CardiacSense CS System 3 User manual

CS System 3
User Manual
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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.
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.

3.2 Warnings and Cautions
3.2.1 Warnings
DO NOT USE CS System 3 BEFORE READING AND UNDERSTANDING THIS
MANUAL.
Do not use the device if you have an ICD or pacemaker or if you are pregnant
or breastfeeding. The device has not been tested, and it is not intended for use
by pregnant and breastfeeding women, people with pacemakers, or ICD
DO NOT adjust medication or delay medical care based on measurement
results from this device. Take medication as prescribed by your physician.
To reduce the risk of suffocation, keep the device away from children and pets
To avoid the potential for electrical shock, the power supply must be
disconnected from the power outlet while cleaning.
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 occur.
To avoid the potential for electrical shock, use only the supplied charger.
This device may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as
using the CS System 3 in a different location.
The use of accessories, transducers, and cables other than those specified or
provided by the manufacturer of this device could increase electromagnetic
emissions or decrease the electromagnetic immunity of this device and result
in improper operation.
MR unsafe: The device should not enter the MRI scanner room

3.2.2 Cautions
A too loose or too tight watch strap may affect measurement results.
Any adverse incident that has occurred in relation to the device should be
reported to CardiacSense Ltd.
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.
Before pairing the watch with the smartphone, ensure the date and time on your
smartphone are correct.
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.
Do not use detergents to clean the watch and cradle.
Do not use the device if the package is damaged.
Do not use the device out of the defined environmental conditions.
If measurement is interrupted by a call, restart the app after the call has ended.
If you are unsure about your medical condition, enter "Don't know". Wrong
medical information input will appear on the report and may lead to false
diagnosis by your physician
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.
Low skin temperature, restricted blood flow, or excessive movement may result
in wrong measurement results or lack of results. In such cases, remove the watch
from your wrist, warm your hands and place it back on.
The device is intended as a single patient use. The device should not be used by
anyone other than you.
To avoid harm to the CS Watch 3, repair and maintenance should be performed
by authorized personnel only.

Using the CS System 3 for unintended purposes may result in incorrect results
and clinical misinterpretations
Verify you have selected the correct country of residence, as it is required for
compliance with local regulatory requirements and new feature releases. Your
country of residence cannot be changed without the aid of customer support.
To reduce the risk of wrong measurements, keep the device sensors clean from
dirt or grease
Do not use the device to diagnose medical-related conditions. All interpretations
should be reviewed by a medical professional for clinical decision-making

4Know 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
Do not use the device if the package is damaged.
1
2
3
4
5
6

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
SpO2and Blood Pressure sensor (for use in future versions)
C
Watch display and on/off button (watch on/off: press for 3 seconds; display
on/off: press momentarily)
D
Thermometer (for use in future versions)
E
ECG sensor used 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 pairing and identifying the watch with a Smartphone
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.

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.
Plug the cradle charger into the power outlet.
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.
In case of degraded battery performance, please contact CardiacSense or your local
distributor.
Note
The battery should be charged at least every 3 months, even when not in use.
Low
battery

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 the watch back turn on, indicating that the PPG sensors work
properly.
Figure 4-7. Watch LEDs

5Preparing the CS System 3
5.1 Charging the CS Watch 3
The CS Watch 3 battery must be charged before its first use.
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.
1. 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.
Accept all terms and conditions displayed during the installation process to enable the app to
operate properly.
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 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 pairing the watch to your smartphone is a 6-step wizard-
guided process comprising:
1. Registration.
2. Creating new account.
Entering personal information.
Entering medical information.
Setting preferences and agreeing to terms.
Pairing the watch.
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

5.3.1 Step 1: Registration
1. To register, 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
Select your language for the application interface from the preset list.
Figure 5-3. Language selection screens
Tap Save. The Login screen appears.