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ITC Hemochron Response Whole Blood Coagulation System User Manual

Page 5

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5

Calculation of Heparin Level
The heparin level will be calculated automatically whenever a PRT, PDA-O or HiTT test is performed. For
the PRT and PDA-O assays, this assumes an average heparin neutralization potency of 118 units/mg

protamine.
Heparin concentrations for the HiTT assay are based on a quantitative chromogenic assay using the

inhibition of Factor IIa (thrombin). See the HiTT package insert for detailed information.
For the HiTT test, heparin level expressed as heparin units/mL of blood is displayed when the value is below

10 units/mL. Heparin levels can also be expressed as mg/kg. The HiTT test will only report heparin levels
between 1.5 and 7.0 mg/kg.

Case Status
Ten cases can be stored on the system. Each case is identified by the PID. The active case is the case that is
currently being run. An open case is any case on which at least one RxDx test was run on the system during
the past eight hours. Additional RxDx tests can be run and added to an open case. A closed case is any
case on which an RxDx test has not been run on the system during the past eight hours. Additional RxDx

tests cannot be added to a closed case.

Note: The patient information from a closed case can be reused to create a new case. See page 19

for details.

RxDx Features
The RxDx system, incorporated into the HEMOCHRON Response Whole Blood Coagulation System, provides
a set of software features that will calculate heparin and protamine doses for patients prior to and during
cardiopulmonary bypass surgery and cardiac catheterization procedures. RxDx software features include:

Patient data can be input to calculate patient blood volume.

Up to ten (10) RxDx cases can be stored.

RxDx is capable of generating different report types (see REPORTS).

A pound symbol (#) follows any result that has been manually entered by the user.

A tilde (~) follows any calculated result that uses values manually entered by the user.

Database Specifications
The RxDx database can store up to ten (10) RxDx cases. The following information is stored for each case:

PID

Height

Weight

Gender

Blood volume

Bolus heparin dose

Target ACT for HRT

Target ACT for PRT

Baseline ACT

Total heparin given

Status ACT

Protamine dose

Results of all RxDx tests run during case

OID and Date/Time are recorded for all test results

If a non-recommended PRT tube type is used, the results are
flagged


Test results from an RxDx case are stored in both the RxDx database and HEMOCHRON Response database.
Dose and other calculations are only stored in the RxDx database.