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HOW TO PERFORM QUALITY TESTING
MANUFACTURER'S QUALITY SYSTEM INSTRUCTIONS (MQSI)
The list below defines the i-STAT Alinity System MQSI components.
1.
Check New or Replacement Instruments with the Electronic Simulator
Use the Electronic Simulator to verify operation of a new or replacement
instrument before use.
2.
Check Temperature Strip for a New Shipment of Cartridges
Verify that the temperature in transit was maintained by reading the
temperature strip included in each shipping container.
3.
Ensure Proper Cartridge Storage according to these criteria:
• Refrigerator storage conditions for stored cartridges range from 2 to 8ºC
(35 to 46ºF).
• Cartridges are not exposed to temperatures exceeding 30ºC (86ºF).
• Cartridges are not used after the expiration date printed on the individual
pouch and box.
• A cartridge taken from refrigerated storage must stand in its pouch at room
temperature for 5 minutes before use.
• A box of pouched cartridges must stand at room temperature for one hour
before use.
• A cartridge allowed to come to room temperature must be labeled with its
new expiration date. See Cartridge Box Information.
• A cartridge is used immediately after it is removed from its pouch.
4.
Ensure Thermal Probe Check is Performed
Ensure the thermal probe check is performed with the electronic simulator
every 6 months on each instrument. This check can be performed in
conjunction with the instrument's software updates.
5.
Train 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).
There may be additional accreditation organization requirements and individual
codes, statutes, or regulations which are not addressed here.
i-STAT Alinity — Quick Reference Guide
SECTION 6
Art: 731848-01
Rev. M
Rev. Date: 25-Jul-2022
25
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