14-12 Art: 714376-00M Rev. Date: 31-Jan-12CONTROLS FOR cTnI CARTRIDGESi-STAT® Cardiac Markers Controls are assayed human sera used to verify theintegrity of newly received i-STAT cTnI cartridges.Handle 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 thecontrol if there is visible evidence of microbial growth or gross contamination.Storage and Stability Store at ≤ –18oC (-1 oF) in a non-defrosting freezer. After thaw, the opened orunopened vial is stable for 4 hours when capped and stored at 2-8oC (35-46oF). Do not re-freeze.Procedure 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.label of the vial in use, and that the software revision above the table matchesthe software revision in the analyzer (check the status page on the analyzer).Note: Target values are specific to the i-STAT System; results obtained from thesereconstituted control plasmas may differ if used with other methods.Warnings andPrecautionsControl Target Valuesand RangesSee value assignment sheet posted on the APOC website at www.abbottpointofcare.com. The value assignment sheet displays target values andranges expected when controls and equipment are performing properly. Shouldresults fall outside the range, refer to the Troubleshooting section that followsthe Procedure for Testing Controls.Always ensure that the lot number and software revision on the valueassignment sheet matches the lot number of the vial in use and the softwarerevision in the analyzer.Target values are specific to the i-STAT System. Results may differ if used withother methods.Intended Use
