USER MANUAL

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.
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.
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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
licensed by the law of the State in which he/she practices to use or order the use of
the device.
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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
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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 Orpheus MedicVOD system:

mediCAST – a stream
decoder which is connected
to a medical scope camera
mediShow – this application
– a viewer for real time
broadcasting from a
mediShow system
mediSearch – a search utility
application to search for and
view videos and still images
previously captured by
mediShow.


1.3. PRODUCT FUNCTIONS
mediShow has the following capabilities:





Automatic connection to the MedicVOD server and to display a list of active mediCAST
video sessions
User choice of up to four active mediCAST live video streams
Zoom and Snapshot capability
“Talk Back” feature to allow the user to have visual and audible interaction with the
operating theater
“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
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Three types of special messages appear in this User Guide:
A warning indicates the possibility of injury to the patient or operator.
A caution indicates a condition that may lead to equipment malfunction.
A note provides other important information.
1.4. CONDITIONS FOR USE
1.4.1. INTENDED USE
The MedicVOD system is intended as a radiological image 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.
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1.5. GLOSSARY
MEDICVOD SYSTEM:
Video On Demand application consisting of these main components:
 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
 VOD SERVER:
Software components used to broadcast, archive and retrieve video streams
OSD:
On Screen Display – picture-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.
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2. SAFETY
2.1. GENERAL SAFETY INSTRUCTIONS
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 mediShow System is compatible with the MedicVOD devices:
 The mediCAST system
 The mediSearch system.
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3. LABELS AND SYMBOLS
3.1 SYMBOLS
Explanation of symbols:
Symbol
Description
Consult instructions for use
2012
Year of Manufacture
2012
Special Requirements for Waste of Electrical and Electronic
Equipment (WEEE Directive)
CE Compliance (Medical Device Directive)
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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
To start the system, double-click the mediShow icon located on the Windows desktop.
LOGIN screen
At first, the login screen appears:
4)
5)
6)
7)
Fill up the MedicVOD server IP name or address
Fill up the user name
Fill up the password
Click the “OK” button
Note: The Server IP, user name and password are provided by the system
administrator of the hospital. The user name and password are either unique to the
MedicVOD system or part of the hospital user name/password policy.
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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:
In this example, the MEDICAST1 session has been chosen. Displayed information:




ID – unique Session ID assigned to this MedicVOD video stream
File – File name assigned in the MedicVOD data system
Department – Hospital department
Start – Time and date that this Session began.
Note: If the MedicVOD server is connected to the hospital’s information system,
additional values may appear, such as patient name, submission department, etc.
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4.4. SUMMARY OF ACTIONS AVAILABLE WITHIN A SESSION
In the selected Session, the user can use the following controls:
Brightness
Audio Enable/Mute
Zoom
Snapshot
Talk Back
OSD ("On Screen Display")
Each of these controls is described in detail below.
4.5. BRIGHTNESS
Click and drag to change the brightness of the Session window.
4.6. AUDIO ENABLE/MUTE
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.
4.7. ZOOM
Select a Session window and then click the Zoom icon. The Session window will zoom to full
screen:
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4.8. SNAPSHOT
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
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.
Note: When activating the Talk Back feature, the audio of the selected window should be “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")
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.
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
used for diagnostic purposes.
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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
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
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 Screen 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
To close the application, press on "X" located on the top right corner of the main window.
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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
Condition
Possible Cause
Recommended Action
In "Talk Back" mode, cannot
hear anything from
mediCAST
Audio of selected
Session not enabled
Enable the Session audio (see section
4.6. Audio Enable/Mute on page 12)
In "Talk Back" mode, user
image not in Session
window
No video signal from
device.
Ensure that webcam is enabled and
turned on
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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 zone
Haifa, 31905
ISRAEL
Tel.: 972-77 437 1228
Fax: 972-77 437 1228
Email: mailto:info@orpheus-medical.com
© 2013 Orpheus Medical Ltd.
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APPENDIX A: APPLICABLE STANDARDS
The following list of standards applies to the System:






Digital Imaging and Communications in Medicine (DICOM): PS 3.3-2004, National
Electrical Manufacturers Association.
IEC/EN 60601-1-4:1997, General Requirements for Programmable Electrical Medical
System.
IEC 62304:2006, Medical Device Software – Software Lifecycle Processes.
IEC/EN-60601-1: 2006 (3rd. ed.), Medical Electrical Equipment; Part 1: General
Requirements for Safety..
IEC/EN 60601-1-2:2001, Medical Electrical Equipment; Part 1-2: Collateral Standard:
Electromagnetic Compatibility- Requirements and Tests
ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels,
labeling and information to be supplied - Part 1: General requirements
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