Материалы расходные к системам контроля уровня глюкозы крови «Акку-Чек®» («Accu-Chek®): контрольный раствор глюкозы:

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:

2022-10-03

Характеристики продукта

E
Device for self-testing
Device for near-patient testing
For in vitro diagnostic use
Intended Use
The Accu-Chek Instant control solution is intended for performing
control tests on the Accu-Chek Instant and Accu-Chek
Instant S blood glucose meters and Accu-Chek Instant test strips. It
is intended for self-testing by people with diabetes and
for near-patient testing by healthcare professionals.
Testing control solutions with known glucose levels establishes that
the operator and the system are performing acceptably.
Control results must be within the defined acceptable ranges before
valid patient testing is allowed.
Important Information
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.
Do not ingest or inject the control solution or use the control
solution as eye drops.
EUH208 - Contains DIAZOLIDINYL UREA. May produce an allergic
reaction.*
* Regulation (EC) No 1272/2008 (CLP)
Contents of the pack
Pack containing 2 × 2.5 mL control solution and package inserts. The
Accu-Chek Instant control solution pack contains
two control solutions, one for the hypoglycaemic range (control
solution 1, gray cap) and one for the hyperglycaemic range
(control solution 2, white cap).
Disposal
All components of the pack can be discarded in domestic waste. Consult
local ordinances as they may vary by country. If you
have any questions, contact Roche.
Control solution storage and handling
•
Refer to the test strip package insert for system operating
conditions.
•
The printed use by date is valid if the unopened control solution is
stored between 2 and 32 ºC.
•
The control sol