Important Safety Information; Indications For Use - Microtech AiDEX User Manual

Important Safety
Information

Indications for Use

TM
The AiDEX Continuous Glucose Monitoring System (CGMS) is indicated for
continuous or regular monitoring of glucose levels in subcutaneous tissue, and is
used for daily detection and self-management of blood glucose levels in persons
14 years or older. It is intended for use by patients at home and in healthcare facil-
ities.
TM
Interpretation of the AiDEX CGM System results should be based on the glucose
TM
trends and several sequential readings over time. The AiDEX CGM System also
aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. Measurements should not be used
to make treatment adjustments, but rather as a reminder of when fingertip testing
is required. The blood glucose detection module built into the Personal Diabetes
1