CardiacSense CS System 3 User manual

CS System 3
User Manual
`

© 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.
DMS-21987 Version A1
Date of issue: June 2022
CardiacSense Ltd.
6 Leshem St.,
Northern Industrial Park
Caesarea
3079868
Israel
M: [e-mail]
www.cardiacsense.com
Authorized Representative in the EU
MedNet EC-REP GmbH
Borkstrasse 10, Münster 48163,
Germany
MedNet SWISS GmbH
Bäderstrasse 18, 5400 Baden,
CHRN -AR-20000730,
Switzerland
2797

Table of Contents
About this User Manual............................................................................6
1Introduction .....................................................................................8
1.1 Proper Use of CS System 3 ..........................................................................8
1.2 CS System 3 Overview .................................................................................8
1.3 CS System 3 Technology..............................................................................8
2Intended Use....................................................................................9
2.1 Indications for Use.......................................................................................9
2.2 Intended Users ............................................................................................9
2.3 Contraindications ........................................................................................9
2.4 Adverse Events ............................................................................................9
3Safety.............................................................................................10
3.1 Data Privacy...............................................................................................10
3.2 Warnings and Cautions..............................................................................11
3.2.1 Warnings........................................................................................................ 11
3.2.2 Cautions ......................................................................................................... 12
4Know your CS System 3 ..................................................................14
4.1 Package Contents ......................................................................................14
4.1.1 CS Watch 3..................................................................................................... 15
4.1.2 Charging Cradle.............................................................................................. 15
4.2 Charging the Watch...................................................................................16
4.3 Turning the Watch ON and OFF ................................................................17
5Preparing the CS System 3..............................................................18
5.1 Charging the CS Watch 3...........................................................................18
5.2 Installing the CS3 Mobile app....................................................................18
5.3 Setting up your Account............................................................................18
5.3.1 Step 1: Registration........................................................................................ 20
5.3.2 Step 2: Creating New Account ....................................................................... 22
5.3.3 Step 3: Entring Personal Information............................................................. 25
5.3.4 Step 4: Entering Medical Information............................................................ 26
5.3.5 Step 5: Setting Preferences and Terms .......................................................... 29
5.3.6 Step 6: Pairing the Watch............................................................................... 30

5.4 Mobile App Screen ....................................................................................33
5.5 Wearing the Watch ...................................................................................34
5.6 Replacing the Watch Strap ........................................................................35
6Using the CS System 3 ....................................................................37
6.1 Watch Display............................................................................................37
6.1.1 Pulse Rate....................................................................................................... 38
6.1.2 Physical Activity.............................................................................................. 38
6.1.3 Settings........................................................................................................... 38
6.1.4 Factory Reset.................................................................................................. 39
6.2 Continuous Monitoring .............................................................................39
6.3 Application Screen.....................................................................................41
6.3.1 Dashboard Tab............................................................................................... 41
6.3.2 Main Menu..................................................................................................... 42
6.4 Detected and Measured Data ...................................................................44
6.4.1 Notifications................................................................................................... 44
6.4.2 Adding Externally Measured Data.................................................................. 44
7Performing an ECG Measurement..................................................46
7.1 ECG Measurement ....................................................................................47
7.1.1 Non-Successful ECG Measurement................................................................ 50
8Event and Monthly Reports............................................................51
8.1 Event Reports ............................................................................................51
8.2 Monthly Reports........................................................................................52
9Changing your Account Information...............................................54
9.1 Changing your Watch ID............................................................................56
9.2 Changing your Personal Information.........................................................57
9.3 Changing your Medical Information..........................................................57
9.4 Changing the Thresholds...........................................................................58
9.5 Changing your Account Password .............................................................59
9.6 Resetting your Password ...........................................................................60
9.7 Changing your Consent Forms...................................................................62
9.8 Changing the Application Language ..........................................................63
9.9 Changing the Units ....................................................................................63
10 The CS3 Cloud application ..............................................................64

11 Troubleshooting and Maintenance.................................................65
11.1 Troubleshooting ........................................................................................65
11.1.1 Troubleshooting the CS Watch 3.................................................................... 65
11.1.2 Troubleshooting the CS3 Mobile application ................................................. 66
11.1.3 Troubleshooting the Cradle............................................................................ 66
11.2 Resetting the Watch to Factory Settings...................................................67
11.3 Updating the Watch Firmware..................................................................68
11.4 Upgrading the Application.........................................................................68
11.5 Cleaning the Watch and the Cradle...........................................................68
11.6 Storing the Watch......................................................................................69
12 Specifications .................................................................................70
12.1 Supported Smartphones ...........................................................................70
12.2 Communication Requirements..................................................................70
12.3 Watch Specifications .................................................................................70
12.3.1 Technical Specifications ................................................................................. 70
12.3.2 Operational and Storage Environment........................................................... 71
12.3.3 PPG................................................................................................................. 71
12.3.4 ECG................................................................................................................. 71
12.4 Electromagnetic Emissions........................................................................72
12.4.1 FCC Radio Frequency Interference Statement............................................... 72
12.4.2 Declaration –electromagnetic emissions ...................................................... 73
12.4.3 Declaration –electromagnetic immunity....................................................... 74
12.4.4 Recommended Separation Distances............................................................. 75
12.5 Essential Performance...............................................................................75
12.6 Compliance................................................................................................76
12.7 Labels and Symbols ...................................................................................77
13 Appendices.....................................................................................78
Medical Terms.............................................................................78

About this User Manual
This manual provides the information necessary to operate and use the CS System safely and
effectively.
Please read the manual before operating CS System 3 and its application. If any part of this
manual is unclear, 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 alerts the reader about a situation which, if not avoided, could result
in death or serious injury. It may also describe potential serious adverse
reactions and safety hazards.
Caution
The term caution is used for the statement of a hazard alert that warns the
reader of a potentially hazardous situation which, if not avoided, may result in
minor or moderate injury to the user or patient or damage to the equipment
or other property. It may also be used to alert against unsafe practices..
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. Tap the Menu icon.
2. Select My profile.
3. Log into 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,
iPhone device and iOS version.

1Introduction
CS System 3 is a wrist-worn medical device, similar to a watch, that measures heart
rate, Pulse Rate and 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 the 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-patient use wearable monitoring device that provides
continuous monitoring of the user’s Pulse Rate from its PPG (Optical) sensor. When
prompted by an indication generated by the PPG sensor, or if feeling an A-Fib episode,
the user can initiate a real-time ECG measurement.
The sensitivity and specificity of A-Fib detection by PPG are 95% and 95% respectively.
Sensitivity for ECG analysis is 95% with specificity of 95%.
The real-time ECG measurements are saved on the smartphone once paired, and are
automatically uploaded to the CS3 Cloud app.
The user can also initiate an ECG monitoring session which can be saved as a report and
shared with physician or anyone else.
1.3 CS System 3 Technology
Combining off-the-shelf ECG electrodes and unique PPG sensors with proprietary
algorithms, the device can detect the presence of A-Fib and notify the user. In addition
to A-Fib detection, CS System 3 continuously monitors the user’s Pulse 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.

2Intended 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 anyone who seeks to monitor their vital signs in
medical facilities, ambulatory conditions, or at home.
The device is intended as a single patient use.
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 people 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
Note
Any serious adverse event / incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of the EU
Member State in which the user and/or patient is established.

3Safety
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, the reports that are created through the mobile app are stored
only on your smartphone. For subscribers, the reports are automatically stored in CS
Cloud App. CardiacSense recommends locking your smartphone’s display to avoid
unauthorized access.
Your personal and measurement data is treated in a HIPAA and GDPR-compliant
manner.