Vivid i and Vivid q User Manual Volume 1 Rev 2 July 2012

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 12.x.x software for the Vivid i and Vivid q ultrasound systems.

g MANUAL STATUS 5432770-100 17 July 2012 Doc ID: DOC0979173

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 ... 3 Indications for use... 3 Contraindications ... 4 Documentation ... 4 Manual contents ... 4 Conventions used in this manual ... 6 Regulatory requirements ... 7 Contacting GE Healthcare Ultrasound ... 8

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 5432770-100 Rev. 2

iii

Table of Contents Acoustic output... 28 Definition of the acoustic output parameters ... 28 ALARA... 28 Safety statement ... 29 System controls affecting acoustic output ... 29 OB Exam ...31 Acoustic Output Considerations ... 33 Concerns surrounding fetal exposure ... 33 Patient safety... 34 Patient identification ... 34 Diagnostic information... 34 Patient guidance... 35 Probe Safety ... 35 Mechanical hazards ... 35 Electrical Hazard ... 36 Biological hazards ...37 Personnel and equipment safety... 38 Explosion hazard... 38 Electrical hazard... 38 Smoke and fire hazard ...39 Biological hazard ... 39 Pacemaker hazard ... 39 LCD Monitor ... 40 Electrical safety... 41 Internally connected peripheral devices ... 41 External Connection of other peripheral devices... 41 Allergic reactions to latex-containing medical devices ... 42 Use of ECG ... 43 Use of Defibrillator ... 43 Use of Electrosurgical Unit ... 43 Electromagnetic Compatibility (EMC) ... 44 EMC performance ...45 Declaration of Emissions... 46 Declaration of Immunity... 46 Notice upon Installation of Product... 46 General notice ... 47 Peripheral Update for EC countries... 48

iv

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Table of Contents Patient Environmental Devices ... 50 Acceptable devices... 50 Unapproved devices ... 50 Accessories, options, and supplies... 50 Computer Virus precaution ... 51 Environmental protection ... 51 RoHS Hazardous Substances ... 52 Name and Concentration of Hazardous Substances... 53

Chapter 2 Getting started Introduction... 56 Preparing the unit for use... 57 Site requirements... 57 Connecting the unit... 58 Switching On/Off... 69 Moving and transporting the unit ... 73 Moving the unit on a Cart... 73 Transporting the unit... 74 Unit acclimation time... 74 System description ... 75 System overview... 75 Control panel ... 76 The scanning screen ... 87 Three-Pedal Footswitch operation... 90 Connecting and disconnecting probes ... 90 Adjusting the display monitor... 93 Additional instructions for upgraded systems ... 93 Screen Saver ... 95 Using Alt-X to toggle internal & external monitor settings... 95 Starting an examination... 96 Creating a new Patient record or starting an examination from an existing patient record... 96 Selecting a Probe and an Application... 101

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

v

Table of Contents

Chapter 3 Basic scanning operations Assignable keys and Soft Menu Rocker ... 105 Using the Assignable Keys Soft Menu ... 106 Using the Soft Menu Rocker ... 109 Trackball operation ...110 Trackball assignment ... 110 The system menu... 111 Cineloop operation ...112 Cineloop overview ...112 Cineloop controls... 114 Using cineloop... 115 Storing images and cineloops ... 116 To store a single image ... 116 To store a cineloop... 116 Removable Media... 117 Intended use... 117 Supported removable media ... 118 Zoom ... 126 To select the type of zoom in use... 126 To Magnify an image... 126 Performing measurements... 127 To perform measurements ... 127 Physiological ECG/Respiratory traces... 128 Connecting the ECG ... 129 Physio controls ... 140 Displaying the ECG trace ... 142 Adjusting the display of the ECG trace... 142 Displaying the Respiratory trace ... 143 Annotations ... 144 To insert an annotation...144 To edit annotation... 147 To erase annotation ... 147 Configuration of the pre-defined annotation list... 148 Bodymarks ... 150

vi

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Table of Contents

Chapter 4 Scanning Modes Introduction... 155 2D-Mode ... 156 2D-Mode overview... 156 2D-Mode controls ... 158 Using 2D ... 165 Optimizing 2D ... 166 M-Mode ... 171 M-Mode overview ... 171 M-Mode controls ... 172 Using M-Mode ... 174 Optimizing M-Mode... 176 Color Mode... 177 Color Mode overview ... 177 Color M-Mode overview... 178 Color Mode controls... 179 Using Color Mode ... 182 Optimizing Color Mode ... 183 PW and CW Doppler... 184 PW and CW Doppler overview ... 184 PW and CW Doppler controls... 185 Using PW/CW Doppler modes ... 188 Optimizing PW/CW Doppler modes... 188 Tissue Velocity Imaging (TVI)... 190 Tissue Tracking ... 194 Strain rate... 198 Strain rate overview ... 198 Strain rate controls... 199 Using Strain rate ... 201 Optimizing Strain rate ... 201 Strain ... 203 Strain overview ... 203 Strain controls... 204 Using Strain ... 206 Optimizing Strain ... 206

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

vii

Table of Contents Tissue Synchronization Imaging (TSI) ... 208 TSI overview... 208 TSI controls ... 209 Using TSI...211 Optimizing TSI... 212 Additional scanning features... 213 LOGIQView ... 213 Compound... 214 B-Flow ... 215 Blood flow imaging ... 215 Virtual Convex ... 216

Chapter 5 Stress Echo Introduction ... 218 Selection of a stress test protocol template... 219 Image acquisition... 220 Starting acquisition ... 221 Continuous capture mode ... 225 Analysis ... 232 Quantitative TVI Stress echo analysis ... 237 Accessing QTVI Stress analysis tools... 238 Vpeak measurement ... 239 Tissue Tracking ... 242 Quantitative analysis ... 243 References ... 243 Editing/creating a template ... 244 Entering the Template editor screen ...244 Template editor screen overview ... 245 Editing/creating a template... 248

viii

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Table of Contents

Chapter 6 Contrast Imaging Introduction... 254 Cardiac imaging... 254 Non-cardiac imaging... 254 Data acquisition... 255 Left Ventricular Contrast Imaging ... 255 LV Contrast overview... 256 LV Contrast controls ... 256 Running LV Contrast ... 259 Optimizing LV Contrast... 259 Vascular Contrast Imaging ... 260 Abdominal Contrast Imaging ... 261

Chapter 7 Measurement and Analysis Introduction... 265 About Measurement results display... 266 The Assign and Measure modality ... 267 Starting the Assign and Measure modality ... 267 Entering a study and performing measurements... 268 Measure and Assign modality... 270 Starting the Measure and Assign modality ... 270 Post-measurement assignment labels... 271 Cardiac measurements ... 274 2D Measurements ... 274 M-Mode Measurements... 278 Doppler Measurements ... 281 TSI Measurements ... 284 Automated Function Imaging... 288 AutoEF Measurements ... 308 Vascular measurements ... 318 B-Mode measurements ... 318 Intima-Media Thickness... 319 M-Mode Measurements... 325 Doppler measurements ... 326 Vivid i / Vivid q User Manual 5432770-100 Rev. 2

ix

Table of Contents Pediatric Calculations... 331 Overview ...331 Hip Dysplasia Calculation... 332 Making Hip Dysplasia Measurement...332 Performing an OB exam ... 334 Patient entry ... 334 Selecting probe and OB application ... 338 OB Measurements and calculations ...340 Introduction... 340 B-Mode measurements ... 341 M-Mode measurements ... 347 Doppler Mode Measurements ... 347 OB parameter configuration ... 351 Configuring OB M&A according to geographical regions .. 351 Measurement package configuration... 356 Measurement package configuration - example ... 356 User-defined formulas ... 361 User-defined formula - example ...361 About units ... 367 Measurement result table... 368 Minimizing the Measurement result table...368 Moving the Measurement result table ... 369 Deleting measurements ... 369 Worksheet... 370 Overview ...370 Using Worksheet ... 371 OB worksheet ... 373 Patient data ... 374 Measurement information... 374 Calculation information...375 OB graphs... 376 Overview ...376 Fetal Growth Curve Graph ... 377 Fetal Trending ... 381 Fetal Growth Bar Graph ... 382 OB-Multigestational ... 383 Multiple Fetus ...383

x

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Table of Contents

Chapter 8 Quantitative Analysis Introduction... 389 Accessing the Quantitative analysis package... 390 In replay mode ... 390 In live ... 390 Quantitative Analysis window... 391 Overview... 391 Generation of a trace... 398 About the sample area... 398 To generate a trace ... 398 Manual tracking of the sample area (dynamic anchored sample area)... 399 Zooming in the Analysis window... 400 Deletion of a trace ... 401 To delete all traces ... 401 To delete one specific trace... 401 Saving/retrieving Quantitative analysis ... 401 Frame disabling ... 402 Disabling frames ... 402 Re-enabling all frames... 402 Optimizing sample area ... 404 Reshaping a sample area... 404 Labelling a sample area... 405 Optimizing the trace display... 406 Optimizing the Y-axis... 406 Trace smoothing ... 407 Switching modes or traces... 409 To switch mode... 409 To switch trace... 409 Cine compound ... 410 Curved Anatomical M-Mode (CAMM)... 411 Introduction ... 411 Using CAMM... 411 Optimizing Curved Anatomical M-Mode ... 413

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

xi

Table of Contents

Chapter 9 Archiving Introduction ... 417 Storing images and cineloops ... 418 Storing an image ... 419 Storing a cineloop... 419 Saving single images and cineloops to a standard format 420 MPEGVue/eVue ... 422 EZ DICOM CD Viewer... 425 Retrieving and editing archived information... 428 Locating a patient record... 428 Selecting a patient record and editing data in the archive. 432 Deleting archived information... 437 Moving examinations... 439 Review images in archive... 441 Review the images from a selected examination ... 441 Select images from the Image list screen ... 442 Connectivity... 446 The dataflow concept ... 446 Stand-alone scanner scenario... 449 A stand-alone scanner and a stand-alone EchoPAC PC environment... 450 A scanner and EchoPAC PC in a direct connect environment... 452 A scanner and EchoPAC PC in a network environment ... 456 A scanner and a DICOM server in a network... 458 Export/Import patient records/examinations... 469 Exporting patient records/examinations ... 469 Importing patient records/examinations ... 478 Disk Management... 481 Configuring the Disk management function ... 482 Running the Disk management function ... 485 Data Backup and Restore ... 488 DICOM spooler ...495 Starting the DICOM spooler ... 495

xii

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Table of Contents

Chapter 10 Report Introduction... 500 Creating a report... 501 Working with the report function ... 501 To print a report ... 504 To store a report ... 504 Retrieving an archived report... 505 Deleting an archived report... 506 Structured Findings ... 507 Prerequisite... 507 Starting Structured Findings ... 508 Structured Findings structure... 508 Using Structured Findings ... 510 Structured Findings configuration ... 513 Direct report ... 523 Creating comments... 523 Creating pre-defined text inputs... 524 Report designer ... 525 Accessing the Report designer... 525 Report designer overview ... 525 Designing a report template... 528 Saving the report template... 539 To exit the Report designer ... 539 Report templates management ... 540 Configuration of the Template selection menu ... 541 Export/Import of Report templates... 542

Chapter 11 Probes Probe overview ... 547 Supported probes ... 547 Intra Cardiac Echo (ICE) catheter... 552 Vivid i Probe/Application Overview... 553 Vivid q Probe/Application Overview... 554 Probe surface-temperature safety mechanisms ... 555

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

xiii

Table of Contents Maximum probe temperature ... 556 Probe orientation ... 557 Probe labelling... 558 Environmental Requirements ... 559 Probe Integration ... 560 Connecting the probe ... 560 Activating the probe... 560 Disconnecting the probe... 561 Using Intra Cardiac Ultrasound Catheters... 561 Care and Maintenance ... 566 Planned maintenance... 566 Inspecting the probe... 567 Special handling instructions... 568 Cleaning and disinfecting probes ... 571 Probe safety... 577 Handling precautions... 577 Electrical hazards ... 577 Mechanical hazards ... 578 Biological hazards ...578 Biopsy ...579 Precaution concerning the use of biopsy procedures ... 579 Preparing the Biopsy guide attachment ... 580 Displaying the Guide zone ... 584 Biopsy needle path verification... 586 Starting the biopsy procedure ... 586 Cleaning, disinfection and disposal ... 586 Surgery/Intra-operative Use ...587 Preparing for Surgery/Intra-operative Procedures ...587

Chapter 12 Peripherals Introduction ... 590 CardioLab™ / Mac-Lab™ support ... 591 Preparing Vivid i / Vivid q to operate with the CardioLab™ / Mac-Lab™ system ... 592

xiv

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Table of Contents CartoSound™ / SoundStar™ support ... 592 Carto & CardioLab Multiple Interfacing option... 593 Video Splitter ... 593 Battery Charger ... 594 Instructions for Use... 594 Safety... 595 Using your Charger... 595 Recharge and Re-calibration Time ... 596 Printing ... 598 To print an image... 598 Specifications for peripherals ... 598 Hooking up the system to an external monitor or projector . 599 Controlling the External VGA Video output... 599 Wireless option... 601

Chapter 13 Presets and System setup Introduction... 605 Starting the Configuration package... 608 To open the Configuration package... 608 Overview... 609 Imaging... 610 The Global setup sheet... 610 Application ... 613 Application menu ... 616 Measure Text... 619 The measurement menu sheet... 619 Configuration of the Measurement menu ... 623 The Advanced sheet... 625 Parameter configuration ... 625 The Modify Calculations sheet... 626 Parameter configuration ... 626 The OB table sheet... 627 Report ... 633 The diagnostic codes sheet ... 634 The Comment texts sheet... 635

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

xv

Table of Contents Connectivity... 638 Dataflow ... 638 Additional outputs... 646 Tools...648 Formats ... 649 TCP-IP... 654 System ... 655 The system settings ... 655 About... 657 Administration... 658 Users ... 659 Unlock Patient ... 662 Service ... 663 Blocking the use of USB storage media... 663

Chapter 14 User maintenance System Care and Maintenance ... 666 Overview ...666 Expected Service Life Description... 666 Inspecting the system... 667 Cleaning the unit ... 668 Prevention of static electricity interference... 670 System self-test... 672 System malfunction ... 672 Using InSite ExC ... 676 InSite ExC Functionalities ... 676 Initiating a Request for Service (RFS)... 676 Clinical Lifeline Mode ... 679 Exiting InSite ExC... 680

Index

xvi

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

Revision History

Revision History Revision

Date

Reason for Change

1

19 March 2012

Initial release for BT12

2

17 July 2012

Updated new (CTO+ATO) paddle option Updated IMT workflow with SET key. Updated probeApplication overview matrix

List of effective pages Revision

Effective Pages

1

All

2

168, 324-325, 553, 554

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 5432770-100 Rev. 2

xvii

Revision History

xviii

Vivid i / Vivid q User Manual 5432770-100 Rev. 2

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 CAUTION

For USA only: 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 5432770-100 Rev. 2

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.

2

Vivid i / Vivid q User Manual 5432770-100 Rev. 2