Vivid 7 Dimension and Vivid 7 PRO Users Manual Volume 1 Ver 7.x.x Aug 2007

g MANUAL STATUS

GE Medical Systems

01/08/2007

© 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.

COMPANY DATA

GE VINGMED ULTRASOUND A/S

FD092052-01

Strandpromenaden 45, N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Table of Contents

Table of Contents Table of Contents Introduction Attention... 1 Safety... 1 Interference caution ... 1 Indications for use ... 2 Contraindications ... 2 Manual contents ... 3 Finding information ... 3 Conventions used in this manual ... 4 Contact information ... 5 Software license acknowledgments ... 6

Chapter 1 Getting started Introduction... 8 Preparing the unit for use... 9 Site requirements... 9 Connecting the unit... 10 Switching On/Off... 16 Moving and transporting the unit ... 18 Wheels... 18 Moving the unit ... 20 Transporting the unit... 21 Reinstalling at a new location ... 21 Unit acclimation time... 22 System description ... 23 System overview... 23 Control panel ... 26 The Scanning screen... 39 Footswitch operation... 42 Connecting and disconnecting probes ... 43 Vivid 7 User's Manual FD092052-01

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Table of Contents Adjusting the monitor display ... 43 LCD monitor adjustment... 46 Starting an examination ... 48 Creating a new Patient record or starting an examination from an existing patient record ... 48 Selecting a Probe and an Application ... 52

Chapter 2 Basic scanning operations Assignable keys and Soft Menu Rocker ... 55 Using the Soft Menu Rocker ... 56 Trackball operation ...57 Cineloop operation ...58 Cineloop overview ...58 Cineloop controls... 60 Using cineloop... 61 Storing images and cineloops ... 62 To store a single image ... 62 To store a cineloop... 62 Using removable media...63 Recommendation concerning CD and DVD handling ... 63 Formatting removable media... 63 Ejecting removable media ... 65 Recording images on VCR ... 66 Zoom ... 67 To magnify an image (Display zoom)... 68 To activate the HR zoom... 68 Performing measurements... 69 To perform measurements: ...69 Physiological traces ... 70 Pinout on AUX connectors ... 71 Connecting the ECG/Respiration ... 71 Connecting the Phono... 73 Connecting the Pulse pressure transducer ... 73 Physio overview ... 74 Physio controls ... 75 Displaying the physiological traces ... 77

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Table of Contents Adjusting the display of physiological traces ... 77 Annotations... 79 To insert an annotation ... 79 To edit annotation ... 82 To erase annotation... 82 Configuration of the pre-defined annotation list ... 83 Bodymarks... 85

Chapter 3 Scanning Modes Introduction... 89 2D-Mode ... 90 2D-Mode overview... 90 2D-Mode controls ... 92 Using 2D ... 95 Optimizing 2D ... 95 M-Mode ... 96 M-Mode overview ... 96 M-Mode controls ... 98 Using M-Mode ... 100 Optimizing M-Mode... 101 Color Mode ... 102 Color 2D Mode overview ... 102 Color M-Mode overview... 103 Color Mode controls... 105 Using Color Mode ... 108 Optimizing Color Mode ... 109 PW and CW Doppler... 110 PW and CW Doppler overview ... 110 PW and CW Doppler controls... 112 Using PW/CW Doppler modes ... 115 Optimizing PW/CW Doppler modes... 115 Tissue Velocity Imaging (TVI)... 117 TVI overview ... 117 TVI controls... 119 Using TVI ... 122 Optimizing TVI ... 122

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Table of Contents Tissue Tracking... 123 Tissue Tracking overview... 123 Tissue Tracking controls ... 125 Using Tissue Tracking... 128 Optimizing Tissue Tracking ...128 Strain rate ... 130 Strain rate overview... 130 Strain rate controls ... 132 Using Strain rate... 135 Optimizing Strain rate... 135 Strain ... 136 Strain overview... 136 Strain controls ... 138 Using Strain... 141 Optimizing Strain ... 141 Tissue Synchronization Imaging (TSI) ... 142 TSI overview... 142 TSI controls ... 144 Using TSI...146 Optimizing TSI... 147 Additional scanning features... 148 LogiqView... 148 Compound... 148 B-Flow ... 149 Blood flow imaging ... 149

Chapter 4 Stress Echo Introduction ... 152 Selection of a stress test protocol template... 153 Image acquisition... 155 Starting acquisition ... 156 Continuous capture mode ... 160 Analysis ... 168 Quantitative TVI Stress echo analysis ... 173 Accessing QTVI Stress analysis tools... 175 Vpeak measurement ... 175

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Table of Contents Tissue Tracking ... 179 Quantitative analysis... 180 References ... 180 Editing/creating a template... 181 Entering the Template editor screen... 181 Template editor screen overview... 182 Editing/Creating a template ... 185

Chapter 5 Contrast Imaging Introduction... 190 Data acquisition ... 190 Quantification... 191 Data acquisition... 193 Left Ventricular Contrast Imaging ... 193 Myocardial Contrast Imaging ... 198 Real-Time Coded Phase Inversion (RTCPI)... 206 Vascular Contrast Imaging ... 214 Abdominal Contrast Imaging ... 218 Rodent Contrast Imaging... 222

Chapter 6 Measurement and Analysis Introduction... 225 About Measurement results display... 225 The Assign and Measure modality ... 227 Starting the Assign and Measure modality ... 227 Entering a study and performing measurements... 229 Measure and Assign modality... 231 Starting the Measure and Assign modality ... 231 Post-measurement assignment labels... 232 Cardiac Measurements ... 235 2D Measurements ... 235 M-Mode Measurements... 239 Doppler Measurements ... 243 TSI Measurements ... 246

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Table of Contents Automated Function Imaging ... 252 Vascular measurements... 270 B-Mode measurements ... 270 M-Mode Measurements ... 274 Doppler measurements ... 275 OB measurements ... 281 OB graphs ... 281 Measurement package configuration... 286 Measurement package configuration - example ... 286 Normal values ... 288 User-defined formulas ... 291 User-defined formula - example ...291 About units ... 297 Measurement result table... 300 Minimizing the Measurement result table...300 Moving the Measurement result table ... 300 Deleting measurements ... 300 Worksheet... 302 Overview ...302 Using Worksheet ... 302

Chapter 7 Quantitative Analysis Introduction ... 307 For TVI: ... 307 For Tissue Tracking:... 307 For Strain rate: ... 307 For Strain:... 307 For Contrast: ... 307 Accessing the Quantitative analysis package ... 308 In replay mode:... 308 In live ... 308 Quantitative Analysis window ... 309 Overview ...309 Generation of a trace ... 316 About the sample area ...316 To generate a trace ... 316

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Table of Contents Manual tracking of the sample area (dynamic anchored sample area)... 317 Zooming in the Analysis window... 318 Deletion of a trace ... 319 To delete all traces ... 319 To delete one specific trace... 319 Saving/retrieving Quantitative analysis ... 319 Frame disabling ... 320 Disabling frames ... 320 Re-enabling all frames... 320 Optimizing sample area ... 322 Reshaping a sample area... 322 Labelling a sample area... 323 Optimizing the trace display... 324 Optimizing the Y-axis... 324 Trace smoothing ... 325 Switching modes or traces... 327 To switch mode... 327 To switch trace... 327 Cine compound ... 328 Curve fitting analysis ... 329 Wash-in curve fitting analysis ... 331 Wash-out curve fitting analysis ... 336 Anatomical M-Mode... 338 Introduction ... 338 Using Anatomical M-Mode... 338 Optimizing Anatomical M-Mode... 340

Chapter 8 Archiving Introduction... 343 Storing images and cineloops ... 344 Storing an image... 346 Storing a cineloop ... 346 Saving stored images and cineloops to a standard format347 MPEGVue/eVue ... 349 Retrieving and editing archived information ... 352 Vivid 7 User's Manual FD092052-01

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Table of Contents Locating a patient record... 352 Selecting a patient record and editing data in the archive. 356 Deleting archived information... 362 Moving examinations... 364 Review images in archive... 367 Review the images from a selected examination ... 367 Select images from the Image list screen ... 368 Connectivity... 372 The dataflow concept ... 372 Stand-alone scanner scenario... 376 A stand-alone scanner and a stand-alone EchoPAC PC environment... 377 A stand-alone scanner and a stand-alone DICOM workstation ... 379 A scanner and EchoPAC PC in a direct connect environment... 380 A scanner and EchoPAC PC in a network environment ... 384 A scanner and a DICOM server in a network... 386 Export/Import patient records/examinations... 396 Exporting patient records/examinations ... 396 Importing patient records/examinations ... 405 Disk management ... 409 Configuring the Disk management function ... 410 Running the Disk management function ... 412 Data Backup and restore... 417 Backup procedure ...418 Restore procedure...422 DICOM spooler ...424 Starting the DICOM spooler ... 424

Chapter 9 Report Introduction ... 428 Creating a report ... 429 Working with the report function...429 To print a report... 432 To store a report... 432

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Table of Contents Retrieving an archived report... 433 Deleting an archived report... 433 Structured Findings ... 434 Prerequisite... 434 Starting Structured Findings ... 435 Structured Findings structure... 435 Using Structured Findings ... 437 Structured Findings configuration ... 440 Direct report ... 451 Creating comments... 451 Creating pre-defined text inputs... 453 Report designer ... 454 Accessing the Report designer... 454 Report designer overview ... 455 Designing a report template... 458 Saving the report template... 468 To exit the Report designer ... 469 Report templates management ... 470 Configuration of the Template selection menu ... 470 Export/Import of Report templates... 472

Chapter 10 Probes Probe overview ... 476 Supported probes ... 476 Probe orientation ... 481 Probe labelling ... 481 Maximum probe temperature... 483 Probe Integration... 485 Connecting the probe ... 485 Activating the probe ... 488 Disconnecting the probe ... 489 Care and Maintenance ... 490 Planned maintenance ... 490 Inspecting the probe ... 491 Cleaning and disinfecting probes... 492 Probe safety ... 495

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Table of Contents Electrical hazards ... 495 Mechanical hazards ... 495 Biological hazards ...496 Biopsy ...497 Precaution concerning the use of biopsy procedures ... 497 Preparing the Biopsy guide attachment ... 498 Displaying the Guide zone ... 502 Biopsy needle path verification... 503 Starting the biopsy procedure ... 503 Cleaning, disinfection and disposal ... 503

Chapter 11 Peripherals Introduction ... 506 VCR/DVD operation...508 VCR/DVD Overview ... 508 Using VCR/DVD ... 509 Printing... 513 To print an image ... 513 Printer configuration ... 514 Specifications for peripherals... 516

Chapter 12 Presets and System setup Introduction ... 519 Starting the Configuration package ... 522 To open the Configuration package ... 522 Overview ... 523 Imaging ... 524 The Global setup sheet ... 524 Application... 527 Application menu... 531 Measure/Text ... 533 The Measurement menu sheet ... 534 The Advanced sheet ... 539 The Modify calculations sheet ... 540

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Table of Contents The OB table sheet... 541 Report ... 547 The diagnostic codes sheet ... 548 The Comment texts sheet... 550 Connectivity ... 553 Dataflow... 554 Additional outputs ... 563 Tools ... 565 Formats... 566 TCP/IP ... 571 System... 572 The system settings... 572 About ... 576 Administration ... 577 Users ... 578 Unlock Patient... 581

Chapter 13 User maintenance System Care and Maintenance... 584 Inspecting the system ... 584 Cleaning the unit... 585 Air filter... 585 Prevention of static electricity interference ... 587 System self-test ... 588 System malfunction ... 588

Chapter 14 Safety Introduction... 593 Owner responsibility ... 594 Important safety considerations ... 595 Notice against user modification... 595 Regulatory information ... 596 Standards used... 596 Device labels... 597 Vivid 7 User's Manual FD092052-01

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Table of Contents Classifications ... 601 Acoustic output... 602 Definition of the acoustic output parameters ... 602 Acoustic output and display on the Vivid 7... 603 ALARA... 604 Safety statement ... 604 System controls affecting acoustic output ... 604 Patient safety... 606 Patient identification ... 606 Diagnostic information... 606 Mechanical hazards ... 606 Transesophageal probe safety ... 607 Electrical Hazard ... 607 Personnel and equipment safety... 608 Explosion hazard... 608 Implosion hazard ... 608 Electrical hazard... 608 Moving hazard... 609 Biological hazard ... 609 Pacemaker hazard ... 610 Electrical safety... 611 Device classifications ... 611 Internally connected peripheral devices ... 611 External Connection of other peripheral devices... 611 Allergic reactions to latex-containing medical devices ... 612 Electromagnetic Compatibility (EMC) ... 613 Environmental protection... 615 System disposal ... 615

Appendix

Product description ... 618 System Architecture ... 618 Ergonomics ... 619 Display Annotations... 619 Tissue Imaging ... 620 Color Doppler ...623 Spectral Doppler... 625 Advanced Options ... 627 Physiological Traces ... 630

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Table of Contents Analysis Program... 630 User Interface ... 631 EchoPAC PC ... 631 Wideband probes... 632 Virus Protection ... 634 Peripherals (options)... 634 Physical Dimensions... 635 Cart ... 635 Electrical Specifications ... 636 Safety... 636 Probe/Application overview ... 637

Index

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Table of Contents

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Introduction

Introduction The Vivid 7 ultrasound unit is a high performance digital ultrasound imaging system. The system provides image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectra, Tissue Velocity imaging and Contrast applications. The fully digital architecture of the Vivid 7 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

Attention Read and understand all instructions in the User's Manual before attempting to use the Vivid 7 ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions. 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 14, ’Safety’ on page 591, should be read and understood before operating the Vivid 7 ultrasound unit.

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,

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Introduction radio-controlled toys, and so on, should not be operated near the unit. 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 7 ultrasound unit is intended for the following applications: • Abdominal • Fetal/Obstetrics • Pediatric • Small Organ • Adult and Neonatal Cephalic • Cardiac • Peripheral Vascular • Musculo-skeletal • Transesophageal • Transrectal • Transvaginal • Interoperative

Contraindications The Vivid 7 ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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Introduction

Manual contents The Vivid 7 User's Manual is organized to provide the information needed to start scanning immediately. If not otherwise specified, the functions described in this manual are common to both Vivid 7 Dimension and Vivid 7 PRO. 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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Introduction

Conventions used in this manual The term Vivid 7 used throughout the manual refers to both Vivid 7 Dimension and Vivid 7 PRO if not otherwise specified. 2-column layout, the right column contains the main text. The left column contains notes, hints and warnings texts. Keys and button, on the control panel are indicated by over and underlined text (ex. 2D refers to the 2D mode key) Bold type, describes button names on the screen. Italic type: describes program windows, screens and dialogue boxes. Icons, highlight safety issues as follow:

DANGER

Indicates that a specific hazard exists that, given inappropriate conditions or actions, will cause: • Severe or fatal personal injury • Substantial property damage

WARNING

Indicates that a specific hazard exists that, given inappropriate conditions or actions, will cause: • Severe personal injury • Substantial property damage

CAUTION

4

Indicates that a potential hazard may exist that, given inappropriate conditions or actions, can cause: • Minor injury • Property damage

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