Calibration Of The I-Stat Alinity Instrument - Abbott i-STAT Alinity Operation Manual

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Calibration of the i-STAT Alinity instrument

The instrument houses the mechanical and electrical systems necessary to control fluid movement
within the cartridge, control the temperature, measure barometric pressure, measure electrical signals
generated by the sensors, and display and transmit results. The instrument's functions are factory
calibrated to specifications that are programmed into the instrument along with acceptability limits,
which, when exceeded, cause the instrument to display quality check messages, or to display *** rather
than results.
Abbott Point of Care developed the internal simulator that functions as a signal-checking mechanism on
every cartridge inserted. The internal simulator is a combination of hardware and software that tests the
ability of the instrument to accurately read sensor signals. The instrument performs an internal simulator
test on every cartridge run. The internal simulator simulates potentiometric, amperometric, and
conductiometric signals at three levels consistent with a range that includes very high and very low
concentrations of analytes. The simulation is conducted depending upon the cartridge inserted to
perform this testing. Therefore, the set of sensors on the inserted cartridge determines the signals
tested.
i-STAT Alinity — System Operations Manual Art: 745527-01 Rev. N Rev. Date: 13-Oct-2022