GlucoRx AiDEX RC2101 User manual

Continuous Glucose Monitoring System
User Guide
GlucoRx Ltd

Content
1. Important safety information 1
1.1 Indications for use 1
1.2 User group 2
1.3 Contraindications 2
1.4 Precautions 3
2. Product description 7
2.1 Component description 7
3. User instruction 13
3.1 Software download and installation 13

3.1.1 Software download 13
3.1.2 Minimum requirements for software installation 15
3.2 Software registration,
login and resetting 16
3.2.1 Software registration 16
3.2.2 Software login 18
3.2.3 Password reset 20
3.3 Introduction 22
3.3.1 Bluetooth setting 22
3.3.2 Notication 24
3.3.3 Do not disturb 26
3.3.4 Alerts and warnings setting 28

3.3.5 Low glucose alert setting 30
3.3.6 High glucose alert setting 32
3.3.7 Connecting a transmitter 34
3.4 Application 37
3.4.1 Pairing a transmitter 37
3.4.2 Unpairing a transmitter 41
3.4.3 Applying a sensor 44
3.4.4 Sensor warm-up 53
3.4.5 Removing a sensor 56
3.5 GlucoRx AiDEX™ App functions 57
3.5.1 Home dashboard 57

3.5.2 History dashboard 60
3.5.3 Trends dashboard 62
3.5.4 Blood glucose (BG) dashboard 65
3.5.5 Events dashboard 69
3.6 Alerts 72
3.6.1 Alert settings 72
3.7 Language 76
3.8 Others 78
3.8.1 Terms of service 78
3.8.2 Privacy policy 78
3.8.3 Delete account 78

4. Maintenance 80
4.1 Caring for your Continuous Glucose
Monitor System(CGMS) 80
4.2 Quality control test 84
5. Data security 84
6. Troubleshooting 86
7. Electromagnetic compatibility 88
8. Explanation of symbols 94

1
1. Important safety
information
1.1 Indications for use
The GlucoRx AiDEX™ 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 GlucoRx AiDEX™ CGMS results
should be based on the glucose trends and

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several sequential readings over time. The
GlucoRx AiDEX™ CGMS also aids in the
detection of episodes of hyperglycaemia and
hypoglycaemia. Measurements should not
be used to make treatment adjustments, but
rather as a reminder of when ngertip testing is
required.
1.2 User group
This CGMS is suitable for people with diabetes
who need regular blood glucose monitoring.
1.3 Contraindications
Patients who:
1. Suffer from alcoholism, drug abuse, severe

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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 or are not capable
of administering diabetes therapy themselves,
or who always need to use CGMS under strict
supervision of parents or qualified healthcare
professionals.
1.4 Precautions
• CGMS readings should only be used as a
reference for the supplemental monitoring of

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diabetes mellitus and should not be used as a
basis for clinical diagnosis.
• The CGMS should be completely removed
before any Magnetic Resonance Imaging (MRI)
scan.
• The CGMS contains small parts that can be
dangerous if swallowed.
• Should there be rapid changes in blood
glucose value displayed by the App (more than
0.1 mmol/L per minute or 1.8 mg/dL per minute),
the displayed blood glucose levels may not be
the same as the actual blood glucose levels.
When the displayed blood glucose levels drop
rapidly, the displayed value could be a higher-
than-actual reading. When the displayed blood

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glucose levels rise rapidly, the displayed value
could be a lower-than-actual reading. When
experiencing symptoms of hypoglycaemia or
hyperglycaemia, please take a ngertip blood
glucose test and do not rely entirely on the
displayed reading on the App.
• Severe dehydration or excessive loss of
water may result in inaccurate results. When
you suspect you are dehydrated, consult a
healthcare professional immediately.
• If you think the displayed reading on the App
is inaccurate or inconsistent, please take a
blood glucose meter test and use the result
to calibrate the glucose sensor. If the problem
persists, replace the sensor.

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• While extensive user testing has been done
on GlucoRx AiDEX™ CGMS in Type 1 and
Type 2 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 compatible consumables should be used
with the CGMS.
• If the product is not working properly or has
been damaged, stop using it.
• When in a medical facility, the operator should
wear gloves while using CGMS.
• Users of the CGMS App should have the basic
skills needed to use Smartphones.
• The App currently does not have available

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support for visually impaired users - Please do
not use it if you are visually impaired.
• Any incident that is related to the App should
be reported to GlucoRx.
• All pictures shown in this guide are for
illustration purpose only. Actual product may
vary due to product enhancement.
2. Product description
2.1 Component description
System Name:
GlucoRx AiDEX™ continuous glucose
monitoring system
System conguration:

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This product uses a GlucoRx AiDEX mobile
App, a Transmitter and a Glucose Sensor.
The Transmitter package consists of the
following components:
1 Transmitter
1 User Guide
1 Quick Guide
The Sensor package consists of the
following components:
1 Continuous Glucose Monitoring Sensor
(Applicator with built-in sensor set)
1 User Guide Download Instruction
Transmitter
The transmitter is used together
with the glucose sensor base.
When the sensor and transmitter

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are activated on the user's body, it measures
and stores glucose readings as well as
transmitting the readings to the GlucoRx
AiDEX™ mobile App.
Sensor
The glucose sensor package contains a
sterilised glucose sensor attached to a sensor
base and a sensor applicator. The package is
sterilised by gamma irradiation.

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Sensor applicator
Sensor base tape
Glucose sensor
Sterile packaging
Sensor components

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App
App name: GlucoRx AiDEX™ Continuous
glucose monitoring App
Model
No. Operating System Unit Release Version
RC2101 iOS mg/dL V1
RC2102 iOS mmol/L V1
RC2103 Android mg/dL V1
RC2104 Android mmol/L V1
Release version: V1

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Blood glucose data measured by the CGMS is
updated every 5 minutes. The App synchronises
the sensor glucose data every 5 minutes.
The GlucoRx AiDEX™ App is compatible with
the following devices: GlucoRx AiDEX™ CGMS
GlucoRx/MicroTech Equivalent Model Numbers

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3 User instruction
3.1 Software download
and installation
3.1.1 Software download
You can download the GlucoRx AiDEX™ App
from App Store (iOS) or Google Play (Android).
Please check the Operating System (OS) on
your phone to make sure you get the correct
App version. To download the App, search
"GlucoRx AiDEX" in App Store (iOS) or Google
Play (Android).

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