Controls For Pt/Inr Cartridges - Abbott i-STAT 1 System Manual

CONTROLS FOR PT/INR CARTRIDGES

Intended Use The i-STAT
used to verify the integrity of newly received PT/INR cartridges.
Contents Each level of control is packaged as a box of 5 vials of lyophilized human plasma
and 5 vials of 9.5
Storage i-STAT PT controls, Levels 1 and 2, are contained in 6 mL vials. Separate 6 mL
vials contain 1-3 mL of calcium chloride solution for reconstitution.
storage at 2 to 8 ºC (35 to 46 ºF) should be maintained until the printed expiration
date on the box and vial labels. Do not use beyond the expiration date on the box
and vial labels.
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.
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
should stand at room temperature 18-30 ºC (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.
STEP
Art: 714376-01P
PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are
®
±
1.5 mmol/L calcium chloride diluent.
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 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.
Rev. Date: 27-Jan-17
reconstituting fluid
2
ACTION
Refrigerated
14-11