Art: 714376-00M Rev. Date: 31-Jan-12 14-9CONTROLS FOR ACT CARTRIDGESIntended Use The i-STAT® ACT Control Level 1 and ACT Control Level 2 are intended for useto verify the integrity of newly received i-STAT ACT cartridges. The controlsproduce clotting times expected for moderate and high level heparinizationto indicate that the cartridges are functioning properly.Contents Each level of control is packaged as a box of 5 vials of lyophilized human plasmaand 5 vials of 9.5 ± 1.5 mmol/L calcium chloride diluent.Storage i-STAT ACT controls, Levels 1 and 2, are contained in 6-mL vials. Separate6-mL vials contain 1-3 mL of calcium chloride solution for reconstitution.Refrigerated storage at 2 to 8ºC (35 to 46ºF) should be maintained until theprinted expiration date on the box and vial labels. Do not use beyond theexpiration date on the box and vial labels.Control solutions may also be stored at room temperature for up to 4 hours (18to 30°C or 64 to -86°F). If left out longer than 4 hours at room temperature,they should be discarded.Warnings andPrecautionsHandle this product using the same safety precautions used when handlingany potentially infectious material. The human plasma used in thepreparation of this product has been tested by FDA approved test methods andfound negative/non-reactive for HIV-1, HIV-2, HBsAg, and HCV. However, noknown test method can offer complete assurance that products derived fromhuman blood will not transmit infectious disease.Dispose of this product as biohazardous waste according to all local, state, andnational regulations.Directions for Use Prior to testing, vials containing the lyophilized plasma and CaCl2 reconstitutingfluid should stand at room temperature (18 - 30ºC or 64 - 86ºF) for a minimumof 45 minutes. For best results, vials, cartridges, and analyzers should be at thesame temperature.Reconstitute only one level of control plasma at a time. CONTROL SOLUTIONSMUST BE USED IMMEDIATELY (less than 30 seconds) AFTER COMPLETINGTHE RECONSTITUTION AND MIXING STEPS.ii. Note: this product is a buffered aqueous solution containingelectrolytes and non-conductive ingredients. The only valueassigned to this fluid is for hematocrit. All other cartridge analyteresults obtained with this control material should be ignored.5. If available, transmit results to the Central Data Station.
