Abbott i-STAT 1 System Manual page 204

Warnings and Handle this product using the same safety precautions used when handling any
Precautions
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.
Directions for Use Prior to testing, vials containing the lyophilized plasma and CaCl
fluid should stand at room temperature (18 - 30 ºC or 64 - 86 ºF) 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.
Control Target Values
and Expected Ranges
14-10
STEP
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 Mix the contents of the vial by swirling gently 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 the reconstituted
fluid 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 ACT cartridge
6 Immediately seal the cartridge and insert it into an analyzer.
Note: Additional ACT cartridges may be tested with the remaining fluid
if used within 30 seconds of complete reconstitution of the sample.
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.pointofcare.abbott. 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 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.
Art: 714376-01P
reconstituting
2
ACTION
Rev. Date: 27-Jan-17