Abbott i-STAT 1 System Manual

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Abbott i-STAT 1 System Manual Manual pdf 20 page image

10 Art: 720672-00J, Rev. Date: 11-Oct-17Quality ControlQuality control procedures are used to ensure the continued accuracy of a test system.The quality control program for the i-STAT System includes:• Automatic quality checks: A series of automatic quality checks are performedduring each test cycle. When there is a quality check failure, a message is displayedwith the cause and corrective action. A complete list of quality check messages canbe found in the System Resources section of this manual. The quality checks detectimproper environmental conditions, handheld function, cartridge filling, cartridgefunction and sensor function.• Electronic Simulator check: An independent check of the handheld's ability to takeaccurate and precise readings from the sensors is performed automatically every 24hours when cartridges are being tested. An external Electronic Simulator is used toverify an internal Electronic Simulator failure and perform the twice yearly Thermal Probecheck described in the System Resources section. Both the internal and externalsimulator results are stored in the handheld’s memory.Both the internal and external Electronic Simulator send signals that simulatethose of a cartridge to the handheld's signal detection system. The signalsare below and above the measurement ranges of the tests and theacceptance limits are tighter than those for liquid control samples. Therefore,the simulator test is more sensitive to an out-of-specification condition thanliquid control samples.The internal simulator check is triggered by the insertion of a cartridge onceevery 24 hours. If the check passes, the cartridge test cycle continues. If thecheck fails, "FAIL" and a failure code are displayed. A cartridge test cannot beperformed until the handheld passes the simulator check. If the FAILmessage is observed when it occurs, the cartridge can be re-inserted. If FAILis displayed a second time, the external simulator can be used to verify thatthe failure is being caused by the handheld and not by a faulty cartridge.Note that if there is a delay between the time the cartridge is inserted and thetime the display is read, use a fresh cartridge and sample or the externalsimulator rather than re-inserting the original cartridge.• Liquid control samples: Used to perform independent checks of systemperformance. Their use is an accepted way of verifying performance with traditionalquantitative tests. Although this is a unit use test system, the waived statuscategorization for this product requires laboratories to test controls. Control testingfrequency: test one cartridge from each lot in each shipment upon receipt and test asingle cartridge from the refrigerator monthly. Select cartridges in the order asspecified in the Testing Procedures section.• Cartridge storage: Proper cartridge storage conditions as described in the cartridgeTesting Procedures section are required for reliable results.