Art: 723085-00K Rev. Date: 30-OCT-2014
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Manufacturer’s Quality System Instructions
Quality control procedures are used to ensure the continued accuracy of a test
system. The quality control program for the VetScan i-STAT 1 System includes:
•
Automatic quality checks:
A series of automatic quality checks are performed
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 Operator’s Manual. The quality checks detect
improper environmental conditions, analyzer function, cartridge filling, cartridge
function and sensor function.
•
Checking New or Replacement Analyzers with the Electronic Simulator:
Use
the Electronic Simulator, internal or external, to verify the operation of a new or
replacement analyzer before use.
The internal Electronic Simulator will automatically activate the first time a new or
replacement analyzer is used and after every 24 hours of use thereafter. The
analyzer can be customized to remind the operator to perform the simulator test
or automatically run the simulator more frequently as required or desired.
•
Performing Daily Quality Control with the Electronic Simulator:
Check each
analyzer with the Electronic Simulator, using either the internal or external
simulator, once on each day of use.
•
Checking Temperature Strip for a New Shipment of Cartridges:
Verify that the
transit temperatures were satisfactory by reading the temperature strip included
in each shipping container.
•
Ensuring Thermal Probe Check is Performed:
Ensure the thermal probe check is
performed every 6 months on each analyzer. This check can be performed in
conjunction with the analyzer software updates as instructed in the Operator’s Manual.
•
Training Staff on Avoidance of Pre- and Post-analytical Errors:
Ensure that
users are trained to avoid pre-analytical errors such as those associated with
sample collection, delays in testing, inadequate sample mixing, and post-analytical
errors (results reporting and communication).
•
Updating Software, then Checking with External Electronic Simulator:
Update the VetScan i-STAT System software as provided by Abaxis. Check the
analyzer with the external Electronic Simulator after software updates. The
thermal probe check can also be taken from this check.
