User's Guide

【Important Safety Information】

Scope of Application

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 diabetic patients.

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 Assistant can be used

in conjunction with MicroTech’s Exactive EQ blood glucose test strips.It

cannot be used for the diagnosis and screening of diabetes, nor as a basis

for drug therapy decisions.

Contraindications

1. Patients with blindness or impaired vision should not use the CGMS.

2. Taking unknown drugs or medications may affect the sensor readings.

3.Hematocrit range of 30% to 55%.

4.Non-critically ill patients (such as those with severe dehydration or

ketoacidosis, etc.).

Precautions

 CGMS readings should only be used as a reference for the supplemental

monitoring of diabetes mellitus and should not be used as a basis for

clinical diagnoses.

 The CGMS should be completely removed before magnetic resonance

imaging (MRI) and replaced afterwards.

 The CGMS contains many small parts that can be dangerous if swallowed.

 During rapid changes in blood sugar (more than 0.1mmol/L per minute),

glucose levels measured in interstitial fluid by the CGMS may not be

the same as blood sugar levels. When blood sugar levels drop rapidly,

the sensor may produce a higher reading than the blood sugar level;

Conversely, when blood sugar levels rise rapidly, the sensor may

produce a lower reading than the blood sugar level. In these cases,

the sensor readings are checked by using a blood glucose meter for

a fingertip blood test.

 Severe dehydration or excessive loss of water may result in inaccurate

results. If you think dehydration is occurring, consult a health care

provider immediately.

 If the patient thinks the CGMS sensor reading is inaccurate or