Mission PT/INR, Руководство пользователя

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1
Section 1 Introduction
Intended Use
The Mission
®
PT/INR Monitoring System is intended for self-testing and
professional use for the monitoring of oral anticoagulant therapy by
quantitative prothrombin time (PT) testing. The
Mission
®
PT/INR Test Strips
work with fresh capillary or non-anticoagulated venous whole blood
specimens from patients on Coumarin-type (e.g. Warfarin) anticoagulation
therapy. The device is not intended to be used for screening purposes.
The easy-to-operate system consists of a portable meter and individual test
strips that analyze the clotting time. A programmed code chip with strip
parameters is provided with each box of strips to ensure proper coding of the
meter. The
Mission
®
PT/INR Monitoring System provides results as
International Normalized Ratio (INR) or INR+PT values in about 2 minutes
and requires only a single drop of whole blood.
The meter can store up to 200 results and can be operated by 4 AA (1.5V)
batteries or the included AC adapter.
Note: It is required that the healthcare professional follows the Mission
®
PT/INR Monitoring System Training Manual to train the self-testing
patient before the patient uses the
Mission ® PT/INR Monitoring
System at home. The self-testing patient must complete the
training and practice running a test on the meter with a health care
professional. To review these training files, visit
ACON website
at www.aconlabs.com. Click on International Clinical Chemistry,
select PT/INR Coagulation, and then click on Download.
To ensure accurate results:

Read the instructions in the User’s Manual and complete any
necessary training before use.

Use the code chip that is included in each box of test strips.

Only use Mission
®
PT/INR Test Strips with the Mission
®
PT/INR Meter.

For in vitro diagnostic use only.

For self-testing and professional use.

Test with fresh fingertip capillary or venous whole blood specimens.

Verify the testing results using clinical laboratory methods before
making any adjustments to your medication, diet, or exercise routines.

Do not use accessories that are not supplied or recommended by the