20-10 Art: 714382-00D Rev. Date: 02/20/06
The analyzer controls all fluid motions in the i-STAT System. The
calibrant and sample are brought to the sensors under instrument
control so that the user does not directly impact on the quality of the
analytical process and therefore cannot impinge on the quality of the
results.
Further, the analyzer uses a fluid sensor to electronically verify the
proper flow of fluids within the cartridge on every run. This can
easily be demonstrated by attempting to fool the system by:
• putting in too much sample
• putting in too little sample
• rerunning the same cartridge
• introducing an air segment into the fluid segment, etc. The
analyzer will flag these conditions and not deliver a result.
3) The design of some unit-use point-of-care devices can allow an
entire batch of unit-use devices to be affected by a single event, for
example, by leaving a tube of paper strips open and exposed to a
high humidity environment.
With the i-STAT System, each unitized device is sealed in a separate
foil pouch and has its own individual history. The only external
factor, which can create a shared history among cartridges, is
temperature. This is controlled by appropriately monitoring the
storage environment.
The Foundation of
i-STAT’s Quality
Control Regimen
– On-Line Tests
The fundamental backbone of i-STAT’s quality regimen is the series of automatic
checks performed each time a cartridge is run.
The tables below list the key elements and operations of the i-STAT System that
are verified each time a cartridge is used.
For completeness, those operations which are qualified by the Electronic
Simulator are also listed.
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