Art: 714377-00K Rev. Date: 31-Jan-12 15-5Calibration 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 i-STAT CHEM8+ Calibration Verification Set is to be used to assesslinearity, plot the analyte value against the mean value of the acceptablerange. The concentrations of analytes in the i-STAT CHEM8+ CalibrationVerification Set are not intended or prepared to be equally spaced.i-STAT CARDIAC MARKER CALIBRATION VERIFICATION SETA three level Calibration Verification Set is available to verify the calibration ofcTnI cartridges throughout the reportable range.There are two 1.0 mL plastic vials of each level in the set.Intended Use i-STAT® Cardiac Markers Calibration Verification Controls are assayed humansera used to verify the calibration of the cTnI test throughout the reportablerange.Warnings andPrecautionsHandle this product using the same safety precautions used when handling anypotentially infectious material. The human sera used in the preparation of thisproduct have been tested by FDA approved test methods and found negative/non-reactive for HIV-1, HIV-2, HBsAg, HCV, HTLV-1 and HTLV-2. However, noknown test method can offer complete assurance that products derived fromhuman blood will not transmit infectious disease.Each vial contains < 0.1% sodium azide as a preservative. Dispose of this productaccording to all local, state and national regulations. If disposed down a drain,the sodium azide in this product may react with lead and copper plumbing toform highly explosive metal azides. Flush drain with large amounts of waterto prevent azide build-up.Do not use if the controls arrive thawed or uncapped.Bacterial contamination can cause an increase in turbidity. Do not use the controlif there is visible evidence of microbial growth or gross contamination.Storage and Stability Store at ≤ –18°C (-1°F) in a non-defrosting freezer. After thaw, the opened orunopened vial is stable for 4 hours when capped and stored at 2-8°C (35-46°F).Do not re-freezeProcedure Step Action1 Remove vial from freezer and thaw at room temperature (18-30°C) for 15 minutes.2 Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.3 Dispense a drop of sample directly from vial into the i-STAT cTnI cartridge and seal thecartridge. Tightly recap the bottle immediately after all sampling is complete and storeat 2-8°C.4 Insert cartridge into an i-STAT analyzer.
