User Manual - Cardio-Jenic

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Safety Summary . . . . . . . . . . . . . . . . . . . . . . . . . . 4

General Overview . . . . . . . . . . . . . . . . . . . . . . . 15

MyoVista Operations . . . . . . . . . . . . . . . . . . . . . 28

Patient Testing . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . 99

Service, Maintenance and Cleaning . . . . . . 103

MyoVista® Wavelet ECG (wavECG™) 12-Lead Cardiac Testing Device

User ManualSoftware Version 2 .0

Hardware Version 002

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USER MANUAL DO-LBL-06035(L) | MyoVista® Wavelet ECG (wavECG™) 12-Lead Cardiac Testing Device

NOTICE: YOU HAVE PURCHASED THE MYOVISTA PRODUCT EXCLUSIVE OF THE SOFTWARE THAT IS INCLUDED INTERNAL TO THE PRODUCT OR IS OTHERWISE SUPPLIED FOR USE WITH THE PRODUCT, AND ANY DATA INCLUDED THEREWITH . THAT SOFTWARE AND DATA IS OWNED BY HEARTSCIENCES, USA, AND IS LICENSED TO YOU . A COPY OF THE END USER LICENSE AGREEMENT (EULA) AT THE DATE OF THIS DOCUMENT IS SET OUT IN APPENDIX F OF THIS USER MANUAL . THE EULA MAY BE UPDATED FROM TIME TO TIME AND YOU SHOULD REFER TO THE HOME SCREEN OF THE MYOVISTA DEVICE FOR THE EULA ASSOCIATED WITH YOUR VERSION OF THE SOFTWARE (YOUR EULA) . YOU SHOULD READ AND UNDERSTAND YOUR EULA WHICH BINDS YOU CONTRACTUALLY . IF YOU DO NOT AGREE WITH YOUR EULA DO NOT OPERATE THE PRODUCT .

THE DOCUMENTS AND RELATED GRAPHICS MAY INCLUDE TECHNICAL INACCURACIES OR TYPOGRAPHICAL ERRORS . PERIODICALLY, CHANGES ARE ADDED TO THE INFORMATION HEREIN . HEARTSCIENCES, AND/OR ITS RESPECTIVE SUPPLIERS MAY MAKE IMPROVEMENTS AND/OR CHANGES IN PRODUCT(S) AND/OR PROGRAM(S) DESCRIBED HEREIN AT ANY TIME .

THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION OF HEARTSCIENCES AND ITS RECEIPT AND POSSESSION DOES NOT CONVEY ANY RIGHTS TO REPRODUCE, DISCLOSE ITS CONTENTS,

OR MANUFACTURE, USE, OR SELL ANYTHING IT MAY DESCRIBE OR REPRESENT . REPRODUCTION, DISCLOSURE, OR USE OF ANY SUCH INFORMATION WITHOUT SPECIFIC LICENSE OR WRITTEN AUTHORIZATION IS STRICTLY FORBIDDEN . THE PUBLICATION OF THIS DOCUMENT BY ANATEL IN BRASIL IS PERMITTED WHEN REQUIRED BY ANATEL .

HEARTSCIENCES, AND/OR ITS RESPECTIVE SUPPLIERS MAKE NO REPRESENTATIONS ABOUT THE SUITABILITY OF THE INFORMATION CONTAINED IN THIS DOCUMENT AND RELATED GRAPHICS PUBLISHED . ALL SUCH DOCUMENTS AND RELATED GRAPHICS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND . HEARTSCIENCES AND/OR ITS RESPECTIVE SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, INCLUDING ALL WARRANTIES AND CONDITIONS OF MERCHANTABILITY, WHETHER EXPRESS, IMPLIED OR STATUTORY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT . IN NO EVENT SHALL HEARTSCIENCES, AND/OR ITS RESPECTIVE SUPPLIERS BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA, OR PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE, OR OTHER TORTIOUS ACTION ARISING OUT OF, OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE INFORMATION CONTAINED IN ALL SUCH DOCUMENTS .

All Copyrights © are owned by HeartSciences . All rights are reserved . No part of this publication may be retransmitted or reproduced in any way, including but not limited to photocopy, photograph, magnetic, or other record, without prior agreement and written consent of HeartSciences . The publication of this document by Anatel in Brasil is permitted when required by Anatel .

MyoVista is a trademark of HeartSciences . All trade names are the property of their respective owners .

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Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .viii Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .viii Typographic Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Contacting HeartSciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ix Electronic Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ix

1 . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Prescription Device Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Patient Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Patient Condition and History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2 . Safety Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Safety Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Symbols Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Device Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Device Label Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Serial Number Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Medical Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3 . General Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 MyoVista wavECG Device Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Conventional 12-Lead ECG Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

iv


Glasgow Interpretative Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 MyoVista wavECG Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 MyoVista Energy Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 MyoVista Summary Statement and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 MyoVista Wavelet Analysis, Algorithms and Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Repolarization Measures Algorithm Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Ischemic or Structural Risk Assessment Statement (if applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 MyoVista Ventricular Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Ventricular Indices Statements (if applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 MyoVista Energy Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Right Side with Patient Cable Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Left Side with USB Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4 . MyoVista Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Unpacking the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Setting up the MyoVista Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

System Setup and Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Setting Up the MyoVista Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Initial Software Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Built-In Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Using the Built-in Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Monitoring the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Maximizing the Battery Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

5 . Patient Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36 Patient Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Patient Condition and History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Attaching Electrodes to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Electrode Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

v


Connecting Leads to Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Common Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Patient Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Displaying the Patient Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Adding a New Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Selecting a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Searching for a Patient Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Scanning a Patient ID via Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Editing Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Deleting a Patient Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Displaying the Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Test Screen Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Setting Test Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Running a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Re-syncing the Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Report Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Displaying the Report Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Report Screen Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Printing a Patient Test Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Selecting Pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Report Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Exporting a Test Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Deleting a Test Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

6 . Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63 Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Displaying the Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Identifying the Current Software and Firmware Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Settings Screen Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Configuring System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Changing the Date/Time Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Updating System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Restoring Device to Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Restoring/Updating Device Reference Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

vi


Configuring Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Network Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Connecting to a Wired Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Connecting to a Wireless Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Setting Up a Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Database Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Viewing the Current Database Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Deleting a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Backing Up a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Restoring a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Configuring Auto-Standby Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Configuring Network Drives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Configuring Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Settings Migration Assistant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Export Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Import Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Export Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 EMR Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 LCD Brightness Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 ECG Filter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Configuring Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 ECG Trace Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Entering or Modifying the Clinic Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Configuring a Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Configuring the Patient Unit of Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Add User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Edit User Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

7 . Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99 Troubleshooting Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

8 . Service, Maintenance & Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Service & Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Maintenance Items to Remember . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

vii


Patient Cable Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 LCD Screen Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Periodic Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Seasonal Safety Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Annual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Appendix A . Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 MyoVista wavECG Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 MyoVista Center Post Electrode Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 ECG Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Data Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Potential Issues with Network-Based Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Potential Issues with Network Storage (Mapped Network Drive(s)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 EMC Declaration Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Electronic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Appendix B Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Appendix C VESA Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Appendix D Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Appendix E MyoVista wavECG Analysis, Algorithms and Statements . . . . . . 117

Appendix F End User License Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Appendix G Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

viii


PrefaceHeartSciences’ MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device (MyoVista Device) is a 12-lead resting electrocardiograph (ECG) device . It uses continuous wavelet transform (CWT) signal processing to provide new energy related information (MyoVista wavECG Information) in addition to conventional ECG voltage-based information . In addition to the wavECG Information, the MyoVista Device also features the capabilities of a full featured 12-lead resting ECG including analysis using the Glasgow Algorithm, one of the world’s most respected interpretive algorithms . The device has a 15 .6-inch high-resolution touchscreen display and incorporates many easy and intuitive to use features commonly associated with a tablet device .

This User Manual describes how to set up, operate, maintain, clean, and troubleshoot the MyoVista Device . It includes technical specifications and error messages . An authorized representative should provide initial installation and training .

Audience

The MyoVista Device is intended for trained medical professionals who use, maintain, clean, and troubleshoot the system . All are expected to have a working knowledge of medical procedures and terminology required for evaluating cardiac patients .

MyoVista wavECG Information and the Glasgow Interpretive Analysis are intended to be used with other relevant patient information and interpreted by a physician .

Document ConventionsIn this User Manual HeartSciences’ MyoVista Wavelet ECG (wavECG) Cardiac Testing Device is also referred to as MyoVista Device, MyoVista wavECG Device, or device and wavECG is used as a precursor to information, measures, analysis, or results primarily derived using wavelet signal processing .

The following additional conventions are used in the User Manual .

Convention Meaning Description

Note Notes emphasize or supplement important points of the main text .

Tip Tips provide helpful information, guidelines, or suggestions for performing tasks more effectively .

Typographic Conventions

Convention Description

Bold Indicates software screen elements including button and icon names, tabs, field names, dialog box titles, etc . Also used for emphasis .

Italics Indicates document titles .

• Bullets Indicate a list .

ix


IMPORTANTAll should read this User Manual carefully before using the medical device .

Contact HeartSciences immediately for any safety concerns .

Contacting HeartSciencesContact HeartSciences product support directly with inquiries and comments: support@heartsciences .com

Electronic ManualThis document sets out original instructions from the manufacturer .

To print this manual completely or in part, download the desired PDF files, which can be found on the USB storage media provided within MyoVista ship container . Follow standard print procedures .

Note: The User Manual cannot be printed directly from the MyoVista Device.

We suggest you print a single page first . You may need to set the printer to Print TrueType Fonts as Bitmaps (or Graphics) if the character spacing requires correction .

1 . Introduction This chapter introduces the MyoVista® wavECG Device

TopicsIntended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Prescription Device Statement . . . . . . . . . . . . . . . . . . . . . . 2 Patient Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Patient Condition and History . . . . . . . . . . . . . . . . . . . . . . . 3

2


Introduction

Intended Use The MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device (MyoVista Device) is a 12-lead resting electrocardiograph with conventional interpretive analysis of the ECG waveform and MyoVista wavelet signal processed information .

The MyoVista wavelet signal processed information is intended to be used as an aid in diagnosis by means of analysis of the ECG waveform in the frequency domain .

Indications for Use• The MyoVista Device is indicated for use on adult populations (18 years and older), by trained

operators in health facilities as one of the tools used to evaluate and diagnose patient cardiac function .

• The device is used to acquire, analyze, display, and print conventional 12-Lead ECG information and provides interpretive analysis and calculations of the QRS, P, and T-wave .

• MyoVista wavelet signal processed information is used to identify patients at risk for LV diastolic dysfunction as an indicator of heart disease, which may require further anatomical testing .

The interpretations offered by the device are significant only when reviewed by a licensed trained medical professional and considered in conjunction with all other relevant patient clinical information .

ContraindicationsThe MyoVista Device is not indicated for the following uses:

• As a sole means of diagnosis .

• As a vital signs physiological monitor .

• To provide alarms for arrhythmia detection .

• For people whose skin is irritated by electrodes with silver and silver chloride or by the electrode adhesive .

• For pediatric patients and infants .

Prescription Device Statement Caution: U.S. Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner. This device is not FDA cleared.

Non U .S . regional or local laws may restrict the sale of this device to, by, or on the order of a licensed healthcare practitioner .

3


Introduction

Patient Recommendations The following patient factors may affect the accuracy of the MyoVista Device results and should be considered by the medical professional when interpreting test results:

• Caffeine consumption within 2 hours prior to testing .1

• Smoking or using Nicotine replacement therapy .2, 3

• Significant alcohol consumption on the previous day .4

• Phlebotomy within 20 minutes prior to testing .5

• Patients who are not in a horizontal position with a resting heart rate during testing .5

• Patient movement during testing .5

Patient Condition and History Certain medications can affect test results . Examples include medications taken for heart disease, hypertension, diabetes (including beta-blockers), digitalis, dobutamine, amildarone, and narcotics . Prior to testing, review the patient’s history of health issues and medications .

1 Silvio Buscemi, Alessandro Mattina, Maria Rosaria Tranchina, Salvatore Verga, “Acute Effects of Coffee on QT Interval in Healthy Subjects”, Nutr J . 2011; 10: 15 . Published online 2011 Feb 2 . doi: 10 .1186/1475-2891-10-15 PMCID: PMC30381452 Gepner AD, Piper ME, Leal MA, Asthana A, Fiore MC, Baker TB, et al . (2013) “Electrocardiographic Changes Associated with Smoking and Smoking Cessation: Outcomes from a Randomized Controlled Trial” . PLoS ONE 8(4): e62311 . https://doi .org/10 .1371/journal .pone .00623113 Ramakrishnan S, Bhatt K, Dubey AK, et al, “Acute electrocardiographic changes during smoking: an observational study”, BMJ Open 2013;3:e002486 . doi: 10 .1136/bmjopen-2012-0024864 Ryan, J M and L G Howes . “Relations between alcohol consumption, heart rate, and heart rate variability in men”, Heart (British Cardiac Society) vol . 88,6 (2002): 641-2 .5 Dekie, L ., “High Quality ECG Recording Assurance”, Applied Clinical Trials, July 13, 2017 .

Note: Ignoring the provided safety information and intended use is considered misuse of the MyoVista Device and could result in harm to the patient, operator, medical facility, or device .

2 . Safety SummaryThis chapter provides information about the safe use and regulatory compliance of the MyoVista wavECG Device . You should be familiar with this information and understand all instructions before using the device .

Topics

Safety Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . 5

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Symbols Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Device Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Medical Device Classification . . . . . . . . . . . . . . . . . . . . . . . 14

5


Safety Conventions Convention Meaning Description

Caution

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in minor injury, harm to the patient or operator, or damage to property or the device .

Warning Warnings indicate a potential hazard or unsafe practice, which, if not avoided, could result in death or serious injury .

General Warnings and CautionsWarningsGeneral Warnings in this User Manual are listed below and displayed with the following Warning symbol .

Warning: Operators must read and understand the following safety-related information before operating the MyoVista Device .

Warning: This is a Class A product . In a domestic environment, this product may cause radio interference, in which case the user may be required to take adequate measures .

Warning: Operators must read and understand the INTENDED USE, INDICATIONS FOR USE, and CONTRAINDICATIONS .

Warning: This device may ONLY be used by trained operators under the direct supervision of a licensed healthcare practitioner .

Warning: DANGER OF ELECTRIC SHOCK . Do not open the device case . Only personnel authorized by the manufacturer may service the device, open the enclosure, or open the battery compartment .

Warning: DANGER OF ELECTRIC SHOCK . THERE ARE NO USER-SERVICEABLE PARTS IN THIS DEVICE . The battery is not user-serviceable .

Warning: DANGER OF ELECTRIC SHOCK . Do not operate the device if the power adapter is damaged or suspected of being damaged .

Warning: DANGER OF ELECTRIC SHOCK . Do not attempt to repair or alter the device . It can result in unpredictable operation and risk to the patient .

Warning: The device, accessories, and packaging have safety labels . Operators must be able to recognize them and understand their meaning (see “Symbols and Icons” on page 9) .

Warning: Only cables and electrodes provided by HeartSciences are to be used with the MyoVista device . Do not use electrodes or cables that have not been approved .

Warning: Do not use electrodes if the backing has been removed or damaged .

Warning: Do not reuse electrodes . The electrodes approved for this device are for single use only . Using electrodes more than once may lead to inaccurate test results .

Safety Summary

6


Warning: Never put any cable other than the power adapter into a wall receptacle .

Warning: Never use the device in the presence of flammable vapors or gases .

Warning: Do not use the device beyond the safe limits of environmental conditions of temperature and humidity (see “Environmental Specifications” on page 108) .

Warning: Do not allow liquids to enter the device . Do not have liquids or drinks near the device . An accidental spill of liquid on the device can create a hazard of electric shock or damage to the device . If liquid does get into the device, contact an authorized technician before use .

Warning: MyoVista Information and Glasgow Interpretative Analysis must be interpreted by a licensed healthcare practitioner .

CautionsGeneral Cautions in this User Manual are listed below and displayed with the following Caution symbol .

Caution: Always confirm the patient’s identification and the information displayed before starting a test .

Caution: When using the VESA mount interface on the back panel, be careful to check the adequacy of the surface (for example, the cart, wall, or shelf) to which the device will be attached . The VESA mount and surface should be able to support 8 kg (17 .6 lbs) .

Caution: When setting up, be careful to place the device in a stable location, away from the edge of tables or carts . Avoid entangling the cables with the patient or the operator .

Caution: Do not attempt to reposition the device by pulling the cables . Be careful not to cause the device to fall by attempting to pull the device by the cables . Always ensure all cables are positioned properly to avoid damage .

Caution: Patient cable must be inserted properly into the device, with the screws secured tightly to ensure signal capture .

Caution: The device should be plugged into a grounded outlet with surge protection .

Caution: The device and cables should be cleaned regularly according to instructions .

Caution: Periodically check the battery performance, and have the battery replaced or serviced by an authorized technician if necessary . For instructions about monitoring the battery, see “Using the Built-In Battery” on page 34 .

Caution: Do not use the device beyond its intended lifetime, which is 7 years from the manufacturing date .

Safety Summary

7


Caution: Improper placement of electrodes, patient cable, and leads can provide improper results . Ensure that correct electrode placement protocol is followed .

Caution: Always use new electrodes from an unopened pouch .

Caution: Do not store or use the device in the presence of strong magnetic fields or ionizing radiation .

Caution: Do not store or use the device next to instruments that generate strong vibration .

Caution: The patient must be at rest and not moving (other than normal breathing) during the test .

Caution: Always check the quality of the ECG waveforms to ensure the patient connections and the device have been set up properly before starting the test .

Caution: If poor electrical grounding exists in the clinic, or if a noisy power source is being used, the device should operate ONLY on battery power when running a test, using the AC power ONLY to maintain battery charging or non-test use .

Caution: At the end of its service life, the device and its accessories must be disposed of in compliance with the local governmental guidelines regulating the disposal of medical devices .

Caution: When the low battery warning is displayed, the user should complete their work and then recharge the device .

Caution: Leaving the device battery fully depleted (0% charge) for a prolonged time may render the battery nonrecoverable and the device unusable until the battery is replaced (see page 34) .

Electrical SafetyLeakage Current: The patient connection interface complies with safety standards for medical device leakage current levels .

Ensure that the AC power voltage complies with the device requirement .

The power adapter/cord is to be used for disconnecting the device from the electric/mains power source .

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012

Safety Summary

8


Safety Summary

Patient SafetyThe MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device (MyoVista Device) meets the essential requirements of the European Medical Device Directive for General Product Safety and complies with the applicable U .S ., Canadian and other medical safety standards where the MyoVista Device is registered to be sold .

The design of the equipment, accompanying documentation, and labeling on the equipment take into consideration that the purchase and use of the MyoVista Device are restricted to trained operators .

This User Manual excludes warnings of various hazards that are obvious to a medical professional and operator of this equipment, consequences of product misuse, and potentially adverse effects in patients with abnormal conditions .

Warning: Do not use the device beyond the safe limits of environmental conditions of temperature and humidity (see “Environmental Specifications” on page 108) .

Warning: Magnetic field: If this device is used in the presence of magnetic resonance imaging (MRI), the picture resolution of the MRI may be affected . This environment might also interfere with the operation of the device .

Caution: RF interference: The device conforms to ANSI/AAMI/EN/IEC 60601-2-25:2011; however, avoid environments with high levels of RF noise .

Caution: Other interference: The presence of an electrocautery device, infrared energy, or defibrillator may impact the operation of this device .

Note: Electromagnetic interference: This device conforms to ANSI/AAMI/EN/IEC 60601-2-25:2011 .

Note: Biocompatibility: All materials that are subject to user or patient contact are of the type commonly used in a clinical environment .

9


Safety Summary

Symbols GlossarySymbols are used to convey warnings, cautions, prohibitions, mandatory actions, or information . Familiarity with these symbols assists in the safe and proper use and disposal of the equipment .

Table 2-1 describes the symbols and icons that might appear on the device or its packaging . Not all of the symbols in the table apply to a particular device or its packaging . The table includes (but is not limited to) standard symbols defined in ISO 15223-1:2016 “Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements” and/or IEC TIR 60878:2015 “Graphical symbols for electrical equipment in medical practice”, and/or IEC 60417:2002 DB “Graphical symbols for use on equipment”

• Colored symbols indicate there might be a danger, warning, or mandatory action .

• Black symbols provide additional information or might indicate a caution .

Table 2-1 . Symbols and Icons on the Device and Its Packaging

Symbol/Icon Description

Manufacturer (might be accompanied by manufacturer name and address)

ISO 15223-1:2016 - 5 .1 .1

Date of manufacture

ISO 15223-1:2016 - 5 .1 .3

Caution (consult accompanying documents)

ISO 15223-1:2016 - 5 .4 .4

Consult Instructions for Use (User Manual)

ISO 15223-1:2016 - 5 .4 .3

Alternating current

IEC TIR 60878:2015 - 5032

Direct current

IEC TIR 60878:2015 - 5031

Kensington security slot

Universal Serial Bus (USB) interface

10


Safety Summary

Network interface

IEC 60417:2002 - 5988

Use by date

ISO 15223-1:2016 – 5 .1 .4

Temperature limit (indicates both upper and lower limits by upper and lower horizontal lines)

ISO 15223-1:2016 – 5 .3 .7

Keep dry

ISO 15223-1:2016 – 5 .3 .4

Device is running on AC power and/or charging

Device is running on DC power; charge level is indicated by battery icon filling and % charge indicator

Device is connected to a wired network

Device is connected to a wireless (Wi-Fi) network

Standby icon; LED is illuminated when device is in standby mode . LED also indicates power source and charge level .

Center negative symbol . Indicates output plug (tip) center is Negative (-) and output plug barrel (ring) is Positive (+) .

IEC 60417:2002 - 5926

Symbol for electrical and electronics devices marking for Directive 2012/19/EU . Device, accessories, and packaging waste must be disposed of properly at end of usage . Local disposal ordinances and regulations must be followed .

Defibrillation-proof Type CF Applied Part

IEC TIR 60878:2015 - 5336

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Safety Summary

Keep away from sunlight ISO 15223-1:2016 – 5 .3 .2

Do not reuse (single use only)

ISO 15223-1:2016 – 5 .4 .2

European Community authorized representative

ISO 15223-1:2016 – 5 .1 .2

Serial number

ISO 15223-1:2016 – 5 .1 .7

Catalog number ISO 15223-1:2016 – 5 .1 .6

Meets FCC requirements

USA only: for use by or on the order of a physician

Conforms with applicable EU directives

Contains silver/silver chloride

Latex free - Not made with natural rubber latex

12


Safety Summary

LabelingTable 2-2 . Shows the labels on the device or its packaging . Not all of the labels in the table apply to your particular device or its packaging . The appearance of the labels in this table may vary slightly from the actual appearance of the physical labels on the device and/or on the device packaging .

Table 2-2 . Labels on the Device and Its Packaging

Label Location Description

Rear of DeviceIdentifies symbols, ports, and connectors . See “Symbols” on page 9 .

Bottom of device

Identifies the ETL classification number and conformance to applicable 60601-based safety standards

Battery compartment

Identifies that the unit is not serviceable by user . The battery is not a user-serviceable part . For all servicing needs, contact HeartSciences or an authorized representative .

Bottom of deviceUniquely identifies this unit . See “Device Identification” on page 13 .

Electrode pouch Identifies directions for use of electrodes

13


Safety Summary

Device IdentificationEvery MyoVista Device has a product label that identifies the manufacturer information, device name, part number, and unique serial number . This information is required when contacting an authorized representative . This label is in conformance with all Unique Device Identification standards (78 FR 58785) .

Device Label FormatThe device label legend in Figure 2-1 and Table 2-3 describes the label component .

Figure 2-1. Device Label

Table 2-3 . Device Label Component Descriptions

Symbol Description

A Manufacturer

B Country of origin

C UDI bar code

D Device serial number

E Device part number

F Date of manufacture in YYYY-MM-DD format

Serial Number FormatEach device has a serial number that uniquely identifies the device and provides important information about the device . The serial number format is shown in the following figure .

Model # Prefix

W = factory designation for place of manufacturing (Winona, MN)

yy = year of manufacturing

#### = unit number (00001-99999)

ww = week of manufacturing

DG-200 Wyyww####

ABF

E

D

C

14


Safety Summary

TrainingThis User Manual provides information about patient setup, performing a test, interpreting the results, and using the software . It is intended as a supplement to, not a substitute for, thorough product training .

Medical Device ClassificationThe device is classified as follows per ANSI/AAMI/EN/IEC 60601-1:2005/(R)2012 .

Category Classification

Protection against electric shock Class I externally powered ME equipment . Internally powered ME equipment .

Degree of protection against electrical shock Defibrillation-Proof Type CF Applied Part .

Protection against harmful ingress of water or particulate matter

The device is classified IP00 (non-protected) for harmful ingress of particulate matter and water .

Methods of sterilization N/A

Suitability for use in an oxygen-rich environment The device is not suitable for use in the presence of flammable vapors or gases .

Mode of operation Continuous operation

3 . General OverviewThis chapter describes the features and capabilities of the MyoVista wavECG Device . It also provides an overview of system elements including MyoVista wavECG Information .

Topics

Conventional 12-Lead ECG Waveform . . . . . . . . . . . . . . . 16 Glasgow Interpretive Analysis . . . . . . . . . . . . . . . . . . . . . . 16 MyoVista wavECG Information . . . . . . . . . . . . . . . . . . . . . . 17 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

16


General Overview

MyoVista wavECG Device Development The MyoVista wavECG Information is developed by HeartSciences . The technology was developed in response to a substantial amount of recent research linking most forms of heart disease with diastolic dysfunction . It is based on years of research by HeartSciences . It provides analysis of ECG information using frequency domain information obtained using wavelet signal processing in addition to conventional ECG information . It can be used to assist in determining patient risk for relaxation abnormalities associated with left ventricular diastolic dysfunction (LVDD) . The MyoVista wavECG Device extensively uses age and sex-based criteria . The quote below describes the relationship between heart disease and diastolic dysfunction and underlines the importance of understanding patient risk related to diastolic dysfunction . The article was published in American Heart Association’s Circulation publication .LV diastolic dysfunction and Prognosis AHA Circulation 2012 Feb 14; 125(6): 743–745. Dalane W. Kitzman, MD and William C. Little, MD

“It is remarkable that serial evaluation of LV diastolic function could be such a powerful predictor of all-cause mortality, not just cardiovascular death….…normal LV diastolic function requires normal function and integration of left ventricular ejection, relaxation, and structure and is an active energy requiring process. Thus, diastolic performance is sensitive to nearly all of the common pathological processes that affect cardiovascular function.”

The MyoVista wavECG Device was developed to include conventional ECG data and MyoVista wavECG Information and Analysis .

Conventional 12-Lead ECG WaveformThe MyoVista Device provides conventional 12-lead ECG waveforms . These waveforms represent the overall direction and magnitude of the heart’s electrical potential during the cardiac cycle by measuring depolarization and repolarization over time from 12 different directions . The waveform is a graph representing voltage versus time . The sampling rate is 500 samples per second .

Glasgow Interpretative AnalysisThe Glasgow Interpretive Analysis software provides an interpretation of the conventional resting 12-lead ECG . It can recognize and report ECG abnormalities such as myocardial infarction, acute myocardial infarction, ventricular hypertrophy, ST-T abnormalities, and other common abnormalities of rhythm . Defects in electrical conduction and other anomalies are also reported .

HeartSciences has validated the implementation of the Glasgow library code within the MyoVista Software application using the Glasgow 1000 ECG validation database and has confirmed the MyoVista Code fully operates in accordance with the Glasgow reference software .

To verify that the Glasgow algorithm library on the MyoVista Device works as expected, the records of Glasgow 1000 ECG Validation Database have been processed as inputs to the MyoVista Device containing the Glasgow Analysis program, which produced the analysis results to match the results provided by Glasgow Royal Infirmary .

Note: Glasgow results are independent of MyoVista wavECG Information results. Reference VAL-10007 for HeartSciences MyoVista Statement of Validation and Accuracy of Glasgow 12- Lead ECG Analysis Program.

17


General Overview

MyoVista wavECG InformationThe MyoVista wavECG Information is designed to provide information related to myocardial energy that may be used by a physician as part of an overall risk assessment to assist in determining if a patient should be receive further clinical testing, evaluation and/or treatment .

HeartSciences recommends using the MyoVista wavECG Information in conjunction with other health-related patient clinical information to determine the appropriate clinical pathway and treatment options for each patient .

The MyoVista Device uses continuous wavelet transform mathematics to display and analyze the myocardial energy detected during the cardiac cycle, with particular emphasis on repolarization (see figure 3-0) . The information is provided in five forms:

A . MyoVista Energy Waveform

B . MyoVista Summary Statement and Indicators

C . MyoVista Wavelet Analysis, Algorithms and Statements

D . MyoVista Ventricular Indices

E . MyoVista Energy Classification

Figure 3-0. MyoVista Device Display Screen

The following section provides a high-level overview of MyoVista wavECG Information .

Note: The MyoVista Wavelet Analysis is independent of Glasgow Interpretive Analysis findings.

The MyoVista Energy Waveform (see “A” on Figure 3-0) is displayed as a scalogram representing the energy distribution pattern of the heart’s electrical activity during the test period on a lead-by-lead basis . This visual representation is provided to give context for the remainder of the wavelet measures and statements provided by the MyoVista Device .

The MyoVista Summary Statement and Indicators (see “B” on Figure 3-0) provide an overall summary of all the wavECG Analysis . The statement categorizes the overall wavECG Analysis results as either “Normal”, “Borderline”, or “Abnormal” and is displayed in text as well as in a color-coded icon .

A

BCDE

18


General Overview

The MyoVista Wavelet Analysis, Algorithms and Statements (see “C” on Figure 3-0) provide theresults of the wavECG Analysis (with inputs from the MyoVista Energy Classification and MyoVistaVentricular Indices, as well as other conventional measures such as T-Axis, sex, and age) and providestatements that can be used to assist in determining the relative-risk of a patient having relaxation abnormalities associated with LV diastolic dysfunction that may require further clinical testing, evaluation and/or treatment .

The MyoVista Ventricular Indices (see “D” on Figure 3-0) represent the relative energy values of the left and right ventricles at specific time points during repolarization (just prior to and after the T-Wave peak) . The indices are displayed as a percentage of energy in relation to the peak energy detected during the cardiac cycle (usually close to or at an R-Wave peak) . There are four Index values provided, as well as numeric comparisons (differences and ratios) for these four measurements

The MyoVista Energy Classification (see “E” on Figure 3-0) provides an overall indication (i .e . aggregation of information from all 12 leads) of relative energy levels detected during the test period and reports this information in a simplified categorization of either “High”, “Moderate” or “Low” .

Detailed information on the MyoVista wavECG Information is described below.

MyoVista Energy WaveformFigure 3-1 . Shows an example of the MyoVista Energy Waveform after signal processing, using Continuous wavelet transform and its relationship to the QRST (Q, R, S, and T-waves) complex .

Figure 3-1. MyoVista Energy Waveform

The color scaling provides a non-linear mapping of energy from 0 to 100% which represents the relative level of energy detected from the heart at each point in time and frequency . Blue represents low energy, red represents high energy, and intermediate energy levels are shown according to the red, blue, green (RGB) color scale above (see the scale key on the left side of Figure 3-1) . The colors represent a distribution of energy detected during the cardiac cycle rather than providing absolute values . The horizontal axis (x-axis) is time and the vertical axis (y-axis) is frequency . The frequencies range from 3 Hz at the bottom of the display to 200 Hz at the top using a non-linear scale .

This visual representation is provided to give context for the remainder of the wavelet measures and statements provided by the MyoVista Device .

MyoVista Summary Statement and IndicatorsThe MyoVista Summary Statement and Indicators have a sensitivity of 74 .3% and a specificity of 72 .9% for the detection of myocardial relaxation abnormalities associated with Left Ventricular diastolic dysfunction (LVDD) based on the overall statistical performance of the Repolarization Measures Algorithm .

Note: See Appendix E- MyoVista wavECG Analysis, Algorithms and Statistical Performance.

19


General Overview

The MyoVista Summary Statement and Indicators provide an overall summary of all the wavECG Analysis . The statement categorizes the overall wavECG Analysis results as either “Normal”, “Borderline”, or “Abnormal” and is displayed in text as well as in a color-coded icon (see Figures 3-2, 3-3, 3-4) .

The summary represents the overall wavECG Analysis results as performed by the software algorithms . MyoVista version 2 .0 software contains algorithms which perform analysis relating to the following:

• Repolarization Measures Algorithm (relaxation abnormalities associated with LV diastolic dysfunction)

Note: Future software releases may be expanded with additional algorithms for enhanced detection of heart disease.

For patients which are not identified by the MyoVista Device as having a significantly elevated risk of relaxation abnormalities associated with LV diastolic dysfunction, a classification of “Normal” is displayed (see Figure 3-2) . This occurs when no abnormalities associated with MyoVista Measures, Analysis and Algorithms are identified .

Note: This is not a “rule-out” measure, but rather a measure representing a lower risk of relaxation abnormalities associated with LV diastolic dysfunction when compared to clinical study patients whose categorizations are “Borderline” or “Abnormal” (as well as comparing against the overall clinical study population).

Figure 3-2

For patients which are identified by the MyoVista Device as having an elevated risk of relaxation abnormalities associated with LV diastolic dysfunction (or where a risk assessment is inconclusive), a categorization of “Borderline” is displayed (see Figure 3-3) . In this case, additional statements explaining the summary categorization will be provided, which include a Repolarization Measures Statement and Ischemic or Structural risk assessment statement and may also include Ventricular Indices Statement(s), if applicable . The relative-risk measure for “Borderline” patients when compared to patients with a “Normal” wavECG is provided in Table 3-1 (see page 21) .

Figure 3-3

20


For patients which are identified by the MyoVista Device as having significantly elevated risk of relaxation abnormalities associated with LV diastolic dysfunction, a categorization of “Abnormal” is displayed (see Figure 3-4) . In this case, additional statements explaining the summary classification will be provided, which include a Repolarization Measures Statement and Ischemic or Structural Risk Assessment Statement and may also include Ventricular Indices Statement(s), if applicable . The relative-risk measure for “Abnormal” patients when compared to patients with a “Normal” result is provided in Table 3-1 (see page 21) .

Figure 3-4

MyoVista Wavelet Analysis, Algorithms and StatementsThe MyoVista Wavelet Analysis, Algorithms and Statements provide the results of the Wavelet Analysis (with inputs from the MyoVista Energy Classification and MyoVista Ventricular Indices, as well as other conventional measures such as T-Axis, sex, and age) and provides statements that can be used to assist in determining the relative-risk of a patient having a relaxation abnormalities associated with LV diastolic dysfunction that may require further clinical testing, evaluation and/or treatment . These statements were developed using clinical study data .

The MyoVista Wavelet Analysis Statements section of the report includes the following types of informational statements (see Figure 3-5):

• Repolarization Measures Algorithm Statement (if applicable – see “A” on Figure 3-5)• Ischemic or Structural risk assessment statement (if applicable – see “B” on Figure 3-5)• Ventricular Indices Statements (if applicable – see “C” on Figure 3-5)

Figure 3-5

General Overview

A CB

21


General Overview

Repolarization Measures Algorithm StatementThe Repolarization Measures Algorithm Statement is optimized to correlate to relaxation abnormalities associated with LV diastolic dysfunction and provide the results of applying a series of criteria using clinical study data . This criteria includes wavECG Measures such as the MyoVista Energy Classification and the MyoVista Ventricular Indices, and also incorporates conventional ECG measures such as T-Axis and demographic information such as age and sex .

The Repolarization Measures Algorithm Statement has three categories: “Normal”, “Borderline” and “Abnormal” .

Table 3-1 . Provides the relative-risk measures for the Repolarization Measures Algorithm Statement .

Example: Clinical studies show that patients with and without cardiac relaxation abnormalities can exist across the entire range of results for the MyoVista Repolarization Algorithm . However, women whose MyoVista Repolarization Measures Algorithm Statement is “Abnormal” are over 170% more likely to have relaxation abnormalities associated with LV diastolic dysfunction when compared to those whose MyoVista Repolarization Measures Algorithm Statement is “Normal” .

The relative-risk calculations have been generated using clinical study data from a validation dataset that was independent from the development dataset (see Appendix E) .

Table 3-1

MyoVista Repolarization Measures Algorithm Statement Sex Relative-Risk

Borderline Repolarization Measure(compared to Categorization

of “Normal”)

Men >4 .0X

Women 2 .0X

Abnormal Repolarization Measure(compared to Categorization

of “Normal”)

Men >5 .0X

Women

2 .7XFor example a patient in this category would

have a greater than 170% higher risk than patients with a categorization of “Normal” .

Ischemic or Structural Risk Assessment Statement (if applicable)If the Repolarization Measures Algorithm Statement is either “Borderline” or “Abnormal”, then an Ischemic or Structural Risk assessment statement will also be displayed below the Repolarization Measures Statement (see Figure 3-5) .

If the Repolarization Measures Algorithm Statement is classified as “Abnormal”, then the statement “Probable Ischemic or Structural Abnormality” is displayed .

If the Repolarization Measures Algorithm Statement is classified as “Borderline”, then additional calculations are applied within the software to further stratify risk, and one of two additional statements will be displayed: “Possible Ischemic or Structural Abnormality” or “Inconclusive Ischemic or Structural Risk Assessment” . Some of the borderline classifications have low statistical significance and in these cases the “Inconclusive Ischemic or Structural Risk Assessment” statement is displayed . The statistical strength of the analysis for these patients was insufficient due to low incidence in the clinical data . This should occur in less than 5% of all patients tested .

22


General Overview

Table 3-2 . Summarizes the relative-risk calculation related to the Ischemic or Structural Risk Assessment Statements .

Table 3-2

Ischemic or Structural Risk Assessment Statement Sex Relative-Risk

Inconclusive Ischemic or Structural Risk Assessment

Men Criteria resulted in statistically insufficient measures.Women

Possible Ischemic or Structural Abnormality

(compared to Categorization of “Normal”)

Men 4 .8X

Women 1 .6X

Probable Ischemic or Structural Abnormality

(compared to Categorization of “Normal”)

Men >5 .0X

Women 2 .7X

MyoVista Ventricular Indices The MyoVista Ventricular Indices represent the relative energy values of the left and right ventricles at specific time points during repolarization (just prior to and after the T-Wave peak) . The indices are displayed as a percentage of energy in relation to the peak energy detected during the cardiac cycle (usually close to or at an R-Wave peak) . There are four Index values provided, as well as numeric comparisons (differences and ratios) for these four measurements . The right ventricle indices are an average of V1 and V2 leads, and the left ventricle indices are an average of V4, V5, and V6 leads .

Figure 3-6 shows an example of a MyoVista Ventricular Indices table .

Table 3-3 defines each cell in the table, including the numeric comparisons (differences and ratios) for these four index measurements .

Figure 3-6. MyoVista Ventricular Repolarization Index Table

Table 3-3

Index Description

VIEM (RV) Ventricular Indices Early Measure (Right Ventricle)

VILM (RV) Ventricular Indices Late Measure (Right Ventricle)

VIEM (LV) Ventricular Indices Early Measure (Left Ventricle)

VILM (LV) Ventricular Indices Late Measure (Left Ventricle)

Diff The difference between the values in the column . This calculation is provided for user convenience .

Ratio The ratio between the values in the row . This calculation is provided for user convenience .

23


General Overview

Ventricular Indices Statements (if applicable)These indices (and numeric comparisons) have ranges which demonstrate an elevated risk of relaxation abnormalities associated with LV diastolic dysfunction .

If any of the criteria for elevated risk related to the MyoVista Ventricular Indices specified are met, then a statement listed in Table 3-4 will be displayed below the Repolarization Measures Algorithm Statement (see Figure 3-7) .

Figure 3-7

Table 3-4 . Provides the relative-risk calculations for a patient having relaxation abnormalities associated with LV diastolic dysfunction

Table 3-4

Sex Rule MyoVista Wavelet Analysis Statement

Relative- Risk

Men and Women VIEM(RV) < 20 Abnormal VIEM(RV) < 20% 1 .4X

Men and Women VILM(RV) < 17 Abnormal VILM(RV) < 17% 1 .3X

Women VIEM(LV) < 22 Abnormal VIEM(LV) < 22% 1 .5X

Women VILM(LV) < 21 Abnormal VILM(LV) < 21% 1 .5X

Women [VIEM(RV) / VIEM(LV)] > 2 .5 Abnormal VIEM Ratio > 2 .5 1 .5X

Women [VILM(RV) / VILM(LV)] > 2 .5 Abnormal VILM Ratio > 2 .5 1 .5X

Women [VIEM(RV) – VILM(RV)] < 0 .4 Borderline RV VIEM-VILM difference < 0 .4 1 .1X

Women [VIEM(RV) – VILM(RV)] > 4 .5 Borderline RV VIEM-VILM difference > 4 .5 1 .4X

Men [VIEM(RV) – VILM(RV)] > 5 .3 Borderline RV VIEM-VILM difference > 5 .3 1 .4X

24


MyoVista Energy Classification The MyoVista Energy Classification (see “E” on Figure 3-0) provides an overall indication (i .e . aggregation of information from all 12 leads) of relative energy levels detected during the test period and reports this information in a simplified category of either “High”, “Moderate” or “Low” (see Figure 3-8) .

The overall calculation performs a complex set of transformations as well as applying a variety of heuristic rules to formulate a final classification of “High”, “Moderate” or “Low” . The MyoVista Energy Classifications primarily use wavECG Measures, but also make adjustments for other factors such as sex and age . The MyoVista Energy Classification is disease non-specific and for information only .

Figure 3-8

General Overview

25


General Overview

System OverviewThis section provides an overview of the MyoVista Device panels and controls .

Front Panel

Figure 3-9. MyoVista Device Front Panel

Table 3-7 . Front Panel Legend

Callout Description

A Touchscreen LCD display

B Home button

C Patient button

D Test button

E Report button

F Standby button and LED

B C D E F

A

26


General Overview

Rear Panel

Figure 3-10. MyoVista Device Rear Panel

Table 3-8 . Rear Panel Legend

Callout Description

A Kensington security slot

B HDMI port

C Two USB ports

D Ethernet port

E Power adapter connector

F Power Switch

G Adjustable stand

Note: A USB storage media uniquely identifies storage media inserted into the top port named as USB1 and the bottom port named as USB2. Only FAT32 and NTFS file formats are supported on USB storage devices.

B C D E F

G

A

27


General Overview

Right Side with Patient Cable PortFigure 3-11 . Shows the right side of the device . Callout A identifies the 15-pin patient cable port .

Figure 3-11. Right Side of the MyoVista Device

Table 3-12 . Right Panel Legend

Callout Description

A 15-pin patient cable port

Left Side with USB PortsFigure 3-9 . Shows the left side of the device . Callouts A and B identify the two USB ports for connecting a USB storage media or peripheral device

Note: A USB storage media inserted into one of the side ports in Figure 3-12 will be shown as follows: port A USB3 and port B USB4.

Figure 3-12. Left Side of the MyoVista Device

Table 3-10 . Left Panel Legend

Callout Description

A USB3 port

B USB4 port

A

A B

4 . MyoVista Operations

This chapter describes the operations you can perform using the MyoVista wavECG Device .

Topics

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 System Setup and Operation . . . . . . . . . . . . . . . . . . . . . . . 30 Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

29


MyoVista Operations

Getting StartedUnpacking the DeviceCarefully unpack the device and make sure that all items listed in “Package Contents” below are included in the package .

All package contents should be visually inspected for damage prior to installation and use .

Caution: Electrode pouches that have been previously opened or damaged should not be used and should be disposed of properly.

Package Contents

Catalog Number Description

MV-DEVICE-1-EA MyoVista Cardiac Testing Device

MV-PWRSU-1-EA-18V48W Power supply, 18VDC, 48W

MV-PWRCO-1-EA-XXXX* Power cord (XXXXX will be indicated in the number with the voltage and the type of plug)

MV-CABLE-1-EA-AHA ** MyoVista Patient Cable 10 leads AHA***

MV-CABLE-1-EA-IEC ** MyoVista Patient Cable 10 leads IEC***

MV-USBLT-1-EA USB Drive w/ Product Literature

MV-ELTRD-25-BX Electrodes, Box of 25 packs (10 ea . per pack)

MV-CBLMGT-09-001 Cable Management Kit

DO-LBL-06111 Quick Start Instructions Insert (MV-USBLT-1-EA will be attached to this insert .)

* Power cord configurations and ratings vary by geographic location . Reference the MyoVista Product Catalog for details .

** Indicates one or the other is included .

*** AHA patient cables are primarily for use in USA and Canada, and may be used in other countries per localized standards . IEC patient cables are primarily for use in EU and in other countries outside the EU, per localized standards

Setting Up the MyoVista Device Setup by an authorized representative is preferred . Installation instructions for the MyoVista Device are provided in “Setting Up the MyoVista Device” on page 30 .

30


MyoVista Operations

System Setup and OperationSetting Up the MyoVista Device

Warning: DANGER OF ELECTRIC SHOCK. Do not operate the device if the power adapter is damaged or suspected of being damaged.

Note: If using the optional VESA mount interface, see Appendix C for VESA mounting instructions.

Tip: For the best viewing experience and to avoid glare, use the recommended minimum viewing angle of 30 degrees.

To set up the MyoVista Device:

1 . Attach the supplied power adapter to the supplied power cord .

2 . Connect the power adapter to the receptacle on the device, as shown in Figure 4-1 .

3 . Plug the power cord into an AC outlet .

4 . Use Power Switch to power on device and begin charge process .

5 . Allow battery to charge for 8 hours or until screen indicator shows 100% before initial use . Device must be plugged in and turned on in order to charge .

Note: To avoid personal injury, store the power cable properly when not in use. The power cord might pose a tripping hazard or result in the device falling and breaking if pulled.

Note: For battery charge instruction, please reference the package insert (DO-LBL-06111)

Warning: AVOID ELECTRICAL SHOCK. This device must be connected only to an AC outlet with protective grounding.

Figure 4-1. Connecting the Power Adapter

(See Table 3-10 for Rear Panel Legend)

Callout Description

A Power Adapter

A

31


MyoVista Operations

6 . Connect the 15-pin patient cable into the patient cable port, as shown in Figure 4-2 and the following figures .

Figure 4-2. Connecting the Patient Cable

Table 4-1 . Right Panel Legend

Callout Description

A 15-pin patient cable port

6a . Align the MyoVista Patient Cable with the 15-pin port on the side of the MyoVista Device .

Ensure the orientation of the cable snout, pins, and shroud matches the orientation of the receiving port on the MyoVista Device .

Insert the MyoVista Patient Cable into the 15-pin port on the side of the MyoVista Device . If it does not plug in easily, check the orientation of the connector on the cable and the MyoVista Device . Forcing the connector may damage the cable or device . DO NOT BEND CONNECTOR PINS .

6b . Tighten the MyoVista Patient Cable thumb screws securely into the device . Do not over tighten .

A

32


MyoVista Operations

Initial Software ConfigurationInitial device configuration and software setup by an authorized representative are highly recommended . The initial configuration of the device must include the following steps, which are performed from the Settings screen:

1 . Configure the language to the applicable setting for the user’s geographic location (page 94) .

2 . Configure the date and time to the applicable settings for the user’s geographic location (page 67) .

3 . Configure the ECG settings for the appropriate AC power frequency for the user’s geography (page 90) .

Note: Before use, configure the Test Length and Filter settings. It is recommended that you find the electric utility/mains frequency of your country/region and set filters appropriately. For example, North America users should set the Frequency Interface to 60 Hz, while users in Europe should set the Frequency Interface to 50 Hz.

Note: For convenience in setting up multiple devices with settings for a given geographic location, please refer to section 6 (or page 84) for instructions on using the “Settings Migration Assistant” feature.

Caution: Myoelectricity Noise Filters - The MyoVista Device provides “muscle noise filtering” capability that reduces higher frequency content to reduce or eliminate muscle noise produced by patients under certain conditions. The selectable bandpass noise filters are designed to attenuate frequencies above the selected frequency. While these filter settings have little to no impact on the conventional 12-lead ECG recording and the Glasgow Interpretive Analysis, MyoVista wavECG Information are quite sensitive and depend on processing the composite myocyte activity that is present in the ECG signal to reliably perform computations required for MyoVista Information. HeartSciences has determined that for myoelectricity settings of 75Hz or higher, there is no significant impact on MyoVista Informatics. For filter settings at frequencies of 45 Hz or below, the performance of MyoVista Informatics may be degraded and it is possible that a patient’s test results may be affected. When muscle noise is present during patient testing use myoelectricity settings at 100 Hz or 75 Hz. If substantial muscle noise is present and lower filter settings of 45 Hz or below are necessary be aware patient results may be affected. The 50Hz and 60Hz line filters do not impact MyoVista Information or conventional ECG recordings.

Built-In BatteryThe MyoVista Device contains a built-in rechargeable battery . The device can be operated either from the AC power adapter or from the battery . The battery should be fully charged prior to the first use on battery power . Also, note that the battery will provide power for a maximum of one hour . HeartSciences recommends keeping the device plugged into AC power .

Note: The MyoVista Device ships with the screen set at a nominal brightness. Increasing the screen brightness setting will impact battery performance.

Note: The MyoVista Device must be in the power “on” status to receive a charge from AC power.

33


MyoVista Operations

If the device screen is active, an icon in the status bar shows the power source (see Table 4-2) . If the device is in standby mode, an illuminated LED on the Standby button shows the power source and/or battery charge level (see Figure 4-3 and Table 4-3) .

Figure 4-3. Power Source Indicator (Standby Button)

Note: The LED on the Standby button is not illuminated when the screen is on .

Table 4-2 . Status Bar Power Indicator (AC/Battery)

LED Description

Device is operating on AC power and/or is charging

Device is operating on battery power and has sufficient charge to perform a test; battery is fully charged

Device is operating on battery power and has sufficient charge to perform a test; battery is partially charged and should be charged and/or switched to AC power

Device is operating on battery power; battery is close to depletion and must be charged and/or switched to AC power

Table 4-3 . Standby Button Power Indicator

Standby battery status Description

Solid green Device is operating on AC power and/or is charging

Blinking green Device is operating on battery power and has sufficient charge to perform a test

Blinking yellow Device is operating on battery power; battery is close to depletion and must be charged and/or device must switch to AC power

Blinking redDevice is operating on battery power; battery is almost fully depleted . The device should be charged immediately and/or device must switch to AC power before running a test

The built-in battery operates in the following modes:

• Charging or Fully Charged

• Discharging

These modes are indicated by symbols in the status bar or the LED on the Standby button .

34


MyoVista Operations

Using the Built-in BatteryDue to storage and transportation time, the initial battery charge might not be sufficient to power up the device or support a complete patient cycle . In order to provide sufficient charge to the device, all new units should be charged for 8 hours upon receipt . When using the device for the first time, operate the MyoVista Device on AC power only . Before running a test, always confirm that the battery has sufficient power to complete the test .

Caution: Do not store new (unpackaged, unused) devices more than 6 months as the battery may become inoperable if stored past 6 months without being charged.

Note: HeartSciences recommends keeping the device plugged into AC power whenever an AC power outlet is readily available.

Monitoring the BatteryMonitor the battery gauge on the status bar of the device . If the battery begins to deplete at a faster rate than usual, it may be time to replace the battery . Contact an authorized representative for service .

Maximizing the Battery LifeUse: Use device on AC power unless it is being transported or used briefly in a location where an AC power outlet is not readily available .

Not In Use: While not in use, store the device plugged into an AC outlet, with the device turned ON with the display active and the battery charge icon showing the device is charging . Alternatively, after booting up the device to the Home Screen on AC power, leave it plugged into AC power and turn the device OFF . This ensures the device is still receiving power to charge the battery from the AC charger while in the OFF state .

If devices are stored long term, please schedule time to charge devices for at least 8 hours every 6 months .

HeartSciences recommends charging devices to 100% within 30 days of receiving a unit or prior to long term storage .

35


MyoVista Operations

Operating EnvironmentThe MyoVista Device is sensitive . Its ability to detect and process electrical signals from the myocardium depends on preventing noise from interfering with the device’s operation . Pay particular attention to the placement of the device and the surrounding environment .

For accuracy and consistency of test results, observe the following:

• The clinical setting should be away from elevators and high-voltage power supplies .

• Lighting should be sufficient to perform the test processes accurately .

• The power adapter should not share an AC outlet with any other device .

• Avoid placing the MyoVista Device next to any other powered device (see page 113) .

• For optimal performance, do not operate the MyoVista Device close to wireless transmission devices or powered ultrasound equipment .

• The power socket must be grounded .

Note: For hazards related to environmental conditions, see the warnings and cautions in Chapter 2.

Caution: If the clinic has poor electrical grounding, or if a noisy power source is being used, run tests using battery power only and use AC power only to maintain battery charging.

Caution: If this device is used in the presence of magnetic resonance imaging (MRI), the picture resolution of the MRI may be affected. This environment might also interfere with the operation of the device.

5 . Patient Testing This chapter describes how to perform patient testing procedures using the MyoVista wavECG Device .

Topics

Patient Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . 37 Patient Condition and History . . . . . . . . . . . . . . . . . . . . . . 37 Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Connecting Leads to Electrodes . . . . . . . . . . . . . . . . . . . . 41 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Patient Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Report Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

37


Patient Testing

Patient Recommendations The following patient factors may affect the accuracy of the MyoVista Device results and should be considered by the medical professional when interpreting test results:

• Caffeine consumption within 2 hours prior to testing .1

• Smoking or using Nicotine replacement therapy .2, 3

• Significant alcohol consumption on the previous day .4

• Phlebotomy within 20 minutes prior to testing .5

• Patients who are not in a horizontal position with a resting heart rate during testing .5

• Patient movement during testing .5

(1,2,3,4,5See References on Page 3)

Patient Condition and History Certain medications can affect test results . Examples include medications taken for heart disease, hypertension, diabetes (including beta-blockers), digitalis, dobutamine, amildarone, and narcotics . Prior to testing, review the patient’s history of health issues and medications .

Electrode PlacementThe MyoVista electrode placement protocol is aligned with the standard AHA or IEC 12-lead ECG electrode placement protocol .

Lead misplacement can cause misinterpretation of an ECG and result in the wrong diagnosis, delaying or prompting poor treatment recommendations that could be harmful to the patient .

Some of the most common lead placement mistakes are 1) limb lead reversal and 2) Incorrect lead placement . Special attention must be given to placing leads at the correct anatomical landmarks while recognizing other soft tissue considerations . Being able to recognize misplacement errors will help to reduce inaccurate testing results .

Attaching Electrodes to the PatientTo obtain adequate signals, connect electrode connectors and electrodes firmly . For instructions about proper placement of electrodes on the patient, see “Electrode Placement” on page 37 .

Caution: To avoid tension on the electrodes, allow sufficient slack in patient cable.

Caution: Electrodes placed on sites with excessive body hair, prior surgical sites, scars, or over implanted devices may impact test results.

Caution: Clothing or tissue causing improper placement of electrodes may impact test accuracy.

1 . Prepare the skin appropriately for good electrode adhesion and conduction . To ensure optimal electrode adhesion and conductivity, shave excessive body hair .

2 . Peel the electrodes from the protective sheet .3 . Place the electrodes on the skin surface (see “Electrode Placement” on page 38) .

38


Patient Testing

Electrode Placement The following figures show various ECG electrode placement guidance .

Figure 5-1. AHA Diagnostics ECG Electrode Chest and Appendages Placement

Figure 5-2. AHA Diagnostics ECG Electrode

Chest Placement

39


Patient Testing

Figure 5-3. IEC Diagnostics ECG Electrode Chest and Appendages Placement

Figure 5-4. IEC Diagnostics ECG Electrode

Chest Placement

40


Patient Testing

Electrode ColorsTable 5-1 . AHA Electrode Identification

System Electrode ID Color CodeLimb Leads RA - Right Arm White

LA - Left Arm BlackRL - Right Leg GreenLL - Left Leg Red

Precordial Leads V1 = 4th intercostal space to the right of the sternum RedV2 = 4th intercostal space to the left of the sternum YellowV3 = Directly between the leads V2 and V4 GreenV4 = 5th intercostal space to the left of the sternum BlueV5 = Level with V4 at left anterior axillary line OrangeV6 = Level with V5 at left midaxillary line (directly under the midpoint of the armpit)

Violet

Table 5-2 . IEC Electrode Identification

System Electrode ID Color CodeLimb Leads RA - Right Arm Red

LA - Left Arm YellowRL - Right Leg BlackLL - Left Leg Green

Precordial Leads C1 = 4th intercostal space to the right of the sternum RedC2 = 4th intercostal space to the left of the sternum YellowC3 = Directly between the leads V2 and V4 GreenC4 = 5th intercostal space at the midclavicular line BrownC5 = Level with V4 at left anterior axillary line OrangeC6 = Level with V5 at left midaxillary line (directly under the midpoint of the armpit)

Violet

41


Patient Testing

Connecting Leads to ElectrodesUse the following procedure to connect the leads to the electrodes .

1 . To attach the MyoVista Patient Cable to the HeartSciences MyoVista Center Post Electrodes, find the peg on the end of the grabber .

2 . Align the grabber peg with the center hole of the MyoVista Center Post Electrodes .

3 . Squeeze to open the claws of the grabber .

4 . Place the peg in the center post, and then release the grabber . Ensure the connection is secure .

42


Patient Testing

Home ScreenThis section describes the MyoVista Device graphical user interface (GUI) software .

Figure 5-5. Home Screen

Note: Figure 5-5 illustrates the “Home Screen” with User Authentication disabled.

Note: The factory default user is an Administrator role which does not require a password to authenticate.

Table 5-3 . Describes the icons in the right toolbar and the Reference Materials icons with their active links .

Table 5-3 . Home Screen Legend

Icon Icon Name DescriptionHome Returns you to the Home screen from

any other screen .

Patient Opens the patient screen .

Test Opens the Test screen .

Report Opens the Report screen .

Settings Opens the Settings screen .

Standby Places device in Standby mode and turns the screen black . This will also lock the screen when User Authentication is enabled .

MyoVista End User License Agreement

Opens the MyoVista End User License Agreement on the Home screen .

43


Patient Testing

Quick Start Guide Opens the Quick Start Guide on the Home screen .

MyoVista User Manual Opens the MyoVista User Manual on the Home screen .

Electrode Placement (AHA)

Opens the Electrode Placement (AHA) Diagram on the Home screen .

Electrode Placement (IEC)

Opens the Electrode Placement (IEC) Diagram on the Home screen .

Common Icons Table 5-4 . Describes frequently used icons .

Table 5-4 . Common Icons

Icon Description

Saves the current screen information .

Cancels the operation and closes the screen without saving new information .

Closes the screen .

Continues the current operation .

Approves/closes the dialog box and proceeds to next operation .

44


Patient Testing

Keyboard Figure 5-6 . Shows the touchscreen keyboard primary function keys and Table 5-5 describes them .

Note: If you prefer using an external keyboard, connect one to a MyoVista Device USB port.

Figure 5-6. Touchscreen Keyboard

Table 5-5 . Touchscreen Keyboard Legend

Callout Description

1 Backspace Deletion key

2 Enter key

3 Up, Down, Right, Left arrow keys

4 Forward Deletion key

5Shift/Caps Lock key: Select this key one time to activate Shift (only one typed capital character) or two times to activate Caps Lock . All typed characters are capitalized until turned off by selecting the key twice .

6 Number key: Displays numeric keypad and other non-alpha characters .

7 Tab key

45


Patient Testing

Patient ScreenUsing the Patient screen, you can:

• Add a new patient record . See “Adding a New Patient” on page 46 .• Select a patient record . See “Selecting a Patient” on page 48 .• Search for a patient record . See “Searching for a Patient Record” on page 48 .• Scan a patient ID via barcode reader . See “Scanning a Patient ID via Barcode Reader” on page 49 . • Edit a patient record . See “Editing Patient Information” on page 50 .• Delete a patient record . See “Deleting a Patient Record” on page 50 .

Displaying the Patient ScreenTo display the Patient screen (Figure 5-7):

• From the tool bar on the right, select the Patient icon .

OR

• Below the screen, select the Patient hard button .

Note: There may be more patient records than shown on the display. To view additional patient records, swipe vertically to scroll through the patient records list.

Figure 5-7. Patient Screen

46


Patient Testing

Table 5-6 . Describes the icons on the Patient screen .

Table 5-6 . Icons on the Patient Screen

Icon Icon Name Description

New Patient Adds a new patient record . See page 46 .

Edit Patient Edits an existing patient record . See page 50 .

Delete Patient

Deletes a patient record . See page 50 .

Note: This is an administrator-only function if User Authentication is enabled .

Caution: If User Authentication is disabled it is possible to delete patient records.

Patient Search Searches for a patient record based on selected criteria . See page 48 .

Scan Opens barcode scanner prompt dialog . See page 49 .

Adding a New PatientTo add a new patient:

1 . Select the New Patient icon . The New Patient screen appears (Figure 5-8) .

Figure 5-8. New Patient Screen

Caution: A Patient ID cannot be edited once a patient record has been initiated.

Note: Using a Barcode Scanner at any time will display the “New Patient” screen with the ID auto-populated if the patients barcode-scanned ID does not already exist on the MyoVista Device.

47


Patient Testing

2 . Enter the following patient information:

Field DescriptionPatient ID Enter a unique identification number for the patient: numeric, alpha, or alphanumeric . We

recommend you use the patient medical record number MRN . This field is required .

The system prevents you from creating duplicate patient IDs . If you receive a warning dialog, confirm that the data you entered is correct . You can search for the existing record using the Search function (see “Searching for a Patient Record” on page 48) .

First Name Enter the first name of the patient .

Last Name Enter the last name of the patient .

Sex Select the patient’s sex . This field is required . Choices are: • Female • Male

Date of Birth Enter the patient’s date of birth . This field is required .

Age Age of the patient . The software calculates this value automatically .

Height Enter the height of the patient . This field is required . To change between imperial and metric units, go to the Settings screen .

Weight Enter the weight of the patient . This field is required . To change between imperial and metric units, go to the Settings screen .

BSA The software calculates this value automatically . • BSA (based on the Mosteller formula)

• Mosteller formula (imperial customary units): BSA =

• Mosteller formula (metric): BSA =

Notes Enter any medical notes .

Note: Only “Sex” and “Age” are currently used in the MyoVista wavECG calculations. However, additional measures such as “Height”, “Weight”, and “BSA” are captured for each patient allowing for future software updates to utilize this information. The user must enter “Height” and “Weight” for each patient. The MyoVista software calculates BSA and presents it as supplemental information.

48


Patient Testing

3 . Select the Save icon to save the record or select Cancel icon to not save the record .

Figure 5-9. Example of Patient Screen with New Record

Selecting a PatientFrom the Patient screen, you can select a patient record or scroll through the patient database to find a patient record . To select a patient record, press or select anywhere on the patient entry . Note that the newest entered patient details are always at the bottom of the list .

Note: Using a Barcode Scanner at any time will select the patient if a matching patient record exists on the MyoVista Device.

Searching for a Patient RecordTo search for a patient record:

1 . On the Patient screen, select the Patient Search icon . The Search Conditions screen appears (Figure 5-10) .

Figure 5-10. Search Conditions Screen

49


Patient Testing

2 . Enter the appropriate search criteria or scan barcode to search via ID .

3 . Select the Search icon to start searching or select Cancel icon to cancel the search . If you select the Search icon, a patient search results screen shows only the records that meet your search criteria .

4 . To select a patient record, select anywhere on the patient entry . The selected patient appears in the Patient Selected screen (see Figure 5-11) . If no matching patient records are found, the following message appears:

No records found!

5 . Select the OK icon to return to the Patient screen .

Figure 5-11. Patient Selected Screen

Scanning a Patient ID via Barcode ReaderA user may scan a Patient ID barcode (1D or 2D only) from any screen . If the Patient ID is found in the patient database, the device will navigate to the Patient screen and select the scanned patient record . If the Patient ID is not found in the patient database, the device will navigate to the Patient screen and open the Add Patient dialog with the scanned Patient ID .

Optionally, the user may choose to use the Scan button on the Patient screen to open the Barcode Scanner Prompt dialog before using the barcode scanner .

Caution: The user should confirm the patient selection after scanning a barcode and before running a test.

50


Patient Testing

Editing Patient Information

Note: Editing a patient ID cannot be done after saving a patient profile and a test is completed.

To edit patient information:

1 . On the Patient screen, select the record of the patient you want to edit .

2 . Select the Edit Patient icon . The Edit Patient screen appears (Figure 5-12) .

Figure 5-12. Edit Patient Screen

3 . Edit the following: First Name, Last Name, Sex, Date of Birth, Height, Weight, and Notes .

4 . Select the Save icon to save the changes or select Cancel icon to discard them .

Deleting a Patient RecordThe following procedure describes how to delete a patient record .

Note: When you delete a patient record, all the records associated with the patient including test results are removed from the device.

Note: This is an administrator-only function if User Authentication is enabled.

Caution: When User Authentication is disabled, any user can delete a patient.

1 . On the Patient screen, select the record of the patient you want to delete .

2 . Select the Delete Patient icon . The following message appears:

Permanently Delete Patient from Database?

3 . Select the Yes icon to delete the record or select No icon to retain it .

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Patient Testing

Test ScreenUsing the Test screen, you can:

• Set test parameters . See “Setting Test Options” on page 52 .

• Run a test . See “Running a Test” on page 54 .

• Re-synchronize the waveforms . See “Re-syncing the Waveforms” on page 55 .

Note: To access the Test screen, you must first select a patient record. The device prompts you to select a patient before performing a test.

Displaying the Test ScreenTo display the Test screen (Figure 5-13):

• From the screen menu on the right side, select the TEST icon .

OR

• Below the screen, press the Test button .

Figure 5-13. Test Screen

Note: We recommend enabling an A/C line-frequency filter in the Settings screen. Enabling this option may require up to 10 seconds for traces to stabilize.

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Patient Testing

Test Screen IconsTable 5-7 . Describes the icons on the Test screen .

Table 5-7 . Icons on the Test Screen


Test Options Sets the test parameters . See page 52 .

Start Test Starts a test . See page 55 .

Stop Test Stops a test; this icon appears after a test starts . See page 55 .

Test Countdown Displays a countdown timer for test completion .

Re-Sync Re-syncs waveforms . See page 55 .

Re-Sync Countdown Time Shows a countdown timer until waveforms are re-synced .

Setting Test OptionsTo set test parameters:

1 . On the Test screen, select the Test Options Icon . The Test Options screen appears, with the test parameters displayed (Figure 5-14) .

Figure 5-14. Test Options Screen

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Patient Testing

The Gain option affects the vertical scale of the ECG traces . This scale represents the amplitude in millivolts (MV) per division on the grid . For each lead, the Gain setting is displayed to the left of the waveform .

Selecting All from the Lead Gain drop-down menu activates the All Gain option icon to change Gain setting for all leads at once . The default option for the Lead Gain setting is x1 .1 .

1 . Select a Gain setting: x2, x1, x0 .5, or x0 .25 .

Note: Default settings can be reset using the Revert button to reset Report Options as below. Gain – All leads 1x Chart Speed – 25mm/s

2 . Under Test Time Setup, select a test duration: 20s, 30s, or 60s .

3 . If necessary, under Myoelectricity Interface, select an option: 25Hz, 35Hz, 45Hz, 75Hz, 100Hz, or Disable .

Caution: The Myoelectricity Interface filter may impact the test results of the MyoVista wavECG calculations. We do not recommend using a filter for this setting unless absolutely necessary. See Caution on page 32.

4 . Select the Save icon to save the settings for this patient test or select Cancel to discard them .

Note: If a new patient is selected, these settings return to their default values. However, you can use the Settings screen to change the settings and have them become the default for all patient tests.

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Patient Testing

Running a TestBefore running any test:

• Be sure waveforms have been given at least 10 seconds to stabilize from the point when the patient was connected properly to the device .

• Confirm the patient’s name, date and sex .

Caution: Entering a patient’s date of birth and sex correctly is critical to the MyoVista algorithms and must be confirmed as accurate before running the test.

• Be sure there is sufficient battery power to complete test . Greater than 20% remaining battery is recommended .

• Check the adequacy of ECG waveforms prior to running a test . Perform any necessary corrections to resolve any noise or other problems with the input signal .

At any point during testing, the MyoVista Device warns if the cables or electrodes are not connected adequately by displaying lead-off indicators and causing the lead label to blink red to indicate that the respective lead needs attention (see Figure 5-15) .

Figure 5-15. Lead Off

55


Patient Testing

To start a test:

1 . On the Test screen, select the Start Test icon (Figure 5-16) . The test begins, a countdown timer appears, and the Start Test icon changes to Stop Test . When the test completes, the Report screen appears .

Caution: If power is lost or interrupted during testing, discard test results. Do not change power source (i.e., switch from AC to battery), disconnect the power, or power down the device during a test.

Caution: Check for any error messages in MyoVista wavECG Information or Glasgow Analysis Report. If present, attempt to resolve the issue and retest the patient.

Figure 5-16. Test Screen

2 . To stop a test:

a . Press the Stop Test icon . The following message appears:

The test results were not saved. Select the OK icon to continue.

b . Select the OK icon to cancel the test and discard the collected data .

Note: Be sure to put the device in standby mode when testing is complete.

Re-syncing the WaveformsIf you observe a problem or misrepresentation of the data on the screen, re-sync the waveform . Re-syncing the waveforms dissipates DC-bias between the patient and the device, and re-centers the traces in the trace areas .

1 . On the Test screen, select the Re-Sync icon . The Re-Sync icon changes to a countdown timer . When the countdown timer reaches 0, the waveforms are re-synced .

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Patient Testing

Report ScreenUsing the Report screen, you can:

• Print a test report . See “Printing a Patient Test Report” on page 58 .

• Export a test report . See “Exporting a Test Report” on page 61 .

• Delete a test report . See “Deleting a Test Report” on page 62 .

Caution: To ensure accuracy, verify all data on the report, including patient height, weight, and units of measurement.

Caution: There may be as much as 10% trace scaling variance when the report is rendered or printed.

Displaying the Report ScreenThe Report screen appears after a test completes successfully .

To manually navigate to the Report screen:

• From the screen menu on the right side, press the Report icon .

OR

• Below the screen, press the Report hard button .

Note: To access the Report screen, you must first select a patient record. The device prompts you to select a patient before viewing a report.

Note: The primary data source for a patient’s test report is a Portable Document Format (PDF) file or printed report.

The ECG trace and MyoVista Energy Waveforms in reports are interactive . To view:

• Other time segments, scroll through the report by swiping horizontally across the device surface on the appropriate leads data .

• Waveform data from other leads, swipe vertically across the device surface . To change a viewable lead, select the drop-down lead icon on the left side of the waveform .

The drop-down box in the top-right corner allows you to view previous reports from the selected patient . Reports are labeled by date and time (Figure 5-17) .

Use the color scale to the left of the MyoVista Energy Waveform to interpret the energy level . The MyoVista wavECG Analysis appears at the top-right side of the active window . The MyoVista Ventricular Repolarization Index appears below the MyoVista wavECG Analysis . For more information about interpreting the MyoVista Information, see “MyoVista Information” on page 16 . If the Glasgow Analysis report area has off-screen text, swipe in that area to scroll and view the text .

57


Patient Testing

Figure 5-17. Report Screen

Report Screen IconsTable 5-8 . Describes the icons on the Report screen .

Table 5-8 . Icons on the Report screen


Print Prints a patient test report . See page 58 .

Export Report Exports a patient test report . See page 61 .

DeleteDeletes a patient test report . See page 62 .

Note: This is an Administrator-only function if User Authentication is enabled . See User Management .

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Patient Testing

Printing a Patient Test ReportWhen printing a patient test report, observe the following guidelines:

• Before printing, select a direct USB printer or a network-based printer . See “Setting Up a Printer” on page 73 .

• To protect patient privacy, do not print to a shared, unmonitored, or remote printer .

• Do not change power source (i .e ., switch from AC to battery), disconnect power, or power down the device while printing .

• Print quality varies and should be considered when viewing a report . If print quality is poor, use the MyoVista on-screen report or an external high-definition monitor .

To print a patient test report:

1 . Select the Print icon . The Print Preview Settings screen appears .

Figure 5-18. Print Preview Settings Screen

2 . Select Report Options (see page 60) . The Report Settings screen appears .

Note: If you change print settings from this screen, the changes apply to the current report only and are not saved. If you print a new report, reconfigure the print settings for the new report as needed or change the global defaults from the settings screen (see page 64).

3 . Select which pages to print, if desired (see page 59) .

4 . Select the Report Template to print, if desired (see pages 59-60) .

5 . Select the Print icon . When a list of configured printers appears, select the appropriate printer, and then select Print .

The Printing screen and progress bar appear, as shown in Figure 5-20 . If no problems are encountered, the Print Settings screen appears after the device sends the report to the printer . The following message confirms the data was sent to the printer:

Print successful

59


Patient Testing

Selecting PagesThe user can choose selected pages for print and export visually using the Select Pages button and clicking pages to remove them from the print or export . Included pages are indicated by green outlines and printer icons in the lower right corner .

Report TemplatesThe MyoVIsta wavECG Device supports multiple ECG Report templates . The report template default settings are configurable (see “Report Settings” page 59-60) .

1 . Summary Report This first (and factory default) report template is a simple 1-page template containing the information below . The leads included in this report can be set using the Report Settings .

Page-1 Demographics MyoVista wavECG Analysis Glasgow Interpretive Analysis 2-lead traces with MyoVista Energy Waveforms

Note: This report is the first page of all other report templates.

2 . Standard 4x3 Report This report contains the Summary Report as page 1 followed by a traditional 4x3 12-lead trace view with a configurable reference trace .

Section-1 Summary Report Section-2 4x3 12-lead trace

3 . Standard 12x1 Report This report contains the Summary Report as page 1 followed by a traditional 12x1 12-lead trace view .

Section-1 Summary Report Section-2 12x1 12-lead trace

4 . Detailed Report This report contains the Summary Report as page 1 followed by a traditional 4x3 12-lead trace view with a configurable reference trace and then 12-lead traces containing the entire test duration .

Section-1 Summary Report Section-2 4x3 12-lead trace Section-3 12x1 traces (entire test duration)

5 . Detailed Report This report contains the Summary Report as page 1 followed by: a traditional 4x3 12-lead trace view with a configurable reference trace, a 12x1 trace view, 12-lead traces with MyoVista Energy Waveforms for the entire test duration, and the detailed Glasgow Interpretive Analysis measurements .

Section-1 Summary Report Section-2 4x3 12-lead trace Section-3 12x1 traces Section-4 Full 12-lead trace + Energy Waveforms Section-5 Glasgow Interpretive Analysis detailed measurements

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Patient Testing

Report SettingsThe following screen appear when Report Options is selected . (Figure 5-19) .

Figure 5-19. Report Options Screen

The gain option affects the vertical scale of the ECG traces . This scale represents the amplitude in millivolts (MV) per division on the grid . For each lead, the gain setting is displayed to the left of the waveform .

Selecting All from the Lead Gain drop-down menu activates the All Gain option icon, as shown in Figure 5-19 . The default option for the Lead Gain setting is x1 .

1 . Select a Gain setting: x2, x1, x0 .5, or x0 .25 .

2 . Under Chart Speed, select a setting: 5mm/s, 12 .5mm/s, 25mm/s, 50mm/s, or 100mm/s .

Note: Default settings can be reset using the Revert button to reset Report Options as below. Gain – All leads 1x Chart Speed – 25mm/s

3 . Select the Save icon to save the print report settings or select Cancel to discard them .

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Patient Testing

Figure 5-20. Printing Screen with Progress Bar

Exporting a Test ReportThe following procedure describes how to export a test report . This requires either a USB storage device or a mapped network drive .

When using a USB storage device, observe the following guidelines when attaching the USB device to the MyoVista wavECG device:

• The USB storage media must be connected directly to one of the Myovista Device USB ports . The MyoVista Device might not recognize USB devices connected through a USB hub .

• The MyoVista Device accesses only the first supported partition of a USB storage media’s main (root) directory . We recommend you use blank media for all USB functions and avoid using storage media with formatted partitions .

• If multiple USB storage media are connected, select one from the drop-down menu . For information about USB mapping, see “Rear Panel” on page 26 .

• Before you export the test report, confirm that the USB storage media is inserted properly into the MyoVista Device USB port . The MyoVista Device may still recognize and attempt to write to a poorly seated USB drive . DO NOT REMOVE THE USB STORAGE MEDIA DURING THE EXPORT PROCESS . Wait for the export to finish before removing the USB storage media .

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Patient Testing

To export a test report (Figure 5-21):

1 . Select destination storage media (USB or mapped drive) from the Disk drop-down .

2 . The Filename field is populated automatically . However, you can change this value if desired .

Figure 5-21. Export Report Screen

3 . The Template selection is populated automatically (from the Print Preview or Report Settings) . However, you can change the Report Template selected if desired .

4 . The Export File(s) will be set automatically . However, you can change the selected export formats if desired .

Note: The EMR export option is disabled until the device EMR Configuration Settings are set and authenticated successfully.

5 . Select Export . If the Export completes successfully, the following message appears:

Export completed successfully.

Deleting a Test ReportTo delete a test report:

1 . On the Report screen, select the test record to delete .

2 . Select the Delete icon . The following message appears:

Delete the current report?

3 . Select the Yes icon to delete the report or select No icon to cancel .

Note: This is an administrator-only function if User Authentication is enabled. See “User Management” on page 96.

6 . Device Settings This chapter describes how to configure settings and functions using the MyoVista wavECG Device .

Topics

Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Configuring Auto-Standby Settings . . . . . . . . . . . . . . . . . 79 Configuring Network Drives . . . . . . . . . . . . . . . . . . . . . . . . 80 Configuring Report Settings . . . . . . . . . . . . . . . . . . . . . . . . 83 Settings Migration Assistant . . . . . . . . . . . . . . . . . . . . . . . . 84 Export Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 EMR Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 LCD Brightness Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 ECG Filter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Configuring Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 ECG Trace Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

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Device Settings

Device SettingsSettings ScreenUsing the Settings screen, you can change:

• System settings . See “Configuring System Settings” on page 67 .

• ECG settings . See “ECG Filter Settings” on page 90 .

• User settings . See “

User Settings” on page 93 .

Displaying the Settings ScreenTo display the Settings screen, from the screen menu on the right side, select the Settings tab .

Figure 5-22. Settings Screen

Identifying the Current Software and Firmware VersionsThe MyoVista software version appears at the lower left side of the Settings screen along with the Glasgow Analysis Engine version . The ECG board firmware version appears at the lower right side of the Settings screen . (Figure 5-22) .

65


Device Settings

Settings Screen Icons

Note: If User Authentication is enabled, not all settings will be available to standard users, but “administrator” users will have access to all device settings.

Table 5-9 describes the icons on the Settings screen .

Table 5-9 . Icons on the Settings Screen

Icon Icon Name Description User

System Settings

Update/Factory Reset

Updates software to a newer version, updates the Home page documentation, restores device settings to factory defaults, and displays the current software version .

Administrator

Network Displays the current network connection and allows you to configure wireless network settings . All

Network Drives Configures settings for network connected storage . Administrator

Printing Configures printer settings . All

Database Displays database information, backs up the current database on external storage media, and deletes and restores the database . Administrator

Report Settings Configures report preferences . All

Settings Migration Exports and imports device settings . Administrator

Export Logs Exports device logs to local USB drive and/or to a network drive . Administrator

Date/Time Sets the system date and time . Administrator

Auto-Standby Sets the timer that places the device in standby mode automatically . All*

EMR This icon allows interface settings and device authentication to an EMR Interface Engine (i .e . Cloverleaf) or web portal . Administrator

Display Brightness Configures screen brightness . All

66


Device Settings

ECG Settings

Filters Sets Line and Myoelectricity Interface filter default settings . All

ECG Trace Color Sets ECG lead trace color and grid brightness . All

Test Length Sets the test length default . All

User Settings

Language Sets the device language . All

Clinic Information Used to input clinic information . All

User Management

Configures device authentication settings including users and password management . All**

Patient Units Sets the default displayed measurement units for patient height and weight . All

* When User Authentication is enabled, the “disable” option in Auto-Standby is not available .

** Functionality is restricted for standard users – standard users only have access to modify their own password management .

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Device Settings

Configuring System SettingsThe following sections describe how to use the functionality and features on the Settings screen as summarized in Table 5-9 .

Changing the Date/Time Settings

To change the system’s date and time settings:

1 . Under System Settings, select the Date/Time icon . The Date/Time screen appears, as shown in Figure 5-23 .

Figure 5-23. Date/Time Screen

2 . Select the appropriate date or time settings field: MONTH, DAY, YEAR, HOUR, and MINUTE .

3 . Modify the information using the touchscreen keypad .

4 . Repeat steps 2 and 3 to modify each field .

Note: After you change the value in a field, the device moves to the next field automatically.

5 . Select AM or PM . The keypad displays only the AM and PM keys .

6 . Select one of the following date formats to change the date order:

– MM-DD-YYYY (Month Day Year)

– DD-MM-YYYY (Day Month Year)

– YYYY-MM-DD (Year Month Day)

7 . Select the Save icon to save the modified settings or select Cancel icon to discard them .

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Device Settings

Updating System Software (This is accessible only by Administrator roles .)

The following procedure describes how to update the system software . When you update the software, all patient data and user settings are preserved . Contact your HeartSciences authorized representative for updates .

Do not remove power from the device until the update process completes . Leave on AC power .

Caution: Do not turn off the device during a system update; otherwise, it can render the MyoVista Device inoperable. System updates should be performed by authorized service representatives.

Note: MyoVista Software can only be updated to newer versions. Once updated you cannot restore to an older version software.

Note: When updating the MyoVista Software from a previous version of MyoVista Software, any previously saved printers will be removed and must be re-configured.

1 . Under System Settings, select the Update/Factory Reset icon . The Update/Factory Reset screen appears, as shown in Figure 5-24 .

Figure 5-24. Update/Factory Reset Screen

2 . Select Update Software icon . The following message appears:

A system update will upgrade your device with a new version of the software. All patient data and relevant user settings will be preserved.

3 . Select the Continue icon to proceed or select Cancel icon to stop the update . If you select Cancel, the following message appears:

The system update has been aborted.

69


Device Settings

4 . Select the desired system update package from the pop-up menu and press OK . File name will either have the .uph file extension or select by system update text .

The MyoVista Device will validate the update package before the following message appears:

WARNING: Do not turn off the device while the system update is in progress.

Restoring Device to Factory Default Settings (This is accessible only by Administrator roles .)

The factory reset function resets device and user settings to their factory default settings and removes all patient data and all instructional/reference documents . It does not change the MyoVista Device software version . During this procedure, you have the option to back up the database .

Warning: Do not remove power from the device until the update/factory reset process completes.

To restore the MyoVista Device to factory default settings:

1 . Under System Settings, select the Update/Factory Reset icon . The Update/Factory Reset screen appears (see Figure 5-24) .

2 . Select the Factory Reset icon . The following message appears:

A factory reset will erase the database. Do you want to back it up?

70


Device Settings

3 . To back up the database before restoring factory defaults, select the Backup icon . Otherwise, select the Skip icon to go directly to the factory reset operation . Selecting the Cancel icon closes the screen without restoring the factory default settings .

– If you select the Backup icon, you are prompted to complete a database backup . After this function is performed, you are prompted to proceed and erase data or cancel the operation . See “Backing Up a Database” on page 76 .

– If you select the Skip icon, you are prompted to proceed and either erase data or cancel the operation .

• If you select the Cancel icon, the factory reset operation ends, the following message appears, and you should select OK to return to the Update/Factory Reset screen:

The Factory Reset operation has been aborted.

• If you select the Proceed and Erase Data icon, the device reverts to factory default settings .

• A pop-up window with a warning will be displayed warning the user not to remove power from the device until the update/factory reset process completes . Click on OK .

4 . The system will start powering down and will go through the reset sequence . The device will boot the MyoVista home screen after reset . The process takes about 2 minutes .

Note: If needed, contact customer service for instructions on how to reset the device ([email protected]).

Restoring/Updating Device Reference Materials (This is accessible only by Administrator roles .)

1 . Select the Settings Menu, then click on Update/Factory Reset icon and then click on Update Manuals icon . A pop up will appear stating “The Reference Materials on the Home tab will be updated .” Click on Continue .

2 . From the USB drive, select the User Manuals update file (MyoVista_DG-200_Manuals_Update_Package_Rev-* .upm) and click OK . Let the MyoVista Update Manuals process complete .

3 . Once completed, a pop up will indicate successful update of the user manuals . Click on OK and then click on Cancel in the Update/Factory Reset tab .

* The letter that appears at this location in the filename indicates the revision of the document package on the USB drive .

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Device Settings

Configuring Network SettingsNetwork Status

Under System Settings, select the Network icon . The Network screen shows the current network status .

• If a wired Ethernet connection is in use, wired network information similar to the following is shown (Figure 5-25) .

Figure 5-25. Wired Network Screen

• If a wireless Ethernet connection is in use, any available wireless network options will be shown in Figure 5-26 .

Figure 5-26. Wireless Network Screen

Connecting to a Wired Network

To connect to a wired network, plug in an Ethernet cable to the port on the rear panel of the device . Open “Network Settings” and confirm the connection is found .

72


Device Settings

Connecting to a Wireless Network

To select a wireless network:

1 . Under System Settings, select the Network icon . The Network screen appears .

2 . Select Enable Wi-Fi icon . A list of available wireless networks appears as shown in Figure 5-27 .

Figure 5-27. Network Screen

3 . Select a wireless network . If the selected network is protected, enter the Wi-Fi password in the password screen (Figure 5-28), and then select the Connect icon . The Network screen appears .

Figure 5-28. Entering a Password

4 . Select the Save icon to save the Wi-Fi connection settings .

5 . Select Close icon to return to the Settings screen .

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Device Settings

Patient TestingPatient Testing

Setting Up a Printer

Note: Before a network-based printer can be connected, a network must be configured properly. See “Configuring Network Settings” on page 71.

To select a printer:

1 . Under System Settings, select the Printing icon . The Printing screen appears, as shown in Figure 5-29 .

Figure 5-29. Printing Screen

2 . Select a printer or select the Add icon to add a new printer . If you select Add, the Add Printer screen in Figure 5-30 appears . A list of available printers will be shown .

Figure 5-30. Add Printer Screen

74


Device Settings

3 . From the Add Printer screen, select the printer you want to use, and then press the Add icon . A dialog box confirms that the printer was set up successfully .

Note: If the printer selection fails, use the Select Driver function to select a driver manually (see Figure 5-31). Select the first driver listed, and then press the Add icon. If printer setup fails again, select other drivers until the printer setup succeeds.

Figure 5-31. Select Driver Screen

75


Device Settings

Database SettingsThis screen is only accessible by Administrators .

Use the procedures in this section to:

• View the current database . See “Viewing the Current Database Information” below .

• Delete the database . See “Deleting a Database” on page 76 .

• Back up the database . See “Backing Up a Database” on page 76 .

• Restore the database . See “Restoring a Database” on page 78 .

Viewing the Current Database Information

To view information from the current database:

1 . Under System Settings, select the Database icon . The Database Information screen appears, as shown in Figure 5-32 .

Figure 5-32. Database Information Screen

The following information appears in the screen:

– Database space = size of the database .

– System disk free space = amount of available storage space .

– Total Patient Count = total number of patient records .

– Total Test Report Count = total number of patient test reports .

76


Device Settings

2 . Use the icons in the screen as required (see Table 5-10) .

Table 5-10 . Icons on the Database Information Screen


Delete Database Removes the current patient database . See page 76 .

Backup Database Creates a database backup to external media . See page 76 .

Restore Database Restores a previously backed up database from external media . See page 78 .

3 . When you finish using the Database Information screen, select Close icon to close it .

Deleting a Database

Note: Be sure to back up the existing database prior to deletion if the existing data needs to be preserved or retained.

To delete a database:


2 . In the Database Information screen, select the Delete icon . The following message appears:

The existing database will be erased. Proceed?

3 . Select Yes icon to delete the database or select No icon to retain it .

Backing Up a Database


2 . Connect a USB storage media to a USB port on the MyoVista Device . Observe the following guidelines when attaching a USB storage media:

• The USB storage media must be connected directly to the USB port . The MyoVista Device might not recognize USB storage media connected through a USB hub .

• The MyoVista Device accesses only the main (root) directory of a USB storage media . We recommend you use blank media for all USB functions .

• Do not move a backed-up database file into a separate directory on the USB storage media . Database files can be restored only when saved in the main (root) directory of the USB storage media .

77


Device Settings

• The MyoVista Device recognizes only the first supported partition on a USB storage media . Do not use storage media with multiple formatted partitions .

• Store backed up databases in compliance with HIPAA controls and policies for handling sensitive patient information .

• Deleting a database deletes all patient information and reports permanently, but does not affect system and device settings .

3 . Select Backup icon . The Backup Database screen appears, as shown in Figure 5-33 .

Note: If multiple USB storage media are connected, select one from the drop-down menu. For information about USB mapping, see “Rear Panel” on page 26.

Figure 5-33. Backup Database Screen

4 . Within the “Notes” field, add an optional note .

Tip: We recommend you add a note in the remark box to help identify the database backup correctly.

5 . Select the Backup icon to back up the existing database or select Cancel icon to not back up the database . If you select Backup icon, the following message appears:

Backup Successful

6 . Select the OK icon to display the Database Information screen or select Cancel icon to return to the Database Information screen .

78


Device Settings

Restoring a Database

Restoring a database deletes the existing database and replaces it with data from the restored database .

Note: Be sure to back up an existing database prior to a restore if the existing data needs to be preserved or retained.

To restore a database:


2 . Connect USB storage media to a USB port on the MyoVista Device .

Note: If multiple USB storage media are connected, select one from the drop-down menu.

3 . Select Restore icon . The Restore Database screen appears, as shown in Figure 5-34 .

Figure 5-34. Restore Database Screen

4 . In the table, select the database file to restore . Review the information in the Notes column to confirm that the correct database is selected .

5 . Select the Restore icon to restore the database or select Cancel icon not to restore . If you select Restore icon, the following message appears:

Restore Successful

6 . Select the OK icon . The Restore Database screen appears .

79


Device Settings

Configuring Auto-Standby SettingsThe Auto-Standby feature places the device in standby mode after a configurable period of inactivity . The factory default setting is to standby after 5 minutes of inactivity .

If user authentication is enabled, auto-standby is required (you are prevented from disabling the standby feature) .

To configure auto-standby settings:

1 . Under System Settings, select the Auto-Standby icon . The Auto-Standby screen appears, as shown in Figure 5-35 .

Figure 5-35. Auto-Standby Screen

2 . Select the number of minutes of inactivity that is acceptable before the device enters standby mode: 5 minutes, 10 minutes, 30 minutes, or Disable .

3 . Select the Save icon to save the setting or select Cancel icon to discard it .

Note: To exit Standby mode, press the Standby icon or press anywhere on the touchscreen.

Note: The disable option cannot be selected if User Authentication is disabled.

Note: Enabling User Authentication will not allow “Auto-Standby” to be disabled.

Tip: If user authentication is enabled, the device will lock when standby mode is entered. Any user can unlock the device to access functionality determined by thier role by entering thier login credentials. The device always unlocks to the home screen.

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Device Settings

Configuring Network Drives (This is accessible only by Administrator roles .)

Map Network Drive allows administrators to connect to a network attached storage device or server shared drive using one of three protocols: (Windows/SMB, NFS, or FTP) . This mapped drive can be used to export test reports and system logs .

Note: other export and restore features still require removable storage devices and do not use mapped network storage locations.

1 . Under System Settings, select the Network Drives icon . The Network Drives screen appears .

2 . Select the Add button, opening the Configure Network Drive screen, as shown in Figure 5-36 .

Figure 5-36. Configure Network Drive Screen

3 . Enter the drive Name .

4 . Select the drive Protocol .

5 . Enter the Server Name or IP address .

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Device Settings

6 . Select the Update button, opening the Drive Authentication dialog as shown in Figure 5-37 .

Figure 5-37. Drive Authentication Dialog

Note: The NFS protocol does not require Authentication Information, so no screen will be displayed.

a . For Windows/SMB, Enter the Domain (optional) .

Note: If left blank, the server’s domain will be assumed.

b . Enter the User Name .

c . Enter the Password .

d . Select the Test button to test the drive and authentication settings .

e . Select OK to save the Authentication information .

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Device Settings

7 . Select the Browse button, opening the Browse Network Drive dialog, as shown in Figure 5-38 .

Figure 5-38. Browse Network Drive Dialog

8 . Select the desired folder on the server and select the ‘Select’ button .

9 . Select the Save button to save the network storage drive .

Caution: Network drive authentication credentials can expire and cause export failures.

83


Device Settings

Configuring Report Settings (This screen is accessible only by Administrator role users . It sets the system default report settings for all users .)

Configure Report Settings allows users to configure the default report template and leads to be included on the summary page and 4x3 views .

1 . Under System Settings, select the Report Settings icon . The Report Settings screen appears, as shown in Figure 5-39 .

Figure 5-39. Report Settings Screen

2 . Select the desired Paper Size .

3 . Select the desired Default Template .

4 . Select the Top lead for the Summary Page 2-lead View .

5 . Select the Bottom lead for the Summary Page 2-lead View .

6 . Select the Reference Lead for the 4x3 Page .

7 . Select the ‘OK’ button to save the updated settings .

84


Device Settings

Settings Migration Assistant (This is an Administrator-only feature .)

Settings Migration Assistant allows administrative users the ability to export and import the system configuration settings using a attached storage device . This feature can be used to quickly replicate a device configuration to a different device(s) .

Export Device Settings1 . Under System Settings, select the Settings Migration Assistant icon . The Settings Migration

Assistant screen appears as shown in Figure 5-40 .

Figure 5-40. Settings Migration Assistant Screen

2 . Select the desired settings to Export .

Note: To export Login Settings or Network Drives, you must enter a Pass Phrase.

85


Device Settings

3 . Select the Export button .

4 . Enter a Pass Phrase if prompted and record/keep the pass phrase in a secure location . Select the OK button, and the Export File screen appears as shown in Figure 5-41 .

Figure 5-41. Export File Screen

5 . Select the Disk to export to .

6 . The system automatically populates the Filename . However, you can change the Filename .

7 . Select the Export button . Upon successful completion, the following message will appear .

Export Succeeded

8 . Select the OK button to dismiss the dialog .

Caution: When exporting login settings, make sure there is at least one Administrator user account and the username and password are known.

86


Device Settings

Import Device Settings (This is an Administrator-only feature .)

1 . Under System Settings, select the Settings Migration Assistant icon . The Settings Migration Assistant screen appears as shown in Figure 5-42 .

Figure 5-42. Settings Migration Assistant Screen

2 . Select the desired settings to Import .

3 . Select the Import button .

Note: To import Login Settings or Network Drives, you must enter the Pass Phrase previously assigned during export.

87


Device Settings

4 . Enter a Pass Phrase and select the OK button, the Import File screen appears as shown in Figure 5-43 .

Figure 5-43. Import File Screen

5 . Select the Disk to import from .

6 . Select the Import File to import settings from .

Note: The file should end with .prf.

7 . Select the OK button . Upon successful completion, the following message will appear .

Import Succeeded


Tip: If needed, export the current device settings (backup) before importing settings.

Caution: Ensure the correct settings and file are chosen before import.

Caution: Importing Login Settings may put the device in a state that requires login credentials. Please verify there is at least 1 Administrator user in the import and that you know the username and password for the Administrator user(s).

88


Device Settings

Export LogsExport Logs allows administrative users to export device logs for troubleshooting and diagnosing device errors .

Note: To protect any sensitive information that may be stored on the device, the file is encrypted and must be sent to your authorized HeartSciences representative for decryption and diagnosis.

1 . Under System Settings, select the Export Logs icon . The Export System Logs screen appears as shown in Figure 5-44 .

Figure 5-44. Export Logs Screen

2 . Select the Disk to export to .

3 . The system automatically populates the Filename . However, you can change the Filename .

4 . Select the Export button . Upon successful completion, the following message will appear .

Export Logs Succeeded


89


Device Settings

EMR SettingsEMR Settings allows administrative users to configure and authenticate the device for electronic data transfer to a supported interface . In software v2 .0, the supported interface is implemented via Cloverleaf Interface Engine utilizing SOAP services in a preconfigured box .

Note: For other interface needs, please consider a Mapped Network Drive and file export to your EMR system

1 . Under System Settings, select the EMR Settings icon . The EMR Settings screen appears as shown in Figure 5-45 .

Figure 5-45. EMR Settings Screen

2 . Select the Auth Service button to authorize the device to the EMR interface .

3 . Complete the EMR Authentication Service entry fields .

6 . Select the Authenticate button . Upon successful completion, the following message will appear .

The device has been registered with the EMR portal.


5 . Enter the EMR settings .

6 . Select the Save button .

90


Device Settings

LCD Brightness SettingsDisplay Brightness allows users to configure the display brightness .

To configure LCD brightness settings:

1 . Under System Settings, select the Display Brightness icon . The Display Brightness screen appears, as shown in Figure 5-46 .

Figure 5-46. Display Brightness Screen

2 . Move the slider left or right to select the appropriate brightness . Adjusting screen brightness may impact battery power run time .

3 . Select the Save icon to save the setting or select Cancel icon to discard it .

ECG Filter SettingsECG Settings allows users to configure the filters for the device .

This section covers the Myoelectricity Interface filters settings (described below) and ECG Trace Color settings (described on page 92) .

Configuring FiltersThe Frequency Interface setting determines the A/C line filter setting .

To configure default settings for filters:

1 . Under ECG Settings, select the Filters icon . The Filters screen appears, as shown in Figure 5-47 .

91


Device Settings

Figure 5-47. Filters Screen

2 . Set the default A/C Line Frequency Interface Filter setting: 50Hz, 60Hz, or Disable .

3 . Set the default Myoelectricity Interface filter setting: 25Hz, 35Hz, 45Hz, 75Hz, 100Hz, or Disable .

Caution: Myoelectricity Noise Filters - The MyoVista Device provides “muscle noise filtering” capability that reduces higher frequency content to reduce or eliminate muscle noise produced by patients under certain conditions. The selectable bandpass noise filters are designed to attenuate frequencies above the selected frequency. While these filter settings have little to no impact on the conventional 12-lead ECG recording and the Glasgow Interpretive Analysis, MyoVista Informatics are quite sensitive and depend on processing the composite myocyte activity that is present in the ECG signal to reliably perform computations required for MyoVista wavECG Information and Measures. HeartSciences has determined that for myoelectricity settings of 75Hz or higher, there is no significant impact on MyoVista Information. For filter settings at frequencies of 45 Hz or below, the performance of MyoVista Information may be degraded and it is possible that a patient’s test results may be affected. When muscle noise is present during patient testing use myoelectricity settings at 100 Hz or 75 Hz. If substantial muscle noise is present and lower filter settings of 45 Hz or below are necessary be aware patient results may be affected. The 50Hz and 60Hz line filters do not impact MyoVista wavECG Information or conventional ECG recordings.

4 . Select the Save icon to save the settings or select Cancel icon to discard them .

Note: You can also configure these settings on the Test screen for each individual test (see “Setting Test Options” on page 52). When configuring test parameter settings directly from the Test screen, the settings return to default values each time a new patient is selected. To change the default values for all patients, go to the Settings screen.

92


Device Settings

ECG Trace ColorsECG Trace Color allows users to configure the ECG trace colors for the device .

To configure ECG trace colors:

1 . Under ECG Settings, select the ECG Trace Color icon . The ECG Trace Color screen appears, as shown in Figure 5-48 .

Figure 5-48. ECG Trace Color Screen

2 . Select a lead to change the color, and then keep pressing over the desired lead to move through all the colors until you select the desired color . The available colors are green, blue, brown, purple, yellow, white, and red .

3 . Repeat step 2 for each desired lead .

4 . Move the Grid Brightness slider to the right or left to select the desired grid brightness .

Note: Grid Brightness determines the transparency of the grid lines behind the ECG waveform traces. It does not change the brightness of the screen where the grid is displayed. To change screen brightness, see “LCD Brightness Settings” on page 90.


93


Device Settings

User SettingsThis section describes the following topics:

• Clinic information setting . See “Entering or Modifying the Clinic Information” below .

• Language setting . See “Configuring a Language” on page 94 .

• Patient unit of measurement . See “Configuring the Patient Unit of Measurement” on page 95 .

Entering or Modifying the Clinic InformationClinic Information allows users to configure the clinic information to be included in the test reports

for the device .

To enter or modify clinic information:

1 . Under User Settings, select the Clinic Information icon . The Clinic Information screen appears, as shown in Figure 5-49 .

Figure 5-49. Clinic Information Screen

2 . Enter or modify the following clinic information in the appropriate fields: Hospital/Clinic Name (appears in printed and exported PDF reports), Telephone Number, Alternate Phone, Fax, Address, and E-mail .

3 . Select the Save icon to save the clinic information or select Cancel icon to discard it .

94


Device Settings

Configuring a LanguageThe Language setting allows users to configure the language for the device .

The following procedure describes how to configure a language . If you change the language, the MyoVista Device reboots .

1 . Under User Settings, select the Language icon . The Language screen appears, as shown in Figure 5-50 .

Figure 5-50. Language Screen

2 . Select the appropriate language .

3 . Select the Save icon to save the setting or select Cancel icon to discard it . If you select Save, the following message appears:

The MyoVista Device will restart to change the language.

4 . Select OK icon to continue with the reboot or select Cancel icon to cancel the operation .

95


Device Settings

Configuring the Patient Unit of MeasurementThe Patient Units settings allows users to configure the height and weight units for the device .

To configure the patient unit of measurement:

1 . Under User Settings, select the Patient Units icon . The Patient Units screen appears, as shown in Figure 5-51 .

Figure 5-51. Patient Units Screen

2 . For Height, select cm or in .

3 . For Weight, select kg or lb .


96


Device Settings

User ManagementUser Management allows administrative users to enable and configure user authentication and user accounts for the device .

Any user is able to change their own user details from this screen, including display name, username, password, and hint .

Add User1 . Under User Settings, select the User Management icon . The Login Configuration screen appears

as shown in Figure 5-52 .

Figure 5-52. Login Configuration Screen

Note: By default, the device ships with User Authentication disabled.

2 . Select the User Authentication button to enable authentication .

Note: Once authentication is enabled, make sure to add at least one administrator account.

Note: If an admin account cannot be accessed (forgot password, “admin” account not configured, etc.) the administrator features of the device can be temporarily accessed by contacting technical support at HeartSciences, where a temporary admin password can be provided.

97


Device Settings

3 . Select the Add button . The Add User screen appears as shown in Figure 5-53 .

Figure 5-53. Add User Screen

4 . Enter the user Name .

5 . Enter a unique Username .

6 . Select the user Type (User or Administrator) .

7 . Enter (and confirm) the user Password .

8 . Optionally, enter a password Hint .

9 . Select the Save button .

Note: Routinely audit the user accounts and delete unused accounts and employees no longer employed.

98


Device Settings

Edit User Password (User type)1 . Under User Settings, select the User Management icon . The Edit User screen appears as shown in

Figure 5-54 .

Figure 5-54. Edit Users Screen

2 . Enter a new Password

3 . Re-enter to confirm password

4 . Optionally, enter an updated password Hint .

5 . Select the Save button

Caution: Protect your password to prevent unintended patient information disclosure.

6 . TroubleshootingIn the event you encounter a problem using the MyoVista® wavECG Device, use the information in this chapter to identify and resolve the problem .

Topics

Troubleshooting Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

100


Troubleshooting

Troubleshooting TableTable 6-1 . Lists common device errors, with their causes and solutions .

Table 6-1 . Troubleshooting Table

Problem Cause SolutionUSB device is not recognized The MyoVista Device may not

recognize the USB device connected to its USB port

Be sure the USB device is connected securely to the USB port

Try a different USB port or USB device

Ensure the USB storage media is properly formatted (see page 26)

A backed-up database cannot be accessed while attempting to restore the database

User changed the database file location on the USB disk

Database file is found in a directory other than the main directory

Move the database file to the main directory on the USB device

One or more waveforms is/are not stable

Patient cable or electrode lead wires are loose, or the electrode has improper skin contact

Be sure the patient cable is fully seated into device’s cable port

Check all electrode lead wire connections to electrodes

Be sure electrodes have proper skin contact .

MyoVista Device does not power up Battery is fully discharged, and the power adapter is not connected

Power cord and supply are not attached

Connect the power adapter to the MyoVista Device

Connect the power cord and supply power to the MyoVista Device

Ensure device Power Switch is in the “On” position while connected to AC power to charge . Contact HeartSciences if auto-reboot cycle is occuring or troubleshooting is ineffective

MyoVista Device powers down Battery is discharged . Power adapter is not connected

Connect the power adapter to MyoVista Device

Incorrect language displays Incorrect language system setting is selected

Select the appropriate device language

Report does not print Printer or network is not configured properly

Select and configure the printer . If using a network printer, be sure the network is configured properly

No network connection Network connection is not configured properly

Configure network settings

Noise or decaying signal artifact present after each pacing pulse

Pacemaker spikes may be interfering with ECG signal quality

Disable the Frequency Interface setting before running test (see “Configuring Filters” on page 90)

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Troubleshooting

No real-time traces present Patient cable is damaged or connected improperly

Confirm that the patient cable is not damaged and is connected properly

If it is damaged, replace itIncorrect report data The device is configured for the

wrong date or time, the date is not set, or the patient information is incorrect

Change or enter the correct data

Degraded test results The environment in which the device is operating is subject to electromagnetic interference (EMI), MRI, or other imaging activity, such as interference from microwaves, cell phones, and similar devices

Move the device to an area that has less interference

See “Consistent Environmental Noise in Signal” at end of Table 6-1

Unable to connect to the Wi-Fi network

The password is not valid for the security mode of the network

Make sure the password is not blank

Enter the correct Wi-Fi access password

Test error(s) indicated by red text in the test Quality Index Indicators

Inadequate electrode contact with the body, or loose lead-to-electrode connection, or patient condition contributing to noise in the ECG signal

Prepare patient skin for electrode attachment, attach the electrodes to the patient, and attach the leads to the electrodes per the Electrode Placement section of this manual .

Ensure patient’s condition is as described in the Patient Recommendations section of this manual .

File export unsuccessful The USB storage media is not connected properly to the MyoVista Device USB port

Confirm that the USB storage media has a secure connection to the MyoVista Device USB port

Push the USB storage media gently into the port to make sure it is seated securely in the port

Exported PDF file shows up as “blank” or “damaged” when opened on a laptop or desktop computer

The USB storage media was either poorly seated during export process or removed before the export operation finished . The USB storage media may not have sufficient storage space .

Confirm that the USB storage media has a secure connection to the MyoVista Device USB port, and then repeat the export

Do not remove the USB storage media until the export operation is finished

Ensure the USB storage media has sufficient storage space

Battery gauge on the status bar flickers or displays wrong charge level

An incompatible HDMI cable is being used

Connect an alternate HDMI cable or contact HeartSciences to purchase a compatible HDMI cable

External monitor not displaying correctly

An incompatible HDMI cable is being used

Connect an alternate HDMI cable

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Troubleshooting

Consistent Environmental Noise in Signal

AC line power EMI

Environmental EMI (OTA) – Seen as elevated when patient cables are plugged into device

AC Line Filters, Use of Recommended UPS system at installation site .

Charge battery, carry device while on testing screen around care unit, moving towards and away as noise amplifies on screen to target EMI offender – Note: Sources of EMI may still emit interfering signals when placed in stand by mode . Recommendation is that identified sources of EMI are either removed from the testing environment, testing environment is moved or devices are fully powered down and unplugged from AC power .

i . Top Offenders:

ii . Ultrasound Machines . See “Recommended Separation Distances” for RF interference guidance on page 113

iii . Elevator or Lift Electric Motors

iV . XRay

V . Centrifuges

vi . Personal Electronics on Patient’s Person

Note: If you are experiencing an issue with the device’s functionality, please capture export logs (see page 88) and email logs to [email protected].

7 . Service, Maintenance & Cleaning

This chapter covers routine device service, maintenance and cleaning procedures for the MyoVista wavECG Device .

Topics

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Service & Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Periodic Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . 107

104


Service – Maintenance & Cleaning

Warnings

Warning: DANGER OF ELECTRIC SHOCK. THERE ARE NO USER-SERVICEABLE PARTS IN THIS DEVICE. The battery is not user-serviceable. Do not open the device case. Only personnel authorized by the manufacturer may service the device, open the enclosure, or open the battery compartment.

Note: MyoVista Device is a self calibrating ECG device and requires no user/technician calibration after manufacture.

Service & MaintenanceRegular maintenance, regardless of how often the MyoVista Device is used, is essential to ensure that the equipment will be functional when used . Regular maintenance includes cleaning and inspection .

Maintenance Items To RememberBefore performing maintenance on the device, be sure that an authorized representative has provided proper training of device functions and safety precautions .

If there is any uncertainty about maintenance or cleaning instructions or procedures, refer to the supplied maintenance and cleaning instructions .

The following maintenance instructions do not override any statutory or local regulations or procedures for the prevention of accidents and environmental protection .

When inspecting and cleaning the device:

• Turn off the system and unplug the device .

• Do not immerse any part of the equipment in liquid .

• Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents . These may damage the equipment surfaces .

Warning: Before cleaning, ensure power is turned off and that the power adapter is unplugged.

Caution: DO NOT use corrosive cleaning agents. DO NOT use cleaning agents that contain phenols.

Caution: DO NOT use detergent solutions for cleaning equipment or cable accessories. DO NOT immerse equipment and cables in liquid.

105



Cleaning and DisinfectingClean and disinfect the exterior surfaces of the MyoVista Device before you use it for the first time . After the initial cleaning, clean the device every month or more frequently if required by healthcare facility protocol .

Housing Cleaning

To clean the housing of the MyoVista Device:

1 . Wipe with a clean cloth dampened in a mild soap and water solution .

2 . To disinfect, wipe with a cloth dampened with alcohol .

3 . Use the following solutions, as recommended in the APIC Guidelines for Selection and Use of Disinfectants (1996):

– Sodium hypochlorite (5 .2% household bleach) minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution

– Any sodium hypochlorite wipe product that meets the above guidelines can be used .

4 . Dry with a clean cloth or paper towel . Drying times depend on environmental conditions .

Patient Cable Cleaning1 . Before cleaning, remove the patient cable and the electrode lead wires from the device .

2 . To clean the cable, wipe with a lightly moistened cloth dampened in a mild soap and water solution .

3 . To disinfect, wipe a cloth dampened with isopropyl alcohol .

Use the following solutions, as recommended in the APIC Guidelines for Selection and Use of Disinfectants (1996):

– Sodium hypochlorite (5 .2% household bleach) minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution

– Any sodium hypochlorite wipe product that meets the previous guidelines can be used .

4 . Dry with a clean soft cloth or paper towel . Drying times depend on environmental conditions .

LCD Screen CleaningThe MyoVista Device incorporates a touch panel . Fingerprints and other stains are likely to appear on the touch panel .

Note: Never use a strong or acidic cleaning solution. Do not wipe the surface with any coarse-textured cloth or gauze, as it may damage the specially coated screen. Use a non-abrasive soft cleaning cloth only.

Use a commercially available cleaning solution designed for LCD screens . A soft cleaning cloth or eyeglass cleaning cloth may also be used . Do not get the device wet or introduce liquids . Dry with a clean soft cloth .

106



Periodic Inspection Visually inspect the MyoVista Device every 6 months or as required by facility protocol .

Warning: If service is required, it should be performed only by authorized service personnel.

Seasonal Safety CheckClean the power adapter plug at least once a year . An excessive amount of dust on the plug might cause a fire .

Note: For proper performance and safety, have the device inspected and tested annually by authorized service personnel. Inspection and testing should be performed only by authorized service personnel trained in maintenance of the MyoVista Device.

Annual InspectionPerform the following safety checks at least every 12 months and record the data per your facilities protocol . If the device is not working properly or fails any of the following conditions, it must be repaired:

• Inspect the equipment and accessories for mechanical and functional damage .

• Inspect the relevant safety labels for legibility .

• Verify that the device functions properly, as described in this User Manual .

107



Battery Maintenance • Avoid water, high temperature, and high humidity . The storage environment should be free of

dust, salt, sulphide gas, and kept dry . See “Environmental Specifications” on page 108 .

• Never open the battery enclosure or remove the battery from the enclosure .

• Monitor the battery performance, and have it serviced or replaced by an authorized service technician when necessary . See “Monitoring the Battery” on page 34 .

• Discontinue battery use if battery power appears weak or appears to discharge at a rate faster than expected .

• Follow local ordinances or regulations for disposal .

Supplies and Accessories Use only genuine HeartSciences disposable MyoVista Center Post Electrodes and MyoVista Patient Cables, HeartSciences Catalog numbers:

MV-CABLE-1-EA-IEC

MV-CABLE-1-EA-AHA

MV-ELTRD-300-CS

MV-ELTRD-25-BX

108


Appendix

A . Technical Data

Device Specifications Specification DescriptionDimensions (H X W X D) 11 .75 in . x 16 .75 in . x 3 .0 in . excluding stand or accessories

Weight 8 .4 lbs . including battery

Patient cable connection DB-15 ECG with proprietary pin-outs

Ports USB (4), DC Power Input, HDMI, LAN

Materials Bayblend FR3010 - Polymer blend based on bisphenol A -polycarbonate/acrylonitrile-butadiene-styrene copolymer (PC/ABS), flame-retarded (low halogen content, free from chlorine and bromine)

Disposal According to WEEE: Directive 2012/19/EU - Device, accessories, and packaging waste must be disposed of properly at end of each usage . Follow Local Ordinances and Regulations for disposal .

Built-In Monitor

Size Effective display area 15 .6 in .

Resolution 1920 x 1080 dots per inch (DPI)

Controls Touchscreen and membrane key panel

Memory

Storage Patient Test Records: > 50,000

Electrical SpecificationsSpecification Description

Power Supply

Voltage 100~240 VAC, 50/60 Hz

Power consumption 48 Watts max

Battery Operation with built-in rechargeable battery

Battery (new battery with full charge)

Capacity Approximately 1 hour normal use . Approximately 2 hours standby

Battery life Normal operating conditions: 1 yr .

Recharging time 90% Capacity: approximately 4 .5 hrs . / 100% Capacity: approximately 10 hrs .

Line frequency filter Distortion-free suppression of superimposed 50 or 60 Hz sinusoidal interferences by adaptive digital filtering

Battery (new device, unpackaged, in storage)

Battery life Normal storage conditions: 6 months

Environmental Specifications - MyoVista Wavelet ECGSpecification Description

Temperature

Operating +5°C to +40°C (41°F to 104°F)

Storage -20°C to +50°C (-4°F to 122°F)

Battery (new battery with full charge)

Operating ≤80% RH non-condensing

Storage ≤80% RH non-condensing

109


Appendix A: Technical Data

Environmental Specifications - MyoVista Center Post Electrodes

Specification Description

MyoVista wavECG Device & MyoVista Cable 10 Leads AHA/IECTemperature


Storage -20°C to +50°C (-4°F to 122°F)

Humidity (non-condensing)

Operating ≥80% RH non-condensing

Storage ≥80% RH non-condensing

Center Post ElectrodesTemperature


Storage +4°C to +38°C (40°F to 100°F)


Operating ≥80% RH non-condensing

Storage ≥80% RH non-condensing

MyoVista wavECG System (Boxed)Temperature

Storage +4°C to +38°C (40°F to 100°F)


Storage ≤80% RH non-condensing

ECG Specifications

Specification DescriptionECGLeads Standard 12 simultaneous leads Touchscreen DisplayLeads 12-channel display of the selected leads, selectable amplitude 5, 10, 20 mm/mVStatus Filter status (on/off) / Insufficient electrode contact / Date-time-Patient demographics PrintoutChart print-out speed 5/25/50/100 mm/s (manual print)Sensitivities 5/10/20 mm/mV, either automatically adjusted or manually selectedRecording track 12-channel presentation, automatic baseline adjustmentData RecordFields Patient data (name, age, sex, height, weight, BSA), user ID, and logo with optional

interpretation program ECG measurements results FilterMuscle noise filter Myoelectric filter: 25 Hz, 35 Hz, 45 Hz, 75 Hz, and 100 Hz can be switched on/off .ECG AmplifierSimultaneous recording 8 channelsSampling frequency 1000 HzResolution <5 µV/14 bit

110


Accuracy (Amplitude) Meets or exceeds ANSI/AAMI/EN/IEC 60601-2-25:2011 Frequency range 0 .05 - 200 Hz (IEC/AHA)Accuracy (Timing) Meets or exceeds ANSI/AAMI/EN/IEC 60601-2-25:2011 Measurement range Dynamic ± 10 mV, DC ± 300 mVCMRR >60 dBInput impedance ≥2 .5MΩ (actually arrived ≥50MΩ)Defibrillation protection 5,000 VDCDefibrillation recovery time <5 sECGDurations and isoelectric waves From Glasgow Interpretive Analysis documentation, “With respect to global QRS

duration, the Glasgow program measures QRS duration from the global QRS onset to the global QRS termination . This means that an isoelectric segment within one particular QRS complex by definition will lead to a shorter QRS duration for that lead compared to the global QRS duration .”

ECG Distortion test filters: No device filters used or required during testing .


111


Configuration

Specification DescriptionEthernet Microtel Gigabit Ethernet: 10/100/1000Mbps IEEE 802 .3 compliantWLAN Intel Dual Band 2 .4 GHz, 5 GHz, IEEE 802 .11 ac/a/b/g/nWi-Fi connection WEP- or WPA-enabled access point with password only (no LDAP- or Active Directory-

enabled authentication requiring username and password)

Data UseThe MyoVista Device transmits ECG test results containing patient information (patient ID, name, date of birth, sex, height, and weight) and ECG tests results (multiple lead traces accompanied by multiple post-test analyses) over network connections .

Potential Issues with Network-Based PrintersDelayed test results can occur due to network availability or load/congestion . If you are unable to print over the network, use another method to view the ECG results (on screen, USB printer, or export to PDF on USB) .

Though unlikely, a report may contain inaccurate data under certain circumstances, such as due to electromagnetic interference . The TCP/IP protocol and Ethernet/WLAN transport typically resolve these issues automatically without software or end-user action . Review and verify all data on printed and exported reports .

Printing to an unattended or remote group printer can result in an unauthorized individual viewing patient and clinical data . We caution against using unattended or remote printers .

Potential Issues with Network Storage (Mapped Network Drive(s))Delayed test results can occur if the account information used to create the network drive become invalid or the folder it is connected to is moved . If you are unable to export to the network drive, you can either use a USB storage media or re-configure network storage and try again .

Though unlikely, a loss in network connectivity may result in an incomplete or invalid report export .

HeartSciences recommends restricting access to the network drive folder to prevent unauthorized disclosure of patient identifiable information .


112



EMC Declaration TablesThe MyoVista Device is intended for use in the electromagnetic environment specified below .

Electromagnetic Emissions

Emission test Compliance Electromagnetic environment - guidanceRF emissions CISPR 11

Group 1 The MyoVista Device 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 .

RF emissions CISPR 11

Class A The MyoVista Device is suitable for use in commercial and hospital quality establishments .

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

Electronic Immunity

Immunity test IEC 60601 test level

Compliance level Compliance level

Electrostatic discharge (ESD)IEC 61000-4-2

±8 kV contact±15 kV air

±8 kV contact±15 kV air

Floors should be wood, concrete or ceramic tile . If floors are covered with synthetic material, the relative humidity should be at least 30% .

Electrical fast transient/burstIEC 6100-4-4

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

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

Mains power quality should be typical of a commercial or hospital environment .

SurgeIEC 61000-4-5

±1 kV differential mode±2 kV common mode

±1 kV differential mode±2 kV common mode

Mains power quality should be typical of a commercial or hospital environment .

1Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11

<5% voltage for 0 .5 cycles; <5% voltage for 1 cycle; 70% voltage for 25 cycles; <5% voltage for 250 cycles

<5% voltage for 0 .5 cycles; <5% voltage for 1 cycle; 70% voltage for 25 cycles; <5% voltage for 250 cycles

Mains power quality should be typical of a commercial or hospital environment . The MyoVista Device provides an internal battery for uninterrupted use during power mains interruptions .

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

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment .

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Conducted RF IEC 6100-4-6Radiated RF IEC 6100-4-3

3 Vrms150 kHz80MHz3 V/m80 MHz2 .7 GHz

3 Vrmsc3 V/mc Portable and mobile RF communications equipment should be used no closer to any part of the MyoVista Device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter .Recommended separation distanced = 1 .2 √Pd = 1 .2 √P 80 MHz – 800 MHzd = 2 .3 √P 800 MHz – 2 .5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) .Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey: A) should be less than the compliance level in each frequency range . B) Interference may occur in the vicinity of RF communications equipment

Note 1: the voltage is mains supply voltage, and the degradation is based on nominal voltage prior to application of the test level . Note 2: These guidelines may not apply in all situations . Electromagnetic propagation is effected by absorption and reflection from structures, objects and people .

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy . To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered . If the measured field strength in the location in which the MyoVista Device is used exceeds the applicable RF compliance level above, then the MyoVista Device should be observed to verify normal operation . If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MyoVista Device .

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m .

c Amplitude modulated at 80% with a modulation frequency of 1KHz per EN 60601-1-2 .

Recommended Separation DistancesRefer to the following table for recommended separation distances between the MyoVista Device and portable and mobile RF communication equipment .

The MyoVista Device is intended for use in an electromagnetic environment in which radiate RF disturbances are controlled . The user of the MyoVista Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MyoVista Device as recommended below, according to the maximum output power of the communications equipment .

Rated maximum output power of transmitter

W

Separation distance according to the frequency of transmitter150 kHz – 80 MHz

d = 1 .2 √P80 MHz – 800 MHz

d = 1 .2 √P800 MHz – 2 .5 GHz

d = 2 .3 √P0 .01 0 .12 0 .12 0 .230 .1 0 .38 0 .38 0 .731 1 .2 1 .2 2 .310 3 .8 3 .8 7 .3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer .

Note1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies .

Note2: These guidelines may not apply in all situations . Electromagnetic propagation is effected by absorption and reflection from structures, objects, and people .

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Appendix

B . Error Messages Message Occurs When . . . Action

The password is not valid for network security mode

The device connects to a wireless network and the wrong password is entered

Select the Close icon, and then enter correct password

Failed to configure network

No storage disk selected

A function requiring a USB device is being performed, but the device did not find a USB device connected to its USB ports

Connect or reconnect a USB drive to one of the USB ports and ensure it is seated properly .

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C . Vesa MountingThis appendix describes how to attach a VESA mount .

Caution: If mounting the device using the VESA mounting interface on the back panel, check the ade-quacy of the surface attachment. The VESA mount and surface should be able to support at least 8 kg (17.6 lbs.).

Note: The MyoVista Device accommodates a 100 mm by 100 mm standard VESA mount. The adjustable stand does not have to be removed when using the VESA mount.

To attach a VESA mount:

Appendix

1 . Locate the four VESA mount holes on the back of the MyoVista Device .

3 . Align the VESA mount kit with the VESA mount holes, and then insert the screws .

2 . Locate the four screws from the VESA mount kit (M4 VESA standard mount screws) .

4 . Tighten the VESA mount screws . Do not overtighten the screws .

5 . Confirm that the mount is secure .

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Appendix

D . GlossaryAcronym Description

CWT Continuous wavelet transform

ECG Electrocardiograph

EMR Electronic Medical Record

GUI Graphical User Interface

HDMI High-Definition Multimedia Interface

IFU Instructions for Use

VIEM Ventricular Index – Early Measure (for both Left Ventricle and Right Ventricle)

VILM Ventricular Index – Late Measure (for both Left Ventricle and Right Ventricle)

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Appendix

E . MyoVista wavECG™ Analysis, Algorithms and Statements Development and Statistical Performance InformationMyoVista wavECG Development

The MyoVista wavECG™ Information is developed by HeartSciences . The technology was developed in response to a substantial amount of recent research linking most forms of heart disease with diastolic dysfunction . It is based on years of research by HeartSciences . It provides analysis of ECG information using frequency domain information obtained using wavelet signal processing in addition to conventional ECG information . It can be used to assist in determining patient risk for relaxation abnormalities associated with Left Ventricular diastolic dysfunction (LVDD) . The MyoVista wavECG Device extensively uses age and sex-based criteria . The quote below describes the relationship between heart disease and diastolic dysfunction and underlines the importance of understanding patient risk related to diastolic dysfunction . The article was published in American Heart Association’s Circulation publication .

LV diastolic dysfunction and Prognosis AHA Circulation 2012 Feb 14; 125(6): 743–745. Dalane W. Kitzman, MD and William C. Little, MD

“It is remarkable that serial evaluation of LV diastolic function could be such a powerful predictor of all-cause mortality, not just cardiovascular death….…normal LV diastolic function requires normal function and integration of left ventricular ejection, relaxation, and structure and is an active energy requiring process. Thus, diastolic performance is sensitive to nearly all of the common pathological processes that affect cardiovascular function.”

Description and Statistical Performance of MyoVista wavECG Information and MeasuresThe MyoVista wavECG Information is designed to provide information related to myocardial energy that may be used by a physician as part of an overall risk assessment to assist in determining if a patient should receive further testing, evaluation and/or treatment .

Clinical data has been generated in prospective, non-randomized, clinical studies conducted at three institutions . Subjects were all adults which were either healthy volunteers with no known cardiac disease or at-risk symptomatic or asymptomatic subjects who were clinically indicated for cardiac screening . All at-risk subjects enrolled had been referred for echocardiographic analysis, computed tomography coronary angiogram and/or coronary angiogram . The Relative-Risks have been calculated from three separate validation datasets (n=124, n=86, n=817; total n=1027) . In some cases, only one or two of these validation datasets were used to provide performance results in this document in order to ensure independence from any data that was used to develop these measures . In these cases, the validation results fall well within the 95% confidence intervals as compared to the performance of the development datasets, therefore confirming that the results provided in the sections below met the performance targets predicted during development of these measures . All patients were measured for Low e’ (<7 septal velocity or <10 lateral velocity) using tissue Doppler echocardiography as the reference measure for determining the presence or absence of relaxation abnormalities associated with LVDD .

HeartSciences recommends using the MyoVista wavECG Information in conjunction with other health-related patient information to determine the appropriate clinical pathway and treatment options for each patient .

The MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device (MyoVista Device) uses Continuous wavelet transform (CWT) mathematics to display and analyze the energy detected during the cardiac cycle, with particular emphasis on repolarization . The information is provided in five forms (Figure E-1):

A . MyoVista Energy Waveform

B . MyoVista Summary Statement and Indicators

C . MyoVista Wavelet Analysis, Algorithms and Statements

D . MyoVista Ventricular Indices

E . MyoVista Energy Classification

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Figure E-1

MyoVista Energy Waveform Figure E-2 shows an example of the MyoVista Energy Waveform after signal processing, using Continuous wavelet transform and its relationship to the QRST (Q, R, S, and T-waves) complex .

Figure E-2. MyoVista Energy Waveform

The color scaling (scalogram) provides a non-linear mapping of energy from 0 to 100% which represents the level of energy detected from the heart at each point in time and frequency . Blue represents low energy, red represents high energy, and intermediate energy levels are shown according to the red, blue, green (RBG) color scale above (see the scale key on the left side of Figure 2) . The colors represent a distribution of energy detected during the cardiac cycle rather than providing absolute values . The horizontal axis (x-axis) is time and the vertical axis (y-axis) is frequency . The frequencies range from 3 Hz at the bottom of the display to 200 Hz at the top using a non-linear scale .

This visual representation is provided to give context for the remainder of the wavelet measures and statements provided by the MyoVista Device .

MyoVista Summary Statement and IndicatorsThe MyoVista Summary Statement and Indicators have a sensitivity of 74 .3% and a specificity of 72 .9% for the detection of myocardial relaxation abnormalities associated with Left Ventricular Diastolic Dysfunction (LVDD) based on the overall statistical performance of the Repolarization Measures Algorithm .

The MyoVista Summary Statement and Indicators provide an overall summary of all the wavECG Analysis . The statement categorizes the overall wavECG Analysis results as either “Normal”, “Borderline”, or “Abnormal” and is displayed in text as well as in a color-coded icon (see Figures E-3, E-4, E-5) .

Appendix E: MyoVista wavECG Information, Measures Development and Statistical Performance

A

BCDE

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The summary represents the overall wavECG Analysis results as performed by the software algorithms . MyoVista version 2 .0 software contains algorithms which perform analysis relating to the following:

• Repolarization Measures Algorithm (relaxation abnormalities associated with LV diastolic dysfunction)

Note: Future software releases may be expanded with additional algorithms for enhanced detection of heart disease.

For patients which are not identified by the MyoVista Device as having a significantly elevated risk of relaxation abnormalities associated with LV diastolic dysfunction, a classification of “Normal” is displayed (see Figure E-3) . This occurs when no abnormalities associated with MyoVista Measures, Analysis and Algorithms are identified .

Note: This is not a “rule-out” measure, but rather a measure representing a lower risk of relaxation abnormalities associated with LV diastolic dysfunction when compared to clinical study patients whose categorizations are “Borderline” or “Abnormal” (as well as comparing against the overall clinical study population).

Note: The MyoVista Wavelet Analysis is independent of Glasgow Interpretive Analysis findings.

Figure E-3

For patients which are identified by the MyoVista Device as having an elevated risk of relaxation abnormalities associated with LV diastolic dysfunction (or where a risk assessment is inconclusive), a categorization of “Borderline” is displayed (see Figure E-4) . In this case, additional statements explaining the summary categorization will be provided, which include a Repolarization Measures Statement and Ischemic or Structural risk assessment statement and may also include Ventricular Indices Statement(s), if applicable . The relative-risk measure for “Borderline” patients when compared to patients with a “Normal” wavECG is provided in Table E-1 .

Figure E-4

For patients which are identified by the MyoVista Device as having a significantly elevated risk of relaxation abnormalities associated with LV diastolic dysfunction, a categorization of “Abnormal” is displayed (see Figure E-5) . In this case, additional statements explaining the summary classification will be provided, which include a Repolarization Measures Statement and Ischemic or Structural risk assessment statement and may also include Ventricular Indices Statement(s), if applicable . The relative-risk measure for “Abnormal” patients when compared to patients with a “Normal” wavECG is provided in Table E-1 .

Figure E-5


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MyoVista Wavelet Analysis, Algorithms and Statements The MyoVista Wavelet Analysis, Algorithms and Statements provide the results of the Wavelet Analysis (with inputs from the MyoVista Energy Classification and MyoVista Ventricular Indices, as well as other conventional measures such as T-Axis, sex, and age) and provides statements that can be used to assist in determining the relative-risk of a patient having a relaxation abnormalities associated with LV diastolic dysfunction that may require further clinical testing, evaluation and/or treatment . These statements were developed using clinical study data .

The MyoVista Wavelet Analysis Statements section of the reports includes the following types of informational statements (see Figure E-6):

• Repolarization Measures Algorithm Statement (if applicable – see “A” on Figure E-6) • Ischemic or Structural risk assessment statement (if applicable – see “B” on Figure E-6) • Ventricular Indices Statements (if applicable – see “C” on Figure E-6)

Figure E-6

Repolarization Measures Algorithm Statement The Repolarization Measures Algorithm Statement is optimized to correlate to relaxation abnormalities associated with LV diastolic dysfunction and provide the results of applying a series of criteria using clinical study data . This criteria includes wavECG Measures such as the MyoVista Energy Classification and the MyoVista Ventricular Indices, and also incorporates conventional ECG measures such as T-Axis and demographic information such as age and sex .

The Repolarization Measures Algorithm Statement has three categorizations: “Normal”, “Borderline” and “Abnormal” .

Based on patients being categorized as borderline or abnormal for having left ventricle relaxation abnormalities associated with diastolic dysfunction .

The MyoVista Summary Statement and Indicators have a sensitivity of 74 .3% and a specificity of 72 .9% for the detection of myocardial relaxation abnormalities associated with Left Ventricular Diastolic Dysfunction (LVDD) based on the overall statistical performance of the Repolarization Measures Algorithm .

NOTE: Patients marked as “Borderline: Inconclusive” were omitted from these calculations.


CBA

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Table E-1 . Provides the relative-risk measures for the Repolarization Measures Algorithm Statement .

Example: Clinical studies show that patients with and without cardiac relaxation abnormalities can exist across the entire range of results for the MyoVista Repolarization Algorithm . However, women whose MyoVista Repolarization Measures Algorithm Statement is “Abnormal” are over 173% more likely to have relaxation abnormalities associated with LV diastolic dysfunction when compared to those whose MyoVista Repolarization Measures Algorithm Statement is “Normal” .

Table E-1

MyoVista Repolarization Measures Algorithm

StatementSex Relative-Risk

(n=210)

Borderline Repolarization Measures

(compared to Categorization of

“Normal”)

Combined3 .04X

95% CI [1 .90, 4 .86] p-value: <0 .0001

Men4 .82X

95% CI [2 .08, 11 .20] p-value: 0 .0003

Women1 .99X

95% CI [1 .04, 3 .83] p-value: 0 .0380

Abnormal Repolarization Measures


“Normal”)

Combined3 .89X

95% CI [2 .47, 6 .11] p-value: <0 .0001

Men6 .73X

95% CI [2 .95, 15 .36] p-value: <0 .0001

Women

2 .73X 95% CI [1 .57, 4 .76]

p-value: 0 .0004For example a patient in this category would have a greater than 173% higher risk than patients with a

categorization of “Normal” .

HeartSciences recommends using the MyoVista wavECG Information in conjunction with other health-related patient information to determine the appropriate clinical pathway and treatment options for each patient .

Ischemic or Structural Risk assessment statement (if applicable)If the Repolarization Measures Algorithm Statement is either “Borderline” or “Abnormal”, then an Ischemic or Structural Risk assessment statement will also be displayed below the Repolarization Measures Statement (see Figure E-6) .

If the Repolarization Measures Algorithm Statement is classified as “Abnormal”, then the statement “Probable Ischemic or Structural Abnormality” is displayed .

If the Repolarization Measures Algorithm Statement is classified as “Borderline”, then additional calculations are applied within the software to further stratify risk, and one of two additional statements will be displayed: “Possible Ischemic or Structural Abnormality” or “Inconclusive Ischemic or Structural Risk Assessment” . Some of the borderline classifications have low statistical significance and in these cases the “Inconclusive Ischemic or Structural Risk Assessment” statement is displayed . The statistical strength of the analysis for these patients was insufficient due to low incidence in the clinical data . This should occur in less than 5% of all patients tested .


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Table E-2 . Summarizes the relative-risk measures for the Ischemic or Structural Risk assessment statements .

Table E-2

Ischemic or Structural Risk assessment

statementSex Relative-Risk

(n=210)

Inconclusive Ischemic or Structural Risk

Assessment

CombinedCriteria resulted in statistically insignificant measures.

(p-value is >0 .05)Men

Women

Possible Ischemic or Structural Abnormality


“Normal”)

Combined2 .92X

95% CI [1 .81, 4 .72] p-value: <0 .0001

Men4 .77X

95% CI [2 .05, 11 .06] p-value: 0 .0003

Women1 .62X

95% CI [0 .76, 3 .47] p-value is 0 .2155

Probable Ischemic or Structural Abnormality


“Normal”)

Combined3 .89X

95% CI [2 .47, 6 .11] p-value: <0 .0001

Men6 .73X

95% CI [2 .95, 15 .36] p-value: <0 .0001

Women2 .73X

95% CI [1 .57, 4 .76] p-value: 0 .0004


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MyoVista Ventricular Indices

The MyoVista Ventricular Indices represent the relative energy values of the left and right ventricles at specific time points during repolarization (just prior to and after the T-Wave peak) . The indices are displayed as a percentage of energy in relation to the peak energy detected during the cardiac cycle (usually close to or at an R-Wave peak) . There are four Index values provided, as well as numeric comparisons (differences and ratios) for these four measurements . The right ventricle indices are an average of V1 and V2 leads, and the left ventricle indices are an average of V4, V5, and V6 leads .

Figure E-7 . Shows an example of a MyoVista Ventricular Indices table .

Table E-3 . Defines each cell in the table, including the numeric comparisons (differences and ratios) for these four index measurements .

Figure E-7

Table E-3

Index Description

VIEM (RV) Ventricular Indices Early Measure (Right Ventricle)

VILM (RV) Ventricular Indices Late Measure (Right Ventricle)

VIEM (LV) Ventricular Indices Early Measure (Left Ventricle)

VILM (LV) Ventricular Indices Late Measure (Left Ventricle)

Diff The difference between the values in the column . This calculation is provided for user convenience .

Ratio The ratio between the values in the row . This calculation is provided for user convenience .


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Ventricular Indices Statements (if applicable) These Indices (and numeric comparisons) have ranges which demonstrate an elevated risk of relaxation abnormalities associated with LV diastolic dysfunction .

If any of the criteria related to the MyoVista Ventricular Indices specified are met, then a statement listed in Table E-4 will be displayed below the Repolarization Measures Algorithm Statement (see Figure E-8) .

Figure E-8

Table E-4 . Provides the relative-risk calculations for a patient having relaxation abnormalities associated with LV diastolic dysfunction as opposed to those who do not trigger the rule stated in that row .

Table E-4

Sex Rule MyoVista Wavelet Analysis Statement

Relative-Risk (n=1027)

Men and Women VIEM(RV) < 20 Abnormal VIEM(RV) < 20%1 .42X

95% CI [1 .16, 1 .76] p-value: 0 .0009

Men and Women VILM(RV) < 17 Abnormal VILM(RV) < 17%1 .33X

95% CI [1 .02, 1 .73] p-value: 0 .0331

Women VIEM(LV) < 22 Abnormal VIEM(LV) < 22%1 .48X

95% CI [1 .27, 1 .73] p-value: <0 .0001

Women VILM(LV) < 21 Abnormal VILM(LV) < 21%1 .53X

95% CI [1 .32, 1 .77] p-value: <0 .0001

Women [VIEM(RV) / VIEM(LV)] > 2 .5 Abnormal VIEM Ratio > 2 .5

1 .46X 95% CI [1 .21, 1 .77] p-value: <0 .0001

Women [VILM(RV) / VILM(LV)] > 2 .5 Abnormal VILM Ratio > 2 .5

1 .45X 95% CI [1 .19, 1 .77] p-value: <0 .0001

Women [VIEM(RV) – VILM(RV)] < 0 .4 Borderline RV VIEM-VILM difference < 0 .4

1 .10X 95% CI [0 .83, 1 .47]

p-value: 0 .5112

Women [VIEM(RV) – VILM(RV)] > 4 .5 Borderline RV VIEM-VILM difference > 4 .5

1 .44X 95% CI [1 .23, 1 .69] p-value: <0 .0001

Men [VIEM(RV) – VILM(RV)] > 5 .3 Borderline RV VIEM-VILM difference > 5 .3

1 .44X 95% CI [1 .22, 1 .70] p-value: <0 .0001


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MyoVista Energy Classification

The MyoVista Energy Classification (see “E” on Figure E-1) provides an overall indication (i .e . aggregation of information from all 12 leads) of relative energy levels detected during the test period and reports this information in a simplified category of either “High”, “Moderate” or “Low” (see Figure E-9) .

The overall calculation performs a complex set of transformations as well as applying a variety of heuristic rules to formulate a final classification of “High”, “Moderate” or “Low . The MyoVista Energy Classifications primarily use wavECG Measures, but also make adjustments for other factors such as sex and age . The MyoVista Energy Classification is disease non-specific and for information only .

Figure E-9


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Appendix

F . END USER LICENSE AGREEMENTEND USER LICENSE AGREEMENT AT THE DATE OF THIS DOCUMENT

This End User License Agreement (the “Agreement”) is entered into by and between Licensee and HeartSciences, a Texas corporation, having a place of business at 550 Reserve Street, Suite 360 Southlake, TX 76092 USA, (the “Licensor”) .

THE TERMS AND CONDITIONS SET FORTH BELOW ARE LEGALLY BINDING ON YOU, AS LICENSEE, WHEN YOU DOWNLOAD, INSTALL, ACCESS, OR OTHERWISE USE SOFTWARE THAT IS WITHIN, OR PROVIDED WITH OR AS PART OF, A HEARTSCIENCES BRANDED MYOVISTA PRODUCT, OR DOWNLOAD ANY UPDATE TO SUCH SOFTWARE . IF YOU DO NOT AGREE WITH ANY OF THESE TERMS AND CONDITIONS, DO NOT DOWNLOAD, INSTALL, ACCESS, OR OTHERWISE USE THE SOFTWARE OR ANY UPDATES THERETO . YOUR PERFORMANCE OF ANY OF THE FOREGOING ACTS SHALL BE DEEMED TO BE YOUR AGREEMENT TO BE BOUND BY EACH OF THE TERMS AND CONDITIONS SET FORTH BELOW .

1 . Definitions1 .1 . “Confidential Information” means the Licensed Software and all Derivative Works thereof (including

Executable Code, Source Code and updates and upgrades of any of the foregoing, regardless of by whom made, and whether or not made in accordance with this Agreement), and all trade secrets, know-how, inventions (whether or not patentable), techniques, processes, programs, ideas, algorithms, formulas, schematics, testing procedures, software design and architecture, computer code, internal documentation, design and functional specifications, product requirements, problem reports, performance information, documents, and other technical, business, product, marketing, third-party customer and financial information, plans and data in or relating to the Licensed Software and/or such Derivative Works . “Confidential Information” also means all other information disclosed or provided by Licensor to Licensee during communications between Licensor and Licensee or otherwise that, given the circumstances under which such information is disclosed or provided by Licensor to Licensee, would lead a reasonable person to conclude that such information is confidential to Licensor . All Confidential Information is the property of Licensor .

1 .2 . “Derivative Work” means a new or modified work that is based on or derived from a preexisting work, including, without limitation, a work that, in the absence of a license, would infringe the copyright in such preexisting work or that uses trade secrets or other proprietary information with respect to such preexisting work . All Derivative Works are owned by, and are the Confidential Information of, Licensor .

1 .3 . “Documentation” means the online, electronic user guides and other online, electronic documentation which Licensor makes available which describes the installation and use of the Licensed Software or other parts of a HeartSciences branded Product .

1 .4 . “Executable Code” means the fully compiled version of the Licensed Software, substantially or entirely in binary, that can be executed by a computer and used by an end user without further compilation, and which is not debuggable .

1 .5 . “Intellectual Property Rights” mean any and all (by whatever name or term known or designated) tangible and intangible and now known or hereafter existing (a) rights associated with works of authorship, including but not limited to copyrights, moral rights, and mask-works, (b) trademark and trade name rights and similar rights, (c) trade secret rights, (d) patents, design rights, and other industrial property rights, (e) all other intellectual and industrial property rights (of every kind and nature and however designated), including logos, “rental” rights and rights to remuneration, whether arising by operation of law, contract, license, or otherwise, and (f) all registrations, patent, trademark or other applications (including continuations, continuations-in-part, and divisions thereof), and renewals, extensions, reissues and re-examinations thereof now or hereafter in force (including all rights in all of the foregoing) .

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Appendix F: End User License Agreement

1 .6 . “Licensed Software” means the current version of Licensor’s computer code that is included internal to the Product or otherwise supplied for use with the Product, and any data included therewith, and may include licensed third party code . “Licensed Software” also means the Documentation . “Licensed Software” also includes new versions that may be provided from time to time, via download or otherwise, by Licensor .

1 .7 . “Licensed Third Party Code” means any code provided by a third party that is licensed for use in the Licensed Software . Licensed Third Party Code includes any documentation provided with or as part of the code .

1 .8 . “Licensee” means the business entity that, through its officers, employees or contractors, downloads, installs, or otherwise uses the Licensed Software, as licensed herein .

1 .9 . “Product” means any HeartSciences-branded MyoVista Product, and any part or accessory thereof, that is distributed by or for HeartSciences .

1 .10 . “Source Code” means the human-readable version of a software program that can be compiled into Executable Code .

1 .11 . “Licensed Third Party Code” means any code provided by a third party that is licensed for use in the Licensed Software . Licensed Third Party Code includes any documentation provided as part of the code .

2 . License and Restrictions2 .1 . Grant of License . In accordance with the terms and conditions of this Agreement, Licensor grants

to Licensee, and Licensee accepts from Licensor, a non-exclusive and non-transferable license (the “License”) to execute the Licensed Software only on the unit of the Product with which or for which it was provided, and solely for the business purposes of Licensee . Such license includes the right for the Licensed Software to be executed by employees and contractors of Licensee who have a demonstrable need to know or execute the Licensed Software in order to perform the internal business of Licensee .

2 .2 . Notwithstanding any other statement in this Agreement, no right to Source Code and no right to make Derivative Works are granted in this Agreement .

2 .3 . The licenses granted herein are granted on the following conditions .

2 .3 .1 . Licensee shall not (a) use the Licensed Software in a manner that violates the law; (b) distribute or otherwise transfer (in whole or in part), disclose, market, rent, lease, grant a security interest in, assign, sublicense, or pledge the Licensed Software; (c) decompile, disassemble or otherwise reverse engineer the Licensed Software, or any portion thereof, or determine or attempt to determine any Source Code, algorithms, methods or techniques used or embodied in the Licensed Software; (d) destroy, remove or alter any copyright, trademark, or other proprietary notice, from the Licensed Software; (e) use or permit use of the Licensed Software by any person or entity other than Licensee or Licensee’s employees or contractors; (f) incorporate or allow the incorporation of the Licensed Software into any computer chip or firmware not manufactured by HeartSciences .

2 .4 . Derivative Works . Although not licensed to do so should Licensee make or have-made a Derivative Work of the Licensed Software or of any such Derivative Work, Licensee hereby assigns all such Derivative Works to Licensor .

2 .5 . Compliance . Licensee acknowledges and agrees that Licensor may monitor compliance with the terms of this Agreement by incorporating license management technology into the Licensed Software, including any security devices, and operating such technology and/or devices . In addition, Licensee grants Licensor the right to verify that Licensee is in compliance with this Agreement .

2 .6 . Ownership . All right, title and interest in and to the Licensed Software, and all world-wide Intellectual Property Rights related to the Licensed Software, all trade names, trademarks and domain names registered, reserved or used by Licensor, all websites owned or operated by Licensor, including the

128



“look and feel” of such websites, all Licensor Products and services, software codes, interfaces, and all other proprietary knowledge, know-how, images, materials and other signals made available by Licensor to the Licensee, and any and all Intellectual Property Rights related thereto, whether registered or unregistered, are solely owned by Licensor and are protected by worldwide copyright, trademark, trade secret and/or patent laws, as well as other intellectual property laws and treaties .

2 .7 . Modifications . Licensor reserves the right at any time and at its sole discretion to modify, suspend or discontinue, temporarily or permanently, the Licensed Software or any part thereof, with or without notice, and without any liability for any modification, suspension or discontinuance thereof .

2 .8 . Updates . Licensor may provide, by download or otherwise, updates to the Licensed Software (“Updates”) . Licensee agrees that Updates are subject to the terms, conditions, restrictions and obligations of this Agreement .

2 .9 . Licensed Third Party Code . The Licensed Software may include Licensed Third Party Code . Licensee’s rights and responsibilities with respect to such Licensed Third Party Code shall be governed in accordance with the third party’s applicable software license . Licensee agrees, on request, to enter into one or more separate “select-accept” license agreements or third party license agreements as part of the installation and/or download process and/or Update process for Licensed Software . Such applicable software license which shall supersede this Agreement with respect to the Licensed Third Party Code covered by such license .

3 . Express Limited Warranty; Disclaimer of Warranty, Limitation of Warranty . 3 .1 . Licensor represents and warrants that it has the right to grant Licensee the licenses granted in this

Agreement .

3 .2 . Limited Software Warranty . Except as indicated otherwise below, HeartSciences warrants that (i) for Ninety (90) days from the date of purchase of such Product, that the Licensed Software will perform substantially in accordance with the applicable Documentation, (ii) it has not inserted any Disabling Code (as defined herein) into the Licensed Software and (iii) it will use reasonable commercial efforts consistent with industry standards to scan the Licensed Software for and remove any software viruses before installation into the Product . Except as indicated otherwise below, HeartSciences warrants that it has the right to license or sublicense the Licensed Software to Customer as set forth in Section 2 .1 (License Grant) . As used in this warranty statement, (i) “Disabling Code” means computer code that is designed to delete, interfere with, or disable the normal operation of the Product; provided, however, that code included in the Licensed Software for monitoring compliance with this Agreement will not be deemed to be Disabling Code .

3 .2 .1 . Exclusions . This Limited Software Warranty does not apply to any Product that was not purchased or leased from HeartSciences or any of its authorized distributors . If the HeartSciences serial number on the Product has been altered, damaged, rendered defective, or removed from the Product, this Limited Software Warranty is void . This Limited Software Warranty does not cover normal wear and tear or any loss, damage, or defects caused by: (1) attempted disassembly or repair by anyone not authorized by HeartSciences; (2) failure to follow instructions for use, maintenance, and cleaning; (3) drops, impacts, fire, water damage, misuse, abuse, neglect, accident, or external forces, (4) the Product having been altered or tampered with in any way, (5) the Product having been used or maintained in any manner that is inconsistent with HeartSciences instructions or warnings included with the Product, as applicable, (6) the Product having been used in any manner that is inconsistent with the intended purpose or design of the Product, as applicable, as described in HeartSciences published documentation for the Product, (7) transportation to the Licensee’s facility, (8) Licensee’s or any third party’s supplied software, interfaces, parts, supplies, or accessories, (9) operation outside of environmental specifications for the Product, or (10) improper site preparation or maintenance . HeartSciences is not responsible for any costs, expenses, or charges incurred by Licensee for any attempted disassembly or repair by anyone not authorized by HeartSciences . This

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Limited Software Warranty does not apply to any accessories that are designed to be disposable or for single use and which have been reused, or attempted to be reused . With respect to Products, if Licensee has not provided HeartSciences with completed warranty registration information within thirty (30) days after purchase or lease of a Product, then the benefits of this Limited Software Warranty do not apply . Notwithstanding any other statement in this Agreement, this Limited Software Warranty does not apply to any third party code within the Licensed Software, which third party code is warranted under the warranty provided by the such third party, if any, to the extent that HeartSciences is authorized to pass such third party warranty through to Licensee .

3 .3 . DISCLAIMER OF WARRANTY . OTHER THAN THE EXPRESS WARRANTY MADE IN SECTIONS 3 .1 AND 3 .2, LICENSOR MAKES NO WARRANTY, WHETHER EXPRESS, IMPLIED OR STATUTORY . FURTHER, THE LICENSED SOFTWARE IS PROVIDED “AS IS” AND WITHOUT ADDITIONAL WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED . TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, AND EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 3 .1 AND 3 .2, LICENSOR DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF, ACCURACY, MERCHANTABILITY, NON-INFRINGEMENT, TITLE, AND FITNESS FOR A PARTICULAR PURPOSE, AND ANY WARRANTIES THAT MAY ARISE FROM COURSE OF DEALING, COURSE OF PERFORMANCE, OR USAGE . LICENSOR DOES NOT WARRANT THAT LICENSEE’S EXERCISE OF RIGHTS GRANTED HEREIN WILL BE UNINTERRUPTED, ERROR-FREE OR SECURE, OR THAT DEFECTS IN THE LICENSED SOFTWARE WILL BE CORRECTED . NO OPINION, ADVICE OR STATEMENT BY OR ON BEHALF OF LICENSOR SHALL CREATE ANY WARRANTY OTHER THAN THAT SET FORTH IN SECTIONS 3 .1 AND 3 .2 . LICENSEE’S EXERCISE OF ANY RIGHTS GRANTED HEREIN IS ENTIRELY AT LICENSEE’S RISK . THIS AGREEMENT PROVIDES NO INDEMNITY TO LICENSEE .

3 .4 . Licensee Representations . Licensee represents and warrants that Licensee has read and understands the description of the Licensed Software as may be included in the Licensed Software or indicated at the address specified by any URL provided for such description .

4 . Consulting Services 4 .1 . No consulting or professional services are provided as part of this Agreement .

5 . Confidential Information .5 .1 . Use and Disclosure Restrictions . The Licensee hereby acknowledges and agrees that Confidential

Information constitutes and contains valuable proprietary information and trade secrets of the Licensor, and embodies substantial creative efforts and Confidential Information, ideas, methods, and expressions . Accordingly, Licensee agrees: (i) to protect Confidential Information of the Licensor from unauthorized dissemination and use; (ii) to use such Confidential Information only for the exercise of its license rights as set forth in Section 2 .1 (Grant of License); (iii) to limit the use of and access to such Confidential Information to such employees and contractors set forth in Section 2 .1 (Grant of License); (iv) not to disclose, license, transfer, sell, publish, disclose, display or otherwise provide to any third party any of the Licensed Software, and/or any of Licensor’s Confidential Information, or any part or parts of such Licensed Software and Confidential Information; (v) to undertake whatever action is necessary to prevent or remedy (or authorize the Licensor to do so in the Licensee’s name) any breach of the confidentiality obligations set forth herein; (vi) not to remove or destroy any proprietary, confidential, or copyright legends or markings placed upon or contained within the Licensed Software, or on any other Confidential Information disclosed or provided by or for the Licensor to the Licensee; and (vii) promptly to notify the Licensor in writing of any unauthorized disclosure, theft and/or unauthorized use of any Confidential Information of the Licensor .

5 .2 . Exceptions . For purposes of this Agreement, Confidential Information shall not include, and the confidentiality and non-use obligations provided hereunder shall not apply to, information that: (i) is

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now or subsequently becomes generally available to the public through no fault of the Licensee; (ii) the Licensee can demonstrate by dated documents was rightfully in its possession prior to disclosure or provision by the Licensor; (iii) the Licensee rightfully obtained or obtains from a third party who has the right, without obligation to the Licensor, to transfer or disclose; or (iv) is released by the Licensor without restriction and in writing .

5 .3 . Disclosure by Order from Authority . If a Licensee becomes legally compelled to disclose any Confidential Information of the Licensor, the Licensee shall immediately notify the Licensor in writing so that the Licensor may, at its option, seek a protective order or other appropriate remedy, or waive compliance with one or more provisions of this Agreement . If the Licensor elects to seek a protective order or other appropriate remedy, the Licensee shall cooperate with, and not object to, any such actions . If a protective order or other remedy is not obtained or the Licensor waives compliance with any of the provisions of this Agreement, the Licensee shall furnish only that portion of the Confidential Information which it reasonably believes on advice of counsel is legally required to be disclosed .

5 .4 . Equitable Relief . Licensee acknowledges that Confidential Information has unusual and extraordinary value, and that the breach or prospective breach of any confidentiality provision of this Agreement, by the Licensee will cause Licensor great and irreparable harm, for which remedies available at law are inadequate . Therefore, Licensor shall be entitled, without posting bond, to seek injunctive and other equitable relief, including, but not limited to, specific performance, to prevent a breach, continued breach or threatened breach of any confidentiality obligation of this Agreement, in addition to any damages that may be awarded to Licensor .

6 . Limitation of Liability .6 .1 . LICENSOR SHALL NOT BE RESPONSIBLE OR LIABLE FOR ANY INDIRECT, INCIDENTAL,

CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR OTHER DAMAGES TO LICENSEE OR ANY OF ITS PERMITTED EMPLOYEES AND CONTRACTORS (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS, LOSS OF DATA OR LOST PROFITS) ARISING OUT OF OR RELATING IN ANY WAY TO THIS AGREEMENT OR TO THE USE OF THE LICENSED SOFTWARE, WHETHER ARISING IN AN ACTION OR CLAIM BASED ON CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF LICENSOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES . IN NO EVENT SHALL LICENSOR’S LIABILITY, WHETHER BASED ON AN ACTION OR CLAIM IN CONTRACT OR TORT, STRICT LIABILITY, OR OTHERWISE, EXCEED THE AMOUNT PAID BY LICENSEE FOR THE PRODUCT .

7 . Option of Licensor As a result of any claim of infringement against the Licensed Software, or if Licensor believes that the Licensed Software is likely to become the subject of a claim of infringement, Licensor at its option and expense may discontinue the licenses granted herein on one (1) month’s written notice .

8 . Termination 8 .1 . Licensor shall have the right to terminate this Agreement or the licenses granted herein:

8 .1 .1 . Upon ten (10) days’ written notice in the event that Licensee or its employee or contractor violates any provision of this Agreement including, but not limited to, confidentiality provisions, or acts beyond the scope of the licenses granted in Section 2 .1 (License Grant) .

8 .1 .2 . In the event Licensee:

8 .1 .2 .1 . Terminates or suspends its business; or

8 .1 .2 .2 . Becomes insolvent or becomes subject to direct control by a trustee, receiver or similar authority .

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8 .2 . If Licensee initiates any proceeding or action, or participates in or otherwise prosecutes any proceeding or action (or assists any third party to initiate, participate in, or otherwise prosecute any proceeding or action) challenging the validity, enforceability or scope of any Intellectual Property Right licensed under this Agreement (including challenging that any of the Licensed Software is not a trade secret), then Licensor may immediately terminate this Agreement effective upon written notice to Licensee .

8 .3 . Obligations on Termination . Upon termination of this Agreement for any reason, all of Licensee’s rights to the Licensed Software and the Documentation including, but not limited to, use and access, shall automatically terminate . In addition, Licensor shall have the right, at any time after termination of the license, to take immediate possession of the Licensed Software and all copies wherever located, without demand or notice .

8 .4 . Survival of Obligations . Licensee agrees that its obligations and duties which by their nature extend beyond the expiration or termination of this Agreement shall survive any expiration or termination and of this Agreement . Termination of the license shall not relieve Licensee of its obligations with respect to the Licensed Software .

8 .5 . Termination of any of the licenses granted herein, or of the entire Agreement, shall be in addition to and not in lieu of any equitable or other remedies available to Licensor . Further, no termination of this Agreement shall relieve Licensee of any obligation of Licensee hereunder .

9 . Miscellaneous9 .1 . No Implied Licenses . Nothing contained in this Agreement shall be construed as conferring any

license or right by implication, estoppel or otherwise, under any Intellectual Property Rights, other than the licenses expressly granted in this Agreement . Licensor is not required hereunder to furnish or disclose to the Licensee any technical information .

9 .2 . Entire Agreement; Amendment; Waiver . This Agreement, together with all exhibits and schedules hereto, if any, constitute the entire agreement between the parties pertaining to the Licensed Software and supersede all prior agreements, understandings, negotiations and discussions, whether oral or written, of the parties . This Agreement may not be amended except by an instrument in writing signed on behalf of each of the parties hereto . Waiver of any of the provisions of this Agreement must be in writing . No waiver shall be deemed or shall constitute a waiver of any other provision hereof (whether or not similar), nor shall any waiver constitute a continuing waiver unless otherwise expressly provided in writing .

9 .3 . Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Texas, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of Texas or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Texas . Each party irrevocably agrees to the jurisdiction of the state and federal courts located in Dallas County, Texas, USA . Notwithstanding the foregoing, any action based on Section 5 .4 (Equitable Relief) may be brought in any court of competent jurisdiction .

9 .4 . Section Headings . The section headings contained in this Agreement are inserted for reference purposes only and are not intended to be a part, nor should they affect the meaning or interpretation, of this Agreement .

9 .5 . Notices . All notices, requests, demands and other communications which are required or may be given under this Agreement shall be in writing and shall be deemed to have been duly given when transmitted for download to Licensee’s unit(s) of the Product, or otherwise provided to Licensee .

9 .6 . Nonassignability . Licensee may not, directly or indirectly, in whole or in part, assign, delegate or transfer this Agreement and any attempted assignment, delegation or transfer shall be null and void . Licensor may assign this Agreement at any time .

9 .7 . Enforcement of Agreement . Licensor shall have the right to collect from Licensee its reasonable

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expenses, including attorney’s fees, incurred in enforcing this Agreement .

9 .8 . Severability . In the event that any one or more of the provisions contained in this Agreement or in any other instrument referred to herein, shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, then to the maximum extent permitted by law, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement or any other such instrument .

9 .9 . Independent Contractors . There is no relationship of agency, partnership, joint venture, employment, or franchise between the parties . Neither party has the authority to bind the other or to incur any obligation on its behalf .

9 .10 . Remedies Cumulative . All rights and remedies with respect to breach of any obligation herein are cumulative of each other and of every other right or remedy such party may otherwise have at law or in equity, and the exercise of one or more rights or remedies shall not prejudice or impair the concurrent or subsequent exercise of other rights or remedies .

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Appendix

G . Limited WarrantyNOTICE: HeartSciences regards any use you make of the Product (defined below), accompanying or embedded software, or any Accessories (defined below) as agreement to the terms of this Limited Warranty set forth below .

GeneralThis HeartSciences Limited Warranty (“Limited Warranty”) and Software Licensing Agreement is made by one of the following: HeartSciences or its subsidiary or affiliate operating in the country where the Purchaser (defined below) is located at the time of initial purchase (collectively, “HeartSciences”) and applies only to the Purchaser of a genuine HeartSciences branded genuine MyoVista product (“Product”), any HeartSciences branded genuine replacement parts, power cables, or accessories such as patient cables/lead wires, patient cable/lead wire connectors or similar products (“Accessories”), and any HeartSciences branded genuine electrodes (“Electrodes”) .

NOTICE The use of unauthorized, non-HeartSciences patient cables or Electrodes voids this Limited Warranty in its entirety . This Limited Warranty does not apply to any non-HeartSciences products or non-HeartSciences branded accessories or peripherals external to the Product such as external storage subsystems, displays, keyboards, mice, printers, and other peripherals, which are provided “AS IS” without HeartSciences warranty of any kind . However, non-HeartSciences manufacturers and suppliers or publishers may provide their own warranties directly to you . HeartSciences is not responsible for any interoperability or compatibility issues that may arise when (1) products, software, options, parts, supplies, peripherals, or accessories not supported by HeartSciences are used; (2) configurations not supported by HeartSciences are used; or (3) Accessories intended for one Product are installed in another of different make or model . A “Purchaser” is defined as the initial end user purchaser of the Product, Accessory, or Electrodes who purchased or leased the Product, Accessory, or Electrode directly from HeartSciences or a HeartSciences authorized representative, and any reference herein to “you” or “your” means the Purchaser . This Limited Warranty gives the Purchaser express limited warranty rights from HeartSciences . In addition, you may also have other legal rights under applicable local law . This Limited Warranty is applicable in all countries and may be enforced in any country or region where HeartSciences or its authorized service providers offer warranty service for the same Product, Accessory, or Electrode model number subject to the terms and conditions set forth in this Limited Warranty . Unless otherwise stated, and to the extent permitted by local law, new Products, Accessories, or Electrodes may be manufactured using new materials or new and used materials equivalent to new in performance and reliability .

Limited Hardware WarrantyHeartSciences warrants to the Purchaser that it will repair or replace the Product, Accessory, or Electrode free of charge (except for those not warranted under “Exclusions” below) if it is defective in materials or workmanship under normal use and service . HeartSciences’ obligation under this Limited Warranty is limited to the repair or replacement, at HeartSciences’ option, of applicable Products, Accessories, and Electrodes . This Limited Warranty will only apply to defects that are reported to HeartSciences within the Applicable Warranty Period and which, upon examination by HeartSciences, prove to be defective . The “Applicable Warranty Period” is defined as: (i) for Products, the one (1) year period commencing on the date of purchase; (ii) for Accessories, the six (6) month period commencing on the date of purchase; and (iii) for Electrodes, the two (2) year period commencing on the date of manufacture (being the Use By date on the Electrode pouch) . The date on your sales receipt or purchase contract is the date of purchase unless HeartSciences or your authorized representative informs you otherwise in writing . This Limited Warranty extends only to the Purchaser of a Product, Accessories, or Electrodes and is not transferable or assignable . HeartSciences may discharge its Limited Warranty as to any Product, Accessory, or Electrode by refunding the purchase price of the Product, Accessory, or Electrode and taking back the Product, Accessory, or Electrode .

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ExclusionsThis Limited Warranty does not apply to any Product, Accessory, or Electrode that was not purchased or leased from HeartSciences or any of its authorized representatives or resellers . If the serial number on the Product, Accessory, or Electrode has been altered, damaged, rendered defective, or removed from the Product, Accessory, or Electrode, this Limited Warranty is void . This Limited Warranty does not cover normal wear and tear or any loss, damage, or defects caused by: (1) attempted disassembly or repair by anyone not authorized by HeartSciences; (2) failure to follow instructions for use, maintenance, and cleaning; (3) drops, impacts, fire, water damage, misuse, abuse, neglect, accident, or external forces, (4) the Product, Accessory, or Electrode having been altered or tampered with in any way, (5) the Product, Accessory, or Electrode having been used or maintained in any manner that is inconsistent with HeartSciences instructions or warnings included with the Product, Accessory, or Electrode, as applicable, (6) the Product, Accessory, or Electrode having been used in any manner that is inconsistent with the intended purpose or design of the Product, Accessory, or Electrode, as applicable, as described in HeartSciences published documentation for the Product, Accessory, or Electrode, (7) transportation to the Purchaser’s facility, (8) Purchaser or third party supplied software, interfaces, parts, supplies, or accessories, (9) operation or storage outside of environmental specifications for the Product, Accessory, or Electrode, or (10) improper site preparation or maintenance . HeartSciences is not responsible for any costs, expenses, or charges incurred by Purchaser for any attempted disassembly or repair by anyone not authorized by HeartSciences . This Limited Warranty does not apply to any Accessories that are designed to be disposable or for single use and which have been reused, or attempted to be reused .

DisclaimersEXCEPT FOR THE LIMITED WARRANTY SET FORTH IN THE IMMEDIATELY PRECEDING PARAGRAPH, HEARTSCIENCES MAKES NO WARRANTY WHATSOEVER WITH RESPECT TO THE PRODUCTS OR ACCESSORIES, INCLUDING ANY (A) WARRANTY OF MERCHANTABILITY, (B) WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE (EVEN IF HEARTSCIENCES HAS BEEN INFORMED OF SUCH PURPOSE), (C) WARRANTY OF DESIGN, (D) WARRANTY OF SATISFACTORY QUALITY, OR (E) WARRANTY AGAINST INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY WHETHER EXPRESS OR IMPLIED BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE . IF ANY IMPLIED WARRANTY CANNOT BE DISCLAIMED UNDER APPLICABLE LAW, THEN SUCH IMPLIED WARRANTY SHALL BE LIMITED IN DURATION TO THE APPLICABLE WARRANTY PERIOD . HEARTSCIENCES DOES NOT WARRANT THAT THE OPERATION OF THIS PRODUCT, ACCESSORY, OR ELECTRODE WILL BE UNINTERRUPTED OR ERROR-FREE . HEARTSCIENCES IS NOT RESPONSIBLE FOR DAMAGE THAT OCCURS AS A RESULT OF YOUR FAILURE TO FOLLOW THE INSTRUCTIONS INTENDED FOR THE HEARTSCIENCES PRODUCT, ACCESSORY, OR ELECTRODE . FURTHER, HEARTSCIENCES DOES NOT WARRANT THAT THE PRODUCT, ACCESSORY, OR ELECTRODE IS NOT VULNERABLE TO INTRUSION OR ATTACK .

Limitation of LiabilityHEARTSCIENCES IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING OR ARISING FROM THE SALE, INSTALLATION, USE OF THE PRODUCT, ACCESSORY, OR ELECTRODE OR A DEFECT OF THE PRODUCT, ACCESSORY, OR ELECTRODE COVERED OR NOT COVERED BY THE LIMITED WARRANTY, INCLUDING BUT NOT LIMITED TO ANY LOSS OF, DAMAGE TO, OR CORRUPTION OF DATA, LOSS OF PROFIT, LOSS OF USE OF PRODUCT, ACCESSORY, OR ELECTRODE OR EITHER’S FUNCTIONALITY, LOSS OF BUSINESS, LOSS OF CONTRACTS, LOSS OF REVENUES, OR LOSS OF ANTICIPATED SAVINGS, INCREASED COSTS OR EXPENSES OR FOR ANY INDIRECT LOSS OR DAMAGE, CONSEQUENTIAL LOSS OR DAMAGE OR SPECIAL LOSS OR DAMAGE . TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEARTSCIENCES’ LIABILITY SHALL BE LIMITED TO THE PURCHASE VALUE OF THE PRODUCT, ACCESSORY, OR ELECTRODE GIVING RISE TO THE LIABILITY . THE LIMITATIONS SET FORTH IN THIS LIMITED WARRANTY ARE INTENDED TO LIMIT THE LIABILITY OF HEARTSCIENCES AND SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED REMEDY .

Appendix G: Limited Warranty

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Limitation of RemediesTHE REMEDIES IN THIS LIMITED WARRANTY ARE YOUR SOLE AND EXCLUSIVE REMEDIES .

Defects Occurring After Applicable Warranty Period for the ProductCharges for repairs to the Product after the Applicable Warranty Period, but within the Product’s service life, will be based upon actual hours spent on the repair at the prevailing rate, plus the price of parts required and transportation charges . You may also elect to purchase an extended warranty . Continued support beyond the Applicable Warranty Period may require an annual support and update fee . For information about purchasing an extended warranty on your Product, contact your authorized representative .

Warranty ServiceYou must obtain a return authorization from your authorized representative to arrange for the return of your Product, Accessory, or Electrode before you send it to the designated HeartSciences service center for repair or replacement . Contact your authorized representative to obtain information on returning the Product, Accessory, or Electrode and obtaining warranty service .

Under this Limited Warranty, Products purchased in one country/region may be transferred to the same Purchaser in another country/region, where HeartSciences or its authorized service providers offer warranty service for the same Product, Accessory, or Electrode model number, without voiding the warranty . Warranty terms, service availability, and service response times may vary from country/region to country/region . Standard warranty service response time is subject to change due to local parts availability . Your HeartSciences authorized service provider can provide you with details . HeartSciences is not responsible for any tariffs or duties that may be incurred in transferring the Products or Accessories . Transfer of the Products or Accessories may be covered by export controls issued by the United States or other governments .

HeartSciences may repair or replace Products or Accessories (a) with new or previously used Products or Accessories or parts equivalent to new in performance and reliability, or (b) with products or accessories that are equivalent to an original Product, Accessory, or Electrode that has been discontinued . Replacement parts are warranted to be free from defects in material or workmanship for the remainder of the Applicable Warranty Period of the Product, Accessory, or Electrode they are replacing or in which they are installed . All component parts or hardware products replaced or removed under this Limited Warranty become the property of HeartSciences .

Customer ResponsibilitiesTo enable HeartSciences to provide the best possible support and service during the Applicable Warranty Period, you will be required to:

• Maintain a proper and adequate environment, and use the Product, Accessory, or Electrode in accordance with the instructions furnished .

• Verify configurations, load most recent firmware or software, install software patches, run HeartSciences diagnostics and utilities, and implement temporary procedures or workarounds provided by HeartSciences while HeartSciences works on permanent solutions if needed .

• Where available and applicable, allow HeartSciences or its authorized representative to keep resident on your systems or sites certain system and network diagnosis and maintenance tools to facilitate the performance of warranty support (collectively referred to as “Proprietary Service Tools”) . Proprietary Service Tools are and remain the sole and exclusive property of HeartSciences .

• Additionally, you will:

– Use the Proprietary Service Tools only during the applicable warranty period and only as allowed by HeartSciences .


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– Install, maintain, and support Proprietary Service Tools, including any required updates and patches .

– Provide remote connectivity through a HeartSciences-approved communications line, if required .

– Assist HeartSciences or its authorized representative in running the Proprietary Service Tools .

– Use the electronic data transfer capability to inform HeartSciences or its authorized representative of events identified by the Proprietary Service Tools .

– Return the Proprietary Service Tools or allow HeartSciences to remove these Proprietary Service Tools upon termination of warranty support .

– Not sell, transfer, assign, pledge, or in any way encumber or convey the Proprietary Service Tools .

– In some cases, HeartSciences may require additional software such as drivers and agents to be loaded on your system in order to take advantage of these solutions and capabilities .

– Use HeartSciences remote solutions where applicable . HeartSciences strongly encourages you to use available technologies provided by HeartSciences . If you choose not to deploy available remote capabilities, you may incur additional costs due to increased resource requirements .

– Cooperate with HeartSciences in attempting to resolve the problem over the telephone . This may involve performing routine diagnostic procedures, installing additional software updates or patches, removing third-party options, and/or substituting options .

– Make periodic backup copies of your configuration data, files, data, or programs stored on your hard drive or other storage media or devices as a precaution against possible failures, alteration, or loss . Before returning any Product, Accessory, or Electrode for warranty support, back up your configuration data, files, data, and programs, and remove any confidential, proprietary, or personal information .

– Maintain a procedure to reconstruct your lost or altered configuration data, files, data, or programs that is not dependent on the Product, Accessory, or Electrode under warranty support .

– Notify HeartSciences if you use Product or Accessories in an environment that poses a potential health or safety hazard to HeartSciences employees or subcontractors . HeartSciences may require you to maintain such Products or Accessories under HeartSciences supervision and may postpone warranty service until you remedy such hazards .

– Perform additional tasks as that HeartSciences may reasonably request in order to best perform the warranty support .

Advance Unit Replacement Warranty ServiceYour HeartSciences Limited Warranty may include an advance unit replacement warranty service for Products or Accessories . Under the terms of the advance unit replacement warranty service, HeartSciences or its authorized representative will ship or deliver a replacement unit directly to you if the Product you purchased is diagnosed as defective . On receiving the replacement unit, you will be required to return the defective unit back to HeartSciences, in the packaging that arrives with the replacement unit, within a defined period of time, normally five (5) days . HeartSciences or its authorized representative will incur all shipping and insurance costs to return the defective unit to HeartSciences, if shipped in accordance with HeartSciences instructions . Failure to return the defective unit may result in HeartSciences or its authorized representative billing you for the replacement unit . In countries or regions where this Limited Warranty may be enforced but where advance unit replacement warranty service is not available, HeartSciences will, in its sole discretion, substitute another type of warranty service .

Transfer to a Third PartyTo the extent allowed by law, this Limited Warranty applies only to bona fide end users of the Product, Accessory, or Electrode and may be enforced only by those end users or their authorized agents . The initial bona fide end user of the Product, Accessory, or Electrode must have purchased the Product, Accessory, or Electrode directly from HeartSciences or a HeartSciences-authorized reseller .


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Freeware Operating Systems and ApplicationsHeartSciences does not provide support for software provided under public license by third parties, including operating systems or applications (“Freeware”) . Support for Freeware provided with Products or Accessories is provided by the Freeware vendor . Please refer to the Freeware operating system or other Freeware application support statement included with the Product, Accessory, or Electrode .

Contacting HeartSciences

If a Product, Accessory, or Electrode fails during the Applicable Warranty Period and the information in the documentation for the Product, Accessory, or Electrode, most recent software release notes, and other technical information on the HeartSciences Web site do not help you solve the problem, contact your local HeartSciences authorized representative . To find your local authorized representative, go to www .heartsciences .com and select “Support” or email us at support@heartsciences .com• Please have the following information available:

• Serial number, name, and model number for the Product, Accessory, or Electrode .

• Detailed description of the symptoms, including when the symptoms first occurred, how frequently they are occurring, and applicable error messages .

• Detailed description of any changes made to your Product, Accessory, or Electrode’s configuration or network environment prior to the start of the symptoms occurring .

• Detailed description of the troubleshooting steps you have performed and the results of those steps .

• Software revision currently on the Product, operating system, and third-party hardware or software on or connected to the Product .

Governing LawThis Limited Warranty is governed by and will be construed in accordance with the laws of the State of Texas, USA exclusive of its conflict of law principles . The United Nations’ Convention on Contracts for International Sale of Goods shall not apply .

Modifications to the Limited WarrantyStatements made by any person, including representatives of HeartSciences, a distributor, reseller or seller of the Product, Accessory, or Electrode, which are inconsistent with or conflict with the terms of this Limited Warranty, shall not be binding upon HeartSciences, unless reduced to writing and signed by an authorized representative of HeartSciences .


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INDEX

AA factory reset will erase the database . Do you want to back it up? message, 69A system update will upgrade your device with a new version of the software . All patient data and relevant user settings will be preserved . message, 68Accessories, 107Add Printer screen, 73Adding a new patient, 46Adjustable stand, 26, 115Annual inspection, 106Audience, viiiAuto-Standby, 79

icon, 79screen, 79

Auto-standby settings, 63, 79

BBacking up a database, 76Backup Database screen, 77Battery, 32-34

LED colors, 33maintenance, 107monitoring, 34using, 35

Battery symbol in status bar, 33Built-in battery

monitoring, 34overview, 32-35

Buttons, 42, 43

CCancel icon, 43Cautions, 5, 6Classification, 14, 24Cleaning, 104-105

housing, 104patient cable, 105touchscreen, 105

Close icon, 43Colors

battery LED, 33ECG trace, 92electrodes, 40

Connecting electrodes to leads, 41Contents, iiiContinue icon, 43Continuous wavelet transform, viii, 116, 117Contraindications, 2Conventions, viii, 5

document, viiisafety, 5typographic, viii

DDatabase

backing up, 76deleting, 76restoring, 78settings, 75current, 65, 75

Database icon, 76Database Information screen, 75

icon, 65displaying, 65

Date/Timeicon, 65screen, 67

Date/time settings, 67Default settings, 69Delete Patient icon, 46, 50Deleting

database, 76patient, 50test report, 62

Deviceclassification, 14identification, 13label format, 13serial number format, 13specifications, 108

Dimensions, 108Disinfecting, 105Display Brightness

button, 65, 66screen, 90

Displayingpatient screen, 45report screen, 56

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settings screen, 64test screen, 51

EECG

settings, 90specifications, 108, 109trace colors, 92

ECG Trace Coloricon, 92screen, 92

Edit Patienticon, 46screen, 50Editing a patient, 50

Editing a Patient screen, 50Electrical

safety, 7specifications, 108

Electrodeattaching to patient, 37colors, 40connecting to leads, 41identification, 40placement, 37-40

Electrode chest and appendages placementAHA diagnostics, 38IEC diagnostics, 39

Electrode chest placementAHA diagnostics, 38IEC diagnostics, 39

Enable WiFi, 72End User License Agreement, 126Energy Classification, 24, 125Environmental specifications, 108Error messages, 114Ethernet port, 26Export

test report, 56, 61to PDF icon, 61

FFactory default settings, 69, 79Factory Reset icon, 65Filters, 90, 91

icon, 66screen, 91

Firmware version, 64Format

device label, 13serial number, 13

Frequency Interface filters settings, 32, 91Front panel of device, 25

GGlasgow Interpretative Analysis, 16Glossary, 116

HHDMI port, 26-27High Energy Classification, 18, 24, 118, 125Home screen, 42

Icon, 43Icons, 9-11, 42-43, 46, 65

Auto-Standby, 10, 42, 65Cancel, 43Close, 43common, 43Continue, 43Database, 65Date/Time, 65Delete, 46Delete Patient, 46Display Brightness, 65ECG Trace Color, 71, 88Edit Patient, 46EMR, 65Filters, 91front panel, 25Home, 42Language, 94Network, 65New Patient, 46OK, 43Patient, 42, 45, 46, 50patient Screen, 46Patient Search, 46Patient Units, 95Print, 65Printing, 73

INDEX

140


Quick Start Guide, 43Report, 56Re-Sync, 52, 55Re-Sync Countdown Time, 52Save, 43Settings, 42Settings, 83, 89settings screen, 42, 64Standby, 10, 42, 52, 65Start Test, 52, 55Stop Test, 52, 55Test, 42Test Countdown, 52Test Length, 66Update/Factory Reset, 65

Identification, 13Indications for use, 2Information

patient, 50database, 75clinic, 93

Initial software setup, 32Inspection

annual, 106periodic, 103seasonal, 106

Installation, 32Intended use, 2

KKensington security slot, 9, 26Keyboard, 44

LLabel format, 13Labeling, 12Language, 32, 94

button, 94screen, 94

LCD brightness settings, 90Lead Off starting test screen, 54Limited warranty, 124

MMaintenance, 103, 104

battery, 107Messages

A factory reset will erase operation has been aborted . Do you want to back it up?, 69A system update will upgrade your device with a new version of the software . All patient data and relevant user settings will be preserved, 68Backup successful, 77Delete the current report?, 62MyoVista will restart to change the language, 94No records found!, 49Permanently Delete Patient from Database, 50Print successful, 60Restore Successful, 78The existing database will be erased . Proceed?, 76The Factory Reset operation has been aborted, 70Export succeeded, 85The system update has been aborted, 68The test results were not saved . Select the OK button to continue, 55

Monitoring the built-in battery, 34Mosteller formula, 47Mounting, 115Myoelectricity, 32, 53, 66, 90

interface filters settings, 56, 90, 91MyoVista Energy Waveform, 18MyoVista wavECG, 16-25

battery, 32classification, 17, 24cleaning and disinfecting, 105contraindications, 2 device identification, 13energy Classification, 17, 24error messages, 114front panel, 25housing cleaning, 105Information, 16-17, 117initial software setup, 32inspection, 106installing, 29, 32intended use, 2labeling, 12maintenance, 104networking, 71-82operating environment, 35rear panel, 26

INDEX

141


right side, 27set up, 29supplies and accessories, 107symbols, 9technical data, 108ventricular Indices, 17, 22, 23, 123, 124VESA mounting, 115

NNetwork, 71-82

icon, 65,screen, 71, 72status, 71wired screen, 71wireless screen, 71

Network-based printers, 73New Patient, 46 icon, 45

screen, 46No records found! message, 49

OOperating environment, 35Overview of MyoVista system, 25

PPackage contents, 29Parameters for test, 52Patient

adding, 46attaching electrodes, 37icon, 42, 45, 46, 50condition and history, 3deleting, 50editing, 50recommendations, 3safety, 8searching, 48selecting, 48unit of measurement, 95

Patient cablecleaning, 105connecting, 41port, 27

Patient screen, 45

displaying, 45Patient Search icon, 46Patient Selected screen, 49Patient Units

icon, 66screen, 95

Periodic inspection, 106Permanently Delete Patient from Database message, 50Ports

Ethernet, 26HDMI, 26, 27power adapter, 26USB, 26

Poweradapter connector, 26source indicators, 33switch, 26

Prescription Device Statement, 2Print icon, 65Print Preview Settings screen, 58Print successful message, 58Printer

network-based, 73, 111selecting, 73settings, 73

Printingicon, 58, 65, 73test report, 58

Printing screen, 58, 73with progress bar,61

QQRST complex, 18, 118Quick Start Guide icon, 43

RRear panel of device, 26Report icon, 56Report screen, 56, 57

screen icons, 57displaying, 57

Report Settings screen, 58, 83Restore Database screen, 76, 78Restore Successful, 78

INDEX

142


Restoringdatabase, 78factory default settings, 69

Re-Sync icon, 52Re-Sync Countdown Time button, 52Resyncing waveforms, 55Right side of device, 27Running a test, 54

SSafety

check, 106conventions, 5electrical, 7patient, 8

Save icon, 43Screens

Add Printer, 73Auto-Standby, 79Backup Database, 76, 77Clinic Information, 66, 93Database Information, 65, 75Date/Time, 67Display Brightness, 90ECG Trace Color, 92Edit Patient, 46, 50Export Report, 56, 57, 61Filters, 56, 90, 91home, 42Language, 66, 94Lead Off starting test, 54Network, 71New Patient, 46patient, 45Patient Selected, 49Patient Units, 95Print Preview Settings, 58, 62Printing, 56, 58, 65, 73Printing with progress bar, 61Report, 57Report Settings, 60, 65, 83Restore Database, 76, 78Search Conditions, 48Select Driver, 74Settings, 64Test, 51, 52Test Time Setup, 53

Update/Factory Reset, 65, 68Wired Network, 10, 71Wireless Network, 65, 72

Search Conditions screen, 48Searching for a patient, 48Seasonal safety check, 106Select Driver screen, 74Selecting

patient, 48printer, 73wireless network, 65, 72

Serial number format, 13Set up, 30Setting test parameters, 52Settings icon, 42, 64Settings screen, 64

displaying, 64Software version, 64, 65, 69Specifications

device, 108ECG, 109electrical, 108environmental, 108

Standby icon, 10, 79LED, 10, 25power source indicator, 33

Start Test icon, 52, 55Status bar, battery symbol, 10, 33Stop Test icon, 52, 55Stopping a test, 55Supplies, 107Symbols on device, 9System

overview, 25, 28-35settings, 67software, 16, 18, 32, 64, 65

TTechnical data, 108Test

icon, 52, 55parameters, 51, 52running, 54stopping, 54

Test Countdown icon, 52Test Length icon 66Test report, 59, 60

INDEX

143


Test screen, 51, 52, 55icons, 52displaying, 55Test Time Setup screen, 53

The existing database will be erased . Proceed? message, 76The Factory Reset operation has been aborted message, 70The system update has been aborted message, 68The test results were not saved . Select the OK button to continue . message, 55Touchscreen, 25, 44

cleaning, 105keyboard, 44Conventional 12-lead ECG Waveform, 16

Troubleshooting, 99

UUnpacking, 29Update/Factory Reset, 65, 68-70

icon, 65screen, 68

Updating System Software, 68USB guidelines, 76, 77USB ports

rear panel, 26right panel, 27

User settings, 93

VVentricular Indices, 22, 23, 123, 124VESA mounting, 115Viewing current database settings, 75

WWarnings, 5-6, 104Waveforms, resyncing, 55Wired Network screen, 71Wireless Network screen, 71Wireless Network setting, 72

INDEX

550 Reserve Street, Suite 360Southlake, TX 76092 USATel: (+1) 682-237-7781Fax: (+1) 817-796-2075HeartSciences.com

©2019. ™ Trademark of HeartSciences. Reg. US Pat. & TM Off. All rights reserved.wavECG and wavEKG are trademarks of HeartSciences. All rights reserved.

DO-LBL-06035(L) Not FDA cleared. Not available in the United States.

User Manual - Cardio-Jenic

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