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).

Intended use 5
Superficial Imaging Applications
You can assess the breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue
structures, ophthalmic structures, and surrounding anatomical structures for the presence or absence of
pathology. You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line
placement, peripheral nerve blocks.
Transcranial Imaging Applications
You can assess the anatomical structures and vascular anatomy of the brain for presence or absence of
pathology. You can use imaging temporally, trans-occipitally, or trans-orbitally.
Vascular Imaging Applications
You can 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
The SonoSite Edge II ultrasound system has no known contraindications.
WARNING To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam
type when performing imaging through the eye. The FDA has established lower
acoustic energy limits for ophthalmic use. The system will not exceed these limits
only if the Orb or Oph exam type is selected.
Note For the intended transducer and imaging modes for each exam type, refer to
“Imaging modes and exams available by transducer” on page 50.

6Hardwarefeatures
Hardware features
The front of the system is shown in Figure 2-1.
Figure 2-1 Front of the SonoSite Edge II Ultrasound System
The back of the system is shown in Figure 2-2.
Figure 2-2 Back of the SonoSite Edge II Ultrasound System
1Control panel 4 USB ports
2AC power indicator 5 Handle
3Display
1DCinput 3I/Oconnector
2Battery 4ECGconnector
2
3
4
5
1
1234

Preparing the system 7
Basic operating steps
1Attach a transducer.
2Turn the system on. For power switch location, see “System controls”on page 13.
3Press the PATIENT key, and complete the patient information form.
4Press an imaging mode key:
2D
MMODE
CCOLOR
DDOPPLER
Preparing the system
Installing or removing the battery
To install the battery
1Disconnect the power supply from the ultrasound system.
2Remove the system from the mini-dock (if present) and turn it upside down.
WARNINGS To avoid injury to the operator and to prevent damage to the ultrasound system,
inspect the battery for leaks prior to installing.
To avoid data loss and to conduct a safe system shutdown, always keep a battery
in the system.
See “Battery safety” on page 153.

8Preparing the system
3Place the battery into the battery compartment, at a slight angle.
4Slide the battery forward until it locks into place.
5Slide the two locking levers outward to secure the battery.
To remove the battery
1Disconnect the power supply from the ultrasound system.
2Remove the system from the mini-dock (if present) and turn it upside down.
3Pull up the two locking levers.
4Slide the battery back.
5Lift the battery from the compartment.

Preparing the system 9
Using AC power and charging the battery
When using AC power, position the system to allow easy access to disconnect it.
The battery charges when the system is connected to the AC power supply. A fully discharged battery
recharges in less than five hours. The system can run on AC power and charge the battery if AC power is
connected to the system directly, to a mini-dock, or to a docking system.
The system can run on battery power for up to two hours, depending on the imaging mode and the display
brightness. When running on battery power, the system may not restart if the battery is low.
To continue, connect the system to AC power.
To operate the system using AC power
1Connect the DC power cable from the power supply to the connector on the system. Refer to Figure 2-2.
2Push the cable in firmly to ensure a secure connection.
3Connect the AC power cord to the power supply and to a hospital-grade electrical outlet.
To separate the system (and any connected equipment) from a supply mains
Disconnect the AC power cord from the power supply or (alternatively, if using a stand) from the AC adapter
on the stand base.
Caution When using AC power, position the system to allow easy access to disconnect it.
WARNING The equipment shall be connected to a center-tapped single phase supply circuit
when users in the United States connect the equipment to a 240V supply system.
Caution Verify that the hospital supply voltage corresponds to the power supply voltage
range. See “Specifications”on page 170.
Note Disconnecting only the DC power cable from the system or dock does not separate
the system from the supply mains.

10 Preparing the system
Turning the system on or off
To turn the system on or off
Press the power switch. See “System controls”on page 13.
To wake up the system
To conserve battery life while the system is on, the system goes into sleep mode if the lid is closed or if the
system is untouched for a preset time.
Press a key, touch the touchpad, or open the lid.
To adjust the time for sleep delay
Refer to “Audio, Battery setup”on page 28.
Connecting transducers
To connect a transducer
1Remove the system from the mini-dock (if present), and turn it upside down.
Caution Do not use the system if an error message appears on the display. Note the error
code and turn off the system. Call FUJIFILM SonoSite or your local representative.
WARNING To avoid injury to the patient, do not place the connector on the patient. Operate
the ultrasound system in a docking system or on a flat hard surface to allow air flow
past the connector.
Caution To avoid damaging the transducer connector, do not allow foreign material in the
connector.
Note The system automatically checks for and notifies you of errors when connecting a
transducer.

Preparing the system 11
2Pull the transducer latch up, and rotate it clockwise. Align the transducer connector with the connector on
the bottom of the system.
3Insert the transducer connector into the system connector.
4Turn the latch counterclockwise.
5Press the latch down, securing the transducer connector to the system.
To remove a transducer
1Pull the transducer latch up.
2Rotate it clockwise.
3Pull the transducer connector away from the system.

12 Preparing the system
Inserting and removing USB storage devices
You can use a USB storage device to import and export various logs and setup configurations, and to archive
images and clips.
Images and clips are saved to internal storage and are organized in a sortable patient list. You can archive the
images and clips from the ultrasound system to a PC using a USB storage device or Ethernet connection.
Although the images and clips cannot be viewed from a USB storage device on the ultrasound system, you can
remove the device and view them on your PC.
There are two USB ports on the system, and one on the mini-dock. For additional USB ports, you can connect
a USB hub into any USB port.
To insert a USB storage device
Insert the USB storage device into any USB port on the system or mini-dock. See Figure 2-1. The USB storage
device is ready when the USB icon appears.
To view information about the device
Refer to “USB Devices setup” on page 34.
To remove a USB storage device
Removing the USB storage device while the system is exporting to it may cause the exported files to be
corrupted or incomplete.
1Wait five seconds after the USB animation stops.
2Remove the USB storage device from the port.
Note USB storage devices must be in FAT-32 format.
WARNING To avoid damaging the USB storage device and losing patient data from it, observe
the following:
Do not remove the USB storage device or turn off the ultrasound system while the
system is exporting.
Do not bump or otherwise apply pressure to the USB storage device while it is in
a USB port on the ultrasound system. The connector could break.
Caution If the USB icon does not appear in the system status area on-screen, the USB storage
device may be defective. Turn the system off and replace the device.

System controls 13
System controls
Table 2-1: Keyboard map
1Control keys Adjust on-screen controls.
2Alphanumeric keys Enter text and numbers.
3Annotation keys See “Alphanumeric keyboard” on page 17.
4Gain
NEAR Adjusts the gain applied to the near field of the image.
FAR In live imaging, adjusts the gain applied to the far field of the image.
On a frozen PW Doppler image, adjusts the angle.
GAIN In live imaging, adjusts the overall gain applied to the entire image.
On a frozen image, moves the cine buffer.
FREEZE
SELECT
CALC SAVE
CLIP
SAVE CALC
CALIPER
SET
NEAR
GAIN
AUTO
FAR
DEPTH
ZOOM UPDATE PROGRAM
AB
DOPPLER
D
2D
M
C
COLOR
MODE
1
2
3
4
5
69
10
11 12 13 14
15
16
17
18
19
78

14 Systemcontrols
5AUTO Adjusts gain automatically.
6ZOOM Magnifies the image 100%.
7DEPTH UP,
DEPTH DOWN
Decreases and increases imaging depth.
8SET
CALIPER
Sets a trace measurement.
Displays calipers on-screen for measuring.
9CALC Turns the calculations menu on and off.
10 Touchpad Selects, adjusts, and moves items on-screen.
11 FREEZE Stops live imaging and displays a frozen image.
12 SAVE Saves an image to internal storage. If configured, also saves calculations to
the report. Refer to “Presets setup”on page 33.
13 SAVE CALC
CLIP
Saves calculations and their measurements to the patient report.
Saves a clip to internal storage.
14 Imaging Modes
MMODE Turns M Mode on, toggles between M-line and M Mode trace.
DOPPLER Turns Doppler on, toggles between D-line and Doppler trace.
COLOR Turns CPD/Color on and off.
2D Turns 2D on.
15 A & B shortcut keys Keys that you can program to perform common tasks.
16 UPDATE Toggles between dual and duplex screens and imaging modes in M Mode
and Doppler (for example, between D-line and Doppler spectral trace).
17 SELECT Used with the touchpad to select items on-screen. Also switches between
Color and Doppler controls, calipers for measurement, pictograph-marker
position and angle, frozen images in duplex and dual screens, and arrow
position and orientation.
18 Forms
PATIENT Accesses patient information.
Table 2-1: Keyboard map (continued)