Electronic Simulator; Relative Humidity; Internal Simulator; External Simulator - Abbott i-STAT 1 System Manual

Overview The Electronic Simulator, external and internal, is a quality control device
for the analyzer's cartridge signal-reading function. It simulates two levels of
electrical signals that stress the analyzer's cartridge signal detection function
both below and above measurement ranges.
While the analyzer performs internal electronic checks and calibration during
each test cycle, the Electronic Simulator test provides an independent check
on the ability of the analyzer to take accurate and sensitive measurements of
voltage, current and resistance from the cartridge. An analyzer will pass or
fail this electronic test depending on whether or not it measures these signals
within limits specified in the analyzer software.
The schedule for the Electronice Simulator can be customized to meet local,
state, or national accreditation requirements. A reminder message for the
operator to run the external simulator can be set by the number of hours on
the i-STAT Portable Clinical Analyzer and by the hours or tests on the i-STAT 1
Analyzer. The schedule for the automatic internal Electronic Simulator can be
set by the number of hours on the i-STAT Portable Clinical Analyzer and by the
hours or tests on the i-STAT 1 Analyzer. For details and lockout options, see the
Customization section of this manual.
Note: All analyzers that pass the Electronic Simulator test are equivalent.

Relative Humidity

The Electronic Simulator test will fail if high humidity interferes with the
measurements. Therefore it is not necessary to record humidity where the
analyzers are in use.

Internal Simulator

When the specified time has elapsed since the last Electronic Simulator test
(internal or external), the internal test will automatically be performed when a
cartridge is inserted before the sample is tested, adding about 20 seconds to the
testing cycle.

External Simulator

The external Electronic Simulator is a stable electronic device, which is inserted
into the cartridge port. The test cycle for the external Electronic Simulator is
about 60 seconds. (The test cycle for the internal simulator is shorter because
it shares the initial part of the test cycle with the cartridge.)
Art: 714367-00D

ELECTRONIC SIMULATOR

Therefore, any representative number of analyzers that pass the
Simulator test may be used for compliance with regulatory and
accreditation quality assurance procedures. These procedures include
initial performance verification studies, calibration verification,
proficiency testing, and method comparison studies.
Rev. Date: 25-Aug-11
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