USER MANUAL
Contents
1. SHOWS USER MANUAL REVISION 3 Copyright 2013 Orpheus Ltd All rights reserved No part of this publication may be reproduced stored in a retrieval system or transmitted in any form by any means electronic mechanical photo reproductive recording or otherwise without the express prior written permission of Orpheus Ltd Orpheus Ltd reserves the right to change or improve its products and accompanying technical literature without specific notice to changes or improvements Doc 20201 Text revised February 2011 CIRP HAE LUIS mea Dic mt Orpheus Medical LTD bldng 30 MATAM industrial zone Haifa 31905 ISRAEL Tel 972 77 437 1228 Fax 972 77 437 1228 Email mailto info orpheus medical com 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 2 User Manual Orpheus mediShow CE Marking by the symbol CE indicates compliance of this device as a Class 1 device with the Medical Device Directives 93 42 EEC 2007 47 CE Authorized Representative in the EU as defined by the Medical Device Directives MEDNET GmbH Borkstrasse 10 Munster 48163 Germany Tel 49 251 322660 Fax 49 251 3226622 Email Email info medneteurope com Federal Law USA restricts this device to sale by or on the order of a practitioner Re Only licensed by the law of the State in which he she practices to use or order the use of the device 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 3 User Manual Orp2. use the following controls OSD On Screen Display Each of these controls is described in detail below Click and drag to change the brightness of the Session window 4 6 AUDIO ENABLE MUTE KJ Use the audio control to enable or mute the audio broadcast from the session The audio volume is managed by the standard Windows volume control Select a Session window and then click the Zoom icon The Session window will zoom to full 4 7 ZOOM screen 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 12 User Manual Orpheus mediShow 4 8 SNAPSHOT a To capture a still image take a snapshot select a Session and then click on the Snapshot icon The captured image is sent automatically to the MedicVOD server to be stored on the main archive and to allow access by the mediSearch application 4 9 TALK BACK s To activate the Talk Back feature first select a Session This is the Session that you will communicate with using the Talk Back feature Click on the Talk Back icon The Talk Back icon will flash while you are in an active Talk Back Session When in Talk Back the image from your web cam and your voice audio are sent to the mediCAST user in the operating theater All mediShow users can also hear and see your Talk Back audio and video To stop Talk Back click on the flashing icon 7 Note When activating the Talk Back feature the audio of the selected window should b
3. e ON not muted If the audio is muted the people in the operating theater and other mediShow users can hear you but you cannot hear them 4 10 OSD ON SCREEN DISPLAY QZiCQMECIICIIPAPZIE OSD On Screen Display allows you to highlight areas of the video The highlighting line can be any color thin or thick opaque or transparent OSD is requested by the mediShow user but must be accepted by the mediCAST Session in the operating theater HHHH Note OSD highlighting is visible to all users of the MedicVOD system Warning The OSD feature is intended as a bi directional training tool It should not be A used for diagnostic purposes 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 13 User Manual Orpheus mediShow The following sections describe each OSD button 4 11 ACTIVATE OSD Click to request OSD activation The icon will flash until the OSD request is accepted by the mediCAST Session Click again to hide all OSD highlighting 4 12 CHANGE PAINT COLOR om The default paint color is green To change the color click the icon and select a new color The paint color is shown in the box to the right in this case the color is red 4 13 CHANGE TRANSPARENCY ow Click to change the OSD transparency level of the highlighting 4 14 CHANGE LINE THICKNESS Click to change the thickness of the line drawn with OSD 4 15 ERASE ALL OSD Click to erase all active On Scr
4. een Display for this Session window To remove the On Screen Display from the window click on the OSD icon again Click to change the thickness of the line drawn with OSD 4 16 CLOSE THE MEDISHOW APPLICATION IEE To close the application press on X located on the top right corner of the main window 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 14 User Manual Orpheus mediShow 5 TROUBLESHOOTING Before addressing the troubleshooting table please check and confirm the following 1 The Windows volume control is set to an audible level 2 For Talk Back the Windows microphone is set to a medium level and the webcam is properly installed 3 Access is available to the network supporting the MedicVOD Server 5 1 BASIC TROUBLESHOOTING Possible Cause Recommended Action In Talk Back mode cannot Audio of selected Enable the Session audio see section hear anything from Session not enabled 4 6 Audio Enable Mute on page 12 mediCAST In Talk Back mode user No video signal from Ensure that webcam is enabled and image not in Session device turned on window 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 15 User Manual Orpheus mediShow 6 MAINTENANCE AND SERVICE mediShow does not require maintenance or calibration on a routine basis 6 1 OBTAINING SERVICE Contact the Orpheus mediShow representative Orpheus Medical LTD bldng 30 MATAM industrial zo
5. heus mediShow Table of Contents 1 Introduction 5 1 1 ABOUT THIS MANUAL 5 1 2 Orpheus mediShow Product Overview 5 1 3 Product functions 5 1 4 Conditions for Use 6 1 5 Glossary 7 2 Safety 8 2 1 General Safety Instructions 8 2 2 Specific Warnings and Cautions 8 2 3 Compatibility with other MedicVOD Devices 8 3 Labels and Symbols 9 3 1 Symbols 9 4 Using the mediShow System 10 4 1 Installation 10 4 2 Startup 10 4 3 Choosing a Session 11 4 4 Summary of Actions Available within a Session 12 4 5 Brightness 12 4 6 Audio Enable Mute 12 4 7 Zoom 12 4 8 Snapshot 13 4 9 Talk Back 13 4 10 OSD On Screen Display 13 4 11 Activate OSD 14 4 12 Change Paint Color 14 4 13 Change Transparency 14 4 14 Change Line Thickness 14 4 15 Erase all OSD 14 4 16 Close the mediShow Application 14 5 TroubleShooting 15 5 1 Basic Troubleshooting 15 6 Maintenance and Service 16 6 1 Obtaining service 16 Appendix A Applicable Standards 17 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 4 User Manual Orpheus mediShow 1 INTRODUCTION 1 1 ABOUT THIS MANUAL This manual provides the information necessary to operate the Orpheus mediShow in a safe and efficient manner Please read and understand this manual before operating the system If any part of this manual is not clear contact Orpheus Customer Support for clarification 1 2 ORPHEUS MEDISHOW PRODUCT OVERVIEW Orpheus mediShow is part of the Orphe
6. mage processing system that allows for the capture transfer display storage and digital processing of medical images 1 4 2 INTENDED USERS mediShow is intended to be uses by medical practitioners and supporting staff who have received training for the use of the system 1 4 3 INDICATIONS The MedicVOD system is a picture archival and communications systems PACS that is intended for image capturing archiving displaying and recording of audio video sequences and patient data during a procedure The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network Information captured and stored by the system are for viewing and reference purposes and are not intended for primary diagnosis 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 6 User Manual Orpheus mediShow 1 5 GLOSSARY MEDICVOD SYSTEM Video On Demand application consisting of these main components e MEDICAST Application for sending and archiving a live video stream from the medical operating theater to remote viewers MEDISEARCH Application for browsing and viewing archived video streams that were created by mediShow MEDISHOW Application for viewing and interacting with the live video stream created by mediShow e VOD SERVER Software components used to broadcast archive and retrieve video streams OSD On Screen Display pic
7. ne Haifa 31905 ISRAEL Tel 972 77 437 1228 Fax 972 77 437 1228 Email mailto info orpheus medical com 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 16 User Manual Orpheus mediShow APPENDIX A APPLICABLE STANDARDS The following list of standards applies to the System e Digital Imaging and Communications in Medicine DICOM PS 3 3 2004 National Electrical Manufacturers Association e IEC EN 60601 1 4 1997 General Requirements for Programmable Electrical Medical System e IEC 62304 2006 Medical Device Software Software Lifecycle Processes e EC EN 60601 1 2006 3 ed Medical Electrical Equipment Part 1 General Requirements for Safety e IEC EN 60601 1 2 2001 Medical Electrical Equipment Part 1 2 Collateral Standard Electromagnetic Compatibility Requirements and Tests e ISO 15223 1 2012 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 1 General requirements 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 17
8. rd are either unique to the MedicVOD system or part of the hospital user name password policy 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 10 User Manual Orpheus mediShow After a successful login procedure the mediShow startup screen appears 4 3 CHOOSING A SESSION mediShow displays four Sessions each in a separate window Only one session is the selected session and has a cyan focused line on the border of the window To select a session 1 Click on or near the speaker icon on the border of the window 2 Or choose an active session from the drop down arrow in the Session List that appears near the session windows The Session List appears as follows SOMOOCLO MEDICAS T1 Value 552369 adrenal efadabt 206e 44c8 5 Pediatric 10 20 2010 3 38 18 Pl In this example the MEDICAST1 session has been chosen Displayed information e ID unique Session ID assigned to this MedicVOD video stream e File File name assigned in the MedicVOD data system e Department Hospital department e Start Time and date that this Session began 9 Note If the MedicVOD server is connected to the hospital s information system additional values may appear such as patient name submission department etc 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 11 User Manual Orpheus mediShow 4 4 SUMMARY OF ACTIONS AVAILABLE WITHIN A SESSION In the selected Session the user can
9. ture within picture on the mediShow display SESSION One complete session of video capture A session may be equivalent to a single surgical operation SESSION ID Unique identifier of a session The Session ID may be entered manually or scanned in via the built in Bar Code reader SNAPSHOT A still image of the video captured by the mediShow user TALK BACK Ability of a mediShow viewer to provide audio or graphic commentary 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 7 User Manual Orpheus mediShow 2 1 GENERAL SAFETY INSTRUCTIONS A A A A A WARNING DO NOT USE BEFORE READING AND UNDERSTANDING THIS MANUAL WARNING THE SYSTEM IS RESTRICTED TO USERS WHO HAVE ATTENDED THE REQUIRED USER TRAINING COURSE FROM ORPHEUS LTD AND WHO HAVE RECEIVED THE PROPER SYSTEM CERTIFICATION Caution Changes or modifications not expressly approved by Orpheus Ltd can affect the safety and effectiveness of the system and will void the system s warranty Caution To avoid potential for electrical shock do not operate with damaged cords or plugs If damaged have the cord or plug replaced immediately by a qualified service technician Caution The system contains no user serviceable components 2 2 SPECIFIC WARNINGS AND CAUTIONS Warning The OSD feature is intended as a bi directional training tool It should not be used for diagnostic purposes 2 3 COMPATIBILITY WITH OTHER MEDICVOD DEVICES The mediSho
10. us MedicVOD system e mediCAST a stream decoder which is connected to a medical scope camera e mediShow this application a viewer for real time broadcasting from a Era e caren mediShow system alae e mediSearch a search utility application to search for and view videos and still images previously captured by mediShow 02 2010 587577 gb dr mos GAME 5844289 dr luntz SOPIE 4 A ie 1 3 PRODUCT FUNCTIONS mediShow has the following capabilities e Automatic connection to the MedicVOD server and to display a list of active mediCAST video sessions e User choice of up to four active mediCAST live video streams e Zoom and Snapshot capability e Talk Back feature to allow the user to have visual and audible interaction with the operating theater e On Screen Display OSD guideline control a layer on top of the video to create visual annotation visible to other users of the system 1 3 1 Special messages Warnings Cautions and Notes 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 5 User Manual Orpheus mediShow Three types of special messages appear in this User Guide A warning indicates the possibility of injury to the patient or operator AN A caution indicates a condition that may lead to equipment malfunction A A note provides other important information 1 4 CONDITIONS FOR USE 1 4 1 INTENDED USE The MedicVOD system is intended as a radiological i
11. w System is compatible with the MedicVOD devices e The mediCAST system e The mediSearch system 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 8 User Manual Orpheus mediShow 3 LABELS AND SYMBOLS 3 1 SYMBOLS Explanation of symbols Description Consult instructions for use Year of Manufacture Special Requirements for Waste of Electrical and Electronic Equipment WEEE Directive CE Compliance Medical Device Directive 2013 Orpheus Medical Ltd Doc 20201 rev 02 2013 Page 9 User Manual Orpheus mediShow 4 USING THE MEDISHOW SYSTEM 4 1 INSTALLATION Installation of the MedicVOD is performed by an authorized Orpheus Medical technician The technician installs and checks all system components prior to first use by the medical staff The mediShow runs on a standard PC Windows XP and upwards with the following minimum memory constraints 1 1GB RAM 2 10 GB hard disk 3 2 2Mbps network throughput 4 2 STARTUP p To start the system double click the mediShow icon located on the Windows desktop LOG N screen Server IP his medicvod org User name medicastuser At first the login screen appears Password EENEN EEE 4 Fill up the MedicVOD server IP name or address 5 Fill up the user name 6 Fill up the password 7 Click the OK button A Note The Server IP user name and password are provided by the system administrator of the hospital The user name and passwo
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