CardiacSense CS System 3 User manual

CS System 3
Instructions for Use

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© 2021 CardiacSense Ltd., all rights reserved.
No part of this manual may be reproduced in any form without the written permission
of CardiacSense Ltd.
CardiacSense Ltd. reserves the right to change or improve its products and any
accompanying technical literature without specific notice of the changes or
improvements.
CS-DC0031A Version 1.0
Date of issue: May 2021
CardiacSense Ltd.
6 Leshem St.,
Northern Industrial Park
Caesarea
3079868
Israel
T: [phone] | Support: [phone]
M: [email protected]
www.cardiacsense.com
Authorized Representative in the EU
MedNet EC-REP GmbH
Borkstrasse 10, Münster 48163,
Germany
2797

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Table of Contents
About this User Manual ............................................................... 6
1 Introduction ........................................................................... 7
1.1 Proper Use of CS System 3 ............................................................. 7
1.2 CS System 3 Overview .................................................................... 7
1.3 CS System 3 Technology ................................................................ 7
2 Intended Use .......................................................................... 8
2.1 Indications for Use ........................................................................... 8
2.2 Intended Users ................................................................................ 8
2.3 Contraindications ............................................................................. 8
2.4 Adverse Events ................................................................................ 8
3 Safety ..................................................................................... 9
3.1 Data Privacy .................................................................................... 9
3.2 Warnings and Cautions ................................................................. 10
3.2.1 Warnings ............................................................................................ 10
3.2.2 Cautions ............................................................................................. 11
4 Know your CS System 3 ..................................................... 12
4.1 Package Contents ......................................................................... 12
4.1.1 CS Watch 3 ........................................................................................ 13
4.1.2 Charging Cradle ................................................................................. 13
4.2 Charging the Watch ....................................................................... 14
4.3 Turning the Watch ON and OFF .................................................... 15
5 Preparing the CS System 3 ................................................ 16
5.1 Charging the CS Watch 3 .............................................................. 16
5.2 Installing the CS3 Mobile App ........................................................ 16
5.3 Setting up your Account ................................................................. 16
5.3.1 Step 1: Sign In .................................................................................... 19
5.3.2 Step 2: Personal Information .............................................................. 21
5.3.3 Step 3: Medical Information ................................................................ 22
5.3.4 Step 4: Preferences and Terms ......................................................... 24
5.3.5 Step 5: Connecting the Watch ............................................................ 25
5.4 Mobile App Screen ........................................................................ 28
5.5 Wearing the Watch ........................................................................ 28

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6 Using the CS System 3 ....................................................... 29
6.1 Watch Display ................................................................................ 29
6.1.1 Airplane Mode .................................................................................... 30
6.2 Continuous Monitoring ................................................................... 30
6.3 Application Screen ......................................................................... 31
6.3.1 Alerts and Notifications ....................................................................... 31
6.3.2 Adding Medical Data .......................................................................... 32
6.3.3 Main Menu .......................................................................................... 33
7 Performing an ECG Measurement ..................................... 36
7.1 ECG Measurement with Report ..................................................... 37
7.1.1 Non-Successful ECG Measurement .................................................. 40
7.2 ECG Measurement Without Report ............................................... 41
8 Event and Monthly Reports ................................................ 42
8.1 Event Reports ................................................................................ 42
8.2 Monthly Reports ............................................................................. 43
9 Changing your Account Information ................................. 45
9.1 Changing your Personal Information ............................................. 46
9.2 Changing your Medical Information ............................................... 46
9.3 Changing the Thresholds ............................................................... 47
9.4 Changing your Consent Forms ...................................................... 48
9.5 Changing the Application Language .............................................. 49
9.6 Changing the Units ........................................................................ 49
9.7 Changing your Account Password ................................................. 50
9.8 Changing the Report Password ..................................................... 51
9.9 Resetting your Password ............................................................... 52
9.10 Unlinking the Watch from your Account ......................................... 53
10 The CS3 Cloud Application ................................................ 54
11 Troubleshooting and Maintenance .................................... 55
11.1 Troubleshooting ............................................................................. 55
11.1.1 Troubleshooting the CS Watch 3 ....................................................... 55
11.1.2 Troubleshooting the CS3 Mobile Application ..................................... 56
11.1.3 Troubleshooting the Cradle ................................................................ 56
11.2 Resetting the Watch to Factory Settings ....................................... 57
11.3 Updating the Watch Firmware ....................................................... 57

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11.4 Upgrading the Application .............................................................. 58
11.5 Cleaning the Watch and the Cradle ............................................... 58
11.6 Storing the Watch .......................................................................... 58
12 Specifications ...................................................................... 59
12.1 Supported Smartphones ................................................................ 59
12.2 Communication Requirements ...................................................... 59
12.3 Watch Specifications ..................................................................... 59
12.3.1 Technical Specifications ..................................................................... 59
12.3.2 Operational and Storage Environment ............................................... 60
12.3.3 PPG .................................................................................................... 60
12.3.4 ECG .................................................................................................... 60
12.4 Electromagnetic Emissions ............................................................ 61
12.4.1 Declaration – electromagnetic emissions ........................................... 61
12.4.2 Declaration – electromagnetic immunity ............................................ 62
12.4.3 Recommended Separation Distances ................................................ 63
12.5 Compliance .................................................................................... 64
12.6 Labels and Symbols ...................................................................... 65
13 Appendices .......................................................................... 66
Medical Terms ................................................................... 66

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About this User Manual
This manual provides the information necessary to operate the CS System in a safe
and effective manner.
Please read the manual before operating CS System 3 and its application. If any part
of this manual is unclear, please contact your local distributor for support.
User manuals in different languages can be found at
https://www.cardiacsense.com/user-manual/.
Conventions
The Conventions section explains basic symbols and navigation concepts used in
this manual.
Symbols
Three types of special messages appear in this User Manual:
Warning
A warning indicates the possibility of injury to the user.
Caution
A caution indicates a condition that may lead to equipment
malfunction.
Note
A note provides other important information that may assist with
operating the system.
Navigation
We have adopted the following shortened instruction form for navigating to the
various application elements.
Shortened Instruction
Replaces
From any of the windows, select:
Menu > My profile > (login) > Personal
information
From any screen:
1. Press the Menu icon.
2. Select My profile.
3. Log in to the application.
4. Select Personal information.
5. Perform the action or edit the
parameter value.
Important Notes
• The content of this manual is subject to change without notice.
• Some of the illustrations or descriptions in this manual may vary due to
changes or improvements in the CS System and its application, Android
device and OS version, or iPhone device and iOS version.

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1 Introduction
Welcome to your new CS System 3.
CS System 3 is a wrist-worn medical device, similar to a watch, that detects
atrial fibrillation (A-Fib) by reading the user’s PPG and ECG values.
CS System 3 comprises a watch (CS Watch 3), a charging cradle, a mobile
application (CS3 Mobile app), and a cloud application (CS3 Cloud app).
1.1 Proper Use of CS System 3
This manual provides the information necessary to operate and use the CS
System 3. Please read this manual to understand CS System 3 and its mobile
application setup process before using the device.
1.2 CS System 3 Overview
CS System 3 is a single-user wearable monitoring device that provides
continuous passive monitoring of the user’s pulse rate from its PPG sensor.
When prompted by an indication generated by the PPG sensor or if feeling an
A-Fib episode, the user can initiate an instantaneous ECG measurement.
The Instantaneous ECG measurements are stored in the smartphone and are
automatically uploaded to the CS3 Cloud app.
The user can also initiate a five-minute ECG monitoring session which can be
saved as a report and shared with medical personnel or anyone else.
1.3 CS System 3 Technology
By combining off-the-shelf ECG and unique PPG sensors, and together with
proprietary algorithms, the device detects the presence of A-Fib and indicates
it to the user. In addition to A-Fib detection, CS System 3 monitors the user’s
heart rate.
The CardiacSense unique PPG sensor compensates for the interference
caused by hand, palm, and finger movement, which in most cases is the
primary source of false notifications.
For more details on A-Fib, ECG, and PPG, see the Appendices in Chapter 13.

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2 Intended Use
2.1 Indications for Use
CS System 3 is intended to measure beat-by-beat heart rate and pulse rate
and detect the presence of atrial fibrillation lasting at least 5 minutes by using
PPG and/or ECG signals.
2.2 Intended Users
CS System 3 is intended to be used by any person who seeks to monitor their
vital signs in medical facilities, ambulatory conditions, or at home.
2.3 Contraindications
• The device has not been tested, and it is not intended for use by children
under the age of 18.
• The device has not been tested, and it is not intended for use by pregnant
and breastfeeding women, people with pacemakers, or ICD.
• The device should not be used by patients with blood flow deficiency-
related conditions.
• The device should not be worn over tattooed or injured skin.
• CS System 3 is not to be used in critical care situations.
2.4 Adverse Events
The device has been tested and found to be biocompatible. There are no
known adverse events related to the use of CS System 3; however, there are
possible adverse events related to monitoring systems that involve sensor
application on the skin. These include the following:
• Edema
• Erythema
• Irritation
• Sensitization

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3 Safety
3.1 Data Privacy
Accessing your account data requires logging into the application using your
account password (created while setting up an account).
To protect your privacy, reports created through the mobile app are stored
only on your smartphone and are password protected. CardiacSense
recommends locking your smartphone’s display to avoid unauthorized access.
CS System 3 comes with a default report password that can be viewed and
changed in the CardiacSense Mobile app. CardiacSense recommends
changing the report password from time to time.
When sharing a report with other persons (such as your physician), you need
to send them the report password to access the data. CardiacSense
recommends sending the password and the data using different applications
(for example, sending the data by WhatsApp and the password by SMS).
Your personal and measurement data is treated in a HIPAA and GDPR-
compliant manner.

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3.2 Warnings and Cautions
3.2.1 Warnings
DO NOT USE CS System 3 BEFORE READING AND
UNDERSTANDING THIS MANUAL.
Using the CS System 3 for unintended purposes may result in
incorrect results and clinical misinterpretations
DO NOT adjust medication based on measurement results from this
device. Take medication as prescribed by your physician.
Low skin temperature may result in less accurate PPG (pulse rate)
measurements.
Use only the supplied cradle with an approved power supply to charge
the CS Watch 3.
To avoid the potential for electrical shock, the power supply must be
disconnected from the power mains while cleaning.
To avoid harm to the CS Watch 3, repair and maintenance should be
performed by authorized personnel only.
To avoid erroneous readings and to save battery life, turn it off when
not wearing the watch.
Use of accessories, transducers, and cables other than those specified
or provided by the manufacturer of this device could result in increased
electromagnetic emissions or decreased electromagnetic immunity of
this device and result in improper operation.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of this device, including cables specified
by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.

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3.2.2 Cautions
Changes or modifications not expressly approved by CardiacSense Ltd.
can affect the safety and effectiveness of the system and void the
system’s warranty.
Do not operate with a damaged screen, cord, or plug. If damaged, have
the cord or plug replaced immediately by a qualified service technician.
If you notice any skin rash or any irritation is developing around the
watch strap, remove the watch immediately from your wrist and inform
your physician and/or medical staff.
The device is intended to be used by a single user. If transferred to a
different user, disinfect all materials that come in contact with the skin.
Before linking the watch, ensure the date and time of your smartphone
are correct.
At the end of its useful life, the watch with its battery must be disposed
of in accordance with local law and the local code concerning electrical
and electronic equipment. Do not discard in a standard trash bin.
Any adverse incident that has occurred in relation to the device should
be reported to CardiacSense Ltd.

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4 Know your CS System 3
4.1 Package Contents
The following items are included in the CS System 3 packaging*:
Figure 4-1. Package contents
* Only one type of charging cradle is supplied (item 2 or item 3)
Item
Description
CS Watch 3
Charging cradle with USB-C to USB-A cable
Charging cradle with power supply
Long replaceable strap
Quick-start guide
Warranty certificate
1
2
3
4
5
6

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4.1.1 CS Watch 3
Look at the watch to identify its physical controls:
Figure 4-2. Watch front and rear view
A
Display
B
Pulse oximeter
C
Watch display and on/off button (watch on/off: press for 3 seconds;
display on/off: press momentarily)
D
Reserved for future use
E
ECG electrode for real-time ECG measurement (by placing your
finger and holding while ECG measurement is performed)
F
ECG sensor (takes various measurements through contact with your
skin)
G
Charging contacts for charging the watch in the cradle
H
PPG sensor
I
Serial number, used for connecting your watch with the
CardiacSense Mobile app
4.1.2 Charging Cradle
The cradle is used for charging the watch. It features four gold-plated pogo-
pins for charging the watch and can be delivered in one of the following
configurations:
• Cradle with connected power supply
• Cradle with a USB-C to USB-A cable, to be used with a standard USB, CE
marked adaptor.

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4.2 Charging the Watch
The CS Watch 3 has an integrated rechargeable battery and is charged by
placing the watch in the cradle.
Before first use, fully charge the watch until it reaches 100%.
Warning
To avoid the potential for electrical shock, use only the supplied
charger.
1. Plug the cradle charger into the mains.
2. Place the watch in the cradle matching the 4 golden contacts on its back to
the 4 golden pogo-pins in the cradle. The cradle has magnets that help
with positioning the watch correctly.
Figure 4-3. Watch in-charge display
While charging, the sensors are disabled, and the display shows the current
battery level.
• Charging time (empty battery to fully charged battery) is around 2 hours.
• Under typical conditions, a fully charged battery provides up to 2 days
(48 hours) of continuous usage.
When the low battery indicator turns on, charge the battery.
Figure 4-4. Battery low-level display
When the battery reaches 10%, the watch screen turns off, and the watch
enters a deep-sleep mode. When the battery depletes faster than expected,
the battery should be replaced.
The battery cannot be replaced. In case of degraded battery performance,
please contact CardiacSense or your local distributor for details.
Note
The battery should be charged at least every 3 months, even when not
in use.
Low
battery

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4.3 Turning the Watch ON and OFF
Press the watch ON / OFF button for 2–3 seconds (the same button is used to
turn the display On and Off by pressing it briefly).
Figure 4-5. Watch ON/OFF button
The watch vibrates momentarily, and its display turns on.
Figure 4-6. Watch face
The two green LEDs on its back turn on, indicate that the PPG sensors work
properly.
Figure 4-7. Watch LEDs

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5 Preparing the CS System 3
5.1 Charging the CS Watch 3
The CS Watch 3 battery must be charged before its first use and is essential
for ensuring correct pulse rate reading results.
For charging the watch, see Charging the Watch in section 4.2.
5.2 Installing the CS3 Mobile App
The CS3 Mobile app is an essential part of CS System 3.
3. Install the CS3 Mobile app on your smartphone in one of two ways:
¨ Scan this QR code , also printed on the provided QSG.
¨ On your smartphone, go to the Play Store (Android-based phones) or
App Store (for iPhones), search for the CardiacSense app and
install it.
4. Accept all terms and conditions displayed during the installation process to
enable the app to operate properly.
5. Enable Location and Bluetooth on your smartphone.
5.3 Setting up your Account
Your account in the CS3 Mobile app holds the personal information needed to
get personalized results from the CS System 3. Your personal information is
treated in a HIPPA- and GDPR-compliant manner.
Most of the personal and medical information entered at this stage may be
changed later (see Chapter 9, Changing your Account Information).
Creating a new account and connecting the watch to the app is a 5-step
wizard-guided process comprising:
1. Signing in.
2. Entering personal information.
3. Entering medical information.
4. Setting preferences and agreeing to terms.
5. Synchronizing the watch with the app.
A progress bar is displayed at the bottom of the screen during the process,
indicating the steps performed and the current step. The step name is
displayed at the top of the screen.
Figure 5-1. Account setup steps

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To create an account:
1. Open the CS3 Mobile app.
The application opens with a splash screen, followed by the language
selection screen.
Figure 5-2. Splash and language screens
2. Select your language for the application interface from the preset list.
Figure 5-3. Language selection screens
3. Tap Save. The Login screen appears.

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Figure 5-4. Create new account screens
4. Tap Create new account.

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5.3.1 Step 1: Sign In
In this step, you create your CardiacSense account consisting of an email
address and password.
Note
The email address you enter here is part of your identification details
and cannot be changed after completing the Sign-In process.
1. Enter your Email address. This address is your user login to the app and is
used by CardiacSense to send you important information.
2. Tap the down arrow next to Password policy to display the rules for setting
your password for the application.
Figure 5-5. Email and Password screens
Invalid email addresses or passwords are indicated by a red rectangle or
message.
3. Enter a Password. If required, tap the eye icon to replace the asterisks with
visible characters to verify your password is what you intended it to be.
Note
If a wrong email address or password were entered more than five
times in a row, the system locks the login screen for 15 minutes.
When both the email address and password are correct, the Next button
becomes active.
4. Tap the Next button.
You will receive an email from CardiacSense requesting you to verify your
email address and activate your account.
Note
You must activate your account with 24 hours; otherwise, you will need
to restart the registration process.

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Figure 5-6. Email verification
To verify your email and activate your account:
1. Open your inbox and open the CardiacSense mail.
Figure 5-7. Email account activation
If the email was not received, check on the CS3 Mobile app that your
email address is correct, and tap Resend email.
2. Click Activate my account. The Congratulations! message is displayed,
indicating your account has been activated.
3. Return to the CS3 Mobile app.
4. Type your account credentials (Email address and Password) to log in to
your account.
5. Tap Next to continue to the next step (Step 2: Personal Information).