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/