GE Vivid S5, Vivid S6 Technical Publications

Page 1
Technical Publications
Vivid S5/Vivid S6
GE Medical Systems
User Manual
Volume 1
Direction R2424458-100
Rev. 2
Copyright © 2010 By General Electric Co.
Page 2
Regulatory Requirements
This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.
This manual is a reference for the Vivid S5 and Vivid S6. It applies to all versions of the 10.2.x software for the Vivid S5 and Vivid S6 ultrasound systems.
g
GE Medical Systems
MANUAL STATUS
R2424458-100
07 February 2010
Doc ID: DOC0600341
COMPANY DATA GE Medical Systems, Israel Ltd.
PRELIMINARY
GE Medical Systems. All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of GE Medical Systems.
4 Etgar Street
39120 Tirat Carmel
Israel
Tel: (+972) 4851 9555 Fax: (+972) 4851 9500
GE Medical Systems Information Technologies GmbH,
Munzinger Strasse 5 D-79111 Freiburg, Germany
Tel: (+49) 761 45 43 0 Fax: (+49) 76145 43 233
Page 3
Table of Contents
Revision History
List of effective pages................................................................. xv
Introduction
Attention......................................................................................... 1
Prescription Device ....................................................................... 1
Safety.............................................................................................. 1
Principles of Operation ................................................................. 2
Interference caution ...................................................................... 2
Indications for use ........................................................................ 3
Contraindications .......................................................................... 3
Documentation .............................................................................. 3
Manual contents ................................................................... 4
Conventions used in this manual ................................................ 5
Regulatory requirements .............................................................. 6
Contact information ...................................................................... 7
Table of Contents
Chapter 1 Safety
Introduction.................................................................................. 15
Hazard symbols.................................................................. 16
Owner responsibility ................................................................... 17
Important safety considerations ................................................ 18
Notice against user modification......................................... 18
Regulatory information............................................................... 19
Directives............................................................................ 19
Product Classifications ....................................................... 19
Conformity to Standards ..................................................... 19
Certifications ....................................................................... 21
Software License Acknowledgements ................................ 21
Device labels................................................................................ 22
Label Locations................................................................... 22
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Table of Contents
Label Icon Description.........................................................23
Acoustic output............................................................................26
Definition of the acoustic output parameters ....................... 26
ALARA.................................................................................26
Safety statement .................................................................27
System controls affecting acoustic output ........................... 27
OB Exam .......................................................................................29
Exam Preparation................................................................29
Acoustic Output Considerations ................................................30
Concerns surrounding fetal exposure .................................30
Patient safety................................................................................31
Patient identification ............................................................31
Diagnostic information.........................................................31
Patient guidance..................................................................32
Probe Safety .................................................................................32
Mechanical hazards ............................................................32
Electrical Hazard .................................................................33
Biological hazards ...............................................................34
Personnel and equipment safety................................................35
Explosion hazard.................................................................35
Electrical hazard..................................................................35
Smoke and fire hazard ........................................................36
Biological hazard.................................................................36
Pacemaker hazard ..............................................................36
LCD Monitor ........................................................................37
Electrical safety............................................................................ 39
Internally connected peripheral devices .............................. 39
External Connection of other peripheral devices.................39
Allergic reactions to latex-containing medical devices ...........40
Use of ECG ...................................................................................41
Use of Defibrillator.......................................................................41
Use of Electrosurgical Unit .........................................................41
Electromagnetic Compatibility (EMC) ........................................ 42
EMC performance ...............................................................43
Declaration of Emissions.....................................................44
Declaration of Immunity.......................................................44
Notice upon Installation of Product......................................44
General notice.....................................................................45
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Peripheral Update for EC countries.................................... 46
Patient Environmental Devices.................................................. 48
Acceptable devices............................................................. 49
Unapproved devices........................................................... 49
Accessories, options, and supplies..................................... 49
Environmental protection.................................................... 50
Chapter 2 Getting started
Introduction.................................................................................. 52
Preparing the unit for use........................................................... 53
Site requirements................................................................ 53
Connecting the unit............................................................. 54
Switching On/Off................................................................. 61
Moving and transporting the unit .............................................. 64
Wheels................................................................................ 64
Moving the unit ................................................................... 64
Transporting the unit........................................................... 66
Reinstalling at a new location ............................................. 67
Preparing Vivid S5/Vivid S6 for scanning ........................... 67
Unit acclimation time........................................................... 68
System description ..................................................................... 69
System overview................................................................. 69
Control panel ...................................................................... 71
The Scanning screen.......................................................... 84
Three-Pedal Footswitch operation...................................... 87
Connecting and disconnecting probes ............................... 87
Adjusting the Display Monitor ............................................. 90
Starting an examination.............................................................. 95
Creating a new Patient record or starting an examination from
an existing patient record.................................................... 95
Selecting a Probe and an Application............................... 100
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Table of Contents
Chapter 3 Basic scanning operations
Assignable keys and Soft Menu Rocker .................................. 103
Using the Assignable Keys Soft Menu ..............................104
Using the Soft Menu Rocker .............................................107
Trackball operation ....................................................................108
Trackball assignment ........................................................108
The system menu..............................................................109
Cineloop operation ....................................................................110
Cineloop overview .............................................................110
Cineloop controls...............................................................111
Using cineloop...................................................................112
Storing images and cineloops ..................................................113
To store a single image .....................................................113
To store a cineloop............................................................113
Removable Media.......................................................................114
Intended use......................................................................114
Supported removable media .............................................115
Zoom ...........................................................................................120
To Magnify an image (Display zoom)................................120
To activate the HR zoom...................................................120
Performing measurements........................................................121
To perform measurements................................................121
Physiological trace ....................................................................122
Connecting the internal ECG.............................................122
Physio controls ..................................................................126
Displaying the ECG trace ..................................................126
Adjusting the display of the ECG trace..............................126
Annotations ................................................................................128
To insert an annotation......................................................128
To edit annotation..............................................................131
To erase annotation ..........................................................131
Configuration of the pre-defined annotation list.................132
Bodymarks ........................................................................134
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Chapter 4 Scanning Modes
Introduction................................................................................ 139
2D-Mode ..................................................................................... 140
2D-Mode overview............................................................ 140
2D-Mode controls ............................................................. 142
Using 2D........................................................................... 148
Optimizing 2D ................................................................... 148
M-Mode ....................................................................................... 150
M-Mode overview ............................................................. 150
M-Mode controls ............................................................... 151
Using M-Mode .................................................................. 153
Optimizing M-Mode........................................................... 155
Color Mode................................................................................. 157
Color Mode overview ........................................................ 157
Color M-Mode overview.................................................... 158
Color Mode controls.......................................................... 159
Using Color Mode ............................................................. 162
Optimizing Color Mode ..................................................... 163
PW and CW Doppler.................................................................. 164
PW and CW Doppler overview ......................................... 164
PW and CW Doppler controls........................................... 165
Using PW/CW Doppler modes ......................................... 167
Optimizing PW/CW Doppler modes.................................. 168
Tissue Velocity Imaging (TVI)........................................... 169
Tissue Tracking ................................................................ 173
Strain rate................................................................................... 178
Strain rate overview.......................................................... 178
Strain rate controls............................................................ 179
Using Strain rate ............................................................... 181
Optimizing Strain rate ....................................................... 181
Strain .......................................................................................... 183
Strain overview ................................................................. 183
Strain controls................................................................... 184
Using Strain ...................................................................... 186
Optimizing Strain .............................................................. 186
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Table of Contents
Tissue Synchronization Imaging (TSI) ..................................... 188
TSI overview......................................................................188
TSI controls .......................................................................189
Using TSI...........................................................................191
Optimizing TSI...................................................................192
Additional scanning features....................................................193
LogiqView..........................................................................193
Compound.........................................................................194
B-Flow ...............................................................................195
Blood flow imaging ............................................................195
Virtual Convex...................................................................196
Chapter 5 Stress Echo
Introduction ................................................................................198
Selection of a stress test protocol template............................199
Image acquisition.......................................................................200
Starting acquisition............................................................201
Continuous capture mode .................................................205
Analysis.............................................................................213
Quantitative TVI Stress echo analysis .....................................218
Accessing QTVI Stress analysis tools...............................219
Vpeak measurement .........................................................220
Tissue Tracking .................................................................223
Quantitative analysis .........................................................223
References........................................................................224
Editing/creating a template .......................................................225
Entering the Template editor screen .................................225
Template editor screen overview ......................................226
Editing/Creating a template...............................................229
Chapter 6 Contrast Imaging
Introduction ................................................................................234
Cardiac imaging ................................................................234
Non-cardiac imaging .........................................................235
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Data acquisition......................................................................... 235
Left Ventricular Contrast Imaging ..................................... 235
LV Contrast overview................................................................ 236
LV Contrast controls ......................................................... 236
Using LV Contrast............................................................. 238
Optimizing LV Contrast..................................................... 239
Vascular Contrast Imaging ....................................................... 240
Abdominal Contrast Imaging ................................................... 241
Chapter 7 Measurement and Analysis
Introduction................................................................................ 246
About Measurement results display.................................. 247
The Assign and Measure modality .......................................... 248
Starting the Assign and Measure modality ....................... 248
Entering a study and performing measurements.............. 249
Measure and Assign modality.................................................. 251
Starting the Measure and Assign modality ....................... 251
Post-measurement assignment labels.............................. 252
Cardiac measurements ............................................................. 255
2D Measurements ............................................................ 255
M-Mode Measurements.................................................... 259
Doppler Measurements .................................................... 262
TSI Measurements ........................................................... 266
Automated Function Imaging............................................ 273
AutoEF Measurements ..................................................... 292
Vascular measurements ........................................................... 302
B-Mode measurements .................................................... 302
Intima-Media Thickness.................................................... 303
M-Mode Measurements.................................................... 308
Doppler measurements .................................................... 309
Pediatric Calculations............................................................... 314
Overview........................................................................... 314
Hip Dysplasia Calculation ................................................. 315
Making Hip Dysplasia Measurement ................................ 315
Performing an OB exam............................................................ 317
Patient entry...................................................................... 317
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Table of Contents
Selecting probe and OB application ..................................321
OB Measurements and calculations ........................................322
Introduction........................................................................322
B-Mode measurements.....................................................323
M-Mode measurements ....................................................330
Doppler Mode Measurements ...........................................330
OB parameter configuration .....................................................333
Configuring OB M&A according to geographical regions .. 333
Measurement package configuration.......................................338
Measurement package configuration - example ...............338
User-defined formulas ...............................................................343
User-defined formula - example ........................................ 343
About units ........................................................................349
Measurement result table..........................................................351
Minimizing the Measurement result table..........................351
Moving the Measurement result table ...............................351
Deleting measurements ....................................................352
Worksheet...................................................................................353
Overview ...........................................................................353
Using Worksheet...............................................................354
OB worksheet.............................................................................356
Patient data .......................................................................357
Measurement information..................................................357
Calculation information......................................................358
OB graphs...................................................................................359
Overview ...........................................................................359
Fetal Growth Curve Graph ................................................360
Fetal Trending ...................................................................364
Fetal Growth Bar Graph ....................................................365
OB-Multigestational ...................................................................366
Multiple Fetus ....................................................................366
GYN Measurements ...................................................................370
Introduction........................................................................370
To Start a Gynecology Exam ............................................370
B-Mode Measurements..............................................................371
Uterus length, width, and height........................................371
Ovary length, width, and height.........................................372
Follicle measurements length, width, and height ..............373
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Endometrium thickness (Endo)......................................... 373
M-Mode Measurements............................................................. 374
Doppler Mode Measurements .................................................. 374
Chapter 8 Quantitative Analysis
Introduction................................................................................ 377
Accessing the Quantitative analysis package........................ 378
In replay mode .................................................................. 378
In live ................................................................................ 378
Quantitative Analysis window.................................................. 379
Overview........................................................................... 379
Generation of a trace................................................................. 386
About the sample area...................................................... 386
To generate a trace .......................................................... 386
Manual tracking of the sample area (dynamic anchored
sample area)..................................................................... 387
Zooming in the Analysis window....................................... 388
Deletion of a trace ..................................................................... 389
To delete all traces ........................................................... 389
To delete one specific trace.............................................. 389
Saving/retrieving Quantitative analysis .................................. 389
Frame disabling ......................................................................... 390
Disabling frames............................................................... 390
Re-enabling all frames...................................................... 390
Optimizing sample area ............................................................ 392
Reshaping a sample area................................................. 392
Labelling a sample area.................................................... 393
Optimizing the trace display..................................................... 394
Optimizing the Y-axis........................................................ 394
Trace smoothing ............................................................... 395
Switching modes or traces....................................................... 397
To switch mode................................................................. 397
To switch trace.................................................................. 397
Cine compound ......................................................................... 398
Anatomical M-Mode................................................................... 399
Introduction ....................................................................... 399
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Table of Contents
Using Anatomical M-Mode ................................................399
Optimizing Anatomical M-Mode ........................................401
Chapter 9 Archiving
Introduction ................................................................................405
Storing images and cineloops ..................................................406
Storing an image ...............................................................407
Storing a cineloop..............................................................407
Saving images and cineloops to a standard format ..........408
MPEGVue/eVue ................................................................410
Retrieving and editing archived information...........................413
Locating a patient record...................................................413
Selecting a patient record and editing data in the archive.418
Deleting archived information............................................422
Moving examinations.........................................................424
Review images in archive..........................................................426
Review the images from a selected examination.............. 426
Select images from the Image list screen .........................427
Connectivity................................................................................431
The dataflow concept ........................................................431
Stand-alone scanner scenario...........................................434
A stand-alone scanner and a stand-alone EchoPAC PC
environment.......................................................................435
A scanner and EchoPAC PC in a direct connect
environment.......................................................................437
A scanner and EchoPAC PC in a network environment ...441
A scanner and a DICOM server in a network....................443
Export/Import patient records/examinations........................... 452
Exporting patient records/examinations ............................452
Importing patient records/examinations ............................460
Disk Management.......................................................................464
Configuring the Disk management function ......................465
Running the Disk management function ...........................468
Data Backup and Restore .................................................471
DICOM spooler ...........................................................................479
Starting the DICOM spooler ..............................................479
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Database import from Vivid 3 or Vivid 4.................................. 482
Transfer Procedure........................................................... 482
Installing the Vivid 3/4 Data Viewer .................................. 485
Using the Vivid 3/4 Data Viewer ....................................... 488
Chapter 10 Report
Introduction................................................................................ 492
Creating a report........................................................................ 493
Working with the report function ....................................... 493
To print a report ................................................................ 496
To store a report ............................................................... 496
Retrieving an archived report............................................ 497
Deleting an archived report............................................... 497
Structured Findings .................................................................. 498
Prerequisite....................................................................... 498
Starting Structured Findings ............................................. 499
Structured Findings structure............................................ 499
Using Structured Findings ................................................ 501
Structured Findings configuration ..................................... 504
Direct report............................................................................... 514
Creating comments........................................................... 514
Creating pre-defined text inputs........................................ 515
Report designer ......................................................................... 516
Accessing the Report designer......................................... 516
Report designer overview ................................................. 516
Designing a report template.............................................. 519
Saving the report template................................................ 530
To exit the Report designer .............................................. 530
Report templates management ................................................ 531
Configuration of the Template selection menu ................. 532
Export/Import of Report templates.................................... 533
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Table of Contents
Chapter 11 Probes
Probe overview...........................................................................537
Supported probes..............................................................537
Vivid S5 Probe/Application Overview ................................ 542
Vivid S6 Probe/Application Overview ................................ 543
Maximum probe temperature ............................................544
Probe orientation...............................................................545
Probe labelling...................................................................546
Environmental Requirements............................................547
Probe Integration .......................................................................548
Selecting probes................................................................548
Connecting the probe........................................................548
Activating the probe...........................................................550
Disconnecting the probe....................................................551
Care and Maintenance ...............................................................552
Planned maintenance........................................................552
Inspecting the probe..........................................................553
Special handling instructions.............................................554
Cleaning and disinfecting probes ......................................556
Probe safety................................................................................562
Biopsy .........................................................................................563
Precaution concerning the use of biopsy procedures .......563
Preparing the Biopsy guide attachment ............................565
Displaying the Guide zone ................................................569
Endocavitary Probe Biopsy Guide Assembly....................571
Biopsy needle path verification..........................................573
Starting the biopsy procedure ...........................................573
Cleaning, disinfection and disposal ................................... 573
Surgery/Intra-operative Use ......................................................574
Preparing for Surgery/Intra-operative Procedures ............574
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Chapter 12 Peripherals
Introduction................................................................................ 576
Printing ....................................................................................... 577
To print an image.............................................................. 577
Specifications for peripherals.................................................. 577
DVR (Digital Video Recorder) ................................................... 578
Overview........................................................................... 578
Using the DVR .................................................................. 578
Configuring the DVR......................................................... 581
Reviewing the DVR Media Externally ............................... 581
Chapter 13 Presets and System setup
Introduction................................................................................ 585
Starting the Configuration package......................................... 588
To open the Configuration package.................................. 588
Overview..................................................................................... 589
Imaging....................................................................................... 590
The Global setup sheet..................................................... 590
Application ........................................................................ 593
Application menu .............................................................. 596
Measure Text.............................................................................. 598
The measurement menu sheet......................................... 598
Configuration of the Measurement menu ......................... 601
The Advanced sheet.................................................................. 603
Parameter configuration ................................................... 603
The Modify Calculations sheet................................................. 604
Parameter configuration ................................................... 604
The OB table sheet........................................................... 605
Report......................................................................................... 611
The diagnostic codes sheet.............................................. 612
The Comment texts sheet................................................. 613
Connectivity............................................................................... 616
Dataflow............................................................................ 616
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Table of Contents
Additional outputs..............................................................623
Tools..................................................................................625
Formats .............................................................................626
TCP-IP...............................................................................632
System ........................................................................................633
The system settings ..........................................................633
About...........................................................................................635
Administration............................................................................636
Users.................................................................................637
Unlock Patient ...................................................................640
Chapter 14 User maintenance
System Care and Maintenance .................................................642
Inspecting the system........................................................642
Cleaning the unit ...............................................................643
Prevention of static electricity interference........................645
System self-test..........................................................................646
System malfunction ...........................................................646
Using InSite ExC ........................................................................650
InSite ExC Functionalities .................................................650
Initiating a Request for Service (RFS)...............................650
Clinical Lifeline Mode ........................................................653
Exiting InSite ExC..............................................................654
Index
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Revision History
Revision Date Reason for Change
1 19 July 2009 Initial release
2 07 February 2010 Updates and additions
List of effective pages
Revision Effective Pages
1All
2All
Please verify that you are using the latest revision of this document. If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Medical Systems Clinical Answer Center at: 1-800-682-5327 or 1-262-524-5698.
Revision History
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Revision History
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Introduction
The Vivid S5/Vivid S6 ultrasound systems are light-weight, high performance innovative ergonomic mobile digital ultrasound imaging systems.
Both systems provide image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectra, LVO Contrast, B-Flow, BFI option applications.
Vivid S6 offers additional modes, like TVI or Tissue Tracking, and options like TSI (Tissue Synchronization Imaging) and SI/SRI (Strain/Strain-rate imaging.
The fully digital architecture of the Vivid S5/Vivid S6 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.
Introduction
Attention
This manual contains necessary and sufficient information to operate the system safely. Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed-upon time period.
Read and understand all instructions in the User's Manual before attempting to use the Vivid S5/Vivid S6 ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions.
Prescription Device
For USA only:
CAUTION
United States law restricts this device to sale or use by, or on the order of a physician.
Safety
All information in Chapter 1, "Safety" on page 13, should be read and understood before operating the Vivid S5/Vivid S6 ultrasound unit.
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Introduction
Principles of Operation
Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a transducer. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of human tissue, an echo is created where a signal passes from an adipose tissue (fat) region to a muscular tissue region. The echoes return to the transducer where they are converted back into electrical signals.
These echo signals are highly amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by the main computer. By selection from the system control panel, the user can alter the characteristics and features of the system, allowing a wide range of uses, from obstetrics to peripheral vascular examinations.
Transducers are accurate, solid-state devices, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance. A sophisticated system design with computer controlled extensive features and functions make the Vivid S5 and Vivid S6 easy systems to use and very user friendly.
Interference caution
Use of devices that transmit radio waves near the unit could cause it to malfunction.
CAUTION
Devices not to be used near this equipment:
Devices which intrinsically transmit radio waves such as cellular phones, radio transceivers, mobile radio transmitters, radio-controlled toys, and so on, should not be operated near the unit.
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Medical staff in charge of the unit are required to instruct technicians, patients, and other people who may be around the unit, to fully comply with the above recommendations.
Indications for use
The Vivid S5/Vivid S6 ultrasound unit is intended for the following applications:
• Abdominal
• Cardiac
Musculoskeletal including Superficial
• Small Organ
• Pediatric
• OB/Gyn
• Fetal Heart
• Transesophageal
• Peripheral Vascular
• Neonatal Cephalic
• Adult Cephalic
• Intraoperative
Introduction
This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.
CAUTION
Contraindications
The Vivid S5/Vivid S6 ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass
DANGER
through the eye.
Documentation
Vivid S5/Vivid S6 documentation consists of two manuals:
The Basic User Manual (TRANSLATED) provides information needed by the user to operate the system safely. It describes the basic functions of the system, safety features, operating modes, measurements/calculations,
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Introduction
probes, and user care and maintenance.
Note: Probe information displayed on screen examples does not necessarily reflect the probes available on your ultrasound system. Please refer to the Probes chapter for a listing of available probes and features.
The Advanced Reference Manual (ENGLISH ONLY) contains M&A formulas and parameter-names, data tables, such as OB and Acoustic Output tables.
Note: The documentation kit provides the Basic User Manual and Advanced Reference Manual in electronic format only. The CD-ROM includes English and all translations. Paper documentation may be ordered.
The Vivid S5/Vivid S6 documentation is written for users who are familiar with basic ultrasound principles and techniques. They do not include sonographic training or detailed clinical procedures.
Note: The original documentation was written in English.
CAUTION
Manual contents
The Vivid S5/Vivid S6 User's Manual is organized to provide the information needed to start scanning immediately.
Some of the functions or features described in this manual are optional and may not be available in the configuration of your specific system.
The safety instruction must be reviewed before operation of the unit.
Finding information
Table of Contents, lists the main topics and their location.
Headers and Footers, give the chapter name and page
number.
Index, provides an alphabetical and contextual list of topics.
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Conventions used in this manual
2-column layout, the right column contains the main text. The left column contains notes, hints, and warnings.
Keys and buttons, on the control panel are indicated by over and underlined text (ex.
Bold type, describes button names on the screen.
Italic type: describes program windows, screens and dialogue
boxes.
Safety icons, highlight safety issues as described in "Introduction" on page 15.
Product icons, indicate product variant features as follows:
Indicates that the relevant feature exists in the standard configuration of Vivid S6 and is not available on Vivid S5.
2D refers to the 2D mode key)
Introduction
Indicates that the relevant feature exists as an option of the Vivid S6 and is not available on Vivid S5.
Indicates that the relevant feature exists as an option on both Vivid S6 and Vivid S5 systems.
Indicates that the relevant feature exists in the standard configuration of Vivid S6 and is available as an option on Vivid S5.
Indicates that the relevant feature exists in the standard configuration of Vivid S5 and is not available on Vivid S6.
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Introduction
Indicates that a specific hazard is known to exist which through inappropriate conditions or actions, will cause:
DANGER
WARNING
CAUTION
• Severe or fatal personal injury
• Substantial property damage
Indicates that a specific hazard is known to exist which through inappropriate conditions or actions, will cause:
• Severe personal injury
• Substantial property damage
Indicates that a potential hazard may exist which through inappropriate conditions or actions, will or can cause:
• Minor injury
• Property damage
Regulatory requirements
The Vivid S5/Vivid S6 ultrasound unit confirms to directives, classifications, and standards, as described in "Regulatory information" on page 19.
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Contact information
If additional information or assistance is needed, please contact the local distributor or the appropriate support resource listed bellow:
Internet
http://www.gehealthcare.com
http://www.gehealthcare.com/usen/ultrasound/products/probe_care.html
USA
GE Healthcare
Ultrasound Service Engineering
9900 Innovation Drive
Wauwatosa, WI 53226
Clinical Questions
For information in the United States, Canada, Mexico and parts of the Caribbean, call the Customer Answer Center.
In other locations, contact your local Applications, Sales or Service Representative.
Tel: (1) 800-437-1171
Fax: (1) 414-721-3865
Tel: (1) 800-682-5327
or (262) 524-5698
Introduction
Service Questions
For service in the United States, call GE CARES
In other locations, contact your local Service Representative.
Accessories Catalog Requests
To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center.
In other locations, contact your local Applications, Sales or Service Representative.
Placing an Order
To place an order, order supplies or ask an accesory-related question in the United States, call the GE Access Center.
In other locations, contact your local Applications, Sales or Service Representative.
Vivid S5/Vivid S6 User Manual 7 R2424458-100 Rev. 2
Tel: (1) 800-437-1171
Tel: (1) 800-643-6439
Tel: (1) 800-472-3666
Page 26
Introduction
Canada
GE Healthcare
Ultrasound Service Engineering
9900 Innovation Drive
Wauwatosa, WI 53226
Customer Answer Center
Latin and South America
GE Healthcare
Ultrasound Service Engineering
9900 Innovation Drive
Wauwatosa, WI 53226
Customer Answer Center
Europe
GE Ultraschall
Deutschland GmbH & Co. KG
Beethovenstraße 239
Postfach 11 05 60
D-42655 Solingen
Tel: (1) 800-664-0732
Tel: (1) 262-524-5698
Tel: (1) 262-524-5300
Tel: (1) 262-524-5698
Tel: 0130 81 6370 toll free
Tel: (33) 130-831-300
Fax: (49)(0) 212-28-02-431
Asia
GE Medical Systems Asia (Singapore)
Service Department - Ultrasound
298 Tiong Bahru Road # 15-01/06
Central Plaza
Singapore 168730
Japan
GE Healthcare Japan Corporation
Customer Service Center
Argentina
GEME S.A.
Miranda 5237
Buenos Aires - 1407
Austria
General Electric Austria GmbH
Euro Plaza, Geb. E, Technologiestr. 10
A-1120 Vienna, Austria
Tel: (65) 291-8528
Fax: (65) 272-3997
Tel: (81) 426-48-2950
Fax: (81) 426-48-2902
Tel: (1) 639-1619
Fax: (1) 567-2678
Tel: +43 1 972 72-0
Fax: +43 1 972 72-2222
8 Vivid S5/Vivid S6 User Manual
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Belgium
GE Medical Systems Benelux
Kouterveldstraat 20
B-1831 Diegem
Brazil
GE Sistemas Médicos
Av Nove de Julho 5229
Paraiso
Cep: 01407-907 - São Paulo, SP
China
GE Healthcare - Asia
No. 1, Yongchang North Road
Beijing Economic & Technology Development Area
Beijing 100176, China
Denmark
GE Medical Systems (Denmark) A/S
Park Allé 295
2605 Broenby
Introduction
Tel: +32 (0)2 719 73 11
Fax: +32 (0)2 719 72 05
Tel: 0800-122345
Fax: (011) 3067-8298
Tel: (8610) 5806-9403
Fax: (8610) 6787-1162
Tel: +45 4348 5400
Fax: +45 4348 5399
France
GE Healthcare France
11 avenue Morane Saulnier
78457 VELIZY CEDEX
Germany
GE Ultraschall
Deutschland GmbH & Co. KG
Beethovenstraße 239
Postfach 11 05 60
D-42655 Solingen
Greece
GE Medical Systems Hellas AP.
Λεωφόρος Κύπρου 156 AP.
TΚ 164 51, ΑΡΓΥΡΟΥΠΟΛΗ
Vivid S5/Vivid S6 User Manual 9 R2424458-100 Rev. 2
Tel: +33 1 34495231
Fax: +33 1 34495202
Tel: (49) 212.28.02.207
Fax: (49) 212.28.02.431
Τηλ.: +30 210 9690990
Φαξ: +30 210 9625931
Page 28
Introduction
Italy
GE Medical Systems Italia S.p.A.
Via Galeno 36
20126 Milano
Luxembourg Tel: 0800 2603 toll free
Mexico
GE Sistemas Médicos de Mexico S.A. de C.V.
Rio Lerma #302, 1° y 2° Pisos
Colonia Cuauhtémoc
06500-México, D.F.
Netherlands
GE Medical Systems Nederland B.V.
Atoomweg 512
NL-3542 AB Utrecht
Poland
GE Medical Systems Polska Sp. z o.o.
UI. Wołoska 9
02-583 Warszawa
Tel: +39 0226001111
Fax: +39 0226001599
Tel: (5) 228-9600
Fax: (5) 211-4631
Tel: 06-022-3797 toll free
Fax: (31)-304-11702
Tel: +48223308300
Fax: +48223308383
Portugal
GE Portuguesa, S.A.
Avenida do Forte, 6 - 6A
Edificio Ramazzotti
2790-072 Carnaxide
Russia
GE Healthcare LLC
18 Krasnopresnenskaya Nab.,
Moscow 123317,
Russian Federation
Spain
GE Healthcare
Edificio Gobelas I
C/ Gobelas 35-37
E- 28023-Madrid
Tel: (+351) 21 4251309
Fax: (+351) 21 4251343
Tel: +7 495 739 69 31
Fax: +7 495 739 69 32
Tel: +34 91 663 25 00
Fax: +34 91 663 25 01
10 Vivid S5/Vivid S6 User Manual
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Sweden
GE Medical Systems Sverige AB
FE-314, Solnastrandväg 98
Se-171 75 Stockholm
Switzerland
GE Medical Systems (Schweiz) AG
Europastrasse 31
CH-8152 Glattbrugg
Turk ey
GE Healthcare
Sun Plaza
Dereboyu Sok. No 24/7
34398 Maslak
Istanbul
United Kingdom
GE Healthcare - Ultrasound,
2 Napier Road,
Bedford,
MK41 0JW
Introduction
Tel: +46 8 559 50 000
Fax: +46 8 559 500 15
Tel: +41 44 8099292
Fax: +41 44 8099222
Tel: 90 (212) 366 29 00
Fax: 90 (212) 366 29 99
Tel: +44 1234 340881
Fax: +44 1234 266261
Other countries NO TOLL FREE
Tel: int. code + 33 1 39 20 0007
Manufacturer
GE Medical Systems, Israel, Ltd.
Einstein Bldg 4, Etgar st.
P.O. Box 2006
Tirat Carmel 39120, Israel
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Fax: (+972) 4851 9500
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Introduction
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Safety
Chapter 1 Safety
• Introduction ................................................................................... .... 15
• Hazard symbols ......................................................................... 16
• Owner responsibility .................................................................... .... 17
• Important safety considerations ................................................. .... 18
• Notice against user modification ................................................ 18
• Regulatory information ................................................................ .... 19
• Directives ................................................................................... 19
• Product Classifications ............................................................... 19
• Conformity to Standards ............................................................ 19
• Certifications .............................................................................. 21
• Software License Acknowledgements ....................................... 21
• Device labels ................................................................................. .... 22
• Label Locations .......................................................................... 22
• Label Icon Description ................................................................ 23
• Acoustic output ............................................................................. .... 26
• Definition of the acoustic output parameters .............................. 26
• ALARA ....................................................................................... 26
• Safety statement ........................................................................ 27
• System controls affecting acoustic output .................................. 27
• OB Exam ........................................................................................ .... 29
• Exam Preparation ...................................................................... 29
• Acoustic Output Considerations ................................................. .... 30
• Concerns surrounding fetal exposure ........................................ 30
• Patient safety ................................................................................. .... 31
• Patient identification ................................................................... 31
• Diagnostic information ................................................................ 31
• Patient guidance ........................................................................ 32
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Safety
• Probe Safety .................................................................................. ..... 32
• Mechanical hazards ....................................................................32
• Electrical Hazard .........................................................................33
• Biological hazards .......................................................................34
• Personnel and equipment safety ................................................ ..... 35
• Explosion hazard ........................................................................35
• Electrical hazard .........................................................................35
• Smoke and fire hazard ................................................................ 36
• Biological hazard ........................................................................36
• Pacemaker hazard ......................................................................36
• LCD Monitor ................................................................................37
• Electrical safety ............................................................................ ..... 39
• Internally connected peripheral devices .....................................39
• External Connection of other peripheral devices ........................39
• Allergic reactions to latex-containing medical devices ............ ..... 40
• Use of ECG .................................................................................... ..... 41
• Use of Defibrillator ....................................................................... ..... 41
• Use of Electrosurgical Unit .......................................................... ..... 41
• Electromagnetic Compatibility (EMC) ........................................ ..... 42
• EMC performance .......................................................................43
• Declaration of Emissions ............................................................44
• Declaration of Immunity ..............................................................44
• Notice upon Installation of Product .............................................44
• General notice ............................................................................45
• Peripheral Update for EC countries ............................................46
• Patient Environmental Devices ................................................... ..... 48
• Acceptable devices .....................................................................49
• Unapproved devices ...................................................................49
• Accessories, options, and supplies ............................................. 49
• Environmental protection ............................................................50
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Page 33
Introduction
This section describes the important safety measures which should be taken before operating the Vivid S5/Vivid S6 ultrasound unit. Procedures for simple care and maintenance of the unit are also described.
Various levels of safety precautions may be found on the equipment, and different levels of severity are identified by one of the following icons that precede precautionary statements in the text.
The following icons and conventions are used to indicate precautions:
Indicates that a specific hazard is known to exist which through inappropriate conditions or actions, will cause:
DANGER
WARNING
• Severe or fatal personal injury
• Substantial property damage
Indicates that a specific hazard is known to exist which through inappropriate conditions or actions, will cause:
• Severe personal injury
• Substantial property damage
Safety
Indicates that a potential hazard may exist which through inappropriate conditions or actions, will or can cause:
CAUTION
• Minor injury
• Property damage
Note:
used in the operation of the ultrasound system, specifically:
Indicates precautions or recommendations that should be
Maintaining an optimum system environment
Using this Manual
Notes to emphasize or clarify a point
Other precautions or prudent-use recommendations are indicated in the note sections in the left column. These are:
Use of the Vivid S5/Vivid S6 ultrasound unit as a prescription device, under the order of a physician.
Maintaining an optimum unit environment.
Reference to the User's Manual.
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Safety
Hazard symbols
Icon description
Potential hazards are indicated by the following icons:
Icon Potential hazard Usage Source
• Patient/user infection due to contaminated equipment
• Electrical micro-shock to patient, e.g., ventricular
• Console, accessories or optional storage devices that can fall on patient, user, or others.
• Collision with persons or objects may result in injury while maneuvering or during system transport.
• Injury to user from moving the console
• Patient injury or tissue damage from ultrasound radiation
• Cleaning and care instructions
• Sheath and glove guidelines
• Probes
• ECG (if applicable)
• Connections to back panel
• Moving
• Using brakes
• Transporting
• ALARA, the use of Power Output following the 'as low as reasonably achievable' principle
ISO 7000 No. 0659
• Risk of explosion if used in the presence of flammable anesthetics
• Patient/user injury or adverse reaction from fire or smoke
• Patient/user injury from explosion and fire
• Flammable anesthetic
• Replacing fuses
• Outlet guidelines
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Owner responsibility
For USA only:
Safety
CAUTION
Federal law restricts this device to use by, or on the orders of, a physician.
It is the responsibility of the owner to ensure that anyone operating the system reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake the installation, maintenance, troubleshooting, calibration and repair of the equipment.
The owner of the Vivid S5/Vivid S6 ultrasound unit should ensure that only properly trained, fully qualified personnel are authorized to operate the system. Before authorizing anyone to operate the system, it should be verified that the person has read, and fully understands, the operating instructions contained in this manual. It is advisable to maintain a list of authorized operators.
Should the system fail to operate correctly, or if the unit does not respond to the commands described in this manual, the operator should contact the nearest field GE Medical Systems Service Office.
For information about specific requirements and regulations applicable to the use of electronic medical equipment, consult the local, state and federal agencies.
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Safety
Important safety considerations
Notice against user modification
Never modify this product, including system components, software, cables, and so on. User modification may cause safety hazards and degradation in system performance. All modification must be done by a GE qualified person.
The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide.
This section includes considerations for the following
• Patient safety
Personnel and equipment safety
The information contained in this section is intended to familiarize the user with the hazards associated with the use of the unit, and to alert them to the extent to which injury and damage may occur if the precautions are not observed.
CAUTION
Improper use can result in serious injury. The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from GE Medical Systems if needed.
Users are obligated to familiarize themselves with these safety considerations and to avoid conditions that could result in injury or damage.
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Page 37
Regulatory information
Any changes to accessories, peripheral units or any other part of the system must be approved by the manufacturer. Ignoring this
CAUTION
advice may compromise the regulatory approvals obtained for the product.
Directives
The GE Healthcare Ultrasound product families are tested to meet all applicable requirements in relevant EU Directives and European/International standards.
Council Directive 93/42/EEC concerning MDD (Medical Devices Directive): the CE label affixed to the product testifies compliance to this Directive.
The location of the CE marking is specified in "Device labels" on page 22.
Product Classifications
Safety
The Vivid S5/Vivid S6 ultrasound unit confirms to the following classifications, in accordance with the IEC/EN 60601-1:6.8.1:
According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.
According to IEC/EN 60601-1, Equipment is Class I, Type B with BF or CF Applied Parts.
According to CISPR 11, this is Group 1, Class B ISM Equipment.
According to IEC 60529, the footswitch rate IPx8 is suitable for use in surgical rooms.
Classification according to the degree of protection against ingress of water as detailed in the current edition of IEC 529 (section 6.1.1): Ordinary for Main Unit (PC), IPX1, IPX7, IPX8 for ultrasound probes (transducers).
Conformity to Standards
To fulfill the requirements of relevant EC directives and/or European Harmonized/International standards, the following documents/standards have been used:
International Electrotechnical Commission (IEC).
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Safety
• IEC/EN 60601-1: Medical Electrical Eqiupment, Part 1 General Requirements for Safety
• IEC/EN 60601-1-2: Medical electrical equipment ­Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
• EN 55011/ CISPR11+A2 ED3.2: Emitted noise according to Class B requirements + Electromagnetic Susceptibility
• IEC/EN 60601-1-4: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
• IEC/EN 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
• IEC/EN 60601-2-37: Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• EN60601-1-1: 2001 - Medical Electrical Equipment Part 1-1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems
International Organization of Standards (ISO)
• ISO 10993-1: Biological Evaluation of Medical Devices ­Part 1: Evaluation & Testing
• ISO 10993-5: Biological Evaluation of Medical Devices ­Part 5: Tests for In Vitro Cytotoxicity
• ISO 10993-10:Biological evaluation of medical devices ­Part 10: Tests for irritation and delayed-type hypersensitivity
Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
• UL 60601-1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
Canadian Standards Association (CSA).
• CSA 22.2, 601.1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
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Safety
NEMA/AIUM Acoustic Output Display Standard (NEMA US-3, 1998).
Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).
Certifications
Quality management standards for medical devices: General Electric Medical Systems is ISO 9001 and ISO13485 certified.
Software License Acknowledgements
WindowBlinds ™ OCX © Stardock ®
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Safety
Device labels
Label Locations
1
Label 1 - Vivid S5 100-120V Label 2 - Vivid S5 220-240V
3
Label 3 - Vivid S6 100-120V Label 4 - Vivid S6 220-240V
1
2
2
4
3
4
5
5
Label 5 - Universal Label, for all systems Vivid S5/Vivid S6 label locations
Figure 1-1: System Label and Location
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Label Icon Description
The following table describes the purpose and location of safety labels and other important information provided on the equipment.
Label Purpose Location
Safety
Identification and Rating Plate
• Manufacturer's name and address
• Date of Manufacture
• Model and serial numbers
• Electrical ratings (Volts, Amps, phase, and frequency)
• Device Listing/Certification Labels
Equipment Type BF, in which protection against electric shock does not rely on basic insulation only. Provides additional safety precautions such as double insulation or reinforced insulation, because there is no provision for protective earthing or reliance upon installation conditions.
Equipment Type CF, indicates equipment having a floating applied part having a degree of protection suitable for direct cardiac contact.
Bottom of unit
Probe connectors.
ECG connector
Bottom of unit.
Alternating current Various
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
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Bottom Cover
Page 42
Safety
Label Purpose Location
Protective earth (ground) Internal
Earth (ground) Internal
Equipotentiality: indicates terminal to be used for connecting equipotential conductors when interconnecting (grounding) with other equipment.
Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high-risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable leakage current limits. An example of a high-risk patient would be a special procedure where the patient has an accessible conductive path to the heart such as exposed cardiac pacing leads.
Attention - Consult accompanying documents: alerts the user to refer to the user documentation when complete information cannot be provided on the label.
This marking on the control panel is especially intended to alert the user to consult the user manual for use BEFORE operation of the system.
Bottom of unit
Various
CAUTION - Dangerous voltage: used to indicate electric shock hazards.
Various
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Label Purpose Location
Safety
Apply a short push on the ON/OFF button to shut down the system.
CAUTION: This Power Switch DOES NOT ISOLATE Mains Supply.
This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.)
Date of manufacture: The date could be a year, year and month, or year, month and day, as appropriate. See ISO 8601 for date formats.
Catalog or model number Rear of unit
Serial number Rear of unit
Direct Current: For products to be powered from a DC supply.
Keyboard
Rear of unit
Rear of unit
GOST-R Mark: per Law of the Russian Federation No. 184-FZ. The field 0000 will contain the number of the institute that issued the GOST label.
Prescription Device Label for United States per 21 CFR 801.109(b)(1)
Vivid S5/Vivid S6 User Manual 25 R2424458-100 Rev. 2
Bottom of unit
Bottom of unit
Page 44
Safety
Acoustic output
Definition of the acoustic output parameters
Thermal Index
TI is an estimate of the temperature increase of soft tissue or bone. There are three thermal index categories:
TIS: Soft tissue thermal index. The main TI category. Used for applications that do not image bone.
TIB: Bone thermal index (bone located in a focal region). Used for fetal application.
TIC: Cranial bone thermal index (bone located close to the surface). Used for transcranial application.
Mechanical Index
MI is the estimated likelihood of tissue damage due to cavitation. The absolute maximum limits of the MI is 1.9 as set by the FDA 510 (k) guidance of 1997.
Note: Further explanation on "cavitation" appears in the Reference Manual Chapter 3 - Nonthermal Bioeffects.
Ispta
The Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum limit of Ispta is 720 MW/cm
FDA 510(k) guidance of 1997.
2
as set by the
ALARA
Ultrasound procedures should be performed using output levels and exposure times As Low As Reasonably Achievable (ALARA) while acquiring clinical information.
Training
During each ultrasound examination the user is expected to weigh the medical benefit of the diagnostic information that would be obtained against the risk of potential harmful effects. Once an optimal image is achieved, the need for increasing acoustic output or prolonging the exposure cannot be justified.
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Safety
It is recommended that all users receive proper training in applications before performing them in a clinical setting. Please contact the local GE sales representative for training assistance.
Safety statement
GE Medical Systems safety statement
Although no harmful biological effects have been demonstrated for ultrasound frequencies, intensities and exposure times used in examination with the GE Vivid S5/Vivid S6 system, GE Medical Systems recommends using the lowest acoustic output settings which will produce diagnostically acceptable information.
System controls affecting acoustic output
The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables in the Reference Manual. These tables show the highest possible acoustic intensity for a given mode, obtainable only when the maximum combination of control settings is selected. Most settings result in a much lower output. It is important to note the following:
The duration of an ultrasound examination is as important as the acoustic output, since patient exposure to output is directly related to the exposure time.
Better image quality yields faster clinical results, making it possible to complete the relevant ultrasound examination more rapidly. Therefore, any control that improves the quality of the examination can help to reduce patient exposure, even though it may not directly affect acoustic output.
Probe selection
As long as the appropriate application is available, any probe can be used with the knowledge that the intensities fall at, or below, those stated in the Acoustic Output Data Tables. The duration of patient exposure is most likely minimized with the use of a probe that is optimized to provide resolution and focal depth, appropriate to the examination.
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Safety
Application selection
Selecting the probe and application preset appropriate to a particular ultrasound examination automatically provides acoustic output limits within FDA guidelines for that application. Other parameters which optimize performance for the selected application are also set automatically, and should assist in reducing the patient exposure time. See page 100, for information on selecting probes and application presets.
Changing imaging modes
Acoustic output depends on the imaging mode selected. The choice of mode (2D, M-Mode, Doppler or Color Flow) determines whether the ultrasound beam is stationary or in motion. This greatly affects the energy absorbed by the tissue.
See Chapter 4, "Scanning Modes" on page 137, for complete information on changing imaging modes.
When operating in a combined mode, such as 2D and M-Mode, the total acoustic output comprises contributions from each individual mode. Depending on the modes in use, either or both output indices may be affected.
The user can override the default settings, but care should be taken to observe the displayed MI and TI values.
Power
It is possible to change the power in all operating modes so that the operator can use the ALARA principle.
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OB Exam
Safety
Exam Preparation
Prior to an ultrasound examination, the patient should be informed of the clinical indication, specific benefits, potential risks, and alternatives, if any. In addition, if the patient requests information about the exposure time and intensity, it should be provided. Patient access to educational materials regarding ultrasound is strongly encouraged to supplement the information communicated directly to the patient. Furthermore, these examinations should be conducted in a manner and take place in a setting which assures patient dignity and privacy.
Prior material knowledge and approval of the presence of nonessential personnel with the number of such personnel kept to a minimum.
An intent to share with the parents per the physician's judgment, either during the examination or shortly hereafter, the information derived.
An offer of choice about viewing the fetus.
An offer of choice about learning the sex of the fetus, if such information becomes available.
Ultrasound examinations performed solely to satisfy the family's desire to know the fetal sex, to view the fetus, or to obtain a picture of the fetus should be discouraged.
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Safety
Acoustic Output Considerations
The Vivid S5/Vivid S6 system is a multi-use device which is capable of exceeding FDA Pre-enactment acoustic output
WARNING
CAUTION
(spatial peak-temporal average) intensity limits for fetal applications.
It is prudent to conduct an exam with the minimum amount and duration of acoustic output necessary to optimize the image's diagnostic value.
Concerns surrounding fetal exposure
Always be aware of the acoustic output level by observing the Acoustic Output Display. In addition, become thoroughly familiar with the Acoustic Output Display and equipment controls affecting output.
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Patient safety
Patient identification
The concerns listed in this section can seriously affect the safety of the patient undergoing a diagnostic ultrasound examination.
WARNING
Always include proper identification with all patient data and verify the accuracy of the patient's name and/or identity number when entering such data. Ensure that the correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis.
Note: For further information on patient identification, see "Starting an examination" on page 95.
Diagnostic information
The images and calculations provided by the system are intended for use by competent users, as a diagnostic tool. They are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis. Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical utility of the system.
Safety
The user should be aware of the product specifications and of the system accuracy and stability limitations. These limitations must be considered before making any decision based on quantitative values. If in doubt, the nearest GE Medical Systems Service Office should be consulted.
Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details in the image. The user must become thoroughly familiar with the operation of the unit in order to optimize its performance and to recognize possible malfunctions. Application training is available through the sales representative.
Be certain to ensure privacy data of patient information.
CAUTION
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Safety
Patient guidance
Remember to assist the patient when moving up to the examination bed, moving down from the bed, or when moving in
CAUTION
the vicinity of the system.
Make sure to keep the patient in full view at all times and never leave the patient unattended while on the examination bed.
Probe Safety
This section includes information on hazards to both the user and the equipment, as follow:
• Mechanical hazards
• Electrical hazards
• Biological hazards
Mechanical hazards
Damaged probes or improper use and manipulation of the transesophageal probe may result in injury or increased risk of infection. Inspect probes frequently for sharp, pointed or rough surface damage that could cause injury or tear protective barriers (gloves and sheaths).
Never use excessive force when manipulating intracavity probes. Become familiar with all instructions and precautions provided with special purpose probes.
The use of damaged probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Become familiar with all instructions and precautions provided with special purpose probes.
Observe immersion levels as displayed in Figure 11-5, page 559.
WARNING
Inspect probes for sharp edges or rough surfaces that could injure sensitive tissue.
DO NOT bend or pull the cable forcefully, to avoid mechanical shock or impact to the probe.
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CAUTION
CAUTION
Safety
Allowing the machine to transmit acoustic output with the probe not in use (or in its holder) can cause the transducer to build up heat. Always turn off acoustic output or freeze the image when not in use. The system's acoustic output remains transmitting when the user controls are being used.
The system is equipped with an Auto Freeze feature which disables acoustic output and freezes the image when the machine is not in use.
Ultrasound transducers are sensitive instruments which can easily be damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens or cable can result in patient injury or serious impairment or operation.
Transesophageal probe safety
Never use excessive force when manipulating the transesophageal probe. The detailed operator manual enclosed with the transesophageal probe must be read carefully.
Electrical Hazard
Probes are driven by electricity, which can injure the patient or user when exposed to contact with conductive solution.
A damaged probe may increase the risk of electric shock if conductive solutions come in contact with internal live pads. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens, or other damage that could allow moisture to enter. Become familiar with the use and care precautions described in Chapter 11, "Probes" on page 535.
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Safety
WARNING
CAUTION
Do not immerse the probe into any liquid beyond the level shown in Figure 11-5, page 559. Never immerse the probe connector or adaptors into any liquid.
Do not subject the probe to mechanical shock or impact, which may result in cracks or chips in the housing and degrade performance.
Inspect the probe before and after each use, as described on page 553, for damage or degradation to the housing, strain relief, lens and seal.
DO NOT apply excessive force to the probe cable, to prevent insulation failure.
Electrical leakage checks should be performed regularly by a GE service representative or qualified hospital personnel, according to the procedures described in EN 60601-1/IEC 60601-1 §19.
Ultrasound can produce harmful effects in tissue and potentially result in patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (As Low As Reasonably Achievable), increasing output only when needed to obtain diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the Advanced Reference Manual for more information.
Biological hazards
Transesophageal probes require a special handling. Refer to the user documentation enclosed with these probes.
CAUTION
To minimize disease transmission, legally marketed and sterile pyrogen-free sheaths should be used for each probe recommended for intra-cavity procedures.
Adequate cleaning and disinfection are essential to prevent disease transmission. It is the responsibility of the user to verify and maintain the effectiveness of the infection control procedures in use.
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Personnel and equipment safety
The hazards listed below can seriously affect the safety of personnel and equipment during a diagnostic ultrasound
DANGER
examination.
Explosion hazard
Never operate the equipment in the presence of flammable or explosive liquids, vapors or gases. Malfunctions in the unit, or sparks generated by fan motors, can electrically ignite these substances. Operators should be aware of the following points to prevent such explosion hazards.
If flammable substances are detected in the environment, do not plug in or turn on the system.
If flammable substances are detected after the system has been turned on, do not attempt to turn off the unit, or to unplug it.
If flammable substances are detected, evacuate and ventilate the area before turning off the unit.
Safety
WARNING
Electrical hazard
The internal circuits of the unit use high voltages, capable of causing serious injury or death by electrical shock.
If any defects are observed or malfunctions occur, stop operating the equipment and perform the proper action for the patient. Inform a qualified service person and contact a Service Representative for information.
To avoid injury
Do not remove the unit's protective covers. No user-serviceable parts are inside. If servicing is required, contact qualified technical personnel.
Connect the attachment plug to a hospital-grade grounding outlet to ensure adequate grounding.
Never use any adaptor or converter of a three-prong-to two-prong type to connect with a mains power plug. The protective earth connection will loosen.
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Safety
CAUTION
Do not place liquids on or above the unit. Conductive fluids seeping into the active circuit components may cause a short-circuit, which could result in an electrical fire.
An electrical hazard may exist if any light, monitor or visual indicator remains on after the unit is turned off.
Fuses blown within 36 hours of being replaced may indicate a malfunctioning electrical circuit within the system. In this event, the unit must be checked by GE Medical Systems service personnel. No attempt should be made to replace the fuses with others of a higher rating.
Do not use this equipment if a safety problem is known to exist. Have the unit repaired and performance verified by qualified service personnel before returning to use.
Smoke and fire hazard
The system must be supplied from an adequately rated electrical circuit. The capacity of the supply circuit must be as specified.
Biological hazard
For patient and personnel safety, beware of biological hazards while performing transesophageal procedures. To avoid the risk of disease transmission:
Use protective barriers (gloves and probe sheaths) whenever necessary. Follow sterile procedures as required.
Thoroughly clean probes and reusable accessories after each patient examination and disinfect or sterilize as needed. Refer to Chapter 11, "Probes" on page 535, for probe use and care instructions.
Follow all in-house infection control policies as they apply to personnel and equipment.
Pacemaker hazard
The possibility of the system interfering with pacemakers is minimal. However, as this system generates high frequency electrical signals, the operator should be aware of the potential hazard this could cause.
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CAUTION
CAUTION
CAUTION
CAUTION
Safety
To avoid injury or system damage, NEVER place any object or liquid on the monitor.
Archived data is managed at the individual sites. Performing data backup (to any device) is recommended.
Do not unpack the Vivid S5/Vivid S6. This must be performed by qualified service personnel only.
Do not use the Vivid S5/Vivid S6 Ultrasound system ECG wave for diagnosis and monitoring.
DO NOT load non-system software on the system computer.
CAUTION
LCD Monitor
DO NOT place a finger, hand or any object on the joint of the monitor or monitor arm to avoid injury when moving the monitor and monitor arm.
To avoid result of injury or system damage, NEVER place any object or liquid on the monitor, whether in the home or flip down/transport position.
DO NOT place any object on the ventilation slots on the upper rear side of the monitor cabinet. Blocking the ventilation slots prevents proper airflow and may result in fire, electric shock, or equipment damage.
Keep small objects or liquids away from the LCD monitor.
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Safety
Small objects or liquid may accidentally fall through the ventilation slots into the cabinet or spill into the cabinet which may result in fire, electric shock, or equipment damage.
If an object or liquid falls/spills into the cabinet, unplug the system immediately. Call a Service Representative for information.
DO NOT scratch or press on the panel with any sharp objects, such as a pencil or pen, as this may result in damage to the panel.
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Electrical safety
Internally connected peripheral devices
The system, together with peripheral devices, such as video tape recorders and printers, meets UL 60601-1 and IEC 60601-1 (1988) standards for electrical isolation and safety. These standards are applicable only when the specified peripheral devices are plugged into the AC outlets provided in the unit.
External Connection of other peripheral devices
External devices can be used only if CE marked and in compliance with related standards (EN 60601-1 or EN 60950).
CAUTION
Conformance to EN 60601-1-1 (2000) must be verified.
External devices meeting EN 60950 should be kept outside of the patient environment, as defined in IEC 60601-1-1 (2000).
Safety
Other external devices, such as laser cameras, printers, VCRs and external monitors, usually exceed allowable leakage limits and, when plugged into separate AC outlets that are then connected to the unit, are in violation of patient safety standards. Suitable electrical isolation of such external AC outlets may be required in order to meet UL2601-1 and IEC 60601-1 (1988) standards for electrical leakage.
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Safety
Allergic reactions to latex-containing medical devices
Due to reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises health-care professionals to identify latex-sensitive patients, and be prepared to treat allergic reactions promptly. Latex is a component of many medical devices, including surgical and examination gloves, catheters, incubation tubes, anesthesia masks and dental dams. Patient reaction to latex has ranged from contact urticaria, to systemic anaphylaxis.
For more details regarding allergic reaction to latex, refer to FDA Medical Alert MDA91-1, March 29, 1991 Medical Alert on latex products.
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Use of ECG
Do not use the Vivid S5/Vivid S6 Ultrasound system ECG wave for diagnosis and monitoring.
CAUTION
Use of Defibrillator
Do not use the Vivid S5/Vivid S6 Ultrasound system with Defibrillator. This equipment does not have defibrillator-
CAUTION
CAUTION
approved applied parts.
Remove the TEE probe from the patient when defibrillators are used.
Use of Electrosurgical Unit
To avoid skin burns in surgical use, do not place ECG electrodes in current path between Electrosurgical Unit (ESU) active and
CAUTION
dispersive electrodes. Keep ESU cables away from ECG leads.
Safety
This equipment provides no special means of protection from high frequency (HF) burns that may result from using an electrosurgical unit (ESU). To reduce the risk of HF burns, avoid contact between the patient and ultrasound transducer while operating the ESU. Where contact cannot be avoided, as in the case of TEE monitoring during surgery, make sure the transducer is not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducer cable.
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Safety
Electromagnetic Compatibility (EMC)
NOTE: This unit carries the CE mark. It complies with regulatory requirements of the European Directive 93/42/EEC concerning medical devices. It also complies with emission limits for a Group 1, Class B Medical Device as stated in IEC/EN 60601-1-2 (2001).
All types of electronic equipment may characteristically cause electromagnetic interference with other equipment, transmitted either through air or connecting cables. The term Electromagnetic Compatibility (EMC), indicates the capability of the equipment to curb electromagnetic influence from other equipment, while at the same time not affecting other equipment with similar electromagnetic radiation.
Radiated or conducted EMC can cause distortion, degradation, or artifacts in the ultrasound image which could potentially obscure diagnostic information.
There is no guarantee that interference will not occur in a particular installation. If this equipment is found to cause or respond to interference, which may be determined by turning equipment on and off, qualified service personnel should attempt to correct the problem by one or more of the following measures:
Re-orient or re-locate the affected device.
Increase the separation between the unit and the affected device.
Power the equipment from a source other than that of the affected device.
Consult the service representative for further suggestions.
The manufacturer is not responsible for any interference or responses caused by the use of interconnecting cables other than those recommended, or by unauthorized changes or modifications to this unit. Unauthorized changes or modifications could void the user's authority to operate the equipment.
To comply with the regulations on electromagnetic interference, all interconnecting cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing or
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Safety
responding to radio frequency interference, in violation of the European Union Medical Device Directive and FCC regulations.
Do not use devices which intentionally transmit RF signals, for example, cellular phones, transceivers, or radio controlled products, in the vicinity of this equipment as it may cause performance outside the published specifications. Keep the power to these types of devices turned off when near this equipment.
EMC performance
Portable and mobile radio communications equipment (e.g. two-way radio, cellular/cordless telephones, wireless computer networks), other than those supplied by GE, should be used no closer to any part of this system, including cables, than determined according to the following method:
Table 1-1: Portable and mobile radio communications equipment distance requirements
Frequency range: 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
Calculation Method:
Where: d= separation distance in meters, P = rated power of the transmitter, V
=compliance value for conducted RF, E1 = compliance value for radiated RF
1
If the maximum
transmitter power
in watts is rated The separation distance in meters should be:
5 2.6 2.6 5.2
20 5.2 5.2 10.5
100 12.0 12.0 24.0
d=[3.5/V root of P
] square
1
d = [3.5/E1] square root of P
d = [7/E1] square root of P
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Safety
Declaration of Emissions
This system is suitable for use in the following environment. The user must assure that it is used only in the electromagnetic environment as specified.
Table 1-2: Declaration of Emissions
Emission Type Compliance Electromagnetic Environment
CISPR 11
RF Emissions
IEC 61000-3-2
Harmonic Disturbance Emissions
IEC 61000-3-3
Voltage Fluctuations/Flicker Emissions
Group 1
Class B
Class B 230V 50Hz
Complies
This system uses RF energy only for its internal function. Therefore, RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. It is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Declaration of Immunity
This system is suitable for use in the following environment. The user must assure that the system is used according to the specified guidance and only in the electromagnetic environment listed.
Notice upon Installation of Product
Separation distance and effect from fixed radio communications equipment: 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 transmitter cannot be predicted theoretically with accuracy. To assess the
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Safety
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 ultrasound system is used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound system should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the ultrasound system or using an RF shielded examination room may be necessary.
1. Use either power supply cords provided by GE Medical Systems or ones designated by GE Medical Systems. Products equipped with a power source plug should be plugged into the fixed power socket which has the protective grounding conductor. Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-to-two-prong converter).
2. Locate the equipment as far away as possible from other electronic equipment.
3. Be sure to use only the cables provided by or designated by GE Medical Systems. Connect these cables following the installation procedures (e.g. wire power cables separately from signal cables).
4. Lay out the main equipment and other peripherals following the installation procedures described in the Option Installation manuals.
General notice
1. Designation of Peripheral Equipment Connectable to This Product. The equipment indicated in Chapter 12, "Peripherals" on page 575 can be hooked up to the product without compromising its EMC performance. Avoid using equipment not designated in the list. Failure to comply with this instruction may result in poor EMC performance of the product.
2. Notice against User Modification The user should never modify this product. User modifications may cause degradation in EMC performance. Modification of the product includes changes in:
• Cables (length, material, wiring, etc.)
• System installation/layout
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Safety
• System configuration/components
• Securing system parts (cover open/close, cover screwing)
3. Operate the system with all covers closed. If a cover is opened for some reason, be sure to shut it before starting/ resuming operation.
4. Operating the system with any cover open may affect EMC performance.
Peripheral Update for EC countries
The following is intended to provide the users in EC countries with updated information concerning the connection of the Vivid S5/Vivid S6 to image recording and other devices or communication networks.
The Vivid S5/Vivid S6 has been verified for overall safety, compatibility and compliance with the following on-board image recording devices:
Sony UP-D895 MD/D897MD Digital Printer
Sony UP-D23 MD Digital Color Printer
HP DeskJet 460 Series Inkjet printer
HP OfficeJet Pro K5400 Series Inkjet printer
The Vivid S5/Vivid S6 has also been verified for compatibility, and compliance for connection to a local area network (LAN) via the rear panel Ethernet connection, provided the LAN components are IEC/EN 60950 compliant.
Connection may also be made to a CE Marked and IEC/ EN 60950 compliant modem using one of the serial or USB ports on the system.
The Vivid S5/Vivid S6 may also be used safely while connected to devices other than those recommended above if the devices and their specifications, installation, and interconnection with the system conform to the requirements of IEC/EN 60601-1-1.
General precautions for installing an alternate on-board device would include:
The added device must have appropriate safety standard conformance and CE Marking.
The total power consumption of the added devices, which
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Safety
connect to Vivid S5/Vivid S6 and are used simultaneously, must be less than or equal to the rated supply of the VividS5/VividS6.
There must be adequate heat dissipation and ventilation to prevent overheating of the device.
There must be adequate mechanical mounting of the device and stability of the combination.
Risk and leakage current of the combination must comply with IEC/EN 60601-1.
• Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2.
General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking.
The added device(s) must be used for their intended purpose having a compatible interface.
Signal or mains isolation devices and additional protective earth may be needed to assure compliance with IEC/EN 60601-1-1.
The connection of equipment or transmission networks other than as specified in the user instructions can result in an electric
CAUTION
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shock hazard or equipment malfunction. Substitute or alternate equipment and connections requires verification of compatibility and conformity to IEC/EN 60601-1-1 by the installer. Equipment modifications and possible resulting malfunctions and electromagnetic interference are the responsibility of the owner.
Page 66
Safety
Patient Environmental Devices
1. Rear Panel
2. Peripheral Devices Power
3. Ethernet network
4. Rear USB Ports
5. Audio Output
6. DVI Video output
7. Power Line Circuit Breaker
8. Ground Line
9. Power Line (AC~)
10. DVD Drive
11. Hard-Copy Printer
(numbers 12 through19 not used in figure)
20. LCD
21. LCD Folding Lever
22. Up/Down & Left/right swivel release levers
23. Front USB Ports
24. RS Probe Connectors
25. LOGIQ Probe Connector (Vivid S6 only)
26. Non-imaging Pencil Probe Connector
27. ECG connector
Figure 1-2: Patient Environmental Devices
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CAUTION
Safety
Acceptable devices
The Patient Environmental devices shown on the previous page are specified to be suitable for use within the PATIENT ENVIRONMENT.
DO NOT connect any probes or accessories without approval by GE within the PATIENT ENVIRONMENT.
See "Peripheral Update for EC countries" on page 46 for more information.
Unapproved devices
DO NOT use unapproved devices.
CAUTION
CAUTION
If devices are connected without the approval of GE, the warranty will be INVALID.
Any device connected to the Vivid S5/Vivid S6 must conform to one or more of the requirements listed below:
• IEC standard or equivalent standards appropriate to devices.
• The devices shall be connected to PROTECTIVE EARTH (GROUND).
Accessories, options, and supplies
Unsafe operation or malfunction may result. Use only the accessories, options and supplies approved or recommended in these instructions for use.
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Safety
Environmental protection
System and battery disposal
the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.)
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Getting started
Chapter 2 Getting started
• Introduction ................................................................................... .... 52
• Preparing the unit for use ............................................................ .... 53
• Site requirements ....................................................................... 53
• Connecting the unit .................................................................... 54
• Switching On/Off ........................................................................ 61
• Moving and transporting the unit ................................................ .... 64
• Wheels ....................................................................................... 64
• Moving the unit ........................................................................... 64
• Transporting the unit .................................................................. 66
• Reinstalling at a new location ..................................................... 67
• Unit acclimation time .................................................................. 68
• System description ....................................................................... .... 69
• System overview ........................................................................ 69
• Control panel .............................................................................. 71
• The Scanning screen ................................................................. 84
• Three-Pedal Footswitch operation ............................................. 87
• Connecting and disconnecting probes ....................................... 87
• Adjusting the Display Monitor ..................................................... 90
• Starting an examination ............................................................... .... 95
• Creating a new Patient record or starting an examination from an
existing patient record ................................................................ 95
• Selecting a Probe and an Application ...................................... 100
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Getting started
Introduction
Only qualified physicians or ultrasound sonographers should perform scans of patients for medical diagnostic reasons. Request training, if needed.
Ensure that unauthorized personnel do not tamper with the unit.
Service representatives authorized by GE Medical Systems will unpack and install the unit. Do not attempt to install the unit alone.
Never set liquids on the unit in order to avoid spillage into the unit or the control panel. Maintain a clean environment. Turn off the circuit breaker before cleaning the unit. Refer to "System Care and Maintenance" on page 642 for cleaning instructions.
To carry out regular preventative maintenance refer to Chapter 14, "User maintenance" on page 641.
All the warnings in "Important safety considerations" on page 18, should be read and understood before operating the
WARNING
unit.
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Preparing the unit for use
The Vivid S5/Vivid S6 ultrasound unit must operate within the proper environment and in accordance with the requirements described in this section. Before using the system, ensure that the requirements are met.
Site requirements
Optimal operation of the unit can be obtained by implementing the following requirements:
Power requirements
The Vivid S5/Vivid S6 ultrasound unit uses a separate power outlet for 100 – 120 VAC or 240 VAC, 50–60 Hz.
Operating the unit with the wrong voltage range causes damages, voiding the factory warranty.
WARNING
Getting started
Operating Environment
Ensure that there is sufficient air flow around the Vivid S5/Vivid S6 ultrasound unit when installed or operated.
Environmental requirements
The Vivid S5/Vivid S6 ultrasound unit requires constant maintenance of its operational environment. Different temperature and humidity requirements are specified for operation, storage and transportation.
Table 2-1: Vivid S5/Vivid S6 temperature and humidity requirements
Requirement Temperature Humidity Air Pressure
Operational 10–40 °C 30–85% 700–1060 hPa
Storage -10–60 °C 30–70% 700–1060 hPa
Transport -10–60 °C 30–70% 700–1060 hPa
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Getting started
Electromagnetic interferences
The Vivid S5/Vivid S6 ultrasound unit is approved for use in hospitals, clinics and other environ­mentally qualified facilities, in terms of the prevention of ra­dio wave interfer­ence. Operation of the unit in an inap­propriate environ­ment can cause electronic interfer­ence to radios and television sets situ­ated near the medi­cal equipment.
Ensure that the unit is protected from electromagnetic interferences as follows:
Operate the unit at least 4.5 meters (fifteen feet) away from equipment that emits strong electromagnetic radiation.
Shield the unit when operating it in the vicinity of radio broadcasting equipment, if necessary.
Connecting the unit
A GE-qualified person should perform the initial system installation.
Connecting the Vivid S5/Vivid S6 ultrasound unit involves preliminary checks of the power adaptor unit and cord, voltage level and compliance with electrical safety requirements.
Use only power supply cords, cables and plugs provided by or designated by GE Medical Systems.
Ensure that the power cord and plug are intact and that the power plug is the proper hospital-grade type (where required).
The unit should be connected to a fixed power socket which has the protective grounding connector. Never use an extension cord or adapter plug.
Failure to provide an adequate earth circuit can cause electrical shock, resulting in serious injury.
WARNING
Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases
WARNING
and is only recommended for situations involving multiple equipment in a high-risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable leakage current limits. An example of a high-risk patient would be a special procedure where the patient has an accessible conductive path to the heart such as exposed cardiac pacing leads
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Getting started
Voltage level check
Check the label near the circuit breaker on the rear side of the system (Figure 2-1 or Figure 2-2).
Figure 2-1: Vivid S5 rating labels
WARNING
Figure 2-2: Vivid S6 rating labels
Check the voltage range indicated on the label:
• 100–120 VAC, 50/60 Hz, 5 A Or
230 VAC, 50/60 Hz, 2.5 A
If the mains supply is not within the specified range, do not connect the unit to the power source. Contact the dealer to have the unit adjusted to the specific mains supply.
Figure 2-3: Universal label
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Getting started
WARNING
Connecting to the electrical outlet
POWER OUTAGE MAY OCCUR. The Vivid S5/Vivid S6 requires a dedicated single branch circuit. To avoid circuit overload and possible loss of critical care equipment, make sure you DO NOT have other equipment operating on the same circuit.
The unit’s power must be supplied from a separate, properly rated outlet to avoid risk of fire. Refer to "Power requirements" on page 53 for rating information.
The power cord should not, under any circumstances, be altered to a configuration rated less than that specified for the current.
Do not use an extension cord or adapter plug.
1. Ensure that the wall outlet is of appropriate type, and that the power switch is turned off.
2. Uncoil the power cable, allowing sufficient slack so that the unit can be moved slightly.
3. Attach the power plug to the system and secure it in place by using the retaining clamp.
4. Secure the power plug in the wall outlet.
a. Retaining clamp for power plug
Figure 2-4: Power plug
Ensure that the retaining clamp for the power plug is fixed firmly.
CAUTION
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CAUTION
WARNING
Getting started
Use caution to ensure that the power cable does not disconnect during system use. If the system is accidentally unplugged, data may be lost.
To avoid risk of fire, the system power must be supplied from a separate, properly rated outlet.
Under no circumstances should the AC power plug be altered, changed, or adapted to a configuration rated less than specified. Never use an extension cord or adapter plug.
To help assure grounding reliability, connect to a "hospital grade" or "hospital only" grounded power outlet.
The battery may only be disassem­bled and re-assem­bled by an authorized field-service engi­neer.
1. 100-120 VAC, 1200 VA Plug and Outlet Configuration
2. 220-240 VAC, 1200 VA Plug and Outlet Configuration
Figure 2-5: Example Plug and Outlet Configurations
Battery
The System contains an internal battery (optional), which is not user-accessible. The internal battery acts as a limited alternative power source, which becomes active when the AC power fails or AC cable is abruptly pulled out.
Display turns off and no scanning is possible while in battery mode. For further information about use of the battery see section "Battery Power Mode" on page 63.
Battery technology
The lithium ion technology used in the system’s battery is significantly less hazardous to the environment than the lithium metal technology used in some other batteries (such as watch batteries). Used batteries should not be placed with common household waste products. Contact local authorities for the location of a chemical waste collection program nearest you.
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Getting started
Viewing Current Battery Status
When the system is running, a status icon is displayed in the system Status bar to indicate the current battery status.
Table 2-2: Battery status icons
Icon Status Description
AC Power is ON; no battery present
AC Power is ON; battery is fully charged (80%-100%)
AC Power is ON; battery is partially charged (40%-80%)
AC Power is ON; battery is almost empty (10%-40%)
Note: The % values mentioned above may fluctuate by up to +/- 3 % points.
View Detailed Battery Status
Refer to page 575 for further informa­tion on peripherals.
CAUTION
In order to view further details about the battery status, click on the battery-status icon. A more detailed status description appears.
A special message may appear, suggestion to replace the battery soon. This message may appear when the battery has aged to such an extent that even after prolonged charging it will not hold enough charge.
Peripherals/Accessory connection
The external Peripherals / accessories connectors are situated on the rear side of the unit See Figure 2-6.
Peripherals/Accessory Connector Panel
Vivid S5/Vivid S6 peripherals and accessories can be properly connected using the rear connector panel.
Use only approved peripherals, accessories or probes.
DO NOT connect any accessories or probes without approval by GE
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Getting started
1. Two isolated AC sockets for peripherals (Max. 250VA total)
2. LAN 10/100 Base-TX Ethernet network connector
3. Two interchangeable USB ports (digital printers or other peripherals)
4. Audio output
5. DVI video output connection to external display
Figure 2-6: Peripherals/Accessory Connector Panel
Accessory equipment connected to the analogue and digital interfaces must be certified according to the respective IEC
WARNING
standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 (1988) for medical equipment). Any person connecting additional equipment to the signal input part or output part is configuring the medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 60601-1-1 (2000). If in doubt, consult the technical service department or your local representative.
Do not touch the conducting parts of the USB or Ethernet cables when connecting equipment to the unit.
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Getting started
The connection of equipment or transmission networks other than as specified in these instructions can result in electric
CAUTION
Table 2-3: Contents of the Rear Panel
Socket Signal type Device type Note
shock hazard. Alternate connections will require verification of compatibility and conformity to IEC/EN 60601-1-1 by the installer.
DVI-I Out DVI-I output high
resolution video
USB Universal serial
bus x2
Ethernet 10/100 Base-TX
Ethernet IEEE 8023 Network device
External monitor
USB Cable / Device
Network device
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Switching On/Off
To switch on the unit:
1. Switch on the circuit breaker on the rear of the unit (see Figure 2-6).
2. Press (on/off button) on the top left of the control panel (see Figure 2-11). After initialization the default scanning screen (2D mode) is displayed, the active probe being the one connected to the left most connector socket.
When turning ON a system while sys­tem is in standby, it takes a few seconds before it responds. Do not push the on/off button again during this period (A second push will initiate a full shut-
down).
By factory Login default, the Opera­tor ID is USR and there is no need to enter a password
LEDs
There are two LEDs above the On/Off switch that indicate the status of the system.
Indicates power status.
After pressing the On/Standby switch, the system power is ON and this LED is lit.
Color: Green
Indicates battery status.
When the battery is charged, the LED is green. When the battery power is low, the LED is orange.
Color: Green and Orange
Password Protection
Log In
During the turn-on process the system may require the user to enter a password in order to operate it. Personal IDs and associated passwords can be configured in the Vivid S5/Vivid S6. See "Presets and System setup" on page 583 for more information.
If IDs and passwords have been entered and "Use Auto Logon" is Off (see "Users" on page 637 for details), the Operator Login window appears, requesting for an ID and password when Power up sequence is completed, or when it is required.
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1. Operator: Select the relevant Operator name
2. Password: Enter the Operator’s password
3. Emergency: Data stored for the duration of the current examination only
4. Log on: Select type of Log on (for example, Standard logon)
5. Cancel: Cancel Log on
Figure 2-7: Operator Login Window
Switching off the unit
When the Vivid S5/Vivid S6 is switched off, the system performs an automatic shutdown sequence. The unit can be switched off into one of three states.
Full shutdown: the entire system is shut down. Full shutdown is recommended if the system is not intended to be used for a whole day or longer. It is recommended to perform a full shutdown at least once a week. This will prevent extreme memory fragmentation, which might cause some computer slowdown.
Standby mode: most of the system is powered down, but a certain portion of the unit remains energized. The standby mode allows a shorter reboot time when the system is used on a daily basis or moved from one place to another.
Battery mode: When AC power is interrupted, the screen and keyboard are powered down. The rest of the system is still powered ON. The fans are heard. When AC power is resumed, the system will turn ON in less than 10 seconds (see "Battery Power Mode" on page 63).
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After switching off the system, wait at least ten seconds be­fore turning it on again.
Getting started
Full shutdown
1. Press (on/off button) on the top left of the control panel. The Exit dialogue window is displayed.
Figure 2-8: The Exit dialogue window
In case of total lock­up of the system, hold the on/off but­ton down a few sec­onds to turn the system off.
2. Select Shutdown. The shutdown process takes a few seconds and is completed when the control panel illumination is turned off. Booting up from Full Shut-down mode may take about 60 seconds.
Standby mode
1. Press (on/off button) on the top left of the control panel. The Exit dialogue window is displayed (Figure 2-8).
2. Select Standby. The system enters Standby mode. Booting up from Standby mode may take about 20 seconds. Note: Whenever the system is fully shut down or put in standby mode, the system will automatically perform "End Exam" to save all data and images of the current patient into the archiving system.
Turning on the system at the new location
1. Plug the AC cable into a proper power outlet.
2. Press (on/off button) (Figure 2-11).
Battery Power Mode
When the system is operating normally, if the AC power is interrupted or the power cable is removed from the wall outlet the screen and keyboard will turn off, but the rest of the system
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Getting started
will continue to operate in "Battery Mode", powered by the internal battery.
While in battery mode, if the AC power is restored within 10 minutes, the system will turn back on within less than 10 seconds.
While in Battery-power mode the system will maintain the current patient active and not perform "End-Exam". As a result, when power is restored, the current patient's details and stored images are readily available on display.
If the AC power is not restored within 10 minutes, the system will shut-down into Standby mode.
If AC is not restored, the system can remain in Standby mode for approximately 1 hour using the internal battery power (assuming battery is fully charged and relatively new). If left for more than about 1 hour while in standby-mode without AC power, the system will switch from Standby in to full Shut-down mode.
Moving and transporting the unit
Wheels
The front wheels of the unit are controlled by the break-pedals situated above each wheel.
The rear wheels of the unit are controlled by the swivel lock / release pedals situated above each wheel (see item 10 in Figure 2-11).
Examine the wheels frequently for defects to avoid breaking or jamming.
Moving the unit
To prepare the unit to be moved
1. Turn system Off to Full shut-down or Standby mode.
2. Remove the AC plug from the power outlet.
3. Wrap the AC power cord to ensure cord is not hanging in the wheel area or beyond the sides of the system.
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CAUTION
Getting started
4. Pull the left handle and swivel the keyboard so it will lock in its central position (see page 93).
5. Disconnect all external cables linking the unit to any off-board peripheral devices and network. (Note the marks on each cable to reconnect them later).
6. Place all probes securely in proper probe holders. Ensure that the probe cables do not protrude from the side of the unit or interfere with the wheels, or foot area. Hang the cords on respective hooks provided, ensuring cords are secure and out of lower portion of the system and do not extend beyond the sides of system.
7. Ensure that no loose items are left on the unit.
8. If intending to travel over bumpy surface or if more visibility is required during transportation, fold the LCD screen forward to a horizontal position (see "Position Adjustment" on page 92).
Before folding the LCD monitor, please make sure that the gel bottle is placed with the dispenser tip down into gel holder or moved sideways in order not touch the monitor's faceplate.
WARNING
9. Unlock the front-wheel’s brakes.
10. Lock the rear wheel brakes (Swivel Brake) for long travel or free it for short distance traveling where maneuvering is needed. Once all cables and cords are wrapped and secure out of the lower portion of the system, not extending beyond sides of system, you are ready for transport.
To ensure safety while moving the unit
1. Ensure that the keyboard console is in central-locked position.
Ensure that the hands of the patient are away from the console when moving the system or keyboard console.
2. Proceed cautiously when crossing door or elevator thresholds. Grasp the front handle grips and push or pull or use the rear handle bar for pushing the system. Do not attempt to move the unit using cables or probe connectors.
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CAUTION
CAUTION
WARNING
Take extra care while moving the unit on inclines. Do not hang or lean body weight on the handles.
The rear handle should only be used for pushing the system, not for pulling, The system might become unstable when hitting an obstacle while pulled with the rear handle.
3. Ensure that the unit does not strike the walls or door frames.
4. Ensure the pathway is clear, and probe cables are secure not to catch onto anything in the path (including wheels and feet).
5. Move the unit slowly and carefully.
Avoid ramps that are steeper than 10 degrees.
Probe cables may get caught on external devices, such as doors, medical devices in the transporting path, wheels, or feet. Please ensure cords are wrapped properly, not extended beyond sides of system and out of the way for portables.
Transporting the unit
Take extra care when transporting the unit by vehicle. In addition to the moving precautions listed on page 64, follow the procedure described below.
1. Disconnect all probes and secure them in their boxes.
2. Lower the system's keyboard to its minimum height.
3. Park the vehicle on a level surface for loading and unloading.
4. Secure the unit while it is on the lift, to prevent rolling. Do not attempt to hold it in place by hand. Cushion the unit and strap the lower part so that it does not break loose.
5. Ensure that the unit is secured inside the vehicle. Secure it with straps to prevent movement while in transit.
6. Drive cautiously to prevent vibration damage.
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Reinstalling at a new location
1. When the unit is in place at a new location, lock the wheel brakes (see "Moving and transporting the unit" on page 64).
2. Follow the installation procedure described on "Connecting the unit" on page 54.
Preparing Vivid S5/Vivid S6 for scanning
1. Lock front Wheel brakes
2. Un-Wrap the AC power cord and plug into power source.
3. Lift the LCD screen to the fully open position while pulling out the lock. Secure the Monitor at full upright position.
4. Turn the system on.
5. Connect external cables if needed (LAN, USB, etc.).
6. Probe being used to scan should be ready, with cables clear of foot area and wheels by wrapping un-used portion of the cord on respective hooks provided.
7. Adjust keyboard's height and swivel (see page 93).
Note: Ensure that the probe cables do not protrude from the unit or interfere with the wheels, or foot area. The Hanging cords may cause damage to system if lodged or hooked onto nearby items. By ensuring cords are secure and out of lower portion of the system, this may provide a more secure atmosphere and avoid unnecessary damage.
Avoiding possible hazards
Avoid dragging cables on the floor. In cases where the wheel rolls over cable or person pushing the system steps on cables, it may generate severe force to break the cable or the connector.
Avoid hanging cables beyond sides of the system. When system is moved, these cables may be caught in door-knobs or other medical equipment and apply severe forces that may break probe cables or connectors.
Check that the Gel bottle is not interfering with the folding screen. The gel bottle needs to be placed with dispenser tip down into gel holder or moved sideways in order not to push on the LCD frame (see Figure 2-9).
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Proper Gel bottle storage Improper Gel bottle storage
Figure 2-9: Proper Gel bottle storage
Unit acclimation time
Following transport the unit may be very cold or hot. Allow the unit to acclimate before being switched on. Acclimation will
take one hour for each 2.5 temperature is below 10
o
C
o
F
Hours 43210023
o
C
o
F
Hours 45678910
02.557.510354042.5
32 36.5 41 45.5 50 95 104 108.5
45 47.5 50 52.5 55 57.5 60
113 117.5 122 126.5 131 135.5 140
o
C increment when the unit’s
o
C or above 40oC.
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System description
System overview
Getting started
Figure 2-10: Vivid S5/Vivid S6 System Overview
Note: Above figure is Vivid S6.
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1. LCD Display Monitor: Swivels to the left and right, tilts backwards and forwards.
2. Display Monitor Spring-lock Release: Pull knob and fold screen forward to a horizontal position. To unfold the screen pull the same knob and lift the screen up.
3. Accessory tray (removable)
4. Rear Handle
5. Probe and gel holders: Removable for cleaning. Situated on either side of the Control panel.
6. Up/down "Flex-Fit" arm
7. DVD Drive
8. Black and white video printer
9. Fans Service Cover
10. Rear Wheels: Swivel wheels. May be swivel-locked
11. Foot Rest (removable)
12. Front Wheels: Each wheel may be braked.
13. Control panel: Contains all the buttons, softkeys and the alphanumeric keyboard used to operate the system.
14. USB Port
15. Probe cable hooks: Located on each side in the front and rear of system
16. Front Handle
17. Console swivel operating handle: Situated on the right side under the control panel Console lifting operating handle: Situated on the left side under the control panel
18. Probe ports: Three RS-type Probe sockets
19. Pencil probe socket
20. ECG connector socket: Also supporting the external ECG input
21. Large probe socket: (Available on Vivid S6 only) Supporting the TEE probes only
22. RS-Socket locking latch
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Control panel
The following pictures illustrate the layout of the Vivid S5/Vivid S6 control panel. The buttons and controls are grouped together for ease of use. A detailed description of the buttons is provided on the following pages.
1. Power status LEDs and light-sensor
2. On/off button
3. Softmenu keys and rotaries
4. Alphanumeric Keyboard
5. 2D-gain and active-gain rotaries
6. TGC sliders
7. Speakers
8. Softmenu 4-way Rocker
9. Alphanumeric Function keys
10. Speaker volume rotary
11. Scan-mode keys
12. Trackball and related keys
13. Freeze keys
Figure 2-11: Vivid S5/Vivid S6 Control Panel
Note: Above figure is Vivid S6.
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Key illumination
The keys on the control panel are illuminated according to their availability:
Illumination in green: the key function is currently active.
Illumination in white: the key function is available (but not active) in the current state of the scanner.
No illumination: The key is not available in the current state of the scanner.
Power On/Off key
Key Description
Turns the unit ON and OFF.
Sets the unit to Standby.
Navigation keys
The following buttons on the top left of the control panel are used for navigating different screens and packages on the scanner. They are related to either pre or post-examination operations. Each of these operations are described in more detail in the following chapters.
Key Description
Displays the Archiving opening page. Enables the user to perform the following functions:
• Create a new patient record
• Edit the current patient’s information
• Browse the Patient List to search for patient records
• End the current examination
For further information, refer to page 95.
Displays the Select Probe and Application dialog box that enables the users to select the desired probe and application preset for the current examination. For information about selecting probes, refer to page 100 and page 535.
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Key Description
Enters Stress Echo mode (optional). The Protocol screen is displayed showing the default stress protocol for the current probe.
Displays the Measurement worksheet where the user may edit or delete measurements, change averaging etc. Refer to page 353 for details on how to operate the worksheet.
Brings the scanner into the Image review mode, that enables the user to select images from the clipboard for analysis, activate the image browser or enter the Image Review screen where bigger previews of the images are shown for image selection. Refer to page 426 for details on the review of images.
Displays the examination report.
Getting started
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Note Key Description
Scan Mode Selection keys
The following keys are used to select the required scan mode, and to select additional tools that enhance the application’s capabilities. Refer to page 137 for detailed information about scanning.
Note: The TVI button is blank on Vivid S5.
Displays the 2D live acquisition mode that is the default scanning screen for the unit. For further information on 2D scanning, refer to page 140.
M-Mode can be added from a 2D scan also in replay.
CW mode is not available on all scanning probes.
Displays the M-Mode examination screen and enables M-Mode functions. Used for viewing motion patterns. For further information, refer to page 150.
Displays the examination screen in Color Flow Mapping mode. Used to display color-coded blood flow information. For further information, refer to page 157.
Displays the examination screen in Pulsed Wave Doppler mode. Used for displaying the Doppler spectrum of blood flow at a selected part of the anatomy. For further information, refer to page 164.
Displays the examination screen in Continuous Wave Doppler mode. Allows examination of blood flow data all along the Doppler CW cursor. For further information, refer to page 164.
Displays the tissue velocity overlay on 2D and M-Mode scans. If TVI is on, the Doppler modes (PW/CW) will also be optimized for tissue velocity. For further information, refer to page 169.
Note: TVI is optional on Vivid S5. The TVI button is always installed even if option is not installed.
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Note Key Description
Depending on the options installed on the scanner, this key will bring up the softkey menu for selection of additional optional scanning modes, such as AMM, TVI, DTI, TSI, SRI, SI, etc.
The Quantitative Analysis option will also appear (if installed) as a softkey button named Q Analysis.
Note: Some functions are available only on Vivid S6.
Basic Mode Parameter Adjustment Controls
The following controls are used to modify and adjust the unit’s display to best suit the user’s requirements, such as color, gain, zoom and image depth, according to the mode being operated by the user.
Controls Description
Gain rotary Controls the total gain of the gray scale images
in 2D Mode.
ATO (Automatic tissue optimization) - while in 2D press the rotary knob to optimize 2D image automatically.
Getting started
Active mode rotary
TGC Six sliding keys that compensate for
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Controls the total gain of other activated modes, such as, M-Mode, Color, PW, or CW Doppler modes.
In combined mode, switches between the mode specific assignable controls without having to exit each mode in order to control it.
depth-related attenuation in an image. The upper slider corresponds to the smallest depth.
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Getting started
Controls Description
Depth Controls the displayed depth of tissue scan. Has
no effect in replay.
Toggles the cursor display on/off in 2D scanning mode.
Changes the Doppler unltrasound beam angle on linear probes. The steering angles are fixed for each linear probe. This key has no effect with sector imaging probes.
Zoom Controls image magnification. Press to activate
"HR-Zoom" mode. Rotate clockwise to activate "Display-zoom" mode and increase zoom factor. Rotate counterclockwise to decrease and turn off zoom (see "Zoom" on page 120).
Auto While in 2D it activates ATO - Automatic Tissue
Optimization to optimize 2D image automatically (see page 144).
While in CW or PW Doppler it activates ASO ­Automatic Spectrum Optimization to optimize the Doppler spectrum.
Flex This button can be configured to function as any
button on the keyboard (see page 590).
Note: with the exception of alphanumeric and soft-menu sections.
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Freeze keys
The freeze keys are used to freeze images and cine loops in all modes for on-line analysis.
Key Description
Stops or restarts all data acquisition. When scan is frozen, the Trackball can be used to scroll through the cine loop.
Activates or freezes 2D mode. In simultaneous mode, pressing deactivate the 2D image, leaving the other mode display unchanged. In freeze mode, stops/starts the cineloop.
Display Format Key
2D FREEZE will activate or
Key Description
Toggles the display priority of 2D-Mode or Doppler/M-Mode and top/bottom or side by side display when working in combined mode.
Enables multiple image display windows in which two or four images can be viewed simultaneously. When reducing the number of images, the active window will always been kept.
Toggles the active window in multiple imaging mode. The active window is indicated by a highlighted frame. All imaging controls are normally applied only to the active window.
Same arrows are used while reviewing images from clipboard, the active frame may be stepped forward or backwards to review the next or previous image.
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Store Button
Key Description
Store Stores the currently active imaging window to
disk. The stored information depends on the configuration of the current application.
Stored images are shown on the clipboard.
Measurement controls
The following keys are used to take measurements and perform calculations.
Key Description
Activates the Measurement & Analysis (M&A) calculation program. This program is context sensitive and will display relevant measurements to the current mode and application. See page 243 for further details on M&A.
Activates measurement tools (unassigned measurement). See page 243 for further details on M&A.
Print and Record Control
Key Description
Record When the DVR option is installed and DVR
media has been mounted, the Record button will activate or pause the real-time recording of the displayed image (See page 578 for details)
Note: This button is available even if the DVR option is not installed.
P1 Prints the current imaging screen content to a
selected (configurable) printer. For more information about printing (see page 577). The
PRINT key can also be configured for alternative
storing of images (see page 623).
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Getting started
Key Description
P2 Prints the current imaging screen content to a
printer assigned to a second port (configurable). The default factory configuration is set to "Secondary Capture". For more information see page 623.
Trackball operation
The Trackball area consists of the trackball and five surrounding keys. Three of these have the very same function
SET function) for ergonomic reasons.
(the
Key Description
Trackball Used for navigation and together with the
surrounding keys, to move, select or activate objects on the screen.
Trackball Button
Set Depending on the situation (see Figure 3-3,
Controls the trackball assignments between the mode-specific options. By pressing the trackball function will cycle through the possible assignments, which are indicated in the lower right corner of the screen (see page 108).
page 109):
• Performs the selected control or highlighted menu item.
• Toggles between the Trackball functions within the active group.
The key is duplicated for ergonomic reasons.
TRACKBALL,
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Getting started
Key Description
Update/Menu In Freeze, activates menu with additional options
and controls not available from the assignable keys.
In live mode, toggles between 2D imaging and live time-motion imaging (Doppler/M-Mode).
Assignable keys and rotary knobs (soft keys)
The functions of the assignable keys and rotaries vary according to the mode and/or module in which the user is working.
Key Description
Soft Rotaries Four assignable rotary knobs, whose
mode-specific functions vary according to the scan mode and position that is currently active. These assignable rotaries are used both as rotary-control knobs and as on/off toggles for different controls on the menu The assigned functions are indicated above the rotary on the LCD display. The mode-specific functions for these rotary knobs are described in Chapter 4, "Scanning Modes" on page 137.
Assignable Buttons
Four assignable buttons, whose mode-specific functions vary according to the scan mode and position that is currently active. These assignable buttons are used as on/off toggles for different controls on the menu. The assigned functions are indicated above the button on the LCD display. The mode-specific functions for these buttons are described in Chapter 4, "Scanning Modes" on page 137.
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The soft menu rocker
Key Description
Getting started
Soft Menu Rocker
A 4-way rocker used to access mode-specific menus, select a menu option and adjust option-related values.
• The vertical arrows are used to select the menu options.
• The horizontal arrows are used to adjust the values.
The mode-specific menus are described in Chapter 4, "Scanning Modes" on page 137.
The Alphanumeric Function keys
Key Description
Help Displays the on-line version of the user manual.
Config/Diag Displays the configuration dialog box, allowing
user configuration of various settings on the scanner.
Diagnostics of the system is activated by pressing Shift >
CONFIG.
LCD To activate LCD adjustments controlled by
softkeys.
Biopsy Displays the biopsy path marker.
Bodymark Displays the available body marks for the current
application.
Page Erase Erases all previously-typed annotations (and
body marks).
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Key Description
Physio Provides access to controls for ECG trace. The
ECG controls appear on the soft-menu.
Arrow Displays an arrow that can be used to point at a
specific structure in the image.
Text Enables text annotation to be inserted on the
image. The annotations can be typed or selected from a (configurable) menu.
Playback For future use
Delete Can be used to delete text during text
annotation.
List of shortcuts on alphanumeric keyboard
Key Description
Alt+E Allows to eject a device like MOD, CD or memory
card.
Alt+L Allows to adjust intensity of keyboard backlight.
Alt+P Allows to view and control printer spooler.
Alt+S Allows to view and control DICOM spooler. (see
"DICOM spooler" on page 479) The DICOM spooler is used for checking the current job's status when a job is saved or when the total spooler status on the right of the Archive windows displays an error.
Alt+D Allows to comment and save logfiles for
diagnostics (see Chapter 14, "Adding Problem description" on page 646).
Alt+B Allows to insert a "bookmark" into the system
failure log ("Adding bookmarks" on page 646)
Shift+Config Allows to run various diagnostics.
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