CardiacSense CS System 3 Instructions For Use Manual
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CardiacSense CS System 3 Instructions For Use Manual

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CS System 3
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Summary of Contents for CardiacSense CS System 3

  • Page 1 CS System 3 Instructions for Use...
  • Page 2 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.

  • Page 3: Table Of Contents

    Table of Contents About this User Manual ............... 6 Introduction ................7 1.1 Proper Use of CS System 3 ............. 7 1.2 CS System 3 Overview ..............7 1.3 CS System 3 Technology ..............7 Intended Use ................8 2.1 Indications for Use ................8 2.2 Intended Users ................
  • Page 4 Using the CS System 3 ............29 6.1 Watch Display ................29 6.1.1 Airplane Mode ..................30 6.2 Continuous Monitoring ..............30 6.3 Application Screen ................. 31 6.3.1 Alerts and Notifications ............... 31 6.3.2 Adding Medical Data ................32 6.3.3 Main Menu ..................
  • Page 5 11.4 Upgrading the Application .............. 58 11.5 Cleaning the Watch and the Cradle ..........58 11.6 Storing the Watch ................58 12 Specifications ..............59 12.1 Supported Smartphones ..............59 12.2 Communication Requirements ............59 12.3 Watch Specifications ..............59 12.3.1 Technical Specifications ..............

  • Page 6: About This User Manual

    This manual provides the information necessary to operate the CS System in a safe and effective manner. Please read the manual before operating CS System 3 and its application. If any part of this manual is unclear, please contact your local distributor for support.

  • Page 7: Introduction

    By combining off-the-shelf ECG and unique PPG sensors, and together with proprietary algorithms, the device detects the presence of A-Fib and indicates it to the user. In addition to A-Fib detection, CS System 3 monitors the user’s heart rate. The CardiacSense unique PPG sensor compensates for the interference caused by hand, palm, and finger movement, which in most cases is the primary source of false notifications.

  • Page 8: Intended Use

    5 minutes by using PPG and/or ECG signals. 2.2 Intended Users CS System 3 is intended to be used by any person who seeks to monitor their vital signs in medical facilities, ambulatory conditions, or at home. 2.3 Contraindications •...

  • Page 9: Safety

    CardiacSense recommends locking your smartphone’s display to avoid unauthorized access. CS System 3 comes with a default report password that can be viewed and changed in the CardiacSense Mobile app. CardiacSense recommends changing the report password from time to time.

  • Page 10: Warnings And Cautions

    3.2.1 Warnings DO NOT USE CS System 3 BEFORE READING AND UNDERSTANDING THIS MANUAL. Using the CS System 3 for unintended purposes may result in incorrect results and clinical misinterpretations DO NOT adjust medication based on measurement results from this device.

  • Page 11: Cautions

    3.2.2 Cautions Changes or modifications not expressly approved by CardiacSense Ltd. can affect the safety and effectiveness of the system and void the system’s warranty. Do not operate with a damaged screen, cord, or plug. If damaged, have the cord or plug replaced immediately by a qualified service technician.

  • Page 12: Know Your Cs System 3

    Know your CS System 3 4.1 Package Contents The following items are included in the CS System 3 packaging*: Figure 4-1. Package contents * Only one type of charging cradle is supplied (item 2 or item 3) Item Description CS Watch 3...

  • Page 13: Cs Watch 3

    Charging contacts for charging the watch in the cradle PPG sensor Serial number, used for connecting your watch with the CardiacSense Mobile app 4.1.2 Charging Cradle The cradle is used for charging the watch. It features four gold-plated pogo- pins for charging the watch and can be delivered in one of the following configurations: •...

  • Page 14: Charging The Watch

    When the battery depletes faster than expected, the battery should be replaced. The battery cannot be replaced. In case of degraded battery performance, please contact CardiacSense or your local distributor for details. Note The battery should be charged at least every 3 months, even when not...

  • Page 15: Turning The Watch On And Off

    4.3 Turning the Watch ON and OFF Press the watch ON / OFF button for 2–3 seconds (the same button is used to turn the display On and Off by pressing it briefly). Figure 4-5. Watch ON/OFF button The watch vibrates momentarily, and its display turns on. Figure 4-6.

  • Page 16: Preparing The Cs System 3

    For charging the watch, see Charging the Watch in section 4.2. 5.2 Installing the CS3 Mobile App The CS3 Mobile app is an essential part of CS System 3. 3. Install the CS3 Mobile app on your smartphone in one of two ways: ¨...
  • Page 17 To create an account: 1. Open the CS3 Mobile app. The application opens with a splash screen, followed by the language selection screen. Figure 5-2. Splash and language screens 2. Select your language for the application interface from the preset list. Figure 5-3.
  • Page 18 Figure 5-4. Create new account screens 4. Tap Create new account...

  • Page 19: Step 1: Sign In

    5.3.1 Step 1: Sign In In this step, you create your CardiacSense account consisting of an email address and password. Note The email address you enter here is part of your identification details and cannot be changed after completing the Sign-In process.
  • Page 20 Figure 5-6. Email verification To verify your email and activate your account: 1. Open your inbox and open the CardiacSense mail. Figure 5-7. Email account activation If the email was not received, check on the CS3 Mobile app that your...

  • Page 21: Step 2: Personal Information

    5.3.2 Step 2: Personal Information In this step, you are requested to enter your personal information, which is essential for the CardiacSense algorithms to provide accurate results, personalize reports with your ID number, and for statistical analyses. 1. Type in your first and last name.

  • Page 22: Step 3: Medical Information

    5.3.3 Step 3: Medical Information In this step, you are requested to indicate your medical condition. It is important to be as accurate as possible, although you can select “Don’t know”. The app displays one condition at a time and indicates your progress (1 of 12 in the following example).
  • Page 23 Figure 5-11. Setting pulse rate threshold 4. Drag the handles or type values to set the upper and lower pulse rate thresholds. 5. After all medical conditions are filled and your pulse rate threshold is set, to proceed to the next step (Step 4: Preference and Terms).

  • Page 24: Step 4: Preferences And Terms

    5.3.4 Step 4: Preferences and Terms In this step, you are asked if you allow CardiacSense to use your data for research purposes (optional) and to accept the terms and conditions for using the product (mandatory). Figure 5-12. Preferences and terms 1.

  • Page 25: Step 5: Connecting The Watch

    5.3.5 Step 5: Connecting the Watch The watch and app must be paired to work together. Both the watch and the app have a unique ID. Once paired, they can only work with each other. This operation needs to be performed once. Unlinking the watch from the app can be triggered from the app (see section 9.10, Unlinking the Watch from your Account) or by Resetting the Watch to Factory Settings (described in section 11.2).
  • Page 26 Your smartphone searches for Bluetooth transmitting devices in its range and displays the list of watches it found. Figure 5-15. Choose watch 4. When found, tap next to your watch’s serial number. Connect If your watch is not on the list, tap for the phone to continue Refresh list searching for additional devices.
  • Page 27 After successfully paired, a message is displayed on the smartphone. Figure 5-17. Watch paired with smartphone 6. Tap Finish setup The watch displays the correct date and time (identical to those on your smartphone) and starts monitoring. Figure 5-18. Watch paired with smartphone Note To save battery power, the display automatically turns off after 3 seconds.

  • Page 28: Mobile App Screen

    The app displays the Home screen (Dashboard tab). Note The application screens are displayed in landscape orientation. Figure 5-19. Home screen (Dashboard tab) 5.4 Mobile App Screen The CS3 Mobile app screen is comprised of three sections: • icon on the screen upper left corner. Menu •...

  • Page 29: Using The Cs System 3

    Using the CS System 3 The CS System 3 is best used when the CS Watch 3 is on your wrist and is in close vicinity to the paired smartphone. 6.1 Watch Display The default watch display shows the time, date (month and day), watch battery status, and Bluetooth status.

  • Page 30: Airplane Mode

    6.1.1 Airplane Mode Airplane mode disconnects the watch from the CS3 Mobile app. Monitoring continues, but the measurement results are only stored in the watch; they are not transferred to the app. To enter Airplane mode: 1. Swipe right until the Bluetooth and Airplane modes are displayed. Figure 6-2.

  • Page 31: Application Screen

    6.3 Application Screen When opening the CS3 Mobile app the Home screen appears. There is no need to log in. Figure 6-5. Home screen The Dashboard tab displays Alerts (if any), the measured Pulse Rate, and manually inserted medical data (see Section 6.3.2, Adding Medical Data). Note The Blood Pressure, SpO , Body Temperature, and Glucose values...

  • Page 32: Adding Medical Data

    6.3.2 Adding Medical Data Medical data that is not measured by the CS Watch 3 can be manually added to the CS3 Mobile app dashboard. Note Adding medical data to the CS3 Mobile app requires internet connection. Figure 6-7. Adding medical data Note The added medical data includes the time of day it was added and is reset every day at midnight, except for weight.

  • Page 33: Main Menu

    6.3.3 Main Menu Tapping the menu icon in the upper left corner of the screen opens a menu with a list of available setup options. Figure 6-9. Menu Note Entering My profile and Settings requires logging into the application and are explained in Chapter 9, Changing your Account Information. •...
  • Page 34 • Info – provides details related to CardiacSense (the CS3 Mobile app version, addresses, and other CS System 3 related details), explains the watch and app icons (see Figure 6-13), opens this user manual, and enables viewing the privacy policy on the CardiacSense website.
  • Page 35 Figure 6-13. Watch icons and meaning...

  • Page 36: Performing An Ecg Measurement

    Performing an ECG Measurement An ECG measurement can be initiated at any time from the watch or when prompted by the watch and app in case of A-Fib detection. Figure 7-1. A-Fib alert When the PPG sensor detects an A-Fib condition, the CS Watch 3 displays an AF alert, followed by an instruction screen to place your fingers on the ECG sensors.

  • Page 37: Ecg Measurement With Report

    9.8, Changing the Report Password. When sharing a report, the report password also needs to be sent to the person you share the report with. CardiacSense recommends using a different sharing app to send the password than the app used to send the report.
  • Page 38 After a few seconds, the watch displays a blue progress line, and the CS3 Mobile app displays the pulse rate, heart rate, and ECG measurement in the Real-time Data tab (on the upper right is a progress percentage). Figure 7-5. ECG measurement (with a report) At the end of the measurement, the app displays the message “...
  • Page 39 ¨ If A-Fib was detected, , the following watch and app screens are displayed. Figure 7-8. ECG complete message (with a report) 4. Remove your fingers from the watch sensors. The measured data is saved on the smartphone (for Pro subscribers, the report is also uploaded to the CS3 Cloud app).

  • Page 40: Non-Successful Ecg Measurement

    7.1.1 Non-Successful ECG Measurement If a measurement stops before successful completion, a notification is displayed on both the app and the watch, requesting to retake it. Figure 7-11. ECG measurement failed The data is not saved, and no report is generated.

  • Page 41: Ecg Measurement Without Report

    7.2 ECG Measurement Without Report 1. Follow the instructions for performing an ECG measurement with a report but skip the first step of pressing “Create report”. Figure 7-12. ECG measuremnt (without a report) 2. At the end of the measurement, the app displays the message “ You may ”.

  • Page 42: Event And Monthly Reports

    Event and Monthly Reports 8.1 Event Reports Event reports are saved as PDF files in the /CardiacSense folder under the device’s internal storage root folder: • iOS based smartphones: Files -> my iphone -> cardiacsense • Android base smartphone: My files -> internal storage -> android -> data - >...

  • Page 43: Monthly Reports

    8.2 Monthly Reports The CS3 Cloud app automatically generates a monthly report of the last 30 days in a PDF file format and is sent to the user’s email at the beginning of each month. The user can also initiate a request to create a 30-day history report from a selected date.
  • Page 44 Figure 8-4. Selected date for the monthly report 3. Tap to confirm the date and have the CS System 3 send the Send request monthly report to your email. A report is generated and sent to your email. Figure 8-5. Confirmation a monthly report is generated 4.

  • Page 45: Changing Your Account Information

    Changing your Account Information Change your account information to correct a mistake (e.g., your birthday) or to reflect a change in your medical condition. Viewing or changing your account information requires logging into your account. If you forgot your account password, see Resetting your Password in section 9.9.

  • Page 46: Changing Your Personal Information

    9.1 Changing your Personal Information 1. Press the icon and select the tab. Menu My profile 2. Press Personal information Figure 9-3. Personal information screen 3. Tap any field you wish to change (except your email address and country of residence). 4.

  • Page 47: Changing The Thresholds

    9.3 Changing the Thresholds 1. Press the icon and select the tab. Menu My profile 2. Press Thresholds Figure 9-5. Medial information screen 3. Modify the upper and lower pulse rate thresholds. 4. When done, tap to return to Save My profile...

  • Page 48: 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 for using your data for research purposes: 1.

  • Page 49: Changing The Application Language

    9.5 Changing the Application Language To change the application language: 1. Select Menu > Settings > (login) >Language 2. Select your preferred language from the preset list (see section 5.3 for reference). 3. Tap Save 9.6 Changing the Units To change the application units of measurement: 1.

  • Page 50: Changing Your Account Password

    9.7 Changing your Account Password CardiacSense recommends changing your account password from time to time for improved data security. To change your account password: 1. Select Menu > Settings > (login) > Account Password 2. Tap Change Password Figure 9-8. Changing account password 3.

  • Page 51: Changing The Report Password

    Save your old passwords. They are required for opening previously created reports. Save the old password and move previously created reports from the CardiacSense folder (in the internal storage root folder of your device) to a different location. To change the report password: Select Menu >...

  • Page 52: Resetting Your Password

    Login Forgot your password? Figure 9-10. Resetting account password 2. In the next screen, type your email address (used by CardiacSense to send you a link for resetting your password) and tap Send 3. Go to your inbox, open the mail with “CardiacSense application password”...

  • Page 53: Unlinking The Watch From Your Account

    9.10 Unlinking the Watch from your Account Both the watch and the app have a unique ID. Once paired, they can only work with each other. Before replacing your watch or smartphone with a new one, you need to unlink the watch-app pair, then reconnect them for the new ID to be recognized (see section 5.3.5, Step 5: Connecting the Watch).

  • Page 54: The Cs3 Cloud Application

    10 The CS3 Cloud Application The CS3 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. Note The CS3 Cloud app communicates with the smartphone via the internet and is not accessible by the user.

  • Page 55: Troubleshooting And Maintenance

    Charge the battery. The green LEDs on the back side are off. The display is on, but the Possible issue with the Contact CardiacSense green LEDs on the back sensors. support. side are off. There is a general...

  • Page 56: Troubleshooting The Cs3 Mobile Application

    11.1.2 Troubleshooting the CS3 Mobile Application Symptom Possible cause Corrective action No results are displayed. There is no mobile Turn on Bluetooth and communication with the Location services. watch. Low battery on the Charge the smartphone. smartphone is causing it to enter battery saving mode and turning off the Location and/or Bluetooth.

  • Page 57: Resetting The Watch To Factory Settings

    11.2 Resetting the Watch to Factory Settings Resetting the watch is necessary if you get a new smartphone or reset your 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.

  • Page 58: Upgrading The Application

    11.4 Upgrading the Application Whenever CardiacSense releases a new version of its CS3 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 will be updated the next time the application is launched, and there is an internet connection.

  • Page 59: Specifications

    12 Specifications 12.1 Supported Smartphones The CardiacSense Mobile app was tested on the following smartphones: • iOS version 12–14 based smartphones: ¨ iPhone 6 Plus ¨ iPhone 8 and more advanced • Android version 7–10 based smartphones: ¨ LG V40 ThinQ ¨...

  • Page 60: Operational And Storage Environment

    12.3.2 Operational and Storage Environment Atmospheric pressure 700 – 1060 hPa IP rating IP67 (per IEC 60529) Operating Temperature +5ºC to +50ºC Storage Temperature -15ºC to +60ºC Relative humidity range 15% to 90%, non-condensing 12.3.3 PPG Pulse rate measurement Continuous Memory capacity Min 72 hours of storage on the watch Pulse rate range...

  • Page 61: Electromagnetic Emissions

    12.4 Electromagnetic Emissions CS System 3 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. 12.4.1 Declaration – electromagnetic emissions Electromagnetic environment –...

  • Page 62: Declaration - Electromagnetic Immunity

    Single phase at 0° 0% System 3 requires UT; 250/300 cycle continued operation during power mains interruptions, it is recommended that CS System 3 be powered from an uninterruptible power supply or a battery. Power frequency 30 (A/m) 30 (A/m)

  • Page 63: Recommended Separation Distances

    12.4.3 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and CS System 3. Rated Separation distance according to frequency of transmitter maximum output 150 kHz to 150 kHz to 80 MHz to 800 MHz to...

  • Page 64: Compliance

    The app will not run if unauthorized software change is detected by integrity checks Data privacy CardiacSense is GDPR-compliant. EMC requirements IEC 60601-1-2:2014 Ed. 4 - Medical electrical equipment - Part 1-2: General requirements for basic safety and...

  • Page 65: Labels And Symbols

    12.6 Labels and Symbols Refer to instructions for use Consult instructions for use Year of manufacture YYYY Special Requirements for Waste of Electrical and Electronic Equipment (WEEE) directive Compliance with 2017/745 Medical Device Regulation (EU) and NB number 2797 Manufacturer Type BF applied part (IEC60601-1) Catalog Number Serial Number...

  • Page 66: Appendices

    13 Appendices Medical Terms A.1. 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.

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