Vivid 7 Dimension and Vivid 7 PRO User Manual Volume 1 ver 5.x.x

g

GE Medical Systems

01/07/2005

 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

MANUAL STATUS FC092710-01

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

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... 21 System description ... 23 System overview... 23 Control panel ... 26 The Scanning screen... 39 Footswitch operation... 42 Connecting and disconnecting probes ... 43 Adjusting the display monitor... 43 Vivid 7 User's Manual FC092710-01

1

Table of Contents Starting an examination ... 45 Creating a new Patient record or starting an examination from an existing patient record ... 45 Selecting a Probe and an Application ... 49

Chapter 2 Basic scanning operations Assignable keys and Soft Menu Rocker ... 53 Using the Soft Menu Rocker ... 54 Trackball operation ...55 Cineloop operation ...56 Cineloop overview ...56 Cineloop controls... 58 Using cineloop... 59 Storing images and cineloops ... 60 To store a single image ... 60 To store a cineloop... 60 Using removable media...61 Recommendation concerning CD and DVD handling ... 61 Formatting removable media... 61 Ejecting removable media ... 63 Recording images on VCR ... 64 Zoom ... 65 To magnify an image (Display zoom)... 66 To activate the HR zoom... 66 Performing measurements... 67 To perform measurements: ...67 Physiological traces ... 68 Pinout on AUX connectors ... 69 Connecting the ECG/Respiration ... 69 Connecting the Phono... 71 Connecting the Pulse pressure transducer ... 71 Physio overview ... 72 Physio controls ... 73 Displaying the physiological traces ... 75 Adjusting the display of physiological traces ... 75

2

Vivid 7 User's Manual FC092710-01

Table of Contents Annotations... 77 To insert an annotation ... 77 To edit annotation ... 80 To erase annotation... 80 Configuration of the pre-defined annotation list ... 81 Bodymarks... 83

Chapter 3 Scanning Modes Introduction... 87 2D-Mode ... 88 2D-Mode overview... 88 2D-Mode controls ... 90 Using 2D ... 93 Optimizing 2D ... 93 M-Mode ... 94 M-Mode overview ... 94 M-Mode controls ... 96 Using M-Mode ... 98 Optimizing M-Mode... 99 Color Mode ... 100 Color 2D Mode overview ... 100 Color M-Mode overview... 101 Color Mode controls... 103 Using Color Mode ... 106 Optimizing Color Mode ... 107 PW and CW Doppler... 108 PW and CW Doppler overview ... 108 PW and CW Doppler controls... 110 Using PW/CW Doppler modes ... 113 Optimizing PW/CW Doppler modes... 113 Tissue Velocity Imaging (TVI)... 115 TVI overview ... 115 TVI controls... 117 Using TVI ... 120 Optimizing TVI ... 120 Tissue Tracking ... 121 Tissue Tracking overview ... 121 Vivid 7 User's Manual FC092710-01

3

Table of Contents Tissue Tracking controls ... 123 Using Tissue Tracking... 126 Optimizing Tissue Tracking ...126 Strain rate ... 128 Strain rate overview... 128 Strain rate controls ... 130 Using Strain rate... 133 Optimizing Strain rate... 133 Strain ... 134 Strain overview... 134 Strain controls ... 136 Using Strain... 139 Optimizing Strain ... 139 Tissue Synchronization Imaging (TSI) ... 140 TSI overview... 140 TSI controls ... 142 Using TSI...144 Optimizing TSI... 145 Additional scanning features... 146 LogiqView... 146 Compound... 146 B-Flow ... 147 Blood flow imaging ... 147

Chapter 4 Stress Echo Introduction ... 150 Selection of a stress test protocol template... 151 Image acquisition... 153 Starting acquisition ... 154 Continuous capture mode ... 158 Analysis ... 166 Quantitative TVI Stress echo analysis ... 171 Accessing QTVI Stress analysis tools... 173 Vpeak measurement ... 173 Tissue Tracking ... 177 Quantitative analysis ... 178

4

Vivid 7 User's Manual FC092710-01

Table of Contents References ... 178 Editing/creating a template... 179 Entering the Template editor screen... 179 Template editor screen overview... 180 Editing/Creating a template ... 183

Chapter 5 Contrast Imaging Introduction... 188 Data acquisition ... 188 Quantification... 189 Data acquisition... 191 Left Ventricular Contrast Imaging ... 191 Myocardial Contrast Imaging ... 196 Real-Time Coded Phase Inversion (RTCPI)... 204 Vascular Contrast Imaging ... 212 Abdominal Contrast Imaging ... 216 Rodent Contrast Imaging... 220

Chapter 6 Measurement and Analysis Introduction... 223 About Measurement results display... 223 The Assign and Measure modality ... 225 Starting the Assign and Measure modality ... 225 Entering a study and performing measurements... 227 Measure and Assign modality... 229 Starting the Measure and Assign modality ... 229 Post-measurement assignment labels... 230 Cardiac Measurements ... 233 2D Measurements ... 233 M-Mode Measurements... 237 Doppler Measurements ... 241 TSI Measurements ... 243 Vascular measurements ... 250 B-Mode measurements ... 250

Vivid 7 User's Manual FC092710-01

5

Table of Contents M-Mode Measurements ... 255 Doppler measurements ... 255 Measurement package configuration... 261 Measurement package configuration - example ... 261 Normal values ... 263 User-defined formulas ... 266 User-defined formula - example ...266 About units ... 272 Measurement result table... 275 Minimizing the Measurement result table...275 Moving the Measurement result table ... 275 Deleting measurements ... 275 Worksheet... 277 Overview ...277 Using Worksheet ... 277

Chapter 7 Quantitative Analysis Introduction ... 283 For TVI: ... 283 For Tissue Tracking:... 283 For Strain rate: ... 283 For Strain:... 283 For Contrast: ... 283 Accessing the Quantitative analysis package ... 284 In replay mode:... 284 In live ... 284 Quantitative Analysis window ... 285 Overview ...285 Generation of a trace ... 292 About the sample area ...292 To generate a trace ... 292 Manual tracking of the sample area (dynamic anchored sample area) ... 293 Zooming in the Analysis window ... 294 Deletion of a trace ... 295 To delete all traces ... 295

6

Vivid 7 User's Manual FC092710-01

Table of Contents To delete one specific trace... 295 Saving/retrieving Quantitative analysis ... 295 Frame disabling ... 296 Disabling frames ... 296 Re-enabling all frames... 296 Optimizing sample area ... 298 Reshaping a sample area... 298 Labelling a sample area... 299 Optimizing the trace display... 300 Optimizing the Y-axis... 300 Trace smoothing ... 301 Switching modes or traces... 303 To switch mode... 303 To switch trace... 303 Cine compound ... 304 Curve fitting analysis ... 305 Wash-in curve fitting analysis ... 307 Wash-out curve fitting analysis ... 312 Anatomical M-Mode... 314 Introduction ... 314 Using Anatomical M-Mode... 314 Optimizing Anatomical M-Mode... 316

Chapter 8 Archiving Introduction... 319 Storing images and cineloops ... 320 Storing an image... 322 Storing a cineloop ... 322 Saving stored images and cineloops to a standard format323 MPEGVue/eVue ... 325 Retrieving and editing archived information ... 328 Locating a patient record ... 328 Selecting a patient record and editing data in the archive 332 Deleting archived information ... 338 Moving examinations ... 340

Vivid 7 User's Manual FC092710-01

7

Table of Contents Review images in archive... 343 Review the images from a selected examination ... 343 Select images from the Image list screen ... 344 Connectivity... 348 The dataflow concept ... 348 Stand-alone scanner scenario... 352 A stand-alone scanner and a stand-alone EchoPAC PC environment... 353 A scanner and EchoPAC PC in a direct connect environment... 355 A scanner and EchoPAC PC in a network environment ... 359 A scanner and a DICOM server in a network... 361 Export/Import patient records/examinations... 372 Exporting patient records/examinations ... 372 Importing patient records/examinations ... 381 Disk management ... 385 Configuring the Disk management function ... 386 Running the Disk management function ... 388 Data Backup and restore... 393 Backup procedure ...394 Restore procedure...398 DICOM spooler ...400 Starting the DICOM spooler ... 400

Chapter 9 Report Introduction ... 404 Creating a report ... 405 Working with the report function...405 To print a report... 408 To store a report... 408 Retrieving an archived report ... 409 Deleting an archived report ...409 Structured Findings ... 410 Prerequisite ... 410 Using Structured Findings ... 411 Structured Findings configuration... 413

8

Vivid 7 User's Manual FC092710-01

Table of Contents Direct report ... 418 Creating comments... 418 Creating pre-defined text inputs... 420 Report designer ... 421 Accessing the Report designer... 421 Report designer overview ... 422 Designing a report template... 425 Saving the report template... 435 To exit the Report designer ... 436 Report templates management ... 437 Configuration of the Template selection menu ... 437 Export/Import of Report templates... 439

Chapter 10 Probes Probe overview ... 442 Supported probes ... 442 Probe orientation ... 447 Probe labelling ... 447 Maximum probe temperature... 449 Probe Integration... 451 Connecting the probe ... 451 Activating the probe ... 453 Disconnecting the probe ... 454 Care and Maintenance ... 455 Planned maintenance ... 455 Inspecting the probe ... 456 Cleaning and disinfecting probes... 457 Probe safety ... 460 Electrical hazards ... 460 Mechanical hazards... 460 Biological hazards... 461 Biopsy... 462 Precaution concerning the use of biopsy procedures... 462 Preparing the Biopsy guide attachment... 463 Displaying the Guide zone... 466 Biopsy needle path verification ... 468 Starting the biopsy procedure... 468 Vivid 7 User's Manual FC092710-01

9

Table of Contents Cleaning, disinfection and disposal ... 468

Chapter 11 Peripherals Introduction ... 470 VCR/DVD operation...472 VCR/DVD Overview ... 472 Using VCR/DVD ... 473 Printing... 476 To print an image ... 476 Printer configuration ... 477 Specifications for peripherals... 479

Chapter 12 Presets and System setup Introduction ... 483 Starting the Configuration package ... 486 To open the Configuration package ... 486 Overview ... 487 Imaging ... 488 The Global setup sheet ... 488 Application... 491 Application menu... 495 Measure/Text ... 497 The Measurement menu sheet ... 498 The Advanced sheet ... 503 The Modify calculations sheet ... 504 The OB table sheet ... 505 Report... 511 The diagnostic codes sheet...512 The Comment texts sheet ... 514 Connectivity... 517 Dataflow ... 518 Additional outputs... 527 Tools...529 Formats ... 530

10

Vivid 7 User's Manual FC092710-01

Table of Contents TCP/IP ... 535 System... 536 The system settings... 536 About ... 540 Administration ... 541 Users ... 542 Unlock Patient... 545

Chapter 13 User maintenance System Care and Maintenance... 548 Inspecting the system ... 548 Cleaning the unit... 549 Air filter... 549 Prevention of static electricity interference ... 551 System self-test ... 552 System malfunction ... 552

Chapter 14 Safety Introduction... 557 Owner responsibility ... 558 Important safety considerations ... 559 Notice against user modification... 559 Regulatory information ... 560 Standards used... 560 Software license acknowledgments... 561 Device labels... 561 Classifications... 564 Acoustic output ... 565 Definition of the acoustic output parameters ... 565 Acoustic output and display on the Vivid 7 ... 566 ALARA ... 567 Safety statement... 567 System controls affecting acoustic output ... 567

Vivid 7 User's Manual FC092710-01

11

Table of Contents Patient safety... 569 Patient identification ... 569 Diagnostic information... 569 Mechanical hazards ... 569 Transesophageal probe safety ... 570 Electrical Hazard ... 570 Personnel and equipment safety... 571 Explosion hazard... 571 Implosion hazard ... 571 Electrical hazard... 571 Moving hazard... 572 Biological hazard ... 572 Pacemaker hazard ... 573 Electrical safety... 574 Device classifications ... 574 Internally connected peripheral devices ... 574 External Connection of other peripheral devices... 574 Allergic reactions to latex-containing medical devices ... 575 Electromagnetic Compatibility (EMC) ... 576 Environmental protection... 578 System disposal ... 578

Appendix

Product description ... 580 System Architecture ... 580 Ergonomics ... 581 Display Annotations... 581 Tissue Imaging ... 582 Color Doppler ...585 Spectral Doppler... 587 Strain rate/Strain imaging (option)... 590 Physiological Traces ... 590 Analysis Program ... 590 User Interface...591 Wideband probes ... 591 Image Management ... 593 MPEGvue ... 593 Advanced Options ... 594 EchoPAC PC... 595

12

Vivid 7 User's Manual FC092710-01

Table of Contents Peripherals (options)... 597 Physical Dimensions... 598 Cart ... 598 Electrical Specifications ... 598 Safety... 598 Probe/Application overview ... 600

Index

Vivid 7 User's Manual FC092710-01

13

Table of Contents

14

Vivid 7 User's Manual FC092710-01

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 555, 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,

Vivid 7 User's Manual FC092710-01

1

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 • Cardiac • Small Organ • Pediatric • Fetal • Transesophageal • Transrectal • Peripheral Vascular • Neonatal • Adult Cephalic

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

2

Vivid 7 User's Manual FC092710-01

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.

Vivid 7 User's Manual FC092710-01

3

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

Vivid 7 User's Manual FC092710-01