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ITC ProTime Microcoagulation System User Manual

Page 29

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29

SET ISI
If SET ISI is selected from the PROGRAM MODE, the following screen is displayed:

To change the ISI used in the calculation, access the PROGRAM MODE from the SET UP on MAIN MENU and
enter the ISI of the local laboratory reagent
Displayed plasma equivalent values are indicative of the results obtained using a laboratory reagent with an
ISI of 1.0. If the ISI of the reagent used in the local facility is significantly different from 1.0, the operator
may wish to select an ISI more closely aligned with their lab reagent. Change the pre-programmed ISI by
pressing the button until the desired ISI is displayed. Press the button to set. The values used for the
normal control population change as the theoretical ISI is changed. The normal control population values
are determined from clinical data.
REPORTABLE RANGE
In clinical trials, no significant difference was observed between fingerstick and venous specimens run on
ProTime. During those trials, ProTime measured patients with an INR range of 0.8 to 7.0. ProTime is
programmed to calculate and report INR results as follows:

If the calculated INR is:

Then ProTime displays:

< 0.6

INR LOW

0.6 – 0.79

INR < 0.8

0.8 – 7.0

Result

7.1 – 9.9

Result - followed by “*”

10.0 – 12.0

INR > 9.9

> 12.0

INR HIGH