Vivid i User Manual Volume 1 Rev 02

g MANUAL STATUS 2378958-100 6/7/2005

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

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 Moving and transporting the unit ... 22 Moving the unit on a Cart... 22 Transporting the unit... 23 Unit acclimation time... 23 System description ... 24 System overview... 24 Connecting and disconnecting probes ... 38 Starting an examination... 42 Creating a new Patient record or starting an examination from an existing patient record... 42 Selecting a Probe and an Application... 46

Chapter 2 Basic scanning operations Vivid i User’s Manual 2378958-100 Rev. 02

3

Assignable keys and Soft Menu Rocker ... 49 Using the Assignable Keys Soft Menu ... 50 Using the Soft Menu Rocker ... 53 Trackball operation ...54 Trackball assignment ... 54 The system menu... 55 Cineloop operation ...56 Cineloop overview ...56 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 Zoom ... 63 To Magnify an image... 63 Performing measurements... 63 To perform measurements: ...63 Physiological ECG trace... 64 Connecting the ECG ... 64 Physio controls ... 65 Displaying the ECG trace ... 66 Adjusting the display of the ECG trace... 66 Annotations ... 67 To insert an annotation...67 To edit annotation... 70 To erase annotation ... 70 Configuration of the pre-defined annotation list... 71

Chapter 3 Scanning Modes Introduction ... 76 2D-Mode ... 77 2D-Mode overview ... 77 2D-Mode controls ... 79 Optimizing 2D...82

4

Vivid i User’s Manual 2378958-100 Rev. 02

M-Mode ... 83 M-Mode overview ... 83 M-Mode controls ... 84 Using M-Mode ... 85 Optimizing M-Mode... 87 Color Mode... 88 Color Mode overview ... 88 Color M-Mode overview... 89 Using Color Mode ... 92 PW and CW Doppler... 94 PW and CW Doppler overview ... 94 Optimizing PW/CW Doppler modes... 98

Chapter 4 Purposely left empty For Future purposes ... 101

Chapter 5 Contrast Imaging Introduction... 104 Left Ventricular Contrast Imaging... 104 LV Contrast overview... 105 LV Contrast controls ... 105 Optimizing LV Contrast... 108

Chapter 6 Measurement and Analysis Introduction... 110 The Assign and Measure modality ... 111 Starting the Assign and Measure modality ... 111 Entering a study and performing measurements... 112 Measure and Assign modality... 114 Starting the Measure and Assign modality ... 114 Cardiac measurements ... 117 2D Measurements ... 117 Vivid i User’s Manual 2378958-100 Rev. 02

5

Vascular measurements... 127 B-Mode measurements ... 127 M-Mode Measurements ... 128 Doppler measurements ... 129 Measurement package configuration... 134 Measurement package configuration - example ... 134 User-defined formulas ... 137 User-defined formula - example ...137 About units ... 143 Measurement result table... 145 Minimizing the Measurement result table...145 Moving the Measurement result table ... 145 Deleting measurements ... 146 Worksheet... 147 Overview ...147

Chapter 7 Purposely Left Empty For Future purposes ... 151

Chapter 8 Archiving Introduction ... 155 Storing images and cineloops ... 156 Storing a cineloop... 157 Saving stored images and cineloops to a standard format158 MPEGVue/eVue ... 160 Retrieving and editing archived information... 168 Locating a patient record... 168 Selecting a patient record and editing data in the archive. 172 Moving examinations... 178 Review images in archive... 181 Review the images from a selected examination ... 181 Select images from the Image list screen ... 182 Connectivity... 186 The dataflow concept ... 186

6

Vivid i User’s Manual 2378958-100 Rev. 02

Export/Import patient records/examinations ... 209 Exporting patient records/examinations... 209 Disk Management ... 220 Configuring the Disk management function... 221 Running the Disk management function... 223 Data Backup and Restore... 226 DICOM spooler... 232 Starting the DICOM spooler... 232

Chapter 9 Report Introduction... 236 Creating a report... 237 Working with the report function ... 237 To print a report ... 240 To store a report ... 240 Retrieving an archived report... 241 Deleting an archived report... 241 Direct report ... 242 Creating comments... 242 Creating pre-defined text inputs... 243 Report designer ... 244 Accessing the Report designer... 244 Report designer overview ... 244 Saving the report template... 257 To exit the Report designer ... 258 Report templates management ... 258 Configuration of the Template selection menu ... 259 Export/Import of Report templates... 260

Chapter 10 Probes Probe overview ... 264 Supported probes ... 264 Probe labelling ... 267

Vivid i User’s Manual 2378958-100 Rev. 02

7

Probe Integration ... 269 Connecting the probe ... 269 Activating the probe... 269 Disconnecting the probe... 270 Care and Maintenance ... 271 Planned maintenance... 271 Probe safety... 276 Electrical hazards ... 276 Mechanical hazards ... 276 Biological hazards ...277

Chapter 11 Peripherals Introduction ... 280 Printing... 281 To print an image ... 281 Specifications for peripherals... 282

Chapter 12 Presets and System setup Introduction ... 284 Starting the Configuration package ... 287 To open the Configuration package ... 287 Overview ... 288 Imaging ... 289 The Global setup sheet ... 289 Application... 291 Application menu... 294 Measure Text ... 296 The measurement menu sheet ... 296 The Advanced sheet ... 302 Parameter configuration: ... 302 The Modify Calculations sheet ... 303 Parameter configuration: ... 303 Report... 304 The Comment texts sheet ... 306

8

Vivid i User’s Manual 2378958-100 Rev. 02

Connectivity ... 309 Tools ... 320 Formats... 321 System... 327 The system settings... 327 About ... 329 Administration ... 330

Chapter 13 User maintenance System Care and Maintenance... 336 Inspecting the system ... 336 Cleaning the unit... 337 Prevention of static electricity interference ... 339 System self-test ... 341 System malfunction ... 341

Chapter 14 Safety Introduction... 345 Owner responsibility ... 346 Important safety considerations ... 347 Notice against user modification... 347 Regulatory information ... 348 Standards used... 348 Device labels... 349 Label Icon Description ... 349 Classifications ... 352 Acoustic output ... 353 Definition of the acoustic output parameters ... 353 Acoustic output and display on the Vivid i ... 353 ALARA ... 354 Safety statement... 355 System controls affecting acoustic output ... 355 Patient safety ... 357 Patient identification... 357 Vivid i User’s Manual 2378958-100 Rev. 02

9

Diagnostic information... 357 Personnel and equipment safety... 359 Explosion hazard... 359 Electrical hazard... 359 Biological hazard ... 360 Pacemaker hazard ... 360 Electrical safety... 361 Device classifications ... 361 Internally connected peripheral devices ... 361 Internally connected battery ... 361 External Connection of other peripheral devices... 361 Allergic reactions to latex-containing medical devices ... 362 Electromagnetic Compatibility (EMC) ... 363 Environmental protection... 365 System disposal ... 365

10

Vivid i User’s Manual 2378958-100 Rev. 02

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-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 343, 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. 02

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 i ultrasound unit is intended for the following applications: • Abdominal • Cardiac • Small Organ • Pediatric • Fetal • 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.

2

Vivid i User’s Manual 2378958-100 Rev. 02

Introduction

Manual contents The Vivid i User's Manual is organized to provide the information needed to start scanning immediately. 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 i User’s Manual 2378958-100 Rev. 02

3

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

Vivid i User’s Manual 2378958-100 Rev. 02

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

Vivid i User’s Manual 2378958-100 Rev. 02

5

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

6

Vivid i User’s Manual 2378958-100 Rev. 02

Getting started

Chapter 1 Getting started • Preparing the unit for use ... ... 9 • Site requirements ... 9 • Connecting the unit ... 10 • Switching On/Off ... 18 • Moving and transporting the unit ... ... 22 • Moving the unit on a Cart ... 22 • Transporting the unit ... 23 • Unit acclimation time ... 23 • System description ... ... 24 • System overview ... 24 • Control panel ... 25 • The Scanning screen ... 35 • Connecting and disconnecting probes ... 38 • Adjusting the display monitor ... 41 • Starting an examination ... ... 42 • Creating a new Patient record or starting an examination from an existing patient record ... 42 • Selecting a Probe and an Application ... 46

Vivid i User’s Manual 2378958-100 Rev. 02

7

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

8

All the warnings in "Important safety considerations" on page 347, should be read and understood before operating the unit.

Vivid i User’s Manual 2378958-100 Rev. 02

Getting started

Preparing the unit for use The Vivid i ultrasound unit must operate within the proper environment and in accordance with the requirements described in this section. Before using the system, ensure that the requirements are met.

Site requirements Optimal operation of the unit can be obtained by implementing the following requirements:

Power requirements The Vivid i ultrasound unit is powered either by its internal battery or by a separate power supply adaptor unit connected to a separate power outlet for any range of 100 – 230 VAC, 50– 60 Hz. Operating the unit with the wrong voltage range causes damages, voiding the factory warranty. WARNING

Operating Environment Ensure that there is sufficient air flow around the Vivid i ultrasound unit when installed or operated.

Environmental requirements The Vivid i ultrasound unit requires constant maintenance of its operational environment. Different temperature and humidity requirements are specified for operation, storage and transportation. Requirement

Temperature

Humidity

Air Pressure

Operational

10–40 °C

30–85%

700–1060 hPa

Storage

-10–60 °C

30–95%

700–1060 hPa

Transport

-10–60 °C

30–95%

700–1060 hPa

Vivid i User’s Manual 2378958-100 Rev. 02

9

Getting started Electromagnetic interferences The Vivid i ultrasound unit is approved for use in hospitals, clinics and other environmentally qualified facilities, in terms of the prevention of radio wave interference. Operation of the unit in an inappropriate environment can cause electronic interference to radios and television sets situated near the medical equipment.

Ensure that the unit is protected from electromagnetic interferences as follows: • Operate the unit at least 4.5 meters (fifteen feet) away from equipment that emits strong electromagnetic radiation. • Shield the unit when operating it in the vicinity of radio broadcasting equipment, if necessary.

Connecting the unit A GE-qualified person should perform the initial system installation. Connecting the Vivid i ultrasound unit involves preliminary checks of the power adaptor unit and cord, voltage level and compliance with electrical safety requirements. Use only power supply cords, cables and plugs provided by or designated by GE Medical Systems. Ensure that the power cord and plug are intact and that the power plug is the proper hospital-grade type (where required). When using the mains outlets, the unit should be connected to a fixed power socket which has the protective grounding connector. Never use an extension cord or adapter plug. Failure to provide an adequate earth circuit can cause electrical shock, resulting in serious injury.

WARNING

10

Vivid i User’s Manual 2378958-100 Rev. 02