Abbott i-STAT 1, Системное руководство

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14-12
Art: 714376-00M Rev. Date: 31-Jan-12
CONTROLS FOR cTnI CARTRIDGES
i-STAT ® Cardiac Markers Controls are assayed human sera used to verify the
integrity of newly received i-STAT cTnI cartridges.
Handle this product using the same safety precautions used when handling any
potentially infectious material. The human sera used in the preparation of this
product 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, no
known test method can offer complete assurance that products derived from
human blood will not transmit infectious disease.
Each vial contains < 0.1% sodium azide as a preservative. Dispose of this product
according 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 to
form highly explosive metal azides. Flush drain with large amounts of water
to 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
control if there is visible evidence of microbial growth or gross contamination.
Storage and Stability Store at
≤
–18
o
C (-1
o
F) in a non-defrosting freezer. After thaw, the opened or
unopened vial is stable for 4 hours when capped and stored at 2-8
o
C (35-46
o
F). Do not re-freeze.
Procedure
Step Action
1 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 the
cartridge. Tightly recap the bottle immediately after all sampling is complete and store
at 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 matches
the 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 these
reconstituted control plasmas may differ if used with other methods.
Warnings and
Precautions
Control Target Values
and Ranges See 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 Troubleshooting section that follows
the Procedure for Testing Controls.
Always ensure that the lot number and software revision on the value
assignment sheet matches the lot number of the vial in use and the software
revision in the analyzer.
Target values are specific to the i-STAT System. Results may differ if used with
other methods.
Intended Use