Quality Controls; Oral Anticoagulant Therapy - iLine microsystems microINR expert Instructions For Use Manual

The meter must be disposed of as indicated in the European WEEE Directive and/or local waste disposal
requirements.
Operating conditions
Use the meter according to the following guidelines to ensure that it works properly:
Only use the meter at room temperature between 15ºC and 35ºC.
Only use the meter at a relative humidity below 80% without condensation.
Place the meter on a flat, stable surface during testing or hold it in your hand and avoid sudden
movements.
Keep the meter away from direct sunlight during the test.
Do not shake or drop the meter. Contact your distributor if the frequency of error messages
increases after the device has been dropped or has suffered an impact.
Only use the meter at indoor settings with a pollution degree of 2.

Quality controls

The microINR system (Expert) performs automatic quality controls on every test.
Electronic quality control
The microINR Expert meter carries out automatic checks on electronic components, battery power level and
ambient temperature conditions when the system is turned on.
Integrated independent on-board quality controls
On-board controls provide quality control checks for each individual microINR Chip used with the microINR
Expert meter throughout testing.
Level 1 – Pre-test
• Chip integrity check
• Proper insertion check
• Automatic system calibration and rejection of expired chips
Level 2 - Measuring channel
• Analytic verification of measurement for proper pre-analytical treatment of the sample and failures in
processing the sample during the test.
Level 3 - Control channel
• The control channel provides highly-controlled clotting times. The system's reliability is guaranteed when
the control clotting time is within a pre-defined range.
Liquid control
iLine Microsystems provides an optional liquid control (microINR EasyControl) for the microINR systems. This
control is provided to help meet the regulatory requirements applicable to your facility. Contact your local
distributor if you wish to acquire it.

1.3 ORAL ANTICOAGULANT THERAPY

Oral anticoagulant therapy is prescribed to patients to prevent thromboembolic events such as venous
thrombosis and pulmonary embolism or those linked to atrial fibrillation or artificial heart valves.
The treatment entails the need to periodically monitor and adjust the doses for each patient on the basis of
a blood test.
A therapeutic range is defined for each patient depending on the condition requiring oral anticoagulant
therapy. This means that the test result should lie within a certain range.
The therapeutic range (INR range) will be established by the patient's healthcare provider on the basis of the
patient's clinical condition.
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