthe information listed below. None of these columnspermit operator entry.

2.33 Quality Control Job - - Individual QC List


3ENTER

37.0 Stand-by 12/01/92 12:20

3 Individual QC List


ControlS.Type

Accumulate

PrintDelete

Reprint QC Report

Transfer to Host

[ ]Serum

[ ]

[ ][ ]

3.21.90.40.6

0.001.092.4

1.670.330.100.190.320.110.0512.45.17

0.2340.42

2.575.491.681.340.005.313.175.353.932.704.034.274.373.016.133.433.790.39

7511

0.02.4

64.30.70.20.50.70.30.125

11.10.500.6

124.634.623.844.71.30

20.5475.6

31.248.403.704.727.502.521.66

202.4150.586.168

108.20

106.0-30.0-20.0-34.0-1.01-17.7-71.0-25.0-7.40-3.30-4.1-6.8-

2.30-1.56-

184.0-143.9-5.82-

106.2-

148.042.028.050.01.4123.785.033.08.804.304.97.6

2.901.96

214.0155.96.62

120.2

23478

10111213151617181920474849

555335555555555552

LDASTALTAMYLTBILIBUNGLUCO"CAUAALB/PTPPHOSCREACHOL

PTN-81

[ ] [ ] - [ ]

[ ] - [ ]

Ch Test N Mean 2SD Limits SD CV(%) Range

NaKCl

2 • 97

CH

This column displays the channel number. Thechannel number corresponds to the test key assignedto a specific test.

Test

This column displays the short test name. This nameis assigned on the CHEMISTRY PARAMETERSscreen.

N

The measurement count is the number of control runsthat have occurred since the data was accumulatedthe last time. A maximum of 30 runs is allowable.

Mean

The mean is the calculated average of measurementresult values for each test item.

2SD Limits

The 2SD limit is the preset mean value ± 2X the presetSD value.

SD

The SD is the measured result calculated from Nobservations for each test item.

CV (%)

The CV % is calculated from the mean and SD for eachtest item.

Range

The range is the maximum measured value minus theminimum measured value.

S. Type

This field automatically displays the class defined forthis control on the CONTROL VALUE SETTINGscreen. No operator entry is permitted.

Accumulate [ ]

Use this field to transfer the individual QC datadisplayed into the cumulative QC file. Accumulationis possible in two ways: by accumulating theindividual QC data (M-R) or by accumulating a chosenspecific measured data point (X-R). Use the SYSTEMPARAMETERS screen to select the method of dataaccumulation. The analyzer must be in Stand-by.

M-R transfers a mean value. This can be a weightedmean, according to the number of points used tocalculate the mean, or it can be a non-weighted mean.Use the SYSTEM PARAMETERS screen to specifythe type of mean used in accumulation.

X-R transfers only one data point. This can be a non-weighted mean value of all individual data points or oneindividual data point.

Accumulate [ ]

Input 1 : To Accumulate : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

When mean accumulation is specified, press 1ENTER. The CRT will display Are You Sure?. Press1 Continue ENTER. Press 0 Cancel ENTER to cancelaccumulation.

Accumulate [ ]

Input No. 1 to 30 (or 99 : Accumulate Mean of IndividualPoints) : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

When individual data point accumulation is specified,enter the sequence number (1 - 30 or 99 for the mean)and press ENTER. The CRT will display Are YouSure?. Press 1 Continue ENTER. Press 0 CancelENTER to cancel accumulation.Delete [ ]



2 • 98

Select Test No. (or 99 : All Tests) via Keyboard 1to 49 : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

This field specifies control data to be excluded fromdata accumulation. A test must be displayed on thescreen to be able to delete data. If a test that is notdisplayed on the screen is selected, an input erroroccurs. Press PAGE CONTINUE to display additionaltests. Enter the test key selections to be deleted (or99 for all tests) and press ENTER. Followingaccumulation, all QC data is automatically deletedfrom this display.

Print [ ]

Input 1:Print List: ENTER

Use this field to print the individual QC list for allmeasured tests from Stand-by. Press 1 Print ListENTER.

NOTETo reprint or transfer results, the control level must bedefined in the Control field.

Reprint QC Reports[ ] [ ] - [ ]

Use these fields to reprint QC reports, eitherindividually, in batch, or on a control-by-control basis.


Choose 1 : Short Format 2 : Report Format : ENTER

Use this field to specify the format for data printout ofthe individual QC data. Select the appropriate formatand press ENTER.


Input Sequence No. (1 to 30) : ENTER

Use this field to specify the first sequence number tobe printed. Enter the sequence number and pressENTER.



Use this field to specify the last sequence number tobe printed. Enter the sequence number and pressENTER.

Transfer to Host [ ] - [ ]

Use these fields to transfer QC data to a host computerfrom Stand-by.



Use this field to specify the first sequence number betransferred to a host computer. Enter the number andpress ENTER. Entering ‘0’ in this field will cancel anydata transfer in progress.



Use this field to specify the last sequence number betransferred to a host computer. Enter the number andpress ENTER.



2 • 99

2.34.3 Example of the INDIVIDUAL QCCHART Screen

Figure 2-48 is an example of the INDIVIDUAL QCCHART screen.

Figure 2-48: INDIVIDUAL QC CHART Screen

2.34.4 INDIVIDUAL QC CHART ScreenFields and Prompts

Each INDIVIDUAL QC CHART screen field and promptis explained below.

NOTEUse the COPY key for a graphical printout of thisscreen.

Test [ ]


Use this field to select the test for which data isdisplayed. Enter the number that corresponds to thetest (1 - 49) and press ENTER.

2.34 Quality Control Job - - Individual QC Chart


2.34 Quality Control Job - -Individual QC Chart

2.34.1 Introduction

The INDIVIDUAL QC CHART screen graphicallydisplays the control data measured in the previous 30measurements. Data points marked with a pound sign(#) indicate the individual data has already beenaccumulated to the cumulative QC data. Data pointsmarked with an asterisk (*) indicate the individual datahas not yet been accumulated.

2.34.2 Displaying the INDIVIDUAL QCCHART Screen

Press QC to display the QC JOB MENU. Press 4ENTER to display the INDIVIDUAL QC CHARTscreen.

4ENTER

37.0 Stand-by 12/01/92 12:20

4 Individual QC Chart


Test [ C1 ]

Control [ PTN-81 ] Serum


Target MeanTarget SDNMeanSDCV %Range

113.23.5

2108.20

0.420.390.6

95.63.0

290.101.271.411.8

Target MeanTarget SDNMeanSDCV %Range

:::::::

:::::::

* Not Yet Accumulated # Accumulated

123.7

120.2

113.2

106.2

102.7

104.6

101.6

95.6

89.6

86.6

#

#

#

##

#

##

##

##**

## #

#

# # # #

#

#

##*

*

2 • 100

NOTEOn the graph that is displayed, the outer linesrepresent ± 3 SD control line, the inner lines represent± 2 SD control line, and the central line represents themean value that was entered.

Control [ ]


Use this field to select the control that is plotted on thefirst graph. Enter the control number and pressENTER. The first graph will be displayed. Up to 30values may be displayed. If a test was not run or wasdeleted from a control sequence number, there will bea gap in the chart. You may want to use a differentcontrol for tests that have controls run less frequently.The statistical data displayed in the table to the left ofthe charts pertains only to the non-accumulated datapoints.

Control [ ]


Use this field to select the control that is plotted on thesecond graph. Enter the control number and pressENTER. The second graph will be displayed. Up to 30values may be displayed. If a test was not run or wasdeleted from a control sequence number, there will bea gap in the chart. You may want to use a differentcontrol for tests that have controls run less frequently.The statistical data displayed in the table to the left ofthe charts pertains only to the non-accumulated datapoints.

All additional fields are displayed for both controls.The target mean and target SD are entered on theCONTROL VALUE SETTING screen. The remainingvalues are calculated by the instrument from the QCdata. No operator entry is permitted in these fields.

Target Mean


Target SD


N

The measurement count is the number of control runsthat have occurred since the data was accumulatedthe last time.

Mean

The mean is the calculated average of measurementresult values for each test item.

SD

The SD is the measured result calculated from Nobservations for each test item.

CV (%)


Range

The range is the maximum measured value minus theminimum measured value.

2.34 Quality Control Job - - Individual QC Chart


2 • 101

2.35 Quality Control Job - -Cumulative QC Monitor

2.35.1 Introduction

The CUMULATIVE QC MONITOR screen displays theaccumulated data of measured control values for eachtest. This screen also is used to deletecontrol data.

2.35.2 Displaying the CUMULATIVEQC MONITOR Screen

Press the QC key to display the QC JOB MENU.Press 5 ENTER to display the CUMULATIVE QCMONITOR.

Up to 20 accumulations can be viewed at onetime. Press PAGE CONTINUE to display theremaining data.

2.35.3 Example of the CUMULATIVEQC MONITOR Screen

Figure 2-49 is an example of the CUMULATIVE QCMONITOR screen.

Figure 2-49: CUMULATIVE QC MONITOR Screen

2.35.4 CUMULATIVE QC MONITORScreen Fields and Prompts

Each CUMULATIVE QC MONITOR screen field andprompt is explained below.

Control [ ]


Use this field to select the level of control for whichdata is displayed. Enter the control (ID) number(1 - 8) and press ENTER.

S. Type


2.35 Quality Control Job - - Cumulative QC Monitor


5ENTER

37.0 Stand-by 12/01/92 12:20

5 Cumulative QC Monitor


ControlS.TypeTest

PrintDelete

Target MeanTarget SD

[ ]Serum

[GLU ]

[ ][ ]

Dev. >2SD

1025

-101

-2-2-2-11

-1-111

-1-1-1-2-2-1-21

-0.490.781.47

11.762.061.080.59

-1.32-0.79-0.661.321.32

-1.58-0.56-1.32-2.63-2.63-0.66-2.631.71

75.376.077.074.074.575.576.575.075.475.577.077.074.875.575.074.074.075.574.077.3

33666331521152124234

32433230310051044122

123456789

1011121314151617181920

12:5017:5017:3217:5517:2517:4517:4517:0016:3316:1816:3216:2416:3016:5516:0213:5716:1615:5415:0515:19

11/2410/2110/1910/1610/1410/0610/0510/0209/3009/0108/3108/2708/2608/1108/1008/0708/0507/2707/2207/14

PTN-81 Date Time Result N Range Deviation %Error

2 • 102

Test [ ]


Use this field to select the test for which data isdisplayed. Enter the number that corresponds to thetest (1 - 49) and press ENTER. Up to 20 sets of valuesmay be displayed at one time. Up to a maximum of31 accumulations are available (first in, first out). Toview additional sets of values, press PAGECONTINUE.

The QC data is displayed in seven columns with theinformation listed below. None of these columnspermit operator entry.

Date

This column displays the date the control wasaccumulated.

Time

This column displays the time the control wasaccumulated.

Result

This column displays the accumulated value for thatcontrol.

N

This column displays the number of control values thatwere accumulated. A maximum of 31 control valuesare available.

Range

This column displays the range between themaximum value and the minimum value in thataccumulation.

Deviation

This column displays the deviation from the meanvalue. This column is highlighted if the deviation isgreater than ± 2SD.

Deviation is calculated by:

accumulated value - preset mean value = deviation

% Error

This column displays the percent error.

Percent error is calculated by:

deviation x 100 = percent errorpreset mean value

If a QC data alarm has occurred, it is listedimmediately following the result value, using a symbol.

Delete [ ]

Input Sequence No. 1 To 31 (or 99 : Delete AllData) : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

Use this field to specify the control sequence numberyou want to delete. Enter the control sequencenumber (1 - 31) and press ENTER. Press 99 Delete AllData ENTER to delete data for all of the sequencenumbers at one time. The CRT prompt line displaysAre You Sure? . Press 1 Continue ENTER to delete theselected data. Press 0 Cancel ENTER to stop thedeletion of the selected data.

Print [ ]

Input 1 : To Print Report : ENTER

Use this field to print a copy of the CUMULATIVE QCMONITOR data from Stand-by. Press 1 To Print ListENTER to request a printout.



2 • 103

Target Mean


Target SD




2 • 104

2.36.3 Example of the CUMULATIVEQC LIST Screen

Figure 2-50 is an example of the CUMULATIVE QCLIST screen.

Figure 2-50: CUMULATIVE QC LIST Screen

2.36.4 CUMULATIVE QC LIST ScreenFields and Prompts

Control [ ]


Use this field to select the level of control for which datais displayed. Enter the control (ID) number (1 - 8) andpress ENTER. The daily results of all measured testsfor the control level selected are displayed.

The QC data displayed contains eight columns withthe information listed below. None of these columnspermit operator entry.

CH

2.36 Quality Control Job - - Cumulative QC List


6ENTER

2.36 Quality Control Job - -Cumulative QC List

2.36.1 Introduction

CUMULATIVE QC LIST displays information oncontrol data for a selected control level that have beenaccumulated. This screen also is used to deleteaccumulated control data.

2.36.2 Displaying the CUMULATIVEQC LIST Screen

Press QC to display the QC JOB MENU.Press 6 ENTER to display the CUMULATIVEQC LIST screen.

Up to 20 tests can be viewed at one time. Press PAGECONTINUE to view additional tests.

37.0 Stand-by 12/01/92 12:20

6 Cumulative QC List


ControlS.Type

PrintDelete

[ ]Serum

[ ][ ]

3.92.21.3

1.022.1

1.270.204.6

0.140.090.150.056.3

3.640.2553.00

2.771.673.614.962.724.252.505.023.801.932.062.893.202.424.062.68

141.8129.935.4

20.5076.3

29.798.1792.13.744.557.351.67

197.4150.516.279

111.89

119.0-106.0-30.0-17.7-71.0-25.0-7.40-78.0-3.30-4.1-6.8-

1.56-184.0-143.9-5.82-

106.2-

169.0148.042.023.785.033.08.80

108.04.304.97.6

1.96214.0155.96.62

120.2

123

10111213141516171920474849

2333333332333333

CKLDASTBUNGLUCO2CATRIGUAALB/PTPCREACHOL

PTN-81Ch Test N Mean 2SD Limits SD CV(%)

NaKCl

2 • 105

This column displays the channel number. Thechannel number corresponds to the test key assignedto a specific test.

Test

This column displays the short test name. This nameis assigned on the CHEMISTRY PARAMETERSscreen.

N

The measurement count is the number ofaccumulations for each test. The maximum numberof accumulations allowable is 31.

Mean

The mean is the average value of the accumulatedvalues for each test. The calculation of the meandepends on the selection made on theSYSTEM PARAMETERS Screen.

2SD Limits

The 2SD limit is the preset mean value ± 2X the presetSD value.

SD

The SD is the measured result calculated from Naccumulations for each test item.

CV (%)


S. Type


Delete [ ]

Select Tests via Keyboard (or 99 : All Tests) : ENTERAre You Sure? 1 : Continue 0 : Cancel

This field specifies accumulated control data to bedeleted. A test must be displayed on the screen to beable to delete data. If a test that is not displayed onthe screen is selected, an input error occurs. PressPAGE CONTINUE to display additional tests. Enterthe test key selections to be deleted (or 99 for alltests) and press ENTER.

Print [ ]

Input 1 : To Print Report : ENTER

Use this field to print from Stand-by the CUMULATIVEQC LIST for all measured tests. Press 1 Print ListENTER.

2.36 Quality Control Job - - Cumulative QC List


2 • 106

2.37 Quality Control Job - -Cumulative QC Chart

2.37.1 Introduction

The CUMULATIVE QC CHART screen graphicallydisplays the control data measured in the previous 31accumulations for a specified test.

Two graphs are displayed for each control level. On theupper graph, the outer lines represent ± 3 SD, the innerlines represent ± 2 SD, and the center line representsthe target mean value. This reflects the accuracy ofthe 911 analyzer.

The lower graph shows the range on individual resultsin each accumulation. The bottom line representszero, or no deviation. The center line is 3X the targetand the top line is 6X the target SD. This reflects theprecision of the 911 analyzer.

2.37.2 Displaying the CUMULATIVEQC CHART Screen

Press QC to display the QC JOB MENU. Press7 ENTER to display the CUMULATIVE QCCHART screen.

2.37.3 Example of the CUMULATIVEQC CHART Screen

Figure 2-51 is an example of the CUMULATIVE QCCHART screen.

Figure 2-51: Cumulative QC Chart Screen

2.37.4 CUMULATIVE QC CHARTScreen Fields and Prompts

Each CUMULATIVE QC CHART screen field andprompt is explained below.

Test [ ]


Use this field to select the test for which data isdisplayed. Enter the number that corresponds to thetest (1 - 49) and press ENTER.

2.37 Quality Control Job - - Cumulative QC Chart


7ENTER

37.0 Stand-by 12/01/92 12:20

7 Cumulative QC Chart


Test [ GLU ]



DateTarget MeanTarget SDNMeanSDCV %

76.03.521

75.20.6

1.62

301.010.0

21311.5

1.14.42

DateTarget MeanTarget SDNMeanSDCV %

:::::::

:::::::

86.5

83.0

76.0

69.0

65.5

331.0

321.0

301.0

281.0

271.0

07/08 - 11/24

07/08 - 11/24

21.0

10.5

0.0

60.0

30.0

0.0

* *

*** ** * *

* ** * *

** *

**

** * * * ** * *

* * * * * * * *** **

*

** * *

**

** * * *

***

** *

* *

**

* ** *

** *

** * * *

* *** *

*

2 • 107

Control [ ]


Use this field to select the control that is plotted on thefirst graph. Enter the control number and pressENTER. The first graph will be displayed. Up to 31accumulations may be displayed.

Control [ ]


Use this field to select the control that is plotted on thesecond graph. Enter the control number and pressENTER. The second graph will be displayed. Up to 31accumulations may be displayed.

All additional fields are displayed for both controls.The target mean and target SD are entered on theCONTROL VALUE SETTING screen. The remainingvalues are calculated by the instrument from theaccumulated QC data. No operator entry is permittedin these fields.

Target Mean


Target SD


N

The measurement count is the number ofaccumulations.

Mean

The mean is the calculated average of theaccumulated values for each test.The calculation of the mean depends on the selectionmade on the SYSTEM PARAMETERS screen.

SD

The SD is the measured result calculated from Naccumulations for each test item.

CV (%)


NOTEThe range graph can be removed from the screen bychoosing Off in the Range Plot field on the secondpage of the SYSTEM PARAMETERS Screen.

2.37 Quality Control Job - - Cumulative QC Chart


2 • 108

2.38 Data Monitor Job - - Menu

2.38.1 Introduction

Use the DATA MONITOR JOB MENU to accessscreens that display graphs of the most recentphotometric reactions. Other screens on this menuare used to view calibration factors; view calibrationcurves and monitor calibrations.

2.38.2 Displaying the DATA MONITORJOB MENU

Press the MONITOR key to display the DATAMONITOR JOB MENU.

2.38.3 Example of the DATA MONITORJOB MENU

Figure 2-52 is an example of the DATA MONITOR JOBMENU screen.

Figure 2-52: DATA MONITOR JOB MENU Screen

2.38.4 DATA MONITOR JOB MENUFields and Prompts

Function No. [ ]

Input Number From List to Access DesiredFunction : ENTER


2.38 Data Monitor Job - - Menu


37.0 Stand-by 12/01/92 12:20

Data Monitor Job Menu


1

2

3

4

5

Reaction Monitor

Calibration Trace

Calibration List

ISE Calibration Monitor

Working Curve

Function No. [ ]

2 • 109

2.39 Data Monitor Job - -Reaction Monitor

2.39.1 Introduction

The REACTION MONITOR display enables you toview (in graph form) photometric absorbance vs. timefor the 360 most recent photometric tests, as well asthe 80 most recent standards and the 80 most recentQC tests.

Absorbance (as Abs x 104) is displayed on the ordinate(Y-axis) and measure points for the time of reaction isdisplayed on the abscissa (X-axis). The scale of theX-axis depends on the reaction time. If the absorbancedata is higher than the upper limit specified, it is plottedat the upper limit. If it is lower than the lower limitspecified (0 on the example below), it is plotted at thelower limit. The data at measurement point numberone are plotted on the Y-axis.

Reaction monitor information is stored in non-batterybacked CRAM and is cleared when the instrument ispowered down. The number of read points displayedon the reaction monitor graph is related to theinformation programmed in CHEMISTRYPARAMETERS.

2.39.2 Displaying the REACTIONMONITOR Screen

Press MONITOR to display the MONITOR JOBMENU. Press 1 ENTER to display the REACTIONMONITOR screen.

Press PAGE CONTINUE to view previous results,such as those of patients run more than once withsame sequence number, if applicable.

2.39 Data Monitor Job - - Reaction Monitor


1ENTER

2 • 110

2.39.3 Example of the REACTIONMONITOR Screen

Figure 2-53 is an example of the REACTIONMONITOR screen.

Figure 2-53: REACTION MONITOR Screen

2.39.4 REACTION MONITORScreen Fields and Prompts

Each REACTION MONITOR field and prompt isexplained below.

Sample [ ] - [ ]

Use these fields to select the sample to be displayed.

Sample [ ] - [ ]

Choose 1 : Routine 2 : Routine Rerun 3 : Stat 4 : StatRerun 5 : Control 6 : STD : ENTER

Use this field to select the type of sample to bedisplayed. Enter the sample type and press ENTER.

Sample [ ] - [ ]

Input Sample No. 1 to 800 : ENTERInput Sample No. 1 to 200 : ENTERInput Sample No. 101 to 830 for Controls : ENTERInput Sample No.11, 12, 21, 22, 31, 32, 41, 42, 51, 52,61, 62 for Standards : ENTER

Enter the sequence number for the sample typeselected in the first field (as listed below) and pressENTER:


ROUTINE ................................................... 1 - 800ROUTINE RERUN ...................................... 1 - 800STAT.......................................................... 1 - 200STAT RERUN ............................................ 1 - 200CONTROL

LEVEL 1 ............................................ 101 - 130LEVEL 2 ............................................ 201 - 230LEVEL 3 ............................................ 301 - 330LEVEL 4 ............................................ 401 - 430LEVEL 5 ............................................ 501 - 530LEVEL 6 ............................................ 601 - 630LEVEL 7 ............................................ 701 - 730LEVEL 8 ............................................ 801 - 830



37.0 Stand-by 12/01/92 12:20

1 Reaction Monitor

Choose 1:Routine 2:Routine Rerun 3:Stat Rerun 5:Control 6:STD : ENTER

SampleScale

CellResult

7460

[ Routine ] - [ 1] Test [ GLU ] Print [ ][ 0 ] - [ 12000 ]

$

3000

6000

9000

12000

03 6 9 12 15

2 • 111

SAMPLE TYPE INPUT RANGE(sequencenumber)

STANDARDSTD 1 .................................................... 11, 12STD 2 .................................................... 21, 22STD 3 .................................................... 31, 32STD 4 .................................................... 41, 42STD 5 .................................................... 51, 52STD 6 .................................................... 61, 62

Test


Use this field to select the test to be viewed. Enter thetest key number or press the test key itself, thenpress ENTER.

The graph displayed is the latest reaction for thespecified sequence number and test. Press PAGECONTINUE to view previous reaction monitors such ascalibrations since the analyzer was powered on orprevious patient runs with this sequence number.

Cell

This field displays the reaction cell where the reactiontook place.

Result

This field displays the final result for patient samplesand controls and the absorbance reading forstandards. If a data flag was issued, the data flag alsois displayed.

Scale [ ] - [ ]

Use these fields to set the absorbance range that isplotted on the Y- axis. The limits are -10,000 to 40,000X 104. These fields default to the previous entries.Changing these settings can improve the resolution ofthe graph.

Scale [ ] - [ ]

Input Minimum Level ABS (-10000 to 40000) :ENTER

Use this field to enter the minimum absorbance x 104.Enter the absorbance and press ENTER.

Scale [ ] - [ ]

Input Maximum Level ABS (-10000 to 40000) : ENTER

Use this field to enter the maximum absorbance x 104.Enter the absorbance and press ENTER.

Print [ ]

Input 1 : To Print : ENTER (Use COPY KEY for Graph)

Use this field to print cell blank values and rawabsorbance data for the displayed graph. Press 1ENTER. Absorbance data can be printed only inStand-by. Absorbance data is stored for 360 normalsamples, 80 control tests, and 80 calibrations.

Press the COPY key to print the graph as shown on theREACTION MONITOR screen.



2 • 112

2.40 Data Monitor Job - -Calibration Trace

2.40.1 Introduction

The CALIBRATION TRACE screen graphicallydisplays the 30 most recent successful calibrationsfor each photometric test (including CALIB alarms)and the 30 most recent calibrations for each ISE test(including failed alarms). For non-linear calibrations,the span point is plotted with an X. For all otherphotometric calibrations, the highest calibrator isplotted with an X.

2.40.2 Displaying the CALIBRATIONTRACE Screen

Press MONITOR to display the Monitor Job Menu.Press 2 ENTER to display the CALIBRATION TRACEscreen.

2.40.3 Example of the CALIBRATIONTRACE Screen

Figure 2-54 is an example of the CALIBRATIONTRACE screen. The scale plots STD 1 values forphotometric tests and Precical values for ISEs. TheX scale plots the span values for non-linearphotometric tests, the highest standard values for allother photometric tests and the slope values for ISEs.

Figure 2-54: CALIBRATION TRACE Screen

2.40.4 CALIBRATION TRACEScreen Fields and Prompts

Each CALIBRATION TRACE field and prompt areexplained below.

Test [ ]


Use this field to select the test to be displayed. Enterthe test code and press ENTER. For manually setreagents, the test name and scale value are displayed,but no graph is drawn.

2.40 Data Monitor Job - - Calibration Trace


4ENTER

37.0 Stand-by 12/01/92 12:20

2 Calibration Trace


TestPrint

ScaleScale

( ) [ ] - [ ]( ) [ ] - [ ]

0 8000X 0 8000

[ GLU ][ ]

Alarm

: STD ( 1) 06 /16 → 11 / 19 X : STD ( 2 ) - ( 6 )

5 10 15 20 25 3000

0

20002000

40004000

60006000

80008000

× ×× × × ××××××

× × ×× ×× ×× ×× ×

2 • 113

SCALE (X) [ ] - [ ]

Use these fields to specify the minimum andmaximum absorbance range for the span or highstandard.

SCALE (X) [ ] - [ ]

Input Low Value : ENTER

For test codes 1-46:Enter minimum ABS (input range: -40,000 - 40,000) ofSTD 2-6.

For test codes 47-49:Enter minimum slope (input range: 0 - 999999) of thelow and high ISE calibrators.

SCALE (X) [ ] - [ ]

Input High Value : ENTER

For test codes 1-46:Enter maximum ABS (input range: -40,000 - 40,000)of STD 2-6.

For test codes 47-49:Enter maximum slope (input range: 0 - 999999) of thelow and high ISE calibrators.

2.40 Data Monitor Job - - Calibration Trace


Print [ ]

Input 1 : To Print : ENTER (Use COPY KEY for Graph)

Use this field to print the results of the 30 most recentcalibrations. Press 1 ENTER to print the results. Theanalyzer must be in Stand-by to request a printout.

Press COPY to get a printout of the graph displayed onthe CALIBRATION TRACE screen.

SCALE ( ) [ ] - [ ]

Use these fields to specify the minimum andmaximum absorbance range for standard 1.

SCALE ( ) [ ] - [ ]


For test codes 1 - 46:Enter the minimum ABS (input range: -40,000 -40,000) of STD 1.

For test codes 47 - 49:Enter the minimum concentration (input range:0 - 999999) of the calibrator (ISE 3).

SCALE ( ) [ ] - [ ]


For test codes 1-46:Enter maximum ABS (input range: -40,000 - 40,000)of STD 1.

For test codes 47-49:Enter maximum concentration (input range:0 - 999999) of the calibrator (ISE 3).

2 • 114

2.41 Data Monitor Job - -Calibration List

2.41.1 Introduction

Use the CALIBRATION LIST screen to viewcalibration data for all programmed tests. This screenis password protected and is not used by the operatorduring routine operation. BM does not recommendthat you change any values on this screen unlessinstructed to do so by a BM representative.

2.41.2 Displaying the CALIBRATIONLIST Screen

Press MONITOR to display the MONITOR JOBMENU. Press 3 ENTER to display the CALIBRATIONLIST screen.

Up to 20 tests are listed on the screen in ascendingorder of test codes. Press PAGE CONTINUE todisplay to the remaining tests in memory.

2.41.3 Example of the CALIBRATIONLIST Screen

Figure 2-55 is an example of the CALIBRATION LISTscreen.

Figure 2-55: CALIBRATION LIST Screen

2.41.4 CALIBRATION LIST ScreenFields and Prompts

Each CALIBRATION LIST field and prompt isexplained below.

S1 ABS

Input ABS. x 10000 : ENTER

Absorbance (x104) of the Standard (1). A (positive ornegative) signed number of up to six characters canbe viewed. This number is updated following eachsuccessful or CALIB flagged calibration. For anendpoint assay, the absorbance value of the reagentblank is shown. For a rate assay, the absorbancechange per minute of the reagent blank is shown. ForSerum Indexes, the reagent blank at each of the threewavelength pairs is displayed.

2.41 Data Monitor Job - - Calibration List2. CRT SCREEN DISPLAY

2ENTER

37.0 Stand-by 12/01/92 12:20

3 Calibration List

Input ABS. X 10000 : ENTER

123456789

1011121314151617181920

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CATRIGUAALB/PTPPHOSCREACHOL

Test S1 ABS K A B C

Alarm

-2-6-1-1002

180

-91211

-38543621348123

7080-5073313

7289

114559413

-7414-74142904687358141220251

-6230513

-76217477023583

464244

1883585

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

2 • 115

K

Input K Factor : ENTER

For the K factor, a signed (positive or negative) numberof up to six characters may be viewed. This displayshows the K factor, which is updated after eachsuccessful or CALIB flagged calibration, forchemistries using other calibration methods.

A

Input A Factor : ENTER

Non-linear coefficient A. A signed (positive ornegative) number of six characters may be viewed.

B

Input B Factor : ENTER

Non-linear coefficient B. A signed (positive ornegative) number of six characters may be viewed.

C

Input C Factor : ENTER

Non-linear coefficient C. A signed (positive ornegative) number of six characters may be viewed.

For more details concerning the CALIBRATION LISTscreen information, see the chemistry section ofChapter 5, Theory.

2.41 Data Monitor Job - - Calibration List


2 • 116

2.42 Data Monitor Job - - ISECalibration Monitor

2.42.1 Introduction

The ISE CALIBRATION MONITOR screen shows theresults from the most recent successful ISEcalibration. This screen is password protected.Boehringer Mannheim does not recommended thatyou change the compensated values.

2.42.2 Displaying the ISE CALIBRATIONMONITOR Screen

Press MONITOR to display the MONITOR JOBMENU. Press 4 ENTER to display the ISECALIBRATION MONITOR screen.

2.42.3Example of the ISE CALIBRATION MONITOR Screen

Figure 2-56 is an example of the ISE CALIBRATIONMONITOR screen.

Figure 2-56: ISE CALIBRATION MONITOR Screen

2.42.4 ISE CALIBRATION MONITORScreen Fields and Prompts

Each ISE CALIBRATION MONITOR field and promptis explained below.

INT. Ref. EMF.

This field displays the electrical potential(electromotive force) of the internal reference solutionin millivolts (mV) for Na+, K+, and Cl-. No operator entryis allowed in this field.

2.42 Data Monitor Job - - ISE Calibration Monitor


4ENTER

37.0 Operation 12/01/92 12:20

4 ISE Calibration Monitor

Input Concentration : ENTER

Int. Ref. EMF.STD(1) Low EMF.STD(2) High EMF.STD(3) Calib. EMF.

Slope

Int. Ref. Conc.STD(3) Conc.

Compensated Values

-30.9-35.8-28.9-32.1

55.2

147.5140.4

-1.4

-33.5-46.5-26.6-34.2

53.5

5.205.04

-0.04

125.9130.7123.2126.3

-42.6

103.9101.6

-1.2

Routine

[ ] [ ] [ ]

Na K Cl

2 • 117

STD (1) Low EMF.

This field displays the electrical potential(electromotive force) of ISE 1 (LOW standard) for Na+,K+, and Cl-. No operator entry is allowed in this field.

STD (2) High EMF.

This field displays the electrical potential(electromotive force) of ISE 2 (HIGH standard) for Na+,K+, and Cl-. No operator entry is allowed in this field.

STD (3) Calib. EMF.

This field displays the electrical potential(electromotive force) of ISE 3 (calibrator) for Na+, K+,and Cl-. No operator entry is allowed in this field.

Slope

This field displays the response (sensitivity) of eachelectrode cartridge for Na+, K+, and Cl-. No operatorentry is allowed in this field.

Int. Ref. Conc.

This field displays the concentration of the internalreference solution as determined during calibration forNa+, K+, and Cl-. No operator entry is allowed in thisfield.

STD (3) Conc.

This field displays the measured concentration of thecalibrator (ISE 3) as determined during calibration forNa+, K+, and Cl-. No operator entry is allowed in thisfield.

Compensated Values [ ] [ ] [ ]

Input Concentration : ENTER

This field is used to enter the calculated compensationvalue. The compensation value is the differencebetween the expected ISE 3 value and the measuredISE 3 value. This compensate value is added to allmeasured controls and patient values to obtain thereported result. Refer to the ISE application sheet foran explanation of how this value is used. Field 1 isused for Na+, Field 2 for K+, and Field 3 for Cl-.

These fields are updated automatically duringcalibration. The compensated value is -99999 to999999.

2.42 Data Monitor Job - - ISE Calibration Monitor


2 • 118

2.43 Data Monitor Job - -Working Curve

2.43.1 Introduction

The WORKING CURVE screen is used to display thecalibration curve for any photometric assay other thanthose using the linear 1-point calibration method.Absorbance is plotted on the ordinate (Y-axis). Thelog of concentration, based on the standards, isplotted on the abscissa (X-axis).

2.43.2 Displaying the WORKINGCURVE Screen

Press MONITOR to display the MONITOR JOBMENU. Press 5 ENTER to display the WORKINGCURVE screen.

2.43.3 Example of the WORKINGCURVE Screen

Figure 2-57 is an example of the WORKING CURVEscreen.

Figure 2-57: WORKING CURVE Screen

2.43.4 WORKING CURVE ScreenFields and Prompts

Each WORKING CURVE field and prompt isexplained below.

Test [ ]


Use this field to select the test to be displayed. Enterthe test code and press ENTER.

2.43 Data Monitor Job - - Working Curve


5ENTER

37.0 Stand-by 12/01/92 12:20

5 Working Curve

Input Tests via Keyboard : ENTER (Use COPY KEY for Graph)

TestScale

[ ][ ] - [ 9000 ]

U/CSF0

10 20 40 80 2000

1800

3600

5400

7200

9000

2 • 119

Scale [ ] - [ ]

Use these fields to set the absorbance range x 104

that is plotted on the Y axis. The limits are -10,000to 40,000. The scale adjusts automatically basedon the reaction time for each test.

If a CAL? or SENS alarm was issued for the specifiedtest, the calibration curve is not updated and the lastsuccessful calibration curve is displayed.

Scale [ ] - [ ]

Input Minimum Level ABS (-10000 to40000) : ENTER

Use this field to enter the minimum absorbance. Enterthe absorbance x 104 and press ENTER.

Scale [ ] - [ ]

Input Maximum Level ABS (-10000 to40000) : ENTER

Use this field to enter the maximum absorbance.Enter the absorbance x 104 and press ENTER.

Press the COPY key to print a copy of the graph asit is displayed on the WORKING CURVE screen.

2.43 Data Monitor Job - - Working Curve


2 • 120

2.44 Parameter Job - - Menu

2.44.1 Introduction

Use the PARAMETER JOB MENU to access screensthat are used to program the instrument to runchemistry assays. Procedures for initial set up ofthese screens are given in the following sections.Procedures for routine screen programming are givenin Section A of this chapter.

2.44.2 Displaying the PARAMETERJOB MENU

Press PARAMETER to display the PARAMETERJOB MENU screen.

2.44.3 Example of the PARAMETERJOB MENU

Figure 2-58 is an example of the PARAMETER JOBMENU screen.

Figure 2-58: PARAMETER JOB MENU Screen

2.44.4 PARAMETER JOB MENU Fieldsand Prompts

Function No. [ ]




2.44 Parameter Job - - Menu

37.0 Stand-by 12/01/92 12:20

Parameter Job Menu


1

2

3

4

5

6

7

8

9

10

Chemistry Parameters

Profiling

Calculated Tests

Print Order

Report Format

Control Test Selection

Control Value Setting

Special Wash Programming

System Parameters

Channel Assignment

Function No. [ ]

2 • 121

2.45 Parameter Job ChemistryParameters

2.45.1 Introduction

The CHEMISTRY PARAMETERS display enablesyou to view parameters for each chemistryprogrammed on the analyzer. You may modify someof these parameters. The screen has two pages thatmay be viewed alternately by pressing the GUIDANCEkey.

Page 1 of the display contains user-definableparameters such as Test Name and ExpectedValues. Page 2 contains test-specific parameterssuch as Wavelengths and Reagent volumes. Page 1parameters may be entered for all availablechemistries, test (application) codes 1 - 400. Mostpage 2 parameters may be entered for test codes 301- 400 only, which correspond to non-BM methods.Automatic calibration information may be changed forapplication codes 1 - 300 only.

For test codes 1 - 300, all photometric chemistryparameters are read from a parameter disk through theCHANNEL ASSIGNMENT screen. (ISE parametersare entered manually during your analyzerinstallation.) Individual entries for each field are foundon the application sheets for each chemistry.

Set points for calibrator materials are found on thepackage inserts and are entered on this screen.

2.45.2 Displaying the CHEMISTRYPARAMETERS Screen -- Page 1

Press PARAMETER to display the PARAMETERJOB MENU. Press 1 ENTER to display page 1 of theCHEMISTRY PARAMETERS screen.

Press PAGE CONTINUE to view parameters foradditional tests.

2.45 Parameter Job - - Chemistry Parameters


1ENTER

2 • 122

2.45.3 Example of the CHEMISTRYPARAMETERS Screen -- Page 1

Figure 2-59 is an example of page 1 of theCHEMISTRY PARAMETERS screen.

Figure 2-59: Chemistry Parameters Screen—Page 1

2.45.4 CHEMISTRY PARAMETERSScreen Fields andPrompts—Page 1

Information read from the parameter diskautomatically fills most of the fields on both pages ofthe CHEMISTRY PARAMETERS screen. Theexplanation of the fields and prompts is most helpful forentering information on reagents that do not haveparameters on the parameter disk.

Test [ ] [ ]

Use this field to select the test for which you want toview the chemistry parameters.

Test [ ] [ ]


Use this field to enter the test key number. Press thetest selection key or enter the test key number (1 - 52)of the desired test, then press ENTER. If parametersare already in memory for the entered test code, fromeither manual entry or reading the parameter disk,they will appear on the screen.

Test [ ] [ ]

Input Application Code No. 00301 to 64999 : ENTERUse this field to view the application code. Ifparameters are stored in memory, this code appearsautomatically. This field may not be changed.

Test Name [ ]

Input Name (Maximum of 5 Characters) : ENTER

Use this field to define the short test name. Enter theshort test name and press ENTER. A maximum of fivecharacters can be used in the short test name. Thistest name appears on the keyboard matrix and CRTscreens. This short test name is printed on shortformat reports.

Unit [ ]

Input Maximum of 6 Characters : ENTER

Use this field to define the unit of measure for the test.Enter the unit of measure and press ENTER. Amaximum of six characters may be entered.



37.0 Stand-by 12/01/92 12:20

1 Chemistry Parameters


TestData Mode

Control Interval

Expected Value < Serum >

Test NameReport Name

Instrument Factor ( Y= aX + b)

[ ] [ ][ ]

[ ]

Alarm

Expected Value < Urine >

BUN 00053On Board

20

[ BUN ] Unit [mg/dL][ Urea Nitrogen ]

a [ 1.0 ]b [ 0 ]

Age (M) (F)

[ ] [ ] [ ] - [ ] [ ] - [ ][ ] [ ] [ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

[ ] - [ ]

Technical Limit < Serum > < Urine >

STD Conc. Pos. Sample Pre. Dil. Calib. Lot No. Qualitative [No ]

1 Y 4 19 4 1912 Y 5 18 5 18

6 19 6 19

0 150 10 150

1200 2000

(1)(2)(3)(4)(5)(6)

(1)(2)(3)(4)(5)(6)

[ ][ ][ ][ ][ ][ ]

[ 0][ 0][ 0][ 0][ 0]

[ ][ ][ ][ ][ ][ ]

18210000

000000

501504999999999999

000000

44

WWWW

0.050.9

0000

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

000000052143000000000000000000000000

2 • 123

Data Mode [ ]

Choose 1 : On Board 0 : Inactive : ENTER

Use this field to specify whether a test is performedon board the analyzer or performed manually withthe results entered into the patient report later. In thecase of ISEs, on-board status is the only statusallowed. Selection of the inactive data mode for ISEsresults in an input error. Press 1 On Board ENTER forall tests that are performed on the analyzer. Press 0Inactive ENTER for all tests that are performedmanually. This field enables you to print results froma manually-performed test directly on the patientreport.

Report Name [ ]

Input Report Name (Maximum of 22 Characters) :ENTER

Use this field to specify the long test name that willappear on the Report Format reports. Enter the testname and press ENTER. A maximum of 22 charactersmay be entered.

Control Interval [ ]

Input Interval in Increments of 10 Samples (10, 20,30,...1000) 0 : Cancel : ENTER

Use this field to select the interval at which controlsare run. Input must be made in multiples of 10. Anyother entry will result in an input error. In the case ofthe ISEs, the same control interval will be used forNa+, K+, and Cl-. Enter the appropriate control interval(10 - 1000) and press ENTER. This can be varied foreach method. If you select 0 Cancel ENTER, thencontrols will not be run.

Instrument Factor (Y=aX+b) a [ ] b [ ]

The instrument recalculates all values obtained forthis chemistry by using the values entered here in theequation y = ax + b. These can be used tocompensate for a manual dilution factor, to allowtemperature conversion for enzymes, to obtaincorrelation with other methodologies or to convert toother units of concentration.


Input Slope Value (a) : ENTER

Instrument Factor (a) is a slope factor. Enter thefactor (-99999 to 999999) by which the test resultsare to be modified, then press ENTER. If no factoringis desired, enter 1.0 for factor a.


Input Intercept Value (b) : ENTER

Instrument Factor (b) is a blank factor (y intercept).Enter the factor (-99999 to 999999) by which the testresults are to be modified, then press ENTER. If nofactoring is desired, enter 0.0 for factor b.

Expected Value <Serum>

Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ][ ] [ ] [ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

Use these fields to enter the expected values range forserum samples of this assay. Values for both malesand females in three different age groups can bespecified.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]


Use this field to enter the numerical age for this rangeof expected values. Enter the appropriate number(0 - 200) and press ENTER.



2 • 124


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]

Choose Age Interval 1 : Days 2 : Months3 : Years : ENTER

Use this field to select the age interval (days, months,or years) for this range of expected values. Enter thenumber that corresponds to the selected interval andpress ENTER.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]

Input Low Value : ENTERInput High Value : ENTER

Use these fields to enter the lower limit and upper limitof the expected value for serum samples. Enter theexpected value lower limit for males in the specifiedage group (-99999 to 999999) and press ENTER.Repeat for the expected value upper limit.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]


Use these fields to enter the lower limit and upper limitof the expected value for serum samples. Enter theexpected value lower limit for females in the specifiedage group (-99999 to 999999) and press ENTER.Repeat for the expected value upper limit.

Expected Value <Urine>[ ] - [ ]


These fields are used to enter the lower limit andupper limit of the expected value for urine samples.Enter the expected value lower limit (-99999 to999999) and press ENTER. Repeat for the expectedvalue upper limit.

NOTEAny result outside of the expected value limits for anyclass or age group will be flagged with “H” or “L” on theprintout next to the result.

Technical Limit <Serum>[ ] - [ ]

Use these fields to set the technical limits for eachassay. Any result outside the limits specified here isflagged with a LIM. L or LIM. H data flag. If theautomatic rerun function is selected on the STARTCONDITIONS display, results exceeding the definedupper limit are automatically rerun with the reducedsample volume or as a pre-diluted sample as specifiedon the CHEMISTRY PARAMETERS screen. Resultsbelow the defined lower limit are rerun with theincreased sample volume as specified on theCHEMISTRY PARAMETERS screen. The technicallimit from the application sheet reflects the linearity ofthe chemistry. Technical limits are based on thenormal sample volume.



Use this field to specify the lower technical limit for theserum samples of this assay. Enter the lower valuefor the test (-99999 to 999999) and press ENTER.



2 • 125



Use this field to specify the upper technical limit forthe serum samples of this assay. Enter the uppervalue for the test (-99999 to 999999) and pressENTER.

Technical Limit <Urine>[ ] - [ ]

Use these fields to set the technical limits for eachurine sample of this assay. Technical limits arebased on the relationship between the serum andurine normal sample volumes.



Use this field to specify the lower technical limit forthe urine samples of this assay. Enter the lowervalue for the test (-99999 to 999999) and pressENTER.



Use this field to specify the upper technical limit forthe urine samples of this assay. Enter the uppervalue for the test (-99999 to 999999) and pressENTER.

These fields are used to define parameters for thestandards used in calibration of the assay. The STDcolumn displays the standard number.Use the first field to enter the standard concentration.The second field displays the position the standardoccupies on the sample disk, entered on the SYSTEMPARAMETERS screen. No entry is allowed in thiscolumn. Use the third field to specify the standardvolume. Use the fourth field to define the pre-dilutedstandard volume. Use the fifth field to define thevolume of diluent used for pre-dilution. Use the sixthfield to define the standard code.

Each of these entries are repeated for up to sixstandards. Each field is described in more detailbelow.

NOTEIn the case of endpoint chemistries, STD (1) isgenerally set up to represent the BLANKCALIBRATOR (usually non-buffered physiologicalsaline). STD (2) generally represents the calibratorfor any test that uses a blank and a single standard orcalibrator.

Input Concentration : ENTERInput 0 to 999999 for Serum Indexes : ENTER

Use this field to define the concentration of eachstandard. For photometric chemistries and ISEs, theconcentration is entered. For serum indexes, thefactor for calculation of the serum index (L, H, or I) isentered. Refer to Section 5.33 for additionalinformation on serum indexes.

Enter the concentration of the specified standard orthe factor for serum index calculation (0 - 999999),then press ENTER. Decimal placement in the STD1 Conc. field determines decimal placement inprinted results.



STD Conc. Pos. Sample Pre. Dil. Calib. Lot No.

(1) [ ] [ ] [ ] [ ] [ ]

(2) [ ] [ ] [ ] [ ] [ ] 0000

(3) [ ] [ ] [ ] [ ] [ ] 0000

(4) [ ] [ ] [ ] [ ] [ ] 0000

(5) [ ] [ ] [ ] [ ] [ ] 0000

(6) [ ] [ ] [ ] [ ] [ ] 0000


(1) [ ] [ ] [ ] [ ] [ ]

2 • 126

This field displays the position of each standard onthe sample disk. Positions 1 - 17 are roomtemperature; positions 18 - 34 are refrigerated. Thisinformation is entered in the Calibrator ID field of theSYSTEM PARAMETER screen.

Input Sample Volume:1 to 50 µL : ENTER

Use this field to define the normal standard volume.Enter the normal standard volume in microliters for thespecified chemistry (range: 1 - 50), then pressENTER. This is the standard volume used forregular test processing. It is also the volume that isdiluted when pre-dilution is chosen.

Input Diluted Sample Volume:1 to 10 µL(0 : Inactive) : ENTER

Use this field to define the volume of diluted standarddispensed for calibration. Enter the volume of dilutedstandard in microliters for the specified chemistry(range: 0 - 10). Then press ENTER. If you choose not

to use the pre-dilution feature, enter 0 in this field.Input Diluent Volume : 25 to 350 µL (0 : Cancel) :ENTER

Use this field to define the volume of diluent dispensedfor pre-dilution. Enter the volume of diluent (range:25 - 350) and press ENTER. If you choose not to usethe pre-dilution feature, enter 0 in this field.

Example:

The above entries could be made into the Sample,Pre., and Dil. fields. In this case, 10 µL of standardis aspirated from the sample cup and diluted with 90µL of diluent. 5 µL of this dilution is resampled for usein the calibration. The total volume must be aminimum of 150 µL.

Input Calibrator Code : Code 001 to 999(000 : Inactivate, 999 : Water) : ENTER

Use this field to define the code for each standard.Enter the appropriate calibrator code for the specificstandard (001 - 999) and press ENTER.

The Lot column displays the lot number of thestandard. No operator entry is allowed in this field.

Qualitative [ ](1) [ ] [ ]

Use these fields to report results in the qualitativemode. When qualitative is selected, the analyzer willreport results using characters defined in these fields.Numerical results can also be reported.




(1) [ ] [ ] [ ] [ ] [ ]


(1) [ ] [ ] [ ] [ ] [ ]


(1) [ ] [ ] [ ] [ ] [ ]


(1) [ ] [ ] [ ] [ ] [ ]


(1) [ ] [10] [5] [90] [ ]


(1) [ ] [ ] [ ] [ ] [ ]


(1) [ ] [ ] [ ] [ ] [ ]

2 • 127


Choose 1:Serum/Plasma 2:Urine 3:Serum/Plasma& Urine 0:Inactivate : ENTER

Use this field to specify the class of the test using thequalitative display. Enter the number thatcorresponds to the selected class and press ENTER.


Input Quantitative Value -99999 To 999999 : ENTER

Use this field to specify the upper limit of themeasured concentration for qualitative display. Enterthe upper limit (-99999 to 999999) and press ENTER.



Use this field to specify the characters that will print onthe patient report. Up to six characters, such as —and ++, or Slight, Mod, and Gross, can be entered.Enter the appropriate character(s) and press ENTER.Leaving this field blank by pressing SPACEBARENTER results in the numeric result printing instead ofa test message.



1ENTER

2.45.5 Displaying the CHEMISTRYPARAMETERS Screen - Page 2

Press PARAMETER to display the PARAMETERJOB MENU. Press 1 ENTER to display page 1 of theCHEMISTRY PARAMETERS screen. PressGUIDANCE to display page 2 of the CHEMISTRYPARAMETERS screen.

Press PAGE CONTINUE to view parameters foradditional tests.

2 • 128

2.45.6 Example of the CHEMISTRYPARAMETERS Screen - Page 2

Figure 2-60 is an example of page 2 of theCHEMISTRY PARAMETERS screen.

Figure 2-60: CHEMISTRY PARAMETERS Screen - -Page 2

2.45.7 CHEMISTRY PARAMETERSScreen Fields and Prompts - -Page 2

Test [ ]


Use this field to select the test for which you want todisplay parameters. If you have pressed theGUIDANCE key after selecting a test on page 1 of theCHEMISTRY PARAMETERS screen, the parametersfor that test are automatically displayed. Enter thetest key code and press ENTER.

NOTEThe following fields (except the automatic calibrationfields) are user programmable for application codes301 - 400 only.

Assay Code [ ] [ ] [ ]

These fields display the assay code or type of theselected test. The reaction time also is specified inthese fields.


Choose 1 : 1 Point 2 : 2 Point Rate 3 : 2 Point 4 :3 Point 5 : 1 Point & Rate 6 : Rate A 7 : Rate B :ENTER

Use this field to select the appropriate assay type.

Press: 1 1 Point ENTER (endpoint assay)

2 2 Point Rate ENTER (fixed time rateor endpiont assay)

3 2 Point ENTER (sample-blankedendpoint assay)

4 3 Point ENTER (two endpoint assays)

5 1 Point and Rate ENTER (endpointand rate assays)

6 Rate A ENTER (rate A assay )

7 Rate B ENTER (two rate assays)


Input the Reaction Time: 3, 4, 5, 10, or15 min. : ENTER

Use this field to enter the length of the reaction inminutes. Enter the reaction time and press ENTER.The time entered in this field indicates the time spanresults can be viewed on the REACTION MONITORscreen.



37.0 Stand-by 12/01/92 12:20


Select Test via Keyboard : ENTER

TestAssay CodeAssay Point

S. Vol. (Normal)S. Vol. (Decrease)S. Vol. (Increase )ABS. LimitProzone LimitReagent

Calibration Type

R1R2R3R4

Wavelength (2nd / Primary)Diluent / Rgt. Stability

Auto Time Out

Auto Change

BlankSpan2 PointFullLotBottle

SD LimitDuplicate LimitSensitivity LimitS1 ABS LimitCompensated Limit

[ BUN ][ Rate-A ] [ 4] [ ][ ] - [ ] - [ ] - [ ]

< Serum > < Urine >

[ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ] [ ][ ]

[ ] / [ ][ ] / [ ]4 12 0 0

428

1554

000

440

000

135145

05000 5000 Decrease

0 0 Lower3208000

0000

212100

00053000530005300053

LINEAR 2 2 0

00

240

0.1500

10000 250002 Point2 Point

376 340W 0

2 • 129


Input Tests via Keyboard (0:Cancel) : ENTER

For channels 1 to 46, use this field to specify thesecond test to be performed in the same reaction cellfor simultaneous measurement tests such as GOT/GPT. TG/CHOL Twin tests.

For serum indexes, use this field to specify the testselected to use during measurement of serumindexes. Press the test key of the selected test andENTER. Press 0 Cancel ENTER in this field to cancelany entry.

Assay Point [ ] - [ ] - [ ] - [ ]

Input First Measure Point 1 to 49 : ENTERInput First Measure Point 0 to 49 : ENTERInput First Measure Point 0 to 49 : ENTERInput First Measure Point 0 to 49 : ENTER

Use these fields to specify the measure points for thereaction. Up to four different measure points may beentered. The number of measure points depends onthe assay type of the reaction. Enter the appropriatemeasure point and press ENTER. Repeat for the otherthree measure points.

Wavelength (2nd/Primary) [ ] / [ ]

Use these fields to specify the wavelengths at whichabsorbance readings will be taken for bothmonochromatic and bichromatic measurements.Twelve wavelengths are available for entry: 340, 376,415, 450, 480, 505, 546, 570, 600, 660, 700, and 800nm.


Choose:340, 376, 415, 450, 480, 505, 546, 570, 600,660, 700, 800 nm (0:Monochromatic) : ENTER

Use this field to enter the secondary (sub) wavelengthfor the specified assay. Enter the appropriatewavelength and press ENTER. When monochromaticanalysis is desired, enter 0 for the secondarywavelength entry.


Choose:340, 376, 415, 450, 480, 505, 546, 570, 600,660, 700, 800 nm : ENTER

Use this field to enter the primary (main) wavelength forthe specified assay. Enter the appropriate wavelengthand press ENTER.

Diluent/Rgt. Stability [ ] [ ]

Use these fields to specify information about thediluent used in sample or standard pre-dilution for thisassay.

Diluent/Rgt. Stability [ ] [ ]

Input Bottle Code No. 00001 to 00400(0:Water) : ENTER

Use this field to specify the bottle code of the diluentto be used in sample or standard pre-dilution. Enterthe appropriate diluent bottle code and press ENTER.Press 0 ENTER to use water as the diluent.

Diluent [ ] [ ]

Input Working Stability: 1 to 99 Days (0:Inactive) :ENTER

Use this field to specify the working stability of thediluent. Enter the number of days until the expirationof the diluent and press ENTER. Press 0 ENTER toinactivate this field.

<Serum> <Urine>S. Vol. (Normal) [ ] [ ] [ ] [ ] [ ] [ ]

Use these fields to specify normal sample volumes forserum or urine samples. Volumes for the sample, pre-diluted sample, and diluent used in pre-dilution arespecified for each class.



2 • 130


Input Sample Volume 1 to 50 µL : ENTER

Use these fields to enter the sample volumeaspirated from the sample cup for either a normalsample or a pre-diluted sample. This volume isdispensed into the reaction cell. Enter the samplevolume in microliters and press ENTER. Use the firstfields in both serum and urine to enter the samplevolume. Press 0 ENTER to inactivate this field. Theminimum total volume of sample and diluent for pre-dilution must be 150 µL.


Input Diluted Sample Volume 1 to 10 µL(0:Inactive) : ENTER

Use these fields to enter the volume of diluted sampleaspirated from one reaction cell and dispensed into asecond reaction cell. Enter the volume of pre-dilutedsample to be used in the reaction and press ENTER.If you choose not to use sample pre-dilution, press 0ENTER.


Input Diluent Volume 25 to 350 µL(0:Cancel) : ENTER

Use this field to specify the volume of diluent added toa reaction cell containing sample for sample pre-dilution. Enter the volume of diluent and press ENTER.Press 0 ENTER if you choose not to use normalsample pre-dilution. The minimum total volume ofsample and diluent must be 150 µL.

<Serum> <Urine>S. Vol. (Decrease) [ ] [ ] [ ] [ ] [ ] [

]

Use these fields to specify decreased sample volumesfor serum or urine samples. This volume would beused for auto rerun of results greater than theTechnical Limit. Volumes for the sample, pre-dilutedsample, and diluent used in pre-dilution are specifiedfor each class.


]


Use these fields to enter the decreased samplevolume aspirated from the sample cup for either asample or a pre-diluted sample. This volume isdispensed into the reaction cell. Use the first fields inboth serum and urine to enter the sample volume.Press 0 ENTER to inactivate this field. The minimumtotal volume of sample and diluent for pre-dilution mustbe 150 µL.


]

Input Diluted Sample Volume 1 to 10 µL (0:Inactive) :ENTER

Use these fields to enter the volume of diluted sampleaspirated from one reaction cell and dispensed into asecond reaction cell. Enter the volume of pre-dilutedsample to be used in the reaction and press ENTER.If you choose not to use decreased sample pre-dilution, press 0 ENTER.



2 • 131


]


Use this field to specify the volume of diluent added toa reaction cell containing sample for decreasedsample pre-dilution. Enter the volume of diluent andpress ENTER. Press 0 ENTER if you choose not touse decreased sample pre-dilution. The minimumtotal volume of sample and diluent must be 150 µL.

<Serum> <Urine>S. Vol. (Increase) [ ] [ ] [ ] [ ] [ ] [ ]

Use these fields to specify increased sample volumesfor serum or urine samples. This volume would beused for auto rerun of results less than the technicallimit. Volumes for the sample, pre-diluted sample,and diluent used in pre-dilution are specified for eachclass.



Use these fields to enter the increased samplevolume aspirated from the sample cup for either asample or a pre-diluted sample. This volume isdispensed into the reaction cell. Enter the samplevolume in microliters and press ENTER. Use the firstfields in both serum and urine are to enter the samplevolume. Enter the sample volume in microliters andpress ENTER. Press 0 ENTER to inactivate thisfield. The minimum total volume of sample anddiluent for pre-dilution must be 150 µL.


Input Diluted Sample Volume 1 to 10 µL(0:Inactive) : ENTER

Use these fields to enter the volume of diluted sampleaspirated from one reaction cell and dispensed into asecond reaction cell. Enter the volume of pre-dilutedsample to be used in the reaction and press ENTER.If you choose not to use increased sample pre-dilution, press 0 ENTER.



Use this field to specify the volume of diluent added toa reaction cell containing sample for increased samplepre-dilution. Enter the volume of diluent and pressENTER. Press 0 ENTER if you choose not to useincreased sample pre-dilution. The minimum totalvolume of sample and diluent must be 150 µL.

<Serum> <Urine>Abs. Limit [ ] [ ] [ ]

Use these fields to specify the absorbance limits forserum or urine and whether the absorbance change isincreasing or decreasing. For rate chemistries, thisis the absorbance limit at which substrate depletion isdetected and the LIM. 1, LIM.2 and LIM.3 flags areissued.


Input 0 To 32000 (ABS x 10000) : ENTER

Use this field to specify the absorbance limit for aserum rate chemistry. Enter the absorbance limit (X104) and press ENTER.



2 • 132


Input 0 To 32000 (ABS x 10000) : ENTER

Use this field to specify the absorbance limit for aurine rate chemistry. Enter the absorbance limit (X104) and press ENTER.


Choose 1 : Decreasing ABS Change 2 : IncreasingABS Change : ENTER

Use this field to specify an increasing or decreasingabsorbance. Press 1 ENTER to specify a decreasingabsorbance kinetic assay. Press 2 ENTER to specifyan increasing absorbance kinetic assay.

<Serum> <Urine>Prozone Limit [ ] [ ] [ ]

Use these fields to specify the saturation limit of anantigen-antibody reaction.


Input -32000 to 32000 (ABS x 10000) [1Point] (%)[2Point] : ENTER

Use this field to specify the prozone limit for a serumchemistry. Enter the prozone limit (-32000 to 32000),then press ENTER.


Input -32000 To 32000 (ABS x 10000) [1Point] %[2Point] : ENTER

Use this field to specify the prozone limit for a urinechemistry. Enter the prozone limit (-32000 to 32000),then press ENTER.


Choose 1:Upper Limit 2:Lower Limit : ENTER

Use this field to specify whether the entered value isan upper or lower limit. Press 1 ENTER to specifyupper limit or 2 ENTER to specify lower limit.

Reagent R1 [ ] [ ] [ ] [ ]R2 [ ] [ ] [ ] [ ]R3 [ ] [ ] [ ] [ ]R4 [ ] [ ] [ ] [ ]

Each photometric test can have up to four differentreagent additions, occurring at different timingintervals. A R1 reagent is added by the R1 probe 10seconds after sample dispense. A R2 reagent isadded by the R2 probe 1.5 minutes after dispense ofthe R1 reagent. A R3 reagent is added by the R2 probe5.0 minutes after addition of the R1 reagent. A R4reagent is added by the R1 probe 10.0 minutes afterdispense of the R1 reagent.

Use these fields to specify information for each ofthese reagent additions. Each reagent additionrequires four entries, as they appear on the applicationsheet. The four entries are: reagent volume, diluentvolume, bottle code, and working solution stability.The four prompts are identical for each reagentaddition. Each individual entry for the first reagentaddition is explained below. Repeat the entries for theother reagent additions.

Reagent R1 [ ] [ ] [ ] [ ]

Input Volume 1 to 350 µL (0:Cancel) : ENTER

Use this field to enter the volume of reagent to bepipetted. Enter the volume of the selected reagent inmicroliters (range 1 - 350, 0 Cancel), then pressENTER.



2 • 133

Reagent R1 [ ] [ ] [ ] [ ]

Input Volume 1 to 350 µL(0:Cancel) : ENTERInput Volume 1 to 250 µL(0:Cancel) : ENTER

Use this field to input the volume of diluent to bepipetted. For R1 and R4, the range is 1 - 350microliters. For R2 and R3, the range is 1 - 250microliters. Enter the correct volume and pressENTER. Press 0 Cancel ENTER to cancel entry in thisfield.

Reagent R1 [ ] [ ] [ ] [ ]

Input Bottle Code 00001 to 00400 : ENTER

Use this field to enter the bottle code for the reagent.Enter the bottle code and press ENTER. For amanually entered chemistry this field corresponds tothe bottle code entered on the REAGENT STATUSscreen.

Reagent R1 [ ] [ ] [ ] [ ]

Input Working Stability 1 to 99 days(0:Inactivate) : ENTER

Use this field to enter the reagent working solutionstability. Enter the available days and press ENTER.This item is not tracked for minimal or partial bar codedreagents.

Calibration Type [ ] [ ] [ ] [ ] [ ]

Use these fields to specify information about thecalibration of the assay. This information appears onthe application sheet for the chemistry.


Choose 1 : Linear 2 : (3P) 3 : (4P) 4 : (5P) 5 : EXPO6 : Spline 7 : ISO. P 8 : ISO. Q : ENTER

Use this field to specify the appropriate calibrationtype from the eight types available, as detailed below:

Press: 1 Linear ENTER (Linear)

2 (3P) ENTER (Logit-Log (3P))

3 (4P) ENTER (Logit -Log (4P))

4 (5P) ENTER (Logit-Log (5P))

5 EXPO ENTER (Exponential)

6 Spline ENTER (Spline)

7 ISO. P ENTER (Isozyme P)

8 ISO. Q ENTER (Isozyme Q)


Select the Number of Calibration Points1 to 6 : ENTER

Use this field to enter the number of standards usedfor calibration. Enter the number of standardsolutions to be measured (range: 1 - 6), then pressENTER. When Linear is selected as the calibrationtype in Field 1 and 1 is specified as the number ofcalibrators in Field 2, then a K factor calibration isused for the assay.


Select Span Point 2 to 6 (0:Cancel) : ENTER

Use this field to specify the span calibration point(standard to be measured in span calibration). Enterthe span point to be used when updating thecalibration curve (2 - 6) and press ENTER. You mustselect a span point.



2 • 134


Input Weight 0,1,2 : ENTER

Use this field to set a weight to be applied to thestandard solution. Enter the appropriate weight (0, 1,2) and press ENTER.


Input Tests via Keyboard (0:Cancel) : ENTER

Use this field to specify a Q channel when enteringISO. P for the calibration type. Enter the appropriatechannel selection (1 - 46, 0 Cancel) and press ENTER.

Auto Time Out Blank [ ]Span [ ]2 Point [ ]Full [ ]

Auto Change Lot [ ]Bottle [ ]

The fields included in the automatic calibration sectionof this screen are used to view or enter parametersrequired for executing automatic calibration. For BMchemistries (test codes 1 - 300), recommendedintervals are on the parameter disk. Any adjustmentto the time out interval must be a shorter interval thanis recommended by BM. For non-BM chemistries(test codes 301 - 400), no operator input is allowed.

Auto Time Out Blank [ ]

Input 1 To 999 Hours (0:Cancel) : ENTER

Use this field to enter or view the duration betweenautomatic calibrations of STD (1).

Span [ ]


Use this field to enter or view the duration betweenautomatic calibration of the span calibrator.

2 Point [ ]


Use this field to enter or view the duration betweenautomatic calibrations using STD (1) and the spancalibrator.

Full [ ]


Use this field to enter or view the duration betweenautomatic calibrations of the full standard curve.

Auto Change Lot [ ]

Choose 1:Blank 2:Span 3:2 Point 4:Full 0:NotRequired : ENTER

Use this field to enter or view the method of lot-to-lotcalibration.

Bottle [ ]

Choose 1:Blank 2:Span 3:2 Point 4:Full 0:NotRequired : ENTER

Use this field to enter or view the method of bottle-to-bottle calibration.



2 • 135

SD Limit [ ]

Input 0.1 to 999.9 (ABS. x 10000) : ENTER

When calibrating non-linear or multipoint linearchemistries, the instrument compares the measuredabsorbance of each calibrator against its idealabsorbance and calculated SD. If the calculated SDis not less than this SD limit, a SD LIM alarm is issued.Enter the Standard Deviation (SD) limit (0.1 - 999.9ABS X 104) for non-linear calibration curveacceptability, then press ENTER. Enter 0 to cancel.

Duplicate Limit [ ]

Input 0 to 32000 (ABS. x 10000) : ENTER

Enter the duplicate limit for calibrator acceptability(0 - 32000), then press ENTER. All photometriccalibrators are run in duplicate; if the difference inabsorbance values of the duplicates exceeds thisduplicate limit, a DUP alarm is issued to indicate afailed calibration.

Sensitivity Limit [ ]

Input 0 to 32000 (ABS. x 10000) : ENTER

Enter the calibration sensitivity limit (0 - 32000), thenpress ENTER. This value specifies that a minimumabsorbance change must be detected between theblank and span calibrator during calibration ofendpoint chemistries. If the difference in absorbancebetween the blank and span calibrator is not greaterthan the sensitivity limit, a SENS alarm is issued toindicate a failed calibration.

S1 ABS Limit [ ] [ ]

Use these fields to enter the lower and upper limits forthe absorbance of the STD 1 during calibration. If theSTD1 absorbance is outside of this range, a S1ABS?alarm is issued to indicate a failed calibration.


Input -32000 to 32000 (ABS x 10000) : ENTER

Enter the lower limit (-32000 to 32000) and pressENTER.


Input -32000 to 32000 (ABS x 10000) : ENTER

Enter the upper limit (-32000 to 32000) and pressENTER. For endpoint chemistries, this limit applies tothe bichromatic absorbance of STD 1. For ratechemistries, this applies to the monochromaticabsorbance of STD 1.

Compensated Limit [ ]

Input Acceptable Deviation: 0.0 to 200.0% : ENTER

Use this field to enter the compensation limit value forthe ISE assays. Entry in this field causes an inputerror for photometric chemistries. Enter thecompensated limit (0.0 - 200.0) and press ENTER. Ifthe difference between the current calibration and theprevious calibration is outside this limit, a CALIB alarmis issued.



2 • 136

2.46 Parameter Job - - Profiling

2.46.1 Introduction

The PROFILING screen is used to define the testsperformed for each chemistry profile. Up to 12 profilescan be defined. Perform a parameter write to storechanges to profiles on the system disk.

2.46.2 Displaying the PROFILINGScreen

Press PARAMETER to display the PARAMETERJOB MENU. Press 2 ENTER to display thePROFILING screen.

2.46.3 Example of the PROFILINGScreen

Figure 2-61 is an example of the PROFILING screen.

Figure 2-61: PROFILING Screen

2.46.4 PROFILING Screen Fields andPrompts

Each PROFILING field and prompt is explained below.

Profile DefinitionProfile Key [ ]Tests [ ]Name [ ]

Use these fields to define or delete profiles. There are12 keys in the numerical keypad on the keyboard thatcan be used for profiles. These keys are lettered Athrough L on the front of the key.

Profile Definition



2ENTER

37.0 Stand-by 12/01/92 12:20

2 Profiling

Input Profile Key ( A - L ) : ENTER

Profile Definition

Default Profile

Print

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

Profile KeyTestsName

[ - ][ - ][ HEART ]

[ On ] [CHEM7]

[ ]

THEO

2 • 137

Profile Key [ ]

Input Profile Key (A-L) : ENTER

Use this field to select the profile key. Press theappropriate profile key (A - L) and press ENTER. Theprofile key will highlight in reverse video on thekeyboard matrix. If test selections have previouslyassigned to this profile key, the selections willhighlight in reverse video on the keyboard matrix.

Profile DefinitionTests [ ]


Use this field to assign individual tests to the selectedprofile key. Press the appropriate test selection keys.Selected tests will highlight in reverse video on thekeyboard matrix. To delete a test that has beenselected, press the test key again. The highlighting forthat test will disappear from the keyboard matrix.When all appropriate test keys are highlighted inreverse video, press ENTER.

Profile DefinitionName [ ]

Input Name (Maximum of 5 Characters) : ENTER

Use this field to assign the name to the profile key.Enter the desired name (five characters maximum)and press ENTER. If the profile is the same as a defaultprofile, the selected name also appears in the DefaultProfile field.

Default Profile [ ] [ ]

Use these fields to set up a default profile. The defaultprofile is used in the event of a sample being placedon the sample disk and having no test selectionsspecified.



Use this field to request a default profile. Press 1Activate ENTER to run a default profile when no testselections are made for a sample. Press 0 InactivateENTER to choose not to run a default profile.


Input Profile Key (A-L) : ENTER

Use this field to specify the profile to be run in thedefault mode. To select the default profile you want touse, press the profile key (A - L) and ENTER.

Print [ ]


Use this field to request a printout of the informationregistered in profile key selections. Press 1 To PrintReport ENTER to request a printout. A copy of theprofiles that have test selections defined will beprinted.



2 • 138

2.47 Parameter Job CalculatedTest

2.47.1 Introduction

The CALCULATED TEST screen is used to define thecalculation formula and parameters for eachcalculated test. This screen also is used to define thecalculation formula of each compensated test.Perform a parameter write to store changes made tothe CALCULATED TEST screen.

2.47.2 Displaying the CALCULATEDTEST Screen

Press PARAMETER to display the PARAMETERJOB MENU. Press 3 ENTER to display theCALCULATED TEST screen.

2.47.3 Example of the CALCULATEDTEST Screen

Figure 2-62 is an example of the CALCULATED TESTscreen.

Figure 2-62: CALCULATED TEST Screen

2.47.4 CALCULATED TEST ScreenFields and Prompts

Each CALCULATED TEST field and prompt isexplained below.

Mode [ ]

Choose 1:Calculated 2:Compensated : ENTER

Use this field to define whether the entry is a calculatedor compensated test. Press 1 Calculated ENTER tochoose a calculated test. Press2 Compensated ENTER to choose a compensatedtest.

2.47 Parameter Job - - Calculated Test


3ENTER

37.0 Stand-by 12/01/92 12:20



ModeTestS. TypeFormula

Expected Value < Serum >

Expected Value < Urine >

Test NameUnitReport Name

[ Calc. ][ A / G ] [ ][ Serum ][ <16> / (<17> - <16> ) ; ]

Alarm

Qualitative

[ A / G ][ ][ Albumin / Globulin Ratio ]

Age (M) (F)

[ ] [ ] [ ] - [ ] [ ] - [ ][ ] [ ] [ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

[ ] - [ ]

[ ] - [ ][ ] - [ ][ ] - [ ][ ] - [ ][ ] - [ ]

100 Y 1.1 1.8 1.1 1.8100 Y 1.1 1.8 1.1 1.8

1.1 1.8 1.1 1.8

0.0 100.0

(1)(2)(3)(4)(5)(6)

Serum A / G = ALB / (TP - ALB )

Serum UN / CR = BUN / CREA

5354555657585960

[ ]

00000

[ No ]

2 • 139

Test Name [ ]

Input Name (Maximum of 5 Characters) : ENTERThis field is used to enter the name of the calculatedtest. Enter the test name (maximum 5 characters)and press ENTER.

Test [ ] [ ]

Use these fields to assign a test code for bothcalculated and compensated tests. These fields alsoare used to define the test to be compensated.

Test [ ] [ ]

Input Test No. 53 to 60 : ENTER

Use this field to assign a test code number to thecalculated test. Enter the test code number (53 - 60)and press ENTER. The second entry in the Tests fieldis not used for calculated tests.

Test [ ] [ ]

Input Program No. 1 to 8 : ENTER

Use this field to assign a number to the compensationformula. Enter the formula number (1 - 8) and pressENTER.

Test [ ] [ ]

Select Tests via Keyboard (0:Cancel) : ENTER

Use this field to specify the test to be compensated.Enter the test key number (1 - 49) and press ENTER.

S. Type [ ]

Choose 1:Serum/Plasma 2:Urine : ENTER

Use this field to define the sample type. Enter theappropriate class number (1 or 2) and press ENTER.

Formula [ ]

Input Formula Using: +, -, *, /, (,), <CH. NO.>,Numeric, (End with;) : ENTER

Use this field to enter the calculation formula. Amaximum of 40 characters (operators, test codes,numbers) can be entered.

Mathematical operators that may be used are: *(multiply), / (divide), + (add), and - (subtract).

Test codes must be placed within less than andgreater than signs (<>) before being entered into abracket field. This distinguishes test codes fromnumeric characters. The formula definition must endwith a semicolon (;). In our display example, Globulinequals:

To clear any formula, enter a semicolon (;) at the firstentry position for that formula.

The formula entered is checked for the errors listedbelow. If errors are found, the appropriate input erroralarm is issued.



Test Code17 (TP)

Subtract Test Code16 Albumin

FormulaEnd

[ <17>-<16>; ]

2 • 140

Unit [ ]


Use this field to enter the unit of measure for thecalculated test. The entry results in an error if thecompensated test mode is specified. Enter the units(maximum of six characters) and press ENTER.

Report Name [ ]

Input Report Name (Maximum 22Characters) : ENTER

Use this field to define the long name for the calculatedtest that is printedon the report format. Enter the report name (22characters maximum) and press ENTER. The entryresults in an error if the compensated test modeis specified.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ][ ] [ ] [ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

Use these fields to enter the expected serum valuesranges for this assay. Values for both males andfemales in three different age groups can be specified.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]


Use this field to enter the numerical age for this rangeof expected values. Enter the appropriate number (0- 200) and press ENTER. The entry results in an errorif the compensated test mode is specified.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]


Use this field to select the age interval (days, monthsor years) for this assay. Enter the number thatcorresponds to the selected interval and pressENTER. The entry results in an error if thecompensated test mode is specified.



FORMULA INPUT ERRORS

1 Operators are specified consecutively: [* /]

2 Test codes are placed consecutively: [<1><2>]

3 Numbers are placed consecutively: [10 200]

4 Numeric value and test code are placedconsecutively: [8<10>]

5 A negative value following an operator is notenclosed in parentheses: [<1> / -2]

6 Formula begins with an operator: [*10.0;]

7 Formula ends with an operator: [10 +;]

8 Left parenthesis follows a test code: [<40>(]

9 A channel number is given after a rightparenthesis: [)<26>]

10 An incomplete expression is enclosed inparentheses: [(10 *)]

11 Brackets and parentheses are not used properly:[ )( )( ]

12 Angle brackets are used improperly: [<9,12>]

13 Brackets or parentheses are not paired properly:[(-12,0/<19>)]

2 • 141


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]


Use these fields to enter the lower limit and upper limitof the expected value for serum samples. Enter theexpected value lower limit for males in the specifiedage group (-99999 to 999999) and press ENTER. Thedecimal placement of this entry determines thedecimal placement of the reported serum result.Repeat for the expected value upper limit. The entryresults in an error if the compensated test mode isspecified.


Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ]


Use these fields to enter the lower limit and upper limitof the expected value for serum samples. Enter theexpected value lower limit for females in the specifiedage group (-99999 to 999999) and press ENTER.Repeat for the expected value upper limit. The entryresults in an error if the compensated test mode isspecified.

Expected Value <Urine>[ ] - [ ]


These fields are used to enter the lower limit and upperlimit of the expected value for urine samples. Enter theexpected value lower limit (-99999 to 999999) andpress ENTER. The decimal placement of this entrydetermines the decimal placement of the reportedurine result. Repeat for the expected value upper limit.The entry results in an error if the compensated testmode is specified.

NOTEAny result outside the expected value limits for anyclass or age group will be flagged with H or L on theprintout next to the result.


Use these fields to report results in the qualitativemode. When qualitative is selected, the analyzerreports results using characters defined in thesefields. Numerical results also can be reported.


Choose 1 : Serum/Plasma 2 : Urine 3 : Serum/Plasma & Urine 0 : Inactivate : ENTER

Use this field to specify the class of the test using thequalitative display. Enter the number thatcorresponds to the selected class and press ENTER.The entry results in an error if the compensated testmode is specified.


Input Quantitative Value -99999 To 999999 : ENTER

Use this field to specify the upper limit of themeasured concentration for qualitative display. Enterthe upper limit (-99999 to 999999) and press ENTER.The entry results in an error if the compensated testmode is specified.



2 • 142



Use this field to specify the characters that will print onthe patient report. Up to six characters, such as —and ++, or Slight, Mod, and Gross, can be entered.Enter the appropriate character(s) and press ENTER.Leaving this field blank by pressing SPACEBARENTER results in the numeric result printing instead ofa test message. The entry results in an error if thecompensated test mode is specified.



2 • 143

2.48 Parameter Job Print Order

2.48.1 Introduction

Use the PRINT ORDER display to assign the reportprint priority for each test. This screen can be usedto custom design patient reports. If no entries aremade on this screen, the print order defaults to thetest key number. The test key numbers are displayedin parentheses. Tests that have been assigned a testkey number are automatically displayed beside thetest key number. The assigned print order number isdisplayed after the short test name. Perform aparameter write following any changes to the PRINTORDER screen.

2.48.2 Displaying the PRINTORDER Screen

Press PARAMETER to display the PARAMETERJOB MENU. Press 4 ENTER to display the PRINTORDER screen.

2.48.3 Example of the PRINTORDER Screen

Figure 2-63 is an example of the PRINT ORDERscreen.

Figure 2-63: PRINT ORDER Screen

2.48.4 PRINT ORDER ScreenFields and Prompts

Each PRINT ORDER field and prompt is explainedbelow.

Test [ ]


Use this field to select the test to which you want toassign a print order. Enter the test key number orpress the test key for the test (input range: 1-60 ortest key) and press ENTER.

2.48 Parameter Job - - Print Order


4ENTER

37.0 Stand-by 12/01/92 12:20

4 Print Order


TestOrder

[ ][ ]

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CATRIGUA

( 1)( 2)( 3)( 4)( 5)( 6)( 7)( 8)( 9)(10)(11)(12)(13)(14)(15)

131415161718192021222324252627

THEO

(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)

434445464748495051525354555657

(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60)

585960616263646566676869707172

NaKClLIPHEMOICTERA/G

UN/CRCAL05CAL06CAL07CAL08

(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)

282930313233343536373839404142

ALBTPPHOSCREACHOLMG

REF

Alarm

2 • 144

Order [ ]

Specify Print Order: 1 to 72 (0: Do Not Print) : ENTER

Use this field to define the print order. Enter the printorder and press ENTER. To remove a test from theprint order, press 0 Do Not Print ENTER.

Each test must be assigned a position in the printorder if results for that test are to be printed. Also, iftwo tests are assigned the same print order, resultswill print only for the test with the higher test keynumber.

NOTEYou may wish to assign a 0 print order to all unusedtest codes to eliminate duplicates.

2.48 Parameter Job - - Print Order


2 • 145

2.49 Parameter Job - - ReportFormat

2.49.1 Introduction

Use the REPORT FORMAT screen to customize theformat of the patient report printout. For examples ofpatient reports, refer to Sections 2.72 and 2.73.Perform a parameter write to save any changes madeon the REPORT FORMAT screen to the system disk.

2.49.2 Displaying the REPORTFORMAT Screen

Press PARAMETER to display the PARAMETERJOB MENU. Press 5 ENTER to display the REPORTFORMAT screen.

2.49.3 Example of the REPORTFORMAT Screen

Figure 2-64 is an example of the REPORT FORMATscreen.

Figure 2-64: REPORT FORMAT Screen

2.49.4 REPORT FORMAT ScreenFields and Prompts

Each REPORT FORMAT field and prompt is explainedbelow.

Reports/Page [ ]

Choose Number of Patient Reports per Page: 1:One2:Two : ENTER

Use this field to define the number of reports printedon one page. The printer can print one report per pageor two reports, side by side, per page. Press 1 ENTERto print one report per page. Press 2 ENTER to printtwo reports per page.

2.49 Parameter Job - - Report Format


5ENTER

37.0 Stand-by 12/01/92 12:20

5 Report Format

Choose Number of Patient Reports per Page: 1:One 2:Two : ENTER

Reports/PagePage Length

TitlePrint

Draw

Sample No.Sample TypeID

TestResultsUnit of MeasureExp. ValueRemarks

[ One ][ 66 ]

Title [ ][ ][ ]

BOEHRINGER MANNHEIM

Char Line Column Char Line Column408585

106

13

2286

176

1449

10564

15

3025201510

87

6789

10

1414

4949494949

2247561414141414

229394969

SexAge

NAMELOCATIONPHYSICIANPATIENT IDDRAWN BY :

Print Example [ ]

[ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ]

( )( )

( )( )( )( )( )

( )( )

( )( )( )( )( )

( )( )( )( )( )

[ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ]

2 • 146

CAUTIONPrior to making changes to this screen, use theCOPY key to make a record of the entries.

Page Length [ ]

Input Number of Lines per Page:5 to 72 : ENTER

Use this field to enter the number of lines in eachreport. Normal 8 1/2 by 11 inch paper is 66 lines. Enterthe length of the report (input range: 5 - 72), then pressENTER.

Title [ ][ ][ ]

Use this field to enter the title of the report. The reporttitle can be up to three lines with a maximum of 40characters per line. Enter each line of the report titleand press ENTER.

NOTEThe maximum length of the character field (CHAR) isset and cannot be edited. However, you do not haveto use the maximum characters available. The lineand column entries are user definable.

Line ColumnTitle [ ] [ ]

Input Line Number for Title: 1 to 72 : ENTERStart Column:Single Reports 1 to 80, Two Reports 1 to40 (0:Do Not Print) : ENTER

Use these fields to choose the line where the title willprint on the report.

Enter the number of the line where the title will print andpress ENTER.

Enter the number of the column where the title willbegin printing and press ENTER. Press 0 No PrintENTER to choose not to print the title.

Line ColumnPrint Date [ ] [ ]

Input Line Number: 1 to 72 : ENTER

Start Column:Single Reports 1 to 80, Two Reports 1 to40 (0:Do Not Print) : ENTER

Use these fields to choose the line where the reportprint date will print on the report.

Enter the number of the line where the print date willprint and press ENTER.

Enter the number of the column where the print datewill begin printing and press ENTER. Press 0 No PrintENTER to choose not to print the print date.

Line ColumnPrint Time [ ] [ ]



Use these fields to choose the line where the reportprint time will print on the report.

Enter the number of the line where the print time willprint and press ENTER.

Enter the number of the column where the print timewill begin printing and press ENTER. Press 0 No PrintENTER to choose not to print the print time.



2 • 147

Line ColumnDraw Date [ ] [ ]



Use these fields to choose the line where the draw datewill print on the report.

Enter the number of the line where the draw date willprint and press ENTER.

Enter the number of the column where the draw datewill begin printing and press ENTER. Press 0 No PrintENTER to choose not to print the draw date.

Line ColumnDraw Time [ ] [ ]



Use these fields to choose the line where the draw timewill print on the report.

Enter the number of the line where the draw time willprint and press ENTER.

Enter the number of the column where the draw timewill begin printing; press ENTER. Press 0 No PrintENTER to choose not to print the draw time.

Line ColumnSample No. [ ] [ ]



Use these fields to choose the line where the samplenumber will print on the report.

Enter the number of the line where the sample numberwill print and press ENTER.

Enter the number of the column where the samplenumber will begin printing and press ENTER. Press 0No Print ENTER to choose not to print the samplenumber.

Line ColumnSample Type [ ] [ ]



Use these fields to choose the line where the sampletype will print on the report.

Enter the number of the line where the sample type willprint and press ENTER.

Enter the number of the column where the sampletype will begin printing and press ENTER. Press 0 NoPrint ENTER to choose not to print the sample type.



2 • 148

Line ColumnID [ ] [ ]



Use these fields to choose the line where the patientID number will print on the report.

Enter the number of the line where the patient IDnumber will print and press ENTER.

Enter the number of the column where the patient IDnumber will begin printing and press ENTER. Press 0No Print ENTER to choose not to print the ID.

Line ColumnSex [ ] [ ]



Use these fields to choose the line where the patient�ssex will print on the report.

Enter the number of the line where the patient�s sex willprint and press ENTER.

Enter the number of the column where the patient�ssex will begin printing and press ENTER. Press 0 NoPrint ENTER to choose not to print the sex.

Line ColumnAge [ ] [ ]



Use these fields to choose the line where the patient�sage will print on the report.

Enter the number of the line where the patient�s age willprint and press ENTER.

Enter the number of the column where the age willbegin printing and press ENTER. Press 0 No PrintENTER to choose not to print the age.

NOTEThe next five fields are operator definable through theSYSTEM PARAMETER screen and may appeardifferently in your software.

Line ColumnName [ ] [ ]



Use these fields to choose the name where thecomment will print on the report.

Enter the number of the line where the name will printand press ENTER.

Enter the number of the column where the name willbegin printing and press ENTER. Press 0 No PrintENTER to choose not to print the name.



2 • 149

Line ColumnLocation [ ] [ ]



Use these fields to choose the line where the patientlocation will print on the report.

Enter the number of the line where the patient locationwill print and press ENTER.

Enter the number of the column where the location willbegin printing and press ENTER. Press 0 No PrintENTER to choose not to print the patient location.

Line ColumnPhysician [ ] [ ]



Use these fields to choose the line where thephysician�s name will print on the report.

Enter the number of the line where the physician�sname will print and press ENTER.

Enter the number of the column where the physicianwill begin printing and press ENTER. Press 0 No PrintENTER to choose not to print the physician�s name.

Line ColumnPatient ID [ ] [ ]



Use these fields to choose the line where the patientID will print on the report.

Enter the number of the line where the patient ID willprint and press ENTER.

Enter the number of the column where the patient IDwill begin printing; press ENTER. Press 0 No PrintENTER to choose not to print the patient ID.

Line ColumnDrawn By: [ ] [ ]



Use these fields to choose the line where the drawn byinformation will print on the report.

Enter the number of the line where the drawn byinformation will print and press ENTER.

Enter the number of the column where the drawn byinformation will begin printing and press ENTER.Press 0 No Print ENTER to choose not to print thedrawn by information.



2 • 150

ColumnTest [ ]


Use this field to choose the column where the testname will print on the report.

Enter the number of the column where the test namewill begin printing and press ENTER. Press 0 No PrintENTER to choose not to print the test name.

ColumnResults [ ]


Use this field to choose the column where the testresult will print on the report.

Enter the number of the column where the test resultwill begin printing and press ENTER. Press 0 No PrintENTER to choose not to print the test result.

ColumnUnit of Measure [ ]


Use this field to choose the column where the unit ofmeasure will print on the report.

Enter the number of the column where the unit ofmeasure will begin printing and press ENTER. Press0 No Print ENTER to choose not to print the unit ofmeasure.

ColumnExp. Value [ ]


Use this field to choose the column where theexpected values will print on the report.

Enter the number of the column where the expectedvalues will begin printing and press ENTER. Press 0No Print ENTER to choose not to print the expectedvalue.

ColumnRemarks [ ]


Use this field to choose the column where the remarkswill print on the report.

Enter the number of the column where the remarks willbegin printing and press ENTER. Press 0 No PrintENTER to choose not to print the remarks.

Print Example [ ]

Input 1:To Print Example : ENTER

Use this field to print an example of your report format.Press 1 To Print Example ENTER.



2 • 151

2.50 Parameter Job - - ControlTest Selection

2.50.1 Introduction

The CONTROL TEST SELECTION screen is used torequest and confirm test selections for each controllevel. Information about masking is displayed in thekeyboard matrix on the lower portion of the screen.Up to eight control levels can be defined.

2.50.2 Displaying the CONTROLTEST SELECTION Screen

Press PARAMETER to display the PARAMETERJOB MENU. Press 6 ENTER to display the CONTROLTEST SELECTION screen.

2.50.3 Example of the CONTROL TESTSELECTION Screen

Figure 2-65 is an example of the CONTROL TESTSELECTION screen.

Figure 2-65: CONTROL TEST SELECTION Screen

2.50.4 CONTROL TEST SELECTIONScreen Fields and Prompts

Each CONTROL TEST SELECTION field and promptis explained below.

Control [ ]


Use this field to specify the control level for which youwant to make test selections. Enter the appropriatecontrol number (1 - 8) and press ENTER. The nameassigned to the specified control level on theCONTROL VALUE SETTING screen will appear in thefield.

2.50 Parameter Job - - Control Test Selection


6ENTER

37.0 Stand-by 12/01/92 12:20

6 Control Test Selection

Select Tests via Keyboard (A - L) : ENTER

ControlTestsS. Type

[ ][ - ]PTN-81

Serum

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L


CA TRIG UA ALB/P TP PHOS CREA CHOL

U/CSF

MON. CHEM6 CHEM7

ALL

2 • 152

Tests [ ]


Use this field to enter test selections for the specifiedcontrol level. Press the appropriate test selectionkey(s) or profile key(s). After a control test selectionis made, the corresponding key(s) will highlight inreverse video on the keyboard matrix. Control testselections are stored in battery backed C-RAM.

S. Type

This field displays the sample type assigned to thiscontrol level on the CONTROL VALUE SETTINGscreen. No operator entry is allowed in this field.

NOTEIn addition to controls automatically initiated by the911 Analyzer, supplemental controls can be selectedat any time by programming the controls as Statsamples. this is done by loading the control materialsin positions 71 through 78 on the sample disk. Thesepositions correspond to disk or control positionslabelled C1 through C8 (control levels 1 through 8) onthe sample disk. The control value check uses theMEAN ± 2 SD rule. Acutal QC ranges print on thereport. (The Expected Values Default on page 1 of theSYSTEM PARAMETERS screen must be set to Yes.)Review the control data by entering the appropriateStat sequence number on the DATA REVIEW screen.The results are not transferred to the 911 QC file, butresults are stored on the data disk as a Stat result andtransmitted to the host.

2.50 Parameter Job - - Control Test Selection


2 • 153

2.51 Parameter Job - - ControlValue Setting

2.51.1 Introduction

Use the CONTROL VALUE SETTING screen to inputthe target mean and SD values for each test on aselected control level. Each control sample typeregistered for Controls 1 through 8 are displayed.Perform a parameter write to record any changes tothe CONTROL VALUE SETTING screen on thesystem disk.

2.51.2 Displaying the CONTROLVALUE SETTING Screen

Press PARAMETER to display the PARAMETERJOB MENU. Press 7 ENTER to display the CONTROLVALUE SETTING screen.

The mean values and SD values can be displayed bypressing the PAGE CONTINUE key.

2.51.3 Example of the CONTROLVALUE SETTING Screen

Figure 2-66 is an example of the CONTROL VALUESETTING screen.

Figure 2-66: CONTROL VALUE SETTING Screen

2.51.4 CONTROL VALUE SETTINGScreen Fields and Prompts

Each CONTROL VALUE SETTING field and prompt isexplained below.

Control No. [ ]


Use this field to select the control level for which targetvalues are displayed or entered. Enter the appropriatecontrol number and press ENTER. If a name has beenpreviously assigned to the control, the name appearsin this field.

2.51 Parameter Job - - Control Value Setting


37.0 Stand-by 12/01/92 12:20

7 Control Value Setting


12.510.53.02.04.52.54.0

0.100.075

1.53.52.0

0.357.5

0.250.20.2

0.150.10

12.510.53.02.04.52.54.0

0.100.075

1.53.52.0

0.357.5

0.250.20.2

0.150.10

123456789

10111213141516171819

1441273624592942

1.210.4020.7

7829.08.1933.84.57.22.6

1.76

1441273624592942

1.210.4020.7

7829.08.1933.84.57.22.6

1.76

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CATRIGUAALB/PTPPHOSCREA

ControlNameS.Type

[ ][ ] [ ]

PTN-81PTN-81

Serum

Individual / Real Time Cumulative

Mean SD Mean SD

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

No. Name Sample Type

12345678

SerumSerumSerumSerumSerumSerumSerumSerum

PTN-81PTA-157Control3Control4Control5Control6Control7Control8

7ENTER

2 • 154

CumulativeMean SD

1Test Name [ ] [ ]

Use these fields to enter the cumulative mean and oneSD value for each test.

CumulativeMean SD

1Test Name [ ] [ ]

Input Value : ENTER

Use this field to define the mean value for eachspecific test within each control level. Enter the meanvalue (maximum of seven digits including decimal)and press ENTER.

CumulativeMean SD

1Test Name [ ] [ ]

Input Value : ENTER

This field is used to define the SD value for eachspecific test within each control level. Enter the 1 SDvalue (maximum of seven digits including decimal) andpress ENTER.

No. Name Sample Type1 Control Serum

As each control level is defined in the fields above, theinformation is displayed on this chart. Any previouslyentered information will be displayed.

NOTEIt is necessary to enter a new lot of QC materials onlyon this screen. The 911 automatically updates all ofthe other QC screens with this information.

2.51 Parameter Job - - Control Value Setting


Name [ ]

Input Name (Maximum 8 Characters) : ENTER

Use this field to assign a name to the selected controllevel. Enter the name (maximum of eight characters)and press ENTER.

Sample Type [ ]

Choose 1:Serum/Plasma 2:Urine : ENTER

Use this field to define the class for a particular controllevel. Press 1 or 2 ENTER.

Individual/Real TimeMean SD

1Test Name [ ] [ ]

Use these fields to enter the individual mean and oneSD value for each test.


1Test Name [ ] [ ]

Input Value : ENTER

Use this field to define the mean value for eachspecific test within each control level. Enter the meanvalue (maximum of seven digits including decimal)and press ENTER.


1Test Name [ ] [ ]

Input Value : ENTER

This field is used to define the SD value for eachspecific test within each control level. Enter the 1 SDvalue (maximum of seven digits including decimal) andpress ENTER.

2 • 155

2.52 Parameter Job - - SpecialWash Programming

2.52.1 Introduction

Use the SPECIAL WASH PROGRAMMING screen toprogram cell and probe washes for prevention ofpotential carryover between tests. Refer to theRandom Access Programming section of thechemistry application sheet for specific information onspecial wash programming. Perform a parameterwrite to save changes made to the SPECIAL WASHPROGRAMMING screen on the system disk.

2.52.2 Displaying the SPECIALWASH PROGRAMMING Screen

Press PARAMETER to display the PARAMETERJOB MENU. Press 8 ENTER to display the SPECIALWASH PROGRAMMING screen.

2.52.3 Example of the SPECIALWASH PROGRAMMING Screen

Figure 2-67 is an example of the SPECIAL WASHPROGRAMMING screen.

Figure 2-67: SPECIAL WASH PROGRAMMING Screen

2.52.4 SPECIAL WASHPROGRAMMING Screen Fieldsand Prompts

Each SPECIAL WASH PROGRAMMING field andpromptis explained below.

Reagent Probe Wash[ ] [ ] [ ] [ ] - [ ] [ ] [ ] - [ ]

It is possible to program up to 16 different reagentprobe wash functions. There are eight entry fields foreach reagent probe wash.

2.52 Parameter Job - - Special Wash Programming


8ENTER

37.0 Stand-by 12/01/92 12:20

8 Special Wash Programming

Input Program No. 1 to 8 : ENTER

Reagent Probe Wash Cell Wash

Sample Probe Wash

[1] [1] [CHOL ] [R1] [LIP ] [R1] [00317] [350] [1] [CHOL ] [00317] [250] - [00317] [100]123456789

10111213141516

12345678

12345678

[ ] [ ] [ ]

1 CHOL R1 LIP R1 00317 350 CHOL 00317 250 - 00317 100

2 • 156


Input Probe Wash Program No. 1 to 16 : ENTER

Use this field to assign a probe wash number to theentry. Enter the reagent probe wash number (1 - 16)and press ENTER.


Input Reagent Probe No. 1 or 2 (0:Cancel) : ENTER

Use this field to designate which reagent probe will bewashed. Enter the reagent probe number and pressENTER. Press 0 Cancel ENTER to cancel a probewash program.


Input Tests via Keyboard (99:All Tests) : ENTER

Use this field to enter the test key number of thechemistry that causes potential carryover. Enter thetest key number (1 - 46) and press ENTER. Enter 99All and press ENTER to choose all chemistries.


Choose Test Type: 1:R1 2:R2 3:R3 4:R4 : ENTER

Use this field to specify which reagent type causespotential carryover. Enter the reagent type (1 - 4) andpress ENTER.


Input Tests via Keyboard (99:All Tests) : ENTER

Use this field to specify the affected test. Enter thetest key number of the affected test (1 - 46 / Test Key;99 All) and press ENTER.


Choose Test Type: 1:R1 2:R2 3:R3 4:R4 : ENTER

Use this field to specify which reagent type is affectedby carryover. Enter the reagent type (1 - 4) and pressENTER.


Input Bottle Code No. 00001 to 00400/0:Water :ENTER

Use this field to specify the wash solution used for theprobe wash. Enter the bottle code for the washsolution (00001 - 64999) and press ENTER.


Input Wash Solution Volume: 1 to 350 µl (0:CancelWash) : ENTER

Use this field to specify the volume of wash solutionused for the probe wash. Enter the volume of washsolution (1 - 350) and press ENTER. Press 0 CancelWash ENTER to cancel this reagent probe washprogramming.

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]

Use the Cell Wash fields to program up to eightdifferent cell wash functions. Six fields are used in cellwash programming.

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]

Input Program No. 1 To 8 : ENTER

Use this field to assign a program number to the cellwash. Enter the number of the cell wash (1 - 8) andpress ENTER.



2 • 157

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]

Input Tests via Keyboard (0:Cancel Wash) : ENTER

Use this field to specify the test that causes potentialcell carryover. Enter the test key number of thecausal test (1 - 46 / Test Key) and press ENTER.Press 0 Cancel ENTER to cancel the test choice.

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]

Input Bottle Code No. 00001 to 00400 / 0:Water :ENTER

Use this field to specify the wash solution used for T1in the cell wash program. Enter the wash solutionbottle code and press ENTER.

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]


Use this field to specify the volume of wash solutionused for T1 in the cell wash program. Enter the washsolution volume and press ENTER.

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]

Input Bottle Code No. 00001 to 00400 / 0:Water :ENTER

Use this field to specify the wash solution used for T2in the cell wash program. Enter the wash solutionbottle code and press ENTER.

Cell Wash[ ] [ ] [ ] -[ ] [ ] - [ ]


Use this field to specify the volume of wash solutionused for T2 in the cell wash program. Enter the washsolution volume and press ENTER.

Sample Probe Wash[ ] [ ] [ ]

Sample Probe Wash is used to program up to eightdifferent sample probe washes. There are threeentries for sample probe wash.


Input Program No. 1 To 8 : ENTER

Use this field to assign a program number to thesample probe wash. Enter the number of the probewash (1 - 8) and press ENTER.


Select Tests via Keyboard (99:All 0:Cancel Wash) :ENTER

Use this field to specify the test requiring the sampleprobe wash. Enter the test key number (1 - 46) andpress ENTER. Enter 99 All and press ENTER to selecta sample probe wash for all tests. Press 0 CancelENTER to cancel the sample probe wash.



2 • 158


Input Wash Cup Position No. 1 to 3 : ENTER

Use this field to specify which cup position on thesample disk the sample probe will aspirate washsolution from. Enter the sample disk position number(1 - 3, corresponding to wash cup position 1, 2, or 3)and press ENTER.

NOTEThroughput on your analyzer is affected by the numberof chemistries programmed for extra cell and probewashes. If you have more than one causal chemistrythat interferes with a particular chemistry, you mustprogram a probe wash for each of the causalchemistries. For more details consult your local BMrepresentative.

When both the probe wash and cell wash functions areutilized, the cell wash function takes priority over theprobe wash. If the cell wash function timing is suchthat it occurs simultaneously with ISE sampling, thecell wash function occurs before the ISE samplingcycle begins.



2 • 159

2.53 Parameter Job - - SystemParameters

2.53.1 Introduction

Use the SYSTEM PARAMETERS screen to assignthe system operating parameters for the analyzer.Previously programmed information is displayed whenthis screen is selected.

The SYSTEM PARAMETERS screen has two pages.Page 1 is used to define comment line configurationand host communication. Page 2 is used to define QCcalculations and change passwords. Perform aparameter write to save changes made to theSYSTEM PARAMETERS screen to the system disk.

2.53.2 Displaying the SYSTEMPARAMETERS Screen - Page 1

Press PARAMETER to display the PARAMETERJOB MENU. Press 9 ENTER to display page 1 of theSYSTEM PARAMETERS screen.

2.53.3 Example of the SYSTEMPARAMETERS Screen - Page 1

Figure 2-68 is an example of page 1 of the SYSTEMPARAMETERS screen.

Figure 2-68: SYSTEM PARAMETERSScreen - - Page 1

2.53 Parameter Job - - System Parameters


9ENTER

37.0 Stand-by 12/01/92 12:20

9 System Parameters

Choose 1:Serum 2:Urine 3:Plasma 4:Spinal Fluid : ENTER

Sample Type Communication Configuration

Comments

Exp. Value Default [Cancel]

1 [ ]2 [ ]

Paper LengthType Size

Date OrderSet Date

SexAge

1 [ ] [ ]2 [ ] [ ]3 [ ] [ ]4 [ ] [ ]5 [ ] [ ]

SpeedParityData BitsStop BitsEnd CodeText SizeRetry CountRetry TimeResults OnlyAuto Rerun T/SManual Rerun T/SStat T/SComm. Log

9600Even72ETX+CS+CR25665

CancelCancelCancelCancelCancel

SerumUrine


YesYesYesYesYes

[ ][ ] [ ]

M30 Y

[ ][ ]

11Large

[ ][ ] [ ] [ ][ ] [ ]

M/D/Y92 yr 12 mo 01 day11 hr 20 min

[ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

2 • 160

2.53.4 SYSTEM PARAMETERSScreen Fields and Prompts - -Page 1

Each SYSTEM PARAMETERS field and prompt isexplained below.

Sample Type 1 [ ]2 [ ]

Choose 1:Serum/Plasma 2:Urine 3:Spinal Fluid4:Other : ENTER

Use these fields to define the sample types. In thefirst field, enter the number that corresponds to thesample type you want defined as sample type 1 andpress ENTER. In the second field, enter the numberthat corresponds to the sample type you want definedas sample type 2 and press ENTER.

Comments 1 [ ] [ ]2 [ ] [ ]3 [ ] [ ]4 [ ] [ ]5 [ ] [ ]

Use these fields to define the name for each of the fivecomment lines that appear on several screens suchas PATIENT TEST SELECTIONS, STAT TESTSELECTIONS, and DATA REVIEW. The first fielddefines the name that will show on your screens foreach comment line. The second field enables you toselect whether or not the line will display on yourscreens.

The first comment line allows operator entry for up to30 characters. The second comment line allows entryfor up to 25 characters. The third comment line allowsentry for up to 20 characters. The fourth comment lineallows entry for up to 15 characters and the fifthcomment line allows entry for up to 10 characters.

Comments 1 [ ] [ ]


Use this field to name the comment line. Enter theappropriate name (maximum of 12 characters) andpress ENTER. Move the cursor to the first field of theremaining comment lines. Use the same procedure toname the four remaining comment lines.

Comments 1 [ ] [ ]

Choose 1:Activate 0:Inactivate : ENTER

Use this field to define whether comment lines 1through 5 appear on the screens and on the patientreport printouts. To display each comment line, press1 Activate ENTER. To choose not to display acomment line, press 0 Inactivate ENTER. Move thecursor to the second field of the remaining commentlines. Use the same procedure to display theremaining comment lines.

Exp. Value Default [ ]Sex [ ]Age [ ] [ ]

Use these fields to define the default patient sex andage for printing of normal ranges on the report format.You also can cancel the use or default patient sex andage normal ranges.



Use this field to activate the default sex and agevalues. Press 1 Activate ENTER to use the defaultranges when no values are entered on the PATIENTTEST SELECTION or STAT TEST SELECTIONscreen. Press 0 Inactivate ENTER to choose not touse the default values. If this field is inactive, QCvalues will not print on the report format.



2 • 161


Choose 1:Male 2:Female : ENTER

Use this field to specify the default sex of the patient.Press 1 Male or 2 Female ENTER.



Use this field to specify the numerical default value forage. Enter the age (0 - 200) and press ENTER.


Input Age Interval 1:Days 2:Months 3:Years : ENTER

Use this field to specify the age interval default setting.Enter the number that corresponds to the choseninterval and press ENTER.

Paper Length [ ]

Choose Paper Length 1:11 Inches 2:12 Inches :ENTER

Use this field to define the paper length. Choose thecorrect paper length and press ENTER. Standardpaper size is 8 1/2 x 11 �.

Type Size [ ]

Choose 1:Large Print 2:Small Print : ENTER

Use this field to set the size of the hard copies thatprint when the COPY key is pressed. Press 1 ENTERfor large (normal) and 2 ENTER for small.

Date Order [ ]

Choose 1:Day/Month/Year 2:Month/Day/Year3:Year/Day/Month 4:Year/Month/Day : ENTER

Use this field to specify the order of the date display.Enter the number that corresponds to the desiredorder and press ENTER.

Set Date [ ] yr [ ] mo [ ] day[ ] hr [ ] min

Use these fields to define the correct date and time tobe displayed on the screen.


Input Year (0 To 99) : ENTER

Use this field to define the year. Enter the appropriateyear and press ENTER.


Input Month (1 To 12) : ENTER

Use this field to define the month. Enter theappropriate month and press ENTER.


Input Day (1 To 31) : ENTER

Use this field to define the day. Enter the appropriateday and press ENTER.



2 • 162


Input Hour (0 To 23) : ENTER

Use this field to define the hour. Enter the appropriatehour and press ENTER.


Input Minute (0 To 59) : ENTER

Use this field to define the minute. Enter theappropriate minute and press ENTER.

Communication Configuration

Use these fields to define the parameters forcommunication with a host computer. Use the STARTCONDITIONS screen to select communication withthe host computer. Prior to making changes in thesefield, discuss any changes to these fields with yourservice representative.

Speed [ ]

Choose Baud Rate (BPS) 1:4800 2:9600 : ENTER

Use this field to specify the Baud rate. Press 1 4800or 2 9600 ENTER.

Parity [ ]

Choose Parity 1:Even 2:Odd 0:No Parity : ENTER

Use this field to specify the parity. Enter the numberthat corresponds to your choice and press ENTER.

Data Bits [ ]

Choose Data Bits 1:7 Bits 2:8 Bits : ENTER

Use this field to specify data bits. Enter the numberthat corresponds to your choice and press ENTER.

Stop Bits [ ]

Choose Stop Bits 1:1 Bits 2:2 Bits : ENTER

Use this field to specify stop bits. Enter the numberthat corresponds to your choice and press ENTER.

End Code [ ]

Choose 1:ETX + BCC 2:CR + LF +ETX 3:ETX 4:ETX +CR + LF 5:ETX + CS + CR : ENTER

Use this field to specify the end code. Enter thenumber that corresponds to your choice and pressENTER.

Text Size [ ]

Choose Text Size 1:256 2:512 : ENTER

Use this field to specify text size. Enter the numberthat corresponds to your choice and press ENTER.

Retry Count [ ]

Input Number of Retries 1 to 99 : ENTER

Use this field to specify the retry count. Enter thenumber of retries and press ENTER.

Retry Time [ ]

Input Retry Time 1 to 99 (sec.) : ENTER

Use this field to specify the retry interval. Enter theretry interval and press ENTER.

Results Only [ ]


Use this field to specify transmission of measureddata results only (mono directional interface). Press1 Activate ENTER.



2 • 163

Auto Rerun T/S [ ]


Use this field to specify test selection inquiry to thehost when the 911 is in the Automatic Rerun mode.Press 1 Activate ENTER.

Manual Rerun T/S [ ]


Use this field to specify test selection inquiry to thehost when the 911 is in the manual rerun mode. Press1 Activate ENTER.

Stat T/S [ ]


Use this field to specify Stat test selection inquiry.Press 1 Activate ENTER. When this field is activated,the operator need only define a position on the STATTEST SELECTION screen.

Comm. Log [ ]


Use this field to specify tracing of hostcommunication. Press 1 Activate ENTER.

2.53.5 Displaying the SYSTEMPARAMETERS Screen- - Page 2

Press PARAMETER to display the PARAMETERJOB MENU. Press 9 ENTER to display page 1 of theSYSTEM PARAMETERS screen. Press theGUIDANCE key to display page 2 of the SYSTEMPARAMETERS screen.

2.53.6 Example of the SYSTEMPARAMETERS Screen - Page 2

Figure 2-69 is an example of page 2 of the SYSTEMPARAMETERS screen.

Figure 2-69: SYSTEM PARAMETERS - - Page 2



9ENTER

37.0 Stand-by 12/01/92 12:20

9 System Parameters

Input Calibrator Position No. 1 to 34 : ENTER

Linearity Limit

Calibrator ID

ISEBarcode Reader

Mean-R or X-RQC CalculationRange Plot

Reagent Check LevelMachine Cycle TimeOriginal ABS.Edited Flag

Password

[ Yes ][ Yes ]

[ M-R ][Weighted ][ On ]

[ 30 ] [ Yes ][ 10 ][ Off ][ Yes ]

[ ] [ ] Open [ ]

( 4 - 8 ) [ 0 ]( 9 - ) [ 10 ]

[ 21 ] [ 504 ] [ PCAL-79 ]

2 • 164

2.53.7 Example of the SYSTEMPARAMETERS Screen Fieldsand Prompts - - Page 2

Each field and prompt on page 2 of the SYSTEMPARAMETERS screen is explained below.

ISE [ ]

Choose 1 : Activate 0 : Inactivate : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

Use this field to specify that the analyzer contains theISE module. Press 1 Activate ENTER. The CRTprompt line will display Are You Sure?. Press 1Continue ENTER.

Barcode Reader [ ]

Choose 1 : Activate 0 : Inactivate : ENTERClear Test Selections? 1 : Yes 0 : No : ENTER

Use this field to turn the sample bar code reader onand off. Press 1 Activate ENTER to turn on the barcode reader. Press 0 Inactivate ENTER to turn off thebar code reader. The CRT prompt line will displayChanging Current Option Will Clear Test Selections.Press 1 Yes ENTER.

Mean-R or X-R [ ]

Choose Method of Calculating QC 1 : Mean-R2 : X-R : ENTER

Use this field to specify whether the analyzer willaccumulate control data using the mean of the dailypoints or an individual point. Press 1 ENTER to specifyMean-R or 2 ENTER to specify X-R (individual point.).

QC Calculation [ ]

Choose Method of Accumulating QC 1:IndividualPoints 2:Weighted : ENTER

Use this field to specify whether the analyzer willcalculate the SD with an equal value for eachaccumulated control result or a weighted value foreach accumulated control result. Press 1 IndividualPoints ENTER to specify equal value calculation.Press 2 Weighted ENTER to specify weightedcalculation. This field applies when Mean-R is chosenas the method of calculation.

Range Plot [ ]

Choose 1 : On 0 : Off : ENTER

Use this field to display the range chart on theCUMULATIVE QC CHART screen. Press 1 On or 0 OffENTER.

Reagent Check Level [ ] [ ]

Use these fields to set the parameters for the reagentlevel flags.


Input Level to Flag Remaining Tests 30 to 500 Tests(0:Cancel) : ENTER

Use this field to set the number of tests left that willsignal a reagent level alarm and show yellowhighlighting on the REAGENT STATUS display. Enterthe number of tests and press ENTER.


Choose 1 Activate 0:Inactivate : ENTER

Use this field to activate the reagent level check flags.Press 1 Activate ENTER. If this field is not activated,reagent flags do not occur.



2 • 165

Analyzer Cycle Time [ ]

Input Analyzer Cycle Time 10 to 99 seconds : ENTER

This field is for use by Boehringer Mannheimpersonnel only.

Original ABS. [ ]

Choose 1 : On 0 : Off : ENTER

Use this field to print out original absorbance data.Press 1 On ENTER to print original absorbance data.If original absorbance is selected, results are notwritten to the data disk and calibration is not allowed.

Edited Flag [ ]

Choose 1 : Activate 0 : Inactivate : ENTER

Use this field to instruct the analyzer to flag editedresults on the patient report. Press 1 Activate ENTER.

Password [ ] [ ] Open [ ]

Use these fields to open and close your password ormake changes to your password. The word Openappears between the last two fields when thepassword is open. This word Open does not appearif the password is closed. All information displayed onthe PARAMETER JOB screens, with the exception ofthe CONTROL VALUE SETTING and CONTROLTEST SELECTION screens, is password protected.


Choose 1 : Turn Password On 0 : Turn PasswordOff : ENTER

Use this field to activate your password. Press 1 TurnPassword On ENTER to activate the password.Press 0 Turn Password Off ENTER to deactivate yourpassword.


Input Current Password (Maximum 4 characters) :ENTER

Use this field to enter your current password. Enteringthe password allows you to access passwordprotected fields and screens. Enter the password andpress ENTER.


Change Password To? (Maximum 4 characters) :ENTER

Use this field to change your password. Enter the newpassword and press ENTER. The password must beopened in the previous field prior to changing it. Besure to keep your password recorded in a safeplace for reference.

Linearity Limit (4 - 8 ) [ ](9 - ) [ ]

Input Linearity Limit 1 to 100% (0:Inactivate) : ENTERInput Linearity Limit 1 to 100% (0:Inactivate) : ENTER

Use these fields to specify the linearity check limitvalues. Use the first field to enter the linearity checklimit in the four to eight point range. Enter the correctvalue (0 to 100%) and press ENTER.

Use the second field to enter the linearity check limitfor nine or more points. Enter the correct value (0 to100%) and press ENTER.

Calibrator ID [ ] [ ] [ ]

Use these fields to enter calibrator information.



2 • 166


Input Calibrator Position No. 1 to 34 : ENTERUse this field to specify the calibrator position on thesample disk. Enter the position number (1 - 34) andpress ENTER.


Input Calibrator Code No. 001 to 999 : ENTER

Use this field to assign the calibrator code number.Enter the code number (001 - 999) and press ENTER.


Input Name (Maximum 8 Characters) : ENTER

Use this field to specify the appropriate calibratorname. Enter the name (maximum of eight characters)and press ENTER. This is the name that appears onthe CALIBRATOR LOAD LIST.

NOTEBoehringer Mannheim recommends that you keep awritten record of the correct system parameters foryour analyzer. After you have all of the parametersprogrammed, make a hard copy of each page of theSYSTEM PARAMETERS screen. Press COPY tomake a copy of page 1 of the SYSTEMPARAMETERS screen. Press GUIDANCE followedby COPY to make a copy of page 2.



2 • 167

2.54 Parameter Job - - ChannelAssignment

2.54.1 Introduction

Use the CHANNEL ASSIGNMENT screen to readchemistry and serum index parameters from theparameter disk. This screen also is used to assignthese parameters to a test key number. TheCHANNEL ASSIGNMENT screen has two pages.Page 1 displays a selected parameter blockconsisting of 20 application codes. Page 2 displaysall of the current test key assignments.

2.54.2 Displaying the CHANNELASSIGNMENT Screen - - Page 1

Press PARAMETER to display the PARAMETERJOB MENU. Press 10 ENTER to display theCHANNEL ASSIGNMENT screen.

2.54.3 Example of the CHANNELASSIGNMENT Screen - - Page 1

Figure 2-70 is an example of page 1 of the CHANNELASSIGNMENT screen.

Figure 2-70: CHANNEL ASSIGNMENTScreen - - Page 1

2.54 Parameter Job - - Channel Assignment


1 0ENTER

37.0 Stand-by 12/01/92 12:20

10 Channel Assignment

Input Application Code No. 001 to 999 : ENTER

Parameter ReadChannel Assignment

[ ][ ] - [ ]

No. Code Test Comment No. Code Test Comment

00000000000000000000000000000000000000000000000000

00000000120001300000000000001600000000180001900020

450011450051123960

AMP

450017450037450034

ALB/GALB/PALC

ALP/A

ALTALT/PNH3

001002003004005006007008009010

011012013014015016017018019020

1

2 • 168

2.54.4 CHANNEL ASSIGNMENTScreen Fields and Prompts - -Page 1

Each CHANNEL ASSIGNMENT field and prompt isexplained below.

Parameter Read [ ]

Input Parameter Block to Read 1 to 50 : ENTERAre You Sure? 1:Continue 0:Cancel : ENTER

This field is used by your BM representative to specifythe parameter block to be read from Parameter disk.A BM library diskette is available for customer's ownuse. Please clear with your local representative.Enter the correct parameter block (1 - 50) and pressENTER. Each block contains 20 test code numbers.The information contained in the selected parameterblock appears on the screen. This informationincludes the application code number, test name, andcomments.

Channel Assignment [ ] - [ ]

Use these fields to assign the parameters to a test keyon the 911.



Use this field to select the application code for thechemistry parameters you want to assign to a testkey. Enter the correct test code (00001 - 00999) andpress ENTER.


Input Channel Assignment 1 to 46 : ENTERClear Data, Check Host Communication, Are YouSure? 1:Yes 0:No : ENTER

Use this field to choose the test key to assign theappropriate chemistry parameters. Enter the correcttest key (1 - 46) and press ENTER. The CRT prompt

line will display Clear QC, Check HostCommunication, or Are You Sure?. This reminds youthat the key could already be assigned to another setof parameters. If you change the key assignment, QCmust be documented and deleted. If you arecommunicating with a host computer, the host mustbe programmed with the channel assignment change.Press 1 Continue ENTER.

2.54.5 Displaying the CHANNELASSIGNMENT Screen - - Page 2

Press PARAMETER to display the PARAMETERJOB MENU. Press 10 ENTER to display page 1of the CHANNEL ASSIGNMENT screen. PressGUIDANCE to display page 2 of the CHANNELASSIGNMENT screen.



2 • 169

2.54.6 Example of the CHANNELASSIGNMENT Screen - - Page 2

Figure 2-71 is an example of page 2 of the CHANNELASSIGNMENT screen.

Figure 2-71: CHANNEL ASSIGNMENTScreen - - Page 2

2.54.7 CHANNEL ASSIGNMENTScreen Fields and Prompts - -Page 2

The entry fields and prompts remain the same on page2 of the CHANNEL ASSIGNMENT screen.

The information displayed on the screen lists all of thetest that have been assigned to a test key. The screendisplays the test key number, short test name,application code, and comment for each assignedtest. Do not assign the same chemistry to morethan one test key or a duplicate bottle codeinstrument alarm will result.



37.0 Stand-by 12/01/92 12:20

10 Channel Assignment


Parameter ReadChannel Assignment

[ ][ ] - [ ]

Ch. Test Code Comment Ch. Test Code Comment Ch. Test Code Comment

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CATRIGUAALB

TPPHOSCREACHOLMG

00074001150003600018000160009300031000510005200053000950004000059001580016000013

00155001330007700072001190032200323003240032500326003270032800329003300033100332

0033300334003350033600337003380033900340003410034200343003440034500346

450025450022450018450017AMP450027EPS

450021450015450014GABAGPO450013450051

450023450024Jaffe450026804551

123456789

10111213141516

17181920212223242526272829303132

3334353637383940414243444546

2 • 170

2.55 Maintenance Job - - Menu

2.55.1 Introduction

Use the MAINTENANCE JOB MENU to requestmaintenance and instrument self-diagnosticfunctions. These functions can be requested onlywhen the instrument is in Stand-by. Press STOP tointerrupt many of these functions. Specificprocedures for performing the functions arereferenced where appropriate. The analyzer must bein Stand-by to perform maintenance procedures.

2.55.2 Displaying the MAINTENANCEJOB MENU

Press MAINTENANCE to display the MAINTENANCEJOB MENU.

2.55.3 Example of the MAINTENANCEJOB MENU

Figure 2-72 is an example of the MAINTENANCE JOBMENU.

Figure 2-72: MAINTENANCE JOB MENU

2.55.4 MAINTENANCE JOB MENUFields and Prompts

Function No. [ ]


To choose a screen from the menu, enter the screennumber and press ENTER. The selected screenappears on the screen.

2.55 Maintenance Job - - Menu


37.0 Stand-by 12/01/92 12:20

Maintenance Job Menu


1

2

3

4

Analyzer Maintenance

Mechanisms Check

Support Function

Working Information

Function No. [ ]

2 • 171

2.56 Maintenance Job - -Analyzer Maintenance

2.56.1 Introduction

The ANALYZER MAINTENANCE display is used toexecute various maintenance procedures. Theinstrument must be in Stand-by to executemaintenance functions.

2.56.2 Displaying the ANALYZERMAINTENANCE Screen

Press MAINTENANCE to display the MAINTENANCEJOB MENU. Press 1 ENTER to display theANALYZER MAINTENANCE screen.

2.56.3 Example of the ANALYZERMAINTENANCE Screen

Figure 2-73 is an example of the ANALYZERMAINTENANCE screen.

Figure 2-73: ANALYZER MAINTENANCE Screen

2.56 Maintenance Job - - Analyzer Maintenance


1ENTER

37.0 Stand-by 12/01/92 12:20

1 Analyzer Maintenance

Choose 1:Wash Cells 2:Wash ISE 3:Wash Cells + ISE : ENTER

Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning

Parameter Read/Write

T/S Read/Write

Calib. Transfer/Lot No.

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

2 • 172

2.56.4 ANALYZER MAINTENANCEScreen Fields and Prompts

Each ANALYZER MAINTENANCE field and screenprompt is explained below.

Wash [ ]

Choose 1 : Wash Cells 2 : Wash ISE 3 : WashCells + ISE : ENTER

Use this field to specify what instrument componentsyou want to wash. Enter the number that correspondsto the required wash and press ENTER. Choosing1:Wash Cells dispenses full strength Hitergent fromposition 33 in the R1 and R2 disks into the reactioncells. This is diluted with DI water to a 2% solution.This wash takes 25 minutes. Choosing 2:Wash ISEdelivers 10 slugs of NaOH to the ISE system andtakes 5 minutes. Choosing 3: Wash Cells + ISEperforms both washes and takes 25 minutes. Ifnumber 2 or 3 is selected make sure the ISEs arecalibrated prior to running patient samples.

Water Tank [ ]

Input 1:Start : ENTER

Use this field to perform heat sterilization of the watertank. Press 1 Start ENTER. This procedure takes 15minutes and cannot be interrupted by pressing theSTOP key.

Photometer Check [ ]


Whenever the reaction bath water is replaced, aphotometer check must be performed to measure theabsorbance of the light path. This procedure also isused as a daily check of the photometer lamp energyand is described in Section 2.2.6. Press 1 StartENTER to perform a photometer check. Thisprocedure takes 2 minutes. All numbers must be lessthan 13,000.

ISE Prime [ ]

Choose 1:Int. Ref. 2:DIL 3:Int. Ref. + DIL 4:KCl 5:PrimeAll : ENTER

This entry field is used to control priming functions forthe ISE unit. Five types of priming are available:

1:Int. Ref.: This prime is used to prime theInternal Reference Solution(IRS) only. Reagentconsumption: 22.5 mL InternalReference Solution.

2:DIL: This prime is used to prime thediluent only. Reagentconsumption: 10.8 mL diluent.

3:Int. Ref. + DIL: This prime is used to prime theIRS and the Diluent. Reagentconsumption: 22.5 mL IRS and10.8 mL diluent.

4:KCl: This prime is used to prime KClonly. Reagent consumption:12.7 mL KCl.

5:Prime All: This prime is used to prime theIRS, diluent, and KCl. Reagentconsumption: 22.5 mL IRS, 10.8mL diluent, and 12.7 mL KCl.

Enter the number that corresponds to the primechosen and press ENTER. This procedure takes 5minutes and should be followed by an ISE calibrationif new reagent was placed on the analyzer. An ISEprime is also required following ISE maintenancesuch as replacing the seals, cartridges or pinch valvetubing.



2 • 173

Cell Blank [ ]

Choose 1:Initiate & Print Cell Blank 2:Reprint CellBlank : ENTER

Use this field to initiate a cell blank. When thephotometer lamp or reaction cells are replaced, a cellblank must be performed. A cell blank also isperformed during weekly maintenance. Section 3.7reviews the cell blank procedure. Press 1 Initiate &Print Cell Blank ENTER to perform the cell blank.Press 2 Reprint Cell Blank ENTER to reprint the mostrecent Cell Blank report. This procedure takes 15minutes and the results are stored in CRAM.

Air Purge [ ]


Use this field to purge air from the reagent and samplepipetting system degassed water lines. Thisprocedure should be performed whenever theinstrument has been inactive for eight or more hours.An air purge occurs automatically duringinitialization. Press 1 Start ENTER to initiate the airpurge. This procedure takes 1 minute. An air purgeshould be performed following maintenance on thesample and reagent pipettors.

Inc. Water Exchange [ ]


The incubation (reaction) bath water is automaticallyreplaced with fresh water when the instrument ispowered ON and during Wake-up. If the instrumentremains ON for more than 24 hours, an Execute Inc.Water Exchange alarm is issued, requesting that thereaction bath water be exchanged. This proceduretakes 2.5 minutes.

Press 1 Start ENTER to initiate a reaction bath waterexchange. This procedure replaces the bath water.Hitergent (6 mLs) is added by the reagent probes.Perform a photometer check after the bath exchange.

Reset [ ]


Use this field to reset all mechanical components totheir home positions. Press 1 Start ENTER to performa reset. This occurs automatically duringInitialization, when the START key is pressed andduring Wake-up. The procedure takes 15 seconds.

FD Utility [ ]

Choose 1 : Format FD in Drive 2 2 : Copy FD Drive 1to Drive 2 3 : Format & CopyAre You Sure? 1 : Continue 0 : Cancel : ENTER

Use this field to format and copy floppy disks.

To format a floppy disk (takes 1 minute):

• Place the disk that is being formatted in drive 2.

• Press 1 ENTER.The CRT displays Are You Sure? (1:Yes0:Cancel).

• Press 1 Yes ENTER or 0 Cancel ENTER.

To copy a disk (takes 2 minutes):

• Place the disk that is being copied in drive 1; placethe formatted blank disk in drive 2.

• Press 1 ENTER.The CRT displays Are You Sure? (1:Yes0:Cancel).

• Press 1 Yes ENTER or 0 Cancel ENTER.

A 3.5 inch double-sided, high density disk is good for100,000 accesses. An instrument alarm, Clean FDDHead, Replace FD, occurs a power ON when the diskneeds to be replaced. Press 3 Format & Copy ENTERto format and copy the disk with one command. Thistakes 3 minutes.



2 • 174

FD Drive Cleaning [ ]

Choose 1 : Clean Drive 1 2 : Clean Drive 2 : ENTERAre You Sure? 1 : Continue 2 : Cancel : ENTER

This field allows you to clean the disk drives. Enter thenumber of the drive to be cleaned (1 or 2) and pressENTER. The CRT displays Are You Sure?. Press 1Continue ENTER.

For additional information on the floppy disk drivecleaning procedure, please refer to Section 3.15.

Parameter Read/Write [ ]

Choose 1 : Read From FD 2 : Write to FD : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

This field is used to read operating parameters from thesystem disk into instrument memory, or to writeoperating parameter changes made in instrumentmemory to the system disk.

A Parameter Write should be performed when:

• any changes are made to any of the PARAMETERJOB displays

• changes are made to masking, start samplenumber, or rerun status on START CONDITIONS

• any pre-set K factor is entered in CALIBRATIONLIST display of Monitor Job

• you are incrementing sequence numbers from oneday to the next and powering the analyzer OFFeach day

• any test received a CALIB and SD LIM alarm duringcalibration and subsequent controls are withinrange

1. Press 1 ENTER to read operating parameters fromthe system disk into instrument memory. The CRTdisplays Are You Sure?.

Press 1 Continue ENTER or 0 Cancel ENTER.

2. Press 2 ENTER to write operating parameters frominstrument memory onto the system disk. TheCRT displays Are You Sure?.

Press 1 Continue ENTER or 0 Cancel ENTER.

The cursor advances to the next entry field uponcompletion. Wait until the requested function iscompleted before attempting the next keyboard entry.

T/S Read/Write [ ]

Choose 1 : Read From FD 2 : Write to FD

Use this field to read or write patient test selections,control, and calibrator test selections to a floppy disk.



2 • 175

2.57 Maintenance Job - -Mechanisms Check

2.57.1 Introduction

Use the MECHANISMS CHECK screen to performchecks on various mechanical parts of the analyzer.

2.57.2 Displaying the MECHANISMSCHECK Screen

Press MAINTENANCE to display the MAINTENANCEJOB MENU. Press 2 ENTERto display the MECHANISMS CHECK screen.

2.57.3 Example of the MECHANISMSCHECK Screen

Figure 2-74 is an example of the MECHANISMSCHECK screen.

Figure 2-74: MECHANISMS CHECK Screen

2.57 Maintenance Job - - Mechanisms Check


2ENTER

37.0 Stand-by 12/01/92 12:20

2 Mechanisms Check

Choose 1:S. Probe (Horiz. ) 2:S. Probe (Vert. ) 3:Reagent Probes 4:Stirrers : ENTER

Probe Adjust

Mechanism CheckBarcode Reader CheckISE Check

Printer Check

Alarm LogHost Communication LogProgram Check

[ ]H1 : 84.6 H2 : 42.4

[ ][ ][ ]

[ ]

[ ] [ ][ ][ ]

2 • 176

2.57.4 MECHANISMS CHECK ScreenFields and Prompts

Each MECHANISMS CHECK field and screen promptis explained below.

Probe Adjust [ ]

Choose 1 : S. Probe(Horiz.) 2 : S. Probe (Vert.)3 : Reagent Probes 4 : Stirrers : ENTER

The sample and reagent probes should be checked forproper alignment. From this field, the instrument canbe instructed to move probes to their dispensepositions at the reaction disk. Follow the procedureoutlined for probe adjust in Section 3.8. beforeattempting a probe adjust.

Press 1 ENTER to adjust the horizontal positioning ofthe sample probe. Press 2 ENTER to adjust thevertical decent of the sample probe. Press 3 ENTER toadjust the horizontal positioning of the reagent probes.Press 4 ENTER to adjust the horizontal positioning ofthe stirring mechanism.

Mechanism Check [ ]

Select the Number of Repetitions 1 To 9999 : ENTER

Use this field to execute a mechanism check. Theanalyzer will move through a complete mechanicalcycle without processing a sample. This may be usedduring troubleshooting. Enter the number of timesthat the requested operation is to be performed (entera minimum of 10 times), then press ENTER. Inputrange: 1 - 9999.

Barcode Reader Check [ ]


Use this field to execute a bar code check. Theprocedure checks the sample bar code reader andboth reagent bar code readers. This may be usedduring troubleshooting. Enter the number of timesthat the requested operation is to be performed (inputa minimum of 10 times), then press ENTER. Inputrange: 1 - 9999. This number reflects the number ofsample tubes placed on the outer ring of the sampledisk. A report will print out following the bar codereader check.

ISE Check [ ]


Use this field to check the ISE system. Theelectromotive force (EMF) of the internal standardthrough the measuring cartridge is measured andthese measurements are printed out. The EMF of theKCL through the reference cartridge is measured.Enter the number of times that the EMF is to bemeasured, then press ENTER. Input range: 1-9999.

Printer Check [ ]

Input 1 : Start : ENTER

The printer check is a diagnostic procedure performedto verify that the instrument can send a full page ofcharacters to the printer, and that the printer can printthem.

Press 1 ENTER to initiate a printer check.

Alarm Log [ ] [ ]

Information about the instrument alarms is stored inCRAM. This information can be selectively printed byusing the Alarm Log fields. The daily alarm log showsthe last 200 alarms. The cumulative alarm log showsalarms from the last 256 days.



2 • 177

Alarm Log [ ] [ ]

Choose 1:Daily Alarm Log 2:Cumulative Alarm Log :ENTER

Use this field to choose between a daily alarm log ora cumulative alarm log. Enter the log you want to printor clear and press ENTER. This fieldis be used by Boehringer Mannheim servicepersonnel during troubleshooting.

Alarm Log [ ] [ ]

Choose 1 : Print Log 2 : Clear Log : ENTERAre You Sure? 1 : Continue 0 : Cancel : ENTER

Use this field to print or clear the selected alarm log.This field is used by Boehringer Mannheim servicepersonnel during troubleshooting. Press 1 Print LogENTER to print a copy of the alarm log. The CRTdisplays Are You Sure?. Press 1 Continue ENTER.Press 2 Clear Alarm Log ENTER to clear the alarm log.The CRT displays Are You Sure?. Press 1 ContinueENTER. Wait until the function is completed beforeattempting another keyboard entry.

Host Communication Log [ ]

Choose 1:Print Log 2:Clear Log : ENTERAre You Sure? 1:Continue 0:Cancel : ENTER

Information about the internal operation of theinstrument is logged (stored) on the System Disk.Information can be selectively printed by using theHost Communication Log field. This entry field isused by Boehringer Mannheim service personnelduring troubleshooting. Press 1 Print Log ENTER toprint a copy of the communication log. The CRTdisplays Are You Sure?. Press 1 Continue ENTER.Press 2 Clear ENTER to clear the communication log.The CRT displays Are You Sure?. Press 1 ContinueENTER. Wait until the requested function is completebefore attempting the next keyboard entry. TheComm. Log field on SYSTEM PARAMETERS mustbe set to active to store this information for printing.

Program Check [ ]

Choose 1 : FD Check (Dr. 1) 2 : FD Check (Dr. 2)3 : FD Check 4 : Memory Check 5 : All : ENTER

Use this field to request printed checks on eitherfloppy disk or ROM (Read Only Memory). Enter thenumber that corresponds to the floppy disk you wantto check and press ENTER.

The memory check is a diagnostic procedure that isperformed if it becomes necessary to verify thecontents of the instrument ROM. Press 4 ENTER toprint the checksum of the instrument ROM.

Wait until the memory check is complete beforeattempting the next keyboard entry.



2 • 178

2.58 Maintenance Job SupportFunctions

2.58.1 Introduction

Use the SUPPORT FUNCTIONS screen to runprecision checks and calculate correlations betweentests. The precision check is automatically printed outand the results of the correlation calculation aredisplayed and plotted on a graph.

2.58.2 Displaying the SUPPORTFUNCTIONS Screen

Press MAINTENANCE to display the MAINTENANCEJOB MENU. Press 3 ENTERto display the SUPPORT FUNCTIONS screen.

2.58.3 Example of the SUPPORTFUNCTIONS Screen

Figure 2-75: SUPPORT FUNCTIONS Screen

2.58 Maintenance Job - - Support Functions


3ENTER

37.0 Stand-by 12/01/92 12:20

3 Support Function


Precision Check

Correlation Analysis

XY

Execute

NRabSyx

Mean

=====

(X)(Y)

90.9901.458-18.810.9

232.0319.4

[ ] [ ] - [ ] [ ] - [ ][ ] [ ] - [ ] [ ] - [ ]AMYL 1 10 0 100REF 1 10 0 100

Test S.No. Scale

[ ]

Sample No. [ ] - [ ]

25 50 75 100100

25

50

75

100

**

**

*

*

* *

*

2 • 179

2.58.4 SUPPORT FUNCTIONS ScreenFields and Prompts

Each SUPPORT FUNCTION field and screen promptis explained below.

Precision CheckS.No. [ ] - [ ]


Use these fields to enter the range of routine samplesfor which you want precision data calculated. Theinstrument calculates the N, mean, range, maximumand minimum values, SD, and CV (%). Test resultsmust be obtained and stored on the data disk beforea precision check can be performed. Results withdata flags are not included in calculations.

Enter the sequence number of the first sample in field1 and press ENTER. Enter the sequence number ofthe last sample in field 2 and press ENTER.

Wait until all test results print out before attemptingthe next keyboard entry.

Correlation AnalysisTest S.No. Scale

X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]

Use these fields to perform a correlation calculationbetween consecutive data pairs. At least three datapairs are needed, and up to 100 data pairs may beentered. This calculation can be used for twomethods that are on board the system or it can beused for correlations between two different systems oranother system to a method on board the 911.

NOTETo perform a correlation analysis between twodifferent systems, you must first set up a separatechannel (test key number) in CHEMISTRYPARAMETERS. Make sure that the entry in the DataMode field is Manual. You then can edit results fromanother system to this channel number on the DATAREVIEW screen, using the Data Editing field.


X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]


Use this field to specify the test to be plotted on theX axis. Enter the test key code and press ENTER.


X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]


Use these fields to specify the sample number rangefor the test to be plotted on the X axis. Enter the firstsample number in field 2 and press ENTER. Enter thelast sample number in field 3 and press ENTER.



2 • 180


X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]

Input Minimum Level : ENTERInput Maximum Level : ENTER

Use these fields to specify the range of the scale forthe X axis. Enter the minimum level of the X-axis scalein field 4 and press ENTER. Enter the maximum levelof the X-axis scale in field 5 and press ENTER.


X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]


Use this field to specify the test to be plotted on theY axis. Enter the test key code and press ENTER.


X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]

Input Sample No. 1 to 800:ENTERInput Sample No. 1 to 800:ENTER

Use these fields to specify the sample number rangefor the test to be plotted on the Y axis. Enter the firstsample number in field 7 and press ENTER. Enter thelast sample number in field 8 and press ENTER.


X [ ] [ ] - [ ] [ ] - [ ]Y [ ] [ ] - [ ] [ ] - [ ]

Input Minimum Level : ENTERInput Maximum Level : ENTER

Use these fields to specify the range of the scale forthe Y-axis. Enter the minimum level of the Y-axisscale in field 9 and press ENTER. Enter the maximumlevel of the Y-axis scale in field 10 and press ENTER.

Execute [ ]

Input 1:To Execute : ENTER (Use COPY KEY forGraph)

Use this field to execute the correlation calculation.Press 1 Execute Correlation ENTER. Press COPY toprint the correlation graph.

N, R, a, b, Syx, MEAN (X and Y)

These numbers are calculated by the analyzer. Nooperator entry is permitted in these fields.

N is the number of data pairs used in the calculation

R is the regression coefficient.

a is the slope of the line.

b is the y-intercept.

Syx is the standard error of the estimate or scatter.

Mean X is the mean of the X values.

Mean Y is the mean of the Y values.



2 • 181

2.59 Maintenance Job WorkingInformation

2.59.1 Introduction

Use the WORKING INFORMATION screen to trackinformation about the scheduled maintenance of youranalyzer.

2.59.2 Displaying the WORKINGINFORMATION Screen

Press MAINTENANCE to display theMAINTENANCE JOB MENU. Press 4 ENTER todisplay the WORKING INFORMATION screen.

2.59.3 Example of the WORKINGINFORMATION Screen

Figure 2-76 is an example of the WORKINGINFORMATION screen.

Figure 2-76: WORKING INFORMATION Screen

2.59.4 WORKING INFORMATIONScreen Fields and Prompts

Each WORKING INFORMATION field and screenprompt is explained below.

PHOTOMETRIC UPDATECells XX/XX/XX [ ]

Input 1:If Changed (OK<21days,??=21-30 days,!!>30days) : ENTER

Use this field to update the date the reaction cellswere changed. Press 1 ENTER and the date willautomatically change to the current date.

2.59 Maintenance Job - - Working Information


4ENTER

37.0 Stand-by 02/05/93 12:20

4 Working Information

PHOTOMETRIC UPDATE

Cells

Lamp

?? ! !

! !

! !

11/12/92

11/12/92

11/12/92

10/29/92

Input 1:If Changed (OK< 21 days, ??= 21-30 days, > 30 days) : ENTER

SEAL CHANGE

Serum

Reagent 1

Reagent 2

01/06/93

11/12/92

11/12/92

11/12/92

11/12/92

ISE SEAL PIECE

Internal STD

Dilution

Sipper

07/09/92

07/09/92 07/09/92

07/09/92

Syringe Filter 10/29/92

Pinch Valve Tubing

Syringe Filter 08/27/92MONTHLY CLEANING

3-MONTH CLEANING

! !

! !

11/12/92

04/27/92

NaOH Reservoir

Maintenance Report

Cumulative Operations Report

02/04/93

?? : Caution

! ! : Over

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ][ ]

[ ]

[ ]

[ ]

[ ]

K

Cl

ElectrodeElectrode

ISE UPDATE

Na

Ref.

Electrode

Electrode

2 • 182

Lamp XX/XX/XX [ ]

Input 1:If Changed (OK<600hrs,??=600-750 hrs,!!>750hrs) : ENTER

Use this field to update the date the photometer lampwas changed. Press 1 ENTER and the date willautomatically change to the current date.

SEAL CHANGESerum XX/XX/XX [ ]

Input 1:If Changed (OK<400hrs,??=400-500 hrs,!!>500 hrs) : ENTER

Use this field to update the date the sample pipettorseals were changed. Press 1 ENTER and the date willautomatically change to the current date.

Reagent 1 XX/XX/XX [ ]


Use this field to update the date the reagent 1 pipettorseals were changed. Press 1 ENTER and the date willautomatically change to the current date.

Reagent 2 XX/XX/XX [ ]


Use this field to update the date the reagent 2 pipettorseals were changed. Press 1 ENTER and the date willautomatically change to the current date.

Syringe Filter XX/XX/XX [ ]


Use this field to update the date the inlet water filterwas changed. Press 1 ENTER and the date willautomatically change to the current date.

MONTHLY CLEANING XX/XX/XX [ ]

Input 1:Initiate Program (OK<21days,??=21-30 days,!!>30 days) : ENTER

Use this field to enter the date the monthly scheduledmaintenance was completed. Refer to the 911Maintenance Log for a list of the monthly maintenanceitems. Press 1 ENTER and the date will automaticallychange to the current date.

3-MONTH CLEANING XX/XX/XX [ ]

Input 1:Initiate Program (OK<81days,??=81-90 days,!!>90 days) : ENTER

Use this field to enter the date quarterly scheduledmaintenance was completed. Refer to the 911Maintenance Log for a list of the quarterlymaintenance items. Press 1 ENTER and the date willautomatically change to the current date.

NaOH Reservoir XX/XX/XX [ ]

Input 1:If Refilled (OK<5days,??=5 - 7 days,!!>7 days) : ENTER

Use this field to update the date the NaOH reservoirwas filled with Multiclean. Press 1 ENTER and thedate will automatically change to the current date.

ISE UPDATENa Electrode XX/XX/XX [ ]

Input 1:If Changed (0K <50 days,??=50-60 days,!!>60 days) : ENTER

Use this field to update the date the Na+ electrodewas changed. Press 1 ENTER and the date willautomatically change to the current date. Change thecartridge when the slope is < 32.



2 • 183

K Electrode XX/XX/XX [ ]

Input 1:If Changed (0K <50 days, ??=50-60 days,!!>60 days) : ENTER

Use this field to update the date the K+ electrode waschanged. Press 1 ENTER and the date willautomatically change to the current date. Change thecartridge when the slope is < 32.

Cl Electrode XX/XX/XX [ ]

Input 1:If Changed (0K <25 days,??=25-30 days,!!>30 days) : ENTER

Use this field to update the date the Cl- electrode waschanged. Press 1 ENTER and the date willautomatically change to the current date. Change thecartridge when the slope is > -34.9.

Ref. Electrode XX/XX/XX [ ]

Input 1:If Electrode Changed (OK<140 days,??=140-180 days, !!>180 days) : ENTER

Use this field to update the date the referenceelectrode was changed. Press 1 ENTER and the datewill automatically change to the current date.

ISE SEAL PIECEInternal STD XX/XX/XX [ ]

Input 1:If Seal Changed (OK<400 hrs,??=400-500hrs, !!>500 hrs) : ENTER

Use this field to update the date the internal referencepipettor seals were changed. Press 1 ENTER and thedate will automatically change to the current date.

Dilution XX/XX/XX [ ]

Input 1:If Seal Changed (OK<400 hrs,??=400-500hrs, !!>500 hrs) : ENTER

Use this field to update the date the diluent pipettorseals were changed. Press 1 ENTER and the date willautomatically change to the current date.

Sipper XX/XX/XX [ ]

Input 1:If Seal Changed (OK<400 hrs, ??=400-500hrs, !!>500 hrs) : ENTER

Use this field to update the date the sipper pipettorseals were changed. Press 1 ENTER and the date willautomatically change to the current date.

Pinch Valve Tubing XX/XX/XX [ ]

Input 1:If Changed (OK<600 hrs, ??=600-750 hrs,!!>750 hrs) : ENTER

Use this field to update the date the pinch valve tubingwas changed. Press 1 ENTER and the date willautomatically change to the current date.

Syringe Filter XX/XX/XX [ ]

Input 1:If Changed (OK<600 hrs,??=600-750 hrs,!!>750 hrs) : ENTER

Use this field to update the date the syringe filter waschanged. Press 1 ENTER and the date willautomatically change to the current date.

?? Caution

Two question marks (??) appear in yellow highlight infront of the date as a caution to indicate that youshould prepare to perform this maintenance task.

!! Over

Two exclamation marks (!!) appear in red highlight infront of the date to indicate that this maintenancefunction is over due and needs to be performed.



2 • 184

Maintenance Report [ ]


Use this field to request a printout of the history of thecleaning and replacement of parts for the last 10 times.Press 1 ENTER to request the printout.

Cumulative Operations Report [ ]


Use this field to request a printout of the cumulativeinformation on routine operation. Press 1 ENTER torequest the printout.



2 • 185

2.60 Overview

2.60.1 Section Contents

Several reports are generated from the BoehringerMannheim/Hitachi 911 Analyzer. This sectioncontains examples of the available reports and brieflydiscusses their content and use.

2.60.2 Report Table

The table below lists the reports available, and thesection where an example of each report is included.

2.60 Overview

2. REPORTS

Report Name(Printout)

Request fromThis Job

Request fromThis Section

SectionNumber

Reagent Status Routine ReagentStatus

2.61

Requisition List -without BCR

Routine Patient TestSelection

2.62

Requisition List -with BCR

Routine Patient TestSelection

2.63

Calibrator LoadList

Routine CalibrationTestSelection

2.64

Rerun List Routine RerunSamples

2.65

Calibration Monitor Routine StartConditions

2.66

Individual QCMonitor

QC Individual QCMonitor

2.67

Individual QC List QC Individual QCList

2.68

Cumulative QCMonitor

QC CumulativeQC Monitor

2.69

Report Name(Printout)

Request fromThis Job

Request fromThis Section

SectionNumber

Cumulative QC List QC CumulativeQC List

2.70

Reaction Monitor Monitor ReactionMonitor

2.71

Patient Reports--Report Format

Routine Data Review 2.72

Patient Reports--Short Format

Routine Data Review 2.73

Calibration Trace Monitor CalibrationTrace

2.74

Profiling List Parameter Profiling 2.75

Photometer Check Maintenance AnalyzerMaintenance

2.76

Cell Blank Maintenance AnalyzerMaintenance

2.77

Bar Code ReaderCheck

Maintenance MechanismsCheck

2.78

ISECheck Maintenance MechanismsCheck

2.79

Printer Check Maintenance MechanismsCheck

2.80

Daily Alarm Trace Maintenance MechanismsCheck

2.81

Cumulative AlarmTrace


2.82

HostCommunicationLog


2.83

Floppy Disk Check Maintenance MechanismsCheck

2.84

Memory Check Maintenance MechanismsCheck

2.85

Precision Check Maintenance SupportFunction

2.86

MaintenanceReport

Maintenance WorkingInformation

2.87

CumulativeOperations List

Maintenance WorkingInformation

2.88

OriginalAbsorbance

Parameter SystemParameters

2.89

PART C

2 • 186

2.61 Reagent Status

2.61.1 Introduction

The Reagent Status report is a printout of theinformation shown on the REAGENT STATUSscreen. The test name, position, remaining tests, lotnumber, and expiration date for all reagentsregistered on board the analyzer are listed.

2.61.2 Printing the Reagent StatusReport

Press ROUTINE 1 ENTER to display the REAGENTSTATUS screen. Move the cursor to the Print field.Press 1 ENTER to print the Reagent Status report.

2.61.3 Printing the Reagent StatusReport

Figure 2-77 is an example of the Reagent Statusreport.

Figure 2-77: Reagent Status Report

2.61 Reagent Status

2. REPORTS

1ENTER

REAGENT STATUS 01/06/93 14:39

CK

LD

AST

ALT

ALP/A

GGT

AMYL

BUN

GLU

CO2

CA

TRIG

UA

ALB/GTP

PHOS

CREA

CHOL

MG

INDEXU/CSF

93

2070

230130

93170

3093

17090

180180

93140110

9380

2200

20060704040

110360

9350608080

0300190520120710

0

6070

54625

150880

80

mL

mL

mL

mL

mL

*

mL

*

mLmLmL

ASSAY TYPE POS. TESTS SIZE LOT NO. SEQ.NO. APP CODE EXP.WK STAB

DILR1R1R3R1R3DILR1R3!DILR1R3R1R3DILR1R3DILR1R1R1R2R1R2R1R2R1R2DILR1R1R3R1R1 ?R2R1R2R1R2R1R1R1R2WWWR1R1R3

1112121121121211211112121212111211212121112112112

6285

2011

62420

621213019

62715

614

328142923311823

164

1826

92628161715

31

2511

91322313212

7

LMMSLSLLMLLMLMLLSLSLLMLLMSLLLLLSLLLLLLLLLMMMMMMSS

049902048803048803048803048800048800049902048796046444049902048795046377048791048791049902046160046160049902051700048799048799048799048794048794048793048793054004054004049902046854048792048792044831048801048801048802048802048797048797

00848004990051900161001210092800848013550001600848000460000100281000790084800014000140084813887002160067300378002650023800621015270020600085008480000300103005130002100513006290030800135007200043500023002960050602820005060050100700

0114701916

045424048804048827048827049901049901049901

053152053152

003110007400074000?400115001150031100036000360031100018000180001600016003110009300093003110003100053000530005300095000950004000040000590005900311001580016000160000120015500155001330013300077000770007200072001190011900317003170031700299

93/5293/1793/1793/1793/3093/4393/5293/2193/0893/5293/2593/0493/0493/4793/5293/5293/5293/5293/4393/4393/4393/4393/4793/3893/4393/1793/4793/4793/5293/4793/0803/0493/1793/1293/1293/4393/4393/4393/4393/3993/4793/3493/3493/4393/4393/43

93/4393/43

54096

23

23

2323

8516

13211616

95313

65151

25

202877

1616

0017100171

*

2 • 187

2.61.4 Explanation of the ReagentStatus Report

ASSAY

The abbreviated test name for each chemistry isprinted in this column. Only tests that are currentlyon the analyzer are listed. A question mark (?) in thiscolumn indicates parameters for this application codeare not entered.

TYPE

The reagent type: R1, R2, R3, R4, diluent, or washsolution is printed in this column. An exclamation (!)after this column indicates that fewer tests remainthan indicated in the Reagent Level Check field on theSYSTEM PARAMETERS screen. (For diluents andwash solutions less than 10 mL remains.) A questionmark (?) indicates that fewer than 10 tests remain inthe bottle. (For diluents and wash solutions, less than1 mL remains.)

POS.

This column indicates which position the reagentoccupies on the analyzer. The first number indicateswhether the reagent is located on reagent disk 1 orreagent disk 2. The second number indicates thereagent disk position number 1 - 32. An asterisk (*)following the disk position number indicates theinformation is for a manually entered reagent. Anexclamation mark (!) following the disk positionnumber indicates that a manually entered reagentwas programmed to a position containing a full bar-coded reagent. A question mark (?) following the diskposition number indicates that a bottle has beenplaced on the wrong disk.

TESTS

This column lists the number of tests remaining foreach reagent in units of 10 tests. This number istruncated to the lowest 10. For diluents and washsolutions this number is mL remaining and is nottruncated.

SIZE

This column indicates the bottle size S (20 mL), M (50mL), or L (100 mL) for each reagent.

LOT NO.

This column lists the lot number for each reagent.

SEQ. NO.

This column indicates the bottle number for thereagent.

APP CODE

This column lists the application code for eachreagent.

EXP. WK

This column indicates the year and week the reagentexpires.

STAB

This column indicates the working reagent stability.This is the number of remaining days beforeexpiration.

2.61 Reagent Status

2. REPORTS

2 • 188

2.62 Requisition List - - WithoutBar Code Reader

2.62.1 Introduction

The Requisition List is a printout of all tests selectedfor each requested sample. This format of theRequisition List is generated only by analyzers thatoperate with the sample bar code reader turned OFF.

2.62.2 Printing the RequisitionList - - Without BarCode Reader

Press ROUTINE 3 ENTER to display the PATIENTTEST SELECTION screen. Move the cursor to thePrint field. Enter the range of sample numbers andpress ENTER to print the Requisition List.

2.62.3 Example of the RequisitionList- Without Bar Code Reader

Figure 2-78 is an example of the Requisition List - -Without Bar Code Reader.

Figure 2-78: Requisition List - - Without BarCode Reader

2.62 Requisition List - - Without Bar Code Reader

2. REPORTS

3ENTER


S.NO. POS. ID 5 10 15 20 25 30 35 40 45R001R002*R003R004R005R006R007R008R009R010R011R012R013R014

0-010-020-03*0-040-050-060-070-080-090-100-110-120-130-14

12345678901231234567890346747584372564723478098723484758943627846347839012837547589327035987082345798487455870950289309834090940783820938704745837409285047070298314904347039842798234

TEST COUNT

CHANNEL TEST QUANTITY CHANNEL TEST QUANTITY CHANNEL TEST QUANTITY

123456789

1011121314151617

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CATRIGUAALB/PTP

110

111313

813

1741

1045100

1819202122232425262728293031323334

PHOSCREATCHOLMG

1100

353637383940414243444546ISE

S.IND

NAKCl

*--**+-*-I-+--D--+-----+-----+-----+-----+-----+-----+

*--**+-*---+-----+--D--+-----+-----+-----+-----+-----+

--*-*+-*-**+--D--+-----+-----+-----+-----+-----+-----+

*-**I+-*D-*+-*I--+-----+-----+-----+-----+-----+-----+

--***+*--ID+-I***+---I-+-----+-----+-----+-----+-----+

*-***+**---+-*-I-+-----+-----+-----+-----+-----+-----+

*-***+**---+-*-D-+-----+-----+-----+-----+-----+-----+

*-***+**---+-*---+-----+-----+-----+-----+-----+-----+

*-**-+-*--D+-*-I-+-----+-----+-----+-----+-----+-----+

*-***+**-*-+-*---+-----+-----+-----+-----+-----+-----+

---**+**-I-+-*-D-+-----+-----+-----+-----+-----+-----+

*-***+-*---+-----+-----+-----+-----+-----+-----+-----+

*-***+**---+-*---+-----+-----+-----+-----+-----+-----+

*-***+**-**+**---+-----+-----+-----+-----+-----+-----+

2 • 189

2.62.4 Explanation of the RequisitionList - Without Bar Code Reader

DATE and TIME

The date and time when the report is printed appearsin the upper right corner of the report.

S. NO.

This column displays the sample number as it wasspecified on the Patient Test Selection display. Anasterisk (*) following the sample number indicates thesample is a type 2 (urine) sample.

ROUTINE: SAMPLE NO. RXXX

RXXX: 0001-800 (routine sequencenumber)

POS.

Two numbers are shown here: the sample disknumber and the sample cup position numberrespectively (as shown above). These numbers areentered on the Patient Test Selection display. Anasterisk (*) following the position number indicatesthe sample was in a micro sample cup.

D: 0-9 (disk number)PP: 01-50 (sample position number)

ID

The patient or sample identification number, amaximum of 13 alphanumeric characters, is shown inthis column as entered on the PATIENT TESTSELECTION screen.

TEST SELECTIONS ( 5 10 15 20 25 3035 40 45 )

These columns indicate the tests that are selected foreach sample number. Tests are listed by channelnumber (1-46). Channel 46 represents Na+, K+,and Cl-.

• An asterisk (*) below the channel numberindicates that the test is selected for the specifiedsample.

• A hyphen (-) indicates that the test is not selected.

• The letter I indicates that an increased samplevolume has been selected for that test.

• The letter D indicates that a decreased samplevolume has been selected for that test.

TEST COUNT

There are three columns that list the channel number,test name, and a cumulative count of the number oftimes each test is requested for the range of samplesincluded in the printout. S.IND represents serumindexes.

2.62 Requisition List - - Without Bar Code Reader

2. REPORTS

2 • 190

2.63 Requisition List - With BarCode Reader

2.63.1 Introduction

The Requisition List is a printout of all tests selectedfor each requested sample. This format of theRequisition List is generated only by analyzers thatoperate with the sample bar code reader turned on.

2.63.2 Printing the Requisition List - -With Bar Code Reader

Press ROUTINE 3 ENTER to display the PATIENTTEST SELECTION screen. Move the cursor to thePrint field. Enter the sample ID number you want tobegin the list with and press ENTER.

2.63.3 Example of the RequisitionList - - With Bar Code Reader

Figure 2-79 is an example of the Requisition List - -With Bar Code Reader.

Figure 2-79: Requisition List - - With Bar CodeReader

2.63 Requisition List - - With Bar Code Reader

2. REPORTS

3ENTER


ID 5 10 15 20 25 30 35 40 45* * 1234567890123

1234567890346747584372564723478098723484758943627846347839012837547589327035987082345798487455870950289309834090940783820938704745837409285047070298314904347039842798234

TEST COUNT

CHANNEL TEST QUANTITY CHANNEL TEST QUANTITY CHANNEL TEST QUANTITY

123456789

1011121314151617

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2CATRIGUAALB/PTP

110

111313

813

1741

1045100

1819202122232425262728293031323334

PHOSCREATCHOLMG

1100

353637383940414243444546ISE

S.IND

NAKCL

*--**+-*-I-+--D--+-----+-----+-----+-----+-----+-----+

*--**+-*---+-----+--D--+-----+-----+-----+-----+-----+

--*-*+-*-**+--D--+-----+-----+-----+-----+-----+-----+

*-**I+-*D-*+-*I--+-----+-----+-----+-----+-----+-----+

--***+*--ID+-I***+---I-+-----+-----+-----+-----+-----+

*-***+**---+-*-I-+-----+-----+-----+-----+-----+-----+

*-***+**---+-*-D-+-----+-----+-----+-----+-----+-----+

*-***+**---+-*---+-----+-----+-----+-----+-----+-----+

*-**-+-*--D+-*-I-+-----+-----+-----+-----+-----+-----+

*-***+**-*-+-*---+-----+-----+-----+-----+-----+-----+

---**+**-I-+-*-D-+-----+-----+-----+-----+-----+-----+

*-***+-*---+-----+-----+-----+-----+-----+-----+-----+

*-***+**---+-*---+-----+-----+-----+-----+-----+-----+

*-***+**-**+**---+-----+-----+-----+-----+-----+-----+

2 • 191

2.63.4 Explanation of the RequisitionList - - With Bar Code Reader

DATE and TIME

The date and time at which the report is printedappears in the upper right corner of the report.

ID

The identification number is a maximum of 13alphanumeric characters as entered on the PATIENTTEST SELECTION screen or downloaded from thehost computer. This number denotes the bar codenumber. Asterisks may appear to the left of the IDnumber in two columns. An asterisk in the firstcolumn indicates the sample was a type 2 (urine)sample. An asterisk in the second column indicatesa micro sample cup was used.

TEST SELECTIONS ( 5 10 15 20 25 3035 40 45 )

These columns indicate the tests that are selected foreach sample number. Tests are listed by channelnumber (1-46). Channel 47 represents Na+, K+, Cl-.An asterisk (*) below the channel number indicatesthat the test is selected for the specified sample. Ahyphen (-) indicates that the test is not selected. Theletter I indicates that an increased sample volume hasbeen selected for that test. The letter D indicates thata decreased sample volume has been selected forthat test.

TEST COUNT

There are three columns that list the channel number,test name, and a cumulative count of the number oftimes each test is requested for the range of samplesincluded in the printout. S. IND represents SerumIndexes.

2.63 Requisition List - - With Bar Code Reader

2. REPORTS

2 • 192

2.64 Calibrator Load List

2.64.1 Introduction

The Calibrator Load List gives a detailed description ofwhere to physically place standards on the sampletray.

2.64.2 Printing the Calibrator Load List

Press ROUTINE 2 ENTER to display theCALIBRATION TEST SELECTION screen. PressGUIDANCE to display the Time Out Status listing.Move the cursor to the Calibrator List field and selectthe type of Calibrator Load List you want to print andpress ENTER.

2.64.3 Example of the CalibratorLoad List

Figure 2-80 is an example of the Calibrator Load List.

Figure 2-80: Calibration Load List

2.64.4 Explanation of the CalibratorLoad List

DATE and TIME

The date and time when the report is printed appearsat the upper right corner of the report.

POS. NO.

Position of each standard on the sample disk. Thisinformation is specified on the SYSTEMPARAMETERS screen.


2. REPORTS

2ENTER

CO2KK

GLUK

CAClCl

CACl

TRIG

TRIG

UA

UA

CALIBRATOR LOAD LIST 01/06/93 14:39

POS.NO. CALIB.NAME - - - - - - - - - - - - - TEST NAME - - - - - - - - - - - - - - - - - - - - - - -[ START UP ]

SALINE CK LD AST ALT ALP/A GGT AMYL TBILI DBILIS18

S19S20S21

(I)

(I)(I)(I)

ISE-LOISE HIPCAL-79

GLUNaNa

TBILI*Na

ALB/P

ALB/P

TP

TP

PHOS

PHOS

CREA

CREA

2 • 193

CALIB.NAME

This lists the name of each calibrator as defined on theSYSTEM PARAMETERS screen.

TEST NAME

Up to 46 tests can be listed for each calibrator (exceptISEs). An asterisk (*) following the test nameindicates the test is masked.


2. REPORTS

2 • 194

2.65 Rerun List

2.65.1 Introduction

This Rerun List shows the sample and tests on thererun schedule. Tests are automatically placed onthe rerun schedule according to the parametersprogrammed for each test. The reruns may be doneautomatically or in a batch mode.

2.65.2 Printing the Rerun List

Press ROUTINE 7 ENTER to display the RERUNSAMPLES screen. Move the cursor to the Print field.Enter sample numbers for the range of samples youwant to print on the Rerun List and press ENTER.

2.65.3 Example of the Rerun List

Figure 2-81 is an example of the Rerun List.

Figure 2-81: Rerun List

2.65.4 Explanation of the Rerun List

DATE and TIME

The date and time when the report is printed appearsin the upper right corner of the report.

S. NO.

The first column represents the sample number. Thisnumber is preceded by an �R� to denote a rerun. Anasterisk (*) following this number indicates this was aurine (type 2) sample.

2.65 Rerun List

2. REPORTS

7ENTER

RERUN LIST 01/06/93 14:39

S.NO. POS. ID 5 10 15 20 25 30 35 40 45R001R002R003R004R005R007*R008*R010*R011R012R013R015

0-010-020-030-040-050-070-080-100-110-120-130-15

TEST COUNT

CHANNEL TEST COUNT CHANNEL TEST COUNT CHANNEL TEST COUNT

123456789

1011121314151617

CKLDASTALTALPGGTAMYLT.BILD.BILBUNGLUCO2CATRIGURICALBT.P.

0000000001

11000111

1819202122232425262728293031323334

PHOSCREATCHOLMGTst22Tst23Tst24Tst25Tst26Tst27Tst28Tst29Tst30Tst31Tst32Tst33Tst34

12000000000000000

0000000000000000

353637383940414243444546ISE

S.IND

Tst35Tst36Tst37Tst38Tst39Tst40Tst41Tst42Tst43Tst44Tst45Tst46

NAKCl

-----+-----+D---*+***--+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+

-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+-----+-----+---*-+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+----*+D----+---*-+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+-----+-----+D----+-----+-----+-----+-----+-----+-----+

2 • 195

POS.

Two numbers are shown here: the sample disknumber (0-9) and the sample position number,respectively. These numbers correspond to thoseentered on the PATIENT TEST SELECTION screen.An asterisk (*) following this number indicates thissample was in a micro cup.

ID

This is the sample identification number, a maximumof 13 alphanumeric characters, which is entered onthe PATIENT TEST SELECTION screen. The IDrepresents the bar code number for those instrumentsusing the bar code reader accessory.

TEST SELECTIONS ( 5 10 15 20 25 3035 40 45 )

These columns indicate the tests that are selected foreach sample number rerun. Tests are listed bychannel number (1-46). Channel 46 represents Na+,K+, and Cl-. An asterisk (*) below the channel numberindicates that the test is selected for rerun. A hyphen(-) indicates that the test is not selected for rerun. Theletter I indicates that an increased sample volume hasbeen selected for that rerun. The letter D indicatesthat a decreased sample volume has been selectedfor that rerun.

TEST COUNT

There are three columns that list the channel number,test name, and a cumulative count of the number oftimes each test is requested for the range of samplesincluded in the printout.

2.65 Rerun List

2. REPORTS

2 • 196

2.66 Calibration Monitor

2.66.1 Introduction

The Boehringer Mannheim/Hitachi 911 Analyzerautomatically issues a Calibration Monitor reportduring calibration when a printout is requested in theCalibration Print field on the START CONDITIONSscreen. This report shows the results of the latestcalibrations, including the ISE calibration.

2.66.2 Printing the Calibration MonitorReport

Press ROUTINE 4 ENTER to display the STARTCONDITIONS screen. Move the cursor to theCalibration Print field and press 1 ENTER to requestthat a real time Calibration Monitor report printsfollowing calibration.

2.66.3 Example of the CalibrationMonitor Report

Figure 2-82 is an example of the Calibration Monitorreport.

Figure 2-82: Calibration Monitor Report

2.66.4 Explanation of the CalibrationMonitor Report

DATE and TIME

The date and time at which the report is printedappears at the upper right corner of the report.

ISE Calibration Information

TEST

This column lists the name of each ISE test.


2. REPORTS

4ENTER

CALIBRATION MONITOR 01/06/93 14:39

CH TEST ---- S1 ---- ---- S2 ---- ---- S3 ---- ---- S4 ---- ---- S5 ---- ---- S6 ----

TEST IS. EMF S1 EMF S2 EMF S3 EMF SLOPE IS.CONC. S3 CONC. C.VALUE

10

20

13

19

1740517323

91049168

11841174

BUN

CHOL

CA

CALIBCREA

Na

K

Cl

-32.6

-37.3

-131.1

-36.8

-51.1

136.7

-29.3

-29.3

128.3

-23.2

-39.3

131.9

60.0

59.2

-47.7

141

5.1

105

138

4.7

101

-2

0.0

0

-17-20

287285

32843288

87

1759917532

287306

37143891

437438

-898-891

95499563

209206

2 • 197

IS. EMF

This column lists the electromotive force (EMF) orelectrical potential generated by the internalreference solution at the specified electrolytecartridge. The value printed is in millivolts (mV).

S1 EMF

This column lists the electrical potential (mV)generated by the LOW standard at the specifiedelectrolyte cartridge.

S2 EMF

This column lists the electrical potential (mV)generated by the HIGH standard at the specifiedelectrolyte cartridge.

S3 EMF

This column lists the electrical potential (mV)generated by the calibrator/compensator at thespecified electrolyte cartridge.

SLOPE

This column lists the sensitivity of the specifiedelectrolyte cartridge. The slope should graduallydecrease with time, reflecting the aging ofthe cartridge.

When the slope falls outside of the optimal sloperange values as presented below, an ISE SLOPEwarning is issued. The SLOPE warning is issued if theslope falls between the optimal and critical ranges.

When a SLOPE warning is seen, check the controlvalues. If the controls are within range, continueoperation until the next convenient time to replace thecartridge.

When an ISE SLOPE ERROR:REPLACECARTRIDE alarm is seen, replace the cartridgeimmediately and recalibrate.

IS CONC.

This column lists the measured concentration of theinternal reference solution (mmol/L) determinedduring calibration.

S3 CONC.

This column lists the measured concentration of thecalibrator/compensator determined duringcalibration.

C. VALUE

This column lists the compensation factor (mmol/L)determined during calibration. This factor is thedifference between the measured concentration ofSTD 3 and the actual value of STD 3. This value isadded to all measured control and patient values.


2. REPORTS

CARTRIDGE OPTIMALISE

SLOPEISE

PREPARE

CRITICALISE

SLOPE

Sodium 38.0 to68.0

> 32 < 38 32.0

Potassium 38.0 to68.0

> 32 < 38 32.0

Chloride -30.0 to-68.0

>-25 <-30 -25.0

≤

≤

≥

2 • 198

Photometric Chemistry Calibration Information

CH

The channel number is listed in the left column.Calibration data are printed in order of channel number.

TEST

The short test name (specified on the CHEMISTRYPARAMETERS screen) is printed to the right of thechannel number.

S1 through S6

Standard levels 1-6 are represented in separatecolumns across the page.

RESULTS

Duplicate absorbance measurement values areprinted, one below the other. Further information onassay type and calibration method can be found inChapter 5, Theory.

DATA ALARMS

Any data alarm that affects an entire test is printed tworows below the test name. Some alarms include: SDLIM, CAL?, and CALIB. See Section 4.5, DataAlarms, for information about these alarms.

Data alarms that affect individual standardmeasurements are printed below the absorbance forthe affected standard. When data alarms occur forboth measurements, the alarm for the first is listed.


2. REPORTS

2 • 199

2.67 Individual QC Monitor

2.67.1 Introduction

The Individual QC Monitor report lists the control datasummary for a specified test and control level. Usethe INDIVIDUAL QC MONITOR screen to select thetest and control level for which you wish to obtain aprintout.

2.67.2 Printing the Individual QCMonitor Report

Press QC 2 ENTER to display the INDIVIDUAL QCMONITOR screen. Move the cursor to the Print field.Select 1 ENTER to print all Individual QC Monitorreports or 2 ENTER to print only non-accumulatedreports.

2.67.3 Example of the Individual QCMonitor Report

Figure 2-83 is an example of the Individual QC MonitorReport.

Figure 2-83: Individual QC Monitor Report

2.67.4 Explanation of the Individual QCMonitor Report

DATE and TIME

The date and time this report was printed appears inthe upper right hand corner of the report.

CONTROL

This is the name of the selected control as specifiedfrom the CONTROL VALUE SETTING screen.

TARGET MEAN

This is the target mean for the selected test andcontrol level that is specified on the CONTROLVALUE SETTING screen.


2. REPORTS

2ENTER

INDIVIDUAL QC MONITOR 01/06/93 14:39

CONTROLCLASSTEST

PTA-156SERUMGLU

TARGETTARGET

MEANSD

30610.0

S.NO. DATE TIME RESULT DEVIATION %ERROR210209208205204202201

27-103

-131

01 / 0601 / 0601 / 0601 / 0601 / 0601 / 0601 / 06

8.82-0.330.000.98

-0.330.980.33

7 : 547 : 527 : 467 : 367 : 327 : 207 : 13

333#305306309305309307

*

2 • 200

S. TYPE

This is the sample type specified on the CONTROLVALUE SETTING screen for the selected test andcontrol level.

TARGET SD

This is the target SD specified for the selected testand control level on the CONTROL VALUE SETTINGscreen.

TEST

This is the short test name specified in theCHEMISTRY PARAMETERS screen for the selectedtest.

S.NO.

This column lists the sample number for each run ofthe selected control level on the selected test.

DATE

This column gives the dates each control run wascompleted for the specified test.

TIME

This column gives the time each control run wascompleted for the specified test.

RESULT

This column gives the result of each control run for thespecified test.

DEVIATION

This column gives the deviation from the mean foreach control run. An asterisk (*) following this numberindicates it is > 2SD from the mean.

%ERROR

This column gives the percent error for each controlrun.


2. REPORTS

2 • 201

2.68 Individual QC List

2.68.1 Introduction

The Individual QC List gives the calculated statisticsfor a specified control level for all tests. Use theINDIVIDUAL QC LIST screen to specify the controllevel for which you want to print the report.

2.68.2 Printing the Individual QC ListReport

Press QC 3 ENTER to display the INDIVIDUAL QCLIST screen. Move the cursor to the Print field. Press1 ENTER to print the Individual QC List report.

2.68.3 Example of the Individual QCList Report

Figure 2-84 is an example of the Individual QC Listreport.

Figure 2-84: Individual QC List Report

2.68.4 Explanation of the Individual QCList Report

DATE and TIME

The date and time the report was printed appears in theupper right hand corner of the report.

CONTROL

This gives the name of the control as specified in theCONTROL VALUE SETTING screen.

S. TYPE

This gives the sample type specified from theCONTROL VALUE SETTING screen.


2. REPORTS

3ENTER

INDIVIDUAL QC LIST 01/06/93 14:39

CONTROL PTA-156 CLASS SERUM

CH TEST N MEAN 2 SD LIMITS SD CV(%) RANGECKASTALTBUNGLUCATRIGUAALB/GTPPHOSCREACHOLNaKCl

134

10111314151617181920474849l

2333333333333333

591.0132.0139.066.83305.313.00220.37.103.035.008.336.57

139.0138.173.54798.83

587.0121.0134.062.80286.012.0

197.06.3

2.804.707.3

6.16129.0126.53.1190.6

785.0159.0170.071.80326.013.6

245.07.9

3.405.308.9

7.16143.0138.93.71

102.6

----------------

0.470.760.720.480.200.770.680.001.980.000.720.910.721.351.441.11

2.81.01.0

0.320.6

0.101.5

0.000.060.000.060.061.0

1.860.0511.10

422

0.61

0.23

0.00.10.00.10.1

23.6

0.102.2

2 • 202

CHThis column lists the channel number for each test.

TEST

This gives the short test name specified in theCHEMISTRY PARAMETERS screen.

N

This column gives the number of times the control wasrun for each test.

MEAN

This column lists the calculated mean for the set ofindividual control values for each test.

2 SD LIMITS

This column lists the target ± 2 SD limit range asspecified on CONTROL VALUE SETTING.

SD

This column lists the calculated SD value for the set ofindividual control values for each test.

CV%

This column lists the calculated percent CV for the setof individual control values for each test.

RANGE

This column lists the difference between the highestand lowest control values for the set of individualcontrol values for each test.


2. REPORTS

2 • 203

2.69 Cumulative QC Monitor

2.69.1 Introduction

The Cumulative QC Monitor report lists theaccumulated control data summary for a specificcontrol level and specific test. Select the control leveland test for which you want the report to print from theCUMULATIVE QC MONITOR screen.

2.69.2 Printing the Cumulative QCMonitor Report

Press QC 5 ENTER to display the CUMULATIVE QCMONITOR screen. Move the cursor to the Print field.Press 1 ENTER to print the Cumulative QC Monitorreport.

2.69.3 Example of the Cumulative QCMonitor Report

Figure 2-85 is an example of the Cumulative QCMonitor report.

Figure 2-85: Cumulative QC Monitor Report

2.69.4 Explanation of the CumulativeQC Monitor Report

DATE and TIME

The date and time the report was printed appears inthe upper right hand corner of the report.

CONTROL

This gives the name of the control as specified on theCONTROL VALUE SETTING screen.

TARGET MEAN

This lists the target mean for the control that isspecified in the CONTROL VALUE SETTING screen.


2. REPORTS

5ENTER

INDIVIDUAL QC MONITOR 01/06/93 14:39

CONTROLCLASSTEST

PTA-156SERUMGLU

TARGETTARGET

MEANSD

30610.0

NO. DATE TIME RESULT N RANGE DEVIATION %ERROR123456789

101112

104050020123

-1311

-2-1-5-81301

01/0601/0601/0601/0601/0501/0501/0401/0401/0401/0301/0301/03

-0.230.980.330.33

-0.65-0.33-1.63-2.610.330.820.000.16

8:228:388:421:23

15:238:12

22:0013:318:55

15:1014:3713:11

305.3309.0307.0307.0304.0305.0301.0298.0307.0308.5306.0306.5

313131122222

2 • 204

S. TYPE

This gives the sample type specified in the CONTROLVALUE SETTING screen.

TARGET SD

This lists the target SD specified from the CONTROLVALUE SETTING screen.

TEST


NO.

This column lists the number for each accumulatedset of data. This may not exceed 31.

DATE

This column gives the dates each set of data wasaccumulated.

TIME

This column gives the time each set of data wasaccumulated.

RESULT

This column gives the mean result of eachaccumulated set of data. If M-R was chosen onSYSTEM PARAMETERS, this is the mean value. If X-R was chosen, this may be an individual result.

N

This column gives the number of control runs in eachaccumulated set of data.

RANGE

This column gives the difference between the highestand lowest control values in the group of accumulateddata.

DEVIATION

This column gives the standard deviation from themean for each accumulated set of data. An asterisk(*) following this number indicates it is > 2SD from themean.

%ERROR

This column gives the percent error for eachaccumulated set of data.


2. REPORTS

2 • 205

2.70 Cumulative QC List

2.70.1 Introduction

The Cumulative QC List report lists the accumulatedcalculated statistics for all tests for a specified controllevel. Specify the control level for which you want toprint accumulated data from the CUMULATIVE QCLIST screen.

2.70.2 Printing the Cumulative QCList Report

Press QC 6 ENTER to display the CUMULATIVE QCLIST screen. Move the cursor to the Print field. Press1 ENTER to print the Cumulative QC List report.

2.70.3 Example of the Cumulative QCList Report

Figure 2-86 is an example of the Cumulative QC Listreport.

Figure 2-86: Cumulative QC List Report

2.70.4 Explanation of the CumulativeQC List Report

DATE and TIME

The date and time the report was printed appears in theupper right hand corner of the report.

CONTROL

This gives the name of the control as specified from theCONTROL VALUE SETTING screen.

S. TYPE

This gives the sample type specified in the CONTROLVALUE SETTING screen.


2. REPORTS

6ENTER

CUMULATIVE QC LIST 01/06/93 14:39

CONTROL PTA-156 CLASS SERUM

CH TEST N MEAN 2 SD LIMITS SD CV(%)CKASTALTBUNGLUCATRIGUAALB/GTPPHOSCREACHOLNaKCl

134

10111314151617181920474849l

2333333333333333

591.0132.0139.066.83305.313.00220.37.103.035.008.336.57

139.0138.173.54798.83

587.0121.0134.062.80286.012.0

197.06.3

2.804.707.3

6.16129.0126.53.1190.6

785.0159.0170.071.80326.013.6

245.07.9

3.405.308.9

7.16143.0138.93.71

102.6

----------------

0.470.760.720.480.200.770.680.001.980.000.720.910.721.351.441.11

2.81.01.0

0.320.6

0.101.5

0.000.060.000.060.061.0

1.860.0511.10

2 • 206

CH

This column lists the channel number for each test.

TEST


N

This column gives the number of times the control wasrun for each test.

MEAN

This column lists the calculated mean for the set ofaccumulated control values for each test.

2 SD LIMITS

This column lists the target ± 2 SD limit range for eachtest as specified on the CONTROL VALUESETTINGS screen.

SD

This column lists the calculated SD value for the set ofaccumulated control values for each test.

CV%

This column lists the calculated percent CV for the setof accumulated control values for each test.


2. REPORTS

2 • 207

2.71 Reaction Monitor

2.71.1 Introduction

The Reaction Monitor report lists all of the absorbancedata for a specific test performed on a specific sample.Specify the sample number and test on theREACTION MONITOR screen. Press the COPY keyto obtain a copy of the reaction graph.

2.71.2 Printing the Reaction MonitorReport

Press MONITOR 1 ENTER to display the REACTIONMONITOR screen. Move the cursor to the Print fieldand press 1 ENTER to request the Reaction Monitorreport.

2.71.3 Example of the ReactionMonitor Report

Figure 2-87 is an example of the Reaction Monitorreport.

Figure 2-87: Reaction Monitor

2.71.4 Explanation of the ReactionMonitor Report

DATE and TIME

The date and time at which the report was printedappears in the upper right corner of the report.


2. REPORTS

1ENTER

REACTION MONITOR 01/06/93 14:39

S.NO. R001 0-01 CELL 011 (LD 425 )

CB1-4 1-5 6-10 11-15 16-20 21-25 26-30 31-35 36-40 41-45 46-49382290273260252

204244239234231231

226223223220219

216215212210208

208206206204701

789850906958

1011

1059

2 • 208

SAMPLE NUMBER

The sample number consists of a sequence number,disk number, and sample position number. Thisinformation is specified on the Patient TestSelection screen for instruments not using a bar codereader, or assigned automatically by the instrumentcomputer for instruments that are using a bar codereader. The range of each number is specific to thetype of sample:

ROUTINE: SAMPLE NO. RXX D-PPR: (routine)XXX: 001-800 (routine sequence number)D: 0-9 (disk number)PP: 01-50 (sample position number)

ROUTINE RERUN: SAMPLE NO. RRXXX-DPPRR (routine rerun)XXX: 001-800 (routine sequence number)D: 0-9 (disk number)PP: 1-50 (sample position number)

STAT: SAMPLE NO. EXXX-DPPE: (stat)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number

without BCR )PP: 1-50 (sample position number

with BCR+ 51-70 for samples without

Barcodelabel)

STAT RERUN: SAMPLE NO. ERXXX-DPPER: (stat rerun)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number

without BCR)PP: 1-50 (sample position number


Barcodelabel)

CONTROL: SAMPLE NO. CXYYC: (control)X: 1-8 (control level)YY: 01-30 (control sequence number)

CALIBRATOR: SAMPLE NO. SXYS: (calibrator)X: 1-6 (standard number)Y: 1-2 (first or second of duplicate

sampling)

CELL NO.

This number indicates which reaction cell containedthe chemical reaction whose results are displayed onthe report.

TEST 1 NAME AND RESULTS

The test name and calculated results appear inparentheses to the right of the cell number. If a dataflag exists, it appears to the right of the numeric result.


If a second test was run within the same cell, the testname and results (as well as any existing data flags)appear in parentheses to the right of the first testname and results.

ID NO.

This field is used only by instruments using a bar codereader. The patient ID NO. denotes the bar codenumber and appears immediately below the samplenumber.


2. REPORTS

2 • 209

ABSORBANCE DATA

Absorbance data points are printed in 11 columnsbelow the ID NO. The first line gives the cycle numberduring which the readings occurred. The first columncontains the cell blank readings (primary minussecondary wavelengths); the other 10 columnscontain the reaction absorbances (primary minussecondary wavelengths) obtained with each passthrough the photometer read window.


2. REPORTS

2 • 210

2.72 Patient Reports - - ReportFormat

2.72.1 Introduction

Patient Reports list all of the results for the testsrequested on each sample. The Patient Reports canbe printed in one of two formats. The report or longformat includes demographic information as well asthe tests results. This section explains the reportformat.

2.72.2 Printing the Patient Report - -Report Format

Press ROUTINE 4 ENTER to display the STARTCONDITIONS screen. Move the cursor to the PrintFormat field. Press 1 ENTER to print real time reportsin the report format. Press 0 ENTER to cancel realtime report printing.

Press ROUTINE 6 ENTER to display the DATAREVIEW screen. Move the cursor to the Data Printfield to request batch printing of patient reports.Choose the report format, and whether you wish toprint all reports or only edited reports. Input the rangeof sample numbers for which you wish to print reportsand press ENTER.

2.72.3 Example of the Patient Report --

Report Format

Figure 2-88 is an example of the Patient Report - -Report Format.

Figure 2-88: Patient Report - - Report Format

2.72 Patient Reports - - Report Format

2. REPORTS

4ENTER

6ENTER

BOEHRINGER MANNHEIM

ID 07037 DATE 01/06/03 12:08S.NO.CLASSAGESEXDRAW DATEDRAW TIME

TEST RESULT UNITS EXPECTED VALUE REMARKSUrea NitrogenGlucoseCreatlinineNaKClBUN/CREATININE RATIO

N002-202SERUM25 Y01/06/9309:12

NAMELOCATIONPHYSICIANPATIENT IDDRAWN BY :

51.81994.4

133.44.5896.1

12

HHH

L

6-70-0.6-133-3.30-96.0-

15-

191051.1

145.05.10

108.024

mg/dLmg/dLmg/dLmmol/lmmol/lmmol/l

( )( )( )( )( )( )( )

2 • 211

2.72.4 Explanation of the PatientReport - - Report Format

TITLE

The title is specified on the Report Format display. Itcan be up to three lines.

ID

A maximum of 13 alphanumeric characters; enteredon the PATIENT TEST SELECTION screen. Thisnumber is used to indicate the bar code number if thebar code reader is being used.

DATE

The date on which the report is printed appears in theupper right corner, below the title.

SAMPLE NUMBER

The sample number consists of a sequence number,disk number, and sample position number. Thisinformation is specified on the PATIENT TESTSELECTION screen for instruments not using a barcode reader, or is assigned automatically by theinstrument computer if a bar code reader is used. Therange of each number is specific to the type ofsample:



STAT: SAMPLE NO. EXXX-DPPE: (stat)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number



Barcodelabel)

STAT RERUN: SAMPLE NO. ERXXX-DPPER: (stat rerun)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number



Barcodelabel)

CLASS, AGE, SEX, DRAW DATE and DRAW TIME

This information is displayed as entered in thePATIENT TEST SELECTION screen.

NAME, LOCATION, PHYSICIAN, PATIENT ID andDRAWN BY

This information is displayed as entered in thePATIENT TEST SELECTION screen. These fieldnames are user definable and may appear differentlyon your analyzer. The titles are defined in SYSTEMPARAMETERS.

TEST

The long test name for each chemistry is printed here.These tests names are defined in CHEMISTRYPARAMETERS.


2. REPORTS

2 • 212

RESULT

The result for each test is printed here. Decimalplacement is determined by the number format usedfor the Std (1) concentration for each test(CHEMISTRY PARAMETERS screen). Test resultsare printed in the order specified on the PRINT ORDERscreen.

UNITS

The units printed are specified on the CHEMISTRYPARAMETERS screen.

EXPECTED VALUE

Each chemistry�s range of expected values is enteredon the CHEMISTRY PARAMETERS screen. Thevalues printed pertain to the sex and age of thepatient; if these are not given, the default range isused.

REMARKS

Data alarms are printed in this column. The lateralposition of this column is specified on the REPORTFORMAT screen.

CALCULATED TESTS

If all tests involved in the calculation of a calculatedtest are run, the result of the calculated test is on theprintout. Placement of the decimal in a calculatedtest result is determined by the number format of theLOW value of its expected range (see CALCULATEDTEST screen).

COMPENSATED TESTS

If a requested test requires a compensating formula(see COMPENSATED TEST screen), and a testnecessary for that formula is not available, an asterisk(*) is printed in place of the compensated result.

An example of this printout can be requested byentering 1 in the Example Print field of the REPORTFORMAT screen.


2. REPORTS

2 • 213

2.73 Patient Reports - - ShortFormat

2.73.1 Introduction

Patient Reports list all of the results for the testsrequested on each sample. The Patient Reports canbe printed in one of two formats. The short reportformat does not include demographic information withthe tests results. This section explains the shortreport format.

2.73.2 Printing the Patient Report - -Short Format

Press ROUTINE 4 ENTER to display the STARTCONDITIONS screen. Move the cursor to the PrintFormat field. Press 2 ENTER to print real time reportsin the short format. Press 0 ENTER to cancel real timereport printing.

Press ROUTINE 6 ENTER to display the DATAREVIEW screen. Move the cursor to the Data Printfield to request batch printing of patient reports.Choose the short format, and whether you wish to printall reports or only edited reports. Enter the range ofsample numbers for which you wish to print reportsand press ENTER.

2.73.3 Example of the Patient Report --

Short Format

Figure 2-89 is an example of the Patient Report - -Short Format.

Figure 2-89: Patient Report - - Short Format

2.73 Patient Reports - - Short Format

2. REPORTS

4ENTER

6ENTER

DATA MONITOR 01/06/93 14:39

S.NO. R001 0-01 ID01 / 06 / 93 LD AST ALT BUN GLUC CO2 CREAT Na KSERUM 425H 146H 156H 67.4H 292H 17.5H 6.4H 126.9 3.41

Cl91.5

UN/CR10.5

2 • 214

2.73.4 Explanation of the PatientReport - - Short Format

DATE and TIME

The date and time of the print-out appears at the upperright corner of the report.

SAMPLE NUMBER

The sample number consists of a sequence number,disk number, and sample position number. Thisinformation is specified on the PATIENT TESTSELECTION screen for instruments not using a barcode reader, or is assigned automatically by theinstrument computer for instruments that are using abar code reader. The range of each number is specificto the type of sample as shown on the next page.



STAT: SAMPLE NO. EXXX-DPPE: (stat)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number)

STAT RERUN: SAMPLE NO. ERXXX-DPPER: (stat)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number)

ID NO.

A maximum of 13 alphanumeric characters; enteredon the PATIENT TEST SELECTION screen. Thisnumber represents the bar code number if a bar codereader is being used.

DATE

The date the sample was drawn appears to the left ofthe report.

CLASS

The class appears below the date.

RESULTS PRINTOUT

Results for several samples are printed on each page.The tests are listed in up to seven rows with as manyas nine columns available in each row. Decimalplacement in the printed result is determined by thenumber format of Std (1) concentration, specified onthe CHEMISTRY PARAMETERS screen. The orderin which test results are printed is specified on thePRINT ORDER screen.

CALCULATED TESTS

Decimal placement in a calculated test result isdetermined by the number format of the LOW value ofits expected range (see CALCULATED TESTscreen).

DATA ALARMS

H and L flags are printed to the right of the test result.Data flags print below the test results.

2.73 Patient Reports - - Short Format

2. REPORTS

2 • 215

2.74 Calibration Trace

2.74.1 Introduction

The Calibration Trace report is a printout of theabsorbance values for Standard 1 and Standards 2-6for a specified photometric test. For ISEs the millivoltvalues for the slope are printed. Choose the test forwhich you want to print standard absorbance valuesfrom the CALIBRATION TRACE screen.

2.74.2 Printing the Calibration TraceReport

Press MONITOR 2 ENTER to display theCALIBRATION TRACE screen. Move thecursor to the Print field and press 1 ENTERto print the Calibration Trace report.

2.74.3 Example of the Calibration TraceReport

Figure 2-90 is an example of the Calibration Tracereport.

Figure 2-90: Calibration Trace Report

2.74.4 Explanation of the CalibrationTrace Report

DATE and TIME

The date and time of the printout appears at the upperright corner of the report.

RESULTS

Absorbance (x104) values listed under column STD 1,and STD 2 - 6, are printed one below the other, to theright of the date measured (month/day). For non-linear tests the absorbance of the highest standard isprinted.


2. REPORTS

2ENTER

CALIBRATION TRACE 01/06/93 14:39

GLU (STD 1)2186218721842191220022152211*2220

21662167*2174*21312290214525512660

1156247712552454*2253221022582255

32423352325525332582248528442544

1556186538854557*2556388628863514

(10/01)(10/02)(10/03)(10/04)(10/05)(10/06)(10/07)(10/08)

(10/09)(10/10)(10/11)(10/12)(10/13)(10/14)(10/15)(10/16)

(10/17)(10/18)(10/19)(10/20)(10/21)(10/22)(10/23)(10/24)

(10/25)(10/26)(10/27)(10/28)(10/29)(10/30)(10/31)(11/01)

(11/02)(11/03)(11/04)(11/05)(11/06)(11/07)(11/08)(11/09)

GLU (STD 2-6)5681572956455829582956635566*5710

26562667*2194*21312560266522312990

2255213431222415*2312321537853548

125515521889*28862661364435512556

284546625645*55622558455657754886

(10/01)(10/02)(10/03)(10/04)(10/05)(10/06)(10/07)(10/08)

(10/09)(10/10)(10/11)(10/12)(10/13)(10/14)(10/15)(10/16)

(10/17)(10/18)(10/19)(10/20)(10/21)(10/22)(10/23)(10/24)

(10/25)(10/26)(10/27)(10/28)(10/29)(10/30)(10/31)(11/01)

(11/02)(11/03)(11/04)(11/05)(11/06)(11/07)(11/08)(11/09)

2 • 216

NOTEFor rate chemistries, the Calibration Trace data forSTD 1 absorbance values may appear to be differentthan the Calibration Monitor data for STD 1 becausethe Calibration Trace absorbance data is taken fromthe first photometric measurement point (sample andreagent dispensed at R1 timing) at the primarywavelength only.

DATA ALARMS

If a CALIB alarm occurs, an asterisk (*) is printed tothe right of the absorbance measurement forphotometric tests. For ISEs this indicates a failedcalibration.


2. REPORTS

2 • 217

2.75 Profiling List

2.75.1 Introduction

The Profiling List printout lists the names of eachdefined profile and the tests which are selected foreach profile.

2.75.2 Printing the Profiling List Report

Press PARAMETER 2 ENTER to display thePROFILING screen. Move the cursor to the Print fieldand press 1 ENTER to request the printout. Anasterisk (*) indicates that test will be performed as apart of the named profile.

2.75.3 Example of the Profiling ListReport

Figure 2-91 is an example of the Profiling List report.

Figure 2-91: Profiling List Report

2.75.4 Explanation of the Profiling ListReport

DATE and TIME

The date and time of the printout appears in the upperright corner.

KEY PROFILE

This lists the name of each profile and the tests thatare selected as part of each profile. An asterisk on thegrid indicates the test will be run as a part of the profile.An asterisk in front of the profile name indicates adefault profile.

2.75 Profiling List

2. REPORTS

2ENTER

PROFILING LIST 01/06/93 14:39

[KEY PROFILE] 5 10 15 20 25 30 35 40 45*A MON.

B CHEM6C CHEM7D ALL

CH TEST NAME CH TEST NAME CH TEST NAME CH TEST NAME

123456789

101112

CKLDASTALTALP/AGGTAMYLTBILIDBILIBUNGLUCO2

131415161718192021222324

CATRIGUAALB/PTPPHOSCREACHOLMG

252627282930313233343536

THEO37383940414243444546ISES.IND

REF

-----+-----+--**-+*****+-----+-----+-----+-----+-----+-*------+----*+*----+---*-+-----+-----+-----+-----+-----+-*------+----*+**---+---*-+-----+-----+-----+-----+-----+-*-*****+*****+*****+*****+-----+-----+-----+-----+*****+**-

2 • 218

CH

This column lists each channel number.

TEST NAME

This column lists the short name assigned to eachchannel.

2.75 Profiling List

2. REPORTS

2 • 219

2.76 Photometer Check

2.76.1 Introduction

The Photometer Check lists the light intensity of thephotometer. According to the light intensity,deterioration of the lamp can be identified. Both thecurrent measurement and the previous measurementare printed on the report.

2.76.2 Printing the Photometer CheckReport

Press MAINTENANCE 1 ENTER to display theANALYZER MAINTENANCE screen. Move the cursorto the Photometer Check field. Press 1 ENTER torequest a Photometer Check report. The data on thereport is given below.

A Photometer Check must be performed following areaction bath exchange. The exchange occursautomatically at power ON or can be requested via theANALYZER MAINTENANCE screen if the analyzer isnot powered OFF daily.


2. REPORTS

1ENTER

2.76.3 Example of the PhotometerCheck Report

Figure 2-92 is an example of the Photometer Checkreport.

Figure 2-92: Photometer Check Report

2.76.4 Explanation of the PhotometerCheck Report

When performing the Photometer Check, theinstrument fills two reaction cells (1 and 119) withdeionized water and rotates them through thephotometer lightpath. The absorbance of both cells isdetermined at each of the 12 available wavelengths,and their mean absorbance (at each wavelength) isprinted. "WV1 (secondary)" and "WV2 (primary)"refer to the internal processing of absorbance data bythe instrument. The results at any given wavelengthshould be similar when comparing WV1 and WV2.

DATE and TIME

The date and time of the printout appears at the upperright corner of the report.

PHOTOMETER CHECK 01/06/93 14:39

----------PREVIOUS DATA---------- ----------CURRENT DATA----------

2ND WL PRIM. WL 2ND WL PRIM. WL

340376415450480505546570600660700800

340376415450480505546570600660700800



882487038742865886198617866886348604860385998684

882487038743865786208619866786338604860385998685

889087398754866986388627866886228583857585628612

889387418756867086418628867086258585857885648614

2 • 220

RESULTS

Previous and current photometer check results areprinted under the appropriate heading. These are usedfor comparison purposes; values should increasegradually from previous to current. If a suddenincrease in values is observed, it must be investigated.If any current value exceeds 13,000, the photometerlamp must be replaced, a cell blank performed, and allchannels must be recalibrated. Factors affecting thePhotometer Check results include:

• reaction bath contents (insufficient Hitergent, dirtin bath water)

• clean reaction cells (must be replaced monthly)

• photometer lamp.


2. REPORTS

2 • 221

2.77 Cell Blank

2.77.1 Introduction

The Cell Blank report lists the absorbance of all 120reaction cells at all 12 wavelengths. Theseabsorbance readings are taken with the reaction cellsfilled with water.

A Cell Blank is performed:

• during weekly maintenance

• when reaction cells are replaced

• when the photometer window is cleaned orphotometer lamp is replaced.

2.77.2 Printing the Cell Blank Report

Press MAINTENANCE 1 ENTER to display theANALYZER MAINTENANCE screen. Move thecursor to the Cell Blank field. Press 1 ENTER torequest a Cell Blank report.

2.77.3 Example of the Cell Blank Report

Figure 2-93 is an example of the Cell Blank report.

Figure 2-93: Cell Blank

2.77 Cell Blank

2. REPORTS

1ENTER

CELL BLANK MEASUREMENTS 01/06/93 14:39

01 / 04 / 93 14 : 39 - - - - - - - - - - - - - - - -- WAVE LENGTH (NM) - - - - - - - - - - - - - - NO. 340 376 415 450 480 505 546 570 600 660 700 800

1

2

3

4

5

6

7

8

9

110

111

112

113

114

115

116

117

118

119

120

89878942

-81-31-26134-791285565278981

103-3773

926

94-31

-145-210-186-249-187-187212

-149-136-121-110-105

11136-10

6423

9121-19128

88198820-113-47-66155

-12126

-34-15-4882

-10-113-74-15221

127-107-162-199-179-223-191-183278

-155-152-137-129-132-4845-5

-36330-5345

-7142

88148943

-84-47-60162

-1058

-47-19-3678

-26-97-61-24300

-29-71

-137-158-150-178-157-150292

-131-126-115-105-113-453426

-21300-4844

-5829

87198713

-73-48-53187

-1003

-53-16-4084

-31-82-48-24216

-34-65

-123-137-137-149-144-134330

-113-113-105-90

-107-402448-8

297-4448

-5326

86858679

-66-53-52204-97

0-60-13-4790

-39-74-40-29225

-40-52

-113-123-129-129-134-121355

-103-107-99-81

-100-391661-2

288-4247

-4819

86598654

-48-58-45215-90-6

-66-10-4892

-50-66-29-32229

215-42

-100-100-116-99

-118-105391-87-92-89-63-89-34

8788

276-3650

-3918

87078793

-44-57-45213-87-8

-63-11-4795

-50-60-27-36225

200-39-92-90

-107-89

-110-97394-81-82-81-57-82-31

68110

270-3445

-3711

86418650

-39-57-45225-84-11-66-13-5099

-55-55-26-39239

218-36-87-82

-100-79

-102-89409-74-78-76-52-79-32

28710

260-3642

-365

85858456

-16-61-39239-82-18-78-5

-5794

-68-42-8

-42242

241-19-74-57-92-45-89-74449-61-65-66-34-74-27-8

10829

250-2448

-24-3

85608679

-15-63-39244-78-23-79-6

-5899

-69-40-8

-44243

239-18-71-50-86-32-82-66462-57-60-60-26-71-27-1111331

242-2442

-24-8

84918456

-16-53-37239-68-21-68-8

-52107-60-37-13-42229

208-21-65-47-73-34-71-61438-48-53-52-26-61-26-8

10823

237-2431

-24-10

84768432

-13-50-34242-65-23-66-8

-50115-63-32-13-45227

202-19-61-40-66-27-63-57446-44-48-48-23-57-24-1010719

231-2426

-24-15

2 • 222

2.77.4 Explanation of the Cell BlankReport

DATE and TIME

The date and time of the printout appears in the upperright corner of the report.

RESULTS

Absorbance (x104) of the first reaction cell at 12wavelengths is printed. Data for subsequent reactioncells are computed as changes in absorbance,compared with the first reaction cell. This informationis automatically written to CRAM after completion ofall 120 cell blanks.

If any data from reaction cells 2 - 120 exceed + 800,refer to Chapter 3 for proper corrective procedures.Data for reaction cell 2 must be < 13,000.

2.77 Cell Blank

2. REPORTS

2 • 223

2.78 Bar Code Reader Check

2.78.1 Introduction

The Bar Code Reader Check report prints out the barcode numbers read by each of the reagent bar codereaders and the sample bar code reader.

2.78.2 Printing the Bar Cod ReaderCheck Report

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe Bar Code Reader Check field. Enter the numberbar codes to be read and press ENTER.

2.78.3 Example of the Bar Code Reader Check Report

Figure 2-94 is an example of the Bar Code ReaderCheck report.

Figure 2-94: Bar Code Reader Check

2.78.4 Explanation of the Bar CodeReader Check Report

DATE and TIME


DISK

This line identifies which bar code reader the datarefers to: reagent disk 1, reagent disk 2, or sampledisk.


2. REPORTS

2ENTER

BARCODE READER CHECK 01/06/93 14:39

R.DISK1POS.NO.------ ID ------

R.DISK2POS.NO.------ ID ------

S.DISKPOS.NO.--- ID ---

010203040506070809101112131415161718192021222324252627282930

010203040506070809101112131415161718192021222324252627282930

010203040506070809101112131415161718192021222324252627282930

059051983006715243

311049902004839323

095051982009963624077048797003627583

160051981012076683053051984014854344040051443036281274

155048801005642003

072051994006296683

158048806006382003

013048835000969203

115051985006134344160051981030056683018048795007674343133052153010555964

160051981009336003

115051985005523664

013048835005669233

077070149005955274095051982011012934

059051983003144373053051984004034364

160051981009476003

155048801002672033

133048802002297613

036046444000101333

018048795000204403

11224059882

1028700162210802163424050

5436187161250800102

3652507210322

1131059901

128421726

960116142115380707512317070291796414606

7262320603268518019

2 • 224

RESULTS

The position number is listed in the POS. NO. column.The ID No. is listed in the ID column, and representsthe bar code number. An asterisk (*) displayed in frontof the POS. NO. column indicates that the instrumentfailed to read the bar code.


2. REPORTS

2 • 225

2.79 ISE Check

2.79.1 Introduction

The ISE Check Report is a printout of the EMFs ofthe internal reference solution, measured for Na+,K+ and Cl-. The replicates should be within ± 2.0mV. The EMF of KCl measured through thereference cartridge is also printed. The replicatesshould be within ± 0.3 mV.

2.79.2 Printing the ISE Check Report

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe ISE Check field. Input the number of repetitionsand press ENTER.

2.79.3 Example of the ISE Check Report

Figure 2-95 is an example of the ISE Check report.

Figure 2-95: ISE Check Report

2.79.4 Explanation of the ISE CheckReport

NO.

This column lists the number of replicates performedduring the ISE check.

NA EMF

This column lists the EMF for Na+ for each ISE checkperformed. The number should fall within the range of-90 to -10 mV.

2.79 ISE Check

2. REPORTS

2ENTER

ISE CHECK 01/06/93 14:39

NO. NA EMF K EMF CL EMF REF EMF123456789

1011121314151617181920

0.80.80.70.80.80.90.90.80.80.80.90.70.60.80.70.90.80.80.60.6

-36.1-36.2-36.2-36.2-36.2-36.2-36.3-36.2-36.3-36.2-36.2-36.2-36.3-36.3-36.2-36.2-36.2-36.2-36.2-36.2

-35.5-35.6-35.7-35.7-35.8-35.8-35.8-35.8-35.9-35.8-35.9-35.9-36.0-36.0-36.0-36.0-36.0-36.0-36.0-36.1

116.9116.9116.9117.0117.0117.0117.0117.1117.1117.0117.1117.1117.1117.1117.2117.2117.2117.2117.2117.2

2 • 226

K EMF

This column lists the EMF for K+ for each ISE checkperformed. The number should fall within the range of-90 to -10 mV.

CL EMF

This column lists the EMF for Cl- for each ISE checkperformed. The number should fall within the range of80 to 160 mV.

REF EMF

This column lists the EMF for the reference cartridgefor each ISE check performed.

2.79 ISE Check

2. REPORTS

2 • 227

2.80 Printer Check

2.80.1 Introduction

The Printer Check is a diagnostic procedure that isperformed to verify that the instrument can send a fullpage of characters to the printer, and that the printercan print them.

2.80.2 Printing the Printer Check Report

Press MAINTENANCE 2 ENTER to display theMECHANISM CHECK screen. Move the cursor to thePrinter Check field. Press 1 ENTER to initiate aprinter check.

2.80.3 Example of the Printer CheckReport

Figure 2-96 is an example of the Printer Check report.

Figure 2-96: Printer Check Report

2.80.4 Explanation of the Printer CheckReport

The report prints out one line of each character toensure the printer is functioning properly.

2.80 Printer Check

2. REPORTS

1ENTER

PRINTER CHECK 01/06/93 14:39

!"#$%&’()*+’-./012345CDEFGHIJKLMNOPQRSTUVWXYZ[]^






































2 • 228

2.81 Daily Alarm Trace

2.81.1 Introduction

The Daily Alarm Trace contains information aboutalarms stored in CRAM. The last 200 alarms can bestored.

2.81.2 Printing the Daily Alarm TraceReport

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe Alarm Log field. Press 1 ENTER to choose thedaily alarm trace. Press 1 ENTER to begin printing thealarm log.

2.81.3 Example of the Daily AlarmTrace Report

Figure 2-97 is an example of the Daily Alarm Tracereport.

Figure 2-97: Daily Alarm Trace Report

2.81.4 Explanation of the Daily AlarmTrace Report

DATE and TIME


ALARM DATE and TIME

The date and time (on the OPERATION MONITORscreen) when the alarm occurred.

2.81 Daily Alarm Trace

2. REPORTS

1ENTER

DAILY ALARM TRACE 01/06/93 14:39

01 / 0501 / 0501 / 0501 / 0501 / 05

10 : 4309 : 5709 : 4708 : 3308 : 28

4437

10

11111

AARRR

051-010-015040-001-070001-002-000052-001-000050-001-000

timingalarm code or retry frequencyalarm class or retry codealarm or retryfrequencyanalyzer statusalarm timealarm date

2 • 229

ANALYZER STATUS

This code represents the status of the instrumentwhen the alarm occurred. The code assignments areas follows:

STATUS # ANALYZER STATUS

1 INITIAL2 STAND-BY3 RESET (prior to Operate)4 OPERATE5 E. STOP6 PHOTOMETER CHECK7 WASH (ALL)8 WASH (CELLS)9 WASH (ISE)10 AIR PURGE11 ISE PRIME (START UP)12 ISE PRIME (IS,DIL)13 ISE PRIME (KCL)14 INC. BATH EXCHANGE15 CELL BLANK16 RESET (Maintenance display)17 PROBE ADJUST18 SAMPLING MECHA.

(Maintenance display)19 DISK20 REAGENT 1 PIPETTING21 REAGENT 2 PIPETTING22 STIRRER (Maintenance display)23 BAR CODE READER

FREQUENCY

Represents the number of successive cycles duringwhich each alarm has occurred since power up.

ALARM OR RETRY

The letter "A" indicates an instrument alarm. Theletter "R" indicates a retry code. Retry codesdocument analyzer functions as monitored by theCPU. Not all retry codes indicate an abnormality.Retry codes are intended for service use only and arenot listed in this manual.

ALARM CLASS

This number, for "A" type alarms, is the same as thealarm class in the instrument alarms table, found inChapter 4.

RETRY CODE

The identification code of the retry (for service useonly).

ALARM CODE

This number is the same as the alarm code in theinstrument alarms table.

RETRY FREQUENCY

The frequency with which the specified retry hasoccurred (for service use only).

TIMING

This represents the time (within a mechanical cycle)at which the alarm occurred. Range: 1-200. Units ofmeasurement: 100 msec.

Up to eight alarms or retries can be listed for eachcycle. If more than eight are encountered, the overflowis not printed here, but will appear on the cumulativealarm log.

2.81 Daily Alarm Check

2. REPORTS

2 • 230

2.82 Cumulative Alarm Trace

2.82.1 Introduction

The Cumulative Alarm Trace report includes allinstrument alarms that have occurred during the mostrecent 256 days. One day is determined as the periodof time from power up to power down.

Alarm or retry information is printed on this display. Aretry occurs when the instrument senses an apparentalarm condition, then rechecks, or "retries", thesensor several times before issuing an alarm.

2.82.2 Printing the Cumulative AlarmTrace Report

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe Alarm Log field. Press 2 ENTER to choose theCumulative Alarm Trace. Press 1 ENTER to print theCumulative Alarm Trace report.

2.82.3 Example of the CumulativeAlarm Trace Report

Figure 2-98 is an example of the Cumulative AlarmTrace.

Figure 2-98: Cumulative Alarm Trace Report

2.82.4 Explanation of the CumulativeAlarm Trace Report

DATE and TIME


DATE

The date on which the alarm occurred appears in thefar left column.


2. REPORTS

1ENTER

LOG OUT (CUMULATIVE) 01/28/93 14:39

28 / 01 / 89 08 : 09 10 : 04 A 040-001-001 051-010-001

27 / 01 / 89 08 : 02 16 : 08 A 021-003-002 040-001-005 051-019-001 101-002-015

24 / 01 / 89 00 : 00 17 : 17 A 012-001-255 040-001-005 101-002-017 021-003-003

23 / 01 / 89 08 : 26 16 : 49 A 082-007-001 040-001-010 051-007-001 050-006-00’

22 / 01 / 89 13 : 49 16 : 56 A 040-001-005 050-006-002 021-003-006 051-006-002

R 050-001

R 051-001

R 027-012

R 050-001

021-019-001

051-002-001

051-006-001

046-001

041-004

027-003

052-001

055-002

054-001

052-001

012-001-003

051-002-001

027-005

129-001

054-001

041-001

050-001

052-001042-001

041-011

041-006

050-001

046-002

041-001

012-001-107

datepower up timelast alarm timealarm or retryretry coderetry frequency

alarm classalarm codealarm frequency

2 • 231

POWER UP TIME

The time at which the instrument is powered up,determined by the real time clock. If the instrument ispowered up continuously, the end of the day isdetermined by the real time clock.

LAST ALARM TIME

The time at which the last alarm occurred, determinedby the real time clock.

ALARM OR RETRY

The letter "A" indicates an instrument alarm. Theletter "R" indicates a retry code. Retry codesdocument analyzer functions as monitored by theCPU. Not all retry codes indicate an abnormality.Retry codes are intended for service use only and arenot listed in this manual.

RETRY CODE

The identification code of the retry (for service useonly).

RETRY FREQUENCY

The frequency with which the specified retry hasoccurred (for service use only).

ALARM CLASS

This number is the same as the alarm code in theinstrument alarms table, Chapter 4.

ALARM CODE

This number is the same as the alarm code in theinstrument alarms table, Chapter 4.

ALARM FREQUENCY

This number represents the number of successivecycles during which this alarm has occurred sincepower-up.

Up to 20 alarms (A) and 20 retries (R) for each of 256days are stored in the cumulative alarm file.


2. REPORTS

2 • 232

2.83 Host Communication Log

2.83.1 Introduction

A trace of information flow between the instrument anda host computer is printed. This feature is usually foruse by Service Representative.

2.83.2 Printing the Host CommunicationLog

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe Host Communication Log field and press 1ENTER to print the report.

2.83.3 Example of the HostCommunication Log Report

Figure 2-99 is an example of the Host CommunicationLog.

Figure 2-99: Host Communication Log

2.83.4 Explanation of the HostCommunication Log Report

For information concerning interpretation of this report,contact Customer Technical Support.

2.83 Host Communication Log

2. REPORTS

1ENTER

SYSTEM COMMUNICATION TRACE01/06/93 14:39

10:04:17-10:04:17 HOST->AU;A 398748 CODE12800398 23311016911212

10:04:16-10:04:17 AU->HOST>ETX

10:04:16-10:04:16 HOST->AU;A 397747 CODE12800397 23311016911212

10:04:15-10:04:16 AU->HOST

ETX

10:04:15-10:04:15 HOST->AU;A 396746 CODE12800396 23311016911212

10:04:14-10:04:15 AU->HOST

ETX

10:04:14-10:04:14 HOST->AU;A 395745 CODE12800395 23311016911212

10:04:13-10:04:14 AU->HOST

ETX

10:04:13-10:04:13 HOST->AU;A 394744 CODE12800394 23311016911212

10:04:12-10:04:13 AU->HOST

ETX

10:04:12-10:04:12 HOST->AU;A 393743 CODE12800393 23311016911212

10:04 10:04:12 AU->HOST>ETX

10:04 10:04:11 HOST->AU;A 392742 CODE12800392 23311016911212

10:04:10-10:04:11 AU->HOST

ETX

10:04:10-10:04:10 HOST->AU;A 391741 CODE12800391 23311016911212

10:04:09-10:04:10 AU->HOST

2 • 233

2.84 Floppy Disk Check

2.84.1 Introduction

The Floppy Disk Utility report includes the version andrevision numbers of each disk, and the checks of eachfile on the disk. This report is performed by, or at therequest of, a Boehringer Mannheim representativewhile the instrument is in Stand-by.

2.84.2 Printing the Floppy Disk CheckReport

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe Program Check field and choose the drive youwant to check.

2.84.3 Example of the Floppy DiskCheck Report

Figure 2-100, shown on the next page, is an exampleof the FD Utility Check report.

2.84.4 Explanation of the FloppyDisk Check Report

Figure 2-100: Floppy Disk Check Report

2.84 Floppy Disk Check

2. REPORTS

1ENTER

FD CHECK 06/06/93 14:39

[SYSTEM DISK] FILE NO. FILE NAME SUM (HEX) REV.NO.7076020-04-11

06/26/930000000000

[TOTAL SUM]75BA

123456789

1011121314151617181920212223242526272829303132333435363738

CHEMPFCALIBDFPARAMDFCNTMSDDFCOMMONPFCNTCMNPFCNTL1PFCNTL2PFTMPADCPFTSTSKPFSYSIFMPFSYSIFSPFFDTSKMPFFDTSKSPFPRINTMPF

026A01FF020F027B0A1FB3C482DEBF3CFC8640B51D6D1CA355C01F23CB7FBD05D3B500163AE6F166FEC7444396C2

0000020001061318060806050304121009050906072121131208101313161008080704020102

KC1PFKC2PFKC3PFKC4PFKC5PFKC6PFSCD1PFSCD2PFREAGPFDAT1PFDAT2PFDAT3PFTMCH1PFTMCH2PFTMCH3PFESTR1PFESTR2PFEINPINFFALMINFPFINITHOSDOSSYTMCH4PF

766B03B9C2158968518786CE731EFA6A4091DFA57706C4758D4B590C

258

[SYSTEM DISK] FILE NO. FILE NAME SUM (HEX) REV.NO.7076001-00-01

06/18/93

[TOTAL SUM]4005

123456789

10111213141516171819202122

NHEADDFNORMDF1NORMDF2NORMDF3NORMDF4NORMDF5NORMDF6NORMDF7NORMDF8NORMDF9NORMDF10

01D4047104BE040C035A03A703F40441048E03E30331037E03CB0418046504B2040001640359039D03EA0437

00000000000000000000000000000000000000000000

EHEADDFEMEGDF1EMEGDF2EMEGDF3EMEGDF4

NORMDF11NORMDF12NORMDF13NORMDF14NORMDF15NORMDF16

2 • 234

2.85 Memory Check

2.85.1 Introduction

The Memory Check report shows the check sum of theinstrument RAM and ROM. Memory Check can onlybe performed while the analyzer is in Stand-by.

2.85.2 Printing the Memory CheckReport

Press MAINTENANCE 2 ENTER to display theMECHANISMS CHECK screen. Move the cursor tothe Program Check field and press4 ENTER to print the Memory Check report.

2.85.3 Example of the Memory CheckReport

Figure 2-101 is an example of the Memory Checkreport.

Figure 2-101: Memory Check Report

2.85.4 Explanation of the MemoryCheck Report

2.85 Memory Check

2. REPORTS

1ENTER

MEMORY CHECK 01/06/93 14:39

0008101820283038404850586068707880889098A0A8B0B8C0C8D0D8E0E8

[VERSION][TOTAL SUM]

7076020-04-086FEE (RAM) DC01 (ROM)

--------------------------------1A6AE2CE37613C12ED39C0035A6D----94D20000----51470000000088C1----------------------------

0109111921293139414951596169717981899199A1A9B1B9C1C9D1D9E1E9

--------------------------------4C7C000061D175D6----F6557D9C----B751E467----B9B4CF0C00001D2B----------------------------

020A121A222A323A424A525A626A727A828A929AA2AAB2BAC2CAD2DAE2EA

--------------------------------88A9000022B136E71FA2174D37F1----0A99C8832FFFC756D61600004FD5----------------------------

030B131B232B333B434B535B636B737B838B939BA3ABB3BBC3CBD3DBE3EB

--------------------------------55830000D648405EDF83429113EB----000054E649B62BC31048------------------------------------

040C141C242C343C444C545C646C747C848C949CA4ACB4BCC4CCD4DCE4EC

--------------------------------FC190000450A1AE9F63394A9C331----0000C83050F729141C91------------------------------------

050D151D252D353D454D555D656D757D858D959DA5ADB5BDC5CDD5DDE5ED

--------------------------------4ADD00009FC748AC7ADD2BD0--------000000007474----232C------------------------------------

060E161E262E363E464E565E666E767E868E969EA6AEB6BEC6CED6DEE6EE

--------------------------------6C8E00003438B6C988EO4CE4--------0000C206CCD8----E0270000--------------------------------

070F171F272F373F474F575F676F777F878F979FA7AFB7BFC7CFD7DFE7EF

--------------------------------3583000073B1BD709E195EE6--------0000E03414CF----00000000--------------------------------

I/O RAM

8D96----

F1F9

F0F8

--------

F2FA

--------

F3FB

--------

F4FC

--------

F5FD

--------

F6FE

--------

F7FF

----EF6B

2 • 235

2.86 Precision Check

2.86.1 Introduction

The Precision Check report is a printout of statisticalcalculations performed on a maximum of 49 tests, fora maximum of 800 patient files (sequence numbers).

2.86.2 Printing the Precision CheckReport

Press MAINTENANCE 3 ENTER to display theSUPPORT FUNCTION screen. Move the cursor to thePrecision Check field and press 1 ENTER to print aPrecision Check report.

2.86.3 Example of the Precision CheckReport

Figure 2-102 is an example of the Precision Checkreport.

Figure 2-102: Precision Check Report

2.86.4 Explanation of the PrecisionCheck Report

DATE and TIME


SAMPLE NO.

This represents the range of sequence numbersrequested for the statistical calculation.


2. REPORTS

1ENTER

PRECISION CHECK 01/06/93 14:39

SAMPLE NO. 0001 - - - - - - 0010

TEST N MEAN RANGE MAX. MIN. SD CV(%)31361323321311444

ALB/PAMYLPHOSTPCREACALDHALTASTGGTTRIGUABILICHOLNaKCl

3.050701.80

8.734.87

3.48014.83

487.15167.70163.73179.70213.90

7.575.3

108.9126.303.73798.85

2.3103.50.1

40.00.10.30.00.2

42.0

0.091.7

4.586.62.3

3.06898.84.9

6.4815.2

489.6169.1164.8181.0213.9

7.65.3109

128.33.7899.6

3.03701.8

8.64.8

6.4814.3

484.7167.0163.2178.4213.9

7.55.3109

124.33.7198.2

0.0170.000.120.05

0.0000.473.461.210.921.840.000.060.000.0

1.650.0340.66

0.560.001.371.030.003.170.710.720.561.020.000.790.000.001.310.910.67

2 • 236

TEST

A maximum of 49 tests may appear, including Na+,K+, and Cl-. Any test not included in the specifiedrange of sequence numbers is not printed.

RESULTS

Test data is read from the data disk, and prints out inorder of test codes. Those results with data alarms(other than H or L) are excluded from the calculation.The number of tests (N) included in the calculation, themaximum value, minimum value, mean (X), SD, andCV% are printed. This can be used to troubleshootchemistry problems or verify precision, particularlyafter performing maintenance.


2. REPORTS

2 • 237

2.87 Maintenance Report

2.87.1 Introduction

The Maintenance Report is a printout of the 10 mostrecent dates the items on the WORKINGINFORMATION screen were performed.

2.87.2 Printing the Maintenance Report

Press MAINTENANCE 4 ENTER to display theWORKING INFORMATION screen. Move the cursorto the Maintenance Report field and press 1 ENTERto print the report.

2.87.3 Example of the MaintenanceReport

Figure 2-103 is an example of the Maintenance report.

Figure 2-103: Maintenance Report

2.87.4 Explanation of the MaintenanceReport

The name of each maintenance item from theWORKING INFORMATION screen is listed on the leftside of the report. The dates each item was performedis listed on the right.

2.87 Maintenance Report

2. REPORTS

1ENTER

MAINTENANCE REPORT 01/06/93 14:39

CELLS

LAMPSERUM

REAGENT 1REAGENT 2

SYRINGE FILTERMONTHLY

3-MONTHS

(ISE)

NA ELECTRODE

K ELECTRODECL ELECTRODEREF. ELECTRODEINT.STDDILUTIONSIPPERSIPPER TUBE

11/12/9209/03/9211/12/9211/12/92

11/12/9211/12/92

10/29/9211/12/9206/17/9204/27/92

11/05/9207/23/9210/29/9210/29/92

10/29/9210/29/92

08/27/9210/29/9204/27/92

10/29/9207/09/9207/09/9208/27/92

07/09/9208/27/92

07/09/9210/08/92

10/15/9206/17/9204/27/9207/09/92

04/27/9207/09/92

04/27/9207/23/92

10/07/9204/27/92

04/27/92

04/27/92

07/09/92

11/12/92

11/12/9211/12/9210/29/9207/09/9207/09/9207/09/9207/07/9208/27/92

10/29/92

10/29/9210/29/9208/27/9204/27/9204/27/9204/27/9204/27/9207/09/92

10/15/92

07/09/9207/09/9207/09/92

04/27/92

07/09/92

04/27/9204/27/9204/27/92

04/27/92

SYRINGE FILTER

2 • 238

2.88 Cumulative OperationsReport

2.88.1 Introduction

The Cumulative Operations report gives an overview ofthe tests that have been performed by the analyzer, aswell as power on time, time in operation, and floppydisk accesses.

2.88.2 Printing the CumulativeOperations Report

Press MAINTENANCE 4 ENTER to display theWORKING INFORMATION screen. Move the cursorto the Cumulative Operations Report field andpress 1 ENTER to print the report.

2.88.3 Example of the CumulativeOperations Report

Figure 2-104 is an example of the CumulativeOperations report.

Figure 2-104: Cumulative Operations Report

2.88.4 Explanation of the CumulativeOperations Report

DATE and TIME


POWER ON TIME

The cumulative number of hours the 911 has beenpowered ON.

2.88 Cumulative Operations List

2. REPORTS

1ENTER

INDIVIDUAL OPERATIONS LIST 01/06/93 14:39

1.2.3.4.5.

POWER ON TIMEOPERATIONSYSTEMDATATEST COUNT

DISKDISK

272165230

3152

HOURSHOURSTIMESTIMES

CHANNEL TEST CODE ROUTINE CALIB. CONT. RERUN STAT TOTAL

6. NO.OF SAMPLES ROUTINE RERUN STAT TOTAL786 143 117 1046

123456789

1011121314151617

52113117115

20000

13112010915213711276

145

363750

264204147280134185169182427123149148103127

ALBAMYLPHOSTPGLUCREATCALDHALTASTGGTALPCPKTRIGBUNUABILI

218182431

18815240123417411725010415513915239793

1191187397

66666666666666666

2424242424242424242424242424242424

2 • 239

OPERATION

The cumulative number of hours of instrumentmechanical operation.

SYSTEM DISK

The number of times that the System Disk has beenaccessed. When a disk has been accessed morethan 100,000 times, it should be replaced and the diskdrive cleaned. Refer to Section 3.15.

DATA DISK

The number of times that the Data Disk has beenaccessed. When a disk has been accessed morethan 100,000 times, it should be replaced and the diskdrive cleaned.

TEST COUNT

A list of each chemistry channel, the name of the testcurrently assigned to that channel, application code,and test count totals for routine, calibration, control,rerun, stat samples. The last column gives a totalcount.

NO. OF SAMPLES

This line includes a total of all samples for routine,rerun, stat, and total.

NOTEThis number resets to zero when a new system diskis formatted.

NOTEThis number resets to zero when a new data disk isformatted.

2.88 Cumulative Operations List

2. REPORTS

2 • 240

2.89 Original Absorbance

2.89.1 Introduction

The Original Absorbance reports original absorbancereadings for a specified sample and test.

2.89.2 Printing the Original Absorbance Report

Press PARAMETER 9 ENTER to display theSYSTEM PARAMETER screen. Move the cursor tothe Original Absorbance field and press 1 ENTER torequest an Original Absorbance printout.

2.89.3 Example of the OriginalAbsorbance Report

Figure 2-105 is an example of the Original AbsorbanceReport.

Figure 2-105: Original Absorbance Report

2.89.4 Explanation of the OriginalAbsorbance Report

DATE and TIME


SAMPLE NUMBER

The sample number consists of a sequence number,disk number, and sample position number. Thisinformation is specified on the PATIENT TESTSELECTION screen. The range of each number isspecific to the type of sample:

2.89 Original Absorbance Monitor

2. REPORTS

1ENTER

ORIGINAL ABS. MONITOR 01/06/93 14:39

S.NO. N001 2-03 CELL 120 (ALB 3.84 )ID NO. 1234567890123CB1-4 1-5 6-10 11-15 16-20 21-25 26-30 31-35 36-40 41-45 46-49

2227272831

-2014

3129283135

3332322932

3329333431

30343434

9823

1008310166102441029410330

1035910379103941040610413

1042010425104301043010435

1043510436104371043510438

10439104381044010440

2 • 241

ROUTINE: SAMPLE NO. RXXX-DPPRXXX: 001-800 (routine sequence number)D: 0-9 (disk number)PP: 01-50 (sample position number)

STAT: SAMPLE NO. EXXX-DPPE: (emergency)XXX: 001-200 (stat sequence number)D: 0-9 (disk number)PP: 51-70 (sample position number


with BCR)

CELL NO.

This number indicates which reaction cell contains thechemical reaction whose results are displayed belowit.


The test name and calculated results appear inparentheses to the right of the cell number. If a dataflag exists, it appears to the right of the numeric result.


If a second test was run within the same cell, the testname and results (as well as any existing data flags)appear in parentheses to the right of the first testname and results.

SERUM INDEXES RESULTS

If serum indexes are ordered on a sample, the resultsare listed in the TEST 2 NAME field as well as on asecond line below the first.

ID NO.

The patient ID NO. appears immediately below thesample number. This number represents the bar codenumber if a bar code reader is being used.


2. REPORTS

PRINT ORDER

Results are printed in order of test codes.

RESULTS

Absorbance (x104) is printed for four cell blanks and upto 49 measurement cycles. The measurement datarepresents the bichromatic absorbance (primaryminus secondary wavelength) for each measurementtaken in the photometric read window. When thismode is chosen, no calibrations are performed and thedata is not stored on the data disk.

2 • 242


2. REPORTS

NOTES

3. MAINTENANCE PART A - SCHEDULED MAINTENANCE

3.1 Maintenance Procedures Overview .......................................................... 3 · 1

3.1.1 Introduction .......................................................................................................................... 3 · 13.1.2 How To Use This Chapter ................................................................................................... 3 · 13.1.3 Replacement Parts ......................................................................................................... ..... 3 · 13.1.4 Required Cleaning Solutions ............................................................................................. 3 · 1

3.2 Working Information ................................................................................... 3 · 2

3.2.1 Introduction .......................................................................................................................... 3 · 23.2.2 Working Information Display .............................................................................................. 3 · 23.2.3 Working Information Timetable ......................................................................................... 3 · 3

3.3 Reaction System Wash .............................................................................. 3 · 4

3.3.1 Introduction .......................................................................................................................... 3 · 43.3.2 Wash Procedure ............................................................................................................ ...... 3 · 4

3.4 Empty Waste Solution Reservoir .............................................................. 3 · 5

3.4.1 Introduction .......................................................................................................................... 3 · 53.4.2 Procedure ................................................................................................................. ........... 3 · 5

3.5 ISE Maintenance ......................................................................................... 3 · 6

3.5.1 Introduction .......................................................................................................................... 3 · 63.5.2 START CONDITIONS ............................................................................................................ 3 · 63.5.3 Using the ANALYZER MAINTENANCE Screen .................................................................... 3 · 7

3.6 Clean DI Water Reservoir ........................................................................... 3 · 8

3.6.1 Introduction .......................................................................................................................... 3 · 83.6.2 Procedure ................................................................................................................. ........... 3 · 8

3. MAINTENANCE

Contents

3. MAINTENANCE

Contents

3.7 Check Reaction Cell Condition ................................................................. 3 · 9

3.7.1 Introduction .......................................................................................................................... 3 · 93.7.2 Perform Cell Blank ........................................................................................................ ...... 3 · 93.7.3 Clean Reaction Cells ...................................................................................................... ..... 3 · 9

3.8 Clean and Adjust Reaction System Components ................................. 3 · 11

3.8.1 Introduction .........................................................................................................................3 · 113.8.2 Clean and Adjust Sample Probe....................................................................................... 3 · 113.8.3 Clean and Adjust Reagent Probes .................................................................................... 3 · 133.8.4 Clean and Adjust Stirrer .................................................................................................. ..3 · 143.8.5 Clean Cell Rinse Unit Nozzles ...........................................................................................3 · 143.8.6 Clean Probe and Stirrer Rinse Bath .................................................................................3 · 15

3.9 Replace Reaction Cells and Clean Reaction Bath ................................. 3 · 16

3.9.1 Introduction .........................................................................................................................3 · 163.9.2 Remove Reaction Cells..................................................................................................... . 3 · 163.9.3 Clean Reaction Bath ....................................................................................................... ...3 · 173.9.4 Clean Reaction Bath Drain Filter ......................................................................................3 · 183.9.5 Reinstall Reaction Cells .................................................................................................. ...3 · 193.9.6 Cell Blank................................................................................................................ ............ 3 · 20

3.10 Clean Sample and Reagent Disk Compartments ................................... 3 · 21

3.10.1 Introduction .........................................................................................................................3 · 213.10.2 Clean Sample Disk Compartment .....................................................................................3 · 223.10.3 Clean Reagent Disk Compartments .................................................................................. 3 · 24

3.11 Clean Refrigerator Condenser Filter ....................................................... 3 · 27

3.11.1 Introduction .........................................................................................................................3 · 273.11.2 Clean Refrigerator Condenser Filter ................................................................................3 · 27

3.12 Clean Inlet Water Filter ............................................................................. 3 · 28

3.12.1 Introduction .........................................................................................................................3 · 283.12.2 Clean Inlet Water Filter .....................................................................................................3 · 29

3.13 Replace ISE Pinch Valve Tubing ............................................................. 3 · 30

3.13.1 Introduction .........................................................................................................................3 · 303.13.2 Replace ISE Pinch Valve Tubing ......................................................................................3 · 303.13.3 Perform ISE Prime .............................................................................................................3 · 31

3.14 Replace Pipettor Seals ............................................................................. 3 · 33

3.14.1 Introduction .........................................................................................................................3 · 333.14.2 Disassemble Pipettor .........................................................................................................3 · 343.14.3 Expose Pipettor Seal .........................................................................................................3 · 353.14.4 Replace Sample Pipettor Seal ..........................................................................................3 · 373.14.5 Replace Reagent Pipettor Seal ........................................................................................3 · 383.14.6 Reassemble Pipettor ..........................................................................................................3 · 403.14.7 Perform an Air Purge .........................................................................................................3 · 423.14.8 Replace ISE Pipettor Seals ...............................................................................................3 · 433.14.9 Perform ISE Prime .............................................................................................................3 · 43

3. MAINTENANCE

Contents

PART B - UNSCHEDULED MAINTENANCE

3.15 Floppy Disk Replacement ........................................................................ 3 · 45

3.15.1 Introduction .........................................................................................................................3 · 453.15.2 Format a Blank Disk ........................................................................................................... 3 · 453.15.3 Create a New System Disk ................................................................................................3 · 463.15.4 Create a New Data Disk .....................................................................................................3 · 47

3.16 System Software Installation ................................................................... 3 · 50

3.16.1 Introduction .........................................................................................................................3 · 503.16.2 System Software Installation ............................................................................................ 3 · 50

3.17 Clean Cell Rinse Unit ................................................................................ 3 · 53

3.17.1 Introduction .........................................................................................................................3 · 533.17.2 Clean Clogged Nozzle .......................................................................................................3 · 533.17.3 Perform a Mechanism Check ............................................................................................ 3 · 55

3.18 Replace Photometer Lamp ...................................................................... 3 · 56

3.18.1 Introduction .........................................................................................................................3 · 563.18.2 Remove Reaction Disk .......................................................................................................3 · 573.18.3 Replace Photometer Lamp ...............................................................................................3 · 583.18.4 Reinstall Reaction Disk ...................................................................................................... 3 · 613.18.5 Perform Cell Blank ............................................................................................................. 3 · 613.18.6 Recalibrate .................................................................................................................... .....3 · 61

3.19 Clean ISE Reagent Flowpath ................................................................... 3 · 62

3.19.1 Introduction .........................................................................................................................3 · 623.19.2 Clean ISE Reagent Flowpath ............................................................................................ 3 · 633.19.3 Calibrate ISE System .........................................................................................................3 · 64

3. MAINTENANCE

Contents

3.20 Replace ISE Measuring Cartridge (Na +, K+, Cl-) ....................................... 3 · 65

3.20.1 Introduction .........................................................................................................................3 · 653.20.2 Remove Old Cartridge .......................................................................................................3 · 663.20.3 Install New Cartridge .........................................................................................................3 · 673.20.4 Prime ISE System............................................................................................................... 3 · 693.20.5 Calibrate ISE System .........................................................................................................3 · 69

3.21 Replace ISE Reference Cartridge ............................................................ 3 · 70

3.21.1 Introduction .........................................................................................................................3 · 703.21.2 Remove Old Cartridge .......................................................................................................3 · 713.21.3 Install New Cartridge .........................................................................................................3 · 733.21.4 Prime ISE System............................................................................................................... 3 · 753.21.5 Calibrate ISE System .........................................................................................................3 · 75

3.22 Check/Refill Multiclean Solution .............................................................. 3 · 76

3.22.1 Introduction .........................................................................................................................3 · 763.22.2 Procedure ....................................................................................................................... ....3 · 76

3.23 Replace Sample Probe ............................................................................. 3 · 79

3.23.1 Introduction .........................................................................................................................3 · 793.23.2 Remove Sample Probe......................................................................................................3 · 803.23.3 Install New Sample Probe .................................................................................................3 · 863.23.4 Check/Adjust Horizontal Sample Probe Alignment.........................................................3 · 903.23.5 Check/Adjust Vertical Sample Probe Alignment .............................................................3 · 913.23.6 Perform an Air Purge .........................................................................................................3 · 91

3.24 Replace Reagent Probes ......................................................................... 3 · 93

3.24.1 Introduction .........................................................................................................................3 · 933.24.2 Remove Reagent Probe.....................................................................................................3 · 943.24.3 Replace Reagent Probe................................................................................................... 3 · 1003.24.4 Check/Adjust Reagent Probe Alignment ........................................................................ 3 · 1063.24.5 Perform an Air Purge ....................................................................................................... 3 · 107

3. MAINTENANCE

Contents

3.25 Replace Stirring Paddle ......................................................................... 3 · 108

3.25.1 Introduction ....................................................................................................................... 3 · 1083.25.2 Replace Stirrer Paddle .................................................................................................... 3 · 1083.25.3 Check Stirrer Action ......................................................................................................... 3 · 109

3.26 Load Continuous-Form Paper ............................................................... 3 · 111

3.26.1 Introduction ....................................................................................................................... 3 · 1113.26.2 Load Continuous-Form Paper ......................................................................................... 3 · 1113.26.3 Set Paper Online .............................................................................................................. 3 · 115

3.27 Replace Printer Ribbon Cassette .......................................................... 3 · 116

3.27.1 Introduction ....................................................................................................................... 3 · 1163.27.2 Procedure ......................................................................................................................... 3 · 116

3. MAINTENANCE

Contents

3 • 1

3.1 Maintenance ProceduresOverview

3.1.1 Introduction

The following maintenance procedures are written foran operator who attended to a BM-technical customertraining with a working knowledge of all instrumentmechanical functions, CRT displays and softwarefunctions. The instrument must be provided withproper care and maintenance to ensure consistentand accurate functioning.

3.1.2 How To Use This Chapter

Each maintenance procedure is divided into two parts:the Introduction and the Procedure.

The Introduction provides important information aboutthe procedure, which includes:

• materials required• time required• precautions.

The Procedure gives step-by-step directions forperforming the required maintenance function. Thispart frequently is divided into smaller procedureblocks to help you organize your approach tomaintenance.

3.1.3 Replacement Parts

A replacement part may be needed for a specificmaintenance procedure.

For most efficient use of time, gather all requiredmaterials corresponding to part- or Id.-Nr. beforestarting a maintenance procedure.

3.1.4 Required Cleaning Solutions

In order to perform some of the maintenanceprocedures contained in this chapter, you mustprepare the specified cleaning solutions. Briefpreparation instructions for the required cleaningsolutions are included below:

· 2% HitergentIn a clean container (plastic or glass) that can beused to store the solution, mix 98 parts deionizedwater with 2 parts concentrated Hitergent. Labelthe container 2% Hitergent.

· 0.525% Sodium HypochloriteIn a clean container (plastic or glass) that can beused to store the solution, prepare 90 partsdeionized water with 10 parts undiluted 5.25%sodium hypochlorite. Once diluted this solutionshould be used completely. Do not store, longerthan 1 week (cool). Old diluted solution cancontaminate instead of clean! Label the container0.525% Sodium Hypochlorite.

· 1 N NaOH

· MulticleanAutomatic cleaning solution, (1 N NaOH), is usedduring automatic cleaning procedures.

· ISE Cleaning solution

3. SCHEDULED MAINTENANCE

3.1 Maintenance Procedures Overview

3 • 2

3.2 Working Information

3.2.1 Introduction

The WORKING INFORMATION screen displays a listof analyzer parts that require routine maintenance.The screen shows the date each maintenanceprocedure was last performed. This screen is an on-board maintenance log for your system.

The analyzer contains an internal timer formaintenance that counts the appropriate time intervaldown during operation and power ON. Two questionmarks (??) prior to the date displayed indicate thedate for scheduled maintenance is approaching andyou should prepare to perform that maintenancefunction. (80% of the maintenance time haselapsed.) Two exclamation marks (!!) prior to the dateindicate the date for scheduled maintenance is due oroverdue and the maintenance function should beperformed as soon as possible.

On the following page is a time table showing when theWorking Information screen will display the caution(??) and over (!!) indicators for each maintenancefunction shown on the screen below.

3.2.2 Working Information Display

To display the WORKING INFORMATION screen, asshown in Figure 3-1, press MAINTENANCE, followedby 4 ENTER.

Figure 3-1: Working Information

After performing any maintenance function, move thecursor to the proper field on the WORKINGINFORMATION screen and press 1 ENTER to resetthe internal timer to the current date as shown on theAnalyzer Status line.



4ENTER

37.0 Stand-by 12/01/92 12:20

4 Working Information

PHOTOMETRIC UPDATE

Cells

Lamp

??

! !

! !

! !

! !

11/12/92

11/12/92

11/12/92

10/29/92

Input 1:If Changed (OK< 21 days, ??= 21-30 days, > 30 days) : ENTER

SEAL CHANGE

Serum

Reagent 1

Reagent 2

01/06/93

11/12/92

11/12/92

11/12/92

11/12/92

?? ISE SEAL PIECE

Internal STD

Dilution

Sipper

07/09/92

07/09/92 07/09/92

07/09/92

Syringe Filter 10/29/92

Pinch Valve Tubing

Syringe Filter 08/27/92MONTHLY CLEANING

3-MONTH CLEANING

! !

! !

11/12/92

04/27/92

NaOH Reservoir

Maintenance Report

Cumulative Operations Report

Clear Test Counter

02/04/93

?? : Caution

! ! : Over

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ][ ]

[ ]

[ ]

[ ]

[ ]

[ ]

K

Cl

ElectrodeElectrode

ISE UPDATE

Na

Ref.

Electrode

Electrode

3 • 3

3.2.3 Working Information Timetable

* Hours powered ON excludes hours in the SleepMode.

Maintenance Item Unit of Time Time ?? !!

Prior Caution Over

CELLS Calendar day ≤ 21 days 21 - 30 days > 30 days

LAMP Hours powered ON* ≤ 600 hours 600 - 750 hours > 750 hours

SEAL PIECE

SERUMREAGENT 1REAGENT 2

Hours of Operation ≤ 400 hours 400 - 500 hours > 500 hours

SYRINGE FILTER Hours powered ON* ≤ 600 hours 600 - 750 hours > 750 hours

PERIODICAL CLEANINGMONTHLY PROGRAM

Calender days ≤ 21 days 21 - 30 days > 30 days

PERIODICAL CLEANING3 MONTH PROGRAM

Calender days ≤ 81 days 81 - 90 days > 90 days

NaOH Reservoir Calender days ≤ 5 days 5 - 7 days > 7 days

ISE PERIODICAL CHECK

Na CARTRIDGEK CARTRIDGECl CARTRIDGEREF CARTRIDGE

Calender daysCalender daysCalender daysCalender days

≤≤≤≤

50 days50 days25 days140 days

50 - 60 days50 - 60 days25 - 30 days140 - 180 days

>>>>

60 days60 days30 days180 days

ISE SEAL PIECE

INT. STDDILUTIONSIPPER

Hours of Operation ≤ 400 hours 400 - 500 hours > 500 hours

SIPPER TUBE Hours powered ON* ≤ 600 hours 600 - 750 hours > 750 hours

ISE SYRINGE FILTER Hours powered ON* ≤ 600 hours 600 - 750 hours > 750 hours



3 • 4

3.3 Reaction System Wash

3.3.1 Introduction

The Reaction System Wash procedure is performedautomatically by the analyzer following completion ofeach sampling run. The following system parts arecleaned:

• reaction cells• sample probe• reagent probes• rinse unit nozzles• stirrers.

Operator time: No additional time.

Instrument time: No additional time.

Materials Required:

Sample CupHitergent Solution (100 mL)Multiclean (1 N NaOH)

3.3.2 Wash Procedure

1 Place a sample cup containing approximately 1mL of System Cleaning Solution in the "W1"position on the middle ring of the sample disk, asshown in Photograph 3-1.

2 Make sure a container with at least 10 mL ofHitergent solution is in position 33 of both the R1and R2 reagent disks.

3 Make sure the Multiclean is in place inside the leftfront panel.

The analyzer will automatically perform the reactionsystem wash at the end of the sampling cycle.

Photograph 3-1:System Cleaning Solution


3.3 Reaction System Wash

3 • 5

3.4 Empty Waste SolutionReservoir

3.4.1 Introduction

The waste solution reservoir receives sample wastefrom the ISE system and reaction cell rinse unit. Thiscontainer should be emptied daily. An alarm, EmptyWaste Reservoir is issued when the container is full.

Operator time: Approximately 2 minutes.

Precaution: Contents of the waste solutionreservoir, and subsequently thewater used to rinse thecontainer, are potentiallybiohazardous. This wasteshould be handled, anddisposed of, in an appropriatemanner. Wear rubber gloveswhen performing this procedure.

Materials Required:

0.525% sodium hypochlorite solutionWater for rinsingPaper towels

3.4.2 Procedure

1 Locate the waste solution reservoir at the back ofthe analyzer.

2 Lift the liquid level sensor assembly from thewaste reservoir, as shown in Photograph 3-2, andplace it on paper towels or other absorbentmaterial.

3 Remove the drain hose from the waste reservoir,making sure any residual waste in the hose drainsinto the waste container. Place the hose by theliquid level sensor on the paper towels.

4 Remove the waste container and dispose of itscontents in a manner acceptable for yourinstitution.

5 Rinse the waste container thoroughly with waterand dispose of the rinse water in the same manner.

6 Pour 0.525% sodium hypochlorite into the wastecontainer until it is approximately 1 cm deep.

7 Place the waste container back in its originalposition at the back of the analyzer.

8 Place the liquid level sensor assembly and drainhose back on the waste container.

9 Properly dispose of the paper towels.

Photograph 3-2:Waste Solution Reservoir


3.4 Empty Waste Solution Reservoir

3 • 6

3.5 ISE Maintenance

3.5.1 Introduction

ISE Maintenance should be initiated daily, afterfinishing the routine job. Performing this procedurecleans the ISE sample flow path. There are two waysto initiate this procedure: from START CONDITIONSor from ANALYZER MAINTENANCE.After cleaning ISE flowpath, the ISE must becalibrated before reusing it.

Operator time: Approximately 1 minute.

Instrument time: Approximately 4 minutes.

Materials Required:

Sample CupISE Cleaning Solution

3.5.2 START CONDITIONS

1 Press the ROUTINE key, followed by 4 ENTER, todisplay the START CONDITIONS screen. Placea sample cup with System Cleaning Solution in the"W2" position on the middle ring of the sampledisk.

2 Move the cursor to the ISE Maintenance entryfield, as shown in Figure 3-2.

Figure 3-2: ISE Maintenance from STARTCONDITIONS

3 Press 1 Initiate ISE Maintenance just before thelast RUN ENTER. After sampling ends, the ISEmaintenance is performed.

4 Other keyboard entries may be made while theanalyzer is executing the ISE Maintenancefunction. The maintenance is complete when theanalyzer status line returns to Stand-by.

5 The field enabling automatic ISE maintenanceshould only be used at the last run of the day: sinceISE maintenance should only be performed onceper day. Also please note that after ISEMaintenance (either from "Start Conditions "Screen or from "Maintenance" Screen) the ISEmust be conditioned and calibrated prior to furthersamples analysis.


3.5 ISE Maintenance

4ENTER

37.0 Stand-by 12/01/92 12:20

4 Start Conditions

Choose 1:Initiate ISE Maintenance at End of Run 0 : No : ENTER



[ ] : [ 0] [ 1][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]


Off

ReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

1ENTER

3 • 7

3.5.3 Using the ANALYZERMAINTENANCE Screen

1 The analyzer must be in the Stand-by mode toperform this function from the ANALYZERMAINTENANCE screen.

2 Press the MAINTENANCE key, followed by 1ENTER to display the ANALYZERMAINTENANCE screen.

3 With the cursor in the Wash field, as shown inFigure 3-3. Press 2 Wash ISE ENTER to initiatethe ISE maintenance. The ISE maintenancefunction is complete when the analyzer status linereturns to Stand-by.

4 Perform dummy sampling with clear human serum10x for ISE (preconditionning).

5 Calibrate the ISEs prior to running patientsamples. An alarm, Execute ISE CALIBRATION,is issued if samples are processed without firstcalibrating.

Figure 3-3: ISE Maintenance from AnalyzerMaintenance


3.5 ISE Maintenance

1ENTER

2ENTER

37.0 Stand-by 12/01/92 12:20


Choose 1:Wash Cells 2:Wash ISE 3:Wash Cells + ISE : ENTER

Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 8

3.6 Clean DI Water Reservoir

3.6.1 Introduction

Your deionized water reservoir may or may not requirefrequent cleaning, depending upon the quality of yourwater supply. As a precaution, clean the reservoirweekly. The deionized water reservoir is locatedinternally and does not have to be accessed toperform the cleaning function. You cannot stop thismaintenance function once it is initiated.



3.6.2 Procedure

1 Press the MAINTENANCE key, followed by 1ENTER, to display the ANALYZERMAINTENANCE screen.

2 Move the cursor to the Water Tank field, as shownin Figure 3-4.

Figure 3-4: Water Reservoir Cleaning

3 Press 1, ENTER to initiate the deionized waterreservoir cleaning.

4 Other keyboard entries may be made while theanalyzer is cleaning the deionized water reservoir.The function is complete when the analyzer statusline returns to Stand-by.


3.6 Clean DI Water Reservoir

1ENTER

1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 9

3.7 Check Reaction Cell Condition

3.7.1 Introduction

During operation of the Analyzer the Cell blank qualityis automatically checked by comparison againstprevious data. The operator should perform thefollowing actions to ensure that the "baseline" cellblank datas stored in the instrument memory isupdated.

Weekly

Perform Cell blank procedure, this will update andprintout cell blank data for each cuvette.

Using the printout-data check that values for the 1st

cell are < 13000 and that for all other cells thedifference does not exceed ± 800 from the 1st cell. Ifthese limits are exceeded the cells should be cleanedusing cell cleaning program and then cell blank shouldbe repeated. If limits are still exceeded the cellsshould be exchanged.

Monthly

Cells should be exchanged monthly to ensurecontinued good performance. Please note that it ispossible that slight scattering of the cells can occurover this time (e.g. scratches) which will notnecessarily give poor cell blank values but canincrease the likelihood of carryover of reactioncontents.

Materials Required:

If reaction cell cleaning is required:2% Hitergent solutionDeionized water

3.7.2 Clean Reaction Cells

1 Move the cursor to the Wash field. Press 1 ENTERto initiate a wash cells.

3.7.3 Perform Cell Blank

1 Press the MAINTENANCE key, followed by 1ENTER , to display the ANALYZERMAINTENANCE screen.

2 Move the cursor to the Cell Blan k field, as shownin Figure 3-5 on the following page, and press 1(Initiate & Print Cell Blank) ENTER to initiate a cellblank. The cell blank function is complete whenthe Analyzer Status line returns to Stand-by.


3.7 Check Reaction Cell Integrity

1ENTER

1ENTER

1ENTER

3 • 10

Figure 3-5: Initiate Cell Blank

3 Verify that the cell blank results are 13000 or lessfor reaction cell number 1 (at all wavelengths) and± 800 for reaction cells 2-120. If the results areoutside the specified range, clean the reactioncells, following the instructions in Section 3.7.3. Ifthe cells are more than one month old, they shouldbe replaced, following the instructions inSection 3.9.


3.7 Check Reaction Cell Integrity

37.0 Stand-by 12/01/92 12:20


Choose 1:Read From FD 2:Write to FD : ENTER

Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 11

3.8 Clean and Adjust ReactionSystem Components

3.8.1 Introduction

Read the entire procedure below before adjusting anyprobes. Failure to follow the procedure as outlinedmay result in probe damage. Sample and reagentprobes should be cleaned daily. Reaction systemcomponents should be adjusted weekly.

This procedure is divided into five parts:

• clean/adjust sample probes• clean/adjust reagent probes• clean/adjust stirring paddles• clean rinse unit nozzles• clean probe rinse baths.


Instrument time: Approximately 5 minutes(concurrent with operator time).

Precaution: Do not use unnecessary forcewhen adjusting probes.

Materials Required:

0.525% sodium hypochlorite2% Hitergent solutionEthanol or Isopropyl AlcoholGauze squaresDeionized water50cc syringe (with tubing attached)

If internal cleaning of probes is required:Wire StyletMulticlean (or 1 N NaOH)


3.8 Clean and Adjust Reaction System Components

3.8.2 Clean and Adjust Sample Probe

NOTERemove all sample cups and tubes from the followingpositions on the sample disk prior to beginning thisprocedure: position 1 on the outer ring, position “W1”on the middle ring and position “S18” on the inner ring.

1 Press the MAINTENANCE key, followed by 2ENTER to display the MECHANISMS CHECKscreen, shown in Figure 3-6 on the following page.

Figure 3-6: Probe Adjust

2 Press 1 (S. Probe (Horiz.)) ENTER to initiate ahorizontal sample probe adjust. Do not continue

2ENTER

37.0 Stand-by 12/01/92 12:20

2 Mechanisms Check


Probe Adjust


Printer Check


FD Special Copy

C-RAM Info Read/Write

[ ]H1 : 84.6 H2 : 42.4

[ ][ ][ ]

[ ]

[ ] [ ][ ][ ]

[ ]

[ ]

3 • 12

until the probe is positioned over the reaction disk.

3 Ground yourself by touching the ISE

compartment screw prior to wiping the sampleprobe.

4 Remove sample disk. Press sample stop toposition the probe over sample disk area. Moistena small gauze square with ethanol or isopropanolalcohol. Beginning from the top of the sampleprobe, wipe, in a downward motion, the entirelength of the sample probe, as shown inPhotograph 3-3. Do not touch the sample probe tipwith your hands. Press sample stop to positionprobe over the cells. Replace sample disk.

Photograph 3-3:Wipe Sample Probe

5 If the sample probe is clogged or heavilycontaminated, proceed to Section 3.23. If thesample probe is not clogged or heavilycontaminated, proceed to Step 6.

6 Check the sample probe for correct alignment

over the reaction cells. The probe tip must becentered over the reaction cell, as shown inFigure 3-7.

Figure 3-7: Align Sample Probe

CAUTIONDO NOT bend the probe sharply. This can crimp theprobe, thereby requiring replacement. The correctalignment of all probes is critical for proper functioningof the instrument. Failure to correctly align all probescan result in damage to the instrument and/orincorrect test results.

7 While firmly holding the probe arm, gently bend theprobe, in an arc, over its entire length to center itstip over the reaction cell beneath it.

8 Press the SAMPLING STOP key to move theprobe to different positions over the sample diskand ISE dilution vessel. Each time theSAMPLING STOP key is pressed, the probemoves to a different position. This can be used tocheck the probe alignment at each of the stoppositions.

9 Press STOP to end adjustment.



1ENTER Reaction Cell

Probe +

+

SAMPLINGSTOP

3 • 13

Do not continue until the probe is at rinsestation-position .

3.8.3 Clean and Adjust ReagentProbes

1 Press 3 (Reagent Probes) ENTER from the ProbeAdjust field to initiate a reagent probe adjust. Donot continue until the probes are positionedover the reaction disk.

2 Place paper towel under the reagent probe to makesure no alcohol comes in contact with the reactioncells. Moisten a small gauze square with ethanolor isopropyl alcohol and gently wipe, in a down-ward motion, the tip of the reagent probes.

3 If a reagent probe is clogged or heavilycontaminated, proceed to Section 3.24. If areagent probe is not clogged or heavilycontaminated, proceed to Step 5.

4 Check the reagent probes for correct alignmentover the reaction cells. The probe tips must becentered over the reaction cells, as shown inFigure 3-8.

Figure 3-8: Align Reagent Probes

CAUTIONDO NOT bend the probe sharply. This can crimp theprobe, thereby requiring replacement. The correctalignment of all probes is critical for proper functioningof the instrument. Failure to correctly align all probescan result in damage to the instrument and/orincorrect test results.

5 While firmly supporting the probe arm, gently bendthe probe, in an arc, over its entire length to centerits tip over the reaction cell beneath it.

6 Press STOP to end adjustment.Do not continue until the probes are at rinsestation position .



3ENTER

STOP

STOP

Reaction Cell

R2

R1

Stirrer

ReagentProbe

3 • 14

5 Press STOP to end adjustment.Do not continue until thestirrers are at rinsestation position .

3.8.5 Clean Cell Rinse Unit Nozzles

1 Moisten a small gauze square with a 2% Hitergentsolution and gently wipe, in a downward motion,the tip of the cell rinse unit nozzles.

2 Apply deionized water to another gauze squareand wipe any excess detergent from the nozzles.



3.8.4 Clean and Adjust Stirrers

1 Press 4 (Stirrers) ENTER from the Probe Adjustfield to initiate a stirrer adjust. Do not continueuntil the stirrers have been positioned .

2 Moisten a small gauze square with a 2% Hitergentsolution and gently wipe, in a downward motion,the tip of the stirrers.

3 Apply deionized water to another gauze squareand wipe any excess detergent from the stirrers.

4 Check the stirrers for correct alignment over thereaction cells. The stirrer must be centered overthe reaction cells, as shown in Figure 3-9. If theyare not, contact Boehringer Mannheim TechnicalSupport.

Figure 3-9: Align Stirrers

4ENTER

STOP

Reaction Cell

R2

R1

Stirrer

ReagentProbe

3 • 15

3.8.6 Clean Probe and Stirrer RinseBaths

1 Fill a 50 cc syringe (with tubing attached) with0.525% sodium hypochlorite (Wash Solution).

2 Inject the Wash Solution (empty the syringe) intothe drain hole of the sample probe rinse bath asshown in Photograph 3-4.

Photograph 3-4:Clean Rinse Bath

3 Fill the syringe with deionized water.

4 Inject the water (empty the syringe) into the drainhole of the sample probe rinse bath.

5 Repeat steps 1 through 4 for both reagent proberinse baths and both stirrer rinse baths.

NOTEIf the probes or stirrers are in the way, making itdifficult to reach the rinse bath drain holes, put thatcomponent into a probe or stirrer adjust. This willmove the component out of the way. Followinstructions in Section 3.8 for performing the adjusts.



3 • 16

3.9 Replace Reaction Cells andClean Reaction Bath

3.9.1 Introduction

The reaction cells should be replaced and the reactionbath cleaned monthly.


• remove reaction cells and disk• clean reaction bath• clean reaction bath drain filter• reinstall reaction disk and new cells• perform cell blank.

NOTENew reaction cells should be soaked overnight in 2%Hitergent before installing. If an emergency makesthis impossible, wipe the outside of the new cells withfull strength Hitergent before installing. In addition,perform a Wash Cells function from the ANALYZERMAINTENANCE screen immediately beforeperforming the Cell Blank.


Precautions: • Handle the reaction cells andreaction disk carefully.

• Do not scratch the photometerwindows.

• Do not touch optical surfaces.• Clean only the photometer

window sides that are incontact with reaction bathwater.

• Wear rubber gloves whencleaning the reaction bath toprevent the introduction ofcontaminants into the system.

Materials Required:

Reaction cell set2% Hitergent solutionDeionized waterGauze squaresReaction bath drain filter

3.9.2 Remove Reaction Cells

1 Remove the retaining nut securing the rinse unit.Carefully lift the entire unit off of the mountingbracket and set it aside, as shown in Photograph3-5.

Photograph 3-5:Remove Cell Rinse Unit


3.9 Replace Reaction Cells and Clean Reaction Bath

3 • 17

2 Loosen and remove the two thumbscrews on eachreaction cell section, as shown in Photograph 3-6,and set them aside. (The thumbscrews will bereused when new reaction cells are installed.)

Photograph 3-6:Loosen Thumbscrews

3 Lift each reaction cell section out of the reactiondisk and discard it.

4 If you do not wish to clean the bath, proceed toSection 3.9.4.

3.9.3 Clean Reaction Bath

1 Press the MAINTENANCE key, followed by 1ENTER to display the ANALYZERMAINTENANCE screen. Move the cursor to theINC. Water Exchange field, as shown in Figure 3-10 on the following page.

Figure 3-10: Reaction Bath Exchange

2 Press 1 ENTER to initiate the reaction bathexchange. After the water drains, power OFF theinstrument.

1ENTER



1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 18

NOTEAn alternative method of draining the reaction bath isto use a 50 cc (or larger) syringe to manually removethe water.

CAUTIONDO NOT scratch the photometer windows. Clean onlywhere they come into contact with the reaction bathwater. Use only gauze moistened with 2% Hitergent.

3 Loosen the retaining nut, as shown in Photograph3-7, and remove the reaction disk from theanalyzer.

Photograph 3-7:Remove Reaction Disk



4 Using a clean gauze square moistened with 2%Hitergent solution, carefully wipe the photometerwindow, as shown in Photograph 3-8.

Photograph 3-8:Clean Photometer Window

5 Using a clean gauze square moistened with 2%Hitergent solution, carefully wipe the insidesurfaces of the reaction bath, as shown inPhotograph 3-9.

Photograph 3-9:Clean Reaction Bath

3 • 19

3.9.4 Clean Reaction Bath Drain Filter

1 Remove the reaction bath drain filter, located at theoutlet port of the reaction bath, as shown inPhotograph 3-10.

Photograph 3-10:Remove Reaction Bath Drain Filter

2 Wash (backflush) the filter with deionized water.

3 Replace the incubation bath drain filter.

4 Using a beaker, fill the reaction bath with 500 mLof deionized water. This eliminates foaming thatmay occur at power UP.

3.9.5 Reinstall Reaction Cells

1 Replace the reaction disk and tighten the retainingnut. Ensure that the pin on the analyzer aligns withthe hole in the top of the reaction disk.

2 Place the new reaction cell sections in the reactiondisk, handling them by their edges only, as shownin Photograph 3-11. Make sure you have soakedor wiped the new reaction cells with Hitergent asoutlined on page 3-18. Do not touch the opticalsurfaces.

Photograph 3-11:Replace Reaction Cells

3 To ensure that each reaction cell section is seatedproperly, align the pins in each set of reaction cellsas shown in Photograph 3-12.

Photograph 3-12:Align Pins



3 • 20

4 Reinstall the thumbscrews securely, as shown inPhotograph 3-13.

Photograph 3-13:Reinstall Thumbscrews

5 Return the rinse unit to its proper position over thereaction disk. Make sure the pin on the mountingbracket aligns with the hole in the bottom of thecell rinse unit.

6 Finger-tighten the retaining nut on the rinse unitmounting bracket, as shown in Photograph 3-14.

Photograph 3-14:Replace Cell Rinse Unit



3.9.6 Cell Blank

1 Turn the instrument power ON.

2 Perform other monthly items (time for foam/airbubbles to disappear).

3 Cell Wash function from ANALYZERMAINTENANCE screen.

4 Cell BlankIf cell is not < 13000 or the remaining cells 2 - 120are not within ± 800, check the following items:

- the new cells have not been soaked/wiped offwell enough so reminders of the separator fluidare on the cells, causing drifted cell blankvalues.

- the cell blank procedure has been carried out tosoon after "Bath exchange" and foamdevelloped during exchange is still on the cellsurfaces and windows.

In both cases perform 1 - 2 additional cell washprocedures and than start a new cell blankprocedure.

- If cell 1 is > 13000 check photometer and ifnecessary replace lamp.

3 • 21

3.10 Clean Sample and ReagentDisk Compartments

3.10.1 Introduction

Clean the sample and reagent disk compartmentsmonthly. As always, sample and reagent spillsshould be cleaned up as they occur . If excessivecondensation occurs, the disk compartments mayneed to be cleaned more frequently.

This procedure is divided into two parts:

• clean sample disk compartment• clean reagent disk compartments.


Precautions: • The instrument must be inStand-by or OFF.

• Handle the sample andreagent disks carefully.

• Do not scratch the bar codereader windows.

• Wear rubber gloves!

Materials Required:

Paper towelsGauze squaresAlcohol prep pad


3.10 Clean Sample and Reagent Disk Compartments

3 • 22

3.10.2 Clean Sample Disk Compartment

1 Move the handle of the sample disk evaporationcover to the OPEN position, as shown inPhotograph 3-15, and remove the cover.

2 Lift the outer ring of the sample disk from theanalyzer, as shown in Photograph 3-16, and placeit on a flat surface.

3 Grasp each of the white snap fasteners on theinner ring of the sample disk and pull upward, asshown in Photograph 3-17, to unfasten the snaps.

Photograph 3-15:Remove Evaporation Cover

Photograph 3-16:Remove Outer Ring

Photograph 3-17:Unfasten Snaps



3 • 23

4 Lift the inner ring of the sample disk from theanalyzer, as shown in Photograph 3-18, and placeit on a flat surface.

5 Wipe the bar code reader with a clean gauzesquare using alcohol or glass cleaner, as shown inPhotograph 3-19.

6 Clean the inside of the sample disk compartment,both inner and outer rings, with gauze or papertowel, as shown in Photograph 3-20. Make sureyou remove all condensation.

Photograph 3-18:Remove Inner Ring

Photograph 3-19:Clean Bar Code Reader

Photograph 3-20:Clean Inside of Disk



3 • 24

7 Replace the inner sample disk and press down onthe white snap fasteners to secure the disk.

8 Replace the outer sample disk.

9 Replace the sample disk evaporation cover. Makesure the guide pins are aligned properly, as shownin Photograph 3-21.

Guide Pins

Align in holes

3.10.3 Clean Reagent DiskCompartments

Use this procedure to clean both reagent diskcompartments.

1 Turn the locking handle on the reagent diskevaporation cover to the OPEN position, asshown in Photograph 3-22, and remove the cover.



Photograph 3-21:Align Guide Pins onEvaporation Cover

Photograph 3-22:Unlock Reagent Cover

3 • 25

2 Grasp each of the white snap fasteners on thereagent disk, as shown in Photograph 3-23, andpull upward to unfasten the snaps.

3 Remove the reagent disk from the instrument, asshown in Photograph 3-24, and place it on a flat,stable surface. If maintenance procedure isnecessary put reagents into fridge.

4 Wipe the reagent bar code reader with clean gauzeusing alcohol or glass cleaner, as shown inPhotograph 3-25.

Photograph 3-23:Unlock Snap Fasteners

Photograph 3-24:Remove Reagent Disk

Photograph 3-25:Clean Bar Code Reader



3 • 26

5 Wipe the inside surface of the reagent diskcompartment with paper towels or other absorbentmaterial, as shown in Photograph 3-26, to removeany foreign material (spills, condensation, etc.).Do not wipe condensation or reagents onto the barcode reader window.

6 Replace the reagent disk. Make sure the hole inthe reagent disk aligns with the screw as shown inPhotograph 3-27.

7 Press each white snap fastener down to secure thedisk.

8 Repeat the entire procedure with the other reagentdisk.

Hole in reagent diskaligns with Allen screw

9 Replace and lock both reagent disk covers, asshown in Photograph 3-28. Verify that the openingin the reagent cover is in the proper positionbetween the guide bars on the top of the instrumentto allow the reagent probes access to the reagentbottles.

Guide Bars

Photograph 3-26:Clean Reagent Disks

Photograph 3-27:Replace Reagent Disk

Photograph 3-28:Replace Reagent Covers



3 • 27

3.11 Clean RefrigeratorCondenser Filter

3.11.1 Introduction

The refrigerator condenser filter and condensercooling fins must be kept free of dust or dirtaccumulation. Perform this procedure monthly.


Precautions: • Instrument power must be inStand-by or OFF.

• Take care not to bend thecondenser cooling fins.

• DO NOT use compressed airto clean the condenser coolingfins as this will blow dust anddirt into the instrument.

Materials Required:

Paper towelsWater for rinsingVacuum cleaner

3.11.2 Clean Refrigerator CondenserFilter

1 Turn instrument power OFF or wait for Stand-by,then open both of the front instrument panels.

2 Remove the condenser filter from its retainingbracket in front of the condenser, as shown inPhotograph 3-29.

Photograph 3-29:Remove Condenser Filter

3 Rinse the filter with water; blot dry with papertowels or vacuum.

WARNINGAvoid touching the cooling fins on the condenser unitas they are very sharp and can cause personal injury.

4 Vacuum the cooling fins on the front of thecondenser unit. (A soft bristle brush can be usedinstead of, or in addition to, the vacuum cleaner.)

5 Reinstall the condenser filter.

6 Close the front instrument panels.

7 Turn the instrument power ON, if powered OFFduring the procedure.


3.11 Clean Refrierator Condensor Filter

3 • 28

3.12 Clean Inlet Water Filter

3.12.1 IntroductionPerformance of this procedure prevents clogging ofthe water system and the reaction bath drain. Performthis procedure quarterly.



• The external instrumentwater supply must be OFF.

• Wear rubber gloves whenhandling internal watersystem components to assistin preventing the introductionof contaminants into thesystem.

Materials Required:

Water pump filter (if replacement is required)Paper towels (in case of spilled water)Deionized water500 mL beaker



3 • 29

3.12.2 Clean Inlet Water Filter

1 Turn the power switch to the OFF position or verifythe analyzer is in Stand-by. Turn off the externalwater supply.

2 Place a 500 mL beaker (or a similar type container)beneath the inlet water manifold.

3 Turn the knurled ring on the water filter capcounterclockwise and disconnect the inlet waterhose, as shown in Photograph 3-30.

4 Unscrew the water filter from the inlet water hoseconnector, as shown in Photograph 3-31. Placethe hose in the beaker.

5 Clean the filter thoroughly with deionized water,then reinstall the filter in the inlet water hoseconnector.

6 Reconnect the inlet water hose to the inlet watermanifold, as shown in Photograph 3-32.

7 Turn the external water supply ON.

8 Turn the power switch to the ON position if theanalyzer was powered OFF during the procedure.

,

Photograph 3-30:Disconnect Inlet Water Hose

Photograph 3-31:Remove Filter

Photograph 3-32:Reconnect Inlet Water Hose



3 • 30

3.13 Replace ISE Pinch ValveTubing

3.13.1 Introduction

The ISE pinch valve tubing must be periodicallyreplaced. Perform this procedure quarterly.


Precaution: The instrument must be inStand-by or OFF.Wear rubber gloves.

Materials Required:

ISE pinch valve tubing

3.13.2 Replace ISE Pinch Valve Tubing

1 Loosen the retaining nut and lift off the ISEcompartment cover, as shown in Photograph3-33.

Photograph 3-33:Remove ISE Cover


3.13 Replace ISE Pinch Valve Tubing

3 • 31

2 Remove the pinch valve tubing by pulling it off ofthe stainless steel connectors on either side of thecompartment, then through the pinch valve, asshown in Photograph 3-34.

3 Push one end of the new pinch valve tubing ontoone of the stainless steel connectors on eitherside of the pinch valve.

4 Thread the pinch valve tubing through the pinchvalve and push the end of the tubing onto theremaining stainless steel connector.

5 Replace the ISE compartment cover and tightenthe retaining nut.

3.13.3 Perform ISE Prime


Photograph 3-34:Remove Pinch Valve Tubing



1ENTER

3 • 32

2 Move the cursor to the ISE Prime field, as shownin Figure 3-11.

Figure 3-11: ISE Prime

3 Press 3 (Int. Ref. + DIL) ENTER to initiate an ISEprime. The ISE prime function is complete whenthe analyzer status line returns to Stand-by.

4 Perform ISE Calibration.

3ENTER



37.0 Stand-by 12/01/92 12:20


Choose 1:Int. Ref. 2:DIL 3:Int. Ref. + DIL 4:KCl 5:Prime All : ENTER

Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 33

3.14 Replace Pipettor Seals

3.14.1 Introduction

Pipettor seals should be replaced every 500 hours ofoperation. Based on the analyzer working 8 hours perday, 5 days per week this frequency is every threemonths. If your analyzer’s work load is higher, pipettorseals may require more frequent replacement.

This procedure is divided into seven parts:

• disassemble pipettor• expose pipettor seal• replace sample pipettor seal• replace reagent pipettor seal (includes ISE

pipettors)• reassemble pipettor• perform an air purge• ISE prime.




• Do not crimp (bend) pipettortubing.

• Perform the entire sealreplacement procedure onone pipettor put clean paperon to a table to work on beforeproceeding to the next.

• Wear rubber gloves whenhandling pipettor componentsand tubing to assist inpreventing the introduction ofcontaminants into the system.

Materials Required:

Sample pipettor:Syringe barrel o-ringO-ringSeals and spacer

Reagent pipettors:Syringe barrel o-ringO-ringSeal

ISE pipettors:Syringe barrel o-ringO-ringSeal

Spanner wrenchAbsorbent towelsGauze squares



3 • 34

3.14.2 Disassemble Pipettor

1 Open the front instrument panels.

2 Have dry gauze ready to catch water spillage.

3 Disconnect the tubing at the top of the lockingscrew (Photograph 3-36) by turning its retaining nutcounterclockwise.

4 Hold a dry gauze square or other absorbentmaterial next to the side tubing on the pipettor;disconnect this tubing by turning its retaining nutcounterclockwise. Use a gauze square to absorbwater as it drains from the tubing, as shown inPhotograph 3-35.

5 Loosen the knurled locking screw from the top ofthe pipettor assembly by turning itcounterclockwise, as shown in Photograph 3-36.

5 Carefully lift the syringe assy a little bit so the blueblase comes free from the aluminium mount block.While taking care that the plunger comes free fromthe U-shoped slot without bending (!) and the glassbarrel to come out of the locking screw pull thesyringe assy completely towards you. In case ofblocking lift further, or completely remove the bluelocking screw on top of the glass barrel.

Photograph 3-35:Disconnect Pipettor Tube

Photograph 3-36:Loosen Locking Screw

Photograph 3-37:Remove Syringe Assembly



3 • 35

7 Remove the glass syringe barrel. Remove the o-ring from the top of the barrel. Set them aside ina safe place. Remove the o-ring that fits below thesyringe barrel, as shown in Photograph 3-38, andset in a safe place. (Note: The o-ring that fitsabove the syringe barrel may not be present onyour analyzer or sticks in the blue locking screw;check and remove the small o-ring out of thelocking screw. This is normal and does not affectthe function of the 911.)

3.14.3 Expose Pipettor Seal

1 Turn the syringe holder upside down and exposethe plunger retaining screw.

2 Apply the spanner wrench to the plunger retainingscrew, as shown in Photograph 3-39, and turn thescrew counterclockwise until it is loose.

Photograph 3-38: Remove O-ring

Photograph 3-39:Remove Plunger Retaining Screw



3 • 36

3 Turn the syringe holder right side up and carefullylift the syringe holder off of the plunger. Leaveall of the parts on the plunger, as shown inPhotographs 3-40 and 3-41 to the right.

4

Photograph 3-40:Sample Plunger

Photograph 3-41:Reagent and ISE Plunger



IF... THEN...

you are replacing thesample pipettor seal

proceed to Section3.14.4.

you are replacing areagent pipettor sealor ISE pipettor seal


3 • 37

3.14.4 Replace Sample Pipettor Seal

1 Remove the first and second seals and spacerfrom the plunger, as shown in Photograph 3-42.

2 Wipe the plunger with a gauze square to removeany debris, carefully!

3 Ensure that the retaining screw and spring arepositioned on the plunger, then place a new sealonto the plunger, closed end first.

4 Thread the new spacer onto the plunger, and followit with the second seal, open end first. Replace theseals as shown in Figure 3-12.

CAUTIONDo not overtighten the syringe retaining screw. If theretaining screw is overtightened, the seal piece wearsout quickly and the plunger may bend, requiringreplacement.

Photograph 3-42:Remove Sample Probe Seals

Figure 3-12:Sample Pipettor Seal



SECONDSEAL

FIRSTSEAL

RETAININGSCREW

SPACER SPRING

3 • 38

5 With the syringe oriented vertically. Place theplunger back into the syringe holder. Tighten theretaining screw with the spanner wrench until thescrew is flush with the bottom surface of thesyringe holder, as shown in Photograph 3-43.

6 Proceed to Section 3.14.6, Reassemble Pipettor.

3.14.5 Replace Reagent Pipettor Seal

1 Remove the seal from the plunger, as shown inPhotograph 3-44.

2 Wipe the plunger with a gauze square or otherabsorbent material to remove any debris,carefully!

Photograph 3-43:Replace Retaining Screw

Photograph 3-44:Remove Reagent Pipettor Seal



3 • 39

3 After you ensure that the retaining screw, springand press piece are positioned on the plunger,place a new seal, with its flat surface up, onto theplunger, as shown in Figure 3-13. The spring fitsin the hollow portion of the press piece.

CAUTIONDo not overtighten the syringe retaining screw. If theretaining screw is overtightened, the seal piece wearsout quickly and the plunger may bend, requiringreplacement.

4 Place the plunger back into the syringe holder.With the syringe oriented vertically, as shown inPhotograph 3-45, tighten the retaining screw withthe spanner wrench until the screw is flush with thebottom surface of the syringe holder.

5 Proceed to Section 3.14.6, Reassemble Pipettor.

Figure 3-13:Reagent Pipettor Seal

Photograph 3-45:Replace Retaining Screw



RETAININGSCREW

SPRING

PRESSPIECE

SEAL

3 • 40

3.14.6 Reassemble Pipettor

1 Place the syringe holder o-ring into the syringeholder. The sample pipettor is used in Photograph3-46 for illustration. If the o-ring is damaged itshould be replaced.

2 Before replacing, all barrels should be cleaned with0,5% Hypochloride solution to remove any growthof alges/bacteriae and flushed with water.

3 Inspect the syringe barrel for chips or cracks at thetop and bottom. If the syringe barrel is etched ordamaged in any way, it should be replaced. Placethe syringe barrel over the piston, onto the syringeholder, as shown in Photograph 3-47. It is easierto place the barrel back on if the barrel and syringeholder are dry.

CAUTIONIf the syringe holder is not properly seated in itsmounting block recess, damage to the syringeassembly may occur.

Photograph 3-46:Replace Syringe Holder O-ring

Photograph 3-47:Replace Syringe Barrel



3 • 41

4 Place the syringe holder back onto its mountingblock by tilting the top of the syringe toward theinstrument, as shown in Photograph 3-48. Ensurethat the syringe holder is in the recess on the topsurface of the mounting block and the plunger isguided into the U-slot simultaneously.

5 Rotate the syringe holder until the side tube port ispositioned to accept the pipettor tubing.

6 Finger-tighten the top knurled locking screw, asshown in Photograph 3-49. Ensure that syringeassembly is seated correctly (not loose orcrooked).

7 After tightening the blue locking screw on top of theglass barrel, place back, if present before, thesmall O-ring via the hole of the blue locking screwon top of the glass barrel, as shown in Photograph3-50.

Photograph 3-48:Replace Barrel and Holder

Photograph 3-49:Tighten Locking Screw

Photograph 3-50:Position the Plunger



3 • 42

CAUTIONThe top and side tubing retaining nuts can bedamaged if excessive force is applied whenreplacing them. Take care not to cross-thread thesenuts.

8 Reconnect the pipettor’s top tubing and finger-tighten its retaining nut.

9 Reconnect the side tubing and finger-tighten itsretaining nut.

3.14.7 Perform an Air Purge


2 Move the cursor to the Air Purge entry field, asshown in Figure 3-14.

Figure 3-14: Air Purge

3 Press 1 (Start) ENTER to begin execution of the airpurge. The air purge function is complete whenthe Analyzer Status line returns to Stand-by.

4 When the air purge is complete, inspect thepipettors to ensure that no air remains in thepipettors, and no leaks are visible at any of theirfittings.

If desired, a precision check can be performed toverify pipettor precision.

1ENTER

1ENTER



37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

IF... THEN...

the sample or reagentseals were replaced


the ISE seals werereplaced


3 • 43

3.14.8 Replace ISE Pipettor Seals

To replace the ISE pipettor seals, follow the sameprocedures outlined for replacing the reagent pipettorseals. Refer to Section 3.14.3. In addition, an ISEPrime must be performed. The sipper syringecontains biohazardous materials. Use caution.

3.14.9 Perform ISE Prime


2 Move the cursor to the ISE Prime entry field, asshown in Figure 3-15.


3 Press the key corresponding to the desired prime,followed by ENTER to execute the ISE prime:

1 (Int. Ref.) ENTER2 (DIL) ENTER3 (Int. Ref. + DIL) ENTER4 (KCl) ENTER5 (Prime All) ENTER

The ISE prime function is complete when theAnalyzer Status line returns to Stand-by.

4 After the ISE Prime is complete, inspect thepipettors to ensure that no air remains in thepipettors and no leaks are visible at any of theirfittings.

If desired, a precision check can be performed toverify pipettor precision.



1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 44



NOTES

3 • 45

3.15 Floppy Disk Replacement

3.15.1 Introduction

The floppy disks must be replaced, when the diskshave been accessed 100,000 times. The instrumentautomatically keeps track of the number of times thedisks are accessed and issues an alarm, Replace FD(alarm code 125-1 or 125-2) at power up when the limitis reached.

Replacement System and Data disks may bepurchased from Boehringer Mannheim, or copiesmay be made onto appropriate blank diskettes (afterthey are formatted). Blank diskettes may bepurchased from most office supply or computersupply stores and must meet the followingspecifications:

• Double sided, unformatted, 3.5 inch• High density (2.0 Megabytes)• Double track (80 sectors/track)• 135 TPI

This procedure is divided into four parts:

• format a new blank disk• create a new system disk• create a new data disk.



Precautions: • The instrument must be inStand-by.

• Use only blank disks that meet

the specifications outlinedabove.

• Wait until a requested functionis complete before attemptinganother keyboard entry.

Materials Required: Boehringer MannheimCatalog Number:

Blank disks obtain locally

3.15.2 Format a Blank Disk


2 Advance the cursor to the FD Utility entry field, asshown in Figure 3-16.

Figure 3-16: Format Blank Disk

3. UNSCHEDULED MAINTENANCE


1ENTER

37.0 Stand-by 12/01/92 12:20


Choose 1:Format FD Dr. 2 2:Copy FD Dr. 1 (to 2) 3.Format & Copy : ENTER

Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 46

CAUTIONFailure to replace the data disk in drive 2 with a blankdisk will result in the LOSS OF ALL DATA ON THEDATA DISK.

3 Remove the data disk from drive 2 and insert thedisk to be formatted.

4 Press 1 (Format FD in Drive 2) ENTER and the CRTdisplays "Are You Sure?".

5 Press 1 (Continue) ENTER and the instrument willformat the new disk, or press 0 (Cancel) ENTER toabort this function. (When the cursor moves to thenext entry field, the formatting procedureis complete.)

3.15.3 Create a New System Disk

NOTEA formatted blank disk must be used to create a newsystem disk. Refer to Section 3.15.3 for diskformatting instructions. Boehringer Mannheimrecommends storing the master copy of your systemdisk in a safe place, and working from a copy of themaster system disk. Section 3.15.4 explains how tocreate a copy of the master system disk.



Figure 3-17: Create System Disk



1ENTER

1ENTER

1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 47

3 Place the master system disk in drive 1. Removethe data disk from disk drive 2, and replace it witha formatted blank disk.

4 Press 2 (Copy FD Drive 1 to Drive 2) ENTER andthe CRT displays "Are You Sure?".

5 Press 1 (Continue) ENTER and the instrument willcopy the system disk in drive 1 onto the blank diskin drive 2, or press 0 (Cancel) ENTER to stop thisfunction. When the cursor moves to the next entryfield, the copy procedure is complete.

6 Remove the newly copied system disk from drive2. Attach a label indicating the drive number,version number of system disk and date ofcreation. Properly store the master system diskand insert the copy of the system disk back intodrive 1. Insert the data disk back into drive 2.



2ENTER

ENTER1

3.15.4 Create a New Data Disk

NOTEA formatted blank disk must be used to create a newdata disk. Refer to Section 3.15.3 for disk formattinginstructions.



Figure 3-18: Create Data Disk

3 Remove the system disk from drive 1 and place itin its protective envelope.

1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 48

4 Remove the data disk from drive 2. Place the datadisk to be copied in drive 1, then place a formattedblank disk in drive 2.

5 Press 2 (Copy FD Dr. (1 to 2)) ENTER and the CRTdisplays "Are You Sure?".

6 Press 1 (Continue) ENTER and the instrument willcopy the data disk in drive 1 onto the blank disk indrive 2, or press 0 (Cancel) ENTER to abort thisfunction. When the cursor moves to the next entryfield, the copy procedure is complete.

7 Remove the old data disk from disk drive 1 andreplace it with the system disk.

8 Press the ROUTINE key, followed by 4 ENTER todisplay the START CONDITIONS screen.

9 Advance the cursor to the Clear Results entryfield, as shown in Figure 3-19.

Figure 3-19: Clear Results

CAUTIONClearing all results also clears individual daily controlresults. If this is not desired, individually clear normaland stat data using options 1 and 2.

10 Press 4 (All) ENTER and the CRT displays"Are You Sure?".

2ENTER

1ENTER

4ENTER

4ENTER



37.0 Stand-by 12/01/92 12:20

4 Start Conditions

Choose 1:Clear Routine Sample Results 2:Stats 3:Controls 4:All : ENTER



[ ] : [ 0] [ 1][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ] : [ ] - [ ][STD Cup ]


Off

ReportOn

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL

3 • 49

11 Press 1 (Continue) ENTER and the instrument willclear all copied patient files from the new DataDisk, or press 0 (Cancel) ENTER to abort thisfunction. When the cursor moves to the next entryfield, the data clear procedure is complete.

ENTER1



3 • 50

3.16 System Software Installation

3.16.1 Introduction

From time to time, Boehringer Mannheim will provideyou with enhanced system software for yourinstrument. The following procedure containsinstructions for installing new system disk software.



Precautions: • Instrument power must beOFF, initially.


3.16.2 System Software Installation

1 Before installing a new system disk, ensure thatyou have made a working copy of your currentmaster system disk. The working copy should beused when performing the new softwareinstallation procedure.

2 Place the new system disk and your existing datadisk in the appropriate drives and power up theanalyzer.

3 After the analyzer has gone to Stand-by, removethe new system disk from the disk drive andreplace it with the old system disk.


5 Move the cursor to the Parameter Read/Writefield, as shown in Figure 3-20.

Figure 3-20:Read Parameters From Old System Disk

6 Press 1 (Read from FD) ENTER. When the prompt“Are You Sure?” appears at the bottom of thescreen, press 1 (Continue) ENTER to read theoperating parameters from the old system disk intomemory. The parameter read function is completewhen the Analyzer Status line returns to Stand-by.

7 Press the ROUTINE key, followed by 1 ENTER to


3.16 System Software Insatllation

1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

1ENTER

3 • 51

display the REAGENT STATUS screen.

Figure 3-21: Check For Parameters

Verify that your parameters are present by checkingthe test key matrix on the bottom of the screen. Thematrix must match your keyboard setup onthe analyzer.

If the matrix does not match the keyboard, performsteps 3-7 again. If it still does not match, callCustomer Technical Support.

NOTEAnother way to verify that your parameters are presentis to display the CHEMISTRY PARAMETERSscreen. Press the PARAMETER key followed by 1ENTER. Once the screen is displayed, press any testkey and verify that the parameters for that test arecorrect by checking the display against theappropriate application sheet.

1ENTER



8 After verifying that your parameters are present,remove the old system disk from the disk driveand replace it with the new system disk.

9 Press the MAINTENANCE key, followed by 1ENTER to call up the ANALYZER MAINTENANCEscreen.

Figure 3-22:Write Parameters to New System Disk

1ENTER

37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

37.0 Stand-by 12/01/92 12:20

1 Reagent Status



CancelPrint

Hitergent Disk 1

1 2 3 4 5 6 7 8 9 10 12

13 14 15 16 17 18 19 20 21 22 23 24

25

11

26 27 28 29 30 31 32 33 34 35 36

37 38 39 40 41 42 43 44 45 46S.IND

ISE A B C

D E F

G H I

J K L



MON. CHEM6 CHEM7

ALL


2

[ ][ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ][ ]

[ ] 80 mL[ ] 80 mL[ ] mL[ ] mL[ ] mL

Y e sY e s3 7 02 3 02 7 0

THEO

3 • 52



Advance the cursor to the Parameter Read/Write field, as shown in Figure 3-23. Press 2(Write to FD) ENTER.

When the prompt “Are You Sure?” appears at thebottom of the screen, press 1 (Continue) ENTER towrite the operating parameters onto the newsystem disk.

10 Verify that all parameters were transferred bypowering OFF the analyzer, then powering it backON with the new system disk. Call up theCHEMISTRY PARAMETER and REAGENTSTATUS screens to verify the presence of yourparameters. If they were not transferred, PowerOFF and repeat this procedure, beginning withstep 2. If the parameters are not transferred afterrepeating the procedure, call Customer TechnicalSupport.

11 When you have verified that all parameters weretransferred, calibrate the analyzer and run controlsto verify proper system operation.

12 Format a disk following the instructions in Section3.15.3. Use this formatted disk to make a copy ofthe new system disk you just installed, using theprocedure found in Section 3.15.4.

2ENTER

ENTER1

3 • 53

3.17 Clean Cell Rinse Unit

3.17.1 Introduction

Normal daily washing sufficiently cleans the cell rinseunit in most cases. If the rinse unit becomes clogged,follow this procedure to thoroughly clean the cloggednozzle.


• clean clogged nozzle• perform Mechanisms Check.



Materials Required:

Wire styletNew nozzle tip (squeegee), if needed

3.17.2 Clean Clogged Nozzle

1 Loosen the retaining nut by turning itcounterclockwise. Remove the cell rinse unitfrom the mounting bracket, as shown inPhotograph 3-52.

Photograph 3-52:



3 • 54

Remove Cell Rinse Unit

2 Insert the wire stylet into the end of each nozzleto clean, as shown in Photograph 3-53. Take carenot to bend the nozzles, or insert the wire stylet todeep into the nozzle.

3 If the nozzle tip is clogged heavily or wornexcessively, replace it with a new one. To removethe nozzle tip, pull it away from the nozzle, asshown in Photograph 3-54. When attaching thenew nozzle tip, make sure it is positioned as shownin the photo to the right.

4 Replace the cell rinse unit in its proper position andtighten the retaining nut, as shown in Photograph3-55. Make sure that the pin on the mountingbracket aligns with the hole on the bottom of thecell rinse unit.

Photograph 3-53:Clean Nozzles

Photograph 3-54:Replace Nozzle Tip

Photograph 3-55:Replace Cell Rinse Unit



3 • 55

3 Type 10 ENTER. The analyzer will perform themechanism check 10 times. Make sure that therinse water does not overflow from the reactioncells to the reaction bath. If the rinse water doesoverflow into the bath, make sure the cell rinse unithas been replaced properly and repeat themechanism check. If the water still overflows,Call Technical Support.



3.17.3 Perform a Mechanism Check

1 Press the MAINTENANCE key, followed by 2ENTER to display the MECHANISMS CHECKscreen.

2 Move the cursor to the Mechanism Check field,as shown in Figure 3-23.

Figure 3-23: Mechanism Check

2ENTER

1 0ENTER

37.0 Stand-by 12/01/92 12:20

2 Mechanisms Check

Select the Number of Repetitions 1 to 9999 : ENTER

Probe Adjust


Printer Check


FD Special Copy


[ ]H1 : 84.6 H2 : 42.4

[ ][ ][ ]

[ ]

[ ] [ ][ ][ ]

[ ]

[ ]

3 • 56

3.18 Replace Photometer Lamp

3.18.1 Introduction

The photometer lamp should be replaced if any of thedaily photometer check values exceed 13000.


• remove reaction disk• replace photometer lamp• reinstall reaction disk• perform cell blank• recalibrate.



Precautions: • Instrument power must beOFF.

• Allow old lamp to cool beforereplacing.

• Do not touch or clean the glasssurface of the new photometerlamp.

• Take care not to damage thereaction cells while thereaction disk is off theinstrument.

Materials Required:

Photometer lampPhillips screwdriverGauze squares



3 • 57

3.18.2 Remove Reaction Disk

1 Turn the instrument power switch OFF.

2 Turn the retaining nut on the reaction cell rinse unitcounterclockwise. When the nut is loosenedcompletely, carefully remove and place the entireunit aside, as shown in Photograph 3-56.

3 Turn the black retaining nut counterclockwise andremove it from the reaction disk, as shown inPhotograph 3-57.

4 Carefully lift the reaction disk from the instrument.Place the disk on a flat, stable surface.

Photograph 3-56:Remove Cell Rinse Unit

Photograph 3-57:Remove Reaction Disk



3 • 58

3.18.3 Replace Photometer Lamp

1 Remove the black and red photometer lamp leadwire connector nuts, as shown in Photograph 3-58.Set them aside in a safe place and remove the leadwires from the connector posts.

2 Loosen the screws on top of the photometer waterjacket with a Phillips screwdriver, as shown inPhotograph 3-59.

3 Lift the water jacket containing the photometerlamp from the analyzer, as shown in Photograph 3-60.

Photograph 3-58:Remove Lead Wire Connector Nuts

Photograph 3-59:Loosen Water Jacket Screws

Photograph 3-60:Remove Water Jacket



3 • 59

4 Loosen screws on the lamp base with a Phillipsscrewdriver, as shown in Photograph 3-61.

5 When both screws are sufficiently loosened, thelamp can be removed from its water jacket, asshown in Photograph 3-62. The lamp mountingscrews are threaded so that they are not easilyremoved from the lamp base plate. This preventsthem from falling into the interior of the instrument.

6 Remove the new lamp from its packaging. Do nottouch or clean the glass surface of the lamp.

7 Insert the new lamp into the water jacket.

8 The alignment pin on the side of the water jacketmust be inserted into the pin alignment in thelamp’s mounting base, as shown in Photograph 3-63.

Photograph 3-61:Loosen Lamp Screws

Photograph 3-62:Remove Photometer Lamp

Photograph 3-63:Replace Photometer Lamp



3 • 60

9 Tighten the lamp mounting screws until snug; donot overtighten them.

10 Replace the water jacket on the analyzer, asshown in Photograph 3-64. Tighten the waterjacket screws.

11 Place the lamp lead wires on the threadedconnector posts, as shown in Photograph 3-65.The lamp lead wires are not color coded and eitherwire may be connected to either post.

12 Replace the black and red lead wire connectornuts and finger-tighten. Do not allow the lead wiresto rotate as the connector nuts are tightened. Itdoes not matter which connector nut is placed onwhich lead wire.

13 With a clean, dry gauze square, carefully wipe theinside surfaces of the U-shaped reaction diskphoto detectors (D101, D102, D103), as shown inPhotograph 3-66.

Photograph 3-64:Replace Water Jacket

Photograph 3-65:Replace Lead Wires

Photograph 3-66:Clean Disk Detectors



3 • 61

3.18.4 Reinstall Reaction Disk

1 Reinstall the reaction disk, aligning the guide pinon the reaction disk shaft with the pin hole in thereaction disk, as shown in Photograph 3-67.

2 Return the black knurled nut to the reaction diskshaft and turn it clockwise until snug, but not tight.

3 Return the reaction cell rinse unit to its properposition over the reaction disk. (An alignment pinon the rinse unit main shaft fits into a slot in therinse unit mounting bracket.)

4 Finger-tighten the knurled nut on the cell rinse unitmounting bracket.

3.18.5 Perform Cell Blank

1 Turn the instrument power switch on and wait forthe instrument to enter Stand-by and for thetemperature to stabilize.

2 Perform a Cell Blank according to the procedure inSection 3.7.2.

3.18.6 Recalibrate

1 Calibrate all photometric chemistries prior toassaying controls and other samples.

2 Follow the procedure for full calibration outlined inSection 2.3.

Photograph 3-67:Align Pin to Position Reaction Disk



3 • 62

3.19 Clean ISE Reagent Flowpath

3.19.1 Introduction

This procedure should be performed only at thedirection of Boehringer Mannheim TechnicalSupport .

This procedure is divided into three parts:

• clean ISE reagent flowpath• perform ISE check• calibrate ISE system.



Precautions: • The instrument must be inStand-by.


• Make certain that the ISEreagent lines are correctlylabeled.

• Wear rubber gloves whenhandling ISE reagent lines toassist in preventing theintroduction of contaminantsinto the system.

Materials Required:

ISE Cleaning Solution500 mL beakerGauze squaresDeionized water



3 • 63

3.19.2 Clean ISE Reagent Flowpath

1 Remove the ISE reagents from the top of theanalyzer.

2 Pour at least 200 mL of ISE Cleaning Solution in a500 mL beaker. Place the beaker where the ISEreagents are normally located on the analyzer. Putthe Internal Reference (IS) and Diluent (DIL) andKCl- reagent lines in the beaker, as shown inPhotograph 3-68.




1ENTER

Photograph 3-68:Put IS and DIL Lines Into NaOH

3 • 64

4 Move the cursor to the ISE Prime field, as shownin Figure 3-24.


5 Press (All) ENTER to initiate an ISE Prime. TheISE Prime function is complete when the AnalyzerStatus line returns to Stand-by.

Once the ISE-cleaning-solution has entered thesystem by priming, immediately preceed to thenext steps, without any break or pause. At all timesit should be prevented that ISE-cleaning solutionhas opportunity to diffuse into the liquid carriingplastic parts of the ISE, due to longer detection.Detection < 5 minutes.

6 Remove the Internal Reference (IS) and Diluent(DIL) and KCl- reagent lines from the beaker of ISECleaning Solution. Dispose of the NaOH and rinsethe beaker several times with deionized water.

7 Execute step 5 again with all reagent lines put intoa beaker with deionized or distilled water.

8 Use a clean gauze square to wipe off the externalsurfaces of the reagent lines, then place the linesback into their respective reagent containers.The ISE reagent lines have white plastic collarsand are labeled as follows:

20 - - Internal Standard30 - - Diluent40 - - KCl

9 Press 3 (IS + DIL) ENTER to initiate an ISE prime.The ISE prime function is complete when theAnalyzer Status line returns to Stand-by. Repeatthe prime.

3.19.3 Calibrate ISE System

Calibrate the ISE system before assaying anyunknown samples. Follow the instructions forcalibration found in Section 2.3. If the calibrationfails, try recalibrating. If recalibration fails, a problemis indicated and should be investigated (see Chapter4, Troubleshooting).



37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3ENTER

3 • 65

3.20 Replace ISE MeasuringCartridge (Na +, K+, Cl-)

3.20.1 Introduction

The electrical response of each measuring cartridgedecreases gradually with the length of time it is in use,and is dependent upon proper maintenance. An ISEcartridge must be replaced when its slope falls outsideof the critical slope values:

When the slope is less than the optimal values, anISE Slope Warning alarm is issued. This alarm alertsyou that a replacement cartridge is needed. Thecartridge that caused the alarm may continue to beused if all controls are still in range. If any controlsare out of range, or the slope falls outside the criticalvalue, the cartridge must be replaced. An ISE SlopeError: Replace Cart. alarm is issued when the valuesfall below the critical slope.


• remove old cartridges• install new cartridges• prime ISE system• precondition with dummy sampling• perform ISE check• calibrate ISE system.



Precautions : • The instrument must be inStand-by or OFF.


• Wear rubber gloves whenhandling internal ISE systemcomponents to assist inpreventing the introduction ofcontaminants into the

system.

Materials Required:

Sodium (Na+) cartridgePotassium (K+) cartridgeChloride (Cl-) cartridgeGauze squaresLarge tweezers


3.20 Replace ISE Measuring Cartridge (Na +, K+, Cl -)

≤ 32

≤ 32

≥ -25

38.0 to 68.0

38.0 to 68.0

-30.0 to -68.0

Sodium (Na+)

Potassium (K+)

Chloride (Cl-)

CARTRIDGE OPTIMAL SLOPE CRITICAL SLOPE

3 • 66

3.20.2 Remove Old Cartridge

1 Loosen the retaining nut holding the ISEcompartment cover in place and lift the cover fromthe compartment, as shown in Photograph 3-69.

2 Remove the color-coded lead wires from thecartridges, as shown in Photograph 3-70.

3 Press the release lever back to loosen thecartridges in their mounting block, as shown inPhotograph 3-71.

Cl -- blue

Na+ - yellow

K +- red

Photograph 3-69:Remove ISE Cover

Photograph 3-70:Remove Lead Wires

Photograph 3-71:Pull Lever to Release


3.20 Replace ISE Measuring Cartridge (Na +, K+, Cl-)

3 • 67

4 Use large tweezers to remove the cartridges fromthe block, as shown in Photograph 3-72.

CAUTIONCheck the expiration date on the new cartridge. Do notuse any cartridge beyond its expiration date.Check if all old cartridges still have there O-ring inposition. If not, check the block, the O-ring could bethere and spoil the sealing of new cartridges.

5 Replace the expired cartridge with a new one,keeping all three cartridges in their original order.

CAUTIONIf the cartridges are not seated properly, the ISEassembly may leak, resulting in a malfunction.

3.20.3 Install New Cartridge

1 Make certain that the o-ring on the upper side ofeach cartridge and the base is dry when thecartridges are fitted together.

2 The cartridges must be stacked in the followingorder, from back to front:

Chloride ........... (blue) .......... BackSodium ............ (yellow) ....... MiddlePotassium ....... (red) ............ Front

The analyzer is marked to show the correctposition of each cartridge. Refer to Figure 3-25 andPhotograph 3-71 for the proper orientation.

Photograph 3-72:Remove Cartridges

Figure 3-25:ISE Cartridge Positioning



Cl- - blue

Na+ - yellow

K+ - red

3 • 68

3 Replace the cartridges as shown in Photograph 3-73.

4 Pull the lock lever forward into place. Thispositions the base fitting of the ISE assembly andsecures the cartridges in place.

5 Reconnect the color-coded lead wires to theirrespective cartridges, as shown in Photograph 3-74. The lead wires must be connected to theproper cartridges.

CAUTIONIf any spilled or leaked liquid is visible in the ISEcompartment, clean and dry the compartment asthoroughly as possible. Liquid and air leaks canprevent the ISE system from operating properly.

6 Replace the ISE compartment cover.

Photograph 3-73:Install Cartridges

Photograph 3-74:Reconnect Lead Wire

3.20.4 Prime ISE System

1 If the analyzer was OFF during cartridgereplacement, turn the power switch back ON.


3.20 Replace ISE Measuring Cartridge (Na +, K+, Cl-)

3 • 69




4 Press 3 (Int. Ref + DIL) ENTER to initiate an ISEprime cycle. The ISE prime is complete when theAnalyzer Status line returns to Stand-by.


- Precondition the system (see 3.19.3)

- Calibrate the ISE system before assaying anyunknown samples. Refer to Section 2.3 forcalibration instructions. If the calibration fails, tryrecalibrating. If recalibration fails, a problem isindicated and should be investigated (see Chapter4, Troubleshooting).

1ENTER

3ENTER



37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 70

3.21 Replace ISE ReferenceCartridge

3.21.1 Introduction

The reference electrode should be replaced at thefollowing conditions:

• Every six months-preventive maintenance• When the ISE check value for the reference

electrode is outside limit ± 7 mV• When slope values for Na+, K+ and Cl- are unstable

nearly or simultaneous.


• remove old cartridge• install new cartridge• prime ISE system• perform ISE check• calibrate ISE system.





• Wear disposable gloves whenhandling internal ISE systemcomponents to assist inpreventing the introduction ofcontaminants into the

system.

Materials Required:

Reference cartridgeLarge tweezersPhillips screwdriverPaper towels


3.21 Replace ISE Reference Cartridge

3 • 71

3.21.2 Remove Old Cartridge

1 Remove the reagent lines from the ISE reagentbottles and place the lines on a paper towel. Makesure the lines do not touch. Remove the reagentbottles from the top of the analyzer.

2 Loosen the retaining nut holding the ISEcompartment cover in place and lift the cover fromthe analyzer, as shown in Photograph 3-75.

3 Using a Phillips screwdriver, remove the screwand washer holding the reference cartridgecompartment cover in place, as shown inPhotograph 3-76.

4 Remove the back left instrument panel from thereference cartridge compartment, as shown inPhotograph 3-77.

Photograph 3-75:Remove ISE Compartment Cover

Photograph 3-76:Loosen Screws

Photograph 3-77:Remove Compartment Cover



3 • 72

5 Disconnect the reference cartridge lead wire, asshown in Photograph 3-78.

6 Push the reference cartridge clamp back with yourthumb and lift the reference cartridge from thecompartment using tweezers, as shown inPhotograph 3-79. Inspect the compartment forsalt buildup and clean if necessary with a dampgauze.Check if the small black O-ring is still on thecartridge and did not stick in the compartment.

Photograph 3-78:Disconnect Lead Wire

Photograph 3-79:Push Clamp Back



3 • 73

3.21.3 Install New Cartridge

1 Install the new reference cartridge; the clamplocks the cartridge into position, as shown inPhotograph 3-80.

2 Reconnect the reference cartridge lead wire, asshown in Photograph 3-81.

3 Replace the back left instrument panel over thereference cartridge compartment, as shown inPhotograph 3-82, and tighten the screws, using aPhillips screwdriver.

Photograph 3-80:Install New Cartridge


Photograph 3-82:Replace Back Left Cover



3 • 74

4 Replace the ISE compartment cover, as shown inPhotograph 3-83.

5 Replace the ISE reagent bottles in the properpositions and insert the correct line into eachreagent bottle.

Photograph 3-83:Replace ISE Compartment Cover



3 • 75

3.21.4 Prime ISE System

1 If the instrument was OFF during cartridgereplacement, turn the power switch back ON.




4 Press 4 KCl ENTER to initiate an ISE prime cycle.The ISE prime function is complete when theAnalyzer Status line returns to Stand-by.


Calibrate the ISE system before assaying anyunknown samples. Follow the instructions forcalibration found in Section 2.4. If the calibrationfails, try recalibrating. If recalibration fails, a problemis indicated and should be investigated (see Chapter4, Troubleshooting).

1ENTER

4ENTER



37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 76

3.22 Check/Refill MulticleanSolution

3.22.1 Introduction

Check the Multiclean container daily. If less than 4cm of liquid remains in the container, refill thecontainer.


Precaution: Multiclean is a concentratedsolution. Wear gloves whenhandling it. Clean any spillsfrom the analyzer immediately.

Materials Required

MulticleanFunnelPaper Towels

3.22.2 Procedure

1 Open the front panels of the analyzer. Check the

level of the Multiclean solution.


3.22 Check/Refill Multiclean Solution

IF... THEN...

the level is lessthan 4 cm

proceed to Step 2.

the level is greaterthan 4 cm

close the front panelsand proceed with dailystart up procedures.

3 • 77

2 Use the metal handle to gently pull the tray holdingthe Multiclean container up, then forward, asshown in Photograph 3-84.

3 Loosen and remove the cap from the container, asshown in Photograph 3-85.

4 Place the funnel into the container. Fill thecontainer with fresh Multiclean solution, as shownin Photograph 3-86.

5 Remove the funnel and place it on a paper towel orother absorbent material. Use a paper towel toclean up any spillage of the solution.

Photograph 3-84:Pull Out Tray

Photograph 3-85:Remove Cap

Photograph 3-86:Fill Bottle



3 • 78

6 Replace the cap on the container, as shown inPhotograph 3-87.

7 Gently slide the tray holding the Multicleancontainer back into position, as shown inPhotograph 3-88.

8 Close the front panels of the analyzer.

Photograph 3-87:Replace Cap

Photograph 3-88:Push Tray Inside Instrument



3 • 79

3.23 Replace Sample Probe

3.23.1 Introduction

Replacing the sample probe is necessary only whena sample probe is bent or otherwise damaged. Youmay, however, need to remove the probe for cleaning.


• remove sample probe• install new sample probe• check/adjust probe alignment• perform an air purge.



Precautions : • The instrument must be inStand-by or OFF during probereplacement.


• Wear disposable gloves whenhandling probe seals to assistin preventing the introductionof contaminants into thesystem.

Materials Required:

Sample probeWire styletGauze squares



3 • 80

3.23.2 Remove Sample Probe

1 Ensure that the instrument is in Stand-by or OFF.Figure 3-28 illustrates the sample probe arm.

2 Before touching any part of the sample arm/probebe sure you are not static loaded. Grab anygrounded metal part (e.g. water-hose) with bothhands for ∼ 10 " before touching the sample arm/probe. Remove the probe arm cover by graspingthe front with your thumb and forefinger and liftingup gently. This exposes the two lead wires and theretaining nut. Refer to Photograph 3-89 and Figure3-29, on the following page.

Figure 3-28: Sample Probe with Cover

Photograph 3-89:Remove Sample Probe Arm Cover



Squeeze to releasesample probe cover

3 • 81

Top of sample probe arm

Retaining nut

Lead wires

Figure 3-29: Removing Sample Probe Cover



3 • 82

3 Disconnect the two lead wires. Hold the end of thelead wire contained in the mounting bracket withthe thumb and forefinger of one hand. Gently pullthe other end of the lead wire out with the thumband forefinger of your free hand until itdisconnects. Repeat the procedure for the secondlead wire. Refer to Photograph 3-90 and Figure 3-30, on the following page.

4 Loosen the sample probe retaining nut by turningit clockwise, as shown in Photograph 3-91. Takecare not to loose the white teflon seal betweentube-end and needle.


Photograph 3-91:Loosen Retaining Nut



3 • 83



Figure 3-30: Sample Probe Lead Wires and Retaining Nut

Ends stay inmounting brackets

Gently pull leadwires out

Turn retaining nutclockwise to loosen

3 • 84

5 Lift the probe from the probe arm, as shown inFigure 3-31 on the following page.

6 Locate the probe seal either on the end of the probeor in the retaining nut, as shown in Photograph 3-92.

7 Place the probe seal in a safe place.

8 Run the thin stainless steel wire stylet through theprobe from the bottom, as shown in Photograph 3-93, until the probe is clear.

9 Rinse the inside of the probe thoroughly withdeionized water, then wipe the probe with cleangauze squares.

10 Replace the probe seal on the probe.

11 Continue with Section 3.23.3, Step 2.

Photograph 3-92:Locate Probe Seal

Photograph 3-93:Clean Sample Probe



IF... THEN...

you are removing thesample probe to cleanit

proceed with Step 7.

you are removing thesample probe toreplace it


3 • 85

Figure 3-31: Removing Sample Probe



Locate probe seal, either on end of probeor inside the retaining nut

Lift probe out ofprobe arm

3 • 86

3.23.3 Install New Sample Probe

1 Insert the new probe seal (packaged with the newprobe) into the sample probe, as shown inPhotograph 3-94.

2 Insert the probe and seal into the sample probearm.

3 Tighten the retaining nut, as shown in Photograph3-95, making sure the probe seal is in place.

4 Reconnect the lead wires, as shown in Photograph3-96 and in Figure 3-32 on the following page. Takecare not to mix up the wire connecfious.

Photograph 3-94:Replace Probe Seal

Photograph 3-95:Tighten Retaining Nut

Photograph 3-96:Reconnect Lead Wires



3 • 87

Figure 3-32: Reconnect Sample Probe Lead Wires and Retaining Nut



Ends stay inmounting brackets

Reconnect leadwires

Turn retaining nutcounter-clockwise to

tighten

3 • 88

5 Replace the sample probe arm cover, making surethe spring inside the cover faces the front of thesample probe arm. Refer to Photograph 3-97 andFigure 3-33, on the following page.

6 Verify proper spring return action of the probe.Grasp the probe between your thumb andforefinger and gently move it up. Upon releasingyour grasp, the probe should spring downward. Ifthe probe does not respond as described, removethe sample arm cover and check the lead wires tomake sure they do not impede movement of theprobe.

Photograph 3-97:Replace Sample Probe Arm Cover



3 • 89

Figure 3-33: Replace Sample Probe Arm Cover



Replace sample probearm cover

Retaining nut

Lead wires inproper position

3 • 90

3.23.4 Check/Adjust Horizontal SampleProbe Alignment

1 If instrument power was OFF during probereplacement, turn the instrument power switchON.


3 Move the cursor to the Probe Adjust field, asshown in Figure 3-34.

Figure 3-34: Probe Adjust



2ENTER

1ENTER

37.0 Stand-by 12/01/92 12:20

2 Mechanisms Check


Probe Adjust


Printer Check


FD Special Copy


[ ]H1 : 84.6 H2 : 42.4

[ ][ ][ ]

[ ]

[ ] [ ][ ][ ]

[ ]

[ ]

Reaction Cell

Probe +

+

4 Press 1 ENTER to initiate a sample probealignment check.

5 Check the sample probe for correct alignment overthe reaction cells. The probe tip must be centeredover the reaction cell, as shown in Figure 3-35.

Figure 3-35: Probe Alignment

6 Gently bend the probe, in an arc, over its entirelength, to center its tip over the reaction cellbeneath it.

7 Press STOP to terminate probe adjust.

STOP

3 • 91

3.23.5 Check/Adjust Vertical SampleProbe Alignment

1 Press 2 S.PROBE 2 ENTER from the ProbeAdjust field to initiate a vertical sample probeadjust.

2 Place an empty normal 2.0 mL sample cup inposition 1 on the outer ring of the sample disk.Press the SAMPLING STOP key. The probe willdescend until the bottom of the sample cup isdetected. The distance descended is stored inmemory (shown as H1 on the MECHANISMSCHECK screen) and the probe returns to the rinsestation.

3 Place a primary tube in position 1 on the outer ringof the sample disk and put an empty sample cupon the tube. Press the SAMPLING STOP key.The probe will descend until the bottom of thesample cup on the tube is detected. The distancedescended is stored in memory (shown as H2 onthe MECHANISMS CHECK screen) and the probereturns to the rinse station.

4 Do not mix up this sequence:H1: Cup onlyH2: Cup on tubePress PAGE FORWARD followed by PAGEBACK to view the new H1 and H2 values as theyare not updated on the CRT on a real-time basis.

NOTEDuring routine sampling, visually verify alignment ofthe sample probe over the sample cup (or tube).Proper alignment of the probe over the reaction cellensures that the sample probe is also centered overthe sample cup (or tube).





2ENTER

SAMPLINGSTOP

SAMPLINGSTOP

1ENTER

3 • 92

2 Move the cursor to the Air Purge entry field, asshown in Figure 3-36.


3 Press 1 ENTER to initiate an air purge. The airpurge function is complete when the AnalyzerStatus line returns to Stand-by.

ENTER1



37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 93

3.24 Replace Reagent Probes

3.24.1 Introduction

Replacing the reagent probe is necessary only whena reagent probe is bent or otherwise damaged. Thereagent probe may need to be removed for cleaning.


• remove damaged reagent probe• install new reagent probe• check/adjust probe alignment• perform an air purge.



Precautions: • The instrument must be inStand-by or OFF during probereplacement.


• Wear disposable gloves whenhandling probe seals to assistin preventing the introductionof contaminants into thesystem.

Materials Required:

Reagent probe Wire styletGauze squares



Put the tube underthe nozzle

Put the tube underthe nozzle

Joint

Joint

Nozzle

3 • 94

3.24.2 Remove Reagent Probe

1 Ensure that the instrument is in Stand-by or OFF.Figure 3-37 illustrates the reagent probe arm.Before touching any part of the reagent arm/probebe sure you are not static loaded.

2 Remove the reagent probe arm cover by graspingthe front with your thumb and forefinger and gentlylifting up. This exposes the lead wire and theretaining nut. Refer to Photograph 3-98 and Figure3-38, on the following page.

Figure 3-37: Reagent Probe with Cover

Photograph 3-98:Remove Reagent Probe Arm Cover



Squeeze here torelease reagent

probe cover

3 • 95

Figure 3-38: Remove Reagent Probe Arm Cover



Remove reagentprobe arm cover

Retaining nut

Lead wire

3 • 96

3 Disconnect the lead wire. Hold the end of the leadwire contained in the mounting bracket with thethumb and forefinger of one hand. With your freehand, gently pull the other end of the lead wire outuntil it disconnects. Refer to Photograph 3-99 andFigure 3-39, on the following page.

4 Loosen the retaining nut by turning itcounterclockwise. Refer to Photograph 3-100 andFigure 3-39, on the following page.Take care not to loose the black rubber sealbetween connector and probe.

5 Locate the probe seal either on the end of the probeor in the retaining nut. Refer to Photograph 3-101on this page and Figure 3-39, on the following page.


Photograph 3-100:Loosen Retaining Nut

Photograph 3-101:Locate Probe Seal



3 • 97

Figure 3-39: Loosen Reagent Probe Lead Wire and Retaining Nut



Pull lead wire apart

Leave in mountingbracket

Probe seal

Turn retaining nutcounter clockwise to

loosen

3 • 98

6 Lift the reagent probe and white plastic holder fromthe reagent probe arm. Refer to Photograph3-102 and Figure 3-40, on the following page.

7 Place the probe seal in a safe place.

8 Run the thin stainless steel wire stylet through theprobe from the bottom until the probe is clear, asshown in Photograph 3-103.

9 Rinse the inside of the probe thoroughly withdeionized water, then wipe the probe with cleangauze squares.

10 Replace the probe seal.

11 Continue with Section 3.24.3, Step 5.

Photograph 3-102:Remove Reagent Probe and Holder

Photograph 3-103:Clean Reagent Probe



IF... THEN...

you are removing thereagent probe toclean it

proceed with Step 7.

you are removing thereagent probe toreplace it

proceed to Section3.24.3, step 1.

3 • 99

Figure 3-40: Removing Reagent Probe and Holder



Remove reagent probefrom the reagent probe arm

3 • 100

3.24.3 Replace Reagent Probe1

1 Remove the old probe from the white plasticholder. Grasp the holder and turn it until the probesnaps loose. Slide the holder down the length ofthe probe to remove it. Do not discard the holder.Refer to Photograph 3-104 and Figures 3-41A and3-41B.

Figure 3-41A: Unsnap Reagent Probe Holder

Figure 3-41B: Remove Reagent Probe Holder

Photograph 3-104:Remove Reagent Probe Holder



B

A

3 • 101

2 Slide the white plastic holder onto the new reagentprobe from the bottom up.

3 Turn the holder and snap in place on the newreagent probe. Refer to Photograph 3-105 andFigures 3-42A and 3-42B.

4 Insert the new probe seal into the retaining nut onthe end of the probe, as shown in Photograph3-106.Check: length of probe has to be checked/adoptedto be 100,0 mm, otherwise dead volume incorrect.

Figure 3-42A: Replace Reagent Probe Holder

Figure 3-42B: Snap Reagent Probe Holder in Place

Photograph 3-105:Replace Reagent Probe Holder

Photograph 3-106:Replace Reagent Probe Seal



A

B

3 • 102

5 Place the probe and holder into the reagent probearm, as shown in Photograph 3-107.

6 Tighten the retaining nut, making sure the seal isin place. Refer to Photograph 3-108 and Figure 3-43, on the following page.

7 Reconnect the lead wire. Refer to Photograph3-109 and Figure 3-43, on the following page.

Photograph 3-107:Replace Probe and Holder

Photograph 3-108:Tighten Retaining Nut




3 • 103

Figure 3-43: Reconnect Reagent Probe Lead Wire and Tighten Retaining Nut



Push lead wiretogether

Leave in mountingbracket

Probe seal

Turn retaining nutclockwise to tighten

3 • 104

8 Replace the reagent probe arm cover, making surethe spring on the under side of the cover aligns withthe front of the reagent probe arm. Refer toPhotograph 3-110 and Figure 3-44 on the followingpage.

9 Verify proper spring return action of the probe.Grasp the probe between your thumb andforefinger and gently move it up. Upon releasingyour grasp, the probe should spring downward. Ifthe probe does not respond as described, removethe sample arm cover and check the lead wires tomake sure they do not impede movement of theprobe.

Photograph 3-110:Replace Reagent Probe Arm Cover



3 • 105

Figure 3-44: Replace Reagent Probe Arm Cover



Remove reagentprobe arm cover

Retaining nut

Lead wire in position

3 • 106

3.24.4 Check/Adjust Reagent ProbeAlignment

1 To check the reagent probes for correct alignmentover the reaction cells, press the MAINTENANCEkey, followed by 2 ENTER to display theMECHANISMS CHECK screen.

Figure 3-45: Adjsut Reagent Probe

2 Move the cursor to the Probe Adjust field, asshown in Figure 3-45, and press 3 ENTER toinitiate a reagent probe alignment check. Both R1and R2 probes will be checked.

3 Check the reagent probes for correct alignmentover the reaction cells. The probe tips must becentered over the reaction cells,as shown in Figure 3-46.

Figure 3-46:Align Reagent Probe

4 Gently bend the probe, in an arc, over its entirelength, to center its tip over the reaction cellbeneath it.

5 After proper probe alignment, press the STOP keyto reset all probes to their home positions.

ENTER

3ENTER

STOP



2

37.0 Stand-by 12/01/92 12:20

2 Mechanisms Check


Probe Adjust


Printer Check


FD Special Copy


[ ]H1 : 84.6 H2 : 42.4

[ ][ ][ ]

[ ]

[ ] [ ][ ][ ]

[ ]

[ ]

Reaction Cell

R2

R1

Stirrer

ReagentProbe

3 • 107



2 Move the cursor to the Air Purge entry field asshown in Figure 3-47.


3 Press 1 ENTER to initiate an air purge. The airpurge function is complete when the AnalyzerStatus line on the OPERATION MONITOR screenreturns to Stand-by.

1ENTER

1ENTER



37.0 Stand-by 12/01/92 12:20



Wash

Water Tank

Photometer Check

ISE Prime

Cell Blank

Air Purge

Inc. Water Exchange

Reset

FD Utility

FD Drive Cleaning


T/S Read/Write


[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ] [ ]

3 • 108

3.25 Replace Stirring Paddle

3.25.1 Introduction

This procedure is necessary only when a stirringpaddle is bent or otherwise damaged.


• replace stirrer paddle• check stirrer action.


Instrument time: Approximately 1 minute.

Precaution: The instrument must be inStand-by or OFF during paddlereplacement.

Materials Required:

Stirring paddleSmall metric Phillips screwdriver

3.25.2 Replace Stirrer Paddle

1 While holding the stirring paddle, loosen (but do notremove) the two Phillips set screws that secure thepaddle to its drive shaft. Refer to Figure 3-48.

Figure 3-48:Loosen Stirring Paddle Set Screws

2 Pull the stirring paddle down and off its drive shaft.

3 Insert a new stirring paddle onto the drive shaft andadjust its position so that the distance between thecuvette and the bottom of the stirrer is 7,5 mm,then tighten the screws.



MOUNTINGPLATE

SETSCREWS

TOP OFSTIRRINGPADDLE

3 • 109

3.25.3 Check Stirrer Action

NOTEVisually inspect the new stirring paddle. If it appearsbent or misaligned, you may wish to install an oldreaction cell section at the stirring position beforetesting the stirrer action. Damage could result if a bentor misaligned paddle comes into contact with areaction cell.

1 If instrument power was OFF during paddlereplacement, turn the instrument power switchON. When the analyzer reaches Stand-by,continue with Step 2.


3 Move the cursor to the Probe Adjust entry field, asshown in Figure 3-49.

Figure 3-49: Adjust Stirrers

4 Press 4 ENTER and verify the stirrer is properlyaligned by its movement.

5 Press STOP to terminate stirrer adjust.



2ENTER

4ENTER

STOP

37.0 Stand-by 12/01/92 12:20

2 Mechanisms Check


Probe Adjust


Printer Check


FD Special Copy


[ ]H1 : 84.6 H2 : 42.4

[ ][ ][ ]

[ ]

[ ] [ ][ ][ ]

[ ]

[ ]

3 • 110



Reaction Cell

R2

R1

Stirrer

ReagentProbe

Figure 3-50: Align Stirrer

6 Move the cursor to the Mechanisms Check field.

7 Press 10 ENTER; observe the stirrers as theymove through stirring cycles.

8 Loosen the stirring paddle set screws, repositionthe paddle, then tighten the set screws.

9 Repeat the stirring cycle. If the stirring paddle stillcomes into contact with the reaction cell, tryanother new stirring paddle. If this does not solvethe problem, call Boehringer Mannheim TechnicalSupport.

IF... THEN...

the paddle comes intocontact with the sidesor bottom of thereaction cell whenstirring

check the paddle. If itis bent, replace it; if itis straight, proceed tostep 8.

correct stirrer action isobserved

no further action isnecessary.

3 • 111

3.26 Load Continuous-FormPaper

3.26.1 Introduction

Use this procedure to load continuous-form paper inthe printer.


Materials Required:

Printer Paper (continuous-form)

NOTEIf paper runs out or jams during printing of patientresults, the results are stored on the data disk. Aftercorrecting the paper supply, results may be reprintedby following the procedure in Routine Job, DataReview, Section 2.25.

3.26.2 Load Continuous- Form Paper

1 Turn the printer power switch to the ON position, asshown in Photograph 3-111.

Photograph 3-111:Turn Printer ON


3.26 Load Continuous-Form Paper

3 • 112

2 Move the cut/continuous-form select lever to thecontinuous-form position, as shown in Photograph3-112.

3 Using both hands, move the front cover forward asshown in Photograph 3-113A.Lift the top cover up and leave it in upright positionas shown in Photograph 3-113B.

Photograph 3-112:Select Continuous-Form Paper

Photograph 3-113A:Lift Up Top and Front Covers

Photograph 113B



3 • 113

4 Remove rear cover, as shown in Photograph3-114.

5 Adjust the paper thickness lever, as shown inPhotograph 3-115, according to the number ofcopies to be printed. Refer to the table below.

6 Slide the left and right bail rollers to theapproximate width of the paper, as shown inPhotograph 3-116.

Photograph 3-114Remove Rear Cover

Photograph 3-115:Adjust Paper Thickness

Photograph 3-116:Move Bail Rollers



Number of Copies Lever Position

54321

44321

3 • 114

7 Release the lock lever of the right sprocket unit bypushing it to the rear of the printer, as shown inPhotograph 3-117.

8 Move the right sprocket unit to the right, as far asit will go, as shown in Photograph 3-118.

9 Unlock the left sprocket unit, and move it to the leftmargin position of the paper. Lock the leftsprocket unit in place. Refer to Photograph 3-119.

Photograph 3-117:Unlock Right Sprocket

Photograph 3-118:Move Right Sprocket to Right

Photograph 3-119:Lock Left Sprocket



3 • 115

10 Open both the left and right paper drive sprocketcovers, as shown in Photograph 3-120.

NOTEMost continuous-form computer paper has roundholes on one side and oblong holes on the other side.If you are using this type of paper, ensure that theround holes are placed on the left paper drive sprocketand the oblong holes are placed on the right sprocket.

11 Align the holes on the left side of the paper with thewheel pins of the left paper drive sprocket. Closethe left sprocket cover.

12 Ensure that the paper is straight. Align the holeson the right side of the paper with the wheel pins ofthe right paper drive sprocket, as shown inPhotograph 3-121. Close the sprocket cover,making sure the paper is not slack.

13 Lift the bail roller to make sure the paper slidesunderneath the roller.

14 Turn the platen knob clockwise to feed the paperuntil its top emerges (about one inch) from the printhead.

15 Put the rear cover back on the printer and lower itto its original position, then lower the top cover toits original position.

Photograph 3-120:Open Drive Sprocket Covers

Photograph 3-121:Align Holes with Wheel Pins



3 • 116

3.26.3 Set Paper Online

1 Press the ONLINE button to bring the printeroffline, as shown in Photograph 3-122. The greenindicator light is not illuminated.

2 Press the FF button.

3 Turn the platen knob until the perforation on thepaper is aligned with the red line on the print head.

4 Press the ONLINE button to bring the printeronline. The green indicator light illuminates.

Photograph 3-122:Turn the Printer Offline



3 • 117

3.27 Replace Printer RibbonCassette

3.27.1 Introduction

Use this procedure to change the printer ribboncassette.


Precaution: Printer power must be OFF.

Materials Required:

Ribbon cassette

3.27.2 Procedure

1 Turn the printer power switch OFF.

2 Open the front cover of the printer. Then place yourindex fingers in the indents on the side of the topcover and lift open the cover.

3 Manually move the print head to the center of theprinter.

4 Pull the ribbon cassette holder forward until thelocking pin of the ribbon cassette is released, thenlift the ribbon cassette out of the printer, as shownin Photograph 3-123.


3.27 Replace Printer Ribbon Cassette

Photograph 3-123:Remove Ribbon Cassette

3 • 118


3.27 Replace Printer Ribbon Cassette

5 Remove the red stopper from the new ribboncassette and turn the ribbon winding knobclockwise to take up excess slack inside thecassette, as shown in Photograph 3-124. (Neverturn the ribbon winding knob counterclockwise.)

6 Place the ribbon cassette on its seat so that theside locking pin is located between the ribboncassette holder’s hook and the carrier frame.

7 Gently push down on the ribbon cassette until it isfirmly seated in the ribbon cassette holder. It maybe necessary to turn the ribbon winding knobclockwise while pushing down on the ribboncassette to make it fit into its seat.

8 Close both the front and top covers.

9 Turn the printer power switch ON.

Photograph 3-124:Wind Excess Ribbon

4. TROUBLESHOOTING

4.1 Troubleshooting Procedures .................................................................... 4 · 1

4.1.1 Introduction .......................................................................................................................... 4 · 14.1.2 Calling Customer Technical Support ................................................................................. 4 · 2

4.2 Troubleshooting Conditions That Occur At Power Up............................ 4 · 3

4.2.1 Introduction .......................................................................................................................... 4 · 34.2.2 Troubleshooting Instrument Power Up .............................................................................. 4 · 3

4.3 Chemistry Troubleshooting ....................................................................... 4 · 4

4.3.1 Introduction .......................................................................................................................... 4 · 44.3.2 Check Preparation of Reagents, Calibrators, Controls .................................................... 4 · 44.3.3 High Test Results ......................................................................................................... ........ 4 · 54.3.4 Low Test Results.......................................................................................................... ........ 4 · 64.3.5 Erratic Test Results ...................................................................................................... ........ 4 · 74.3.6 Chemistry Troubleshooting Flowcharts ............................................................................. 4 · 8

4.4 Instrument Troubleshooting .................................................................... 4 · 12

4.4.1 General Considerations .................................................................................................... .4 · 124.4.2 General Mechanical Problem Isolation............................................................................4 · 124.4.3 Types of Alarms ........................................................................................................... .......4 · 12

4.5 Data Alarms ............................................................................................... 4 · 13

4.5.1 Introduction .........................................................................................................................4 · 134.5.2 Data Alarms Table......................................................................................................... .....4 · 14

4. TROUBLESHOOTING

Contents

4. TROUBLESHOOTING

Contents

4.6 Instrument Alarms .................................................................................... 4 · 21

4.6.1 Introduction .........................................................................................................................4 · 214.6.2 Instrument Alarms Display ................................................................................................. 4 · 214.6.3 Troubleshooting Alarm Conditions ...................................................................................4 · 234.6.4 Instrument Alarms Quick Reference Table ......................................................................4 · 234.6.5 Instrument Alarms Table ................................................................................................... 4 · 27

4 • 1

4.1 Troubleshooting Procedures


4.1.1 Introduction

To identify and isolate problems effectively, you needa good understanding of the theory of operation,operating procedures, emergency procedures andchemistry reaction descriptions covered in thismanual. Follow a logical and sequential series ofsteps to isolate a problem into one or a combinationof the following areas:

Chemistry problems:

• reagent considerations• sample considerations• operator error.

Instrument problems:

• electrical/electronic considerations• mechanical considerations• operator error.

Computer problems:

• incorrect parameters, faulty chemistry parameterdisk

• faulty system parameter on disk or disk load• operator error.

Facility problems:

• heat• humidity• power• water (guidance, germ index)• drain.

The operator’s primary troubleshooting responsibilitylies in the following areas that are detailed in theOperator’s Manual:

• reagent preparation and storage• sample considerations• instrument mechanical alignments and

adjustments performed by the operator• computer parameters and general computer input/

output operations• basic component replacement• operator technique in overall operation of the

instrument• maintenance.

THE BASIC OPERATOR IS NOT RESPONSIBLEFOR TROUBLESHOOTING ELECTRICALPROBLEMS, EXCEPT AS COVERED IN THEOPERATOR’S MANUAL, AND SHOULD NOTATTEMPT REMOVAL OF PRINTED CIRCUITBOARDS UNLESS SPECIFICALLY INSTRUCTEDTO DO SO BY A BOEHRINGER MANNHEIMSERVICE REPRESENTATIVE.

It is understood that different operators will havedifferent aptitudes in chemistry, mechanics andelectronics. Where one person may be wellexperienced in one or two areas, he/she may also notbe as experienced in other areas. Whatever the case,when a problem arises that you feel is beyond yourcapabilities and/or scope as a basic operator, consultBoehringer Mannheim’s Customer Technical SupportDepartment. When troubleshooting, observe thealarms and isolate the problem to the area denoted bythe alarms. In many cases, you may be able to findthe problem, correct it, and then resume chemistryprocessing.

The remainder of this chapter provides you withinstructions and guidelines to aid in isolatingproblems.

4 • 2

4.1.2 Calling Customer TechnicalSupport

If it becomes necessary to consult CustomerTechnical Support to troubleshoot a chemistry orinstrument problem, please be prepared with thefollowing information:

Chemistry Problem

• account number• chemistry(ies) affected• description of the problem• catalog and lot numbers of reagents, calibrators,

and controls in use• calibration parameters from the last few

calibrations performed• control results from the last few calibrations

performed• patient results (with correlation results, if relevant).

Instrument Problem

• account number• instrument serial number, ID Nr. of software used• description of the problem including relevant

alarm(s)• other instrument or maintenance related

information.


4 • 3

4.2 Troubleshooting Conditions That Occur At Power Up

4.2.1 Introduction

Certain conditions can affect instrument power up.These conditions are presented in the table below.

To troubleshoot a problem, find the category belowthat best describes the problem, and follow therecommended remedy. If all remedies areunsuccessful, call Customer Technical Support.

4.2.2 Troubleshooting InstrumentPower Up

4.2 Troubleshooting Conditions That Occur At Power Up

CAUSE ORDESCRIPTION

REMEDY

PROBLEM: The instrument does not power up.

1 Main circuit breakerin OFF position (rightside of instrument).

1 Switch main circuitbreaker to the ONposition.

2 The CPU RUN lightcomes on, but noimage appears on theCRT. (The CPU runlight is at theinstrument’s rightrear, to the right ofthe connectors goingto the control unit forthe printer, keyboard,and CRT.)

2 The CRT brightnesscontrol may be turneddown. Turn the CRTbrightness control up(control is belowCRT, to the left of theCRT ON/OFFswitch).

3 The circuit breakerfor the instrument lineis tripped.

3 Have your facilityelectrician check theappropriate circuitbreaker.

CAUSE ORDESCRIPTION

REMEDY

PROBLEM:When instrument is powered up,this message appears: "SYSTEMNOT FOUND --- PLEASE CHECKFLOPPY DISK AND RETRY."

1 Data disk is in drive#1 (system diskdrive).

1 Place system disk indrive #1 and powerup again.

2 System disk isdamaged.

2 Place backup systemdisk in drive #1 andpower up again.

3 Disk not inserted intodisk drive properly.

3 Re-insert disk andpower up again.

4 No disk in drive #1. 4 Place system disk indrive #1 and powerup again.

4 • 4

4.3 Chemistry Troubleshooting

4.3.1 Introduction

Mechanical problems can be identified by visualinspection or when the analyzer shows an alarmmessage. A chemistry problem may display a dataflag, such as Z or W, or may only become evident withan unexpected result.

Deciding that a problem exists is the first step in theprocess. The following situations requiretroubleshooting:

• error codes during calibration• data flags for control or patient samples• quality control sample results fall outside

established ranges• patient tests yield unexpected results.

To troubleshoot effectively, eliminate extraneousinformation and pinpoint the problem. Using thecalibration report, quality control results, or patientresults, decide which of the following conditions applyand perform the checks associated with them:

• high test results• low test results• erratic test results• single sample affected—all tests• single chemistry affected—all samples• multiple chemistries affected:

- all photometric chemistries- only photometric chemistries using multiple

reagents- only photometric chemistries using one

reagent- all chemistries including ISEs- all chemistries using two set-points- only enzyme chemistries- only rate chemistries- no pattern

• only ISE chemistries affected.

4.3.2 Check Preparation of Reagents,Calibrators, Controls

Sometimes conditions arise that cannot be detectedby the instrument. These conditions do not causeinstrument alarms and therefore must be detected bythe operator. When one or more of these conditionsis present, test results can be extremely high, low, orerratic.

To identify the cause of high, low, or erratic testresults, first verify the preparation of your reagents,calibrators and controls by answering the questionslisted on the facing page. Next, review the tables inSections 4.3.3, 4.3.4 and 4.3.5, which list additionalcauses for high, low, and erratic results.

When preparing reagents, calibrators and controls,always read and follow the directions on thepackage insert or value sheet .

When preparing reagents:

Has the catalog number changed?What is the correct preparation procedure?What is the expiration date of the prepared reagent?What is the expiration date of the reagent lot?Was fresh, bacteria-free, deionized water or the properdiluent used in reconstitution?

When reconstituting controls:

If the lot number has changed, are the correct valuesentered in CONTROL VALUE SETTING?What is the correct reconstitution volume?What is the recommended storage?What is the expiration date of the reconstitutedmaterial?Was the volumetric pipette used to reconstitute?What is the expiration date of the control lot?Was the appropriate diluent used in reconstitution?


4 • 5

When reconstituting calibrators:

Has the lot number changed?What is the correct reconstitution volume?What is the recommended storage?What is the expiration date of the reconstitutedmaterial?Was the volumetric pipette used to reconstitute?What is the expiration date of the calibrator lot?Was the appropriate diluent used in reconstitution?

After verifying the above information, proceed to thenext sections, which list additional causes for high,low, or erratic results.

4.3.3 High Test Results

PROBLEM: High test results.


CAUSE REMEDY

1 Insufficient reagentvolume.

• Verify reagent volumeon ChemistryParameters screen.

• Check reagentpipetting system.

• Repeat analysis withsufficient reagent.

2 Evaporation ofsample, calibrator, orcontrol.

• Repeat analysis withfresh sample,calibrator, and/orcontrol.

3 Poor calibrationresults.

• Verify calibrator pre-paration.

• Verify propercalibrationprogramming; repeatcalibration ifnecessary.

4 Incorrect sampling ordilution of sample.

• Verify correctassembly of sampleprobe and pipettorparts.

• Check all fittings forleaks.

• Replace o-rings andseals.

5 Incubation bathtemperature too high.

• Insert thermometer inthe opening near areagent probe. If bathtemperature does notread 37 ± 0.1 °C, callTechnical Support.

6 Reagents notproperly prepared.

• Check reagentpreparation.

7 Calibrators notproperly prepared.

• Check calibratorpreparation.

4 • 6

4.3.4 Low Test Results

PROBLEM: Low test results.


CAUSE REMEDY

1 Reagents expired. • See package insert forstability of the preparedreagent.

2 Reagents notproperly prepared.

• See package insert forproper preparationinstructions.

3 Reagents notproperly stored.

• See package insert forproper storage.

4 Incubation bathtemperature low.

• Insert thermometer inthe opening near areagent probe. If bathtemperature does notread 37 ± 0.1 °C, callTechnical Support.

5 Information notcorrect on ChemistryParameters screen.

• Check ChemistryParameters screenagainst applicationsheet and calibratorvalue sheet for specificchemistry.

6 Too much reagentvolume.

• Verify reagent volumeon ChemistryParameters screen.

• Check reagentpipetting system.

• Repeat analysis withcorrect reagent.

7 Calibrators notproperly prepared.

• Check calibratorpreparation.

CAUSE REMEDY

8 Too little samplevolume.

• Sufficient sample incontainer?

• Check samplepipetting system.

• Check sample probefor obstructions.

• Check CHEMISTRYPARAMETERSscreen againstapplication sheet forcorrect samplevolume.

4 • 7

4.3.5 Erratic Test Results

PROBLEM: Erratic test results.


CAUSE REMEDY

1 Maintenance notperformed properly orat recommendedfrequency on sampleor reagent pipettor orprobes.

• If maintenance hasrecently beenperformed on thesample or reagentprobes or pipettors:

− Was air purgeperformed aftermaintenance?

− Verify correctassembly of allparts.

− Check all fittingsfor air leaks.

− Replace sampleand reagent probeseals.

2 Fibrin clot in onesample cup, or insample probe (if lowvalues printed forseveral samples).

• Check sample probefor fibrin; clean probeas outlined in Section3.23.2, Clean Probes.Request Air Purge onANALYZERMAINTENANCEscreen.

3 Information notcorrect onCHEMISTRYPARAMETERSscreen.

• Check CHEMISTRYPARAMETERSscreen againstapplication sheet andcalibrator valuesheets for specificchemistry.

CAUSE REMEDY

4 Sample probe doesnot reach the bottomof the reaction cellwhen dispensingsample.

• Perform MechanismCheck on theMECHANISMSCHECK screen, andverify that the probereaches the bottom ofthe cell. Check thespring mechanism tomake sure the probemoves up and downfreely.

5 Insufficient samplevolume.

• Repeat analysis withsufficient sample.

6 Contaminatedincubation bath.

• Check for "Particles"in incubation bath.Perform incubationbath exchange.

4 • 8

4.3.6 Chemistry TroubleshootingFlowcharts

The table below outlines chemistry problems and thepatterns that may occur. Refer to the appropriateflowchart to troubleshoot each problem.


Pattern of ChemistryProblem Occurring

TroubleshootingFlowchart Figure

Single Sample/Control Figure 4-1

Single Chemistry Figure 4-2

All Chemistries with twosetpoints

Figure 4-3

Multiple Chemistries(photometrics only)

Figure 4-4

Multiple Chemistries(only photometrics using R2sor R3s)

Figure 4-5

All Chemistries includingISEs

Figure 4-6

Rate Chemistries with onesetpoint

Figure 4-7

ISE -- all results are erratic -excessive air in sippersyringe

Figure 4-8

ISE results erratic Figure 4-9

4 • 9


NO

YES

NO

NO

NO

NO

Appropriate sample type (serum,plasma, CSF, urine)?

Proper sample/control placement?

Sufficient sample volume?

Acceptable sample integrity(fibrin, L, H, I)?

Appropriate collection time anddate of sample?

Incorrect test selections?

Call Customer Technical Support

YES

YES

YES

YES

YES

NO

Correct placementand rerun.

Singlesample/control

Increase samplevolume and rerun.

Verify sample integrity.

Verify sample type;check application sheetfor acceptablespecimen types.

Verify collection.

Verify test selectionson PATIENT TESTSELECTION display

NO

YES

NOWere calibrators properlyprepared and stored?

Are calibrator setpointsacceptable?

YES

Prepare new calibratorsand rerun.

All chemistrieswith two setpoints

Verify proper setponitson CHEMISTRYPARAMETERS screenfor each test.

Call Customer Technical Support.

YES

NO

Verify correctparameters using theapplication sheet.

NO

NO

Properlyprepared reagents?

Reagents expired, contaminated,or discolored?

Correct parameter information onCHEMISTRY PARAMETERS screen?

YES

Prepare new reagentusing the packageinsert.

Singlechemistry

Prepare new reagentusing the packageinsert.

YES

NO

Is the reagent bottle in the correctchannel position (for manually setreagents only)?

Is selected test masked?

YES

YES

NO Verify correct channelposition using theREAGENT STATUSdispaly.


Verify test status on REAGENT STATUSdisplay.

NO

YES

NO

Verify connections in R1probe arm and pipettor.Verify seal integrity.

YES

NOIs the photometer lamp OK?

Is R1 probe misaligned?

Is R1 system leaking?

Is incubation bath free of debris?


NO

YES

YES

Perform probe adjust.Multiplechemistries(photometrics only)

Perform air purge.

Perform PhotometerCheck.

Perform maintenance.

Figure 4-1: Single Sample/Control

Figure 4-2: Single Chemistry

Figure 4-3: All Chemistries with Two Setpoints

Figure 4-4: Multiple Chemistries (Photometrics Only)

4 • 10

Figure 4-7: Rate Chemistries with One Setpoint

Figure 4-8: ISE — All Results Are Erratic - Excessive Airin Sipper Syringe


YES

NO

YESIs R2 probe misaligned?

Is R2 system leaking?

NO

Perform probe adjust.Multiplechemistries(only photometricsusing reagentsdispensed asR2 or R3)

Perform air prug.


Verify connections in R2probe arm and pipettor.Verify seal integrity.

NO

YES

YESIs sample probe obstructed?

NO

Is sample system leaking?

Were controls/calibratorsproperly prepared and stored?


NO

YES

Perform air purge.All chemistriesincluding ISEs

Verify proper dispense.Clean/replace probe.

Verify connections.

Perform air purge.

Prepare newcontrols/calibrators.

NO

YES

Was standard 1 properlyprepared and stored?

NOIs incubation bathtemperature correct?

Is almp acceptable?


NO Verify calibrator integrityand rerun.

Rate chemistrieswith one setpoint

Verify bathtemperature at 37 °C± 1°C.

Perform PhotometerCheck.

If unacceptable,call Technical Support.

YES

YES

NO

YES

NO

NO

NOIs reference cartidge placedproperly?

All reagent volumes sufficient,reagent lines in the bottles?

Is the system leaking?

Are measuring cartridgesplaced properly?


YES

YES

YES

Verify reagent volumes.ISE-- allresults areerratic -excessive air insipper syringe

Verify all connectionsfor leaks. Tighten loosefittings. Verify sealintegrity for IS, Diluent,and sipper syringes.

Verify cartridgeplacement.

Verify cartridgeplacement.

Figure 4-5: Multiple Chemistries (Only PhotometricsUsing Reagents Dispensed as R2 or R3)

Figure 4-6: All Chemistries Including ISEs

4 • 11

Figure 4-9: ISE Results Erratic


NO

YES

YES

YES

NO

YESIs microbial growth present inthe reagent system?

Are reagents correctly placed?

Is there salt buildup oneletrodes or syringes?

Is the reference cartridge inpoor condition?


NO

NO

Verify placementprime, and rerun.

ISE resultserratic

Clean all salt buildupwith wet gauze.

Clean ISE reagentflowpath.

Replace ISEreference cartridge.

4 • 12

4.4 Instrument Troubleshooting

4.4 Instrument Troubleshooting

4.4.1 General Considerations

You are required to troubleshoot the instrument onlyto the extent of the procedures covered in this manual(see Chapter 3, Maintenance). With more complexproblems you may be able to isolate and identify theproblem, but may not be able to correct it yourself. Insuch cases, contact Customer Technical Support foradvice.

4.4.2 General Mechanical ProblemIsolation

The computer controls and monitors all mechanicalfunctions of the instrument. When a mechanicalproblem arises within the instrument, it isimmediately recognized by the computer. An audiblealarm sounds and an alarm message appears on thelower portion of the OPERATION MONITOR screen,alerting you to the specific problem.

If a problem affects the instrument’s performance, thecomputer terminates the Operation mode and entersthe Sampling Stop (S.Stop) or Stop mode. In theSampling Stop mode, the computer allows completionof the samples in process which have not beenaffected by the failure. If the problem affects allsamples in process, the computer immediatelyterminates the Operation mode with a Stop orEmergency Stop.

The remainder of this chapter provides a completelisting of all alarms and suggested remedies for each.

WARNINGCertain instrument problems may arise that thecomputer does not monitor. There will be no alarm onthe CRT to alert the operator. Such problems includeworn parts, air leaks in the pipettor system, reagentcontamination, etc. When you encounter these typesof problems, decide whether to continue to processsamples or to terminate the Operation mode,according to the possibility of causing damage to theanalyzer or reporting erroneous test results.

4.4.3 Types of Alarms

The instrument issues two types of alarms: dataalarms and instrument alarms. Alarms that arespecific to calibration and abnormal quality control arelisted in both the data and instrument alarms sections.The table below shows you where you can observe theactual alarm.

ALARMTYPE

OPERATIONMONITOR

DATAREVIEW

REALTIMEDATA

MONITOR

Data X X

Instrument X

Calibration X

QC X X

ALARMTYPE

RERUNSAMPLES

INDIVIDUALQC

MONITOR

ANALYZERPRINTOUT

Data X X

Instrument

Calibration X

QC X X

4 • 13

4.5 Data Alarms

4.5 Data Alarms

4.5.1 Introduction

Data alarms flag unusual reaction conditions(insufficient sample or reagent, substrate depletion,etc). This type of alarm appears on printed reports andthe DATA REVIEW screen, as well as the RERUNSAMPLES and REAL TIME DATA MONITORscreens. The data alarms section shows the codethat prints on reports in the Printed column and thealarm code that appears in the Data Review column onthe DATA REVIEW screen, as well as the RERUNSAMPLES and REAL TIME DATA MONITORscreens.

A description of each alarm and remedy is containedin the remainder of Section 4.5.

The remedy for some data alarms may refer you to aspecific instrument alarm described in Section 4.6.

4 • 14

4.5 Data Alarms

4.5.2 Data Alarm Table

DATA PROCESSING ALARMS

ALARM PRINTED DATA REVIEW DESCRIPTION REMEDY

ADCabnormal

ADC A The ADC (analog digital converter) value isabnormal.

a. See alarm code ADCCounter Failure (35-1to 35-4).

Cell blankabnormal

CELL Q The difference between the current passed cellblanks and the previous cell blank measured bythe CELL BLANK function on the ANALYZERMAINTENANCE screen is greater than 0.1 ABS.

a. See alarm code CellBlank Out of Limits(30 to 34).

SampleShort

SAMP. V There is insufficient sample volume in thesample cup.

a. Add sample andrerun.

Reagentshort

RGNT T There is insufficient reagent volume in thereagent bottle. (photometric)

There is insufficient ISE reagent volume.

a. See alarm codeReplace Low Reagent(42-1 to 42-32).

Absorbanceover

ABS? Z The absorbance value to be used for calculationafter cell blank correction exceeds 3.3 ABS.

a.

b.

c.

d.

e.

f.

Check if there is anobstacle in the opticalpath of thephotometer.Check if theincubation bath iscontaminated.Check if the waterbathis full.Check if the reagenthas been preparedproperly.Check if the reactioncell is scratched.Is sample grosslylipemic or anextremely high value?

Prozoneerror

xxxxxP(’xxxxx’indicates theprozonecheck value.)

P In one-point or two-point assay with prozonecheck, the prozone check value (PC value)exceeds the specified upper/lower limit. Shownbelow is the relationship between the PC valueand upper/lower limit on occurrence of the error.

a.

b.

Check if the reagenthas been preparedproperly.Check upper/lowerlimit (Prozone Limit)on CHEMISTRYPARAMETERSscreen.

An - Apn - p

Am - Apm - p

x 100

Analyticalmethod

PC value

Relationship betweenPC value and upper/lower limit onoccurrence of error

LOWER UPPER

One-pointassay

(Note)

PC value < Limit value

PC value > Limit value

x {(Am+Am-1) -

k(Al+Al-1)}

Two-pointassay

(Note)

Note: [l], [m], [n] and [p] are photometric read cycle.

12

4 • 15

4.5 Data Alarms



Reactionlimit over(only for rate assayincludingtwo-pointrate assay)

LIM.1 I The main wavelength absorbance exceeds thereaction limit at all photometric points to be usedfor calculation.

a.

b.

Dilute and rerun thesample.Check ABS. Limit onCHEMISTRYPARAMETERSscreen.

LIM.2 J The main wavelength absorbance exceeds thereaction limit at the second and subsequentphotometric points to be used for calculation.

LIM.3 K The main wavelength absorbance exceeds thereaction limit at the third or fourth andsubsequent photometric points to be used forcalculation.

Linearityabnormal(only for rateassay)

LIN. W When the number of photometric points withinthe reaction limit range is nine or more, acomparison of the absorbance change rates atboth the first and last six points exceeds thelinearity limit value as entered in systemparameters. Refer to Section 5.32 for moredetails.

a.

b.

c.

d.

Check the stirringmechanism.Dilute and rerun thesample.Check Linearity Limiton SYSTEMPARAMETERSscreen.Ensure water bathfree of debris.

LIN.8 F When the number of photometric points withinthe reaction limit range is eight or less, acomparison of the absorbance change rates atboth the first and last three points exceeds thelinearity limit value as entered in systemparameters. Refer to Section 5.32 for moredetails.

Standard 1absorbanceabnormal

S1 ABS? -- During calibration, the average of two measuredvalues of STD (1) is outside the STD (1)absorbance range.S1 is bichromatic reading forendpoints, monochromatic for rate.

a.

b.

c.

Check S1 ABS Limiton CHEMISTRYPARAMETERSscreen.Check reagentpreparation andcalibration.Recalibrate.

Duplicateerror

DUP -- During calibration, the difference between tworeplicate measured absorbances of anystandard is larger than the test’s duplicate limit.

a.b.

Recalibrate.Check Duplicate Limiton CHEMISTRYPARAMETERSscreen.

Edited Test EDITED * An edited 1st result or replaced rerun data ismarked with a $ on the DATA REVIEW screen.This also prints on the patient report, as well asthe Rerun Samples and Real Time Data Monitorscreens.

Note: If the entered assay points [l] and [m] donot satisfy ‘l + 2 < m’, the reaction limit isalways exceeded.

4 • 16

4.5 Data Alarms



Standarderror

CAL? -- 1. During photometric calibration, any one ofthe following alarms is encountered:

a. See alarm codeCalibration Error (70-1to 70-49).

ADC abnormal, cell blank abnormal,sample short, reagent short,absorbance over, reaction limit over,Iinearity abnormal, prozone error,duplicate error, calculation disabledor standard 1 absorbance abnormal.

2.

3.

4.

During calibration, calculation is disabled.During nonlinear calibration, an extremevalue appears.During ISE calibration, any one of thefollowing alarms is encountered:

ADC abnormal, sample short,calculation disabled, noise error,and level error. Calibration is invalid.

Sensitivityerror

SENS -- Sensitivity is checked for linear (2 to 6 points),nonlinear or isozyme-P calibration.This error is indicated if the difference inmean absorbance between STD (1) and STD(N)* is smaller than the sensitivity limit (inputvalue).

a.

b.

See alarm codeSensitivity Error (73-1to 73-46).Check Sensitivity Limiton CHEMISTRYPARAMETERSscreen.*N: =

=

2.........

2 to6...

(two calibration points) Linear(2-point) or isozyme-P(span point input value)Nonlinear, linear (multi-point)calibration, or nonlinear(logit-log 3P/4P) calibration

Note: For span calibration, the previous S1ABS (linear) or previous meanabsorbance (nonlinear) of standardsolution (l) is used for sensitivitycheck.

Calibrationerror

CALIB -- For photometric assay: during calibration,there is a difference of ± 20% or morebetween the current K factor and the previousvalue. For ISEs, the calibration concentrationor slope level does not satisfy the followingexpression:

a. See alarm codeCalibration FactorError (71-1 to 71-49).

SD error SD LIM -- During nonlinear or multipoint linearcalibration the SD value is larger than the SDlimit.

a.

b.

See alarm code SD LimitExceeded (72-1to72-46).Check SD Limit onCHEMISTRYPARAMETERS screen.

Noise error NOISE N The difference between the maximum andminimum potential values exceeds thefollowing values during measurement:

a.

b.

Check for excess airin the ISE reagentlines; examinepipettors andcartridges for leaks.If alarm occurredduring calibration,correct problem andrecalibrate.

Na+ : 0.7 mVK+ : 1.0 mVCl- : 0.8 mV

Previous Value - Current Value ( Previous Value + Current Value) / 2

Compensate Level

± 10%x 100 >

4 • 17

4.5 Data Alarms



Level error LEVEL L During measurement of internal reference,potential is not within the following range:(Internal Standard Solution)

a.

b.

c.

d.

Check ISE compart-ment for liquidleakage and/or airbubbles.If other ISE alarms arepresent, correct thosealarm conditions andrecalibrate.Check referencecartridge.Salt bridges.

Slopeabnormal

SLOPE? -- The slope for the specified electrolyte cartridgeis outside of the acceptable range.

The electrode response is poor. The carryoverrate is shown below:

If the slope hasdecreased gradually overtime, replace thecartridge. Otherwise,examine ISE system forother abnormalities:check standards,reagents, priming leaks incartridges. Perform aWASH (ISE) from theAnalyzer Maintenancescreen.

Preparationabnormal(electrodepreparation)

PREP. -- The slope for the specified electrolyte cartridgeis not within the following range:

The electrode response characteristic hasdeteriorated. The carryover rate (A) is within thefollowing range:

If control values are inrange, no action isnecessary. Be preparedto replace a cartridgesoon (when the SLOPEalarm occurs), as long asthe slope has decreasedgradually over time.Otherwise, examine ISEsystem for otherabnormalities: checkstandards, reagents,priming, leaks incartridges. Correctabnormalities andrecalibrate.

InternalStandardconcentrationabnormal

I.REF -- The concentration of Internal Standard solutionis not within the following range:

Check Internal Standardreagent volume andpreparation.

Na+, K+ : SLOPE ≤ 32.0 mVCl- : SLOPE ≥ -25.0 mV

Na+ : 0.232 < AK+ : 0.160 < ACl- : 0.490 < A

Na+ : -90.0 mV to -10 mVK+ : -90.0 mV to -10 mVCl- : 80.0 mV to 160.0 mV

Na+ : 0.154 < AK+ : 0.107 < ACl- : 0.330 < A

Na+ : 120.0 mmol/L to 160.0 mmol/L

K+ : 3.0 mmol/L to 7.0 mmol/L

Cl- : 80.0 mmol/L to 120.0 mmol/L

Na+, K+ : 32.0 mV ≤ SLOPE ≤ -37.9 mVor 68.1 mV ≤ SLOPE

Cl- : -29.9 mV ≤ SLOPE ≤ -25.0 mVor -68.1 mV ≤ SLOPE

4 • 18

4.5 Data Alarms



Samplevalueabnormal

R.OVER & The concentration of sample is outside thefollowing range:

Test-to-testcompensationerror

CMP.T C 1.

2.

In test-to-test compensation calculation, anydata alarm other than those shown below isindicated for the compensation test data.In isozyme-Q concentration calculation, anydata alarm other than those shown below isindicated for the isozyme-P concentration,

a. Check the relevantdata.

Calculation disabled, test-to-testcompensation disabled, overflow, randomerror, systematic error, QCerror and outside of expected value.

Test-to-testcompensationdisabled

CMP.T! M 1.

2.

3.

4.

During test-to-test compensationcalculation, the denominator becomes zero.The test to be used for test-to-testcompensation has not been measured yet.Any test to be used for test-to-testcompensation has the data alarm‘calculation disabled’ or ‘test-to-testcompensation disabled’.Any compensation test has the data alarm(SAMP., RGNT., etc.) that leaves the datablank.


Technicallimit over

LIM.HLIM.L

$ The measured value is outside the technicallimit range.

a.

b.

Check Techincal Limiton CHEMISTRYPARAMETERSscreen.Rerun the sample andcheck the measuredvalue.

Greater than the upper limit value(LIM.H).Less than the lower limit value (LIM.L).

Randomerror

RANDOM @ 1.

2.

Any of the current and (N-1) precedingcontrol X values are larger than 2SD andany of the current and (N-1) precedingcontrol Y values are smaller than -2SD(range > 4 SD).Any of the current or preceding control Xvalues are smaller than -2SD and any ofthe current or preceding control Y valuesare larger than 2SD.Legend:

a.

b.

NOTE: Check isperformed only whenRULE R-4SD isselected.

See alarm codeRandom Control Error(74).

N = control runnumber entered onReal Time QC screen

X:

Y:

Control number entered for X on REALTIME QC.Control number entered for Y on REALTIME QC.

Mean, SD: Values specified on REALTIME QCData: Measured value mean.

Na+ : 10 mmol/L to 250 mmol/L

K+ : 1 mmol/L to 100 mmol/L

Cl- : 10 mmol/L to 250 mmol/L

4 • 19

4.5 Data Alarms



Systematicerror 1

SYSTM1 # 1.

2.

The control X and Y data values are largerthan 2SD.The control X and Y data values aresmaller than -2SD.

a.

NOTE: This check isperformed only whenRULE 2-2SD isselected.

See alarm codeSystematic ControlError (75).

Systematicerror 2

SYSTM2 # 1.

2.

3.

4.

The last two control X data values arelarger than 2SD.The last two control X data values aresmaller than -2SD.The last two control Y data values arelarger than 2SD.The last two control Y data values aresmaller than -2SD.

a.



Systematicerror 3

SYSTM3 # 1.

2.

The last two control X and last two controlY data values are larger than 1SD.The last two control X and last two controlY data values are smaller than -1SD.

a.



Systematicerror 4

SYSTM4 # 1.

2.

3.

4.

The last four control X data values arelarger than 1SD.The last four control X data values aresmaller than -1SD.The last four control Y data values arelarger than 1SD.The last four control Y data values aresmaller than -1SD.

a.



Systematicerror 5

SYSTM5 # 1.

2.

The last five control X and last five controlY data values are all positive--above themean value.The last five control X and last five controlY data values are all negative--below themean value.

a.

NOTE: This check isperformed only whenRULE 10X is selected.


Systematicerror 6

SYSTM6 # 1.

2.

3.

4.

The last 10 control X data values areall positive--above the mean value.The last 10 control X data values areall negative--below the mean value.The last 10 control Y data values areall positive--above the mean value.The last 10 control Y data values areall negative--below the mean value.

a.

NOTE: This check isperformed only whenRULE 10X is selected.


4 • 20

4.5 Data Alarms



QC error 1 QCERR1 + 1.

2.

The control X data value or control Y datavalue is larger than 3SD.The control X data value or control Y datavalue is smaller than -3SD.

a.


See alarm code RealTime QC Error (76).

QC error 2 QCERR2 + 1.

2.

The control X data value or control Y datavalue is larger than 2.5SD.The control X data value or control Y datavalue is smaller than -2.5SD.

a.

NOTE: This check isperformed only whenRULE 1-2.5SD isselected.

See alarm code RealTime QC Error (76).

Calculationtest error

CALC? % Any data alarm other than those shown below isindicated for the test to be used for calculation.


Calculation disabled, test-to-testcompensation disabled and outside ofexpected values.

Overflow OVER O The result data cannot be output within thespecified number of digits.Note: Blank space is left for data.

a. Try rerun.

Calculationdisabled

??? X 1.

2.

3.

During calculation, the denominatorbecomes zero.An overflow occurs in logarithmic orexponential calculation.In isozyme-Q channel concentrationcalculation, the data alarm ‘calculationdisabled’ is indicated for theisozyme-Pchannel data or the isozyme-Pchannel is not measured.

Note: Result is left blank.

a. Check if there is alogical error incalculation formulas.

Outside ofexpectedvalue

H -- For patient samples, the calculatedconcentration is larger than the upper limit ofthe expected value. For control samples, aconcentration exceeds the values input onControl Value Setting.

L For patient samples, the calculatedconcentration is smaller than the lower limit ofthe expected value. For control samples, aconcentration is lower than the values enteredvia Control Value Setting.

CalibrationResultAbnormal

CALIB! ! Any alarm (other than CALIB) has occurredduring the latest calibration.

a.

b.

Correct the conditioncausing the CAL? orSENS alarm.

Recalibrate.

4 • 21

37.0 Stand-by 12/01/92 12:20

Operation Monitor

Alarm MessageStirrer 2:Execute Mech. Check

LevelSTOP

Code02-006

Time10:20

51 2 3 4 5 6 7 8 9 60 1 2 3 4 5 6 7 8 9

1 2 3 4 5 6 7 8 9

1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 1 2 3 4 5

70

E E E E E

R:R. Finished

E:S. Finished

R:Routine

E:Stat

R:R. Finished

E:S. Finished

R:N. Rerun

E:S. Rerun

26 7 8 9 30 1 2 3 4 5 6 7 8 9 40

10 20

50

R R R R RR R R R R

Currently Sampling

OuterRing

MiddleRing

S.No.

R52

Pos.

42

ID

1234567890123

Test

AMYL

4.6 Instrument Alarms


4.6.1 Introduction

Instrument alarms flag unusual instrument conditions(abnormal reaction bath temperature, mechanicalmalfunctions, etc.). This type of alarm appears onthe OPERATION MONITOR screen and causes anaudible alarm if the buzzer has not been inactivatedat the keyboard.

4.6.2 Instrument Alarms Display

Press OPERATION MONITOR , followed byGUIDANCE, to display the instrument alarms list.The OPERATION MONITOR, screen shown below inFigure 4-10, illustrates how the alarms appear on theanalyzer.

Figure 4-10: Operation Monitor Alarms Display

The lower portion of the Operation Monitor screenprovides the following information about each alarm:

• Alarm Message• Alarm Level• Alarm Code• Time Alarm Occurred

ALARM MESSAGE - Descriptive name

of the alarm.

TIME -Time alarmoccurred.

CODE -Identifies the alarm

code for easyreference in table.

LEVEL -Severity

of the alarm.

4 • 22

ALARM LEVELS

The alarm level indicates the severity of the alarmcondition. The four alarm levels are:

• WARNING• S. STOP• STOP• E. STOP

WARNING:

When a WARNING alarm is issued, there is noimmediate danger to the analyzer and operation is notinterrupted. Refer to the Operation Monitor screen,note the alarm message, and correct the problem.

S. STOP:

The S. STOP (Sampling Stop) alarm is issued toindicate a problem that affects the sampling system.The instrument stops sampling, but continues toprocess any samples which have already beendispensed. Correct the alarm condition, note whichsample was last to be dispensed, and resumeoperation with the next sample to be processed.

STOP:

The STOP alarm is issued when an instrumentproblem prevents completion of analyses in process.The instrument stops all mechanical functions at theend of the current (10-second) cycle. Correct thealarm condition, note which specimen was last toprint out before the alarm, and resume operation,repeating those samples that did not print out.

E. STOP:

The E. STOP (Emergency Stop) alarm is issued whenan alarm condition is present that could damage theinstrument. Under these conditions, the instrumentstops all mechanical functions as soon as the alarmcondition is detected. Correct the alarm condition,note which specimen was last to print out before thealarm, and resume operation, repeating thosesamples that did not print out.

4.6.3 Troubleshooting AlarmConditions

The quick reference table on the following pages listthe class and alarm Message, along with theoperator’s manual page where a description of eachalarm is located. This table is designed for use as aquick reference to the instrument alarms section.

The instrument alarms table follows the quickreference guide. This table is arranged in order ofalarm message, code, level, description, andremedy. The alarm message, code, and level appearas shown above on the OPERATION MONITORscreen.

To troubleshoot instrument alarm conditions:


2 Look at the alarm display. If there are any alarmslisted, record the alarm class and code, then findthe description of the alarm in the InstrumentAlarms table on page 4-29 through 4-66.

3 The description may list more than one cause fora single alarm. Read the entire description beforeproceeding to remedy the situation. The remedycolumn provides troubleshooting steps insequential order. One remedy section may beapplicable to more than one alarm. Follow therecommended procedure for correcting the alarmcondition that is listed in the remedy column.

If the remedy column lists “Call Technical Support”as the first or only step for the alarm you areexperiencing, call Boehringer MannheimCustomer Technical Support immediately.

If the alarms recur, call Customer TechnicalSupport.


4 • 23

4.6.4 Instrument Alarms QuickReference Table

INSTRUMENT ALARMSQUICK REFERENCE TABLE

Code Alarm Message Page

1 Stirrer 1: Execute MECH

CHECK 4•27

2 Stirrer 2: Execute MECH

CHECK 4•28

3 Rinse: Execute MECH

CHECK 4•28

4 Reaction Disk (Homing

Failure) 4•29

5 Abnormal Sample Probe

Movement 4•30

6 Sample Disk: Execute

MECH CHECK 4•32

7 Abnormal S. Syringe

Movement 4•34

8 Abnormal R1 Probe

Movement 4•35

9 Abnormal R2 Probe

Movement 4•35

10 Check R1 Disk then:

MECH CHECK 4•36

11 Check R2 Disk then:

MECH CHECK 4•37


12 Replace R1 Disk Cover 4•38

13 Replace R2 Disk Cover 4•38

14 Abnormal R1 Syringe

Movement 4•38

15 Abnormal R2 Syringe

Movement 4•39

16 ISE Sipper: Execute

MECH CHECK 4•39

17 ISE Vacuum: Execute

MECH CHECK 4•39

18 Abnormal ISE Syringe

Movement 4•40

19 ISE Stopped: Resolve

ISE Alarm 4•41

20 Incubator Water Temp Error 4•41

21 Incubator Water Level Error 4•41

22 Execute INC. WATER

EXCHANGE 4•41

23 Water Reservoir Level

Too Low 4•41

24 Empty Waste Reservoir 4•42

25 Power Supply Unit

> 70 degrees 4•42

26 Degasser Heater

> 70 degrees 4•42


4 • 24


42 Replace Low Reagent

(R2) 4•46

43 R1 < User Defined Level 4•46

44 R2 < User Defined Level 4•47

45 Check R1 Position and

App Code 4•47

46 Check R2 Position and

App Code 4•47

47 R1 Label: Execute

MANUAL SET 4•47

48 R2 Label: Execute

MANUAL SET 4•47

49 Load Cell Wash Bottle 4•48

50 Load Probe Wash Bottle 4•48

51 Dup. Barcode: Replace

Bottle 4•48

52 Dup. Barcode: Relabel

Sample 4•48

53 Enter Test Selections 4•48

54 T/S Exceed 800 Patients 4•49

55 Sampling Delay 4•49

56 No More Samples to

Process 4•49

57 C-RAM Error 4•49



27 Check Stoppers on

Vacuum Tank 4•42

28 Liquid in Vacuum Tank 4•42

29 3 ABS Readings > 3.3 4•42

30 Cell Blank Out of

Limits (2X) 4•43


Limits (3X) 4•44


Limits (10X) 4•44


Limits (10X) 4•44


Limits (2X) 4•44

35 ADC Counter Failure 4•44

36 ADC Voltage: Execute

RESET 4•45

37 Sample Barcode Error 4•45

38 Barcode Reader Error 4•45

39 R1 Barcode Error 4•46

40 R2 Barcode Error 4•46

41 Replace Low Reagent

(R1) 4•46

4 • 25


58 Interrupt Error 4•49

59 DC Error: Turn 911

OFF then ON 4•49

60 Replace Fuse 4•49

61 Power Failure Has

Occurred 4•50

62 Controller Motor

Error 4•50

63 Controller Motor

Failure 4•50

65 Replace Cell Wash

Solution 4•50

66 Replace Probe Wash

Solution 4•50

67 Cell Wash Solution

< 10 mL 4•51

68 Probe Wash Solution

< 10 mL 4•51

69 Stat Error, Testing

Incomplete 4•51

70 Calibration Error 4•51

71 Calibration Factor Error 4•52

72 SD Limit Exceeded 4•52

73 Sensitivity Error 4•52


74 Random Control Error 4•53

75 Systematic Control Error 4•53

76 Real Time QC Error 4•54

80 ISE Int. Ref. Error 4•54

81 ISE Noise: Execute

ISE CHECK 4•54

82 ISE Slope Warning 4•54

83 ISE Slope Error:

Replace Cart. 4•54

84 ISE I. Ref Concentration

Error 4•55

85 Execute ISE

CALIBRATION 4•55

87 Replace Low ISE

Reagent 4•55

88 Replace Low

Hitergent 4•55

89 Check Hitergent

Position 4•55

90 Twin Test Parameter

Error 4•55

91 Check App Code and

Assay Point 4•56

92 Calibration Parameter

Error 4•56


4 • 26


93 Check R1-4 Dispense

Volumes 4•57

94 Isozyme Parameter Error 4•57

95 Range Error 4•58

96 Check COMP. TEST

Parameters 4•58

97 Serum Index Test Error 4•58

99 Check REAGENT

PROBE WASH 4•58

100 No Measurable Channel

On Board 4•59

101 Execute 10 sec.

CYCLE TIME 4•59

102 Duplicate Bottle Code 4•59

103 Test Selection Error 4•59

104 Cannot Execute ORIG.

ABS. Now 4•59

105 Check Hitergent Position 4•59

106 Refill Hiterg, Do Bath

Exchange 4•60

107 Execute REAGENT

REGISTRATION 4•60


108 Check ISE Standard Codes 4•60

110 Printer Error 4•60

111 System Interface Error 4•61

112 Non Existing Key Code

Entered 4•62

113 C-RAM Error 4•62

114 Real Time Clock Error 4•62

115 APU Fail: Turn 911 OFF

then ON 4•62

116 ACI Fail: Turn 911 OFF

then ON 4•62

120 Reinsert Floppy Disk 4•62

121 Wrong FD in Drive 4•63

122 FD Reading Error 4•63

123 FD Writing Error 4•64

124 Write Protected Disk

in Drive 4•64

125 Clean FDD Head,

Replace FD 4•64


4 • 27


4.6.5 Instrument Alarms Table

INSTRUMENT ALARMS

Alarm Code Level Description Remedy

Stirrer 1:Execute MECHCHECK

1-1 STOP Stirrer 1 does not reach itshighest position (rinse bathside) when ascending.

a.

b.

The MECHANISMS CHECKscreen: execute MechanismCheck 10 times.

Resume operation; if alarmrecurs, call Technical Support.

1-2 STOP Stirrer 1 does not reach itshighest position (cell side)when ascending.

a.

b.



1-3 STOP Stirrer 1 does not descend intothe reaction cell.

a.

b.



1-4 STOP Stirrer 1 does not reach therinse bath position whenrotating toward the rinse bath.

a.

b.



1-5 STOP Stirrer 1 does not move to thereaction disk.

a.

b.



1-6 STOP When RESET, stirrer 1 doesnot return to the rinse bath(home) position.

Manually raise the stirring unit toits highest position, then executeReset on theANALYZERMAINTENANCE screen.

1-7 STOP When RESET, stirrer 1 doesnot leave the rinse bath(home) position.


1-8 STOP Stirrer 1 does not rotate in thehighest position.


4 • 28


INSTRUMENT ALARMS


Stirrer 2:ExecuteMECH CHECK

2-1 STOP Stirrer 2 does not reach itshighest position (rinse bath side)when ascending.

a.

b.

MECHANISMS CHECKscreen: execute MechanismCheck 10 times.


2-2 STOP Stirrer 2 does not reach itshighest position (cell side) whenascending.

a.

b.



2-3 STOP Stirrer 2 does not descend intothe reaction cell.

a.

b.



2-4 STOP Stirrer 2 does not reach the rinsebath position when moving to therinse bath.

a.

b.



2-5 STOP Stirrer 2 does not move to thereaction disk.

a.

b.



2-6 STOP When reset, stirrer 2 does notreturn to the rinse bath (home)position.

Manually raise stirring unit to highestposition, then execute Reset onANALYZER MAINTENANCE screen.

2-7 STOP When reset, stirrer 2 does notleave the rinse bath (home)position.


2-8 STOP Stirrer 2 does not rotate in thehighest position.


Rinse:ExecuteMECH CHECK

3-1 STOP The rinse mechanism does notreach the highest position whenascending.

a.

b.



4 • 29


INSTRUMENT ALARMS


Rinse:Execute MECHCHECK(cont’d)

3-2 STOP The rinse mechanism doesnot descend into cell.

a.

b.



Reaction Disk(HomingFailure)

4-1 STOP Reaction disk does not detectits stop position.

a.

b.

c.

Check for water droplets onbottom of reaction disk, if diskhas been recently washed.Dry thoroughly.

Check for water droplets on thedetector below reaction disk.Dry thoroughly.


4-2 STOP The reaction disk does notstop at the correct position.

a.

b.

c.




4-3 STOP Reaction disk does not detectits home position whenRESET.

a.

b.

c.




4-4 STOP The first reaction cell does notstop at the specified positionwhen RESET.

a.

b.

c.




4 • 30


INSTRUMENT ALARMS


Reaction Disk(HomingFailure)(cont’d)

4-5 STOP When the reaction disk rotates,the sample probe, reagentprobe, stirrer, or cell rinsemechanism is not set at thehighest point.

a.

b.

ANALYZER MAINTENANCEscreen: execute Reset.


AbnormalSample ProbeMovement

5-1 S. STOP The sample probe does notascend to the highest pointwhen leaving any position otherthan the reaction cell.

a.

b.

MECHANISMS CHECK screen:execute Mechanism Check 10times.


5-2 STOP The sample probe does notascend to the highest pointwhen leaving the reaction cell.

a.

b.



5-3 S. STOP Sample probe descendsabnormally at any position otherthan at the reaction cell.

a.

b.

c.

d.

e.

f.


Inspect probe where it isattached to the sample probearm. The probe is spring-mounted and should travel freelyup and down.

Inspect cup bottom for properheight.

Check sample cup for distortion.

MECHANISMS CHECK screen:execute vertical Probe Adjust.


5-4 STOP The sample probe descendsabnormally into the reaction cell.

a.

b.

c.

d.


Inspect probe where it isattached to the sample probearm. The probe is spring-mounted and should travel freelyup and down.

MECHANISMS CHECK screen:execute vertical Probe Adjust.

Resume operation. If alarmrecurs, call Technical Support.

4 • 31


INSTRUMENT ALARMS


AbnormalSample ProbeMovement(cont’d)

5-5 S. STOP The sample probe does notdescend at any position otherthan the reaction cell.

a.

b.



5-6 STOP The sample probe does notdescend into the reaction cell.

a.

b.



5-7 WARNING Sample probe continues todescend abnormally. Theabnormal descent detectorremains on.

Inspect probe where it is attached tothe sample probe arm. The probe isspring-mounted and should travelfreely up and down. If necessary,remount the probe.

5-8 S. STOP Sample probe cannot detect thecorrect cell position as it rotatesto the reaction disk.

a.

b.



5-9 S. STOP Sample probe does not leavecell position when trying torotate.

a.

b.



5-10 S. STOP Sample probe does notdescend properly at the ISEdilution vessel.

a.

b.

MECHANISMS CHECK screen:execute Probe Adjust. (Press1 ENTER for Horizontal Probeadjust.) Press SAMPLE STOPfour times to position probe overISE dilution vessel.


5-11 S. STOP Liquid level detector is notreset.

a.

b.



5-12 WARNING Sample probe descendsabnormally during rotation ofS. Probe in PROBE ADJUST.

a.

b.

c.


Verify probe wire connection.


4 • 32


INSTRUMENT ALARMS


AbnormalSample ProbeMovement(cont’d)

5-13 S. STOP The sample probe does notrotate in its highest position.

a.

b.



Sample Disk:ExecuteMECH CHECK

6-1 S. STOP Sample disk cannot detect thestop position on outer ring.

a.

b.

c.

d.

Do not touch the sample diskduring operation.

If anything is obstructing sampledisk movement, correct thesituation.



6-2 S. STOP Sample disk does not stop atcorrect position on outer ring.

a.

b.

c.

d.





6-3 S. STOP Sample disk cannot detect itsstop position on middle ring.

a.

b.

c.

d.





4 • 33


INSTRUMENT ALARMS


Sample Disk:ExecuteMECH CHECK(cont’d)

6-4 S. STOP Sample disk does not stop atthe correct position on themiddle ring.

a.

b.

c.

d.





6-5 S. STOP Sample disk cannot detect thestop position on inner ring.

a.

b.

c.

d.





6-6 S. STOP Sample disk does not stop atcorrect position on inner ring.

a.

b.

c.

d.





6-7 STOP Sample disk does not stop atthe home position during RESET.

a.

b.

c.

d.





4 • 34


INSTRUMENT ALARMS


Sample Disk:ExecuteMECH CHECK(cont’d)

6-8 STOP Sample disk does not leavehome position during RESET.

a.

b.

c.

d.





6-9 STOP Sample disk does not stop atspecified home position duringRESET.

a.

b.

c.

d.





AbnormalS. SyringeMovement

7-1 S.STOP Sample syringe does not ascendto the highest point.

a.

b.

c.

d.

e.


If sample pipettor was recentlyserviced, verify that retainingscrew is not overtightened.

Verify that sample pipettorretaining screw is not bent.

ANALYZER MAINTENANCEscreen: execute Air Purgeand observe sample syringe forascending movement.


7-2 S.STOP Sample syringe will not descendfrom the highest point.

a.

b.

c.

d.

e.


If sample pipettor was recentlyserviced, verify that retainingscrew is not overtightened.

Verify that sample pipettorretaining screw is not bent.

ANALYZER MAINTENANCEscreen: execute Air Purgeand observe sample syringe forascending movement.


4 • 35


INSTRUMENT ALARMS


AbnormalR1 ProbeMovement

8-1 STOP The Reagent 1 probe does notascend to the highest point whenleaving any position other thanthe reaction cell.

a.

b.



8-3 STOP Reagent 1 probe descendsabnormally at any position otherthan the reaction cell.

a.

b.

c.

Verify that reagent bottle isuncapped.

Verify that reagent disk cover isin the proper position.

Verify that Reagent 1 probe isnot bent.

8-4 STOP Reagent 1 probe does notdescend from the highest pointat any position other than overthe reaction cell.

a.

b.



8-6 WARNING Reagent 1 probe continues todescend abnormally.

Verify that cushioning of theReagent 1 probe is normal.

8-7 STOP Reagent 1 probe cannot detectthe reaction cell position as itrotates to the reaction cell.

a.

b.



8-8 STOP Reagent 1 probe does not leavethe cell position when trying torotate.

a.

b.



8-9 STOP Liquid level detector is not reset. a.

b.



8-10 STOP Reagent 1 probe does not rotatein its highest position.

a.

b.



AbnormalR2 ProbeMovement

9-1 STOP The Reagent 2 probe does notascend to the highest point whenleaving any position other thanthe reaction cell.

a.

b.



4 • 36


INSTRUMENT ALARMS


AbnormalR2 ProbeMovement(cont’d)

9-3 STOP Reagent 2 probe descendsabnormally at any position otherthan the reaction cell.

a.

b.

c.

Verify that reagent bottle isuncapped.

Verify that reagent disk cover isin the proper position.

Verify that Reagent 2 probe isnot bent.

9-4 STOP Reagent 2 probe does notdescend from the highest point atany position other than over thereaction cell.

a.

b.



9-6 WARNING Reagent 2 probe continues todescend abnormally.

Verify that cushioning of the Reagent2 probe is normal.

9-7 STOP Reagent 2 probe cannot detectthe cell position as it rotates tothe reaction cell.

a.

b.



9-8 STOP Reagent 2 probe does not leavethe cell position when trying torotate.

a.

b.



9-9 STOP Liquid level detector is notRESET.

a.

b.



9-10 STOP Reagent 2 probe does not rotatein its highest position.

a.

b.



Check R1Disk then:MECH CHECK

10-1 STOP Reagent 1 disk does not detectits stop position.

a.

b.

c.

d.

e.

Do not touch the reagent diskduring operation.

Remove item(s) such as reagentlids, which may be obstructingdisk rotation.

Ensure reagent bottles areinserted properly.



4 • 37


INSTRUMENT ALARMS


Check R1Disk then:MECH CHECK(cont’d)

10-2 STOP Reagent 1 disk does not stop atthe correct position.

a.

b.

c.

d.

e.


Remove item(s), such as reagentlids, that may be obstructingdisk rotation.


MECHANISMS CHECK screen:execute Mechanism Check10 times.


10-3 STOP Reagent 1 disk does not detectits home position.

a.

b.

c.

d.

e.






Check R2Disk then:MECH CHECK

11-1 STOP Reagent 2 disk does not detectits stop position.

a.

b.

c.

d.

e.






11-2 STOP Reagent 2 disk does not stop atcorrect position.

a.

b.

c.

d.

e.






4 • 38


INSTRUMENT ALARMS


Check R2Disk then:MECH CHECK(cont’d)

11-3 STOP Reagent 2 disk does not detectits home position.

a.

b.

c.

d.

e.


Remove item(s), such as reagentlids, that may be obstructing diskrotation.




Replace R1Disk Cover

12-1 WARNING Reagent 1 disk cover is left openat the start of operation.Instrument will not start.

Close the reagent 1 disk cover.

12-2 WARNING Reagent 1 disk cover is openedduring operation or samplingstop.


12-3 WARNING Reagent 1 disk cover is openedduring reagent registration.


12-4 WARNING Reagent 1 disk cover is left openfor 5 minutes or more duringstand-by or stat stand-by.


Replace R2Disk Cover

13-1 WARNING Reagent 2 disk cover is left openat the start of operation.Instrument will not start.


13-2 WARNING Reagent 2 disk cover is openedduring operation or samplingstop.


13-3 WARNING Reagent 2 disk cover is openedduring reagent registration.


13-4 WARNING Reagent 2 disk cover is left openfor 5 minutes or more duringstand-by or STAT stand-by.


AbnormalR1 SyringeMovement

14-1 STOP Reagent 1 syringe does notreach its highest position.

a.

b.

c.

Verify that the retaining screwof the reagent 1 system is notovertightened.

ANALYZER MAINTENANCEscreen: execute Air Purgeand observe reagent 1 syringefor ascending movement.


4 • 39


INSTRUMENT ALARMS


AbnormalR1 SyringeMovement(cont’d)

14-1 STOP Reagent 1 syringe does notdescend from its highestposition.

a.

b.

c.


ANALYZER MAINTENANCEscreen: execute Air Purge andobserve reagent 1 syringefor descending movement.


AbnormalR2 SyringeMovement

15-1 STOP Reagent 2 syringe does notreach its highest position.

a.

b.

c.




15-2 STOP Reagent 2 syringe does notdescend from its highestposition.

a.

b.

c.




ISE Sipper:ExecuteMECH CHECK

16-1 WARNING/STOP*1

ISE sipper nozzle does not reachthe lowest position (during reset/operation).

a.

b.

MECHANISMS CHECK screen:execute ISE Check 10 times.


16-2 WARNING/STOP*1

ISE sipper nozzle cannot leavethe lowest position.

a.

b.



ISE Vacuum:Execute MECHCHECK

17-1 WARNING/STOP*1

ISE vacuum nozzle does notreach the lowest position.

a.

b.



17-2 WARNING/STOP*1

ISE vacuum nozzle cannot leavethe lowest position.

a.

b.



4 • 40


INSTRUMENT ALARMS


AbnormalISE SyringeMovement

18-1 WARNING/STOP*1

ISE sipper syringe does notreach the highest position.

a.

b.

c.

If syringe was recentlyreassembled, check forproper assembly.



18-2 WARNING/STOP*1

ISE sipper syringe cannot leavethe highest position.

a.

b.

c.




18-3 WARNING/STOP*1

Diluent syringe cannot reach thehighest position.

a.

b.

c.




18-4 WARNING/STOP*1

Diluent syringe cannot leave thehighest position.

a.

b.

c.




18-5 WARNING/STOP*1

Internal standard solution syringecannot reach the highestposition.

a.

b.

c.




18-6 WARNING/STOP*1

Internal standard solution syringecannot leave the highestposition.

a.

b.

c.




4 • 41


INSTRUMENT ALARMS


ISE Stopped:Resolve ISEAlarm

19-1 WARNING/STOP*1

ISE function stops due to analarm.

Remedy the presented alarm, thenresume operation.

IncubatorWater TempError

20-1 WARNING Water temperature in theincubation bath exceeds 45 °C.

a.

b.

c.

Ensure that radiator filter onfront of instrument is notclogged with dust.

Verify that both liquid levelsensors are plugged in.


20-2 WARNING Water temperature in theincubation bath is outside arange of 37 ± 0.5 °C.

a.

b.

c.

d.

e.

Ensure that radiator filter onfront of instrument is not cloggedwith dust.

Ensure that room temperature is15 to 32 °C.

Verify that incubation bath wateris circulating.


Call Technical Support.

IncubatorWater LevelError

21-1 WARNING Incubation bath water level istoo low.

a.

b.

c.

d.

e.

Verify that pump does not containair. If so, repeat Inc. WaterExchange on the MAINTENANCEscreen several times.

Ensure that pump filter is notclogged.

Check Hitergent level in supplybottle.



ExecuteINC. WATEREXCHANGE

22-1 WARNING More than 24 hours haveelapsed since the last incubationbath water exchange.

MAINTENANCE screen: executeInc. Water Exchange.

WaterReservoirLevel Too Low

23-1 STOP Deionized water reservoir levelis too low.

a.

b.

c.

d.

e.

Ensure that water supply is ON.

Ensure that water supplypressure is 15-25 psi.

Ensure that external supplywater flow rate is 100 liters(26.4 gallons) per hour.

Clean inlet water filter.


4 • 42


INSTRUMENT ALARMS


Empty WasteReservoir

24-1 WARNING Waste reservoir full. a.

b.

c.

Empty waste reservoir.

Ensure that liquid level sensorwires in drain tubing cap are nottouching each other, or the cap.


Power SupplyUnit > 70Degrees

125- WARNING Temperature of power supplyunit is above 70 °C.

a.

b.

c.

d.

Ensure that instrument coolingfans are clean and operational.

If room temperature exceeds 30°C (86° F), correct the roomtemperature.

If the instrument is less thanthree feet from a wall (or otherbarrier) on any side, move theinstrument according toinstallation requirements.


DegasserHeater > 70Degrees

26-1 STOP Heater temperature in thedegasser is 70 °C or higher.


CheckStoppers onVacuum Tank

27-1 STOP Vacuum pump is not supplyingenough negative pressure.


Liquid inVacuum Tank

28-1 WARNING Liquid detected in vacuum tank. a.

b.

c.

Verify that drain hose to wastecontainer is properly placed andnot pinched.

Verify that main drain tubing frominstrument is not pinched.


3 ABSReadings> 3.3

29-1 WARNING During normal operation, thestopped cell blank absorbancemeasurement for onewave-length is greater than 3.3ABS.

NOTE: This cell is not used foranalysis.

a.

b.

c.

d.

Ensure that reaction bath is full,and water is not cloudy.

If reaction bath is not full, or if thebath water is cloudy, performInc. Water Exchange.

Ensure that lamp leads are nottouching and that lead wires aresecurely fastened.

Replace photometer lamp.

4 • 43


The ADC 2,2 or λ 1-12 value ofthe stopped cell blankmeasurement of one cell differsfrom the reference value of thecell blank measurement (takenfrom ANALYZER MAINTENANCE)by more than 0.1 ABS for twoconsecutive measurements.

INSTRUMENT ALARMS


3 ABSReadings> 3.3 (cont’d)

29-2 S. STOP(STOP*)

During normal operation, thestopped cell blank absorbancemeasurement for all wave-lengths is greater than 3.3 ABS.

NOTE: This cell is not used foranalysis. * STOP appears if thisalarm is issued in any modeother than Operate.

a.

b.

c.

d.





29-3 S. STOP(STOP*)

Alarm code 29-1 isencountered 10 consecutivetimes.

NOTE: This cell is not used foranalysis. * STOP appears ifthis alarm is issued in anymode other than Operate.

a.

b.

c.

d.





Cell Blank Outof Limits (2X)

30-1 -30-120*

WARNING

*Subcode 1-120 indicates thereaction cell number.

NOTE: This cell is not used foranalysis.

a.

b.

c.

d.

e.

f.

g.

Verify that reaction cell is notcontaminated or cracked.

Verify that there are no airbubbles formed in the watercontained in the reaction cell.

Ensure that no dust particles arein the incubation bath.

ANALYZER MAINTENANCEscreen: perform Wash Cells.

Perform Cell Blank afterreplacement of lamp or cell.

Ensure that there is an adequateamount of rinse water.

Verify that there are no airbubbles formed in the incubationbath.

4 • 44


The ADC 1,2 or λ 1-12 valueof the stopped cell blankmeasurement of a cell differsfrom the reference value of thecell blank measurement (fromANALYZER MAINTENANCE)by more than 0.1 ABS for threeconsecutive reaction cells.STOP occurs if this alarmappears in any mode otherthan operation.

The ADC 1,2 or λ 1-12 valueof the stopped cell blankmeasurement of a cell differsfrom the reference value of the cellblank measurement (fromANALYZER MAINTENANCE)by more than 0.1 ABS for 10consecutive reaction cells.STOP occurs if this alarmappears in any mode otherthan operation.

The ADC 1,2 or λ 1-12 valueof the passing cell blankmeasurement of a cell differsfrom the reference value of thecell blank measurement (fromANALYZER MAINTENANCE)by more than 0.1 ABS for 10consecutive reaction cells.

The ADC 1,2 or λ 1-12 valueof the passing cell blankmeasurement of one cell differsfrom the reference value of thecell blank measurement (fromANALYZER MAINTENANCE)by more than 0.1 ABS for two out ofthe last three reaction cells.

INSTRUMENT ALARMS


Cell BlankOut of Limits(3X)

31-1-31-120*

S. STOP(STOP)

Follow the same procedures outlinedfor the Cell Blank out of Limits (2X)alarm, error 30.

*Subcode 1-120 indicates the reactioncell number.


32-1-32-120*

S. STOP(STOP)

Follow the same procedures outlinedfor the Cell Blank out of Limits (2X)alarm, error 30.



33-1-33-120*

S. STOP Follow the same procedures outlinedfor the Cell Blank out of Limits (2X)alarm, error 30.



34-1-34-120*

WARNING Follow the same procedures outlinedfor the Cell Blank out of Limits (2X)alarm, error 30.

*Subcode 1-120 indicates the reactioncell number.NOTE: If the passed cell blankdiffers one time, then the average ofthe two normal readings are used.

ADC CounterFailure

35-1 WARNING ADC for sub (secondary)wavelength fails to operatenormally.

a.

b.

c.

d.

Correct any other alarmconditions in OPERATIONMONITOR appearing beforeADC Counter Failure.


If reaction disk was removedrecently, dry detectors asshown in Section 3.9, CleanReaction Bath.


4 • 45


INSTRUMENT ALARMS


ADC CounterFailure(cont’d)

35-2 WARNING ADC for main (primary)wavelength fails to operatenormally.

a.

b.



35-3 WARNING ISE ADC abnormal. a.

b.



35-4 WARNING ADC for temperature control failsto operate normally.

a.

b.



ADC Voltage:ExecuteRESET

36-1 WARNING ADC reference voltage for sub(secondary) wavelengthproduces abnormal count.

a.

b.



36-2 WARNING ADC reference voltage for main(primary) wavelength producesabnormal count.

a.

b.



36-3 WARNING ADC reference voltage for ISEproduces abnormal count.

a.

b.



36-4 WARNING ADC reference voltage fortemperature producesabnormal count.

a.

b.



SampleBarcode Error

37-1 -37-50

WARNING At the sample positioncorresponding to subcode1-50, data reception from thebar code reader was notcompleted before ID receptiontimed out. (Read error due toimproper label, empty positionor defective bar code reader.)

a.

b.

c.

MECHANISMS CHECK screen:execute Barcode Reader Check.

Verify that bar code label is notobscured or removed.


BarcodeReader Error

38-1 -38-3*

WARNING Error is encountered duringcommunication with the bar codereader. (Parity, framing, oroverrun error.)

a.

b.

c.

MECHANISMS CHECK screen:execute Barcode Reader Check.

Verify that bar code label is notobscured or removed.

Call Technical Support.* Subcode 1

Subcode 2

Subcode 3

-

-

-

Reagent 1bar codeReagent 2bar codeReagent 3bar code

4 • 46


INSTRUMENT ALARMS


R1 BarcodeError

39-1 -39-32*

WARNING During bar code reading on theR1 disk, bar code data does notconform to the label protocol(code out of normal range).

*Subcode indicates the reagentbottle position.

a.

b.

c.

d.

Verify the label protocol.

Replace the errant reagentbottle with one labelledcorrectly.

Verify that Hitergent is inposition 33 on the reagent disk.


R2 BarcodeError

40-1 -40-32*

WARNING In bar code reading on the R2disk, bar code data does notconform to the label protocol(code out of normal range).


a.

b.

c.

d.

Verify the label protocol.

Replace the errant reagentbottle with one labelledcorrectly.

Verify that Hitergent is inposition 33 on the reagent disk.


Replace LowReagent (R1)

41-1 -41-46*

WARNING 1.

2.

Remaining reagentvolume on R1 disksufficient for less than 10tests.

Remaining diluent orwash solution volumeon the R1 disk is lessthan 1 mL.

a.

b.

c.

Verify reagent volumes ontheREAGENT STATUS screen.

Replace low reagent with anew one.


*Subcode indicates the test keyassignment.

Replace LowReagent (R2)

42-1 -42-46*

WARNING 1.

2.

Remaining reagentvolume on R2 disksufficient for less than 10tests.

Remaining diluent orwash solution volumeon the R2 disk is lessthan 1 mL.

a.

b.

c.

Verify reagent volumes ontheREAGENT STATUS screen.

Replace low reagent with anew one.



R1 < UserDefined Level

43-143-46*

WARNING 1.

2.

Volume of reagent is lessthan the reagent check levelspecified in SYSTEMPARAMETERS.

Diluent or wash solutionvolume is less than 10 mL.

a.

b.

c.

Verify reagent volumes on theREAGENT STATUS screen.

Make sure that the reagentcheck level set on the SYSTEMPARAMETERS screen iscorrect.

Resume operation; if alarmrecurs, call Technical Support.*Subcode indicates the test key

assignment.

4 • 47


INSTRUMENT ALARMS


R2 < UserDefined Level

44-1 -44-46*

WARNING 1.

2.

Volume of reagent is lessthan the reagent checklevel specified in SystemParameters.

Diluent or wash solutionvolume is less than 10 mL.

a.

b.

c.

Verify reagent volumes on theREAGENT STATUS screen.

Make sure that the reagentcheck level set on the SYSTEMPARAMETERS screen is proper.



Check R1Position andApp Code

45-1 -45-32*

WARNING 1.

2.

A R2 or R3 reagent isloaded on the R1 disk.

A reagent is on board thatdoes not have parametersassigned.

a.

b.

c.

Verify that there is not a reagentwhose type does not match thedisk on the REAGENT STATUSscreen.

Ensure that all app code nos. canbe accessed on the CHEMISTRYPARAMETERS screen.

Resume operation; if alarmrecurs, call Technical Support.*Subcode indicates the reagent

bottle position.

Check R2Position andApp Code

46-1 -46-32*

WARNING 1.

2.

R1, R4 reagent, or diluentbottle is loaded on theR2 disk.

A reagent is on board thatdoes not have parametersassigned.

a.

b.

c.

Verify that there is not a reagentwhose type does not match thedisk on the REAGENT STATUSscreen.

Ensure that all app code nos. canbe accessed on the CHEMISTRYPARAMETERS screen.

Resume operation; if alarmrecurs, call Technical Support.*Subcode indicates the reagent

bottle position.

R1 Label:ExecuteMANUAL SET

47-1 -47-32*

WARNING A bottle with a minimal bar codelabel has been loaded in positionon the R1 disk without enteringreagent information.


a.

b.

c.

Ensure that ‘?????’ is displayedfor the channel concerned on theREAGENT STATUS screen.

Manually enter reagent data.


R2 Label:ExecuteMANUAL SET

48-1 -48-32*

WARNING A bottle with a minimal bar codelabel has been loaded in positionon the R2 disk without enteringreagent information.


a.

b.

c.

Ensure that ‘?????’ is displayedfor the channel concerned on theREAGENT STATUS screen.

Manually enter reagent data.


4 • 48


INSTRUMENT ALARMS


Load CellWash Bottle

49-1 -49-8*

WARNING In reagent registration, the washsolution bottle specified in theCell Wash field on the SPECIALWASH PROGRAMMING screenis not loaded on the reagent disk.

*Subcode indicates numberspecified on SPECIAL WASHPROGRAMMING screen.

a.

b.

c.

Verfiy the washing solutionsetting on the SPECIAL WASHPROGRAMMING screen.

Load the wash solution bottle.


Load ProbeWash Bottle

50-1 -50-16*

WARNING In reagent registration, the washsolution bottle specified in theReagent Probe Wash on theSPECIAL WASHPROGRAMMING screen is notloaded on the reagent disk.

*Subcode indicates numberspecified on SPECIAL WASHPROGRAMMING screen.

a.

b.

c.

Verfiy the washing solutionsetting on the SPECIAL WASHPROGRAMMING screen.

Load the wash solution bottle.


Dup. Barcode:Replace Bottle

51-1 -51-2*

WARNING Duplicate reagent bar code isregistered.

*Subcode indicates reagent disknumber.

Change the reagent, or diluent washbottle with the duplicate bar code.

Dup. Barcode:RelabelSample

52-1*?? WARNING Duplicate sample bar code isregistered.

*Subcode indicates sample diskposition.

Enter TestSelections

53-1 -53-50*

WARNING 1.

2.

3.

A sample number wasprogrammed with no testsselected.A sample has been placedon the sample disk with notests selected.Host did not respond in timewith test selections and noselections were found.

a.

b.

Rerun the tests that were notanalyzed.

Enter test selections beforeplacing samples on the analzyer.

*Subcode indicates sample diskposition.

NOTE: This alarm is issued onlywhen real-time test selectioninquiry from a host is specified.

4 • 49


INSTRUMENT ALARMS


T/S Exceed800 patients

54-1 WARNING 1.

2.

3.

Tests for > 800 sampleshave been requested.Tests for > 800 sampleshave been requested byreal-time downloading.Tests for > 800 sampleshave been requested bybatch downloading.

After completing the analysis of thefirst 800 samples, program theremaining samples.

SamplingDelay

55-1 WARNING There is a delay in result dataprintout during analysis for up to40 samples. (printer)

If the remaining samples are movedfrom their original positions on thesample disk, return them beforerestart of sampling.

55-2 WARNING There is a delay in result datatransmission during analysis forup to 40 samples. (systeminterface)

If the remaining samples are movedfrom their original positions on thesample disk, return them beforerestart of sampling.

No MoreSamples toProcess

56-1 WARNING There are no more routinesamples to be measured. Thisalarm indicates completion ofsampling.

C-RAM Error 57-1 WARNING C.RAM is abnormal. Call Technical Support.

Interrupt Error 58-1 WARNING Fast interrupt error. FIRQ error.

Call Technical Support.58-2 WARNING IRQ interrupt error.

58-3 WARNING NMI interrupt error.

DC Error: Turn911 OFFthen ON

59-1 STOP 15V DC power abnormality. a.

b.

Turn instrument OFF, thenback ON.

If alarm recurs, call TechnicalSupport.

59-2 STOP -15V DC power abnormality.

59-3 WARNING 12V DC power abnormality (forlamp).

59-4 STOP 15V DC power abnormality (formechanism controller).

59-5 E. STOP DC power 24V abnormality (formechanism controller).

Replace Fuse 60-1 E. STOP Fuse has blown. Check fuses. Note which fuseexhibits a white flag (if any), then callTechnical Support. DO NOTREPLACE ANY FUSE UNLESS SODIRECTED BY BOEHRINGERMANNHEIM TECHNICAL SUPPORT.

4 • 50


INSTRUMENT ALARMS


Power FailureHas Occurred

61-1 WARNING AC power is abnormal. Thisalarm is normally seenfollowing a power failure.

a.

b.

If a power failure (includingmomentary power failure)happens, this alarm informs theuser.


ControllerMotor Error

62-1 -62-22*

STOP The data is not transmitted tothe controller motor properly.

*Subcodes are as follows:


123456789

101112

13

14

15

16171819202122

Sample arm up/downSample arm rotationReaction disk rotationSample disk rotationReagent 1 disk rotationReagent 1 arm up/downReagent 1 arm rotationReagent 2 arm up/downReagent 2 arm rotationReagent 2 disk rotationRinse mechanism up/downStirring mechanism (1) armup/downStirring mechanism (1) armrotationStirring mechanism (2) armup/downStirring mechanism (2)rotationSample syringe up/downReagent-1 syringeReagent-2 syringeISE stirrerStirring rod rotationDIL/IS syringeISE sipper syringe

ControllerMotor Failure

63-1 -63-22*

E. STOP Motor controller does notrecognize any command otherthan stop.

*Subcodes are same as above.


Replace CellWash Solution

65-1 -65-8*

S. STOP Less than 1 mL wash solutionremaining.

*Subcode indicates numberprogrammed in SPECIALWASH PROGRAMMING.

Remove bottle, then load new washsolution onto reagent disk.

Replace ProbeWash Solution

66-1 -66-16*

S. STOP Less than 1 mL wash solutionremaining.

*Subcode indicates numberprogrammed in SPECIAL WASHPROGRAMMING.


4 • 51


INSTRUMENT ALARMS


Cell WashSolution< 10 mL

67-1 -67-8*

S. STOP Washing solution < 10 mL.



Probe WashSolution< 10 mL

68-1 -68-16*

S. STOP Washing solution < 10 mL



Stat Error,TestingIncomplete

69-1 WARNING Stat sample or stat rerun samplecould not be analyzed for thefollowing reasons:

a.

b.

c.

Enter the correct ID.

Issue a test selection request orturn off masking.

Return to the original sample disknumber.

1.2.

3.

4.

ID read error.The read sample ID and IDentered on the screen donot match.Test selections notreceived or test selectionsare masked.Prior to sampling, sampledisk number was changedand restart executed.

CalibrationError

70-1 -70-49*

WARNING Photometric assay: Photometric:

1.

2.

During calibration, thestandard absorbance isabnormal.During calibration,calculation is disabled.

a.

b.

c.

d.

e.

f.

Verify Duplicate andSensitivity Limit value onthe CHEMISTRY PARAMETERSscreen.

Check quantity of standard,sample and reagents.

Check to see if a cell blank alarmhas been issued.

Check to see if the absorbance is3.3 ABS or more.

Check to see if the reaction limitvalue is exceeded.

Check to see if the linearityabnormal alarm is issued.

ISE assay:

1.

2.

During calibration, thepotential data ofstandard or internalstandard solution isindicated with ADC error,insufficient sample alarm,noise alarm, or level alarm.During calibration,calculation is disabled.


ISE:Check to see if the ADC alarm hasbeen issued.

4 • 52


INSTRUMENT ALARMS


CalibrationFactor Error

71-1 -71-49*

WARNING K factor determined throughcalibration differs from theprevious value by more than ±20%. Display values for ISEcalibration, slope, or ISE 3differed from the previouscalibration by a value greaterthan the compensated limit(%).*Subcode indicates the testkey assignment.NOTE: Theresult of this calibration isupdated but not saved to floppydisk.

a.

b.

If alarm occurs at same time asother alarms, correct the otheralarm condition.

Check standards, reagents, andcontrols. If controls are in rangeand standards and reagents areacceptable, go to theMAINTENANCE screen andexecute Parameter WriteContinue operating. Otherwise,correct abnormalities andrecalibrate.

SD LimitExceeded

72-1 -72-46*

WARNING During multi-point calibration, themean remainder is larger thanthe SD limit.*Subcode indicatesthe test key assignment.NOTE:The result of this calibration isupdated but not saved to floppydisk.

a.

b.

c.

Verify SD limit, standardconcentrations, and positionson the CHEMISTRYPARAMETERS screen.

Check preparation and expirationdates of standards and reagents.

Recalibrate affected test.

SensitivityError

73-1 -73-46*

WARNING In linear, nonlinear, or isozyme-P calibration, the differencebetween mean STD (1)absorbance and mean STD (N)is smaller than the sensitivitylimit on the CHEMISTRYPARAMETERS screen.

NOTE:N = 2 for linear orisozyme-P calibration.N = 3 to 6 for nonlinearcalibration or multipoint linearcalibration.

If only STD (1) or STD (N) ismeasured, the previousabsorbance is used forsensitivity check.


NOTE: The result of thiscalibration is updated but notsaved to floppy disk.

a.

b.

c.

d.

Verify the Sensitivity Limitspecified on the CHEMISTRYPARAMETERS screen.

Check reagent and calibrators.

Check sample pipettor for leaks.

Recalibrate affected test.

4 • 53


INSTRUMENT ALARMS


RandomControl Error

74-1 -74-49*

WARNING Random error occurs in realtime QC.


a.

b.

Verify the X and SD for thespecified assay are enteredcorrectly on the CONTROLVALUE SETTING screen.

Check calibrators, controls, andreagents:

Have they been properly prepared?

Have they been properly stored?

Have they been used beyond theirrecommended expiration date?

Are calibrators and controls in thecorrect positions on the sample disk?

c.

d.

e.

f.

Check Hitergent bottle. Ifempty, replace and performInc. Water Exchange on theMAINTENANCE screen.

Verify that there are no airbubbles on the inner or outerwall of the reaction cell.

Perform Photometer Check.


SystematicControl Error

75-1 -75-49*

WARNING Systematic error occurs inreal-time QC.


a.

b.

c.

Are the X and SD for thespecified assay entered correctlyon the CONTROL VALUESETTING screen?

Is all information enteredcorrectly on the CHEMISTRYPARAMETERS screen?

Check calibrators, controls, andreagents:

Have they been properly prepared?

Have they been properly stored?

Have they been used beyond theirrecommended expiration date?

Are calibrators and controls in thecorrect positions on the sample disk?

d.

e.

f.

g.

Has maintenance beenperformed properly on sampleand reagent pipettors?

Verify that there are no airbubbles on the inner or outer wallof the reaction cell.

Perform Photometer Check.


4 • 54


Na+ : 0.7 mV

K+ : 1.0 mV

Cl- : 0.8 mV

Na+ : -90 to -10 mV

K+ : -90 to -10 mV

Cl- : 80 to 160 mV

Na+ : Less than 32or A > 0.232

K+ : Less than 32or A > 0.160

Cl- : Greater than -25or A > 0.490

A = carry-over rate

Na+ : 32.0 ≤ SLOPE ≤ 37.9 orSLOPE ≥ 68.1 or A > 0.154

K+ : 32.0 ≤ SLOPE ≤ 37.9 orSLOPE ≥ 68.1 or A > 0.107

Cl- : -29.9 ≤ SLOPE ≤ 25.0 orSLOPE ≥ -68.0 or A > 0.330

INSTRUMENT ALARMS


Real TimeQC Error

76-1 -76-49*

WARNING QC error occurs in real-time QC


Perform same steps as SystematicControl Error alarm (75-71 to 75-49).

ISE Int. Ref.Error

80-1

80-2

80-3

WARNING

WARNING

WARNING

During measurement of internalreference, potential is not withinthe following range:

a.

b.

c.

d.

e.

Perform ISE Check on theMECHANISMS CHECK screen.

Check for air in sipper line.

Check internal referencesolution.

Check ISE cartridge for leakage.

Check reference and groundelectrodes for leakage.

ISE Noise:Execute ISECheck

81-1

81-2

81-3

WARNING

WARNING

WARNING

Noise level exceeds the followingvalues during measurement:

a.

b.

Perform ISE Check on theMECHANISMS CHECK screen.


ISE SlopeWarning

82-1

82-2

82-3

WARNING

WARNING

WARNING

During calibration, slope exceedsthe following limits:

If control values are in range, noaction is necessary. Be prepared toreplace a cartridge soon (whenSLOPE alarm occurs).

ISE SlopeError:Replace Cart.

83-1

83-2

83-3

WARNING

WARNING

WARNING

During calibration, slope exceedsthe following limits:

If slope has changed gradually overtime, replace cartridge. Otherwise,examine ISE system for otherabnormalities: check standards,reagents, priming, leaks in cartridges.Correct abnormalities and recalibrate.

4 • 55


Na+ : 120 to 160 mmol/L

K+ : 3.0 to 7.0 mmol/L

CI- : 80 to 120 mmol/L

I.S. < 50 mL

DIL < 30 mL

KCL< 30 mL

INSTRUMENT ALARMS


ISE I. RefConcentrationError

84-1

84-2

84-3

WARNING

WARNING

WARNING

Internal Reference (IS)concentration calculated from agenerated calibration curve is notwithin the following range.

If slope is acceptable, perform aWash ISE.

a.

b.

c.

d.

Check ISE standards onsample disk.

Check ISE reagents.

Correct any other alarms.

Recalibrate.

Execute ISECalibration

85-1 WARNING Calibration was not performedfollowing ISE MAINTENANCE,CELL WASH, or WASH CELLS& ISE.

Execute ISE Calibration from STARTCONDITIONS screen.

Replace LowISE Reagent

87-1

87-2

87-2

WARNING

WARNING

WARNING

The ISE reagent volume is lessthan the following:

Replace ISE reagent.

Replace LowHitergent

88-188-2

WARNING The volume of Hitergent is lessthan 2 mL.

Replace with fresh bottle of Hitergent.

CheckHitergentPosition

89-189-2

WARNING 1.

2.

3.

A bottle other than Hitergent(reagent, diluent, washsolution) is in position 33 onthe reagent disk.

The Hitergent bottle is ina position other thanposition 33.

The reagent bottle bar codein position 33 was not read.

1.

2.

3.

Replace the bottle in position 33withHitergent.

Move the Hitergent bottle toposition 33.

Ensure that the barcode isapplied correctly to the reagentbottle; on REAGENT STATUSscreen, specify cancel forHitergent bottles until a newbottle is placed on the analyzer.

Twin TestParameterError

90-1 -90-46*

WARNING 1.

2.

When twin test mode isselected, the second test isnot specified.

When twin test mode is notselected, a second test isspecified.

a.

b.

Make sure that the first test andsecond test are specifiedcorrectly in the twin test mode.

Make sure the chemistryparameters are loaded correctly.

4 • 56


INSTRUMENT ALARMS


Twin TestParameterError (cont’d)

3. In the twin test mode, thetwo tests differ from eachother in at least one of thefollowing parameters:


Check AppCode andAssay Point

91-1 -91-46*

WARNING 1.

2.

Relationship betweenassay code and measurepoint is invalid.

Assigned photometric pointlags behind the specifiedreaction time.

a.

b.

Check the Assay Code on theCHEMISTRY PARAMETERSscreen.

Check the specified reactiontime.


CalibrationParameterError

92-1 -92-46*

WARNING 1.

2.

3.

4.

5.

6.

7.

8.

Relationship betweenassay code and calibrationtype is invalid.

Calibration points necessaryfor calibration type have notbeen entered.

Standard solution positionnecessary for calibration hasnot been entered.

An improper span pointvalue has been entered.

Relationship betweencalibration type andcalibration method is invalid.

Concentration value ofstandard solution is not setin ascending order (exceptstandard solutions 3 and 4for isozyme.)

‘99’ is specified forstandard position 2 andthe concentration is notequal to zero.

The standard code orposition is not assignedon the SYSTEMPARAMETERS screen.

a.

b.

Program CHEMISTRYPARAMETERS screen asindicated on chemistryapplication sheet.

When running a nonlinearassay, assign three or morestandards for that test.


• CONTROL INTERVAL• S. VOL. (NORMAL,

INCREASE, DECREASE)• DILUTION• STD POS.• STD PRE. VOL.• CALIB. POINTS• AUTO CALIB.• ASSAY CODE

• R VOLUME (R2 - R4)• STD CODE• STD S. VOL.• CALIB TYPE• SPAN POINT• DIL. BOTTLE CODE/

AVAILABLE DAYS• DATA MODE• REACTION TIME

4 • 57


INSTRUMENT ALARMS


Check R1-R4DispenseVolumes

93-1 -93-46*

WARNING 1.

2.

3.

4.

5.

6.

7.

Total liquid volume up tothe last photometric point> 700 µL.

Discharge volume ofconcentrated reagent(diluent volume + reagentvolume) is > 350 µL.

Volume of R2 and R3reagents is not within arange of 0 to 250 µL.

Diluent volumes for thesecond and third reagentsare not within a range of 0to 250 µL.

Volumes of R1 through R4reagents are all zero.

Some volume of reagent isprogrammed to be pipettedafter the reaction time iscompleted.

Relationship betweensample dilution andsample volume isimproper.

*Subcode indicates the testkey assignment.

Verify that the parameters are correcton the CHEMISTRY PARAMETERSscreen.

IsozymeParameterError

94-1 -94-46*

WARNING 1.

2.

3.

4.

Reaction time differsbetween the isozyme-Pchannel and isozyme-Qchannel tests.

In case of the isozyme-Pchannel, the isozyme-Qchannel is not specified.

In case of the isozyme-Qchannel, a second test isspecified.

Isozyme-P channel andisozyme-Q channel are notpaired in one-to-onerelationship.

*Subcode indicates the testkey assignment.

a.

b.

Verify that parameters arecorrect for the isozyme-Pchannel and isozyme-Qchannel on the CHEMISTRYPARAMETERS screen.

Make sure that the isozyme-Pchannel specifies the isozyme-Qchannel test and the isozyme-Qchannel does not specify theisozyme-P channel test.

4 • 58


INSTRUMENT ALARMS


Range Error 95-1 -95-46*95-53 -95-60**

WARNING The low value is greater than thehigh value for the expectedvalue, technical limit, or S1 ABSlimit.


**Subcode indicates thecalculated test number.

Verify test parameters specified onthe CHEMISTRY PARAMETERS orCALCULATED TESTS screens.

CheckCOMP. TESTParameters

96-1 -96-8*

WARNING Compensated test specificationsare wrong:

Verify that the parameters enteredon the CALCULATED TESTSscreen are correct.

1.

2.

3.

A test used in compensationis not measurable.

A compensated test is notincluded in the formula.

When compensated test isphotometric, an ISE test isspecified.

*Subcode indicates thecompensated test number.

Serum IndexTest Error

97-1 -97-46*

WARNING 1.

2.

The test used for serumindex measurement doesnot have the Rate A assaycode specified.

The test used for serumindex measurement has themanual mode specified.

Specify the Rate A assay code forthe test used for serum indexmeasurement.


CheckREAGENTPROBE WASH

99-1 -99-8*

WARNING 1.

2.

Relationship between thereagent types (R1 and R4)has been enteredincorrectly on the SPECIALWASH PROGRAMMINGscreen:R1 and R4 for probe R1,R2 and R3 for probe R2.

When water is used to rinsethe R2 probe, the dischargevolume is greater than250µL.

Check the parameters specified in theReagent Probe Wash field on theSPECIAL WASH PROGRAMMINGscreen.

*Subcode indicates the numberof the reagent wash.

4 • 59


INSTRUMENT ALARMS


No MeasurableChannel OnBoard

100-1 WARNING There is no measurablechannel. MANUAL is specifiedin the Data Mode field for allchannels.

There is no channel for whichnecessary reagents areprepared.

a.

b.

Verify that the parameterson the CHEMISTRYPARAMETERS screen arecorrect.

Check the parameter specifiedin the Data Mode field on theCHEMISTRY PARAMETERSscreen.

Execute 10 secCYCLE TIME

101-1 WARNING 1.

2.

In transition to the STATRECEPTION mode, thecycle time is not 10 sec.

In modes other thanORIGINAL ABS., the cycletime is not 10 sec.

Check the Cycle Time setting on theSYSTEM PARAMETERS screen.

101-2 WARNING When attempting to start fromSTAT Stand-By, STAT Rerunmode is set to On.

Verify the STAT Rerun setting onthe START CONDITIONS screenis set to Off.

DuplicateBottle Code

102-1 WARNING The same reagent bottle code isspecified for multiple channels.

Check the Bottle Code No. ofreagent on the CHEMISTRYPARAMETERS screen.

Test SelectionError

103-1 WARNING When registering rerun of TSfrom the host computer to theanalyzer, the first measurementis not yet completed.

Check the Sample List on theRERUN SAMPLES screen.

CannotExecute ORIG.ABS. Now

104-1 WARNING Execution of ORIGINAL ABS.was attempted during batchprintout or batch transfer ofmeasured data.

Check the Original ABS. settingon the SYSTEM PARAMETERSscreen.

CheckHitergentPosition

105-1 WARNING Bar-coded Hitergent is not onReagent Disk 1.

a.

b.

Place Hitergent in position 33on Reagent Disk 1.

Check the Hitergent Disk 1for proper settings on theREAGENT STATUS SETTINGscreen. If you are not usingbar-coded Hitergent, changethe field to Cancel.

105-2 WARNING Bar-coded Hitergent is not onReagent Disk 2.

a.

b.

Place Hitergent in position 33on Reagent Disk 1.

Check the Hitergent Disk 2field for proper settings on theREAGENT STATUS SETTINGscreen. If you are not usingbar-coded Hitergent, changethe field to Cancel.

4 • 60


INSTRUMENT ALARMS


Refill Hiterg,Do BathExchange

106-1 WARNING No Hitergent was added toincubation bath during waterexchange. 106-1 indicatesReagent Disk 1.

a.

b.

Place Hitergent in position 33 onReagent Disk 1.

Request bath exchange.

106-2 WARNING No Hitergent was added toincubation bath during waterexchange. 106-2 indicatesReagent Disk 2.

a.

b.

Place Hitergent in position 33 onReagent Disk 2.

Request bath exchange.

ExecuteREAGENTREGISTRATION

107-1 WARNING 1.

2.

3.

4.

Reagent registration wasnot successfullycompleted at Start Up.

Reagent registration wasnot successfullycompleted at Wake Up.

Reagent registration wasnot successfullycompleted after closingthe reagent disk cover.

Reagent registration wasnot successfully completedafter requesting fromREAGENT STATUS screen.

a.

b.

Request Read ReagentBarcodes from REAGENTSTATUS screen.


Check ISEStandardCodes

108-1 WARNING The ISE standard code orposition is not assigned on theSYSTEM PARAMETERS screen.

Assign ISE standard position on theSYSTEM PARAMETERS screen.

Printer Error 110-1 WARNING 1.

2.

Hardware is faulty.(Acknowledgment is notreturned from printer.)

Time-out error occurs.

a.

b.

c.

d.

e.

Is printer ON?

Is printer ON LINE light ON? Ifnot, press ON LINE button onprinter.

Is printer connected toinstrument?

Carry out Printer Check onMECHANISMS CHECK screen.


110-2 WARNING 1.

2.

3.

Printer paper is not set.

Printer select button is OFF.

Connector is disconnected.

Remove and replace paper. Ensurethat paper detector switch is engaged.

110-3 WARNING Self check error is found. Press ON LINE button on printer.

4 • 61


INSTRUMENT ALARMS


Printer Error(cont’d)

110-4 WARNING When the print mode selected isreport mode, measurement datacannot print out with PAGELENGTH.

Verify the Page Length parametervalue specified on the REPORTFORMAT screen.

SystemInterface Error

111-1 WARNING The text cannot be received fromthe system within thepredetermined period of time.

a.

b.

c.

d.

e.

f.

Check host computer. Is itON?

Verify Host Communication onSTART CONDITIONS.

Check cable connectionsbetween instrument and hostcomputer.

Check host computer transmitcondition.

Ensure that host andinstrument are utilizingsame baud rate.


111-2 WARNING Data cannot be sent to thesystem within the predeterminedtime period.

111-3 WARNING Communication has beenattempted regardless of anunsuccessful initialization of thebuffered controller.

111-4 WARNING A command cannot be issued tothe buffered controller.

111-5 WARNING The end-of-command interrupt isnot returned from the bufferedcontroller.

111-6 WARNING An abnormal command or datawrite has been attempted to thebuffered controller.

111-7 WARNING An error has occurred inaccessing the FIFO buffer of thebuffered controller.

111-8 WARNING The serial interface LSI circuit ofthe buffered controller is faulty.

111-9 WARNING An invalid interrupt has beenissued from the bufferedcontroller.

111-10 WARNING In response to each frametransmitted from the analyzer,the REP frame has beenreturned from the hostsuccessively more thanspecified.

111-11 WARNING The received text contains anillegal character.

111-12 WARNING The character count in the testreceived is out of range.(Thecharacter count between STX toETX is out of range.)

4 • 62


INSTRUMENT ALARMS


SystemInterface Error(cont’d)

111-13 WARNING The host has sent the text indisregard of the transmissionprocedure.

a.

b.

c.

d.

e.

f.

Check host computer. Is it ON?

Verify Host Communication onSystem Parameters.

Check cable connectionsbetween instrument and hostcomputer.

Check host computer transmitcondition.

Ensure that host and instrumentare utilizing same baud rate.


111-14 WARNING A vertical parity error occurredduring data reception.

111-15 WARNING Overrun error occurred duringdata reception.

111-16 WARNING Framing error occurred duringdata reception.

111-17 WARNING BCC error found in received test.

111-18 WARNING BCC error in data transfer fromhost to analyzer.

Non ExistingKey CodeEntered

112-1 WARNING A non-existent key code hasbeen entered.


C-RAM Error 113-1 WARNING Error occurred in C-RAM. Call Technical Support.

Real TimeClock Error

114-1 WARNING Faulty RTC read. (RTC: RealTime Clock)


APU Fail:Turn 911 OFFthen ON

115-1 WARNING APU reset time-out error hasoccurred. (APU: ArithmeticProcessor Unit)

a.

b.

Turn instrument OFF, then backON.

Call Technical Support.115-2 WARNING DATA READY time-out error

has occurred.

115-3 WARNING STATUS READY time-out errorhas occurred.

115-4 WARNING Command execution time-outerror has occurred.

ACI Fail:Turn 911 OFFthen ON

116-1 -116-4

WARNING The ACI for barcode has beeninitialized unsuccessfully.1: Sample2: Reagent 13: Reagent 24: Transfer


ReinsertFloppy Disk

120-1 WARNING The system disk is not insertedinto drive 1.

Insert the FD properly.

120-2 WARNING The data disk is not inserted intodrive 2.

Insert the FD properly.

4 • 63


INSTRUMENT ALARMS


Wrong FD inDrive

121-1 WARNING Wrong disk is inserted in drive 1. a.

b.

Ensure that both floppy disksare correctly inserted in theproper disk drives.


121-2 WARNING Wrong disk is inserted in drive 2.

121-3 WARNING During FD read/write for stat andstat rerun samples, a data diskthat cannot be accessed by thefloppy drive has been insertedinto drive 2.

FD ReadingError

122-1 WARNING A hardware error occurred inparameter reading.

a.

b.

c.

Clean the floppy disk drive asshown in Section 3.15.

Check if floppy disk needs to bereplaced. The useful life of afloppy disk is approximately100,000 accesses.Refer toSection 2.88, CumulativeOperations List, for the accesscount of the disk currently in use.


122-4 WARNING A hardware error occurred inreading of result data for theroutine or routine rerun sample.

122-5 WARNING A hardware error occurred inreading of result data for the stator stat rerun sample.

122-6 WARNING A hardware error occurred inreading of C-RAM data.

122-7 WARNING A hardware error occurred whenreading the analytical testparameters from the parameterdisk.

122-10 WARNING 1.

2.

3.

4.

5.

A hardware error occurredduring execution of the FDcopy command on the drive1 side.

A hardware error occurredduring execution of the FDcheck.

A hardware error occurredduring reading of the FDaccess count.

A hardware error occurredduring reading of the FDversion number and revisionnumber.

A hardware error occurredduring reading of the disk ID.

122-11 WARNING When reading test selectiondata, the barcode reader modesof the floppy disk and theanalyzer do not match.

4 • 64


INSTRUMENT ALARMS


FD WritingError

123-1 WARNING A hardware error occurred inwriting parameters.

a.

b.

c.

Clean the floppy disk drive asshown in Section 3.15.

Check if floppy disk needs to bereplaced. Useful life of floppydisk is approximately 100,000accesses.


123-2 WARNING A hardware error occurred inwriting the calibration result data.

123-5 WARNING A hardware error occurred whenwriting the result data for theroutine/routine rerun samples.

123-6 WARNING A hardware error occurred whenwriting the result data for the stator stat rerun samples.

123-7 WARNING A hardware error occurred whenwriting the C-RAM data.

123-8 WARNING A hardware error occurredwhen writing the analyticaltest parameters onto theparameter disk.

123-10 WARNING 1.

2.

A hardware erroroccurred during executionof the FD copy commandon the drive 2 side.

FD head formatting hasbeen unsuccessful.

WriteProtected Diskin Drive

124-1 WARNING WRITE PROTECTED disk isinserted in the system disk drive.

a.

b.

Uncover the write protect notchon the disk.

Be sure that you are writingappropriate information on thecorrect disk.

124-2 WARNING WRITE PROTECTED disk isinserted in the data disk drive.

Clean FDDHead, ReplaceFD

125-1 WARNING System disk has been accessed100,000 times on the drive 1side.

a.

b.

Clean the FDD read/write hadusing the cleaning disk (seeChapter 3, for the procedure).

Replace floppy disk.125-2 WARNING Data disk has been accessed100,000 times on the drive 2side.

NOTE: This alarm is only issuedat Power-Up.

5. THEORY PART A - INSTRUMENT THEORY

5.1 Overview...................................................................................................... 5 · 1

5.1.1 Introduction .......................................................................................................................... 5 · 15.1.2 General Characteristics ................................................................................................... ... 5 · 15.1.3 Sample Route .............................................................................................................. ........ 5 · 2

5.2 Cell Rinse And Blanking ............................................................................ 5 · 5

5.2.1 Introduction .......................................................................................................................... 5 · 55.2.2 Reaction Cell Rinse Unit .................................................................................................. ... 5 · 55.2.3 Cell Blanking ............................................................................................................. .......... 5 · 7

5.3 Begin Operation .......................................................................................... 5 · 8

5.3.1 Introduction .......................................................................................................................... 5 · 85.3.2 Mechanical Cycle .......................................................................................................... ...... 5 · 8

5.4 Sample Aspiration and Dispense ............................................................ 5 · 14

5.4.1 Sample Aspiration......................................................................................................... .....5 · 145.4.2 Sample Dispense—Start of Rotation #1............................................................................5 · 155.4.3 Sample Probe Rinse ........................................................................................................ ..5 · 17

5.5 Sample Predilution ................................................................................... 5 · 18

5.5.1 Diluent Aspiration........................................................................................................ .......5 · 185.5.2 Diluent Dispense.......................................................................................................... .......5 · 195.5.3 Reagent Probe Rinse ....................................................................................................... ..5 · 195.5.4 Sample and Diluent Stirring..............................................................................................5 · 205.5.5 Pre-diluted Sample Aspiration ..........................................................................................5 · 21

5. THEORY

Contents

5. THEORY

Contents

5.6 Reagent Aspiration and Dispense .......................................................... 5 · 22

5.6.1 Reagent Aspiration at R1 Timing ......................................................................................5 · 225.6.2 Reagent Dispense at R1 Timing ........................................................................................5 · 235.6.3 Reagent Probe Rinse ....................................................................................................... ..5 · 235.6.4 Sample and Reagent Stirring ...........................................................................................5 · 245.6.5 Reagent Dispense at R2 Timing ........................................................................................5 · 255.6.6 Reagent Dispense at R3 Timing ........................................................................................5 · 265.6.7 Reagent Dispense at R4 Timing ........................................................................................5 · 275.6.8 Aspirate Reaction Mixture to Waste .................................................................................5 · 28

5.7 Sampling End............................................................................................ 5 · 29

5.7.1 Overview ....................................................................................................................... ......5 · 295.7.2 Sampling End .............................................................................................................. ....... 5 · 29

5.8 ISE System Components ......................................................................... 5 · 30

5.8.1 Introduction .........................................................................................................................5 · 305.8.2 Internal Reference Flowpath ............................................................................................ 5 · 305.8.3 Dilution Vessel ........................................................................................................... .........5 · 335.8.4 ISE Sampling .............................................................................................................. ........5 · 345.8.5 Diluent Flowpath .......................................................................................................... ...... 5 · 355.8.6 KCl and Reference Cartridge Flowpath ...........................................................................5 · 365.8.7 Measuring Cartridge Flowpath ..........................................................................................5 · 375.8.8 Sample Processing Sequence ..........................................................................................5 · 39

PART B - CHEMISTRY THEORY

5.9 Overview.................................................................................................... 5 · 40

5.9.1 Introduction .........................................................................................................................5 · 405.9.2 General Photometric Characteristics................................................................................5 · 40

5.10 Assay Techniques .................................................................................... 5 · 43

5.10.1 Introduction .........................................................................................................................5 · 435.10.2 Selecting Assay Type and Measure Points ......................................................................5 · 435.10.3 Example of Endpoint Assay ...............................................................................................5 · 445.10.4 Automatic Rerun Feature ..................................................................................................5 · 45

5.11 1-Point Endpoint Assay ........................................................................... 5 · 46

5.11.1 1-Point Endpoint Assay Characteristics ............................................................................5 · 465.11.2 1-Point Endpoint Assay Graph ...........................................................................................5 · 465.11.3 1-Point Endpoint Assay Calculation ..................................................................................5 · 47

5.12 2-Point Rate Assay ................................................................................... 5 · 48

5.12.1 2-Point Rate Assay Characteristics ....................................................................................5 · 485.12.2 2-Point Rate Assay Graph ..................................................................................................5 · 485.12.3 2-Point Rate Assay Calculation .........................................................................................5 · 50





5. THEORY

Contents

5.15 1-Point Endpoint and Rate Assay ........................................................... 5 · 56

5.15.1 1-Point Endpoint and Rate Assay Characteristics ............................................................5 · 565.15.2 1-Point Endpoint and Rate Assay Graph ...........................................................................5 · 565.15.3 1-Point Endpoint and Rate Assay Calculation ..................................................................5 · 57

5.16 Rate A Assay ............................................................................................. 5 · 58

5.16.1 Rate A Assay Characteristics .............................................................................................5 · 585.16.2 Rate A Assay Graph ........................................................................................................... 5 · 585.16.3 Rate A Assay Calculation ................................................................................................... 5 · 60

5.17 Rate B Assay - - Mode 1 ........................................................................... 5 · 61

5.17.1 Rate B Assay - - Mode 1 Characteristics ...........................................................................5 · 615.17.2 Rate B Assay - - Mode 1 Graph ..........................................................................................5 · 625.17.3 Rate B Assay - - Mode 1 Calculation .................................................................................5 · 62

5.18 Rate B Assay - - Mode 2 ........................................................................... 5 · 64

5.18.1 Rate B Assay - - Mode 2 Characteristics ...........................................................................5 · 645.18.2 Rate B Assay - - Mode 2 Graph ..........................................................................................5 · 645.18.3 Rate B Assay - - Mode 2 Calculation .................................................................................5 · 65

5.19 Summary of Assay Techniques .............................................................. 5 · 66

5.20 Calibration Overview ................................................................................ 5 · 67

5.20.1 Explanation of the Calibration Monitor Report by Assay Type ....................................... 5 · 675.20.2 Calibration Methods ........................................................................................................... 5 · 695.20.3 Programming Calibration Methods ...................................................................................5 · 69

5. THEORY

Contents

5.21 1-Point Linear Calibration ........................................................................ 5 · 71

5.21.1 Selecting 1-Point Linear Calibration ................................................................................5 · 715.21.2 1-Point Linear Calibration Graph ......................................................................................5 · 715.21.3 1-Point Linear Calculation .................................................................................................5 · 725.21.4 Assay Types ........................................................................................................................5 · 72

5.22 2-Point Linear Calibration ........................................................................ 5 · 73

5.22.1 Selecting 2-Point Linear Calibration ................................................................................5 · 735.22.2 2-Point Linear Calibration Graph ......................................................................................5 · 735.22.3 2-Point Linear Calculation .................................................................................................5 · 745.22.4 Assay Types ........................................................................................................................5 · 74

5.23 Multipoint Linear Calibration.................................................................... 5 · 75

5.23.1 Selecting Multipoint Linear Calibration ...........................................................................5 · 755.23.2 Multipoint Linear Calibration Graph.................................................................................5 · 755.23.3 Multipoint Linear Calculation ............................................................................................5 · 765.23.4 Assay Types ........................................................................................................................5 · 76

5.24 Non-Linear Logit-log 3P Calibration....................................................... 5 · 77

5.24.1 Selecting Non-Linear Logit-log 3P Calibration ................................................................5 · 775.24.2 Non-Linear Logit-log 3P Calibration Graph .....................................................................5 · 775.24.3 Non-Linear Logit-log 3P Calculation ................................................................................5 · 785.24.4 Assay Types ........................................................................................................................5 · 78

5.25 Non-Linear Logit-log 4P Calibration........................................................ 5 · 79

5.25.1 Selecting Non-Linear Logit-log 4P Calibration ................................................................5 · 795.25.2 Non-Linear Logit-log 4P Calibration Graph .....................................................................5 · 795.25.3 Non-Linear Logit-log 4P Calculation ................................................................................5 · 805.25.4 Assay Types ........................................................................................................................5 · 80

5. THEORY

Contents

5.26 Non-Linear Logit-log 5P Calibration ........................................................ 5 · 81

5.26.1 Selecting Non-Linear Logit-log 5P Calibration ................................................................ 5 · 815.26.2 Non-Linear Logit-log 5P Calibration Graph ..................................................................... 5 · 815.26.3 Non-Linear Logit-log 5P Calculation ................................................................................5 · 825.26.4 Assay Types ........................................................................................................................5 · 82

5.27 Non-Linear Exponential Calibration ........................................................ 5 · 83

5.27.1 Selecting Non-Linear Exponential Calibration ................................................................ 5 · 835.27.2 Non-Linear Exponential Calibration Graph ..................................................................... 5 · 835.27.3 Non-Linear Exponential Calculation ................................................................................5 · 845.27.4 Assay Types ........................................................................................................................5 · 84

5.28 Non-Linear Spline Calibration ................................................................. 5 · 85

5.28.1 Selecting Non-Linear Spline Calibration .........................................................................5 · 855.28.2 Non-Linear Spline Calibration Graph ............................................................................... 5 · 855.28.3 Non-Linear Spline Calculation ..........................................................................................5 · 865.28.4 Assay Types ........................................................................................................................5 · 86

5.29 Isozyme P Calibration .............................................................................. 5 · 87

5.29.1 Selecting Isozyme P Calibration....................................................................................... 5 · 875.29.2 Isozyme P Calibration Graph ............................................................................................ 5 · 875.29.3 Isozyme P Calculation .......................................................................................................5 · 885.29.4 Assay Types ........................................................................................................................5 · 88

5.30 Isozyme Q Calibration .............................................................................. 5 · 89

5.30.1 Selecting Isozyme Q Calibration ......................................................................................5 · 895.30.2 Isozyme Q Calibration Graph ............................................................................................ 5 · 895.30.3 Isozyme Q Calculation .......................................................................................................5 · 905.30.4 Assay Types ........................................................................................................................5 · 90

5. THEORY

Contents

5.31 ISE Calibration .......................................................................................... 5 · 91

5.31.1 Introduction .........................................................................................................................5 · 915.31.2 Slope Calculation...............................................................................................................5 · 915.31.3 Internal Standard Calculation ...........................................................................................5 · 925.31.4 Single-Point Adjustment ....................................................................................................5 · 925.31.5 Compensation Overview ...................................................................................................5 · 925.31.6 Compensation Value Calculation .....................................................................................5 · 935.31.7 Reference Cartridge ...........................................................................................................5 · 935.31.8 Nernst Equation ..................................................................................................................5 · 935.31.9 Calculation of Unknown Sample Concentrations ............................................................5 · 94

5.32 Result Integrity Checks ............................................................................ 5 · 95

5.32.1 Introduction .........................................................................................................................5 · 955.32.2 Prozone Effect ................................................................................................................. ...5 · 955.32.3 Linearity Verification (LIN, LIN 8) ......................................................................................5 · 965.32.4 Substrate Depletion (LIM. 1, 2, 3) ......................................................................................5 · 97

5.33 Serum Index Function .............................................................................. 5 · 98

5.33.1 Introduction .........................................................................................................................5 · 985.33.2 Definition of Serum Indexes..............................................................................................5 · 985.33.3 Serum Index Parameters ..................................................................................................5 · 985.33.4 Using Existing Chemistry Channel ....................................................................................5 · 995.33.5 Using a Saline Channel .....................................................................................................5 · 995.33.6 Graphic Representation of Serum Indexes .................................................................... 5 · 1015.33.7 Calculation of Serum Indexes......................................................................................... 5 · 102

5.34 Real Time QC Evaluation ....................................................................... 5 · 103

5.34.1 Introduction ....................................................................................................................... 5 · 1035.34.2 Rule 1: 1-2SD .................................................................................................................. .. 5 · 1035.34.3 Rule 2: 1-3SD .................................................................................................................. .. 5 · 1035.34.4 Rule 3: 2-2SD .................................................................................................................. .. 5 · 1045.34.5 Rule 4: R-4SD .................................................................................................................. .. 5 · 1055.34.6 Rule 5: 4-1SD .................................................................................................................. .. 5 · 1065.34.7 Rule 6: 10X .................................................................................................................... .... 5 · 1075.34.8 Rule 7: 1-2.5SD................................................................................................................ .. 5 · 1085.34.9 Flowchart ...................................................................................................................... .... 5 · 109

5. THEORY

Contents

5.35 Reagent Labelling ................................................................................... 5 · 110

5.35.1 General Information ......................................................................................................... 5 · 1105.35.2 Reagent Labelling ............................................................................................................5 · 110

5. THEORY

Contents

5 • 1

5.1 Overview

5.1.1 Introduction

The Instrument Theory section of Chapter 5 gives adetailed explanation of the role of the analytical unit’smechanical systems. These systems include:

• Cell rinse system• Photometric measuring system• Reaction bath system• Sampling system• ISE system• Reagent system

These mechanical systems work together with thechemistry system and the control unit to produce finalresults.

5.1.2 General Characteristics

The analyzer is a totally self-containedCOMPUTERIZED, PROGRAMMABLE, DISCRETE,SELECTIVE, SEQUENTIAL, FULLY AUTOMATEDCHEMISTRY ANALYZER. Each of these terms isdefined below as they relate to the analyzer.

COMPUTERIZED - - Automatic calibration,calculations, and quality control analyses are performedby a built-in computer. Test parameters are read froma floppy disk and stored in memory. The mechanicalfunctions of the instrument are also controlled by thecomputer. The computer is a powerful datamanagement system that gives the operator flexibilityin data handling.

PROGRAMMABLE - - The operator provides input tothe instrument computer for test requests, qualitycontrol manipulation, and calculated tests.Maintenance procedures are requested from theinstrument keyboard. Sample predilution can beincluded as part of the chemistry parameters to

minimize manual predilution.DISCRETE - - Each photometric test is performed inits own reaction cell. Most chemistry proceduresrequire no pretreatment of the sample by the operatoror the instrument.

The Ion-Selective Electrode (ISE) Assembly assayssodium, potassium, and chloride on a single sampleat the same time. The electrolytes can be performedalone, or at the same time photometric chemistriesare performed.

SELECTIVE - - The operator programs the instrumentto perform one test, several tests, or a full test profileon each sample. The analyzer performs only theselected tests on each sample.

SEQUENTIAL - - Tests are performed in reaction cells,which are positioned in the reaction disk. The reactiondisk rotates 360° plus two cell positions every 20seconds. The rotation allows sequential processing tooccur.

FULLY AUTOMATED - - After pressing the STARTkey, the analyzer performs all programmed tests oneach sample without operator intervention.

5.1 Overview

5. INSTRUMENT THEORY

5 • 2

5.1.3 Sample Route

Figure 5-1 on the facing fold-out page outlines thesequence of events in the processing of a sample.The remainder of this section explains in detail thetheory of instrument operation involved in sampleprocessing.

5.1 Overview


5.1 Overview5. INSTRUMENT THEORY

5 • 3

Fig u re 5-1: Sa m ple Proces s ing

5 • 4

5.1 Overview


NOTES

5 • 5

5.2 Cell Rinse and Blanking

5.2.1 Introduction

After test selections are made and start conditionsare specified, press the START key to beginoperation.

The instrument performs a parameter check andresets all mechanical components to their homepositions. The reaction cell rinse unit cleans reactioncells and assists in photometrically blanking reactioncells before sample dispense. It is active once duringeach mechanical cycle when the instrument is in theOperate mode.

5.2.2 Reaction Cell Rinse Unit

Photo 5-1, to the right, shows the reaction cell rinseunit. Probe #1, at the far right side of the rinse unit, isthe home or starting position for the reaction cells.The reaction disk moves counter-clockwise and thereaction cells are indexed through the rinse unit fromright to left.

Photo 5-1: Cell Rinse Unit



Figure 5-2, on the facing page, shows the water andvacuum supply to the cell rinse unit. Probe #1 is atthe far right.

The function of the reaction cell rinse unit can best bedescribed by following a reaction cell as it indexesthrough the rinse unit.

Once every ten seconds the cell rinse unit lowers intothe reaction cells and vacuum is applied to its vacuumprobes. These spring-loaded probes touch the bottomof the reaction cells and aspirate the liquid from them.

Fifty disk rotations after sample is added to a reactioncell, that same cell pauses at cell rinse probe #1. Theresults have been calculated and reported for thereaction mixture in this cell. Nozzle D of cell rinseprobe #1 aspirates the reaction mixture into a vacuumtrap. (Refer to Figure 5-2.) The waste drains into theserum waste container.

A solenoid valve opens, permitting wash solution toflow through nozzle C of probe #1 into the reaction cell.The cell rinse unit raises and the reaction disk beginsits next rotation. Wash solution remains in the celluntil it reaches the next cell rinse probe (20 secondslater). This "soak" allows effective cleaning ofreaction cells.

Twenty seconds later, this reaction cell is positionedat cell rinse probe #2, nozzle B, which aspirates thewash solution and transfers the cell contents to themain instrument drain. Nozzle A dispenses deionizedwater, warmed to about 37 °C, into the cell. The rinseunit raises, and the reaction disk begins its nextrotation.

Cell rinse probe #3, nozzle B, aspirates the distilledwater and transfers the cell contents to the maininstrument drain. Nozzle A dispenses warmdeionized water into the cell. The rinse unit raises, andthe reaction disk begins its next rotation.

Cell rinse probe #4 has a Teflon block at its tip. Thisblock directs a vacuum to the corners of the reactioncell as the probe removes all water from the cell. Therinse unit raises and the reaction disk begins its nextrotation.

Cell rinse probe #5, nozzle E, dispenses warm

5 • 6

G F F E B A B A B CD

#7 #6 #5 #4 #3 #2 #1

deionized water into the cell. This water is left in thecell for reading cell blank absorbance. The cell rinseunit raises and the reaction disk begins its nextrotation.

This 500 µL of deionized water remains undisturbedin the reaction cell during the next four reaction diskrotations. During each rotation, cell blankabsorbance is determined and compared to cell blankdata stored in battery supported memory.

Cell rinse probe #6 aspirates cell blank water from thecells. The cell rinse unit is raised and the reactiondisk begins its next rotation.

Cell rinse probe #7 aspirates remaining water from thecells. Probe #7 has a Teflon block at the tip of nozzleF, to direct a vacuum to the corners of the reactioncell. Nozzle G dispenses water to rinse the Teflonblock on nozzle F. This occurs only during the first fewrotations preceding the first sample aspiration. Thecell rinse unit raises and the reaction disk begins itsnext rotation.

Sample is dispensed into the cell one rotation aftercompleting the cell rinse and blank.



E: Dispenses water for cell blankF: Aspirates water from cell blankG: Dispenses rinse water for nozzle

cleaning

A: Dispenses rinse waterB: Aspirates wash solution/

rinse waterC: Dispenses wash solutionD: Aspirates reaction solution

Figure 5-2: Cell Rinse Unit

5 • 7

5.2.3 Cell Blanking

Cell blank absorbances are used for two purposes:

• to confirm the optical characteristics of the cell• to serve as a baseline for the reaction

measurement.

Weekly cell blanking is performed from theANALYZER MAINTENANCE display. All reactioncells are filled with deionized water. The cells passthrough the photometer lightpath, where theirabsorbances are measured at 12 wavelengths. Themeasured absorbance data for all 120 cells is storedin C RAM for subsequent comparison.

When reaction cells are photometrically blankedduring operation, the values obtained are comparedwith those stored in C RAM. The absorbance of eachreaction cell filled with deionized water is measured onfour consecutive rotations. One of these cell blanksis a stop blank, taken with the reaction cell in astopped position. The stop blank measures all 12wavelengths. The other three cell blanks are streakblanks, taken while the reaction disk is in motion. Thestreak blank measures only the two reactionwavelengths needed for the assay to be performedin the cell.

To confirm the cell’s optical characteristics, eachmeasurement of the water-filled cell is compared tothe reading of that same cell obtained during CellBlank on the MAINTENANCE JOB display. (This cellblank reading is automatically updated when eachnew cell blank procedure is performed.) If acceptable,the readings serve as the zero offset or baseline forcalculating final results. The first time thesepresample cell blank readings are outside comparisonlimits for the absorbance in memory for that cell, noalarm is issued, but the cell is not used for a test. Thesample dispense is held until the next acceptable cellis available. If additional cells are not acceptable, aseries of cell blank alarm messages may occur.



5 • 8

5.3 Begin Operation

5.3.1 Introduction

This section describes the mechanical function of theinstrument. The mechanical cycle is defined as aseries of mechanical events occurring at specifictimes within a 10-second time period. Twomechanical cycles occur during each reactiondisk rotation.

1 ISE Dilution Vessel2 Sample Disk3 Sample Probe4 Cell Rinse Unit5 Photometer (beneath top

surface of analyzer)6 Photometer Lamp (beneath top

surface of analyzer)

5.3.2 Mechanical Cycle

The reaction disk (part of the photometric measuringsystem) is the central component of reactionprocessing. All other systems associated withreaction processing are distributed around thereaction disk. The discussion of the mechanicalcycle centers on the activity of the reaction disk andits associated components, as shown in Figure 5-3.

7 Reaction Disk8 Reagent Probe 19 Reagent Probe 2

10, 11 Stirrers12 Reagent Disk 113 Reagent Disk 2

5.3 Begin Operation


Figure 5-3: Reaction Processing Components

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

➄

➃

➂

➆

➁

➉

➇

➈

1

2

5 • 9

Figure 5-4 illustrates the reaction disk in a close-upview. The reaction cell positions are numbered andthe position where each component interacts with thereaction disk is labelled. The counter-clockwiserotation is also illustrated.

Figure 5-4: Reaction Disk Positions

5.3 Begin Operation


Counter-clockwiseRotation

Reaction cell No. 1in the reset position

Photometer Lamp

13 4 5

120119118117

2

13

57 9 11 13 15 17 19

2123

2527

2931

33

35

37

39

41

43

45

47

49

51

53

5557

5961

6365

6769717375777981

8385

8789

91

93

95

97

99

101

103

105

107

109

111

113

115117

119

12

3

4

5

R2/R3 Dispense positionR2/R3 Stirring position

R4 Stirring positionR1 Stirring positionR4 Dispense positionR1 Dispense positionAspiration of

deionized water

Sampling position

Dispense of deionizedwater for water blank

measurement

Rinsing withdeionized water

Aspiration of reaction mixture;Dispense of wash solution

5 • 10

During each 10-second mechanical cycle, thereaction disk rotates counter-clockwise 180° plus onereaction cell position. The reaction disk pauses threetimes during each 10-second cycle.

The reaction disk rotates as follows:

Moves 22 cells - - pausesMoves 37 cells - - pausesMoves 2 cells - - pauses.

This completes one mechanical cycle. This series ofmovements and pauses allow the analyzer to:

• pipette sample every 10 seconds (once per cycle)• pre-dilute sample• advance each reaction cell one position every 10

seconds• rotate each reaction cell through the lightpath• pipette up to four reagents per test• stir the reaction mixture.

Two mechanical cycles are completed each time thereaction disk rotates one complete turn of 360° plustwo reaction cells. During each reaction disk rotation,one photometric measurement per reaction cell istaken. This photometric measurement also is referredto as a measure point or absorbance reading.

Figure 5-5 illustrates the timing of the reactionprocessing sequence.

Figure 5-6, on the next page, illustrates the timing ofthe mechanical cycles and reaction disk rotations.

In the following sections of Chapter 5, reactionprocessing is explained in terms of reaction diskrotations, not mechanical cycles.

5.3 Begin Operation


Figure 5-5: Reaction Processing Sequence

(49 measurements per reaction cell)




Sta

rt K

ey O

N

Inst

rum

ent r

eset

Rin

sing

of r

eact

ion

cell

Cel

l Bla

nk

Asp

iratio

n of

wat

er

Sam

plin

g

Add

ition

of R

eage

ntat

R1

timin

g

Stir

ring

Add

ition

of R

eage

ntat

R2

timin

g

Add

ition

of R

eage

ntat

R3

timin

g

Add

ition

of R

eage

ntat

R4

timin

g

Stir

ring

Com

plet

ion

of a

llm

easu

rem

ents

Rin

sing

of r

eact

ion

cell

Aut

omat

ic s

top

(incl

udin

g w

ashi

ng s

tep)

Stir

ring

4 times(water blankcorrectionfor eachtest)

About3.7 min.

(Less time STAT reception mode)About

16 min.About

4.0 min.

Printout of final results

3-Min reaction

4-Min reaction

5-Min reaction

10-Min reaction

15-Min reaction


5 • 11

0 5 10 15 20 (sec)

1 cycle (1/2 turn + 1 cell)

Time

Stop Stop Stop Stop Stop Stop

22 cells 37 cells 2 cells 22 cells 37 cells 2 cells

S . . . . . . . . . . . . . . . . . . . . . . R1 to R4 . . . . . . . . . . . . . . . .M1 to M4 . . . . . . . . . . . . . . . . . . . . . . . .CB . . . . . . . . . . . . . . . . . . . . . . . . . . R1 to R7 . . . . . . . . . 1 to 49

Sample dispenseReagent dispense

StirringCell blank

Rinse aspiration/dispensePhotometric point. . . . . . . . . . . . . . . . .

123

5

67S

R2M2

R1 M1

M3

M4

R3

R4

STOPPEDCELL BLANK

CB1CB2CB3

12345678910111213

1415161718192021222324

25262728293031323334353637383940414243

444546474849

DIL.S

15-min reaction dataprocessing point





R

R

R

R

R

R

R

5.3 Begin Operation


Figure 5-6: Mechanical Cycle and Reaction Disk Rotation Timing

5 • 12

The first reagent is pipetted during the first rotation.The second reagent is added during the fourthrotation. The third reagent is added during the 16throtation. The fourth reagent is added during the 31strotation.

Figure 5-7 illustrates the timing of reaction events inrelation to reaction disk rotation.

Figure 5-7: Reaction Processing Timing

5.3 Begin Operation


Measure Point Time Time Interval(Reaction Disk Rotation) (seconds) (seconds) Remarks

Pipetting ofsample andreagent at R1timing,R1 stirring

12345678910111213141516171819202122232425

262728293031323334353637383940414243444546474849

0.0019.9239.8459.7679.6999.61

119.53139.45159.37179.29199.21219.14239.06255.74275.66295.59325.51335.43355.35375.27395.19415.11435.04454.96472.16

490.43510.35530.27550.20570.12590.04609.96629.88649.80669.73689.65709.57729.49749.41769.33789.25809.18829.10865.70885.63905.55925.47945.39965.31

About19.92

About16.69About19.92

About17.20About18.27About19.92

About36.61About19.92

R2 pipettingR2 stirring

R3 pipetting andstirring

R4 pipetting andstirring

5 • 13

The absorbance of the reaction mixture is measuredevery 20 seconds (one time per reaction disk rotation).The photometer lightpath is positioned approximatelyso that when the reaction disk is stationary, the lightpasses through a reaction cell. Most absorbancemeasurements are determined while the reaction diskis moving. Absorbance measure points to be used inresult calculation are programmed in theCHEMISTRY PARAMETERS screen. For a moredetailed explanation of absorbance measurements,refer to Part B of this chapter, Chemistry Theory.

Figure 5-8 illustrates absorbance measure points overtime, throughout reaction processing.

Figure 5-8: Absorbance Measure Points Over Time

The next five sections follow one sample throughpredilution, reagent addition, absorbance readings,and aspiration to waste.

5.3 Begin Operation


0 5 10 15 (min)

Sto

pped

cel

l Bla

nkS

trea

k ce

ll bl

ank

Waterblank

Add

ition

of R

eage

nt a

t R1

timin

g

Add

ition

of R

eage

nt a

t R2

timin

g

Add

ition

of R

eage

nt a

t R3

timin

g

Add

ition

of

Rea

gent

at

R4

timin

g

Stir

ring Stir

ring Stir

ring

Stir

ring

Sam

ple

pipe

ting

1 2 3 45

67

151617

1819

303132

48 49

- - -

- - -

- - -

- - -

- - -

TIME

5 • 14

5.4 Sample Aspiration andDispense

5.4.1 Sample Aspiration

The first reaction cell receives sample and reagent(s)after it has been rinsed and blanked. Theinstrument’s computer searches its memory anddetermines whether a calibrator, control, or patientsample to be aspirated first.

1 Sample Aspiration

The sample disk can rotate in either direction to bringthe sample to the sample aspiration position. Thereare three sample aspiration positions, one for each ofthe rings on the sample disk. The arc of movementby the sample probe arm determines the sampleaspiration position. The sample probe aspirates fromthe inner ring through a hole in the evaporation cover.

Figure 5-9, below, shows the sample disk in thecorrect position. The sample probe arm pivots andmoves the sample probe to rest over the first sample.The sample pipettor motor activates, and a smallvolume of air (5 µL) is aspirated into the tip of theprobe. This air interface prevents the sample frommixing with water in the sample pipetting system.

2 Sample Probe Rinse Station

5.4 Sample Aspiration and Dispense


Figure 5-9: Sample Aspiration

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➁➀

5 • 15

The sample probe arm motor lowers the sample probeinto the sample cup. The sample probe acts as aliquid level sensor while it descends. If no sample isdetected, a data alarm, SAMP., is issued on theprintout next to the result. In addition, aphotodetector is located in the sample probe arm todetect any abnormality in the descent of the arm. Theprobe tip is immersed in the sample and the samplepipettor aspirates the correct sample volume. Whenusing a micro sample cup, the sample probe utilizesmeniscus chasing to continue to descend as thesample is aspirated. This ensures that even thesmallest sample volume is pipetted accurately. Thecorrect sample volume is part of the informationprogrammed in the chemistry parameters for eachtest.

A small volume of extra sample (12 µL) is aspiratedwith the first test of each sample. This sample bufferremoves any water that may line the interior wall of thesample probe. The buffer is discarded to waste afterthe last test of the sample is dispensed. Also, 1 µL ofextra sample is aspirated for spit-back. When thestepper motor reverses direction from aspiration todispense, this extra volume is “spit-back” into thesample cup. This ensures a reliable sample volume.The sample probe moves to the sample dispenseposition.

5.4.2 Sample Dispense - - Start ofRotation #1

Sample can be dispensed in two different places - -the ISE dilution vessel or a photometric reaction cell.

When ISEs are selected, 15 µL of sample is deliveredinto the special ISE sample port. The ISE unit dilutesthe sample 1:31. The diluted sample flows throughthe Na+, K+, and Cl- cartridges. The sample stops sothat an electrical voltage can be measured. Thevoltage is proportional to the concentration of theelectrolytes in the sample. This measurementoccurs alone when no photometric chemistries areordered. When photometric chemistry assays arealso requested, ISE measurement occurs at thesame time.

When photometric chemistries are selected, thesample probe moves to the dispense position. (Referto Figure 5-10 on the following page.) The sampleprobe is spring-loaded where it connects to the probearm. This allows the probe to touch the bottom of thereaction cell as it is lowered. The sample probetouches the reaction cell bottom to ensure precisedelivery of an accurate volume.

If the sample volume is <5 µL, the sample probe raisesslowly from the sample cup and reaction disk. Thismakes sure a small sample volume is delivereddirectly to the bottom of the reaction cell.



5 • 16

The sample pipettor dispenses the required samplevolume into the bottom of the reaction cell. The probeis lifted from the cell, and either goes back to thesample disk (if there are more tests to be performedon the sample) or moves to the sample probe rinsestation.

1 ISE Dilution Vessel for sampledispense



Figure 5-10: Sample Dispense

2 Sample dispense #1(photometric tests)

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

➁

5 • 17

5.4.3 Sample Probe Rinse

The sample probe is rinsed between samples. Whenthe last test for a sample has been pipetted, thesample probe moves to the probe rinse station. Wateris flushed through the probe and over the outersurface of the probe.

While the sample probe is being rinsed, the reactiondisk continues to rotate. The reaction disk moves 22cell positions and pauses. The reaction disk thenmoves another 37 cell positions and pauses. Thereaction cell containing sample is now in position toreceive any reagent with R1 timing.



5 • 18

5.5 Sample Predilution

5.5.1 Diluent Aspiration

The R1 reagent disk also rotates during the sampleprobe rinse to bring the correct reagent container to thereagent aspiration position. Both reagent disks rotatein either direction, using the shortest route to positionthe correct reagent. The reagent aspiration positionsare defined by the arc of the reagent probe movement.Cutaway sections in the reagent disk evaporationcovers give the reagent probes access.

1 Reaction Cell ContainingSample

2 Sample #2 Aspiration

When the reagent disk stops, the R1 probe pivotsover the disk. Figure 5-11 below shows the R1 probein position to aspirate the correct diluent. In thisexample, diluent is dispensed for a sample pre-dilution. The reagent pipettor is activated andaspirates a small volume of air (15 µL) into the reagentprobe. This air interface prevents reagent frommixing with water in the reagent pipetting system.The probe moves down, acting as a liquid levelsensor, to detect the reagent. A photodetector islocated in the reagent probe arm to detect anyabnormality in the descent of the arm. The computercalculates the distance the probe descends and usesthis information in determining the number of mLs ofdiluent remaining. The number of milliliters (mL) ofdiluent remaining is updated on the REAGENTSTATUS display.

3 Diluent Aspiration4 Reagent Probe Rinse Station



Figure 5-11: Diluent Aspiration

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂➃

➁

➀

5 • 19



While the tip of the reagent probe is immersed indiluent, the reagent pipettor motor activates andaspirates diluent into the reagent probe. The volumeaspirated includes:

• a small diluent volume to take up any water thatcould possibly dilute the diluent being dispensed

• the diluent volume stored in chemistry parametersfor each specific reagent

• a small "spit-back" volume.

5.5.2 Diluent Dispense

Figure 5-12 below shows the reagent probe 1 in thereagent dispense position. The pipettor motoractivates, and diluent is dispensed into the reactioncell containing sample. The reagent probe does notdescend into the reaction cell, but dispenses from thetop of the cell.

1 Diluent Dispense

5.5.3 Reagent Probe Rinse

The reagent probe arm brings the reagent probe to itsrinse station after completion of diluent dispense.Water is flushed through the probe as well as onto itsexterior surface to ensure proper cleaning. This rinsemechanism is similar to that used for the sampleprobe.

Figure 5-12: Diluent Dispense

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

➁

5 • 20

5.5.4 Sample and Diluent Stirring

While reagent probe 1 is rinsing, the reaction diskcompletes the first half of the rotation by moving twocells. Figure 5-13 below shows the stirrer at thereaction disk and stirring the sample and diluent. Atthe same time, sample #2 is dispensed into a reactioncell. After the reaction mixture is stirred, the stirrermoves to its rinse station and is rinsed with deionizedwater.

The reaction disk moves 22 cells and pauses. Thereaction disk then moves another 37 cells andpauses. The sample and R1 reagent disks rotate atthis time, if necessary, to bring the appropriate sampleand reagent into position for the next dispense.

1 Stirring 2 Sample #2 Dispense

Figure 5-13: Sample 1 + Diluent Stirring



48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

➁

5 • 21

5.5.5 Pre-diluted Sample Aspiration

The Sample #1 + diluent mixture is now in position forthe sample probe to aspirate pre-diluted sample. Thesample probe is brought to the reaction disk andreenters the reaction cell. The correct volume ofSample #1 + Diluent (maximum of 10 µl) is aspirated.The sample probe moves up out of the reaction cell.At the same time, reagent probe 1 dispenses thereagent at R1 timing into the reaction cell containingSample #2.

1 Original Sample #1 + Diluent3 Pre-diluted Sample Dispense

The reaction disk moves two cells and pauses. Thismovement completes the first reaction disk rotationof 360° plus two cells. The sample probe descendsand dispenses the pre-diluted sample (Sample #1 +diluent) into a new reaction cell. This pre-dilutedsample is treated like Sample #3 in the mechanicaltiming sequence. (Refer to Figure 5-14 below.) At thesame time, the stirrer moves to the reaction disk andstirs Sample #2 + R1 Reagent. Following dispense,the sample probe moves to the probe rinse station.

2 Stirring Sample #2 + R1Reagent

Figure 5-14: Pre-diluted Sample Dispense



48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1➀

➁

➂

5 • 22

5.6 Reagent Aspiration andDispense

5.6.1 Reagent Aspiration at R1 Timing

The R1 reagent disk also rotates during the sampleprobe rinse to bring the correct reagent container to thereagent aspiration position.

1 Reaction Cell Containing Pre-diluted Sample

2 Sample #3 Aspiration

When the reagent disk stops, reagent probe 1 pivotsover the disk. Figure 5-15 below shows reagent probe1 in position to aspirate the correct reagent. Thereagent pipettor is activated and aspirates a smallvolume of air (15 µL) into the reagent probe. This airinterface prevents reagent from mixing with water inthe reagent pipetting system. The probe movesdown, acting as a liquid level sensor, to detect thereagent. A photodetector is located in the reagentprobe arm to detect any abnormality in the descent ofthe arm. The computer calculates the distance theprobe descends and uses this information indetermining the number of tests remaining. Thenumber of tests remaining is automatically updatedon the REAGENT STATUS display.

3 Reagent Aspiration at R1 Timing4 Reagent Probe Rinse Station

5.6 Reagent Aspiration and Dispense


Figure 5-15: Reagent Aspiration at R1 Timing

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂➃

➁

➀

5 • 23

While the tip of the reagent probe is immersed inreagent, the reagent pipettor motor activates andaspirates reagent into the reagent probe. The volumeaspirated includes:

• a small reagent volume to take up any water thatcould possibly dilute the reagent being dispensed

• the reagent volume stored in ChemistryParameters for each specific reagent

• a small “spit-back” volume.

5.6.2 Reagent Dispense at R1 Timing

Figure 5-16 below shows the R1 probe in the R1 timingreagent dispense position. The pipettor motoractivates, and R1 reagent is dispensed into thereaction cell that contains the diluted sample. Thereagent probe does not descend into the reaction cell.

1 R1 Reagent Dispense

5.6.3 Reagent Probe Rinse

The reagent probe arm brings the reagent probe to itsrinse station after completion of R1 reagent dispense.Water is flushed through the probe as well as onto itsexterior surface to ensure proper cleaning. This rinsemechanism is similar to that used for the sampleprobe.

2 Sample Dispense

Figure 5-16: Reagent Dispense at R1 Timing



48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

➁

5 • 24

5.6.4 Sample and Reagent Stirring

While the R1 probe is rinsing, the reaction diskcompletes the first half of the rotation by moving twocells. Figure 5-17 below shows the stirrer at thereaction disk and stirring the sample and R1 reagent.At the same time, another sample is dispensed into areaction cell. After the reaction mixture is stirred, thestirrer moves to its rinse station and is rinsed withdeionized water.

The reaction disk moves 22 cells and pauses. Thereaction disk then moves another 37 cells andpauses. The sample and R1 reagent disks rotate atthis time, if necessary, to bring the appropriate sampleand reagent into position for the next dispense.

1 StirringFigure 5-17: Prediluted Sample + R1 Reagent Stirring

2 Sample Dispense



48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

➁

5 • 25


At the end of each 20 second rotation, the reactioncell containing the pre-diluted sample moves twopositions closer to the R2 timing reagent dispenseposition. Figure 5-18 below shows this reaction cellat the beginning of the fourth rotation followingdispense of the pre-diluted sample. This reaction cellcontaining pre-diluted sample + R1 reagent is nowmoving into position for dispense of R2 reagent. Thisoccurs approximately one minute and 20 secondsafter dispense of the diluted sample (4 rotations × 20seconds per rotation = 80 seconds). R2 reagent isdispensed by reagent probe 2 after the first 22-cellmovement by the reaction disk in rotation 4. Stirringoccurs after the next 20 second rotation.

1 Pre-diluted Sample + R1 + R2Reagent Dispense

3 Sample Aspiration Continues

2 Reagent Aspiration Continues




48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂

➁

➀

5 • 26


Figure 5-19 below shows the reaction cell during the16th rotation. This reaction cell (containing pre-dilutedsample + R1 reagent + R2 reagent) is now moving intoposition for dispense of the reagent at R3 timing, ifrequired. Reagent probe 2 is used to dispense the R3reagent. This occurs approximately five minutes afterdispense of the pre-diluted sample (16 rotations × 20seconds per rotation = about 5 minutes). The R3reagent addition occurs following the second 37-cellmovement by the reaction disk in rotation 16. Stirringoccurs following the second two-cell movement inrotation 16, immediately after R3 reagent addition.

1 Pre-diluted Sample + R1 Reagent +R2 Reagent + R3 Reagent Dispense


2 Reagent Dispense continues3 Sample Dispense continues



48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂

➁

➀

5 • 27


Figure 5-20 below shows the reaction cell at thebeginning of the 31st rotation. The reaction cellcontaining pre-diluted sample + R1 reagent + R2reagent + R3 reagent is now moving into position fordispense of reagent at R4 timing. Reagent probe 1 isused to dispense reagent at R4 timing. This occursapproximately 10 minutes after dispense of the pre-diluted sample (31 rotations × 20 seconds per rotation= about 10 minutes). R4 reagent is dispensedfollowing the second 37-cell movement by thereaction disk in rotation 31. Prediluted sample + R1reagent + R2 reagent + R3 reagent + R4 reagentstirring occurs following the second two-cellmovement in rotation 31, immediately after R4reagent is added.

1 Pre-diluted Sample + R1 Reagent +R2 Reagent + R3 Reagent +Reagent Dispense at R4 Timing

Samples and reagents are aspirated and dispensedthroughout this time. The cell rinse unit is also active,cleaning and blanking reaction cells for more sampledispenses.

2 Sample Dispense Continues3 Reagent Dispense Continues




48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➂

➁

➀

5 • 28

5.6.8 Aspirate Reaction Mixtureto Waste

At the beginning of the 50th rotation, the first reactionmixture is in position at the first probe of the cell rinseunit (shown below in Figure 5-21). By this time, allphotometric readings have occurred for this reactionmixture, and results have been calculated. The cellrinse unit is lowered, the reaction mixture is aspiratedto the waste container, and the cell is filled with washsolution.

During the next ten rotations, the reaction cell is rinsedand photometrically blanked. One rotation later, it willagain be in position for sample dispense.

1 Pre-diluted Sample + R1 Reagent +R2 Reagent + R3 Reagent +R4 Reagent Aspirated to Waste



Figure 5-21: Sample Aspiration to Waste

48

23

47

22

46

21

45

20

44

19

43

18

42

17

41

16

40

15

39

14

38

13

37

12

36 11

35

10

34

9

33

8

32

7

31

6

30

5

29

4

28

3

27

2

26

1

25

50

24

49

E66

S16

E65

S15

E64

S14

E63

S13

E62

S12

E61

S11

E60

S10

E59

S9

E58

S8

E57

S7

E56S

6

E55

S5

E54

S4

E53

S3

E52

S2

E51

S1

W3

E70

W 2

E69

W 1

S68

S17

S67

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

161514

13

1211

109

87

65

4

32 1 33 32 31

3029

2827

2625

2423

2221

2019

1817

R2

R1

➀

5 • 29

5.7 Sampling End

5.7.1 Overview

The instrument continues to pipette samples until oneof these conditions occurs:

• the next sample to be aspirated is located on thenext sample disk

• the next sample is assigned a sample positionnumber of 0 (without bar code reader)

• the next sample position has a zero bar code label(with bar code reader)

• the bar code reader registers 10 empty positions• the operator pressed the SAMPLING STOP key.

5.7.2 Sampling End

If you are using the bar code reader accessory, a "0"bar code should be placed in the position following thelast specimen to be sampled. This informs theinstrument to stop sampling patients and begin thecleaning procedure.

If you are not using the bar code reader accessory, thelast patient specimen programmed becomes the lastsequence number to be assigned a sample diskposition number. The following sequence numberretains its sample position number of "0." This informsthe instrument that the next sequence number has notbeen programmed, and, therefore, is not to besampled. If, during routine patient test selection,without the bar code reader, a sample position numberof "0" is inadvertently entered, the instrument will stopsampling immediately prior tothat specimen.

When any of these conditions listed above occurs,the analyzer automatically aspirates three samplesof the System Cleaning Solution from the "W1" cup onthe middle ring of the sample disk. This cleaningsolution is aspirated into the sample probe to clean it,

and then is deposited into a reaction cell. During thistime the Analyzer Status line at the top of the screenreads Washing Probe.

After the cleaning solution aspiration is complete, aNo More Samples to Process warning is issued, andthe instrument stops sampling. When this occurs,place the next sample disk on the instrument andpress START to resume operation.

5.7 Sampling End


5 • 30

5.8 ISE System Components

5.8.1 Introduction

The ISE system determines sample concentrationsof sodium, potassium and chloride. ISE analysis ofa sample can occur at the same time as photometricchemistry assays, or can occur alone. The ISEsystem can process up to 180 samples per hour. TheIon-Selective Electrodes used by this instrument arecolor-coded, modular plug-in cartridges.

A diagram of the ISE system is shown in Figure 5-23on the next page. The main components of thissystem include: three ISE measuring cartridges, areference cartridge, three syringes, a dilution vessel,and a degassing unit.

The sipper, internal standard and diluent syringes arebehind the left front panel. The electrodes anddilution vessel are positioned in a temperature-controlled compartment. The compartment is foundon the top surface of the analyzer to the left of thesample probe. Because the response of theelectrodes is affected by temperature, the ISEcompartment is heated to a constant temperaturewith 37 °C water. The degassing unit is inside theanalyzer and is connected to the ISE vacuumsystem.

5.8.2 Internal Reference Flowpath

The Internal Standard syringe moves down and 600 µLof reagent is aspirated from its container. The reagentflows into the IS syringe assembly. The syringemoves up and the IS flows through a preheater and isdispensed into the dilution vessel. This rinses thesystem. The dispense cycle is repeated with 450 µLof reagent that is used for measurement. Figure 5-22on Page 5 • 33 diagrams the flow of the internalstandard.



5.1 Overview5. INSTRUMENT THEORY

5 • 31

911 ISE Flowpath

Fig u re 5-23: ISE Dia g ra m

1 Dilition Vessel:m ixing ves s el u s ed to dilu te s a m ple

2 ISE Nozzle Platform:m oves the ISE nozzle u p a nd dow n

3 Vacuum Nozzle Platform:m oves the Va cu u m nozzle u p a nd dow n

4 ISE Measuring Cartridges:ion-s elective electrodes u s ed to m ea s u reconcentra tion of Na +, K + a nd Cl-

5 Pinch Valve:helps control w hich s olu tion is being pu lledby the s ipper s yring e

6 Reference Cartridge:s erves a s a reference for ca lcu la tion du ringISE m ea s u rem ent

7 Internal Standard Solution:m ea s u red a t ca libra tion a nd before everys a m ple to com pens a te for m inor drifts

8 Diluent Solution:u s ed to dilu te s a m ples a nd controls

9 Reference Solution:u s ed to m ea s u re electric ba s eline

10 Degassing Unit:u s ed to deg a s the dilu ent a nd reference s olu tions

11 Diluent Syringe:pos itive dis pla cem ent s yring e u s ed to dis pens edilu ent into the dilu tion ves s el

12 Internal Standard Syringe:pos itive dis pla cem ent s yring e u s ed to dis pens einterna l s ta nda rd into the dilu tion ves s el

13 Sipper Syringe:pos itive dis pla cem ent s yring e u s ed to pu ll s olu tions fromthe m ea s u ring ca rtridg es a nd the reference ca rtridg e

14 Drain to Waste Container:exces s s olu tion ins ide the dilu tion ves s el is va cu u m edto w a s te

ISVs:s olenoid va lves

5 • 32



NOTES

5 • 33

Figure 5-22: Internal Standard Flowpath

5.8.3 Dilution Vessel

The dilution vessel allows the ISE sample to bediluted 1:31 with diluent prior to measurement throughthe cartridges. A sipper nozzle is permanentlyinserted into the dilution vessel. It is mounted to aspring-loaded platform that, when lowered, extendsalmost to the bottom of the vessel. This nozzleprovides the path for diluted sample and the internalstandard solution to flow through the ISE cartridges.Dispense lines for internal standard and diluent arealso positioned in the vessel. Another spring-mounted nozzle, the vacuum nozzle, is activated toremove residual waste from the dilution vessel. Thisnozzle is connected directly to a vacuum vessel thatempties waste from the vessel into the biohazardouswaste container. Figure 5-24 below diagrams thedilution vessel and nozzles.

Figure 5-24: Dilution Vessel



DilutionVessel

SIPSyringe

ISSyringe

DILSyringe

Drain

Drain

Sipper

Degasser

RefK Na Cl

PinchValve

LS2 LS1

IS(600 mL)

DIL(300 mL)

REF(300 mL)

Pre

heat

er (

IS)

Pre

heat

er (

DIL

)

Pre

heat

er (

RE

F)

Vacuum


ISE Unit

DilutionVessel

LS2 LS1

To Cartridges

Delivers Diluent

Delivers to IS

To Waste

5 • 34

5.8.4 ISE Sampling

The sample probe moves from its position at the proberinse station to the sample aspiration position.Sample (15 µL) is aspirated into the probe when thesample syringe piston moves downward. The sampleprobe then moves to the dilution vessel shutter andthe shutter opens to allow the probe to lower into thevessel. Before the sample can be drawn through themeasuring cartridge flowpath, it must be diluted 1:31with 450 µL of ISE diluent. Figure 5-25 below indicatesthe flow direction in the system.

Figure 5-25: ISE Sample Flowpath



DI Water Supply(temperature

controlled anddegassed)

SampleSyringe

SolenoidValve

SampleProbe

5 • 35

5.8.5 Diluent Flowpath

ISE diluent is added to the dilution vessel via thediluent syringe positioned behind the left front panel ofthe analytical unit. This syringe is filled with ISEdiluent, which is located on top of the analytical unit.

A solenoid valve controls the inlet to each syringe.The solenoid valve opens when an ISE Prime isexecuted. This purges the Internal Standard (IS) anddiluent dispense lines with reagent. A 3-way solenoidvalve, located at the outlet of the diluent syringe,connects the diluent reagent bottle to a vacuum trap.During ISE Prime, the vacuum draws the diluent intothe reagent coils.

On the downward stroke of the syringe piston, thediluent is aspirated from its container. When thepiston moves upward, diluent is pushed through apreheater, and into the dilution vessel. The force ofthe dispense thoroughly mixes the diluted sample.Before the diluted sample is drawn through thecartridges, a baseline potential is taken by measuringKCl through the reference cartridge.

Figure 5-26 below illustrates the diluent flowpath.

Figure 5-26: Diluent Flowpath



DilutionVessel

SIPSyringe

ISSyringe

DILSyringe

Drain

Drain

Sipper

Degasser

RefK Na Cl

PinchValve

LS2 LS1

IS(600 mL)

DIL(300 mL)

REF(300 mL)

Pre

heat

er (

IS)

Pre

heat

er (

DIL

)

Pre

heat

er (

RE

F)

Vacuum


ISE Unit

5 • 36

5.8.6 KCI and Reference CartridgeFlowpath

The sipper syringe downstrokes and pulls liquidthrough one of two flowpaths, the measuring flowpathor the reference flowpath. Sipper syringe aspirationtubing divides where the two flowpaths meet, at thereference cartridge block. The reference flowpathoriginates at the KCl bottle and past the referencecartridge. The measuring flowpath originates at thedilution vessel, through the three measuringcartridges and past a pinch valve.

Figure 5-27: KCl Flowpath

The reference cartridge is positioned in the KClflowpath. This flowpath is electrically continuous withthe measuring cartridge flowpath. The analyzermeasures the difference in potential between the twoflowpaths. This reference potential serves as the zerobaseline in ISE calculations. Before every ISEmeasurement, the pinch valve closes and thesolenoid valve opens and 65 µL of KCl is drawn into thereference cartridge by the action of the sipper syringe.The solenoid valve closes and the pinch valve opensas the syringe’s piston continues downward, drawingthe diluted sample through the electrodes.

To prevent electronic noise, the reference cartridgeflowpath must be free from air bubbles. KCl flowsthrough a degassing unit before entering the referencecartridge flowpath. A vacuum within the degasserremoves any dissolved air from the KCl.

Figure 5-27 below illustrates the flowpath of thereference cartridge.



DilutionVessel

SIPSyringe

ISSyringe

DILSyringe

Drain

Drain

Sipper

Degasser

RefK Na Cl

PinchValve

LS2 LS1

IS(600 mL)

DIL(300 mL)

REF(300 mL)

Pre

heat

er (

IS)

Pre

heat

er (

DIL

)

Pre

heat

er (

RE

F)

Vacuum


ISE Unit

5 • 37

5.8.7 Measuring Cartridge Flowpath

There are three electrodes housed in cartridges (blue= chloride, yellow = sodium, and red = potassium).These channeled cartridges are connected togetherto form a flowpath for the sample. The action of thesipper syringe piston draws the diluted sample fromthe dilution vessel into the electrodes.

WARNINGPatient sample is pulled through the sipper syringe.Exercise the normal precautions required forbiohazardous material when handling the sippersyringe.

A pinch valve controls the soft tubing that leads fromthe aspiration probe (at the dilution vessel) to themeasuring cartridges. The pinch valve opens and theKCl line solenoid valve closes. The sipper syringedownstrokes to aspirate contents of the dilutionvessel through the plastic tubing and into themeasuring flowpath.

Figure 5-28 below illustrates the measuring cartridgeflowpath.

Figure 5-28: Measuring Cartridge Flowpath



K Na Cl Ref

Sipper(Drain)

Reference(REF)

Diluent(DIL)

InternalStandard

(IS)DilutionVessel

Drain

LS2 LS1

PinchValve

5 • 38

As the diluted sample sits in the electrodes,equilibration is achieved and a measurement of theElectromotive Force (EMF) or voltage at themembrane of the electrode is taken. Figure 5-29below shows the relative position of membrane tosample in each electrode.

Figure 5-29: Measuring Cartridge

The selectivity of the membrane to a particular ion isdependent on the composition of the membrane.

The composition of the membrane in each electrodedetermines its selectivity for a certain ion:

• The PVC (polyvinyl chloride) material of thesodium electrode membrane contains a neutralcarrier that provides a cavity for capturing thesodium ion.

• The molecular structure of the antibioticvalinomycin in a PVC membrane in the potassiumelectrode makes the electrode selective for thepotassium ion.

• The chloride electrode membrane employs ionexchange with a type of salt in the membrane thatpairs with chloride ions.



Diluted Sample Flowpath Internal Filling Gel

Ag/AgClMembrane

O-ring

5 • 39

5.8.8 Sample Processing Sequence

The step-action table below lists the sequence ofevents in ISE sample processing.



Step Action Purpose

1 Dispense internalstandard

600 µL of Internal Standard (IS) is dispensed torinse the vessel.

2 Empty vessel The vacuum nozzle aspirates the internal standardused for rinse to waste.

3 Draw KCI Sipper syringe draws 65 µL of KCl through referenceand ground electrodes.

4 Dispense internalstandard

450 µL of IS are dispensed for one-point calibrationmeasurement.

5 Draw internalstandard

Internal Standard is drawn through the electrodes (bysipper syringe) for a one-point calibration check.

6 Empty vessel The vacuum nozzle aspirates the remaining internalstandard to waste.

7 Dispense sample 15 µL of sample is dispensed into the bottom of thedilution vessel for dilution purposes.

8 Add diluent 450 µL of ISE diluent is dispensed, mixing with thesample.

9 Draw KCl Sipper syringe draws 65 µL of KCl through referenceand ground electrodes.

10 Draw dilutedsample

300 µL of diluted sample is aspirated (by sippersyringe) into the electrodes.

11 Empty vessel The vacuum nozzle aspirates the remaining dilutedsample to waste.

5 • 40

5.9 Overview

5.9.1 Introduction

The rest of this chapter provides you with informationabout the assay types and calibration methods usedby the analyzer. Cross references are made to otherinformation concerning calibration and calculation ofresults contained in the manual.

5.9.2 General PhotometricCharacteristics

The photometer is positioned so that absorbancereadings of each reaction cell are taken as the reactiondisk is moving. This arrangement enables theinstrument to read the absorbance of each reactioncell as frequently as once every 20 seconds.

The light from the photometer lamp passes throughthe following structures in sequence:

1 Lens2 Inner reaction bath window3 Incubation bath water4 Reaction cell and its contents5 Incubation bath water6 Outer reaction bath window7 Photometer

An illustration of the light path to the photometer isshown on the following page in Figure 5-30. (Thiscutaway is taken from the top of the analyzer, directlyin front of the cell rinse unit.) When the light beamenters the photometer, it strikes a diffraction grating,which separates the light into its constituentwavelengths, and reflects them onto a fixed array of12 photodiodes. Each photodiode is permanentlypositioned to detect light at a different wavelength.

Absorbance readings are taken each time a reactioncell rotates past the photometer. When the reactioncell passes through the photometer lightpath,absorbance at the two programmed wavelengths foreach individual assay is measured. Readings fromthe programmed measure cycle(s) or measurepoint(s) are forwarded to the computer for calculationof final results.

All Boehringer Mannheim chemistries use twowavelength readings to calculate results. The endproduct of a chemical reaction absorbs the most lightat one particular wavelength. However, using thedifference between readings at two wavelengths(bichromatic system) eliminates the effect ofinterferences sometimes found when using a singlewavelength (monochromatic system).

5.9 Overview

5. CHEMISTRY THEORY

5 • 41

Figure 5-30: Photometer Lightpath

5.9 Overview

5. CHEMISTRY THEORY

Light Source Water Jacket

Lens

Inner

Outer

Photometer

Reaction BathWindows

5 • 42

Bichromatic analysis uses two wavelengths: one thatis at or near the peak absorbance of the chromogenproduced by the reaction, and a second wavelengthat which little or no absorbance of the desiredchromogen occurs.

Any absorbance (A2) that occurs, due to interference

from other substances in the sample, is measured atthe secondary wavelength. This amount is thensubtracted from the total absorbance (A

1) occurring at

the primary wavelength to yield the net absorbance(AC), shown graphically in Figure 5-31 below:

Figure 5-31: Bichromatic Absorbance

The optimum measure points for each test are part ofthe chemistry parameters.All measure points for Boehringer Mannheimchemistries are included with the chemistryparameters when they are downloaded from theParameter disk. These measure points are alsolisted in the Instrument Settings section of theapplication sheet for each chemistry.

The assay code and calibration method programmedfrom the chemistry parameters on the Parameter diskdetermine how final results are calculated for eachtest. Assay codes and calibration methods arediscussed in the following sections.

5.9 Overview

5. CHEMISTRY THEORY

ABSORBANCE

WAVELENGTH

OBSERVED

CHROMOPHORE

BLANK

λ1 λ2

A1

AC

A2

5 • 43

5.10 Assay Techniques

5. CHEMISTRY THEORY


5.10.1 Introduction

There are two fundamental types of assays on thisinstrument:

• endpoint assays• rate assays

Measurements are taken by the photometer atspecific measure points. If measurements are takenafter the reactions have stopped (are completed), theintensity of the colored (or turbid) product is anindicator of the sample component’s concentration.These are called endpoint assays.

If measurements are taken as the reaction proceeds,the rate of the reaction is proportional to the samplecomponent’s concentration or activity beinganalyzed. These are called rate reactions. There arealso modifications of these two techniques possiblein this instrument, as well as a combination of the two.

5.10.2 Selecting Assay Type andMeasure Points

The CHEMISTRY PARAMETERS screen displaysthe assay type and measure points that have beendownloaded from the Parameter disk for an individualtest.

To view the assay type or measure point for a specifictest, press the PARAMETER key.

Press 1 ENTER and GUIDANCE . This calls up thesecond page of the CHEMISTRY PARAMETERSscreen. Press the test key (1-46) for the test you wantto view. The Assay Code field displays the assaytype selected and the Assay Point field displays themeasure points selected.

1ENTER

Figure 5-32: Assay Code and Assay Point Display

37.0 Stand-by 12/01/92 12:20





Calibration Type

R1R2R3R4


Auto Time Out

Auto Change



[ PHOS ][ 2POINT END ] [ 3 ] [ ][ ] - [ ] - [ ] - [ ]

< Serum > < Urine >

[ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ] [ ][ ]

[ ] / [ ][ ] / [ ]4 10 0 0

53

10

30105

000

550

000

120140

00 0 Increase

0 0 Lower250100

00

0000

0000

00133001330013300133

LINEAR 2 2 0

999000

0.1100

14000 6000

2PointBLANK

376 340W 0

5 • 44

5.10.3 Example of Endpoint Assay

Boehringer Mannheim’s phosphorus reagents areused to determine phosphorus in a patient sampleusing the endpoint assay technique.

The Assay Code entry field will display:[2POINT END] [ 3] [ ] .

This assay is sample-blanked; "2POINT END"means that the instrument will read the absorbance ofthe reaction mixture at two points. The reaction timeis three minutes.

The Assay Point entry field will display:[ 4] - [10] - [ 0] - [ 0] .

The sample blank absorbance (sample plus the firstreagent) is determined by the measurement takenduring reaction disk rotation 4. The absorbance of thesample plus the first and second reagents isdetermined by the measurement taken during rotation10.

The instrument always makes endpoint assayabsorbance determinations in duplicate. Themeasure points for phosphorus are defined as diskrotations 4 and 10; in each case, a duplicate readingis also made in the previous disk rotation. The sampleblank readings occur during disk rotations 3 and 4.The final absorbance readings occur during rotations9 and 10.

When a sample is diluted with R1 reagent and read asa blank, it cannot be compared to the reading takenafter the addition of R2 reagent, R3 reagent, and/or R4reagent unless a correction for the dilution (from R2,R3, R4) is taken into account:

dilution factor =

The Assay Code field has three separate entries. Thefirst entry displays the assay type selected. There areseven different assay types including:

1: 1 Point2: 2 Point Rate3: 2 Point End4: 3 POINT5: 1 point and rate6: Rate-A7: Rate-B

Assay Code selections 1: 1 POINT, 3: 2 POINT ENDand 4: 3 POINT are all endpoint assays. Assay Codeselections 2: 2 POINT RATE, 6: RATE-A and 7:RATE-B are all rate assays. Assay Code selection5: 1 POINT AND RATE is a combination of endpointand rate assay type.

The second entry displays reaction time. The thirdentry is used for performing serum indexes or morethan one test in a reaction cell.

Assay Point has four entries. Each entry displays achosen measure point.

Sections 5.11 through 5.19 explain the assay types indetail. In each of these sections, the CHEMISTRYPARAMETERS screen for that assay type is shownas follows:

• CHEMISTRY PARAMETER screen displays:

Assay Code [Assay Type] [ ] [ ]Assay Point [ ] - [ ] - [ ] - [ ]

sample vol. + R1 reagent vol.

sample vol. + R1 vol. + (R2, R3, R4) vol.


5. CHEMISTRY THEORY

5 • 45

The dilution factor (d) is applied as a multiplier to theabsorbance values used for calculations in thephosphorus example.

Such as:

d = dilution factorA

3= absorbance at reaction disk rotation 3

A4

= absorbance at reaction disk rotation 4

5.10.4 Automatic Rerun Feature

The 911 analyzer performs reruns automatically.Automatic rerun is requested from the STARTCONDITIONS screen. When automatic rerun isselected, a sample with a triggering data alarmattached to the result is automatically routed back intothe routine processing cycle. This sample will bererun only once through the use of automatic rerun.

A sample may also be automatically rerun at areduced sample volume, depending on the type ofdata alarm that occurs. The automatic rerun feature,using a reduced sample volume, is designed as anadded laboratory convenience. High-end resultsfalling within the chemistry-specific dynamic rangeneed not be further tested utilizing a reduced samplevolume.

The accuracy of the chemistry application relies onthe accuracy of the calibration or factoring. Becausethese events are performed with the normal samplevolume, rerunning results using a reduced samplevolume can result in a bias. This bias is generallyabout 5% (positive) depending on the ratio of theoriginal sample volume to the reduced sample volumebeing used. The bias can approach 10% if there is alarge difference between the normal and reducedsample volume, and if the reducedsample volume is less than three microliters.

When calculating results, the 911 analyzer rounds theresults to the appropriate decimal place. This roundednumber becomes the reported result.

Use the Data Editing field on the DATA REVIEWscreen to correct results for manually diluted samplesbefore reporting the results. When the reducedsample volume feature is used, results on the DATAREVIEW screen are automatically corrected by theanalyzer.


5. CHEMISTRY THEORY

d A 3 + A4

2( )

5 • 46

5.11 1-Point Endpoint Assay

5. CHEMISTRY THEORY


5.11.1 1-Point Endpoint AssayCharacteristics

• CHEMISTRY PARAMETERS screen displays:

Assay Code [ 1POINT ] [ ] [ ]Assay Point [ ] - [ 0] - [ 0] - [ 0]

The first entry of the Assay Code displays assaytype [1POINT]. The second entry displays theresult printout designation time in minutes. Thethird entry is not applicable. The first entry of theAssay Point displays the measure point between1 and 49. The other three entries are not applicablefor 1-point Endpoint assays.

• Called 1-point because only one measure point (orduplicate reading at mp1) is taken (and only onemeasure point is designated in the CHEMISTRYPARAMETERS screen as explained above).

• Includes one or more reagent additions.• No sample blanking required.• The absorbance reading for this type of assay can

be taken during any disk rotation between 1 and 49if one reagent is added.

• The absorbance reading for this type of assay canbe taken during any disk rotation, after addition ofthe final reagent, when more than one reagent isadded.

• Total reagent volume must be between 250 and500 µL.

5.11.2 1-Point Endpoint Graph

A graphic representation of a 1-Point Endpoint Assayusing a reagent dispensed at R1 timing is shownbelow in Figure 5-33A.

A graphic representation of a 1-point Endpoint Assayusing reagents dispensed at R1 and R3 Timing andR3 timing is shown on next page in Figure 5-33B.

Figure 5-33A: 1-Point Endpoint Assay - - Reagentat R1 Timing

MP1

ABSORBANCE

TIME

1-Point Endpoint Assay(1 reagent)

LEGEND:

SR1ST1MP1

====

Sample additionreagent addition at R1 timingstirring after R11st measuring point

S,R1,ST1

5 • 47

Figure 5-33B: 1-Point Endpoint Assay - - Reagents atR1

5.11.3 1-Point Endpoint Calculation

The calculation of AX uses the following equation:

Ax

=

Ax

= mean absorbance of the unknownA

mp1= absorbance at measure point 1

Amp1-1

= absorbance at reaction disk revolutionprior to measure point 1

The calculation of an unknown sample concentrationuses the following equation:

Cx

= [{K (Ax - A

b) + C

b} · IF

A] + IF

B

Cx

= concentration of the unknown patientsample

K = calibration factorA

x= mean absorbance of the unknown

Ab = absorbance of STD1Cb = concentration of STD1IF

A , IF

B= instrument constants, representing

slope and intercept

Amp1

+ Amp1-1

2


5. CHEMISTRY THEORY

ABSORBANCE

TIME

1-Point Endpoint Assay(2 reagents)

LEGEND:

SR1ST1R3ST3MP1

======

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R3 timingstirring after R31st measuring point

MP1ST3R3S,R1,ST1

5 • 48

5.12 2-Point Rate Assay

5.12.1 2-Point Rate AssayCharacteristics


Assay Code [ 2 POINT RATE ] [ ] [ ]Assay Point [ ] - [ ] - [ 0] - [ 0]

The first entry of the Assay Code displays assaytype [2POINT RATE] . The second entry displaysthe result printout designation time in minutes.The third entry is not applicable. The first entry ofthe Assay Point displays the first measure point(between measure point 1 and measure point 2).The second entry displays the second measurepoint (between measure point 1 and 49). The thirdand fourth entries are not applicable.

• Rate Assay measures change in absorbance perminute.

• Called 2-point because there are two measurepoints (or duplicate readings at mp

1 and mp

2)

entered in the CHEMISTRY PARAMETERSscreen.

• Allows for two or more reagent additions.• The first absorbance reading for this type of assay

can be taken during anydisk rotation after the second reagent is added.

• The second absorbance reading for this type ofassay can be taken during any disk rotation afterthe final reagent is added.



5. CHEMISTRY THEORY

5.12.2 2-Point Rate Assay Graph

A graphic representation of a 2-Point Rate Assayusing a reagent dispensed at R1 timing is shown belowin Figure 5-34A.

Figure 5-34A: 2-Point Rate Assay - - Reagent at R1Timing

ABSORBANCE

TIME

2-Point Rate Assay(1 reagent)

LEGEND:

SR1ST1MP1MP2

=====

Sample additionreagent addition at R1 timingstirring after R11st measuring point2nd measuring point

MP2MP1S,R1,ST1

5 • 49

A graphic representation of a 2-Point Rate Assayusing reagents dispensed at R1 and R2 timing isshown below in Figure 5-34B.

Figure 5-34B: 2-Point Rate Assay - - Reagents atR1 and R2 Timing

A graphic representation of a 2-Point Rate Assayusing reagents dispensed at R1 and R3 timing isshown below in Figure 5-34C.

Figure 5-34C: 2-Point Rate Assay - - Reagents atR1 and R3 Timing


5. CHEMISTRY THEORY

S,R1,ST1

ABSORBANCE

TIME

2-Point Rate Assay(2 reagents)

LEGEND:

SR1ST1R2ST2MP1MP2

=======

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R2 timingstirring after R21st measuring point2nd measuring point

MP1 MP2ST2R2

ABSORBANCE

S,R1ST1

TIME

2-Point Rate Assay(2 reagents)

LEGEND:

SR1ST1R3ST3MP1MP2

=======


MP1 MP2ST3R3

5 • 50

5.12.3 2-Point Rate Assay Calculation


AX =

where:

Ax

= mean absorbance of the unknownAmp1 = absorbance at measure point 1A


t = time in minutes between measure point 1and 2


Cx

= [{K ( DAx - DA

b ) + C

b} · IF

A ] + IF

B

where:

Cx


K = calibration factorDAx = mean absorbance of the unknown, as

change in absorbance per minuteDAb = mean absorbance of STD1, as change

in absorbance per minuteC

b= concentration of STD1

IFA

, IFB

= instrument constants, representingslope and intercept

( )


5. CHEMISTRY THEORY

Amp2 + Amp2-1

2 ( )Amp1

+ Amp1-1

2-

t

5 • 51

5.13 2-Point Endpoint Assays

5. CHEMISTRY THEORY




Assay Code [ 2 POINT END ] [ ] [ ]Assay Point [ ] - [ ] - [ 0] - [ 0]

The first entry of the Assay Code displays assaytype [2POINT END] . The second entry displaysthe result printout designation time in minutes.The third entry is not applicable. The first entry ofthe Assay Point displays the first measure point(between measure point 1 and measure point 2).The second entry displays the second measurepoint (between measure point 1 and 49). The thirdand fourth entries are used for prozone check readpoints.

• Called 2-point because there are duplicatereadings at mp

1 and mp

2 (blank and final), which

are designated in the CHEMISTRYPARAMETERS screen.

• Allows for two or more reagent additions.• Sample blanking is possible.• The first absorbance reading for this type of assay

can be taken during any disk rotation before thefinal reagent is added.

• Measure point (mp2) is at endpoint of reaction afterfinal reagent addition.

• The second absorbance reading for this type ofassay can be taken during any disk rotation afterthe final reagent is added.


5.13.2 2-Point Endpoint Assay Graph

A graphic representation of a 2-Point Endpoint Assayusing reagents dispensed at R1 and R2 timing isshown below in Figure 5-35A.

Figure 5-35A: 2-Point Endpoint Assay - - Reagents atR1 and R2 Timing

ABSORBANCE

TIME

2-Point Endpoint Assay

LEGEND:

SR1ST1R2ST2MP1MP2

=======


MP1 R2 ST2 MP2S,R1,ST1

5 • 52

A graphic representation of a 2-Point Endpoint Assayusing reagents dispensed at R1 and R3 timing isshown below in Figure 5-35B.

Figure 5-35B: 2-Point Endpoint Assay - - Reagents atR1 and R3 Timing


5. CHEMISTRY THEORY

ABSORBANCE

TIME


LEGEND:

SR1ST1R3ST3MP1MP2

=======



5 • 53


5. CHEMISTRY THEORY


Cx = [{K (A

x - A

b) + C

b} · IF

A] + IF

B

where:

Cx


K = calibration factorAx = mean absorbance of the unknownA

b= mean absorbance of STD1

Cb

= concentration of STD1IF

A , IF


s l o p eand intercept

5.13.3 2-Point Endpoint AssayCalculation


AX =

d =

where:

Ax

= mean absorbance of the unknownA


Amp2 = absorbance at measure point 2d = liquid volume correction factor (dilution

factor)S = sample volumeRi, Rj = reagent volumesa = number of sample blanked reagents

at mp1

b = number of reagents not sample blankedat mp2

(Amp2 + Amp2-1 ) - d (A mp1 + Amp1-1 )

2

S + S Ri

a

i = 1

S + Σ Rj

b

j = 1

5 • 54



• Used to perform two different tests in one reactioncell


Test 1:

Assay Code [ 3 POINT ][ ] [ ]Assay Point [ ] - [ 0] - [ 0] - [ 0]

The first entry of the Assay Code field displaysassay type [3POINT] . The second entry displaysthe result printout designation time in minutes.The third entry displays the test key number of thesecond test to be performed in this cell (describedbelow).

The first entry of the Assay Point field displays thefirst measure point or the first test, mp

1. The

second, third, and fourth entries are not applicable.

Test 2:

Assay Code [ 3 POINT ][ ] [ ]Assay Point [ ] - [ ] - [ 0] - [ 0]

The first entry of the Assay Code field displaysassay type [3POINT] . The second entry displaysthe result printout designation time in minutes.The third entry is not applicable.

The first entry of the Assay Point field displays thefirst measure point of the second test, mp

2. The

second entry displays the second measure pointof the second test, mp

3. The third and fourth

entries are not applicable.

• 1 ≤ mp1 ≤ mp2 < mp3 ≤ 49• The first reagent may or may not participate in the

second reaction. (The first reagent may only actas a sample diluent for the second endpointreaction.)


5.14.2 3-Point Endpoint Assay Graph

A graphic representation of a 3-Point Endpoint assayusing reagents dispensed at R1 and R3 timing isshown below in Figure 5-36.

Figure 5-36: 3-Point Endpoint Assay - - Reagents atR1 and R3 Timing


5. CHEMISTRY THEORY

ABSORBANCE

TIME


LEGEND:

SR1ST1R3ST3MP1MP2MP3

========

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R3 timingstirring after R31st measuring point2nd measuring point3rd measuring point


MP2

5 • 55


Test 1:

Cx = [{K ( A XA - Ab ) + Cb} · IFA]+ IFB

where:

Cx = concentration of the unknown patientsample

K = calibration factor (Test 1)A

XA= mean absorbance of sample

Ab

= mean absorbance of STD1C


IFA, IFB = instrument constants representing slopeand intercept

Test 2:

Cx = [{K ( A xB - Ab ) + Cb} · IFA] + IFB

where:



XB= mean absorbance of sample

Ab

= mean absorbance of STD1C


IFA, IFB = instrument constants representing slopeand intercept


5. CHEMISTRY THEORY

Amp1

+ Amp1-1

2

(Amp3 + Amp3-1) - d (Amp2 + Amp2-1)

2

5.14.3 3-Point Endpoint AssayCalculation

The calculation of the mean sample absorbance usesthe following equations:

Test 1:

AXA

=

Test 2:

AXB

=

d =

where:

AXA = mean absorbance of the unknown forTest 1

AXB = mean absorbance of the unknown forTest 2

S = sample volumeA

mp1= absorbance at mp

1

Amp2

= absorbance at mp2

Amp3 = absorbance at mp3

d = dilution factorRi, Rj = reagent volumesa = number of sample blanked reagents

at mp2

b = number of reagents not sample blankedat mp

3

S + S Ri

a

i = 1

S + S Rj

b

j = 1

5 • 56

5.15 1-Point Endpoint and RateAssay

5.15.1 1-Point Endpoint and RateAssay Characteristics


Test 1:

Assa y Code [ 1 POINT&RATE ] [ ] [ ]Assa y Poin t [ ] - [ 0] - [ 0] - [ 0]

The first entry of the Assay Code field displaysassay type [1POINT&RATE ] . The second entrydisplays the result printout designation time inminutes. The third entry displays the test keynumber of the second test to be performed inthis cell.

The first entry of the Assay Point field displaysthe measure point for the first test, mp3. Thesecond, third, and fourth entries are notapplicable.

Test 2:Assa y Code [ 1 POINT&RATE ] [ ] [ ]Assa y Poin t [ ] - [ ] - [ ] - [ ]

The first entry of the Assay Code field displaysassay type [1POINT&RATE ] . The second entrydisplays the result printout designation time inminutes. The third entry is not applicable.

The first entry of the Assay Point field displaysthe first measure point of the second test, mp

1.

The second entry displays the second measurepoint of the second test, mp

2. The third entry

displays the third measure point of the secondtest, mp

4. The fourth entry displays the fourth

measure point of the second test, mp5.

• Performs two different tests and two differenttypes of tests in one reaction cell

• The first test is an endpoint assay, the second testis a rate assay with blank.

• 1 ≤ mp1 < mp

2 ≤ mp

3 < mp

4 < mp

5 ≤ 49

• mp1 + 2 < mp

2, mp

4 + 2 < mp

5

• Rate assay blank = ∆ Abs (mp1, mp

2)

• Rate (A) assay final reaction = ∆ Abs (mp4, mp5)• Linearity and substrate depletion of Rate A test

are monitored.• Endpoint measure point = mp

3 = Test 1

result =

5.15.2 1-Point Endpoint and RateAssay Graph

A graphic representation of a 1-Point Endpoint andRate assay using reagents dispensed at R1 and R3timing is shown below in Figure 5-37.

Figure 5-37: 1-Point Endpoint and Rate Assay - -Reagents at R1 and R3 Timing

Amp3

+ Amp3-1

2

5.15 1-Point Endpoint and Rat e Assay

5. CHEMISTRY THEORY

R3 ST3

ABSORBANCE

TIME

1-Point Endpoint and Rate Assay

LEGEND:

SR1ST1R3ST3MP1MP2MP3MP4MP5

=========

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R3 timingstirring after R31st measuring point2nd measuring point3rd measuring point4th measuring point5th measuring point

MP1S,R1,ST1

MP2 MP4 MP5MP3

5 • 57

5.15.3 1-Point Endpoint and RateAssay Calculation

The calculation of the mean sample absorbance (Test1) and change in absorbance per minute (Test 2) usesthe following equations:

Test 1:

AXA

=

Test 2:

DAXB

= DAmp4

· mp5 - d DAmp1

· mp2

d =

where:

AXA

= mean absorbance of the unknownforTest 1

AXB

= change in absorbance per minuteof the unknown for Test 2

S = sample volumeDAmp1 • mp2 = change in absorbance per minute

between mp1 and mp2

Amp3

= absorbance at mp3

DAmp4 • mp5

= change in absorbance per minutebetween mp

4 and mp

5

d = dilution factorRi, Rj = reagent volumesa = number of sample blanked

reagents at ∆Amp2 • mp1

b = number of reagents not sampleblanked at ∆A

mp4 • mp5


Test 1:

Cx = [{K ( A XA - Ab ) + Cb} · IFA] + IFB

where:

Cx



XA= mean absorbance of sample

Ab

= mean absorbance of STD1Cb = concentration of STD1IF

A, IF


slope and intercept

Test 2:

Cx=[{K ( DAXB - DAb ) + Cb} · IFA] + IFB

where:

Cx

= concentration of the unknownK = calibration factor (Test 2)DA

XB= change in absorbance per minute of

sample at ∆Amp4 • mp5

- d ∆Amp1 • mp2

DAb = change in absorbance per minute ofSTD1 at ∆Amp4 • mp5 - d ∆Amp1 • mp2

Cb = concentration of STD1IF

A, IF


slope and intercept

S + S Ri

a

i = 1

S + S Rj

b

j = 1

Amp3

+ Amp3-1

2

5.15 1-Point Endpoint and Rate Assay

5. CHEMISTRY THEORY

5 • 58

5.16 Rate A Assay

5.16.1 Rate A Assay Characteristics


Assay Code [RATE A] [ ] [ ]Assay Point [ ] - [ ] - [ 0] - [ 0]

The first entry of the Assay Code field displaysassay type [RATE-A] . The second entry displaysthe result printout designation time in minutes.The third entry may be used for serum indexes.

The first field of the Assay Point displays the firstmeasure point, mp1. The second field displays thesecond measure point, mp2. The third and fourthfields are not applicable.

• One or more reagent assays possible.• Total reagent volume must be between 250 and

500 µL.• Measure points (disk rotations) between initial

(mp1) and last (mp2) reading used for verification oflinearity.

• Rate of absorbance change is calculated by leastsquares method.

• Substrate depletion is monitored.• 1 ≤ mp

1 < mp

2 ≤ 49, mp

1 + 2 < mp

2

5.16.2 Rate A Assay Graph

A graphic representation of a Rate A assay using areagent dispensed at R1 timing is shown below inFigure 5-38A:

Figure 5-38A: Rate A Assay - - Reagent at R1 Timing

A graphic representation of a Rate A assay usingreagents dispensed at R1 and R2 timing is shownbelow in Figure 5-38B:

Figure 5-38B: Rate A Assay - - Reagents atR1 and R2 Timing

5.16 Rate A Assay

5. CHEMISTRY THEORY

ABSORBANCE

TIME

Rate A Assay

LEGEND:

SR1ST1MP1MP2

=====

Sample additionreagent addition at R1 timingstirring after R11st measuring point2nd measuring point

MP1S,R1,ST1

MP2

ABSORBANCE

TIME

Rate A Assay

LEGEND:

SR1ST1R2ST2MP1MP2

=======


MP1S,R1,ST1

MP2ST2R2

5 • 59

A graphic representation of a Rate A assay usingreagents dispensed at R1 and R3 timing is shownbelow in Figure 5-38C:

Figure 5-38C: Rate A Assay - - Reagents atR1 and R3 Timing

A graphic representation of a Rate A assay usingreagents dispensed at R1, R3 and R4 timing is shownbelow in Figure 5-38D:

Figure 5-38D: Rate A Assay - - Reagents atR1, R3 and R4 Timing

5.16 Rate A Assay

5. CHEMISTRY THEORY

ABSORBANCE

TIME

Rate A Assay

LEGEND:

SR1ST1R3ST3MP1MP2

=======


MP1S,R1,ST1

MP2ST3R3 R3 ST3

ABSORBANCE

TIME

Rate A Assay

LEGEND:

SR1ST1R3ST3R4ST4MP1MP2

=========

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R3 timingstirring after R3reagent addition at R4 timingstirring after R41st measuring point2nd measuring point

MP1S,R1,ST1

MP2R4 ST4

5 • 60

5.16.3 Rate A Assay Calculation

Calculation of the change in absorbance per minuteuses the following equation:

DAX

= D Amp1

• mp2

where:

DAX

= change in absorbance per minute ofunknown

D Amp1

• mp2


1 and mp

2.

Calculation of an unknown sample concentration usesthe following equation:

Cx

= [{K ( DAx - DA

b ) + C

b} · IF

A] + IF

B

where:

Cx

= concentration of sampleK = calibration factorD Ax = measured change in absorbance per

minute of unknownD A

b= measured change in absorbance per

minute of STD 1C

b= concentration of STD 1

IFA, IF


slope and intercept

5.16 Rate A Assay

5. CHEMISTRY THEORY

5 • 61

5.17 Rate B Assay - - Mode 1

5.17.1 Rate B Assay - - Mode 1Characteristics

• Blank compensation is available for Test 2 in twomodes: Mode 1 (described in Section 5.17) andMode 2 (described in Section 5.18).a) In Mode 1, blank compensation is performed

only if Test 1 and Test 2 have identicalwavelengths.

b) In Mode 2, blank compensation is alwaysperformed regardless of wavelengths selected.


Test 1:

Assay Code [RATE B] [ ] [ ]Assay Point [ ] - [ ] - [ 0] - [ 0]

The first entry of the Assay Code field displaysassay type [RATE B] . The second entry displaysthe result printout designation time in minutes.The third entry displays the test key number of thesecond test to be performed in this cell.

The first entry of the Assay Point field displays thefirst measure point of the first test, mp1. Thesecond entry displays the second measure pointof the first test, mp2. The third and fourth entriesare not applicable.

Test 2:


The first entry of the Assay Code field displaysassay type [RATE B] . The second entry displaysthe result printout designation time in minutes.The third entry is not applicable.

The first entry of the Assay Point field displays thefirst measure point of the second test, mp3. Thesecond entry displays the second measure pointof the second test, mp4. The third and fourthentries are not applicable.

• Used to perform two different rate reactions in thesame reaction cell.

• 3 ≤ mp1 < mp

2 < mp

3 < mp

4 ≤ 49

• mp1 + 2 < mp

2, mp

3 + 2 < mp

4

• During the first half of the incubation, Test 1 ismeasured. During the final half of the incubation,Test 2 is measured.

• Linearity and substrate depletion are monitored.• Rate of absorbance change is calculated by least

squares method.• Total reagent volume must be between 250 and

500 µL.

5.17 Rate B Assay--Mode 1

5. CHEMISTRY THEORY

5 • 62

5.17.2 Rate B Assay - - Mode 1 Graph

A graphic representation of a Rate B - - Mode 1 assayusing reagents dispensed at R1 and R3 timing isshown below in Figure 5-39:

Figure 5-39: Rate B - - Mode 1 Assay - - Reagents atR1 and R3 Timing

5.17.3 Rate B Assay - - Mode 1Calculation

The calculation of the change in absorbance perminute when Test 1 and Test 2 are measured atdifferent wavelengths uses the following equations:

Test 1:

DAXA

= D Amp1 • mp2

Test 2:

DAXB

= D Amp3

•

mp4

where:

DAXA

= change in absorbance per minute ofTest 1 unknown

DAXB = change in absorbance per minute ofTest 2 unknown

D Amp1

•

mp2= change in absorbance per minutebetween mp

1 and mp

2

DAmp3

•

mp4= change in absorbance per minute

between mp3 and mp

4

The calculation of the mean sample absorbance whenTest 1 and Test 2 are measured at the samewavelengths uses the following equations:

Test 1:

DAXA = D Amp1 • mp2

Test 2:

DAXB = D Amp3 • mp4 - d DAmp1 • mp2


5. CHEMISTRY THEORY

MP1 MP2 R3 ST3

ABSORBANCE

TIME

Rate B Assay

LEGEND:

SR1ST1R3ST3MP1MP2MP3MP4

=========

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R3 timingstirring after R31st measuring point2nd measuring point3rd measuring point4th measuring point

MP3S,R1,ST1

MP4

5 • 63

d =

where:

DAXA

= change in absorbance per minute ofthe unknown for Test 1

DAXB


S = sample volumeDA

mp1 • mp2= change in absorbance per minute

between mp1 and mp

2

DAmp3 • mp4 = change in absorbance per minutebetween mp3 and mp4

k = dilution factorRi, Rj = reagent volumesa = number of sample blanked reagents

at ∆ Amp1 • mp2

b = number of reagents not sampleblanked at ∆ Amp3 • mp4

The calculation of an unknown sample concentrationuses the following equation, no matter whether Test1 and Test 2 use the same or different wavelengths:

Test 1:

Cx = [{K ( D AXA - D Ab ) + Cb} · IFA] + IF B

where:

Cx


K = calibration factor (Test 1)DA

XA= change in absorbance per minute of

sampleDA

b= change in absorbance per minute of

STD1Cb = concentration of STD1IF

A, IF


slope and intercept

Test 2:

Cx = [{K ( D AXB - D Ab ) + Cb} · IFA] + IF B

where:

Cx




sampleDAb = change in absorbance per minute of


A, IF


slope and intercept

S + S Ri

a

i = 1

S + S Rj

b

j = 1


5. CHEMISTRY THEORY

5 • 64

5.18 Rate B Assay - - Mode 2

5.18.1 Rate B Assay - - Mode 2Characteristics

• Blank compensation is available for Test 2 in twomodes: Mode 1 (described in Section 5.17) andMode 2 (described in Section 5.18).a) In Mode 1, blank compensation is performed

only if Test 1 and Test 2 have identicalwavelengths.

b) In Mode 2, blank compensation is alwaysperformed regardless of wavelengths selected.


Test 1:


The first entry of the Assay Code field displaysassay type [RATE B] . The second entry displaysthe length of reaction time in minutes. The thirdentry displays the test key number of the secondtest to be performed in this cell.

The first entry of the Assay Point field displays thefirst measure point of the first test, mp1. Thesecond entry displays the second measure pointof the first test, mp2. The third and fourth entriesare not applicable.

Test 2:

Assay Code [RATE B] [ ] [ ]Assay Point [ ] - [ ] - [ ] - [ ]

The first entry of the Assay Code field displaysassay type [RATE B] . The second entry displaysthe length of reaction time in minutes. The thirdentry is not applicable.

The first entry of the Assay Point field displaysthe first measure point of the second test, mp

3.

The second entry displays the second measurepoint of the second test, mp

4. The third entry

displays the third measure point of the secondtest, mp5. The fourth entry displays the fourthmeasure point of the second test, mp6.

• Used to perform two different rate reactions in onereaction cell.

• 3 ≤ mp1 < mp

2 < mp

3 < mp

4 < mp

5 < mp

6 ≤ 49

• mp1 + 2 < mp2, mp3 + 2 < mp4, mp4 + 2 < mp5

• Linearity and substrate depletion are monitored .• Rate of absorbance change is calculated by least

squares method.

5.18.2 Rate B Assay - - Mode 2 Graph

A graphic representation of a Rate B - - Mode 2 assayusing reagents dispensed at R1 and R3 timing isshown below in Figure 5-40:

Figure 5-40: Rate B - - Mode 2 Assay - - Reagents atR1 and R3 Timing


5. CHEMISTRY THEORY

MP3MP1 MP4MP2 R3 ST3

ABSORBANCE

TIME

Rate B Assay

LEGEND:

SR1ST1R3ST3MP1MP2MP3MP4MP5MP6

===========

Sample additionreagent addition at R1 timingstirring after R1reagent addition at R3 timingstirring after R31st measuring point2nd measuring point3rd measuring point4th measuring point5th measuring point

MP5S,R1,ST1

MP6

6th measuring point

5 • 65

5.18.3 Rate B Assay - - Mode 2Calculation

The calculation of the mean sample absorbance usesthe following equations:

Test 1:

DAXA

= D Amp1 •

mp2

Test 2:

DAXB

= D Amp5 •

mp6

- d D Amp3

• mp4

d =

where:

DAXA = change in absorbance per minute ofthe unknown for Test 1

DAXB


S = sample volumeDA

mp1 • mp2= change in absorbance per minute

between mp1 and mp

2

DAmp3 • mp4


3 and mp

4

DAmp5 • mp6 = change in absorbance per minutebetween mp5 and mp6

d = dilution factorRi, Rj = reagent volumesa = number of sample blanked reagents

at ∆ Amp1 • mp2

b = number of reagents not sampleblanked at ∆ A

mp3 • mp4


Test 1:

Cx = [{K ( DAXA - DAb ) + Cb} · IFA] + IFB

where:



XA= change in absorbance per minute of

sampleDA

b= change in absorbance per minute of

STD1C


IFA, IFB = instrument constants, representingslope and intercept

Test 2:

Cx = [{K ( DAXB - DAb ) + Cb} · IFA] + IFB

where:

Cx




sampleDAb = change in absorbance per minute of


A, IF


slope and intercept

S + S Ri

a

i = 1

S + S Rj

b

j = 1


5. CHEMISTRY THEORY

5 • 66

5.19 Summary of AssayTechniques

5.19 Summary of Assay T echniques

5. CHEMISTRY THEORY

ASSAY TYPE TEST MEASURE POINTS CALCULATION OF UNKNOWN

1-point assay TEST 1

1-point assay(with prozonecheck)

TEST 1

2-point assay TEST 1

2-point assay(with prozonecheck)

TEST 1

2-point rateassay

TEST 1

3-point assay TEST 1 & 2

1-point andrate assay

TEST 1

TEST 2

Rate A assaywith serumindexmeasurement

TEST 1

Rate Aassay

TEST 1

Rate Bassay

Mode 1

TEST 1

TEST 2

Mode 2

TEST 1

TEST 2

1 ≤ mp1 ≤ 49

1 ≤ mp1 < mp2 ≤ 49

1 ≤ mp1 < mp2 ≤ 49

1 ≤ mp1 < mp3 < mp4

< mp2 ≤ 49

1 ≤ mp1 ≤ mp

2 < mp

3 ≤ 49

1 ≤ mp1 < mp

2 ≤ mp

3 < mp

4

< mp5 ≤ 49;

mp1+2

< mp1; mp

4+2 < mp

5

5 ≤ mp1 < mp2 ≤ 49;mp

1 + 2 ≤ mp

2

1 ≤ mp1 < mp

2 ≤ 49;

mp1 + 2

≤ mp2

3 ≤ mp1 < mp

2 < mp

3

< mp4 ≤ 49;

mp1 + 2

< mp2;

mp3 + 2

< mp4

3 - mp1 < mp2 < mp3 < mp4

< mp5 < mp

6 - 49;

mp1 + 2

< mp2;

mp3 + 2 < mp4;mp

4 + 2 < mp

5

Cx = [{K (A

x - A

b) + C

b} • IF

A] + IF

B

Cx = [{K (A

x - A

b) + C

b} • IF

A] + IF

BProzone Check:

{(A mp2 + A mp2 - 1) -d(A mp1 + A mp1 - 1)}

12

Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB

Cx = [{K (A

x - A

b) + C

b} • IF

A] + IF

B

Prozone Check:(∆ A (mp2 • mp3)/∆ A (mp4 • mp3) x 100

Cx = [{K (∆A

x - ∆A

b) + C

b} • IF

A] + IF

B1 ≤ mp

1 < mp

2 ≤ 49

Cx = [{K (A

x - A

b) + C

b} • IF

A] + IF

B

Cx = [{K (A

x - A

b) + C

b} • IF

A] + IF

B

Cx = [{K (∆ A

mp4 • mp5 - d ∆ A

mp1 • mp2

- ∆Ab) + C

b} • IF

A] + IF

B

Cx = [{K (∆ Amp1 • mp2 - ∆Ab) + Cb}• IF

A] + IF

B

Cx = [{K (∆ A

mp1 • mp2 - ∆A

b) + C

b}

• IFA] + IF

B

Cx = [{K (∆ A

mp1 • mp2 - ∆A

b) + C

b}

• IFA] + IF

B

Cx = [{K (∆ A

mp3 • mp4 - d ∆A

mp1 • mp2-

∆Ab) + C

b} • IF

A] + IF

B1

Cx = [{K (∆ A

mp3 • mp4 - ∆A

b) + C

b}

• IFA] + IFB2

Cx = [{K (∆ A

mp1 • mp2 - ∆A

b) + C

b}

• IFA] + IFB

Cx = [{K (∆ A

mp5 • mp6 - d ∆ A

mp3 • mp4-

∆Ab) + C

b} • IF

A] + IF

B

1Identical wavelengths to test 1.2Different wavelengths from test 1.

5 • 67

5.20 Calibration Overview

5.20.1 Explanation of theCalibration Monitor Reportby Assay Type

The Calibration Monitor report is discussed in detail inSection 2.66. An example of the report is shown inFigure 5-41.

Figure 5-41: Calibration Monitor Report

The absorbance figures on the photometric portion ofthe Calibration Monitor report are calculateddifferently, depending on the assay type that is used.The remainder of this section outlines the bichromaticand monochromatic absorbance calculations for eachassay type.


5. CHEMISTRY THEORY

LEGEND

S1 = Standard 1S2 = Standard 2R1 = Reagent dispensed at R1 timingR2 = Reagent dispensed at R2 timingR3 = Reagent dispensed at R3 timingR4 = Reagent dispensed at R4 timingΣR = The sum of all reagents dispensedmp1 = Measure Point 1mp2 = Measure Point 2d = correction for dilution

d =Sample Volume + ΣR volumes at mp1

Sample Volume + ΣR volumes at mp2

CALIBRATION MONITOR 01/06/93 14:39

TEST IS.EMF S1 EMF S2 EMF S3 EMF SLOPE IS.CONC. S3 CONC. C.VALUE

Na

K

Cl

CH TEST ----S1---- ----S2---- ----S3---- ----S4---- ----S5---- ----S6----

-32.6

-37.3

131.1

-36.8

-51.1

136.7

-29.3

-29.3

128.3

-23.2

-39.3

131.9

60.0

59.2

-47.7

141

5.1

-47.7

138

4.7

101

-2

0.0

0

-17-20

1759917532

1740517323

-898-891

287285

32843288

87

437438

209206

11841174

31743891

95499563

91049168

287306

10

20

13

19

BUN

CHOL

CA

CALIBCREA

5 • 68


5. CHEMISTRY THEORY

——S1——Bichromatic ABS ofS1 + ΣR at mp1

Monochromatic ABS ofS1 + ΣR at mp1

——S2——Monochromatic ABS ofS2 + ΣR at mp1

Bichromatic ABS ofS2 + ΣR at mp1

ENDPOINT, mp1 ® mp

2 (sample blanked)

——S1—— ——S2——Bichromatic ABS ofS1 + ΣR at mp2 -d (S1 + ΣR at mp1)

Monochromatic ABSofS1 + ΣR at mp2

Bichromatic ABS ofS2 + ΣR at mp

2 -

d (S1 + ΣR at mp1)


RATE A, mp1® mp

2

——S1——

Bichromatic ∆ABS/MIN of(S1 + ΣR at mp1 → mp2)


RATE B, Mode 1 (Test 1)

——S1——

Bichromatic ∆ABS/MIN of(S1 + ΣR at mp1 → mp2)


RATE B, Mode 1 (Test 2 wavelengths ¹ Test 1 wavelengths)

——S1——Bichromatic ∆ABS/MIN of(S1 + ΣR at mp1 →mp2)for Test 2


for Test 2

RATE B, Mode 1 (Test 2 wavelengths = Test 1 wavelengths)

——S1——Bichromatic ∆ABS/MIN of(S1 + ΣR at mp 1 → mp

2)

for Test 2 - d (S1 + ΣRat mp1 → mp2) for Test 1

RATE B, Mode 2 (Test 1)

——S1——Bichromatic ∆ABS/MIN of(S1 + ΣR at mp1 → mp2)


for Test 2

Monochromatic ABS ofS1 + ΣR at mp

1

RATE B, Mode 1 (Test 2 wavelengths = or ¹ Test 1 wavelengths)

——S1——Bichromatic ∆ABS/MIN of(S1 + ΣR at mp1 → mp2)for Test 2 - d (S1 + ΣRat read cycles 20 - 24)


for Test 2

ENDPOINT, mp1

5 • 69

5.20.2 Calibration Methods

The following calibration methods are available on thisanalyzer:

• Linear Calibration• 1-Point Linear Calibration (K Factor)• Multipoint Linear Calibration• 2-Point Linear Calibration

• Nonlinear Calibration• Logit-log 3P Calibration• Logit-log 4P Calibration• Logit-log 5P Calibration• Exponential Calibration• Spline Calibration

• Isozyme Calibration• Isozyme P• Isozyme Q

The linear calibration methods are used for tests whenthe plotted absorbance readings at differentconcentrations form a linear curve.

Nonlinear calibration is used for those samplecomponents (e.g., therapeutic drug assays) whoseassay absorbances at different concentrations form anonlinear, but reproducible, plot. At least three and amaximum of six calibrators are required forcalibration.

Isozyme calibration is used to analyze samples wheretwo similar isozymes are present.

A K factor is used in the calculation of unknownsample results. Any test requiring more than just ablank during calibration will have its K factorcalculated via the measured absorbances of theblank and the other standard(s). A fixed K factor isused to calculate results of all other reactions. TheK factor can be applied to all samples tested using thesame reagent as that used in calibration (within therecommended calibration interval).


5. CHEMISTRY THEORY

5.20.3 Programming CalibrationMethods

The CHEMISTRY PARAMETERS screen displaysthe calibration type that has been downloaded fromthe Parameter disk for an individual test.

To view the calibration type for a specific test, pressthe PARAMETER key and 1, ENTER, GUIDANCE.This displays the second page of the CHEMISTRYPARAMETERS screen. Press the test key (1-46) forthe test you want to view. The Calib. Type field hasfive entries available. This field is highlighted on thedisplay shown below in Figure 5-42.

1ENTER

Figure 5-42: Calibration Type Display

37.0 Stand-by 12/01/92 12:20





Calibration Type

R1R2R3R4


Auto Time Out

Auto Change



[ PHOS ][ 2POINT END ] [ 3 ] [ ][ ] - [ ] - [ ] - [ ]

< Serum > < Urine >

[ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ] [ ][ ]

[ ] / [ ][ ] / [ ]4 10 0 0

53

10

30105

000

550

000

120140

00 0 Increase

0 0 Lower250100

00

0000

0000

00133001330013300133

LINEAR 2 2 0

999000

0.1100

14000 6000

2PointBLANK

376 340W 0

5 • 70

The Calib. Type field has five entries. The first entrydisplays the calibration method selected. There areeight different calibration methods including:

1 : LINEAR2 : LOGIT-LOG(3P)3 : (4P)4 : (5P)5 : EXPO.6 : SPLINE7 : ISO. P8 : ISO. Q

The second entry displays the number of standards(1 - 6) used in calibration.

The third entry displays the calibrator used in SPANcalibration. Any calibrator except standard 1 (blank)can be used.

The fourth entry displays the weight applied to thestandard solution used in calculation.

The fifth entry displays the Q channel used inIsozyme P calibration.

The following sections discuss each calibrationmethod in detail. The Calib. Type entry for eachmethod is shown as follows:

Calib. Type [ ] [ ] [ ] [ ] [ ]

An explanation of each entry, as it applies to thecalibration method, is contained in each section.


5. CHEMISTRY THEORY

5 • 71

5.21.2 1-Point Linear CalibrationGraph

A graphic representation of this calibration method isshown below in Figure 5-43.

Figure 5-43: 1-Point Linear Calibration

5.21 1-Point Linear Calibration

5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

K FACTOR1

(KNOWN SLOPE

Cb Cx

∆Ax

∆Ab


5.21.1 Selecting 1-Point LinearCalibration

This calibration method is used for those sampleconstituents (e.g., LD, AST, ALP) whose rate ofchange in absorbance at different concentrationsforms a linear plot and the slope of the plot is alreadyknown. Enzymes cannot be weighed out but theiractivity can be determined. The slope is based on themolar absorptivity of the absorbing species (e.g.,NADH) of that particular chemistry’s reaction. The Kfactor for most enzyme assays, and some substrateassays, is established by a Boehringer Mannheimrepresentative at installation according to thefollowing formula:

K =

In 1-point linear calibration, a zero or blank calibrator(saline) is run and the absorbance and concentrationof this, as well as the predetermined K factor, are usedin the calculation of final results of the sample(unknown). Saline is commonly used as a zero orblank calibrator.

CHEMISTRY PARAMETERS displays the following:

Calib. Type [LINEAR ] [ 1] [ 0] [ 0] [ ]

The first entry displays [LINEAR] as the calibrationmethod. The second entry displays [1] for the numberof standards chosen. The third entry displays [0] toshow that SPAN calibration is not selected. Thefourth entry displays [0] to show that no weightingmethod applies to this calibration method. The fifthentry is not applicable.

total reaction volume (mL) x 100

molar absorptivity x lightpath (cm) x specimen volume (mL)

5 • 72

Substituting our expressions:

Cx = [{K (A

x - A

b) + C

b} · IF

A] + IF

B

where:

Cx

= concentration of unknownA

x= measured absorbance of unknown

Cb

= concentration of STD 1 (blank)K = K factor (reciprocal of slope)A

b= blank absorbance

IFA, IF


slope and intercept

5.21.4 Assay Types

Assay techniques possible with this type ofcalibration:

1-point assay2-point assay3-point assay2-point rate assay1-point and Rate assayRate A assayRate B assay


5. CHEMISTRY THEORY

(y - b)

a

1a

5.21.3 1-Point Linear Calculation

The final result of an unknown is calculated using theequation for a straight line:

y = ax + b or x = or x = (y - b)

where:

x = concentrationy = absorbancea = slopeb = y-intercept or offset

K = Therefore: x = K (y - b)

where:

x = Concentration of xK = K factory = Absorbance of xb = Absorbance of blank, when C

b = 0

The final result of an unknown is calculated using theequations below:

when Cb = 0:

b = Ab

Cx = x A

x = y K =


Cx = [K (A

x - A

b) · IF

A] + IF

B

when Cb

¹ 0:

b = Ab - a · Cb Cx = x Ax = y K =

1a

1a

1a

5 • 73


5.22.1 Selecting 2-Point LinearCalibration

For 2-point linear calibration, saline is commonlyused as a zero or blank calibrator. A secondcalibrator with a known value is also run. These twopoints are used to establish a linear plot and the slopeof this “curve” is used in the calculation of subsequentcontrol and patient results.


Calib. Type [LINEAR ] [ 2] [ 2] [ 0] [ ]

The first entry displays [LINEAR] as the calibrationmethod. The second entry displays [2] for the numberof standards chosen. The third entry displays [2] toshow that if a SPAN calibration is selected, STD2 willbe used as the SPAN calibrator. The fourth entrydisplays [0] to show that no weighting method appliesto this calibration. The fifth entry is not applicable.

5.22.2 2-Point Linear CalibrationGraph

A graphic representation of this calibration method isshown below in Figure 5-44.

Figure 5-44: 2-Point Linear Calibration


5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb Cs

As

Ab

When Cb = 0

ABSORBANCE

CONCENTRATION

Cb Cs

As

Ab

When Cb ≠ 0

5 • 74

5.22.3 2-Point Linear Calculation

The slope for a 2-point linear calibration is calculatedfrom the equation for a straight line:

y = ax + b or x = or x = (y - b)

where:

y = absorbancea = slopex = concentrationb = y-intercept or offset

Solving for slope (a) using two points:

a =

Substituting our terms for these expressions then:

a = K = or K =

Solving for y intercept (b) using two points:

when Cb = 0:

b = A b

when Cb ¹ 0:

b = Ab - b · C

b

where:

As

= absorbance of the second calibrator reactionA

b= absorbance of the blank calibrator reaction

Cs = concentration of the second calibratorCb = concentration of the blank calibratorK = calibration factor


From the equation for a straight line:

x = (y - b) Therefore: x = K (y - b)

when Cb = 0:

b = Ab

Cx = x A

x = y K =


Cx = K (A

x - A

b)

when Cb ¹ 0:

b = Ab - a • C

bC

x = x A

x = y K =


Cx = [{K (A

x - A

b) + C

b} • IF

A] + IF

B

where:

Cx

= concentration of unknownA

x= measured absorbance of unknown

Cb

= concentration of STD 1 (blank)K = K factor (reciprocal of slope)A

b= blank absorbance

IFA, IF


slope and intercept

5.22.4 Assay Types

Assay techniques possible with this type ofcalibration are:

1-point assay2-point assay3-point assay2-point rate assay1-point and rate assayRate A assayRate B assay


5. CHEMISTRY THEORY

1a

1a

(y - b)

a1a

D y

D x

As - Ab

Cs - C

b

1a

Cs - C

b

As - Ab

1a

5 • 75

5.23 Multipoint Linear Calibration

5.23.1 Selecting Multipoint LinearCalibration

Multipoint linear calibration is used for those sampleconstituents requiring more than two standards forlinear calibration.


Calib. Type [LINEAR ] [ ] [ ] [ ] [ ]

The first entry displays [LINEAR] as the calibrationmethod. The second entry displays the number ofstandards chosen. The third entry displays thecalibrator selected for SPAN calibration. The fourthentry displays the weight that has been given to thiscalibration for purposes of calculation. The fifth entryis not applicable.

5.23.2 Multipoint Linear CalibrationGraph

A graphic representation is shown below inFigure 5-45.

Figure 5-45: Multipoint Linear Calibration


5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

CS1 CS2 CS3 CS4 CS5 CS6

AS6

AS1

AS2

AS3

AS4

AS5

5 • 76

5.23.3 Multipoint Linear Calculation

Multipoint linear calibration is carried out solving forslope (a) and y-intercept (b) by using the method ofleast squares.

Calculations to solve for slope (a) and y-intercept (b)are as follows:

y = ax + b or x = or x = (y - b)

a = • r

b = Y - a X

where:

y = absorbance of standardx = concentration of standardS

y= SD of absorbance of standards 1 - 6

SX

= SD of concentration of standards 1 - 6r = correlation coefficientY = mean absorbance of standards 1 - 6X = mean concentration of standards 1 - 6


From the derivation of equations above:

x = (y - b) Therefore: x = K (y - b)

when Cb = 0:

b = Ab

Cx = x A

x = y K =


Cx = K (A

x - A

b)

when Cb ¹ 0:

b = Ab - a • Cb Cx = x A x = y K =


Cx = [{K (A x - Ab) + Cb} • IFA] + IFB

where:

Cx = concentration of unknownAx = Measured absorbance of unknownCb = concentration of blank or STD 1K = K factor (reciprocal of slope)Ab = blank absorbanceIFA, IFB = instrument constants representing

slope and intercept

5.23.4 Assay Types


1-point assay2-point assay3-point assay2-point rate assay1-point and rate assayRate A assayRate B assay

Sy

Sx

1a

(y - b)

a

1a

1a

1a


5. CHEMISTRY THEORY

5 • 77

5.24 Non-Linear Logit-log 3PCalibration

5.24.1 Selecting Non-linear Logit-log3P Calibration

The non-linear method 1, LOGIT-LOG 3P, is appliedto a working curve in which the absorbance increasesor decreases in a non-linear manner as theconcentration increases.


Calib. Type [LOGIT-LOG(3P)] [ ] [ ] [ ] [ ]

The first entry displays [LOGIT-LOG(3P)] as thecalibration method. The second entry displays thenumber of standards chosen. The third entry displaysthe calibrator selected for SPAN calibration. Thefourth entry displays the weight that has been givento this calibration for purposes of calculation. Thefifth entry is not applicable.

5.24.2 Non-linear Logit-log 3PCalibration Graph

A graphic representation of this calibration is shownbelow in Figure 5-46.

Figure 5-46: Logit-log 3P Calibration

5.24 Non-Linear Logit-log 3P Calibration

5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb CS2 CS3 CX CN

AN

Ab

AS2

AS3

AX

5 • 78

5.24.3 Non-linear Logit-log 3PCalculation

The math model for non-linear logit-log 3P calibrationcurve approximation is shown below:

A = B +

where:

A = measured absorbance value or absorbancevariation rate of standard solution (exceptSTD1 solution)

B = measured absorbance value or absorbancevariation rate of STD 1

a, b = calibration curve parametersC = concentration of standard solution

The formula for sample concentration calculation isshown below:

CX = (C + C1) · IFA + IFB

C = { }

AX = B +

where:

CX

= sample concentration corrected forSTD 1 concentration and instrumentfactors

C = sample concentrationC1 = concentration of STD 1IF

A, IF


slope and intercepta, b = calibration curve parametersA

X= sample absorbance value

B = STD 1 measured absorbance value orabsorbance variation rate

5.24.4 Assay Types

Nonlinear logit-log 3P calibration can be used with thefollowing assay types:

1-point assay2-point rate assay2-point assayRate A assay

a

1 + bC

a - (Ax - B)

Ax - B

1

b

a

1 + bC


5. CHEMISTRY THEORY

5 • 79






The first entry displays [LOGIT-LOG(4P)] as thecalibration method. The second entry displays thenumber of standards chosen. The third entry displaysthe calibrator selected for SPAN calibration. Thefourth entry displays the weight that has been givento this calibration for purpose of calculation. The fifthentry is not applicable.



Figure 5-47: Logit-log 4P Calibration


5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb CS2 CS3 CX CN

AN

Ab

AS2

AS3

AX

5 • 80

B = STD 1 measured absorbance valueor absorbance variation rate

5.25.4 Assay Types




5. CHEMISTRY THEORY

a

1 + bCc

a

1 + bCc

1b

a - (Ax - B)

Ax - B



A = B +

where:

A = measured absorbance value orabsorbance variation rate of standardsolution (except STD 1 solution)

B = measured absorbance value orabsorbance variation rate of STD 1

a, b, c = calibration curve parametersC = concentration of standard solution


CX = (C + C1) • IFA + IFB

Cc = { }

AX = B +

where:

CX


C = sample concentrationC1 = concentration of STD 1IFA, IFB = instrument constants, representing

slope and intercepta, b, c = calibration curve parametersA


5 • 81






The first entry displays [LOGIT-LOG(5P)] as thecalibration method. The second entry displays thenumber of standards chosen. The third, fourth, andfifth entries are not applicable.



Figure 5-48 Logit-log 5P Calibration


5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb CS2 CS3CX CN

AN

Ab

AS2

AS3

AX

5 • 82



A = B +

where:

A = measured absorbance value orabsorbance variation rate of standardsolution (except STD1 solution)


a, b, c = calibration curve parametersC = concentration of standard solutionlnC = natural log of standard concentration


CX = (C + C1) · IFA + IF B

a + blnC + c · C - ln [ ] = 0

AX = B +

where:

CX


C = sample concentrationC

1= concentration of STD 1

IFA, IF





K = scale parameterlnC = natural log of sample concentration

5.26.4 Assay Types




5. CHEMISTRY THEORY

Ax - B

K - (Ax - B)

K

1 + EXP { - (a + bln C + c • C)}

K

1 + EXP { - (a + bln C + c · C)}

5 • 83

5.27 Non-Linear ExponentialCalibration

5.27.1 Selecting Non-linearExponential Calibration

The non-linear method 4, EXPONENTIAL, is appliedto a working curve in which the absorbance increasesor decreases in a non-linear manner as theconcentration increases.


Calib. Type [EXPONENTIAL] [ ] [ ] [ ] [ ]

The first entry displays [EXPONENTIAL] as thecalibration method. The second entry displays thenumber of standards chosen. The third, fourth, andfifth entries are not applicable.

5.27.2 Non-linear ExponentialCalibration Graph


Figure 5-49: Exponential Calibration

5.27 Non-Linear Exponential Calibration

5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb CS2 CS3 CX CN

AN

Ab

AS2

AS3

AX

5 • 84

5.27.3 Non-linear ExponentialCalculation

The math model for non-linear exponential calibrationcurve approximation is shown below:

A = B + K · EXP {a (lnC) + b (lnC) 2 + c (lnC) 3}

where:



K = scale parametera, b, c = calibration curve parametersC = concentration of standard solution


CX = (C + C

1) · IF

A + IF

B

a (lnC) + b (lnC) 2 + c (lnC)3 - ln ( ) = 0

AX = B + K · EXP {a (lnC) + b (lnC) 2 + c (lnC) 3}

where:

CX


C = sample concentrationC

1= concentration of STD 1

IFA, IF





K = scale parameterlnC = natural log of sample concentration

5.27.4 Assay Types

Assay types that can be used with this calibrationinclude:

1-point assay2-point assay2-point rate assayRate A assay

5.27 Non-Linear Exponential Calibration

5. CHEMISTRY THEORY

Ax - B

K

5 • 85

5.28 Non-Linear SplineCalibration

5.28.1 Selecting Non-linear SplineCalibration

The non-linear method 5, SPLINE, is applied to aworking curve in which the absorbance increases asthe concentration increases. The range betweenstandard samples x and x - 1 measure values areapproximated and a curve is drawn.


Calib. Type [SPLINE ] [ ] [ ] [ ] [ ]

The first entry displays [SPLINE ] as the calibrationmethod. The second entry displays the number ofstandards chosen. The third, fourth, and fifth entriesare not applicable.

5.28.2 Non-linear Spline CalibrationGraph


Figure 5-50: Spline Calibration

5.28 Non-Linear Spline Calibration

5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb CS2 CS3 CX CN-1 CN

AN

Ab

AS2

AS3

AX

AN-1

5 • 86

5.28.3 Non-linear Spline Calculation

The math model for non-linear spline calibration curveapproximation is shown below:

A = a ( I ) + b ( I )(C-C( I)) + c ( I )(C-C( I ))2

+ B ( I )(C-C( I ))3

where:



a, b, c = calibration curve parametersC = concentration of standard solutiona (I ), b (I ),c (I ), d (I )= calibration curve parameters used

only in MODEL 5. These parametersare determined according to thestandard solution numbers "I"and "I+1." (1 ≤ I ≤ 5).


CX = (C + C

1) • IF

A + IF

B

a ( I ) + b ( I )(CX-C( I )) + c ( I )(C

X-C( I ))2 + B ( I )

(CX-C( I ))3- A

X = 0

AX = a ( I ) + b ( I )(CX-C( I )) + c ( I )(CX-C( I ))2

+ B ( I ) (CX-C( I ))3

where:

CX


C = sample concentrationC1 = concentration of STD 1IF

A, IF





K = scale parameterlnC = natural log of sample concentrationa (I ), b (I ),c (I ), d (I )= calibration curve parameters used

only in MODEL 5. These parametersare determined according to thestandard solution numbers "I"and "I+1." (1 ≤ I ≤ 5).

5.28.4 Assay Types

Non-linear spline calibration can be used with thefollowing assay types:


5.28 Non-Linear Spline Calibration

5. CHEMISTRY THEORY

5 • 87

5.29 Isozyme P Calibration

5.29.1 Selecting Isozyme P Calibration

This calibration technique is used in analyzingisozymes (isoenzymes) - - one of a group of enzymesvery similar in their properties.

Isozyme P calibration:

• uses reagent that measures the total activity of thegroup of isozymes; that is, the total enzymeactivity (enzyme "A")

• calculates total activity of the enzyme.


Calib. Type [ISOZYME P ] [ ] [ ] [ ] []

The first entry displays [ISOZYME P ] as thecalibration method. The second, third, and fourthentries are not applicable. The fifth entry designatesthe Isozyme Q channel.

5.29.2 Isozyme P Calibration Graph

A graphic representations of isozyme P calibration isshown below in Figure 5-51.

Figure 5-51: Isozyme P Calibration


5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb Cx CA

Ab

AC

Ax

AB

AA

5 • 88

5.29.3 Isozyme P Calculation

K = =

where:

K = calibration factorCA = concentration of enzyme A STD2

solutionCb = concentration of the STD1 solutionA

A= absorbance of enzyme A STD2

reactionA

b= absorbance of the STD1 reaction

AB

= absorbance of isozyme B reactionAC = absorbance of isozyme C reactionAx = absorbance of sample enzyme

reaction (unknown)

Calculation of Results:

CX = [{K (A X - Ab) + Cb} · IFA] + IFB

C3

= [{K (A3 - A

b) + C

b} · IF

A] + IF

B

C4

= [{K (A4 - A

b) + C

b} · IF

A] + IF

B

where:

Cx,C

3, C

4= total enzyme activity (isozyme P) for

sample, STD 3, and STD 4K = calibration factorAx,A3, A4 = absorbance of sample, STD 3, and

STD 4 enzyme reaction or its changeper minute

Ab

= absorbance of STD 1 reactionC

b= concentration of the STD 1 (blank)

IFA, IF

B= instrument constants representing

slope and intercept

5.29.4 Assay Types

Assay types:



5. CHEMISTRY THEORY

D x

D y

CA - Cb

AA - Ab

5 • 89

5.30 Isozyme Q Calibration

5.30.1 Selecting Isozyme Q Calibration

Isozyme Q (Isozyme C - inhibiting reagent)calibration:

• uses reagent that inhibits a specific isozyme(isozyme "C") but measures the remainingenzyme activity.

• calculates activity of isozymes not inhibited(isozyme "B").

• automatically uses K from isozyme P calibration.


Calib. Type [ISOZYME Q ] [ ] [ ] [ ] [ ]

The first entry displays [ISOZYME Q ] as thecalibration method. The second, third, fourth, and fifthentries are not applicable .

5.30.2 Isozyme Q Calibration Graph

A graphic representations of Isozyme Q calibration isshown below in Figure 5-52.

Figure 5-52: Isozyme Q Calibration


5. CHEMISTRY THEORY

ABSORBANCE

CONCENTRATION

Cb C′x

A′b

A′C

A′x

A′B

5 • 90

5.30.3 Isozyme Q Calculation

Calculation of preliminary results (with inhibitingreagent):

Cx’ = [{K (A

x’ - A

b’) + C

b} • IF

A] + IF

B

C3' = [{K (A

3' - A

b’) + C

b} • IF

A] + IF

B

C4' = [{K (A

4' - A

b’) + C

b} • IF

A] + IF

B

where:

Cx’, C

3', C

4' = residual sample, STD 3, and STD

4 enzyme activity (with inhibitingreagent)

K = calibration factor (from isozyme Preaction)

Ax’, C3', C4' = absorbance of sample isozyme Qreaction

Ab’ = absorbance of STD 1 reaction

Cb

= concentration of STD 1

Calculation of inhibition ratio:

a = b =

where:

a = inhibition ratio of isozyme BA’

B= absorbance of isozyme B reaction

(using inhibiting reagent)AB = absorbance of isozyme B reaction

(no inhibition)b = inhibition ratio of isozyme CA’

C= absorbance of isozyme C reaction

(using inhibiting reagent)A

C= absorbance of isozyme C reaction

(no inhibition)

Calculation of printed results:

C''x

=

where:

C’’x

= final concentration of sampleisozyme of interest

C’x

= residual sample enzyme activity(using inhibiting reagent)

b = inhibition ratio of isozyme Ca = inhibition ratio of isozyme BC

x= total enzyme activity

5.30.4 Assay Types




5. CHEMISTRY THEORY

A'B

AB

A'C

AC

C’x - b (C

x)

a - b

5 • 91

5.31 ISE Calibration

5.31.1 Introduction

The ISE system requires full calibration once every 24hours. Calibration of Na+, K+, and Cl- in the ISE unitrequires the ISE Standard 1 (Low) and ISE Standard2 (High), which are aqueous standards, and ISEStandard 3 (Compensator), a protein-based standard.If the analyzer is in the Stat Reception mode and theISE system has been inactive for 10 minutes ofoperation, a single point calibration (internal standard(IS)) is automatically performed. The ElectromotiveForce (EMF) (voltage) is measured after equilibrationoccurs at the electrode membrane as shown below inFigure 5-53.

Figure 5-53: Electromotive Force Measurement

Based upon these readings and the assay value ofthe standards, the instrument computer thencalculates a slope for the calibration. IS is theInternal Standard, and its measured value iscalculated from its EMF as shown graphically above.This value is stored in the computer memory for laterreference.

5.31.2 Slope Calculation

The slope is calculated in millivolts per decade (mV/decade) from the aqueous high and low standards.Ideally, the slope for an ion with a single charge is 61.6mV/ decade of ion concentration at 37 oC. Due tofactors such as the condition of the electrodes, themeasured slope may deviate from this ideal slope.Therefore, the slope for the ISE accessory should fallwithin the following ranges:

Na+ 38 to 68 mV/decadeK+ 38 to 68 mV/decadeCl- -30 to -68 mV/decade

The slope is calculated according to the followingformula:

Equation:

S = = mV/decade

where:

S = slopeE

H= voltage of high standard

EL = voltage of low standardCH = concentration of high standardC

L= concentration of low standard


5. CHEMISTRY THEORY

EH - E

L

CH

CL

Log

LOG (Concentration)

ElectromotiveForce(Voltage)

C (Low) C (IS) C (High)

EMF (High)

EMF (IS)

EMF (Low)

5 • 92

5.31.4 Single-Point Adjustment

An Internal Standard (IS), labelled Internal ReferenceSolution, is measured as a sample during routinecalibration and before every sample. Thesemeasurements are used to correct for drift due tojunction potential, electrode condition, etc., betweensamples and to provide a periodic single-pointcalibration adjustment as shown below inFigure 5-54.

Figure 5-54: Single Point Calibration Adjustment

5.31.5 Compensation Overview

Because the low and high standards are aqueous, thecompensator is used to adjust the offset of the slope.This compensates for activity differences betweenthe aqueous standards and protein-based serum.This difference between the calculated and actualvalues is referred to as the compensate value (C.Value on the calibration report).


5. CHEMISTRY THEORY

5.31.3 Internal Standard Calculation

In any ISE measurement system a number ofjunctions between lead wires, membranes, andreagents exist. The internal standard compensatesfor the junction potential variations.

After the slope is established during calibration, toestablish the internal standard, the y-intercept (E

IS) is

measured. The solution also is measured as a samplebefore every sample to check the calibration curve (Yintercept) for drift between calibrations and to providea periodic single-point calibration adjustment. Thecalculated value of the internal standard, as well asthe voltage, is shown on the calibration report.

The concentration of Na+, K+, and Cl- in the internalstandard is calculated from the electromotive force(voltage) of each electrode measured duringcalibration according to the formula below.

Equation:

CIS

= CL x 10

where:

CIS = concentration of the specific ion in theinternal standard

CL

= input concentration of the low standardE

IS= electromotive force (voltage) for the

same specific ion of the internalstandard

EL

= electromotive force (voltage) of thel o w

standard for the specific ionS = slope

The effect of the y-intercept shift is illustrated inSection 5.31.4.

EIS - EL

s

LOG (Concentration)

ElectromotiveForce(Voltage)

Calibration Curve(Compensated)

Calibration Curve(Corrected for E’)

EMF (IS)at later time

EMF (IS)at calibration

C (IS) atCalibration(Fixed)

∆

E’

EMFShift (E’)

5 • 93

5.31.6 Compensation ValueCalculation

The Serum-based is recommended compensator toadjust for differences in electrode response betweenaqueous and protein-based solutions.

The concentration of ions in the compensator iscalculated according to the following formula:

Equation:

CX = CIS x 10

where:

CX

= measured concentration of thespecific ion in the compensator

CIS

= concentration of the internal standard,determined during calibration

EC

= electromotive force (voltage) of thecompensator for the specific ion

EIS = electromotive force (voltage) of theinternal standard for the specific ion

S = slope

The formula for finding the compensation factor (K)is:

K = assigned value (Calibrator) -calculated value (Calibrator) (Thisvalue is Cx in the equation above.)

K is displayed as the Compensated Value found in theISE CALIBRATION MONITOR display. This value isautomatically updated by the instrument followingsuccessful calibration. If during calibration thepercent difference in the current and previouscompensators is greater than the Calib. Limit setunder the ISE PARAMETER display, an alarm isissued.

5.31.7 Reference Cartridge

A 1N KCl solution is measured concurrently with eachsample analysis. A reference cartridge is used for thispurpose. This function serves as a reference point forall measurements and compensates for anyelectronic variations in the system. All other voltagesare reported using reference cartridge voltage as thezero point; i.e., the reference cartridge voltage issubtracted from all other voltages.

5.31.8 Nernst Equation

The Nernst equation is used to calculate theconcentration for a specific ion in solution as follows:

Equation 1:

E = EIS + x ln

where:

E = specific electrode (Na+, K+, Cl-)Electromotive Force (EMF) (voltage)

EIS

= EMF of the Internal StandardR = gas constantT = temperaturen = charge of the ionF = Faraday’s constantC

t= ion concentration in the sample/diluent

mixtureC

i= ion concentration in the internal filling

gelf = activity coefficientln = natural log


5. CHEMISTRY THEORY

RT

nF

(f x Ct)

(f x Ci)

EC - E

IS

s

5 • 94

Because the sodium, potassium, and chloride ionseach carry a single charge, R, T, n, and F arecombined into a single value referred to as the slope(S). Also, because the instrument dilutes the sampleto approximately 1:31, the ionic strength and activitycoefficient (f) are essentially constant. These terms,then, can be factored into the EIS term. The Nernstequation can be rewritten to reflect the above statedconditions as follows:

Equation 2:

E = E’IS + S x ln (C

t)

where:

E = specific electrode electromotive force(voltage)

E’ IS = internal standard electromotive force(voltage) (with constants)

S = slopeC

t= ion concentration in sample/diluent

mixtureln = natural log

This rewritten equation demonstrates that theelectromotive force (voltage) of a specific electrodeis directly proportional to the log of the activity of thediffusible ion in the sample/reagent mixture. Thisequation can be likened to the basic equation used forlinear, photometric chemistries, as follows:

Equation 3:

ISE: E = S x ln (C

t ) +

E’

IS

Photometric: y = ax + b

where:

E = y (y axis)S = a (slope)ln C t = x (x axis)E’IS = b (y intercept)

The Nernst equation can be rewritten again to expressconcentration as follows:

Equation 4:

Ct = 10

where the definitions shown above are true.

5.31.9 Calculation of Unknown Sample Concentrations

The concentration of the sodium, potassium, andchloride in unknown samples is calculated bydetermining the electromotive force (voltage) of thespecific electrode and calculating the resultsaccording to the following equation:

Equation:

Ct = K + C

IS x 10

where:

Ct

= concentration of the specific ion in theunknown sample/diluent (test) mixture

K = compensation factor (COMP.VALUE)

CIS = concentration of the internal standard,determined during calibration

Et

= electromotive force (voltage) of theunknown sample for the specific ion

EIS

= electromotive force (voltage) of theinternal standard for the specific ion

S = slope


5. CHEMISTRY THEORY

E - E'IS

s

Et - E

IS

s( )

5 • 95

5.32 Result Integrity Checks

5.32.1 Introduction

Several methods are used by the system to ensurethat final results are valid. The messages found inSection 4.5, Data Alarms, appear on the resultsprintout to indicate possible data errors. Some ofthese also activate the audible alarm and reveal alarmmessages on the display.

5.32.2 Prozone Effect

Some tests (such as immunoglobulin methodologies)use the principle of antibody/antigen complexformation (agglutination) as a measurementtechnique. The turbidity caused by this specificagglutination can be measured by photometricmeans.

The antibody/antigen complex formation ispredictable as long as an excess of reagent(antibody) exists. In patient samples with very highlevels of antigen, however, the reaction may begin toreverse (deagglutination) because of the effect of theexcess antigen. This is called a prozone effect andwithout checking for this phenomenon, abnormallyhigh samples may give incorrect or even false normalresults.

The 911 analyzer may perform a check for theprozone effect in a 1-point assay by adding a dilutionof the antigen as an additional reagent (T2, T3, or T4).If the reaction continues in the same direction(increasing or decreasing absorbance) as in the initialreaction, then prozone is not occurring. If the reactionproceeds in the opposite direction, after additionalreagent is added, then prozone is occurring and theresult is invalid and the data alarm XXXP is printed onthe patient report.

When the prozone limit is entered on the CHEMISTRYPARAMETERS screen, "UPPER" or "LOWER" mustalso be specified to indicate whether absorbance isexpected to increase or decrease (respectively) whenprozone is occurring. If "UPPER" is specified when"LOWER" should be, all subsequent results for thattest will exhibit a prozone data alarm.

One-point assays are checked for prozone if onemeasuring point is programmed. Two-point assaysare checked only if two measure points areprogrammed. Figure 5-55 below shows an example ofa 1-point assay prozone check.

Figure 5-55: Prozone Check


5. CHEMISTRY THEORY

S,R1,ST1

ABSORBANCE

TIME

LEGEND:

SR1ST1R3ST3MP1MP2

=======


MP1 MP2ST3R3

Prozone Check

5 • 96

5.32.3 Linearity Verification (LIN, LIN 8)

Figures 5-56 and 5-57 represent the process by whichthe instrument verifies the linearity of a kineticreaction. In the illustration below, the assay is a RateA, and absorbance measurements are taken duringrotations 22 through 49. For example, the observedchange in absorbance during rotations 44 through 49(the last five rotations of the read period) is subtractedfrom the observed change in absorbance duringrotations 22 through 27 (the first five rotations of theread period). This difference is divided by the totalchange in absorbance (∆A) per minute, thenmultiplied by 100. The value obtained must be lessthan the linearity limit defined in SYSTEMPARAMETERS. If the value is above this number, a"LIN." data alarm is issued. If any absorbancereading taken during the programmed interval (22through 49, in this example) exceeds the ABS. LIMITparameter, that absorbance reading is excluded fromthe least squares rate calculation.

Calculation: x 100 > defined limit,then LIN. alarmoccurs

where:

D Ai = rate of absorbance change (∆ A/MIN) duringthe first five rotations of the read period

D Af = rate of absorbance change (∆ A/MIN) duringthe last five rotations of the read period

D A = total change in absorbance per minute(∆ A/MIN)

Figure 5-56: Linearity Verification - - LIN.

If the number of data points available for thiscalculation is less than nine, the rate of absorbancechange during the last three read rotations of thereaction is subtracted from the rate of absorbancechange during the first three read rotations of thereaction. This is then divided by the total change inabsorbance (∆ A) per minute. If this value (x 100) isgreater than the value entered on the SYSTEMPARAMETERS screen in the Linearity Limit (4-8)field, a "LIN. 8" data alarm is issued.

If the absorbance change per minute is less than6 X 10-3, no check is made.

Calculation: x 100 > defined limit,then LIN. 8 alarmoccurs


5. CHEMISTRY THEORY

D Ai - D Af

D A

Di' - D Af'

D A

S,R1,ST1

ABSORBANCE

TIME

LEGEND:

SR1ST1R3ST3MP1MP2

=======


MP1 MP2ST3R3

"LIN. "

∆Af

∆Ai

∆A

5 • 97

where:

DAi’ = rate of absorbance change (∆ A/MIN) duringthe first three read rotations of the reaction

DAf’ = rate of absorbance change (∆ A/MIN) duringthe last three read rotations of the reaction

DA = total change in absorbance per minute(∆ A/MIN)

Figure 5-57: Linearity Verification - - LIN. 8

5.32.4 Substrate Depletion (LIM. 1, 2, 3)

An "Absorbance Limit" value is designated on theCHEMISTRY PARAMETERS screen for each rateassay. This value is included on the applicationsheet for each rate chemistry. This value specifiesthe absorbance of the reaction mixture at whichsubstrate concentration is too low for a reliable, linearreaction to take place. The absorbance limit isusually reached as a result of very high analyteconcentration in the sample, but may occur whenoutdated or improperly prepared reagent is used.

In case of excessive sample absorbance (caused bylipemia, icterus, etc.), the measured absorbancevalue is compared with the initial absorbance level of

the reaction. The difference (sample absorbancelevel - STD 1 absorbance level) is measured and the"Absorbance Limit" value is adjusted accordinglywhen checking for substrate depletion.

• LIM. 1 - indicates that the reaction exceededthe absorbance limit at all measurepoints.

• LIM. 2 - indicates that the reaction exceededthe limit at all but one measure point.

• LIM. 3 - indicates that the reaction exceededthe limit at all but two measure points.

These flags allow for an approximation of the sampledilution necessary to bring the reaction into themeasurable range. During auto rerun, these flagscause the analyzer to make an on-board dilution anduse the decreased sample volume found inCHEMISTRY PARAMETERS. All data alarms areexplained in detail in Chapter 4 of this manual.

Figure 5-58 below depicts this substrate depletiondetection.

Figure 5-58: Substrate Depletion


5. CHEMISTRY THEORY

S,R1,ST1

ABSORBANCE

TIME

LEGEND:

SR1ST1R3ST3MP1MP2

=======


MP1 MP2ST3R3

Absorbance Limit as setin Chemistry Parameters

"LIM. 1""LIM. 2"

"LIM. 3"

S,R1,ST1

ABSORBANCE

TIME

LEGEND:

SR1ST1R3ST3MP1MP2

=======


MP1 MP2ST3R3

"LIN. 8"

∆Af’

∆Ai’ ∆A

5 • 98

5.33 Serum Index Function

5.33.1 Introduction

Serum indexes are calculations of absorbancemeasurements that provide a semi-quantitativerepresentation of icterus, hemolysis, or lipemia(turbidity) amounts present in samples. Serumindexes may be determined in one of two ways:

• using an existing chemistry channel• using a separate channel, with the serum index

function using saline as the reagent dispensed atR1 timing.

Requirements for the test selected for running serumindexes are listed below:

• The test must be a rate-A reaction.• The test must read at a primary wavelength of

340 nm.• The test must have a reagent dispensed at R1

timing that is clear and non-reactive.• Recommended tests to use are AST or ALT.

5.33.2 Definition of Serum Indexes

The icterus index, I, is reported in icterus units that arelinear, up to 60 mg/dL, and semi-quantitative. Forexample, an icterus index of 20 is equivalent to aknown unconjugated bilirubin concentration ofapproximately 20 mg/dL.

The hemolysis index, H, is reported in hemolysisunits that are linear, up to 1000 mg/dL, and semi-quantitative. For example, a hemolysis index of 500is equivalent to a known hemoglobin concentration ofapproximately 500 mg/dL.

The lipemia index, L, is reported in lipemia unitsbased on Intralipid® (Kabi-Vitrum, Inc.). These unitsare linear, up to 1000 mg/dL, and semi-quantitative.

For example, a lipemia index of 1000 is equivalent toa 1000 mg/dL Intralipid solution.

5.33.3 Serum Index Parameters

Before running serum indexes, make sure that theparameters for icterus, hemolysis, and lipemia havebeen loaded onto your System disk.

Press the PARAMETER key, followed by 1 ENTER,to display the CHEMISTRY PARAMETERS screen.Enter 50, 51, or 52 to display the parameters forlipemia (50), hemolysis (51), or icterus (52). The fixedfactors utilized for calculation of the serum index,factors A through F, are displayed in the STD CONC.column. The factors are identical for lipemia,hemolysis, and icterus. If these factors do notappear, call Technical Support.

The measurement results of reagent blank solutions(480/505) for icterus, (570/600) for hemolysis, and(660/700) for lipemia are automatically indicated asS1 ABS on the CALIBRATION LIST screen and entryof these values is not required.

Qualitative report names can be modified.


5. CHEMISTRY THEORY

1ENTER

5 • 99

Figure 5-59 shows an example of the CHEMISTRYPARAMETERS screen with factors A through F in theSTD CONC. column.

Figure 5-59: Serum Index Factors

5.33.4 Using Existing ChemistryChannel

Press the GUIDANCE key to move to the second pageof the CHEMISTRY PARAMETERS screen. Movethe cursor to the third entry of the ASSAY CODE field.Enter the channel number of the desired channel forserum index measurement and press ENTER. Referto Section 2.48 to assign a print orderto channels 50, 51, and 52.

Figure 5-60 shows an example of the CHEMISTRYPARAMETERS display, with AST as the testselected.

Figure 5-60: Serum Index Using Existing ChemistryChannel

5.33.5 Using a Saline Channel

The following is a brief description of the procedureused to program a saline channel for the serum indexfunction.

• Do not assign a print line (order) for saline.

• Factors for L, H, and I should be programmed asshown in Section 5.33.3.

Follow the instructions in Section 2.54 for loading thesaline index parameters. Assign the index parametersto a test key, according to these instructions.


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20



TestData Mode

Control Interval

Expected Value <Serum> Expected Value < Urine>


Instrument Factor (Y=aX+b) ab

Alarm

UnitLIPEMLipemia

[ ] [ mg/dL ][ ]

[ ][ ]

[ ] [ ][ ]

[ ]

LIPEM

Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ] [ ] - [ ][ ] [ ] [ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

Technical Limit < Serum > < Urine >[ 0 ] - [ 1000 ] [ 0 ] - [ 1000 ]

STD Conc. Pos. Sample Pre. Dil. Calib. Lot No. Qualitative [ No ]

(1)(2)(3)(4)(5)(6)

(1)(2)(3)(4)(5)(6)

[ ][ ][ ][ ][ ][ ]

25122000

101600

19000180000

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ] [ ][ ] [ ][ ] [ ][ ] [ ][ ] [ ]

[ ]

37.0 Stand-by 12/01/92 12:20





Calibration Type

R1R2R3R4


Auto Time Out

Auto Change



[ LIPEM ][ ] [ ] [ AST ][ ] - [ ] - [ ] - [ ]

< Serum > < Urine >

[ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ] [ ][ ]

[ ] / [ ][ ] / [ ]

5 • 100

NOTEDo not use the saline index key to select serumindexes for a sample. Use the SERUM INDEX key formaking test selections.

Press the PARAMETER JOB key, followed by 1ENTER, to display the first page of the CHEMISTRYPARAMETERS screen. Press the test key to whichthe index parameters were assigned and pressENTER. Make sure the parameters have been loadedas shown below in Figure 5-61.

Figure 5-61: Index Saline Parameters, page 1

Press the GUIDANCE key to display the second pageof the CHEMISTRY PARAMETERS screen. Makesure the parameters match those shown in Figure5-62 on the following page.

Figure 5-62: Index Saline Parameters, page 2

Press the GUIDANCE key to return to the first pageof the CHEMISTRY PARAMETERS screen. Enter50, 51, or 52 in the Test field to display the parametersfor L, H, or I. Press the GUIDANCE key to move tothe second page of the Lipemia parameters.

Enter the channel number assigned to the index orsaline channel in the third ASSAY CODE field entry.This entry will automatically be entered on the othertwo serum index parameter screens. Figure 5-63shows an example of the serum index parametersusing the saline channel.

1ENTER


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20



TestData Mode

Control Interval

Expected Value <Serum> Expected Value < Urine>


Instrument Factor (Y=aX+b) ab

Alarm

UnitINDEXIndex

[ ] [ ][ ]

[ ][ ]

[ ] [ ][ ]

[ ]

INDEX 00299On Board

0

Age (M) (F)[ ] [ ] [ ] - [ ] [ ] - [ ] [ ] - [ ][ ] [ ] [ ] - [ ] [ ] - [ ]

[ ] - [ ] [ ] - [ ]

Technical Limit < Serum > < Urine >[ 0 ] - [ 1000 ] [ 0 ] - [ 1000 ]

STD Conc. Pos. Sample Pre. Dil. Calib. Lot No. Qualitative [ No ]

(1)(2)(3)(4)(5)(6)

(1)(2)(3)(4)(5)(6)

[ ][ ][ ][ ][ ][ ]

0.00.00.00.00.00.0

100000

000000

000000

00000

501501501501501501

101010101010

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ][ ][ ]

[ ] [ ][ ] [ ][ ] [ ][ ] [ ][ ] [ ]

[ ]

1.00.0

10 Y 0.0 100020 Y 0.0 1000

0.0 1000

0.0 10000.0 10000.0 1000

0.0 100.0

000001000002000000000000000000000000

37.0 Stand-by 12/01/92 12:20





Calibration Type

R1R2R3R4


Auto Time Out

Auto Change



[ LIPEM ][ RATE-A ] [ ] [ INDEX ][ ] - [ ] - [ ] - [ ]

< Serum > < Urine >

[ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ] [ ][ ]

[ ] / [ ][ ] / [ ]5 10 0 0

101010

101010

000

000

000

000

32000 32000 INCREASE0 0 LOWER

250000

0000

0000

00299002990029900299

LINEAR 1 0 0

0000

0.1100

0-500 500

CANCELCANCEL

376 34000400 0

5 • 101

Figure 5-63: Serum Index Using the Saline Channel

The saline used for the serum index function does nothave a full bar code label. You must manually set theRegistration from the REAGENT STATUS screen.

When all parameter information has been entered,perform a parameter write from the ANALYZERMAINTENANCE screen.

The saline index channel must be calibrated afterbeing entered the first time. Press ROUTINE,followed by 2 ENTER, to display the CALIBRATIONTEST SELECTION screen. Move the cursor to theMODE field. Press 2 ENTER to select a repeatcalibration. Move the cursor to the TESTS field.Press 1 ENTER for a blank calibration. Press theINDEX key to calibrate the saline index channel.

Press PAGE FORWARD two times to display theSTART CONDITIONS screen. Move the cursor to theRepeat Calibration field and press 1 ENTER toselect a repeat calibration.

5.33.6 Graphic Representation ofSerum Indexes

The bichromatic wavelength pairs used for serumindex measurement are 480 nm and 505 nm (range 1),570 nm and 600 nm (range 2), and 660 nm and 700 nm(range 3). The absorbance readings for the lipemiaindex are taken in range 3. The absorbance readingsfor the hemolysis index are taken in ranges 2 and 3.The absorbance readings for the icterus index aretaken in ranges 1, 2, and 3. The calculation formulasused for the serum indexes include corrections tocompensate for the spectral overlap.

Figure 5-64 is a graphic representation of the spectralmeasurement of these serum characteristics.

Figure 5-64: Serum Index Measurement


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20





Calibration Type

R1R2R3R4


Auto Time Out

Auto Change



[ LIPEM ][ ] [ ] [ INDEX ][ ] - [ ] - [ ] - [ ]

< Serum > < Urine >

[ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ] [ ]

[ ] [ ] [ ][ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ][ ] [ ] [ ] [ ] [ ]

[ ][ ][ ][ ][ ][ ]

[ ][ ][ ][ ] [ ][ ]

[ ] / [ ][ ] / [ ]

Absorbance

Wavelength

340 480 505 546 570 600 660 700

Hemolysis

Icterus

Lipemia

NADH

Range 1 Range 2 Range 3

(nm)

5 • 102

5.33.7 Calculation of Serum Indexes

Icterus Index

The formula to calculate the icterus index (I) is:

I = x [ (D Abs1) - E x { (D Abs

2) - B

x (D Abs3) } - F x (D Abs

3) ]

where:

I = icterus indexD = scaling factor for bilirubinE = corrects bilirubin measurement

(absorbance) for hemoglobinB = corrects hemoglobin measurement

for lipemiaF = corrects bilirubin measurement for

lipemiaD Abs 1,2,3 = absorbance values of the 480 -

505 nm, 570 - 600 nm, and 660 -700 nm bichromatic ranges,respectively, in relation to the blankabsorbances

Hemolysis Index

The formula to calculate the hemolysis index (H) is:

H = x [ (D Abs2) - B x (D Abs

3) ]

where:

H = hemolysis indexA = scaling factor for hemoglobinB = corrects hemoglobin measurement

for lipemiaD Abs

2,3= absorbance of the 570 - 600 nm and

660 - 700 nm bichromatic ranges,respectively, in relation to the blankabsorbances

Lipemia Index

The formula to calculate the lipemia index (L) is:

L = x (D Abs3)

where:

L = lipemia indexC = scaling factor for lipemiaD Abs

3= absorbance of the 660 - 700 nm

bichromatic range in relation to theblank absorbances

1

A

1

C


5. CHEMISTRY THEORY

1

D

5 • 103

5.34 Real Time QC Evaluation

5.34.1 Introduction

Real Time QC is evaluated by a multi-rule Shewhart-type method using the Westgard algorithm. Thisalgorithm applies the set of rules selected in REALTIME QC. Any combination of rules may bespecified. A pair of controls for each chemistry beingprocessed is compared against a known standarddeviation (SD) and mean. In some cases, only oneof the controls (X or Y) may fail the test applied by therule. When a control sample fails a test, a data alarmis issued and the graph on the CRT displays a symbolcorresponding to the type of QC error detected. Analarm may print on the patient report. The followingis an explanation of each QC rule, using a displayexample where appropriate.

5.34.2 Rule 1: 1-2SD

1-2SD represents the control rule where one controlobservation exceeds limits defined as mean ± 2SD.Each control sample X and Y is compared against itsrespective expected mean and standard deviation. Ifboth X and Y are within the mean ± 2SD, the QC dataare accepted. If either X or Y data are outside themean ± 2SD, the test fails, but no alarm is issued.The next selected rule is then checked.

5.34.3 Rule 2: 1-3SD

Rule 2: 1-3SD—Alarm QCERR11-3SD is the control rule violated when a single controlresult exceeds the limit defined as mean ± 3SD. Eachcontrol sample X and Y is compared against itsrespective expected mean and standard deviation. Ifboth X and Y are within the mean ± 3SD, the QC dataare accepted.

If either X or Y data are outside the mean ± 3SD, aQCERR1 alarm is issued for an indeterminate QCerror, unless a later rule is also violated. In that case,the alarm for the last rule violated is issued. A “+”displays in part of the highlighted area as shown inFigure 5-65 below.

Figure 5-65: QCERR1 Alarm Situation


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

0001


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

+

5 • 104

5.34.4 Rule 3: 2-2SD

Rule 3: 2-2SD—Alarm SYSTM1The results of one assay on each control areevaluated (a total of two control results are tested).

The results of the most recent control pair of X and Yare compared against standard deviations. If both Xand Y deviate outside ±2SD and both are either aboveor below the means, the test fails. A SYSTM1 dataalarm is issued for a systematic QC error, unless alater rule is also violated. In that case, the alarm forthe last rule violated is issued. A "#" displays on thegraph as shown in Figure 5-66 below.

The SYSTM1 alarm is issued when the 2 results (bothX and Y in this case) are outside the ± 2SD limit,across control material. This is a systematicviolation.

Figure 5-66: SYSTM1 Alarm Situation

Rule 3: 2-2SD—Alarm SYSTM2The results of the two most recent assays of eachcontrol are evaluated. A total of four control results aretested. If either or both X and Y data deviate outside±2SD, the test fails. A SYSTM2 data alarm is issuedfor a systematic QC error, unless a later rule is alsoviolated. In that case, the alarm for the last ruleviolated is issued. A "#" displays on the graph.Figures 5-67 and 5-68 on the next page show thisalarm.

The SYSTM2 alarm is issued when two control resultsare outside of the 2SD limit, within a control material.This is a systematic violation.

Figure 5-67: SYSTM2 Alarm Situation for Control X


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

0010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

1010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

*

#

5 • 105

Figure 5-68: SYSTM2 Alarm Situation for Control Y

5.34.5 Rule 4: R-4SD

Rule 4: R-4SD—RANDM AlarmR-4SD is the control rule in which there is a range ora difference between the control materials thatexceeds 4SD, such as would be the case if the Xcontrol exceeded the -2SD limit and the Y controlexceeded the +2SD limit.

The run size specified when Rule 4 is selected on theReal Time QC display determines the number ofconsecutive control X and Y samples tested. Themaximum deviations of X minus the minimumdeviations of Y, and the maximum deviations of Yminus the minimum deviations of X are computed. Ifeither of these differences is greater that 4SD, thetest fails. A RANDM data alarm is issued for arandom QC error, and a "@" displays on the graph, asshown in Figure 5-69 above.

Figure 5-69: RANDM Alarm Situation


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

1010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

* #

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

0100


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

@

5 • 106

5.34.6 Rule 5: 4-1SD

Rule 5: 4-1SD—Alarm SYSTM34-1SD is the control rule violated when fourconsecutive control results exceed the same limit,either mean + 1SD or mean - 1SD. The SYSTM3alarm is issues when three control results are outsidethe ±2SD limit and 1 control result is outside the±2SD limit across control materials. This is asystematic alarm.

The results of two consecutive assays of eachcontrol are evaluated (total four samples tested). Ifinsufficient data are available, the test is notperformed. If all X and Y data exceed ± 1SD, andeither the current X or Y value exceeds ± 2SD, and allare on the same side of the mean, then the test fails.A SYSTM3 data alarm is issued for a systematic QCalarm, and a "#" displays on the graph as shown belowin Figure 5-70.


Rule 5: 4-1SD—Alarm SYSTM4The results of four consecutive assays of eachcontrol are evaluated (total of eight samples tested).If fewer that four samples are available, the test is notperformed. If all X or Y data exceed one standarddeviation, and fall on the same side of the mean, andthe current X or Y value exceeds 2 SD then the testfails. A SYSTM4 data alarm is issued for asystematic QC alarm, and a "#" displays on the graphas shown in Figures 5-71 and 5-72 on the next page.

The SYSTM4 alarm is issued when three controlresults are outside the ±1SD limit and one controlresult is outside the ± 2SD limit within a controlmaterial. This is a systematic violation.



5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

0011


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#

+

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

3010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#

*

**

5 • 107


5.34.7 Rule 6: 10x

Rule 6: 10X—Alarm SYSTM510X is the control rule where there are 10 consecutivecontrol observations on the same side of the mean.The SYSTM5 alarm is issued when nine controlresults are on the same side of the mean and onecontrol was outside the ±2SD limit, across controlmaterials. This is a systematic violation.

The results of five consecutive assays of eachcontrol are evaluated (total 10 samples tested). Iffewer than five samples are available for eachcontrol, the test is not performed. The signs of allsample deviations for both controls are comparedwith zero. If all are non-zero and have the same sign,and one of the current X and Y samples exceeds 2SD,then the test fails. A SYSTM5 data processing alarmis issued for a systematic QC alarm, and a "#"displays on the graph as shown above in Figure 5-73.


Rule 6: 10X—Alarm SYSTM6The results of 10 consecutive assays of each controlare evaluated (total 20 samples tested). If fewer than10 samples are available for each control, the test isnot performed. All sample deviations are comparedwith zero. If all are non-zero and have the same sign,and the current sample (X or Y) exceeds 2SD, the testfails. A SYSTM6 data alarm is issued for asystematic QC alarm, and a "#" displays on the graphas shown in Figures 5-74 and 5-75 on the followingpage.


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

3010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#

* **

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

4010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#* ** *

5 • 108

The SYSTM6 alarm is issued when nine controlresults are on the same side of the mean and onecontrol result is outside the ±2SD limit within a controlmaterial. This is a systematic violation.



5.34.8 Rule 7: 1-2.5SD

Rule 7: 1-2.5SD—Alarm QCERR21-2.5s symbolizes the control rule violated when onecontrol result exceeds the limit defined as mean ±2.5SD.

If tighter QC restrictions are desired, this rule may beselected in place of Rule 2: 1-3SD. If both this rule andRule 2 are selected, this rule takes precedent overRule 2. The deviation of a single sample is comparedagainst 2.5 SD for each control. If either control X orY is ± 2.5 SD, the test fails. A QCERR2 dataprocessing alarm is issued for an indeterminate QCerror, and a "+" displays on the graph as shown belowin Figure 5-76.

Figure 5-76: QCERR2 Alarm Situation


5. CHEMISTRY THEORY

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

9010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#

* * * *

* * ** *

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

9010


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

#

* * * *

* * ** *

37.0 Stand-by 12/01/92 12:20

1 Real Time QC


Test


( * )(@)( # )(+ )

0001


0 1 2 3-1-2-3

0

1

2

3

-1

-2

-3



1-2S2-2S4-1S1-2.5S

1-3SR-4S (1)10X

(X) (Y)

[ C1 ]

[PTN-81 ] [PTA-157 ]

Serum Serum

113.23.5

95.63.0

+

5 • 109

5.34.9 Flowchart


5. CHEMISTRY THEORY

Out of controloccurrence of alarm

In control

Control dataXn, Yn

No

Yes

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

12S

12.5S 13S 22SA R4S 22SW 41SA 41SW 10XA 10XW

Figure 5-77: Real Time QC Flow Chart

5 • 110

5.35 Reagent Labelling

5.35.1 General Information

The following sections illustrate where specificinformation may be found on reagent container labels,reagent package labels, and reagent packageinserts.

WARNINGFailure to follow package insert instructions forreagent preparation, storage, and expiration mayresult in inaccurate patient results.

5.35.2 Reagent Labelling

5.35 Reagent Labelling and Package Inserts

5. CHEMISTRY THEORY

Illustration for example only.Information may not reflectcurrent information.

Cholesterol/HP

Reagent NumberLot Number andExpiration Date

Name of Test

Catalog NumberandApplication Code

Bar Code Label

Figure 5-78: 911 Analyzer Reagent Bottle

roche hitachi 911 user manual

Documents