Vivid q N User Manual Volume 1 Rev 01

Regulatory Requirements This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0470 This manual is a reference for Vivid q N. It applies to all versions of the 11.x.x software for the Vivid q N ultrasound system.

g MANUAL STATUS FQ092004 24 October 2011

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 VINGMED ULTRASOUND A/S Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

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 ... 2 Indications for use ... 3 Contraindications ... 3 Documentation ... 3 Manual contents ... 4 Conventions used in this manual ... 5 Regulatory requirements ... 5 Contacting GE Healthcare Ultrasound ... 6

Chapter 1 Safety Introduction... 13 Hazard symbols ... 14 Owner responsibility ... 15 Important safety considerations ... 16 Notice against user modification... 16 Regulatory information ... 17 Directives ... 17 Product Classifications ... 17 Conformity to Standards ... 18 Certifications ... 19 Software License Acknowledgements ... 19 Device labels... 20 Label Locations... 20

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Table of Contents Label Icon Description... 22 Acoustic output... 25 Definition of the acoustic output parameters ... 25 ALARA... 25 Safety statement ... 26 System controls affecting acoustic output ... 26 OB Exam ...27 Acoustic Output Considerations ... 29 Concerns surrounding fetal exposure ... 29 Patient safety... 30 Patient identification ... 30 Diagnostic information... 30 Patient guidance... 31 Probe Safety ... 31 Mechanical hazards ... 31 Electrical Hazard ... 32 Biological hazards ...33 Personnel and equipment safety... 34 Explosion hazard... 34 Electrical hazard... 34 Smoke and fire hazard ...35 Biological hazard ... 35 Pacemaker hazard ... 35 Electrical safety... 37 Internally connected peripheral devices ... 37 External Connection of other peripheral devices... 37 Allergic reactions to latex-containing medical devices ... 38 Use of ECG ... 39 Use of Defibrillator ... 39 Use of Electrosurgical Unit ... 39 Electromagnetic Compatibility (EMC) ... 40 EMC performance ...41 Declaration of Emissions... 42 Declaration of Immunity... 42 Notice upon Installation of Product... 43 General notice ... 43 Peripheral Update for EC countries... 44

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Table of Contents Patient Environmental Devices ... 46 Acceptable devices... 46 Unapproved devices ... 46 Accessories, options, and supplies... 46 Computer Virus precaution ... 47 Environmental protection ... 47

Chapter 2 Getting started Introduction... 50 Preparing the unit for use... 51 Site requirements... 51 Connecting the unit... 52 Switching On/Off... 63 Moving and transporting the unit ... 67 Moving the unit on a Cart... 67 Transporting the unit... 68 Unit acclimation time... 68 System description ... 69 System overview... 69 Control panel ... 70 The scanning screen ... 81 Three-Pedal Footswitch operation... 84 Connecting and disconnecting probes ... 84 Adjusting the display monitor... 87 Screen Saver ... 88 Starting an examination... 89 Creating a new Patient record or starting an examination from an existing patient record... 89 Selecting a Probe and an Application... 94

Chapter 3 Basic scanning operations Assignable keys and Soft Menu Rocker ... 97 Using the Assignable Keys Soft Menu... 98 Using the Soft Menu Rocker... 101

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Table of Contents Trackball operation ...102 Trackball assignment ... 102 The system menu... 103 Cineloop operation ...104 Cineloop overview ...104 Cineloop controls... 106 Using cineloop... 107 Storing images and cineloops ... 108 To store a single image ... 108 To store a cineloop... 108 Removable Media... 109 Intended use... 109 Supported removable media ... 110 Zoom ... 118 To select the type of zoom in use... 118 To Magnify an image... 118 Performing measurements... 119 To perform measurements ... 119 Physiological ECG/Respiratory traces... 120 Connecting the ECG ... 121 Physio controls ... 131 Displaying the ECG trace ... 132 Adjusting the display of the ECG trace... 133 Displaying the Respiratory trace ... 133 Annotations ... 135 To insert an annotation...135 To edit annotation... 138 To erase annotation ... 138 Configuration of the pre-defined annotation list... 139 Bodymarks ... 141

Chapter 4 Scanning Modes Introduction ... 145 2D-Mode ... 146 2D-Mode overview ... 146 2D-Mode controls ... 148

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Table of Contents Using 2D ... 155 Optimizing 2D ... 155 M-Mode ... 157 M-Mode overview ... 157 M-Mode controls ... 158 Using M-Mode ... 160 Optimizing M-Mode... 162 Color Mode... 163 Color Mode overview ... 163 Color M-Mode overview... 164 Color Mode controls... 165 Using Color Mode ... 168 Optimizing Color Mode ... 169 PW and CW Doppler... 170 PW and CW Doppler overview ... 170 PW and CW Doppler controls... 171 Using PW/CW Doppler modes ... 174 Optimizing PW/CW Doppler modes... 174 Tissue Velocity Imaging (TVI)... 176 Tissue Tracking ... 180 Strain rate... 184 Strain rate overview ... 184 Strain rate controls... 185 Using Strain rate ... 187 Optimizing Strain rate ... 187 Strain ... 189 Strain overview ... 189 Strain controls... 190 Using Strain ... 192 Optimizing Strain ... 192 Tissue Synchronization Imaging (TSI) ... 194 TSI overview ... 194 TSI controls... 195 Using TSI ... 197 Optimizing TSI ... 198 Additional scanning features ... 199 LOGIQView... 199 Compound ... 200 B-Flow... 201 Vivid q N User Manual FQ092004-01

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Table of Contents Blood flow imaging ... 201 Virtual Convex ... 202

Chapter 5 Stress Echo Introduction ... 204 Selection of a stress test protocol template... 205 Image acquisition... 206 Starting acquisition ... 207 Continuous capture mode ... 212 Analysis ... 219 Quantitative TVI Stress echo analysis ... 224 Accessing QTVI Stress analysis tools... 225 Vpeak measurement ... 226 Tissue Tracking ... 229 Quantitative analysis ... 229 References ... 230 Editing/creating a template ... 231 Entering the Template editor screen ...231 Template editor screen overview ... 232 Editing/creating a template... 235

Chapter 6 Contrast Imaging Introduction ... 240 Cardiac imaging ... 240 Non-cardiac imaging ... 240 Data acquisition ... 241 Left Ventricular Contrast Imaging... 241 LV Contrast overview ... 242 LV Contrast controls... 242 Running LV Contrast ... 245 Optimizing LV Contrast ... 245

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Table of Contents Vascular Contrast Imaging ... 246 Abdominal Contrast Imaging ... 247

Chapter 7 Measurement and Analysis Introduction... 251 About Measurement results display... 252 The Assign and Measure modality ... 253 Starting the Assign and Measure modality ... 253 Entering a study and performing measurements... 254 Measure and Assign modality... 256 Starting the Measure and Assign modality ... 256 Post-measurement assignment labels... 257 Cardiac measurements ... 260 2D Measurements ... 260 M-Mode Measurements... 264 Doppler Measurements ... 267 TSI Measurements ... 270 Automated Function Imaging... 274 AutoEF Measurements ... 294 Vascular measurements ... 303 B-Mode measurements ... 303 Intima-Media Thickness... 304 M-Mode Measurements... 309 Doppler measurements ... 310 Pediatric Calculations ... 315 Overview... 315 Hip Dysplasia Calculation ... 316 Making Hip Dysplasia Measurement ... 316 Performing an OB exam... 318 Patient entry... 318 Selecting probe and OB application ... 322 OB Measurements and calculations... 323 Introduction ... 323 B-Mode measurements ... 324 M-Mode measurements... 331 Doppler Mode Measurements ... 331

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Table of Contents OB parameter configuration ... 334 Configuring OB M&A according to geographical regions .. 334 Measurement package configuration... 339 Measurement package configuration - example ... 339 User-defined formulas ... 344 User-defined formula - example ...344 About units ... 350 Measurement result table... 351 Minimizing the Measurement result table...351 Moving the Measurement result table ... 352 Deleting measurements ... 352 Worksheet... 353 Overview ...353 Using Worksheet ... 354 OB worksheet ... 356 Patient data ... 357 Measurement information... 357 Calculation information...358 OB graphs... 359 Overview ...359 Fetal Growth Curve Graph ... 360 Fetal Trending ... 364 Fetal Growth Bar Graph ... 364 OB-Multigestational ... 365 Multiple Fetus ...365

Chapter 8 Quantitative Analysis Introduction ... 373 Accessing the Quantitative analysis package ... 374 In replay mode... 374 In live ... 374 Quantitative Analysis window ... 375 Overview ...375 Generation of a trace ... 382 About the sample area ...382 To generate a trace ... 382

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Table of Contents Manual tracking of the sample area (dynamic anchored sample area)... 383 Zooming in the Analysis window... 384 Deletion of a trace ... 385 To delete all traces ... 385 To delete one specific trace... 385 Saving/retrieving Quantitative analysis ... 385 Frame disabling ... 386 Disabling frames ... 386 Re-enabling all frames... 386 Optimizing sample area ... 388 Reshaping a sample area... 388 Labelling a sample area... 389 Optimizing the trace display... 390 Optimizing the Y-axis... 390 Trace smoothing ... 391 Switching modes or traces... 393 To switch mode... 393 To switch trace... 393 Cine compound ... 394 Curved Anatomical M-Mode (CAMM)... 395 Introduction ... 395 Using CAMM... 395 Optimizing Curved Anatomical M-Mode ... 397

Chapter 9 Archiving Introduction... 401 Storing images and cineloops ... 402 Storing an image... 403 Storing a cineloop ... 403 Saving single images and cineloops to a standard format 404 MPEGVue/eVue ... 406 Retrieving and editing archived information ... 409 Locating a patient record ... 409 Selecting a patient record and editing data in the archive 414 Deleting archived information ... 418 Vivid q N User Manual FQ092004-01

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Table of Contents Moving examinations... 420 Review images in archive... 422 Review the images from a selected examination ... 422 Select images from the Image list screen ... 423 Connectivity... 427 The dataflow concept ... 427 Stand-alone scanner scenario... 430 A stand-alone scanner and a stand-alone EchoPAC PC environment... 431 A scanner and EchoPAC PC in a direct connect environment 433 A scanner and EchoPAC PC in a network environment ... 437 A scanner and a DICOM server in a network... 439 Export/Import patient records/examinations... 449 Exporting patient records/examinations ... 449 Importing patient records/examinations ... 458 Disk Management... 461 Configuring the Disk management function ... 462 Running the Disk management function ... 465 Data Backup and Restore ... 468 DICOM spooler ...475 Starting the DICOM spooler ... 475

Chapter 10 Report Introduction ... 480 Creating a report ... 481 Working with the report function...481 To print a report... 484 To store a report... 484 Retrieving an archived report ... 485 Deleting an archived report ...485 Structured Findings ... 486 Prerequisite ... 486 Starting Structured Findings... 487 Structured Findings structure ... 487 Using Structured Findings ... 489

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Table of Contents Structured Findings configuration ... 492 Direct report ... 502 Creating comments... 502 Creating pre-defined text inputs... 503 Report designer ... 504 Accessing the Report designer... 504 Report designer overview ... 504 Designing a report template... 507 Saving the report template... 518 To exit the Report designer ... 518 Report templates management ... 519 Configuration of the Template selection menu ... 520 Export/Import of Report templates... 521

Chapter 11 Probes Probe overview ... 525 Supported probes ... 525 Intra Cardiac Echo (ICE) catheter... 530 Vivid q N Probe/Application Overview ... 530 Maximum probe temperature... 532 Probe orientation ... 533 Probe labelling ... 534 Environmental Requirements ... 535 Probe Integration... 536 Connecting the probe ... 536 Activating the probe ... 536 Disconnecting the probe ... 537 Using Intra Cardiac Ultrasound Catheters ... 537 Care and Maintenance ... 542 Planned maintenance ... 542 Inspecting the probe ... 543 Special handling instructions ... 544 Cleaning and disinfecting probes... 547 Probe safety ... 553 Handling precautions ... 553 Electrical hazards ... 553 Mechanical hazards... 554 Vivid q N User Manual FQ092004-01

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Table of Contents Biological hazards ...554 Biopsy ...555 Precaution concerning the use of biopsy procedures ... 555 Preparing the Biopsy guide attachment ... 556 Displaying the Guide zone ... 560 Biopsy needle path verification... 562 Starting the biopsy procedure ... 562 Cleaning, disinfection and disposal ... 562 Surgery/Intra-operative Use ...563 Preparing for Surgery/Intra-operative Procedures ...563

Chapter 12 Peripherals Introduction ... 566 CardioLab™ / Mac-Lab™ support ... 567 Preparing Vivid q N to operate with the CardioLab™ / Mac-Lab™ system ... 568 CartoSound™ / SoundStar™ support... 568 Carto & CardioLab Multiple Interfacing option ... 569 Video Splitter ... 569 Battery Charger ... 570 Instructions for Use ... 570 Safety ... 571 Using your Charger ... 571 Recharge and Re-calibration Time... 572 Printing... 574 To print an image ... 574 Specifications for peripherals... 574 Hooking up the system to an external monitor or projector.. 575 Controlling the External VGA Video output ... 575

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Table of Contents Wireless option... 577

Chapter 13 Presets and System setup Introduction... 581 Starting the Configuration package... 584 To open the Configuration package... 584 Overview... 585 Imaging... 586 The Global setup sheet... 586 Application ... 589 Application menu ... 592 Measure Text... 595 The measurement menu sheet... 595 Configuration of the Measurement menu ... 599 The Advanced sheet... 601 Parameter configuration ... 601 The Modify Calculations sheet... 602 Parameter configuration ... 602 Report ... 603 The diagnostic codes sheet ... 604 The Comment texts sheet... 605 Connectivity ... 608 Dataflow... 608 Additional outputs ... 615 Tools ... 617 Formats... 618 TCP-IP ... 623 System... 624 The system settings... 624 About ... 626 Administration ... 627 Users ... 628 Unlock Patient... 631

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Table of Contents

Chapter 14 User maintenance System Care and Maintenance ... 634 Inspecting the system... 634 Cleaning the unit ... 635 Prevention of static electricity interference... 637 System self-test... 639 System malfunction ... 639 Using InSite ExC ... 643 InSite ExC Functionalities ... 643 Initiating a Request for Service (RFS)... 643 Clinical Lifeline Mode ... 646 Exiting InSite ExC... 647

Index

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Revision History

Revision History Revision 1

Date 08 September 2011

Reason for Change Initial release

List of effective pages Revision 1

Effective Pages All

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 q N ultrasound unit is a compact, high performance portable 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, 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 q N 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 q N ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions.

Prescription Device 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 the Safety chapter (Chapter 1, "Safety", page 11), should be read and understood before operating the Vivid q N 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 q N easy systems to use and very user friendly.

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, radio-controlled toys, and so on, should not be operated near the unit.

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