Abbott i-STAT 1, System Manual

Page: 204 / 658

14-10
Art: 714376-00M Rev. Date: 31-Jan-12
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 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.
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 Mix the contents of the vial by swirling gently for 1
m i n u t e , t h e n i n v e r t i n g s l o w l y f o r 3 0 s e c o n d s .
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.
CONTROLS FOR PT/INR CARTRIDGES
Intended Use The i-STAT
®
PT Control Level 1 (normal) and PT Control Level 2 (abnormal)
are 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 calcium chloride diluent. The Level 1 control vials contain
9.5
±
1.5 mmol/L calcium chloride, while the Level 2 control vials contain
12
±
2.0 mmol/L calcium chloride.
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.
Refrigerated storage at 2 to 8ºC (35 to 46ºF) 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.