G-425-3 Easy Blood Glucose Monitor – Bioland

INTRODUCTION TO THE SYSTEM Intended Use

The system is intended for use outside the body (in vitro diagnostic use). It is for single-patient use. It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples taken from the finger and the alternative sites including the palm, the forearm. The system is intended for use at home. It should not be used for the diagnosis of diabetes or for the testing of newborns..

■The System is to be used by a single person and should not be shared

The System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The “G-425-3” Test Strips are for use with the Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm and forearm.

The Bioland control solutions is intended for use with the System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the strips vial bottles.