CardiacSense CS System 4 User manual

CS System 4
User Manual

2
© 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

3
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

4
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

5
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

6
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

7
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.

8
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.

9
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.

10
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.

11
4. Safety
Data Privacy
CardiacSense protects the user’s personal and medical information in a
HIPAA and GDPR-compliant manner.
In order to access their personal account data, user’s must enter the login
credential’s (username and password) established at setup.
To protect the user’s privacy, reports that are created through the mobile app
are stored only on the paired smartphone and are password-protected.
CardiacSense recommends locking the smartphone’s display to avoid
unauthorized access. The default report password can be viewed and
changed in the CardiacSense Mobile app. CardiacSense recommends
changing the report password regularly.
When sharing a report with other persons (such as your physician), user’s
must provide the report password to access the data. CardiacSense
recommends sending the password and the data separately, using different
applications (for example, send the data by WhatsApp and the password by
text message).

12
5. Warnings and Cautions
Warnings
DO NOT USE CS System 4 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 or people
with pacemakers or ICD
DO NOT adjust medication or delay medical care based on
measurement results from this device. Take all medication as
prescribed and follow all medical care instructions provided by your
physician.
To reduce the risk of choking or other injury, keep the device away
from children and pets
To avoid the potential for electrical shock, use only a standard quality
market-approved charger. Also, the power supply must be
disconnected from the power outlet while cleaning.
To avoid degradation of the performance of this device, 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. This includes
cables specified by
the manufacturer.
This device may cause radio interference or may disrupt the operation
of nearby equipment. If so, try using the CS System 4 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.
Do not use gel nail polish while measuring SpO2. Using gel nail
polish may result in wrong measurement results.

13
Cautions
It is important that the CS Watch 3 is fitted
properly. If the strap is too
loose or too tight, measurements will be adversely affected.
Any
problems with or damages 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 concerning electrical and electronic
equipment.
DO NOT DISCARD IN A STANDARD TRASH BIN.
Before pairing the watch with the smartphone, ensure the d
ate and time
on your smartphone are correct.
Do not make c
hanges or modifications to the device that are not
expressly approved by CardiacSense Ltd.
Doing so can affect the safety
and effectiveness of the
System and void the System’s warranty.
Do
not operate the System with a damaged screen, cord, or plug. If
damaged, have the
item replaced immediately by a qualified service
technician.
Do not use the device if the package is damaged.
Do not use the device out of the defined
environmental conditions.
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
irritation around the watch strap, remove
the watch immediately from your wrist and inform your physician and/or
medical staff.
L
ow skin temperature, restricted blood flow, or excessive movement
m
ay result in inaccurate measurement results. In such cases, remove
the watch
from your wrist, warm your hands, and then re-attach the
watch
.
The device is intended
for a single patient use. The device should not be
used by anyone other than
the registered user.
To avoid erroneous readings and save battery life, turn
the watch off
when not wearing
it.
To avoid harm to the CS Watch 3, repair and maintenance should
only
be performed by authorized personnel.
Using the
CS System 4 for unintended purposes may result in
inaccurate
measurements and clinical misinterpretations.

14
To ensure compliance
with local regulatory requirements and new
feature releases
, verify that the correct country of residence is selected.
This setting
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 detergents to clean the watch and
cradle.
Do not use the device to diagnose medical
related conditions. All
interpretations should be reviewed by a medical professional
for crucial
decision
-making.

15
6. Know your CS System 4
Package Contents
The following items are included in the CS System 4 package*:
Figure 4-1. Package contents
Item Description
1 CS Watch 3
2 Charging cradle with USB-C to USB-A cable
3 Long replaceable strap
4 Quick-start guide
5 Warranty certificate
Do not use the device if the package is damaged.
1
2
3
5
4

16
CS Watch 3
The CS Watch 3 includes the following physical controls:
Figure 4-2. Watch front and rear view
A Display
B SpO2(and Blood Pressure)* sensor (*This sensor is not used in this
version of the watch for blood pressure).
C Watch display and on/off button. Press quickly to turn the display on
or off. Press and hold for 3 seconds to turn the watch on or off.
D Thermometer (This sensor is not used in this version of the watch.)
E ECG electrode. This electrode is used for real-time ECG
measurement.
F ECG electrode. This electrode 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 to identify the watch when pairing with a
Smartphone
Charging Cradle
The charging cradle is used to replenish the watch’s power supply. The four
gold-plated pogo-pins connect to the four charging contacts (Figure G above)
to provide power to the watch. The charging cradle is available in 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.

17
Charging the Watch
The CS Watch 3 has an integrated rechargeable battery and is charged by
placing the watch in the charging cradle.
Before first use, fully charge the watch until it reaches 100%.
Warning
To avoid the potential for electrical shock, use only a standard quality
market-approved charger.
1. Plug the charging cradle into a power outlet.
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.
An empty battery will take approximately 2 hours to be fully charged.
Under typical conditions, a fully charged battery provides up to 2 days
(48 hours) of continuous usage.
A low battery indicator will appear on the watch display when it’s time to
charge the battery.
Figure 4-4. Battery low-level display
When the remaining battery life drops to 5%, the watch display turns off, and
the watch enters a deep-sleep mode.
If your watch will not charge properly or if the battery dies too quickly (less
than 24 hours), 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

18
Turning the Watch ON and OFF
The On/Off button is used to turn your watch and your display on or off. To
turn your watch on or off, press the On/Off button and hold for 2-3 seconds.
To turn your display on or off, press the On/Off button and release
immediately.
Figure 4-5. Watch ON/OFF button
When turning your watch on, press and hold the 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 are working properly.
Figure 4-7. Watch LEDs
Note
LEDs will turn on only after the initial setup process has been
completed.

19
7. Preparing the CS System 4
Charging the CS Watch 3
The CS Watch 3 battery must be fully charged before its first use. For step-by-
step directions, see Charging the Watch in section 4.2.
Installing the CS4 Mobile app
The CS4 Mobile app is an essential part of CS System 4 and must be
installed on your smartphone in order to use the system.
1. Install the CS4 Mobile app on your smartphone in one of two ways:
Option 1: Scan this QR code , also printed on the provided Quick
Start Guide.
Option 2: On your smartphone, go to the Play Store (Android-based phones)
or App Store (for iPhones), and search for the CardiacSense app .
When you locate the CardiacSense app, follow your phone’s prompts to install
it.
2. Accept all terms and conditions displayed during the installation process to
enable the app to operate properly.
3. Make sure that both Location and Bluetooth are enabled on your
smartphone.
Setting up your Account
Your account in the CS4 Mobile app holds the personal information needed to
get personalized results from the CS System 4. Your personal information is
treated in a HIPAA- and GDPR-compliant manner.
It is important to enter your information accurately. Most of the personal and
medical information entered at this stage may be changed later, if necessary
(see Chapter 10, Changing your Account Information).
Creating a new account and pairing the watch to your smartphone is a 5-step
wizard-guided process comprising:
1. Registration.
2. Creating new account.
3. Entering personal information.
4. Entering medical information.
5. Setting thresholds
6. Setting preferences and agreeing to terms.
7. Pairing the watch.

20
A progress bar is displayed at the bottom of the screen during the set-up
process, indicating the steps performed and the current step. The name of the
current step is displayed at the top of the screen.
Figure 5-8. Account setup steps