Abbott i-STAT Alinity, Руководство по эксплуатации

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1.9 - Manufacturer's Quality System Instructions
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.
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i-STAT Alinity — System Operations Manual Art: 745532-01 Rev.D Rev. Date: 04-Mar-2021