Vivid i User Manual Volume 1 Rev 03

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GE Medical Systems

15/6/2006

© 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 Medical Systems Ultrasound Israel Ltd.

MANUAL STATUS 2378958-100

Einstein Bldg 7, Etgar st. P.O. Box 2006 Tirat Hacarmel 39120, Israel Tel: (+972) 4851 9555 Fax: (+972) 4851 9500

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... 19 Moving and transporting the unit ... 23 Moving the unit on a Cart... 23 Transporting the unit... 24 Unit acclimation time... 24 System description ... 25 System overview... 25 Control panel ... 26 The Scanning screen... 38 Connecting and disconnecting probes ... 41 Adjusting the display monitor... 44 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 Vivid i User’s Manual 2378958-100 Rev. 03

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Table of Contents

Chapter 2 Basic scanning operations Assignable keys and Soft Menu Rocker ... 53 Using the Assignable Keys Soft Menu ... 54 Using the Soft Menu Rocker ... 57 Trackball operation ... 58 Trackball assignment ...58 The system menu... 59 Cineloop operation ... 60 Cineloop overview ... 60 Cineloop controls... 62 Using cineloop... 63 Storing images and cineloops ... 64 To store a single image ... 64 To store a cineloop... 64 Using removable media... 65 Recommendation concerning CD and DVD handling ... 65 Formatting removable media... 65 Ejecting removable media ... 67 Zoom ... 68 To Magnify an image... 68 Performing measurements...68 To perform measurements ... 68 Physiological ECG trace... 69 Connecting the ECG ... 69 Physio controls ...70 Displaying the ECG trace ... 71 Adjusting the display of the ECG trace... 71 Annotations ... 72 To insert an annotation... 72 To edit annotation... 75 To erase annotation ... 75 Configuration of the pre-defined annotation list... 76 Bodymarks ... 78

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Table of Contents

Chapter 3 Scanning Modes Introduction... 82 2D-Mode ... 83 2D-Mode overview... 83 2D-Mode controls ... 85 Using 2D ... 89 Optimizing 2D ... 89 M-Mode ... 90 M-Mode overview ... 90 M-Mode controls ... 91 Using M-Mode ... 92 Optimizing M-Mode... 94 Color Mode... 95 Color Mode overview ... 95 Color M-Mode overview... 96 Color Mode controls... 97 Using Color Mode ... 99 Optimizing Color Mode ... 100 PW and CW Doppler... 101 PW and CW Doppler overview ... 101 PW and CW Doppler controls... 102 Using PW/CW Doppler modes ... 104 Optimizing PW/CW Doppler modes... 105 Tissue Velocity Imaging (TVI)... 107 Tissue Tracking ... 111 Additional scanning features ... 115 Compound ... 115

Chapter 4 Stress Echo Introduction... 118 Selection of a stress test protocol template ... 119 Image acquisition ... 120 Starting acquisition ... 121 Continuous capture mode... 126 Vivid i User’s Manual 2378958-100 Rev. 03

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Table of Contents Analysis ... 133 Editing/creating a template ... 137 Entering the Template editor screen ... 137 Template editor screen overview ...138 Editing/Creating a template ...141

Chapter 5 Contrast Imaging Introduction ... 146 Cardiac imaging ... 146 Non-cardiac imaging ... 146 Data acquisition ... 147 Left Ventricular Contrast Imaging...147 LV Contrast overview ... 148 LV Contrast controls... 148 Running LV Contrast ... 151 Optimizing LV Contrast ... 151 Vascular Contrast Imaging...152 Abdominal Contrast Imaging ... 153

Chapter 6 Measurement and Analysis Introduction ... 157 About Measurement results display ... 158 The Assign and Measure modality ... 159 Starting the Assign and Measure modality... 159 Entering a study and performing measurements ... 160 Measure and Assign modality ... 162 Starting the Measure and Assign modality... 162 Post-measurement assignment labels ... 163 Cardiac measurements... 166 2D Measurements ... 166 M-Mode Measurements ... 170 Doppler Measurements ... 173 Vascular measurements... 177 B-Mode measurements ... 177

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Table of Contents Intima-Media Thickness... 178 M-Mode Measurements... 182 Doppler measurements ... 183 Measurement package configuration ... 188 Measurement package configuration - example... 188 User-defined formulas ... 193 User-defined formula - example ... 193 About units... 199 Measurement result table ... 200 Minimizing the Measurement result table ... 200 Moving the Measurement result table... 201 Deleting measurements... 201 Worksheet ... 202 Overview... 202 Using Worksheet ... 203

Chapter 7 Purposely Left Empty For Future purposes ... 205

Chapter 8 Archiving Introduction... 209 Storing images and cineloops ... 210 Storing an image... 211 Storing a cineloop ... 211 Saving stored images and cineloops to a standard format212 MPEGVue/eVue ... 214 Retrieving and editing archived information ... 217 Locating a patient record ... 217 Selecting a patient record and editing data in the archive 221 Deleting archived information ... 225 Moving examinations ... 227 Review images in archive ... 229 Review the images from a selected examination ... 229 Select images from the Image list screen... 230

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Table of Contents Connectivity... 234 The dataflow concept ...234 Stand-alone scanner scenario... 237 A stand-alone scanner and a stand-alone EchoPAC PC environment... 238 A scanner and EchoPAC PC in a direct connect environment 240 A scanner and EchoPAC PC in a network environment ... 244 A scanner and a DICOM server in a network... 246 Export/Import patient records/examinations... 255 Exporting patient records/examinations ...255 Importing patient records/examinations ...263 Disk Management... 266 Configuring the Disk management function ... 267 Running the Disk management function ... 270 Data Backup and Restore ... 273 DICOM spooler ...280 Starting the DICOM spooler ...280

Chapter 9 Report Introduction ... 284 Creating a report ... 285 Working with the report function... 285 To print a report...288 To store a report... 288 Retrieving an archived report ... 289 Deleting an archived report ...289 Structured Findings ... 290 Prerequisite ... 290 Starting Structured Findings...291 Structured Findings structure ... 291 Using Structured Findings ... 293 Structured Findings configuration...296 Direct report... 306 Creating comments ... 306 Creating pre-defined text inputs ... 307

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Table of Contents Report designer ... 308 Accessing the Report designer... 308 Report designer overview ... 308 Designing a report template... 311 Saving the report template... 322 To exit the Report designer ... 322 Report templates management ... 323 Configuration of the Template selection menu ... 324 Export/Import of Report templates... 325

Chapter 10 Probes Probe overview ... 328 Supported probes ... 328 Maximum probe temperature... 331 Probe orientation ... 332 Probe labelling ... 332 Probe Integration... 334 Connecting the probe ... 334 Activating the probe ... 334 Disconnecting the probe ... 335 Care and Maintenance ... 336 Planned maintenance ... 336 Inspecting the probe ... 337 Cleaning and disinfecting probes... 338 Probe safety ... 341 Electrical hazards ... 341 Mechanical hazards... 341 Biological hazards... 342

Chapter 11 Peripherals Introduction... 344 Battery Charger ... 345 Instructions for Use... 345 Safety... 346

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Table of Contents Using your Charger ... 346 Recharge and Re-calibration Time... 347 Printing... 349 To print an image ... 349 Specifications for peripherals... 349

Chapter 12 Presets and System setup Introduction ... 353 Starting the Configuration package ... 356 To open the Configuration package ... 356 Overview ... 357 Imaging ... 358 The Global setup sheet ... 358 Application... 360 Application menu... 363 Measure Text ... 365 The measurement menu sheet ... 365 Configuration of the Measurement menu ... 368 The Advanced sheet ...370 Parameter configuration ... 370 The Modify Calculations sheet ... 371 Parameter configuration ... 371 Report... 372 The diagnostic codes sheet...373 The Comment texts sheet ... 374 Connectivity... 377 Dataflow ... 377 Additional outputs... 386 Tools... 388 Formats ... 389 TCP-IP... 394 System ... 395 The system settings ... 395 About... 397 Administration... 398 Users ... 399

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Table of Contents Unlock Patient... 402

Chapter 13 User maintenance System Care and Maintenance... 404 Inspecting the system ... 404 Cleaning the unit... 405 Prevention of static electricity interference ... 407 System self-test ... 408 System malfunction ... 408

Chapter 14 Safety Introduction... 413 Owner responsibility ... 414 Important safety considerations ... 415 Notice against user modification... 415 Regulatory information ... 416 Standards used... 416 Device labels... 418 Label Icon Description ... 418 Classifications ... 420 Acoustic output ... 421 Definition of the acoustic output parameters ... 421 ALARA ... 421 Safety statement... 422 System controls affecting acoustic output ... 422 Patient safety ... 424 Patient identification... 424 Diagnostic information ... 424 Mechanical hazards... 425 Personnel and equipment safety ... 426 Explosion hazard ... 426 Electrical hazard ... 426 Biological hazard ... 427 Pacemaker hazard... 427 Vivid i User’s Manual 2378958-100 Rev. 03

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Table of Contents Electrical safety...428 Device classifications ...428 Internally connected peripheral devices ...428 Internally connected battery ...428 External Connection of other peripheral devices... 428 Allergic reactions to latex-containing medical devices ...429 Electromagnetic Compatibility (EMC) ...430 Environmental protection... 432 System disposal ... 432 Battery disposal...432

Index

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Introduction

Introduction The Vivid i 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-Doppler imaging (TDI) and LVO Contrast option applications. The fully digital architecture of the Vivid i 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 i 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 411, should be read and understood before operating the Vivid i 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 i User’s Manual 2378958-100 Rev. 03

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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 i ultrasound unit is intended for the following applications: • Abdominal • Cardiac • Small Organ • Pediatric • Fetal Heart • Transesophageal • Peripheral Vascular • Neonatal • Adult Cephalic

Contraindications The Vivid i 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 i User's Manual is organized to provide the information needed to start scanning immediately. Some of the functions or features described in this manual are optional and may not be available in the configuration of your specific system. 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 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

Software license acknowledgments WindowBlinds ™ OCX © Stardock ®.

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Getting started

Chapter 1 Getting started • Introduction ... ... 8 • Preparing the unit for use ... ... 9 • Site requirements ... 9 • Connecting the unit ... 10 • Switching On/Off ... 19 • Moving and transporting the unit ... ... 23 • Moving the unit on a Cart ... 23 • Transporting the unit ... 24 • Unit acclimation time ... 24 • System description ... ... 25 • System overview ... 25 • Control panel ... 26 • The Scanning screen ... 38 • Connecting and disconnecting probes ... 41 • Adjusting the display monitor ... 44 • 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

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Getting started

Introduction Only qualified physicians or ultrasound sonographers should perform scans of patients for medical diagnostic reasons. Request training, if needed. An authorized GE representative will unpack and install the unit. Do not attempt to install the unit alone. The Vivid i does not contain any operator serviceable internal components. Ensure that authorized personnel do not tamper with the unit. Perform regular preventive maintenance. See 'System Care and Maintenance' for more information. Maintain a clean environment. Turn OFF, and if possible, disconnect the system before cleaning the unit. See 'Cleaning the system' for more information. Never set liquids on the unit to ensure that liquid does not drip into the control panel or unit.

WARNING

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All the warnings in "Important safety considerations" on page 415, should be read and understood before operating the unit.

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