Quality Control (QC) testing of the iSTAT-1 Glucose Test consists of the following:
· A series of automatic checks during each test cycle.
· An automatic internal electronic simulator check triggered by the insertion of a cartridge performed once every 24 hours when the analyzer is used continuously.
· An external electronic simulator test performed when the internal electronic simulator test fails or after the iSTAT is dropped.
· Testing the cartridges in accordance with the Package Insert using two levels of Liquid Quality Controls (LQC: Level 1 and Level 3). LQC should be performed monthly on a rotational basis by location and whenever new shipments and new lots of control materials or creatinine cartridges are received. Acceptable QC results will be indicated by a PASS status on the iSTAT screen.