FujiFilm SonoSite iViz User manual

USER GUIDE

iViz, Sonosite, and the Sonosite logo are trademarks and registered trademarks of FUJIFILM Sonosite, Inc. in various jurisdictions.
FUJIFILM is a trademark and registered trademark of FUJIFILM Corporation in various jurisdictions.
Dicom is a registered trademark of the National Electrical Manufacturers Association.
All other trademarks are the property of their respective owners.
Part Number: P20016-05
Publication Date: November 2017
Copyright © 2017 FUJIFILM SonoSite, Inc. All rights reserved.
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
FUJIFILM SonoSite B.V.
Joop Geesinkweg 140
1114 AB Amsterdam,
The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW, 2100
Australia
Caution Federal (United States) law restricts this device to sale by or on the order
of a physician.

iii
CONTENTS
Chapter 1: Introduction
About the SonoSite iViz User Guide ............................................................................................................ 1
Document conventions .......................................................................................................................... 1
Getting help ................................................................................................................................................ 2
Chapter 2: Getting Started
About SonoSite iViz ........................................................................................................................................... 3
Intended use ........................................................................................................................................................ 3
Diagnostic ultrasound ............................................................................................................................. 3
Contraindications ...................................................................................................................................... 4
Accessories and peripherals ........................................................................................................................... 4
Hardware features .............................................................................................................................................. 5
General interaction ............................................................................................................................................ 7
Using the touchscreen ............................................................................................................................ 7
Using gestures ............................................................................................................................................ 9
Using the control wheel ......................................................................................................................... 9
Opening menus and tool drawers ....................................................................................................10
Entering text .............................................................................................................................................11
Put the system into the protective case ...................................................................................................11
Plugging in a transducer ...............................................................................................................................12
Installing the battery and charging SonoSite iViz ................................................................................12
Installing the battery .............................................................................................................................12
Charging the battery .............................................................................................................................13
Removing the battery ...........................................................................................................................15
Turning SonoSite iViz on and off ................................................................................................................15
Turning on SonoSite iViz ......................................................................................................................16
Turning off SonoSite iViz ......................................................................................................................16
Putting the system into sleep mode ................................................................................................16
Chapter 3: Configuring SonoSite iViz
Configuring Android settings ......................................................................................................................17
Activating security settings .................................................................................................................17
Connecting to a wireless network ....................................................................................................17
Connecting to a virtual private network (VPN) ............................................................................18
Connecting to a Bluetooth device ....................................................................................................18
Setting the date and time ....................................................................................................................19

iv
CONTENTS
Adjusting the volume ............................................................................................................................19
Adjusting the screen brightness .......................................................................................................20
Configuring sleep mode .......................................................................................................................20
Adding a wireless printer .....................................................................................................................21
Configuring SonoSite iViz settings ............................................................................................................21
Opening the SonoSite iViz Settings screen ...................................................................................22
Configuring preferences .......................................................................................................................22
Configuring OB measurements and calculations ........................................................................24
Configuring labels ..................................................................................................................................24
Setting up a DICOM profile ..................................................................................................................25
Configuring patient search settings .................................................................................................27
Configuring EMR settings and preferences ...................................................................................28
Connecting to a separate display ...............................................................................................................28
Chapter 4: Managing Patient Records
About SonoSite iViz studies ..........................................................................................................................31
Accessing patient information ....................................................................................................................31
Searching for a patient record ............................................................................................................31
Managing studies .............................................................................................................................................33
Viewing scheduled studies ..................................................................................................................33
Browsing and viewing scheduled studies ......................................................................................33
Creating or updating a patient study ..............................................................................................34
Ending a study .........................................................................................................................................35
Sharing a study ........................................................................................................................................36
Managing reports ............................................................................................................................................36
Editing a report ........................................................................................................................................37
Printing a report ......................................................................................................................................37
Sharing a report .......................................................................................................................................38
Chapter 5: Performing an Exam
Understanding optimal thermal performance ......................................................................................39
Beginning an exam ..........................................................................................................................................39
Understanding imaging modes ..................................................................................................................40
Exam overview .........................................................................................................................................41
Choosing a transducer and exam type ...........................................................................................42
Reviewing patient information ..........................................................................................................44
Scanning in 2D ..................................................................................................................................................44
Scanning in color ....................................................................................................................................44

v
CONTENTS
Switching between CVD and CPD ....................................................................................................47
Controlling color gain ............................................................................................................................47
Adjusting scale .........................................................................................................................................48
Inverting the blood flow colors .........................................................................................................49
Filtering .......................................................................................................................................................49
Controlling flow .......................................................................................................................................50
Scanning in M Mode .......................................................................................................................................50
Moving the M Line ..................................................................................................................................51
Updating in M Mode .......................................................................................................................................51
Changing the sweep speed .................................................................................................................51
Setting the image orientation .....................................................................................................................52
Optimizing the image ....................................................................................................................................53
Adjusting depth and gain .............................................................................................................................54
Adjusting depth .......................................................................................................................................54
Adjusting gain ..........................................................................................................................................55
Controlling the dynamic range ...................................................................................................................56
Accessing guided protocols .........................................................................................................................57
Physical .......................................................................................................................................................57
eFAST ...........................................................................................................................................................58
FATE ..............................................................................................................................................................58
RUSH ............................................................................................................................................................59
Chapter 6: Managing Images and Clips
Freezing an image ............................................................................................................................................61
Saving an image or a clip ..............................................................................................................................62
Reviewing an image or clip ..........................................................................................................................63
Zooming in and out of an image ......................................................................................................63
Adding labels .....................................................................................................................................................63
Deleting images and clips .............................................................................................................................65
Sending and sharing images and clips ....................................................................................................65
Chapter 7: Measurements and Calculations
Taking measurements ....................................................................................................................................67
Working with calipers ............................................................................................................................67
Viewing and deleting measurement results .................................................................................68
Taking basic measurements ...............................................................................................................68
About calculations ...........................................................................................................................................71
Overview ....................................................................................................................................................71

vi
CONTENTS
Calculating volume ................................................................................................................................72
Exam-based calculations ...............................................................................................................................74
Cardiac calculations ...............................................................................................................................74
Obstetrics calculations ..........................................................................................................................76
Abdomen, breast, lung, MSK, and nerve calculations ...............................................................79
Chapter 8: Measurement References
Measurement accuracy ..................................................................................................................................81
Measurement publications and terminology ...............................................................................82
Chapter 9: Troubleshooting and Maintenance
Troubleshooting ...............................................................................................................................................93
Common problems ................................................................................................................................93
Understanding error messages. .........................................................................................................93
Troubleshooting connectivity problems ........................................................................................96
DICOM common problems ..................................................................................................................96
Maintenance ......................................................................................................................................................98
Upgrading SonoSite iViz software and firmware ........................................................................98
iViz performance testing ...............................................................................................................................99
Overview ....................................................................................................................................................99
Recommended test equipment ........................................................................................................99
Functional acceptance ..........................................................................................................................99
2D performance tests ......................................................................................................................... 100
Additional performance tests .......................................................................................................... 102
M Mode imaging .................................................................................................................................. 103
Chapter 10: Cleaning and Disinfecting
Before getting started ................................................................................................................................. 105
Determining the required cleaning and disinfection level ............................................................ 107
Spaulding classifications ................................................................................................................... 107
Clean and disinfect system and transducer to a high level (semi-critical uses) ............ 107
Clean and disinfect system and transducer to a low level (non-critical uses) ................ 114
Cleaning the iViz carry case ....................................................................................................................... 120
Storing the transducer ................................................................................................................................ 120
Transporting the transducer ..................................................................................................................... 120
Disposing of the system ............................................................................................................................. 122

vii
CONTENTS
Chapter 11: Safety
Ergonomic safety ........................................................................................................................................... 123
Minimize eye and neck strain .......................................................................................................... 124
Support your back during an exam .............................................................................................. 124
Minimize reaching and twisting ..................................................................................................... 124
Promote comfortable shoulder and arm postures .................................................................. 124
Employ comfortable postures ......................................................................................................... 124
Use comfortable wrist and finger postures with transducers .............................................. 125
Take breaks, exercise, and vary activities ..................................................................................... 125
System and transducer temperatures ................................................................................................... 126
Electrical safety .............................................................................................................................................. 126
Electrical safety classification .......................................................................................................... 128
Equipment safety .......................................................................................................................................... 128
Battery safety .................................................................................................................................................. 129
Clinical safety .................................................................................................................................................. 131
Hazardous materials ..................................................................................................................................... 131
Electromagnetic compatibility ................................................................................................................. 132
Wireless transmission ......................................................................................................................... 133
Electrostatic discharge ....................................................................................................................... 134
Separation distance ............................................................................................................................ 134
Compatible accessories and peripherals ..................................................................................... 135
Guidance and manufacturer’s declaration ................................................................................. 136
labeling symbols .......................................................................................................................................... 143
Specifications .................................................................................................................................................. 145
Dimensions ............................................................................................................................................ 145
Environmental limits ........................................................................................................................... 146
Electrical specifications ...................................................................................................................... 146
Battery specifications ......................................................................................................................... 146
Equipment specifications .................................................................................................................. 147
Standards ......................................................................................................................................................... 147
Electrical safety standards ................................................................................................................ 147
EMC standards classification ............................................................................................................ 147
Acoustic standards .............................................................................................................................. 148
Biocompatibility standards .............................................................................................................. 148
Airborne equipment standards ...................................................................................................... 148
DICOM standard ................................................................................................................................... 148
Security and privacy standards ....................................................................................................... 148
Wireless standards ............................................................................................................................... 148

viii
CONTENTS
Chapter 12: Acoustic Output
ALARA principle ............................................................................................................................................. 151
Applying the ALARA principle ......................................................................................................... 151
Direct, indirect, and receiver controls ........................................................................................... 152
Acoustic artifacts ........................................................................................................................................... 152
Guidelines for reducing MI and TI ........................................................................................................... 153
Output display ................................................................................................................................................ 154
MI and TI output display accuracy ................................................................................................. 154
Factors that contribute to display uncertainty .......................................................................... 154
Related guidance documents ......................................................................................................... 155
Transducer surface temperature rise ..................................................................................................... 155
Acoustic output measurement ................................................................................................................ 156
Tissue models and equipment survey .......................................................................................... 157
Acoustic output tables ................................................................................................................................ 158
Acoustic measurement precision and uncertainty .................................................................. 163
Terminology in acoustic output tables ........................................................................................ 163
Glossary ............................................................................................................................................................ 165
General terms ........................................................................................................................................ 165
Chapter 13: IT Network
Functions .......................................................................................................................................................... 167
Network for connecting the device ........................................................................................................ 167
Specifications for the connection ........................................................................................................... 167
Hardware specification ...................................................................................................................... 167
Software specifications ...................................................................................................................... 167
Security .................................................................................................................................................... 167
Data flow ................................................................................................................................................. 168
IT network failure recovery measures .................................................................................................... 169

About the SonoSite iViz User Guide 1
Chapter 1: Introduction
About the SonoSite iViz User Guide
The SonoSite iViz User Guide provides information about configuring and using the SonoSite iViz ultrasound
system, including:
Managing patient data
Performing exams
Taking measurements and calculations
Cleaning and disinfecting
The information and procedures in this user guide apply to the SonoSite iViz system and its included
accessories. Other accessories and third-party equipment are subject to their own instructions and
restrictions.
The SonoSite iViz User Guide is intended for a user familiar with ultrasound. It does not provide training in
sonography, ultrasound, or clinical practices. Before using SonoSite iViz, you must complete such training.
Document conventions
The document follows these conventions:
A WARNING describes precautions necessary to prevent injury or loss of life.
A Caution describes precautions necessary to protect the products.
A Note provides supplemental information.
Numbered and lettered steps must be performed in a specific order.
Single-step procedures begin with this symbol: 
Bulleted lists present information in list format but do not imply a sequence.

2About the SonoSite iViz User Guide
Getting help
In addition to this user guide, the following resources are available:
Instructional videos
On-board help videos
FUJIFILM SonoSite Technical Support:
Phone
(U.S. or Canada)
877-657-8118
Phone
(outside U.S. or Canada)
425-951-1330, or call your local representative
Fax [phone]
Email [email protected]
Web www.sonosite.com
Europe Service Center Main: [phone]
English support: [phone]
French support: [phone]
German support: [phone]
Italian support: [phone]
Spanish support: [phone]
Asia Service Center [phone]

About SonoSite iViz 3
Chapter 2: Getting Started
Use this section to help familiarize yourself with the SonoSite iViz system and its uses.
About SonoSite iViz
SonoSite iViz is a portable, hand-held device that acquires and displays high-resolution, real-time ultrasound
images. Features available on the system include:
2D scanning mode with color Doppler
Measurement and calculation support
Image labeling
DICOM support
EMR system integration
On-board help videos
Intended use
Diagnostic ultrasound
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient
monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for
evaluation by ultrasound imaging and fluid flow analysis.
In the ultrasound scanning application, the SonoSite iViz system with an attached transducer obtains
ultrasound images as described below:
Abdominal imaging applications are designed to assess the liver, kidneys, pancreas, spleen, gallbladder,
bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures for the
presence or absence of pathology transabdominally. Abdominal imaging can be used to evaluate the
presence or absence of blood flow in abdominal organs.
Cardiac imaging applications are designed to assess the pericardial effusion or cardiac tamponade
possibility, cardiac valves, the great vessels, heart size, cardiac function, lung, and surrounding
anatomical structures for the presence or absence of pathology.
Obstetrical imaging applications are designed to assess the fetal anatomy, viability, estimated fetal
weight, fetal heart rate, fetal position, gestational age, amniotic fluid, and surrounding anatomical
structures for the presence or absence of pathology transabdominally.

4Accessories and peripherals
Color Power Doppler (CPD) and Color Velocity Doppler (CVD) imaging tools are intended to evaluate the
blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures in all cases,
including high-risk pregnancies. High-risk pregnancy indications include, but are not limited to,
multiple pregnancies, fetal hydrops, placental abnormalities, maternal hypertension, diabetes, and
lupus.
CPD and color imaging tools are not intended as a sole means of diagnosis nor as a sole method of high-
risk pregnancy screening.
Superficial imaging applications are designed to assess the breast, thyroid, testicle, lymph nodes,
nerves, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical
structures for the presence or absence of pathology.
Vascular imaging applications are designed to assess the carotid arteries, deep veins, and arteries in the
arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small
vessels feeding organs for the presence or absence of pathology.
Contraindications
SonoSite iViz is not intended for opthalmic use or any application that causes the acoustic beam to pass
through the eye.
Accessories and peripherals
The SonoSite iViz ultrasound system is designed to support a variety of accessories and peripherals, including:
2-in-1 micro USB flash drive (64 GB)
Protective case with handle and kickstand
SonoSite iViz carry case
Pelican case
SonoSite iViz batteries
USB charger
Battery bay charger with power supply
Dual charging station
Caution Use only accessories and peripherals recommended by FUJIFILM SonoSite, including
the power supply. Connection of accessories and peripherals not recommended by
FUJIFILM SonoSite could result in electrical shock. Contact FUJIFILM SonoSite or
your local representative for a list of accessories and peripherals available from or
recommended by FUJIFILM SonoSite.

Hardware features 5
To order accessories, or to find out if a specific piece of equipment is compatible with the SonoSite iViz
ultrasound system, contact FUJIFILM SonoSite or your FUJIFILM SonoSite representative. See “Getting help”
on page 2.
Hardware features
The front of the system is shown in Figure 2-1.
Figure 2-1 Front of the SonoSite iViz ultrasound system
1Volume up 6 Micro USB port
2Volume down 7 Power on/off
3Transducer socket 8 Power status LED
4Audio out 9 Microphone
5Micro HDMI port 10 Front camera

6Hardwarefeatures
The back of the system is shown in Figure 2-2.
Figure 2-2 Back of the SonoSite iViz ultrasound system
1Batterybay 3Speaker
2 Camera and flash

General interaction 7
General interaction
When you first turn on SonoSite iViz, the Home screen displays, as shown in Figure 2-3.
Figure 2-3 SonoSite iViz Home screen
The system has three main modules that are accessible from the Home screen: Patient, Scan, and Learn.
Patient - This module lets you search for a patient, view the scheduled list of patients, and select a SonoSite
iViz study. In addition, you can add and edit a patient form and view and share images and clips.
Scan - This module is where you perform patient exams.
Learn - This module contains general ultrasound training videos and SonoSite iViz on-board help videos.
Using the touchscreen
When scanning, the SonoSite iViz touchscreen is divided into two main areas: the left side contains your
controls, and the right side is the scan area, as shown in Figure 2-4.

8Generalinteraction
Figure 2-4 Touchscreen while in scan mode
The system is designed so that you can use one hand to hold the system and the other hand to hold the
transducer. If you’re not scanning, you can always use two hands.
1 Scan mode selector 8 Power management indicator: flashing white -
Slow frame rate mode. Solid blue - Freeze
mode.
2 Thumb-operated control wheel 9 Time, date, and percent charged
3 Freeze an image 10 Tool drawer handle
4 Capture an image or a clip 11 Scan area
5 Number of saved images and clips in this study 12 Android controls
6 Patient name and data (tap to go to Patient
module)
13 End the study and return to patient record
7Typeofexam
FREEZE SAVE Patient: John Smith ID: 1234567890 P21v: Abdomen
End Study
2D
C
COLOR
Orient
Dynamic
Range
Opt
Depth: 16.4cm
89%
13%
09:15
01/01/2015
MI:
0.0
TI:
0.0
DR:
0
Pen
MHz
0.00
RES
PEN
THI

General interaction 9
Using gestures
You interact with the touchscreen the same as with many other touchscreen devices:
Swipe - Move your finger quickly across the screen.
Drag - Move one or two fingers across the screen, usually to move an object from one location to another.
Tap - Quickly touch the screen once.
Press and hold - Touch your finger to the screen, and hold it there for about two seconds.
Pinch or zoom - Slide two fingers together or apart on the screen.
The controls that appear on the wheel depend on the scan mode you've selected. The function of each control
is discussed in detail in Chapter 5, “Performing an Exam.”
Using the control wheel
In scanning mode, use the control wheel to scroll through the available controls.

10 Generalinteraction
Opening menus and tool drawers
You can access additional controls by opening menus and tool drawers.
This symbol indicates a drop-down menu.Tap or swipe down on this symbol to open the menu. For
instance, the Exam Type menu allows you to choose between several preset exam types.
This symbol indicates a drawer that you can open. Swipe up on this symbol to open the tool drawer.
The tool drawer contains additional options such as labels, measurements, and guided protocols.
This symbol indicates the drawer that opens the cine buffer when you are taking measurements or
adding labels. Slide the drawer to the right to display the cine buffer, and slide it to the left to close it.

Put the system into the protective case 11
Entering text
When filling out forms in SonoSite iViz, such as when you are updating patient records or configuring settings,
you can enter text by tapping the text field you want to edit. An on-screen keyboard appears, as shown in
Figure 2-5.
Figure 2-5 Use the keyboard to type information.
Put the system into the protective case
To put the system into the protective case
1Insert the system into one end of the case.
2Bring the opposite case end over the system to hold it in place.
Caution SonoSite iViz device emits RF emissions. While the system meets SAR standards,
using the protective case is recommended to reduce RF exposure.

12 Plugging in a transducer
Plugging in a transducer
Insert the transducer connector into the bottom of the SonoSite iViz system, with the transducer cable
facing away from the other connectors, until you hear it click.
Installing the battery and charging SonoSite iViz
Installing the battery
To install the battery
1On the back of the SonoSite iViz system, position the battery in the battery slot so that the beveled edge of
the battery is nearest the side of the SonoSite iViz system.
2Press the battery firmly into the back of the SonoSite iViz system until it locks in place.
Note Battery performance depends on numerous factors, such as the scanning modes
used, battery age, and display brightness.
WARNING To avoid injury to the operator and to prevent damage to the ultrasound system,
inspect the battery for leaks before installing.