INTELLIGO IGF 2.1 User manual

Continuous Glucose Monitoring
Systems
Transmitter, Sensor, App
USER MANUAL
Model：IGF 2.1
INTELLIGO B.V.
IGF 2.1
version no. A/2
effective date: 2020/07/01

Table of Contents
Terminology.....................................................................................................................................1
1 Product overview..........................................................................................................................2
1.1 Sensor overview.................................................................................................................2
1.2 Transmitter overview........................................................................................................4
1.3 App overview .....................................................................................................................4
1.4 Analysis overview ..............................................................................................................6
2 Safety Information .......................................................................................................................7
2.1 Application definition .......................................................................................................7
2.2 Important user information .............................................................................................7
2.3 Contraindications..............................................................................................................7
2.4 Warning..............................................................................................................................7
2.5 Precautions ........................................................................................................................9
3 Risk and Efficacy .......................................................................................................................11
3.1 Risk...................................................................................................................................11
3.2 Efficacy.............................................................................................................................11
4 Installation and Use ...................................................................................................................12
4.1 Installation .......................................................................................................................12
4.2 Use ....................................................................................................................................15
4.3 End session and remove sensor......................................................................................18
4.4 Calibration.......................................................................................................................20
5 App interface introduction and function application..............................................................23
5.1 Main interface .................................................................................................................23
5.2 Function Bar....................................................................................................................25
5.3 Alarm/Alert......................................................................................................................28
6 Faults and Troubleshooting.......................................................................................................30
The Sensor pad is not sticky enough....................................................................................30
Calibration troubleshooting .................................................................................................30
Sensor low power ..................................................................................................................30
Notification failure ................................................................................................................30
7 Maintenance ...............................................................................................................................31
8 Travel information .....................................................................................................................32
9 EMC Statement..........................................................................................................................33
10 User help ...................................................................................................................................35
11 The warranty ............................................................................................................................36
11.1 The scope and duration of warranty............................................................................36
11.2 The following conditions are not in the scope of warranty........................................36
11.3 Warranty liability..........................................................................................................36
11.4 Warranty Statement......................................................................................................36
12 Label symbol and graphic description ...................................................................................38
13 Date of manufacture ................................................................................................................39
Appendix........................................................................................................................................40

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Terminology
Sensor
Component of the monitoring system, including the applicator,
sensor electrode and sensor base. The applicator inserts the
sensor electrode under the skin to measure glucose level in
interstitial fluids.
CGM
Abbreviation for Continuous Glucose Monitoring
CGMS
Abbreviation for Continuous Glucose Monitoring Systems
Applicator
A disposable component that inserts the sensor electrode under
the skin and will be removed after the sensor electrode is
inserted.
Sensor
electrode
A device inserted under the skin that reacts with the interstitial
fluid and converts biological signals into electrical signals.
Sensor base
A small plastic base attached to the abdomen skin to hold the
transmitter.
Releaser
A plastic part, used for removing the transmitter from the sensor
base.
Transmitter
The transmitter is a component of the Continuous Glucose
Monitoring system, which is embedded in the sensor base and
sends the glucose information to the Mobile Application
wirelessly via Bluetooth Low Energy.
Transmitter
serial number
Consisting of numbers and letters, it is unique for each
transmitter and can be found on the back of the transmitter and
on the transmitter package.
App
The mobile software that receives glucose information, displays
blood glucose readings, trend curves, trend arrows and
transmitter status.
Default value
The values that come with the system.
Calibration
Blood glucose value measured by a blood glucose meter and
entered into the App for calibration to ensure the accuracy of the
CGMS reading.
Blood Glucose
value
Values measured by blood glucose meter.
Sensor Glucose
readings
Values measured by Continuous Glucose Monitoring Systems
Trend curve
Displays changes and tendencies of glucose readings over a
period of time and current glucose status.
Trend arrow
Indicates the speed and tendency of changes of glucose
readings.
Data receiving
range
The communication distance between the App and the
transmitter, which shall be within 2 m without obstacle.
Repeat prompt
When the first notification is not confirmed, the prompt will be
information repeated.

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1 Product overview
The Continuous Glucose Monitoring Systems consists of a disposable Sensor, a
Transmitter, Mobile Application，and Analysis Software. It is recommended to
wear the sensor on the abdomen and avoid movement where the sensor is applied.
The sensor electrode chemically reacts with glucose in the hypodermic interstitial
fluid to generate an electrical signal. Transmitter analyzes and calculates the
electrical signal, and generates the glucose values, which is sent to the mobile App.
The user analysis software downloads and collects data from the mobile App for
processing and analysis, then gives reports.
During the monitoring period, blood glucose values optionally could be entered into the
CGM App for calibration for better accuracy. The CGMS measures a glucose reading every
three minutes, totaling 480 readings each day. The system is indicated for continuous
monitoring of the glucose data for 14 days and form a continuous blood glucose curve. In
addition, dining, sport, medication and other activities can be recorded as an event.
The Intelligo Free CGM MARD is 9,86%
Continuous Glucose Monitoring System
1.1 Sensor overview

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Sensor
The continuous glucose monitoring sensor is a product in a sterile sealed pouch. The
sensor is mainly made up of an applicator, a sensor base and a sensor electrode. An
adhesive pad is attached to the sensor base. Insert the sensor electrode into the
subcutaneous tissue of the abdomen and remove the applicator. The sensor base is
attached to the skin for up to 14 days of monitoring. Please dispose of the sensor,
according to your local regulations for medical waste, after the sensor session is
finished,
The performance parameters of sensor
Model No.
IG2-SR-1P
Measurement range
2.2-22.2 mmol/L
Effective working time
14 days
Calibration method
Glucose Meter
Calibration range
2.2-22.2 mmol/L
Storage conditions
Temperature:2oC-25 oC;
Relative humidity:15%-85%
Transport conditions
Room temperature for transportation
Rated voltage
d.c. 3V
Working conditions（After
the transmitter placed in the
sensor base）
Temperature：10 oC-40 oC；
Relative humidity：10%-95%
Battery lifetime
No less than 14 days
Sterilization method
Irradiation sterilization

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Validity period
11 months
Power support
Internal power supply
1.2 Transmitter overview
The continuous glucose monitoring transmitter is a component connected to the
sensor base. Once the transmitter is embedded in the sensor base and the sensor
electrode is activated through the App, the transmitter sends the sensor glucose
value to the App. When properly worn, the transmitter and App have a transmission
range of 2 meters without obstruction. Wireless connection might be disrupted in
swimming pools, bathtubs and waterbed.
The performance parameters of transmitter
Model No.
IG2-TR-1P
Size
length33.1 mm *width19.35 mm *height 8.3mm
Weight
3.7 g
Display interval
3 mins
Calibration method
Blood Glucose Meter
Calibration frequency
optional
Data receiving range
2 m（without obstruction）
Expect product service life
Reused up to 36 months
Validity period
36 months
Operation mode
Continuous performance
Protection grade
IP27
Working conditions（After
the transmitter placed in the
sensor base）
Temperature：10 oC-40 oC；
Relative humidity：10%-95%
Atmospheric pressure
70kPa-106 kPa
Transport and Storage
conditions
Temperature：0 oC-45 oC；
Relative humidity：10%-95%
Wireless
Bluetooth 5.0, 2402-2480 MHz, GFSK, 0 dBm
1.3 App overview
The App is a mobile medical application for its continuous glucose monitoring
system to receive and process glucose readings. The software displays real-time

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blood glucose readings, trend curves, trend arrows, and transmitter status. It has
functions such as adding Notes, Alarms/Alerts, Logbook Entries, Reports, Data
Export feature and so on.
Main interface of App
The main interface of App displays blood glucose readings, trend curves and trend
arrows. App and transmitter can be connected through Bluetooth, pairing for data
communication. A blood glucose meter is also needed to use the Continuous
Glucose Monitoring System.
The performance parameters of App
Item
Detail
Operating system
Android 6.0 and above/IOS 13.1 and above
Connection
One App can only connect to one transmitter at
the same time
Data transmission
Transmitter and App (phone) transmit data via
Bluetooth protocol
The file exported by the app is transferred to
the analysis software
Storage Format
App export data storage format is Excel file

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1.4 Data Management Software and Data Sharing– Statistical
Analysis overview
All Glucose Datas are transmitted real time from Mobile App to Intelligo Free
portal, www.intelligofreeshare.com.
The user can give access to third users for remote monitoring.
The portal includes statistical Analysis software for processing and analyzing
glucose data, and producing useful statistical reports.
Warning:
The software does not provide any medical advice and cannot be used for such
purpose. Do not adjust your treatment plan without consulting your medical
diabetes team.

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2 Safety Information
2.1 Application definition
The device is intended for continuous or periodic recording of glucose levels in
interstitial fluid for adult patients with diabetes aged 18 or older. The information is
intended to support, rather than to replace standard glucose monitor and is intended
for detecting trends and track pattern to provide reference information for patients to
better manage diabetes. The system provides real-time blood glucose value, which
is received and displayed by the App. The blood glucose value data can be further
imported into the software for analyzing historical blood glucose values.
Apply site：
Abdomen
Frequency of data interaction:
Once every 3mins
Reuse:
Sensor is disposable；The transmitter can be reused up to 3 years.
Warning
CGMS(i3) does not provide any medical advice and cannot be used for such
purpose. Do not adjust your treatment plan without discussing it with your
medical diabetes team.
2.2 Important user information
In order to use this product safely, please review your product instructions before
using your Continuous Glucose Monitoring System. The instructions include
contraindications, warnings, cautions, and other important user information. Discuss
with your doctor how to use the information to help you control your blood glucose.
The instruction manual contains important information about system
troubleshooting and equipment performance characteristics.
2.3 Contraindications
Part of the sensor shall pierce the skin, so it is recommended that people with
delicate skin use the device cautiously. The product must be removed before you
undergo magnetic resonance imaging (MRI).
Intake of acetaminophen while wearing the sensor may falsely raise your sensor
glucose readings.
2.4 Warning
Read the instructions thoroughly. incorrect use of the continuous blood glucose
monitoring system may lead to misunderstanding of the information provided

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by the system or affect the performance of the system and miss low/high blood
glucose incidents.
Continuous glucose monitoring cannot be used as a basis for diabetes diagnosis,
such as for insulin injection treatment. It cannot replace blood glucose meter.
The value of blood glucose may differ from the reading of glucose. Using
glycemic readings as a diagnostic basis for diabetes may result in low/high
blood glucose.
Do not ignore the symptoms of high / low blood glucose levels. If the sensor
glucose reading does not match the symptoms, a blood glucose meter should be
used to measure the blood glucose even if the CGM reading is within the
normal range.
Calibrate optionally, or when the sensor glucose readings might be inaccurate
and you might miss a low or high blood glucose value.
In rare cases, the sensor electrode may fracture. If the sensor electrode breaks
and there is no visible sensor electrode on the skin, do not attempt to remove it
yourself. Seek professional medical help in the condition of infection or
inflammation - redness, swelling or pain. If the sensor electrode ruptures, please
report to our technical support.
Do not use sensors when its sterile packaging is damaged. Using unsterilized
sensors may lead to infection.
The storage temperature of the sensor is 2oC-25oC. The sensor can be
transported at room temperature. The storage time is the shelf life (8 months) of
the sensor. If the temperature range of the refrigerator is 2oC-25oC, the sensor
can be stored in the refrigerator. Improper storage results in inaccurate blood
glucose readings and missing low/high blood glucose levels. If the sensor is
stored in the refrigerator, please take it out half an hour before use. The sensor
can be used at room temperature.
The device is not designed to remain in the body long-term, or to be replaced
‘immediately’ with a similar or identical device.
Your transmitter communicates with your App via Bluetooth. The
communication might be affected by strong electro-magnetic field, keep your
CGMS away from any strong electro-magnetic field. Otherwise, degradation of
the performance of this equipment could result in malfunctioning of the system.
With the prompt function turned off, the App cannot give a prompt
(notification) even if the Transmitter and the App are within communication
range.
Symptoms that may be caused by high/low blood glucose should not be
ignored. If the symptoms you are experiencing do not match the CGMS
readings, or you suspect that the CGMS readings may be inaccurate, check the
glucose by performing a fingerstick blood test using a blood glucose meter.
When CGMS shows that your glucose level is low or near the low limit,
perform a fingerstick blood test using a blood glucose meter.
The CGMS contains small parts that may cause choking once swallowed, keep

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them off the reach of children.
2.5 Precautions
The sensors and transmitters of the CGMS should be matched. The products of
different generations cannot be connected and cannot work. Make sure that the
system uses the correct software version.
Before opening the sensor package, wash your hands with soap and water and
dry them.
Before inserting the sensor, clean the skin with alcohol wipes and let it dry up.
This helps prevent infection. Do not insert the sensor until the skin is dry so that
the tape on the sensor base can be better attached to the skin.
Change the insertion site each time. Using the same insertion site too often may
not allow the skin to heal, and may cause scars or skin allergies.
Do not insert sensors in areas that may be bent, squeezed, tattooed, hairy or
allergic. These sites are not ideal for measuring blood glucose. Inserting sensors
in these places may affect the performance, missing low/high blood glucose
values.
Do not insert sensors within 5 cm of insulin injection and placement of insulin
pump. Insulin may affect the performance of the sensor, missing low/high blood
glucose levels.
To calibrate, enter the exact blood glucose value measured by the glucometer
within 3minutes. Inaccurate input or input exceeding 3minutes may affect the
performance of the sensor and result in missing low/high blood glucose values.
Rapid changes in blood glucose level may not be displayed in time, such as
during exercise or after meals. There is always a time lag between glucose level
in the blood and glucose level in the interstitial fluid, the lag time is different
from person to person.
When properly worn, the transmitter and App have a transmission range of 2 m
without obstruction. Wireless connection in the water is not very well, so the
range of connections in places like swimming pools, bathtubs and waterbeds
will be reduced. If the distance between the transmitter and App is more than 2
m or if the distance between them is blocked, they may not be connected or the
connection distance may be shorter. You may miss the low/high blood glucose
level notifications Yet all the data will still be stored in your transmitter, so your
App is able to display all the data when there is good communication again.
The transmitter can be reused up to 3 years in its lifetime, so do not discard it.
In rare cases, the sensor may give inaccurate glucose readings. If the glucose
reading is believed to be incorrect or inconsistent with your symptoms, perform
a fingerstick glucose test and check to ensure that the sensor is not loose.
Intense exercise may cause the sensor to be detached or loosened. If the Sensor
is loose, you may not get a reading or the reading may not be reliable and may
not match how you feel. Follow instructions on selecting the appropriate site for

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wearing the sensor.
Severe dehydration or excessive water loss may result in inaccurate CGMS
readings.
On rare occasions, patients may experience mild skin redness and swelling on
the insertion site.

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3 Risk and Efficacy
3.1 Risk
Inserting sensors and wearing adhesive tapes are less likely to cause infection,
bleeding, pain or skin irritation (redness, swelling, bruising, itching, scarring or
discoloration). If these symptoms occur, the patient may feel uncomfortable at the
location where the sensor is inserted.
In rare cases, the sensor electrode may break and remain in the body. This
phenomenon did not appear in the clinical study. If you feel the sensor is broken
inside your skin, contact your medical diabetes team and technical support.
When the prompt function is turned off or the transmitter and App are not within the
communication range, the prompt cannot be obtained.
When you cannot hear the tone or feel the vibration, you may not notice the prompt.
Sometimes the sensor glucose readings may be slightly different from the values
measured by blood glucose meter. In most cases, the sensor glucose reading moves
with the blood glucose level and will remind you when the glucose level exceeds the
target range.
If you are at high/low blood glucose levels and you miss the reminding and warning
message, you might not test your blood glucose with blood glucose meter and miss
high/low blood glucose values.
3.2 Efficacy
The Continuous Glucose Monitoring Systems provides more effective and
comprehensive information than the blood glucose meter. In 14-day monitoring, the
continuous glucose monitoring system provides a glucose reading every three
minutes to inform you where your glucose is heading. Dynamic information can
help you check the current glucose status, as well as the glucose direction and speed
of glucose changes. Recognizing trends in glucose can help you be proactive and
take the necessary actions to avoid high/low glucose levels.
App alerts when blood glucose levels exceed your target glucose limits or when
blood glucose drops or rises rapidly. The alerts can remind you to take the necessary
actions and be proactive, in order to avoid low/high glucose levels.

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4 Installation and Use
This chapter describes how to use your Intelligo Free CGM system, please read
carefully before use, and follow the indication step-by-step.
4.1 Installation
4.1.1 App installation and setting
a) Download App from Google Play / App Store；
b) After installed, register an account.
c) Setting your target and Alarm/Alert Sound type.
4.1.2 Prerequisites
Turn on the Bluetooth of the mobile phone and keep the phone within 2 meters of
the Transmitter in an accessible state. Allow the App to access your smart device
location.
4.1.3 Sensor Insertion
1）Prepping
a) Do NOT use if the sensor package seems to be damaged or is already opened.
b) Do NOT use after the sensor expiry date.
c) Wash your hands
d) Clean bottom of transmitter with alcohol wipe;
e) Let the transmitter dry.
Note: Be careful, don’t touch its metal dots on the back of the transmitter and
scratch it (that may damage the water-resistant seal).
2）Insertion site
a) Only on the Abdomen；
b) 5 cm away from the belly button；
c) 5 cm away from the insulin Injection site；
d) Avoid position where it can be pressed when you are wearing a belt;
e) Avoid fatty clotting site
f) Avoid tattoos, excessive hair, scars, inflammation etc.
Note ：
Change insertion site after previous use
Clean the skin condition before insertion
Check whether package is broken
Check expiration date before insertion

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Insertion site
3）Clean insertion site
a) Clean the insertion site with an alcohol wipe and allow it to dry before
proceeding.
b) Make sure area is clean and free of lotions, perfumes, and medications.
4）Apply Sensor
Remove the protective liners from the bottom of
the sensor base, and don't touch the adhesive tape.
Place sensor horizontally on the abdomen;
Press the applicator to ensure that the tape is firmly
attached on the skin.
Hold the applicator and pull the Safety Lock to
unlock mode.

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Press the top button of the applicator, and the
sensor electrode will be inserted automatically;
Gently pull applicator up until you see adhesive
patch.
Ensure the tape firmly bonded.
Run your fingers around the adhesive.
Slide transmitter (pointy side) into the slot against one end of the sensor base.

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Press both transmitter corners until it clicks into the holder, you will hear 2-clicks
sound.
If the transmitter isn’t embedded properly，it may cause the transmitter to break
away.
Warning
The sensors（Model No. IG2-SR-1P）and transmitters（Model No. IG2-TR-
1P）of the Continuous Glucose Monitoring Systems should be suitable for
each other. The products of different generations cannot be connected to each
other and thus cannot work. Make sure that the system uses the correct
Intelligo Free software version.
4.2 Use
4.2.1 Pairing Transmitter
Enter Transmitter SN and PIN Code to start pairing.
Note: For problems in pairing, check
<Troubleshooting>.

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Enter Sensor Lot Number to “Start CGM”
Warm up time: 190 Mins.
Note: No High/Low Alarm during warming up; Keep
the connection between transmitter and smart phone
during warming up.

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Initial calibration after warm-up;
Note: Do the calibration before meal.
4.2.2 Sensor glucose readings and curve
Blood glucose readings and trend curve are shown in App’s Home Screen.
Home Screen
Logbook
Caution
Continuous glucose monitoring cannot be used as a basis for diabetes
diagnosis, such as insulin injection. It cannot replace the blood glucose meter.

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The value of blood glucose may not be consistent with the CGM reading of
glucose. Using glycemic readings as a diagnostic basis for diabetes may result
in low/high blood glucose.
4.3 End session and remove sensor
Settings→Export Data
Note: After 14 days’ monitoring, CGMS will be
stopped automatically, also can be ended manually.
Export Now：CGMS monitoring information can
be export as an Excel file in phone’s storage.
It can be found in settings→EXPORT
NOW→Internal
storage→Documents→intelligo_csv_exports.
Note: Data can be analyzed by Analysis Software.