FujiFilm VisualSonics Vevo MD User manual

Legal Notices
Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021
USA
T: 1-888-482-9449 or 1-425-951-1200
F: 1-425-951-1201
ECAuthorized Representative
Emergo Europe
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2513 BH, The Hague
Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW, 2100
Australia
Caution: United States federal law restricts this device to sale by or on the
order of a physician.
SonoSite, VisualSonics, Vevo, Vevo MD and the VisualSonics logo are registered and
unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. All other
trademarks are the property of their respective owners.
Patents: CA 2501647; CA 2525220; CN 201430080125.0; CN ZL200380101220.3; CN ZL200380105066.7; CN ZL20040013162.3;
CN ZL200480019107.5; CN ZL200580020418.8; CN ZL200680014137.6; CN 200680018668; CN 200680050246; CN
ZL200780016016.X; CN ZL200780027688.0; EU 1853169; FR 1465531; FR 1625630;FR 1642154; FR 1715897; FR 1738407; FR
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8,708,909; US 8,827,907; US 8,847,467; US 8,945,014 and pending.
Part Number: 51370-01 1.0
Publication Date: March 2017
Copyright © 2017 FUJIFILM SonoSite, Inc. All rights reserved.

Contents
About the Vevo MD Imaging System User Manual 13
Getting started 15
Quick start tutorial 16
Vevo MD Imaging System Overview 17
Moving and setting up the system 18
Starting up and shutting down the system 22
System components 26
Transducers 39
Exam types 55
Using the control panel 57
Indications for use 62
Contraindications 67
System settings 68
Backup and restore 71
Connectivity 75
DICOM 78
Configuring the system for DICOM transfer 79
DICOM configuration pages 82
Associating devices with locations 90
4

Archiving 95
To associate a routing selection during an exam 100
To associate a routing selection after an exam has ended 101
DICOM log files 102
Display information 104
Exam types and presets 106
Exam types 106
Customizing exam types 113
Exporting exam types and presets 115
Importing exam types and presets 117
Presets 118
Export 126
USB devices 129
USB memory sticks 129
DICOMDIR 131
Measurements and annotations 132
Annotations 132
General 136
System information 139
System logs 142
5

User management 145
Logging on for the first time 147
User login 149
Managing user accounts 156
Patient 165
Patient image data 166
Patient form fields 170
Entering patient information manually 173
Entering patient information from the worklist 175
Updating and querying the worklist 178
Ending the exam 181
To end an exam 181
Editing patient information 182
Completed exams 185
Exporting patient exams 190
To export patient exams manually to a USB memory stick 190
To export completed exams 190
To export from the review images page 192
To export from the mode window 192
Export folder structure 193
6

Protecting patient information 194
HIPAA standard 196
Scanning 197
Customizing controls 207
2D acquisition and analysis 215
2D image acquisition 216
2D clinical display 217
2D control panel 218
Controls in 2D 222
Adding 2D measurements 228
M-Mode acquisition and analysis 229
M-Mode image acquisition 230
M-Mode clinical display 232
M-Mode control panel 234
Controls in M-Mode 238
Adding M-Mode measurements 246
Color Doppler Mode acquisition and analysis 247
ColorDoppler Mode image acquisition 248
Color Doppler Mode clinical display 250
Color Doppler Mode control panel 252
7

Controls in Color Doppler Mode 255
Adding Color Doppler Mode measurements 267
Freeze 268
Saving images 269
Annotations 276
Measurements 282
Using the measurement panel 287
To change measurement properties 287
To delete a measurement 289
Adding a depth measurement 290
Adding a linear measurement 292
To add a linear measurement 292
Adding a time measurement 294
To add a time measurement 294
Adding a traced area measurement 295
To add a traced area measurement 295
Adding a traced distance measurement 298
To add a traced distance measurement 298
Adding a velocity measurement 300
To add a velocity measurement in M-Mode 300
8

Adding an IMT measurement 302
To add an IMT measurement on a 2D image 303
To add an IMT measurement to an M-Mode image 305
To add an I/M measurement to a 2D image 308
Report 312
To create a report 312
To interact with your report 313
To export a report 313
Cleaning and disinfecting 316
Determining the required cleaning and disinfecting level 316
StepA: Semi-critical contact cleaning and disinfecting of system and
transducer 319
Step B: Non-critical contact cleaning and disinfecting of the system and
transducer 326
Cleaning and disinfecting the foot switch 331
Cleaning and disinfecting level 331
Spaulding classification 331
Before getting started 332
Non-critical contact cleaning and disinfecting of the foot switch 333
Non-critical cleaning and disinfecting 335
Appendices 337
9

Safety 338
Product safety 339
Clinical safety 349
Electrical safety 351
Electromagnetic compatibility 362
Environmental limits 366
Ergonomic safety 367
Minimize eye and neck strain 367
Support your back during an exam 367
Minimize reaching and twisting 368
Promote comfortable shoulder and arm postures 368
Promote comfortable hand, wrist, and finger postures 368
Equipment safety 370
Hazardous materials 371
Manufacturer's declaration 371
Acoustic output 377
ALARA principle 378
Acoustic artifacts 379
Guidelines for reducing MI and TI 379
Output display 381
10

Transducer surface temperature rise 383
Acoustic output measurement 384
Acoustic output tables 388
Acoustic measurement precision and uncertainty 400
Specifications and standards 403
Electromechanical safety standards 405
EMC standards classification 406
DICOM standard 406
HIPAA standard 407
Measurement accuracy 407
Troubleshooting 410
Contact information 415
Related guidance documents 418
Glossary 419
Index 423
11

12

About the Vevo MD Imaging System User
Manual
The Vevo MD Imaging System User Manual is intended for a user familiar with
ultrasound; it does not provide training in sonography, ultrasound or clinical practices.
Before using the Vevo MD Imaging System, training should be completed.
This manual provides detailed descriptions and procedures for configuring and using
the system. The first half of the manual provides an overview of the system and the
commonly used features, regardless of which imaging mode you are using. The
second part of the manual covers image acquisition and the detailed analysis of your
images, in each imaging mode.
Document Conventions
WARNING: Introduces precautions that prevent injury or death.
Caution: Introduces precautions that prevent damage to the equipment.
Important: Introduces important information that you need to be aware of.
Note: Introduces helpful information for you to better understand the subject matter.
lNumbered steps in procedures must be performed in order
lBulleted lists in procedures can be performed in any order
lThe step in a single-step procedure begins with ♦
lLower-alpha lists display choices
About the Vevo MD Imaging System User Manual 13

Getting More Information
lVevo MD Getting Started Guide printable PDF version provided with Vevo MD
Imaging System
lTechnical Support: See "Contact information" on page415
14 About the Vevo MD Imaging System User Manual

Getting started
WARNING: Do not use the system if it exhibits erratic or inconsistent
behavior. Such behavior may indicate a system failure. Contact "Technical
support" on page415.
About the Vevo MD Imaging System
The Vevo MD Imaging System is a software-controlled device that acquires and
displays high-resolution, real-time ultrasound images. Available features depend on
your system configuration, transducer, and operational mode.
Basic Operating Steps
1Connect a transducer. See "Transducers" on page39.
2Turn on the system. See "Starting up and shutting down the system" on page22.
3Select an exam type. See "Exam types" on page55.
4Scan. See "Scanning" on page197.
5Enter Patient information. See "Patient" on page165.
6Archive or export exams. See "Archiving exams" on page95 or "Exporting patient
exams" on page190.
WARNING: Use only the power cord provided by FUJIFILM SonoSite with
the system.
Caution: If the equipment is used in a manner not specified by the manufacturer,
you void the terms of the product warranty, and the protection provided by the
equipment may be impaired.
Getting started 15

Quick start tutorial
This tutorial provides a high-level overview for acquiring and analyzing an image and
then exporting your data.
WARNING: Before using the Vevo MD Imaging System users must read and
observe the Safety Warning and Precautions listed in .
To acquire and export a 2D image and analysis
1Turn the system on. See "Starting up and shutting down the system" on page22.
2Log in, or use the Guest button. See "Logging on for the first time" on page147.
3Connect a transducer (see "Transducers" on page39), and select an exam type.
The system begins acquiring 2D data. See "Exam types" on page55.
4A new patient exam is created. To change the details of the exam, see "Editing
patient information" on page182.
5Refine your image using the various controls, see "Scanning" on page197 and
"Controls in 2D" on page222.
6Tap Freeze to stop data acquisition, see "Freeze" on page268. To re-start
acquisition, tap Unfreeze.
7To place a measurement on a paused clip, move to a frame where you would like to
place a measurement, tap Measurements and select your measurement type. Place
the measurement by dragging the calipers. See "Measurements" on page282.
8Tap Save Frame to save a frame. See "Saving images" on page269.
9Tap Review Images to review saved images. Double tap a thumbnail to load that
image into review.
16 Getting started

Vevo MD Imaging System Overview
The Vevo MD Imaging System houses the electronics, software, and monitors, that
control the transducer functions, and processes the image data.
The Vevo MD Imaging System provides two imaging modes: Frame-based imaging
mode and Time-Based imaging mode.
Frame-based imaging mode captures images in frames, based on two-dimensional
2D data. Frame-based mode includes:
l2D
lColor Doppler Mode
Time-based imaging mode captures images measured in seconds, based on unique
source data characteristics. Time-based mode includes:
lM-Mode
Vevo MD Imaging System Overview 17

Moving and setting up the system
Remove the system from the packing box, see the Vevo MD Getting Started Guide
included with the Vevo MD Imaging System.
Wheel the system to the intended destination by following these instructions—
"Moving the system" on the facing page.
Before moving the system, read the warnings and cautions below to avoid injury to
yourself and others, or the system.
WARNING: Before you complete the following step(s), ensure that the main
power is off and that the Vevo MD Imaging System is not connected to any
AC outlet.
WARNING: Do not move the system when the plug is connected to the
power outlet.
WARNING: Keep the clinical display and control panel monitors folded
until you have reached your destination. When moving the system, ensure
your view is not obstructed.
WARNING: The glass used on the clinical display is very fragile, and can
shatter upon impact causing cuts to the user. Adjust, move and position the
clinical display monitor with care.
WARNING: Do not modify the attachment plug or use an adapter. This
could cause an electrical hazard. If you need to use a different plug, contact
a Technical Support Representative. See "Technical support" on page415.
WARNING: When transporting your system, push forward on the grab bars
instead of pushing or leaning on the clinical monitor. FUJIFILM SonoSite
recommends having two people to move a system—one positioned at the
front of the system and one positioned at the back of the system, both using
the available grab bars.
18 Getting started

WARNING: Lock the wheels whenever the system is unattended or
stationary.
Caution: Care should also be taken when handling heavy items, as it is easy to
crush limbs when lifting or moving them.
Caution: Use extra care when moving the system over thresholds, inclines and on
or off elevators.
Caution: Folding the clinical display monitor past the horizontal position may
damage the monitor or support.
Caution: Do not place anything on the collapsed clinical display monitor.
Moving the system
Before moving the system, remove the cord from the power outlet and fold both
monitors.
1Turn off the system using the power button.
2Turn off the main power switch.
3Unplug the AC power cord from the power outlet at the bottom of the stand base.
4Adjust the control panel angle to the lowest position.
5Grasp the clinical display monitor on both sides, and then align it squarely above the
control panel.
6Fold the clinical display monitor downward over the control panel until it is
horizontal.
7Using one person at the front of the system and one person at the back of the
system, use the grab bars provided to push or pull the system—do not push
downward on the grab bar.
Moving and setting up the system 19

Clinical display collapsed for system transport
8When the system is at its desired location, lock the wheels by pressing down on the
lever on the wheels.
9Grasp the clinical display monitor on both sides and fold it upward.
10 Grasp the clinical display monitor on both sides and tilt or rotate it to adjust its
angle.
11 Grasp both sides of the control panel and pull it forward or push it backward to the
desired angle.
Setting up the system
Ergonomic scanning guidelines are provided in the section "Ergonomic safety" on
page367, and are intended to assist you in setting up the system so you are
comfortable and effective when using the Vevo MD Imaging System.
Review the warnings and cautions in this section when considering a location to set
up your system.
20 Getting started