ELECTRONIC SIMULATOR 5Art: 714367-00D Rev. Date: 25-Aug-11 5-1The external Electronic Simulator is a stable electronic device, which is insertedinto the cartridge port. The test cycle for the external Electronic Simulator isabout 60 seconds. (The test cycle for the internal simulator is shorter becauseit shares the initial part of the test cycle with the cartridge.)Overview The Electronic Simulator, external and internal, is a quality control devicefor the analyzer’s cartridge signal-reading function. It simulates two levels ofelectrical signals that stress the analyzer’s cartridge signal detection functionboth below and above measurement ranges.While the analyzer performs internal electronic checks and calibration duringeach test cycle, the Electronic Simulator test provides an independent checkon the ability of the analyzer to take accurate and sensitive measurements ofvoltage, current and resistance from the cartridge. An analyzer will pass orfail this electronic test depending on whether or not it measures these signalswithin 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 theoperator to run the external simulator can be set by the number of hours onthe i-STAT Portable Clinical Analyzer and by the hours or tests on the i-STAT 1Analyzer. The schedule for the automatic internal Electronic Simulator can beset by the number of hours on the i-STAT Portable Clinical Analyzer and by thehours or tests on the i-STAT 1 Analyzer. For details and lockout options, see theCustomization section of this manual.Note: All analyzers that pass the Electronic Simulator test are equivalent.Therefore, any representative number of analyzers that pass theSimulator test may be used for compliance with regulatory andaccreditation quality assurance procedures. These procedures includeinitial performance verification studies, calibration verification,proficiency testing, and method comparison studies.Relative Humidity The Electronic Simulator test will fail if high humidity interferes with themeasurements. Therefore it is not necessary to record humidity where theanalyzers 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 acartridge is inserted before the sample is tested, adding about 20 seconds to thetesting cycle.External Simulator
