1. Introduction
1.1 Before You Start
Before using the qLabs
®
ElectroMeter to test Prothrombin Time (PT)
and International Normalized Ratio (INR), read the entire User’s Manual
carefully.
Self-testing users must complete a proper training on the qLabs
®
ElectroMeter and practice with a health care provider before regular use.
1.2 Intended Use
The qLabs
®
PT-INR monitoring system is used for quantitative
measurement of Prothrombin Time in fresh, capillary whole blood
samples. The qLabs
®
PT-INR monitoring system is intended for in vitro
diagnostics and is not intended to be used for screening purposes.
For self-testing users, the qLabs
®
ElectroMeter should only be used with a
prescription from your physician.
1.3 Test Principle
The qLabs
®
PT-INR monitoring system consists of the qLabs
®
ElectroMeter and Prothrombin Time (PT)-International Normalized Ratio
(INR) test strips. The qLabs
®
ElectroMeter automatically detects the
insertion of a qLabs
®
PT-INR test strip and heats the strip to a preset
operating temperature. When a drop of blood is added to the sample
well of the strip, it ows through channels to two reaction zones: a Test
Zone and a Control Zone. In these zones the blood mixes with pre-
printed reagents and begins to coagulate. Each reaction zone contains
a pair of electrodes to which a constant voltage is applied by the qLabs
®
ElectroMeter. As the coagulation of the blood proceeds, the current
monitored across the two electrodes changes. The qLabs
®
ElectroMeter
detects the change of the current and determines the PT and INR results.
1.4 Packaging
The qLabs
®
ElectroMeter is packed individually.
Upon receiving the package, please open and remove the packaging
materials. Place the qLabs
®
ElectroMeter on a at surface and connect
the power adapter.
Do not keep the qLabs
®
ElectroMeter in direct sunlight, near a high heat
source, or near an area with a strong magnetic eld.
3
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