Vivid S5 and Vivid S6 Users Manual Vol 1 Rev 4

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 7.0.x software for the Vivid S5 and Vivid S6 ultrasound systems.

g MANUAL STATUS R2419715-100 21-May-2008

GE Medical Systems © 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.

PRELIMINARY COMPANY DATA

GE Medical Systems Ultrasound Israel Ltd.

Einstein Bldg, 4 Etgar st. P.O. Box 2006 Tirat Carmel 39120, Israel

Tel: (+972) 4851 9555 Fax: (+972) 4851 9500

GE Medical Systems Information Technologies GmbH, Munzinger Strasse 3 D-79111 Freiburg, Germany Tel: (+49) 761 45 43 0 Fax: (+49) 76145 43 233

Table of Contents

Table of Contents Revision History List of effective pages... xiii

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

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 ... 20 Software License Acknowledgements ... 20 Device labels... 21 Label Icon Description ... 21

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Table of Contents Acoustic output... 24 Definition of the acoustic output parameters ... 24 ALARA... 24 Safety statement ... 25 System controls affecting acoustic output ... 25 OB Exam ... 27 Exam Preparation... 27 Acoustic Output Considerations ... 28 Concerns surrounding fetal exposure ... 28 Patient safety... 29 Patient identification ... 29 Diagnostic information... 29 Patient guidance... 30 Probe Safety ... 30 Mechanical hazards ... 30 Electrical Hazard ... 31 Biological hazards ...32 Personnel and equipment safety... 33 Explosion hazard... 33 Electrical hazard... 33 Smoke and fire hazard ...34 Biological hazard ... 34 Pacemaker hazard ... 34 LCD Monitor ... 35 Electrical safety... 37 Internally connected peripheral devices ... 37 External Connection of other peripheral devices... 37 Allergic reactions to latex-containing medical devices ... 38 Use of ECG ... 39 Use of Defibrillator ... 39 Use of Electrosurgical Unit ... 39 Electromagnetic Compatibility (EMC) ... 40 EMC performance ...41 Declaration of Emissions... 42 Declaration of Immunity... 42 Notice upon Installation of Product... 42 General notice ... 43 Peripheral Update for EC countries... 44

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Table of Contents Patient Environmental Devices ... 46 Acceptable devices... 47 Unapproved devices ... 47 Accessories, options, and supplies... 47 Environmental protection ... 48

Chapter 2 Getting started Introduction... 50 Preparing the unit for use... 51 Site requirements... 51 Connecting the unit... 52 Switching On/Off... 59 Moving and transporting the unit ... 62 Wheels... 62 Moving the unit ... 62 Transporting the unit... 64 Reinstalling at a new location ... 64 Unit acclimation time... 65 System description ... 66 System overview... 66 Control panel ... 68 The Scanning screen... 81 Three-Padel Footswitch operation... 84 Connecting and disconnecting probes ... 85 Adjusting the Display Monitor ... 88 Starting an examination... 92 Creating a new Patient record or starting an examination from an existing patient record... 92 Selecting a Probe and an Application... 97

Chapter 3 Basic scanning operations Assignable keys and Soft Menu Rocker ... 101 Using the Assignable Keys Soft Menu... 102 Using the Soft Menu Rocker... 105

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Table of Contents Trackball operation ...106 Trackball assignment ... 106 The system menu... 107 Cineloop operation ...108 Cineloop overview ...108 Cineloop controls... 109 Using cineloop... 110 Storing images and cineloops ... 111 To store a single image ... 111 To store a cineloop... 111 Using removable media...112 Recommendation concerning CD and DVD handling ... 112 Writing on CD or DVD media ... 112 Formatting removable media... 113 Ejecting removable media ... 114 Zoom ... 115 To Magnify an image... 115 Performing measurements... 115 To perform measurements ... 115 Physiological trace ...116 Connecting the ECG ... 116 Physio controls ... 118 Displaying the ECG trace ... 119 Adjusting the display of the ECG trace... 119 Annotations ... 120 To insert an annotation...120 To edit annotation... 123 To erase annotation ... 123 Configuration of the pre-defined annotation list... 124 Bodymarks ... 126

Chapter 4 Scanning Modes Introduction ... 131 2D-Mode ... 132 2D-Mode overview ... 132 2D-Mode controls ... 134

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Table of Contents Using 2D ... 138 Optimizing 2D ... 138 M-Mode ... 140 M-Mode overview ... 140 M-Mode controls ... 141 Using M-Mode ... 143 Optimizing M-Mode... 144 Color Mode... 146 Color Mode overview ... 146 Color M-Mode overview... 147 Color Mode controls... 148 Using Color Mode ... 151 Optimizing Color Mode ... 152 PW and CW Doppler... 153 PW and CW Doppler overview ... 153 PW and CW Doppler controls... 154 Using PW/CW Doppler modes ... 156 Optimizing PW/CW Doppler modes... 156 Tissue Velocity Imaging (TVI)... 158 Tissue Tracking ... 162 Tissue Synchronization Imaging (TSI) ... 166 TSI overview ... 166 TSI controls... 167 Using TSI ... 169 Optimizing TSI ... 170 Additional scanning features ... 171 LogiqView ... 171 Compound ... 172 B-Flow... 172 Blood flow imaging... 172

Chapter 5 Stress Echo Introduction... 176 Selection of a stress test protocol template ... 177 Image acquisition ... 178 Starting acquisition ... 179

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Table of Contents Continuous capture mode ... 184 Analysis ... 191 Editing/creating a template ... 195 Entering the Template editor screen ...195 Template editor screen overview ... 196 Editing/Creating a template ...199

Chapter 6 Contrast Imaging Introduction ... 204 Cardiac imaging ... 204 Non-cardiac imaging ... 204 Data acquisition ... 205 Left Ventricular Contrast Imaging... 205 LV Contrast overview ... 206 LV Contrast controls... 206 Running LV Contrast ... 208 Optimizing LV Contrast ... 209 Vascular Contrast Imaging... 210 Abdominal Contrast Imaging ... 211

Chapter 7 Measurement and Analysis Introduction ... 216 About Measurement results display ... 217 The Assign and Measure modality ... 218 Starting the Assign and Measure modality... 218 Entering a study and performing measurements ... 219 Measure and Assign modality ... 221 Starting the Measure and Assign modality... 221 Post-measurement assignment labels ... 222 Cardiac measurements... 225 2D Measurements ...225 M-Mode Measurements ... 229 Doppler Measurements ... 232 TSI Measurements ... 235

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Table of Contents Vascular measurements ... 240 B-Mode measurements ... 240 Intima-Media Thickness... 241 M-Mode Measurements... 245 Doppler measurements ... 246 Performing an OB exam... 251 Patient entry... 251 Selecting probe and OB application ... 254 OB Measurements and calculations... 256 Introduction ... 256 B-Mode measurements ... 257 M-Mode measurements... 264 Doppler Mode Measurements ... 264 OB parameter configuration... 267 Configuring OB M&A according to geographical regions . 267 Measurement package configuration ... 272 Measurement package configuration - example... 272 User-defined formulas ... 277 User-defined formula - example ... 277 About units... 283 Measurement result table ... 285 Minimizing the Measurement result table ... 285 Moving the Measurement result table... 285 Deleting measurements... 286 Worksheet ... 287 Overview... 287 Using Worksheet ... 288 OB worksheet ... 290 Patient data... 291 Measurement information ... 291 Calculation information ... 292 OB graphs ... 293 Overview... 293 Fetal Growth Curve Graph... 294 Fetal Trending... 298 Fetal Growth Bar Graph... 299 OB-Multigestational... 300 Multiple Fetus ... 300

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Table of Contents GYN Measurements ... 304 Introduction... 304 To Start a Gynecology Exam ... 304 B-Mode Measurements... 305 Uterus length, width, and height...305 Ovary length, width, and height... 306 Follicle measurements length, width, and height ... 307 Endometrium thickness (Endo) ... 307 M-Mode Measurements ...308 Doppler Mode Measurements ... 308

Chapter 8 Purposely Left Empty For Future purposes ... 309

Chapter 9 Archiving Introduction ... 313 Storing images and cineloops ... 314 Storing an image ... 315 Storing a cineloop... 315 Saving stored images and cineloops to a standard format316 MPEGVue/eVue ... 318 Retrieving and editing archived information... 321 Locating a patient record... 321 Selecting a patient record and editing data in the archive. 325 Deleting archived information... 329 Moving examinations... 331 Review images in archive... 333 Review the images from a selected examination ... 333 Select images from the Image list screen ... 334 Connectivity... 338 The dataflow concept ... 338 Stand-alone scanner scenario... 341 A stand-alone scanner and a stand-alone EchoPAC PC environment... 342

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Table of Contents A scanner and EchoPAC PC in a direct connect environment ... 344 A scanner and EchoPAC PC in a network environment... 348 A scanner and a DICOM server in a network ... 350 Export/Import patient records/examinations ... 359 Exporting patient records/examinations... 359 Importing patient records/examinations... 367 Disk Management ... 370 Configuring the Disk management function... 371 Running the Disk management function... 374 Data Backup and Restore... 377 DICOM spooler... 384 Starting the DICOM spooler... 384

Chapter 10 Report Introduction... 388 Creating a report... 389 Working with the report function ... 389 To print a report ... 392 To store a report ... 392 Retrieving an archived report... 393 Deleting an archived report... 393 Structured Findings ... 394 Prerequisite... 394 Starting Structured Findings ... 395 Structured Findings structure... 395 Using Structured Findings ... 397 Structured Findings configuration ... 400 Direct report ... 411 Creating comments... 411 Creating pre-defined text inputs... 412 Report designer ... 413 Accessing the Report designer... 413 Report designer overview ... 413 Designing a report template... 416 Saving the report template... 427

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Table of Contents To exit the Report designer ...427 Report templates management... 428 Configuration of the Template selection menu... 429 Export/Import of Report templates ... 430

Chapter 11 Probes Probe overview...435 Supported probes... 435 Vivid S5 Probe/Application Overview ... 438 Vivid S6 Probe/Application Overview ... 439 Maximum probe temperature ... 440 Probe orientation ... 441 Probe labelling... 441 Environmental Requirements ... 442 Probe Integration ... 443 Selecting probes... 443 Connecting the probe ... 443 Activating the probe... 445 Disconnecting the probe... 446 Care and Maintenance ... 447 Planned maintenance... 447 Inspecting the probe... 448 Special handling instructions... 449 Cleaning and disinfecting probes ... 451 Probe safety... 457 Biopsy ...458 Precaution concerning the use of biopsy procedures ... 458 Preparing the Biopsy guide attachment ... 459 Displaying the Guide zone ... 462 Biopsy needle path verification... 464 Starting the biopsy procedure ... 464 Cleaning, disinfection and disposal ... 464 Surgery/Intra-operative Use ...465 Preparing for Surgery/Intra-operative Procedures ...465

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Table of Contents

Chapter 12 Peripherals Introduction... 468 Printing ... 469 To print an image... 469 Specifications for peripherals ... 469

Chapter 13 Presets and System setup Introduction... 473 Starting the Configuration package... 476 To open the Configuration package... 476 Overview... 477 Imaging... 478 The Global setup sheet... 478 Application ... 481 Application menu ... 484 Measure Text... 486 The measurement menu sheet... 486 Configuration of the Measurement menu ... 489 The Advanced sheet... 491 Parameter configuration ... 491 The Modify Calculations sheet... 492 Parameter configuration ... 492 The OB table sheet... 493 Report ... 499 The diagnostic codes sheet ... 500 The Comment texts sheet... 501 Connectivity ... 504 Dataflow... 504 Additional outputs ... 512 Tools ... 514 Formats... 515 TCP-IP ... 520

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Table of Contents System ... 521 The system settings ... 521 About... 523 Administration... 524 Users ... 525 Unlock Patient ... 528

Chapter 14 User maintenance System Care and Maintenance ... 530 Inspecting the system... 530 Cleaning the unit ... 531 Prevention of static electricity interference... 533 System self-test... 534 System malfunction ... 534

Index

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Revision History

Revision History Revision

Date

Reason for Change

1

March 1 2007

Initial release

2

December 2007

Corrections and updates Preliminary watermark removed

3

March 2008

Corrections and updates

4

April 2008

Corrections and updates

List of effective pages Revision

Effective Pages

1

All

2

All

3

All

4

All

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 Ultrasound Clinical Answer Center at: 1-800-682-5327 or 1-262-524-5698.

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Revision History

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Introduction

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 and options like TVI, Tissue Tracking, and TSI (Tissue Synchronization 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.

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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Introduction 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 This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination. CAUTION

Contraindications

DANGER

The Vivid S5/Vivid S6 ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass 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, probes, and user care and maintenance.

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Introduction

•

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.

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. CAUTION

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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