Art: 714377-00K Rev. Date: 31-Jan-12 15-3Acceptable Criteria Target values (determined by testing multiple ampules of each level usingmultiple lots of i-STAT cartridges with analyzers that have passed the ElectronicSimulator test) are printed on a Value Assignment Sheet posted on the APOCwebsite at www.abbottpointofcare.com.Calibration throughout the reportable range of each analyte is verified if eachanalyte value falls within the corresponding range in the Value AssignmentSheet.If the result for a level is outside the range published in the Value AssignmentSheet, two additional cartridge runs should be performed on this level and thethree results averaged and then compared to the Value Assignment Sheet range.If this average value is still outside the acceptable range, troubleshooting maybe required.Note: If the Calibration Verification Set is to be used to assess linearity, plotthe analyte value against the mean value of the acceptable range. Theconcentrations of analytes in the Calibration Verification Set are notintended or prepared to be equally spaced.If testing at extreme altitude refer to Correction of PO2 at Extreme Altitudeunder Controls for Blood Gas/Electrolyte/Metabolite Cartridges in the QualityControl section of the manual.Overview of Procedure i-STAT recommends that each sensor type be included in the CalibrationVerification procedure using a selection of analyzers that have passed theElectronic Simulator check. See the Technical Bulletin "Calibration Verficationand the i-STAT System" for more information.Calibration VerificationSolutions for CHEM8+CartridgesA five-level Calibration Verification Set is available to verify the calibration ofi-STAT CHEM8+ cartridges throughout the reportable ranges for:Sodium TCO2 GlucosePotassium BUN/Urea CreatinineChloride Ionized CalciumThere are four 1.7mL glass ampules of each level in the set.An additional i-STAT CHEM8+ Calibration Verification Level 1b is available forpurchase to verify the calibration of the i-STAT CHEM8+ TCO2 at the low endof the reportable range.Reactive Ingredients See the table on page 14-6 of the Quality Control section for fullinformation.Storage Refrigerated storage at 2 to 8 °C (35 to 46°F) should be maintained untilthe printed expiration date on the box and ampule labels. i-STAT CHEM8+Calibration Verification fluids may also be stored at room temperature for upto 5 days (18 to 30 °C or 64 to 86°F). Prolonged storage at temperatures greaterthan 30 °C (86°F) may cause changes in the values of some analytes. Do notuse beyond the expiration date on the box and ampule labels.Ampule Use A separate ampule must be used for each cartridge being tested.i-STAT CHEM8+ CALIBRATION VERIFICATION SET
