Материалы расходные к системе контроля уровня глюкозы крови "Акку-Чек® Актив" (Accu-Chek® Active): тест-полоски "Акку-Чек® Актив" (Accu-Chek® Active):

Country: Belarus

Language: Russian

Source: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Available from:

Roche Diabetes Care GmbH, ГЕРМАНИЯ

Class:

изделия медицинского назначения

Manufactured by:

Roche Diabetes Care GmbH

Authorization date:

2022-06-21

Summary of Product characteristics

09387358001(01)
07124287 / 07124112
E
Test Strips
Intended Use
The test strips with the dedicated blood glucose meter are intended to
quantitatively
measure glucose in fresh capillary, venous, arterial and neonatal
blood. They are
indicated for self-testing by people with diabetes and for
near-patient testing by
healthcare professionals.
The dedicated blood glucose meter is the Accu-Chek Active blood
glucose meter.
People with diabetes may use fresh capillary blood from the fingertip
or alternative
sites. Healthcare professionals may also use venous blood
anticoagulated with
lithium heparin or ammonium heparin or EDTA, arterial blood, and
neonatal blood.
The Accu-Chek Active system is indicated to monitor glucose in
diabetes mellitus.
The
Accu-Chek
Active
system
consists
of
the
Accu-Chek
Active
meter,
the
Accu-Chek Active test strips, and the Accu-Chek Active control
solutions.
Before You Get Started
Read this package insert and the User’s Manual of the Accu-Chek
Active blood
glucose meter before testing your blood glucose with these test
strips. The User’s
Manual contains all the information you need to perform a test and to
understand
your test results. If you have any questions, contact customer
support.
The package insert contains warnings:
A WARNING indicates a foreseeable serious hazard.
Self-testing is not a substitute for visits to your healthcare
professional. You must
receive proper instruction from a qualified healthcare professional
before you start
self-testing your blood glucose. Your healthcare professional will
determine the
appropriate blood glucose target range jointly with you.
The cap of the test strip container contains a non-toxic
silicate-based drying agent.
If you accidentally swallow any of this, drink plenty of water!
These test strips deliver results that correspond to blood glucose
concentrations
in plasma as per the recommendation of the International Federation of
Clinical
Chemistry and Laboratory Medicine (IFCC) [1]. Therefore, your meter
displays blood
glucose values that refer