Abbott i-STAT 1, Системное руководство

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Art: 714376-00M Rev. Date: 31-Jan-12
14-11
Control solutions may also be stored at room temperature for up to 4 hours (18
to 30°C or 64 to
-
86°F). If left out longer than 4 hours at room temperature,
they should be discarded.
Directions for Use Prior to testing, vials containing the lyophilized plasma and CaCl
2
reconstituting fluid should stand at room temperature 18-30ºC (64-86ºF) for a
minimum of 45 minutes. For best results, vials, cartridges, and analyzers should
be at the same temperature.
Reconstitute only one level of control plasma at a time. CONTROL SOLUTIONS
MUST BE USED IMMEDIATELY (less than 30 seconds) AFTER COMPLETING
THE RECONSTITUTION AND MIXING STEPS.
STEP ACTION
1 After 45 minute room temperature equilibration, remove the cap
and stopper from one lyophilized human plasma control vial and
remove the cap from one vial of calcium chloride reconstituting
fluid.
2 Pour the entire contents of the calcium chloride vial into the
lyophilized human plasma control vial. Place the stopper back
in the reconstituted control vial, sealing the vial appropriately so
that the contents do not leak or spill out.
3 Allow the vial to sit at room temperature for 1 minute.
4 M i x t h e c o n t e n t s o f t h e v i a l b y s w i r l i n g g e n t l y
for 1 minute, then inverting slowly for 30 seconds.
Note : To minimize foaming of the control sample, avoid vigorous
or rapid mixing motion. Visually inspect the control vial to ensure
that the sample is fully reconstituted. If not, discard and start
over with fresh vials.
5 Using a plastic transfer pipette, plastic syringe, or plastic
capillary tube with no anticoagulant, immediately transfer the
solution from the vial into the PT/INR cartridge.
6 Immediately seal the cartridge and insert it into an analyzer.
Note : Additional PT/INR cartridges may be tested with
the remaining fluid if used within 30 seconds of complete
reconstitution of the sample.
Handle this product using the same safety precautions used when handling
any potentially infectious material. The human plasma used in the
preparation of this product has been tested by FDA approved test methods and
found negative/non-reactive for HIV-1, HIV-2, HBsAg, and HCV. However, no
known test method can offer complete assurance that products derived from
human blood will not transmit infectious disease.
Dispose of this product as biohazardous waste according to all local, state, and
national regulations.
Warnings and
Precautions
Control Target Values
and Expected Ranges Target values (determined by testing multiple vials of each level using multiple
lots of i-STAT cartridges with analyzers that have passed the Electronic Simulator
test) are printed on a value assignment sheet posted on the APOC website at
www.abbottpointofcare.com. The ranges displayed represent the maximum
deviation expected when controls and cartridges are performing properly.
Should results outside the range be obtained, refer to the Troubleshooting
portion of this section of the i-STAT System Manual. Always be sure that the lot
number printed on the value assignment sheet matches the lot number on the