Trevi SugarBEAT User manual

Instructions For Use
(IFU)
Continuous Glucose
Monitoring System

2
Contents
Starting out with sugarBEAT®� � � � � � � � � � � � � � � � � � � � 5
Your sugarBEAT®system � � � � � � � � � � � � � � � � � � � � � � � 6
Glossary of Terms � � � � � � � � � � � � � � � � � � � � � � � � � � � 8
Intended Use � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 12
What do you need to know before using sugarBEAT®? � � � � � � � 12
Contraindications � � � � � � � � � � � � � � � � � � � � � � � 13
Warnings � � � � � � � � � � � � � � � � � � � � � � � � � � � 14
What to know before you apply your sugarBEAT®device � � � � 16
Your blood glucose level compared with sugarBEAT®readings � � � 16
Cybersecurity Best Practice � � � � � � � � � � � � � � � � � 17
Smart Device Settings � � � � � � � � � � � � � � � � � � � � � � 19
When to remove your device � � � � � � � � � � � � � � � � � 20
Precautions � � � � � � � � � � � � � � � � � � � � � � � � � � � � 21
Labelling & Packaging of sugarBEAT®� � � � � � � � � � � � � � � � 25
What is in your sugarBEAT®Device Box? � � � � � � � � � � � � � � 26
Transmitter � � � � � � � � � � � � � � � � � � � � � � � � � 26
Docking Station � � � � � � � � � � � � � � � � � � � � � � � 26
Transmitter Password Card � � � � � � � � � � � � � � � � � � 27
Charger � � � � � � � � � � � � � � � � � � � � � � � � � � � 27
Quick Start Guide � � � � � � � � � � � � � � � � � � � � � � 27
What is in your sugarBEAT®Sensor Kit Box? � � � � � � � � � � � � � 27
Sensor � � � � � � � � � � � � � � � � � � � � � � � � � � � 27
Guiding Frame � � � � � � � � � � � � � � � � � � � � � � � 28

3
The sugarBEAT®Smart Device App � � � � � � � � � � � � � � � � � 28
Getting started with sugarBEAT®� � � � � � � � � � � � � � � � � � 32
1� Charging the Transmitter � � � � � � � � � � � � � � � � � 32
2� Initial App Set- Up � � � � � � � � � � � � � � � � � � � � 33
3� Connect the Transmitter to the sugarBEAT®App � � � � � � 37
4� Preparing your skin before attaching sugarBEAT®� � � � � 41
5� Attaching the Sensor � � � � � � � � � � � � � � � � � � � 44
6� Placing the Transmitter on your Arm � � � � � � � � � � � 46
7� Calibrating the Transmitter � � � � � � � � � � � � � � � � 47
sugarBEAT®‘In-App’ Symbols and Settings � � � � � � � � � � � � 50
Battery Symbols � � � � � � � � � � � � � � � � � � � � � � 53
Review of Settings � � � � � � � � � � � � � � � � � � � � � � � 54
Alerts on the sugarBEAT®App � � � � � � � � � � � � � � � � � � � 56
App Alerts: Low Limits � � � � � � � � � � � � � � � � � � � � 58
App Alerts: High Limits � � � � � � � � � � � � � � � � � � � 60
Glucose Trend Arrows � � � � � � � � � � � � � � � � � � � � 62
Time-in-Range (TIR) � � � � � � � � � � � � � � � � � � � � � 63
Viewing & Exporting Data � � � � � � � � � � � � � � � � � � � � � 65
Transmitter Removal + Storage � � � � � � � � � � � � � � � � � � 69
Everyday Use of the App / Transmitter � � � � � � � � � � � � � � � � 71

4
Diary Functions – Logging Food, Medication, Wellbeing and Activity � � 73
A� Activity � � � � � � � � � � � � � � � � � � � � � � � � � 73
B� Medication � � � � � � � � � � � � � � � � � � � � � � � 75
C� Food � � � � � � � � � � � � � � � � � � � � � � � � � � 76
D� Wellbeing � � � � � � � � � � � � � � � � � � � � � � � � 77
Troubleshooting � � � � � � � � � � � � � � � � � � � � � � � � � � � 79
A� Transmitter � � � � � � � � � � � � � � � � � � � � � � � 79
B� Application � � � � � � � � � � � � � � � � � � � � � � � 80
C� Docking Station / Charging � � � � � � � � � � � � � � � 85
Guidance and Manufacturer’s Declaration
- Electromagnetic Immunity � � � � � � � � � � � � � � � � � � � � 86
Electrical Safety testing and compliance � � � � � � � � � � � 87
IEC Classifications � � � � � � � � � � � � � � � � � � � � � � 87
Training � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 87
Additional Information � � � � � � � � � � � � � � � � � � � � � � 88
Specifications � � � � � � � � � � � � � � � � � � � � � � � � � � � � 89
A� sugarBEAT®Specifications � � � � � � � � � � � � � � � � 89
B� sugarBEAT®Sensor Specifications � � � � � � � � � � � � � 90
C� sugarBEAT®Accuracy Specifications � � � � � � � � � � � � 91
Wireless Quality of Service Summary � � � � � � � � � � � � � � � 92
Wireless Security � � � � � � � � � � � � � � � � � � � � � � � � � � 94
Disposal of sugarBEAT® Device and Sensor � � � � � � � � � � � � 94
Skin Care Tips � � � � � � � � � � � � � � � � � � � � � � � � � � � � 95
Manufacturer Contact Details � � � � � � � � � � � � � � � � � � � 95

5
Starting out with
sugarBEAT®
sugarBEAT®is for people with Type 2
diabetes or prediabetes who wish to
have assistance with monitoring their
glucose levels throughout their day
sugarBEAT®also works well for people
who wish to monitor their glucose as
part of a healthy lifestyle�
This Instructions for Use covers your experience with
the sugarBEAT®device� It covers what the sugarBEAT®
device is and how to use it as well as how to
download and use the sugarBEAT®App�
It is important to read all the Instructions for Use
before you use sugarBEAT®as it contains important
information about the device� You should keep your
Instructions for Use somewhere safe as you may need
to refer to it again in the future�

6
Your sugarBEAT®system
Below is a brief summary of what
the sugarBEAT®system is and what
it does� More detailed information
is provided later in this guide�
sugarBEAT®is a non-invasive Continuous Glucose
Monitoring (CGM) system for tracking glucose trends
and patterns and is intended to help people with Type 2
diabetes and prediabetes better manage, reverse and
prevent the onset of this condition� It can also be used
by those who simply want to better understand the
impact their lifestyle and diet is having on their glucose
levels� sugarBEAT®is intended to be complimentary to
Self-Monitoring Blood Glucose (SMBG) testing for those
with diabetes although everyone will need to use blood
glucose values from a Blood Glucose Meter (BGM) to
calibrate their sugarBEAT®system�
This document contains important safety
information� Read this document before using
sugarBEAT®� Keep these instructions for use in a
safe place as you may need to read them again�

7
The sugarBEAT®system is composed
of the following:
Transmitter: The Transmitter records glucose levels
and transmits data to the smart device application
using Bluetooth� It is a small, rechargeable and reusable
electronic device in a plastic casing�
Sensor Kit: The Sensor kit consists of a foil pouch containing
a single use disposable glucose Sensor and a Guiding
Frame that allows the correct and accurate placement
of the Transmitter onto your arm�
Docking Station: The Docking Station connects to a USB
cable and power supply and is used to charge the Transmitter�
Smart Device Application (App): The App connects to
the Transmitter via Bluetooth and is used to download
and present data on a smart device�
Once attached to your arm, the sugarBEAT®Transmitter
provides glucose readings to the App on your smart device at
5 minute intervals and can be worn for up to 14 hours at a time�

8
Acronym/
word Definition
App A software application on a smart device such as
a mobile phone or tablet�
Type BF
Applied Part Not suitable for direct cardiac application�
Blood
Glucose
(BG) Value
BG is an abbreviation for Blood Glucose� Blood Glucose
Value is the amount of glucose measured in the blood
using a BGM�
Blood
Glucose
Meter /
BG Meter /
SMBG Meter
A medical device used to measure how much glucose
is in the blood�
Calibration
The App needs a BGM reading to enable it to convert the
Sensor signals into glucose readings� The more you calibrate
the more accurate the App glucose reading will be�
CGM
Continuous Glucose Monitor� A device which determines
glucose levels in your body and uses a transmitter to
continuously send these values to an App which converts
and then displays them�
Contra-
indication
A situation where sugarBEAT® must not be used as the
risk of use outweighs the benefit�
EMC
Electromagnetic Compatibility is the ability of electrical
equipment and systems to work in the environment that
they are being used in�
Glossary of Terms

9
Acronym/
word Definition
Fingerstick
Testing / Test
strip testing /
SMBG
One way of determining your BG level� Using a BGM
and test strips you can determine your BG level from
a sample of blood from e�g� your fingertip�
Hyper-
glycaemia
Medical term for high blood sugar (glucose levels�
Sometimes called a ‘hyper’ or ‘high’ and is typified
by higher than average glucose levels in the bloodstream�
It is a serious condition and if untreated can lead to
complications such as Diabetic Ketoacidosis (DKA)�
The alert in sugarBEAT®for ‘Glucose High’ is set at
13�9 mmol/L and 22�2 mmol/L at for ‘Glucose Urgent High’
bearing in mind that sugarBEAT®is to be used alongside
values from a BGM rather than as a replacement�
Alerts are discussed in more detail later in this document�
Hypo-
glycaemia
Medical term for low blood sugar (glucose) levels�
Sometimes called a ‘hypo’ or ‘low’ and is typified by
lower than average glucose levels in the bloodstream�
It is a serious condition and if untreated can lead to
serious complications such as unconsciousness�
The alert in sugarBEAT®for ‘Glucose Low’ is set at
4�4 mmol/L and at 3�6 mmol/L for ‘Glucose Urgent Low’
bearing in mind that sugarBEAT®is to be used alongside
values from a BGM rather than as a replacement�
Alerts are discussed in more detail later in this document�
IEC
International Electrotechnical Commission is a recognised
standards organisation for electrical / electronic
technologies�

10
Acronym/
word Definition
IFU Instruction For Use�
Indication A condition making a particular treatment or procedure
advisable�
IP
The Ingress Protection (IP) marking is one of the IEC safety
standards which classifies and rates how protected an
electronic device is against water, dust, accidental contact
etc� IP ratings are numerical with the number based on the
conditions the device may come across�
MARD
Mean Absolute Relative Difference� Currently the most
common way to assess the performance of a CGM
system� MARD is the average of the absolute error
between all CGM values and matched reference values�
The smaller the percentage the closer the CGM readings
are to the reference glucose value�
Precaution A measure to be taken by you or your doctor to ensure
the safe and effective use of sugarBEAT®�
RF Radio frequency�
Safety
Statement
A statement of the intended uses of sugarBEAT®and
relevant warnings, precautions and contraindications�
Smart Device
A mobile device that can wirelessly connect to a network
via Wi-Fi or a mobile data connection e�g� 3G, 4G, 5G�
Smart phones and tablets are examples of smart devices�
SMBG
Self-Monitoring Blood Glucose� This is the method of
determining your BG by use of a BGM and a blood
sample applied to a BG test strip� Commonly called
Fingerstick Testing�

11
Acronym/
word Definition
Time-in-
Range (TIR)
TIR is the percentage of time that a person spends with
their glucose levels in a target range�
Warning
A type of safety statement which describes a feature
and important information about the risks involved�
Describes things to be aware of when using sugarBEAT®,
their possible consequences and how to avoid them�
WEEE
Waste Electrical and Electronic Equipment should be
disposed of in accordance with local requirements�
This is discussed in more detail later in this document�

12
Intended Use
What do you need to know
before using sugarBEAT®?
sugarBEAT®is a non-invasive Continuous Glucose
Monitoring (CGM) system for tracking glucose patterns
and is intended to help people with Type 2 diabetes
and prediabetes better manage, reverse and prevent
the onset of this condition�
It can also be used by those who simply want to better understand
the impact their lifestyle and diet is having on their glucose levels�
sugarBEAT®is intended to be complimentary to SMBG testing for those
with diabetes although everyone will need to use blood glucose levels
from a BGM to calibrate their system�
Remember that sugarBEAT®is not designed to replace SMBG testing and
adjustments of your treatment e�g� insulin dose should not be made
based on readings from it�
Not using sugarBEAT®and its components according
to these instructions and safety information / warnings
may result in you not getting the best from the system
or it not working as it should�
Safety information appears throughout this document� This includes
indications, relevant warnings, precautions and contraindications� Please
read all of this information Instructions for Use to ensure you use the product
safely and get the most from it� Information that is particularly relevant
to the successful operation of sugarBEAT®is shown immediately below�

13
Contraindications
There are a small number of people who should not use sugarBEAT®
and these are listed below:
• Persons with skin conditions which preclude the wearing of the
Transmitter at the application site (e�g� recent burns / scalds,
open wounds or skin lesions)�
• Persons with known allergies to medical grade adhesives�
• Persons under 18 years of age*
• Persons over 70 years of age*
• Critically ill patients*
• Pregnant women*
• Persons undergoing dialysis*
* The accuracy of sugarBEAT®has not yet been tested in these groups
and as such its use cannot be recommended as the accuracy of readings
cannot be confirmed�
Persons with suspected allergies to skin adhesives should consult their
healthcare professional before using sugarBEAT®� If skin irritation around
or under the Sensor area is identified, use of the Transmitter should be
stopped� If the irritation does not improve after 2-3 days, or worsens
after 2 days, consult a doctor�
DO NOT USE sugarBEAT®:
• If the Sensor Kit or Sensor appear to be damaged or are already
opened when you receive them�
• If the Transmitter’s plastic case is or appears to be damaged�
• If any component has passed its use by date�
• If you plan to swim or take a shower / bath�
• Whilst you are in surgery�
During intense exercise, the Transmitter may loosen or come off due to
sweat or movement� If this occurs, replace the Sensor and reapply the
Transmitter�

14
Warnings
The following table gives advice / warnings to help ensure that you use
your sugarBEAT®device safely and effectively:
Read this (IFU) before use� It is important to read and follow this
information� Keep it safe so you can refer to it again�
Explosion hazard� Do not place near to or use sugarBEAT®in the
presence of any flammable substances, anesthetics or gases�
sugarBEAT®should only be used with the plug provided� Do not
attempt to use alternative universal power supplies with the system
as they may not meet the required standards�
You should not ignore symptoms that may be due to low or high blood
glucose� If you experience symptoms that are not consistent with the
glucose readings from sugarBEAT®, confirm your blood glucose using
a BGM and if necessary, consult a healthcare professional�
During conditions such as uncontrolled diabetes or rapidly changing
blood glucose levels, you must confirm the sugarBEAT®readings with
those from your BGM and / or recalibrate at regular intervals�
Do not attempt to modify the equipment or system as this may
cause injury� If you experience any unexpected events while using
this device, please contact the manufacturer – details are provided
at the end of this (IFU)�
Do not immerse any part of the equipment in any liquid�
No user serviceable parts�
Keep out of the sight and reach of children�
Do not ignore the ‘High’ or ‘Low’ alerts even if you feel fine� Check
your blood glucose using a BGM and if necessary, recalibrate your
sugarBEAT® Sensor�
Note: If the radio link between the Transmitter and your smart
device becomes unavailable, the glucose “Alert” functions will not
operate correctly�

15
Always check your glucose readings using a BGM� sugarBEAT®is
intended to be used as an adjunct to a conventional BGM� The
system does not intend to replace Self-Monitoring Blood Glucose
(SMBG) devices�
Impaired awareness of Hypoglycaemia� sugarBEAT®has not been
evaluated for use with patients that have impaired awareness of
hypoglycaemia� Caution is advised with the use of this device in
these patients�
Skin conditions, e�g� Psoriasis, Neurodermatitis� sugarBEAT®has
not been evaluated for patients with these conditions (or similar)�
Consult your physician before using this device�
Choking hazard: sugarBEAT®contains small parts (including a
Lithium-Ion battery) which may be dangerous if swallowed�
Transport / Flying: The Transmitter contains a Lithium-Ion battery�
The device must either be attached to your arm and in use or
placed in carry-on cabin baggage (recommended)� Always check
current airline rules prior to travel to an airport� Be aware that if the
Transmitter is in use and you activate flight mode on your mobile
device and Bluetooth connection is lost, the data transfer will
automatically resume when you reconnect Bluetooth� No data will
be lost�
Transport / Air Cargo: The battery cannot be shipped alone� It must
be contained within sugarBEAT®or packed in the same primary
container as sugarBEAT®� Contact your shipping agent BEFORE
packing and shipping and check current International Air Transport
Association (IATA) rules�

16
• Ensure the application site is clean, dry and free from moisturisers
/ lotions, excess sweat or dirt� If present, wipe them away with
a standard alcohol wipe� It is recommended to change the
application site after each use to prevent irritation� Leave a
minimum of 24 hours before re-using an application site�
• Transmitter application is not approved for sites other than the
upper arm� If placed on other sites, it may not function properly�
• Avoid skin areas with scars, moles, stretch marks, excessive hair,
lumps, tattoos or insulin injection sites� Select a flat surface (no
bent or folded skin) and one where muscle movement will be
as little as possible� Choose a site that is at least 2�5 cm (1 inch)
away from an insulin injection site�
What to know before you
apply your sugarBEAT®device
Your blood glucose level compared
with sugarBEAT®readings
There is a short lag period of, on average, 10-45 minutes from when
sugarBEAT® measures your glucose level and it being displayed on
the App� Differences in glucose readings between a BGM reading and
sugarBEAT®may therefore be observed during times when blood
glucose changes rapidly, such as after exercise, eating and insulin
administration�

17
Cybersecurity Best Practice
Part of the sugarBEAT®system is an App which works on your smart
device and displays the glucose readings detected by the Sensor� The
App and the Transmitter are connected by Bluetooth technology and
it is important that you take appropriate cybersecurity precautions in
order to keep your data safe:
• The sugarBEAT®App should only be downloaded from official
App locations (Google Play Store / App Store) to ensure only the
official version is used�
• It is recommended that smart devices and associated accounts
(i�e� Google Device) have user enabled passwords / pass codes
/ biometric identification i�e� fingerprint recognition enabled to
prevent unauthorised access to the smart device and App data�
• It is recommended that a strong and unique password / pass
code is used for smart devices and associated accounts�
• It is recommended that a lock-out timer is set to prevent
unauthorised access to the smart device and App data�
• The rooting or jailbreaking of smart devices may prevent
App security features from operating correctly and may give
unauthorised access to the smart device and App data� It is
not recommended to use sugarBEAT®with jailbroken or rooted
smart devices�
• It is recommended that anti-virus and anti-malware software is
installed on the smart device and security scans are enabled�

18
• It is recommended that App data backups are enabled and the
Transmitter is periodically backed up and these backups are
secured�
• It is recommended that the ‘Scan device for Security Threats’
feature is enabled (Android user only)�
• Never give unauthorised access to the smart device and App�
• It is recommended to keep the software on your smart device
and the App up to date by installing updates when prompted�
• Be aware that information e�g� your glucose readings sent over
an unencrypted email are not secure and could be intercepted�

19
Smart Device Settings
It is important to ensure that the settings on your smart device are correct
so that you do not miss an important alert when using sugarBEAT®�
It’s important to be aware that a smart device’s internal settings or
other accessory devices such as a smart watch or fitness tracker may
interfere with or override the alerts in the sugarBEAT® App� To make
sure this does not occur:
• Ensure that your smart device has a security password set�
• Make sure the notifications for the sugarBEAT®App are turned
on in the settings menu of your smart device�
• Ensure sugarBEAT®has access to your smart device’s location,
even when running in the background�
• Ensure Bluetooth is enabled on your smart device�
• Turn off ‘Do Not Disturb’ on your smart device (if available)�
• Always have the sugarBEAT®App running; do not close it down�
• Make sure any (new) devices you connect to your smart device
do not interfere with or change the settings�
• Ensure the volume on your phone is set at a level that you can
hear bearing in mind where you might be during the day�
• Ensure sugarBEAT®has permission to write to your smart device’s
storage�
The alert vibrations on the sugarBEAT®App are no different to other
vibrating alerts on your smart device e�g� from a fitness tracker�
As such the only way to see if a notification is from sugarBEAT®
is to look at your smart device�

20
When to remove your device
• Remove your device after a maximum of 14 hours use�
• If you believe the reading from sugarBEAT®is incorrect or it is
inconsistent, check it using your BGM� If the problem continues
remove your device, charge your Transmitter and fit a new Sensor�
• Be aware that if the device becomes loose, you may get no or
inconsistent readings�