Fujifilm Sonosite S II User Manual
USER GUIDE
Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021 USA
T: 1-888-482-9449 or 1-425-951-1200
F: 1-425-951-1201
EC Authorized Representative
FUJIFILM SonoSite B.V.
Joop Geesinkweg 140
1114 AB Amsterdam,
The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW, 2100
Australia
Caution
SonoSite SII, SonoHD2, SonoMB, 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.
FUJIFILM is a registered and unregistered trademark of FUJIFILM Corporation in various jurisdictions.
Patents: 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 8,376,103; US 8,216,146; US
8,213,467; US 8,137,278; US 8,066,642; US 7,978,461; US 7,804,970; US 7,740,586; US 7,686,766; 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 6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US 6,371,918; US
6,364,839; US 6,135,961; US 5,893,363; US 5,817,024; US 5,782,769; US 5,722,412; US 8,805,047; US 8,527,033; US 8,858,436; US 8,861,822;
US 8,956,296; AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CA 2,373,065; CN103237499; CN101231457; CN 97113678.5; CN
98106133.8; CN 200830007734.8; EP 0875203; EP 0881492; EP 1175713; EP P22783-01; EP 1180971; EP 1552792; EP 1589878; JP 5782428;
JP 4696150; KR 528102; and KR 532359.
Part number: P20536-04
Publication date: November 2017
Copyright © 2017 FUJIFILM SonoSite, Inc. All rights reserved.
Federal (United States) law restricts this device to sale by or on the order of a
physician.
ii
1. Introduction
Document conventions ...................................................................................................................................... 1-1
Getting help .............................................................................................................................................................. 1-2
2. Getting Started
About the system .................................................................................................................................................. 2-1
License Key .............................................................................................................................................................. 2-1
Preparing the system .......................................................................................................................................... 2-2
Components and connectors ................................................................................................................ 2-2
Installing or removing the battery ....................................................................................................... 2-3
Using AC power and charging the battery .................................................................................... 2-4
Turning the system on or off ................................................................................................................. 2-5
Connecting transducers ............................................................................................................................ 2-6
Inserting and removing USB storage devices .............................................................................. 2-7
System controls ...................................................................................................................................................... 2-9
Screen layout ........................................................................................................................................................... 2-9
General interaction ..............................................................................................................................................2-11
Touchpad ........................................................................................................................................................2-11
Touch screen ................................................................................................................................................2-12
Control buttons and knobs ...................................................................................................................2-12
Entering text .................................................................................................................................................2-12
Preparing transducers .......................................................................................................................................2-14
Acoustic coupling gel ...............................................................................................................................2-14
Intended uses ........................................................................................................................................................2-15
3. System Setup
Displaying the Settings pages ........................................................................................................................ 3-1
Administration setup ............................................................................................................................................ 3-2
Security settings ........................................................................................................................................... 3-2
Administering users .................................................................................................................................... 3-3
CONTENTS
Exporting and clearing the Event log ................................................................................................ 3-5
Logging in as user ................................................................................................................................................. 3-5
Choosing a secure password ................................................................................................................. 3-5
System setup ........................................................................................................................................................... 3-6
Annotations settings .................................................................................................................................. 3-6
Audio, Battery settings ............................................................................................................................. 3-7
iii
Connectivity settings ................................................................................................................................. 3-8
Date and Time settings ............................................................................................................................. 3-9
Display Information settings .................................................................................................................3-10
Footswitch settings ...................................................................................................................................3-10
Network Status settings .........................................................................................................................3-10
OB Calculations settings .........................................................................................................................3-11
Presets settings ...........................................................................................................................................3-11
System Information settings ................................................................................................................3-12
USB Devices settings ...............................................................................................................................3-12
Limitations of JPEG format ...................................................................................................................3-13
4. Imaging
Imaging modes ....................................................................................................................................................... 4-1
2D imaging ...................................................................................................................................................... 4-1
M Mode imaging .......................................................................................................................................... 4-3
CPD and Color imaging ............................................................................................................................. 4-4
Adjusting depth and gain .................................................................................................................................. 4-5
Freezing, viewing frames, and zooming ................................................................................................... 4-6
Needle visualization ............................................................................................................................................. 4-7
About Steep Needle Profiling technology ...................................................................................... 4-7
Needle size and angle ............................................................................................................................... 4-9
Additional recommendations ...............................................................................................................4-10
Centerline .................................................................................................................................................................4-10
Imaging modes and exams available by transducer ........................................................................4-11
Annotating images ..............................................................................................................................................4-15
Patient information form ..................................................................................................................................4-16
Patient information form fields ............................................................................................................4-18
Images and clips ...................................................................................................................................................4-19
Saving images and clips .........................................................................................................................4-19
Reviewing patient exams ......................................................................................................................4-20
Printing, exporting, and deleting images and clips ..................................................................4-22
5. Measurements and Calculations
CONTENTS
Measurements ........................................................................................................................................................ 5-1
Working with calipers ................................................................................................................................ 5-1
Saving measurements ............................................................................................................................... 5-3
2D measurements ....................................................................................................................................... 5-4
M-Mode measurements .......................................................................................................................... 5-5
iv
Calculations ............................................................................................................................................................... 5-7
Calculations menu ....................................................................................................................................... 5-7
Performing and saving measurements in calculations ............................................................. 5-8
Displaying and deleting saved measurements in calculations ............................................. 5-8
General calculations .................................................................................................................................... 5-8
Cardiac calculations ...................................................................................................................................5-10
MSK calculations ........................................................................................................................................5-15
Gynecology (Gyn) calculations ..........................................................................................................5-16
OB calculations ............................................................................................................................................5-17
Patient report .........................................................................................................................................................5-20
MSK worksheets ..................................................................................................................................................5-21
6. References
Measurement accuracy ...................................................................................................................................... 6-1
Sources of measurement errors .................................................................................................................... 6-2
Measurement publications and terminology .......................................................................................... 6-2
Cardiac references ....................................................................................................................................... 6-3
Obstetrical references ................................................................................................................................ 6-8
Gestational age tables ............................................................................................................................... 6-9
Ratio calculations ........................................................................................................................................6-12
General references ....................................................................................................................................6-12
7. Troubleshooting and Maintenance
Troubleshooting ...................................................................................................................................................... 7-1
Software licensing ................................................................................................................................................. 7-2
Maintenance ............................................................................................................................................................. 7-3
Cleaning and disinfecting ......................................................................................................................... 7-4
8. Cleaning and disinfecting
Before getting started ......................................................................................................................................... 8-1
CONTENTS
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) 8-9
Storing the transducer ......................................................................................................................................8-12
Transporting the transducer ...........................................................................................................................8-12
v
Cleaning the stand ..............................................................................................................................................8-14
Cleaning accessories ..........................................................................................................................................8-14
Air dry or towel dry with a clean cloth. .........................................................................................8-14
.............................................................................................................................................................................8-14
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 classification ........................................................................................................................... 9-4
Electrical safety ....................................................................................................................................................... 9-4
Equipment safety .................................................................................................................................................. 9-6
Battery safety .......................................................................................................................................................... 9-7
Clinical safety ........................................................................................................................................................... 9-8
Hazardous materials ............................................................................................................................................. 9-8
Electromagnetic compatibility ......................................................................................................................... 9-9
Wireless transmission ..............................................................................................................................9-10
Electrostatic discharge .............................................................................................................................9-11
Separation distance ..................................................................................................................................9-12
Compatible accessories and peripherals .......................................................................................9-12
Manufacturer’s declaration ...................................................................................................................9-14
Labeling symbols .................................................................................................................................................9-18
Specifications .........................................................................................................................................................9-22
System .............................................................................................................................................................9-22
Supported transducers ...........................................................................................................................9-23
Imaging modes ...........................................................................................................................................9-23
Images and clips storage .......................................................................................................................9-23
Accessories ...................................................................................................................................................9-24
Peripherals .....................................................................................................................................................9-24
Environmental limits .................................................................................................................................9-24
Electrical specifications ...........................................................................................................................9-25
Battery specifications ...............................................................................................................................9-25
Standards .................................................................................................................................................................9-25
CONTENTS
Electromechanical safety standards .................................................................................................9-25
EMC standards classification ................................................................................................................9-26
Biocompatibility standards ....................................................................................................................9-26
Airborne equipment standards ...........................................................................................................9-26
DICOM standard .........................................................................................................................................9-27
HIPAA standard ...........................................................................................................................................9-27
vi
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
Guidelines for reducing MI and TI ...............................................................................................................10-3
Output display .......................................................................................................................................................10-6
MI and TI output display accuracy ....................................................................................................10-8
Factors that contribute to display uncertainty ............................................................................10-8
Related guidance documents ..............................................................................................................10-8
Transducer surface temperature rise ........................................................................................................10-9
Acoustic output measurement ..................................................................................................................10-10
In Situ, derated, and water value intensities ............................................................................10-10
Tissue models and equipment survey .........................................................................................10-11
Acoustic output tables ...................................................................................................................................10-12
Terms used in the acoustic output tables ..................................................................................10-47
Acoustic measurement precision and uncertainty ................................................................10-48
11. IT Network
Functions ..................................................................................................................................................................11-1
Network for connecting the device ...........................................................................................................11-1
Specifications for the connection ................................................................................................................11-1
Hardware specification ............................................................................................................................11-1
Software Specifications ..........................................................................................................................11-1
Security ...........................................................................................................................................................11-2
Data flow ........................................................................................................................................................11-2
A. Glossary
Terms ...........................................................................................................................................................................A-1
CONTENTS
Abbreviations ...........................................................................................................................................................A-3
Index ..................................................................................................................................... B-1
vii
viii
Introduction
This SonoSite SII Ultrasound System User Guide provides information on preparing and
using the SonoSite SII 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.
Features Description
rP19x needle guide; HFL38xi
and L25x armored transducers;
Footswitch; new USB export
option
Needle guide enabled for the rP19x transducer.
HFL38xi and L25x armored transducers, and
footswitch now available. Option to disable USB
export.
Document conventions
The user guide follows these conventions:
A
WARN ING 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.
Chapter 1
Bulleted lists present information in list format but do not imply a sequence.
Single-step procedures begin with
Symbols and terms used on the system and transducer are explained in “Labeling
symbols” on page 9-18 and the “Glossary” on page A-1.
Introduction 1-1
.
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)
Phone
(outside U.S. or
Canada)
Fax 425-951-6700
Email ffss-service@sonosite.com
Web www.sonosite.com
Europe Service Center Main: +31 20 751 2020
Asia Service Center +65 6380-5581
877-657-8118
425-951-1330, or call your local representative
English support: +44 14 6234 1151
French support: +33 1 8288 0702
German support: +49 69 8088 4030
Italian support: +39 02 9475 3655
Spanish support: +34 91 123 8451
1-2 Introduction
Getting Started
About the system
The SonoSite SII ultrasound system is a portable, software-controlled device using
all-digital architecture. The SonoSite SII includes the following configurations:
S-Total
S-Vascular
S-Vet
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 7-2. On occasion, a software upgrade may be required. FUJIFILM SonoSite provides
a USB device containing the software. One USB device can upgrade multiple systems.
Basic steps
1 Turn the system on. For power switch location, refer to Figure 2-1 on page 2-2.
2 Attach a transducer.
3 Ta p Patient, and then tap Information.
4 Complete the patient information form.
Chapter 2
Getting Started 2-1
If all imaging modes are licensed, press Mode, and select an imaging mode.
Note By default, the system is in 2D imaging.
Preparing the system
Connector block (see detail below)
Battery
Transducer connector ports
USB ports
RJ45
Network port
HDMI out
DC
power in
Printer
output
Mounting holes
Power switch
Connector block detail
Components and connectors
The back of the system has compartments for the battery and two transducers as well as connectors for
USB devices, power cord, network cable, and more. Refer to Figure 2-1.
Figure 2-1 System Back
2-2 Getting Started
Each connector has a symbol that describes its use.
USB
DC input
Composite video out
Print control
Ethernet
HDMI HDMI video out
Installing or removing the battery
WA RN I N GS 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.
To install the battery
1 Ensure the ultrasound system is turned off.
2 Disconnect the power supply.
3 At the back of the system, slide the four prongs on the end of the battery into the slots on the right side
of the battery compartment.
Getting Started 2-3
4 Push the battery into the battery compartment and press until the latch engages.
To remove the battery
1 Ensure the ultrasound system is turned off.
2 Disconnect the power supply.
3 Slide the locking lever on the left side of the battery, and lift the battery up.
Using AC power and charging the battery
The battery charges when the system is connected to the AC power supply. A fully discharged battery
recharges in less than five hours.
When the system is connected to AC power, the system can operate and charge the battery at the same
time.
Depending on the imaging mode and the display brightness, the system can run on battery power for up to
two hours. When running on battery power, the system may not restart if the battery charge is low. If the
system will not start due to a low battery condition, connect the system to AC power.
WA RN I N GS Verify that the hospital supply voltage corresponds to the power supply voltage
range. Refer to “Electrical specifications” on page 9-25.
Plug the system only into a grounded hospital-grade outlet.
Use only power cords provided by FUJIFILM SonoSite with the system.
2-4 Getting Started
To operate the system using AC power
Caution Be sure to keep the battery inserted in the system even if the system is connected
to the AC power supply.
1 Connect the DC power cable from the power supply to the power connector on the system. Refer to
Figure 2-1 on page 2-2.
2 Connect the AC power cord to the power supply, and then plug it in to a hospital-grade electrical outlet.
To separate the system (and any connected equipment) from a supply mains
Cautions The equipment is not provided with an AC mains po wer 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.
Disconnect the AC power cord from the stand base.
Turning the system on or off
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.
To turn the system on or off
Press the power switch. Refer to Figure 2-1 on page 2-2.
To wake up the system
To conserve battery life while the system is on, the system goes into sleep mode if untouched for a preset
time. To adjust the time for sleep delay, refer to “Audio, Battery settings” on page 3-7.
Press a key, or touch the touchpad.
Getting Started 2-5
Connecting transducers
WARNIN G To avoid injury to the patient, do not place the connector on the patient.
Caution To avoid damaging the transducer connector, do not allow foreign material in the
connector.
To connect a transducer
1 Pull the transducer latch up, and rotate it clockwise.
2 Align the transducer connector with the connector on the back of the system.
3 Insert the transducer connector into one of the transducer ports on the system.
4 Turn the latch counterclockwise.
5 Press the latch down, securing the transducer connector to the system.
2-6
To remove a transducer
1 Pull the transducer latch up, and rotate it clockwise.
2 Pull the transducer connector away from the system.
Inserting and removing USB storage devices
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. Although the images
and clips cannot be viewed from a USB storage device on the ultrasound system, you can remove the USB
storage device and view the images on your PC.
You can also import and export user accounts and the Event log using a USB storage device.
There are three USB ports located on the back of the system near the top. For additional USB ports, you can
connect a USB hub into any USB port.
WA RN I N GS 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 or software encrypted. Turn the system off and
replace the device.
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.
Getting Started 2-7
To insert a USB storage device
Insert the USB storage device into a USB port on the system. Refer to Figure 2-1 on page 2-2. The USB
storage device is ready when the USB icon appears.
To remove a USB storage device
Removing the USB storage device while the system is exporting may cause the exported files to be
corrupted or incomplete.
1 Wait at least five seconds after the USB animation stops.
2 Remove the USB storage device from the port.
2-8 Getting Started
System controls
1
2
4
6
57
8
9
3
9
1 Control
knobs
2 Freeze key Press and hold to freeze or
3 Touchpad Moves the pointer and other
4Touchpad
key
5 Print key Available only when a printer is
6 Save keys Tap one of these keys to save an
7 Image mode Tap one of these keys to change
8 System
controls
Turn to adjust gain, depth, cine
buffer, brightness, and more,
depending on context. Current
functions appear on-screen above
the knobs.
unfreeze the image.
items.
Works in conjunction with the
touchpad. Tap to activate an item
on-screen, or to switch between
color box functions. (active only
when the image is frozen.)
connected to the system. Tap to
print from a live or frozen scan.
image or a clip.
the imaging mode.
Change system settings, switch
transducers, add labels, or see
patient information.
9Image
controls
Use these to adjust the image.
Figure 2-2 Control layout
Screen layout
The layout of the S onoS ite SII syste m scree n and the c ontrols that appear on it chan ge according to imaging
mode or the specific task you are performing, such as measuring or annotating. During scanning, the
following information is available:
Getting Started 2-9
Figure 2-3 Screen layout
Patient name
Exam number
Facility
Date and time
Exam type
Transducer
Mechanical &
thermal indexes
Depth
Image status
System
controls
Image controls
2-10 Getting Started
General interaction
Touchpad
The touchpad is an area centered below the screen that you can use as a pointing device. When the
touchpad is active, drag your finger on the surface to move the item on screen.
Figure 2-4 Using the touchpad
You can use the touchpad to do the following:
Place labels
Move calipers
Move and shape region of interest (ROI) boxes
Position the M-line
Point to a text field in a form
Use the Select key below the touchpad to select or set the item after you have moved it.
Getting Started 2-11
Touch screen
As an alternative to the touchpad, you can move some items directly by dragging your finger on the screen.
Figure 2-5 Using the touch screen
Control buttons and knobs
There are two types of controls on the SonoSite SII system:
Screen controls
The controls that appear on the touchscreen change dynamically depending on the context. For example,
freezing an image may display the controls for zooming, performing measurements, and reviewing the
cine buffer. Only the controls that are available in the current mode or function will appear. To select a
control on the touchscreen, tap it once.
System controls
The buttons and knobs located below the touchscreen are persistent, but some may be disabled during
certain modes or conditions. Controls are lighted when active and dark when disabled. The label for each
knob appears on the screen just above it. The label and function of the knobs may change depending on
the mode or condition.
Entering text
In forms and annotations, you can enter text in text fields using either the on-screen keyboard or an external
USB keyboard connected to a USB port on the system.
2-12 Getting Started
If you are using an external USB keyboard, enter characters by typing. The TA B key navigates among text
fields.
WARNIN G To avoid contamination, do not use the USB keyboard supplied by FUJIFILM
SonoSite in a sterile environment. The USB keyboard is not sterilized and cannot
withstand sterilization.
To enter text in text fields using the on-screen keyboard
1 Using the touchpad or the touchscreen, select a text field.
The on-screen keyboard appears with the text field at the top.
2 On the touchscreen, tap each character you want to enter.
The Äñ key displays and hides international characters.
The Symbols key displays symbols and punctuation.
The Caps Lock key turns capital letters on and off.
The Shift key turns capital letters on or off for the next letter entered.
The Delete key deletes the character right of the pointer.
The backspace key deletes the character to the left of the pointer.
3 To navigate among text fields:
Ta p Next to advance to the next field.
Ta p Prev to return to the previous field.
4 To exit the keyboard, click one of the following:
OK to save changes.
2D to save changes and display 2D imaging.
Getting Started 2-13
Preparing transducers
WA RN I N GS Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
Some gels and disinfectants can cause an allergic reaction in some individuals.
Cautions To avoid damage to the transducer, use only gels recommended by FUJIFILM
SonoSite. Using gels other than the one recommended by FUJIFILM SonoSite can
damage the transducer and void the warranty. If you have questions about gel
compatibility, contact FUJIFILM SonoSite or your local representative.
FUJIFILM SonoSite recommends that you clean and disinfect transducers after
each use. Refer to “Cleaning and disinfecting” on page 8-1.
Acoustic coupling gel
Acoustic coupling gel must be used during exams. Although most gels provide suitable acoustic coupling,
some gels are incompatible with some transducer materials. FUJIFILM SonoSite recommends Aquasonic
gel and provides a sample with the system.
For general use, apply a liberal amount of gel between the transducer and the body. For invasive procedures,
apply a transducer sheath.
®
WARNIN G To prevent contamination, the use of sterile transducer sheaths and sterile coupling
gel is recommended for clinical applications of an invasive nature. Do not apply the
transducer sheath and gel until you are ready to perform the procedure.
To apply a transducer sheath
To lessen the risk of contamination, install the sheath only when you are ready to perform the procedure.
1 Place gel inside the sheath.
2 Insert the transducer into the sheath.
3 Pull the sheath over the transducer and cable until the sheath is fully extended.
4 Secure the sheath using the bands supplied with the sheath.
Check for and eliminate bubbles between the face of the transducer and the sheath.
Note Bubbles between the face of the transducer and the sheath may affect the
ultrasound image.
5 Inspect the sheath to ensure that there are no holes or tears.
2-14 Getting Started
Intended uses
The SonoSite SII 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.
For the intended transducer for each exam type, refer to “Imaging modes and exams available by
transducer” on page 4-11.
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. 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 to provide ultrasound guidance for biopsy and drainage procedures, vascular line
placement, peripheral nerve blocks, 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, fetal hydrops, placental abnormalities, as well as maternal
hypertension, diabetes, and lupus.
Getting Started 2-15
WA RN I N GS During the first trimester, you should limit the duration of ultrasound imaging
based on MI/TI. For more information, see “Acoustic Output” on page 10-1.
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)
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 to provide ultrasound guidance for biopsy and drainage procedures,
vascular line placement, and peripheral nerve blocks.
WARNIN G To avoid injury to the patient, use only an 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
Oph exam type is selected.
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 SII ultrasound system has no known contraindications.
2-16 Getting Started
System Setup
Use the Settings pages to customize the system and set preferences. The Settings pages
are organized into the following categories:
Administration - Control access to the system, including user accounts and passwords.
See “Administration setup” on page 3-2
Annotations - Create and customize predefined labels. See “Annotations settings”
on page 3-6
Audio and battery - Set audio alerts and power management settings. See “Audio,
Battery settings” on page 3-7
Connectivity - Manage connections and certificates to information storage services.
See “Connectivity settings” on page 3-8
Date and time - Set the system date and time. See “Date and Time settings” on
page 3-9
Display information - Control the amount of information that appears on-screen during
imaging. See “Display Information settings” on page 3-10
Network - View the st atus of your wireless network connection. See “Network Status
settings” on page 3-10
OB calculations - Select authors for OB gestational calculations. See “OB Calculations
settings” on page 3-11
Presets - Set general preferences. See “Presets settings” on page 3-11
System information - View system hardware and software versions. See “System
Information settings” on page 3-12
USB devices - View information on all connected USB devices. See “USB Devices
settings” on page 3-12
Displaying the Settings pages
Chapter 3
To display a settings page
1 Ta p Settings.
2 Under Settings Pages, select the page you want by tapping it.
System Setup 3-1
3 To return to imaging from a setup page, tap Done.
Administration setup
On the Administration settings page, you can configure the system to require users to log in and enter
passwords. Required login helps protect patient data. You can also add and delete users, change passwords,
import and export user accounts, disable USB export, and display the Event log.
To log in as Administrator
1 On the Administration settings page, type Administrator in the Name box. Refer to “Entering
text” on page 2-12.
Note The entries for Name and Password are case-sensitive.
2 Type the administrator password in the Password box.
If you don’t have the administrator password, contact FUJIFILM SonoSite. Refer to “Getting help” on
page 1-2.
WA RN I N G Restoring an administrative password will result in the deletion of data. Back up all
data prior to resetting the administrative password.
3 Ta p Login.
To log out as Administrator
Turn off or restart the system.
Security settings
WARNING Health care providers who maintain or transmit health information are required
by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and
the European Union Data Protection Directive (95/46/EC) to implement
appropriate procedures: to ensure the integrity and confidentiality of
information; to protect against any reasonably anticipated threats or hazards to
the security or integrity of the information or unauthorized uses or disclosures of
the information.
Security settings on the system allow you to meet the applicable security requirements listed in the HIPAA
standard. Users are ultimately responsible for ensuring the security and protection of all electronic protected
health information collected, stored, reviewed, and transmitted on the system.
3-2 System Setup
To require user login
You can set the system to display the User Login screen at startup.
1 Log in as Administrator.
2 In the User Login list, tap On.
On requires a user name and password at startup.
Off allows access to the system without a user name and password.
To change the administrator password or let users change passwords
1 Log in as Administrator.
2 Under User List, tap Administrator.
3 To change the administrator password:
a Under User Information, in the Password box, type the new password.
b In the Confirm box, type the new password again. For more information about passwords, see
“Choosing a secure password” on page 3-5.
4 To let users change their passwords, select the Password changes check box.
5 Ta p Save.
To limit USB export of exam data
1 Log in as Administrator.
2 Select Disable USB Export.
Administering users
These settings enable you to manage user information directly.
To add a new user
1 Log in as Administrator.
2 Ta p New.
3 Under User Information, fill in the Name, Password, and Confirm boxes. For more information about
passwords, see “Choosing a secure password” on page 3-5.
(Optional) In the User box, type the user’s initials to display them in the patient header and the User
box in the patient information form.
(Optional) Select the Administration Access check box to allow access to all administration
privileges.
System Setup 3-3
4 Ta p Save.
To modify user information
1 Log in as Administrator.
2 Under User List, tap the user.
3 Under User Information, make changes as desired.
4 Ta p Save. Any change to the user name replaces the previous name.
To delete a user
1 Log in as Administrator.
2 Under User List, tap the user.
3 Ta p Delete.
4 Ta p Ye s.
To change a user password
1 Log in as Administrator.
2 Under User List, tap the user.
3 Type the new password in the Password box and Confirm box.
4 Ta p Save.
Exporting or importing user accounts
The export and import commands let you configure multiple systems and back up user account information.
To export user accounts
1 Insert a USB storage device. For more information, see “Inserting and removing USB storage devices”
on page 2-7.
2 Log in as Administrator.
3 Ta p Export. A list of USB devices appears.
4 Tap the USB storage device, and then tap Export.
All user names and passwords are copied to the USB storage device. Passwords are encrypted.
To import user accounts
1 Insert the USB storage device that contains the accounts. For more information, see “Inserting and
removing USB storage devices” on page 2-7.
3-4 System Setup
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