Intended Use - Medtronic CLOTtrac Manual Del Usuario

clottrac_chap.fm 10/27/04 10:55 am
3.875 x 3.187 inches (98 mm x 81 mm)

1 INTENDED USE

®
The CLOTtrac Citrated Whole Blood (CWB) Coagulation Control is used to confirm
the performance of the ACT instrument, and the following cartridges: Low range
activated clotting time (LRACT), recalcified activated clotting time (RACT) and the
general purpose cartridge (GPC).
For In Vitro Diagnostic Use.
2 SUMMARY
The Activated Clotting Time (ACT) test was originally described by Hattersley in 1966.
The test and its variations have been widely used to monitor the effect of heparin.
Controls have been developed by Medtronic to monitor the performance of this test.
The control consists of lyophilized citrated sheep plasma and erythrocytes. Nonsterile,
deionized Type I reagent grade water is used to reconstitute the control (refer to
Procedure Section for instructions on reconstitution). Once reconstituted, the control
behaves like a patient's fresh whole blood sample. The control verifies the
performance of the ACT instrument and the applicable test.
3 PRINCIPLES
The control provides a clotting time, which can be used to satisfy quality assurance
programs requiring at least two levels of control testing. This control provides one of
2
the two levels. The reconstituted control mimics a fresh whole blood sample. If an
electronic control is to be used in conjunction with this control, please refer to the
electronic control operators manual for detailed information.
A08718002-01
Medtronic Confidential
CS003
1
English Instructions For Use 3