Abbott i-STAT 1 System Manual

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Abbott i-STAT 1 System Manual Manual pdf 206 page image

14-12 Art: 714376-01P Rev. Date: 27-Jan-17Control Target Valuesand Expected RangesTarget values (determined by testing multiple vials of each level using multiplelots of i-STAT cartridges with analyzers that have passed the Electronic Simulatortest) are printed on a value assignment sheet posted on the APOC website atwww.pointofcare.abbott. The ranges displayed represent the maximum deviationexpected when controls and cartridges are performing properly. Should resultsoutside the range be obtained, refer to the Troubleshooting portion of this sectionof the i-STAT System Manual. Always be sure that the lot number printed on thevalue assignment sheet matches the lot number on the label of the vial in use, andthat the software revision above the table matches the software revision in theanalyzer (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.CONTROLS FOR i-STAT cTnI, BNP, AND CK-MB CARTRIDGESIntended Use:i-STAT cTnI, BNP, and CK-MB Control Levels 1, 2, and 3 are intended for use as an assayed quality controlmaterial which can be used to verify the integrity of newly received i-STAT cTnI, BNP, and CK-MB cartridges.Notes:• These controls do not contain sodium azide as a preservative.• These controls do not require freezing.Warnings and PrecautionsEach plasma donor unit used in the manufacture of this product has been tested by FDA accepted methodsand found negative/non-reactive for the presence of HBsAg and the antibody to HIV-1/2, HCV, HIV NAT, andHIV-1 Ag. While these test methods are highly accurate, they do not guarantee that all infected units willbe detected. Because no known test method can offer complete assurance the hepatitis B virus, hepatitisC virus, human immunodeficiency virus (HIV) or other infectious agents are absent, all products containinghuman source material should be considered potentially infectious and handled with the same precautionsused with patient specimens.Bacterial contamination of the control can cause an increase in turbidity. Do not use the control materialif there is visible evidence of microbial growth or gross contamination.Storage and StabilityControl material is a ready-to-use liquid control requiring no reconstitution or frozen storage. The controlsare stable until the expiration date on the vial label when stored unopened at 2-8 ºC (35-46 ºF). Onceopened, these controls are stable for 30 days when stored tightly capped at 2-8 ºC (35-46 ºF).Procedure1. Access the Control option under Quality Tests in the Administration Menu. Enter the requiredinformation. The handheld allows 15 minutes (or the customized timeout period) to insert the cartridgeafter the last data entry.2. Immediately before use, gently mix the contents of the control vial to ensure homogeneity. Avoidfoaming of the sample.3. Open the vial and transfer a drop of the fluid into the i-STAT cartridge using the dropper tip, a plaincapillary tube, plain syringe, or plastic transfer pipette. Tightly recap the control vial and store it at2-8 ºC (35-46 ºF).4. Seal the cartridge and immediately insert it into the i-STAT 1 handheld.