Chronolife Smart Textile User manual

Chronolife Smart Textile - User Guide ©2022 Chronolife S.A.S
USER GUIDE
Ref : NEX-0001-LBL-06 March 2022

Chronolife Smart Textile - User Guide ©2022 Chronolife S.A.S
2
We would like to thank you for choosing this Chronolife Smart Textile
product. These instructions are intended to help you use the garment and
application safely and e󰀨ectively.
This manual describes the features, set-up and operation of the Chronolife
wearable monitoring solution and is intended to provide instructions for its
safe and e󰀨ective use.
This monitoring solution consists of:
• A wearable measuring garment referred to as “smart shirt”
• A data transmission application referred to as “smartphone application’
or “app”
• A Web interface referred to as “web interface”
INTRODUCTION

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Table of contents
1. INTENDED USE AND CLAIMS 4
2. ENVIRONMENT FOR USE 4
3. WARNINGS AND PRECAUTIONS WHEN USING 4
3.1 Contra-indications 4
3.2 Reactions 5
3.3 Warnings 5
4. DEFINITIONS OF SYMBOLS 6
5. DEVICE’S GENERAL PRESENTATION 8
5.1 Overview of device use 8
5.2 Principles for functioning 8
5.3 Presentation of the kit 9
5.4 Presentation of the smart shirt 10
6STEPS FOR USAGE 11
6.1 Charging the smart shirt’s battery 11
6.2 Connection to the smartphone app 12
6.3 Connection of the smart shirt to the smartphone application 13
6.4 Wearing the smart shirt 14
6.5 Remove and turn o󰀨 the T-shirt 16
6.6 Using the smartphone app 16
7. MAINTENANCE AND CHANGING OF THE SMART SHIRT 21
7.1 Maintenance of the smart shirt 21
7.2 Changing of the smart shirt 22
7.3 Use and storage conditions 23
8 ALERT MESSAGES 23
9TROUBLE-SHOOTING 29
10 SAFETY INFORMATION 32
11 REGULATORY INFORMATION 32
12 ELECTROMAGNETIC COMPATIBILITY 34
13 SMART SHIRT TECHNICAL SPECIFICATIONS 37

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3. WARNINGS AND PRECAUTIONS WHEN USING
1. INTENDED USE AND CLAIMS
2. ENVIRONMENT FOR USE
Before using Chronolife Smart Textile monitoring solution, this document should be
read in its entirety. Not complying with these instructions can lead to serious injuries
or damage. The Chronolife Smart Textile solution should only be used according to
its intended use, as described in this manual. This manual should be kept for future
reference.
The Chronolife Smart Textile solution is a wireless remote monitoring system
intended for continuous collection of physiological data in home or outdoors. These
data can include single-lead electrocardiography (ECG), thoracic impedance,
thoracic respiration, abdominal respiration, skin temperature and physical activity.
A multi-sensor embedded smart shirt records data which are transmitted wirelessly
to a paired smartphone app, and from the app to a secured certied server where
the raw data can be stored and downloaded for analysis. The device does not
process the raw data into clinical format and no claims are being made for the
display and analysis of the raw data in terms of accuracy, precision or reliability.
Never use this device in the following cases :
• If you have an open wound
• If you are taking a bath or washing yourself (do not wet/
soak the device)
• If you are allergic to the following constituents :
elastane or polyester
3.1 Contra-indications
!
The Chronolife Smart Textile monitoring solution is intended for general use.
The smart shirt is not suitable for pregnant women due to the size availability.
Chronolife Smart Textile is not a medical device. It is not designed or intended to
be used to diagnose disease or other health problems or to cure, mitigate, treat
or prevent any disease. The use of this product is not a substitute for medical
consultation and if you have any questions about your health, please consult your
doctor as soon as possible.
Warnings

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If there are skin reactions or those of an allergic nature, remove the smart shirt
immediately and consult your doctor.
3.2 Reactions
3.3 Warnings
Warnings
• Proper functioning of the system is dependent on correct and regular transmission of
data from the Smart shirt. You must ensure that the smartphone and the smart shirt
are always connected for this to occur.
• When you are wearing the smart shirt continuously, if your smart shirt and your
smartphone are disconnected for more than 10 hours, your data will not be recorded.
• The Chronolife Smart Textile monitoring solution is a device intended for adults (aged
over 18). Keep out of the reach of children.
• Do not wear any clother (bra,etc) under the smat shirt.
• In the event of an anomaly or dysfunction, stop using the device and contact the
organism who provide you the smart shirt.
• Do not modify the device. Do not personalize the smart shirt (coloring, bleaching).
That may lead to a dysfunction.
• Do not use the smart shirt and cables, if the devices are damaged. Do not attempt to
repair the equipment yourself. Return all damaged equipment to the organism who
provide you the smart shirt.
• Do not share your smart shirts with third parties. The smart shirt has been designed
for personal use only. Sharing your smart shirt with other people can lead to the
transfer of incorrect information.
• Keep the smart shirt away from ames and heat sources. The battery could overheat
and explode, causing a re or damage to property or the body.
• Only use the charger and cables authorized by the manufacturer. The use of non-
authorized parts and accessories can damage the smart shirt or injure the user.
• Do not use the smart shirt in the immediate area of strong sources of electromagnetic
interference, especially near electro-medical equipment or a microwave oven. Please
comply with the information signs and instructions prohibiting or limiting the use of
electronic devices.
• Do not put the smart shirt in the microwave. It is not intended to be there.
• Do not use several smartphones or tablets to connect the smart t-shirt. This could
alterate or destroy the data measured by the smart t-shirt. If you change your
smartphone, check that all the data have been entirely synchronized on the previous
smarphone: Refer to the page «Data Transfer Status» on the app and check.
1. If the status is equal to «00h00m», the application can be uninstall.
2. If not, check your connexion and wait until the sending data status is «00h00m»
to uninstall the app.If you smartphone is only on 4G, please verify in the app
parameters that the box «Wi Only» is unchecked.

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4. DEFINITIONS OF SYMBOLS
SYMBOL DEFINITION
Carefully read the instructions for use.
Manufacturer
Wash at 40°C maximum, Delicate cycle
Bleaching is prohibited
Tumble drying is prohibited
Ironing is prohibited
Dry cleaning is prohibited
Serial number
Reference number of element
Batch number of element
Store away from light and sunlight
Do not expose to moisture
SN

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SYMBOL DEFINITION
Temperature limit to be observed for storage and transit
Humidity level limit for storage and transit
Atmospheric pressure limit to observed for storage and transit
A device which includes an RF transmitter or which intentionally
uses electromagnetic RF energy
Conforms with european directives:
• 2014/30/UE Electromagnetic Compatibility Directive
• 2014/35/UE Electrical equipment designed for use within
certain voltage limits Directive
• 2014/53/UE Radio Equipment Directive
Conforms with Federal Communications Commision regulations:
• Part 15 of the FCC rules
Conforms with wireless charger (Qi) standard
Conforms with european directives 2002/95/CE Restriction of
hazardous substances in electrical and electronic equipment
(RoHS)
This device must be recycled and must not be disposed of with
other waste, according to directives 2006/66/CE and 2012/19/
EU
This device can be recycled.
Common marking for recyclable products French Decree 2014-
1577
Recyclable plastic bag (polypropylene)

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5. DEVICE’S GENERAL PRESENTATION
5.1 Overview of device use
5.2 Principles for functioning
The Chronolife Smart Textile monitoring solution is designed for use in adults ages 18
years and older for collection and continuous storage of vital physiological parameters,
whether at home or outdoors. The measured parameters are: electrocardiogram (ECG,
1 derivation), abdominal and thoracic respiration, skin temperature, thoracic impedance
(in order to detect the presence of uid in the lungs) and physical activity (movements
by the user).
The smart shirt is battery-powered and the smartphone application will help to monitor
the smart shirt power levels and connectivity and alert the wearer when the power levels
are low or connexion is lost, all essential to avoid loss of smart shirt data.
The smart shirt has been designed to be worn 24 hours a day and 7 days a week. It
is highly important that the smart shirt is of the correct size for the wearer because
the smart shirt must be in direct and rm contact with the skin to guarantee precise
measurement of the parameters. You should verify that the smart shirt is actually your
size and contact your prescriber if the t is not good.
You may have received one or several smart shirts in a kit to allow for easy integration
as a smart shirt or undergarment - adaptable to continuous use in daily life.
The application also displays the wearer’s step counter but this functionality should not
be used in any medical context.
The smart shirt uses electrodes and sensors to measure the di󰀨erent physiological
parameters and its wearer’s physical activity. The smart shirt can be activated once
the electronic board is awake. The user must then connect his smart shirt to the mobile
app. Once the smart shirt is connected to the mobile app, the user can wear it. Then
the parameters may be sent via Bluetooth® to the smartphone application, which then
transmits the data received to an accredited health data server (using the WiFi or mobile
network). This data is then accessible only to authorized users via the Web Interface.
So that the data is transmitted correctly, ensure that your smartphone and the smart
shirt are always connected.
Ensure that your smartphone maintains a distance of no more than two (2) meters from
the smart shirt, so that the app is able to detect the smart shirt.
If not, the smart shirt and the smartphone will disconnect. The smart shirt will always be
active while it is worn and your data will then be stored locally on the smart shirt. Once
your smartphone is once more within range of detection (at least two (2) meters) from
the smart shirt, the connection will be automatically re-established and the transfer of
data to the app will follow.
The smart shirt is battery-powered with a battery that has been fully integrated into the
smart shirt. It should be charged using the charger and power pack provided in the kit.

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The Chronolife Smart Textile application which is an essential component for the
functioning of the system is to be downloaded onto the wearer’s smartphone (see
section 6.2. Connection to the smartphone application)
5.3 Presentation of the kit
The Chronolife Smart Textile kit comprises of the following components:
One or several smart shirt
One induction charger and its power pack to charge the smart shir’s
battery
One Instruction for Use Manual and one Quick Start Guide
1
2
3
Make sure your smartphone is charged before using the smart shirt.
The data storage is carried out on the electronic card of the smart shirt when it
is not connected to the smartphone. The storage capacity on the smart shirt is
10 hours. If the smart shirt and the application are disconnected for more than
10 hours, the collected data will be lost.
Warnings
Warnings
The length of the charging cable complies with the regulations (25cm for the
whole charger).
1
No maintenance is intended to be performed by the user for the Chronolife Smart
Textile solution. No maintenance should be performed during use of the smart
shirt.

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5.4 Presentation of the smart shirt
This symbol is a QRCode and is present on the exterior of the smart shirt located
near the zipper. This code contains information about the smart shirt and is essen-
tial for pairing the smart shirt to its smartphone application.
In order to be able to use the smart shirt, the label including the QR Code
must not be cut o󰀨 or detached.
The card situated at the bottom of the smart shirt must not be bent, cut or
torn o󰀨.
Warnings
Warnings
Size Label
Outside of Smart Shirt
Inside of Smart Shirt
Temperature
sensors
Front Back
Electrocardiogram
electrodes
Red line for passing
of head
Zip Closure
Electronic part
Thoracic impedance
electrodes
Thoracic
breathing wire
Abdominal
breathing wire
Pairing label

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6. STEPS FOR USAGE
6.1 Charging the smart shirt’s battery
Before recharging the smart shirt, remove it
Connect the USB cable to the wireless
charger and the power supply
Gently insert the charger into the pocket :
the charger’s LED must be on the top when
you insert it
Locate the front pocket on the outside of
the shirt, and lift the tab
Leave your device to charge for 3 hours
minimum for a full recharge.
1.
2.
3.
4.
6.
Before using the Chronolife Smart Textile solution for the rst time, please charge
the smart shirt.
Warning
If your T-shirt is connected to the application, please press the «Disconnect
T-shirt» button on your smartphone application.
Connect the power supply to an electrical
outlet
5.
Do not use the smart shirt while it’s being charged.
Check on the app. that your smart shirt has been su󰀩ciently charged.
If your smart shirt has not charged correctly, remove it and contact the orga-
nism who provide you the smart shirt. Do not attempt to replace the battery.
Make sure that the battery use is in accordance with the specications laid
out in this User Manual.
Please use the charger provided with the t-shirt.
Please not use an external or portable battery to charge the t-shirt.
Warnings

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The wireless charger is not connected
to an electrical outlet
The wireless charger is only connected
to an electrical outlet
The t-shirt is charging The t-shirt is fully charged
The wireless charger is in fault: make
sure there is no object capable of
receiving energy around the charger
The wireless charger is in fault: make
sure there is no foreign object on the
charger
The right
blue LED is
flashing
The right
blue LED is
continuously
lighting
Both LED are
continuously
lighting
Both LED are
off
The left red
LED is
continuously
lighting
The left red
LED is
flashing
In case the charger fails (left LED on red), please:
• unplug the USB-C cable from the charger,
• replace the charger in the pocket, and then
• reconnect the USB-C cable to the charger.
Make sure the right blue LED lights up, indicating the proper charging of
the t-shirt.

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6.2 Connection to the smartphone app
Please enter the ID number
provided to you in the « ID » eld
and click on « Log in ”.
You can now use the Chronolife Smart Textile app. for smartphone.
Open the app. on your smartphone.
2.
3.
4.
Warnings
When logging in for the rst time, please allow the application to access:
• To the camera
• To smartphone storage
• To the geolocation
Make sure that these authorizations are always active.
Also make sure that WiFi and Bluetooth are activated.
The smartphone must not be energy-saving when using the app.
Download and install the free app on your smartphone on:
1.
Or scan this
QR Code
or on: https://chronolife.net/smarttextile/app.html
Warnings
Make sure to keep the ID number provided to you, in case you need to log in
again to the smartphone application.

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6.3 Connection of the smart shirt to the smartphone application
Locate the outer label (next to the
zipper) with the « QR Code ».
Keep the « QR Code » label at.
Check that your smartphone’s Bluetooth® connection is active
(smartphone settings).
Open the app. on the smartphone.
Press the button « Scan
T-shirt QR Code ».
Position the smartphone’s camera facing
the “QR Code” at about 20cm away.
1.
2.
3.
4.
5.
15-25
cm
Turn on the T-shirt: shake the low
front part of the t-shirt at the electro-
nic board level.
6.
Your smart shirt is now connected to your smartphone and your data will
be sent automatically by the latter. Ensure that you are always connected
to the WiFi or mobile network, so that the data can be transferred to an
accredited server for the storage of medical data.
If you fail to connect your smart shirt to your smartphone, please refer to section
8. ALERT MESSAGES
Once the « QR Code » has
been detected, the following
message appears.
7.

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6.4 Wearing the smart shirt
Check that the smart shirt is right side out (electrode pins not visible
and therefore in direct contact with the skin).
Check that the smart shirt’s zipper is open .
Locate the opening for the head (the red seam indicates the collar).
Slip the smart shirt over the head (at the collar level) and make sure
that the inner label is at the back of your neck and the zipper on the
right.
Pass the left arm through the hole provided for this purpose, opposite
the zipper.
Gently close the zipper of the smart shirt by going up from bottom to
top (on your right side).
1.
2.
3.
4.
Be sure to pull up the zipper gently to avoid pinching your skin.
Please ensure that the zipper is closed correctly so that it does not get
damaged.
Be sure to put the zipper cover on correctly after closing the zipper
gently, so you do not hurt your skin.
Warning
You can, if necessary, get help to put the shirt on, place it correctly
and close the zipper.
Make sure that the electrodes are correctly positioned and that the
smart shirt ts snugly.
5.

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Electrodes
The smart shirt is the right
size and ts correctly
Electrodes are mis-
places
The smart shirt is not
the right size
The shirt should be worn ush with the body and the electrodes should be
correctly positioned: the electrodes should be located just above the chest
and pressed against your skin when you stand upright.
See the illustration below.
If this is not the case, please contact the organization that provided you with
the shirt in order to change it.

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To do this, press the button « Disconnect
t-shirt » from the application.
6.6 Using the smartphone app
Description of the welcome page
Allows access to the app. by
entering the ID which has been
given to you
6.5 Remove and turn o󰀨 the smart shirt
When you with to remove the smart shirt:
Open the zipper on your right side.
1.
2. Put the smart shirt over your head.
3. Turn o󰀨 the T-shirt after removing it.
In order to download the data stored
in the shirt, press the « Download
and disconnect » button. The shirt will
then disconnect automatically.
4.

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Description of the welcome page, when the smartphone is not connected
to the smart shirt
Allows access to the « Settings
page » of the app
Indicates that the smartphone is
not connected to the smart shirt
Allows scanning of the QR Code
label to connect the smart shirt to
the smartphone
Indicates the level of storage
available on the smartphone to
store the data
Description of the welcome page, when the smartphone is connected to
the smart shirt (out of charging)
Allows access to the
« Settings page » of
the app
Indicates that the smart-
phone is connected to the
smart shirt, whose series
no. is DiagW-XXXX
Disconnects the smart-
phone from the smart shirt
Indicates the battery level
of the smart shirt
Displays the number of
steps
Indicates the storage avai-
lable on the smart shirt
Indicates the time
remaining to transfer data
from the smartphone to
the server
Displays the activities
history of the week

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Displays the Week’s activity details page
Displays the number of steps
taken during the day
Displays the results for
steps taken during the
week
Description of the Settings page of the app
Allows quitting the
« Settings page » and re-
turn to the welcome page
Allows selection of the
app.’s language
Allows to select only Wi for
data transfer
Allows access to the
FAQs
Allows online access
to the user notice
Allows to log out to the
app.
Once the button is acti-
vated, your data will be not
collected
Allows access to the
legal notice

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Indicates smart shirt’s
rmware version
Description of the Legal notice page
Indicates user ID
Indicates app. version
Allows to leave the « Legal
notice » page and return
to the settings page
Indicates solution
reference Indicates that the user
manual must be read
Indicates the manufactu-
rer’s information: name,
logo and address
Description of the Re-activation page
Allows to log in to the app.
Once activated, your data are
collected again