Abbott i-STAT 1, Системное руководство

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PROCEDURE MANUAL FOR THE i-STAT SYSTEM
18
REV. DATE: 16-Oct-12 ART: 714446-00L
QUALITY CONTROL
Daily Procedures
Handheld Verification
Verify the performance of each handheld in the i-STAT System using the internal or external Electronic Simulator every 24
hours of use, or as needed for regulatory compliance. In the USA, verification is required every 8 hours for blood gases,
hematocrit, ACT, PT/INR, cTnI, CK-MB, and BNP.
Action:
If PASS is displayed on the handheld screen (after using the external Electronic Simulator):

Remove the external Electronic Simulator after the LCK or Simulator Locked message disappears from the
display screen.

Transmit the result to the Central Data Station.

Use the handheld as required.
Note:
If the internal Electronic Simulator is used, the “PASS” message will not be displayed on the handheld
screen. The “PASS” record will appear in the handheld’s stored results for transmission to the Central Data Station.
Remedial Action:
If FAIL is displayed on the analyzer screen:

Repeat the procedure with the same external Electronic Simulator or rerun the cartridge if the internal
Electronic Simulator is being used. If PASS is displayed use the handheld as required.

If FAIL is displayed repeat the procedure with a different external Electronic Simulator.
If PASS is displayed with the second external Electronic Simulator:

Use the handheld as required.

Deliver the questionable external Electronic Simulator to the i-STAT System Coordinator.
If FAIL is displayed with the second external Electronic Simulator:

DO NOT analyze patient samples with the handheld.

Transmit the results to the Central Data Station.

Deliver the faulty handheld to the i-STAT System Coordinator.

Record the failure in the i-STAT QC Log along with the action taken.
Verification of Cartridge Storage Conditions
Refrigerated Cartridges

Verify that the cartridges stored in the refrigerator are all within the expiration date printed on the boxes.
Deliver any expired cartridges to the i-STAT System Coordinator.

Verify that the refrigerator did not exceed the limits of 2 to 8°C (35 to 46°F).

Document in the i-STAT QC Log.
Action:
If the temperature of the cartridge storage refrigerator is within the range of 2 to 8°C (35 to 46°F) use
cartridges as required.
Remedial Action:
If the temperature is outside the range of 2 to 8°C (35 to 46°F), quarantine the cartridges in the storage
refrigerator. Notify the i-STAT System Coordinator immediately. DO NOT USE the cartridges from this
refrigerator. Record the QC failure in the i-STAT QC Log along with the action taken.