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

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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.

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• Triglycerides above 46.9 mmol/L and cholesterol
above 12.9 mmol/L may lead to inaccurate test
results.
• If you are ill (for example: severe dehydration or
ketoacidosis), this may lead to inaccurate test
results.
• The blood glucose meter is only suitable for clinical
screening tests or self-blood glucose monitoring.
The test results cannot be considered as validated
results. In order to ensure the accuracy of the
results, the test results can be further verified by
other methods, such as biochemical methods.
• Test results should always be reviewed by a
physician along with other clinical evidence to reach
a diagnosis conclusion.
• Carefully process waste caused by blood glucose
tests according to the relevant local laws and
regulations, as blood samples are considered a
biohazard.

8
Product
components
Name: AiDEX™ Continuous Glucose Monitoring
System
System configuration: This product includes a
Glucose Sensor, a Transmitter, a Personal Diabetes
Assistant (optional).
Personal Diabetes Assistant will be referred as PDA in
the text below.
The PDA & Transmitter system consists of the
following components:
• Personal Diabetes Assistant (Li-ion battery included)
• Transmitter
• PDA Charger
• PDA Charging Cable
• Quick User Guide

9
The glucose sensor system consists of the
following components:
• Applicator with Built-in Sensor
Component description
Personal Diabetes Assistant
The PDA is used to display glucose readings and
historical data when paired with an operational sensor-
transmitter set.
1
5 9
6 7
8
2 3 4
10
11
12

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① Power button
Power on: Press and hold the power button, the
PDA will vibrate indicating that the device is starting
up. After about 30 seconds, it will enter the Home
Screen.
Power off: Hold the power button until a
confirmation notification appears. Confirm and
shutdown the device.
Display on: While in standby mode, press the
power button and the display will show the locked
screen.
Display off: When the display is on, press the
power button once and the display will turn o󰀨. The
PDA will enter standby mode.
② Help button
When certain functions are not clear, you
can consult the Help-button to display helpful
information.
③ Home button
Press the Home Button to return to the Home

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Screen.
④Back button
Click this button to return to the previous screen or
close a pop-up dialog.
⑤Up button
⑥Down button
The Up and Down Button can be used to adjust the
brightness of the PDA screen dispaly.
⑦Enter button
The Enter Button can be used to conrm entered
information without touching the screen.
⑧Display
3.5 inch color touchscreen.
⑨USB port
For PDA charging and USB data transmission.
⑩Blood Glucose Test Strip Port
Insert a blood glucose test strip into this port and

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the PDA’s blood glucose test function will appear.
For a more detailed description of the blood
glucose test function, refer to the chapter “Using
the Built-in Blood Glucose Meter (BGM)”.
⑪Test strip ejector
Used to eject used blood glucose test strips.
⑫Speaker
Transmitter
The transmitter is used together with the glucose
sensor base. When the sensor and transmitter are
activated on one’s body, it measures and stores
glucose readings as well as transmitting
the readings to the PDA/the AiDEX ™
mobile App.
Glucose sensor package
The glucose sensor package contains a sterilized
glucose sensor attached to a sensor base, and a

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sensor applicator.
The package is sterilized by gamma irradiation.
Sensor applicator
Sensor base tape
Glucose sensor
Sterile packaging
Sensor components

14
Using a new
glucose sensor
Applying a sensor
• Recommended areas for
sensor application includes
the abdomen, the outside
and the back of the upper
arm. For best performance,
avoid excessive motion
which may weaken the
sensor and its adhesive
tape. Avoid accidental
knocking off the sensor. It
is strongly recommended
to insert the sensor on the
abdomen rather than the
arms.
• Before application, use

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alcohol pads to disinfect your
selected skin area and wait
for a minute to let the skin
dry. Change your sensor
sites regularly to avoid
discomfort or skin irritation.
• Open the sensor package.
Ensure the sensor is not expired by checking its
expiration date. If the sensor is expired or the
sterilized package is damaged, please do not use it.
Note
• Take out the sensor
applicator by turning it anti-
clock wise.
• Place the applicator on the
top of the desired sensor
site. Press it rmly against skin and press the button
to launch the sensor. After inserting the sensor, wait

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a few seconds to allow
the sensor base patch to
adhere to the skin.
• Remove the applicator. The
sensor should be applied
successfully.
Align the transmitter to the sensor base and press the
transmitter rmly
onto it until it
snaps onto the
sensor base and
Note
Applying a sensor may cause bruising or bleeding.
If bleeding does not stop, remove the sensor and
apply a new sensor to a di󰀨erent location.