Quality Control - Abbott i-STAT 1 System Manual

Quality Control

Quality 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 performed
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during each test cycle. When there is a quality check failure, a message is displayed
with the cause and corrective action. A complete list of quality check messages can
be found in the System Resources section of this manual. The quality checks detect
improper environmental conditions, handheld function, cartridge filling, cartridge
function and sensor function.
Electronic Simulator check: An independent check of the handheld's ability to take
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accurate and precise readings from the sensors is performed automatically every 24
hours when cartridges are being tested. An external Electronic Simulator is used to
verify an internal Electronic Simulator failure and perform the twice yearly Thermal Probe
check described in the System Resources section. Both the internal and external
simulator results are stored in the handheld's memory.
Both the internal and external Electronic Simulator send signals that simulate
those of a cartridge to the handheld's signal detection system. The signals
are below and above the measurement ranges of the tests and the
acceptance limits are tighter than those for liquid control samples. Therefore,
the simulator test is more sensitive to an out-of-specification condition than
liquid control samples.
The internal simulator check is triggered by the insertion of a cartridge once
every 24 hours. If the check passes, the cartridge test cycle continues. If the
check fails, "FAIL" and a failure code are displayed. A cartridge test cannot be
performed until the handheld passes the simulator check. If the FAIL
message is observed when it occurs, the cartridge can be re-inserted. If FAIL
is displayed a second time, the external simulator can be used to verify that
the 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 the
time the display is read, use a fresh cartridge and sample or the external
simulator rather than re-inserting the original cartridge.
Liquid control samples: Used to perform independent checks of system
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performance. Their use is an accepted way of verifying performance with traditional
quantitative tests. Although this is a unit use test system, the waived status
categorization for this product requires laboratories to test controls. Control testing
frequency: test one cartridge from each lot in each shipment upon receipt and test a
single cartridge from the refrigerator monthly. Select cartridges in the order as
specified in the Testing Procedures section.
Cartridge storage: Proper cartridge storage conditions as described in the cartridge
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Testing Procedures section are required for reliable results.
10 Art: 720672-00J, Rev. Date: 11-Oct-17