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REVISION
STATUS
* 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.
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.
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.
Maintenance
Frequency
Log Sheet
Order
informatio
n for
Expendabl
es
Quality Controls
Calibration
Troubleshooting
Coagulation
s Errors
Troubleshooting Error Codes
Troubleshooting Calibration Errors
AccuTrak
Enrollment
(Host) Transmit
Delete
Details
New Sample
Note
Patient Name
Patient Details
Resume Hold
Starts the operations paused due to a
STAT request
Data Base View Ready
The system goes back to the database Operating
view or “Main” screen Hold
Host Status Ready
Icon appears only during communication Operating
with the Host to inform the operator Hold
about the status of this action. Failure
Warning Ready
This icon appears when Operating
there is at least one Hold
warning. Press to open Failure
“Warning List”.
Log Out Ready
Allows the operator to Failure
exit the screen.
Confirmation is
required
Icon Meaning
QUALITY CONTROL
Indicates there are data (results) in the database
QUALITY CONTROL
Indicates a failure in a quality control test result
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
Empty or STAT
Available
Not Pending
Programmed
Programmed Complete
Processing Not
Programmed
Complete Sample
Processing
Pending Quality
Control
Warning or Low
Errors Volume
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.
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.
PN 774413 Rev AA (November 2010)
Miami Education Center Page 7 of 30
Sample Status
Selecting the sample position circle will display the information about that sample.
Instrument Status in Ready, prepare the start of a run by performing these tasks
or verify performance:
Reagent Status – Check for adequate reagent volumes and acceptable on-
board stability (See Materials Map page, Training Manual or Operators Manual
for specifics)
1. Place primary tubes with barcode labels facing outward on Sample Tray
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.
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
4. Select the Test Profile with the tests ordered for the specimens placed on the
Sample Tray
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:
3. Message appears asking; “The running session will be held. Is that OK?”
Answer Yes
5. The instrument will prompt; “STAT sample can be inserted now” Select OK
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)
Load Samples
Select
Analysis
No
Host
Host
Non
Barcoded Barcoded
Start
Warning:
Material ID Specimen
Map
Enter demographics
Order tests
Verify
Reagents
Review Start
Results
Daily:
Check Wash R Emulsion volume
Check Liquid Waste, if necessary
Empty Rotor Waste Container
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
Log Sheet
Make Copies
as needed
Year
DAILY
CHECK WASH R-EMULSION
LEVEL
EMPTY LIQUID WASTE IF
NECESSARY
EMPTY ROTOR WASTE
CONTAINER
PERFORM NEEDLE CLEANING
PROCEDURE
CLEAN WASTE LINE,
DEPENDENT ON DAILY
WORKLOAD
PRIMING - START OF
SHIFT/DAY
PRIMING- END OF SHIFT/DAY
WEEKLY
CLEAN INSTRUMENT
CLEAN RINSE RESERVOIR
BIWEEKLY
REBOOT THE ANALYZER
CLEAN ROTOR HOLDER AND
OPTIC PATH
MONTHLY
CHECK AND CLEAN AIR FILTER
AS NEEDED
MAINTENANCE
REPLACE NEEDLE
NEEDLES POSITION
PERFORM WASTE LINE
BLEACHING
DECONTAMINATION
PROCEDURE
CLEAN LCD SCREEN
HARD DRIVE MAINTENANCE
DISK
TECH INITIALS
PN 774413 Rev AA (November 2010)
Miami Education Center Page 16 of 30
Ordering Information for Expendables
Set up QC
1. Select QC
2. Setup / Review
o Target Mean
o Target SD
o SD Range
9. Select Flag Patient Results-Flags patients results after an out of range control is
detected
Setup QC LoadList
10. Analysis
12. Select the Multi-test that contains the tests for QC material
13. Select Add QC, a list will display all setup QC Liquid List
1. Select Analysis
8. Select Confirm
9. Select Start
11. QC out of range will show the QC icon with a red ! alert
12. Results:
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:
Clear
Single
Clear
Print All
Today QC
Print
All QC Cumulative
Levey
Jennings
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
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
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)
Review data:
Review
Calibration Acceptable r2 value
No calibration errors
Accept Calibration
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.
4. Isolate the issue and develop a plan (what can I do before calling Call Center?)
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
Parallelism Errors P 7
Errors on Algorithms, Ratio, Ranges W 8
Materials Errors M 9 (lowest)
12 Coag error R Error 12 Maximum peak of the first derivative is below the
No result 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 Maximum peak of the second derivative is below the
No result 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 Offset of the initial part of the curve is above the selected
No result limit value. Initial reaction turbidity is relatively high.
Review the clot reaction curve.
30 Offset error R Error 30 Initial reaction turbidity is relatively low. Review the clot
(delta No result reaction curve. Check integrity of reagents, and make
algorithm ) sure no bubbles are present.
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)
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
1. Call the AccuTrak center at 1-800-678-0710, option 7 and request a new users
account.
After that, additional supplies can be ordered online at the website below or by
calling at the number above.
Once enrolled, you will receive an e-mail confirming registration and activation
of your account.
Drop Down
arrow Cancel
Date/Time Confirm
View/Define:
Enable Test
Setup Modify Ranges
Test Calculation Setup
Mean of the Normal Range (MNR)
QC Setup/Review:
QC Mean & SD
QC Range Check
Patient Flag