Abbott Point of Care Inc. • Abbott Park, IL 60064 • USA
Art: 721317-00D Rev. Date: 13-Aug-12
TECHNICAL BULLETIN
i-STAT
®
The i-STAT System Manufacturer’s
Quality System Instructions
(for U.S.A. Laboratories only)
OVERVIEW
The Manufacturer’s Quality System Instructions (MQSI) represent what are necessary to ensure quality
results (accurate, precise and reliable) based upon the specific characteristics of the i‑STAT System.
Three key technological characteristics of the i‑STAT System underlie the MQSI:
1. The unit‑use cartridges are stable when stored properly.
2. The system has been designed so that any user influence on the analytical process is detected
and flagged.
3. The performance of the handheld reader is verified by a combination of automated quality
checks and procedural controls during each test event, supplemented by electronic quality
control.
MANUFACTURER’S QUALITY SYSTEM INSTRUCTIONS
The list below defines the i‑STAT System MQSI components.
Number MQSI Description
1 Perform Daily Quality Control with Electronic Simulator
Check each Handheld reader with the Electronic Simulator, using either the internal or external
simulator, once on each day of use.
2
Check New or Replacement Handheld Readers with the Electronic Simulator
Use the Electronic Simulator, internal or external, to verify operation of a new or replacement
handheld reader before use.
The internal Electronic Simulator will automatically activate the rst time a new or replacement
handheld is used and after every 24 hours of use thereafter. The handheld can be customized
to remind the operator to perform the simulator test (i‑STAT Portable Clinical Analyzer and
i‑STAT 1 Analyzer) or automatically run the simulator (i‑STAT 1 Analyzer) more frequently as
required or desired.
3 Check 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.
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