FujiFilm SonoSite Edge II User manual

SonoSite Edge II
Ultrasound System User Guide
USER GUIDE

SiteLink, SonoSite Edge, SonoHD2, SonoMB, Steep Needle Profiling, SonoSite, and the SonoSite logo are trademarks and registered
trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America
Corporation.
DICOM is a registered trademark of the National Electrical Manufacturers Association.
All other trademarks are the property of their respective owners.
Patents: US 9,151,832; US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US 8,527,033; US 8,500,647; 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;
US 8,052,606; US 7,819,807; US 7,804,970; US 7,740,586; US 7,686,766; US 7,604,596; US 7,591,786; 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; US 6,569,101; 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; US 5,817,024; US 5,782,769; US 5,722,412; AU: 730822;
AU: 727381; CA 2,372,152; CA: 2,371,711; CN103237499; CN101231457; CN 98108973.9; CN 98106133.8; CN 97113678.5; DE
69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE 602004023816.3; 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; FR 0881492; 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 5782428;
JP 4696150; KR 532359; KR 528102; NO 326814; NO 326202 and pending.
Part number: P20516-04
Publication Date: May 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
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 Federal (United States) law restricts this device to sale by or on the order of a
physician.

iii
CONTENTS
1. Introduction
Changes in version 1.2 ....................................................................................................................................... 1-1
Document conventions ...................................................................................................................................... 1-1
Getting help .............................................................................................................................................................. 1-2
2. Getting Started
About the system .................................................................................................................................................. 2-1
License key ............................................................................................................................................................... 2-1
Intended uses ......................................................................................................................................................... 2-1
Hardware features ................................................................................................................................................. 2-4
Preparing the system .......................................................................................................................................... 2-5
Installing or removing the battery ....................................................................................................... 2-5
Using AC power and charging the battery .................................................................................... 2-7
Turning the system on or off ................................................................................................................. 2-8
Connecting transducers ............................................................................................................................ 2-9
Inserting and removing USB storage devices ............................................................................2-10
System controls ...................................................................................................................................................2-12
Screen layout .........................................................................................................................................................2-14
General interaction ..............................................................................................................................................2-15
Touchpad and cursor ..............................................................................................................................2-15
On-screen controls ....................................................................................................................................2-16
Annotation and text ................................................................................................................................2-17
Preparing the transducers ...............................................................................................................................2-19
3. System Setup
Displaying the setup pages .............................................................................................................................. 3-1
Restoring default settings ................................................................................................................................. 3-1
A & B Key, Footswitch setup ........................................................................................................................... 3-1
Administration setup ............................................................................................................................................ 3-2
Security settings ........................................................................................................................................... 3-2
User setup ....................................................................................................................................................... 3-4
Exporting or importing user accounts ............................................................................................... 3-5
Exporting and clearing the Event log ................................................................................................ 3-5
Logging in as user ....................................................................................................................................... 3-6
Choosing a secure password ................................................................................................................. 3-6
Annotations setup ................................................................................................................................................. 3-7

iv
Audio, Battery setup ............................................................................................................................................ 3-8
Cardiac Calculations setup ............................................................................................................................... 3-9
Connectivity setup ................................................................................................................................................ 3-9
Date and Time setup ......................................................................................................................................... 3-10
Display Information setup .............................................................................................................................. 3-10
Network Status setup ....................................................................................................................................... 3-11
OB Calculations setup ...................................................................................................................................... 3-11
OB Custom Measurements setup .............................................................................................................. 3-12
OB Custom Tables setup ................................................................................................................................. 3-12
Presets setup ........................................................................................................................................................ 3-14
System Information setup .............................................................................................................................. 3-15
USB Devices setup ............................................................................................................................................ 3-16
Limitations of JPEG format ................................................................................................................... 3-17
4. Imaging
Imaging modes ....................................................................................................................................................... 4-1
2D imaging ...................................................................................................................................................... 4-1
M Mode imaging .......................................................................................................................................... 4-4
CPD and Color imaging ............................................................................................................................. 4-4
PW and CW Doppler imaging ............................................................................................................... 4-6
Adjusting depth and gain .................................................................................................................................. 4-9
Freezing, viewing frames, and zooming ................................................................................................. 4-10
Visualizing needles ............................................................................................................................................. 4-11
About Steep Needle Profiling technology ................................................................................... 4-11
Needle size and angle ............................................................................................................................ 4-13
Additional recommendations .............................................................................................................. 4-14
Centerline ................................................................................................................................................................ 4-14
Imaging modes and exams available by transducer ........................................................................ 4-15
Annotating images ............................................................................................................................................. 4-23
Patient information form .................................................................................................................................. 4-25
Patient information form fields ........................................................................................................... 4-27
Images and clips .................................................................................................................................................. 4-28
Saving images and clips ........................................................................................................................ 4-28
Reviewing patient exams ..................................................................................................................... 4-30
Printing, exporting, and deleting images and clips ................................................................. 4-32
ECG ............................................................................................................................................................................ 4-34
ECG controls ................................................................................................................................................ 4-35
5. Measurements and Calculations
Measurements ......................................................................................................................................................... 5-1
Working with calipers ................................................................................................................................ 5-1
Saving measurements ............................................................................................................................... 5-2
2D measurements ....................................................................................................................................... 5-3
M Mode measurements ........................................................................................................................... 5-4

v
Doppler measurements ............................................................................................................................ 5-5
General Calculations ............................................................................................................................................. 5-7
Calculations menu ........................................................................................................................................ 5-7
Performing and saving measurements in calculations ............................................................. 5-8
Displaying, repeating, and deleting saved measurements ................................................... 5-8
EMED calculations ....................................................................................................................................... 5-9
Percent reduction calculations ............................................................................................................... 5-9
Volume calculation .................................................................................................................................... 5-11
Volume flow calculation ......................................................................................................................... 5-11
Exam-based calculations ................................................................................................................................ 5-13
Arterial calculations .................................................................................................................................. 5-13
Cardiac calculations .................................................................................................................................. 5-15
Gynecology (Gyn) calculations .......................................................................................................... 5-29
OB calculations ........................................................................................................................................... 5-30
Small Parts and MSK calculations ..................................................................................................... 5-35
Transcranial Doppler and Orbital calculations ............................................................................ 5-36
Patient reports and worksheets .................................................................................................................. 5-38
Arterial and cardiac patient reports ................................................................................................. 5-39
OB patient report ...................................................................................................................................... 5-39
TCD patient report .................................................................................................................................... 5-40
EMED and MSK worksheets ............................................................................................................... 5-40
6. Measurement references
Measurement accuracy ...................................................................................................................................... 6-1
Sources of measurement errors ........................................................................................................... 6-3
Measurement publications and terminology ........................................................................................... 6-4
Cardiac references ....................................................................................................................................... 6-4
Obstetrical references ............................................................................................................................. 6-14
General references ................................................................................................................................... 6-20
7. Troubleshooting and Maintenance
Troubleshooting ...................................................................................................................................................... 7-1
Software licensing ................................................................................................................................................. 7-3
Maintenance ............................................................................................................................................................. 7-4
Cleaning and disinfecting ......................................................................................................................... 7-4
8. Cleaning and Disinfecting
Before getting started ......................................................................................................................................... 8-1
Determining the required cleaning and disinfecting level ................................................................ 8-2
Spaulding classifications ........................................................................................................................... 8-3
Clean and disinfect system and transducer to a high level (semi-critical uses) ................... 8-3
......................Clean and disinfect system and transducer to a low level (non-critical uses) 8-8

vi
Storing the transducer ..................................................................................................................................... 8-11
Transporting the transducer .......................................................................................................................... 8-11
Cleaning the stand ............................................................................................................................................. 8-13
Cleaning accessories ......................................................................................................................................... 8-13
Cleaning and disinfecting the ECG cable and slave cable ................................................... 8-13
9. Safety
Ergonomic safety ................................................................................................................................................... 9-1
Position the system .................................................................................................................................... 9-2
Position yourself ........................................................................................................................................... 9-2
Take breaks, exercise, and vary activities ....................................................................................... 9-3
Electrical safety ....................................................................................................................................................... 9-4
Electrical safety classification ................................................................................................................. 9-7
Equipment safety ................................................................................................................................................... 9-8
Battery safety .......................................................................................................................................................... 9-9
Clinical safety ........................................................................................................................................................ 9-10
Hazardous materials .......................................................................................................................................... 9-11
Electromagnetic compatibility ...................................................................................................................... 9-11
Wireless transmission ............................................................................................................................. 9-12
Electrostatic discharge ............................................................................................................................ 9-13
Separation distance .................................................................................................................................. 9-14
Compatible accessories and peripherals ....................................................................................... 9-14
Manufacturer’s declaration ................................................................................................................... 9-17
Labeling symbols ................................................................................................................................................ 9-20
Specifications ........................................................................................................................................................ 9-24
Dimensions ................................................................................................................................................... 9-24
Environmental limits ................................................................................................................................ 9-25
Electrical specifications ........................................................................................................................... 9-25
Battery specifications .............................................................................................................................. 9-25
Standards ................................................................................................................................................................ 9-26
Electromechanical safety standards ................................................................................................ 9-26
EMC standards classification ............................................................................................................... 9-26
Biocompatibility standards ................................................................................................................... 9-27
Airborne equipment standards .......................................................................................................... 9-27
DICOM standard ........................................................................................................................................ 9-27
HIPAA standard .......................................................................................................................................... 9-27
10. Acoustic Output
ALARA principle .................................................................................................................................................. 10-1
Applying the ALARA principle ........................................................................................................... 10-1
Direct controls ............................................................................................................................................. 10-2
Indirect controls .......................................................................................................................................... 10-2
Receiver controls ....................................................................................................................................... 10-3
Acoustic artifacts ................................................................................................................................................. 10-3

vii
Guidelines for reducing MI and TI .............................................................................................................. 10-3
Output display ...................................................................................................................................................... 10-7
MI and TI output display accuracy ................................................................................................... 10-9
Factors that contribute to display uncertainty ........................................................................... 10-9
Related guidance documents ............................................................................................................. 10-9
Transducer surface temperature rise ..................................................................................................... 10-10
Acoustic output measurement ................................................................................................................. 10-11
In Situ, derated, and water value intensities ........................................................................... 10-11
Tissue models and equipment survey ........................................................................................ 10-12
Acoustic output tables .................................................................................................................................. 10-13
Terms used in the acoustic output tables ................................................................................. 10-68
Acoustic measurement precision and uncertainty ............................................................... 10-70
11. IT Network
Functions ................................................................................................................................................................. 11-1
Network for connecting the device ........................................................................................................... 11-1
Specifications for the connection ............................................................................................................... 11-1
Glossary
Terms ............................................................................................................................................................................A-1
Abbreviations ...........................................................................................................................................................A-2
Index .....................................................................................................................................B-1

viii

Introduction 1-1
CHAPTER 1
Introduction
This SonoSite Edge II Ultrasound System User Guide provides information on preparing
and using the SonoSite Edge II ultrasound system and on cleaning and disinfecting the
system and transducers. It also provides system specifications, and safety and acoustic
output information.
The user guide is for a reader familiar with ultrasound techniques. It does not provide
training in sonography or clinical practices. Before using the system, you must have
ultrasound training.
Refer to the applicable FUJIFILM SonoSite accessory user guide for information on using
accessories and peripherals. Refer to the manufacturer’s instructions for specific
information about peripherals.
Changes in version 1.2
Document conventions
The user guide 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.
Single-step procedures begin with .
Features Description
rP19x needle guide; HFL38xi
and L25x armored transducers;
lowered MI setting; new USB
export option
Needle guide enabled for the rP19x transducer.
HFL38xi and L25x armored transducers now
available. MI setting lowered for LVO On control.
Option to disable USB export.

1-2 Introduction
Symbols and terms used on the system and transducer are explained in “Labeling symbols” on page 9-20
and the “Glossary” on page A-1.
Getting help
In addition to this user guide, the following resources are available:
Instructional videos available on-line.
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]

Getting Started 2-1
CHAPTER 2
Getting Started
About the system
The SonoSite Edge II ultrasound system is a portable, software-controlled device using
all-digital architecture. The SonoSite Edge II includes the following configurations:
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.
License key
A license key is required to activate the software. Refer to “Software licensing” on
page 7-3. On occasion, a software upgrade may be required. FUJIFILM SonoSite provides
a USB device containing the software. One USB device can upgrade multiple systems.
Intended uses
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.

2-2 Getting Started
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.
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.
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.
WARN ING To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms.
The FUJIFILM SonoSite ECG option is a non-diagnostic feature.

Getting Started 2-3
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.
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.
WARNINGS During the first trimester, you should limit the duration of ultrasound imaging
based on MI/TI. See Chapter 10, “Acoustic Output,” for more information.
To prevent injury or misdiagnosis, do not use this system for fetal growth
screening if the advanced OB calculations and reports package is not available.
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).
WARN ING 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.

2-4 Getting Started
Arterial and venous 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.
Hardware features
Figure 2-1 Front of the SonoSite Edge II Ultrasound System
Note For the intended transducer and imaging modes for each exam type, see
“Imaging modes and exams available by transducer” on page 4-15.
1Control panel 4 USB ports
2AC power indicator 5 Handle
3Display
2
3
4
5
1

Getting Started 2-5
Figure 2-2 Back of the SonoSite Edge II Ultrasound System
Basic operating steps
1Attach a transducer.
2Turn the system on. For power switch location, see “System controls” on page 2-12.
3Press the PATIENT key, and complete the patient information form.
4Press an imaging mode key:
2D
MMODE
C COLOR
D DOPPLER
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.
1DCinput 3I/Oconnector
2 Battery 4 ECG connector
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 9-9.
1234

2-6
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.

Getting Started 2-7
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
on page 2-5.
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.
WARN INGS Verify that the hospital supply voltage corresponds to the power supply voltage
range. See “Specifications” on page 9-24.
Plug the system only into a grounded hospital-grade outlet.
Use only power cords provided by FUJIFILM SonoSite with the system.
Cautions The equipment is not provided with an AC mains power switch. To disconnect the
equipment from mains, use the appliance coupler or mains plug on the power
supply cord.
Install the ultrasound system in a place where you can easily connect or
disconnect the AC power cord.
Disconnecting only the DC power cable from the system does not separate the
system from the supply mains.

2-8 Getting Started
Turning the system on or off
To turn the system on or off
Press the power switch. See “System controls” on page 2-12.
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 3-8.
Caution Do not use the system if an error message appears on the image display: note the
error code; call FUJIFILM SonoSite or your local representative; turn off the
system by pressing and holding the power key until the system powers down.

Getting Started 2-9
Connecting transducers
To connect a transducer
1Remove the system from the mini-dock (if present), and turn it upside down.
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.
WARN ING 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.

2-10 Getting Started
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.
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.
Note The system does not support password-protected or encrypted USB storage
devices. Make sure that the USB storage device you use does not have password
protection or encryption enabled.
USB storage devices must be in FAT-32 format.
Caution 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.