CS System 4 Wearable Medical Heart Rate Monitor Watch

CS System 4 User Manual

Specifications

• Product Name: CS System 4

• Manufacturer: CardiacSense Ltd.

• Address: 6 Leshem St., Northern Industrial Park, Caesarea
  3079868, Israel

• Contact: T: +972-73-3703-979 | Support: +972-4-6270702

• Email: support@cardiacsense.com

• Website: www.cardiacsense.com

About this User Manual

This user manual provides detailed information on the CS System
4, including its features, intended use, safety instructions, and
usage guidelines. It is important to read and understand this
manual before using the product.

Introduction

CS System 4 Overview

The CS System 4 is a cardiac monitoring system developed by
CardiacSense Ltd. It utilizes advanced technology to provide
accurate measurements of ECG, SpO2, and respiratory rate.

CS System 4 Technology

The CS System 4 incorporates state-of-the-art sensors and
algorithms to capture and analyze vital signs. It offers real-time
monitoring and data transmission capabilities for healthcare
professionals and users.

Intended Use

The CS System 4 is intended for use by healthcare professionals
and individuals for monitoring and recording cardiac activity,
oxygen saturation, and respiratory rate.

Indications for Use

The CS System 4 is indicated for use in the following
situations:

• Monitoring of patients with known or suspected cardiac
  conditions

• Assessment of oxygen saturation levels

• Tracking respiratory rate during sleep or physical
  activities

Intended Users

The CS System 4 is designed for use by healthcare professionals,
including doctors, nurses, and technicians, as well as individuals
who require personal cardiac monitoring.

Contraindications

The CS System 4 should not be used in the following cases:

• Patients with severe skin allergies or sensitivities

• Individuals with pacemakers or other implanted electronic
  devices

• Neonates or infants without medical supervision

Adverse Events

Potential adverse events associated with the CS System 4 may
include skin irritation, discomfort, or allergic reactions. If any
adverse events occur, discontinue use and consult a healthcare
professional.

Safety

Data Privacy

CardiacSense Ltd. takes data privacy seriously. The CS System 4
complies with relevant regulations and guidelines to ensure the
security and confidentiality of user data. Personal information is
encrypted and protected during transmission.

Warnings and Cautions

It is important to follow these warnings and cautions to ensure
safe and effective use of the CS System 4:

Warnings

• Do not modify or tamper with the CS System 4.

• Avoid exposing the device to extreme temperatures or
  moisture.

• Keep the device out of reach of children and pets.

• If any unusual symptoms or discomfort occur during use, consult
  a healthcare professional.

Cautions

• Do not use the CS System 4 as a substitute for professional
  medical advice or diagnosis.

• Ensure proper placement and contact of the sensors for accurate
  measurements.

• Regularly clean and maintain the CS System 4 according to the
  provided instructions.

Know your CS System 4

This section provides an overview of the components and features
of the CS System 4:

[Include information about the components and features of the CS
System 4]

Preparing the CS System 4

Before using the CS System 4, follow these steps to ensure
proper preparation:

1. [Include step-by-step instructions for preparing the CS System
   4]

Using the CS System 4

To use the CS System 4, follow these instructions:

1. [Include step-by-step instructions for using the CS System
   4]

Performing an ECG Measurement

To perform an ECG measurement using the CS System 4, follow
these steps:

1. [Include step-by-step instructions for performing an ECG
   measurement]

Using Paired External Devices

The CS System 4 can be paired with external devices for
additional measurements. Follow these instructions to use paired
external devices:

Blood Pressure Monitors

[Include instructions for using blood pressure monitors with the
CS System 4]

SpO2 Monitor

[Include instructions for using an SpO2 monitor with the CS
System 4]

Glucometer

[Include instructions for using a glucometer with the CS System
4]

Weight

[Include instructions for measuring weight with the CS System
4]

Measurement and Monthly Reports

The CS System 4 provides measurement and monthly reports for
tracking and analysis. Follow these instructions to access and
interpret the reports:

Measurement Reports

[Include instructions for accessing and understanding
measurement reports]

Monthly Reports

[Include instructions for accessing and understanding monthly
reports]

Changing your Account Information

If you need to change your account information, follow these
steps:

1. [Include step-by-step instructions for changing account
   information]

The CS4 Cloud Application

The CS4 Cloud application allows users to store and manage their
data securely. For more information on using the CS4 Cloud
application, refer to the separate user manual provided.

FAQ (Frequently Asked Questions)

Q: How often should I perform ECG measurements?

A: The frequency of ECG measurements depends on your healthcare
professional’s recommendations. It is advisable to follow their
guidance.

Q: Can I use the CS System 4 without a smartphone?

A: Yes, the CS System 4 can be used independently without a
smartphone. However, using the CS4 Cloud application provides
additional features and data management capabilities.

Q: How long does it take to receive measurement reports?

A: Measurement reports are usually available immediately after
completing an ECG measurement. Monthly reports are generated at the
end of each month.

CS System 4
User Manual

© 2023 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, H-1 Date of issue: July 2023

CardiacSense Ltd.
6 Leshem St., Northern Industrial Park Caesarea 3079868 Israel T: +972-73-3703-979 | Support: +972-4-6270702

M: support@cardiacsense.com 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, SpO2 and Respiratory Rate Measurements …………………………… 47 Non-Successful ECG Measurement……………………………………………………… 51
Using Paired External Devices …………………………………………. 52
Blood Pressure Monitors …………………………………………………………….. 52 SpO2 Monitor …………………………………………………………………………….. 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.

Shortened Instruction
From any of the windows, select: Menu > My profile > (login) > Personal information

Replaces
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.

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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 20.
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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.
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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).
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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.
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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 date and time on your smartphone are correct.
Do not make changes 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.
Low skin temperature, restricted blood flow, or excessive movement may 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.
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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.
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6. Know your CS System 4
Package Contents
The following items are included in the CS System 4 package*:
1

2

3

4

5

Figure Error! No text of specified style in document.-1. Package contents

Item 1 2 3 4 5

Description CS Watch 3 Charging cradle with USB-C to USB-A cable Long replaceable strap Quick-start guide Warranty certificate Do not use the device if the package is damaged.

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CS Watch 3 The CS Watch 3 includes the following physical controls:
Figure Error! No text of specified style in document.-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.
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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 Error! No text of specified style in document.-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.
Low battery
Figure Error! No text of specified style in document.-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.
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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 Error! No text of specified style in document.-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 Error! No text of specified style in document.-6. Watch face
The two green LEDs on the watch back turn on, indicating that the PPG sensors are working properly.
Figure Error! No text of specified style in document.-7. Watch LEDs
Note LEDs will turn on only after the initial setup process has been completed.
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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- bystep directions, see Charging the Watch in section 0.
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 Start Guide.

, also printed on the provided Quick

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 13, 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.

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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 Error! No text of specified style in document.-8. Account setup steps
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Step 1: Registration Before you begin your registration process, please make sure that both Bluetooth® and Location are enabled on your mobile phone. In addition, make sure that any battery restrictions are cancelled. If these settings are not in place, the CS4 Mobile app will not operate. 1. To register, open the CS4 Mobile app on your smartphone. The application opens with a splash screen, followed by the language selection screen.
Figure Error! No text of specified style in document.-9. Splash and language screens
2. Tap the downward arrow to select your language from the preset list.
Figure Error! No text of specified style in document.-10. Language selection screens
3. Tap Save. The Login screen appears. 21

Figure Error! No text of specified style in document.-11. Create new account screens
4. Tap the Create account button to create a new account.
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Step 2: Creating New Account To create your CardiacSense account, you must have a valid email address. 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 used to 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. Please read these rules carefully. Your password must include all of these elements to proceed.
Figure Error! No text of specified style in document.-12. Email and Password screens
Invalid email addresses or passwords are indicated by a red rectangle or error message. 3. Enter a Password. As you enter your password, asterisks will serve as placeholders for the characters entered. Tap the eye icon to replace the asterisks with visible characters to verify the password is what you intended it to be. When both the email address and password are typed correctly, the Next button becomes active. 4. Tap the Next button. You will receive an email from CardiacSense requesting that you verify your email address and activate your account.
Note You must activate your account within 24 hours; otherwise, you will need to restart the registration process.
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Figure Error! No text of specified style in document.-13. Email verification
To verify your email and activate your account: 5. Go to your email inbox and open the message sent from CardiacSense.
Figure Error! No text of specified style in document.-14. Email account activation
If you did not receive the verification email, first make sure that it’s not in your spam folder, then check on the CS4 Mobile app to verify that your email address is correct. Tap on Resend email. 6. Tap on Activate my account. The Congratulations! message is displayed, indicating your account has been activated. 7. Return to the CS4 Mobile app and tap Continue to log in. 8. Type your account credentials (Email address and Password) to log into your account. 9. Tap Next to continue to the next step (Step 3: Personal Information).
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Step 3: Entering Personal Information personal information is essential for the CardiacSense algorithms to provide accurate results and personalize reports. 1. Type your first name and last name in the boxes as labeled. 2. Type your government issued ID number.
Figure Error! No text of specified style in document.-15. Personal information screens
3. Tap the calendar icon to select your date of birth. A confirmation screen with your age is displayed. Tap Yes to confirm your age.
4. Enter your weight, height, and select your biological gender. Note Make sure the correct units of measure are selected when entering your weight (kg/lb) and height (cm/ft). These values may be updated later, if necessary (see section 0).
5. Enter your country of residence using autocomplete. As you type, you will see your country on the list below. Tap on the correct country to select it. Caution 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.
6. After all the fields are filled, tap Next to proceed to the next step (Step 4: Medical Information).
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Step 4: Entering Medical Information When entering your medical information, it is important to be as accurate as possible. If you are unsure of the correct response, select “Don’t know”. Caution If you are unsure about your medical condition, enter “Don’t know”. Inaccurately entered medical information will appear on your report and may lead to an inappropriate diagnosis and treatment by your physician The app displays each condition individually and displays a counter to indicate your progress. For example, 1/11, as shown below, indicates that this is the first of eleven screens in this section.
Figure Error! No text of specified style in document.-9. Medical information screens
1. For each condition, select your current medical state. Remember to select Don’t know if you are unsure. Select Next to move to the next condition.
2. After answering all questions, review your answers. If you need to edit any answers, locate the condition and tap on the answer. The question will display again, and you may select a different answer.
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Figure Error! No text of specified style in document.-16. Changing a medical condition
3. After all medical conditions are completed, tap Next to set thresholds for your medical measured and manually entered parameters. Thresholds are preset to default values. These values determine when notifications are sent. Before you make any changes to your thresholds, consult your physician.
Figure Error! No text of specified style in document.-17. Setting thresholds
Note The medical parameters have default thresholds. To continue without changing the default thresholds, tap Next. The thresholds can be updated later (see section 0). 4. Tap each medical parameter to set its threshold.
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5. Values may be entered by dragging the handles or typing values to set the upper and lower thresholds. Tap Restore default to return to default parameters for any medical condition.
6. Tap Save to save the changes and continue to the next medical parameter.
7. After all of your medical conditions and thresholds are set, tap Next to proceed (Step 5: Preference and Terms).
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Step 5: Setting Preferences and Terms CardiacSense constantly strives to modify and improve our services. Analyzing the data and experiences of our current users aid us in that pursuit. We would appreciate your permission to use your data for research purposes (optional). We also require that you review and accept the terms and conditions for using the product (mandatory).
Figure Error! No text of specified style in document.-18. Preferences and terms
1. If you wish to allow CardiacSense to use your data for research purposes, tap to place a checkmark in the first checkbox. Data for research purposes is used anonymously, and no personal information is shared with any third party. The data is only used to improve the CardiacSense algorithms to benefit its users’ health management. Tap on More info to learn more about how your data may be used.
2. In order to use the CS System 4, you must agree to the Terms and conditions. Tap to place a checkmark in the second checkbox (mandatory). Select Read terms & conditions for more information.
CardiacSense will keep you informed about any future changes to the privacy policy and ask you to agree to the revised terms. 3. After checking the Terms and conditions, tap Next to proceed (Step 6:
Pairing the Watch).
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Step 6: Pairing the Watch To use the CS System 4, your watch and smartphone must work together. For these two devices to work together, they must be paired. This operation should be performed only once. Caution Before pairing with the watch, ensure the date and time on your smartphone are correct. 1. Make sure that Bluetooth and Location are enabled on your smartphone and that your watch and phone are within 4m (13 feet) of each other. 2. If your watch has turned off, press and hold the ON/OFF button for 2­3 seconds to turn it on. The watch vibrates momentarily, and its display turns on.
Figure Error! No text of specified style in document.-19. Turn on the watch
3. On the CS4 Mobile App, tap Scan for watches. The watch displays its synchronization screen with the watch serial number.
Figure Error! No text of specified style in document.-20. Watch sync screen
Your smartphone searches for Bluetooth transmitting devices in its range and displays the list of watches it found.
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Figure Error! No text of specified style in document.-21. Choose watch
4. When found, tap Pair next to your watch’s serial number. If your watch is not on the list, tap Refresh list and your phone will continue searching for additional devices.
5. Tap the blue checkmark () on the watch to confirm pairing within 1 minute to finish the process.
Figure Error! No text of specified style in document.-22. Confirm pairing on watch
If there is no response from the watch within 1 minute, or if the watch has declined the pairing, do one of the following on the next screen: Tap Resend request. Tap Search for watches to return to the list of watches. After the watch and the smartphone are successfully paired, a message will be displayed on the app.
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Figure Error! No text of specified style in document.-23. Watch paired with the smartphone
Figure Error! No text of specified style in document.-24. Watch paired with a smartphone
Note To save battery power, the display automatically turns off after 3 seconds. To turn it back on, press the watch ON / OFF button, or turn your wrist with the watch towards you to view the watch face. The watch display turns on by itself in case an A-Fib is detected. The app displays the Main screen (Dashboard tab). Note The application screens are displayed in landscape orientation. Unpairing the watch and the app can be done from the setting menu in the app (see instructions in section 13 by tapping Reset watch on the Factory reset (described in section 0).
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Mobile App Screen
The CS4 Mobile app screen includes a menu three screen tabs.

icon (see section 0) and

Figure Error! No text of specified style in document.-19. Main screen (Dashboard tab)
Dashboard tab ­displays notifications, measurements that were taken with the watch, and any manually entered medical information from external devices (see details in section 0).

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Wearing the Watch
When the watch is fully charged, wear it on your left or right wrist, just above the wrist bone, over intact skin. Tighten the strap so that the watch is in full contact with your skin and feels comfortable. Do not overtighten the watchstrap.
Caution A too loose or too tight watch strap may affect measurement results.
Once your CS Watch 3 and smartphone are paired, the watch starts monitoring your pulse and respiratory rates. You may close the app; the watch continues to monitor your rates even when the CS4 Mobile app is closed.
Caution Low skin temperature, restricted blood flow, or excessive movement may result in inaccurate measurements or lack of results. If that happens, remove the watch, warm your hands, and then place the watch back on your wrist. The CS Watch 3 is categorized as IP-67, which means that you may use the watch during exercise, rain, and while washing your hands or taking a shower. Note It is recommended to turn the watch off when not in use.
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Replacing the Watch Strap
If the strap connected to the CS Watch 3 is too short to fit comfortably around your wrist, replace the strap with the longer strap provided with the CS System 4 (see item 4 Figure Error! No text of specified style in document.-1). To remove the strap: 1. Turn the watch over to see its back side.
Figure Error! No text of specified style in document.-25. Watch back side
2. Slide the small silver spring lever inwards.
Figure Error! No text of specified style in document.-26. Strap silver spring lever
3. While under compression (spring-loaded), gently rotate the strap, pivoting around the stationary end.
Figure Error! No text of specified style in document.-27. Rotating the strap
4. Remove the strap.
Figure Error! No text of specified style in document.-28. Watch strap removed
To connect the replacement strap: 1. Insert the pin on the far end from the silver lever into the small cavity in the
watch strap holder/lug, as shown in Figure Error! No text of specified style in document.-27. 2. Slide the small silver spring lever inwards (as shown in Figure Error! No text of specified style in document.-26), and while under compression (spring-loaded), gently rotate the strap into place, pivoting around the stationary end (see Figure Error! No text of specified style in document.-27).
35

3. Insert the pin on the silver lever side into the other small cavity in the watch strap holder/lug. A click may sound when the pin enters the cavity.
4. Gently push or pull the strap to hear a click and ensure the strap is firmly connected to the watch.
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8. Using the CS System 4
The CS System 4 works best when the CS Watch 3 is on your wrist and is close (within 4 meters or 13 feet) to the paired smartphone.
Watch Display
The default watch display shows the time, date (month and day), watch battery status, and Bluetooth status.
To navigate through the watch display screens, swipe left to the next screen.

Notifications Battery status

Date

Watch status
Figure Error! No text of specified style in document.-29. Watch face
During operation, the following icons may appear on the watch display. These icons are also listed in the CS4 Mobile app (see section 0).
A-Fib detected: CS System 4 detected A-Fib conditions. The watch vibrates when the A-Fib episode starts (onset) and ends (termination. You should notify your physician that your CardiacSense watch detected A-Fib arrhythmia.
Battery status: Full 25% 10% At 40%, it is recommended that you charge
the watch. At 10%, the watch should be charged. At 5%, the watch screen turns off, and the watch enters a deep-sleep mode.
Bluetooth status: Red=hardware failure, Blue=connected, Gray=disconnected. Airplane mode (see section 0).
Memory status: Yellow=low/ Red=very low/ White=not recording

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Pulse Rate Swiping right from the main screen displays a screen showing the physical activity information (calories & steps) you’re your pulse rate.
Figure 6.2. Physical Activity
Settings Swiping to the settings screen displays the CS Watch 3 serial number and allows you to switch from Bluetooth to Airplane mode.
Figure Error! No text of specified style in document.-3. Airplane mode
The sliding switch allows you to toggle from Bluetooth mode to Airplane mode, which disconnects the watch from the CS4 Mobile app. When in Airplane mode, monitoring continues, but the measured results are only stored in the watch; they are not transferred to the app.
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Factory Reset The Factory reset screen displays a Confirmation button.
Figure Error! No text of specified style in document.-4. Factory reset
Pressing the check sign erases the internal memory of the watch and deletes the pairing data with the app on your smartphone. It does not revert the watch firmware to its factory or previous version. For details on resetting the watch to factory settings, see section 0.
Continuous Monitoring
Once the watch is placed on your wrist and turned on, it continuously monitors your pulse rate and respiratory rate.
Figure Error! No text of specified style in document.-5. AF notification
When A-Fib is detected, the AF icon is displayed on the watch screen. You are advised to perform an ECG measurement (see instructions in Chapter 9).
Figure Error! No text of specified style in document.-6. ECG measurement
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Application Screen
When you open the CS4 Mobile app, the Main screen appears. There is no need to log in.
Figure Error! No text of specified style in document.-7. Main screen (dashboard tab)
Dashboard Tab The Dashboard tab is the application’s main screen. The screen displays activity parameters, sleeping time in the last 24 hours, notifications (if any), the real-time measured Pulse Rate and Respiratory Rate, Oxygen Saturation, and other measured or manually inserted medical parameters. Note Fields with a “+” sign require manually inserted values. All other field values are updated automatically with watch measurements.
The Blood Pressure and Glucose values may be entered manually by the user or electronically via a paired external device. Values are reset at midnight (see details in section 0). The SpO2 is measured when performing an ECG measurement by placing your fingers on the sensors (see section 10). The Body Temperature may be entered manually by the user. The Weight value is entered manually during the account setup process and displays the last entry date (it does not reset). Real-Time measurement screen The Real-time measurement screen displays the measured Pulse rate (value and graph), measured Heart rate (value and graph), measured Respiratory Rate (value), and measured SpO2 (value) as measured by the CS Watch 3. This screen appears automatically when you initiate a real-time measurement by the watch. For more details on performing an ECG measurement, see Chapter 9.
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Main Menu Tap the menu icon in the upper left corner of the screen to open a list of available menu options.
Figure Error! No text of specified style in document.-8. Menu
Note To access My profile you must log into the application (explained in Chapter 13, Changing your Account Information). Dashboard ­ returns to the Dashboard screen. My profile ­ allows changes to the watch (if you need to replace it), personal and medical information, re-set thresholds and passwords, and access consent forms for preferences and terms (see Chapter 13).
Figure Error! No text of specified style in document.-9. My profile
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Monthly report ­ used to request a 30-day history report from a selected date (see details in section 0). External devices ­ access and configure external devices that may be paired with the CS System 4 or values may be manually entered. For details, see section 6.4.2. Settings ­ allows changes to application-related settings such as the app interface language and measuring units. (For details, see Chapter 13, Changing your Account Information).You can also view the user manual and FAQ.
Figure Error! No text of specified style in document.-10. Settings
Monthly report ­ used for requesting a 30-day history report from a selected date (see details in section 0).
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Detected and Measured Data
The Dashboard tab displays notifications and alerts you to any medical parameter irregularities. Notifications When A-fib is detected, an A-Fib notification will appear and, if any of the medical parameters (e.g., pulse rate) exceeds the set thresholds, their values are displayed in red with a red border.
Figure Error! No text of specified style in document.-11. Notifications
Adding Externally Measured Data Medical data not measured by the CS Watch 3 can be manually added to the CS4 Mobile app dashboard or may be automated by pairing approved devices. Before you begin, make sure that the external device is turned on. For information on using specific device types, see Section 8.

1. From the Dashboard menu, select External devices.
   Figure 6-12. External devices
   2. Select the type of device you want to add. You will see a list of eligible devices. You may only add one device per type. 43

Figure 6-13 ­ Example: Supported Devices List
3. Locate your device and tap on Search. Note Adding externally measured medical data to the CS4 Mobile app requires an internet connection and the device must be turned on.
4. When your device has been detected, you will see the device number. Tap on Pair.
Figure 6-14 – Example: Pair your device
5. The next screen will notify you that your device has been successfully paired. Tap on Ok. 44

Note The added values, except weight, include the time of day added and are reset every day at midnight. To electronically add a value: 6. Tap on the plus (+) sign in the lower right-hand corner of the desired device type. 7. On the next screen, follow the instructions for the selected device type. A connection will be established, and the measurement will begin. 8. The measurement value will be sent to the CS System 4 app along with the time that the value was sent.
Figure Error! No text of specified style in document.-15. Adding external measured data
To manually add a value: 1. Open the CS4 Mobile app. It opens to the Dashboard tab. 2. Locate the measurement that you wish to enter. Tap the “+” symbol
located in the lower right corner of the relevant field. A window opens to enter your current measurement value.
Figure Error! No text of specified style in document.-16. Updating external measured values
3. Type in the measurement value or use the arrows to change the values.
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4. Tap the Update button to save the changes. You will be returned to the Dashboard display. Warning DO NOT adjust medication or delay medical care based on measurement results from this device. Take medication as prescribed by your physician.
46

9. Performing an ECG Measurement
An ECG measurement can be initiated at any time from the watch, regardless of whether A-Fib has been detected.
Figure Error! No text of specified style in document.-30. A-Fib notification
When the watch PPG sensor detects an A-Fib condition, the CS Watch 3 displays an AF notification, followed by an automatically pop-up display of an instruction screen (on the watch display) to Place your fingers on the ECG sensors. The app automatically displays the Real-time measurement screen.
Figure Error! No text of specified style in document.-31. AF instruction for ECG
Note Taking an ECG measurement does not require logging into the app but does require a Bluetooth connection between the CS Watch 3 and the paired smartphone. Note Make sure your wrist is not sweaty or wet when performing ECG measurements, it may result in lack of measurement results.
Note The watch touchscreen is disabled during ECG measurements. The ECG measurement only works if your watch is on your wrist and your fingers are placed on the ECG sensors (see Figure Error! No text of specified style in document.-2) please seat still with both elbows on the table.
47

48

10. ECG, SpO2 and Respiratory Rate Measurements
ECG measurements are saved as Measurement Reports and can be shared with medical personnel or anyone you choose.
Do not use gel nail polish while measuring SpO2. Using gel nail polish may result in wrong measurement results.
Note The ECG measurement may take up to 5 minutes. Sit in an upright position and avoid moving while performing the ECG measurement. To take an ECG and SpO2 measurement: 1. Swipe left on your watch face until you reach the screen shown below:
2.
Figure 7-3. V-sign to start ECG
3. Tap the V sign. 4. Place your fingers on the ECG and SpO2 sensors and keep them on the
sensors until the message “You may remove your fingers” is displayed on the app screen.
Figure Error! No text of specified style in document.-32. Watch ECG sensors
After around 20 seconds of data collection, the watch displays a blue progress line, and the CS4 Mobile app displays the Heart rate ECG measurement (on the upper right is a progress percentage).
49

Figure Error! No text of specified style in document.-33. ECG measurement (with a report)
In addition to the pulse rate, heart rate, and the ECG measurement graph, the watch and app also display the measured SpO2 and respiratory rate values.
Note Removing your fingers during an ECG measurement pauses the measurement. Place them back to continue. Removing your fingers for more than 20 seconds ends the ECG measurement without a report.
At the end of a complete ECG measurement, the app displays the message “Generating report… You may remove your fingers”. The blue round bar do not necessarily have to reach 100%
Figure Error! No text of specified style in document.-34. ECG measurement ended
5. Remove your fingers from the ECG and SpO2 sensors. The measured data is saved on your smartphone. For Pro subscribers, the report is also uploaded to the CS4 Cloud app.
If A-Fib was not detected, the following watch and app screens are displayed.
50

Figure Error! No text of specified style in document.-35. ECG complete message (No A-Fib)
51

If A-Fib was detected, the following watch and app screens are displayed.
Figure Error! No text of specified style in document.-36. ECG complete message (A-Fib detected)
Caution It is recommended to notify your physician that your CardiacSense watch detected A-Fib arrhythmia 6. Select Share Measurement report if you want to share the report with anyone.
Figure 37. Share Report
7. Choose the app you wish to use for sharing.
Figure Error! No text of specified style in document.-38. ECG report sharing
After sharing, the Main screen is displayed.
52

Tap Back to dashboard to decline sharing a report. A message asking if you want to leave without sharing the report is displayed. Click on Back to dashboard again.
Figure Error! No text of specified style in document.-39. Leaving without sharing the report
Detailed measurement report option When choosing the option of creating a detailed measurement report a message that states “Generating report…Please keep the app open” will show along with a progress bar. Once the generation of the report is done (in the CS cloud application), a message will appear that states that “An email will be sent to you in the next few minutes”. This email will include a link to your report. See an example of the detailed measurement report in figure 14-16 Please note that the detailed measurement report is available only for PRO program (monthly subscription fee users) Non-Successful ECG Measurement
If an ECG measurement stops before successful completion, a notification is displayed on both the app and the watch, requesting that you retake the measurement. The data is not saved, and no report is generated.
Figure Error! No text of specified style in document.-40. ECG measurement failed
53

11. Using Paired External Devices
Certain approved devices are able to communicate with your CS System 4. To see if your device can be paired, follow the steps in Section 6.4.2.
Figure 8.1 Adding External Data from Dashboard
Blood Pressure Monitors
Make sure that your device has been paired with your CS System 4. 1. Tap the plus sign (+) in the lower right corner of the Blood Pressure box.
2. Place the inflating cuff around your upper arm as instructed and tap on Done.
Figure 8.2 Wear the inflating cuff on upper hand
3. Once the measurement starts, you will see the percentage of completion. When it reaches about 30% the blood pressure should start to inflate.
4. When your measurement is complete, tap on Ok.
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Figure 8.3 Measurement is complete
When the measurement has completed, the values will be displayed on the Dashboard screen.
SpO2 Monitor
Make sure that your device has been paired with your CS System 4. 1. Tap the plus sign (+) in the lower right corner of the SpO2 box. 2. Place your oximeter on your finger and click the button on your device.
Figure 8.5 Place oximeter on finger
55

3. When your measurement is complete, tap on Ok.
Figure 8.6 Oximeter measurement is complete.
Glucometer
Make sure that your device has been paired with your CS System 4 app. 1. Tap on the plus sign (+) in the lower right corner of the Glucose box. 2. When prompted, take your blood sugar measurement.
Figure 8.7 Glucose measurement
56

3. When your measurement is complete, tap on Ok. You value will populate on your Dashboard screen.
Figure 8.8 Glucose measurement complete
Weight
Make sure that your scale has been paired with your CS System 4. Tap on the plus sign (+) in the lower right corner of the Weight box. Turn on your scale and wait for it to connect, then tap on Start.
Figure 8.9 Connect to Scale
57

Step on the scale and your weight measurement will start.
Figure 8.10 Start weight measurement
When the measurement is complete, tap on Ok.
Figure 41 Weight measurement complete
58

12. Measurement and Monthly Reports
Measurement Reports
Measurement reports are saved as PDF files in the CardiacSense folder under the device’s internal storage root folder: Android based smartphone: My files

Internal storage > Download >
CardiacSense
iOS based smartphones: Files > On My iPhone > CardiacSense> Reports The naming convention of report files is: Results <Hour-minutes- seconds>.pdf. The Measurement report includes ECG measurement graphs and can be very long. The CardiacSense folder on your smartphone may contain many reports. Old reports may be removed using the File Manager.
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Monthly Reports
The CS4 Cloud app automatically generates a monthly report of medical measurements for the last 30 days in a PDF file format. The report is sent to the user’s email at the beginning of each month. The user can also request a 30-day history report from any selected date. The PDF format report is sent to the user’s email and can be shared with any other person(s). These reports are not shared via the CS4 Mobile app. To initiate a monthly report: 1. Tap the menu icon in the upper left corner of the screen.
Figure 9-42. Initiating a monthly report
2. Select Monthly report. On the screen displayed, select the date for the report, keeping in mind that the data will include the previous 30 days.
Figure 9-43. Selecting date for a monthly report
3. Tap Confirm date. A confirmation message with the selected dates appears.
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Figure 9-44. Selected date for the monthly report
4. Tap Send request to confirm the date and have CS System 4 send the monthly report to your email. A report is generated and sent to your email.
Figure 9-45. Confirmation a monthly report is generated
5. Tap OK to close the message.
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13. Changing your Account Information
You can make changes to your account information to correct a mistake (e.g., your birthday), to reflect a change in your medical condition, or amend certain CS System 4 settings that require a password. To view or change your account information, you must log into your account with your email address and password. If you have forgotten your account password, see Error! Reference source not found. in section 10.7.
Figure 10-46. Login screen
1. Tap the Menu icon 2. Select My profile. 3. Login to your account.
The My Profile menu options become available.
Figure Error! No text of specified style in document.-47. Account submenus
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Changing your Watch
Both the CS Watch 3 and the CS System 4 app have unique IDs, and once paired, they can only work with each other. Before replacing your watch or smartphone with a new one, the old watch must be unpaired from the app and the new watch must be paired. From the My profile menu, select Watch ID.
Figure 10-3. Removing the watch
2. Tap Remove watch. 3. Tap Yes when asked, “Are you sure you want to remove the watch from
your account”. After removing, the app takes you to the “Connecting the watch” screen (see Figure Error! No text of specified style in document.-19 in section 0). Pair the new devices as described in Step 6: Pairing the Watch (section 0). Resetting the Watch to Factory Settings (See section 0) also unpairs the watch from the app.
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Changing your Personal Information
4. From the My profile menu, select Personal information.
Figure 10-4. Personal information screen
5. Tap any field you wish to change (except your email address and country of residence). Enter the desired change.
6. When done, tap Save to return to the My profile screen.
Changing your Medical Information
1. From the My profile menu, select Medical information.
Figure 10-5. Medial information screen
2. Tap any of the blue values and select another value from the list. 3. When done, tap Back to return to My profile.
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Changing the Thresholds
1. From the My profile menu, Select Thresholds.
Figure 10-6. Thresholds screen
2. Modify the upper and lower rate thresholds. 3. When done, tap Save to return to My profile.
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Changing your Account Password
CardiacSense recommends changing your account password from time to time for improved data security. To change your account password: 1. From the My profile menu, select Account password. 2. Tap Change Password.
Figure 10-7. Changing account password
3. Enter your Current password, the New password (according to the password policy), and then re-type the new password to confirm.
4. Tap Save. You will see a message that Your password has been
successfully changed.
5. Tap OK to return to the Settings screen.
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Resetting your Password
If you have forgotten your password, you will need to choose a new one. To reset your password: 1. Tap Menu and select My Profile. 2. In the Login screen, tap “Forgot your password?”
Figure 10-8. Resetting account password
3. In the next screen, type your email address (used by CardiacSense to send you a link to reset your password) and tap Send.
4. Go to your email inbox, open the mail with “CardiacSense application password” in the Subject and click Reset My password.
Figure 10-9. Create a new account password
5. Create a new password (observing Password policy rules), confirm your password, and click Save. 67

Changing your Consent Forms
Data used for research purposes is anonymized, and no personal information is shared with any third party. The data is used only to improve the CardiacSense algorithms for the benefit of its users’ health management. To change your consent to use your data for research purposes: 1. From the My profile menu, select Consent forms.
Figure 10-10. Preferences and terms screen
2. Check the checkbox if you agree that “CardiacSense may use my data for research purposes” or uncheck (clear) the checkbox if you disagree.
3. When done, tap Back to return to My profile.
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Changing the Application Language
To change the application language: 1. Tap Menu > Settings. 2. Select Language. 3. Choose your preferred language from the preset list (see section 0 for
reference). 4. Tap Save.
Changing the Units
To change the application units of measurement: 1. Tap Menu > Settings. 2. Select Units.
Figure 10-11. Preferences and terms screen
3. Choose the units of measurements to use in the CS4 Mobile app. 4. Tap Save.
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14. The CS4 Cloud application
The CS4 Cloud app stores the user’s personal information and medical data, and generates a monthly report that is sent to the user’s email.
Note The CS4 Cloud app communicates with the smartphone via the internet and is not accessible by the user.
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15. Troubleshooting and Maintenance

Troubleshooting

Troubleshooting the CS Watch 3

Issue

Possible cause

The display is not working. Watch is turned off, or the

The green LEDs on the

battery is depleted.

back side are off.

The display is on, but the green LEDs on the back side are off.

Possible issue with the sensors.

There is a general problem with the watch or its sensors.

Corrective action Turn on the watch or charge the battery.
Contact CardiacSense support.
Contact CardiacSense support.

The watch did not detect contact with your fingers on the ECG sensors.

Release your fingers and place them again on the ECG sensors.

Watch battery is only 10% Place the watch in the

charged.

cradle and charge it.

The watch has very limited Verify that your watch

memory storage.

and smartphone are

paired.

The watch is not recording the measurements because it is out of memory storage.

Verify that your watch and smartphone are paired.

Bluetooth is off on the watch or smartphone, or the distance/interference between them does not enable Bluetooth linkage.
Bluetooth hardware failure.

Turn on the Bluetooth on the watch and the smartphone and verify they are paired.
Please contact support.

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Troubleshooting the CS4 Mobile application

Symptom No results are displayed.
No signals are displayed, and the app moves to the background. The report creation process is interrupted.
(upper right corner of the screen)
(upper right corner of the screen)

Possible cause

Corrective action

There is no mobile communication with the watch.

Turn on Bluetooth and Location Services.

Low battery on the smartphone is causing it to enter battery saving mode and turning off the Location Services and/or Bluetooth.

Charge the smartphone.

Incoming call or notification while viewing real-time signals.

Relaunch the app.

Low battery on the watch or smartphone, or incoming notification on the smartphone.

Charge the watch or smartphone if needed. Repeat the process.

No internet connection.
Data is not saved in the app.

Check your smartphone internet connection.

No connection with the watch.

Check your Bluetooth pairing with the watch.
Verify that the distance between the watch and smartphone is less than 4 m (13 ft).

Troubleshooting the Cradle

Symptom LED indicator failure. The watch is not charging.

Possible cause
Hardware failure.
Watch is placed backward on the cradle.

Corrective action
Replace the cradle.
Place the watch in the cradle in the correct orientation. Use the cradle magnet to position the watch correctly in the cradle.

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Resetting the Watch to Factory Settings
Resetting the watch is necessary if you get a new smartphone or if you have reset your current smartphone to its factory defaults. The watch resetting process deletes the pairing data with the previous app. It erases its internal memory, where all the raw and processed data is stored but does not revert the watch firmware to its factory or previous version. To reset the watch: 1. Swipe to the left or right until the Factory reset screen appears:
Figure 12-48. Factory reset screen
2. Tap Reset Watch. You will see a verification screen, asking Are you sure?
Figure 12-49. Reset confirmation
3. Tap the blue approval sign to reset the watch. A new watch and app pairing can then be performed. See Step 6: Pairing the Watch (section 0).
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Updating the Watch Firmware
When a new firmware for the watch is available, it is automatically updated on the watch. The app displays a message that the watch software is being updated and to keep the Mobile app open during the update.
Figure 12-50. Updating watch firmware
Upgrading the Application
Whenever CardiacSense releases a new version of its CS4 Mobile app, the new version automatically replaces the current one on your smartphone (unless automatic app updates are not permitted on your smartphone). In any case, the app is updated the next time the application is launched and there is an internet connection. The upgrade is performed in the background and does not affect the pairing of the watch and app. Your saved data, reports, and passwords are preserved.
Cleaning the Watch and the Cradle
To ensure the good and long-lasting performance of the CS Watch 3 and its charging cradle, clean them regularly. Wipe the watch and cradle clean with a nonabrasive, lint-free dry cloth. If necessary, lightly dampen the cloth with fresh water.
Warning To avoid the potential for electrical shock, the power supply must be disconnected from the power outlet while cleaning.
Caution To reduce the risk of wrong measurements, keep the device sensors clean from dirt or grease.
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Caution Do not use detergents to clean the watch and cradle.
Storing the Watch
Before storing the watch, make sure it is fully charged and turned off. The battery should be charged even when not in use.
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16. Specifications

Supported Smartphones
The CardiacSense Mobile app was tested on the following smartphones:
iOS version 12­14 based smartphones: iPhone 6 Plus iPhone 8 and more advanced Android version 7­10 based smartphones: LG V40 ThinQ Samsung Galaxy S8­S20 Xiaomi Redmi Note 8­20 Huawei P20 OnePlus 7

Communication Requirements
Wi-Fi Wi-Fi (802.11g and up).
Bluetooth® Low Energy Version 4.
Internet connection Logging into the CS4 Mobile app and loading data to the CS4 Cloud app requires the smartphone to have access to the internet, either via a Wi-Fi network and a local router or via a cellular data network, and a cellular network carrier. It is recommended to use a Wi-Fi network.

Watch Specifications

Technical Specifications

Battery type Expected battery life Expected operation time

3.7V, 300 mAh Lithium-Ion
24 months typical use
~48 hours (from fully charged battery to recharge)

Operation voltage Power consumption Weight Dimensions
Wrist circumference Expected service life

3.7V <10 mA/h 40 grams (1.41 ounces) Diameter 44mm (1.73 inches) Thickness 15mm (0.59 inches) Min: 14 cm (5.5″), Max 20 cm (7.8″) 2 years

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Operational and Storage Environment Atmospheric pressure IP rating (per IEC 60529)
Operating Temperature Storage Temperature Relative humidity range

700 ­ 1060 hPa Watch – IP67 Cradle ­ IP22 +5ºC to +50ºC -15ºC to +60ºC 15% to 90%, non-condensing

Note: If the device has been stored or transported within the temperatures exceeding the specified operational temperatures, let the device reach its intended operational temperatures before use.
Do not use the device out of the defined environmental conditions.

PPG
Pulse rate measurement Memory capacity Pulse rate range Pulse rate accuracy A-fib detection performance
ECG
A/D sampling rate CMRR Common mode input impedance Differential range ECG channel Frequency response Heart rate range Input dynamic range Memory capacity Resolution User interface

Continuous Min 72 hours of storage on the watch 30­220 BPM 3 BPM Sensitivity of 95%, Specificity of 95%
256 Hz 80 dB 5 G ±300 mV Single lead 0.5­40 Hz 30­220 BPM 10 mV peak to peak Min 72 hours of storage on the watch 17 bit 3 stainless steel electrodes

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SpO2 Sensor parameters Range of displayed functional O2 saturation (SpO2, %) Accuracy (%)
Alarms Data update period
Respiratory Rate Range Error standard deviation

Red – 660 nm, IR ­ 940 nm 70%-100%
ARMS 3% (for 2/3 of the measurements); no measurements are made when motion is detected or in low perfusion conditions No alarms Data is typically updated within 30 sec.; in case data is not updated, the watch display shows “- -“. In the mobile app, last app will be shown with the time of measurement
6-40 BrPM 3 BrPM

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17. Electromagnetic Emissions
CS System 4 is intended for use in the electromagnetic environment specified in the following tables. It is not a life-sustaining device. The user must ensure that it is used in such an environment.
FCC Radio Frequency Interference Statement FCC ID: 2A4CTCS322 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. CardiacSense Ltd. is not responsible for any radio or communication interference caused by using other than specified or recommended cables and battery or by unauthorized changes or modifications to this equipment. Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 4. This device may not cause harmful interference, and 5. This device must accept any interference received, including interference that may cause undesired operation.
Warning 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.
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Declaration ­ electromagnetic emissions

Emissions test
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2 Voltage Fluctuations and Flicker IEC 61000-3-3:2013

Compliance
Group1 Class B
Class A Complies

Electromagnetic environment ­ guidance
CS System 4 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
CS System 4 is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:
Warning: 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 4 in a different location.

Warning
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.

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Declaration ­ electromagnetic immunity Immunity test IEC 60601 test level

Compliance level

Electrostatic discharge 8 kV contact 2, 4, 8,

(ESD)

15kV air

IEC 61000-4-2

8 kV contact 2, 4, 8, 15kV air

Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

2 kV for power supply lines
1 kV for input/output lines

Evaluated during AC/DC adapter approval

1 kV line(s) to line(s)
2 kV line(s) to earth
2 kV Signal input/output) to earth

Evaluated during AC/DC adapter approval

0% UT; 0.5 cycle at 0°, 45°, 90°, 135°,180°, 225°, 270° and 315°
0% UT; 1 cycle and 70% UT; 25/30 cycles
Single phase at 0° 0% UT; 250/300 cycle

Evaluated during AC/DC adapter approval

Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8

30 (A/m)

30 (A/m)

Note: UT is the a.c. power voltage prior to application of the test level.

Electromagnetic environment ­
guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Power quality should be that of a typical commercial or hospital environment.
Power quality should be that of a typical commercial or hospital environment.
Power quality should be that of a typical commercial or hospital environment. If the user of the CS System 4 requires continued operation during power interruptions, it is recommended that CS System 4 be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and CS System 4.

Rated maximum
output
power of transmitter
[W]

Separation distance according to frequency of transmitter [m]

150 kHz to 80 MHz outside
ISM bands

150 kHz to 80 MHz
in ISM bands

80 MHz to 800 MHz

800 MHz to 2,5 GHz

0.01

0.12

0.2

0.4

1

0.1

0.37

0.64

1.3

2.6

1

1.17

2

4

8

10

3.7

6.4

13

26

100

11.7

20

40

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Essential Performance
The CS System 4 shall be able to provide the essential performance as intended and remain safe.
The essential performance of CS System 4 is defined as the ability of the System to collect continuous measurements of, pulse rate and respiratory rate, spot check measurements of heart rate and SpO2 and to detect the presence of atrial fibrillation lasting at least 5 minutes, within the defined performance rates.
Essential performance is maintained by implementing an internal built-in test mechanism, which presents status and failure notifications to the user and allows for fail-safe operation.

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18. Compliance

Basic safety and essential performance Basic safety of electrocardiograph devices Batteries
Biocompatibility
Clinical evaluation Cybersecurity
Data privacy EMC requirements
FCC
Home care use
Labeling and symbols Optical safety Shock and vibration

ANSI/AAMI IEC/EN 60601- 1:2005/(R)2012 + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-2-47:2012 Medical electrical equipment – Part 247: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic Systems
IEC 62133-2:2017 – Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications – Part 2: Lithium Systems
ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process: permanent contact with intact skin
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice
Proprietary communication protocol with CRC is used to prevent unauthorized reading of measurement data and tampering of measurement and patient data. The watch software checks program flash checksum to prevent unauthorized firmware change. The app will not run if unauthorized software change is detected by integrity checks
CardiacSense is GDPR-compliant.
IEC 60601-1-2:2014 Ed. 4 – Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
The Federal Communications Commission (FCC), Part 15. RADIO FREQUENCY DEVICES, 47 CFR Subpart B Unintentional Radiators
IEC 60601-1-11:2015 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical Systems used in the home healthcare environment
EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirement
IEC 62471:2006 Safety analysis performed based on IEC 62471 or other lamp optical safety standards
ASTM D4332-14, ASTM D4169-16, ASTM D5276-98, ASTM D642-15, ASTM D999-08, ASTM D4728-17

Usability

IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices

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19. Labels and Symbols
Refer to instructions for use Consult instructions for use

YYYY

Year of manufacture
Special Requirements for Waste of Electrical and Electronic Equipment (WEEE) directive

2797

Compliance with 2017/745 Medical Device Regulation (EU) and NB number
Manufacturer

Type BF applied part (IEC60601-1)

IP-67 IP-22

Catalog Number
Serial Number
Medical Device Protected from total dust ingress. Protected from immersion between 15 cm and 1 m in depth. Protected from touch by fingers and objects greater than 12 mm. Protected from water spray
Storage temperature range

BT SIG Membership Number

Do not use if the package is damaged Compliance with FCC part 15 subpart B

Unsafe for Magnetic Resonance Imaging

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20. Patient Portal
The CardiacSense Patient Portal provides cloud-based, access to your CS System 4 real-time data as well as daily and monthly reports. Only you and those you specify will be able to access the Patient Portal. The portals are available only to PRO program subscribers.
Figure 14-1: Patient Portal Login Screen
Logging into the Portal
Go to https://portal.cardiacsense-cloud.com. Log into the Patient Portal using the same username and password used in the mobile application. Click on Login. If you do not remember your password, click on “Forgot your password?” to reset it. For more information on how to reset your password, see “Resetting Your Password”.
Figure 14-2: Forgot your password
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Home Page
After login, the Patient Portal will open to the Home Page.
Figure 14-3: Home Page
Note For the dashboard to show updated information, please open the app on your phone Menu The Menu is located on the left side of the Patient Portal Homepage and displays your name and the date and time of your last entry. Home ­ Returns you to the Patient Portal Homepage. My Profile ­ Allows you to view and edit your personal and medical information, thresholds, and password. Reports ­ Generate daily or monthly reports, or access previously generated reports.
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Dashboard The Dashboard mirrors the Dashboard tab in the CS System 4 mobile application. It displays Notifications (if any), the real-time measured Pulse Rate and Respiratory Rate, and other measured or manually inserted medical parameters.
Figure 14-4: Patient Portal Dashboard
Physicians In this tab the user can see a list of all physicians that are providing services to the user via the CardiacSense system and were authorized by the user to view his/her medical information and also perform remote actions. It this screen connecting/disconnecting a physician to/from the patient portal.
Figure 14-5: Physicians screen
Viewers In this tab the user can see the list of people (limited to two) that can view the user medical information, by its authorization only, and also perform connection/disconnection of a viewer to/from this service.
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Figure 14-5: Patient Portal viewers screen
Daily Charts The Daily Charts are located below the Dashboard and displays a graph of each medical measurement of your vital signs from midnight through the current time. The chart displays spot checks in lines by hours. You may use the forward and backward arrows to navigate to previous days or click on the Print icon located in the upper right-hand corner to print the graph.
Figure 14-5: Daily Chart
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Monthly Graphs Clicking a vital sign measurement will produce a monthly graph for that element below the Dashboard. Click on the vital sign measurement on the Dashboard. The graph for that vital sign will generate for the current month. Click the backward arrows to navigate to previous months. Click on the Print icon to print the graph or to generate a PDF. Click on another vital sign measurement to change to another graph. Click on the same vital sign measurement a second time to close the monthly graph.
Figure 14-6: Sample Monthly graph
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My Profile
Your profile information populates in the Patient Portal from the CS System 4 mobile application. Profile information is divided into tabs and fields. Only certain fields may be modified in the Patient Portal, indicated by the pencil icon at the right end of the field. Personal Information All fields on the Personal Information tab can be edited except your email address and country of residence. To change those two fields, contact customer support. To make changes to all other fields: 1. Click on the edit icon (pencil) at the right end of the field you want to
update. 2. Type the new field information. 3. Save your changes.
Figure 14-7: Personal Information
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Medical Information The Patient Portal displays each condition individually. When modifying medical information, it is important to be as accurate as possible. All changes will be shown in the app as well.
Figure 14-8: Medical Conditions
For modify your medical condition settings: 1. Select the edit icon (pencil) for the condition you want to modify. 2. Select your current medical status. If you are unsure of the correct response, select “Don’t know”. 3. Click on Save.
Figure 14-9: Modify Medical Condition
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Thresholds Thresholds are preset to default values. These values determine when notifications are sent. Before you make any changes to your thresholds, consult your physician. Tap the edit icon (pencil) for each medical vital sign to set its threshold. Values may be entered by dragging the handles or typing values to set the upper and lower thresholds. Tap Restore default to return to default parameters for any medical data measurement. Tap Save to save the changes.
Figure 14-10: Medical Data Thresholds
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Passwords CardiacSense suggests that you change your password periodically for improved data security. To change your password in the Patient Portal: Select the Password tab. Enter your current password. Enter your new password. Confirm your new password by entering it again. Click on Save.
Figure 14-11: Account Password Change
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Reports
The Patient Portal makes it easy to generate and retrieve daily and monthly reports. Keep in mind that some reports may not be available to all users.
Reports Marketplace This view displays the reports that are available to you.

To generate a report:

Figure 14-12: Ask for report

1. Click on the report you want to generate. 2. Select the date. If you are requesting a daily report, select the date of
the report. For a monthly report, select the last date of the report. The report will include the previous 30 days.

Figure 14-13: Select Report Date
3. Click on Generate. 4. The report will open in a new tab. You will be able to view the report on
screen and/or save it as a PDF.
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Figure 14-14: Sample Report
Reports Archive Using the Reports Archive, you can access previously generated reports. These reports are arranged according to report type: · Measurement Reports · Annotation Reports · Monthly Reports To open a report, click on the report name.
Figure 14-15: Archive Reports
Note When finished working in the user portal, log out by pressing the Log Out button on the upper right corner.
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Detailed Measurement Report

Figure 14-16: Detailed Measurement Report

Report appendix

Figure 14-17: Detailed Measurement Report
96

RSV (Relative Stroke Volume) – The ratio of the area of a specific PPG pulse to the area of the median PPG pulse area. RSV is denoted in percentages over the PPG strip. PI (Perfusion Index) – The ratio of the pulsatile blood flow to the non-pulsatile blood flow PWV (Pulse Wave Velocity) – The velocity at which the blood pulse propagates. It may be used by your physician to estimate the measure of arterial stiffness/health. RSI (Respiratory Stability Index) – An indication for respiratory stability. It can be used by your physician to predict whether heart failure condition, if exists, is worsened.
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21. Appendices

Medical Terms

.0.

About A-Fib

A-Fib is a reentrant cardiac arrhythmia marked by rapid randomized contractions of the atrial myocardium, causing an irregular, rapid atrial rate. It is recognizable on an electrocardiogram by the absence of P waves and an irregular ventricular response.

A-Fib is an independent risk factor for stroke and thromboembolism that cause mortality. Although A-Fib rates are increasing globally, improved outcomes may be achieved by complex treatment and early detection.

.1.

About ECG and PPG

ECG and PPG are the two primary technologies for measuring heart rate.

ECG (electrocardiography) uses electrodes to measure the bio-potential generated by electrical signals that control the expansion and contraction of heart chambers.
PPG (photoplethysmography) uses light-based technology to sense the rate of blood flow as controlled by the heart’s pumping action.

.2.

About HR and PR

Heart rate (HR) is the number of times your heart beats in a minute.

Pulse rate (PR) is the number of times your arteries create a noticeable “pulse” due to an increase in blood pressure resulting from your heart contracting. Therefore, the pulse rate is essentially your heart rate.

.3.

About Respiratory Rate

Your respiratory rate is the number of breaths you take per minute.

The normal respiration rate for an adult at rest is 12 to 20 breaths per minute. A respiration rate under 12 or over 25 breaths per minute while resting is considered abnormal.

.4.

About SpO2

SpO2, also known as oxygen saturation, is a measure of the amount of oxygen- carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen. Normal arterial blood oxygen saturation levels in humans are 95­100 %.

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Appendix A. Glossary
Account – Personal information needed to get personalized results from the CS System. The information is treated in a HIPAA- and GDPR-compliant manner.
Airplane mode – Placing your device in Airplane mode suspends all wireless communications (Radio Frequency transmissions such as Bluetooth). .
Algorithm – A process or set of rules used in calculations or problem-solving. . Ambulatory ­ Patients who are able to walk and are not bedridden. Authorized Personnel – Individuals designated by the manufacturer to perform
certain functions or actions. Battery – A power cell used to generate electrical energy. Biocompatible – Materials used in medical devices or surgical procedures that are
not harmful to living tissue. Bluetooth – A wireless technology that enables the exchange of data between
devices using radio frequency wavelength BrPM ­ Breaths per minute Cloud Application – An internet-based software where the user interacts via a web
browser and some or all of the processing and data storage is performed in the cloud. The CS4 Cloud app stores the user’s personal information, stores the user’s medical data, and generates a monthly report that is sent to the user’s email. Compliance ­ Adherence to rules and policies that prohibit or regulate specific products, services, or processes. Consent Forms – A written informed consent of an individual for a medical study, clinical trial, or activity. Dashboard – A home page on a website or app that provides a graphical summary and quick access to various capabilities or functions. Deep-Sleep Mode ­ Watch status after a period of inactivity. The watch will shut down with no active use of the battery. Display – A computer output that shows text and graphic images. May also be used as an input device (i.e., touchscreen). ECG Measurement – Measures electrical activity of the heart to detect cardiac problems. Edema – Swelling caused by excess fluid accumulation in body tissues. Electrode- A conductor through which electricity enters or leaves an object Electromagnetic Emissions- Electromagnetic waves emitted by a device which are synchronized oscillations of electric and magnetic fields.
99

Erythema – A type of skin rash caused by injured or inflamed blood capillaries that usually occurs in response to a drug, disease, or infection.
Essential Performance – Performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk (from IEC 60601-1)
Measurement Report – A report that is automatically generated following an eligible event. For example, a report generates immediately following a successful ECG measurement.
Externally Measured Data – Medical data not measured by the CS System. This data may be manually entered.
Factory Reset ­ Software function which erases user data from the device’s internal storage and disconnects smartphone pairing.
FCC – The Federal Communications Commission, an agency of the United States federal government, regulates communications by radio, television, wire, satellite, and cable across the country.
Firmware – A type of software that provides instructions, much like a low- level operating system, for a specific device.
GDPR – The General Data Protection Regulation is an EU law protecting data and privacy in the European Union. Its aim is to enhance individuals’ control and rights over their personal data and to simplify regulations for international business.
HIPAA – The Health Insurance Portability and Accountability Act stipulates how personally identifiable information maintained by the healthcare and healthcare insurance industries should be protected and prohibits the disclosure of protected information to anyone other than a patient and the patient’s authorized representatives without their consent.
Implantable Cardioverter-Defibrillator (ICD) – A small battery-powered device placed in a patient’s chest to monitor heart rhythm and detect irregular heartbeats, and restore regular heartbeats by using electrical shock.
Icon – a symbol or graphic representation on a screen of a program, option, or window.
ID number – A unique identification number assigned by a government entity. Acceptable US ID numbers include a state issued driver’s license number or a federally issued Social Security number
Intermittent Data – Data recorded at irregular intervals, not steady or continuous.
Internal Storage – Storage of user data within the device. This usually occurs when a Bluetooth connection is not available such as when the device is in airplane mode.
IP-67 – One of the highest degrees of protection offered by an IP rating, it provides protection against ingress of dust and immersion of water up to 1 meter.
Light Emitting Diode (LED) – A semiconductor device that emits light when an electric current flows through it.
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Medical Condition – A disease, illness or injury; any physiologic, mental or psychological condition or disorder
Medical Device – Any instrument, apparatus, machine, appliance, implant, software, material or other article, intended by the manufacturer to be used for one or more specific medical purpose and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Medical Information – The collection, handling and dissemination of patient information on medications, and medical conditions.
Medical Parameters ­ A medical variable whose measure is indicative of a quantity or function that cannot itself be directly determined precisely but is estimated by statistical computation from samples.
Memory Status – Shows the status of your physical memory in the form of a gradient from green to red. The status will be green when your physical memory usage is low and turns red as your physical memory usage increases.
Mitigation – The process or result of making something less severe, dangerous, painful, harsh, or damaging.
Mobile Application – A software application designed to run on a mobile device such as a phone, tablet, or watch.
Monitoring Device – A device that acquires, transmits, processes, and stores data, enabling users to keep track of their vitals and/or Medical Parameters from any location.
Monthly Report ­ A report that is automatically generated and sent to the user’s email address each month and contains user’s data for the previous 30 days. This report may also be manually initiated.
Nonabrasive – Material that will not cause damage, wear, or removal of surface material by grinding or rubbing.
Notifications – Messages generated by applications to provide information to the user.
Pacemaker – A small device surgically implanted under the collarbone to control heartbeats.
Pairing – A process in which two Bluetooth devices, such as a mobile phone and a medical device, establish a unique connection to communicate with each other.
Password-Protected – Accessible is only available to users entering the correct password.
PDF – Portable Document Format, used to distribute read-only files that preserve the layout of the page and can be viewed and printed on compatible devices.
Peripherals – Hardware components or devices that are easily attached to or removed from a computer and are controlled by the computer system
101

Personal Information – Information that enables CS 4 to identify an individual, including name, address, date of birth, and phone number.
Physiological Parameters – Medical parameters which are used to assess the internal state of an individual, such as heart rate, blood pressure, body temperature, serum levels of various stress hormones and immunological functions.
Pogo-Pins – A type of electrical connector mechanism that is used in many electronic applications, considered more durable than other connectors because the pin does not scratch the surface of the contact pad.
Portable RF ­ A Portable Radio Frequency device using electromagnetic waves.
Power Supply – A hardware component that supplies electrical power.
Profile – A collection of settings and information associated with a specific user; A digital representation of the identity of the user within the application.
Progress Bar – A graphic representation of the current status of a task being completed. Sometimes text is included to provide the percentage of completion or the number of steps remaining.
QR Code – A two-dimensional version of a Barcode that can convey a wide variety of information when scanned by a mobile device. A QR code is available to install the CS 4 mobile app.
Quick-Start Guide (QSG) – A short manual supplied with the device, meant to make users familiar with the CS System 4 and to supply quick set-up guidance.
Radio Interference – Unwanted radio frequency signals that disrupt the use of RF device or cordless telephone. The disruption may cause the phone or device to fail, or it may affect the quality of the sound or picture.
Real-time Data – Data that is passed along to the end user as quickly as it is gathered. The data is processed using real-time computing but can be stored for later data analysis and reports.
Sensitization – An enhanced response to a substance after repeated exposure to the same substance.
Sensors ­ A component which detects or measures a physical property and records, indicates, or otherwise responds to it. For example, the CS 4 watch contains ECG and PPG sensors.
Separation Distance – The minimum distance that should be kept between devices, beyond which hazards associated with functioning may occur.
Serial Number ­ A unique product identifier provided by the manufacturer.
Single Patient Use ­ An application or device that is intended to be used by only one user.
SMS – Short Message (or Messaging) Service, a system that enables mobile phone users to send and receive text messages.
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Splash Screen – An introduction page, consisting of a window containing an image, a logo, and sometimes the current version of the software, that is displayed as a program is loading.
Third Party – Any person or company who is not a party to a contract or transaction but may have an involvement.
Transducer – A device that converts variations in a physical quantity, such as pressure or brightness, into an electrical signal, or vice versa.
Troubleshooting ­ A set of actions that are recommended by the manufacturer to perform in case errors occur in the device.
Units of Measure – A standard quantity used to express a length, weight, capacity (volume), time, or other parameters. The CS System 4 uses Metric or Imperial measurements.
Upgrade – Important changes and/or new features and options that are not included in the current version of a software and the user is required to install.
Upload ­ Transfer data from a local computer or device to another computer, generally a larger server or the cloud.
USB-C to USB-A Cable – The most popular cable types available, used mostly to connect computers to peripheral devices such as cameras, camcorders, printers, scanners, and more.
Vital Signs – Clinical measurements, specifically pulse rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient’s essential body functions.
Watch Strap – A watch wristband made of cloth, rubber, leather or other material. Wizard ­ A user interface that leads the user to complete a complex task through a
series of pre-defined step
103

References

• Home page - CardiacSense
• CardiacSense Portal
• Privacy policy - CardiacSense
• User Manual - CardiacSense

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