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)
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
Charing the Personal Diabetes Assistant (PDA) .. 50
Caring for your Continuous Glucose
Monitoring System (CGMS)................................... 51
Electromagnetic compatibility 55
Appendix 61

1
Important safety
information
Indications for use
The AiDEXTM Continuous Glucose Monitoring System
(CGMS) is indicated for continuous or regular moni-
toring 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 hypo-

2
glycemia. Measurements should not be used to make
treatment adjustments, but rather as a reminder of
when ngertip testing is required. The blood glucose
detection module built into the Personal Diabetes
Assistant controller can be used in conjunction with
MicroTech’s Exactive EQ blood glucose test strips. It
cannot be used for the diagnosis and screening of dia-
betes, nor as a basis for drug therapy decisions.
Patients
This Continuous Glucose Monitoring System is suit-
able for patients with diabetes requiring regular blood
glucose monitoring.
The blood glucose test function of the Personal Di-
abetes 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 (3000mg/dL) or
cholesterol below 12.9 mmol/L (500 mg/dL).
Contraindications
Patients who:
1. Suffer 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. User below the age of 14 or are not capable of
administering diabetes therapy themselves or who
always need to use Continuous Glucose Monitor
under strict supervision of parents or qualified
healthcare professionals.

4
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 diagno-
sis.
• 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 lev-
els 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 hypoglycemic
or hyperglycemic, the sensor readings are checked
by using a blood glucose meter for a ngertip blood

5
glucose test.
• 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 eval-
uated 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.

6
• When used in a medical facility, the operator should
wear gloves while using.
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/

7
L (20-600 mg/dL).
• Triglycerides above 46.9 mmol/L (3000mg/dL) and
cholesterol above 12.9 mmol/L (500 mg/dL) will lead
to inaccurate test results.
• If you are severely ill (for example: serverely dehy-
dration or ketoacidosis), you blood samples are not
suitable for determining the blood glucose value us-
ing the built-in blood glucose meter.
• The blood glucose meter is only suitable for clinical
screening tests or self-blood glucose monitoring. The
test results cannot be considered as validated re-
sults. In order to ensure the accuracy of the results,
the test results can be further veried by other meth-
ods, such as biochemical methods.
• Test results should always be reviewed by a phy-
sician 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 regu-
lations, because blood samples are considered as a
biohazard.

8
Product
components
Name: AiDEX™ continuous glucose monitoring sys-
tem
System conguration: This product includes a Per-
sonal Diabetes Assistant, a Transmitter and a Glucose
Sensor.
Personal Diabetes Assistant will be referred as PDA in
the text below.
The PDA & Transmitter system consists of the fol-
lowing components:
• Personal Diabetes Assistant (Li-ion battery included)
• Transmitter
• PDA Charger
• PDA Charging Cable

9
• Quick User Guide
The glucose sensor system consists of the follow-
ing 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 sen-
sor-transmitter set.
1
5 9
6 7
8
2 3 4
10
11
12

10
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 conrma-
tion notification appears. Confirm and shutdown
the device.
Display on: While in stand by mode, press the
power button and the display will show the lock
screen.
Display off: When the display is on, press the
power button once and the display will turn off. The
PDA will enter standby mode.
② Help button
When certain functions are not clear, you can con-
sult the Help-button to display helpful information.
③ Home button
Press the Home Button to return to the Home
Screen.

11
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
3.2 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 portand
the PDA’s blood glucose test function will appear.

12
For a more detailed description of the blood glu-
cose 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 ac-
tivated 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 glu-
cose sensor attached to a sensor base, and a sensor
applicator.
The package is sterilized by gamma irradiation.

13
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 sen-
sor and its adhesive tape.
Avoid accidental knocking off
the sensor. It is strongly rec-
ommended to put sensor on
your abdomen rather than
arms or other areas.
• Before application, use alco-
hol pads to disinfect your se-

15
lected 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 steril-
ized package is damaged, please do not use it.
Note
• Take out the sensor appli-
cator by turning it anti-clock
wise.
• Place the applicator on the
top of the desired sensor
site. Press it firmly against
skin and press the button
to launch the sensor. After
inserting the sensor, wait
a few seconds to allow the
Release button

16
sensor base patch to adhere
to the skin.
• Remove the applicator. The
sensor should be applied
successfully.
Note
Applying a sensor may cause bruising or bleeding.
If bleeding does not stop, remove the sensor and
apply a new sensor to a different location.
Align the transmitter to the sensor base and press the
transmitter firmly onto the sensor base until it snaps
onto the sensor base and attaches to it securely.