البلد: روسيا البيضاء
اللغة: الروسية
المصدر: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Roche Diabetes Care GmbH, ГЕРМАНИЯ
изделия медицинского назначения
Roche Diabetes Care GmbH
2023-02-08
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 اقرأ الوثيقة كاملة