Abbott i-STAT 1 System Manual page 306

The Foundation of The fundamental backbone of i-STAT's quality regimen is the series of
i-STAT's Quality
automatic checks performed each time a cartridge is run.
Control Regimen –
On-Line Tests
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.
Unit-Use Cartridge
20-10
• 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.
Verification
Microfabricated Electrochemical Sensor Elements
• verify sensors are present
• verify sensor characteristics are consistent with
expectations of a properly manufactured and maintained
device (by testing calibration fluid), if applicable
Calibration Fluid (if applicable)
• verify fluid is present
• verify fluid is delivered free of bubbles
• verify fluid has proper concentration
Fluidic System
• verify sample holding chamber is sealed
• verify fluid flowpaths are intact (no part of the analyzer
comes into direct contact with fluid)
• verify waste chamber is not occluded
Elements that interact with the handheld analyzer
• verify electrical contact pads (that allow access to sensor
signals) are unoccluded
• verify internal element of cartridge that allows the
handheld analyzer to control the release of calibration
fluid, if applicable, over the sensors is functioning
properly.
• verify internal element of cartridge that allows the
analyzer to control the replacement of calibration fluid, if
applicable, with sample is functioning properly
Art: 714382-01D
When Verified
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Every cartridge use
Rev. Date: 01-Apr-14