ITC Hemochron Signature Elite Whole Blood Microcoagulation System User Manual

Page 9

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9

Test Cuvettes
Tests are performed with single-use disposable HEMOCHRON Jr. test cuvettes. Each test cuvette contains a label,
a sample well, a test channel containing reagents, an enclosed waste reservoir, and one or more optical
detection windows.

The cuvette label is human- and instrument-readable. The current test is automatically read by the instrument
and displayed for confirmation when the operator inserts the cuvette into the test chamber. After the cuvette has
warmed, Add Sample and Press Start are displayed by the instrument, alerting the operator to place a drop of
blood in the sample well and begin the test by pressing the START key.

Note: Refer to the package insert accompanying the HEMOCHRON Jr. test cuvettes for storage and
handling instructions.

Features
The HEMOCHRON Signature Elite has a number of performance and convenience features. These are
summarized below:

the system is portable for bedside use

fresh whole blood or citrated whole blood can be used (assay dependent)

only one drop of blood is required

results are available in minutes

results are displayed appropriately as whole blood, plasma equivalent, Celite equivalent seconds, or INR

test type is automatically read from the cuvette

barcode or manual entry of identification numbers, cuvette lot information, and quality control lot
information

test results are automatically stamped with date and time

results from 600 patient tests and 600 QC tests can be stored

stored results can be printed and/or downloaded to a personal computer

stored results can be printed by Patient ID

instrument self checks are automatically performed

internal Electronic Quality Control (EQC) is designed to check instrument operation at two levels

Electronic Quality Control (EQC) levels selectable for 300 seconds or 500 seconds using HEMOCHRON
Configuration Manager software

internal temperature verification is designed to check test chamber temperature

the display is illuminated for viewing in low light

the user is alerted when the battery is low

an optional printer can be connected

the system can be customized using a personal computer and HEMOCHRON Configuration Manager
software

User Notes can be entered to add additional information to the test results

Patient/QC test reports can be created using a personal computer and ITC data management software
programs

POCT 1A compliant

Operator certification lockout

Cuvette expiration lockout

QC expiration lockout

sample well

overflow area

test channel

label

detection

window

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