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cobas c 311

Roche cobas c 311 Short Guide

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cobas c 311 analyzer Short Guide
1
Preparing the analyzer ............................................................................................... 2
Starting the analyzer................................................................................................... 2
System Overview – Workflow Guide ......................................................................... 2
Daily Maintenance................................................................................................. 2
Sample Data Clear ................................................................................................ 2
Reagent Preparing ................................................................................................ 3
Calibration and QC Select.................................................................................... 4
End of routine........................................................................................................ 4
Application, Calibration and QC set up .................................................................... 5
Loading application parameters from cobas link .............................................. 5
Checking parameter settings for each test ........................................................ 5
Assigning tests to the photometric or ISE unit .................................................. 5
Assigning tests to test keys................................................................................. 6
Loading calibrator data from cobas link............................................................. 6
Adding calibrator data manually ......................................................................... 6
Loading control data from cobas link ................................................................. 7
Adding control data manually.............................................................................. 7
Checking the Report Format................................................................................ 8
Assigning sample positions for non-barcoded calibrators............................... 8
Assigning sample positions for non-barcoded controls................................... 8
Customer Maintenance Overview ............................................................................. 9
cobas c 311 analyzer Short Guide
2
Preparing the analyzer
Always take suitable safety measures as described in the Operator’s Manual.
1 Check that the container for highly concentrated waste is clean and empty.
2 Check for any leaks inside or around the instrument.
3 Check that the cell covers, pipetter probes, ISE sipper nozzle, and the rinse nozzles are clean.
If a trouble occurs, take the necessary remedial action.
Starting the analyzer
1 Switch on instrument. When the automatic power up is specified in the analyzer software, the pipe
function will be executed automatically.
2 Switch on control unit computer.
3 Switch on water supply.
4 Logon to the analyzer software using your operator ID and password.
Note: When the analyzer is in sleep mode, it starts up automatically by using the sleep pipe function
(Power Up Pipe with starting time).
System Overview – Workflow Guide
Daily Maintenance
1 Check for alarms.
2 Perform required maintenance action or maintenance pipe function:
Daily
Maintenance
>
Select
>
Execute
Sample Data Clear
All measurement results of routine and STAT samples will be deleted. The measurement results of
quality control samples will be moved to the QC view area of data storage control section.
1
Sample
Data Clear
>
Clear or Backup and Clear
>
OK
.
cobas c 311 analyzer Short Guide
3
Reagent Preparing
1 Select the Preventive Action check box on the System Overview screen.
2
Reagent
Preparing
>
Reagent Load/
Unload List
>
Yes
The Reagent Load list will be printed for reagents with yellow, purple, or red alarm.
3 Load reagents onto the instrument according to the reagent load list.
4 Remove all empty cobas c packs from the analyzer.
Replacing ISE reagents
1 Before replacing a reagent bottle, put the analyzer in Maintenance mode or Shutdown status.
2 After replacement turn the maintenance switch back to Operation mode (or power up the analyzer if
it was in Shutdown status).
3 Perform a Reagent Prime if an ISE Ref. or ISE IS bottle has been replaced:
Reagent
Preparing
>
Reagent Prime
.
4 Select all.
5
Execute
6 Recalibrate the ISE unit before you resume routine operation.
Module System Reagent Bottle size Notes
NaOH-D 2.0 L CellCln Position 1
Acid Wash Solution 2.0 L CellCln Position 2
Multiclean 70 mL SmpCln Position 1
SMS 70 mL SmpCln Position 2
Reagent
Volume Reset
NaCl 9% Diluent c pack DIL on reagent disk
NaOH-D c pack D1 on reagent disk
SMS c pack D2 on reagent disk
Photometric
unit
Hitergent c pack Hit-D on reagent disk
ISE Ref. 300 ml
ISE Dil. 300 ml
ISE unit
ISE IS 600 ml
Reagent
Level Reset
cobas c 311 analyzer Short Guide
4
Calibration and QC Select
The analyzer automatically recommends calibrations and controls to be performed. But the
recommended calibrations and QCs must be confirmed by the operator before they can be
measured.
1
Calibration and
QC Select
>
Recommended
2 Print the Calibrator and QC Load List:
Print
.
3 Load calibrator and QC samples onto the analyzer according to the calibrator and QC load list.
4
Start
End of routine
1 Load wash solutions for ISE wash:
Pos. W1: ISE Cleaning Solution SysClean
Pos. W2: ISE Activator
SmpCln Position 1: Multiclean
2
Utility
>
Maintenance
3 Select maintenance item (10) ISE Wash.
4
Select
>
Execute
cobas c 311 analyzer Short Guide
5
Application, Calibration and QC set up
Loading application parameters from cobas link
1
Utility
>
Application
>
Download
2 Select one of the available search conditions.
3
Search
4 Select the check box of the parameters to be downloaded.
5
Download
>
OK
>
OK
6 Check that the parameters have been downloaded.
Note: For the first installation the parameters for diluent and cleaners have to be downloaded.
Checking parameter settings for each test
1
Utility
>
Application
>
Analyze
2
Utility
>
Application
>
Calib.
3 Change to QC Violation, if required.
4
Utility
>
Application
>
Range
5 If required, change the Unit, define a Report Name, select Automatic Rerun, define Repeat Limit,
Control Interval Time, AutoQC On Board Stability time, Qualitative fields and Expected Values.
6
Utility
>
Application
>
Others
7 Enter the Calibrator Code for ISE tests.
Assigning tests to the photometric or ISE unit
1
Utility
>
Module Set
>
Test
Assignment
2 Check if the Assign check box is active for each test.
3 Select Mandatory, if a reagent has to be on board all the time.
4 Select Na, K, Cl or Na, K (ISE).
5
OK
cobas c 311 analyzer Short Guide
6
Assigning tests to test keys
1
Utility
>
System
>
Key Setting
2 Select an empty test key.
3 Select a test.
4
OK
>
Update
>
OK
Loading calibrator data from cobas link
1
Calibration
>
Install
>
Download
2 Select one of the available search conditions.
3
Search
4 Select the check box of the calibrators to be downloaded.
5
Download
>
OK
>
OK
6 Check that the calibrator data has been downloaded.
Adding calibrator data manually
1
Calibration
>
Install
2 Select a blank line.
>
Add
3 Type all necessary data in the Add Calibrator window.
>
OK
The new calibrator appears on the calibrator list.
4
Edit
5 Type in the concentration values for each test.
6
Update
>
OK
cobas c 311 analyzer Short Guide
7
Loading control data from cobas link
1
QC
>
Install
>
Download
2 Select one of the available search conditions.
3
Search
4 Select the check box of the control to be downloaded.
5
Download
>
OK
>
OK
6 Check that the control data has been downloaded.
Adding control data manually
1
QC
>
Install
2 Select a blank line.
>
Add
3 Type all necessary data in the Add Control window.
>
OK
The new control appears on the control list.
4
Edit
5 Enter Target mean, Target SD, and confidence limits High and Low, if necessary.
6
Update
>
OK
Activating control tests:
1
QC
>
Install
2 Select a control from the list on the left.
3 Select a test to be activated from the list on the right.
4
Activate Test
Activated test are highlighted green.
cobas c 311 analyzer Short Guide
8
Checking the Report Format
1
Utility
>
Report Format
Area: Print Order
2 Check if a Line number is defined for each test. Otherwise this result will not be printed.
Assigning sample positions for non-barcoded calibrators
1
Calibration
>
Calibrator
>
Position
Assignment
2 Select the calibrator to be assigned from the list on the left.
3 Select an empty sample position from the list on the right.
4
Assign-->
5 To undo an assignment
<--Remove
6 After all assignments are completed:
OK
.
Assigning sample positions for non-barcoded controls
1
QC
>
Control
>
Position
Assignment
2 Select the control to be assigned from the list on the left.
3 Select the corresponding sample position from the list on the right.
4
Add-->
5 To undo the assignment
<--Remove
6 After all assignments are completed:
OK
.
cobas c 311 analyzer Short Guide
9
Customer Maintenance Overview
Always take suitable safety measures as described in the Operator’s Manual.
Daily Every 2 months
Clean pipetter probes and ISE sipper
[M2]
1
Every 2 months or 9000 tests: Replace
ISE measuring cartridges [M14]
Clean cell rinse nozzles [M3]
2
Clean the ISE drain port [M4]
2
Quarterly
Empty the waste solution container Clean the ultrasonic mixer [M15]
3,2
Check the drain tube of the vacuum
tank (empty it if necessary)
Replace the ISE pinch valve tubing
[M16]
Clean up instrument surfaces
1
Replace the ISE sipper tubing [M17]
Daily Sleep pipe
Every 3 months or 112,500 tests (56,250
tests for ISE): Replace the syringe seals
[M18]
Perform (10) ISE wash [M1]
(W1: SysClean, W2: Activator)
Every 6 months
Only if running DAT assays:
Perform (10) ISE Wash and (6) Wash
Reaction Parts
Clean the inlet water filter [M19]
2
Vacuum clean the cooling fan [M20]
Every 750 hours or if photometer check
value exceeds 14,000:
Replace the photometer lamp [M21]
Weekly
Replace the ISE ref. cartridge [M22]
Perform (6) Wash Reaction Parts and
(3) Cell blank [M5]
Clean cell covers [M6]
1
Clean the probe rinse stations
3,2
and
drying cylinders
1
[M7]
As needed
Check / clean the water tank [M8]
2
Eliminate clogging of sample / reagent
probe (sample probe: 0.2 mm, reagent
probe 0.5 mm stainless steel wire) or
replace probes [M23]
Monthly
Replace cell rinse nozzle tips [M24]
Replace reaction cells and clean
incubator bath [M9]
2 or 3
Drain the vacuum tank [M25]
Clean ISE Ref. aspiration filter [M10]
4,2
Clean detergent aspiration filters
[M11]
4,2
Vacuum clean the radiator filter [M12]
Perform (12) Flow path wash
(Cell wash II) [M13]
1
with 70% Ethanol
2
with deionized water
3
with 2% Hitergent solution
4
with tap water
/