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Troubleshooting
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.
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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 ............32 6.1 Watch Display ................32 6.1.1 Pulse Rate ..................33 6.1.2 Settings .................... 33 6.1.3 Factory Rest ..................34 6.2 Continuous Monitoring ..............34 6.3 Application Screen ................ 35 6.3.1 Dashboard Tab ................. 35 6.3.2...
- Page 5 11.1.2 Troubleshooting the CS3 Mobile application ........60 11.1.3 Troubleshooting the Cradle .............. 60 11.2 Resetting the Watch to Factory Settings ........61 11.3 Updating the Watch Firmware ............62 11.4 Upgrading the Application ............. 62 11.5 Cleaning the Watch and the Cradle ..........62 11.6 Storing the Watch .................
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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: 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 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 anyone 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
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... -
Page 14: 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... -
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 Create new account 4. Tap...
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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...
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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 and personalize reports with your ID number. 1. Type in your first and last name. - Page 22 Figure 5-9. Setting the PDF password Note If a personal PDF password is not set, the application sets a default Next password. To continue without creating a password, tap Change password 5. Tap to create a personal PDF password. The password must be a 6-digit password. Password Save.
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Page 23: 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 24 Setting thresholds is required for triggering notifications. Figure 5-12. Setting thresholds Note The medical parameters have default thresholds. To continue without Next changing the default thresholds, tap The thresholds can later be updated (see section 9.3). 4. Tap the medical parameter to set its threshold. 5.
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Page 25: 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 5-13. Preferences and terms 1. -
Page 26: Step 5: Pairing The Watch
5.3.5 Step 5: 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. Removing the watch from the app can be triggered from the app (see instructions in section 9.10) or by resetting the watch to factory settings (described in section 11.2). - Page 27 Your smartphone searches for Bluetooth transmitting devices in its range and displays the list of watches it found. Figure 5-16. Choose watch next to your watch’s serial number. Pair 4. When found, tap Refresh list If your watch is not on the list, tap for the phone to continue searching for additional devices.
- Page 28 After successfully paired, a message is displayed on the app. Figure 5-18. Watch paired with the smartphone Finish setup 6. Tap The watch displays the correct date and time (identical to those on your smartphone) and starts monitoring. Figure 5-19. Watch paired with a smartphone Note To save battery power, the display automatically turns off after 3 seconds.
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Page 29: Mobile App Screen
5.4 Mobile App Screen The CS3 Mobile app screen includes a menu icon (see section 6.3.4) and three screen tabs. Figure 5-20. Main screen (Dashboard tab) • tab – displays Notifications, the measured Pulse Rate, and Dashboard measured or manually entered medical parameters measured externally (see details in section 6.3.1). -
Page 30: Wearing The Watch
5.5 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 31: Replacing The Watch Strap
5.6 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 32: 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. 6.1 Watch Display The default watch display shows the time, date (month and day), watch battery status, and Bluetooth status. -
Page 33: Pulse Rate
6.1.1 Pulse Rate Swiping right from the main screen displays a screen showing the real-time measurements of your pulse rate. Figure 6-2. Pulse rate 6.1.2 Settings Swiping to the settings screen displays the CS Watch 3 serial number. Below is a sliding switch for going from Bluetooth mode to Airplane mode, which disconnects the watch from the CS3 Mobile app. -
Page 34: Factory Rest
6.1.3 Factory Rest Reset watch Swiping to the Factory reset screen displays a button. Figure 6-4. Factory reset Pressing Reset watch 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 35: Application Screen
6.3 Application Screen When opening the CS3 Mobile app, the Main screen appears. There is no need to log in. Figure 6-7. Main screen (dashboard tab) 6.3.1 Dashboard Tab The Dashboard tab is the application's main screen. The screen displays Notifications (if any), the real-time measured Pulse Rate, and other measured or manually inserted medical parameters. -
Page 36: Annotations Tab
6.3.3 Annotations Tab The annotations tab enables the user to report momentary feelings and other selected occurrences, which are then added to the reports (see chapter 8). Figure 6-8. Annotations tab To add an annotation: 1. Tap an annotation that describes how you feel. A pop-up message appears, letting you know your feeling has been reported. -
Page 37: Main Menu
6.3.4 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 6-10. Menu Note Entering My profile and Settings requires logging into the application and are explained in Chapter 9, Changing your Account Information. •... - Page 38 • 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 6-14), opens this user manual, and enables viewing the privacy policy on the CardiacSense website.
- Page 39 Figure 6-14. Watch icons and meaning...
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Page 40: Detected And Measured Data
6.4 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 6-15. - Page 41 To manually add a value: 1. Open the CS3 Mobile app in the Dashboard tab. 2. Tap the “+” symbol of the relevant field. A window for updating the values appears. Figure 6-17. Updating external measured values 3. Type in the measurement value or use the arrows to change the values. Update 4.
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Page 42: 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 Place your displays an AF notification, followed by an instruction screen to fingers on the ECG sensors... -
Page 43: Ecg Measurement
7.1 ECG Measurement ECG measurements are saved as password protected Event Reports and can be shared with medical personnel or anyone of your choice. For details on the PDF report password, see sections 5.3.2 and 9.8. A sample of an event report is shown in section 8.1. Note The ECG measurement may take up to 5 minutes. - Page 44 At the end of a complete ECG measurement, the app displays the message “ ”. Generating report… You may remove your fingers Figure 7-5. ECG measurement ended 2. Remove your fingers from the ECG sensors. If A-Fib was not detected, the following watch and app screens are displayed.
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Page 45: Non-Successful Ecg Measurement
Figure 7-9. Leaving without sharing the report 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 for sending the report. -
Page 46: 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: • My files > Internal storage > Android > data > Android base smartphone: com.cardiacsense > files > CardiacSense •... -
Page 47: 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 48 Figure 8-4. Selected date for the monthly report Send request 4. Tap to confirm the date and have CS System 3 send the monthly report to your email. A report is generated and sent to your email. Figure 8-5. Confirmation a monthly report is generated 5.
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Page 49: 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 50: Changing Your Personal Information
9.1 Changing your Personal Information Menu > My profile 1. Tap and log into your account. Personal information 2. Select Figure 9-3. Personal information screen 3. Tap any field you wish to change (except your email address and country of residence). Save 4. -
Page 51: Changing The Thresholds
9.3 Changing the Thresholds Menu > My profile 1. Tap and log into your account. Thresholds 2. Select Figure 9-5. Thresholds screen 3. Modify the upper and lower pulse rate thresholds. Save My profile 4. When done, tap to return to... -
Page 52: 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: Menu >... -
Page 53: Changing The Application Language
9.5 Changing the Application Language To change the application language: Menu > Settings 1. Tap and log into your account. Language 2. Select 3. Choose your preferred language from the preset list (see section 5.3 for reference). Save 4. Tap 9.6 Changing the Units To change the application units of measurement: Menu >... -
Page 54: 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: Menu > Settings 1. Tap and log into your account. Account Password 2. Select Change Password 3. -
Page 55: Changing The Pdf Report Password
Save your old passwords. Previously created reports can only be opened with the old password assigned to them. Save the old password and move previously created reports from the CardiacSense folder (saved in your smartphone's internal storage root folder) to a different location. To change the report password: Menu >... -
Page 56: Resetting Your Password
Forgot your password? 2. In the Figure 9-10. Resetting account password 3. In the next screen, type your email address (used by CardiacSense to Send send you a link for resetting your password) and tap 4. Go to your inbox, open the mail with “... -
Page 57: Removing The Watch From Your Account
9.10 Removing the Watch from your Account Both the watch and the app have a unique ID, and once paired, they can only work with each other. Before replacing your watch or smartphone with a new one, the old watch needs to be removed from the app. Resetting the Watch to Factory Settings (see section 11.2) also removes the watch from the app. -
Page 58: 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 59: Troubleshooting And Maintenance
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 60: 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 Services and/or... -
Page 61: 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 62: 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 63: 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 64: Operational And Storage Environment
12.3.2 Operational and Storage Environment 700 – 1060 hPa Atmospheric pressure 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 65: 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 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. -
Page 66: Declaration - Electromagnetic Emissions
Compliance 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. Harmonic emissions... -
Page 67: 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 68: 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 69: Compliance
The app will not run if unauthorized software change is detected by integrity checks Data privacy CardiacSense is GDPR-compliant. IEC 60601-1-2:2014 Ed. 4 - Medical electrical equipment - EMC requirements Part 1-2: General requirements for basic safety and... -
Page 70: 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 71: 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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