MICROPOINT qLabs ElectroMeter - Introduction; Before You Start; Intended Use; Test Principle

4
1 Introduction
1.1 Before You Start
Before using the qLabs
®
ElectroMeter to test Prothrombin Time (PT) ,
International Normalized Ratio (INR) and Activated Partial Thromboplastin
Time (APTT), read the entire User’s Manual carefully.
1.2 Intended Use
The qLabs
®
monitoring system is used for quantitative measurement of
Prothrombin Time in fresh, fresh capillary whole blood or fresh venous
whole blood samples. The qLabs
®
monitoring system is intended for in
vitro diagnostics and is not intended to be used for screening purposes.
1.3 Test Principle
The qLabs
®
ElectroMeter automatically detects the insertion of a qLabs
®
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, the blood ows
through the test channels to two reaction zones: a Test Zone and a
Control Zone. In these zones the blood reacts 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 in the test zone and determines the PT and/or APTT results. The
qLabs
®
ElectroMeter and test strips provide APTT, 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.
2 Product Overview