Abbott i-STAT 1 System Manual page 541

B. Warnings and Precautions
Handle the products using the same safety precautions used when handling
any potentially infectious material. The human plasma used in the preparation
of these products has been tested by FDA approved test methods and found
negative/non-reactive for HBsAg, anti-HIV 1 / 2, anti-HCV, and HIV 1 Ag.
However, no known test method can offer complete assurance that products
derived from human blood will not transmit infectious disease.
Do not use if the controls arrive uncapped.
Bacterial contamination of the control can cause an increase in turbidity. Do not
use the control material if there is visible evidence of microbial growth or gross
contamination.
C. Storage and Stability
i-STAT Total β-hCG Control fluids are ready-to-use liquid controls requiring no
reconstitution or frozen storage. They are stable until the expiration date on the vial
label when stored unopened at 2-8 °C (35-46 °F). Once opened, i-STAT Total β-hCG
Control fluids are stable for 30 days when stored tightly capped at 2-8 °C (35-46 °F).
D. Procedure
1. Access the Control option under Quality Tests in the Administration Menu. Enter
the required information. The handheld allows 15 minutes (or the customized
timeout period) to insert the cartridge after the last data entry.
2. Immediately before use, gently mix the contents of the control vial to ensure
homogeneity. Avoid foaming of the sample.
3. Open the vial and transfer a drop of the fluid into the i-STAT Total β-hCG
cartridge using the vial dropper tip. Tightly recap the control vial and store
it at 2-8 °C (35-46 °F).
4. Seal the cartridge and immediately insert it into the i-STAT 1 handheld.
E. Target Value and Ranges
Target values (determined by testing multiple vials of each level using multiple
lots of cartridges and i-STAT 1 handhelds that pass the Electronic Simulator test)
are printed on a Value Assignment Sheet posted on the APOC website at
www.abbottpointofcare.com. The Value Assignment Sheet displays target values
and ranges expected when controls and equipment are performing properly.
Should results fall outside the range, refer to the Quality Control section of the
i-STAT 1 System Manual.
Always ensure that the control lot number and software revision on the Value
Assignment Sheet matches the lot number of the vial in use and the software
version in the handheld.
Target values are specific to the i-STAT System. Results may differ if used with
other methods.
Always remember to analyze the control material in the Control pathway under
the Quality Tests option of the i-STAT 1 Handheld Administration Menu.
Rev. Date: 14-Mar-16 Art: 730475-01F
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