Vivid i and Vivid q User Manual Volume 1 Rev 1 Oct 2010

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 Vivid i and Vivid q. It applies to all versions of the 11.x.x software for the Vivid i and Vivid q ultrasound systems.

g MANUAL STATUS 5400907-100 6 October 2010 Doc ID: DOC0761455

COMPANY DATA

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. GE Medical Systems, Israel Ltd. 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

Table of Contents

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

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 Contacting GE Healthcare Ultrasound ... 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 ... 20 Certifications ... 21 Software License Acknowledgements ... 21 Device labels... 22 Label Locations... 22 Label Icon Description ... 24 Vivid i / Vivid q User Manual 5400907-100 Rev. 1

iii

Table of Contents Acoustic output... 27 Definition of the acoustic output parameters ... 27 ALARA... 27 Safety statement ... 28 System controls affecting acoustic output ... 28 OB Exam ...29 Acoustic Output Considerations ... 31 Concerns surrounding fetal exposure ... 31 Patient safety... 32 Patient identification ... 32 Diagnostic information... 32 Patient guidance... 33 Probe Safety ... 33 Mechanical hazards ... 33 Electrical Hazard ... 34 Biological hazards ...35 Personnel and equipment safety... 36 Explosion hazard... 36 Electrical hazard... 36 Smoke and fire hazard ...37 Biological hazard ... 37 Pacemaker hazard ... 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 ... 48

iv

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Table of Contents Unapproved devices ... 48 Accessories, options, and supplies... 48 Computer Virus precaution ... 49 Environmental protection ... 49

Chapter 2 Getting started Introduction... 52 Preparing the unit for use... 53 Site requirements... 53 Connecting the unit... 54 Switching On/Off... 65 Moving and transporting the unit ... 69 Moving the unit on a Cart... 69 Transporting the unit... 70 Unit acclimation time... 70 System description ... 71 System overview... 71 Control panel ... 72 The scanning screen ... 83 Three-Pedal Footswitch operation... 86 Connecting and disconnecting probes ... 86 Adjusting the display monitor... 89 Screen Saver ... 90 Starting an examination... 91 Creating a new Patient record or starting an examination from an existing patient record... 91 Selecting a Probe and an Application... 96

Chapter 3 Basic scanning operations Assignable keys and Soft Menu Rocker ... 99 Using the Assignable Keys Soft Menu... 100 Using the Soft Menu Rocker... 103 Trackball operation ... 104 Trackball assignment... 104 The system menu ... 105 Vivid i / Vivid q User Manual 5400907-100 Rev. 1

v

Table of Contents Cineloop operation ...106 Cineloop overview ...106 Cineloop controls... 108 Using cineloop... 109 Storing images and cineloops ... 110 To store a single image ... 110 To store a cineloop... 110 Removable Media... 111 Intended use... 111 Supported removable media ... 112 Zoom ... 120 To select the type of zoom in use... 120 To Magnify an image... 120 Performing measurements... 121 To perform measurements ... 121 Physiological ECG/Respiratory traces... 122 Connecting the ECG ... 123 Physio controls ... 133 Displaying the ECG trace ... 134 Adjusting the display of the ECG trace... 135 Displaying the Respiratory trace ... 135 Annotations ... 137 To insert an annotation...137 To edit annotation... 140 To erase annotation ... 140 Configuration of the pre-defined annotation list... 141 Bodymarks ... 143

Chapter 4 Scanning Modes Introduction ... 147 2D-Mode ... 148 2D-Mode overview ... 148 2D-Mode controls ... 150 Using 2D... 157 Optimizing 2D...157

vi

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Table of Contents M-Mode ... 159 M-Mode overview ... 159 M-Mode controls ... 160 Using M-Mode ... 162 Optimizing M-Mode... 164 Color Mode... 165 Color Mode overview ... 165 Color M-Mode overview... 166 Color Mode controls... 167 Using Color Mode ... 170 Optimizing Color Mode ... 171 PW and CW Doppler... 172 PW and CW Doppler overview ... 172 PW and CW Doppler controls... 173 Using PW/CW Doppler modes ... 176 Optimizing PW/CW Doppler modes... 176 Tissue Velocity Imaging (TVI)... 178 Tissue Tracking ... 182 Strain rate... 186 Strain rate overview ... 186 Strain rate controls... 187 Using Strain rate ... 189 Optimizing Strain rate ... 189 Strain ... 191 Strain overview ... 191 Strain controls... 192 Using Strain ... 194 Optimizing Strain ... 194 Tissue Synchronization Imaging (TSI) ... 196 TSI overview ... 196 TSI controls... 197 Using TSI ... 199 Optimizing TSI ... 200 Additional scanning features ... 201 LOGIQView... 201 Compound ... 202 B-Flow... 203 Blood flow imaging... 203 Virtual Convex ... 204 Vivid i / Vivid q User Manual 5400907-100 Rev. 1

vii

Table of Contents

Chapter 5 Stress Echo Introduction ... 206 Selection of a stress test protocol template... 207 Image acquisition... 208 Starting acquisition ... 209 Continuous capture mode ... 214 Analysis ... 221 Quantitative TVI Stress echo analysis ... 226 Accessing QTVI Stress analysis tools... 227 Vpeak measurement ... 228 Tissue Tracking ... 231 Quantitative analysis ... 231 References ... 232 Editing/creating a template ... 233 Entering the Template editor screen ...233 Template editor screen overview ... 234 Editing/creating a template... 237

Chapter 6 Contrast Imaging Introduction ... 242 Cardiac imaging ... 242 Non-cardiac imaging ... 242 Data acquisition ... 243 Left Ventricular Contrast Imaging... 243 LV Contrast overview ... 244 LV Contrast controls... 244 Running LV Contrast ... 247 Optimizing LV Contrast ... 247 Vascular Contrast Imaging... 248 Abdominal Contrast Imaging ... 249

viii

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Table of Contents

Chapter 7 Measurement and Analysis Introduction... 253 About Measurement results display... 254 The Assign and Measure modality ... 255 Starting the Assign and Measure modality ... 255 Entering a study and performing measurements... 256 Measure and Assign modality... 258 Starting the Measure and Assign modality ... 258 Post-measurement assignment labels... 259 Cardiac measurements ... 262 2D Measurements ... 262 M-Mode Measurements... 266 Doppler Measurements ... 269 TSI Measurements ... 272 Automated Function Imaging... 276 AutoEF Measurements ... 296 Vascular measurements ... 305 B-Mode measurements ... 305 Intima-Media Thickness... 306 M-Mode Measurements... 311 Doppler measurements ... 312 Pediatric Calculations ... 317 Overview... 317 Hip Dysplasia Calculation ... 318 Making Hip Dysplasia Measurement ... 318 Performing an OB exam... 320 Patient entry... 320 Selecting probe and OB application ... 324 OB Measurements and calculations... 326 Introduction ... 326 B-Mode measurements ... 327 M-Mode measurements... 333 Doppler Mode Measurements ... 333 OB parameter configuration... 337 Configuring OB M&A according to geographical regions . 337

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

ix

Table of Contents Measurement package configuration... 342 Measurement package configuration - example ... 342 User-defined formulas ... 347 User-defined formula - example ...347 About units ... 353 Measurement result table... 354 Minimizing the Measurement result table...354 Moving the Measurement result table ... 355 Deleting measurements ... 355 Worksheet... 356 Overview ...356 Using Worksheet ... 357 OB worksheet ... 359 Patient data ... 360 Measurement information... 360 Calculation information...361 OB graphs... 362 Overview ...362 Fetal Growth Curve Graph ... 363 Fetal Trending ... 367 Fetal Growth Bar Graph ... 368 OB-Multigestational ... 369 Multiple Fetus ...369

Chapter 8 Quantitative Analysis Introduction ... 375 Accessing the Quantitative analysis package ... 376 In replay mode... 376 In live ... 376 Quantitative Analysis window ... 377 Overview ...377 Generation of a trace ... 384 About the sample area ...384 To generate a trace ... 384 Manual tracking of the sample area (dynamic anchored sample area) ... 385

x

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Table of Contents Zooming in the Analysis window... 386 Deletion of a trace ... 387 To delete all traces ... 387 To delete one specific trace... 387 Saving/retrieving Quantitative analysis ... 387 Frame disabling ... 388 Disabling frames ... 388 Re-enabling all frames... 388 Optimizing sample area ... 390 Reshaping a sample area... 390 Labelling a sample area... 391 Optimizing the trace display... 392 Optimizing the Y-axis... 392 Trace smoothing ... 393 Switching modes or traces... 394 To switch mode... 394 To switch trace... 394 Cine compound ... 395 Curved Anatomical M-Mode (CAMM)... 396 Introduction ... 396 Using CAMM... 396 Optimizing Curved Anatomical M-Mode ... 398

Chapter 9 Archiving Introduction... 401 Storing images and cineloops ... 402 Storing an image... 403 Storing a cineloop ... 403 Saving single images and cineloops to a standard format 404 MPEGVue/eVue ... 406 Retrieving and editing archived information ... 409 Locating a patient record ... 409 Selecting a patient record and editing data in the archive 414 Deleting archived information ... 418 Moving examinations ... 420

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

xi

Table of Contents Review images in archive... 422 Review the images from a selected examination ... 422 Select images from the Image list screen ... 423 Connectivity... 427 The dataflow concept ... 427 Stand-alone scanner scenario... 430 A stand-alone scanner and a stand-alone EchoPAC PC environment... 431 A scanner and EchoPAC PC in a direct connect environment... 433 A scanner and EchoPAC PC in a network environment ... 437 A scanner and a DICOM server in a network... 439 Export/Import patient records/examinations... 449 Exporting patient records/examinations ... 449 Importing patient records/examinations ... 458 Disk Management... 461 Configuring the Disk management function ... 462 Running the Disk management function ... 465 Data Backup and Restore ... 468 DICOM spooler ...475 Starting the DICOM spooler ... 475

Chapter 10 Report Introduction ... 480 Creating a report ... 481 Working with the report function...481 To print a report... 484 To store a report... 484 Retrieving an archived report ... 485 Deleting an archived report ...485 Structured Findings ... 486 Prerequisite ... 486 Starting Structured Findings... 487 Structured Findings structure ... 487 Using Structured Findings ... 489 Structured Findings configuration... 492

xii

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Table of Contents Direct report ... 502 Creating comments... 502 Creating pre-defined text inputs... 503 Report designer ... 504 Accessing the Report designer... 504 Report designer overview ... 504 Designing a report template... 507 Saving the report template... 518 To exit the Report designer ... 518 Report templates management ... 519 Configuration of the Template selection menu ... 520 Export/Import of Report templates... 521

Chapter 11 Probes Probe overview ... 525 Supported probes ... 525 Intra Cardiac Echo (ICE) catheter... 530 Vivid i Probe/Application Overview... 531 Vivid q Probe/Application Overview... 532 Probe surface-temperature safety mechanisms ... 533 Maximum probe temperature... 534 Probe orientation ... 535 Probe labelling ... 536 Environmental Requirements ... 537 Probe Integration... 538 Connecting the probe ... 538 Activating the probe ... 538 Disconnecting the probe ... 539 Using Intra Cardiac Ultrasound Catheters ... 539 Care and Maintenance ... 544 Planned maintenance ... 544 Inspecting the probe ... 545 Special handling instructions ... 546 Cleaning and disinfecting probes... 549 Probe safety ... 555 Handling precautions ... 555 Electrical hazards ... 555 Vivid i / Vivid q User Manual 5400907-100 Rev. 1

xiii

Table of Contents Mechanical hazards ... 556 Biological hazards ...556 Biopsy ...557 Precaution concerning the use of biopsy procedures ... 557 Preparing the Biopsy guide attachment ... 558 Displaying the Guide zone ... 562 Biopsy needle path verification... 564 Starting the biopsy procedure ... 564 Cleaning, disinfection and disposal ... 564 Surgery/Intra-operative Use ...565 Preparing for Surgery/Intra-operative Procedures ...565

Chapter 12 Peripherals Introduction ... 568 CardioLab™ / Mac-Lab™ support ... 569 Preparing Vivid i / Vivid q to operate with the CardioLab™ / Mac-Lab™ system ... 570 CartoSound™ / SoundStar™ support... 570 Carto & CardioLab Multiple Interfacing option ... 571 Video Splitter ... 571 Battery Charger ... 572 Instructions for Use ... 572 Safety ... 573 Using your Charger ... 573 Recharge and Re-calibration Time... 574 Printing... 576 To print an image ... 576 Specifications for peripherals... 576 Hooking up the system to an external monitor or projector.. 577 Controlling the External VGA Video output ... 577 Wireless option ... 579

xiv

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Table of Contents

Chapter 13 Presets and System setup Introduction... 583 Starting the Configuration package... 586 To open the Configuration package... 586 Overview... 587 Imaging... 588 The Global setup sheet... 588 Application ... 591 Application menu ... 594 Measure Text... 597 The measurement menu sheet... 597 Configuration of the Measurement menu ... 601 The Advanced sheet... 603 Parameter configuration ... 603 The Modify Calculations sheet... 604 Parameter configuration ... 604 Report ... 605 The diagnostic codes sheet ... 606 The Comment texts sheet... 607 Connectivity ... 610 Dataflow... 610 Additional outputs ... 618 Tools ... 620 Formats... 621 TCP-IP ... 626 System... 627 The system settings... 627 About ... 629 Administration ... 630 Users ... 631 Unlock Patient... 634

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

xv

Table of Contents

Chapter 14 User maintenance System Care and Maintenance ... 636 Inspecting the system... 636 Cleaning the unit ... 637 Prevention of static electricity interference... 639 System self-test... 641 System malfunction ... 641 Using InSite ExC ... 645 InSite ExC Functionalities ... 645 Initiating a Request for Service (RFS)... 645 Clinical Lifeline Mode ... 648 Exiting InSite ExC... 649

Index

xvi

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Revision History

Revision History Revision 1

Date 6 October 2010

Reason for Change Initial release

List of effective pages Revision 1

Effective Pages 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 Medical Systems Clinical Answer Center at: 1-800-682-5327 or 1-262-524-5698.

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

xvii

Revision History

xviii

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

Introduction

Introduction The Vivid i / Vivid q ultrasound units are compact, high performance portable 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, Tissue Velocity imaging, Tissue Tracking, TSI (Tissue Synchronization Imaging), Tissue-Doppler imaging (TDI), B-Flow, BFI, and LVO Contrast option applications. The fully digital architecture of the Vivid i / Vivid q 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 i / Vivid q 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 the Safety chapter (Chapter 1, "Safety", page 13), should be read and understood before operating the Vivid i / Vivid q ultrasound unit.

Vivid i / Vivid q User Manual 5400907-100 Rev. 1

1

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 i and Vivid q 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.

2

Vivid i / Vivid q User Manual 5400907-100 Rev. 1