Microtech AiDEX User manual

AiDEXTM Continuous Glucose Monitoring System
User Guide
MicroTech Medical (Hangzhou) Co., Ltd.

Index
Important safety information 1
Indications for use ...................................................1
Patients ....................................................................2
Contraindications .....................................................3
Precautions ..............................................................4
Blood glucose test module precautions ...................6
Product components 8
Component description ............................................ 9
Using a New Glucose Sensor 14
Applying a sensor ..................................................14
Setting the Personal Diabetes Assistant (PDA)
up for the rst time .................................................18
Sensor start-up ......................................................20
Sensor calibration ..................................................24

Removing a sensor 30
PDA settings 31
Target glucose range .............................................31
Date and time settings ...........................................33
Using the PDA 34
Pairing with a new transmitter ...............................34
Alarm system description .................................... 38
Using the built-in Blood Glucose Meter (BGM) ..... 41
Charging the Personal Diabetes Assistant (PDA) 51
Caring for your Continuous Glucose
Monitoring System (CGMS)................................... 52
Electromagnetic compatibility 56
Appendix 62

1
Important safety
information
Indications for use
The AiDEXTM 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 people 14 years or older. It is
intended for use by patients at home and in healthcare
facilities.
Interpretation of the AiDEXTM CGMS results should be
based on the glucose trends and several sequential
readings over time. The AiDEXTM CGMS also aids
in the detection of episodes of hyperglycemia and

2
hypoglycemia.CGM readings should not be used to
make treatment decisions but rather to detect blood
glucose trends and track patterns in persons with
diabetes.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.
Patients
This Continuous Glucose Monitoring System is
suitable for patients with diabetes requiring regular
blood glucose monitoring.
The blood glucose test function of the Personal
Diabetes Assistant is suitable for measuring the blood
glucose level of whole blood samples that meet the
following requirements:

3
1. Hematocrit range of 30% to 55%.
2. Triglycerides below 46.9 mmol/L or cholesterol
below 12.9 mmol/L.
Contraindications
Patients who:
1. Su󰀨er from alcoholism, drug abuse, severe mental
disorders (such as depression, schizophrenia).
2. Are unconscious.
3. Are unable to understand or master the usage of the
device.
4. Have severe hearing or vision impairment.
5. Are below the age of 14 years, who are not capable
of administering diabetes therapy themselves
or who always require strict supervision from
caregivers or qualified healthcare professionals
when using a CGMS.

4
Precautions
• CGM readings should not be used to make treatment
decisions but rather to detect blood glucose trends
and track patterns in persons with diabetes.
• The CGMS should be completely removed before
Magnetic Resonance Imaging (MRI).
• The CGMS contains many small parts that can be
dangerous if swallowed.
• During rapid changes in blood glucose (more than
0.1mmol/L per minute), glucose levels measured in
interstitial uid by the CGMS may not be the same
as blood glucose levels. When blood glucose levels
drop rapidly, the sensor may produce a higher
reading than the blood glucose level.Conversely,
when blood glucose levels rise rapidly, the sensor
may produce a lower reading than the blood glucose
level. When experiencing symptoms of hypoglycemia
or hyperglycemia, the sensor readings should be
conrmed with a ngertip blood glucose test, using a
blood glucose meter.

5
• Severe dehydration or excessive loss of water may
result in inaccurate results. When you suspect you
are dehydrated, consult a heathcare professional
immediately.
• If you think the CGMS sensor reading is inaccurate
or inconsistent, use a blood glucose meter to test
your blood glucose level or calibrate the glucose
sensor. If the problem persists, remove and replace
the sensor.
• While extensive user testing was done on AiDEXTM
CGMS in Type I and Type II diabetic patients, the
study groups did not include women with gestational
diabetes.
• The performance of the CGMS has not been
evaluated when used with another implantable
medical device, such as a pacemaker.
• Only MicroTech Medical consumables should be
used with the CGMS.
• If the product is not working properly or has been
damaged, stop using the product.
• The healthcare professional should wear gloves

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during sensor insertion.
Blood glucose test module
precautions
• This function should only be used in vitro and can
only be used with MicroTech’s Exactive EQ blood
glucose test strips. Use of other brand test strips will
result in incorrect test results.
• The blood glucose test function can only be used to
determine blood glucose levels using whole blood
samples. Do not use serum or plasma samples.
• The blood glucose test function is not intended for
neonatal applications.
• Test results may not be accurate for blood hematocrit
of above 55% or below 30%.
• Blood containing high levels of vitamin C or other
reducing agents can lead to inaccurate results.
• The blood glucose meter test range is 1.1-33.3mmol/
L.