instrumentation laboratory acl elite / elite · pdf filesetup / review system configuration...
TRANSCRIPT
INSTRUMENTATION LABORATORY ACL ELITE / ELITE PRO* System
QUICK REFERENCE GUIDE
PN 774413AA (November 2010) Miami Education Center Miami, FL 33196
i
REVISION STATUS
Revision A Initial Issue (May, 2006)
Software release 3.05
Revision AA Software release 3.01.04
Library V 02.00.00
New Operators Manual * Instrumentation Laboratories, the IL Logo , ACL, ACL Elite, HemosIL and Accutrak are trademarks or registered trademarks of Instrumentation Laboratory Company in the United States and in several international jurisdictions.
PN 774413 Rev AA (November 2010) Miami Education Center ii
PN 774413 Rev AA (November 2010) Miami Education Center iii
WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS and IMPORTANTS alert you as follows:
WARNING – Can cause injury. CAUTION – Can cause damage to the instrument. IMPORTANT – Can cause misleading results.
BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. WARNING Risk of operator injury if: • All doors, covers and panels are not closed and secured in place prior to and during instrument operation. • The integrity of safety interlocks and sensors is compromised. • Instrument alarms and error messages are not acknowledged and acted upon. • You contact moving parts. • You mishandle broke parts. • Doors, covers and panels are not opened, closed, removed and/or replaced with care. • Improper tools are used for troubleshooting. To avoid injury: • Keep doors, covers, and panels closed and secured in place while the instrument is in use.
• Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. • Acknowledge and act upon instrument alarms and error messages. • Keep away from moving parts.
• Report any broken parts to your Beckman Coulter Representative. • Open/remove and close/replace doors, covers and panels with care. • Use the proper tools for troubleshooting.
CAUTION System integrity might be compromised and operational failures might occur if: • This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product
Manuals. • You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your
system’s computer with software authorized by Beckman Coulter. • You install software that is not an original copyrighted version. Only use software that is an original copyrighted
version to prevent virus contamination. IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.
HEMOSTASIS: ENDOTHELIUM AND PROTEINS PN 774413 Rev AA (November 2010) Miami Education Center iv
PN 774413 Rev AA (November 2010) Miami Education Center
ACL ELITE / ELITE PRO Quick Reference Guide
Table of Contents
Components / Icons / Colors Software Tree Hardware Components Overview Windows / Toolbar / Message Icons Reagent / Sample Loading Material Status Colors Materials Map Sample Status Pre-run Checklist Processing Samples Maintenance Frequency Log Sheet Order information for Expendables Quality Controls Calibration Troubleshooting Coagulations Errors Troubleshooting Error Codes Troubleshooting Calibration Errors AccuTrak Enrollment New Test Setup (flowchart) New Lot
SOFTWARE TREE
ANALYSIS QC CALIBRATION DIAGNOSTIC SETUP UTILITY
PN 774413 Rev AA (November 2010) Miami Education Center Page 1 of 29
MULTI TEST SESSION Single Test Session
Loadlist Session History
Calibrate Upgrade IL Library Tests ► Review Calibration Backup / Restore Multi-Test ► Analytical Reference Archive Liquids
QC Software ► Interfaces ► Setup / Review Save Rotor Map System Configuration
Save Trace Security Test / Material ► Audible Alarms
Priming Debug (dimmed) Date / Time Cleaning Testing (dimmed)UnitsMaintenance Temperature Control Needles Position
View / Define SW Identification Session Error History Sort Test SW Upgrade ► File Error History Interference Table Logbook Default Tests Service (dimmed) Reflex Tests
Software Upgrade SW Master ► SW Slave► SW REM►
Profiles Test Groups
Backup Test Group Profiles Sort Multi-Tests Upload Default Multi-Test
Upload Upgrade
Host Printer Internal Barcode External Barcode Keyboard Network (dimmed) Modem (dimmed)
Hardware Component Overview
PN 774413 Rev AA (November 2010) Miami Education Center Page 2 of 30
Window Icons
Window Icons Command / Action
Confirm
Cancel (dimmed if Edit action not allowed)
PN 774413 Rev AA (November 2010) Miami Education Center Page 3 of 30
i t i (Host) Transmit
Delete
d l t i Add to the list
Remove an item from the list
Transfer an item from one list to
another
Details
Information in different languages
New Sample
t i
Extract Sample Data
Note
Patient Name
Patient Details
Save information to floppy disk
Toolbar Icons
Toolbar Icons
Commands / Actions
Instrument Status
(Icon active)
Short Turn Around Time (STAT) - Urgent sample Pressing this button opens a window that guides the operator. Confirmation is required
Operating Hold
Instrument Status Informs the operator about the status of
the operation in progress
O Operating Hold
Close/Open cover This operation is disabled if there is a
possible interference with the instrument operation
Ready Hold
STOP Confirmation is required
Ready Operating
Hold
Resume Starts the operations paused due to a
STAT request
Hold
Data Base View The system goes back to the database
view or “Main” screen
Ready Operating Hold
Host Status
h t d i
Icon appears only during communication with the Host to inform the operator about the status of this action.
Ready Operating Hold Failure
Warning This icon appears when there is at least one warning. Press to open “Warning List”.
Ready Operating Hold Failure
Log Out Ready Allows the operator to Failure exit the screen. Confirmation is required
PN 774413 Rev AA (November 2010) Miami Education Center Page 4 of 30
Message Icons
Icon Meaning
QUALITY CONTROL Indicates there are data (results) in the database
QUALITY CONTROL Indicates a failure in a quality control test result
REAGENT VIAL ICON Indicates the status of the reagent map. (Warning No reagent)
REAGENT VIAL ICON Indicates the status of the reagent map. (Warning reagent low)
REAGENT VIAL ICON Indicates the status of the reagent map. (Sufficient reagent)
ERROR. To call attention to high priority failures and fault messages
WARNING To deliver different kinds of messages, i.e. to warn the user of a “not allowed/wrong” operation, or of problems/errors detected by the instrument during or after an operation
QUESTION To request confirmation by the user before starting an operation or before canceling an action
INFORMATION To offer general information. In some boxes, but not always, the message is followed by a request for confirmation
PN 774413 Rev AA (November 2010) Miami Education Center Page 5 of 30
Material Status Colors
Color Status Letter / Symbol Status
PN 774413 Rev AA (November 2010) Miami Education Center Page 6 of 30
Empty or Available
STAT
Not Programmed Pending
Programmed Complete
Not Programmed Processing
Sample Processing Complete
Quality Control Pending
Warning or Errors
Low Volume
Sample not Identified
Empty Cup in Position Empty
Materials Map
PN 774413 Rev AA (November 2010) Miami Education Center Page 7 of 30
Reagent Loading – The Materials map displays a graphical representation of liquid positions on the instrument. The map displayed above represents an ACL Elite PRO only. An ACL Elite does not have positions (R9-R12), as shown above. The external barcode reader can be used to load liquid reagents in displayed materials map. Or select the icons: reset volume and start timer when loading a new liquid, this is an optional operation defined by the user. The materials map screen can display the status of liquids by color onboard along with additional information when clicked on each colored circle positions: Green – Volume of liquid position is greater than the warning limit and stability is OK. Orange – Volume of liquid position is less than the warning limit or either the onboard or lot number stability has expired. Red – Instrument detects the shortage of liquid in the position. NOTE: When you select start / resume a run, the materials map is not checked by the instrument sample arm liquid sensor for volume status. The analysis will proceed regardless of color of the reagent position. The colors displayed are only visual alerts. Make it a habit to: check the status of the reagents before starting a run, physically and color making appropriate adjustments, as needed.
Sample Status
Sample Positions are displayed by quadrants, ten per quadrant, (1-10, 11-20, 21-30 and 31-40). Refer to Material Status Colors for additional information.
Selecting the sample position circle will display the information about that sample.
PN 774413 Rev AA (November 2010) Miami Education Center Page 8 of 30
#: Sample Position on the tray +: Sample Priority - STAT indicated by a checkmark S: Status of Tests (P, C, or N) P – Pending; one or more tests missing a result C – Complete; all tests programmed are analyzed N – No Test; Identified sample has no tests programmed F: Flags associated with sample
PN 774413 Rev AA (November 2010) Miami Education Center Page 9 of 30
Pre-run Checklist
Instrument Status in Ready, prepare the start of a run by performing these tasks or verify performance:
Daily Maintenance (See Maintenance section, Training Manual or Operators manual for specifics)
Reagent Status – Check for adequate reagent volumes and acceptable on-board stability (See Materials Map page, Training Manual or Operators Manual for specifics)
Check QC Status – if necessary program and process controls (See QC section, Training Manual or Operators Manual for specifics)
Process Patient Samples – Program if necessary (See Sample Status Sample Programming, Training Manual or Operators manual for specifics)
Processing Samples
Connected to Host with Default Tests Enabled
1. Place primary tubes with barcode labels facing outward on Sample Tray
2. Select Materials Map icon and confirm: reagents are onboard, in correct position, lot number and volumes are updated, Rotors and Wash R Emulsion supplies are onboard
3. Select Start icon
Note: May be prompted to load new rotor or identify the next available cuvette position; can occur when user has requested rotor cover to open or sensor detects questionable position availability due to reagents dried out in a cuvette position.
Default Tests enabled and sample having no tests ordered after host query, the default tests will be completed on the sample.
PN 774413 Rev AA (November 2010) Miami Education Center Page 10 of 30
No Host Connection and No Default Tests Enabled
1. Place primary tubes with or without barcode labels, and/or sample cups onto Sample Tray (Ensure barcode specimens are orientated outward)
2. Select Analysis
3. Multi-test Session (or Single Test Session)
4. Select the Test Profile with the tests ordered for the specimens placed on the Sample Tray
5. Select Read Bar Codes icon
Note: The Sample Tray engages, the barcode reader reads any bar coded specimens and the sensor places any non-bar coded sample positions on the map and generates the following message:
Warning: Error in Sample Identification
6. Acknowledge the message by selecting OK
7. Locate the unidentified sample position icon within the Quadrant
8. Select Program Sample icon
9. Enter the patient information/demographics based on your laboratory protocol
10. Select Tests order tests from list of enabled tests
11. Select Confirm OR select the to move to the next unidentified specimen. Repeat entering patient information/demographics until all samples identified.
12. Select Prev. Prog. icon if tests requested are same as previous sample, if different select Tests
13. Select Materials Map icon and confirm: reagents are onboard, in correct position, lot number and volumes are updated, Rotors and Wash R Emulsion supplies are onboard
14. Select Start icon
PN 774413 Rev AA (November 2010) Miami Education Center Page 11 of 30
PN 774413 Rev AA (November 2010) Miami Education Center Page 12 of 30
Pause Session / Adding STAT
1. Instrument Status is Operating
2. Select STAT / Pause Session icon
3. Message appears asking; “The running session will be held. Is that OK?” Answer Yes
4. Message appears; “STAT has been requested please wait”
5. The instrument will prompt; “STAT sample can be inserted now” Select OK
6. Add primary tube or cups
7. Select Read Bar Codes icon (With Host Connection, tests will be ordered based on the host query. If not….)
8. Identify any samples, order tests, select STAT icon for STAT priority
9. Select Resume / Start icon (Resume / Start icon now located in lower left corner of toolbar, took position of STAT icon)
10. Message; “STAT was successfully resumed” Select OK
Note: Database View screen displays STAT samples by automatically placing a in the column
PN 774413 Rev AA (November 2010) Miami Education Center Page 13 of 30
SAMPLE ANALYSIS
Review Results
Load Samples
Select Analysis
Host
Material Map
Barcoded Non Barcoded
Warning: ID Specimen Enter demographics Order tests
Verify Reagents
No Host
Start
Start
PN 774413 Rev AA (November 2010) Miami Education Center Page 14 of 30
Maintenance
Be sure to wear personal protective equipment (PPE) when completing maintenance: Lab coat, gloves, and either full face shield or protective eyewear. Refer to Maintenance Module in Training Guide and/or Chapter 5 in Operators Manual for complete instructions. Daily:
Check Wash R Emulsion volume Check Liquid Waste, if necessary Empty Rotor Waste Container Perform Clean Cycle Clean Waste Line, if necessary, dependent upon daily workload Perform Prime Procedure
Weekly:
Clean all key instrument areas Clean Rinse Waste Reservoir
Bi-Weekly:
Reboot Instrument Clean Rotor Holder and Optic Path
Monthly: Clean Air Filter
As Needed: Replace Needle Block Align Needles Waste Line Bleaching Decontamination Clean LCD Touch Screen Hard Drive Maintenance Disk – Defrags and Optimizes Hard Drive
PN 774413 Rev AA (November 2010) Miami Education Center Page 15 of 30
Maintenance
Log Sheet
Make Copies as needed
ev A
A (N
ovem
ber 2
010)
Pa
ge 1
6 of
30
AC
L E
LIT
E /
EL
ITE
PR
O S
yste
m M
aint
enan
ce L
og1
2 3
4 5
6 7
8 9
1011
1213
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Mon
th__
____
____
Ye
ar _
____
____
__
DA
ILY
CH
EC
K W
AS
H R
-EM
ULS
ION
LE
VE
L
EM
PTY
LIQ
UID
WA
STE
IF
NE
CE
SS
AR
Y
EM
PTY
RO
TOR
WA
STE
C
ON
TAIN
ER
PE
RFO
RM
NE
ED
LE C
LEA
NIN
G
PR
OC
ED
UR
E
CLE
AN
WA
STE
LIN
E,
DE
PE
ND
EN
T O
N D
AIL
Y
WO
RK
LOA
D
PR
IMIN
G -
STA
RT
OF
SH
IFT/
DA
Y
PR
IMIN
G- E
ND
OF
SH
IFT/
DA
Y
W
EEK
LY
CLE
AN
INS
TRU
ME
NT
C
LEA
N R
INS
E R
ES
ER
VO
IR
B
IWEE
KLY
R
EB
OO
T TH
E A
NA
LYZE
R
CLE
AN
RO
TOR
HO
LDE
R A
ND
O
PTI
C P
ATH
M
ON
THLY
CH
EC
K A
ND
CLE
AN
AIR
FIL
TER
A
S N
EED
ED
MA
INTE
NA
NC
E
RE
PLA
CE
NE
ED
LE
NE
ED
LES
PO
SIT
ION
P
ER
FOR
M W
AS
TE L
INE
B
LEA
CH
ING
DE
CO
NTA
MIN
ATI
ON
P
RO
CE
DU
RE
CLE
AN
LC
D S
CR
EE
N
HA
RD
DR
IVE
MA
INTE
NA
NC
E
DIS
K
TE
CH
INIT
IALS
PN
774
413
RM
iam
i Edu
catio
n C
ente
r
PN 774413 Rev AA (November 2010) Miami Education Center Page 17 of 30
Ordering Information for Expendables
Catalog Number
Item Description # Pieces in Package
Unit 181108-98* Sample Tray for 13x75 & 13x100 mm, (5 mL)
tubes 1
181812-85 Sample Tray for Sarstedt 11.5x66 mm (3 mL) & 11.5x92 mm (5 mL) tubes
1
190764-00 Sample Tray adapter for plastic cup 4 190763-00 Sample Tray adapter for 4 mL vials 6 181812-65 Adapter for 10 mL reagent vials with magnetic
stirring (gray) 4
190762-00 Adapter for 10 mL reagent vials without magnetic stirring (pink)
6
190761-00 Adapter for 4 mL reagent vials without magnetic stirring (green)
4
97466-06 Magnetic Stirrer 6 189241-00 Glass Vials, 10 mL 10 67992-00 Sample Cups, 0.5 mL 1000 55751-00 Sample Cups, 2 mL 1000 67994-00 Cups, 4 mL, plus Labels 100 68000-00 Rotors- 20 cuvettes 100 181812-77 Rotor Refill Tool 1 181108-97 Rotor Waste Container 1 181108-43 Block Probe Assembly 1 181039-41 Needles Adjustment Tool 1 73289-01 Sample and Reagent Tubing, 1.5 m 1 181080-65 Sample and Reagent Tubing Extractor Tool 1 181812-72 Waste Reservoir, for needles wash 1 181057-69 Liquid Waste Bottle 1 99095-03 Waste Tube, 1.5 m 1 181812-71 Air Filter, molded 1 68931-02 Fuses 6.3 AT 2 148821-00 Power Cord, 100-115 V 1 197255-00 Power Cord, 220-240 V 1 84864-50 External Printer Cable 1 184202-38 Host Computer Cable (9 pin – 9 pin) 1 200024-00 Wash/Reference Emulsion, 1 liter 1 190068-00 Operator’s Manual, English version 1
*Sample Tray included in Start-up Kit
PN 774413 Rev AA (November 2010) Miami Education Center Page 18 of 30
Quality Control
Set up QC
1. Select QC
2. Setup / Review
3. Select Control Material from list to define and setup QC
4. Select Tests from Enabled Test list
5. Move Selected Tests to Configured Test List
6. Enter Lot Number and Expiration Date of QC Material
7. Select each Configured Test and input:
o Units for each Test
o Target Mean
o Target SD
o SD Range
8. Select QC Range Check-Flags if out of Range based on input
9. Select Flag Patient Results-Flags patients results after an out of range control is detected
Setup QC LoadList
1. Analysis
2. Multi-Test Session
3. Select the Multi-test that contains the tests for QC material
4. Select Add QC, a list will display all setup QC Liquid List
5. Select QC Material, continue until all QC is setup
6. Store Loadlist, 1-20
7. Select Confirm
Running Quality Controls
1. Select Analysis
2. Select Multi-test Session
3. Check Loadlist No. icon
4. Enter Loadlist number for QC Materials
5. Select Enter, programmed Loadlist will display on Multi-test Analysis Screen
6. Label cups with QC Material and place on tray based on display
7. Select Materials Map, confirm all reagent levels
8. Select Confirm
9. Select Start
Review Quality Control Results
1. Select icon from Toolbar region on screen
2. QC out of range will show the QC icon with a red ! alert
3. Results:
o Within range display in black
o Outside 2SD range display in violet or blue
o Outside 3SD range display in red
Results can be omitted by selecting Cumulative file from the QC List OR QC / Setup /Review, then Select QC level and Specific test to be reviewed / omitted ( displays in omit column)
4. Select Note icon add a note for QC out of range (note can contain up to30 alphanumeric characters)
5. To clear icon, clear single QC level out of range from the QC List (results remain in QC database until a new lot is entered)
6. The Levey Jennings Chart from the Plot / Statistics screen displays:
o Black asterisk result within range
o Blue diamond ◊ result outside 2SD
o Red triangle Δ result outside 3SD (point is in direction out)
PN 774413 Rev AA (November 2010) Miami Education Center Page 19 of 30
Printing Controls
Print All QC
Print Today QC
Levey Jennings
Cumulative
Clear All
Clear Single
1. Select the Print Today QC icon to print only today’s QC
2. Select the Print All QC icon prints all QC in List (stores 100 tests)
3. Review a specific result and QC file, Select the Cumulative Results icon
4. View a Levey Jennings chart for a control level, Select Plot and Statistics icon
5. Review and Confirm to close
PN 774413 Rev AA (November 2010) Miami Education Center Page 20 of 30
PN 774413 Rev AA (November 2010) Miami Education Center Page 21 of 30
Calibrations
Calibration procedures are common to all calibrated tests. Variables are test-specific reagents and material used during calibration. The instrument requires certain tests to be calibrated either prior to or during sample analysis.
Dedicated: Calibration is a separate session, is initiated from the Calibration menu and is stored as the last executed calibration curve. The curve is viewable under calibration review from drop down menu.
In Session: Calibration is executed with the sample run and then can be used in later sample runs. (Calibration Plasma onboard sample tray, calibration will be performed automatically; if not the onboard stored calibration curve will be utilized for additional sample runs.)
Each Rotor: Every time a new rotor is loaded for that test a calibration must be done for that assay.
Calibration Summary
1. Select Calibration from drop down menu
2. Select Calibrate
3. Select Test from Tests to Calibrate
4. Select Materials Map and ensure: all reagents are onboard have ample volume and stability, this includes rotor supply, and Wash R Emulsion
5. Select Start
6. Upon completion review data and ensure r2 value is in acceptable range for assay and no errors are displayed (Repeat if necessary)
7. Successful completion, select Confirm to store calibration
CALIBRATION
Calibration
Materials Map
Verify/Change Lot Specific Information: • Lot Number • Expiration Date • ISI • Calibration Target
Analysis
Calibrate Select the Test to Calibrate
Review Calibration
Review data: • Acceptable r2 value • No calibration errors • Accept Calibration
Select Multi-Test or Single Test • Check Materials Map • Load Samples • Select Start
• Drop down menu displays all enabled tests for calibration
PN 774413 Rev AA (November 2010) Miami Education Center Page 22 of 30
PN 774413 Rev AA (November 2010) Miami Education Center Page 23 of 30
Troubleshooting
Types of messages generated with system problems
Warnings: displays as a yellow icon in the lower right toolbar region. Selecting the warning icon allow viewing of description of error. Instrument may continue to run, with some limitations depending on problem.
Alarm: warns user of problem requiring immediate attention. Some sub-functions and operations will still be available. Log off instrument, power off and on again; if error persists contact Call Center.
Failure: message indicates a problem serious enough to prevent further use of instrument. Attempt to log off instrument (if serious enough may not be able to navigate in software), power off and on again; if error persists contact Call Center.
Troubleshooting steps:
1. Gather information (what, how, when….)
2. Identify the symptoms (only when we do ____ )
3. Broadly Categorize (QC, sample tray, rotor area, temperature…)
4. Isolate the issue and develop a plan (what can I do before calling Call Center?)
5. Correct the issue
6. Verify the corrective action (run QC, re-calibrate, run samples….)
7. Document (use for regulatory or future training for peers)
Coagulation Errors
Error Description Abbreviated Flag Priority
Data Reduction Errors R 1 (highest)
Temperature Errors T 2
Instrument Errors E 3
Calibration Errors C 4
Analytical Reference Errors A 5
QC Errors Q 6
Parallelism Errors P 7
Errors on Algorithms, Ratio, Ranges W 8
Materials Errors M 9 (lowest)
PN 774413 Rev AA (November 2010) Miami Education Center Page 24 of 30
Error codes/meanings/remedies
Error Code
Meaning Flags Results Action
1 No flush/optical error
R Cycle abort
No results Replace Reference Emulsion bottle, clean optics and retest sample.
5 Optical failure
R Error 5 No result
ADC saturation (signal above 9.5 V at the end of clotting curve). Possible high Fibrinogen concentration. Dilute the sample 1:1 with factor Diluent and repeat the test.
6 No Coag R Error 6 No result
First threshold not passed. Sample does not clot within the acquisition time. Repeat the test in extended acquisition time.
7 Coag error R Error 7 No result
Second threshold not passed. Sample clot is noisy and does not give a normal clot signal within the acquisition time. Repeat the test in extended acquisition time.
8 Coag error R Error 8 No result
Delta time between the two thresholds is higher than the selected value. Possible non-phasic clotting curve. Review the clot curve. Possible sample interference with clotting reaction.
9 Coag error R Error 9 No result
Initial slope of the reaction curve is higher than the selected value. Possible bi-phasic clotting curve. Review the clot curve. Possible sample interference with the clotting reaction.
10 Coag error R Error 10 No result
Final slope of the reaction curve is higher than the selected value. Unstable endpoint of the clotting curve. Review the clot curve. Possible sample interference with the clotting reaction. Repeat the test in the extended acquisition time.
11 Final delta error
R Error 11 No result
Final delta of the reaction curve is higher than the selected value. If this is a nephelometric reaction, it may be an indication of an unstable endpoint in the clotting curve. Review the clot curve. Possible sample interference with the clotting reaction. Repeat the test in extended acquisition time. If this is an absorbance test, it may be an indication of an absorbance value outside the specified limit.
12 Coag error R Error 12 No result
Maximum peak of the first derivative is below the selected limit value. First derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time.
13 Coag error R Error 13 No result
Maximum peak of the second derivative is below the selected limit value. Second derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time.
14 Offset error R Error 14 No result
Offset of the initial part of the curve is above the selected limit value. Initial reaction turbidity is relatively high. Review the clot reaction curve.
30 Offset error (delta algorithm )
R Error 30 No result
Initial reaction turbidity is relatively low. Review the clot reaction curve. Check integrity of reagents, and make sure no bubbles are present.
PN 774413 Rev AA (November 2010) Miami Education Center Page 25 of 30
Error Code
Meaning Flags Results Action
31 Minimum Curve Delta not met
R. Error 31 instead of the result.
Review the curve and rerun the sample. Sample may have an extended clotting time.
32 Reaction curve baseline readings are erratic
Q-Noisy Baseline/ Reaction curve
Numeric Result displayed
Review Curve and repeat sample.
33 Reaction curve baseline readings are erratic
Q-Noisy Baseline/ Reaction curve
Numeric Result displayed
Review Curve and repeat sample.
40 QC not valid (No check QC selected)
Error 40. No QC result
No flag on samples
QC gives a non-valid result. Review the reaction curves. Repeat the test with freshly prepared materials.
41 QC not valid No flag on samples
Error 41. No QC result
QC gives a non-valid result. Review the reaction curves. Repeat the test with freshly prepared materials.
42 QC out of range
No flag on samples
QC result is not flagged
QC gives a result out of range. Review the reaction curves. Repeat the test with freshly prepared materials.
43 QC invalid s Q – Flag on patient samples
Error 43. No QC result
QC gives a non-valid result. Review the reaction curves. Repeat the test with freshly prepared materials.
44 QC out of range
Q – Flag on patient samples
QC is flagged
QC gives a non-valid result. Review the reaction curves. Repeat the test with freshly prepared materials.
70 Curve Sequence error
R Error 70 No result
Check sample and rerun. Clot curve not available. Sample may have an extended clotting time.
71 Too many spikes error
R Error 71 No result
Review curve, check sample and rerun. Invalid result. Sample may have an extended clotting time.
72 Baseline SD error
R Error 72 No results
Review curve, check sample and rerun. Invalid result. Sample may have an extended clotting time.
73 SyX value greater than Max. SD
R Error 73 No results
Review curve, check sample and rerun. Invalid result. Sample may have an extended clotting time.
Note: Full list of all errors codes are in Operators Manual, Chapter 6. This list represents a numerical sequence of more common error codes. (Operators Manual separates error codes by type of error, for example: QC, Calibration, Session Errors, Ratio and INR…, not necessarily sequenced numerically)
AccuTrak
AccuTrak is Instrumentation Laboratory’s inter-laboratory quality control program. This program will assist your QC program by:
• Statistically comparing your results with other labs using like reagents and instrumentation.
• Providing users with ongoing peer comparisons for managing laboratory quality. • Monitoring laboratory accuracy and precision. • Providing users with a selection of reports excellent for reviewing instrument
performance and satisfying inspectors’ requirements.
Enrolling in AccuTrak There are two choices for enrollment.
1. Call the AccuTrak center at 1-800-678-0710, option 7 and request a new users account.
• AccuTrak Laboratory Code Number. • AccuTrak Quality Control Program Procedures Manual. • 2 sets of data input forms. • Pre-addressed mailing envelopes. • Calendar with mailing dates indicating when your data should be put in
the mail. • AccuTrak On-Line Account Access registration information for on-line
QC services. After that, additional supplies can be ordered online at the website below or by calling at the number above.
2. Enroll on-line at www.ilus.com by selecting:
Service and Support ► AccuTrak ►complete enrollment information then Send Request.
Or type entire URL:
Once enrolled, you will receive an e-mail confirming registration and activation of your account.
PN 774413 Rev AA (November 2010) Miami Education Center Page 26 of 30
WWW.ILUS.COM
PN 774413 Rev AA (November 2010) Miami Education Center Page 27 of 29
PN 774413 Rev AA (November 2010) Miami Education Center Page 28 of 30
CHANGE THE DATE AND TIME
Select Setup / Date/Time
Drop Down arrow Cancel
Confirm Date/Time
Select Date Format- Use The Drop Down Box ▼ • dd.mm.yyyy (European style)
• yyyy.mm.dd (Japanese style)
• mm.dd.yyyy (USA style)
Set Date and Time, two numeric fields are available.
Note: Changing date to a previous date may impact results (Patient, QC and Calibration) and database FIFO (First In, First Out) operation. Follow the same procedure when changing the time to Daylight Savings Time (if applicable).
Review and select Confirm
PN 774413 Rev AA (November 2010) Miami Education Center Page 29 of 30
NEW TEST SETUP
Select the Test to Calibrate • Load Reagents. Per Materials Map: • Calibrate the Assay • When calibration is complete
review data and ensures that there is not error.
Setup Liquids
Enter Lot Specific Information: • Lot Number • Expiration Date • ISI* • Calibration Target
Select Multi-Test or Single Test • Check Materials Per Materials Map • Load Samples • Press Start
Analysis
Setup Test
• Enable Test • Modify Ranges • Calculation Setup
Mean of the Normal Range (MNR)
QC QC Setup/Review: • Mean & SD • QC Range Check • Patient Flag
View/Define:
Calibrate (dedicated)
New Test Setup
PN 774413 Rev AA (November 2010) Miami Education Center Page 30 of 30