Microtech AiDEX Manual de usuario
AiDEXTM Continuous Glucose Monitoring System
User Guide
MicroTech Medical (Hangzhou) Co.,Ltd.
Index
Important Safety Information 1
Indications for Use ...............................................................................................1
Patients ................................................................................................................2
Contraindication ...................................................................................................2
Precautions ..........................................................................................................3
BG Test Module Precautions ...............................................................................5
Product Components 7
Component Description .......................................................................................8
Starting a New Glucose Sensor 12
Applying a Sensor .............................................................................................12
Set up the PDA for the First Time ......................................................................14
Basic Settings ....................................................................................................15
Sensor Startup ...................................................................................................16
Sensor Calibration .............................................................................................20
Removing a Sensor 24
PDA settings 25
Target glucose range .........................................................................................25
Time and date Settings ......................................................................................27
Pairing with a new transmitter ...........................................................................28
Alarm System Description .................................................................................32
Use the built-in BGM .........................................................................................34
Charging the PDA ..............................................................................................41
Caring for your CGMS .......................................................................................42
Electromagnetic Compatibility 45
Appendix 50
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 persons
14 years or older. It is intended for use by patients at home and in healthcare facil-
ities.
Interpretation of the AiDEXTM CGM System results should be based on the glucose
trends and several sequential readings over time. The AiDEXTM CGM System also
aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. 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
2
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
The blood glucose test function of the Personal Diabetes Assistant is suitable for
measuring the blood sugar level of whole blood samples that meet the following
requirements:
1. Hematocrit range of 30% to 55%.
2. Triglyceride concentration does not exceed 3,000 mg/dL or cholesterol concen
tration does not exceed 500 mg/dL.
3. Non-critically ill patients (such as those with severe dehydration or ketoacidosis,
etc.).
Contraindications
Patients who:
1. Suffer from alcoholism, drug abuse, severe mental disorders (such as depres
sion,schizophrenia).
3
2. Are unconscious.
3. Unable to understand or master the usage of the device.
4. Have severe hearing or vision impairment.
5. Children too young to administer diabetes therapy themselves.
Precautions
• CGMS readings should only be used as a reference for the supplemental moni
toring of diabetes mellitus and should not be used as a basis for clinical diagno
ses.
• 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 uid 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 ngertip blood test.
4
• 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 inconsistent with
the way he feels, a blood glucose meter can be used to test the blood sugar lev
el or calibrate the glucose sensor. If the problem persists, remove and replace
the sensor.
• While extensive user testing was done on AiDEX TM CGMS in Type I and Type
II diabetic patients, the study groups did not include women with gestational dia-
be tes.
• The performance of the CGMS has not be evaluated when used in conjunction
with another implantable medical device, such as a pacemaker.
• Only MicroTech Medical disposable supplies should be used with the CGMS.
• If the product is not working properly or has been damaged, cease using the
product.
• When used in a medical facility, the operator should wear gloves to avoid the
spread of infection.
5
BG Test Module Precautions
• This module 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 more than 55% or be
low 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 (20-600 mg/dL).
• Triglycerides above 3,000 mg/dL and cholesterol above 500 mg/dL will lead to
inaccurate test results.
• Patients with serious illness (such as severe dehydration or ketoacidosis) are
not suitable for measuring blood sugar using the blood sugar test system.
• The blood glucose meter is only suitable for clinical screening tests or family
self-monitoring. The test results cannot be referred to as conrmed cases. In
order to ensure the accuracy of the results, the test results can be further con
6
rmed by other methods, such as biochemical methods.
• As with all diagnostic reagents, test results must be linked with a professional
doctor’s diagnosis from the other clinical symptoms.
• Carefully process waste caused by blood glucose tests according to the relevant
local laws and regulations, because blood samples are considered a biohazard.
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