Материалы расходные к системе контроля уровня глюкозы крови «Акку-Чек® Инстант» (Accu-Chek® Instant): тест-полоски «Акку-Чек® Инстант» (Accu-Chek® Instant):

Страна: Беларусь

Язык: русский

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

Доступна с:

Roche Diabetes Care GmbH, ГЕРМАНИЯ

класс:

изделия медицинского назначения

Производитель:

Roche Diabetes Care GmbH

Дата Авторизация:

2023-02-08

Характеристики продукта

Format DIN A4 for registration purpose only
Формат DIN A4 – только для целей
регистрации
Page / Страница 1
E
Device for self-testing
Device for near-patient testing
Intended Use
The Accu‑Chek Instant test strips with the Accu‑Chek Instant and
Accu‑Chek Instant S meters are indicated to quantitatively
measure glucose in fresh capillary whole blood from the finger, palm,
forearm, and upper arm as an aid in monitoring the
effectiveness of glucose control.
The Accu‑Chek Instant test strips with the Accu‑Chek Instant and
Accu‑Chek Instant S meters are intended for in vitro
diagnostic self‑testing by people with diabetes.
The Accu‑Chek Instant test strips with the Accu‑Chek Instant and
Accu‑Chek Instant S meters are intended for in vitro
diagnostic near‑patient testing by healthcare professionals in
clinical settings. Venous, arterial, and neonatal blood testing is
limited to healthcare professional use.
This system is not for use in diagnosis of diabetes mellitus, nor for
testing neonate cord blood samples.
Consumer Information
Read this package insert and the User’s Manual before performing a
blood glucose test.
The package insert contains warnings and precautions:
A WARNING indicates a foreseeable serious hazard.
A PRECAUTION describes a measure you should take to use the product
safely and effectively or to prevent damage to the
product.
W WARNING
Risk of suffocation
This product contains small parts that can be swallowed. Keep the
small parts away from small children and people who
might swallow small parts.
W WARNING
Risk of a serious health incident
Failure to follow testing instructions or test strip storage and
handling instructions can lead to an incorrect test result that
may lead to improper therapy.
Carefully read and follow the instructions in the User’s Manual and
package inserts for the test strips and control
solutions.
Risk of infection: Human blood is a potential source for the
transmission of infection. Avoid exposing other people to