PROCEDURE MANUAL FOR THE i-STAT SYSTEM
19
REV. DATE: 16-Oct-12
ART: 714446-00L
Room Temperature Cartridges
Verify that all boxes of cartridges at room temperature have been out of the refrigerator less than the time
frame indicated on the cartridge box. Deliver any expired cartridges to the i-STAT System Coordinator.
Verify that room temperature has not exceeded 30°C.
Document in the i-STAT QC log.
Action:
If the measured temperature of the room has been continuously below 30°C (86°F) use cartridges as required.
Remedial Action:
If the measured room temperature has exceeded 30°C (86°F) for any period of time:
Quarantine the cartridges.
Notify the i-STAT System Coordinator immediately.
DO NOT USE the cartridges.
Record the out-of-control event in the i-STAT QC Log and the action taken.
Monthly Procedures
Print Electronic Simulator Results
Print a copy of the Electronic Simulator results from the Central Data Station. Include the report in the i-STAT QC Log.
CDS version lower than 5: Click on System and Electronic Simulator.
CDS version 5 and above: Click on the Simulator Viewer.
Print Control Fluid Analysis Results
Print results for any control fluids analyzed from the Central Data Station. Include the report in the i-STAT QC Log.
CDS version lower than 5: Use the Trend function.
CDS version 5 and above: Click on the Control Results Viewer.
Periodic Procedures for Cartridges
For acceptance of newly received cartridge lots, check the Temperature Monitor and perform integrity testing.
Check Temperature Monitor
i-STAT cartridges are shipped refrigerated with a four-window indicator to monitor temperature during transit.
Action:
Fill out the record of receipt and forward materials to refrigerator.
If all windows are white or if only the A or B windows are blue or the 1 or 2 windows are red, then transit
temperatures were satisfactory and the cartridges can be used.
Remedial Action:
If the C or D windows are blue, or the 3 or 4 windows are red:
Quarantine the suspect cartons.
Notify the i-STAT System Coordinator immediately.
DO NOT USE cartridges from the suspect cartons.
Record the out-of-control event in the i-STAT QC Log.
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