FujiFilm SonoSite Edge II User manual

SonoSite Edge II
Ultrasound System User Guide
USER GUIDE

SiteLink, Edge, SonoCalc, SonoHD2, SonoMB, Steep Needle Profiling, SonoSite, and the SonoSite logo are registered and unregistered
trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions.
DICOM is a registered trademark of the National Electrical Manufacturers Association.
All other trademarks are the property of their respective owners.
Patents: US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; 8,805,047; US 8,527,033; US 8,439,840; US 8,398,408; US 8,355,554; US
8,216,146; US 8,213,467; US 8,147,408; US 8,137,278; US 8,088,071; US 8,066,642; US8,052,606; US 7,819,807; US 7,804,970; US 7,740,586;
US 7,686,766; US 7,604,596; US7,591,786; US 7,588,541; US 7,534,211; US 7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US
6,575,908; US6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US 6,364,839; US 6,203,498; US 6,135,961; US 5,893,363; US5,817,024;
US 5,782,769; US 5,722,412; AU: 730822; AU: 727381; CA 2,372,152; CA: 2,371,711; CN 98108973.9; CN98106133.8; CN 97113678.5; DE
69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE602004023816.3; DE: 60034670.6; DE 60029777.2; EP 1589878; EP
1552792; EP 1180971; EP 0875203; EP 0815793;EP 1180970; EP 0881492; ES 2229318; ES 159878; ES 1552792; ES 0881492; FR 158978; FR
1552792; FR 1180970; FR0881492; FR 0875203; FR 0815793; GB 158978; GB 1552792; GB 1180971; GB 1180970; GB 0881492; GB 0875203;
GB 0815793; IT 1589878; IT 1552792; IT 0881492; IT 0815793; JP 4696150; KR 532359; KR 528102; NO 326814; NO 326202 and pending.
Part Number: P20516-02
Publication Date: March 2016
Copyright © 2016 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
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW, 2100
Australia
Caution United States law restricts this device to sale by or on the order of a physician.

i
Contents
Chapter 1: Introduction
About the SonoSite Edge II User Guide .................................................................1
Document conventions ......................................................................................1
Getting help .....................................................................................................................2
Chapter 2: Getting Started
About the system ...........................................................................................................3
Intended use ...................................................................................................................3
Hardware features .........................................................................................................6
Preparing the system ....................................................................................................7
Installing or removing the battery .................................................................7
Using AC power and charging the battery ..................................................9
Turning the system on or off ..........................................................................10
Connecting transducers ...................................................................................10
Inserting and removing USB storage devices ..........................................12
System controls ............................................................................................................13
Screen layout .................................................................................................................15
General interaction .....................................................................................................16
Touchpad and cursor .......................................................................................16
On-screen controls .............................................................................................16
Annotation and text ..........................................................................................17
Preparing the transducers ........................................................................................19
Chapter 3: System Setup
Displaying the setup pages ......................................................................................21
Restoring default settings ........................................................................................21
A & B Key, Footswitch setup .....................................................................................21
Administration setup ..................................................................................................22
Security settings ..................................................................................................22
User setup .............................................................................................................23
Exporting or importing user accounts ........................................................24
Exporting and clearing the Event log .........................................................25
Logging in as user ..............................................................................................26
Choosing a secure password ..........................................................................26
Annotations setup .......................................................................................................26
Audio, Battery setup ...................................................................................................28
Cardiac Calculations setup ......................................................................................28
Connectivity setup ......................................................................................................28
Date and Time setup ...................................................................................................29
Display Information setup ........................................................................................29
Network Status setup .................................................................................................30
OB Calculations setup ................................................................................................30
OB Custom Measurements setup ..........................................................................31

ii
OB Custom Tables setup ...........................................................................................31
Presets setup .................................................................................................................33
System Information setup ........................................................................................34
USB Devices setup .......................................................................................................34
Limitations of JPEG format ..............................................................................35
eFilm Lite image-viewer ...................................................................................36
Chapter 4: Imaging
Imaging modes ............................................................................................................37
2D imaging ...........................................................................................................37
M Mode imaging ................................................................................................39
CPD and color Doppler imaging ...................................................................40
PW and CW Doppler imaging ........................................................................41
Adjusting depth and gain .........................................................................................44
Freezing, viewing frames, and zooming .............................................................45
Needle visualization ...................................................................................................46
About Steep Needle Profiling technology ................................................46
Needle size and angle .......................................................................................48
Additional recommendations ........................................................................49
Centerline .......................................................................................................................49
Imaging modes and exams available by transducer ......................................50
Annotating images .....................................................................................................55
Patient information form ..........................................................................................57
Images and clips ..........................................................................................................60
Saving images and clips ...................................................................................60
Reviewing patient exams ...............................................................................61
Printing, exporting, and deleting images and clips ...............................63
ECG Monitoring ............................................................................................................65
Chapter 5: Measurements and Calculations
Measurements ..............................................................................................................67
Working with calipers .......................................................................................67
2D measurements ..............................................................................................68
M Mode measurements ...................................................................................70
Doppler measurements ...................................................................................70
General calculations ...................................................................................................73
Calculations menu .............................................................................................73
Performing and saving measurements .....................................................74
Displaying, repeating, and deleting saved measurements ................74
EMED calculations ..............................................................................................75
Percent reduction calculations ......................................................................75
Volume calculations ..........................................................................................76
Volume flow calculations .................................................................................77
Exam-based calculations ..........................................................................................79
Cardiac calculations ...........................................................................................79
Gynecology (Gyn) calculations ......................................................................95
OB calculations ....................................................................................................96

iii
Small Parts and MSK calculations ..............................................................100
Transcranial Doppler and Orbital calculations ......................................101
Vascular calculations ...................................................................................... 104
Patient report .............................................................................................................106
Vascular and cardiac patient reports ........................................................ 106
TCD patient report .......................................................................................... 107
OB patient report .............................................................................................107
EMED and MSK worksheets ......................................................................... 108
Chapter 6: Measurement References
Measurement accuracy ..........................................................................................111
Sources of measurement errors ..........................................................................112
Measurement publications and terminology ................................................. 113
Cardiac references ...........................................................................................113
Obstetrical references ....................................................................................123
Gestational age tables ...................................................................................125
Growth analysis tables ...................................................................................127
Ratio calculations .............................................................................................129
General references ..........................................................................................129
Chapter 7: Troubleshooting and Maintenance
Troubleshooting ........................................................................................................133
Software licensing ....................................................................................................134
Maintenance ...............................................................................................................135
Chapter 8: Cleaning and Disinfecting
Cleaning and disinfecting the system and transducer ...............................137
Before getting started ....................................................................................137
Determining the required cleaning and disinfecting level ..............138
Option A: Semi-critical cleaning of system and transducer and disinfecting of system and transducer
(semi-critical uses) ...........................................................................................139
Option B: Non-critical cleaning and low-level disinfecting of system and transducer (non-critical uses) 143
.................................................... Cleaning and disinfecting the battery 145
Cleaning the footswitch ................................................................................145
Cleaning and disinfecting the ECG cable and slave cable ................ 145
Chapter 9: Safety
Ergonomic safety ......................................................................................................147
Position the system ......................................................................................... 148
Position yourself ............................................................................................... 148
Take breaks, exercise, and vary activities ................................................149
Electrical safety ..........................................................................................................149
Electrical safety classification ......................................................................152
Equipment safety ......................................................................................................152
Battery safety ..............................................................................................................153
Clinical safety ..............................................................................................................154

iv
Hazardous materials ................................................................................................ 155
Electromagnetic compatibility ............................................................................ 156
Wireless transmission ..................................................................................... 157
Electrostatic discharge .................................................................................. 157
Separation distance ........................................................................................ 159
Compatible accessories and peripherals ................................................ 159
Manufacturer’s declaration .......................................................................... 162
Labeling symbols ...................................................................................................... 165
Specifications ............................................................................................................. 170
Dimensions ........................................................................................................ 170
Environmental limits ..................................................................................... 170
Electrical specifications ................................................................................. 171
Battery specifications ..................................................................................... 171
Standards ..................................................................................................................... 172
Electromechanical safety standards ......................................................... 172
EMC standards classification ....................................................................... 172
Biocompatibility standards .......................................................................... 173
Airborne equipment standards .................................................................. 173
DICOM standard ............................................................................................... 173
HIPAA standard ................................................................................................ 173
Chapter 10: Acoustic Output
ALARA principle ........................................................................................................ 175
Applying the ALARA principle .................................................................... 175
Direct controls .................................................................................................. 176
Indirect controls ............................................................................................... 176
Receiver controls ............................................................................................. 176
Acoustic artifacts ...................................................................................................... 176
Guidelines for reducing MI and TI ....................................................................... 177
Output display ........................................................................................................... 180
MI and TI output display accuracy ............................................................. 181
Factors that contribute to display uncertainty ..................................... 181
Related guidance documents ..................................................................... 182
Transducer surface temperature rise ................................................................. 182
Acoustic output measurement ............................................................................ 183
In Situ, derated, and water value intensities .......................................... 183
Tissue models and equipment survey ..................................................... 185
Acoustic output tables ............................................................................................ 186
Terms used in the acoustic output tables ............................................... 233
Acoustic measurement precision and uncertainty ............................. 234
Glossary
Terms ............................................................................................................................. 237
Abbreviations ............................................................................................................. 239

About the SonoSite Edge II User Guide 1
Chapter 1: Introduction
About the SonoSite Edge II User Guide
The SonoSite Edge II Ultrasound System User Guide provides information about configuring and using the
SonoSite Edge II ultrasound system including:
Managing patient data
Performing exams
Taking measurements and calculations
Cleaning and disinfecting the system
The information and procedures in this user guide apply to the SonoSite Edge II ultrasound system and its
included accessories. Other accessories and third-party equipment are subject to their own instructions and
restrictions.
The SonoSite Edge II Ultrasound System User Guide is intended for a user familiar with ultrasound. It does not
provide training in sonography, ultrasound, or clinical practices. Before using the system, 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.
Bulleted lists present information in list format but do not imply a sequence.

2Gettinghelp
Getting help
In addition to this user guide, the following resources are available:
Instructional videos available on-line.
FUJIFILM SonoSite Technical Support:
Printed in the U.S.
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 [e-mail]
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 the system 3
Chapter 2: Getting Started
Use this section to help familiarize yourself with the SonoSite Edge II ultrasound system and its uses.
About the system
The SonoSite Edge II is a portable, software-controlled device using all-digital architecture. The system has
multiple configurations and feature sets used to acquire and display high-resolution, real-time ultrasound
images. Features available on your system depend on system configuration, transducer, and exam type.
A license key is required to activate the software. See “Software licensing” on page 134. On occasion, a
software upgrade may be required. FUJIFILM SonoSite provides a USB device containing the software. One
USB device can be used to upgrade multiple systems.
Intended use
The SonoSite Edge II ultrasound system is a general purpose ultrasound system intended for use by qualified
physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the
human body.
The system is used with a transducer attached and is powered either by battery or by AC electrical power. The
clinician is positioned beside the patient and places the transducer onto (or into for invasive procedures) the
patient’s body where needed to obtain the desired ultrasound image.
The system transmits ultrasound energy into the patient’s body to obtain ultrasound images as described
below.
Abdominal Imaging Applications
You can 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.
Cardiac Imaging Applications
You can assess the heart size and function, cardiac valves, great vessels, visualize blood flow through cardiac
valves, and assess for the presence or absence of pathology. In addition, you can identify the presence and
location of fluid around the heart and lungs used to assist in pericardiocentesis and thoracentesis procedures.
You can detect normal lung motion for the presence or absence of pathology.

4Intendeduse
You can obtain the patient’s electrocardiogram (ECG). The ECG is used for timing of cardiac events.
Gynecology and Infertility Imaging Applications
You can assess the uterus, ovaries, adnexa, and surrounding anatomical structures for the presence or absence
of pathology transabdominally or transvaginally.
Interventional Imaging Applications
You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement,
peripheral nerve blocks, ova harvesting, amniocentesis and other obstetrical procedures, and provide
assistance during abdominal, breast, and neurological surgery.
Obstetrical Imaging Applications
You can assess the fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and
surrounding anatomical structures for the presence or absence of pathology transabdominally or
transvaginally. CPD and Color imaging are intended for high-risk pregnant women. High-risk pregnancy
indications include, but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, as well
as maternal hypertension, diabetes, and lupus.
Pediatric and Neonatal Imaging Applications
You can assess the pediatric and neonatal abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal
head, and surrounding anatomical structures for the presence or absence of pathology.
WARNING The ECG is not used to diagnose cardiac arrhythmias and is not designed for long
term cardiac rhythm monitoring.
WARNINGS To prevent injury or misdiagnosis, do not use this system for Percutaneous
Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not
been validated to be proven effective for these two uses.
CPD or Color images can be used as an adjunctive method, not as a screening
tool, for the detection of structural anomalies of the fetal heart and as an
adjunctive method, not as a screening tool, for the diagnosis of Intrauterine
Growth Retardation (IUGR).