Sinocare i3 User manual

CGM User Guide
1 LEGAL DISCLAIMER
User Guide
CGM

User Guide
I
TABLE OF CONTENTS
TABLE OF CONTENTS..........................................................................I
LEGAL DISCLAIMER ............................................................................1
IMPORTANT SAFETY INFORMATION.................................................2
Getting started with iCan Continuous Glucose Monitoring System
(CGM)....................................................................................................3
Resources .............................................................................................4
Section 1: System Overview..................................................................6
1.1 System Description..........................................................................7
1.2 Intended Purpose ..........................................................................10
1.3 User Safety....................................................................................10
Section 2: Start Your Sensor ...............................................................19
2.1 Prepare the Sensor .......................................................................20
2.2 Choose a Site................................................................................29
2.3 Pair Your Sensor with the Transmitter ...........................................30
2.4 Apply Your Sensor .........................................................................33
2.5 Sensor Warmup.............................................................................38
Section 3: Understand Your iCan i3 CGM Results ..............................39
3.1 Home Screen Overview.................................................................40
3.2 Glucose Information ......................................................................40
3.3 Navigation and Status Bar.............................................................46
3.4 Events............................................................................................49

User Guide
II
3.5 Alerts..............................................................................................51
3.6 Access ...........................................................................................57
Section 4: Treatment Decisions...........................................................60
4.1 Talk with your Healthcare Professionals (HCPs)...........................61
4.2 When to Use Your Blood Glucose Meter.......................................61
4.3 Using Your CGM to Help for Your Treatment Decisions ................ 61
Section 5: End a Session ....................................................................63
5.1 End Your Sensor Session..............................................................64
5.2 Remove Sensor.............................................................................66
5.3 Start New Sensor Session.............................................................66
Attachment A: Troubleshooting............................................................67
Attachment B: Security and Air Travel.................................................71
Attachment C: Take Care of Your CGM...............................................72
Attachment D: Technical Information...................................................76
Attachment E: Label Symbols .............................................................83
Attachment F: Alerts Vibrations and Sounds .......................................86
Glossary ..............................................................................................96

CGM User Guide
1 LEGAL DISCLAIMER
LEGAL DISCLAIMER
©2022 Sinocare Inc. Sinocare iCan is a trademark of Sinocare Inc.
US and International Patents Pending. All rights reserved.
All trademarks and copyrights are the property of their respective
owners.
The Bluetooth®word mark and logos are registered trademarks owned
by Bluetooth SIG, Inc. and any use of such marks by Sinocare Inc. is
under license. Other trademarks and trade names are those of their
respective owners.
Apple, the Apple logo, iPhone and iPod touch are trademarks of Apple
Inc., registered in the U.S. and other countries. APP Store is a service
mark of Apple Inc.
Android is a trademark of Google LLC. Google Play and the Google
Play logo are trademarks of Google LLC.

CGM User Guide
IMPORTANT SAFETY INFORMATION 2
IMPORTANT SAFETY INFORMATION
Before you use the iCan i3 Continuous Glucose Monitoring (CGM)
System, read the instructions included in the Instruction for Use.
The Instruction for Use includes important safety information, and
instructions for use. Discuss with your healthcare professional about
how you should use the information from your iCan i3 CGM to help
manage your diabetes.
Failure to use the iCan i3 CGM System and its components according
to the instructions for use and all indications, contraindications,
warnings, precautions, and cautions may result in you missing a
severe hypoglycemia (low blood glucose) or hyperglycemia (high blood
glucose) occurrence and/or making a treatment decision that may result
in injury. If your glucose alerts and result from the iCan i3 CGM do not
match your symptoms or expectations, use a ngerstick blood glucose
(BG) value from your blood glucose meter to make diabetes treatment
decisions. Seek medical attention when appropriate.
Any serious incident that has occurred in relation to the iCan i3 CGM
should be reported to the Sinocare and the competent authority of the
Member State in which you are established

CGM User Guide
3 Getting started with iCan Continuous Glucose Monitoring System (CGM)
Getting started with iCan Continuous Glucose
Monitoring System (CGM)
Continuous Glucose Monitoring System (hereafter referred as CGM)
gives you a more complete picture of your glucose control than blood
glucose (BG) monitoring alone. Using a sensor allows you to receive
up to 480 sensor glucose (SG) readings every 24 hours, lling the
gaps between your BG checks. CGM alerts notify you of high and low
glucose values.
Graphs and trend arrows show the speed and direction your glucose
levels are moving.
This Instructions for Use (also called User Guide) is provided to help
you understand the setup and operation of your iCan Continuous
Glucose Monitoring (CGM) System. To help you nd the information
you need, you can use the table of contents at the beginning of the
user guide and the index at the end of the user guide. There is also a
glossary of terms at the end of the user guide.
The following table describes certain terms, conventions, and concepts
used in this user guide.
Convention Description
Note Provides additional helpful information.
CAUTION Noties you of a potential hazard which, if not avoided, may result in minor or
moderate injury or damage to the equipment.
WARNING Noties you of a potential hazard which, if not avoided, could result in death
or serious injury. It may also describe potential serious adverse reactions and
safety hazards.
Bold Text To indicate screen items and buttons. For example, "Select Next to continue”

CGM User Guide
Resources 4
Resources
Tutorial:
Our tutorial walks you through your rst sensor session, including
picking a display device, inserting the sensor, and using alerts.
The tutorial is available at: iCan-cgm.com
In-App Videos:
There is an in-App Videos can help you learn:
• Overview: See how your CGM shows where your sensor glucose is
now, where it is going, and where it has been
• Sensor Insertion: Walks through inserting your sensor
You can watch these videos when you set up your app or anytime at
Settings > Help > Videos.
Guides:
• Quick Reference Guide: guides you through setting up your display
devices, inserting your sensor, and starting your rst sensor session.
You can nd it with your iCan box.
• Instruction of Use (User Guide): This User Guide is your
encyclopedia. It gives you the most extensive overview of the iCan
System, detailing features, important safety information, and so much
more.
You can download both guides or ask for a printed version:
Download a PDF at iCan-cgm.com
Ask for a free copy by email: [email protected]

CGM User Guide
5Resources
Sinocare provides Customer Care email for assistance. If you
experience problems, report the issue to [email protected]. When
you send the request, please make sure the serial number of your
device is included in your email. The serial number is listed on your
sensor kit package.
Contact Information
Customer Care Email [email protected]
Website iCan-cgm.com

CGM User Guide
Section 1: System Overview 6
Section 1: System Overview
• System Description
• Intended Purpose
• User Safety

CGM User Guide
7 Section 1: System Overview
1.1 System Description
Thank you for choosing the iCan i3 Continuous Glucose Monitoring
System (hereafter referred as CGM). The iCan i3 CGM System consists
of three main components: a Sensor Pack, a Bluetooth Low Energy
(BLE) Transmitter Pack, and a mobile application (APP).
The iCan i3 CGM provides real-time glucose levels and allows you to
continuously view your sensor glucose values on your selected mobile
device. The system tracks your glucose every 3 minutes by measuring
the amount of glucose in the interstitial uid. A sensor, inserted in your
skin, sends glucose results to the transmitter, and the transmitter sends
glucose results to the iCan Continuous Glucose Monitor System APP
(CGM APP). The APP then displays your glucose levels and long-term
glucose trends. The APP also provides alerts if your glucose is in or
projected to be in an unsafe zone.
The iCan i3 CGM also detects trends and tracks patterns and aids
in the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments. Interpretation
of the system results should be based on the glucose trends and
several sequential results over time.
Note: Please read all the instructions provided in this Instruction for
Use before using the system.

CGM User Guide
Section 1: System Overview 8
1.1.1 Device Components
What you see What it’s
called What it does
Sens or Pack
This is a sterile package where
the Sensor is stored. The Sensor
Pack is designed for single use.
Button Safety Switch
Applicator
Sensor
(inside the
retractable needle)
Sensor-
Applicator
The Sensor-Applicator helps you
insert the Sensor under your
skin. It contains a needle which
is used to puncture the skin to
introduce the exible sensor tip
into skin but will be retracted into
the canister once the sensor is
placed. So there is no needle left.
The Sensor can be worn for up
to 15 days.
See Chapter 2 for details how to
use your Sensor.
Transmitter
Transmitter
Tray
Transmitter
Pack
The Transmitter snaps into the
Sensor and sends real- time
glucose readings wirelessly to
your compatible display device
via Bluetooth. When you use
it, you don’t need take the
Transmitter out of the Tray.
See Chapter 2 for details how to
use your Transmitter.

CGM User Guide
9 Section 1: System Overview
1.1.2 The iCan CGM APP
The iCan CGM APP serves as the display for the iCan i3 CGM and
supports Android and iOS devices (mobile devices). The APP is
available on Google Play (Android) and the APP Store (iOS). To see a
list of compatible mobile devices, visit iCan-cgm.com
WARNING: Missing alerts from the iCan CGM APP may result in
undetected low and high glucose levels. Follow the instructions and
safety warnings in this Instruction for Use to make sure you receive
alerts as intended.

CGM User Guide
Section 1: System Overview 10
1.2 Intended Purpose
The Continuous Glucose Monitoring System is a real time, continuous
glucose monitoring device indicated for the management of diabetes
for adult people (age 18 and older). It is intended to replace ngerstick
blood glucose testing for diabetes treatment decisions.
The CGM also detects trends and tracks patterns, and aids in the
detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. Interpretation of the
System results should be based on the glucose trends and several
sequential readings over time.
The CGM can be used in conjunction with smart devices with
corresponding application where the user manually controls actions for
therapy decisions.
1.3 User Safety
This section includes important safety information such as indications,
contraindications, safety warnings, potential adverse reactions, and
how to protect the system from radiation exposure damage.
1.3.1 Contraindications
• Do not use the iCan i3 CGM if you are pregnant, on dialysis,
implanted with a pacemakers or critically ill. It is not known how
di󰀨erent conditions or medications common to these populations
may a󰀨ect performance of the system. iCan i3 CGM results may be
inaccurate in these populations.

CGM User Guide
11 Section 1: System Overview
• No MRI/CT/Diathermy
Do not wear your iCan i3 CGM (sensor, transmitter, receiver, or
mobile device) for magnetic resonance imaging (MRI), computed
tomography (CT) scan, or high-frequency electrical heat (diathermy)
treatment.
The iCan i3 CGM has not been tested in those situations. The
magnetic elds and heat could damage the components of the iCan
i3 CGM, which may cause it to display inaccurate sensor glucose
results or may prevent alerts. Without iCan i3 CGM results or alert
notications, you might miss a severe low or high glucose event.
To get the most out of your session, we advise that you try to
schedule your procedure near the end of your sensor session
to avoid needing an extra sensor. Please consult your doctor for
recommendations with any other medical procedures.
Bring your Blood Glucose Meter with you when you go to your
procedure.
MR UNSAFE
• Do not use iCan i3 CGM, if you are su󰀨ering from coagulation
disorders or taking anticoagulant drugs.

CGM User Guide
Section 1: System Overview 12
1.3.2 Safety Warnings
1.3.2.1 General Warnings
WARNINGS:
• Do not Ignore Low/High Symptoms
Do not ignore symptoms that may be due to low or high blood
glucose. Keep your blood glucose meter close to you. If you have
symptoms that do not match the sensor glucose results or suspect
that your results may be inaccurate, check the result by conducting a
ngerstick test using a blood glucose meter. If you are experiencing
symptoms that are not consistent with your glucose results, consult
your healthcare professional.
• No Treatment Decision if….
If your iCan i3 CGM does not show a number or arrow, or your
results do not match your symptoms, use your Blood Glucose Meter
to make diabetes treatment decisions.
• No modication is allowed.
The patient is an intended operator. No modication of this equipment
is allowed.
• No Use if….
WARNING: Do not use the iCan i3 CGM if you are pregnant, on
dialysis, implanted with a pacemakers or critically ill. It is not known
how di󰀨erent conditions or medications common to these populations
may a󰀨ect performance of the system. iCan i3 CGM results may be
inaccurate in these populations.

CGM User Guide
13 Section 1: System Overview
1.3.2.2 APP and Mobile Device
• When you start a new sensor, you will not get any CGM results or
alerts during the 2- hour sensor warmup period. Use a blood glucose
meter to make diabetes treatment decisions.
• Make sure Bluetooth is on, even if your mobile device is in Airplane
mode. If Bluetooth is o󰀨, you will not get sensor glucose information
or alerts.
• Do not use the iCan CGM APP if your mobile device screen or
speakers are damaged. If your mobile device is damaged or lost, you
may not get sensor glucose alerts and sensor glucose information
may not be shown correctly.
• Alerts for the iCan CGM APP will sound through your headphones
when headphones are connected. If you leave your headphones
connected when not in use, you may not hear sensor glucose alerts.
• If your mobile device restarts, the iCan CGM APP may not restart
automatically. If you do not open the APP again, you may not get
sensor glucose alerts. Always make sure to open the APP after your
mobile device restarts.
1.3.2.3 Transmitter
• Do not use the device if you see any cracking, aking, or damage
to the transmitter. A damaged transmitter could cause injuries from
electrical shocks and may make the iCan i3 CGM not work correctly.
• Do not allow children or pets to put small parts in their mouth. This
product poses a choking hazard for young children and pets.
• Do not use the transmitter adjacent to other electrical equipment
that may cause interference with the normal system operation. For
more information on other electrical equipment that may compromise
normal system operation, see Attachment D for details.

CGM User Guide
Section 1: System Overview 14
• Do NOT operate your transmitter in the presence of ammable
anesthetics or explosive gases.
• Do not discard the transmitter in a medical waste container or expose
it to extreme heat. The transmitter contains a battery that may ignite
and result in injury.
1.3.2.4 Sensor
• Do not ignore broken or detached sensor tip. A sensor tip could
remain under your skin. If this happens, please contact our Customer
Care Email or your Healthcare Professional. If a sensor tip breaks o󰀨
under your skin and you cannot see it, do not try to remove it. Seek
for professional medical help or contact our Customer Care Email.
• Store your iCan i3 CGM between 2°C and 30°C. Do not store
Sensors Pack in the freezer.
• Do not use a sensor past its expiration date because it may give
incorrect results. The expiration date is in YYYY-MM-DD (Year-
Month-Day) format on the sensor package label beside the hourglass
symbol.
• Do not use sensor if its sterile package has been damaged or
opened, because it might cause an infection.
• Do not open the sterile package until you are ready to insert the
sensor because an exposed sensor can become contaminated.
• Use of barrier methods or patches may a󰀨ect the performance of the
device. If you are having skin reactions to this sensor, contact your
healthcare professional to discuss if you should continue to use this
device.

CGM User Guide
15 Section 1: System Overview
1.3.2.5 Bleeding
• In order to insert the sensor to reach the interstitial uid, it must
penetrate the dermis layer of the skin using a needle, which has
blood vessels scattered throughout.
• Penetration of these blood vessels may cause bleeding if the needle
pierces them. If the sensor is inserted too deep into the body, it may
also bleed. Ensure you are not using excess pressure when inserting
with the applicator.
• If bleeding occurs, do the following:
■ Apply steady pressure, using sterile gauze or a clean cloth placed
on top of the sensor, for up to three minutes.
■If bleeding stops, connect the APP to the sensor.
■If bleeding does not stop, remove the sensor and clean the area
using sterile gauze. Apply a new sensor on a di󰀨erent location at
least 7 cm (3 inches) from the bleeding site.
1.3.3 Precautions
1.3.3.1 General Precautions
• Avoid exposing your iCan i3 CGM to insect repellent and sunscreen.
Contact with these skin care products may cause damage to your
CGM.
• Do not wear the iCan i3 CGM in a hot tub.
• If you notice signicant skin irritation around or under your sensor,
remove the sensor and stop using the CGM. Contact your healthcare
professional before continuing to use the CGM.
• The CGM system is designed for single use. Reuse may cause no
glucose results and infection.

CGM User Guide
Section 1: System Overview 16
• Monitoring results of the product can only be used as a reference
for the auxiliary diagnosis of diabetes, not as the basis for clinical
diagnosis.
• If there is a burning sensation, or any discomfort, please remove the
CGMS immediately
1.3.3.2 Testing Your Blood Glucose
Glucose levels in the interstitial uid can be di󰀨erent to blood glucose
levels and may mean that sensor glucose results are di󰀨erent to blood
glucose. You may notice this di󰀨erence during times when your blood
glucose is changing quickly; for example, after eating, taking insulin, or
exercising. If you suspect that your result may be inaccurate, check the
result by conducting a ngerstick test using a blood glucose meter.
1.3.3.3 Get Ready Before Start
• Clean and dry your hands and your insertion site before inserting
your sensor. Wash your hands with soap and water, not gel cleaners,
and then dry them before opening the Sensor Pack. If your hands are
dirty when you insert the sensor, you may get germs on the insertion
site and get an infection.
• Clean your insertion site with alcohol wipes to prevent infections.
Do not insert the sensor until your skin is dry. If your insertion site
is not clean and completely dry, you run the risk of infection or the
transmitter not sticking well.
• Make sure you do not have insect repellent, sunscreen, perfume, or
lotion on your skin.
• Things to check before insertion:
■Keep the safety guard locked until you put the armed applicator
against your skin. If you remove the safety guard to unlock rst,

CGM User Guide
17 Section 1: System Overview
you may hurt yourself by accidentally pushing the button that
inserts the sensor before you mean to.
■Change your insertion site with each sensor. Using the same site
too often might not allow the skin to heal, causing scarring or skin
irritation.
• The sensor placement site must:
■At least 7 cm (3 inches) from insulin pump infusion set or injection
site;
■Away from waistband, scarring, tattoos, irritation, and bones;
■Unlikely to be bumped, pushed, or laid on while sleeping
1.3.3.4 Potential Risks Related to Sensor Use
• Going Through Security Check Point
■When wearing your iCan i3 CGM, ask the Transportation Security
Administration (TSA) for a full-body pat-down with a visual
inspection of your sensor and transmitter. Don’t put your iCan i3
CGM System components through x-ray machines. The e󰀨ect of
AIT body scanner and x-ray machine have not been evaluated or
know the damage they may cause the iCan i3 CGM.
• Bathing, Showering and Swimming
■The sensor can be worn while bathing and showering but not hot
tub, exposure to heat for longtime may damage the sensor or
cause inaccurate results. You can also swim while wearing the
sensor in place up to a depth of 2.5 meters for up to 2 hours (IP28).
Exceeding the depth or time may damage the sensor or cause
inaccurate results.