CardiacSense CS System 3 User manual

CS System 3
Instructions for Use

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© 2021 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.
CS-DC0031A Version 1.0
Date of issue: May 2021
CardiacSense Ltd.
6 Leshem St.,
Northern Industrial Park
Caesarea
3079868
Israel
T: [phone] | Support: [phone]
M: [email protected]
www.cardiacsense.com
Authorized Representative in the EU
MedNet EC-REP GmbH
Borkstrasse 10, Münster 48163,
Germany
2797

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Table of Contents
About this User Manual ............................................................... 6
1 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
2 Intended Use .......................................................................... 8
2.1 Indications for Use ........................................................................... 8
2.2 Intended Users ................................................................................ 8
2.3 Contraindications ............................................................................. 8
2.4 Adverse Events ................................................................................ 8
3 Safety ..................................................................................... 9
3.1 Data Privacy .................................................................................... 9
3.2 Warnings and Cautions ................................................................. 10
3.2.1 Warnings ............................................................................................ 10
3.2.2 Cautions ............................................................................................. 11
4 Know your CS System 3 ..................................................... 12
4.1 Package Contents ......................................................................... 12
4.1.1 CS Watch 3 ........................................................................................ 13
4.1.2 Charging Cradle ................................................................................. 13
4.2 Charging the Watch ....................................................................... 14
4.3 Turning the Watch ON and OFF .................................................... 15
5 Preparing the CS System 3 ................................................ 16
5.1 Charging the CS Watch 3 .............................................................. 16
5.2 Installing the CS3 Mobile App ........................................................ 16
5.3 Setting up your Account ................................................................. 16
5.3.1 Step 1: Sign In .................................................................................... 19
5.3.2 Step 2: Personal Information .............................................................. 21
5.3.3 Step 3: Medical Information ................................................................ 22
5.3.4 Step 4: Preferences and Terms ......................................................... 24
5.3.5 Step 5: Connecting the Watch ............................................................ 25
5.4 Mobile App Screen ........................................................................ 28
5.5 Wearing the Watch ........................................................................ 28

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6 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 .......................................................................................... 33
7 Performing an ECG Measurement ..................................... 36
7.1 ECG Measurement with Report ..................................................... 37
7.1.1 Non-Successful ECG Measurement .................................................. 40
7.2 ECG Measurement Without Report ............................................... 41
8 Event and Monthly Reports ................................................ 42
8.1 Event Reports ................................................................................ 42
8.2 Monthly Reports ............................................................................. 43
9 Changing your Account Information ................................. 45
9.1 Changing your Personal Information ............................................. 46
9.2 Changing your Medical Information ............................................... 46
9.3 Changing the Thresholds ............................................................... 47
9.4 Changing your Consent Forms ...................................................... 48
9.5 Changing the Application Language .............................................. 49
9.6 Changing the Units ........................................................................ 49
9.7 Changing your Account Password ................................................. 50
9.8 Changing the Report Password ..................................................... 51
9.9 Resetting your Password ............................................................... 52
9.10 Unlinking the Watch from your Account ......................................... 53
10 The CS3 Cloud Application ................................................ 54
11 Troubleshooting and Maintenance .................................... 55
11.1 Troubleshooting ............................................................................. 55
11.1.1 Troubleshooting the CS Watch 3 ....................................................... 55
11.1.2 Troubleshooting the CS3 Mobile Application ..................................... 56
11.1.3 Troubleshooting the Cradle ................................................................ 56
11.2 Resetting the Watch to Factory Settings ....................................... 57
11.3 Updating the Watch Firmware ....................................................... 57

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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 ..................................................................... 59
12.3.2 Operational and Storage Environment ............................................... 60
12.3.3 PPG .................................................................................................... 60
12.3.4 ECG .................................................................................................... 60
12.4 Electromagnetic Emissions ............................................................ 61
12.4.1 Declaration – electromagnetic emissions ........................................... 61
12.4.2 Declaration – electromagnetic immunity ............................................ 62
12.4.3 Recommended Separation Distances ................................................ 63
12.5 Compliance .................................................................................... 64
12.6 Labels and Symbols ...................................................................... 65
13 Appendices .......................................................................... 66
Medical Terms ................................................................... 66