CardiacSense CS System 3 User Manual
  1. Manuals
  2. Brands
  3. CardiacSense Manuals
  4. Medical Equipment
  5. CS System 3
  6. User manual

CardiacSense CS System 3 User Manual

Hide thumbs Also See for CS System 3:
Table of Contents

Advertisement

Quick Links

Download this manual
CS System 3
User Manual
`

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the CS System 3 and is the answer not in the manual?

Questions and answers

Related Manuals for CardiacSense CS System 3

Summary of Contents for CardiacSense CS System 3

  • Page 1 CS System 3 User Manual...
  • 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 ..................8 Proper Use of CS System 3 ................8 CS System 3 Overview ................. 8 CS System 3 Technology ................8 Intended Use ..................9 Indications for Use ..................9 Intended Users ....................
  • Page 4 Mobile App Screen ..................33 Wearing the Watch ................... 34 Replacing the Watch Strap ................ 35 Using the CS System 3 ..............37 Watch Display .................... 37 6.1.1 Pulse Rate ....................... 38 6.1.2 Physical Activity ....................38 6.1.3 Settings......................38 6.1.4...
  • Page 5 11 Troubleshooting and Maintenance ..........65 11.1 Troubleshooting ..................65 11.1.1 Troubleshooting the CS Watch 3 ..............65 11.1.2 Troubleshooting the CS3 Mobile application ..........66 11.1.3 Troubleshooting the Cradle................66 11.2 Resetting the Watch to Factory Settings ........... 67 11.3 Updating the Watch Firmware ..............

  • Page 6: About This User Manual

    This manual provides the information necessary to operate and use the CS System safely and effectively. Please read the manual before operating CS System 3 and its application. If any part of this manual is unclear, contact your local distributor for support.
  • Page 7 Shortened Instruction Replaces From any of the windows, select: From any screen: Menu > My profile > (login) > Personal 1. Tap the Menu icon. information 2. Select My profile. 3. Log into the application. 4. Select Personal information. 5. Perform the action or edit the parameter value.

  • Page 8: Introduction

    Introduction CS System 3 is a wrist-worn medical device, similar to a watch, that measures heart rate, Pulse Rate and detects atrial fibrillation (A-Fib) by reading the user’s PPG and ECG values. CS System 3 comprises a watch (CS Watch 3), a charging cradle, a mobile application (CS3 Mobile app), and a cloud application (CS3 Cloud app).

  • Page 9: Intended Use

    5 minutes by using PPG and/or ECG signals. Intended Users CS System 3 is intended to be used by anyone who seeks to monitor their vital signs in medical facilities, ambulatory conditions, or at home. The device is intended as a single patient use.

  • Page 10: Safety

    To protect your privacy, the reports that are created through the mobile app are stored only on your smartphone. For subscribers, the reports are automatically stored in CS Cloud App. CardiacSense recommends locking your smartphone’s display to avoid unauthorized access.

  • Page 11: Warnings And Cautions

    Warnings and Cautions 3.2.1 Warnings DO NOT USE CS System 3 BEFORE READING AND UNDERSTANDING THIS MANUAL. Do not use the device if you have an ICD or pacemaker or if you are pregnant or breastfeeding. The device has not been tested, and it is not intended for use...

  • Page 12: Cautions

    Before pairing the watch with the smartphone, ensure the date and time on your smartphone are correct. Changes or modifications not expressly approved by CardiacSense Ltd. can affect the safety and effectiveness of the system and void the system’s warranty.
  • Page 13 Using the CS System 3 for unintended purposes may result in incorrect results and clinical misinterpretations Verify you have selected the correct country of residence, as it is required for compliance with local regulatory requirements and new feature releases. Your country of residence cannot be changed without the aid of customer support.

  • Page 14: Know Your Cs System 3

    Know your CS System 3 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 15: Cs Watch 3

    4.1.1 CS Watch 3 Look at the watch to identify its physical controls: Figure 4-2. Watch front and rear view Display and Blood Pressure sensor (for use in future versions) Watch display and on/off button (watch on/off: press for 3 seconds; display on/off: press momentarily) Thermometer (for use in future versions) ECG sensor used for real-time ECG measurement (by placing your finger and...

  • Page 16: Charging The Watch

    Figure 4-4. Battery low-level display When the battery reaches 10%, the watch screen turns off, and the watch enters a deep-sleep mode. In case of degraded battery performance, please contact CardiacSense or your local distributor. Note The battery should be charged at least every 3 months, even when not in use.

  • Page 17: Turning The Watch On And Off

    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 18: Preparing The Cs System 3

    Enable Location and Bluetooth on your smartphone. Setting up your Account Your account in the CS3 Mobile app holds the personal information needed to get personalized results from CS System 3. Your personal information is treated in a HIPPA - and GDPR-compliant manner.
  • Page 19 Figure 5-1. Account setup steps...

  • Page 20: Step 1: Registration

    5.3.1 Step 1: Registration 1. To register, open the CS3 Mobile app. The application opens with a splash screen, followed by the language selection screen. Figure 5-2. Splash and language screens Select your language for the application interface from the preset list. Figure 5-3.
  • Page 21 Figure 5-4. Create new account screens Create new account...

  • Page 22: Step 2: Creating New Account

    5.3.2 Step 2: Creating New Account 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 23 Figure 5-6. Email verification To verify your email and activate your account: 1. Open your inbox and open the mail sent from CardiacSense mail. Figure 5-7. Email account activation If you did not receive and, check on the CS3 Mobile app that your email address is...
  • Page 24 Return to the CS3 Mobile app and tap Continue to log in. Type your account credentials ( ) to log in to your account. Email address Password to continue to the next step (Step 2: Personal Information). Next...

  • Page 25: Step 3: Entring Personal Information

    Step 3: Entring Personal Information In this step, you are requested to enter your personal information, which is essential for the CardiacSense algorithms to provide accurate results and personalize reports with your ID number. 1. Type in your first and last name.

  • Page 26: Step 4: Entering Medical Information

    5.3.4 Step 4: Entering Medical Information In this step, you are requested to indicate your medical condition. It is important to be as accurate as possible, and if you are unsure, select “ ”. Don’t know Caution 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 The app displays one condition at a time and indicates your progress (1 of 12 in the...
  • Page 27 Figure 5-10. Changing a medical condition After all medical conditions are filled in, tap to set thresholds for your medical measured Next and manually entered parameters. Thresholds are preset to default values that affect notifications. Before changing thresholds, consult your physician. Figure 5-11.
  • Page 28 Drag the handles or type values to set the upper and lower thresholds (tapping Restore default returns to the app default values). to save the change and continue to the next medical parameter. Save After all medical conditions are filled, and your thresholds are set, tap to proceed to the Next next step...

  • Page 29: Step 5: Setting Preferences And Terms

    5.3.5 Step 5: Setting 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 30: Step 6: Pairing The Watch

    5.3.6 Step 6: Pairing the Watch The watch and the smartphone must be paired to work together. Once paired, they can only work with each other. This operation needs to be performed only once. Unpairing the watch and the app can be done from the setting menu in the app (see instructions in section Changing your Watch ID) and only then by tapping Reset watch...
  • Page 31 Your smartphone searches for Bluetooth transmitting devices in its range and displays the list of watches it found. Figure 5-15. Choose watch When found, tap next to your watch’s serial number. Pair If your watch is not on the list, tap for the phone to continue searching Refresh list for additional devices.
  • Page 32 After successfully paired, a message is displayed on the app. Figure 5-17. Watch paired with the smartphone Figure 5-18. 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.

  • Page 33: Mobile App Screen

    Mobile App Screen The CS3 Mobile app screen includes a menu icon (see section 6.3.2) and two screen tabs. Figure 5-19. Main screen (Dashboard tab) • tab –displays notifications, the measured Pulse Rate, or manually Dashboard entered medical information from external devices Pulse Rate(see details in section 6.3.1).

  • Page 34: Wearing The Watch

    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.

  • Page 35: Replacing The Watch Strap

    Replacing the Watch Strap If the strap connected to the CS Watch 3 is too short, replace the strap with the longer strap provided with the CS System 3 (see item 4 Figure 4-1). To remove the strap: 1. Turn the watch over to see its back side.
  • Page 36 Gently push or pull the strap to hear a click and ensure the strap is firmly connected to the watch.

  • Page 37: Using The Cs System 3

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

  • Page 38: Pulse Rate

    6.1.2 Physical Activity Physical Activity is tracked automatically in real time by CS System 3. The CS Watch 3 displays the number of steps taken and the number of calories burned. All physical activity measurements are reset every night at midnight.

  • Page 39: Factory Reset

    6.1.4 Factory Reset Swiping to the Factory reset screen displays a button. Confirmation Figure 6-5. Factory reset Pressing the check sign erases the internal memory of the watch and deletes the pairing data with the app. It does not revert the watch firmware to its factory or previous version.
  • Page 40 Figure 6-8. ECG measurement...

  • Page 41: Application Screen

    Application Screen When opening the CS3 Mobile app, the Main screen appears. There is no need to log Figure 6-9. Main screen (dashboard tab) 6.3.1 Dashboard Tab The Dashboard tab is the application's main screen. The screen displays real-time measured physical activity, Notifications (if any), the real-time measured Pulse Rate, and other measured or manually inserted medical parameters.

  • Page 42: Main Menu

    6.3.2 Main Menu Tap the menu icon in the upper left corner of the screen to open a list of available menu options. Figure 6-3. Menu Note To access My profile you must log into the application (explained in Chapter 9, Changing your Account Information).
  • Page 43 • Settings – allows changes to application-related settings such as the app interface language and measuring units. (For details, see Chapter 9, Changing your Account Information.) Figure 6-5. Settings • Monthly report – used for requesting a 30-day history report from a selected date (see details in section 8.2).

  • Page 44: Detected And Measured Data

    Detected and Measured Data The Dashboard tab displays notifications and medical parameters. 6.4.1 Notifications When A-fib is detected, or 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 6-6.
  • Page 45 To manually add a value: 1. Open the CS3 Mobile app to the Dashboard tab. 2. Tap the “+” symbol located in the lower-right corner of the relevant field. A window for updating the values appears. Figure 6-8. Updating external measured values Type in the measurement value or use the arrows to change the values.

  • Page 46: 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 notification When the watch PPG sensor detects an A-Fib condition, the CS Watch 3 displays an AF notification, followed by an instruction screen to Place your fingers on the ECG sensors The app displays the Real-time Data tab with the same instruction.

  • Page 47: Ecg Measurement

    ECG Measurement ECG measurements are saved as Event Reports and can be shared with medical personnel or anyone of your choice. A sample of an event report is shown in section 8.1. Note The ECG measurement may take up to 5 minutes. Sit in an upright position and avoid moving while performing the ECG measurement.
  • Page 48 Figure 7-5. ECG measurement (with a report) 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 “...
  • Page 49  If A-Fib was detected, the following watch and app screens are displayed. Figure 7-8. ECG complete message (A-Fib detected) Caution Do not use the device to diagnose medical-related conditions. All interpretations should be reviewed by a medical professional for clinical decision-making The measured data is saved on the smartphone (for Pro subscribers, the report is also uploaded to the CS3 Cloud app).

  • Page 50: Non-Successful Ecg Measurement

    Figure 7-10. Leaving without sharing the report 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 7-4. ECG measurement failed The data is not saved, and no report is generated.

  • Page 51: Event And Monthly Reports

    Event and Monthly Reports Event Reports Event reports are saved as PDF files in the /CardiacSense folder under the device’s internal storage root folder: • Android base smartphone: My files > Internal storage > Android > data > com.cardiacsense > files > CardiacSense •...

  • Page 52: Monthly Reports

    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 53 Figure 8-3. Selected date for the monthly report to confirm the date and have CS System 3 send the monthly report to your Send request email. A report is generated and sent to your email. Figure 8-4. Confirmation a monthly report is generated...

  • Page 54: Changing Your Account Information

    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 3 settings that require a password. To view or change your account information, you must log into your account with your email address and password.
  • Page 55 Figure 9-2. Account submenus...

  • Page 56: Changing Your Watch Id

    Changing your Watch ID Both the CS Watch 3 and the CS System 3 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 removed from the app and the new watch must be paired.

  • Page 57: Changing Your Personal Information

    Changing your Personal Information 1. From the My profile menu, select Personal information Figure 9-4. Personal information screen 2. Tap any field you wish to change (except your email address and country of residence). Enter the desired change. 3. When done, tap to return to the My profile screen.

  • Page 58: Changing The Thresholds

    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 to return to Save My profile...

  • Page 59: Changing Your Account Password

    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 9-7. Changing account password 3.

  • Page 60: Resetting Your Password

    Login Forgot your password? Figure 9-9. 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 “...
  • Page 61 5. Create a new password (observing Password policy rules), confirm your password, and click Save...

  • Page 62: Changing Your Consent Forms

    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.

  • Page 63: Changing The Application Language

    Changing the Application Language To change the application language: 4. Tap Menu > Settings. 5. Select Language 6. Choose your preferred language from the preset list (see section 5.3 for reference). 7. Tap Save Changing the Units To change the application units of measurement: 8.

  • Page 64: The Cs3 Cloud Application

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

  • Page 65: Troubleshooting And Maintenance

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

  • Page 66: Troubleshooting The Cs3 Mobile Application

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

  • Page 67: 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 68: Updating The Watch Firmware

    Figure 11-3. Updating watch firmware 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 is updated the next time the application is launched and there is an internet connection.

  • Page 69: Storing The Watch

    If necessary, lightly dampen the cloth with fresh water. 11.6 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.

  • Page 70: Specifications

    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 71: Operational And Storage Environment

    12.3.2 Operational and Storage Environment Atmospheric pressure 700 – 1060 hPa IP rating (per IEC 60529) Watch - IP67 Cradle - IP22 Operating Temperature +5ºC to +50ºC Storage Temperature -15ºC to +60ºC Relative humidity range 15% to 90%, non-condensing Note: If the device have been stored or transported within the temperatures exceeding the specified operational temperatures, let the device reach its intended operational temperatures 12.3.3 PPG...

  • Page 72: 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 FCC Radio Frequency Interference Statement...

  • Page 73: Declaration - Electromagnetic Emissions

    Electromagnetic environment – guidance RF emissions CISPR 11 Group1 Class B CS System 3 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.

  • Page 74: Declaration - Electromagnetic Immunity

    270° and 315° approval commercial or hospital supply input lines environment. If the 0% UT; 1 cycle and 70% user of the CS System 3 IEC 61000-4-11 UT; 25/30 cycles requires continued Single phase at 0° 0% UT; operation...

  • Page 75: Recommended Separation Distances

    Essential Performance 12.5 The essential performance of CS System 3 is defined as the ability of the System to continuously measure beat-by-beat heart rate and Pulse Rate and to detect the presence of atrial fibrillation lasting at least 5 minutes within the defined performance rates.

  • Page 76: 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 essential...

  • Page 77: Labels And Symbols

    12.7 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 78: Appendices

    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. A-Fib is an independent risk factor for stroke and thromboembolism that cause mortality.

Table of Contents