Vivid 7 Dimension and Vivid 7 PRO Users Manual Vol 1 ver 4.x.x

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GE Medical Systems

05/07/2004

 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 FC092520 Rev. 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... 22 System description ... 23 System overview... 23 Control panel ... 26 The Scanning screen... 40 Footswitch operation... 43 Connecting and disconnecting probes ... 44 Adjusting the display monitor... 44 Vivid 7 User's Manual FC092520 Rev. 01

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Table of Contents Starting an examination ... 46 Creating a new Patient record or starting an examination from an existing patient record ... 46 Selecting a Probe and an Application ... 50

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 ... 74 Adjusting the display of physiological traces ... 75 Annotations ... 77

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Table of Contents 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 Tissue Tracking controls... 123 Vivid 7 User's Manual FC092520 Rev. 01

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Table of Contents 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 References ... 178

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Table of Contents 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... 188 Data acquisition... 190 Left Ventricular Contrast Imaging ... 190 Myocardial Contrast Imaging ... 195 Real-Time Myocardial Contrast Imaging ... 203

Chapter 6 Measurement and Analysis Introduction... 213 The Assign and Measure modality ... 214 Starting the Assign and Measure modality ... 214 Entering a study and performing measurements... 216 Measure and Assign modality... 218 Starting the Measure and Assign modality ... 218 Post-measurement assignment labels... 219 Cardiac Measurements ... 222 2D Measurements ... 222 M-Mode Measurements... 226 Doppler Measurements ... 230 TSI Measurements ... 232 Vascular measurements ... 235 B-Mode measurements ... 235 M-Mode Measurements... 236 Doppler measurements ... 237 Measurement package configuration ... 243 Measurement package configuration - example... 243 User-defined formulas ... 246

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Table of Contents User-defined formula - example ...246 About units ... 252 Measurement result table... 255 Minimizing the Measurement result table...255 Moving the Measurement result table ... 255 Deleting measurements ... 256 Worksheet... 257 Overview ...257 Using Worksheet ... 257

Chapter 7 Quantitative Analysis Introduction ... 263 For TVI: ... 263 For Tissue Tracking:... 263 For Strain rate: ... 263 For Strain:... 263 For Contrast: ... 263 Accessing the Quantitative analysis package ... 264 In replay mode:... 264 In live ... 264 Quantitative Analysis window ... 265 Overview ...265 Generation of a trace ... 272 About the sample area ...272 To generate a trace ... 272 Manual tracking of the sample area (dynamic anchored sample area) ... 273 Zooming in the Analysis window ... 274 Deletion of a trace ... 275 To delete all traces ... 275 To delete one specific trace ... 275 Saving/retrieving Quantitative analysis ... 275 Frame disabling... 276 Disabling frames... 276 Re-enabling all frames ...276 Optimizing sample area...278

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Table of Contents Reshaping a sample area... 278 Labelling a sample area... 279 Optimizing the trace display... 280 Optimizing the Y-axis... 280 Trace smoothing ... 281 Switching modes or traces... 283 To switch mode... 283 To switch trace... 283 Cine compound ... 284 Curve fitting analysis ... 285 Wash-in curve fitting analysis ... 287 Wash-out curve fitting analysis ... 292 Anatomical M-Mode... 294 Introduction ... 294 Using Anatomical M-Mode... 294 Optimizing Anatomical M-Mode... 296

Chapter 8 Archiving Introduction... 299 Storing images and cineloops ... 300 Storing an image... 302 Storing a cineloop ... 302 Saving stored images and cineloops to a standard format303 MPEGVue/eVue ... 305 Retrieving and editing archived information ... 313 Locating a patient record ... 313 Selecting a patient record and editing data in the archive 317 Deleting archived information ... 323 Moving examinations ... 325 Review images in archive ... 328 Review the images from a selected examination ... 328 Select images from the Image list screen... 329 Connectivity ... 333 The dataflow concept... 333 Stand-alone scanner scenario ... 337 A stand-alone scanner and a stand-alone EchoPAC PC

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Table of Contents environment... 338 A scanner and EchoPAC PC in a direct connect environment... 340 A scanner and EchoPAC PC in a network environment ... 344 A scanner and a DICOM server in a network... 346 Export/Import patient records/examinations... 357 Exporting patient records/examinations ... 357 Importing patient records/examinations ... 366 Disk management ... 370 Configuring the Disk management function ... 371 Running the Disk management function ... 373 Data Backup and restore... 378 Backup procedure ...379 Restore procedure...383 DICOM spooler ...385 Starting the DICOM spooler ... 385

Chapter 9 Report Introduction ... 390 Creating a report ... 391 Working with the report function...391 To print a report... 394 To store a report... 394 Retrieving an archived report ... 395 Deleting an archived report ...395 Direct report... 396 Creating comments ... 396 Creating pre-defined text inputs ...398 Report designer... 399 Accessing the Report designer ... 399 Report designer overview... 400 Designing a report template ... 403 Saving the report template ... 413 To exit the Report designer ...414 Report templates management... 415 Configuration of the Template selection menu... 415

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Table of Contents Export/Import of Report templates... 417

Chapter 10 Probes Probe overview ... 420 Supported probes ... 420 Probe orientation ... 425 Probe labelling ... 425 Probe Integration... 427 Connecting the probe ... 427 Activating the probe ... 429 Disconnecting the probe ... 430 Care and Maintenance ... 431 Planned maintenance ... 431 Inspecting the probe ... 432 Cleaning and disinfecting probes... 433 Probe safety ... 436 Electrical hazards ... 436 Mechanical hazards... 436 Biological hazards... 437 Biopsy... 438 Precaution concerning the use of biopsy procedures... 438 Preparing the Biopsy guide attachment... 439 Displaying the Guide zone... 442 Biopsy needle path verification ... 444 Starting the biopsy procedure... 444 Cleaning, disinfection and disposal ... 444

Chapter 11 Peripherals Introduction... 446 VCR/DVD operation ... 448 VCR/DVD Overview... 448 Using VCR/DVD ... 449 Printing ... 452 To print an image... 452

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Table of Contents Printer configuration ... 453 Specifications for peripherals... 455

Chapter 12 Presets and System setup Introduction ... 458 Starting the Configuration package ... 461 To open the Configuration package ... 461 Overview ... 462 Imaging ... 463 The Global setup sheet ... 463 Application... 466 Application menu... 470 Measure/Text ... 472 The Measurement menu sheet ... 473 The Advanced sheet ... 478 The Modify calculations sheet ... 479 The OB table sheet ... 480 Report... 486 The diagnostic codes sheet...487 The Comment texts sheet ... 489 Connectivity... 492 Dataflow ... 493 Additional outputs... 502 Tools...504 Formats ... 505 TCP/IP... 510 System ... 511 The system settings ... 511 About... 515 Administration... 516 Users ... 517 Unlock Patient ... 520

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Table of Contents

Chapter 13 User maintenance System Care and Maintenance... 522 Inspecting the system ... 522 Cleaning the unit... 523 Air filter... 523 Prevention of static electricity interference ... 525 System self-test ... 526 System malfunction ... 526

Chapter 14 Safety Introduction... 531 Owner responsibility ... 532 Important safety considerations ... 533 Notice against user modification... 533 Regulatory information ... 534 Standards used... 534 Software license acknowledgments... 535 Device labels... 535 Acoustic output ... 538 Definition of the acoustic output parameters ... 538 Acoustic output and display on the Vivid 7 ... 539 ALARA ... 540 Safety statement... 540 System controls affecting acoustic output ... 540 Patient safety ... 543 Patient identification... 543 Diagnostic information ... 543 Mechanical hazards... 543 Personnel and equipment safety ... 545 Explosion hazard ... 545 Implosion hazard ... 545 Electrical hazard ... 545 Moving hazard ... 546 Biological hazard ... 546 Vivid 7 User's Manual FC092520 Rev. 01

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Table of Contents Pacemaker hazard ... 547 Electrical safety... 548 Device classifications ... 548 Internally connected peripheral devices ... 548 External Connection of other peripheral devices... 548 Allergic reactions to latex-containing medical devices ... 549 Electromagnetic Compatibility (EMC) ... 550 Environmental protection... 552 System disposal ... 552

Appendix

Product description ... 554 System Architecture ... 554 Ergonomics ... 555 Display Annotations... 556 Tissue Imaging ... 556 Color Doppler ...558 Spectral Doppler... 560 Strain rate/Strain imaging (option)... 562 Physiological Traces ... 562 Analysis Program ... 562 User Interface...563 Wideband probes ... 563 Image Management ... 565 Advanced Options ... 565 EchoPAC PC... 566 Peripherals (options) ... 568 Physical Dimensions ... 568 Cart... 568 Electrical Specifications... 569 Safety ... 569 Probe/Application overview ...570

Index

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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 529, 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 • 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.

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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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Introduction

Contact information If additional information or assistance is needed, please contact the local distributor or the appropriate support resource listed bellow: Europe GE Ultraschall KG

Tel: 0130 81 6370

Deutschland GmbH & Co.

Tel: (49)(0) 212-28-02-208

Beethovenstraße 239 Postfach 11 05 60 D-42655 Solingen USA GE Medical Systems

Tel: (1) 800-437-1171

Ultrasound Service Engineering

Fax: (1) 414-647-4090

4855 W. Electric Avenue Milwaukee, WI 53219 On-line Applications Support

Tel: (1) 800-682-5327 or (262) 524-5698

Canada GE Medical Systems

Tel: (1) 800-664-0732

Ultrasound Service Engineering 4855 W. Electric Avenue Milwaukee, WI 53219 On-line Applications Support

Tel: (1) 800-682-5327 or (262) 524-5698

Asia GE Ultrasound Asia

Tel: (65) 291-8528

Service Department Ultrasound

Fax: (65) 272-3997

298 Tiong Gahru Road # 15-01/06 Central Plaza Singapore 168730

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Introduction Latin and South America GE Medical Systems

Tel: (1) 305-735-2304

Ultrasound Service Engineering 4855 W. Electric Avenue Milwaukee, WI 53219 On-line Applications Support

Tel: (1) 800-682-5327 or (262) 524-5698

Brazil GE Ultrasound

Tel: (55.11) 887-8099

Rua Tomas Carvalhal, 711

Fax: (55.11) 887-9948

Paraiso Cep: 04006-002 - São Paulo, SP

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