cd ruby operator manual 08h5602

7/23/2019 CD Ruby Operator Manual 08H5602

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Operators Manual

List Number 08H56-02


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Revision Status

Document ControlNumbers

RevisionDate

Section(s)Revised

Pages Revised,Added or Deleted

LN08H56-01A/

LN08H56-02

9212934A (TEXT)

9159955A (CD ROM)

May 2006 9140559A

Revision and Status Log

Initial release; all sections

new.

9140540AForeword

9140541A

Master Table of Contents

9140542A

List of Figures

9140543AList of Tables

9140544ASystem

Documentation

9140545A

Use or Function

9140546A

Installation Procedures and

Special Requirements

9140547A

Principles of Operation

9140548A

Performance Characteristics

and Specifications

9140549A

Operating Instructions

9140550A

Calibration Procedures

9140551A

Operational Precautions and

Limitations

9140552A

Hazards

9140553A

Service and Maintenance


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9140554ATroubleshooting and

Diagnostics

9140555A

Quality Control

9140556A

Reticulocyte Package

9140561AAppendices

9140562AIndex

LN08H56-03A/

LN08H56-02B9212934B (TEXT)

9159955B (CD ROM)

August

2006

9140559B


9140540BForeword

9140541B


9140542B

List of Figures

9140545B

Use or Function

9140549BOperating Instructions

9140552B

Hazards

9140553B


9140561BAppendices

LN08H56-03B/

LN08H56-02C

9212934C (TEXT)

9159955C (CD ROM)

July 2008 9140559C


9140540CForeword

9140541C


9140542C

List of Figures

9140543BList of Tables

Document Control

Numbers

Revision

Date

Section(s)

Revised

Pages Revised,

Added or Deleted


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9140544BSystemDocumentation

9140545C

Use or Function

9140546B



9140547B


9140548B

Performance Characteristicsand Specifications

9140549C


9140550B


9140551B


Limitations

9140552C

Hazards9140553C


9140554B

Troubleshooting and

Diagnostics

9140555B

Quality Control

9140556B


9140561CAppendices

9140562BIndex

Document Control

Numbers

Revision

Date

Section(s)

Revised

Pages Revised,

Added or Deleted


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LN08H56-03D/LN08H56-02E

9212934D (TEXT)

9159955F (CD ROM)

December2008

9140559DRevision and Status Log

9140540DForeword

9140541D


9140542D

List of Figures

9140543CList of Tables

9140545DUse or Function

9140546C



9140547C


9140548C


and Specifications

9140549DOperating Instructions

9140550C


9140551C


Limitations

9140552D

Hazards

9140553D

Service and Maintenance9140554C

Troubleshooting and

Diagnostics

9140555C

Quality Control

9140556C


Document Control

Numbers

Revision

Date

Section(s)

Revised

Pages Revised,

Added or Deleted


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9140561DAppendices

9140562CIndex

LN08H56-03F/

LN08H56-02F

9212934E (TEXT)

9159955G (CD ROM)

September

2013

9140559E


ALL

9140540EForeword ALL

9140541E


ALL

9140542E

List of Figures

ALL

9140543DList of Tables ALL

9140544CSystem

Documentation

ALL

9140545E

Use or Function

ALL

9140546D



ALL

9140547D


ALL

9140548D


and Specifications

ALL

9140549E


ALL

9140550D


ALL

9140551D


Limitations

ALL

9140552E

Hazards

ALL

9140553E


ALL

9140554D

Troubleshooting and

Diagnostics

ALL

Document ControlNumbers

RevisionDate

Section(s)Revised

Pages Revised,Added or Deleted


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9140555DQuality Control

ALL

9140556D


ALL

9140561EAppendices ALL

9140562DIndex ALL

Document Control

Numbers

Revision

Date

Section(s)

Revised

Pages Revised,

Added or Deleted


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Revision Log

Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have

been added to your paper manual.

1. Record the document control number of the revised section in the first column. You will find the number in

the footer. Make an entry for each chapter you receive and place the revised section(s) in the manual.

2. Record the revision date, also found in the footer, in the second column.

3. Record the current CELL-DYN Ruby software version in the third column.

4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in the

manual.

5. Record the date that you added the revised section to the manual in the fifth column.

Document

ControlNumber

RevisionDate

SoftwareVersion

Revision

Incorporatedby

DateIncorporated


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CELL-DYN Ruby System Operators Manual i9140540ESeptember 2013

Foreword

Congratulations on becoming the operator of a CELL-DYN Ruby. Your System,which includes state-of-the-art technology, is designed to function consistently and

dependably from day to day.

The CELL-DYN Ruby is backed by dedicated professionals who excel in

engineering, medical technology, training, and service. As part of the customer

training program, we will teach you to operate, maintain, and troubleshoot your

System.

Abbott Laboratories is dedicated to manufacturing the highest quality, most

reliable instrumentation available. We look forward to serving your needs in any

way possible.

Customer ServiceIf you need information or help in diagnosing a problem, technical assistance is

available by telephone. In the USA, this service is available by calling Abbott

Diagnostics Customer Service 24 hours a day, seven days a week.

United States: 1-877-4ABBOTT (1-877-422-2688)

Canada: 1-800-387-8378

Outside of USA and Canada: Contact your Country Service and Support

Representative.

For correspondence, the address in the USA is:

Abbott Diagnostics DivisionCustomer Service

200 Abbott Park Road

Abbott Park, IL 60064, USA

Proprietary Statement

The CELL-DYN Ruby software programs and system documentation are protected

by copyright (2008 and 2013). All rights are reserved.

The software and manual were developed solely for use with the CELL-DYN Ruby

and for in vitrodiagnostic applications as specified in the operating instructions.

The information and related graphics published herein (the Information) are thesole property of Abbott Laboratories. Permission to use the Information is granted,

provided that:

the copyright notice appears on all copies;

use of the Information is for operation of Abbott products by Abbott trained

personnel or informational use only;

the information is not modified in any way; and

no graphics are used separate from accompanying text.


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Each person assumes full responsibility and all risks arising from use of the

Information. The Information is presented as isand may include technical

inaccuracies or typographical errors. Abbott Laboratories reserves the right to

make additions, deletions, or modifications to the Information at any time withoutany prior notification.

Patent Statement

The CELL-DYN Ruby is covered by one or more of the following USA Patents:

5,017,497; 5,378,633; 5,510,267; 5,733,784. Additional patents may be pending.

Disclaimers

All samples (printouts, graphics, displays, screens, etc.) are for information and

illustration purposes only and shall not be used for clinical or maintenance

evaluations. Data shown in sample printouts and screens do not reflect actualpatient names or test results. Labels depicted in the manual may appear different

from actual product labels.

Abbott Laboratories makes no representations or warranties about the accuracy and

reliability of the information contained in or printed from the CELL-DYN Ruby

Operators Manual CD-ROM.

The information was developed to be used by Abbott Laboratories trained

personnel, by other persons knowledgeable or experienced with the operation and

service of the product identified, or under the direct supervision and with

cooperation from Abbott Laboratories technical sales or service representatives.

In no event shall Abbott Laboratories or its affiliates be liable for any damages or

losses incurred in connection with or arising from the use of the information on thismedia by persons not fully trained by Abbott Laboratories. This limitation shall not

apply to those persons knowledgeable or experienced with the operation and

service of the product identified, or under the direct supervision and with

cooperation from Abbott Laboratories technical sales or service representatives.

No confidential relationship shall be established in the event that any user of the

Information should make any oral, written or electronic response to Abbott

Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.).

Such response and any information submitted therewith shall be considered non-

confidential, and Abbott shall be free to reproduce, publish, or otherwise use such

information for any purposes whatsoever including, without limitation, the

research, development, manufacture, service, use, or sale of products incorporatingsuch information. The sender of any information to Abbott is fully responsible for

its content, including its truthfulness and accuracy and its non-infringement of any

other persons proprietary rights.

Abbott Laboratories is not engaged in rendering medical advice or services.

Updates to the information may be provided in either paper or electronic format.

Always refer to the latest documents for the most current information.


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List numbers are unique identifiers that are used when ordering products. The list

number and quantity provided in Appendix A:Parts and Accessoriesare intended

for guidance only and are subject to change. Contact your Abbott representative for

the most current information regarding list numbers.

All operating instructions must be followed. In no event shall Abbott be

responsible for failures, errors, or other liabilities resulting from customers non-

compliance with the procedures and precautions outlined herein.

The CELL-DYN Ruby is a Class I Laser Product per IEC 60825-1 (2007). Use of

controls or adjustments or performances of procedures other than those specified

may result in hazardous radiation exposure.


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Warranty Statement for USA Customers Only

Abbott Laboratories warrants the CELL-DYN Ruby Analyzer, sold by Abbott

Sales Representatives, to be free of defects in workmanship and materials duringnormal use by the original purchaser. This warranty shall continue for a period of

one (1) year, commencing twenty-one (21) days from the date of shipment to the

original purchaser or until title is transferred from the original purchaser,

whichever occurs first (the Warranty Period).

If any defects occur during the Warranty Period, contact your Abbott Customer

Support Center immediately and be prepared to furnish pertinent details

concerning the defect, the model number, and the serial number.

Abbotts Warranty coverage limits are as follows:

1. Abbott Customer Service: 24 hours per day, 7 days per week phone support

in the United States.

2. Field Service Representative support: 8:30 A.M. to 5:00 P.M. Monday

through Friday (excluding all Abbott-observed holidays).

3. Any on-site service performed at other times and all service required to

correct defects or malfunctions not covered by this Warranty (as noted in the

paragraph below) will be billed at Abbotts labor rates then in effect.

This Warranty does not cover defects or malfunctions which:

1. Are not reported to Abbott during the Warranty Period and within one week

of occurrence.

2. Result from chemical decomposition or corrosion.

3. Are caused primarily by customer or third party abuse, misuse, or negligence,

or by failure to comply with any requirement or instruction contained in theapplicable Abbott Operations Manual.

4. Result from maintenance, repair, or modification performed without Abbotts

authorization.

Abbotts liability for all matters arising from the supply, installation, use, repair,

and maintenance of the Instrument, whether arising under this Warranty or

otherwise, shall be limited solely to the repair or (at Abbotts sole discretion)

replacement of the Instrument or of components thereof. In no event shall Abbott

be liable for injuries sustained by third parties, incidental or consequential

damages, or lost profits. Replaced parts shall become the property of Abbott

Laboratories.

THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT

LABORATORIES REGARDING THE INSTRUMENT; AND ABBOTT

SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED

OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF

MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR

PURPOSE.

The CELL-DYN Ruby is manufactured by Abbott Diagnostics Division, Abbott

Laboratories, Abbott Park, IL 60064, USA. Please direct all inquiries concerning

information in this manual to the foregoing address.


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Regulatory and Safety Agency Approvals

Trademark Statements

CELL-DYN Sapphire, CELL-DYN Ruby, eQC, MAPSS, CELL-DYN and

CELL-DYN HemCal are trademarks of Abbott Laboratories in various

jurisdictions.

All other trademarks are the property of their respective owners.

All Abbott Laboratories product names and trademarks are owned by or licensed

to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbotttrademark, trade name, trade dress, or product name may be made without the prior

written authorization of Abbott Laboratories, except to identify the product or

services of Abbott Laboratories. All other trademarks, brands, product names, and

trade names are the property of their respective companies. All rights reserved.

Except as permitted above, no license or right, express or implied, is granted to any

person under any patent, trademark, or other proprietary right of Abbott

Laboratories.

In Vitro Diagnostic Directive 98/79/EC

Legal Manufacturer Abbott Laboratories

Abbott Park, IL 60064, USA

Authorized Representative ABBOTT

Max-Planck-Ring 265205 Wiesbaden

Germany


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Symbols

The symbols listed below are used in labeling for the CELL-DYN Ruby, including that on the instrument,

reagents, calibrator, controls, and in this manual.

Instrument/Power related

Symbol Definition/Use Symbol Definition/Use

Alternating Current

InputPressure 1

Application Software Pressure 2

Busy Pressure 3

Fault Ready

Filter 1 or 2 Reservoir

Frequency Revision

HGB Flow Cell Serial Number

Line Voltage Set-Up Disk

Maximum Power Shear Valve

Mixing ChamberStand By

Model Number Trap

OFF Vacuum 1 or 2

ON Vent

Operating System Waste

Peristaltic Pump Waste Sensor

Power

AC INPUT PRESS 1

APPLICATION SOFTWARE PRESS 2

BUSY PRESS 3

FAULT READY

FILTER 1/2 RESERVOIR

FREQUENCY REV

HGB

FLOW CELLSN

LINE VOLTAGE SET-UP DISK

MAX POWER SHEAR VALVE

MIXING

CHAMBER

MODEL TRAP

VAC 1/2

VENT

OPERATING SYSTEM WASTE

PERISTALTIC PUMP WASTE SENSOR

POWER


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Reagent related

Cyanide-Free Hemoglobin/Nuclear Optical Count Lyse Reagent

Diluent Reagent

Diluent/Sheath Reagent

Enzymatic Cleaner Concentrate

Use by

Hemoglobin

Hemoglobin Lyse

Batch Code

Red Blood Cell

Sheath Reagent

Temperature Limitation (Example shows Store at 28C)

White Blood Cell

WBC Lyse Reagent

CN-FREE HGB/NOC LYSE

DILUENT

DILUENT/SHEATH

ENZYMATIC CLEANER CONCENTRATE

HGB

HGB LYSE

LOT

RBC

SHEATH

8

WBC

WBC LYSE


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Calibrator/Control related

Assay Value

Calibrator

Calibrator

Control

Control Assay Files

Control, Level I, II, or III or Level L, N, or H

Control, Tri-Level

Danger: Respiratory Sensitizer

Mean Range

Mean Value

Parameter

Catalogue number

Reticulocyte Control

System

ASSAY VALUE

CAL

CALIBRATOR

CONTROL

CONTROL ASSAY FILES

CONTROL I/II/III or L/N/H

CONTROL L|N|H

DANGER: SENSITIZER

MEAN RANGE

MEAN VALUE

PARAMETER

REF

RETIC CONTROL

SYSTEM


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Miscellaneous

Authorized Representative in the European Community

Biological risks

Caution, consult accompanying documents

(Note: for Instrument reagents)

Caution, risk of danger / Caution, consult accompanying documents

(Note: for Instruments)

CE-mark

Consult Instructions for Use

Date of Manufacture

In VitroDiagnostic Medical Device

Catalogue Number

Separate collection for electrical and electronic equipment waste perDirective 2002/96/EC in the European Union

Separate Collection of spent batteries per Directive 2006/66/EC in the

European Union.

Manufacturer

EC REP

IVD

REF


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Instrument Labeling

The following labels are affixed to the CELL-DYN Ruby.

Analyzer Rear Panel

Figure 1: Class 1 Laser Product Label

Figure 2: CELL-DYN Ruby US Patent Label

Figure 3: CE Mark and Legal Manufacturer

PN 9230702C

CLASS 1 LASER PRODUCT/Lasergert der Klasse 1/Produit laser de classe 1/Lser declase 1/Prodotto laser di classe 1/Produto laser da classe 1/Klasse 1-laserprodukt/Klass 1 laserprodukt/ 1

The following U.S. Patents are relevant to the CELL-DYN Ruby or its

components. There are other such patents and patent applications in theUnited States and worldwide.

5,017,497 5,378,633 5,510,267 5,733,784

PN: 9231334A

9221334A indd 1 6 24 2005 9:16:12 AM

ABBOTTMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580

ABBOTT LABORATORIESAbbott Park, IL 60064 USA

PN 9230751


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Figure 4: CE Label

Figure 5: ETL Certification Label

Analyzer Right Flow Panel

Figure 6: Analyzer Serial Number Labels

PN 9231514A

EC REPABBOTTMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580

Abbott

Diagnostics Division

ABBOTT LABORATORIES

Diagnostics Division

Abbott Park, IL 60064 USA

9221514A indd 1 1 16 2008 12:16:45 PM

ABBOTT DIAGNOSTICS DIVISIONAbbott Laboratories

Abbott Park IL, 60064, USA

DATE OF MANUFACTURE

REVREF

SN

MODEL

PN 9230308 REV J

THIS PRODUCT COMPLIES WITH FDAPERFORMANCE STANDARDS FOR LASER

PRODUCTS EXCEPT FOR DEVIATIONSPURSUANT TO LASER NOTICE NO. 50,

DATED JULY 26, 2001.

MODEL

PN 9230308 REV K

PRODUCT COMPLIES WITH FDA PERFORMANCESTANDARDS FOR LASER PRODUCTS EXCEPTFOR DEVIATIONS PURSUANT TO LASER NOTICE

NO. 50, DATED JULY 26, 2001.

Manufactured for Abbott LaboratoriesAbbott Park, IL 60064 USA

Product of Singapore

SN

REF REV


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Analyzer Left Flow Panel

Figure 7: CELL-DYN Ruby Service Technical Service Bulletin Record Label

Figure 8: Laser Warning Label

Analyzer Front and Rear

Figure 9: Biohazard

CAUTION Class 3B laser light when open. Avoidexposure to beam.VORSICHT Bei offener Abdeckung Laserstrahlung derKlasse 3B. Nicht direkt in den Laserstrahl blicken.ATTENTION Rayon laser de classe 3B si ouvert. Evitertoute exposition au faisceau laser.PRECAUCIN: Haz de lser de clase 3B. Evite laexposicin al lser cuando el analizador est abierto.ATTENZIONE:fascio laser di classe 3B se aperto. Evitarelesposizione al raggio.ATENO Quando aberto, emite luz laser da classe3B. Evitar a exposio ao raio laser.VIGTIGT:Klasse 3B-laserlys ved bning. Undgeksponering for strlen.VIKTIGT:Klass 3B laserljus nr luckan r ppen. Undvikexponering fr strlen. 3 .

.UPOZORNN:Po oteven krytu nebezpe ozenlaserem tdy 3B. Vyvarujte se kontaktu s paprskem.

PN 9230701F

PN 9231477A


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Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Warranty Statement for USA Customers Only. . . . . . . . . . . . . . . . . . iv

Regulatory and Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . v

Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Analyzer Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xAnalyzer Right Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

Analyzer Left Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

Analyzer Front and Rear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Organization of the online HTML Operators Manual. . . . . . . . . . . . . 2

Conventions for the online HTML Operators Manual . . . . . . . . . . . . 5

Access to the online HTML Operators Manual from

the system software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Printed documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Access to the PDF Operators Manual from

a stand-alone computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Specimen Processing Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Specimen Loading and Presentation. . . . . . . . . . . . . . . . . . . . . . 1-5

Specimen Identification and Test Selection . . . . . . . . . . . . . . . . . . . 1-5Test Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Analyzer Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Analyzer Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Analyzer Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Analyzer Sample Processing Area . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-


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Analyzer Flow Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Analyzer Internal Assemblies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17

Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Data Module Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22Flat Panel Display with Touch Screen . . . . . . . . . . . . . . . . . . . . . . 1-24

Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25

Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Hand-Held Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28

Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29

System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31

Analyzer Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31

Data Station Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31

Screen Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32

Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32Title Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Tool Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35

Status Bar and System Messages Region . . . . . . . . . . . . . . . . . 1-38

NOTE Region (Next Open Tube Entry) . . . . . . . . . . . . . . . . . . 1-40

Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42

CELL-DYN Ruby Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

CELL-DYN Diluent/Sheath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

CELL-DYN CN-Free HGB/NOC Lyse . . . . . . . . . . . . . . . . . . . . . 1-43

CELL-DYN WBC Lyse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44

CELL-DYN Reticulocyte Reagent . . . . . . . . . . . . . . . . . . . . . . . . . 1-44

Controls, Calibrator, and Standard Reference Particles . . . . . . . . . . . . . . . 1-45

Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45

Calibrators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45

Standard Reference Particles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45

Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Unpacking and Inspection Guidelines . . . . . . . . . . . . . . . . . . . . . . . 2-4

System Connection and Start Up Guidelines . . . . . . . . . . . . . . . . . . 2-5

System Relocation and Shipping Guidelines . . . . . . . . . . . . . . . . . . 2-5

System Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
http://-/?-http://-/?-


25/712



Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Patient Sample Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Patient Sample Setup, Limits Tab View. . . . . . . . . . . . . . . . . . 2-10

Demographics Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Customize Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Demographic Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Unit Sets Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Unit Format Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Customize Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Customize Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

Datalog, QC View, and Groups View . . . . . . . . . . . . . . . . . . . 2-30Customize Moving Average View . . . . . . . . . . . . . . . . . . . . . . . 2-32

Customize Printed Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

Customize Report Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

Auto Print Chartable Page Report . . . . . . . . . . . . . . . . . . . . . . 2-35

Other Printed Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

QCID Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37

Moving Average Acceptance Setup... . . . . . . . . . . . . . . . . . . . . . . 2-37

Administrative Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37

Operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

User Interface Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50

Tool Tip Display Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51

QCID Daily Cleanup Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51

Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52

Instrument ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54

Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-56

Orders Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58

Automatic Order Cleanup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58

No Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59

LIS Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61

LIS Configuration Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64

LIS Tests Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65QC Download ID File Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65

Flag Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66

Logs Auto Backup Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67

Rule Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68


26/712



Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Instrument Flushed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Instrument Rinsed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Introduction to Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Detection with the Optical Bench. . . . . . . . . . . . . . . . . . . . . . . . 3-8

Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

WBC Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

WBC Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Mononuclear-Polymorphonuclear Separation . . . . . . . . . . . . . 3-12

Neutrophil-Eosinophil Separation . . . . . . . . . . . . . . . . . . . . . . 3-13

Mononuclear Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Other Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15Nuclear Optical Count (NOC) . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Resistant RBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

NWBC-LYM-MONO Histogram. . . . . . . . . . . . . . . . . . . . . . . 3-17

MONO-POLY Histogram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

NOC Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

WBC Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

RBC Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

HCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

MCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

MCHC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

RDW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21


27/712


28/712



Nominal Aspiration Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Recommended Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Specimen Tube Dimensions (Closed Mode) . . . . . . . . . . . . . . . 4-5

Recommended Specimen Collection Tubes (Closed Mode) . . . 4-6Recommended Volume Requirements in Specimen

Collection Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Specification for Bar Code Symbols, Bar Code Labels,

and their Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

CBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Imprecision (Reproducibility). . . . . . . . . . . . . . . . . . . . . . . . . . 4-13Analytical Measurement Range (AMR). . . . . . . . . . . . . . . . . . 4-14

Comparability (Correlation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Operating Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

System Priming, Interruption, and Standby . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

System Priming, Interruption, and Standby . . . . . . . . . . . . . . . . . . . 5-3

Power On and Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

System Priming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Interruption Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Procedural Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

The To Standby Task Button . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Specimen Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Specimen Analysis Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Preparing to Run Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Preparing to Run Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Operator ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15Signing On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Running Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Preparing and Handling Specimens . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Specimen Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Specimen Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17


29/712



Specimen Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Specimen Identification Methods . . . . . . . . . . . . . . . . . . . . . . . 5-18

Introduction to the Orders View . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20Default Patient Test Selection Processing Conditions . . . . . . . 5-21

Pending Orders (Match Specimen ID or Match Rxx Tyy). . . . 5-22

Pending Order Entries from the LIS. . . . . . . . . . . . . . . . . . . . . 5-22

Processing with the Orders View . . . . . . . . . . . . . . . . . . . . . . . 5-22

Create Manual Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25

Printing a Pending Orders Log . . . . . . . . . . . . . . . . . . . . . . . . . 5-27

Orders Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28

Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30

Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Post-Analysis Processing Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . 5-33Alerts and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Out of Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

System Messages and Fault Conditions . . . . . . . . . . . . . . . . . . 5-33

Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Backing up and Restoring System Data . . . . . . . . . . . . . . . . . . 5-40

Creating an Electronic Monthly Archive on the

CELL-DYN Ruby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Advanced Data Management Groups View . . . . . . . . . . . . . . . . . . . . . . 5-47

Creating Orders From the Group View . . . . . . . . . . . . . . . . . . . . . 5-48

Deleting Records From the Group View . . . . . . . . . . . . . . . . . . . . 5-48

Advanced Data Management Rules Based Annotations . . . . . . . . . . . . . 5-51

Creating Rules and Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53

Creating Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53

Creating Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53

Procedure: Creating Annotations . . . . . . . . . . . . . . . . . . . . . . . 5-59

Enabling/Disabling Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-60

Rule Validation (within software) . . . . . . . . . . . . . . . . . . . . . . . . . 5-66Evaluating Rules During Run Time . . . . . . . . . . . . . . . . . . . . . . . . 5-70

Displaying Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71

Printing the Rules Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74

Printing a Group of Specimens with Annotations . . . . . . . . . . 5-75

Importing /Exporting Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-76


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Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Calibration Bias Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Calibrating with Commercial Calibrator . . . . . . . . . . . . . . . . . . 6-6

Calibrating with Assayed Whole Blood . . . . . . . . . . . . . . . . . . . 6-6

Recommendations and Requirements for

Whole Blood Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Recommendations for Reference Methodologies. . . . . . . . . . . . 6-7Requirements for Obtaining Whole Blood Reference Values . . 6-8

Pre-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Pre-Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Pre-Calibration Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

CELL-DYN Ruby Pre-Calibration Procedures Checklist . . . . . . . 6-13

Calibration Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15

Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

Last Auto-Calibration Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17Quick Precision Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18

Calibration Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20

Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

Auto-Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

Auto-Calibration Wizard - Open . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26

Using Commercial Calibrator. . . . . . . . . . . . . . . . . . . . . . . . . . 6-26

Running the Open/Closed Mode Bias Check . . . . . . . . . . . . . . . . . 6-42

Whole Blood Auto-Calibration Wizard - Open Mode . . . . . . . . . . 6-45

Using Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45

Running the Open/Closed Mode Bias Check . . . . . . . . . . . . . . . . . 6-61

Running the Calibration Bias Wizard. . . . . . . . . . . . . . . . . . . . . . . 6-65

Manual Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-72

Manual Calibration Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . 6-72

Manual Calibration Primary Mode - Open. . . . . . . . . . . . . . . . 6-73


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Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77

Backing Up Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77

General Concepts and Guidelines. . . . . . . . . . . . . . . . . . . . . . . 6-77

Backup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77Manual Calibration Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-80

Worksheet 1 Open Mode Calibration - New Factors . . . . . 6-81

Worksheet 2 Open Mode Factor % Difference . . . . . . . . . . 6-82

Worksheet 3 Open Mode Calibration Range Criteria . . . . . 6-83

Worksheet 4 Calibration Verification . . . . . . . . . . . . . . . . . 6-84

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-85

Operational Precautions and Limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

General Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Precautions and Requirements for System Operation . . . . . . . . . . . 7-3

Precautions Before Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Requirements for Handling Specimens . . . . . . . . . . . . . . . . . . . . . . 7-6

Interfering Substances and Conditions . . . . . . . . . . . . . . . . . . . . . . . 7-8

Limitations of Result Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Laser Caution Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Hazard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Biological and Chemical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Spill Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Waste Handling and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Disposing of Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

Decontamination Procedure Requirements . . . . . . . . . . . . . . . . 8-8

Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

Physical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13


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Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

When to Run QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2QC Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Quality Control Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Guidelines for Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Control Material Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Assay Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Establishing the Mean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

Program Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

QCID Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10Quality Control Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13

Using QC View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

Main QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

Scrolling Through the QC View. . . . . . . . . . . . . . . . . . . . . . . 11-15

View QC Spec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20

QCID L-J Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-22

QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23

Download QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27

View QC Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-28

Moving Average View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-34Moving Average Levey Jennings View. . . . . . . . . . . . . . . . . . . 11-36

Quality Control Software Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 11-39

QCID File Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-39

QC Download ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-59

Moving Average Acceptance Setup . . . . . . . . . . . . . . . . . . . . 11-60

Performing a QC Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-64

Rejecting/Accepting Specimens . . . . . . . . . . . . . . . . . . . . . . . 11-64

Edit QC Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-65

Moving QCID Specimen Runs from One QCID File to Another 11-67

Evaluating and Investigating Commercial and Patient Control Results. . 11-69

Analyzing QCID File Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-71

Levey-Jennings Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-71

Westgard Rule Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-72

Westgard Rules for the CELL-DYN Ruby. . . . . . . . . . . . . . . . . . 11-72

Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-73

Moving Average Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-75

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-75


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How Moving Average Programs Work . . . . . . . . . . . . . . . . . . . . 11-75

Principles of Moving Average Analysis. . . . . . . . . . . . . . . . . . . . 11-76

Guidelines for Setting Up X-B Moving Average

Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-76Establishing the Target Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-77

Guidelines for Interpreting X-B Moving Average

Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-78

Guidelines for Setting Up and Interpreting Other Moving Average

Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-79

Moving Average Program Operation . . . . . . . . . . . . . . . . . . . . . . 11-81

Data Collection Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-81

Investigating Moving Average Data Problems. . . . . . . . . . . . . . . 11-82

Investigating One Batch Out. . . . . . . . . . . . . . . . . . . . . . . . . . 11-82

Investigating Two Batches Out. . . . . . . . . . . . . . . . . . . . . . . . 11-82Printing Moving Average Programs Information. . . . . . . . . . . . . 11-82

Customizing Moving Average Programs . . . . . . . . . . . . . . . . . . . 11-83

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-85

Reticulocyte Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3

Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7

RETIC Test Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9

Enabling Reticulocyte Processing . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Disable Reticulocyte Processing. . . . . . . . . . . . . . . . . . . . . . . . . . 12-10

Routine Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11

Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11

Specimen Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12

Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14

Specimen Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15

Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15

Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-21

Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-22

Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-23Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25

General Guidelines for Reticulocyte Troubleshooting. . . . . . 12-25

Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . 12-26

Dispersional Data Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26

References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-29


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Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Appendix B Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1


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CELL-DYN Ruby System Operators Manual List of Tables-19140543DSeptember 2013

List of Tables

List of Tables

Use or FunctionTable 1.1 Status Indicator LEDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Table 1.2 Reagent Inlet Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20

Table 1.3 Keyboard Keys and Their Functions on the CELL-DYN Ruby. . . 1-26

Table 1.4 Mouse Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Table 1.5 Printing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29

Table 1.6 Menu Bar Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Table 1.7 Tool Bar Button Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35

Table 1.8 Status Bar Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40

Table 1.9 Tab Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42

Installation Procedures and Special Requirements

Table 2.1 Customizable Menu Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Table 2.2 Limit Set Default Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Table 2.3 To Change the User Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22

Table 2.4 To Select the Default Patient Test Selection . . . . . . . . . . . . . . . . . 2-22

Table 2.5 Procedure to Change the Unit Sets Selection . . . . . . . . . . . . . . . . . 2-23

Table 2.6 Procedure to Customize Parameter Set - Chartable Page . . . . . . . . 2-25

Table 2.7 Customize the Run View - Lab Page . . . . . . . . . . . . . . . . . . . . . . . 2-27

Table 2.8 Procedure to Customize the Run View - Graphs Page . . . . . . . . . . 2-29

Table 2.9 Procedure to Customize Tab Titles and Column Headingsin Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

Table 2.10 Procedure to Add/Delete Tab Pages in Data View. . . . . . . . . . . . . 2-32

Table 2.11 To Customize the Printed Report Header . . . . . . . . . . . . . . . . . . . . 2-34

Table 2.12 Procedure to Auto Print Chartable Page Report . . . . . . . . . . . . . . . 2-35

Table 2.13 Procedure to Print Using Other Printed Report Options. . . . . . . . . 2-36

Table 2.14 Operator ID and Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Table 2.15 Procedure to Add an Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

Table 2.16 Add Operator Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41

Table 2.17 Procedure to Remove an Operator . . . . . . . . . . . . . . . . . . . . . . . . . 2-42

Table 2.18 Procedure to Edit Operator Information . . . . . . . . . . . . . . . . . . . . . 2-43Table 2.19 Edit Operator Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44

Table 2.20 Procedure for Editing Permission Access Rights for Laboratory

Levels I and II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46

Table 2.21 Procedure for Setting Up Second Sign Ons . . . . . . . . . . . . . . . . . . 2-48

Table 2.22 Changing the Tool Tip Display Time. . . . . . . . . . . . . . . . . . . . . . . 2-51

Table 2.23 Procedure to Set Up Bar Code Including Symbology Setups . . . . 2-56

Table 2.24 Procedure to Change Automatic Order Cleanup . . . . . . . . . . . . . . 2-59
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List of Tables-2 CELL-DYN Ruby System Operators Manual9140543DSeptember 2013

List of Tables

Table 2.25 Procedure to Change Use Rack and Tube Matching . . . . . . . . . . . 2-60

Table 2.26 Setting Up Auto-Transmission and Manual Transmission. . . . . . . 2-62

Table 2.27 Flag Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66

Table 2.28 Logs Auto Backup Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67


Table 3.1 5-Part Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25

Table 3.2 5-Part Differential Plus Additional Parameters . . . . . . . . . . . . . . . 3-25

Table 3.3 Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29

Table 3.4 Parameters Marked With an Asterisk (*) . . . . . . . . . . . . . . . . . . . . 3-30

Table 3.5 Parameters with Suppressed Results. . . . . . . . . . . . . . . . . . . . . . . . 3-31

Table 3.6 Patient Specimen Type + CBC Test Selection . . . . . . . . . . . . . . . . 3-34

Table 3.7 Patient Specimen Type + CBC+RRBC Test Selection . . . . . . . . . 3-37

Table 3.8 Patient Specimen Type + CBC+NOC Test Selection. . . . . . . . . . . 3-38

Performance Characteristics and Specifications

Table 4.1 CELL-DYN Ruby Physical Specifications. . . . . . . . . . . . . . . . . . . . 4-3

Table 4.2 CELL-DYN Ruby Power Specifications . . . . . . . . . . . . . . . . . . . . . 4-3

Table 4.3 CELL-DYN Ruby Fuse Specifications. . . . . . . . . . . . . . . . . . . . . . . 4-3

Table 4.4 Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Table 4.5 Clearance Requirements for Service Access . . . . . . . . . . . . . . . . . . 4-4

Table 4.6 Recommended Collection Tube Dimensions for use in Closed mode. 4-5

Table 4.7 Recommended Specimen Collection Tubes for use in Closed Mode 4-6

Table 4.8 Characteristics of the Bar Code Symbologies Supported by theCELL-DYN Ruby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Table 4.9 Background Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Table 4.10 Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Table 4.11 Reticulocyte Carryover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Table 4.12 Fresh Blood Imprecision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Table 4.13 Analytical Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Table 4.14 Comparability (Correlation) of CBC and Differential to

CELL-DYN Sapphire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Table 4.15 Comparability (Correlation) of WBC Differential to Microscopy . 4-16


Table 5.1 Procedure to Power-up the Instrument When the System Main Power

Switch is in ON Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Table 5.2 Procedure to Power-up the Instrument When the System Main Power

Switch is in OFF Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Table 5.3 Procedure to Power Off and Reboot the System . . . . . . . . . . . . . . . 5-6


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List of Tables

Table 6.21 Buttons Welcome to the CELL-DYN Auto-Calibration Wizard

Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46

Table 6.22 Buttons Pre-Calibration Maintenance Check Status Dialog Box6-47

Table 6.23 Buttons Pre-Calibration Reagent/Waste Dialog Box. . . . . . . . . 6-48

Table 6.24 Buttons Pre-Calibration Precision Check Status Dialog Box . . 6-49

Table 6.25 Buttons Pre-Calibration Background Check Status Dialog Box 6-52

Table 6.26 Buttons Calibration Setup Dialog Box . . . . . . . . . . . . . . . . . . . 6-53

Table 6.27 Buttons Calibration Setup - Reference Values for Whole Blood

Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

Table 6.28 Buttons Auto-Calibration Data View Dialog Box. . . . . . . . . . . 6-56

Table 6.29 Fields Post-Calibration New Factors Dialog Box . . . . . . . . . . . 6-58

Table 6.30 Buttons Post-Calibration New Factors Dialog Box. . . . . . . . . . 6-58

Table 6.31 When to Select Apply New Factor for Acceptance . . . . . . . . . . . . 6-59

Operational Precautions and Limitations

Table 7.1 Recommended Collection Tube Dimensions for Use in Closed Mode 7-6

Hazards

Table 8.1 Safety Icons and Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Table 8.2 Hazard Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5


Table 9.1 Scheduled Service and Maintenance Procedures . . . . . . . . . . . . . . . 9-4

Table 9.2 As-Needed Service and Maintenance Procedures . . . . . . . . . . . . . . 9-4Table 9.3 Nonscheduled Service and Maintenance Procedures . . . . . . . . . . . . 9-4

Table 9.4 Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Quality Control

Table 11.1 Screen Navigation Bar and Buttons . . . . . . . . . . . . . . . . . . . . . . . 11-16

Table 11.2 QC View Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17

Table 11.3 Function Keys View QC Spec. . . . . . . . . . . . . . . . . . . . . . . . . 11-20

Table 11.4 Function Keys QCID File Levey-Jennings View . . . . . . . . . . 11-22

Table 11.5 Function Keys QCID Data Dialog Box . . . . . . . . . . . . . . . . . . 11-24

Table 11.6 Field QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . . . 11-28Table 11.7 Buttons QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . 11-28

Table 11.8 Fields QCID Setup: View, Control Data Dialog Box . . . . . . . 11-30

Table 11.9 Fields QCID Setup: View, QC Limits Dialog Box . . . . . . . . . 11-30

Table 11.10 Fields QCID Setup: View, Westgard Dialog Box. . . . . . . . . . 11-31

Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box. . . . . . 11-31

Table 11.12 Function Keys QC Moving Average View . . . . . . . . . . . . . . . 11-35

Table 11.13 Function Keys-Levey Jennings View. . . . . . . . . . . . . . . . . . . . . . 11-36


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List of Tables

Parts and Accessories

Table A.1 CELL-DYN Ruby Hardware List Numbers. . . . . . . . . . . . . . . . . . . A-1

Table A.2 CELL-DYN Ruby Accessories Kit (List Number 09H04-01) . . . . . A-2Table A.3 CELL-DYN Ruby Optional Accessories . . . . . . . . . . . . . . . . . . . . . A-3

Table A.4 CELL-DYN Ruby Support Documentation List Numbers. . . . . . . . A-4

Table A.5 CELL-DYN Calibrator and Controls for use on CELL-DYN Ruby A-4

Table A.6 CELL-DYN Reagents for use on CELL-DYN Ruby. . . . . . . . . . . . A-5

Potential Causes of Spurious Results

Table B.1 Potential Causes of Spurious Results with Automated

Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1


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CELL-DYN Ruby System Operators Manual 39140544CSeptember 2013

Section 3 Principles

of Operation

Refer to this section for an explanation of:

Scientific and technical principles

Types of system measurements

Data analysis and parameter reporting conventions

System Initiated Messages (SIMs) and Data Flags

Section 4PerformanceCharacteristics and

Specifications

Refer to this section for details such as:

Dimensions of the instrument

Power requirements

Environmental specifications

Operational specifications

Bar Code specifications

Performance specifications and performance characteristics

Section 5 OperatingInstructions

Use this section to learn how to perform:

Various tasks related to routine system operation

System customization

Background counts

Basic and advanced patient data management including reviewing,printing, and transmitting to Laboratory Information Systems

Section 6 CalibrationProcedures

Use this section to learn:

When to calibrate

Pre-Calibration procedures

Calibration procedures

Post-Calibration procedures

Section 7 OperationalPrecautions andLimitations

Refer to this section to understand the precautions, limitations, andrequirements associated with:

System operation

Handling consumables

Handling specimens

Identifying substances and conditions

Interpreting results

Section 8 Hazards Refer to this section for important hazard and safety information, such as: Safety icons, laser caution labels, and hazard symbols

Biological, chemical, electrical, mechanical, and physical hazards

Section 9 Service and

Maintenance

Refer to this section for:

Descriptions of all maintenance procedures

Recommended schedules for service and maintenance

Instructions for performing scheduled and as-needed maintenanceprocedures

Step-by-step instructions for replacing components

Table 1: Online Operators Manual Organization (Continued)


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Table 4: Online HTML Operators Manual Search Navigation

Actions Steps Reference

Using thetable ofcontents

1. Select the Contents tab on thenavigation pane to provide a visual tableof contents of the operators manual(See graphic to the right).

2. Select the box icons and page icons toview subsections.

NOTE: The box icons expand andcollapse correspondingsubsections as they are selected.

3. Click on the desired topic to select thattopic. The topic page displays in thetopic pane (right side of window).

Scrollingthrough thecontent

1. Select the Contents tab on thenavigation pane (see graphic to theright), and then select a topic title. Thetopic content displays in the topic pane.

2. Drag the scroll bar on the right side ofthe topical pane to display subsequentcontent within the section.

3. Repeat step 2 as often as desired.

Pagingbetweensections

1. Select the Contents tab on thenavigation pane and select a topic title.The desired topic then displays in thetopic pane.

2. Select a left or right section arrow(located in the upper right-hand corner ofthe topic pane) to move betweensections of the manual (see graphic tothe right).

NOTE: Section arrows are also

visible at the bottom of the topicpane when viewing the end of asection.

2

1

1A

1

2

1

12


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8 CELL-DYN Ruby System Operators Manual9140544CSeptember 2013

Using theindex

1. Select the Index tab on the navigationpane (see graphic to the right).

2. Type in a keyword to find all referencesto the keyword within the manual. Or,click on any topic in the Index.

The topic content displays in the topic pane.

Using theSearchbutton

1. Select the Search button (see graphic tothe right).

2. Type a keyword (or phrase) in the fieldindicated and select List Topics

3. Review the topics displayed in theresults pane and double-click on a topicfor further review. This topic is thendisplayed in the topic pane.

4. To search for new content, type anotherkeyword (or phrase) in the field indicatedand select List Topics.

Table 4: Online HTML Operators Manual Search Navigation (Continued)

Actions Steps Reference

1

2

1

2


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Printed documentation

The printed version of the CELL-DYN Ruby Operators Manual contains complete

instructions for using and maintaining the CELL-DYN Ruby system. You will findit a valuable aid and an essential reference as you learn to use the system.

Printed documentationtopics include:

Organization of the printed operators manual

Conventions for the printed documentation

Organization of the printed operators manual

The printed CELL-DYN Ruby Operators Manual provides the following tools to

help you access desired information:

Tabs

Primary tabs mark the start of each section. Subtabs mark the start of subsections

within certain sections.

Tables of Contents

The Master Table of Contents at the beginning of the manual lists each section and

its subsections. Section tables of contents are located immediately behind primary

tabs in all major sections.

The printed CELL-DYN Ruby Operators Manual is organized as follows:

Table 5: Online Operators Manual Organization

Revision Status andLog

Refer to this section for the Revision Status and History of theCELL-DYN Ruby Operators Manual.

Foreword Refer to this section for important information such as: Customer Service Contact Information

Proprietary and Patent Statements

Disclaimers

Warranty details

Trademark statements

Key to symbols and instrument labeling

Master Table of

Contents

Refer to the Table of Contents for a list of all:

Sections Subsections

List of Figures

List of Tables


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10 CELL-DYN Ruby System Operators Manual9140544CSeptember 2013

System

Documentation


Information on content organization

Organization of the online HTML Operators Manual

Conventions for the online HTML Operators Manual

Access to the online HTML Operators Manual from the system software

Access to the online PDF Operators Manual for a stand-alone computer

Section 1 Use orFunction

Refer to this section for a brief description of the CELL-DYN Ruby, such as:

Intended use

Specimen processing sequence

Main hardware components

Basic features of the system software

Reagents, Controls, Calibrator, and Standard Reference Particles

Section 2 InstallationProcedures andSpecial Requirements


Information on site requirements for installation

System installation and start-up guidelines

System software customization and procedural guidelines

System relocation and shipping guidelines

Section 3 Principlesof Operation

Refer to this section for an explanation of:

Scientific and technical principles

Types of system measurements

Data analysis and parameter reporting conventions

System Initiated Messages (SIMs) and Data Flags

Section 4PerformanceCharacteristics andSpecifications

Refer to this section for details such as:

Dimensions of the instrument

Power requirements

Environmental specifications

Operational specifications

Bar Code specifications

Performance specifications and performance characteristics

Section 5 OperatingInstructions

Use this section to learn how to perform:

Various tasks related to routine system operation

System customization

Background counts Basic and advanced patient data management including reviewing,

printing, and transmitting to Laboratory Information Systems

Section 6 CalibrationProcedures

Use this section to learn:

When to calibrate

Pre-Calibration procedures

Calibration procedures

Post-Calibration procedures

Table 5: Online Operators Manual Organization (Continued)


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Section 7 Operational

Precautions andLimitations

Refer to this section to understand the precautions, limitations, andrequirements associated with:

System operation

Handling consumables

Handling specimens

Identifying substances and conditions

Interpreting results

Section 8 Hazards Refer to this section for important hazard and safety information, such as: Safety icons, laser caution labels, and hazard symbols

Biological, chemical, electrical, mechanical, and physical hazards

Section 9 Service andMaintenance


Descriptions of all maintenance procedures

Recommended schedules for service and maintenance

Instructions for performing scheduled and as-needed maintenanceprocedures

Step-by-step instructions for replacing components

Section 10Troubleshooting andDiagnostics


Troubleshooting basics and procedures

Information on probable causes and corrective actions for observedproblems, System Initiated Messages (SIMs), and Data-Related problems

Section 11 QualityControl


Internal and external quality control programs

Principles and procedures for running quality control using commercialcontrol material and whole blood patient controls

Procedures to customize system quality control files

Quality control data management

Section 12


This section is a self-contained module that describes how the Reticulo

cd ruby operator manual 08h5602

Documents