Vivid i and Vivid q User Manual Volume 1 Rev 3 Jan 2013

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 software for the Vivid i and Vivid q ultrasound systems.

g MANUAL STATUS 5432770-100 31 January 2013 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

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Table of Contents Label Icon Description... 24 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

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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... 70 Moving and transporting the unit ... 74 Moving the unit on a Cart... 74 Transporting the unit... 75 Unit acclimation time... 75 System description ... 76 System overview... 76 Control panel ... 77 The scanning screen ... 88 Three-Pedal Footswitch operation... 91 Connecting and disconnecting probes ... 91 Adjusting the display monitor... 94 Additional instructions for upgraded systems ... 94 Screen Saver ... 96 Using Alt-X to toggle internal & external monitor settings... 96 Starting an examination... 97 Creating a new Patient record or starting an examination from an existing patient record... 97 Selecting a Probe and an Application... 102

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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

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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 ... 167 M-Mode ... 172 M-Mode overview ... 172 M-Mode controls ... 173 Using M-Mode ... 175 Optimizing M-Mode... 177 Color Mode... 178 Color Mode overview ... 178 Color M-Mode overview... 179 Color Mode controls... 180 Using Color Mode ... 183 Optimizing Color Mode ... 184 PW and CW Doppler... 185 PW and CW Doppler overview ... 185 PW and CW Doppler controls... 186 Using PW/CW Doppler modes ... 189 Optimizing PW/CW Doppler modes... 189 Tissue Velocity Imaging (TVI)... 191 Tissue Tracking ... 195 Strain rate... 199 Strain rate overview ... 199 Strain rate controls... 200 Using Strain rate ... 202 Optimizing Strain rate ... 202 Strain ... 204 Strain overview ... 204 Strain controls... 205 Using Strain ... 207 Optimizing Strain ... 207

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Table of Contents Tissue Synchronization Imaging (TSI) ... 209 TSI overview... 209 TSI controls ... 210 Using TSI...212 Optimizing TSI... 213 Additional scanning features... 214 LOGIQView ... 214 Compound... 215 B-Flow ... 216 Blood flow imaging ... 216 Virtual Convex ... 217

Chapter 5 Stress Echo Introduction ... 220 Selection of a stress test protocol template... 221 Image acquisition... 222 Starting acquisition ... 223 Continuous capture mode ... 227 Analysis ... 234 Quantitative TVI Stress echo analysis ... 239 Accessing QTVI Stress analysis tools... 240 Vpeak measurement ... 241 Tissue Tracking ... 244 Quantitative analysis ... 245 References ... 245 Editing/creating a template ... 246 Entering the Template editor screen ...246 Template editor screen overview ... 247 Editing/creating a template... 250

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Table of Contents

Chapter 6 Contrast Imaging Introduction... 256 Cardiac imaging... 256 Non-cardiac imaging... 256 Data acquisition... 257 Left Ventricular Contrast Imaging ... 257 LV Contrast overview... 258 LV Contrast controls ... 258 Running LV Contrast ... 261 Optimizing LV Contrast... 261 Vascular Contrast Imaging ... 262 Abdominal Contrast Imaging ... 263

Chapter 7 Measurement and Analysis Introduction... 267 About Measurement results display... 268 The Assign and Measure modality ... 269 Starting the Assign and Measure modality ... 269 Entering a study and performing measurements... 270 Measure and Assign modality... 272 Starting the Measure and Assign modality ... 272 Post-measurement assignment labels... 273 Cardiac measurements ... 276 2D Measurements ... 276 M-Mode Measurements... 280 Doppler Measurements ... 283 TSI Measurements ... 286 Automated Function Imaging... 290 AutoEF Measurements ... 312 Vascular measurements ... 321 B-Mode measurements ... 321 Intima-Media Thickness... 322 M-Mode Measurements... 328 Doppler measurements ... 329 Vivid i / Vivid q User Manual 5432770-100 Rev. 3

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Table of Contents Pediatric Calculations... 334 Overview ...334 Hip Dysplasia Calculation... 335 Making Hip Dysplasia Measurement...335 Performing an OB exam ... 337 Patient entry ... 337 Selecting probe and OB application ... 341 OB Measurements and calculations ...343 Introduction... 343 B-Mode measurements ... 344 M-Mode measurements ... 350 Doppler Mode Measurements ... 351 OB parameter configuration ... 354 Configuring OB M&A according to geographical regions .. 354 Measurement package configuration... 359 Measurement package configuration - example ... 359 User-defined formulas ... 364 User-defined formula - example ...364 About units ... 370 Measurement result table... 371 Minimizing the Measurement result table...371 Moving the Measurement result table ... 372 Deleting measurements ... 372 Worksheet... 373 Overview ...373 Using Worksheet ... 374 OB worksheet ... 376 Patient data ... 377 Measurement information... 377 Calculation information...378 OB graphs... 379 Overview ...379 Fetal Growth Curve Graph ... 380 Fetal Trending ... 384 Fetal Growth Bar Graph ... 385 OB-Multigestational ... 386 Multiple Fetus ...386

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Table of Contents

Chapter 8 Quantitative Analysis Introduction... 393 Accessing the Quantitative analysis package... 394 In replay mode ... 394 In live ... 394 Quantitative Analysis window... 395 Overview... 395 Generation of a trace... 402 About the sample area... 402 To generate a trace ... 402 Manual tracking of the sample area (dynamic anchored sample area)... 403 Zooming in the Analysis window... 404 Deletion of a trace ... 405 To delete all traces ... 405 To delete one specific trace... 405 Saving/retrieving Quantitative analysis ... 405 Frame disabling ... 406 Disabling frames ... 406 Re-enabling all frames... 406 Optimizing sample area ... 408 Reshaping a sample area... 408 Labelling a sample area... 409 Optimizing the trace display... 410 Optimizing the Y-axis... 410 Trace smoothing ... 411 Switching modes or traces... 413 To switch mode... 413 To switch trace... 413 Cine compound ... 414 Curved Anatomical M-Mode (CAMM)... 415 Introduction ... 415 Using CAMM... 415 Optimizing Curved Anatomical M-Mode ... 417

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Table of Contents

Chapter 9 Archiving Introduction ... 421 Storing images and cineloops ... 422 Storing an image ... 423 Storing a cineloop... 423 Saving single images and cineloops to a standard format 424 MPEGVue/eVue ... 426 EZ DICOM CD Viewer... 429 Retrieving and editing archived information... 432 Locating a patient record... 432 Selecting a patient record and editing data in the archive. 436 Deleting archived information... 441 Moving examinations... 443 Review images in archive... 445 Review the images from a selected examination ... 445 Select images from the Image list screen ... 446 Connectivity... 450 The dataflow concept ... 450 Stand-alone scanner scenario... 453 A stand-alone scanner and a stand-alone EchoPAC PC environment... 454 A scanner and EchoPAC PC in a direct connect environment... 456 A scanner and EchoPAC PC in a network environment ... 460 A scanner and a DICOM server in a network... 462 Export/Import patient records/examinations... 473 Exporting patient records/examinations ... 473 Importing patient records/examinations ... 482 Disk Management... 485 Configuring the Disk management function ... 486 Running the Disk management function ... 489 Data Backup and Restore ... 492 DICOM spooler ...499 Starting the DICOM spooler ... 499

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Chapter 10 Report Introduction... 504 Creating a report... 505 Working with the report function ... 505 To print a report ... 508 To store a report ... 508 Retrieving an archived report... 509 Deleting an archived report... 510 Structured Findings ... 511 Prerequisite... 511 Starting Structured Findings ... 512 Structured Findings structure... 512 Using Structured Findings ... 514 Structured Findings configuration ... 517 Direct report ... 527 Creating comments... 527 Creating pre-defined text inputs... 528 Report designer ... 529 Accessing the Report designer... 529 Report designer overview ... 529 Designing a report template... 532 Saving the report template... 543 To exit the Report designer ... 543 Report templates management ... 544 Configuration of the Template selection menu ... 545 Export/Import of Report templates... 546

Chapter 11 Probes Probe overview ... 551 Supported probes ... 551 Intra Cardiac Echo (ICE) catheter... 556 Vivid i Probe/Application Overview... 557 Vivid q Probe/Application Overview... 558 Probe surface-temperature safety mechanisms ... 560

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Table of Contents Maximum probe temperature ... 561 Probe orientation ... 562 Probe labelling... 563 Environmental Requirements ... 564 Probe Integration ... 565 Connecting the probe ... 565 Activating the probe... 565 Disconnecting the probe... 566 Using Intra Cardiac Ultrasound Catheters... 566 Care and Maintenance ... 571 Planned maintenance... 571 Inspecting the probe... 572 Special handling instructions... 573 Cleaning and disinfecting probes ... 576 Probe safety... 582 Handling precautions... 582 Electrical hazards ... 582 Mechanical hazards ... 583 Biological hazards ...583 Biopsy ...584 Precaution concerning the use of biopsy procedures ... 584 Preparing the Biopsy guide attachment ... 585 Displaying the Guide zone ... 589 Biopsy needle path verification... 591 Starting the biopsy procedure ... 591 Cleaning, disinfection and disposal ... 591 Surgery/Intra-operative Use ...592 Preparing for Surgery/Intra-operative Procedures ...592

Chapter 12 Peripherals Introduction ... 594 CardioLab™ / Mac-Lab™ support ... 595 Preparing Vivid i / Vivid q to operate with the CardioLab™ / Mac-Lab™ system ... 595

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Table of Contents CartoSound™ / SoundStar™ support ... 596 Carto & CardioLab Multiple Interfacing option... 597 Video Splitter ... 597 Battery Charger ... 598 Instructions for Use... 598 Safety... 599 Using your Charger... 599 Recharge and Re-calibration Time ... 600 Printing ... 602 To print an image... 602 Specifications for peripherals ... 602 Hooking up the system to an external monitor or projector . 603 Controlling the External VGA Video output... 603 Wireless option... 605

Chapter 13 Presets and System setup Introduction... 609 Starting the Configuration package... 612 To open the Configuration package... 612 Overview... 613 Imaging... 614 The Global setup sheet... 614 Application ... 617 Application menu ... 620 Measure Text... 623 The measurement menu sheet... 623 Configuration of the Measurement menu ... 627 The Advanced sheet... 629 Parameter configuration ... 629 The Modify Calculations sheet... 630 Parameter configuration ... 630 The OB table sheet... 631 Report ... 637 The diagnostic codes sheet ... 638 The Comment texts sheet... 639

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Table of Contents Connectivity... 642 Dataflow ... 642 Additional outputs... 650 Tools...652 Formats ... 653 TCP-IP... 658 System ... 659 The system settings ... 659 About... 661 Administration... 662 Users ... 663 Unlock Patient ... 666 Service ... 667 Blocking the use of USB storage media... 667

Chapter 14 User maintenance System Care and Maintenance ... 670 Overview ...670 Expected Service Life Description... 670 Inspecting the system... 671 Cleaning the unit ... 672 Prevention of static electricity interference... 674 System self-test... 676 System malfunction ... 676 Using InSite ExC ... 680 InSite ExC Functionalities ... 680 Initiating a Request for Service (RFS)... 680 Clinical Lifeline Mode ... 683 Exiting InSite ExC... 684

Index

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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

3

31 January 2013

Typo corrections Added support for a new rear-panel and new labels Update AFI/AutoEF user interface details Updated list of contact details

List of effective pages Revision

Effective Pages

1

All

2

168, 324-325, 553, 554

3

Xvii, 8-12, 23, 67-68, 117-119, 158-160, 199, 214, 293-296, 300-303, 310-314, 343, 424, 428, 469, 552, 557-559, 570

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.

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Revision History

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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.

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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 i and Vivid q easy systems to use and very user friendly.

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