CardiacSense CS System 4 User manual

CS System 4
User Manual

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© 2022 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-16852, G-1
Date of issue: Dec 2022
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
1. About this User Manual ....................................................... 7
2. Introduction .......................................................................... 9
CS System 4 Overview............................................................................9
CS System 4 Technology ........................................................................9
Intended Use.............................................................................. 10
Indications for Use.................................................................................10
Intended Users ......................................................................................10
Contraindications...................................................................................10
Adverse Events .....................................................................................10
Safety ......................................................................................... 11
Data Privacy ..........................................................................................11
Warnings and Cautions .........................................................................12
Warnings........................................................................................................ 12
Cautions......................................................................................................... 13
Know your CS System 4 ........................................................... 15
Package Contents .................................................................................15
CS Watch 3.................................................................................................... 16
Charging Cradle............................................................................................. 16
Charging the Watch...............................................................................17
Turning the Watch ON and OFF............................................................18
Preparing the CS System 4....................................................... 19
Charging the CS Watch 3......................................................................19
Installing the CS4 Mobile app................................................................19
Setting up your Account ........................................................................19
Step 1: Registration........................................................................................ 21
Step 2: Creating New Account ....................................................................... 23
Step 3: Entering Personal Information............................................................ 25
Step 4: Entering Medical Information.............................................................. 26
Step 5: Setting Preferences and Terms.......................................................... 29
Step 6: Pairing the Watch............................................................................... 30
Mobile App Screen ................................................................................33
Wearing the Watch................................................................................34
Replacing the Watch Strap....................................................................35

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Using the CS System 4 ............................................................. 36
Watch Display .......................................................................................36
Pulse Rate and Respiratory Rate ................................................................... 37
Settings 37
Factory Reset................................................................................................. 38
Continuous Monitoring...........................................................................38
Application Screen.................................................................................39
Dashboard Tab .............................................................................................. 39
Real-Time Tab ............................................................................................... 39
Main Menu ..................................................................................................... 40
Detected and Measured Data................................................................42
Notifications ................................................................................................... 42
Adding Externally Measured Data .................................................................. 42
Performing an ECG Measurement ........................................... 46
ECG, SpO2and Respiratory Rate Measurements.................................47
Non-Successful ECG Measurement............................................................... 51
Using Paired External Devices................................................. 52
Blood Pressure Monitors .......................................................................52
SpO2Monitor.........................................................................................53
Glucometer............................................................................................54
Weight ...................................................................................................55
Measurement and Monthly Reports......................................... 57
Measurment Reports.............................................................................57
Monthly Reports ....................................................................................58
Changing your Account Information ....................................... 60
Changing your Watch ID .......................................................................61
Changing your Personal Information .....................................................62
Changing your Medical Information.......................................................62
Changing the Thresholds ......................................................................63
Changing your Account Password ........................................................64
Resetting your Password.......................................................................65
Changing your Consent Forms..............................................................66
Changing the Application Language......................................................67
Changing the Units................................................................................67
The CS4 Cloud application ....................................................... 68

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Troubleshooting and Maintenance .......................................... 69
Troubleshooting.....................................................................................69
Troubleshooting the CS Watch 3.................................................................... 69
Troubleshooting the CS4 Mobile application .................................................. 70
Troubleshooting the Cradle ............................................................................ 70
Resetting the Watch to Factory Settings ...............................................71
Updating the Watch Firmware ...............................................................72
Upgrading the Application .....................................................................72
Cleaning the Watch and the Cradle.......................................................72
Storing the Watch..................................................................................73
Specifications............................................................................ 74
Supported Smartphones........................................................................74
Communication Requirements ..............................................................74
Watch Specifications .............................................................................74
Technical Specifications................................................................................. 74
Operational and Storage Environment ........................................................... 75
PPG ......................................................................................................... 75
ECG ......................................................................................................... 75
SpO2......................................................................................................... 76
Respiratory Rate ............................................................................................ 76
Electromagnetic Emissions ...................................................................77
FCC Radio Frequency Interference Statement............................................... 77
Declaration – electromagnetic emissions ....................................................... 78
Declaration – electromagnetic immunity......................................................... 79
Recommended Separation Distances ............................................................ 80
Essential Performance ..........................................................................80
Compliance ...........................................................................................81
Labels and Symbols ..............................................................................82
Patient Portal ............................................................................. 83
Logging into the Portal...........................................................................83
Home Page ...........................................................................................84
Menu 84
Dashboard ..................................................................................................... 85
Daily Charts ................................................................................................... 86
Monthly Graphs.............................................................................................. 87
My Profile ..............................................................................................88

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Personal Information ...................................................................................... 88
Medical Information........................................................................................ 89
Thresholds ..................................................................................................... 90
Passwords ..................................................................................................... 91
Reports..................................................................................................92
Reports Marketplace ...................................................................................... 92
Reports Archive.............................................................................................. 93
Appendices................................................................................ 96
Medical Terms.......................................................................................96
Appendix A. Glossary ...........................................................................97

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1. About this User Manual
This manual provides the information necessary to configure and operate the CS
System 4 safely and effectively. Please read the manual carefully before using this
medical device and its software. 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 following basic symbols and navigation concepts are 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
A caution symbol 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.

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Shortened Instruction Replaces
From any of the windows, select:
Menu > My profile > (login) > Personal
information
From any screen:
Tap the Menu icon.
Select My profile.
Log into the application.
Select Personal information.
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/or other compatible
applications or devices including Android device and OS version, iPhone
device and iOS version.

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2. Introduction
CS System 4 includes a watch (CS Watch 3), a charging cradle, a mobile
application (CS4 Mobile app) and a cloud portal (CS4 Cloud app).
The CS Watch 3 is a wrist-worn medical device that measures the user’s
heart rate, pulse rate, respiratory rate, blood saturation (SpO2), and detects
atrial fibrillation (A-Fib) by reading and analyzing the user’s PPG and ECG
values.
The CS4 Mobile app is installed on the user’s smartphone and used to setup
the user’s account and enter personal information. The smartphone
communicates with the CS Watch 3 via Bluetooth® pairing. Proper Use of CS
System 4
The CS4 Cloud app securely stores the user and processed data over
designated databases. It provides the mechanism of creating and sending
periodical reports which are sent to the user’s email both automatically and
on-demand.
This manual provides the information necessary to setup and use the CS
System 4. It is important to read the manual to understand the CS System 4
and properly setup the mobile application before using the device.
CS System 4 Overview
The CS System 4 is a wearable device intended for use in adult patients in
home environments, hospitals, hospital-type facilities and transport. The
system collects intermittent data of physiological parameters, when no motion
is detected, such as beat-by-beat Heart Rate (HR), Respiration Rate (RR),
Blood O2 saturation (SpO2) and single-channel electrocardiogram rhythm
(ECG) with no interpretation. The data is processed and displayed by the
system. The device may be connected to external medical devices, and
directly display their measurements results.
The user can generate an ECG measurement report that can be saved and
shared with medical professionals.
The system does not provide any alarms; the results should be interpreted
only by healthcare professionals.
CS System 4 Technology
Combining off-the-shelf ECG electrodes and unique PPG sensors with
proprietary algorithms, CS System 4 can detect the presence of A-Fib and
notify the user. In addition to A-Fib detection, CS System 4 continuously
monitors the user’s pulse rate.
The CardiacSense unique PPG sensor compensates for the interference
caused by hand, palm, and finger movement, which is the primary source of
false notifications.
For more details on A-Fib, ECG, and PPG, see the Appendices in Chapter 14.

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3. Intended Use
Indications for Use
CS System 4 is indicated for use in adults to measure beat-by-beat heart rate
and pulse rate and to detect the presence of atrial fibrillation lasting at least 5
minutes by using ECG and/or PPG signals. The CS System 4 also measures
continuous respiratory rate and spot-check blood oxygen saturation
percentage (SpO2) when little to no motion is detected. It is intended for at
home use, ambulatory use (active/mobile patients at rest), in hospitals and
hospital-type facilities, and during transport.
Intended Users
CS System 4 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 for use by a single patient.
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 (Implantable
Cardioverter Defibrillator).
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.
Do not swim with the device in either sweet or salty water
CS System 4 is not to be used in critical care situations.
Adverse Events
The device has been tested and found to be biocompatible. There are no
known adverse events related to the use of the CS System 4; however, there
are possible adverse events related to monitoring systems that involve
sensors 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.