SuperSonic Imagine

510, rue René Descartes Bat F

13857 Aix en Provence Cedex

SuperSonic Imagine Ultrasound products may be manufactured under

0459 or operate in accordance with one or more of the following United States
patents and corresponding patents in other countries:

U.S. Patent Numbers:

• (US) 5606971
• (US) 5810731
• (US) 9117439
• (US) 7252004

Other patent applications are pending in various countries.

The software used for this system includes software owned by
SuperSonic Imagine and licensed to SuperSonic Imagine by a licensor.

Availability of this software and related documents is restricted.

The software and related documents must be used only for this system.

The intellectual property of this software and related documents is not

assigned to you.

You must not copy the software or documents, nor modify the software
in whole or in part.

You must not recompile or reassemble the software.

You must not assign, disclose, transfer, or sublicense the software or

documents to a third party.

The ultrasound system software is subjected to the US and French Export

and Administration Laws and Regulations and you must not export or re-
export the software in whole or in part unless properly authorized by the
US or French government.

The information in the documents, or programs in the software are subject

to change without notice.

No modification of this equipment is allowed.

The following names are trademarked or registered by SuperSonic
Imagine, Inc:

• Aixplorer®
• The Theragnostic Company™
• ShearWave™ Elastography
• SWE™ Mode
• Q-Box™
• UltraFast™ Imaging
• SuperCompound™
• UltimateFocus™
• SuperRes™
• TissueTuner™
• SonicTouch™
• SonicSoftware™
• ManualTouchTGC™
• SuperLinear™ 15-4 transducer
• SuperLinear™ 18-5 transducer
• SuperCurved™ 6-1 transducer
• SuperEndocavity™ 12-3 transducer
• SuperEndocavity™ Volumetric 12-3 transducer
• SuperLinear™ Volumetric 16-5 transducer
• SuperLinear™ 10-2 transducer
• SuperMicroConvex™ 12-3 transducer
• SuperLinear™ HockeyStick 20-6 transducer
• TouchRing™
• SonicResearch™
• MultiWave™
• Thy-RADS™
• ReportBuilder™
• UltraFast™ Doppler
• PLanewave UltraSensitive™
Welcome and congratulations on your purchase of the Aixplorer®
Ultrasound System.

The following documents are available for the Aixplorer® Ultrasound

System:

• Quick Guide
The Quick Guide contains basic information regarding the use of the
product.
It does not replace the User's Guide.
• User's Guide
This User's Guide contains important information regarding the use
and safety of the product. Please read this guide carefully and store it
in a location where it can be easily accessed.
• Fusion/Navigation Guide (optional)
The Fusion/Navigation Guide contains important information
regarding the use of the fusion/navigation feature.
• Obstetrical References
The Obstetrical References Guide contains the detailed obstetrical
tables and equations that are used on Aixplorer®.

The Aixplorer® system has been designed with the safety of the operator
and patient in mind.

Please read the following chapters thoroughly before you start working
with the system.

SuperSonic Imagine guarantees the system will perform as intended only

when all cautions and warnings specified in this user's guide are observed.
This user's guide contains important information about the use of your
ultrasound system.

The features described in this user's guide may be optional. Please contact
your local SuperSonic Imagine sales or service representative for further
information.

Pictures are not contractual and are only displayed for general
information purposes.

It also contains information about contacting SuperSonic Imagine for

support.

This guide is intended for use by, or by the order of, and under direct
supervision of a licensed physician qualified to direct the use of the
ultrasound device.

This guide is intended for users who have been trained or are otherwise
familiar with the use of medical ultrasound devices.

Clinical guidance on how to perform an ultrasound examination is not

provided in this manual.

This user's guide complies with the following:

• 93/42/EEC European Directive modified by 2007/47/EEC European

Directive
• FDA regulation, 21 CFR § 801

In case further information is needed, trainings are advised and

available upon request at SuperSonic Imagine. Please contact your local
representative for more information.
The SuperSonic Imagine Aixplorer® system is a cart based ultrasound
imaging system used to perform diagnostic general purpose ultrasound
imaging studies.

The system contains a scan converter and can be coupled to a variety of

linear, curved, micro-convex, and motorized linear array transducers to
produce images, which are displayed on a LCD monitor.

An adjustable control panel with integrated touch screen allows the user
to perform an ultrasound exam quickly and efficiently in accordance with
ALARA principles.

The system also allows the user to perform measurements and associated
calculations, capture images to digital memory or to an external device
(such as a printer), and review diagnostic studies in the form of a report.

The system functions in a manner similar to existing devices and

transducers for the imaging modes: B-Mode, M-mode, Color Doppler
imaging, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Power
Doppler imaging, Directional Amplitude Power imaging, Contrast
Imaging, Elasticity Imaging, and 3D imaging.

The SuperSonic Imagine Aixplorer® ultrasound system is intended for

general purpose pulse echo ultrasound imaging, Doppler fluid flow
analysis of the human body, and tissue elasticity imaging of soft tissues.
The SuperSonic Imagine Aixplorer® ultrasound system is indicated
for use in the following applications: Abdominal, Small Organs,
Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral
Vascular, Non-invasive Cardiac, OB-GYN, Pelvic, Pediatric, Urology,
Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic.

The system also provides the ability to measure anatomical

structures (Abdominal, Small Organs, Musculoskeletal, Superficial
Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology,
Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics).

This device is intended for use by, or by the order of, and under the
supervision of a licensed physician qualified to use or direct the use of
the device1.

This system should only be used by trained sonographers who are

knowledgeable about the risk of excessive acoustic energy in the body,
particularly in the case where a great amount of fluid is present in the
scanning area.

The Aixplorer® system is not designed for ophthalmic use or any use
causing the acoustic beam to pass through the eye.

The use of the Aixplorer® system with a defibrillator is prohibited.

The Aixplorer® system is not intended for use with flammable

anaesthetics or in conjunction with flammable agents.

Caution: United States federal law restricts the sale of diagnostic

ultrasound devices to sale by or on the order of a physician 1.
1
Information delivered by the device must be used by a licensed physician qualified to
establish a diagnosis.
According to 93/42/EEC European Directive modified by 2007/47/EEC
European Directive, Aixplorer® is a Class IIa Medical Device.

According to :

• IEC/EN 60601-1, Equipment is Class I, type BF.

• IEC 60601-1-2, Equipment is Class A.

The product is compliant to the following standards:

• UL 60601-1 Medical Electrical Equipment, Part 1: General

Requirements for Safety
• CAN/CSA-C22.2 No. 601.1Medical Electrical Equipment - Part 1:
General Requirements for Safety
• IEC/EN 60601-1-1 Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety requirements for
medical electrical systems.
• IEC/EN 60601-1-2 Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard: Electromagnetic
compatibility – Requirements and tests.
• IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular
requirements for the safety of ultrasonic medical diagnostic and
monitoring equipment.
• IEC 62304 Medical device software – Software life cycle processes
• NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment
• NEMA UD 3 Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment
• EN ISO 10993-1 Biological evaluation of medical devices – Part 1:
Evaluation and testing
• EN ISO 14971: Medical devices – Application of risk management to
medical devices
• IEC/EN 60601-1 Medical electrical equipment – Part 1: General
requirements for safety
• IEC 61340-5-1: Electrostatics – Part 5-1: Protection of electronics
devices from electrostatic phenomena – General Requirements
• IEC 61340-5-2: Electrostatics – Part 5-2: Protection of electronics
devices from electrostatic phenomena – User guide
• EN 50419: 2006 Marking of electrical and electronical equipment in
accordance with Article 11(2) of Directive 2002/96/EC (WEEE)
• Digital Imaging and Communications in Medicine (DICOM) standard:
PS 3 -2011

SuperSonic Imagine is ISO 13485 certified.

SuperSonic Imagine is ISO 14001:2015 certified.

Customer service representatives are available regionally to help answer
your questions.
Please contact your local SuperSonic Imagine sales or service
representative for assistance.

SuperSonic Imagine
Les Jardins de la Duranne - Bât E & F
510, rue René Descartes
13857 Aix en Provence Cedex - France
Telephone: +33 (0)442 99 24 32
Telephone: +33 (0)426 70 02 70
Fax: +33 (0)442 52 59 21
E-mail: contactsFR@supersonicimagine.com

SuperSonic Imagine, Inc.

2625 Weston Road
Weston, FL 33331- North America
Telephone: +1(954) 660 3528
E-mail: contactsUSA@supersonicimagine.com

SuperSonic Imagine Ltd.,

18 Upper Walk
Virginia Water
Surrey GU25 4SN - United Kingdom
Telephone: +44 (0)845 643-4516
E-mail: contactsUK@supersonicimagine.com

SuperSonic Imagine GmbH

Zeppelinstr. 71 – 73
81669 München - Germany
Phone: +49 89 36036 - 844
Fax: + 49 89 36036 - 700
E-mail: contactsDE@supersonicimagine.com

SuperSonic Imagine
Suite 2304, Block D, Ocean International, DongSiHuan ZhongLu,
Chaoyang District, Beijing (100025), China
Phone : +86-10- 85861023/ 2951/ 2917
Fax: + 86-10-8586 2389
E-mail: beijing@supersonicimagine.com

Call your SuperSonic Imagine local representative.

The SuperSonic Imagine Aixplorer® ultrasound system is intended to
provide many years of service.

The lifetime of the product is directly impacted by the following

variables:

• Hours of clinical operational use of the product

• Hours of clinical non-operation use while the product is energized and
in the “on” state
• Environmental exposure of the product with regard to temperature,
humidity and pressure
• Appropriate electrical power conditions
• Proper handling and moving of the product
• Proper storage of the product when not in use
• Proper maintenance and cleaning of the product
• Quality of repairs
• Quality of accessories used with the device

The SuperSonic Imagine Aixplorer® ultrasound system has to be

installed by an authorized SuperSonic Imagine sales or service
representative.

To optimize operation and maximize the life of the product, we

recommend having an annual maintenance performed by a SuperSonic
Imagine authorized representative.

Maintenance and service contracts are available.

All repairs must be conducted by a SuperSonic Imagine authorized

representative.

Maintenance operations as described in Chapter 9, System Care &

Maintenance [429] can be performed by the user.

Improper installation, repair or maintenance will void any warranties

associated with the product.

Please contact a SuperSonic Imagine sales or service representative for

further information.
Upgrades may be announced that consist of hardware or software
improvements.

Updated user information will accompany those system upgrades.

Always verify that you are using the revision of this document
appropriate for your product version.

To verify the correct version of the document for your system or to obtain
the latest revision, contact your SuperSonic Imagine representative or
local distributor.
Width: 61cm (24in)

Height:

• 169cm (66.5in), with monitor fully raised

• 131cm (51.5in), with monitor locked

Depth: 105cm (41.5in)

Weight: about 97kg (214 Lbs) without any accessories.

The system contains an internal power supply which is designed to work
at the following voltage ranges:

• 100-240V, 50/60Hz, 1500W.

Power must be available through a grounded, hospital-grade outlet (UL

60601-1).
Externally powered USB devices powered are not permitted to be
connected to the USB ports of the Aixplorer® ultrasound system.

Ethernet connectors must only be connected to IEC certified equipment.

Any USB device may be connected to the system as long as it is SELF-

powered through the USB port (two USB ports can be used) or powered
from an external supply IEC60601 compliant.

When using a USB port, ensure that both the user and the patient do not
place hands or any other body parts on or in the USB port.

The following ports are available on the system:

• One USB port is located on the rear side of the control panel:
In this USB port, you can plug a memory stick.

• Two USB ports are located on the rear side of the system, above the
air filters:

• One USB port is located between the two foot rests:

In this USB port, you can plug the footswitch.

A two-pedal KINESIS footswitch is provided with the Aixplorer®

system (optional).

To connect the footswitch:

• Plug the USB cable into the USB port located between the two foot
rests (see picture above).
• When the system is on, you can configure the function of the two pedals
in the Setups (see Chapter 8, Customizing the System [377]).

A DVI port is available on the rear of the system. The port supports
connections of type DVI-D.

Only equipments compliant with IEC 60601-1 may be connected to the

DVI socket.

An external monitor which supports DVI capability may be connected

to this port.

For more details, see the section called “Additional Video

Devices” [23] .

The CD Drive is located on the left side of the control panel:

The CD/DVD drive supports the following media:

• DVD-R
• DVD+R
• DVD-RW
• DVD+RW
• CD-R
• CD-RW

To eject a CD/DVD:

1. Click on the appropriate icon (CD or DVD)

2. Follow the instructions that appear on the screen

For information on icons, refer to the section called “Notification

Icons” [167].

If you need to manually eject the CD/DVD, insert one end of a paper clip
in the hole located right next to the CD/DVD player.
A SONY black and white thermal printer is integrated on the system. It
is located at the rear of the cart.

The SONY black and white thermal printer provided with the system
should remain on.

It will stay in an energy-saving mode. Turning Off and restarting the

printer stresses the Aixplorer® system and could cause other electrical
problems.

You may want to plug an additional printer to your Aixplorer® device.

Never plug a printer that does not comply with IEC 60601-1 standard to
a USB port of your Aixplorer®.

If the printer complies with the IEC 60950 standard, perform the
following steps:

1. Make sure that the Aixplorer® device is connected to the network

(the Ethernet port is located at the rear of the cart)
2. Plug the power cable of your external printer to the wall plug
3. Plug the network cable of your external printer to the network
4. Turn your external printer on
5. Configure the Aixplorer® system to connect to the printer on the
same network
The Aixplorer® and the external printer may be plugged into the same
network at your facility.

If the printer complies with the IEC 60601-1 standard, perform the
following steps:

1. Plug the power cable of your external printer to the wall plug
2. Do one of the following, depending on the printer model:
• connect the printer to Aixplorer® with the USB cable
• connect the printer to Aixplorer® with the network cable

For the list of the recommended printers, please contact your Local
SuperSonic Imagine representative.
You may want to attach an additional video device such as a LCD monitor
or video projector to your Aixplorer® device.

The video output of the Aixplorer® is digital video, with a native

resolution of 1920x1080.

You may connect video devices to the Aixplorer® which are compatible
with the port type and support this video resolution.

If your external video device complies with the IEC60601-1 and with
these requirements, perform the following steps:

1. Power your external video device.

2. Be sure your external video device is powered ON, and it is set such
that its input is specified to receive signals from the DVI connector.
See the User’s guide of the external video device for more details.
3. Connect your external video device to the Aixplorer® by means of a
DVI cable, no longer than 5 m* (15 ft*) in length.
4. Turn on the power of the Aixplorer®. The main display will be
mirrored on the system display and on the external monitor.

*DVI cables of 5 m in length have been tested with Aixplorer®. Longer

cables may cause digital signal degradation or loss.

External video devices which do not support the resolution of 1920x1080

may result in the following:

1. No signal displayed on the external video device

2. A “letterbox” effect where the video display is shown with a black
border around the edges.
3. An aspect ratio adjusted signal is displayed. This may result in the
image being stretched or compressed to fit the display.

If you experience problems with the video quality or aspect ratio, it

is most likely caused by external video devices which do not support
the native resolution of 1920x1080. This can be resolved by adding
a “digital scaler” between the external monitor and the Aixplorer®.
For more information, please contact your local SuperSonic Imagine
representative.

Additional equipment connected to medical electrical equipment must

comply with the respective IEC or ISO standards (e.g. IEC 60950 for data
processing equipment).

Furthermore all configurations shall comply with the requirements for

medical electrical systems (see IEC 60601-1).

Any person connecting accessory equipment to medical electrical

equipment is configuring a medical system and is therefore responsible
that the system(s) complies with the requirements for medical electrical
systems.

Attention is drawn to the fact that local laws take priority over the above
mentioned requirements.

If in doubt, consult your local representative or the technical service

department.
The Aixplorer® supports a model of hand-held barcode scanner
especially designed for healthcare applications and environements, for
logging data as patient ID: barcode scanner (JADAK Flexpoint HS-1M).

If only Patient ID is acquired from barcode scanner, the Patient ID can

be acquired reading in Patient, Worklist or Q&R Aixplorer screens.

When delivered by SuperSonic Imagine, the HS-1M barcode scanner is

factory programmed and therefore doesn't need any customizations by the
user. If you need to change these settings, programming is accomplished
by scanning the bar codes in this guide or by sending the commands
below them.

See the section called “Cleaning and Disinfecting the Barcode

Scanner” [436] for details regarding disinfection and cleaning of the
HS-1M barcode scanner.

The HS-1M contains a laser based aiming system that is fully compliant
with eye safety certifications.

This device emits CDRH/IEC Class 2 laser and IEC Class 1M light.

Do not stare into beam.

When not in use you can store HS-1M in an available probe holder.
 1. LED Green: A barcode was
successfully decoded.
Red: A data transmission
error or reader
malfunction occured.
2. Scan window Scan the barcode.
3. Trigger Press to decode.

Plug the barcode scanner USB cable into a USB port available on the
Aixplorer® and ensure the connector is properly secured. When properly
plugged in, the barcode scanner emits a sound.

The scanner has factory settings and is set to be used to read 1D barcodes
only.

The scanner supports some user-defined functions as introduced below.

For more details, please contact SuperSonic Imagine customer service

department.
 United States: United Kingdom:

Belgium: Denmark:

Finland/Sweden: France:

Germany: Italy:

Netherlands: Norway:

Portugal: Spain:

The led indicator can be enabled or disabled in response to a good read.

 Enable Disable

The beeper may be programmed On or Off in response to a good read.

Turning this option off only turns off the beeper’s response to a good read
indication. All error and menu beeps are still audible.

Enable Disable

The beeper volume codes modify the volume of the beep the HS-1M
emits on a good read. When set to off, error and menu beeps are still
audible.

Off Low

Medium High

Scan one of the following codes to set the tone or pitch of the Good Read
beep.
 Low Medium

High

Scan one of the following codes to set the duration of the Good Read
beep.

Short Medium

Long

Scan one of the following codes to enable or disable the power-up beep
cycle of the scanner.

Enable Disable

The HS-1M has an optional internal Vibration motor function that can be
used to indicate errors, reads / no reads, etc. This can be very helpful in
an environment where an audible beep would be unwanted; for instance
in a patient ward at night in a hospital, where patients are sleeping.

The HS-1M can use its vibration engine to vibrate in different situations.
Use one of the codes below to set the vibration mode of the HS-1M.

Don't Vibrate Vibrate on BEL (from host)

Vibrate on error Vibrate on No Read

Vibrate on good read

Set the Vibration Pulse count (i.e. number of vibrations) between 1 and
5 pulses. Each pulse’s duration will be determined by the vibration time
setting (see next page).

1 Vibration Pulse 2 Vibration Pulses

3 Vibration Pulses 4 Vibrations Pulses

 5 Vibration Pulses

Sets the Vibration (and Pulse) Time in steps of 1 millisecond from 1ms
up to 1 second. Several commonly used Vibration Time menu command
barcodes are included below.

Sample settings:

Vibration Time = 100ms Vibration Time = 200ms

Vibration Time = 300ms Vibration Time = 500ms

As the JADAK HS-1M can be programmed by scanning menu bar codes,

there is an option to restrict the ability to scan menu codes. By setting
MNUENAB 0, you can no longer scan menu programming barcodes.
The only command or scannable menu barcode to revert this will be
MNUENAB 1.

Enable Disable

1. Ensure all connections are secure

2. Put the pointer over the field to fill in
3. Aim the scanner at the barcode. Press the trigger.

Ensure the scan line cross every bar and space of the symbol, see the
figure below.

4. Upon successful decode, the reader beeps and the LED turns green.

• GS-1 Databar Limited (RSS Limited)

• GS-1 Databar Expanded (RSS Expanded)
• Codabar
• Code 11
• Interleaved 2 of 5
• Code 128
• Matrix 2 of 5
• Code 39
• Code 93
• NW7
• MSI
• EAN/JAN-13
• EAN/JAN-8
• UPC-A
• GS1-128
• UPC-E
• GS-1 Databar (RSS-14)
• UPC-E1
Refer to the following table for parameter defaults of the Jadak HS-1M
Barcode Scanner

Option Name Value Key

Interface USB HID Keyboard HOSTCFG1
Keyboard Country Layout United States KBD_CTY 0
Keyboard Control Disable KBD_NPE 0
Character Output
Numeric Keypad Mode Disable KBD_NMPS 0
LED - LED on Good Read Enable LEDGDRD 1
Beeper - Good Read Enable BEPGDRD 1
Beeper Volume High BEPLEVL 3
- Good Read
Beeper Tone - Good Read High BEPTONE 2
Beeper Time - Good Read Long BEPTIME 2
No Reads Disable No Read NO_READ 0
No Read Message No Read Message NORDMSG
Beeper - Beep on [BEL] Disable BEEPBEL 0
Beeper - Power Up Beep Enable BEEPPWR 1
Error LED Duration Error LED ELEDDUR 100
duration = 100 ms
Aimer Mode Enable AIMMODE 1
Aimer Delay Aimer Delay Off AIM_DLY 0
Vibration Modes Don't vibrate VIBMODE 0
Vibration Pulse Count 1 Vibration pulse VIBNUMB 1
Vibration Time Vibration time = 100 ms VIBTIME 100
Trigger Modes Manual (lever) Trigger TRGMODE 0
Multiple Symbols Mode Multiple Symbol Mode Off MULTSYM 0
Good Read Delay No Good Read Delay DLYGDRD 0
Re-read Delay Re-read delay 0.6 seconds DLYRERD 600
Transmit AIM Don't Transmit AIM ID XMITCID 0
ID Character
Prefixes Disable PREENAB 0
 Option Name Value Key
Suffixes Disable Suffixes SUFENAB 0
Illumination Brightness Illumination LEDSPWR 3
Brightness High
Decode Window Disable Decode WINDECE 0
Windowing
Symbologies Enable only 1D barcode
(no matrix, no QR code)
Menu Bar Code Scanning Enable MNUENAB 1
The system should be operated, stored, and transported within the
parameters outlined below.

Either its operational environment must be constantly maintained or the

unit must be turned Off.
Operational Storage Transport
Temperature From 15°C to 35°C From -20°C to 50°C From -20°C to 50°C
(From 50°F to 95°F) (From -4°F to 122°F) (From -4°F to 122°F)
Relative From 30% to 80% From 30% to 80% From 30% to 80%
Humidity
Pressure From 700 hPa From 500 hPa From 500 hPa
to 1060 hPa to 1060 hPa to 1060 hPa
Altitude Below 3000 m

Upon delivery and initial installation, please allow SuperSonic Imagine

authorized personnel to open the system packaging. If you need to send
the device back to SuperSonic Imagine for service, please do not pack it.
Contact your Local SuperSonic Imagine representative.

The Aixplorer® system must be installed only by SuperSonic Imagine

authorized personnel.

It is imperative to leave the system 48 hours at room temperature before

it is first switched on.

The Aixplorer® ultrasound system may be stored indefinitely provided

that it is done so under ambient conditions which do not exceed the limits
outlined in this chapter.
In the case of extremely long periods of storage (greater than 1 year), it
is possible that on-board batteries may become discharged.

If you plan to store the system for extended periods of time, please consult
your authorized SuperSonic Imagine service representative regarding
battery removal prior to storage.

It is also prudent to have a service representative on-site when re-starting

the system for the first time after prolonged storage.

The Aixplorer® ultrasound system contains components that are similar

to those found in a typical personal computer.

As such, the electronic parts contained within the housing may contain
small amounts of lead (electrical components), mercury (electrical
components and batteries) and lithium ions (batteries).

The housing is also composed of plastic material, which can be recycled.

Please verify with your local regulations regarding recycling of electrical
components, plastics and overall safe disposal of this device.

Please contact your SuperSonic Imagine representative for further

information.
The following symbols are used in this document:

A WARNING symbol describes precautions necessary to prevent injury

or loss of life.

WARNING

A CAUTION symbol describes precautions necessary to protect the

equipment.

CAUTION
The following symbols are used on the ultrasound device.

Symbol Meaning

General Controls
On the power switch, represents system power ON and OFF

On the control panel, represents system ON/Standby

Electricity and Electronics

USB input/output port

Ethernet connection

Equipotentiality ground

Isolated patient connection. Type BF

Earth

DVI out

Other
CE marking of conformity to 93/42/EEC European Directive
amended by 2007/47/EEC European Directive

Assure safe disposal of the device

ESD sensitive component

Caution: Read the user’s guide

Warning: Read the user’s guide

Symbol Meaning

Pinch Point. Keep hands and fingers away.

Do not push or pull the system from the side or from the monitor, or
against an excessive resistance. The system could tip over.

Do not sit on the system, including printer covers, control panel, or

handles

Manufacturer - Manufacturing date

Humidity limitation
Indicates the range of humidity to which the medical device can be
safely exposed.
Atmospheric pressure limitation
Indicates the range of atmospheric pressure to which the medical
device can be safely exposed.

Temperature limitation
Indicates the range of temperature to which the medical device can
be safely exposed.
Read the User’s Guide carefully and get acquainted with the transducers
and the ultrasound system before using them.

Do not remove system covers. Hazardous voltages are present inside the
system.

To avoid electrical shock, use only the supplied power cords and connect
to properly grounded wall receptacles.

Do not operate the system in the presence of flammable anesthetics.

Explosion can result.

Never operate the system if a significant quantity (2 mL or greater, wet to

the touch) of liquid (gel, water, saline, alcohol, blood, etc.) has penetrated
the outer casing, including control panel. Discontinue use of the device
until the liquid is removed or completely dried.

Exercise caution when negotiating ramps and narrow hallways.

Keep hands and feet away from system wheels when moving or
transporting the system.

Before performing maintenance or cleaning, always press the On/

Standby switch to put the system into standby mode, set the power switch
to Off, and then disconnect the system from the wall outlet.

Do not push the system from the side, or against an excessive resistance.
The system could tip over.

Repairs must be performed by authorized personnel only.

Repairs and maintenance performed by unauthorized parties are at the

user’s risk, and shall void all warranties, explicit or implied.
For optimal performance, the Aixplorer® system should be connected to
an electrical circuit that is able to sustain at least 1500W.

To avoid interference, avoid operating the system in an environment

where portable and mobile radio-frequency (RF) communications are in
use.

Avoid handling fluids near the system. Fluids leaking through the air
vents of the system may cause electrical failure.

Warm air will be exhausted from the rear, the sides and the bottom of the
system. This is normal behavior when the system is in operation. Do not
block or obstruct air vents at the rear of the system.

Use the handle to move the system.

To prevent damage to system cables or transducer cables, be careful not

to run over them with the machine.

Never attempt to open system covers, transducers or transducer

connectors.

Do not submerge the system cables or the transducer cables in liquid.

Ultrasound transducers are easily damaged when handled improperly.

Avoid dropping the transducer or bringing it into contact with any sharp
or abrasive surfaces or objects.

Improper cleaning or sterilization of the transducers may

cause permanent damage. See Chapter 9, System Care &
Maintenance [429].

The automatic Freeze feature will turn Off the acoustic output to the
transducer when the system is not in use. This will help prevent heat
build-up and damage to the transducer.

If an error message appears on the monitor indicating a hazardous

condition, note the error code and turn Off the power to the system.
Contact the SuperSonic Imagine Customer Service Department to relate
and troubleshoot the problem.

Do not load the system with any peripheral devices or equipment

weighing more than 10 kg (20 lbs). Doing so may cause the system to
become unstable and tip over.
If an excessive internal temperature is reached, the system displays a
warning message and will eventually automatically shut down for 30
minutes to prevent over-heating damage.

This device has been tested by a third-party testing agency and is

described as a Class 1 electrical device with Type BF isolated patient
applied parts.

This device has demonstrated conformance to the following standards:

• IEC 60601-1, UL 60601-1, CAN/CSA-C22.2 No. 601.1

Shock hazards may exist if this system is not properly grounded. The
system must be plugged into a fixed power socket that is grounded.
The grounding wire must not be defective. Never use an adaptor or
converter to connect with a power source plug (three- prong to two- prong
converter).

Use only the cables provided by SuperSonic Imagine and connect these
cables according to the installation process.

To avoid electrical shock and fire hazard, check power cables and plugs
for damage on a regular basis.

Hazardous voltages exist inside the system; therefore, the protective

covers on the system should not be removed. Any internal adjustment or
replacement must be made by an authorized SuperSonic Imagine service
representative.

Servicing the power supply : the system must be unplugged for a

minimum of two minutes before accessing the live parts of the power
supply.

To avoid risk of electrical shock hazards, always inspect the transducer

before use. Make sure the face is not cracked, torn or chipped and that
the housing of the transducer or the cord is not damaged before use.
Electrostatic discharge (ESD) or static shock is a natural phenomenon.
Static shock is a discharge of electrical energy that can be transferred
to file cabinets, computer equipment, metal door knobs and other
individuals. Static shock occurs most often during low humidity
conditions that can be brought on by heating or air conditioning.

To avoid damage to the system or transducers resulting from an electrical

energy discharge from a system user or patient, the use of anti-static mats,
anti-static sprays or a ground wire connection between the system and
the patient table are recommended.

Ethernet connectors must only be connected to IEC certified equipment.

Any USB device may be connected to the system as long as it is self-
powered.

Use caution when plugging in or unplugging the system.

Do not touch transducer connector pins when plugging in or unplugging

a transducer.

Do not insert any objects through openings in the system covers.

If a foreign object should fall into an opening in the system cover,

immediately power down the system and discontinue use until the system
can be inspected by an authorized service representative.

Medical electrical equipments need special precautions regarding EMC

and need to be installed and put into service according to the
EMC information. The Aixplorer® system must be installed only by
SuperSonic Imagine authorized personnel. This equipment has been
tested and found to comply within the limits for medical devices in
IEC 60601-1-2 Class A. These limits are designed to provide reasonable
protection against harmful interference in a typical medical institution.
This equipment can radiate radio frequency energy, and if not installed
and used in accordance with the instructions, may interfere with other
devices in the vicinity. Powering the system Off and On can determine
if the problem is caused by this unit. In addition, electromagnetic fields
from fixed transmitters such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio
broadcast, and TV broadcast may interfere with the use of this device.
Portable and mobile RF communications equipment can affect the device.
These fields may cause degradation of the image quality of the device.
Sources of electromagnetic interference cannot be predicted theoretically
with accuracy.

If this system causes harmful interference to other devices, or the system

demonstrates an interference pattern on the image, the user is encouraged
to try to correct the interference by:

• Increasing the distance separating the pieces of equipment

• Ensuring the system is not connected to the same outlet as the other
device(s)
• Using only shielded cabling when connecting the device to networks
and peripherals
• Reorienting the device
• Consulting the manufacturer or field service representative for help

If abnormal performance persists, additional measures may be necessary,

such as relocating the system.
The Aixplorer® is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the
user of the Aixplorer® can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Aixplorer® as
recommended below, according to the maximum output power of the
communications equipment.

Rated maximum Separation distance according to frequency of transmitter

output power m
of transmitter
150 kHz to 80 MHz to 800 MHz to
w
80 MHz 800 MHz 2,5 GHz

0.01 3.5 0.12 0.23

0.1 11 0.40 0.73
1 35 1.2 2.3
10 111 3.8 7.3
100 350 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.

This equipment/system is intended for use by healthcare professionals

only.
This equipment/system may cause radio interference or may disrupt the
operation of nearby equipment.

It may be necessary to take mitigation measures, such as re-orienting or

relocating Aixplorer® or shielding the location.

Use of this system in the presence of an electromagnetic field can cause

the equipment to perform outside of the published performances.

Avoid using cellular phones, pagers, radios, TVs, or microwave

transmission equipment near the machine.

The use of cables, transducers, and accessories other than those supplied
with the product may result in increased emissions from the system.

Do not touch transducer connector pins when plugging in or unplugging

a transducer.

Do not connect transducers to the system unless ESD precautionary

procedures are used.

Aixplorer® is provided with the following cables:

Cable Type Length

Power Supply Cable 3m
Probe Cables 2.10m
Ethernet Cable 5m

Aixplorer® has been EMC tested with the following accessories:

• SONY UP-D711MD Black and white printer (integrated)

• SONY UP-D898DC Black and white printer (integrated)
• SONY UP-D25MD Color printer and its printer bay
• SuperSonic Imagine SL15-4 probe
• SuperSonic Imagine SL18-5 probe
• SuperSonic Imagine SC6-1 probe
• SuperSonic Imagine XC6-1 probe
• SuperSonic Imagine SE12-3 probe
• SuperSonic Imagine SEV12-3 probe
• SuperSonic Imagine SLV16-5 probe
• SuperSonic Imagine SL10-2 probe
• SuperSonic Imagine SLH20-6 probe
• SuperSonic Imagine SMC12-3 probe
• SuperSonic Imagine XP5-1 probe
• Ethernet cable, CAT6a SSTP (PIMF) 500Mhz (shielded) AWG26/7,
meets standards EIA/TIA 568 B2- ISO/IEC11801, maximum length
5 meters
• Foot switch

Using accessories and cables other than those listed above may result in
increased emissions or decreased immunity of the system.
Aixplorer® is suitable for use in the following environment. The user
must assure that it is used only in the electromagnetic environment as
specified.

Emission Test Compliance Electromagnetic

environment - guidance
RF Emission CISPR 11 Group 1 Aixplorer® uses RF
energy only for its internal
function. Therefore, its
RF emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
RF Emission CISPR 11 Class A Aixplorer® is suitable for
use in all establishments
Harmonic emission Class A
other than domestic
IEC 61000-3-2
and those directly
Voltage fluctuation/Flicker Complies connected to the public
emissions IEC 61000-3-3 low-voltage power supply
network that supplies
buildings used for domestic
purposes.

Aixplorer® with its peripherals should not be used adjacent to or stacked

with other electrical equipment.

If the use of adjacent or stacked electrical equipment is necessary, verify

the normal operation of Aixplorer® and its peripherals.
 Guidance and manufacturer’s declaration - electromagnetic immunity
Aixplorer® is suitable for use in the following environment.
The user must assure that the system is used according to the
specified guidance and only in the electromagnetic environment
listed in the electromagnetic environment as specified.
Immunity IEC 60601 Compliance Electromagnetic
Test Test Level Environment Guidance
Conducted 3 Vrms 0.10 Vrms Portable and mobile RF communications
RF 150 kHz 3.0 V/m equipment should be used no closer
IEC to 80 MHz to any part of Aixplorer®, including
61000-4-6 3 V/m cables, than the recommended
Radiated RF separation distance calculated
80 MHz to
from the equation applicable to
IEC 2,5 GHz
the frequency of the transmitter.
61000-4-3
Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2,5 GHz

where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Interference may occur in the
vicinity of equipment marked
with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies

NOTE 2 These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should
be considered. If the measured field strength in the location in which
Aixplorer® is used exceeds the applicable RF compliance level above,
Aixplorer® should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
re-orienting or relocating the Aixplorer®.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should
be less than [VI] V/m.

Immunity Test IEC 60601 Compliance Level Electromagnetic

Test Level Environment
Guidance
Electrostatic ±6 kV contact ± 4 kV contact Floors shall be
discharge (ESD) ±8 kV air ± 8 kV air wood, concrete
IEC 61000-4-2 or ceramic tile.
If floors are
covered with
synthetic material,
the relative
humidity shall
be at least 30 %
Electrical fast ±2 kV for power ±2 kV for power Main power quality
transient/burst supply line supply line shall be that of a
IEC 61000-4-4 ±1 kV for input/ ±1 kV for input/ typical commercial
output lines output lines or hospital
environment.
Surge IEC ±1 kV ±1 kV Main power quality
61000-4-5 differential mode differential mode should be that of a
±2 kV ±2 kV typical commercial
common mode common mode or hospital
environment.
Voltage dips, short <5 % UT <5 % UT Main power quality
interruptions and (>95% dip in UT) (>95% dip in UT) should be that of a
voltage variations for 0.5 cycle for 0.5 cycle typical commercial
on power supply or hospital
40 % UT 40 % UT
input line IEC environment. If
61000-4-11 (60% dip in UT) (60% dip in UT) the user of the
for 5 cycles for 5 cycles Aixplorer® requires
70 % UT 70 % UT continued operation
(30% dip in UT) (30% dip in UT) during power mains
for 25 cycles for 25 cycles interruptions, it is
<5 % UT <5 % UT recommended that
(>95 % dip in UT) (>95 % dip in UT) the Aixplorer®
be powered from
for 5 sec for 5 sec
an uninterruptible
NOTE : UT is the a.c. main voltage prior to application of the test level.
Immunity Test IEC 60601 Compliance Level Electromagnetic
Test Level Environment
Guidance
power supply
or a battery.
Power frequency 3 A/m 3 A/m Power frequency
(50/60Hz ) magnetic fields
Magnetic field should be at levels
IEC 61000-4-8 characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE : UT is the a.c. main voltage prior to application of the test level.
Our device has been designed to have a surface temperature not
exceeding 50°C in air and 43°C when in contact with the patient or user
when measured under the requirements of the IEC 60601-2-37 standard.
Some heat is generated by the ultrasound system, and by the transducer.
Heat generated by the electrical components of the ultrasound system is
dissipated through specific outlets.

Heat may also be generated at the surface of the ultrasound transducer.

In some cases the heat of the transducer may be detected at the surface
of the skin. This would occur if the transducer remains in contact with a
part of the body for a prolonged period of time.

The ultrasound system has been equipped with internal sensors which
monitor the temperature rise within the chassis. Alarms and WARNING
messages may be displayed on the system in the event of an overheating
condition. In the case of extreme or prolonged heat build-up, the system
may automatically shut-down.

If heating of either the transducer or system is determined to be a problem,

please call your SuperSonic Imagine service representative immediately.

Ultrasound system overheating may occur if the environment exceeds the

recommended ambient operating conditions. To avoid overheating, be
sure the system is operated under normal “room temperature” conditions,
and adequate ventilation is provided.

Ultrasound can produce harmful effects in tissue and potentially result

in patient injury. Always minimize exposure time and keep ultrasound
levels low when there is no medical benefit (ALARA principle).

A system which is overheating due to external conditions or an internal

fault may issue a warning followed by a spontaneous shut-down to
prevent heat damage or fire. If this occurs, discontinue use of the system
and call your SuperSonic Imagine service representative.

Transducer surfaces may experience heat-build up. This is especially true

if the transducer is in prolonged use and/or the point of contact with the
body is stationary. Please use ALARA principles to prevent unnecessary
heating of the patient or the transducer.

Using the “Freeze” control is recommended to suspend acoustic energy

to the transducer when not in use.

Do not maintain the transducer in one position on the body for prolonged
periods of time. Prolonged exposure can produce minor burns.

Do not operate the system if ambient temperature is above the

recommended limit.

Use caution when operating the system in small spaces. Ambient room
temperature increases may occur.

Change or clean air filters regularly to prevent system overheating.

The ultrasound system is designed to auto-Freeze if the imaging controls

are not changed for a duration defined by the user. This is designed to
reduce heat build-up of the transducer. Use the Freeze button to resume
scanning.

If a system persistently issues an operating temperature-related warning,

discontinue use of the system and call your SuperSonic Imagine service
representative.

If the system reaches a certain temperature, follow the instructions that

appear on the screen.

The ultrasound system has been ergonomically and mechanically

optimized to be pleasant, efficient and safe, provided that it is used as
intended and all instructions, warnings and cautions specified in this
Guide are followed.

If the system suffers mechanical damage, discontinue use and call an

authorized SuperSonic Imagine representative for assistance.
Never use the system if any of the exterior covers are cracked, damaged,
missing or improperly installed.

Touching internal electrical or mechanical parts may cause injury or

death.

If a foreign object should fall into an opening in the system cover,

immediately power down the system and discontinue use until the system
can be inspected by an authorized service representative.

Do not push or pull the system from the side or from the monitor, or
against an excessive resistance. The system could tip over.

Use caution when accessing the peripheral bays.

Use caution when accessing cables on the back of the system. Some
mechanical exterior parts may cause abrasion.

If the system does not roll smoothly on its wheels, do not force the system
to move.

Do not load the system with any peripheral devices or equipment

weighing more than 20 lbs (10kg). Doing so may cause the system to
become unstable and tip over.

To prevent damage to system cables or transducer cables, be careful not

to run over them with the machine.

Never attempt to open a transducer or a transducer connector.

Do not submerge the system cables or the transducer cables in liquid.

Ultrasound is sound at a very high frequency above human hearing, i.e.
above 20 kiloHertz (kHz). For medical diagnostic purposes, ultrasound
systems generate ultrasound waves typically ranging from 1 to 20
MegaHertz (MHz). A probe, or transducer, is applied on the patient’s
body. It emits ultrasound waves that pass into the body, then reflect
off the different tissue boundaries. The transducer then receives these
reflections, which are assembled and processed by a computer system
to generate a picture displayed on a video monitor. Key parameters
of the ultrasound waves can vary, such as their frequency, density,
focusing and aperture. For example, beams at higher frequencies produce
higher resolution images but cannot penetrate as deeply into the body
as lower frequencies, which penetrate more deeply but show lower
resolution. Therefore, the choice of frequency is a trade-off between
spatial resolution of the image and imaging depth. Energy levels of
ultrasound waves are measured in W/cm². The two typical values that are
calculated and taken into account are the spatial-peak temporal average
intensity ( ), measured in mW/cm² and of the spatial-peak pulse
average intensity ( ), measured in W/cm². Diagnostic ultrasound
systems usually use energy levels corresponding to an ranging
between 0 and 720 mW/cm².
The first guidelines and recommendations ever published for ultrasound
manufacturers was proposed by the American Institute of Ultrasound in
Medicine (AIUM) in 1983. These guidelines were revised in 1988 where
the energy maximum limit was fixed to 100 mW/cm². Below this limit, no
adverse bioeffects had ever been reported on animals or patients, although
contradictory observations have been reported later, in 1993. Since 1993,
the Food and Drug Administration (FDA) imposed a maximum limit on
the acoustic output of ultrasound devices. However, due to the continuous
development of sophisticated systems with improved image quality and
diagnostic sensitivity, it was realized that safely increasing the limit
under specific circumstances could bring diagnostic advantages (i.e.,
patients with fatty tissues). In 1997, the FDA increased the maximum
limit of energy output level up to a much higher value (see section
Present state of output levels) and recognized an increased role of the
operator in limiting the potential for ultrasound bioeffects. In conclusion
the operator has the responsibility of making an informed decision
concerning the desired diagnostic information in comparison to possible
adverse bioeffects. Achieving this goal requires an adapted education that
needs to be provided to every operator in order to make an informed
and balanced decision. In this context, the AIUM document published
in 1994, "Medical Ultrasound Safety", is highly recommended, as is this
particular educational content.

Ultrasound really started to be used in clinical medicine in the 1950’s.

It has always been considered as a potential medical imaging technique
despite continuing concerns of potential related risks: from the beginning,
some studies demonstrated that sufficient ultrasound levels could harm
biological material, even with lower doses than used today. Due to the
absence of adverse effects reported on patients, the diagnostic ultrasound
technology kept on being developed and improved, culminating in the
mid-1980’s with grayscale and real-time imaging modes. In parallel,
the ability to quantify ultrasonic fields also improved considerably, thus
giving a tool to measure accurately ultrasound energy levels. Diagnostic
ultrasound imaging has accumulated an excellent safety record over the
past 50 years. The recent development of new applications and new
modes and the increase in ultrasound use have not impacted on this
safety record. However, ultrasound safety continues to be discussed
and regulatory authorities are continuously revising the guidelines and
standards in order to minimize potential risks and maintain a safe
framework for patients, manufacturers and users.

The first deleterious effects of ultrasound were observed by Paul

Langevin in 1917: “fishes placed in the beam in the neighborhood of
the source operation in a small tank were killed immediately, and certain
observers experienced a painful sensation on plunging the hand in this
region”. In 1930, Harvey released the first review paper on biological
effects of ultrasound: he reported on the physical, chemical, and
biological effects in which alterations were produced in macromolecules,
micro-organisms, cells, isolated cells, bacteria, tissues, and organs with
a view towards the identification of the interaction mechanisms. In the
mid 1990’s, an animal study observed lung and intestine hemorrhage
with a pulsed, 2 MHz ultrasound exposure for 3 minutes, although this
observation was not confirmed intraoperatively with transesophageal
echocardiography.

Here are some examples of possible deleterious bioeffects of ultrasound:

• Cells of the sensory organs (eye, ear, nervous tissue) are particularly
sensitive to ultrasound and can be destroyed by thermal effect.
• Cavitation mechanisms can create tearing lesions of the inner layer of
blood vessels, thus leading to thrombogenic processes.
• Cell lysis has been observed in vitro with 1 MHz continuous ultrasound
exposure, due to cavitation.
• Cardiac premature contractions have been observed in frogs with 1.2
MHz exposure to a single 5-millisecond pulse with normal recovery.
• The development of blood cells has been reported to be altered in
monkeys after multiple exposures to ultrasound at diagnostic levels.

Moreover, potential bioeffects of ultrasound at the subcellular level

may lead to structural and functional changes in cell membranes, thus
affecting signal transduction, for example.
Ultrasound can cause heating of the tissues (thermal effect) and can create
non-thermal effects (mechanical effects).

An ultrasonic wave propagating into a biological tissue is attenuated with

distance from its emission source, due to scattering (redirection of the
ultrasound beam) and/or absorption (conversion into heat). Depending
on the tissue characteristics, a temperature increase will occur if the rate
of heating is greater than the rate of cooling the tissue. Operators must be
aware of that risk, which may counterbalance the benefits of ultrasound
examination.

Non-thermal effects include cavitation, production of audible sounds,

movement of cells in liquid, electrical changes in cell membranes,
shrinking and expansion of bubbles in liquid, and pressure changes.
Cavitation has been extensively studied: it happens when bubbles
located in an ultrasound field start to resonate. This effect has not been
demonstrated in human tissue; some observations of haemorrhagia have
only been made in lung or intestine of laboratory animals. Other non-
thermal effects caused by ultrasound include changes in pressure, force,
torque (causing tissues to rotate) and streaming. Audible sounds and
electrical changes of cell membranes can derive from such changes,
potentially causing cell damage. Consequences of non-thermal bioeffects
can cause damage to the tissue, eventually cell death, cell membrane
disruption or ruptures of small blood vessels. Although these bioeffects
have not been observed in humans, they could potentially occur with
future technology.

The bioeffects of ultrasound on fetuses have always been of concern,

due to the presence of developing tissues. This has become even more
present due to new ultrasound modalities arising in the late 1980’s
(harmonic imaging, color Doppler and 3D imaging) that have allowed
new diagnostic capabilities. Since these methods potentially required
more ultrasound energy, the FDA revised its diagnostic ultrasound
regulatory guidelines in the early 1990’s. As a result, the upper limit
of output intensity allowed in fetal examinations has been raised more
than 7 times its original value. Some concerns have arisen about
the new regulations and researchers conducted epidemiological studies
looking for associations between ultrasound exposure and newborn
defects linked to fetal development. As reviewed by the National
Council on Radiation Protection and Measurements (NCRP), one of
the largest studies followed 15,000 women in Australia, but was not
designed to study birth defects. Therefore, the lack of increase in birth
defects was reassuring but not conclusive. Another large Canadian
study focused on the correlation between ultrasound screening and
prematurity. It concluded that the group receiving more ultrasound scans
during pregnancy had slightly lower birth weights. The interpretation
of epidemiological studies, however, can be biased by the prescription
of ultrasound due to a suspected fetal problem. Additionally, the NCRP
has stated that there is insufficient evidence to conclude that diagnostic
ultrasound is the cause of adverse effects such as low birth weight, or any
adverse effect whatsoever. However, this conclusion does not preclude
the possibility of any effect. Research is limited because physicians
cannot perform more stringent experiments on their patients. As a
preliminary mandatory step, more animal studies are recommended by
the NCRP.

Diagnostic ultrasound systems provide diagnostic information that

creates a clear benefit to the patient, to the physician, and to healthcare
systems. Currently available systems give very good quality images
and highly relevant information that allow physicians to make optimal
decisions.

Ultrasound imaging is a favorite imaging technique because:

• It appears to be safe,
• It is known to provide diagnostic information with great sensitivity and
specificity,
• It is widely accepted by patients,
• It has low costs when compared to other radiological modalities.

However, there are risks in doing or not doing an ultrasound exam:

On the one hand, performing an ultrasound examination may expose the

patient to potential adverse bioeffects by heating or cavitation, although
no such incidents have ever been reported on humans at diagnostic
ultrasound levels. Physicians must also weigh the expected benefit
against the potential risks of the ultrasound exam. They must balance
the intensity and energy that is used to perform the exam against the
beneficial information it brings. Increasing the intensity, the exposure
time, focal properties, and the pressure are associated with an increased
risk of bioeffects. However, using a low intensity may lead to poor
diagnostic information.

On the other hand, not doing an ultrasound examination may prevent

physicians and patients from getting relevant diagnostic information,
or may lead to the acquisition of the same information through other
modalities, which may be more invasive or require exposure to ionizing
radiation. There currently should be no hesitation when choosing
to perform an ultrasound examination when a significant clinical
benefit is expected. For example, cardiac ultrasound examinations with
transesophageal echocardiography give the ability to image the structure
and function of the heart and great vessels, and allow the operator
to follow the course of blood flow within the heart. In obstetrics, the
National Institute of Health consensus development conference held
in the early 1980's recommended not to perform routine ultrasound
examination, but identified a number of appropriate clinical indications
for the use of ultrasound imaging during pregnancy.

"Diagnostic ultrasound has been in use since the late 1950s. Given its
known benefits and recognized efficacy for medical diagnosis, including
use during human pregnancy, the American Institute of Ultrasound in
Medicine herein addresses the clinical safety of such use: No confirmed
biological effects on patients or instrument operators caused by exposure
at intensities typical of present diagnostic ultrasound instruments have
ever been reported. Although the possibility exists that such biological
effects may be identified in the future, current data indicate that the
benefits to patients of the prudent use of diagnostic ultrasound outweigh
the risks, if any, that may be present."
Since the adoption of the Output Display Standard (ODS) in 1992 and the
publication of the revised FDA guidelines in September 1997, diagnostic
ultrasound systems that follow the Output Display Standard, including
fetal Doppler applications (except fetal heart rate monitors), must have
a maximum energy level that is not application-specific. Therefore, the
maximum energy level is currently defined by (1) a derated limit
of 720 mW/cm² and (2) a maximum MI of 1.9 or a derated of
190 W/cm². The only application-specific exception to these guidelines is
the ophthalmic use with lower maximum values. When compared to the
maximum application-specific limits that were decided and published in
1985 and 1987 as shown in the tables below, the actual maximum values
available on today’s systems have become much higher.

Table 3.1. FDA’s pre-amendments levels of diagnostic ultrasound devices

(FDA, 1985)

Derated Intensity Values

(mW/cm²) (W/cm²) Im (W/cm²)

Cardiac 430 65 160

Peripheral Vessel 720 65 160
Ophthalmic 17 28 50
Fetal Imaging 46 65 160
and other*

* Abdominal, Intraoperative, Small Organ (breast, thyroid, testes),

Neonatal Cephalic, Adult Cephalic

Table 3.2. FDA’s pre-amendments levels of diagnostic ultrasound devices

(FDA, 1987).

Derated Intensity Values

(mW/cm²) (W/cm²) Im (W/cm²)

Cardiac 430 190 310

Peripheral Vessel 720 190 310
Ophthalmic 17 28 50
Fetal Imaging 94 190 310
and other*
* Abdominal, Intraoperative, Small Organ (breast, thyroid, testes),
Neonatal Cephalic, Adult Cephalic

However, with the publication of the ODS in 1992, the ultrasound

users have been given the ability to operate their systems with real-
time information on the potential risk of biological effects within the
tissue. The real-time information consists of two biophysical indices
known as the Thermal Index (potential risk for temperature increase)
and the Mechanical Index (potential risk for mechanical tissue damage).
This has allowed operators to make appropriate and informed clinical
decisions, to weigh risks versus benefits, and to implement the “As Low
As Reasonably Achievable” (a.k.a. ALARA) principle.

The Thermal Index (TI) estimates the temperature increase within the
insonified tissue; its value derives from the ratio of the total acoustic
power to the acoustic power required to raise the tissue temperature by
1°C. Every type of tissue has different absorption characteristics, and
therefore a different absorption coefficient, which is directly proportional
to the ultrasound wave frequency: the higher the frequency, the greater
the absorption and the lower the depth penetration. Thus, optimizing
the image penetration should take into account the increased risk
of a temperature rise in the tissue. Because various tissues (blood,
amniotic fluid, cerebrospinal fluid, urine, soft tissue, and bone) have
different absorption capabilities and coefficients, some devices further
subcategorize the TI according to the nature of the insonified tissue: soft
tissue thermal index (TIS) for soft homogeneous tissues, cranial bone
thermal index (TIC) for bone at or near the surface, and bone thermal
index (TIB) for bone after the beam has passed through soft tissue. Bone
has a very high absorption coefficient. Biological liquids such as amniotic
fluid, blood, cerebrospinal fluid, and urine have an absorption coefficient
of zero and therefore show minimal temperature rise. Soft tissue has an
absorption coefficient that falls somewhere between fluid and bone.
The mechanical or non-thermal effects of ultrasound absorption are
estimated by a relative measure: the Mechanical Index (MI). It is
calculated by dividing the spatial-peak value of the peak rarefractional
pressure (rated by 0.3 dB/cm-MHz at each point along the beam axis)
by the square root of the center frequency. As described above, the
mechanical effects are the result of compression and decompression
in the tissue and the formation of microbubbles (cavitation). This
phenomenon is related to the peak negative pressure during a pulse,
which is related to the pulse-average intensity. Therefore, the spatial-peak
pulse-average intensity ( ) is related to cavitation. Many ultrasound
products use for specifications and therefore, operator awareness
is a necessity. Current standards recommend that if an ultrasound device
is capable of achieving a TI or MI of greater than 1.0, then the output
display screen must show the appropriate index value for the operator to
predict the potential for adverse bioeffects.
As introduced in the previous section, the absorption of ultrasound
energy by biological tissues can produce heating. The self-heating of
the probe may also contribute to heating in tissue. The mechanism of
thermal bioeffects is well understood and can be estimated for different
exposure conditions. However, even if some studies in mammalian
tissue demonstrate that some aspects of the theory are reasonably well
understood, many unanswered concerns still remain in terms of being
able to assess in vivo temperature increase.

The rate of heat generation per unit volume is directly proportional to:

• the ultrasonic temporal-average intensity, which is itself proportional

to the pressure amplitude and inversely proportional to the density of
the medium
• the ultrasonic amplitude absorption, which increases with the
increasing frequency

If damage occurs during exposure of tissue to elevated temperature, the

extent of damage will be dependent upon the duration of the exposure
as well as on the temperature increase achieved. Detrimental effects in
vitro are generally noted at temperatures of 39–43°C, if maintained for
a sufficient time period. At higher temperatures (>44°C) coagulation of
proteins can occur. These effects have been documented in experimental
studies of heat-induced cell death in cell cultures. Ultrasound machine
operators must be particularly aware that risks may offset the benefits
of ultrasound exposures when the temperature rise at the focal point of
the ultrasound beam is calculated to be, for example in fetus echographic
studies, more than 3°C for ten minutes or more. In Aixplorer®, the
temperature is calculated according to the Standard for real-Time Display
of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment, NEMA UD3-2004 (refer to the section "Meaning
of the TI and MI and Relation with Bioeffects"). However, threshold-
based data suggest that for non-fetal soft tissue, and for scanning
conditions consistent with conventional B-mode ultrasound exams for
which the exposure durations at the same in situ location would be less
than a few seconds, the allowable maximum temperature increase could
be relaxed relative to longer exposures.
 Table 3.3. Temperature thresholds for biological risks on embryonic and adult
tissues

Thermal threshold Temperature (°C) Biological risk

Physiological level 37.0 safe region
Embryonic tissues 39.5 risks for obstetrics
and pediatrics
Adult tissues 41.0 general risks

Ultrasonic waves propagating into biological tissues are attenuated

due to the properties of the tissue. This attenuation is due to either
absorption (portion of the wave energy that is converted into heat) or
scattering (portion of the wave energy which changes direction). The
higher the absorption, the higher the potential risk of rise of temperature
within the tissue. Furthermore, as explained above, tissues with poor
vascularization, (eye, tendon, fat) and tissues that conduct the heat (bone),
are subject to higher temperature rises.

Several technical factors also affect the temperature rise in the insonified
tissue:

• Frequency of the ultrasound wave

Tissue heating depends on the absorption of ultrasound; absorption

depends on the frequency of the ultrasound wave received. Therefore,
heating in tissues will increase as the frequency of the ultrasound wave
increases.

• Beam focusing
 It improves the image resolution but it also increases the intensity and
the potential of a temperature rise.

• Type of ultrasound wave form (pulsed or continuous waveforms)

Pulsed waves usually produce less heat than continuously emitted

waves. The spatial-peak temporal-average intensity (ISPTA) is defined
as the intensity at the maximum temporal-average intensity.

Other factors include pulse duration, pulse repetition frequency and

beam/scanning configuration. The duty cycle is the product of the
pulse duration and pulse repetition frequency. The heating in tissue is
proportional to the duty cycle.

• Exposed tissue volume

Scanned modes (B-mode and color flow Doppler) allow a greater

volume of tissue exposed to the ultrasound energy; this decreases the
risk of heating. Unscanned modes (M-mode and spectral Doppler)
use a stationary beam over a narrower volume of tissue; these modes
show a higher risk of heating in tissues. The greatest temperature rise
occurs between the focal point and the surface, the exact location of
the “hottest point” depending on tissue attenuation, absorption, and the
focal depth.

• Duration of ultrasound exposure

Temperature is affected by energy absorption during ultrasound

exposure. The longer the tissue is exposed, the greater the absorption,
thus the greater the risk for potential heating.

An immediate consequence of a temperature increase is an increase in

biochemical reaction rates. Most enzymes have their biological activity
increased by a factor 3 for each 10°C temperature increase. However,
they become denatured over 39°C, and deleterious effects are seen
in vitro at temperatures ranging from 39 to 43°C, if exposure lasts a
sufficient time. The concept of thermal dose describes the dependence
between the duration of exposure and the increase of temperature. In
biological tissues, the temperature of 43°C has been found to be a
transition threshold temperature, which serves as a reference, units of
thermal dose being “equivalent minutes at 43°C”. Practically every
increase of 1°C above 43°C halves the equivalent time, while every
decrease of 1°C below 43°C results in a 4-fold equivalent time.

All biological tissues are sensitive to temperature, which can have

deleterious irreversible effects. The fetus and the lens of the eye are two
examples of some tissues that are more sensitive. During pregnancy,
the fetus can absorb higher temperature elevation than its mother's
surrounding tissue. Also, the ongoing ossification that occurs during the
first trimester can lead to alteration of brain tissue by heat conduction
within the neonatal skull. The 1998 recommendations from the World
Federation of Ultrasound in Medicine and Biology (WFUMB) with
regard to ultrasound-induced temperature elevation are as follows:

1. A diagnostic ultrasound exposure that produces a maximum in situ

temperature rise of no more than 1.5°C above normal physiological
levels (37°C) may be used clinically without reservation on thermal
grounds.
2. A diagnostic ultrasound exposure that elevates embryonic and fetal in
situ temperature above 41°C (4°C above normal temperature) for 5
min or more should be considered potentially hazardous.
3. The risk of adverse effects is increased with the duration of exposure.

The volume rate of heat generation due to absorption is proportional

to the acoustic intensity and absorption at a single frequency. After the
initial propagation, the heat diffuses slowly into the tissue, expands,
smoothes out, and diminishes from the original pattern. Tissue properties
influence the temperature rise induced by ultrasound energy in the way
the absorption of heat is directly affected by the protein proportion
tissue contains (collagen has particularly high absorption capabilities). In
most of the clinical situations, bone tissues have the greatest absorption
coefficient, skin and tendon have intermediate absorption capabilities,
brain, liver and kidney have a low absorption and finally, fluids show
absorption coefficients close to zero. Absorption properties are known
to be dependent on the wave frequency, but it is important to know
that amplitude and shape of waveforms also change as they propagate
and energy is absorbed into the medium. Absorption in the body is a
highly significant effect, especially because it limits the penetration of
ultrasound waves in the body, i.e. the maximum depth at which tissues
can be imaged. Usually imaging systems have a way of increasing
acoustic amplitude as a function of depth to compensate for the
absorption phenomenon.

The actual temperature rise in tissue depends on several factors including

the local specific heat capacity, the time of exposure, the rate of
temperature rise and the rate of distribution of heat in neighboring tissue.
The measurable parameter for this distribution of heat, known as the
perfusion length, depends directly on the thermal conductivity of the
tissue and inversely on the blood perfusion flow rate and the specific
heat capacity of blood. Perfusion lengths are measured in millimeters
and range for different tissues from 1 (for highly vascularized organs)
to 20 (for poorly perfused tissue). Blood perfusion plays a significant
role in cooling the tissue and must be considered when estimating the
tissue temperature and its variations. Tissue with poor vascularization,
such as tendon, fat and cornea, and tissue that conduct the heat, such as
bone, are subject to higher temperature rises. Where the perfusion length
is smaller than any dimension of the insonated volume, heat transfer
from surrounding tissue is small. On the contrary, where it is larger than
any of the dimensions of the insonated volume, heat transfer within the
insonated volume becomes important. Therefore, tissues adjacent to bone
are particularly susceptible to heat increase via conduction.

Temperature rise by heat conduction refers to the increase of the local

temperature of a tissue that is located close to another heating object.
When the temperature gets elevated in a bone structure within the body,
due to absorption, the surrounding tissue may then be subject to heating
by conduction. This phenomenon is of particular concern for brain
heating due to the proximity of the skull. It can also happen when a
transducer is selected but left unused. Acoustic power may flow to the
outer absorbing lens where it causes self-heating. The transducer itself
can then heat the body by conduction due to direct contact when the
operator starts the exam. However, temperature of the probe surface is
controlled not to exceed a few degrees when in air and air-gel mixture.
When the transducer is in use, the temperature contribution through
conduction is often neglected because it is limited to the surface of the
body and it is smaller than the absorption contribution.

The scattering effect depends on the shape and roughness of the object
insonified (scatterer). Three categories can be distinguished, depending
on the size of the scatterer.

Specular scattering relates to reflections from objects whose shapes are

much bigger than a wavelength. If the object’s dimensions are larger than
the wavelength, the approximation of the reflection on the object forms
a wavefront that mimics the shape of the object.

Diffusive scattering happens for objects that are much smaller than a
wavelength. Irregularities on the surface of the object create individual
reflections that do not cause any significant interference effects. It has
important implications in medical imaging because biological tissue is
often considered as aggregates of small sub-wavelength point scatterers.
Doppler methods measure blood flow depending on scattering effect
by numerous small spatially unresolved blood cells. Most ultrasound
contrast agents also act as tracers to enhance the scattering of ultrasound
on gas-filled resonant spheres.

Diffractive scattering occurs on objects slightly less than a wavelength to

hundreds of wavelengths. This group of scattering objects is the largest.
Scattered waves in this situation can be considered to be originating from
the surfaces of the scatterers, which act as secondary ultrasound sources.
For a given duration of ultrasound exposure and a given level of acoustic
energy delivered, larger volumes of insonated tissue will be submitted to
a more diffuse heating, avoiding too high temperatures. At the precise
location of ultrasound beam focusing, the temperature will be higher than
before or after the focus zone. The aperture of the ultrasound beam also
impacts the heating capabilities of the ultrasound beam in the way it
generates a more or less focused ultrasound beam, bringing more or less
energy into the tissue. As described above, the scanning mode used can
also impact the spatial volume of insonified tissue.

The homogeneity of tissue being insonified is a key characteristic in heat

transfer. The ultrasound waves must typically pass through the several
layers of tissue that form organs. These layers influence the absorption
of the ultrasound energy since increased absorption in any given layer
decreases the ultrasound energy available at the point of interest. The
effect of tissue layering on the biological effects of ultrasound has been
extensively studied in obstetrics. They demonstrated that the attenuation
model that applies best to real observations is the overlying tissue
model, in which attenuation depends upon both frequency and non-fluid
distance. Furthermore, they demonstrated that the attenuation coefficient
asked by the international standards was 2 to 3 times lower than the
measured mean values to estimate ultrasonic intensity quantities in tissue.
In addition to heat, ultrasound waves also have various types of
mechanical effects on biological tissue and media, also called non-
thermal effects.

Acoustic cavitation may occur when the ultrasound beam crosses a cavity
area, such as a gas pocket. Some adult tissue contains gas bubbles (lung
and intestine), and therefore are more vulnerable to cavitation. With
acoustic cavitation, pre-existing bubbles are modified or new bubbles
are formed, due to both expansion and contraction of the gas body.
The ultrasound waves can lead the bubbles to expand and contract
rhythmically, i.e. to pulsate or resonate. The hypothesis of bubbles that
would form in tissues and organs that do not contain gases is currently
under investigation.

Under ultrasound insonification and certain conditions, a gas bubble

can resonate and grow instead of dissolving in the medium liquid. The
ultrasound wave makes the bubble expand and outer dissolved gases get
pumped in, which increases its size rapidly.

The generation of cavitation depends on numerous factors including the

ultrasonic pressure, the type of ultrasound wave emitted (focused or not,
pulsed or continuous), the presence of standing waves and the nature
and state of the material. Cavitation can be prevented by first being
aware of whether or not gas bubbles stay in the tissue being imaged. In
liquid media, another significant biological factor over cavitation is the
density of the liquid: higher density liquids create intense cavitation with
a greater implosive force. Some technical factors can also be of great help,
including limitation of the pressure amplitude of the ultrasound pulse
and length of the pulse. When gas bubbles are present in the tissue, their
number, size and location are also significant contributors to the effect.

Stable cavitation refers to the periodic expansion or contraction of

a gas bubble. The gaseous body pulsates due to the ultrasound
field, and remains stable. Part of the liquid medium surrounding the
gaseous bubbles can begin to stream with the oscillations, leading to
microstreaming. Theoretically, microstreaming could also be caused by
“acoustic streaming” in fluid media, due to the stirring action of the
ultrasound wave. As happens in microstreaming, the acoustic streaming
results in a flow of liquid speeding up as the acoustic pressure of the
ultrasound increases. This phenomenon could damage cell membranes,
which could undergo disruption. However, the real effect of cell
membrane damage has only been observed in animal experiments and
whether it occurs in humans remains unclear.

When the insonified tissue contains bubbles, gas or vapor, the ultrasound-
induced strain may induce cavitation originating from the location of
the gas, termed as a “nucleation site”. The exact nature and source of
nucleation sites are not well understood in a complex medium such as
tissue. Theoretical analyses and predictions have not yet been verified
experimentally.

The inertial cavitation, called unstable or ‘‘transient cavitation’’ when

first observed, refers to the rapid growth and violent collapse of a
bubble, seen as a threshold event that tends to increase with frequency.
This phenomenon is closely linked to very high temperatures (about
5000°K) and its consequences include the generation of biological toxic
compounds, the generation of shock waves, and ‘‘sonoluminescence.’’

Ultrasound waves can also generate other mechanical effects that are not
related to bubbles. They include changes in pressure, force, torque and
streaming; they can produce audible sounds and cause electrical changes
in cell membranes, thus increasing their patency to large molecules; they
can lead to the movement and redistribution of cells in liquid, and they
can also damage cells.

Recently, static or dynamic acoustic radiation force techniques have been

applied to ultrasound diagnosis. Amongst the different techniques that
use radiation force to locally move or vibrate tissue, the technique used
by the Aixplorer® system is Supersonic Shear Imaging. This technique
utilizes the ultrasound-induced temporal-average force on the medium to
create the tissue motion. The magnitude of the effect is proportional to
the local temporal-average intensity and is in the range of microns.

The cavitation effect is a far more rapid response than temperature rise
and is also a threshold phenomenon. In inertial cavitation, the threshold
is defined by the amplitude of the ultrasound wave, its frequency, and the
size of the pre-existing nucleation sites. The threshold is such that there
is a critical size range over which bubbles will undergo inertial cavitation
if insonified by an appropriate sound field. In other words, for a given
frequency and sound pressure amplitude, bubbles within a certain radius
range will undergo inertial cavitation, and those outside of it will not.

Under experimental circumstances, ultrasound has to be used outside of

the diagnostic range in order to be able to detect any adverse bioeffect.
Among them, lung hemorrhage is probably the most extensively studied,
although its mechanism still remains unclear. Thermal bioeffects and
inertial cavitation have both been excluded as being responsible for
lung lesions. However, general observations can be made from the
large amount of ultrasound-induced lung damage threshold studies. First,
the degree of damage observed in animals does not appear to be a
concern since the extent of lung damage is limited and the organ can
recover from the effect. Second, the mechanisms of lung injury seem
to be similar in all species and the features of the lesions induced are
independent from the frequency, pulse repetition frequency, and the
beamwidth. Therefore similar biological mechanisms may be of concern
in patients undergoing ultrasound lung exposure, and especially patients
with pulmonary disorders or “at risk” neonates.
Without question, ultrasound imaging has had a significant impact on
the field of medical diagnostic imaging. Examples of the benefits of
ultrasound diagnostic imaging can be easily found in cardiology and
obstetrics. In cardiology, ultrasound allows for the detailed visualization
of the anatomical structure and function of the heart and its great vessels.
The radiologist can see the blood flow within the heart ventricles and
atria as well as the function of the valves under normal and pathological
conditions. In obstetrics, there is a particular concern for potential
bioeffects on the embryo-fetus during pregnancy. However, because
of its excellent safety record, this imaging modality is routinely used
worldwide. During the past few years, the technology of ultrasound
imaging has greatly improved and refers to an expanding array of clinical
applications. A variety of ultrasound systems are currently available
for specific medical and clinical situations such as elasticity imaging,
vascular medicine, cardiac studies and musculoskeletal applications.
Recent technological developments have allowed for images of far
better quality and also better diagnostic information. However, these
technological advances and applications also require more responsibility
to be assumed by the operators. From both healthcare systems
and patients’ perspectives, the cost effectiveness and non invasive
nature of ultrasound examinations make them very well tolerated.
Ultrasound examinations are universally accepted by patients and their
reimbursement agencies.

Despite the excellent safety record, the potential risk of adverse biological
effects at the tissue and cellular levels exist. As mentioned above,
biological mechanisms of lung injury similar to the ones observed in non-
human mammals may be of concern in patients undergoing sonographic
procedures with lung exposure. There is also the theoretical potential
for bioeffects to occur at the subcellular level, although these effects are
poorly understood. Adverse bioeffects that were observed in mammals
have never been reported to occur in human patients. Therefore, the
regulation now reinforces the operator’s responsibility in limiting the
potential risk of ultrasound adverse bioeffects to their patients. To achieve
this, the operator should be given all the necessary information to make
an informed balanced decision, weighing possible bioeffects against
the expected diagnostic information. However, newer applications
(transesophageal echocardiography, intravascular ultrasound) may cause
bioeffects that have never been anticipated. Further specific research is
needed in these fields before all risks can be defined.

In the meantime, ultrasound operators should permanently weigh

potential biological effects against the real risks of not doing the
examination and thus missing key diagnostic information. In obstetrics
and cardiology, the clinical diagnostic value of ultrasound information is
so well accepted by the medical community, that it is acknowledged that
there is a higher risk to the patient if an ultrasound exam is not performed.
Ultrasound imaging provides a large amount of highly valuable clinical
information that is pertinent to a variety of diagnostic applications. This
information can be used instead of a higher risk procedure, or can be
used in conjunction with other diagnostic procedures, in order to improve
diagnostic confidence or to obtain crucial diagnostic information. In
most cases, obtaining the same information with other tests or imaging
methods would be at a higher cost or with increased risk.

At the tissue site where the ultrasound temporal-average intensity is ,

the rate of heat generation per unit volume is given by the expression
, where stands for the ultrasonic amplitude absorption
coefficient. This means that the increase in temperature is proportional to
an average value of the ultrasound intensity over a time period, also called
the acoustic output. Therefore, the risk of generating thermal bioeffects
within insonified tissues depends directly on the acoustic output.
Since 1991, the technical evolution of ultrasound systems has allowed for
significant increases in acoustic output and therefore has lead to better
spatial resolution, enhanced contrasts, increased image definition and
improved diagnostic sensitivity. Real 3D and 4D imaging modes, color
Doppler, and recently strain imaging illustrate the new and enhanced
imaging capabilities of current ultrasound systems. Other potential
benefits of increasing the acoustic output include the ability to image
at greater depths due to improved echo and Doppler signal acquisition
and penetration, and improvements in resolution due to the transmission
of higher frequencies. Simultaneously, the scientific knowledge of
biological adverse effects of ultrasound has largely expanded and has
raised the concept of weighing the risks against the benefits of getting a
better ultrasound image.

In relaxing the limits of the acoustic output power on current

ultrasound systems, the regulatory authorities of course have allowed
the development of increased diagnostic capabilities and image quality,
but they have also placed increased responsibility on operators. The
operator has to evaluate the risks and benefits of diagnostic ultrasound
in general, but also of increasing the acoustic output power to get
better images. To fulfil this responsibility, ultrasound operators need
to have full knowledge of ultrasound systems and tools. This requires
specific education and training, which has now been included as part of
the accreditation process for ultrasound clinical use in most developed
countries.

The operator should:

1. be familiar with the possible risk factors,

2. be aware of the need to adjust the acoustic output to obtain a good
image,
3. evaluate and consider the patient’s clinical state and
4. know all the system controls that affect the acoustic output.
Current ultrasound systems allow the operator to balance risks versus
benefits and make an informed decision. Systems display real-time
information on the potential risks of adverse bioeffects via indices that
refer to the output intensity and the possible thermal and mechanical risks
(Thermal Index: TI, and Mechanical Index: MI). According to the NCRP,
the risks of diagnostic ultrasound have to be weighed against the benefits
when the MI is above 0.5 or the TI is above 1.0. Practically speaking,
generating a better image may lead to greater risks, especially depending
on the patient’s anatomy and presentation: thin and obese patients do not
present the same risks, full and empty bladder at the time of examination
do not have the same risks, and the presence of gas bubbles in the scanned
area of the body may increase risk.
According to the International Commission of Radiological Protection
“Medical exposure is the only category in which large reductions in
average dose are possible, and it is therefore highly desirable to reduce
applications of medical radiation which are of no benefit to the patients
and to minimize useless radiation in the course of medical examinations”.
To reduce the risks related to ultrasound exposure, the ALARA principle
can be applied to ultrasound examinations. ALARA stands for “As Low
As Reasonably Achievable”. It means that the total ultrasound exposure
has to be kept as low as reasonably achievable, in order to guarantee the
patient’s safety while optimizing diagnostic information.

The ALARA principle applied to ultrasound diagnostic imaging

recommends that the total ultrasound energy should be maintained below
a level at which bioeffects are generated while diagnostic information
is preserved. The implementation of ALARA enables obtaining the
information needed while keeping the potential for bioeffects as low as
reasonably achievable. The operator should start the exam by selecting
the correct transducer frequency and application and then use a low
output level. Then all image quality controls should be used to optimize
the image (focus, receiver gain…). Only if the image is not diagnostically
useful at this point, then acoustic output can be increased. The output
power control allows the operator to select intensity levels less than the
established maximum. Prudent use dictates that the operator select the
lowest output intensity that is consistent with good image quality.

The indices that are displayed do not take into account the length
of exposure. As the total amount of energy received at a location is
proportional to length of exposure of this particular site, the operators
should also keep the total exposure time in one location as short as
possible. Therefore, a more complete definition of the ALARA principle
is to use the lowest output setting that will yield the best possible
diagnostic information, while keeping the exposure time as short as
possible.
The operating guidelines that derive from the ALARA principle should
remain very clear and have the only goal of quality of the diagnostic
information.

In addition, the operator should ensure that:

• only medically required scanning is performed,

• an exam is not rushed,
• the quality is never compromised.

A poor exam will most probably require a secondary exam or a follow-

up, thus increasing exposure time.

Selecting the most appropriate system setup (transducer, application) is

the first step to take before starting an ultrasound scan. Then the operator
should select the correct range of acoustic intensity for the application,
if not done automatically by the system. Ultimately, the operator has the
responsibility for proper clinical use. The Aixplorer® ultrasound system
provides both automatic (default) settings and manual (user-selectable)
settings.

The system offers the possibility to control the acoustic output thanks to
3 different types of controls.

Direct controls affect directly the acoustic intensity. They include the
Application Selection (see above) and the control of the Output Power.
The Application Selection affects the allowable output intensity range.
Selecting the correct range of acoustic intensity for the application is
one of the first things that occur in any exam. For example, peripheral
vascular intensity levels are not recommended for fetal exams. Some
systems automatically select the proper range for a particular application,
while others require manual selection. Ultimately, the user has the
responsibility for proper clinical use. The Aixplorer® ultrasound system
provides both automatic (default) settings and manual (user-selectable)
settings. The Output Power directly affects the acoustic intensity, by
increasing or decreasing it. Once the application has been established,
the Output Power control allows the operator to select intensity levels
less than the established maximum. Prudent use dictates that the operator
select the lowest output intensity that is consistent with good image
quality.

Indirect Controls are those that have an indirect effect on acoustic

intensity. They refer to the transducer selection (see “Effects of
transducer capabilities” below), the imaging mode (see “Effects of
operating mode” below), the pulse repetition frequency, the focal depth
and the pulse length. All of them indirectly impact the output intensity
for specific reasons: for example, the transducer operating frequency
has to be adapted to the expected depth of scanning; also, a scanned
and a stationary mode will not deliver the same amount of energy in a
particular location. For complete details on other indirect controls the
operator should refer to sub-section “Indirect Controls” in the section
“Applying ALARA with the Aixplorer® Ultrasound Imaging System”.
Pulse repetition frequency or rate refers to the number of ultrasound
bursts of energy over a specific period of time. The higher the pulse
repetition frequency, the more pulses of energy in a period of time.
Several controls affect pulse repetition frequency: focal depth, display
depth, sample volume depth, flow optimization, scale, number of focal
zones, and sector width controls. Focus of the ultrasound beam affects
the image resolution. To maintain or increase resolution at a different
focus requires a variation in output over the focal zone. This variation
of output is a function of system optimization. Different exams require
different focal depths. Setting the focus at the proper depth improves
the resolution of the structure of interest. Pulse length is the time during
which the ultrasonic burst is turned on. The longer the pulse, the greater
the time-average intensity value. The greater the time-average intensity,
the greater the likelihood of temperature increase and cavitation. Pulse
length or burst length or pulse duration is the output pulse duration
in pulsed Wave Doppler. Increasing the Doppler sample volume size
increases the pulse length.

Receiver controls have no effect on acoustic output and can be used by

the operator to improve image quality. They only change the way the
ultrasound echo is received and should always be used before the output
power is increased. They include gain, TGC, dynamic range, and image
processing features. The important thing to remember, relative to output,
is that receiver controls should be optimized before output is increased.
For example: before increasing output, optimize gain to improve image
quality.

The choice of imaging mode determines the nature of the ultrasound

beam. For example, the B-Mode is a scanning mode, while Doppler is a
stationary or unscanned mode. A stationary ultrasound beam concentrates
energy in a single location. A moving or scanned ultrasound beam
disperses the energy over an area such that the beam is concentrated on
the same area for only a fraction of the time as that of an unscanned mode.

Transducer selection indirectly affects acoustic output intensity. Tissue

attenuation changes with frequency. The higher the transducer operating
frequency, the greater the attenuation of the ultrasonic energy. A higher
transducer operating frequency requires more output intensity to scan
at a deeper depth. To scan deeper at the same output intensity, a lower
transducer frequency should be required. Using more gain and output
beyond a point, without corresponding increases in image quality, can
mean that a lower frequency transducer is needed.

Ultrasound exposure time should always be limited; however, do not rush

the exam.

Ensure that the indices are kept to a minimum and that exposure time is
limited without compromising diagnostic sensitivity.
The system Output Display Standard (ODS) comprises two basic indices:
a mechanical index and a thermal index. The thermal index further
consists of the following indices: a thermal index for soft tissue (TIS), a
thermal index for bone or tissue located near bone (TIB), and a thermal
index for cranial bone (TIC). The Aixplorer® user is able to choose
the TI and MI display format in the System Configuration, i.e TIS and/
or TIB and/or TIC, or the maximum value of the three TI, which in
return depends upon the application at hand. Either the TIS or TIB or the
maximum value of those indices will be displayed at all times. Which
one is displayed depends upon the system preset or user’s choice, which
in return depends upon the application at hand. The application-specific
nature of the default index setting is also an important factor in index
behavior. A default setting is a system control state which is preset by
the manufacturer or the operator. The system has default index settings
corresponding to each transducer application. The default settings are
invoked automatically by the ultrasound system when power is turned
on, new patient data is entered into the system data base, or a change in
application takes place.

The decision as to which of the 3 thermal indices, or the maximum value

of the three, to display should be based on the following criteria:

• Appropriate index for the clinical application: TIS is used for imaging
soft tissue TIB for a focus at or near bone, and TIC when imaging
through the cranial bone or near the skull.
• Factors that might create artificially high or low thermal index
readings: location of fluid or bone, or blood flow. For example, if there
is a highly attenuating tissue path so that the actual potential for local
zone heating is less than the thermal index displays.

Scanned modes versus unscanned modes of operation affect the thermal

index. For scanned modes, heating tends to be near the surface; for
unscanned modes, the potential for heating tends to be deeper in the focal
zone.
Mechanical bioeffects are threshold phenomena that occur when a certain
level of output is exceeded. The threshold level varies, however, with
the type of tissue. The potential for mechanical bioeffects varies with
peak rarefactional pressure and ultrasound frequency. The MI accounts
for these two factors. The higher the MI value, the greater the likelihood
of mechanical bioeffects occurring. There is no specific MI value that
indicates that a mechanical effect is actually occurring. The MI should
be used as a guide for implementing the ALARA principle.

The TI informs the user about conditions that might lead to an increase
in temperature at the surface of the body, within the body tissue, or at the
point of focus of the ultrasound beam on bone. That is, the TI informs the
user of the potential for temperature rise in body tissue. It is an estimate
of temperature increase in body tissue with specific properties. The actual
amount of any temperature rise is influenced by factors such as tissue
type, vascularity, mode of operation and others. The TI should be used as
a guide for implementing the ALARA principle. The bone thermal index
(TIB) informs the user about potential heating at or near the focus after
the ultrasound beam has passed through soft tissue or fluid, for example,
at or near second or third trimester fetal bone. The cranial bone thermal
index (TIC) informs the user about the potential heating of bone at or near
the surface, for example, cranial bone. The TI informs the user about the
general potential for heating within tissue. Depending on the Aixplorer®
user's choice, the TIS or TIB or TIC or the maximum value of the three
is continuously displayed over the range of 0.0 to maximum output. The
mechanical index is continuously displayed over the range of 0.0 to 1.9.

As mentioned above, and depending on the Aixplorer® user's choice, the

TIS or TIB or TIC, or the maximum value of the three is continuously
displayed from 0.0 to maximum output, based on the transducer and
application, in increments of 0.1. The mechanical index is continuously
displayed from 0.0 to 1.9, in increments of 0.1. Therefore, the MI and TI
precision is 0.1 unit on the Aixplorer® system. The MI and TI display
accuracy estimates for the Aixplorer® system are given in Acoustic
Output Tables in this user manual. These accuracy estimates are based
on the variability range of transducers and systems, inherent acoustic
output modelling errors and measurement variability, as discussed below.
The displayed values should be interpreted as relative information to
help the operator achieve the ALARA principle through prudent use
of the system. The values should not be interpreted as actual physical
values in interrogated tissues or organs. The initial data that is used
to support the output display is derived from laboratory measurements
based on the AIUM measurement standard. The measurements are
then put into algorithms for calculating the displayed output values.
Many of the assumptions used in the process of measurement and
calculation are conservative in nature. Over-estimation of actual in situ
intensity exposure, for the vast majority of tissue paths, is built into the
measurement and calculation process.

For example:

• The measured water tank values are derated using a conservative,

industry standard, and attenuation coefficient of 0.3 dB / cm-MHz.
• Conservative values for tissue characteristics were selected for use
in the TI models. Conservative values for tissue or bone absorption
rates, blood perfusion rates, blood heat capacity, and tissue thermal
conductivity were selected.
• Steady-state temperature rise is assumed in the industry standard TI
models, and the assumption is made that the ultrasound transducer is
held steady in one position long enough for steady state to be achieved.

A number of factors are considered when estimating the accuracy of the

displayed values: hardware variations, estimation algorithm accuracy,
and measurement variability. Variability among transducers and systems
is a significant factor. Transducer variability results from piezoelectric
crystal efficiencies, process-related impedance differences, and sensitive
lens focusing parameter variations. Differences in system pulser voltage
control and efficiency may also contribute to variability. There are
inherent uncertainties in the algorithms used to estimate acoustic output
values over the range of possible system operating conditions and
pulser voltages. Inaccuracies in laboratory measurements are related to,
among others, differences in hydrophone calibration and performance,
positioning, alignment, and digitization tolerances, and variability among
test operators. The conservative assumptions of the output estimation
algorithms of linear propagation, at all depths, through a 0.3 dB/cm-MHz
attenuative medium is not considered in the accuracy estimate for the
display. Neither linear propagation, nor uniform attenuation at the 0.3
dB/cm-MHz rate, occurs in water tank measurements or in most tissue
paths in the body. In the body, different tissues and organs have dissimilar
attenuation characteristics. In water, there is almost no attenuation. In
the body, and in particular, in water tank measurements, non-linear
propagation and saturation losses occur as pulser voltages increase.
Therefore, the display accuracy estimates are based on the variability
range of transducers and systems, inherent acoustic output modelling
errors, and measurement variability. Display accuracy estimates are not
based on errors in, or caused by measuring according to, the AIUM
measurement standards, or the effects of non-linear loss on the measured
values.

The TI gives a relative indication of the potential for temperature increase

at a specific point along the ultrasound beam. The reason for the term
‘relative’ is that the assumed conditions for heating in tissue are so
complex that this index cannot be assumed to give the actual increase in
temperature for all possible conditions. Thus, a TI of 2 represents a higher
temperature rise than a TI of 1, but does not necessarily represent a rise of
2° C. This temperature rise is a theoretical estimate based on experimental
conditions that may not apply to clinical conditions. The important point
to remember about the TI is that it is designed to make users aware of the
possible temperature rise at a particular point in tissue. The concern over
temperature rise induced by ultrasound in the body is based on observed
changes in cellular activity as a function of temperature. In general, for
healthy activity of enzymes, the enzymatic activity doubles for every 10°
C rise. The human body is able to tolerate hot drinks and fevers for a
certain period of time. A fever of +2° C is not a problem, where 37° C is
taken as an average core body temperature. The following table identifies
stages of temperature effects.
 Table 3.4. Temperature Effect from Millet and Ziskin, 1989

Temperature Effect
Range
(Degrees
Centigrade)
37-39 No harmful effects for extended periods
39-43 Detrimental effects for long enough times
>41 Threshold for fetal problems for extended periods
44-46 Coagulation of protein
>45 Enzymes become denatured
>41.8 Cancer cells die (fail to reproduce)
Often taken as damage threshold, except eye

The temperature rise in tissue during ultrasonic exposure is due to the

absorption of acoustic energy. Absorption is the conversion of ultrasonic
energy into heat. The extent of the absorption depends on the tissue type.
A specific way in which tissue absorption characteristics are quantified
is the “Absorption coefficient”. The absorption coefficient is expressed
in decibels per centimeter per MegaHertz. Absorption coefficients are
very dependent on the organ or tissue type that is being imaged. Amniotic
fluid, blood and urine have very low absorption coefficients, which
mean that there is little temperature elevation and the ultrasound goes
through the fluid with very little decrease. Bone, however, has a very
high absorption coefficient. Dense bone absorbs the energy very quickly
and causes the temperature to rise rapidly. Soft tissues vary in density
depending on the particular organ, but the density does not vary much
within an organ. Ultrasonic frequency affects absorption. The higher
the frequency, the higher the absorption. How to minimize temperature
rise: The temperature increase depends on the intensity, duration of
exposure at the same location, transducer focal point size and location,
and absorption of the energy by the tissue. The operator can control the
intensity (output power control), the duration or the exposure time. The
transducer is typically moved frequently during the exam, which reduces
the exposure duration at a specific tissue location. The other important
factor of temperature rise is absorption of the ultrasound energy in tissue
layers in front of the point of interest. Increased absorption in these layers
decreases the ultrasound energy available at the point of interest.
In addition to heat effect, various types of mechanical effects on the body
are generated by ultrasonic exposure. These effects can be divided into
two categories. The first category is called acoustic cavitation. Cavitation
can occur when sound passes through an area that contains a cavity, such
as a gas bubble or other air pocket. Some tissues, most notably adult lung
and intestine, do contain air bubbles, and are therefore more vulnerable
to these cavitation effects. The fetal lung and intestine do not contain
obvious air bubbles, because the fetus does not breathe air yet—it gets
oxygen from the mother’s blood stream. However, tiny bubbles could
potentially form in parts of the body other than the lung and intestine.
More research is needed in this area. In cavitation, the sound waves can
cause the bubbles or air pockets to expand and contract rhythmically:
in other words, to pulsate, or resonate. When they pulsate, the bubbles
send secondary sound waves off in all directions. If the bubbles contract
towards the point of collapsing, they can build up very high temperatures
and pressures for a few tens of nanoseconds. These high temperatures and
high pressures can produce highly reactive chemicals called free radicals,
and other potentially toxic compounds which, although considered
unlikely, could theoretically cause genetic damage. The rapid contraction
of bubbles in cavitation can also cause micro-jets of liquid which
can damage cells. When diagnostic ultrasound is focused on the lung
or intestine of laboratory animals, which contain gas bubbles, these
cavitation effects can cause ruptures in very small blood vessels. The
safety guidelines for diagnostic ultrasound are designed to try to prevent
cavitation effects, because these effects can be damaging. Restrictions
on the pressure amplitude of the ultrasound pulse, in combination with
awareness of whether or not there are gas bubbles in the tissue being
imaged, can help prevent cavitation. Other factors such as the length
of the pulse, and the density of the liquid, also influence whether or
not cavitation occurs. And if there are gas bubbles, the number, size
and location of the bubbles also contribute to the effect. The occurrence
of cavitation and its behavior depend on many factors, including the
ultrasonic pressure and frequency, the focused or unfocused and pulse or
continuous ultrasonic field, the degree of standing waves, and the nature
and state of the material and its boundaries. Currently there is no evidence
of cavitation occurring in human tissue or fluids resulting from diagnostic
ultrasonic exposure. In addition, the control parameters on our ultrasound
imaging system limit the peak output. Ultrasound can also create other
mechanical effects that do not require the presence of bubbles in order to
occur. These effects include changes in pressure, force, torque (causing
things to rotate) and streaming (stirring of the liquid). These changes,
in turn, can cause audible sounds, electrical changes in cell membranes
that make them more permeable to large molecules, movement and
redistribution of cells in liquid, and cell damage. When ultrasound passes
through liquid, it causes a sort of stirring action called acoustic streaming.
As the acoustic pressure of the ultrasound increases, the flow of liquid
speeds up. This stirring action, in theory, could occur in fluid-filled parts
of a patient’s body, such as blood vessels, the bladder or amniotic sac.
In experiments with animals, when streaming of the liquid comes near a
solid object, shearing can occur, and this can damage platelets and lead
to abnormal blood clotting (thrombosis). It is not clear to what extent
this effect occurs in humans exposed to diagnostic ultrasound. Although
possible adverse effects of ultrasound exist, the overall risk of undergoing
an ultrasound diagnostic examination has been found to be minimal, even
under moderate to prolonged exposure. Under normal circumstances of
diagnostic examination, ultrasound applied prudently using the ALARA
principle has been shown to be a safe, effective and reliable diagnostic
tool.
The guiding principle for the use of diagnostic ultrasound is defined
by the “As Low As Reasonably Achievable” (ALARA) principle. The
decision as to what is reasonable has been left to the judgment and
insight of qualified personnel. No set of rules can be formulated that
would be sufficiently complete to dictate the correct response to every
circumstance. By keeping ultrasound exposure as low as possible, while
obtaining diagnostic images, users can minimize potential ultrasonic
bioeffects.

Since the threshold for diagnostic ultrasound bioeffects is undetermined,

it is the operator’s responsibility to control total energy transmitted into
the patient. The operator must reconcile exposure time with diagnostic
image quality. To ensure diagnostic image quality and limit exposure
time, an ultrasound system provides controls that can be manipulated
during the exam to optimize the results of the exam. The ability of the user
to abide by the ALARA principle is important. Advances in diagnostic
ultrasound - not only in the technology but in the applications of that
technology, have resulted in the need for more and better information to
guide the user. The output display indices are designed to provide that
important information. There are a number of variables which affect the
way the output display indices can be used to implement the ALARA
principle. These variables include index values, body size, location of the
bone relative to the focal point, attenuation in the body, and ultrasound
exposure time. Exposure time is an especially useful variable, because it
is controlled by the user. The ability to limit the index values over time
supports the ALARA principle.
The ALARA concept is achieved by using the information displayed on
the screen in the form of biologically relevant exposure indices: the TI
and the MI. The display of biological index information is only a tool.
Safe use of the ultrasound imaging device can be ensured by using the
lowest indices that will yield the best possible diagnostic information.

An ultrasound scan of a patient begins with selecting the appropriate

transducer frequency. After selecting the transducer and the application,
which are based on patient anatomy, adjustments to output power should
be made to ensure that the lowest possible setting is used to acquire an
image. After the image is acquired, adjusting the focus of the transducer,
and then increasing the receiver gain, dynamic range, and the TGC to
produce a uniform representation of the tissue follows. If an adequate
image can be obtained with the increase in gain and adjusting the TGC,
then a decrease in output should be made. Only after making these
adjustments should the operator increase output to the next level. Having
acquired the B-mode display of the scanned organ, Color Flow Imaging
can be used to localize blood flow. As with the B-mode image display,
gain, TGC, and image processing controls must be optimized before
increasing output. Having localized the blood flow, use the Doppler
controls to position the sample volume over the vessel. Before increasing
output, adjust velocity range or scale and Doppler gain to obtain an
optimal Doppler trace. Only if maximum Doppler gain does not create
an acceptable image does the operator increase output. In summary:
select the correct transducer frequency and application for the job; start
with a low output level; optimize the image using focus, receiver gain,
and other imaging controls; if the image is not diagnostically useful at
this point, then increase output. Overall gain and TGC are the 2 most
important receiver controls that must be used by the operator to improve
image quality, before increasing the acoustic output. These controls have
no effect on acoustic output and only affect the way the ultrasound
echo is received. The important thing to remember, relative to output,
is that receiver controls should be optimized before output is increased.
For example: before increasing output, optimize gain to improve image
quality. Dynamic range and image post-processing are also receiver
controls that have no effect on acoustic output power. Again, it is of
first importance for the operator to remember that these two controls also
should be optimized before output is increased.

Application selection and the Output Power control directly affect

acoustic intensity. There are different ranges of allowable intensity or
output based on operator’s selection. Selecting the correct range of
acoustic intensity for the application is one of the first things that occurs
in any exam. For example, peripheral vascular intensity levels are not
recommended for fetal exams. Some systems automatically select the
proper range for a particular application, while others require manual
selection. Ultimately, the user has the responsibility for proper clinical
use. The Aixplorer® ultrasound system provides both automatic (default)
settings and manual (user-selectable) settings. Output Power has direct
impact on acoustic intensity. Once the application has been established,
the Output Power control can be used to increase or decrease the intensity
output. The Output Power control allows the operator to select intensity
levels less than the established maximum. Prudent use dictates that the
operator selects the lowest output intensity that is consistent with good
image quality.

The controls that affect the acoustic output are:

• pulse repetition frequency,

• focus depth,
• pulse length,
• transducer selection.

Pulse repetition frequency or rate refers to the number of ultrasound

bursts of energy over a specific period of time. Dwell time is equal to
the inverse of the pulse repetition frequency minus the burst length. The
higher the pulse repetition frequency, the more pulses of energy in a
period of time and the shorter the dwell time. Several controls affect
pulse repetition frequency: focal depth, display depth, sample volume
depth, flow optimization, scale, number of focal zones, and sector width
controls. Focus of the ultrasound beam affects the image resolution. To
maintain or increase resolution at a different focus requires a variation
in output over the focal zone. This variation of output is a function
of system optimization. Different exams require different focal depths.
Setting the focus at the proper depth improves the resolution of the
structure of interest. Pulse length is the time during which the ultrasonic
burst is turned on. The longer the pulse, the greater the time-average
intensity value. The greater the time-average intensity, the greater the
likelihood of temperature increase and cavitation. Pulse length, also
known as burst length or pulse duration, is the output pulse duration in
pulsed Doppler. Increasing the Doppler sample volume size increases
the pulse length. Transducer selection indirectly affects intensity. Tissue
attenuation changes with frequency. The higher the transducer operating
frequency, the greater the attenuation of the ultrasonic energy. A higher
transducer operating frequency requires more output intensity to scan
at a deeper depth. To scan deeper at the same output intensity, a lower
frequency transducer is required. Using more gain and output beyond a
point, without corresponding increases in image quality, can mean that a
lower frequency transducer is needed.

The choice of imaging mode determines the nature of the ultrasound

beam. B-mode is a scanning mode, Doppler and M-mode are stationary
or unscanned modes. A stationary ultrasound beam concentrates energy
in a single location. A moving or scanned ultrasound beam disperses the
energy over an area such that the beam is concentrated on the same area
for only a fraction of the time as that of an unscanned mode.

ShearWave™ Elastography mixes the two types of scanned and

unscanned modes:

• the generation of the acoustic radiation force is a scanned ultrasound

emission,
• the acquisition of the Shearwave propagation is achieved by unscanned
flat insonification at a very high frequency (UltraFast™),
• the B mode imaging is performed in an interleaved manner with the
elastography sequence and is a scanned mode.
One important contributor to ALARA, not incorporated in the output
display indices, is the element of time. As the total exposure is directly
proportional to the amount of time the ultrasound beam remains in
one area, users should remember that, besides keeping the TI and
MI as low as possible, the total exposure time in any one location
should be kept as short as possible. The concept of ALARA is to use
the lowest output setting that will yield the best possible diagnostic
information, while keeping the exposure time as short as possible. With
a clear understanding of the new responsibilities, users will have more
capabilities and potentially more diagnostic information available from
these higher output devices, while minimizing risk to patients. Ensure
that scanning time is kept to a minimum, and ensure that only medically
required scanning is performed. Never compromise quality by rushing
through an exam. A poor exam may require a follow-up, which ultimately
increases exposure time. Diagnostic ultrasound is an important tool in
medicine, and, like any tool, it should be used efficiently and effectively.

The system imaging mode used depends upon the information needed. B-
mode imaging provides anatomical information. Pulsed Doppler, Color
Power Imaging (CPI), Directional Color Power Imaging (dCPI) and
Color Flow Imaging (CFI) provide information about blood flow. The
M-mode is used for cardiac assessment and measurement of the fetal
heart rate. ShearWave™ Elastography Imaging displays information
about tissue stiffness via color-scale or grayscale. A scanned mode,
like B-mode, SWE™, CPI, dCPI, or CFI, disperses or scatters the
ultrasonic energy over an area, while an unscanned mode, like Pulsed
Wave Doppler, concentrates ultrasonic energy. The M-mode should be
used instead of spectral Pulsed Wave Doppler imaging to document
embryonic/fetal heart rate. Understanding the nature of the imaging mode
being used allows the operator to apply the ALARA principle with
informed judgment. Additionally, knowing the transducer frequency,
system setup values, and scanning techniques, and the operator’s
experience allow him or her to meet the ALARA principle. The decision
as to the amount of acoustic output is, in the final analysis, up to the
operator. This decision must be based on the following factors: type
of patient, type of exam, patient history, ease or difficulty of obtaining
diagnostically useful information, and the potential localized heating
of the patient due to transducer surface temperatures. Prudent use of
the system occurs when patient exposure is limited to the lowest index
reading for the shortest amount of time necessary to achieve acceptable
diagnostic results. Although a high index reading does not mean that
a bioeffect is actually occurring, a high index reading should be taken
seriously. Every effort should be made to reduce the possible effects
of a high index reading. Limiting exposure time is an effective way to
accomplish this goal. There are several system controls that the operator
can use to adjust the image quality and limit the acoustic intensity.
These controls are related to the techniques that an operator might use to
implement ALARA. These controls can be divided into three categories:
direct, indirect, and receiver controls. As various system controls are
adjusted, the TI and MI values may change. This will be most apparent
as the Output Power control is adjusted; however, other system controls
will affect the on-screen output values.

Output Power controls the system acoustic output. Two real-time output
values are on the screen: a TI and MI. They change as the system responds
to Output Power adjustments. In combined modes, such as simultaneous
CFI, B-mode, the individual modes each add to the total TI. One mode
will be the dominant contributor to this total. The displayed MI will be
from the mode with the largest peak pressure.
SECTOR WIDTH

Narrowing the sector angle may increase frame rate. This action will
increase the TI. Pulser voltage may be automatically adjusted down with
software controls to keep the TI below the system maximums. A decrease
in pulser voltage will decrease MI.

ZOOM

Increasing the zoom magnification by pressing Zoom may increase frame

rate. This action will increase the TI. The number of focal zones may also
increase automatically to improve resolution. This action may change MI
since the peak intensity can occur at a different depth.

NUMBER OF FOCAL ZONES

More focal zones may change both the TI and MI by changing frame
rate or focal depth automatically. Lower frame rates decrease the TI. MI
displayed will correspond to the zone with the largest peak intensity.

FOCUS

Changing the focal depth will change MI. Generally, higher MI values
will occur when the focal depth is near the natural focus of the transducer.

The M-mode is accessible from the B-mode controls. All 2D controls

mentioned above apply to the M-mode image. Similarly, the MI and/or
TI are displayed on the Aixplorer® monitor when operated in M-mode.
Additional indirect controls dedicated to the M-mode also impact on the
TI and MI.

SAMPLE VOLUME DEPTH

When M-mode sample volume depth is increased the PRF may

automatically increase, leading to an increase of the TI.

VELOCITY OPT

Increasing the Color sensitivity with the Velocity Opt control may
increase the TI. More time is spent scanning the Color image. Color
pulses are the dominant pulse type in this mode.

COLOR BOX/SECTOR WIDTH

Narrower color sector width will increase color frame rate and the TI will
increase. The system may automatically decrease pulser voltage to stay
below the system maximum. A decrease in pulser voltage will decrease
the MI.

COLOR BOX/SECTOR DEPTH

Deeper color sector depth may automatically decrease color frame rate or
select a new color focal zone or color pulse length. The TI will change due
to the combination of these effects. Generally, the TI will decrease with
increased color sector depth. MI will correspond to the peak intensity of
the dominant pulse type which is a color pulse.

SCALE

Using the scale control to increase the color velocity range may increase
the TI. The system may automatically adjust pulser voltage to stay below
the system maximums. A decrease in pulser voltage will also decrease
MI.

SECTOR WIDTH

A narrower 2D sector width in Color imaging will increase color frame

rate. The TI will increase. MI will not change.

SAMPLE VOLUME DEPTH

When Doppler sample volume depth is increased the Doppler PRF may
automatically decrease. An increase in PRF will increase the TI. The
system may also automatically decrease the pulser voltage to remain
below the system maximum. A decrease in pulser voltage will decrease
MI.

ELASTOGRAPHY BOX/SECTOR WIDTH

Narrower Elastography sector width may increase elastography frame

rate and the TI will increase. The system may automatically decrease
pulser voltage to stay below the system maximum. A decrease in pulser
voltage will decrease the MI.

ELASTOGRAPHY BOX/SECTOR DEPTH

Deeper Elastography sector depth may automatically decrease

elastography frame rate. The TI will change. Generally, the TI will
decrease with increased Elastography sector depth. MI will correspond
to the peak intensity of the dominant pulse type in the combined mode.
SECTOR WIDTH

A narrower 2D sector width in Elastography imaging will decrease the

Elastography frame rate. The TI will increase. MI will not change.

B-MODE, CFI, CPI, DCPI, PULSED WAVE DOPPLER, AND

ELASTOGRAPHY

When a new imaging mode is selected, both the TI and MI may change
to default settings. Each mode has a corresponding pulse repetition
frequency and maximum intensity point. In combined or simultaneous
modes, the TI is the sum of the contribution from the modes enabled
and MI is the MI for the focal zone and mode with the largest derated
intensity.

DEPTH

An increase in B-mode depth will automatically decrease the B-

mode frame rate. This would decrease the TI. The system may also
automatically choose a deeper B-mode focal depth. A change of focal
depth may change the MI. The MI displayed is that of the zone with the
largest peak intensity.

APPLICATION

Acoustic output defaults are set when the operator selects an application.
Factory defaults vary with transducer, application, and mode. Defaults
have been chosen below the FDA limits for intended use.
For any small parts, the clinician starts with selecting the appropriate
application and Tissue Preset Setting (Breast/Breast, Superficial Breast,
Deep Breast, Genitourinary/Scrotum, Thyroid/Thyroid, or General on the
SL15-4 or or Breast or General on the SLV16-5 or Breast or Thyroid
on the SL10-2, or Breast on the SL18-5), the clinician starts imaging
the tissue and starts adjustments of the output power to ensure that the
lowest possible setting is used to obtain a B Mode image. The user shall
then adjust the spread and depth of the focal zone of the transducer, and
then using the AutoTGC key or increasing the receiver gain to produce a
uniform representation of the tissue follows. If an adequate image can be
obtained with the adjustment/ increase in gain, then a decrease in output
should be made. Only after making these adjustments should the operator
increase output to the next level in the case of an unsatisfying image.

Having acquired the B Mode images of the small part/superficial tissue,

CFI CPI and/or dCPI can be used to localize blood flow. As with the
B Mode image display, gain and image processing controls must be
optimized before increasing output, if ever needed.

Having localized the blood flow, the clinicians shall use the Pulsed
Wave Doppler controls to position the sample volume over the vessel.
Before increasing output, the user shall adjust velocity range or scale
and Doppler gain to obtain an optimal Doppler trace. Only if maximum
Doppler gain does not create an acceptable Doppler spectrum does the
operator increase output.

Having acquired 2D, Color Flow and Pulsed Wave Doppler,

Elastography can be used to assess the tissue stiffness. SWE Opt. setting
(Resolution, Standard or Penetration), size and location of the SWE
Box and SWE gain shall be adjusted to obtain an optimal Elastography
image before increasing output. Only if optimal settings and maximum
Elastography gain do not create an acceptable image does the operator
increase output.

A Three-dimensional acquisition can be performed with the SLV16-5

of B-Mode of ShearWave ™ Elastography once the conventional two-
dimensional planes have been acquired.
For any MSK imaging, the clinician starts with selecting the appropriate
application and Tissue Preset Setting (MSK/ Shoulder, Elbow, Wrist/
Hand, Knee, Ankle/Foot or Muscle on the SL15-4, SL18-5, SL10-2,
SLH20-6 probe) then the clinician starts imaging the tissue and starts
adjustments of the output power to ensure that the lowest possible setting
is used to obtain a B Mode image. The user shall then adjust the spread
and depth of the focal zone of the transducer, and then using the AutoTGC
key or increasing the receiver gain to produce a uniform representation
of the tissue follows. If an adequate image can be obtained with the
adjustment/increase in gain, then a decrease in output should be made.
Only after making these adjustments should the operator increase output
to the next level in the case of an unsatisfying image.

Having acquired the B Mode images of the small part/superficial tissue,

CFI, CPI and/or dCPI can be used to localize blood flow. As with the
B Mode image display, gain and image processing controls must be
optimized before increasing output, if ever needed.

Having localized the blood flow, the clinicians shall use the Pulsed
Wave Doppler controls to position the sample volume over the vessel.
Before increasing output, the user shall adjust velocity range or scale
and Doppler gain to obtain an optimal Doppler trace. Only if maximum
Doppler gain does not create an acceptable Doppler spectrum does the
operator increase output.

Having acquired 2D, Color Flow and Pulsed Wave Doppler,

Elastography can be used to assess the tissue stiffness (not available on
SLH20-6). SWE Opt. setting (Resolution, Standard or Penetration), size
and location of the SWE Box and SWE gain shall be adjusted to obtain
an optimal Elastography image before increasing output. Only if optimal
settings and maximum Elastography gain do not create an acceptable
image does the operator increase output.
For abdominal imaging, the clinician starts with selecting the appropriate
transducer (SC6-1 and XP5-1 for deep abdominal Imaging and SL15-4,
SL18-5 or SL10-2 intestine Preset for superficial) and the appropriate
Tissue Preset Setting (Renal, Abdomen, Prostate, Gyn for SC6-1 and
XP5-1 and Intestine for the SL15-4 or SL10-2). The clinician then starts
imaging the target organ and adjusts the output power to ensure that the
lowest possible setting is used to obtain an adequate B Mode image. After
the first B Mode image is obtained, adjusting the depth and spread of the
focal zone, and then increasing the receiver gain should be used first to
produce a uniform representation of the tissue. If an adequate image can
be obtained with the increase in gain, then a decrease in output should be
made. Only after making these adjustments should the operator increase
output to the next level, if ever needed.

Having acquired the B Mode images of the target organ, CFI, CPI and/
or dCPI can be used to localize blood flow. As with the B Mode image
display, gain and image processing controls must be optimized before
increasing output. In case of artifacts due to the increase in gain, the user
shall activate the Flash suppression key to be able to increase gain and
decrease output acoustic power.

Having localized the blood flow, the operator shall use the pulsed wave
Doppler controls to position the sample volume over the vessel. Before
increasing output, the operator shall adjust velocity range or scale and
Doppler gain to obtain an optimal Doppler trace. Only if maximum
Doppler gain does not create an acceptable Doppler spectrum does the
operator increase output.

Having acquired 2D, Color Flow and Doppler, Elastography can be

used to assess the organ tissue stiffness. Before increasing output, the
user should first adjust the appropriate SWE Opt. setting (Resolution,
Standard or Penetration), adjust the size and location of the SWE box
and adjust SWE gain to obtain an optimal Elastography image. Only if
maximum Elastography gain does not create an acceptable image does
the operator increase output.
For genitourinary and gynecologic imaging, the clinician starts with
selecting the appropriate transducer (SE12-3 for intracavitary scanning),
the desired clinical application and the appropriate Tissue Preset Setting
(Genitourinary/ Prostate or OB-GYN/Gyn/). The clinician then images
the target organ and adjusts the output power to ensure that the lowest
possible setting is used to obtain a B Mode image. After the first B Mode
image is obtained, adjusting the depth and spread of the focal zone, and
then increasing the receiver gain should be used first to produce a uniform
representation of the organ. If an adequate image can be obtained with
the increase in gain, then a decrease in output should be made. Only after
making these adjustments should the operator increase output to the next
level, in case of poor quality images.

Having acquired the B Mode images of the organ, CFI, CPI and/or
dCPI can be used to localize blood flow. As with the B Mode image
display, gain and image processing controls must be optimized before
increasing output. The user shall then turn one the Power Doppler Mode
and adjust its controls to position the sample volume over the vessel.
Before increasing output, the user shall adjust velocity range or scale
and Doppler gain to obtain an optimal Doppler trace. Only if maximum
Doppler gain does not create an acceptable image does the operator
increase output.

Having acquired B Mode, Color Flow and Pulsed Wave Doppler images,
Elastography can be used to assess the target organ tissue stiffness
(not available on any obstetrical presets). Before increasing output, the
user should first adjust the appropriate SWE Opt. setting (Resolution,
Standard or Penetration), adjust the size and location of the SWE box
and adjust SWE gain to obtain an optimal Elastography image. Only if
maximum Elastography gain does not create an acceptable image does
the operator increase output.
For vascular imaging, the clinician starts with selecting the appropriate
transducer (SL15-4, SL18-5 and SMC12-3 for superficial vascular
imaging, SL10-2 for deep vascular imaging; SC6-1 for vascular
abdominal imaging and XP5-1 for Transcranial imaging) and the
appropriate Tissue Preset Setting (Carotid, Upper Extremity Arterial/
Venous, Lower Extremity Arterial/Venous for SL15-4, SL18-5,
SMC12-3 or SL10-2, Vascular Abdominal for SC6-1). The clinician then
starts imaging the target vessel or organ and adjusts the output power
to ensure that the lowest possible setting is used to obtain an adequate
B Mode image. After the first B Mode image is obtained, adjusting the
depth and spread of the focal zone, and then increasing the receiver gain
should be used first to produce a uniform representation of the vessel
or the organ. If an adequate image can be obtained with the increase in
gain, then a decrease in output should be made. Only after making these
adjustments should the operator increase output to the next level, if ever
needed.

Having acquired the B Mode images of the target vessel or organ, CFI,
CPI and/or dCPI can be used to localize blood flow. As with the B Mode
image display, gain and image processing controls must be optimized
before increasing output. In case of artifacts due to the increase in gain,
the user shall activate the Flash suppression key to be able to increase
gain and decrease output acoustic power.

Having localized the blood flow, the operator shall use the pulsed wave
Doppler controls to position the sample volume over the vessel. Before
increasing output, the operator shall adjust velocity range or scale and
Doppler gain to obtain an optimal Doppler trace. Only if maximum
Doppler gain does not create an acceptable Doppler spectrum does the
operator increase output.
Diagnostic ultrasound studies of the fetus are generally considered
safe during pregnancy. This diagnostic procedure should be performed
only when there is a valid medical indication, and the lowest possible
ultrasonic exposure setting should be used to gain the necessary
diagnostic information under the ALARA (as low as reasonably
achievable) principle.

The thermal index for soft tissue (TIS) should be used at earlier than 10
weeks’ gestation, and the thermal index for bone (TIB) should be used at
10 weeks’ gestation or later when bone ossification is evident. In keeping
with the ALARA principle, M-mode imaging should be used instead of
spectral Doppler imaging to document embryonic/fetal heart rate.

For a use of the Early OB preset on the SC6-1 and SE12-3, the
system is limiting the Mechanical Index to a maximum value of 1.0 (on
both probes) and the Thermal Index to a maximum value of 2.0 (on
both probes). These limits are following the recommendations and the
guidelines for safe use of an ultrasound diagnostic system during a fetal
exam:

• American institute of ultrasound of medicine (AIUM)

• British medical ultrasound society (BMUS)
• European committee for medical ultrasound safety (ECMUS)
• Société des obstétriciens et gynécologues du Canada (SOCG) et Santé
Canada

And more particularly the information provided by the AIUM on the

ultrasound biological effects, its recommendations published in the
Journal of Ultrasound in Medicine in April 2008, and the article published
by DL Miller.

During the first trimester of pregnancy and especially during the first 10
weeks, it is essential to follow these recommendations.

For obstetrics imaging, the clinician starts with selecting the appropriate
transducer (SE12-3 for Early OB scanning, SC6-1 for General OB
scanning) and the desired clinical application (OB-GYN- application,
GYN, Early OB or Gen OB). The clinician then images the target
organs and adjusts the output power to ensure that the lowest possible
setting is used to obtain a B Mode image. (Obstetrics presets have
a limited Mechanical Index and Thermal Index [MI & TI] to follow
the recommendations and guidelines from AIUM, BMUS, ECMUS and
SOCG). After the first B Mode image is obtained, adjusting the depth and
spread of the focal zone, and then increasing the receiver gain should be
used first to produce a uniform representation of the organ. If an adequate
image can be obtained with the increase in gain, then a decrease in output
should be made. Only after making these adjustments should the operator
increase output to the next level, in case of poor quality images.

Having acquired the B Mode images of the organs, CFI, CPI and/or dCPI
can be used to localize blood flow. As with the B Mode image display,
gain and image processing controls must be optimized before increasing
output.

Having acquired B Mode and Color Flow, the user can image the desired
organ using M Mode imaging. M Mode can be used to assess the beats
per minute of fetal cardiac activity. Before increasing output, the user
should first adjust the appropriate B/M Modes parameters such as gain,
maps, and dynamic range; adjust the size and location of the M zone to
obtain an optimal M Mode trace. Only if maximum M-Mode gain does
not create an acceptable trace does the operator increase output.

Having acquired B Mode, Color Flow and M Mode, the clinician also
has the ability to use the Pulsed Wave (PW) Doppler Mode and adjust its
controls to position the sample volume over the vessel. Before increasing
output, the user shall adjust velocity range or scale and Doppler gain to
obtain an optimal Doppler trace. Only if maximum Doppler gain does
not create an acceptable image does the operator increase output. PW
Doppler can be used to assess blood flow in the later stages of the fetal
development.
For any pediatric exam, the clinician starts with selecting the appropriate
transducer (superficial Pediatric on the SL15-4, SL18-5, SL10-2,
SLH20-6 or SMC12-3 and deep Pediatric on the SC6-1, SMC12-3)
and appropriate application and Tissue Preset Setting (Pediatrics/general
and neonatal head) the clinician starts imaging the tissue and starts
adjustments of the output power to ensure that the lowest possible setting
is used to obtain a B Mode image. The user shall then adjust the spread
and depth of the focal zone of the transducer, and then using the AutoTGC
key or increasing the receiver gain to produce a uniform representation
of the tissue follows. If an adequate image can be obtained with the
adjustment/ increase in gain, then a decrease in output should be made.
Only after making these adjustments should the operator increase output
to the next level in the case of an unsatisfying image.

Having acquired the B Mode images of the Pediatric tissue, CFI CPI and/
or dCPI can be used to localize blood flow. As with the B Mode image
display, gain and image processing controls must be optimized before
increasing output, if ever needed.

Having localized the blood flow, the clinicians shall use the Pulsed
Wave Doppler controls to position the sample volume over the vessel.
Before increasing output, the user shall adjust velocity range or scale
and Doppler gain to obtain an optimal Doppler trace. Only if maximum
Doppler gain does not create an acceptable Doppler spectrum does the
operator increase output.

Having acquired 2D, Color Flow and Pulsed Wave Doppler,

Elastography can be used to assess the tissue stiffness (not available on
SLH20-6). SWE Opt. setting (Resolution, Standard or Penetration), size
and location of the SWE Box and SWE gain shall be adjusted to obtain
an optimal Elastography image before increasing output. Only if optimal
settings and maximum Elastography gain do not create an acceptable
image does the operator increase output.
The usage of the Aixplorer® ultrasound system requires the physical
presence of the operator. The operator and patient are co-located to the
system. Thus the Aixplorer® alarm system is composed of visual alarms
only. The Aixplorer® alarm system utilizes either a pop-up window
with suggested actions or a message in the information area of the main
monitor. The Aixplorer® alarm conditions are not configurable by an
operator. The Aixplorer® logs the occurrences of alarms for later review
by a SuperSonic Imagine representative.

The medium priority alarms are used to intervene automatically by

halting the system upon detection of an alarm condition that may result in
harm to the patient, operator, or the system. The operator is instructed via
a visual alarm. The course of operator’s actions is limited to contacting
an SuperSonic Imagine representation and acknowledgement of the
restarting the system.

The low priority alarms are used as informational. The user may be able
to take action to resume system usage or the alarm is strictly to inform
the user of a condition that may impact workflow.
The following alarms display pop-windows of a medium priority:

Alarm Message
Condition
Acoustic API error : Please reboot and contact representative
power A problem in acoustic power intensity computation has occurred.
BLS (Board Hardware error : reboot is required.
Level Please contact a SuperSonic Imagine representative.
Sequencer) BLS instruction fault.
BLS CRC Hardware error : reboot is required.
Please contact a SuperSonic Imagine representative.
A problem has occurred on CRC transmit.
Channel Hardware error : reboot is required.
Group Please contact a SuperSonic Imagine representative.
Hardware Controller Board Alert.
Hardware Hardware error : reboot is required.
enumeration Please contact a SuperSonic Imagine representative.
A problem has occurred during the DAB enumeration process.
Hardware Hardware error : reboot is required.
failure Please contact a SuperSonic Imagine representative.
Hardware Controller Failure Alert.
Hardware Hardware error: Reboot is required.
loading Please contact a SuperSonic Imagine representative.
sequence A problem has occurred during sequence loading.
Hardware Hardware error : reboot is required.
version Please contact a SuperSonic Imagine representative.
A DAB driver version error has occurred.
Power Hardware error: Reboot is required.
Supply Please contact a SuperSonic Imagine representative.
A problem has occurred in the TPC : Communication
Power Hardware error: Reboot is required.
Supply Please contact a SuperSonic Imagine representative.
monitoring A problem has occurred in the TPC : Monitoring
Power Hardware error: Reboot is required.
Supply Please contact a SuperSonic Imagine representative.
setting A problem has occurred in the TPC : Settings
Temperature ERROR
monitoring An error occurred, Temperature monitoring is not
available. The hardware may not be supported.
 Alarm Message
Condition
Transducer Hardware error: Reboot is required.
Interface Please contact a SuperSonic Imagine representative.
A problem has occurred in the SHI
Transducer Hardware error : reboot is required.
Interface Please contact a SuperSonic Imagine representative.
temperature A temperature alarm has been raised by SHI.
Unexpected Hardware error: Reboot is required.
hardware Please contact a SuperSonic Imagine representative.
problem An unexpected problem has occurred.
Signal Hardware error: Reboot is required.
processing Please contact s SuperSonic Imagine representative.
stopped Acquired data not being processed.
High System must be stopped for safety reason (temperature is too high).
temperature
Process ERROR
Exited An error occurred, the system will restart
Process nor ERROR
responding Process processName not responding,
wait a few seconds or force restart
Error ERROR
detected An error occurred, restart is required
3D Error Error: 3D acquisition went wrong. Please contact a
SuperSonic Imagine representative. Try a new 3D acquisition.
Non- The software version that is currently running
released on your Aixplorer system is an engineering
software release that is not approved for human diagnosis.
The following alarms display pop-windows of a low priority:

Alarm Condition Message

3D Controller unconnected 3D Imaging is not available.
Do not use 3D probe for Biopsy.
Please contact a SuperSonic Imagine representative.
The 3D controller is not connected.
3D Controller version 3D Imaging is not available.
Do not use 3D probe for Biopsy.
Please contact a SuperSonic Imagine representative.
The 3D controller is not identified.
3D Controller USB 3D Imaging is not available.
Do not use 3D probe for Biopsy.
Please contact a SuperSonic Imagine representative.
The 3D motor controller USB is unplugged.
3D Controller Timeout 3D Imaging is not available.
Do not use 3D probe for Biopsy.
Please contact a SuperSonic Imagine representative.
The 3D controller is not responding.
3D Acquisition memory Memory error : 3D acquisition requires
more memory than is available.
Please contact a SuperSonic Imagine representative.
Try to change acquisition parameters.
CPU processor temperature ERROR
Temperature is too hot
Graphic card temperature ERROR
Temperature is too hot
Hard drive temperature ERROR
Temperature is too hot
Image review Review error : Image cannot
be loaded due to corrupted date
You will be redirected to Bmode
IRQ Timeout DMA export DMA sequencing warning – 0x000001
You may unfreeze to continue.
IRQ Timeout DMA import DMA sequencing warning – 0x000002
You may unfreeze to continue.
IRQ Timeout DMA sequencing warning – 0x000003
You may unfreeze to continue.
IRQ Timeout Trigger Trigger Timeout – 0x000004
Press a Mode button to continue
 Alarm Condition Message
No active exam for Report No exam in progress.
You cannot access the report
PCI bus temperature ERROR
Temperature is too hot
Serial temperature ERROR
Temperature is too hot
Too many jobs in the job list The job list contains more than 50
pending jobs. Please select and delete
these jobs manually from the job list.
Jobs older than 1 The job list contains some pending jobs
week in the job list older than one week. Please select and
delete these jobs manually from the job list.
Invalid SGL DMA warning : Invalid SGL Handle
You may unfreeze to continue
Hardware Main HWC main loop lock timeout
Loop Lock Timeout You may unfreeze to continue

The following alarms display a message for a duration of time on the

main monitor. These are of a low priority:

Alarm Condition Message

Too many jobs Too many jobs in the job list:
The job list contains more than 50
pending jobs. Please select and delete
these jobs manually from the job list.
Jobs older than 1 week in the job list:
The job list contains some
pending jobs older than one week.
Please select and delete these
jobs manually from the job list.
Hard disk space WARNING HARD
DISK ALMOST FULL
Please delete data from your system
USB transfer ERROR while transferring
data to USB device
The Aixplorer® system is a cart-based ultrasound system composed of a
central processing unit enclosed in a lower housing, an articulated control
panel, a touch screen, a monitor and a variety of transducers.

1. Monitor 2. Articulated monitor arm

3. Touch screen 4. Storage area
5. Handles 6. Transducer connectors
7. Air filters 8. Wheel locks

1. Gel holders 2. Touch screen

3. Speakers 4. Trackball
5. TouchRing™ 6. Hand rest
The monitor is mounted on an articulated arm that permits it to be
positioned vertically and horizontally.

You can adjust the position of the monitor to suit different operating
positions and operator heights.

When it is released from its locked transport position, the monitor can be
tilted up and down, swiveled left and right, and moved from side to side.

To release the monitor from its locked transportation position, rotate the
screw on the arm counterclockwise.

For transportation, put the monitor in its lower position and rotate the
screw clockwise in order to lock the monitor in this position.

To adjust the monitor, simply grasp it by the sides and tilt, swivel or move
it.
1. Push the button located on the tip of the right handle, as shown below:

2. Do one of the following, while the button is still pressed:

• To push the control panel down, push the handle down
• To lift the control panel up, just let it go up without pulling it

1. Pull the lever located under the control panel to unlock it

2. Rotate the control panel to the left or to the right for your convenience
The Audio Volume may be adjusted by rotating the knob with the speaker
symbol located on the control panel, next to the on/off button.

Do not get fluids into the speaker grills.

Be sure to clean any unused gel from the surface of the control panel after
system use.

Avoid placing fluids close to the speaker grills.

Connect the transducer and turn the lock handle clockwise to lock the
connector.

When disconnecting the transducer, turn the lock handle

counterclockwise to unlock the connector and then hold the connector
and pull it straight out.

If a transducer is connected or disconnected with an image displayed, the

system and/or the transducer may malfunction.

Do not connect or disconnect a transducer during the system startup or

shutdown process. This may result in system malfunction.

If a transducer is dropped or other significant impact occurs, inspect the

transducer carefully before use.
Verify that the transducer cover has not been cracked, and the cable and
insulation are intact.

If there is any doubt of the integrity of the transducer, discontinue use

and contact an authorized SuperSonic Imagine Service Representative.

When a transducer is not currently in use, you may want to store it on

the system.
“Plug” the probe in the connector holder and place the probe in the probe
holder.
1. Place the bottom part of the cable holder on the ring under the control
panel
2. Use the screw to fix the cable holder

1. Once the cable holder is mounted, insert the probe cable inside the
two hooks
2. Place the cable on the top part before scanning

The cable holder is flexible for a comfortable scanning position.

On-cart gel holders have been provided as a convenience.
The gel holders are located on either side of the touchscreen.
Standard sized 250ml gel bottles may be placed in the holders for easy
access during clinical exams.

Place gel bottles in the holders with the nozzle down so that the gel is
always ready to flow.

The gel holders are removable so they may be easily cleaned.

Use warm water and a soft bristle brush to remove stubborn dried gel.

This area may be used to store basic items such as notebooks, charts,
DVD’s and towels.
Do not attempt to open the cart to attach devices.

Call your SuperSonic Imagine sales or service representative for

assistance.

Incorrectly connecting electronic devices to the ultrasound system will

void all warranties and may result in malfunction, electrical shock or fire.

Do not overload the system with peripheral devices or other equipment

weighing more than 9kg (20lbs).

Excessive loading of the system with peripherals, or stacking peripherals

outside of the designated peripheral bay may cause system instability,
resulting in the peripheral or system falling over.
The SuperSonic Imagine Aixplorer® ultrasound system is a transportable
cart based system.

The chassis is mounted on four swivel wheels (casters) which allow you
to easily roll the system over flat surfaces.

Swivel wheels allow the user to steer the system around corners.

Pushing the system is much easier and safer than pulling it. Grasp the
handles firmly and maintain an upright posture when pushing.

Front mounted handles are provided to comfortably and safely grasp the
system while moving.
Large handles mounted beneath the control panel allow the user to firmly
and safely grasp the system when moving.
To steer the system, move the handles in the opposite direction you
would like the cart to go (e.g. push handles to the right to steer the cart
to the left).

The handles are not designed to be used to lift the system.

The handles are to be used only to push and pull the system.

To lift the system, it must be secured to a pallet, or be contained in its

original shipping crate.

Do not use a hand-truck to move the system.

Wheel locks are provided to stabilize the system when moving, scanning
or when storing.
The wheel lock mechanism is located on each wheel.
The mechanism may be engaged by stepping on the black pedal.

Putting the pedal to the position locks the wheel so that the system
may no longer move freely.
Use this control to stabilize the cart prior to scanning.

Putting the pedal to the position locks the wheel in direction so that
the system can be moved forward and backward but cannot be rotated.

Putting the pedal to the position unlocks the wheel and the system
can be moved freely.
It is recommended that the wheels be locked when the system is
unattended or stored in hallways or other areas where there is a risk of
accidental bumping or collision.

Wheel locks are not intended to stabilize the system on ramps or inclines.

Do not park or store the system on slopes or uneven surfaces.

Two foot rests have been provided for convenience.

They are located between and above the front wheels.
These rests provide an ergonomic option for resting the legs in a neutral
position when scanning in a seated position.
1. Turn the system power off.
2. Unplug the main power cord, and disconnect any accessory cords
(network, etc.).
3. Use the transducer cable management system to raise transducer
cables up from wheel level.
4. Remove or ensure that all peripherals and items in the storage area are
secure.
5. Lock the articulating monitor arm in its lowest position.
6. Unlock the wheel locks.

1. Grasp the handles at the front of the machine firmly.

2. Keeping an upright posture, push the system forward.
3. Steer by moving the handles in the opposite direction you would like
the cart to go (e.g. push handles to the right to steer the cart to the left).

Use caution when moving the system. It could cause injury to you or
others if it rolls over feet or into shins.

Use the monitor arm and control panel locking mechanisms when moving
the system.

Never attempt to lift the system manually.

In order to prevent injury, an aide such as a ramp or elevator must be used.

Exercise caution when going up or down ramps.

Do not push the system from either side with excessive force. The system
could tip over.
Do not allow the wheels to roll over transducer or power cables.

If you encounter any failure of the wheels, handles or braking

mechanisms, park the system on a level surface in a safe area, set
the wheel locks and discontinue use until the mechanical parts can be
inspected by an authorized SuperSonic Image Service representative.
Be sure to connect the power plug to a three-pin grounded outlet meeting
the ratings indicated on the rating name plate.

If this type of outlet is not available, contact your SuperSonic Imagine

representative.

When the system is turned on, the color of the three LEDs located next
to the main power switch indicates the following conditions:

LED STATUS
Green Normal operation
Yellow High voltage fault
Blue or white Power supply failure

When a yellow, blue or white LED is lit, please turn off the system and
contact your Local SuperSonic Imagine representative.

Wait until the power supply GREEN LED is lit and not blinking before
you turn the control panel on.
To use another medical device in combination with this system, an
equipotential wire for connecting to an equipotential bus must be
supplied. For more information, contact your SuperSonic Imagine
representative. Be sure to connect the potential-equalization lead wire
before inserting the equipment power plug into the receptacle. Also, be
sure to remove the equipment power plug from the receptacle before
disconnecting the wire to avoid electrical shock.

Under some use conditions, additional materials provided by third-party

vendors may be used by clinicians performing exams with the system.
The decision to use the system and transducers with third-party products
is completely at the discretion of the clinician. The following tables
list products which are suitable for use with the Aixplorer® system
and transducers. The use of third-party products outside of those on the
following lists is to be done at the user’s and patient’s own risk.
Most water-based gels are compatible with the ultrasound system
transducers.

The following gels are recommended because of their compatibility with

our transducers. Please check whether the recommended products in the
tables below are approved for use in your country.

Gel Sterility Manufacturer

Aquasonic 100 Non Sterile Parker Laboratories, Inc
Ultra/Phonic Conductivity Non Sterile Pharmaceutical
Innovations
Steril Aquasonic 100 Sterile Parker Laboratories, Inc
Steril Ultrasound Gel Sterile Sonogel

Use only recommended gels (lubricants). Alternate products can damage

the probe and void the warranty.
A gel warmer has been provided for your convenience.
It heats gel to 104°F (40°C).
Please refer to the gel warmer mounting instructions and instructions for
use provided with the gel warmer.

Do not warm the gel too much to avoid the risk of injuries or burns.

The gel warmer has 2 overheating prevention systems: a sensor and a

cutoff. Please refer to the gel warmer User's Guide.

Only use the gel warmer with recommended gels for Aixplorer® that are
also recommended by Parker.

Respect the expiry date of the gel.

The system and its accessories are not intended to be used outdoor.

The gel warmer may be cleaned by using a soft, damp cloth and a mild
detergent or hospital grade disinfectant, such as ProteX™ Wipes.

Use care not to wet the electronic controls.

Do not use an abrasive cleaner or isopropyl alcohol to clean the gel

warmer.

Do not submerge or immerse the gel warmer in water.

Refer to the gel warmer user's guide.

Set the gel warmer properly, in a stable position.

In case the gel warmer is located in the storage area of the system, be
careful when moving the system, as the gel warmer may fall down.
Only use ultrasound gels in the gel warmer. Do not use any other
products.

The gel warmer has a limited warranty. Please refer to the gel warmer
user's guide.

Under certain conditions where the transducer may come in contact with
mucous membranes, blood or other bodily fluids, the use of a transducer
sheath is recommended.

The use of a transducer cover is recommended.

After use, the single-use sheath should be removed and discarded.

Endocavity probe should be used with a sterile sheath.

If these probes are used to assist biopsy procedures, all of the biopsy
accessories should be sterile for the procedure and should be cleaned
and resterilized according to manufacturer’s recommendations, after each
use.

The SE12-3 and SEV12-3 probes should be cleaned and received high
level disinfection after use, even if a sterile sheath was used.

Sheaths can fail during use and the level of resulting contamination may
not be easily visible.

The following tables list basic information regarding sterile transducer

sheaths which will physically fit our ultrasonic transducers. Please check
whether the recommended products in the tables below are approved for
use in your country.
Transducer width 6.58 cm (2.6 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free CIV-Flex/ 610-637 8,9 x
Telescopically 91,5cm
Folded
CIVCO Sterile Latex Free CIV-Flex/ 610-1000 10.2 x
Telescopically 147cm
Folded
CIVCO Sterile Latex Free CIV-Flex/ 610-001 8.9 x 61cm
Flat Folded
CIVCO Non-Sterile Latex Free CIV- 610-362 14 x 61cm
Flex/Flat
Folded (3D)

Transducer width 7.89 cm (3.11 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free CIV-Flex/ 610-637 8,9 x
Telescopically 91,5cm
Folded
CIVCO Sterile Latex Free CIV-Flex/ 610-1000 10.2 x
Telescopically 147cm
Folded
Manufacturer Sterility Latex/ Description Product Dimensions
Latex Free Number
CIVCO Sterile Latex Free CIV-Flex/ 610-542 14 x 91.5cm
Telescopically
Folded (3D)
CIVCO Non-Sterile Latex Free CIV- 610-362 14 x 61cm
Flex/Flat
Folded (3D)

Transducer width at tip 2.42 cm (0.96 in.), transducer maximum width

at handle 4 cm (1.58 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free CIV-Flex/ 610-006 11.9 tapered
Flat Folded to 3.8
x 61cm
CIVCO Non-sterile Latex Free CIV-Flex/ 610-007 11.9 tapered
Flat Folded/ to 3.8
No Gel x 61cm
CIVCO Sterile Latex Rolled 610-1199 3,5 x 20cm
CIVCO Sterile Latex Neo-Guard 610-213 2,6 x 30cm
CIVCO Sterile Latex Rolled/ 610-214 3,5 x 20cm
Individual
perforated
packets
CIVCO Sterile Latex Free Neo-Guard/ 610-843 2,6 x 30cm
Rolled

Transducer width at tip 2.47 cm (0.97 in.), transducer maximum width

at handle 4 cm (1.58 in.), cable length 2.1 m (82.7 in.)
Manufacturer Sterility Latex/ Description Product Dimensions
Latex Free Number
CIVCO Sterile Latex Rolled/ 610-214 3,5 x 20cm
Individual
perforated
packets

Transducer width 6.4cm (2.52 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free Surgi 610-023 15,2 tapered
Intraoperative/ to 7,6 x
Accordion 244cm
Folded/
No Gel
CIVCO Sterile Ultra-Pro II CIV-Flex/ 610-608 14 x 91,5cm
Disposable Telescopically
Replacement Folded (3D)
Kit

Transducer width 3.2 cm (1.25 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free Poly 610-797 15,2 x
telescopically- 244cm
folded/
attached
form-
fitting tip
Manufacturer Sterility Latex/ Description Product Dimensions
Latex Free Number
CIVCO Sterile Latex Free Non- 610-956 7,6 tapered
pyrogenic/ to 4,1 x
CIV-Flex/ 147 cm
Telescopically-
folded
with bands
Transducer width 5.92 cm (2.33 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free CIV-Flex/ 610-323 6 x 91.5cm
Flat Folded
CIVCO Sterile Latex Free CIV-Flex/ 610-001 8,9 x 61cm
Flat Folded

Transducer width at tip 2.89 cm (1.13 in.), transducer maximum width

at handle 3.79 cm (1.49 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Free CIV-Flex/ 610-323 6 x 91.5cm
Flat Folded
Transducer width at tip 0.91 cm (0.36 in.), transducer maximum width
at handle 2.78 cm (1.09 in.), cable length 2.1 m (82.7 in.)

Manufacturer Sterility Latex/ Description Product Dimensions

Latex Free Number
CIVCO Sterile Latex Latex Pro/ 610-213 2,6 x 30cm
Rolled
CIVCO Sterile Latex Free Neo-Guard/ 610-1126 2 x 30cm
Rolled
CIVCO Non-sterile Latex Free Neo-Guard/ 610-838 4 x 30cm
Rolled

All are CE approved as CE 0120. All are FDA approved:

• General purpose CIV-Flex Latex Free covers are under FDA K970513
• CIV-Flex 3D covers are under FDA K002546
• Neo-Guard, and Eclipse covers are under FDA K991236
• General Purpose Latex covers are under FDA K970515
Transducers may be sheathed in latex or latex-free sheaths for semi-
critical applications. However, the use of latex sheaths for any procedure
may involve the risk of an allergic reaction.

The following medical alert has been reprinted to inform the user of the
possible risk of using latex sheaths.

FDA Medical Alert, March 29, 1991, Allergic Reactions to Latex-

Containing Medical Devices (FDA MDA91-1)

Because of reports of severe allergic reactions to medical devices

containing latex (natural rubber), the FDA is advising health care
professionals to identify their latex sensitive patients and be prepared to
treat allergic reactions promptly.

Patient reactions to latex have ranged from contact urticaria to systemic

anaphylaxis.

Latex is a component of many medical devices, including surgical and

examination gloves, catheters, intubation tubes, anesthesia masks, and
dental dams.

Reports to the FDA of allergic reactions to latex-containing medical

devices have increased lately.

One brand of latex cuffed enema tips was recently recalled after several
patients died as a result of anaphylactoid reactions during barium enema
procedures.

More reports of latex sensitivity have also been found in the medical
literature.

Repeated exposure to latex both in medical devices and in other consumer

products may be part of the reason that the prevalence of latex sensitivity
appears to be increasing.

For example, it has been reported that 6% to 7% of surgical personnel

and 18% to 40% of spina bifida patients are latex sensitive.

Proteins in the latex itself appear to be the primary source of the allergic
reactions.
Although it is not known how much protein is likely to cause severe
reactions, the FDA is working with manufacturers of latex- containing
medical devices to make protein levels in their products as low as
possible.

FDA’s recommendations to health professionals in regard to this problem

are as follows:

When taking general histories of patients, include questions about latex

sensitivity.

For surgical and radiology patients, spina bifida patients and health care
workers, this recommendation is especially important.

Questions about itching, rash or wheezing after wearing latex gloves or

inflating a toy balloon may be useful.

Patients with positive histories should have their charts flagged.

If latex sensitivity is suspected, consider using devices made with

alternative materials, such as plastic. For example, a health professional
could wear a non-latex glove over the latex glove if the patient is
sensitive.

If both the health professional and the patient are sensitive, a latex middle
glove could be used. (Latex gloves labeled “Hypoallergenic” may not
always prevent adverse reactions.)

Whenever latex-containing medical devices are used, especially when the

latex comes in contact with mucous membranes, be alert to the possibility
of an allergic reaction.

If an allergic reaction does occur and latex is suspected, advise the patient
of a possible latex sensitivity and consider an immunologic evaluation.

Advise the patient to tell health professionals and emergency personnel

about any known latex sensitivity before undergoing medical procedures.

Consider advising patients with severe latex sensitivity to wear a medical

identification bracelet.

The FDA is asking health professionals to report incidents of adverse

reactions to latex or other materials used in medical devices. (See the
October 1990 FDA Drug Bulletin)
To report an incident, call the FDA Problem Reporting
Program, operating through the U.S. Pharmacopeia toll-free number:
800-638-6725.

For questions about FDA activity related to latex sensitivity and

anesthesiology, call the Office of Health Affairs, Center for Devices and
Radiological Health, Rockville MD.

For a single copy of a reference list on latex sensitivity, write to: LATEX,
FDA, HFZ-220, Rockville, MD 20857.

See Chapter 9, System Care & Maintenance [429] for details

regarding disinfection and cleaning and associated products.

See Chapter 9, System Care & Maintenance [429] for details

regarding changing printer paper and toner and associated products.

Additional equipment connected to medical electrical equipment must

comply with the respective IEC or ISO standards (e.g. IEC 60950 for data
processing equipment).

Furthermore all configurations shall comply with the requirements for

medical electrical systems (see IEC 60601-1).

Any person connecting accessory equipment to medical electrical

equipment is configuring a medical system and is therefore responsible
that the system(s) complies with the requirements for medical electrical
systems.

Attention is drawn to the fact that local laws take priority over the above
mentioned requirements.
If in doubt, consult your local representative or the technical service
department.

Biopsy guides are used during an ultrasound-guided biopsy exam, whose

aim is to take a sample of tissue or fluid from a lesion.

The following biopsy kits may be used:

Guides Manufacturer Product SL15-4 SC6-1 SE12-3 SEV12-3

Number SL18-5 XC6-1

Infiniti plus in-plane CIVCO 672-001

guidance system
Ultra-Pro II needle CIVCO 672-002
guidance system
Disposable endocavity CIVCO 657-014
needle guide
Reusable endocavity CIVCO 610-666
needle guide
Disposable CIVCO 610-1275
sterile endocavity
needle guide
Disposable PROTEK Aquamarine
sterile endocavity #9000
needle guide

For an exhaustive list, please refer to the last applicable version of

suppliers' catalog for SuperSonic Imagine compatible accessories.
This user's guide uses the following conventions:

All procedures are numbered. You must complete steps in the sequence
they are presented to ensure a correct result.

Bulleted lists indicate general information about a particular function or

procedure. They do not imply a sequential procedure.

Control names, menu items and/or titles are spelled as they are on the
system.

Symbols appear as they appear on the system.

The left side of the system is to your left as you stand in front of the
system, facing the system.

Touch means to press a button on the touch screen.

These conventions are used in the system:

The software that runs the system uses graphic display elements similar
to those used in many personal computers.

On a menu, or other display, a highlight bar indicates that the item or

name contained within the boundaries of the highlight bar is in the process
of being selected.

Pressing Select actually selects the item, assigns a value to a system

parameter, or initiates the action related to the selected item

To enter text into a text field, move the cursor to the field and use the
touch screen keyboard.

To display a list, click the down arrow.

To scroll through a list, make sure the pointer is over the list. Then use the
TouchRing™ to scroll. Moving your finger clockwise scrolls down
a list, moving your finger counterclockwise scrolls up a list.
Controls on the control panel include buttons, knobs, and knob-buttons.

Press a button to activate or deactivate its function.

Turn a knob to change the selected setting.

Press a knob-button to activate its function, turn it to change the selected

setting.

Pressing on buttons related to options that are not available will have no
effect.
The touch screen contains several types of controls, depending on the
function to perform.

Touching this type of control... ... triggers this event

Touch a part of the wheel to display
a different imaging mode menu.
In this example, touching B displays a
menu of controls associated with B-
mode, but does not switch to B-mode.

Touch Other Settings to display another

page of controls associated with the
current mode. For most imaging modes,
2 pages of settings are available.
Touch to open a particular page or
function. Touching the Keyboard control
in this example displays the keyboard.
Touch to turn a function On or Off. The
LED button is orange when the function
is on, and dark blue when it is Off.

Touch to change the value

displayed on the button.
Repeatedly pressing this type of
button cycles through all the values.
The value displayed is indicated
by the position of the orange mark.
Rotate the knob located below the
touch screen label to change the value.

Touch to change the value

displayed on the button. The value
displayed is indicated in the box.

Touch the appropriate part of

the button to change its value.
The system can be set to two different power modes: On and Off.

1. Press I on the switch located at the rear of the cart.

Wait until the power supply GREEN LED is lit and not blinking
before you turn the control panel on.
1. Press the On/Off button on the control panel, next to the left speaker.
The system automatically checks a certain number of components
and peripherals and boots up.

1. Press the On/Off button on the control panel, next to the left speaker.
2. The shutdown menu appears.

3. Select Yes.

1. Press 0 on the switch located at the rear of the cart to complete the
shutdown of the system.

If some elements are still in queue to be exported, the following

shutdown menu appears:

By default, the remaining jobs will restart at next start of the system. If
you want to cancel the remaining jobs from the system, uncheck the box
before shutting down the system.

When set to Off, the system consumes no power. To achieve a

balance between convenience and energy efficiency, follow these
recommendations:
• If the system will not be used overnight, switch the system to Off at
the end of the day. Press the On/Off switch above the control panel to
turn the system off.
• If the system will not be used for longer than overnight, power the
system down. Press the On/Off button on the control panel to power
the system down.

Always use the procedures listed here for turning off the system, if
possible.

Turning off the system in any other way will result in longer initialization
time when the system is turned on again, and may cause other problems.

Turn on the system only after the power has been off for more than 15
seconds. If the system is turned on immediately after being turned off,
the system may malfunction.

If power cannot be turned off by the normal procedure, press and hold
down On/Off for at least 5 seconds. If the power is still not turned off,
turn off the switch of the power supply panel at the rear of the system.

These methods should not be used under normal conditions. They may
damage the system.

If the power is not turned off by following the normal procedures, B-

mode images may not be displayed when the system power is turned on
again. This does not indicate system failure. Turn off the switch on the
power supply panel on the rear of the system, wait at least 15 seconds,
and then turn the system power on.

Never shut down the system while files are being transferred. Data
corruption or loss may result.

For emergency stop of the device, use the switch located at the bottom
rear of Aixplorer®
The system includes a clock/calendar function, which maintains accurate
time and date even when the system is turned off and disconnected from
power.

Refer to chapter Chapter 8, Customizing the System [377] for

instructions on setting up time and date.

You can configure the system user interface language and regional
parameters in the system configuration.

Refer to chapter Chapter 8, Customizing the System [377] for

instructions on setting up the language.

The system supports standard network functions, which include printing

to DICOM printers, local printers and report printers (options).

Refer to Chapter 8, Customizing the System [377] for instructions

on network configuration.

The system uses four ports for connecting transducers that can be
occupied at the same time, but only one transducer can be active at a
time.
When a transducer is not in use, store it in one of the transducer holders.
Always use the cable management system to prevent cables from being
stepped on or run over by the cart wheels.
See the section called “Connecting a Transducer” [121].

When the system is turned on, the system defaults to the last used
transducer, application and preset.

It is possible to select among the four connected transducers during

system operation.

1. Press Probe on the control panel.

The touch screen will display the applications that are compatible
with the transducers that are connected to the system

2. Touch the tab corresponding to the desired clinical application.

Ex: Vascular
The touch screen will display the probes you can use for the selected
application, and the associated Presets.
3. Press the desired Preset.
Ex: Carotid
The Probe touch screen closes and the system is in live B-mode.

The factory presets appear in darker blue and the user-created presets
appear in lighter blue.
It is possible to customize the displayed list of presets in the system
configuration. Refer to Chapter 8, Customizing the System [377]

The selected transducer, application and preset appear on the header of

the imaging main display.

Use only recommended gels (lubricants). Alternate products can damage

the probe and void the warranty.

Before acquiring images, you may want to create a patient exam or

retrieve a patient you already created in the system.
Before scanning a new patient, make sure the previous exam has been
ended, by doing one of the following:

• Press End Exam on the control panel.

• Press New Patient on the touch screen.
1. Press Patient on the control panel.
The Patient Data Entry is displayed on the main screen.

The General Information tab of the Patient Data Entry gathers the
fields related to the patient identity.

The Worklist Information tab of the Patient Data Entry displays

information coming from the Modality Worklist (if associated and
configured).

Seven other tabs are available, each of them displaying specific clinical
information:

• Breast
• Thyroid
• Abdominal
• OB-GYN
• Genitourinary
• MSK
• Vascular
To navigate through the tabs, move the cursor to the tab you want to
open and press Select on the control panel.
To enter new data, place the cursor in the field you want to fulfill. The
active field is automatically highlighted in orange.
Type the desired text with the keyboard.

You can visualize the text you are currently typing directly on the touch
screen, in the preview area.

Patient ID: The system uses a unique ID to identify each patient. You
may enter your own ID, or the system will create one automatically.
Images and reports are stored based on the patient ID.

The name and ID appear at the top of all image displays.

The ID can be also obtained by the barcode reader.

Be careful to confirm the patient name and ID before starting an

examination for a new patient.

Check the date format before entering date of birth, Last Menstrual Period
(LMP), Estimated Date of Delivery (EDD), Date Of Conception (DOC)
and Ovulation Date. Incorrect entry of these parameters will result in an
incorrect Gestational Age (GA).

Enter the EDD and GA in the patient's medical record for backup.

Check the "Activate OB calcs" button on the Patient Data Entry page
(PDE) in order to perform obstetric calculations.

It is necessary to specify which OB author is to be used for each particular

measurement to calculate the GA and get an Estimated Fetal Weight
(EFW).

A diagnosis can not be only based on one measurement or data. Be careful

to always consider the overall clinical evaluation of the patient, including
the medical record.

Depending on fetal position, some measurements may be incorrect. Be

careful to always consider the overall clinical evaluation of the patient,
including the medical record.

The system provides fetal measurements for up to five fetuses. Be careful

not to confuse the fetuses during measurements.

For each measurement performed, you can select either the first,
last, average, minimum, maximum or specifically one of the five
measurements that are allowed to be displayed, using the selector feature
in the Measurements tab of the Report.

Be careful when deleting measurements, as this will affect the selector

result.

Deviations from the normal values of measurements must be judged

based on the graphs and literature.

1. Move the cursor to the arrow on the right of the drop-down list.
2. Press Select to display the list.
3. Move the cursor down to the selected value and press Select again
to validate your choice.
You can save the Patient Data Entry as an image of the exam.
To do so, press Save Image while in the Patient Data Entry.
This will save the active tab as a screenshot.

This feature is available if the system is connected to the network and the
DICOM feature is enabled.

1. Press Patient on the control panel.

The Patient Data Entry is displayed on the main screen.

The Patient touch screen is now displayed.

If a Modality Worklist is configured and associated, pressing

End Exam will automatically display the Modality Worklist (if
configured).

2. Touch M.Worklist on the touch screen.

The modality worklist is displayed on the main screen.

 Check the boxes above the list to filter it.

Place the Pointer over a column header and then press Select to
sort the list by the selected column.

Use the search box to find a given patient.

3. Move the cursor over the patient file you want to open.
4. Press Select on the control panel.

The Patient Data Entry is displayed on the main screen and pre-
populated.

You can edit some of the information for this patient.

See Chapter 8, Customizing the System [377] for more information

on how to configure the Modality Worklist.

Aixplorer® offers the two types of queries defined by the IHE

(Integrating the Healthcare Enterprise): broad queries and patient queries.

By default, the Worklist performs broad queries.

Patient Query limits the number of answers that are returned, and
therefore increases the confidentiality, limits the risk to select by mistake
the wrong patient in the worklist, and limits the quantity of data to be
transferred to the system.

To use Patient Query:

1. Press Patient Query on the touch screen to perform a query on

a specific patient only. Use this mode especially if your network is
slow.
A window pops up.

2. Enter data for the specific patient you want to retrieve on the worklist.
At least one mandatory field must be filled in to perform the query.
3. Click on Query to perform the query on the specific patient.

Press Broad Query on the touch screen to switch to the Broad

Worklist query mode.
The Modality Worklist can be used when the system is disconnected
from the network. See Chapter 8, Customizing the System [377] for
more details.

Data may be edited for the current patient. Some information can be
edited at any time during an exam, if not imported from the Modality
Worklist.
1. Place the text cursor in the field you want to edit.

The active field is highlighted in orange.

2. Type the new text with the keyboard.

If you edit one of the identifier fields, a pop up message is displayed.

Press Yes to confirm or No to cancel.

The identifier fields are the following:

• Patient Last Name

• Patient First Name
• Patient Middle Name
• Patient ID
• Accession Number
• All the fields in the DICOM tab of the Patient Data Entry

If you edit one of the fields listed above AFTER the exam was sent to
a server, the DICOM store may start a new exam with the new patient
information.

Entering the patient's height and weight automatically calculates the

Body Mass Index (BMI).

Make sure all the images you need are saved.

After the exam is complete, end the exam as follows:
Press End Exam on the control panel.
The Aixplorer® ultrasound system offers a set of imaging modes via the
mode selection buttons.

On the control panel, the mode buttons (orange) are located below the
touch screen.

• Press B to scan in grayscale B-mode.

• Press SWE™ to scan in grayscale B-mode with a real-time color
elasticity map superimposed.
• Press COL to use Color Flow Imaging (CFI), Color Power Imaging
(CPI), or Directional Color Power imaging (dCPI)
• Press PW to use Pulsed Wave Doppler
• Press CEUS to use Contrast Enhanced Ultrasound imaging
Access to 3D and M modes is given on the touch screen.

In any mode other than B-mode, whenever the B key is pressed, the
current mode is exited and B-mode is displayed.

The previous settings are restored.

The imaging main display contains an ultrasound image, the exam and
image information and some indicators.

The image area is located approximately in the center of the imaging

display.

To the right of the image itself are a depth scale and a grayscale bar and/
or color bar.

Patient and exam data are displayed in the area directly above the
ultrasound image. This area also includes the current time and date, the
institution name, the selected transducer and clinical application, the
Thermal Index (TI) and Mechanical Index (MI) values.

Image parameters are displayed on the left of the image.

1. Ultrasound image 2. Patient/Exam data

3. Image Parameters 4. Depth scale
5. Grayscale bar 6. Transducer/Preset
7. MI and TI 8. Notification icons

Refer to each mode for a detailed description of each imaging main

display.
Some icons appear at the bottom left of the main display to inform you
about the state of the system.

Icon Meaning

There is a CD in the CD/DVD drive

The system is burning a CD

Error during CD burning

There is a DVD in the CD/DVD drive

The system is burning a DVD

Error during DVD burning

No CD or DVD in the CD/DVD drive

There is a USB device plugged in

The system is exporting data to a USB device

Error during USB export

The system is connected to a network

Network error

The system is exporting data to a DICOM store SCP

Error with the DICOM Modality Worklist SCP

Icon Meaning

Error with the DICOM Store SCP

The system is printing to a DICOM printer

Error with a DICOM printer

Error with a DICOM commit server

The system is printing to a local printer

Error with a local printer

Modality Performed Procedure Step (MPPS) is busy

Error with MPPS

DICOM Modality Worklist is refreshing

Error with DICOM Modality Worklist

DICOM Modality Worklist: Offline mode

DICOM Modality Worklist filtered

Check the air filters

Available storage on the hard drive.

Do not try to acquire more data if the hard drive is full.

&R Query and Retrieve

Icon Meaning

WIFI is deactivated

WIFI is connected. No signal

WIFI is connected. Signal intensity levels

The imaging touch screen varies according to the scanning mode.

It contains:

• permanent controls available in all imaging modes

• imaging parameters that are related to the current active mode(s)
• rotary controls that can be used with their corresponding knobs, located
under the touch screen
• a navigation wheel that allows you to change parameters for all the
active modes

1. Permanent controls 2. Imaging parameters

3. Rotary controls 4. Navigation wheel

Refer to each imaging mode to have a detailed overview of the

parameters.
Some controls are common to all imaging modes. These controls are
detailed below.

For a description of controls specific to each imaging mode, refer to the

detailed section on each imaging mode.

When in Live imaging, press Freeze on the control panel to freeze the
image. A snowflake appears on the image to indicate the image is frozen.
When the image is frozen, press Freeze to unfreeze the image and
return to live imaging.

Depth controls the distance over which the B-mode displays anatomy.
When you increase the depth, you capture echoes from deeper in the
body. Therefore, it takes longer for the transducer to receive all the
signal. The receive time is increased and there is more information to
process. The time between two ultrasound beams is increased.
As a result, the frame rate is decreased.
Depth is located on the control panel and adjustable only in live
imaging.
Rotate Depth:

• clockwise to increase the depth and visualize deeper structures

• counterclockwise to reduce the depth and focus on shallower
structures.

Depth increments vary by application and mode.

Depth is displayed on the imaging display in centimeters.
Overall gain increases or decreases the amount of echo information
displayed in an image.

It may have the effect of brightening or darkening the image if sufficient

echo information is generated.

Gain is adjustable in live imaging and on a frozen image.

Gain is adjustable in all modes with each mode knob.

Rotate B, SWE™, COL or PW according to the active mode:

• clockwise to increase the overall gain in order to obtain a brighter

image
• counterclockwise to decrease the overall gain in order to obtain a
darker image.

AutoTGC automatically adjusts the B-mode gain at different depths

and for different tissue attenuations.
Overall brightness is automatically adjusted depending on setting
of AutoTGC Offset (see the section called “AutoTGC
Offset” [184]).
AutoTGC is located on the control panel.
Press AutoTGC. If needed, you can make independent gain
adjustments (see the section called “Gain” [172] above).

While in PW mode, press AutoTGC to automatically adjust the Scale

and Baseline. See the section called “Setting Up PW” [230]
Turning this mode On enable the automatic TGC adjustments when
changing the imaging controls. To activate or deactivate it, see the
section called “System” [380]

You can selectively adjust the uniformity of brightness throughout the

image.
Press TGC on the touch screen.
The B-mode image is simultaneously displayed behind the slide pods.
Draw the TGC curve as needed with a stylus or finger.
You can also change the position of each virtual control on its line by
touching another place on the same line.

The focal zone is the depth at which the lateral resolution is the best on
the image.
The focal position is the depth at which the transmitted ultrasound
energy is focused.

You can choose the Focal Zone Management to be Manual or Automatic.

You can control this setting in the System/Display sub-tab System. See
the section called “System” [380]

By selecting manual, you will be able to define and manage the Focal
zone and position.

Focus is adjustable only on live imaging.

Focus is located on the control panel.

Rotate Focus:

• clockwise to place the focal zone deeper

• counterclockwise to place the focal zone at a shallower depth

Press Focus and then rotate it:

• clockwise to increase the size of the focal zone

• counterclockwise to decrease the size of the focal zone

Press Focus again to move the focal zone.

Changing the size of the Focal Zone affects the frame rate.

The larger the Focal Zone, the slower the frame rate.

By using the automatic option, the Focal Zone will be automatically

managed to provide the most appropriated focal zone size and position.
The ratio between the Focal Zone size and depth will be maintained and
the Focal Zone position will be adjusted within any depth change.

A region of interest in imaging modes can be magnified for closer

examination. Two types of zoom are available on Aixplorer®: HD Zoom
and Digital Zoom.

HD Zoom concentrates the system acquisition and processing ability on

a specific region of interest in the real-time image display.
The result is a reduced field of view overall, but greater detail and higher
frame rate, which contribute to better image quality over the region of
interest.

HD Zoom is adjustable only in live imaging.

To use the HD Zoom function:

1. Press Zoom on the control panel

A box appears on the image.

2. Use the trackball to move the zoom box
3. Press Select to arbitrate the trackball to Box size
4. Use the trackball to resize the zoom box
5. Press Zoom again to have an enlarged image
6. Press Zoom again to exit zoom

Digital Zoom is a magnifying post-processing function. As such, it has

no effect on the frame rate.

Digital Zoom is adjustable in live imaging and on a frozen image.

Rotate Zoom:

• clockwise to increase the zoom factor

• counterclockwise to decrease the zoom factor

In live imaging, both HD Zoom and Digital zoom may be used at the
same time.

Press Reset Zoom to set the zoom back to the preset default value.
Left/Right flips the image along the left-right axis.
Touch Left/Right to flip the image.

Top/Bottom flips the image along the up-down axis.

Touch Top/Bottom to flip the image.

Touch Dual to activate or deactivate dual mode.

The left image will be active.
Press Select to freeze the left side and make the right side active.

Press Freeze to have both sides frozen.

• the active image has an orange S as the orientation marker

• the inactive image has a white S as the orientation marker

You can switch which of the dual images is active by pressing Select.
Imaging settings will always be applied to the active image in dual.
Imaging settings will be maintained independently for the dual images.
If you press Freeze before Select, you can change image settings and
modes on the active side.
When the image is frozen, in all modes, a Play button appears on the
touch screen.
Play allows you to view clips. See Chapter 7, Image and Data
Management [347] for more information on viewing clips.

Dual Top/Bottom is the same feature as Dual, but split the screen
into a top image and a bottom image.

1. Press Dual to enable Dual Top/Bottom.

2. Press Dual Top/Bottom to activate or deactivate the Dual Top/
Bottom display format.

Hide Patient Name allows you to temporarily hide the patient

information from the imaging screen. However, the hidden information
remain in the database.

If several functions are available with the trackball, they are displayed
at the bottom of the image. The active function is displayed in orange.
Press the Pointer to change the active trackball function.
Press Select to change between Box move (position of the box) and
Box size (resize the box).
Press Select to switch between Img1 and Img2 in dual displays.
B-Mode is an ultrasound imaging mode which allows you to assess two-
dimensional anatomy by displaying the echoes returning from tissues of
different density in various shades of gray.

Press B on the control panel from any other modes.

1 3 5
4 2

10

7
9

1. institution name 2. date and time

3. patient name 4. patient ID
5. transducer/Preset/ MI/TI 6. imaging parameters
7. ultrasound image 8. depth scale
9. focal zone 10. grayscale
When in B-mode, the touch screen displays various image controls which
help you to optimize your B-mode image.

There are two pages of B-mode parameters. These settings are controlled
by touching the control on the touch screen, or by turning the rotary knob
directly below the touch screen.

You can navigate through the pages by touching Other Settings.

Harmonic imaging mode is used to reduce image clutter and
reverberation, and enhance borders.
Harmonic imaging is available only in live imaging.
Press Harmonic Imaging to activate/deactivate harmonic imaging.

Res/Pen allows you to change center frequency to obtain increased

resolution or increased penetration. Res/Pen is available only in live
imaging. Press Res/Pen to change value.
The orange LED indicates which one is the active value:

• Left LED: Res (resolution)

• Middle LED: Gen (general)
• Right LED: Pen (penetration)

HD/Fr. Rate allows you to adjust frame rate and line density to achieve
increased spatial or temporal resolution.
Touch HD/Fr. Rate to change value.
There are three options to choose from:

• HD (High Definition): left LED

• Balanced: middle LED
• Fr. Rate (Frame Rate): right LED
TissueTuner™ allows you to adjust the receive parameters
associated with the assumed speed of sound of ultrasound in the body.
Adjusting the speed of sound parameter to match the type of tissue being
interrogated results in increased spatial and lateral resolution.
TissueTuner™ is available only in live imaging.
Rotate the knob located under TissueTuner™:

• clockwise for a denser tissue (higher speed of sound values)

• counterclockwise for a less dense tissue (lower speed of sound values)

TissueTuner™ values depend on the selected application.

Dynamic Range Dynamic Range allows you to change the range

over which the amplitudes of returning ultrasound signals are displayed.
Dynamic Range is available in live imaging and on a frozen image.
Rotate the rotary knob located under Dynamic Range:

• clockwise to compress the grayscale values

• counterclockwise to decrease the dynamic range

Dynamic range values depend on the selected application.

2D Map assigns the display of echo amplitudes to a range of grayscale

or chromatic colors.
2D Map is available in live imaging and on a frozen image.
Rotate the rotary knob located under 2D Map:

• clockwise to view next map

• counterclockwise to view previous map
SuperCompound combines the returning ultrasound from a large
number of steered echo lines to create an image which provides
superior texture, enhanced edge delineation and reduces shadowing.
SuperCompound is available in live imaging only.
Press SuperCompound to activate or deactivate the
SuperCompound mode.

Acoustic Power regulates the output power of the system.

Acoustic Power is available only in live imaging.
Rotate the knob located under Acoustic Power:

• clockwise to increase acoustic power output

• counterclockwise to decrease acoustic power output

Maximum acoustic power is 0dB and minimum is -30dB.

See Chapter 3, Safety [37] for information on output power regulations.

PRF allows you to change the pulse repetition frequency for the B-
mode image.
Decreasing the PRF may correct the reverberation artefacts.
Rotate the knob located under PRF to change its value.
AutoTGC offset allows you to program automatic overall gain when
using the AutoTGC.
AutoTGC Offset is located on the second page of parameters.
Rotate the knob located under AutoTGC offset:

• clockwise if you prefer a brighter image

• counterclockwise if you prefer a darker image

This frame averaging technique reduces noise on the image.

Persistence is available in live imaging and on a frozen image (to
view clips).
Rotate the rotary knob located under Persistence:

• clockwise to increase persistence

• counterclockwise to decrease persistence

SuperRes™ is an image processing feature which reduces speckle,

improves image texture and enhances borders without an impact on
frame rate.
SuperRes is available in live imaging and on a frozen image.
Rotate the rotary knob located under SuperRes:

• clockwise to increase SuperRes

• counterclockwise to decrease SuperRes

SuperRes values depend on whether SuperCompound is On or

Off.
Sector Size widens or narrows the size of the sector angle to
maximize the image’s region of interest. Changing the sector size affects
the frame rate. The narrower the sector size, the faster the frame rate.

Wide Image allows you to increase the field of view.

Press Wide Image to activate/deactivate the wide imaging mode.
Biopsy guides are used to assist in the guidance of a biopsy tool. The
system generates a guideline that represents the anticipated path of the
biopsy tool.

See the section called “Compatible Accessories and Kits” [131] for
the list of compatible biopsy kits.

Inspect all components and the transducer.

Ensure that the biopsy guide you are using is the correct one for the
transducer, the system, and system software.

Some biopsy guides must be installed over a sterile transducer cover.

Refer to the instructions provided with the biopsy guide.

After each use, biopsy guides must be either sterilized or disposed of,
depending upon the type. Refer to the instructions included with the
biopsy guide.

Refer to the biopsy kit instructions on how to attach the biopsy guide on
the probe.

The Aixplorer® generates two biopsy guide lines which are the “lines”
shown on the ultrasound image.

The displayed guide lines indicate the anticipated path of the needle, and
should not be used as a standard in which the needle must lie within the
two guide lines.
Please understand that the biopsy guide lines displayed do not indicate
the exact location of the needle when performing the biopsy.

Make sure you correctly adjust the TissueTuner before performing a

biopsy. The ideal TissueTuner setting results in a sharply resolved image,
which improves needle guidance.

When the biopsy is on, the auto-freeze time is disabled in B-mode.

Make sure to turn the biopsy off after the procedure is complete, to avoid
damaging the probe.

The biopsy guideline's availability depends on the probe.

1. Scan in B-mode and optimize the image as needed

2. Locate the area to biopsy
3. Press Biopsy on the touch screen

Biopsy Angle and Hide Biopsy are activated (un-grayed). The

biopsy guidelines appear on the screen.

1. Press Biopsy Angle until the desired biopsy angle is displayed on

the button
2. Use the Trackball to move the biopsy target along the guidelines
3. Perform the biopsy

Biopsy Steering allows you to steer the ultrasound image in order to

enhance the needle visualization during a biopsy procedure.

If the needle is introduced from the right side of the transducer, press
Biopsy Steering until Right is selected.
If the needle is introduced from the left side of the transducer, press
Biopsy Steering until Left is selected.
Needle PL.U.S. is a new feature from SuperSonic Imagine that facilitates
the biopsy procedure by improving the needle visualization, improving
overall confidence in the biopsy procedure, helping the physician to keep
the needle in the best elevation plane and providing a guidance tool to
plan the needle trajectory and secure the procedure’s accuracy. It may
be used in all applications, all presets, except Neonatal Head preset on
SL10-2, SL18-5 and SLH20-6.

See the section called “Compatible Accessories and Kits” [131] for
the list of compatible biopsy kits and sheaths.

Make sure you correctly adjust the TissueTuner before performing a

biopsy. The ideal TissueTuner setting results in a sharply resolved image,
which improves needle guidance.

1. When Needle PL.U.S. is on, the auto-freeze time is disabled in B-

mode. Make sure to turn the Needle PL.U.S. off after the procedure is
complete, to avoid damaging the probe.
2. This feature improves the visualization of the needle main body in
the enhancement area. It does not allow to have a larger view of the
needle tip.

In this feature the following conditions are recommended:

• Insertion angle of the needle: 5° to 45° (-5° to -45°)
• Needle Size: from 14 to 25 GA
3. According to the settings, especially the gain, other signals than needle
information could be enhanced instead of the needle. Please, adjust
the insertion angle and the settings in order to avoid it.
4. During a biopsy procedure, adjust the probe position in order to have
an insertion angle of the needle between 5° and 45° (-5° to -45°)
from the target. Out of these values, the automatic calculation of the
insertion angle will not display any angle (« A --° » on the monitor).
5. The enhancement area is defined by a white dotted line. Please do not
locate the area to biopsy beyond this limit line.
6. It is recommended to use this feature with only one needle.
7. Needle PL.U.S. must not be combined with Biopsy Steering
functionnality, in which case the image can be degraded.
8. The cineloop is lost when Needle PL.U.S. is activated or deactivated.
9. Needle Path, Freeze, and Save Image functions can be set on the Foot
switch in Syst. Config./System/Display/System/User controls/Action
of the Foot Switch; and on the S key in Syst. Config./System/Display/
System/User controls/Action of the S key, in order to avoid the use of
hands during the procedure.

The Needle PL.U.S. availability depends on the probe and on the preset.

1. Scan in B-mode and optimize the image as needed

2. Locate the area to biopsy
3. Press Needle PL.U.S. on the touch screen

Orientation, Needle Gauge and Show Needle Path can be

activated.

1. If the needle is introduced from the right side of the transducer, press
Orientation until Right is selected.
2. If the needle is introduced from the left side of the transducer, press
Orientation until Left is selected.
3. If needed, the insertion side could be modified during the
biopsy procedure. The insertion side is also displayed on
the image as a reminder by the following circular icon:

4. Press Needle Gauge until the desired needle gauge range is

displayed on the button. If needed, this value could be adjusted during
the procedure.
5. If needed, press Show Needle Path which generates a biopsy
guide line which is the “line” shown on the ultrasound image. The
displayed guide line indicates the anticipated path of the superior edge
of the needle, and should not be used as a standard in which the needle
must lie within the guide line.
6. Perform the biopsy
7. When the biopsy is performed, press Needle PL.U.S. on the touch
screen to deactivate the feature.

Opacity allows you to change the transparency of the needle

enhancement over the B-mode image.

Opacity is available in live imaging and on a frozen image. Rotate the

knob located under Opacity:

• clockwise to increase the prominence of the needle enhancement over

the B-mode image
• counterclockwise to decrease the prominence of the needle
enhancement over the B-mode image

Opacity ranges from 0 to 100%. The default setting is 80%.

Needle Map assigns the display of echo amplitudes to a range of

grayscale or chromatic colors.

Needle Map is available in live imaging and on a frozen image. Rotate

the rotary knob located under Needle Map:

• clockwise to view next map

• counterclockwise to view previous map

The default setting is 0.

This frame averaging technique reduces noise on the image.

Persistence is available in live imaging. Rotate the rotary knob
located under Persistence:

• clockwise to increase persistence

• counterclockwise to decrease persistence

The default setting is Medium (Med).

Edge enhancement is a mixture of different tools used for

sharpening the enhanced needle in order to provide a more consistent
appearance of the needle edges.

Edge enhancement is available in live imaging and on a frozen

image. Rotate the knob located under Edge enhancement:

• clockwise to increase the Edge Enhancement effect

• counterclockwise to decrease the Edge Enhancement effect

The default setting is 2.

Panoramic imaging registers individual frames as the transducer is moved
along a structure of interest and superimposes the registered frames to
generate a composite image, allowing the visualization and measurement
of large structures of interest that would not fit within the transducer's
field of view.

Use adequate quantities of gel along the entire segment to be scanned to

ensure smooth motion during the panoramic acquisition.

Panoramic imaging is available for the SL15-4, SL18-5, SLH20-6 and

SL10-2 probes.

Press Panoramic on the touch screen.

The system enters the Panoramic Stand-by stage.
1. Adjust the available imaging parameters to optimize image quality
and frame rate.
2. Press Select to start the acquisition.

You can configure the S key to start the panoramic acquisition in the
system configuration.

3. Move the probe in a smooth and continuous manner along the

structure of interest, making sure that the scanning motion is as much
as possible parallel to the scan plane.
The system automatically detects the probe’s motion direction and
the composite image is being created accordingly.
4. If needed, scan backwards to erase unwanted parts of the panoramic
composite image, then resume scanning along the original motion
direction.
5. Press Freeze.
The system displays the whole composite image.

• Ensure that the scanned surface is flat or gently curved, and avoid tissue
areas dominated by noise or lacking structural details
• Use plenty of gel and apply sufficient (but not excessive) transducer
pressure, to ensure good contact with the skin throughout the
Panoramic acquisition.
• Use a slow and steady scanning motion without wobbling, twisting or
abrupt changes in the scanning direction, staying within the same scan
plane as much as possible.

• Panoramic registration errors are manifested by the presence of

artifacts such as image gaps, irregular skin line contours and jagged
 edges, clearly visible “seams” between successive input image frames,,
and blurred or poorly defined areas. If such artifacts are encountered, it
is strongly recommended to discard the current Panoramic composite
image and repeat the Panoramic acquisition.

• All measurements derived from a Panoramic composite image are

marked by an asterisk, to indicate that they represent estimated
measurement results and may have been affected by Panoramic
registration errors.
• When the structure to be measured can fit within the transducer's field
of view, it is strongly recommended to use a standard B-mode image
frame and not the Panoramic composite image.

Use the Zoom functionality as for regular B-mode.

Use the Pan functionality as for regular B-mode.
Use the Rotate button or TouchRing™ to rotate the panoramic
composite image.
Use the Smoothing knob to soften abrupt transitions between input
frames in the Panoramic composite image.

Trim allows you to discard frames from the start or end of the panoramic
acquisition, so that they don’t contribute to the panoramic composite
image.

1. Press Trim on the touch screen to start trimming

The trackball is arbitrated to Trim Start.
2. Move the trackball towards the end of the panoramic acquisition to
discard the required frames from the start of the acquisition.
3. Press Select to arbitrate the Trackball to Trim End.
4. Move the trackball towards the start of the panoramic acquisition to
discard the required frames from the end of the acquisition.
5. Turn Trim off to cut the trimmed frames out.

The remaining panoramic composite image will be automatically

zoomed to fit on the screen.
Press Trim Reset to return the Trim Start and Trim End frames to the
start and end of the panoramic acquisition, respectively.

Skinline Tick-Marks allows you to display or hide the tickmarks

along the skinline.
Press Skinline Tick-Marks to activate/deactivate the skinline
tickmarks.

Smoothing is a spatial filter used to smooth the panoramic image in

order to provide a more homogeneous appearance.
Rotate the knob located under Smoothing:

• clockwise to increase smoothing

• counterclockwise to decrease smoothing
Press Meas. on the control panel to access measurements available in
panoramic imaging.

• Do not perform measurements on Panoramic composite images

acquired with substantial out-of-plane motion components (such as
when following a tortuous structure).
• Do not perform measurements across structures which appear as
strongly hypoechoic or very noisy in the Panoramic composite image.
• Do not perform measurements on Panoramic composite images of
highly-curved objects such as transverse sections through the arm or
leg.

Basic measurements (distance, ellipse, trace, …) on a Panoramic

composite image are performed as in standard B-mode. Please refer to
the section called “Basic Measurements” [275] for a description of
such measurements.

You can measure the distance of a curve on a panoramic image. The

Curved Distance measurement tool is similar to the Trace measurement
tool, but the curved distance trace is not closed. The Curved Distance
measurement tool provides a distance measurement result.

To perform a Curved distance measurement:

1. Acquire the panoramic image

2. Press Meas. on the Control Panel
3. Press Curved Distance on the touch screen
A first caliper is displayed.
4. Move the first caliper at the desired location
5. Press Select to anchor the first caliper
6. Move the Trackball to start tracing the curve
7. Use the Trace knob to erase the trace if needed
8. Press Select to complete the measurement
The system displays the curved distance measurement result in the
measurement result area.

Press Save Image to store the current Panoramic composite image so

that it can be reviewed, manipulated, trimmed and measured at a later
time.

Press the Panoramic button on the touch screen to turn it off and exit
panoramic imaging.
Use appropriate Preset for each organ being scanned

Set depth to achieve desired field of view

Place focal zone at the depth of the area of interest or slightly below

Press AutoTGC to obtain a homogeneous image

Adjust overall gain to obtain the appropriate brightness

Adjust TissueTuner™ to achieve the best resolution

Increase focal zone region for a larger focal area and increased resolution

Use Harmonic Imaging to clear fluid-filled structures

Use Res setting of Res/Fr. rate control for increased resolution

Use Fr. Rate setting of Res/Fr. rate control for increased temporal
resolution
The ShearWave™ Elastography (SWE™) mode displays information
about tissue elasticity in the form of an easy to interpret color-coded
image.

The elasticity information is also quantitative. Local estimation of the

tissue stiffness is displayed per pixel, and can be expressed in kPa or in
m/s over a wide range of values.

Press SWE™ on the control panel from any other mode.

1. Exam and patient information 2. Transducer/Preset/ MI/TI

3. Ultrasound image 4. Elasticity map
5. Clip buffer 6. Grayscale and elasticity bars
When in SWE™, the touch screen displays various image settings which
help you to optimize your elasticity image.

There are two pages of SWE™ parameters. These settings are controlled
by touching the control on the touch screen or turning the rotary knob
directly below it.

You can navigate through the pages by touching Other Settings.

SWE Opt allows you to optimize the elastography resolution and
penetration according to the area you are scanning.
SWE Opt is available in live imaging only.
Rotate the knob located under SWE Opt:

• clockwise to go to next value

• counterclockwise to go to previous value

There are 3 settings to choose from:

• Resolution

Use this setting when imaging small shallow areas of interest.

This setting will also help to clear any erroneous elastography signal out
of areas which are suspected to be comprised of fluid.

• Standard

This setting is balanced between resolution and penetration.

Use this setting as the default starting point for evaluation the stiffness
of a object of interest

• Penetration

Use this setting when imaging deeper or larger areas (anechoic or

hypoechoic) which may show posterior dropout in the echo image.
These areas are suspected to be stiff and require a penetration mode
optimized for high velocity shear waves.
This control allows you to change the color bar scale for SWE™ from
kPa to m/s.
Display Unit is available in live mode and on a frozen image.
Touch Display Unit to change its value.

The Elasticity Range in SWE™ mode is similar to the dynamic

range in B-mode. It changes the maximum elastic value displayed.
It is used to compress the colored image for better visualization of tissues
which have a variety of stiffnesses.
It does not affect the actual values of elasticity, as long as they are within
the elasticity range.
Elasticity Range is available in live imaging or on a frozen image.
Rotate the knob located under Elasticity Range:

• clockwise to increase the elasticity range

• counterclockwise to decrease the elasticity range

Elasticity Range is displayed in kPa, the values depend on the

selected application.
Stiff tissue should appear yellow, orange or red.
Increase the Elasticity Range if you see predominantly dark red in
the color box.

The Velocity Range works in the same manner as the Elasticity

Range.

Velocity Range appears and replaces Elasticity Range when the

Display Unit is set to m/s.
It changes the maximum velocity value displayed.

It is used to compress the colored image for better visualization of tissues

which have a variety of stiffnesses.

It does not affect the actual values of velocity, as long as they are within
the velocity range.

This control changes the format in which B-mode and SWE™ images
are presented on the main display.
Display Format is available in live imaging and on a frozen image.
Press Display format until you select the desired format. The top/
bottom format is the default setting.
Three formats are available:

• top/bottom
• side by side
• single

Opacity allows you to change the transparency of the velocity map

over the B-mode image.
Opacity is available in live imaging and on a frozen image.
Rotate the knob located under Opacity:

• clockwise to increase the prominence of the color image over the B-

mode image
• counterclockwise to decrease the prominence of the color image over
the B-mode image

Opacity ranges from 0 to 100%.

The default setting is 50%.
Elasticity Map determines how elasticity values are displayed in
terms of color graduations.
Elasticity Map is available in live imaging and on a frozen image.
Rotate the knob located under Elasticity Map:

• clockwise to go to the next map

• counterclockwise to go to the previous map

Acoustic Power indicates the output acoustic power.

Acoustic Power is available only in live mode.
Rotate the knob located under Acoustic Power:

• clockwise to increase acoustic power

• counterclockwise to decrease acoustic power

Acoustic Power values vary from 0dB to -30dB.

Smoothing is a spatial filter used to smooth the elasticity map in order

to provide a more homogeneous appearance.
Smoothing is available only in live imaging.
Rotate the knob located under Smoothing:

• clockwise to increase smoothing

• counterclockwise to decrease smoothing
This frame averaging technique reduces noise on the image.
Persistence is available in only in live imaging.
Rotate the rotary knob located under Persistence:

• clockwise to increase persistence

• counterclockwise to decrease persistence

As is the case with all other ultrasound imaging modes - the SWE mode
is associated with a significant learning curve, and may exhibit operator
dependence if suboptimum scanning techniques are employed.

It is recommended to carefully review the “Elastography Measurements”

Section of this user guide in order to become aware of the SWE
capabilities and limitations with regards to penetration depth, spatial
resolution, estimation bias and estimation precision.

When SWE is used to document the stiffness of a lesion, be aware that

the bias and precision of shear wave velocity estimates vary as a function
of lesion size and transducer resolution. Please see the SWE Bias and
Precision Tables in the “Elastography Measurements” section of this user
guide for further information.

With the exception of intercostal liver scanning where adequate pressure

is advisable to obtain good acoustical contact, the manual pressure used
while scanning in SWE should be minimal. Please keep in mind that
compression with the probe may change the velocity of shear waves in
the tissue being imaged.

TriVu allows you to display simultaneously stiffness information with

SWE mode and flow information with COL+. TriVu is available on
linear probes on Breast and Thyroid applications.
Press TriVu to activate the TriVu display.
Avoid using the same color maps for SWE and CPI

Refer to the section called “Q-Box™” [292].

Refer to the section called “Q-Box™ Ratio” [292].

Remember the 3 S’s:

Scan Softly, Smoothly and Slowly

Scan Softly: no manual compression is needed (with the exception of

intercostal liver scanning), just a light touch and plenty of gel between
skin and transducer

Scan Smoothly: transducer automatically induces vibrations in tissues so

no need to shake or push on the transducer

Scan Slowly: Adapt your speed of scanning to the frame rate. Once you
are imaging the area of interest, avoid any movements and wait for image
stabilization

Always start with the default setting of Standard for SWE Opt, and then
go to Resolution or Penetration to fine tune the image.

Controls that can be used in live or frozen mode such as Elasticity Range,
display format, etc. should be done after freezing to make it easier for
user since it is imperative to hold a steady hand during elastography
Color imaging modes use Doppler principles to generate a color image
of the mean flow velocity or flow power.

On the Aixplorer® ultrasound system, three color modes are available:

Color Flow Imaging (CFI), Color Power Imaging (CPI), and Directional
Color Power Imaging (dCPI).

Color imaging modes use Doppler principles to generate a color image

of the mean flow velocity or flow power.

On the Aixplorer® ultrasound system, three color modes are available:

Color Flow Imaging (CFI), Color Power Imaging (CPI), and Directional
Color Power Imaging (dCPI).

Color Flow Imaging is a Doppler mode intended to add color-coded

quantitative information concerning the relative velocity and direction
of fluid motion within the B-mode image.

Color Power Imaging is a color flow mapping technique used to map

the strength of the Doppler signal coming from the flow rather than the
frequency shift of the signal. Using this technique, the ultrasound system
displays the magnitude of the flow based on the number of reflectors that
are moving, regardless of their velocity. CPI does not map flow velocity.
Directional Color Power Imaging (dCPI) is a new flow imaging mode,
which complements the two existing flow imaging modes, namely Color
Flow Imaging (CFI) and Color Power Imaging (CPI). dCPI displays the
mean Doppler frequency of each pixel inside the Color box, including
the direction of flow relative to the transducer.
The color maps used in dCPI are separated into parts which typically
contain red and blue hues, respectively, with positive Doppler
frequencies (flow towards the transducer) displayed using the top part of
the dCPI color map, and negative Doppler frequencies (flow away from
the transducer) displayed using the bottom part of the dCPI color map.
dCPI is useful in indicating the flow direction within the vessels of
interest, as well as identifying areas of high flow velocities (aliasing),
flow reversals, etc.
Press COL on the control panel from any other modes.

1. Focal Zone 2. Grayscale

3. Color bar 4. Color box
When in color modes, the touch screen displays various image settings
which help you to optimize the color image.

There are two pages of color parameters. These settings are controlled
by touching the control on the touch screen or turning the rotary knob
directly below it.

You can navigate through the pages by touching Other Settings.

Color Mode allows you to switch between CFI, dCPI and CPI.
Color Mode is available only in live imaging.
Touch Color Mode to select the desired mode.

See the section called “Dual” [176].

Res/Pen allows you to change the center frequency to reach increased

resolution or increased penetration.
Res/Pen is available only in live imaging.
Press Res/Pen to change the value.
The orange LED indicates which value is active:

• Left LED: Res (resolution)

• Middle LED: Gen (general)
• Right LED: Pen (penetration)
HD/Fr. rate allows you to adjust frame rate and line density to achieve
increased spatial or temporal resolution.
There are three options to choose from:

• HD (High Definition): left LED

• Medium: middle LED
• Fr. Rate (Frame Rate): right LED

Touch HD/Fr. Rate to change its value.

Invert lets you view blood flow from an inverse perspective, e.g.
red away (negative velocities) and blue toward (positive velocities) the
transducer.
Invert is available in live imaging and on a frozen image.
Invert is available only in CFI mode.
Touch Invert to activate and deactivate it.

Scale allows you to adjust the maximum displayed velocity.

Scale is available only in live imaging.
Rotate the knob located under Scale:

• clockwise to increase the scale

• counterclockwise to decrease the scale
Hide Color hides the color information over the B-mode image.
Hide Color is available in live imaging and on a frozen image.
Touch Hide Color to activate and deactivate it.

This parameter filters out low velocity signals.

It helps to decrease motion artifacts caused by patient or transducer
motion. Wall Filter is available only in live imaging.
Touch Wall Filter until you select the desired value.

Velocity Opt.allows you to quickly optimize multiple parameters

with one control to achieve a desired flow optimization.
Velocity Opt. changes the following parameters:

• scale
• wall filter
• resolution/frame rate
• persistence

Velocity Opt. is available only in live imaging.

Touch Velocity Opt. until you select the desired value.
Side by Side allows you to split the screen in two live parts:

• the left side displays the B-mode only, for reference

• the right side displays the B-mode and the color image

Baseline is a horizontal graphical line on the Color Map that

represents the level of zero velocity.
The baseline position contributes in defining the maximum positive and
negative velocities.
By changing the baseline position, you increase the maximum positive
velocity and decrease the maximum negative velocity, or vice versa.
Baseline is available only in live imaging and on a frozen image.
Rotate the knob located under Baseline:

• clockwise to increase the maximum positive velocities

• counterclockwise to increase the maximum negative velocities

Note: The Baseline control is available only in CFI mode. In CPI, it

is replaced by Dynamic Range.
Dynamic Range allows you to change the range over which the
amplitude of returning ultrasound signals are displayed. It behaves in
the same manner as Baseline.

Quick Steer allows you to quickly steer the insonifying beam.

Press Quick Steer to change its value.
Use the Steering knob for finer settings.
To maximize the sensitivity and accuracy of color Doppler modes, it is
usually recommended that clinical Doppler examinations be conducted
with a Doppler angle equal to or less than 60 degrees between the
ultrasound beam and the vessel direction.
Steering is available only in live imaging.
Rotate the knob located under Steering to steer the color box.

Acoustic Power indicates the output acoustic power.

Acoustic Power is available only in live mode.
Rotate the knob located under Acoustic Power:

• clockwise to increase acoustic power

• counterclockwise to decrease acoustic power

Acoustic Power values vary from 0dB (maximum power) to -20dB

(minimum power).

Smoothing is a spatial filter used to smooth the color image in order

to provide a more homogeneous appearance.
Smoothing is available only in live imaging.
Rotate the knob located under Smoothing:

• clockwise to increase smoothing

• counterclockwise to decrease smoothing
This frame averaging technique reduces noise on the image.
Persistence is available in live imaging and on a frozen image (to
view clips).
Rotate the rotary knob located under Persistence:

• clockwise to increase persistence

• counterclockwise to decrease persistence

Color Priority allows you to select a level beyond which color data
are not displayed over the gray map.
Color Priority is available in live imaging and on a frozen image.
Rotate the knob located under Color Priority:

• clockwise to increase the color priority

• counterclockwise to decrease color priority

The range and default value depend on the application.

Color Map determines how flow values are displayed in terms of color
graduations.
Color Map is available in live imaging and on a frozen image.
Rotate the knob located under Color Map:

• clockwise to go to next map

• counterclockwise to go to previous map
This button controls the level of transparency of the color image that is
superimposed on the B-mode image.
When Blending is on, the color image is smoothly overlayed on the
grayscale image.
When Blending is Off, the transition between B-mode and color is
sharper.
Blending is available in live imaging and on a frozen image.
Press Blending to turn it On or Off.

Flash Suppression utilizes an adaptive wall filtering scheme in

order to suppress the flash artifacts due to tissue motion.
When Flash Suppression in On, the frame rate is reduced.
Flash Suppression is available only in live imaging.
Press Flash Suppression to turn it On or Off.

UltraFast™ Doppler Duration allows you to select the duration

of the UltraFast™ Doppler Acquisition.
Touch UltraFast™ Doppler Duration until you select the desired
value.
UltraFast™ Doppler Acquisition launches a prospective capture
of CFI, CPI or dCPI at high frame rates.
UltraFast™ Doppler Acquisition is only available with the
SL10-2 and SC6-1 probes.
Once you have chosen the imaging plane, press UltraFast™
Doppler Acquisition to start the acquisition.
Do not move the probe as long as the message “acquiring...” is displayed
on the screen.
When the acquisition is complete, you have access to the following
controls:

Rotate the COL button in order to change the gain in review:

• clockwise to increase the gain

• counterclockwise to decrease the gain

Display Format allows you to change the view mode as follows:

• Full screen displays the image only

• Quad divides the screen into 4 parts: Clip, Mean Velocities, Peak
Systolic frame and Max Velocities
• Spectrogram displays the image on the top and the spectrograms
underneath.

Press Display Format until you select the desired format.

The button next to Display Format allows you to control the image:
Clip allows you to scroll the UltraFast™ Doppler clip

• PS displays the image of the UltraFast™ Doppler clip that contains

the peak systolic frame
• Max displays a calculated image corresponding to the maximum
velocity of each pixel within the UltraFast™ Doppler clip
• Mean displays a calculated image corresponding to the mean
velocity of each pixel within the UltraFast™ Doppler clip

Press the desired part of the button to change the view mode.

This control automatically locates and displays the peak frame in the
UltraFast™ Doppler CFI clip buffer.
See the section called “Color Map” [218].

See the section called “Blending” [219].

See the section called “Hide Color” [215].

See the section called “Persistence” [218].

See the section called “Color Priority” [218].

In UltraFast™ Doppler mode, you have the capability to add up to
3 sample volumes on the reviewed image to compute simultaneous
spectrograms.

1. Press Add Spectrogram to add a spectrogram

2. Use the TouchRing™ to resize the sample volume
3. Move the Trackball to locate the sample volume on the image and
update the spectrogram

The active spectrogram appears surrounded with an orange rectangle.

Press Select on the Control Panel to change the active spectrogram.
You may add measurements on the active spectrogram. See the section
called “Performing Measurements” [275].
Once a spectrogram has been added, you have access to a variety of PW
parameters and tools.

This control deletes the active spectrogram and corresponding sample

volume from the image.

See the section called “Wall Filter” [215].

This control is available in review in UltraFast™ Doppler mode.

See the section called “Sweep Speed” [235].

You may change the following parameters for the individual active
spectrogram:

See the section called “Dynamic Range” [232].

See the section called “Scale” [234].

See the section called “Smoothing” [217]

See the section called “PW Coarse Angle” [231].

See the section called “Fine Angle Correct” [232].

See the section called “PW Map” [233].

See the section called “Invert” [233].

Rotate the PW button in order to change the gain in review:

• clockwise to increase the gain

• counterclockwise to decrease the gain

Angio PL.U.S. is a Color mode optimization for a better visualization

of slow flows. It may be used in Breast, MSK, Abdominal, and Thyroid
applications on SL10-2, SL15-4, SL18-5, XC6-1 probes.

Please note that Angio PL.U.S. is a Color Doppler technique and,

therefore, provides only qualitative maps of Doppler velocity.
1. Press Probe
2. Select the appropriate application and preset
3. Optimize the B-mode image
4. Press Color
5. Press Angio PL.U.S. RT on the touch screen
6. The Angio PL.U.S. is in live mode
7. Select the plane of interest
8. Press Angio PL.U.S. HD Acquisition for enhanced
performances
9. A prospective clip is being acquired
10.The system freeezes
11.Review the clip
Scan to obtain best angle to maximize flow sensitivity.

Use the TouchRing™ to change size of color box if needed. A larger box
will cause a decrease in temporal resolution (frame rate).

Increase Color Gain until you see noise and then reduce the gain just
to eliminate noise. This will ensure that you have the best color flow
sensitivity possible.

If scanning smaller vessels (i.e. breast, thyroid), center steer is typically

the best choice. In larger vessels (i.e. carotid artery, axillary artery) steer
color box to obtain the best (least) angle to flow. You will see a change
in sensitivity when you choose the appropriate steering angle.

Select the appropriate Velocity Optimization level according to the type

of vessel you are interrogating.

Low is typically used for smaller vessels with lower velocities and venous
flows.

High is used for larger vessels with higher velocities and for arteries.

To increase flow sensitivity, you can lower the Scale or lower the Wall
Filter.

To eliminate aliasing (CFI only), increase the Scale.

Do not move the probe while acquiring an UltraFast™ Doppler CFI clip
Pulsed Wave Doppler (PW) is a Doppler mode that measures velocity of
blood flow within a small region called the Doppler sample volume.

This information is presented as a sweeping display of velocity (or

Doppler frequency) over time. This display is often called a spectral
Doppler trace, or Doppler trace. The information may also be heard as
a stereo audio output.

In addition to the Doppler velocity display, an image (grayscale only or

grayscale and color) is also presented to guide you for proper positioning
of the Doppler sample volume.

Press PW on the control panel from any other modes.

1. Grayscale image 2. Spectral display

3. Doppler line 4. Sample volume
When in PW, the touch screen displays various image settings which help
you to optimize your PW image and trace.

There are two pages of PW parameters. These settings are controlled

by touching the control on the touch screen or turning the rotary knob
directly below it.

You can navigate through the pages by touching Other Settings.

Move the trackball left and right to move the Doppler line in the 2D
image.

Move the trackball up and down to move the sample volume on the
Doppler line.

Slide your finger on the TouchRing™ to change the size of the

sample volume.
Quick Steer allows you to quickly steer the insonifying beam.
Press Quick Steer to change its value.
Use the Steering knob for finer settings.

The insonifying beam can be steered in a direction as close as possible

to the expected direction of motion, within limitations imposed by the
transducer and the image plane geometry.
Steering is available only in live imaging.
Rotate the knob located under Steering to steer the Doppler line.

PW Coarse Angle is available in live imaging and on a frozen

image.
Touch PW Coarse Angle until you select the desired value.
Fine Angle Correct is available in live imaging and on a frozen
image.
Rotate the knob located under Fine Angle Correct.

Acoustic Power indicates the output acoustic power.

Acoustic Power is available only in live mode.
Rotate the knob located under Acoustic Power:

• clockwise to increase acoustic power

• counterclockwise to decrease acoustic power

Acoustic Power values vary from 0dB (maximum power) to -20dB

(minimum power).

You can optimize the PW dynamic range independently from the B-

mode dynamic range.
Rotate the rotary knob located under Dynamic Range:

• clockwise to increase the dynamic range

• counterclockwise to decrease the dynamic range
Display Format is available in live imaging and on a frozen image.
Press Display Format to change its value.
5 display formats are available:

• 2D only
• ½ B-mode and ½ spectral side by side display
• Spectral display only
• 2/3 B-mode and 1/3 spectral display
• 1/3 B-mode and 2/3 spectral display

PW Map is available in live imaging and on a frozen image.

Rotate the knob located under PW Map:

• clockwise to go to previous map

• counterclockwise to go to next map

Invert vertically flips the spectral display without affecting the baseline
position.
Typically, positive velocities (velocities toward the transducer) are
shown above the baseline while negative velocities (velocities away
from the transducer) are shown below the baseline.
Invert flips the location of positive and negative velocities relative to
the baseline.
Invert is available in live imaging and on a frozen image.
Touch Invert to activate and deactivate it.
This parameter filters out low velocity signals.
It helps to decrease motion artifacts caused by patient or transducer
motion.
Wall Filter is available only in live imaging.
Touch Wall Filter until you select the desired value.

Scale allows you to modify the maximum velocities displayed on the

Doppler spectrum.
Scale is available only in live imaging.
Rotate the knob located under Scale:

• clockwise to increase the scale

• counterclockwise to decrease the scale

Baseline is a horizontal graphical line that represents the level of zero

velocity.
The baseline position contributes in defining the maximum positive and
negative velocities.
By changing the baseline position, you increase the maximum positive
velocity and decrease the maximum negative velocity, or vice versa.
Baseline is available only in live imaging and on a frozen image.
Rotate the knob located under Baseline:

• clockwise to increase the maximum positive velocities

• counterclockwise to increase the maximum negative velocities
Sweep Speed allows you to change the speed with which the spectral
columns are updated on the display.
Sweep Speed is available in live imaging and on a frozen image.
Touch Sweep Speed until you reach the desired value.

Simultaneous allows real-time evaluation of vascularity when

respiration or motion make stand alone PW evaluation more difficult.
Simultaneous is available only in live imaging.
Touch Simultaneous to turn it On or Off.
In B-mode, Simultaneous displays and updates the PW spectral
trace and the B-mode image.
In Color, Simultaneous displays and updates the PW spectral trace
and the Color image.

High PRF allows you to measure flows of higher velocities than those
that can be measured with the maximum conventional available PRF, by
increasing the PRF above the Nyquist limit and avoiding aliasing.

High PRF extends the PW Doppler velocity scale beyond the

maximum velocity limit that can be measured for a given sample volume
in a nonambiguous manner. Beyond this limit, the Pulse Repetition
Frequency (PRF) of the transmitted PW Doppler pulses corresponds to
a Pulse Repetition Interval (PRI) which is shorter than the roundtrip
propagation time from the transducer to the current sample volume depth,
resulting in range ambiguity (the analyzed Doppler signals emanate not
only from the primary sample volume of interest but also from one or two
secondary sample volumes along the Doppler beam.

Touch High PRF to turn it on.

The maximum scale available is increased as a function of depth.

High PRF is available for all presets on all probes in live PW.

• Position the primary SV in the area of interest, as you would in

conventional PW Doppler.
• Avoid, as much as possible, placing secondary SV’s in areas
dominated by noise artifacts, shadowing, or areas of flow.
• These tips may assist you in positioning secondary High PRF SV’s to
optimize the signal and avoid interference with the primary SV:
• Vary the velocity range to change the secondary sample volume
position.
• Vary the depth of the image to change the secondary sample volume
position.
• Reduce the velocity range to remove the secondary sample volume.
• Reduce gain.
• Vary 2D image orientation.
• Change the acoustic window.

This control allows you to perform automatic PW measurements.

You may customize which measurements are displayed when
performing a PW Autotrace in the System Configuration.
PW Autotrace is available in live imaging and on a frozen image.
Press PW Autotrace to display the envelope of the peak velocity of
the flow as a function of time.
When the PW Autotrace is activated, you have access to the
following settings:

Press Mean Trace to display the mean flow velocity as a function of

time.

Press Velocity Points to display the PSV and EDV on the spectrum.

Trace Detection allows you to switch between various displays:

• the positive peak velocity

• the negative peak velocity
• both positive and negative peak velocity

Press Trace Detection to change its value.

This control defines the detection threshold for the PW Autotrace.
Press Sensitivity to change its value.

This control allows you to change the cardiac cycles on which the values
calculated when the PW Autotrace is launched are averaged.
Rotate the knob located under Select Cycles:

• clockwise to select next cycle(s)

• counterclockwise to select previous cycle(s)

By default, the calculated values when the PW Autotrace is launched are

averaged on 3 cardiac cycles from the end of the PW spectrum.
Press Nb Cycles to change its value.

This control allows you to manually change the goalposts for the
AutoTrace calculation.

1. Press AutoTrace Trim to edit the goalposts

2. Move the Trackball to place the left goalpost
3. Press Select to anchor it
4. Move the Trackball to place the right goalpost
5. Press Select to anchor it
As in color Doppler, optimize the scan plane for the best angle to flow.

Activate the PW cursor by pressing PW. Optimize the steering angle

and sample volume size (trackball ring) before initiating the PW spectral
trace. If Color is activated before pressing PW, then the cursor will be at
the same steer angle as the color box.

Optimize Doppler gain. Decrease gain to eliminate background noise.

Increase scale or shift baseline to eliminate aliasing.

You can always shift baseline, change display format, PW map and sweep
speed after freezing.

Use Simultaneous mode when vessels are difficult to follow due to

respiration, motion or small vessel size.
The 3D package is available with the SLV16-5 probe for the Breast and
General applications, and the SEV12-3 probe for the Genitourinary and
OB-Gyn applications.

The 3D mode is available with B-mode, Color and SWE modes

depending on the probe and application/preset combination.

Before starting a 3D acquisition:

1. Make sure the 3D probe is plugged in

2. Press Probe on the control panel
3. Select an application tab on the touch screen
4. Select the desired Preset
5. Scan to locate the region of interest and optimize the B-mode, Color
or SWE image

1. Press Volume Size until you select the size of the volume you want
to acquire:
• M
• L
• XL
2. Press the 3D Acquisition button to start the 3D acquisition

During the acquisition, a progress bar is displayed on the screen.

To cancel the 3D acquisition in progress, press 3D Acquisition again.

Press A (Axial), C (Coronal), T (Transverse), or 3D to select the active
view.

When the 3D acquisition is complete, the system displays the default

Multi Plane view.

Rotate the knob located under View Mode to change the Multi Plane
view mode.
The active view will define the reference view to be displayed in the
different view modes.
When the Pointer is ON:

1. Press Navigation on the touch screen until Translate is selected

2. Select the navigation view with the Select button
3. Use the TouchRing™ and the Trackball to navigate in the
selected view

When the Pointer is OFF:

1. Press Navigation on the touch screen until Translate is selected

2. Use the TouchRing™ and the Trackball to navigate in the
selected view

When the Pointer is ON:

1. Press Navigation on the touch screen until Rotation is selected

2. Move the Pointer on the view you want to rotate
3. Use the TouchRing™ to rotate the selected view
4. Press Select to center the planes that are perpendicular to the
selected view

When the Pointer is OFF:

1. Press Navigation on the touch screen until Rotation is selected

2. Use the TouchRing™ and the Trackball to rotate the selected
view
Rotate the knob located under Slab thickness to change the value

Rotate the knob located under Slab Render to change the value.

• Use Min to reinforce hypoechoic structures

• Use Max to reinforce hyperechoic structures
• Use Avg or Median to enhance contrast/resolution trade-off

Rotate Zoom to zoom on the intersection of A, T and C planes.

Press Multi Slice on the touch screen to access Multi Slice mode

Press A, C or T to select the active view.

Move the pointer on a given view to highlight it in the reference view.

Press Slice Number to change the number of slices displayed on the

screen.
Use the TouchRing™ to translate the middle plane of the MultiSlice
display.

Rotate the knob located under Slice distance to change the value.

Rotate the knob located under Slab thickness to change the value.

Rotate the knob located under Slab rendering to change the value.

You can view a clip of the 2D images acquired during the 3D acquisition.
Deactivate Multiplane and Multislice on the touch screen. The
system is in 3D history loop mode.
Use the trackball to scroll the 3D history loop.
3D Filter is a smoothing spatial filter that allows you to smooth the
elasticity map.

Rotate the knob located under 3D Filter to increase or decrease

smoothing.

In addition to the 2d measurement tools, Aixplorer® is providing various

measurement features for the assessment of volume both in Multiplanar
and MultiSlice displays:

• 3D volume calculated from an ellipse and a distance (MPR)

• 3D volume calculated from 3 distances (MPR)
• 3D volume calculated from a collection of traces distributed in a
volume (MS).

Refer to 2D the section called “Basic Measurements” [275] for a

step by step description of distance, ellipse, trace, Q-Box™ and Q-Box
Ratio™ measurements.
Refer to 2D the section called “Labeled Measurements” [298].

The Ellipse distance 3D volume measurement tool is available in MPR

display only.

1. Press Meas. Tools on the touch screen

2. Press Volume (Ellipse + Distance)
3. Use your preferred method to draw an ellipse on the plane of interest
(see 2D the section called “Basic Measurements” [275])
Once the ellipse is drawn, the system displays the first caliper of a
distance measurement.
4. Choose an orthogonal plane to draw the distance
Once the distance is drawn, the system displays the values of the
volume in the measurement result area.

The 3-distance 3D volume measurement tool is available in MPR display

only.

1. Press Meas. Tools on the touch screen

2. Press Volume (3 Distance)
3. Use your preferred method to draw 2 distances (see 2D the section
called “Basic Measurements” [275]) on the plane of interest

Once the first distance is drawn, the system displays the first caliper of
the second distance measurement.

1. Once the second distance is drawn, choose an orthogonal plane to draw

the last distance
Once the last distance is drawn, the system displays the values of the
volume in the measurement result area.

The trace collection 3D volume measurement tool is available in MS

display only.

1. Press Meas. Tools on the touch screen

2. Press Volume (Trace Method)
3. Use your preferred method to draw a first trace on a given slice (see
2D the section called “Basic Measurements” [275])

Once the first trace is drawn, the system displays the first caliper of the
next adjacent slice.

1. Draw as many trace measurements as needed (a minimum of 2 is

required to calculate a volume)
2. Press End to finalize the measurement

The system displays the values of the volume in the measurement result
area.

1. Press Probe
2. Select the Genitourinary application and the Prostate preset of the
SEV12-3
3. Optimize the B-mode image of the prostate
4. Press 3D Acquisition
5. The system is in Multiplanar imaging (refer to 3D chapter of this
User's Guide)
6. Press Volume measurement on the touch screen
7. Perform 2 distance measurements on one plane
8. Perform 1 distance measurement on another plane
9. The system displays the 3 distance results together with a calculated
volume
Make sure the image quality of the 3D acquisition is sufficient in order
to perform a 3D volume measurement.

The 3D on-cart review package allows you to append a closed exam

and save a secondary capture with new information from acquired 3D
volumes coming from the former exam.
Contrast Enhanced Ultrasound Imaging (CEUS) is a mode of imaging
which allows you to assess micro and macro-vascular perfusion
information in an ultrasound image.

CEUS requires that the ultrasound imaging be performed in conjunction

with the injection of a microbubble based contrast agent.

The microbubbles appear as intravascular tracers in the ultrasound image,

allowing the differentiation of structures based on their vascularity.

SuperSonic Imagine does not sell contrast agent products.

CEUS is available only for the liver in the USA. Do not use CEUS in
other organs.

Carefully follow manufacturer’s instructions for use, including

indications and contra indications, when administering ultrasound
contrast agents.
Press CEUS on the control panel from any other mode.
This will engage the CEUS and B-mode side-by-side display.

1. contrast image 2. grayscale image

3. MI and TI information 4. Timers

The CEUS display on the left is the default image, and the CEUS controls
are active by default.

Some panel controls such as the Gain knob and AutoTGC are shared
between CEUS and B-mode. The currently selected mode will determine
which image the control will act upon.
When in CEUS mode, the touch screen displays various image controls
which help you to optimize the CEUS mode image.

There are two pages of CEUS mode parameters, and two pages of Low-
MI B-mode parameters. These settings are controlled by touching the
control on the touch screen, or by turning the rotary knob directly below
the touch screen.

CEUS touch screen parameters

Low-MI B-mode touch screen parameters

You can navigate through the pages by touching Other Settings.

Contrast Agent control allows you to optimize several CEUS
imaging parameters to better visualize specific commercially available
microbubble contrast agents.
Press Contrast Agent to choose a commercially available
microbubble contrast agent.

CEUS Res/Pen acts on the CEUS image and allows you to change
center frequency to obtain increased contrast resolution or increased
penetration.
CEUS Res/Pen is available only in live imaging.
Press CEUS Res/Pen to change value.
The orange LED indicates which one is the active value:

• Left LED: Res (resolution)

• Middle LED: Gen (general)
• Right LED: Pen (penetration)

CEUS HD/Fr. Rate allows you to adjust the CEUS image frame rate
and line density to achieve increased spatial or temporal resolution.
Touch CEUS HD/Fr. Rate to change value.
There are three options to choose from:

• HD (High Definition): left LED

• Balanced: middle LED
• Fr. Rate (Frame Rate): right LED
MVI allows you to visualize vascular architecture by tracing the
movement of microbubbles.
Press the MVI button to activate.
Press the MVI button again to de-activate and clear the accumulated
image display.

POI displays a Point of Interest (POI) on both CEUS and Low-MI B-

mode images.
Use the Trackball to move the POI across the image.

Display 1-up allows you to change the screen display to enlarge the
CEUS image and hide the B-mode image.
Press the Display 1-up button to activate.
Press the Display 1-up button again to de-activate and return the
display to the CEUS and B-mode side-by-side display.

CEUS TGC allows the user to adjust the time-gain compensation of

the CEUS display.
See above for more information on adjusting TCG controls.
CEUS Gain allows the user to adjust the overall gain of the CEUS image.
The CEUS gain control is the same knob as the B-mode gain knob while
in CEUS mode.
To adjust image Gain in CEUS mode:
Rotate the B mode knob on the control panel when the mode indicator
is labeled CEUS.

Timer allows you to start a clock which is used to record the time of
microbubble contrast delivery.
Timer is available in live imaging only.
Press the Timer button to activate. The LED indicator will light.
Press the Timer button again to pause the clock.

Flash will send a limited number of high acoustic power frames into
the ultrasound imaging sequence.
The Flash frames are intended to clear the imaging plane
of microbubbles, allowing you to observe dynamic microbubble
replenishment.
Flash is available in live imaging only. Press the Flash button to
activate the delivery of the flash sequence.

CEUS Acoustic Power regulates the output power of the system

delivered to the CEUS image.
Generally, very low acoustic power levels are used to avoid the
unwanted destruction of fragile microbubble contrast agents.
CEUS Acoustic Power is available only in live imaging.
Rotate the knob located under Acoustic Power:

• clockwise to increase acoustic power output

• counterclockwise to decrease acoustic power output

Maximum acoustic power is 0dB and minimum is -30dB.

See Chapter 3, Safety [37] for information on output power regulations.

Flash Power regulates the output power of the system delivered to

the CEUS image when the Flash control is pressed.
Generally, the Flash power is set to a high acoustic power level and
is delivered in a just a few frames. The high Flash acoustic power
will destroy microbubbles in the CEUS image, allowing you to observe
dynamic microbubble replenishment.
Flash Power is available only in live imaging.
Rotate the knob located under Flash Power:

• clockwise to increase acoustic power output

• counterclockwise to decrease acoustic power output

See Chapter 3, Safety [37] for information on output power regulations.

CEUS Dynamic R. allows you to change the range over which the
amplitudes of returning ultrasound signals are displayed in the CEUS
image.
CEUS Dynamic R. is available in live CEUS imaging and on a
frozen CEUS image.
Rotate the rotary knob located under CEUS Dynamic R.:

• clockwise to compress the grayscale values

• counterclockwise to decrease the dynamic range
CEUS Map assigns the display of the CEUS echo signals to a range
of grayscale or chromatic colors.
CEUS Map is available in live CEUS imaging and on a frozen CEUS
image.
Rotate the rotary knob located under CEUS Map:

• clockwise to view next map

• counterclockwise to view previous map

Flash Duration determines the duration of the Flash sequence.

Rotate the knob to adjust the desired time.
Optimize the B-mode image as usual. Then press CEUS

Select the Contrast Agent setting most appropriate for the microbubble
contrast agent being used.

Administer an amount of contrast agent advised by the contrast agent

manufacturer for the targeted application.

Press Save Clip, when agent arrives to capture prospectively the contrast
bolus.

Use a low CEUS Acoustic Power to minimize microbubble destruction.

Adjust the Res/Pen control to optimize the image.

Adjust the HD/Fr. Rate control to optimize the image.

Allow the contrast agent to completely clear before administering the

dose appropriate for diagnostic imaging.

Remember to start the Timer when injecting contrast agent!

Touch M-mode on the B-mode touch screen. The M-mode is
accessible only if one of these presets has been selected: GYN, Early
OB or Gen OB.

1. Grayscale image 2. M-mode

3. M line
When in M-mode, the touch screen displays various image settings which
help you to optimize your M-mode image.

There are two pages of M-mode parameters. These settings are controlled
by touching the control on the touch screen or turning the rotary knob
directly below it.
You can navigate through the pages by touching Other Settings.
Move the trackball left and right to move the M-line in the 2D image.

Move the trackball up and down to move the M-zone on the M-line.

Slide your finger on the TouchRing™ to change the size of the M-

zone.
Res/Pen allows you to change center frequency to obtain increased
resolution or increased penetration. Res/Pen is available only in live
imaging. Press Res/Pen to change value.
The orange LED indicates which one is the active value:

• Left LED: Res (resolution)

• Middle LED: Gen (general)
• Right LED: Pen (penetration)

Acoustic Power indicates the output acoustic power.

Acoustic Power is available only in live mode.
Rotate the knob located under Acoustic Power:

• clockwise to increase acoustic power

• counterclockwise to decrease acoustic power

Acoustic Power values vary from 0dB (maximum power) to -20dB

(minimum power).

You can optimize the M-mode dynamic range as follows:

Rotate the knob located under M Dynamic Range:

• clockwise to increase the dynamic range

• counterclockwise to decrease the dynamic range
Contrast is a display threshold of the M-mode.
Rotate the knob located under Contrast:

• clockwise to darken anechoic areas

• counterclockwise to brighten anechoic areas

Display Format is available in live imaging and on a frozen image.

Press Display Format to change its value.
3 display formats are available:

• ½ B-mode and ½ M-mode display

• 2/3 B-mode and 1/3 M-mode display
• side by side display

M Map is available in live imaging and on a frozen image.

Rotate the knob located under M Map:

• clockwise to go to next map

• counterclockwise to go to previous map

Sweep Speed allows you to change the speed with which the M-
mode columns are updated on the display.
Sweep Speed is available in live imaging and on a frozen image.
Touch Sweep Speed until you reach the desired value.
Smoothing is a spatial filter used to smooth the M-mode in order to
provide a more homogeneous appearance.
Smoothing is available only in live imaging.
Rotate the knob located under Smoothing:

• clockwise to increase smoothing

• counterclockwise to decrease smoothing
The M-mode will represent movements of structures along one line over
time.

Initially a B-mode image is acquired.

Optimize the grayscale image by adjusting the image depth and zoom
factor, and by setting the appropriate focal zone (position and spread).

Other optimization controls shall be used as necessary such as the

AutoTGC, the B-mode map, the overall gain and the dynamic range.

Activate the M-mode with the dedicated button on the touch screen.

Set the proper size and positioning of the M zone.

Decrease the gain to eliminate background noise.

The M-mode has a good temporal resolution, and the sweep speed may be
adjusted if needed to match the speed of the movements that are observed.

The display format can be changed to match the user's working

conditions.
The Aixplorer® offers you a fusion/navigation feature which provides
you with additional image information from a second modality during
a therapeutic or diagnostic ultrasound session. This is accomplished by
mounting a tracking device on the transducer, which provides the position
and orientation in space while the standard ultrasound procedure takes
place.

The information from the tracking device and the 3D dataset of the 2nd
modality (typically a CT scan) is combined to compute a virtual slice
image that is spatially comparable to the currently displayed ultrasound
scan.

Please refer to the Fusion/Navigation dedicated User's Guide.

Body Mark. is available in live imaging and on frozen image.
Body Mark. is located on the control panel.
Press Body Mark. to add a body marker to an image.

The default body marker will appear on the on the touch screen and on
the main monitor display to the lower right of the image.

Touch PICTO to change the body marker pictogram.

A selection of body markers appears on the touch screen.
Touch the desired body marker to select it.

The transducer orientation can be indicated directly on the pictogram.

To add a transducer orientation to the pictogram, simply touch the

pictogram to indicate the edge of the transducer that corresponds to the
orientation marker on the transducer.

Then touch the pictogram again to indicate the edge of the transducer
opposite the orientation marker. The transducer orientation appears.

Use the Rotate knob to rotate the transducer orientation on the body
marker.
Press Exit on the touchscreen to close the Body Marker page.
Touch HIDE to hide the picto on the image.
To restore a body marker to the main display, touch SHOW.

You can customize the body marker libraries in the system configuration.

You can choose to display the body marker touch screen every time you
press Freeze.

See Chapter 8, Customizing the System [377] for more information.

You can add text annotations and arrows on an image to denote
anatomical structures and locations.
Annot. is located on the control panel.
The annotation feature is available in live imaging and on frozen image.
To annotate an image, press Annot. on the control panel.

A list of annotations appears on the touchscreen and an annotation cursor

appears on the main monitor display.
Rotate the Page knob to access various pages of annotations.

To add an annotation, you can choose from the following actions:

• Choose one of the pre-programmed annotations in the library of

annotations. Touch the desired annotation to add it to the main display.
• Touch Keyboard to display a keyboard and manually enter an
annotation.
• Touch Arrow on the touchscreen to add an arrow graphic to the main
display.

Use the trackball to position the arrow.

To remove annotations from the main display, use the following

functions:

• Clear All removes all the annotations and arrows from the main
display.
• Delete Annot. removes the annotation over which the text cursor
has been positioned using the trackball.
• Del. Last Arrow removes the last arrow marker applied to the
image.

The annotations feature has some specialty controls to facilitate

annotation workflow.
When you add an annotation as a title, it will remain when you unfreeze
the image.
When you add an annotation as a free annotation, it will be removed
when you unfreeze the image.
Press Mode to change the annotation mode.

Annotations can be grouped by color. If they have a specific color, they

belong to the same group. When you select a first annotation from a
group, it will be added to the screen. When you select an annotation from
the same group, it will replace the one that is already on the screen, if it
is from the same group.

Annotations on transparent (blue) buttons do not belong to a given group.

Therefore they will not be replaced.

Annotations all appear in white when the image is saved or printed.

You can move the annotations added to the screen:

1. Select an annotation from the touch screen to add it

2. Move the cursor over the newly added annotation
3. Press Select
The annotation is selected
4. Move the cursor where you want to move the annotation
5. Press Select to release the annotation

If you move an annotation over an existing annotation, the existing

annotation will be replaced.
You can edit the library of pre-set annotations by manually entering your
own. Touch EDIT LIB. to edit the library of annotations.
This opens the System Configuration page, the System/Display tab, and
Annotation sub-tab.
Here you can manage the annotations for the desired clinical application.
See Chapter 8, Customizing the System [377] for more details.

Touch Set Home to define the current position of the cursor as the
Home position for the current display format.

Touch Home to move the annotations cursor to the home position.

Touch EXIT to exit annotations.

When annotating the Dual screen, exit the annotation touch screen
before updating the image with the Select key.

You can choose to display the annotation touch screen every time you
press Freeze.

See Chapter 8, Customizing the System [377] for more information.

You can perform measurements to assess the dimension, area, perimeter,
or volume of anatomical features.

Two types of measurements are available on Aixplorer®:

• Basic measurements, which can be done with a set of measurement

tools
• Labeled measurements, which correspond to the actual anatomy of the
body. Labeled measurements are not linked to an image. They appear
in the report even if the image on which they were performed is deleted.

Make sure the image is correctly optimized before performing any

measurements.

Press Meas. on the control panel to enter the measurement mode. A

default caliper appears on the main display.
Note that the image area is duplicated on the touch screen to facilitate
stylus measurements.
Measurements that appear with a star (*) are estimated measurement
results.

Touch Meas. Tools on the touch screen.

The system displays the measurement tools that are available for the
active mode.
Measurement results are displayed in the Measurement ResultBox
which is located to the lower right of the image, below the grayscale
bar, on the main display. This ResultBox can be moved and placed all
over the image.
In Meas. Tools you can press the Reset ResultBox position
button to automatically replace the ResultBox to its initial place.
Touch the desired measurement tool:

Distance is available in all modes.

Method 1: with the Trackball and Select

1. Touch Distance.
2. Use the trackball to move the active cursor to the first measurement
point.
3. Press Select to anchor the first point.
The system anchors the first cursor and displays a second active
cursor.
The system displays the value of distance in the measurement result
area to the right of the image on the main display.
4. Touching End will end the measurement.

Method 2: with the Touch Screen

1. Touch Distance.

The active cursor appears.

2. Touch the image on the touch screen where you want to anchor the
first cursor.

The system moves the cursor to the position indicated, anchors the
first cursor, and displays a second active cursor.
3. Touch the image on the touchscreen where you would like to position
the second cursor.
4. Touch End to anchor the second cursor.

It is possible to combine the approaches of Method1 and Method2 to

optimize the measurement workflow.
Ellipse is available in all modes.
Method 1: with the Trackball and Select

1. Press Select to anchor the first point.

The system anchors the first cursor and displays a second active
cursor.
2. Use the trackball to move the active cursor to the second point of
measurement.
3. Press Select to anchor the second cursor.
The system displays an ellipsoid trace between the two points.
4. Use the trackball to adjust the shape of the ellipse.
5. Pressing Select will sequentially arbitrate control to the first cursor,
second cursor and ellipse trace.
6. Touch End to complete the measurement.

Method 2: with the Touch Screen

1. Touch Ellipse.

The active cursor appears.

2. Touch the image on the touch screen where you want to anchor the
first cursor.

A second cursor will automatically appear.

3. Without lifting the finger or stylus, drag the second active cursor along
the axis of the ellipse.

The system displays an ellipsoid trace between the two points.

Lifting the stylus or finger will anchor the second cursor.

4. Touch the image near the opposite axis of the ellipse.
5. Without lifting the finger or stylus, drag the ellipse trace to the desired
position.
6. Touch End to complete the measurement.

It is possible to combine the approaches of Method1 and Method2 to

optimize the measurement workflow.
Trace is available in all modes.
Method 1: with the Trackball and Select

1. Touch Trace.
2. Use the trackball to move the active cursor to the first measurement
point.
3. Press Select to anchor the first point.
The system anchors the first cursor and displays a second active
cursor directly on top of the first.
4. Use the trackball to move the active cursor to the second
measurement point.
The path will be displayed.
5. Press Select to anchor the second cursor.
The system will automatically connect the end points of the trace.
6. Alternately, touch End to complete the measurement.

If the start and end points of the trace become very near to each other,
the system will automatically close the trace.
The knob under Trace can be used on an active trace to incrementally
erase the trace in reverse and redo the trace.

Method 2: with the Touch Screen

1. Touch Trace

The active cursor appears.

2. Touch the image on the touch screen where you want to anchor the
first cursor.

A second cursor will automatically appear directly on top of the first.

3. Without lifting the finger or stylus, drag the second active cursor along
the path of the desired trace.

The path will be displayed.

Lifting the finger will pause the trace.

Touching the cursor will reactivate the trace.

4. Touch End to complete the measurement.

If the start and end points of the trace become very near to each other,
the system will automatically close the trace.

This tool allows you to define the depth on the image at a particular point
of interest.

To access depth calculation, press Meas. Tools.

1. Press Depth
2. Anchor it at the desired point
3. The depth value will be displayed.

A three distance volume allows you to use three independent distances

in the same or in orthogonal images to create a volume calculation.

To access volume calculation, press Meas. Tools.

1. Press Volume
2. Use your preferred method (see above, Distance measurements) to
draw three distances
3. The system calculates a volume from the three distances

You can also calculate a volume with labeled measurements. See the
section called “Labeled Measurements” [298].
1. Press Meas. Tools on the touch screen
2. Press Volume (Ellipse + Distance)
3. Use your preferred method to draw an ellipse on the plane of interest

Once the ellipse is drawn, the system displays the first caliper of a
distance measurement.
4. Choose an orthogonal plane to draw the distance

Once the distance is drawn, the system displays the values of the
volume in the measurement result area.

Hip Angle allows you to calculate the angles between the roof line and
the baseline ( ), and between the inclination line and the baseline( ).

To access hip angle calculation, press Meas. Tools.

1. Press Hip Angle

2. Draw the baseline as a regular distance
3. Draw the roof line as a regular distance
is calculated.
4. Draw the inclination line as a regular distance
is calculated.

d:D allows you to calculate the coverage of the femoral head by the bony
acetabulum.

To access femoral head coverage calculation, press Meas. Tools.

1. Use the Trackball to position the circle at the center of the femoral
head
2. Press Select
3. Use the Trackball to resize the circle to fit the femoral head
D is calculated.
4. Draw the baseline as a regular distance
d is calculated.
The d:D ratio is calculated.

IMT calculates the Intima Media Thickness of a region of interest.

Press IMT to start the measurement .

A box of interest is displayed on the image, the intima and media are
automatically traced within the box of interest and the IMT measurement
is displayed in the measurement result area.

• IMT indicates the Intima Media Thickness

• W indicates the width of the box of interest
• Fit indicates the percentage of the box of interest for which the IMT
is calculated

Use the Trackball to move the box of interest.

Press Select on the control panel to be able to resize and rotate the box
of interest. The box of interest is outlined with a dotted line.
Use the Trackball to resize the box of interest.
Use the TouchRing™ to rotate the box of interest.
Press Select again to exit the resize/rotate mode.

You have access to various parameter to optimize the IMT calculation:

Allows you to select between various detection algorithms, as a function

of the visually estimated IMT.

Rotate the knob under IMT Opt to change its value.

Rotate the knob under IMT Display to hide or show the IMT trace on
the image.

Rotate the knob under zoom to zoom the image that is duplicated on the
touch screen.

You may want to slightly change the IMT trace.

1. Press Edit Intima or Edit Media as needed

2. Move the cursor to modify the trace
3. Turn off Edit Intima or Edit Media to exit the edition of the IMT
trace

You may want to manually draw the IMT trace.

1. Press Manual Redefine

2. Press Redefine Intima or Redefine Media as needed
3. The Intima or Media trace is erased a cursor appears
4. Move the cursor to manually draw the Intima or Media
5. Press Exit Manual Redefine to exit the Manual Redefine mode

Draw backwards to erase the trace.

Press Exit IMT to exit.

B-mode Ratio allows you to compare the brightness of two regions of

interest (ROI) on the same image.
B-mode Ratio is available only in B-mode, on a frozen image.

1. Touch B-mode Ratio

2. A circle is displayed that can be resized using the Touchring and
moved using the Trackball
3. Place the circle within the defined region of interest
4. Press Select to anchor it
5. Another circle is displayed, that can be resized using the
Touchring and moved using the Trackball
6. Place it on the second region of interest
7. Press Select to anchor it
8. The value of each ROI, their depth, their diameter and the Ratio
between the two regions is displayed.

This tool allows you to compare the diameter of the unreduced vessel to
the diameter of the stenotic or reduced lumen.

1. Press % Diam Reduction

2. Move the cursor at the first point of the residual diameter
3. Press Select to anchor it
4. Move the next cursor to the second point of the residual diameter
5. Press Select to anchor it
6. Move the next cursor to the first point of the vessel diameter
7. Press Select to anchor it
8. Move the next cursor to the second point of the vessel diameter
9. Press Select to complete the measurement

The system calculates the vessel diameter, the residual diameter, and the
reduction between the two.

Two tools allow you to compare a cross-sectional outline of the

unreduced vessel to a tracing of the stenotic or reduced lumen.
Ellipse Method

1. Press % Area Reduction (Ell)

2. Use the ellipse to deine the vessel area
3. Press Select
4. Move the Trackball to draw the residual area
5. Press Select to complete the measurement

Trace Method

1. Press Meas. Tools on the touch screen

2. Press % Area Reduction (Trace)
3. Move the cursor to the first point of the residual area
4. Press Select to start drawing
5. Move the Trackball to draw the residual area
6. Press Select to validate
7. Move the next cursor to the first point of the vessel area
8. Press Select to start drawing
9. Press Select to complete the measurement

The system calculates the vessel area, the residual area, and the reduction
between the two.

1. Press Distance Ratio

2. Perform a first distance measurement
3. Perform a second distance measurement
The system calculates a ratio between the two distance
measurements.

Follicle counting allows you to count and measure the follicles within
each ovary.
1. Scan in B-mode
2. Make sure the image quality is sufficient in order to detect the follicles
within the ovary
3. Freeze the image
4. Select the frame that contains the maximum number of follicles

Not all follicles may be visible in the same frame. Repeat the whole
procedure in different frames if needed.

• Follicle measurements
1. Press 1-distance, 2-distance or 3-distance (in 3D)
Follicle on the touch screen in order to measure a first follicle
2. A cursor appears
3. Click to start the measurement procedure
4. When the measurement of a follicle is completed, it appears in the
follicle list
 5. Repeat the procedure to measure several follicles
6. The total number of follicles appear on the top of the follicle list

Click on Right Ovary or Left Ovary before performing the follicle

measurement.

The follicle measurements and counting data is integrated in the report.

In 3D, click on the follicle you want to measure on each plane in order
to center it so that it is visible on each plane.

Ejection Fraction allows you to calculate the ejection fraction from

the change in the left ventricular volume between diastole and systole
(monoplane Modified Simpson method). The left ventricular volumes are
calculated from traces of the endocardium performed at end diastole and
end systole.

1. Obtain an apical four chambers or two chambers view with the XP5-1
2. Optimize the image as needed
3. Press Freeze
4. Use the Trackball to select the best diastolic frame
5. Press Meas. on the control panel
6. Select the A4Cd LV or A2Cd LV measurement in the labeled
measurements list
7. Use the Trackball to move the first caliper on the first point of the
mitral annulus
8. Press Select to anchor it
9. Trace the left ventricular border up to the second point of the mitral
annulus
10.Press Select to anchor it
11.Use the Trackball to adjust the long axis as needed
12.Press Select to anchor it
13.Perform the same operations on the best systolic frame (A4Cs LV
or A2Cs LV measurement)

The Ejection Fraction is calculated with the monoplane Modified

Simpson method.

This tool is available in UltraFast™ Doppler mode and cardiac preset.

It allows you to calculate time shifts between 2 timelines and compare the
temporal behaviors of multiple spectrograms or to measure basic Doppler
Time in PW on the cardiac preset.

1. Add UltraFast spectrograms (see the section called “Add

Spectrogram” [223]) or perform PW Trace in cardiac
2. Press Meas Tools on the touch screen
3. Press Doppler Time
4. Position the first timeline
5. Press Select to validate
6. Position the second timeline
7. Press Select to validate

The Doppler time shift is displayed in the measurement result area, in

milliseconds.

See the section called “PW Autotrace” [236].

Velocity is available only in PW mode.

1. Touch Velocity.
A Vel caliper is displayed on the PW spectrum, together with a
vertical axis and a horizontal axis.
2. Press Select to anchor the caliper.

The Velocity tool results in a Doppler Velocity (Vel) measurement (in

cm/s) and a Pressure Gradient (PG) calculation (in mmHg).

PSV/EDV is available only in PW mode.

1. Touch PSV/EDV.
A first PSV caliper is displayed on the PW spectrum, together with
a vertical and a horizontal axis.
2. Press Select to anchor it.
A second caliper is displayed, with the following label:
• EDV if the caliper is above the baseline
• MDV if the caliper is below the baseline
3. Press Select to anchor it.

The PSV/EDV tool results in the following:

• Peak Systolic Velocity (PSV)

• End Diastolic Velocity (EDV)
• Resistive Index (RI)
• Systolic to Diastolic Ratio (S/D)
• Peak Pressure Gradient (PG)

Vessel Diam allows you to measure the diameter of a vessel.

Vessel Diam is available only in PW mode.

1. Touch Vessel Diam.
A first caliper is displayed within the sample volume
2. Use the Trackball to resize the first part of the caliper
3. Press Select to anchor
A second caliper is displayed within the sample volume
4. Use the Trackball to resize the second part of the caliper
5. Press Select to anchor.

Doppler Slope allows you to measure the acceleration or deceleration

slope on the Doppler spectrum.

Doppler Slope is available only in PW mode.

1. Touch Doppler Slope.
A first caliper is displayed
2. Press Select to anchor the first caliper
The system anchors the first caliper and displays a second active
caliper
3. Use the Trackball to move the active caliper
4. Press Select to anchor the second caliper

Doppler Trace allows you to trace a single heart cycle on the Doppler
spectrum.

Doppler Trace is available only in PW mode.

1. Touch Doppler Trace.
2. Use the trackball to move the active caliper to the first
measurement point.
3. Press Select to anchor the first point.
The system anchors the first caliper and displays a second active
cursor.
4. Use the trackball to move the active caliper along the desired path.
 The path will be displayed.
5. Press Select to anchor the second caliper.

Congestion Index allows you to calculate the ratio between the cross-
sectional area (cm²) and the blood flow velocity (cm/s) of the portal vein.

1. Adjust the Angle correction parallel to the portal vein

2. Press Select to update the PW spectrum
3. Freeze the image
4. Touch Congestion Index
5. Adjust the portal vein diameter by positioning the first and second
caliper with the Trackball and Select button
6. Draw the Doppler trace during one cardiac cycle
7. Press Select to end the measurement

This tool allows you to measure a heart rate from M-mode and PW.

1. In M-mode or PW measurement, touch Heart Rate.

A first vertical line is displayed.
2. Use the trackball to move the vertical line on the beginning of one
heart cycle.
3. Press Select to validate.
A second vertical line is displayed.
4. Use the trackball to move the second vertical line on the end of the
same cardiac cycle.
5. Press Select to validate.

In OB/GYN the vertical lines have to be positioned on two cardiac cycles

to get the correct heart rate.
In PW mode, you have the capability to measure the volume flow rate
within a vessel.

1. Adjust the Sample Volume size so that it covers the whole diameter
of the vessel
2. Adjust the Angle correction parallel to the vessel
3. Press Select to update the PW spectrum
4. Freeze the image
5. Press Meas. on the Control Panel
6. Press Volume Flow on the Touch Screen
7. Adjust the vessel diameter by positioning the first and second caliper
with the Trackball and Select button
8. Draw the Doppler trace during one cardiac cycle
9. Press Select to end the measurement
The system displays the volume flow rate.

When the Autotrace is on:

1. Press Volume Flow

2. Adjust the vessel diameter by positioning the first and second caliper
with the Trackball and Select button

The system displays the volume flow rate.

This tool allows you to measure a vertical distance between two calipers.
It is similar to a distance measurement in B-mode.

1. In M-mode measurement, touch M Distance.

A first caliper is displayed.
2. Use the trackball to move the first caliper
3. Press Select to validate.
A second caliper is displayed.
4. Use the trackball to move the second caliper
5. Press Select to validate.

The Quantification Box (Q-Box™) allows you to accurately quantify the

stiffness of an area.

Q-Box™ is available only in SWE™ mode, on a frozen image.

1. Touch Q-Box™
Q-Box™ displays a circle that can be resized or moved, and that
is duplicated on the B-mode image (in side by side and top bottom
formats), for reference purposes.
2. Select to anchor it.

Q-Box™ Ratio allows you to compare the stiffness of two areas on

the same image.

Q-Box™ Ratio is available only in SWE™ mode, on a frozen image.

1. Touch Q-Box™ Ratio.

Q-Box™ Ratio displays a circle that can be resized or moved,
and that is duplicated on the B-mode image (in side by side and top
bottom formats), for reference purposes.
2. Place the Q-Box™ within the stiffest visualized area
3. Press Select to anchor it
4. Another Q-Box™ is displayed.
5. Place it on soft tissue.
6. Press Select to anchor it.
The values for ShearWave speed and tissue modulus are relative
indices intended only for the purpose of comparison with other
measurements performed using the Aixplorer®, and absolute values for
these measurements should not be compared to shear wave elastography
measurements from other manufacturers' ultrasound imaging systems.

Please note that suspicious breast lesions on mammography and

sonography may contain blue coded areas. This may be due to soft focal
areas in the tumor or noisy data that triggers errors in Shear Wave speed
estimation. Place the ROI in the stiffest part of either the lesion or tissue
immediately adjacent to the lesion to gain the most relevant diagnostic
information.

Q-Box™ Trace allows you to manually trace a Q-Box in SWE

imaging mode in order to obtain some elasticity values within the traced
area.

Q-Box™ Trace is available only in SWE™ mode, on a frozen image.

1. Touch Q-Box™ Trace
2. Use your preferred method (with the Trackball, or with the
touchscreen, see the section called “Trace” [278]) to draw a trace
3. Press Select to end the measurement

Multi Q-Box™ allows you to automatically calculate the average of

several Q-Box measurements.
Multi Q-Box™ is available only in SWE™ mode, on a frozen image.

1. Touch Multi Q-Box™

2. Resize and move the Q-Box as needed
3. Press Select to validate
4. If you want to add an other Q-box, repeat the operation
The system calculates the average of each Q-Box result.
You can continue the Multi Q-Box measurement cycle on several
images.
5. Press End to end the Multi Q-Box measurement cycle

The SWE stability index tool (labelled SI in the Q-Box results) allows
you to assess the temporal consistency of the SWE estimates within the
Q-Box. It is available in the Abdomen, Liver and Vascular Abdominal
presets of the XC6-1 probe.

1. Press Probe
2. Select the Liver preset in the Abdominal application on the XC6-1
transducer
3. Optimize the B-mode image on the liver right lobe
4. Make sure the patient is holding his/her breath
5. Press SWE and optimize as needed
6. Freeze the image
7. Perform a Q-box measurement of the imaged tissue
8. If the displayed stability index is <90%, this suggests temporal
variability, and therefore you may have to set the Q-Box to another
location within the SWE box or restart the acquisition.

A stability index >90% does not validate the elasticity accuracy.

The Stability Index must be analyzed only in the presets/probe

mentioned above.
If necessary, the Stability Index tool can be disabled in the system
configuration.
The measurements touch screen has some specialty controls to facilitate
measurement workflow.

Erase All allows you to erase all of the measurements displayed on

the frozen image.

Erase Last allows you to erase only the last caliper anchored.

End will end the active measurement.

The knob under Undo/Redo can be used on an active trace to

incrementally erase the trace in reverse and redo the trace.

Zoom allows you to enlarge the size of the image area displayed on
the touch screen.
Rotate the knob located under Zoom:

• clockwise to increase the zoom factor

• counterclockwise to decrease the zoom factor

Use “Fit” to fit the image in the touch screen measurement area.
Assign Last allows you to assign the last measurement performed to
a label.

1. Perform a measurement
2. Touch Assign Last on the touch screen
The system displays the list of available labels for your measurement
3. Click on the desired label

For more information on labeled measurements, refer to the section

called “Labeled Measurements” [298]

Exit completes any active measurements, closes the measurements

touch screen and returns to the frozen image state.
Press Meas. on the control panel.
A list of labeled measurements is displayed on the right side of the
image.
The available labels depend on the selected application and on the
current active mode.
The label packages can be configured in the System Configuration. See
the section called “Packages” [420].

Press Pointer.
To scroll the list, place the Pointer over it, and use the
TouchRing™.
Pick the appropriate label from the list by pressing Select.
The appropriate measurement tool is launched (distance...).
Perform the measurement as for a basic measurement.
You can make up to 5 measurements for the same label. They appear
with their corresponding caliper in the list.
Note: Labeled measurements may be hidden, depending on the selected
option from the system configuration.

You can customize the measurements in the system configuration.

You can choose to display the measurement touch screen every time you
press Freeze.

See Chapter 8, Customizing the System [377] for more information.

The table below shows the measurement accuracy and range for the 2D
measurements available on the ultrasound system.

Measurement Accuracy Range Notes

Type
Axial Distance ±10% or 1 mm 0.01 to 25 cm Whichever is larger
Lateral Distance ±10% or 2 mm 0.01 to 20 cm Whichever is larger
Diagonal Distance ±10% or 2 mm 0.01 to 25 cm Whichever is larger
Area ±10% or 25 mm² 0.01 to 1000 cm2 Whichever is
larger *Continuous
trace accuracy
depends on user.
Perimeter ±10% or 5 mm 0.03 to 10,000 cm Whichever is
larger *Continuous
trace accuracy
depends on user.
Ellipsoid Volume ±10% 0.01 to 2000 cm3 Whichever is larger
Ejection Fraction ±20% 10 to 80% Whichever is
(calculated) larger *Continuous
trace accuracy
depends on user.

*The tolerances specified apply only to measurements made in a

homogeneous medium with a speed of sound of 1540 m/s and with a non-
refractive surface and with insonification angle of 90 degrees relative to
the surface of the transducer.

Metric Specification Test Level Notes

Transducer SL15-4 / General I 1
Name / Preset
Geometry Linear I 1
 Metric Specification Test Level Notes
Nominal Center 8.5 MHz I 1,2
Frequency
Imaging 4.0 – 15.0 MHz I 1,2
Frequency Range
Panoramic Distance ± 10% M 3
Measurement
Accuracy

Metric Specification Test Level Notes

Transducer SL18-5 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 8.5 MHz I 1,2
Frequency
Imaging 4.0 – 15.0 MHz I 1,2
Frequency Range
Panoramic Distance ± 10% M 3
Measurement
Accuracy

Metric Specification Test Level Notes

Transducer SL10-2 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 6.0 MHz I 1,2
Frequency
Imaging 2.0 – 10.0 MHz I 1,2
Frequency Range
Panoramic Distance ± 10% M 3
Measurement
Accuracy

Explanation of symbols used in the Panoramic Distance

Measurements tables

Test Level I: Verified by inspection or qualitative analysis.

Test Level M: Verified by measurement.

Note 1: Specification is for information purposes only, and is not a

testable requirement at the system level.
Note 2: Specification refers to the ultrasound pulses used in the imaging
part of the B-mode sequence.

Note 3: The Panoramic distance measurement accuracy test is performed

using the ATS 551 Small Parts phantom and covers a maximum distance
of approximately 20 cm.
 Metric Specification Test Level Notes
Transducer SC6-1 / OB I 1
Name / Preset
Geometry Curved I 1
Nominal Center 3.5 MHz I 1,2
Frequency
M-mode TX/ 2.5/4.5 MHz I 1,2
RX Frequency
Axial Distance ± 10% or 1mm M 3, Whichever
Measurement is greater
Accuracy
Heart Rate ± 10% M 4
Measurement
Accuracty

Metric Specification Test Level Notes

Transducer XC6-1 / OB I 1
Name / Preset
Geometry Curved I 1
Nominal Center 3.5 MHz I 1,2
Frequency
M-mode TX/ 2.5/4.5 MHz I 1,2
RX Frequency
Axial Distance ± 10% or 1mm M 3, Whichever
Measurement is greater
Accuracy
Heart Rate ± 10% M 4
Measurement
Accuracty

Metric Specification Test Level Notes

Transducer SE12-3 / OB I 1
Name / Preset
Geometry Curved I 1
Nominal Center 7 MHz I 1,2
Frequency
M-mode TX/ 3.75/7.5 MHz I 1,2
RX Frequency
 Metric Specification Test Level Notes
Axial Distance ± 10% or 1mm M 3, Whichever
Measurement is greater
Accuracy
Heart Rate ± 10% M 4
Measurement
Accuracty

Metric Specification Test Level Notes

Transducer SEV12-3 / OB I 1
Name / Preset
Geometry Curved I 1
Nominal Center 7 MHz I 1,2
Frequency
M-mode TX/ 3.75/7.5 MHz I 1,2
RX Frequency
Axial Distance ± 10% or 1mm M 3, Whichever
Measurement is greater
Accuracy
Heart Rate ± 10% M 4
Measurement
Accuracty

Explanation of symbols used in the M-mode Measurements tables

Test Level I: Verified by inspection or qualitative analysis.

Test Level M: Verified by measurement.

Note 1: Specification is for information purposes only, and is not a

testable requirement at the system level.

Note 2: Specification refers to the ultrasound pulses used in the M-mode

sequence.

Note 3: The M-mode distance measurement accuracy test is performed

using the CIRS Model 040GSE phantom.

Note 4: The fetal heart rate timing accuracy is measured using the
following material: AWG Agilent 33220A Oscilloscope Tektronix
DPO4034 Ultrasound Gel Pad Aquaflex Ref. 04-02 HI-FI speaker
Monacor SP60/4.
 Table 5.1. Axial distance measurement accuracy - acceptance criteria and measurement results

Transducer Acceptance Measurement Results

criteria
Maximal Preset Setting TX/RX Range Calibrated Measured Error Test
axial Frequency Distance Distance Result
distance (MHz) (mm) (mm)
error
SC6-1 10% Early OB THI 2.5/4.5 0.01 to 10 10 0% Pass
MHz 20cm
SE12-3 10% Early OB Fund 9/7.5 MHz 0.01 to 10 9.5 5% Pass
8.5cm
SEV12-3 10% Early OB Fund 9/7.5 MHz 0.01 to 10 9.5 5% Pass
8.5cm
XC6-1 10% Abdomen THI 1.875/3.75 0.01 to 10 9,7 3% Pass
MHz 20cm

Table 5.2. Timing accuracy - acceptance criteria and measurement results

Transducer Acceptance Measurement Results

criteria
BPM Preset Setting TX/RX Range Period Measured Error Test
error Frequency per BPM Result
(MHz) minute
(scope)
SC6-1 10% Early OB THI 2.5/4.5 16-1000bpm 180 180 0% Pass
MHz
SE12-3 10% Early OB Fund 6.42/6.42 16-1000bpm 180 180 0% Pass
MHz
SEV12-3 10% Early OB Fund 6.42/6.42 16-1000bpm 180 180 0% Pass
MHz
XC6-1 10% Early OB THI 2.8/5.6 16-1000bpm 180 180 0% Pass
MHz
Doppler measurement calipers are positioned on a single pixel in a
desired location.

Velocity measurements are displayed in units of cm/s or m/s with at least

1 digit past the decimal point.

The table below shows the measurement accuracy, range and tolerance
for the Doppler measurements available on the ultrasound system.

Doppler System Tolerance Accuracy Range[r]

Measurement (whichever based on
is greater)
Velocity <15% relative error Acquisition PW:6.2cm/
measurement s - 370cm/s

The tolerances specified apply only to measurements made in a

homogeneous medium with a speed of sound of 1540 m/s and with a non-
refractive surface and a Doppler angle of 0°. These accuracies arise from
the positioning of the cursors on the Doppler display and the subsequent
measurements made.

Measurement Doppler Accuracy and Sensitivity Summary for the

transducers

Items marked by a dagger (†) indicate that the specified value is for
information purposes only and is not a testable requirement at the system
level.

Test Level I: verified by inspection or analysis

Test Level M: verified by measurement

† : for reference only

(1) Transmitter center frequencies for grayscale imaging

(2) Using CIRS 043 Doppler string phantom.

Doppler Velocity Accuracy measurements in Aixplorer® for the SL15-4
transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SL15-4/ Breast I
Geometry † Linear
Nominal Center Frequency 8.5 MHz
PW Doppler 5MHz I
Center Frequency
PW Doppler Spectral =12.5% error M
Velocity accuracy (2)

Metric (Notes) Specification Test Level

Transducer Name / Preset SL18-5/ Breast I
Geometry † Linear
Nominal Center Frequency 8.5 MHz
PW Doppler 5MHz I
Center Frequency
PW Doppler Spectral =12.5% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer® for the SC6-1

transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SC6-1/Abdomen I
Geometry † Curved
Nominal Center Frequency 3.5 MHz
Imaging Frequency 1.0 – 6.0 MHz I
Range (1)
PW Doppler 2.25 MHz M
Center Frequency
PW Doppler Spectral =13% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer® for the XC6-1

transducer.
 Metric (Notes) Specification Test Level
Transducer Name / Preset XC6-1/Abdomen I
Geometry † Curved
Nominal Center Frequency 3.5 MHz
Imaging Frequency 1.0 – 6.0 MHz I
Range (1)
PW Doppler 2.25 MHz M
Center Frequency
PW Doppler Spectral =13% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer® for the SE12-3

transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SE12-3/Prostate I
Geometry † Micro-convex
Nominal Center Frequency 7 MHz
Imaging Frequency 3 - 12 MHz I
Range (1)
PW Doppler 4.5 MHz M
Center Frequency
PW Doppler Spectral =15% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer® for the SEV12-3

transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SEV12-3/Prostate I
Geometry † Micro-convex
Nominal Center Frequency 7 MHz
Imaging Frequency 3 - 12 MHz I
Range (1)
PW Doppler 4.5 MHz M
Center Frequency
PW Doppler Spectral =15% error M
Velocity accuracy (2)
Doppler Velocity Accuracy measurements in Aixplorer® for the SLV16-5
transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SLV16-5 / Breast I
Geometry † Motorized
Nominal Center Frequency 8.5 MHz
Imaging Frequency 5 - 16 MHz I
Range (1)
PW Doppler 5 MHz M
Center Frequency
PW Doppler Spectral =5% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer®for the SL10-2

transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SL10-2 / Vascular I
– Carotid
Geometry † Linear
Nominal Center Frequency 6 MHz
Imaging Frequency 4.5 - 15 MHz I
Range (1)
PW Doppler 3.75 MHz M
Center Frequency
PW Doppler Spectral =3% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer® for the

SMC12-3 transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SMC12-3 / I
General – Vascular
Geometry † Micro-convex
Nominal Center Frequency 7.5 MHz
 Metric (Notes) Specification Test Level
Imaging Frequency 3-12 MHz I
Range (1)
PW Doppler 4.5 MHz M
Center Frequency
PW Doppler Spectral =14.5% error M
Velocity accuracy (2)

Doppler Velocity Accuracy measurements in Aixplorer® for the SLH20-6

transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset SLH20-6 / MSK I
Geometry † Linear
Nominal Center Frequency 11 MHz
Imaging Frequency 6-20 MHz I
Range (1)
PW Doppler 7.5 MHz M
Center Frequency
PW Doppler Spectral =15% error M
Velocity accuracy

Doppler Velocity Accuracy measurements in Aixplorer® for the XP5-1

transducer.

Metric (Notes) Specification Test Level

Transducer Name / Preset XP5-1 / Vascular – TCD I
Geometry † Phased
Nominal Center Frequency 2.9 MHz
Imaging Frequency 1-5 MHz I
Range (1)
PW Doppler 1.875 MHz M
Center Frequency
PW Doppler Spectral =15% error M
Velocity accuracy
The purpose of this test is to measure the penetration of color flow
imaging performance.

Each transducer is placed in Color Flow.

The Color Flow Doppler Phantom equipped with a 4 mm diameter

sloping cylindrical vessel is imaged to measure the Color Doppler
Sensitivity in centimeters.

The Doppler angle is approximately 72°.

The maximal depth (penetration) at which the Doppler signal can be

detected on the display is measured using the calipers with one caliper at
skin line and the other where the color flow signal starts to show dropouts.

The distance between them is considered to be the penetration.

The flow signals that fall below the threshold are considered to be noise
and are not valid Color Doppler signals.

The Color Flow Doppler Phantom is used with a constant flow waveform.

(1) Transmitter center frequencies for grayscale imaging

(2) Using Shelley medical accuFlow-Q pump with QATP — 100/Z

Model (Zerdine™ tissue mimicking material speed of sound 1540 m/s ± 6
m/s at 22ºC, attenuation coefficient 0.5 dB/cm/MHz) blood flow phantom
set at minimal, maximal, and midrange Doppler mean velocities output.

Metric (Notes) Specification Test Level

Transducer Name / Preset SL15-4/ Breast I
Geometry † Linear
Nominal Center Frequency 8.5 MHz
Imaging Frequency 4.0 – 15 MHz I
Range (1)
Color Flow 5-9 MHz M
Frequency Range
Color Penetration (2) 41 mm M
Angio PL.U.S. Penetration 48 mm
 Metric (Notes) Specification Test Level
Transducer Name / Preset SL18-5/ Breast I
Geometry † Linear
Nominal Center Frequency 8.5 MHz
Imaging Frequency 4.0 – 15 MHz I
Range (1)
Color Flow 5-9 MHz M
Frequency Range
Color Penetration (2) 41 mm M
Angio PL.U.S. Penetration 48 mm

Metric (Notes) Specification Test Level

Transducer Name / Preset SC6-1/Abdominal I
Geometry † Curved
Nominal Center Frequency 3.5 MHz
Imaging Frequency 1.0 – 6.0 MHz I
Range (1)
Color Flow 1.9 - 3.8 MHz M
Frequency Range
Color Penetration (2) 12.5 cm M

Metric (Notes) Specification Test Level

Transducer Name / Preset XC6-1/Abdominal I
Geometry † Curved
Nominal Center Frequency 3.5 MHz
Imaging Frequency 1.0 – 6.0 MHz I
Range (1)
Color Flow 2 - 2.5 MHz M
Frequency Range
Color Penetration (2) 12.5 cm M
Angio PL.U.S. Penetration 125 mm

Metric (Notes) Specification Test Level

Transducer Name / Preset SE12-3/ Prostate I
Geometry † Micro-convex
Nominal Center Frequency 7.5 MHz
 Metric (Notes) Specification Test Level
Imaging Frequency 3 - 12 MHz I
Range (1)
Color Flow 4.5 - 7.5 MHz M
Frequency Range
Color Penetration (2) 5.0 cm M

Metric (Notes) Specification Test Level

Transducer Name / Preset SEV12-3/ Prostate I
Geometry † Micro-convex
Nominal Center Frequency 7.5 MHz
Imaging Frequency 3 - 12 MHz I
Range (1)
Color Flow 4.5 - 7.5 MHz M
Frequency Range
Color Penetration (2) 5.0 cm M

Metric (Notes) Specification Test Level

Transducer Name / Preset SLV16-5/ I
Geometry † Motorized
Nominal Center Frequency 8.75 MHz
Imaging Frequency 5 - 16 MHz I
Range (1)
Color Flow 5 - 9 MHz M
Frequency Range
Color Penetration (2) 4.0 cm M

Metric (Notes) Specification Test Level

Transducer Name / Preset SL10-2/LowExtVenous I
Geometry † Linear
Nominal Center Frequency 6 MHz
Imaging Frequency 4.5 to 15 MHz I
Range (1)
Color Flow 3.7 to 6.4 MHz M
Frequency Range
Color Penetration (2) 62 mm M
Angio PL.U.S. Penetration 71 mm
 Metric (Notes) Specification Test Level
Transducer Name / Preset SMC12-3/ Vascular I
Geometry † Micro-convex
Nominal Center Frequency 7.5 MHz
Imaging Frequency 3 - 12 MHz I
Range (1)
Color Flow 4.5 - 7.5 MHz M
Frequency Range
Color Penetration (2) 5.0 cm M

Metric (Notes) Specification Test Level

Transducer Name / Preset SLH20-6/ MSK I
Geometry † Linear
Nominal Center Frequency 11 MHz
Imaging Frequency 6 - 20 MHz I
Range (1)
Color Flow 6.4 - 9 MHz M
Frequency Range
Color Penetration (2) 3.5 cm M

Metric (Notes) Specification Test Level

Transducer Name / Preset XP5-1/ TCD I
Geometry † Phased
Nominal Center Frequency 2.9 MHz
Imaging Frequency 1 - 5 MHz I
Range (1)
Color Flow 2.2 - 2.5 MHz M
Frequency Range
Color Penetration (2) 12.5 cm M
The tables below document the SWE elasticity estimation accuracy, SWE
penetration depth, and spatial resolution for all transducers where the
SWE mode is available.

Metric Specification Test Level Notes

Transducer SLV16-5 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 8.8 MHz I 1, 2
Frequency
Imaging 5.0 – 16.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 28 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer SL15-4 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 8.5 MHz I 1, 2
Frequency
Imaging 4.0 – 15.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 30 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution
 Metric Specification Test Level Notes
Transducer SL18-5 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 8.5 MHz I 1, 2
Frequency
Imaging 4.0 – 15.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 30 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer SL10-2 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 6.0 MHz I 1, 2
Frequency
Imaging 2.0 – 10.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 45 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer SLH20-6 / General I 1
Name / Preset
Geometry Linear I 1
Nominal Center 11.0 MHz I 1, 2
Frequency
Imaging 6.0 – 20.0 MHz I 1, 2
Frequency Range
 Metric Specification Test Level Notes
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 1 - 20 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer SE12-3 / General I 1
Name / Preset
Geometry Micro-curved linear I 1
Nominal Center 7.5 MHz I 1, 2
Frequency
Imaging 3.0 – 12.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 30 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer SEV12-3 / General I 1
Name / Preset
Geometry Micro-curved linear I 1
Nominal Center 7.5 MHz I 1, 2
Frequency
Imaging 3.0 – 12.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 30 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution
 Metric Specification Test Level Notes
Transducer SMC12-3 / General I 1
Name / Preset
Geometry Micro-curved linear I 1
Nominal Center 7.5 MHz I 1, 2
Frequency
Imaging 3.0 – 12.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 2.5 - 30 mm M 4
Depth Range
SWE Spatial 3.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer SC6-1 / General I 1
Name / Preset
Geometry Curved linear I 1
Nominal Center 3.5 MHz I 1, 2
Frequency
Imaging 1.0 – 6.0 MHz I 1, 2
Frequency Range
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 25 - 75 mm M 4
Depth Range
SWE Spatial 3.0 mm M 5
Resolution

Metric Specification Test Level Notes

Transducer XC6-1 / General I 1
Name / Preset
Geometry Curved linear I 1
Nominal Center 3.5 MHz I 1, 2
Frequency
Imaging 1.0 – 6.0 MHz I 1, 2
Frequency Range
 Metric Specification Test Level Notes
Elasticity ± 30 % or 3 M 3
Estimation kPa (whichever
Accuracy is greater)
SWE Penetration 25 - 70 mm M 4
Depth Range
SWE Spatial 2.0 mm M 5
Resolution

Test Level I: Verified by inspection or qualitative analysis.

Test Level M: Verified by measurement.

Note 1: Specification is for information purposes only, and is not a

testable requirement at the system level.

Note 2: Specification refers to the ultrasound pulses used in the imaging

part of the SWE sequence.

Note 3: SWE elasticity estimation accuracy is defined as the difference

between the SWE-based elasticity measurement from a given phantom
target and the reference elasticity for this target provided by the phantom
manufacturer. The SLV16-5, SL15-4, SL18-5, SL10-2, SLH20-6,
SE12-3, SEV12-3, SMC12-3, XC6-1 and SC6-1 accuracy specifications
were derived from SWE measurements on the four spherical targets
(reference elasticities equal to 8.4, 17.7, 47.7, and 80.1 kPa) and the
uniform-elasticity background (reference elasticity equal to 29 kPa)
contained in the CIRS 049 Quality Assurance Elasticity phantom.

Note 4: SWE penetration is defined as the maximum depth for which the
SWE image exhibits good color filling and minimal noise. The SLV16-5,
SL15-4, SL18-5, SL10-2, SLH20-6, SE12-3, SEV12-3, SMC12-3 ,
XC6-1 and SC6-1 SWE penetration specifications were derived by
scanning regions of uniform-elasticity background material of the CIRS
049 Quality Assurance Elasticity phantom.

Note 5: The SLV16-5, SL15-4, SL18-5, SL10-2, SLH20-6, SE12-3,

SEV12-3, SMC12-3 , XC6-1 and SC6-1 SWE spatial resolution
specifications were derived by using a custom-made phantom containing
two rectangular tissue-mimicking blocks with an elasticity ratio equal to
3, scanning the custom-made phantom twice so that the interface between
the two blocks is oriented first axially and then laterally, and measuring
the average width of the SWE elasticity vs. distance curves across the
block interfaces on the axially- and laterally-oriented SWE images.

The tables below document the estimation bias and estimation precision
as a function of target size and target stiffness for all transducers where
the SWE mode is available.

The table results were obtained by performing experiments on a CIRS

049A Quality Assurance elasticity phantom. This phantom contains
stepped-cylinder targets of four stiffness types I – IV corresponding to
nominal shear wave velocities of 1.6, 2.2, 3.9 and 5.2 m/s of different
diameters, embedded in uniform-elasticity background (nominal shear
wave velocity of 2.9 m/s). Note that the bias and precision specifications
listed below should not be extrapolated when scanning tissue types with
shear wave velocities outside the shear wave velocity range of [1.6– 5.2]
m/s considered in these experiments.

SWE estimation bias was derived as the difference between the mean
of five independent SWE shear wave velocity measurements and the
nominal shear wave velocity, normalized by the nominal shear wave
velocity and expressed as a percentage.

SWE estimation precision was derived as the standard deviation of five

independent SWE shear wave velocity measurements normalized by the
mean of the five independent SWE measurements, and expressed as a
percentage.

SLV16-5

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
4.1 21.9 3.9 -7.0 2.2 -19.2 2.3 -24.1 1.9
6.5 7.6 0.6 -7.8 2.2 -8.7 1.3 -12.5 2.2
 SLV16-5

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
10.4 6.4 2.2 -8.6 1.8 -3.2 1.3 3.7 0.9
16.7 1.6 0.6 -8.6 1.8 -0.2 1.0 9.5 0.9

SL15-4

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
4.1 19.5 0.6 -5.3 0.5 -16.2 2.4 -24.5 2.3
6.5 7.6 0.6 -7.8 2.2 -9.7 0.3 -12.5 0.9
10.4 1.6 0.6 -9.4 0.5 -3.7 1.3 -0.9 1.5
16.7 1.6 0.6 -8.6 1.8 5.3 0.3 8.8 1.3

SL18-5

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
4.1 19.5 0.6 -5.3 0.5 -16.2 2.4 -24.5 2.3
6.5 7.6 0.6 -7.8 2.2 -9.7 0.3 -12.5 0.9
10.4 1.6 0.6 -9.4 0.5 -3.7 1.3 -0.9 1.5
16.7 1.6 0.6 -8.6 1.8 5.3 0.3 8.8 1.3

SL10-2

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
4.1 25.5 0.6 -4.5 1.7 -21.8 1.3 -22.2 1.0
6.5 13.5 0.6 -5.3 0.5 -10.2 1.1 -9.8 1.7
10.4 7.6 0.6 -5.3 0.5 -0.2 1.0 -0.1 2.0
16.7 1.6 0.6 -5.3 0.5 6.3 1.2 7.2 0.9
 SLH20-6

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
6.5 9.5 1 -1.8 1 -0.5 4 -11.2 7
10.4 5.2 1 -3.6 1 -1.6 4 0.35 7
16.7 0.8 1 -2.1 1 1.2 4 -1.44 7

SE12-3

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
6.5 26.7 1.9 -2.8 2.1 -13.7 1.4 -17.9 1.9
10.4 7.6 0.6 -6.1 1.8 -5.7 1.3 -0.9 0.8
16.7 1.6 0.6 -5.3 0.5 1.3 1.2 9.9 0.7

SEV12-3

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
6.5 33.1 3 -0.4 2 -22.2 2 -21.4 3
10.4 14.7 3 -1.8 2 2 2 -14 4
16.7 3.3 3 -4.3 2 -5.2 2 -5.8 2

SC6-1

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
6.5 43.4 0.6 2.1 1.6 -27.3 0.3 -39.6 1.3
10.4 21.9 2.4 -2.0 1.7 -14.2 1.2 -22.2 1.0
16.7 5.2 2.8 -7.0 2.2 -7.2 0.3 -11.0 3.4
 XC6-1

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
6.5 44 1 21 1 -28 1 -42 2
10.4 25 1 11 1 -23 1 -26 1
16.7 1 1 1 1 -10 1 -12 1

SMC12-3

Target Target Type I Target Type II Target Type III Target Type IV
Diameter Bias Precision Bias Precision Bias Precision Bias Precision
(mm) (%) (%) (%) (%) (%) (%) (%) (%)
6.5 26.7 1.9 -2.8 2.1 -13.7 1.4 -17.9 1.9
10.4 7.6 0.6 -6.1 1.8 -5.7 1.3 -0.9 0.8
16.7 1.6 0.6 -5.3 0.5 1.3 1.2 9.9 0.7

The SW generated using SWE mode is broadband. The frequency

bandwidth displayed on the screen corresponds to the minimal and
maximal frequencies of the SW pulse.

Note that the SW speed map may vary as a function of frequency of the
SW.

Transducer Mode TX/RX Depth (mm) Transverse

Frequencies resolution (mm)
SLV16-5 THI 20 1.3

3D transverse spatial resolution measurements for B-mode imaging for

the SLV16-5
 Transducer Mode TX/RX Depth (mm) Transverse
Frequencies resolution (mm)
SEV12-3 Fundamental 35 2

3D transverse spatial resolution measurements for B-mode imaging for

the SEV12-3

The volume measurement accuracy is defined at ±10% in the range of

0.01 to 2000cm3.
The Breast Imaging Reporting and Data System (BI-RADS®), developed
by the American College of Radiology, provides a standardized
classification for ultrasound studies of the breast.

It is composed of a series of descriptors, from which an assessment linked

to a category can be made by the physician.

BI-RADS® score Assessment

0 Assessment incomplete: Need additional Imaging Evaluation
1 Negative
2 Benign finding
3 Probably benign finding
4 Suspicious Malignancy
4a Low suspicion for malignancy
4b Moderate suspicion for malignancy
4c High suspicion for malignancy
5 Highly suggestive of malignancy
6 Known biopsy-proven malignancy

The American College of Radiology BI-RADS® assessment

categorization for ultrasound.

All BI-RADS criteria are displayed in English on the system, regardless

of the selected language.

You can easily perform BI-RADS® classification using the integrated

BI-RADS® Lexicon Classification form.

Up to twelve lesions may be classified in a single study.

1. In any mode, freeze the image.
2. Touch Add New Lesion.
A new lesion touch screen button will appear (e.g. Lesion A).
3. Using the trackball, position the lesion arrow marker to indicate
the lesion of interest on the main display.
4. Press Select to anchor the arrow marker.
The BI-RADS® menu will appear to the left of the image on the main
display.

5. Select the results in the BI-RADS® lexicon classification form using

the pointer and Select button
6. Click on the NEXT button in the menu or the Lesion Pagecontrol
on the touch screen to move to the next page of the BI-RADS® menu.
7. Press Save Image.
8. Touch Exit to close the BI-RADS® menu.
You must press Save Image after filling out the BI-RADS®
classification form and exiting the menu or the data will not be saved.

The BI-RADS® menu can be accessed as many times as needed to

complete the assessment for a particular lesion.

Measurements performed while in the BI-RADS® menu will be directly

associated with the Lesion selected (e.g. Lesion A) in the final report.

Measurements performed in the BI-RADS® menu will appear on page 4.

A single image is not able to document all of the features contained in

the BI-RADS® lexicon classification form.

To assist in documentation of lesion features, the integrated BI-RADS®

menu offer you the advantage of documenting one or more BI-RADS®
features with an associated image.

1. Define a new lesion and activate the BI-RADS® menu.

2. Using the pointer and Select button, results may be selected in the
BI-RADS® lexicon classification form.
3. Press Save Image.

Note that the image number appears to the right of the selected answer
on the BI-RADS® lexicon classification form.
4. You may exit BI-RADS® after each Save Image and return to the
same lesion to enter additional data associated with new images.
5. In the case that disparate results are entered for the same lesion,
reconciliation of results can be done in the Report (see Chapter 6,
Reports [331]).
The Thyroid Reporting and Data System (Thy-RADS™), developed by
SuperSonic Imagine, provides a set of clinical assessment criteria for
ultrasound studies of the thyroid.

You can easily perform Thy-RADS™ analysis using the integrated Thy-
RADS form.

Up to 8 nodules may be classified in a single study.

1. In the Thyroid application, freeze the image.

2. Touch Thy-RADS.
3. Touch Add new Nodule.
A new nodule touch screen button will appear (e.g. Nodule A).
4. Using the trackball, position the nodule arrow marker to indicate
the nodule of interest on the main display.
5. Press Select to anchor the arrow marker.
The Thy-RADS™ menu will appear to the left of the image on the
main display.
6. Select the results in the Thy-RADS™ lexicon classification form
using Pointer and Select button
7. Click on the NEXT button in the menu or the Nodule Page
control on the touch screen to move to the next page of the Thy-
RADS™ menu.
8. Press Save Image.
9. Touch Exit to close the Thy-RADS™ menu.

You must press Save Image after filling out the Thy-RADS™
classification form and exiting the menu or the data will not be saved.

The Thy-RADS™ menu can be accessed as many times as needed to

complete the assessment for a particular nodule.

Measurements performed while in the Thy-RADS™ menu will be

directly associated with the Nodule selected (e.g. Nodule A) in the final
report.

Measurements performed in the Thy-RADS™ menu will appear on page

4.
A single image is not able to document all of the features contained in
the Thy-RADS™ lexicon classification form.

To assist in documentation of lesion features, the integrated Thy-

RADS™ menu offer you the advantage of documenting one or more Thy-
RADS™ features with an associated image.

1. Define a new nodule and activate the Thy-RADS™ menu.

2. Using the Pointer and Select button, results may be selected in the
Thy-RADS™ lexicon classification form.
3. Press Save Image.

Note that the image number appears to the right of the selected answer
on the Thy-RADS™ lexicon classification form.
4. You may exit Thy-RADS™ after each Save Image and return to
the same nodule to enter additional data associated with new images.
5. In the case that disparate results are entered for the same lesion,
reconciliation of results can be done in the Report (see Chapter 6,
Reports [331]).
The Aixplorer® ultrasound system allows you to manage all the
informations collected during the study and generate a report.

The Report features is composed of two different views:

• the Report Builder, which allows you to create and customize the report
• the Report Preview, which allows you to view the report as it will be
printed or generated as pdf file

Press Report to access the report feature.

The Report Builder is displayed.

The Report Builder allows you to choose which elements of the

examination are to be included in the final report.

The Report Builder is composed of five tabs:

• Patient Info, where you can retrieve/edit patient informations

• Images, where the images acquired during the exam, associated
measurements, BI-RADS®/Thy-RADS™ and comments are stored
• Measurements, where you can view all the labeled measurements
and calculations of the exam
• Worksheet, where you can visualize the constitutive elements of
the final report, modify patient information and patient data entry, use
 diagram or anatomical data to locate or precise the performed labeled
measurements
• Conclusion, where you can add your conclusion of the exam

The Patient Info tab displays the patient information, which is populated
with the same information as the Patient Data screen.

As with the Patient Data screen, the Patient Information tab displays
general information, as well as further information specific to each
clinical application.

You can edit all the information from the Patient Information tab.

You can enter information in more than one tab if multiple applications
have been used.

If you press Patient to return to Patient Data entry, all your edits from
the Report Builder will be saved and updated.

You can choose what information to show in the final report by using the
Show/Hide Info icons:

•
Selecting the Show Info icon will designate that information
to appear in the final report
•
Selecting the Hide Info icon will designate that information to
not appear in the final report

Information which is hidden in the final report always remains part of the
study as stored on the ultrasound system.
The Images tab in the Report Builder displays all of the images
acquired in the exam.

The images are organized into clinical application tabs.

Vertical tabs are dedicated to images associated with BI-RADS® and

Thy-RADS™ table.

You can choose which images to show in the final report by selecting
them.

Click on the icon above the image to have it included in or excluded from
the report.

Images which are not shown in the final report always remain part of the
study as stored on the ultrasound system.

Next to each image is a text box designated for comments.

Select the white text box next to the image for which you want to add
comments.
Enter comments using the Keyboard.

Measurements associated with each image are shown in the area to the
right.

You can choose to show/hide the measurements in the final report by

using the Show/Hide Info icons:

• Selecting the Show Info icon will designate the measurements to

appear in the final report
• Selecting the Hide Info icon will designate the measurements to not
appear in the final report

If no measurements were performed on the set of selected images, the

region may appear empty.
For OB images on which labeled measurements were performed, click
on GRAPH to display the growth chart corresponding to the selected
reference table.
The Measurement tab allows you to view the labeled measurement
results and associated calculations performed during the exam.

In this tab, you can show or hide each label measurement result in the
final report.

1. Select the desired application sub-tab (available only for applications

in which label measurements were performed during the exam).

Note that even if the image on which the labeled measurements were
taken was deleted, the corresponding labeled measurements are kept
in the database.
2. You can show or hide each labeled measurement result individually
with the checkbox next to each measurement.

Hidden labeled measurement results will not appear in the final report.

For multiple instances of the same measurement, you can select which
instance will be displayed in the report.

Click on the + to display all the sub-results of the performed

measurements.
The Worksheet tab is divided in sub-tabs corresponding to the
applications and presets used to perform the exam.

For all applications, the Worksheet displays the informations contained

in the Patient Data Entry and the Patient Information tab. It includes
diagrams and clinical informations for Breast, Genito Urinary and
Thyroid, and Area of pain for MSK. The measurements are also displayed
and BI-RADS or THY-RADS if they have been performed.

For the Vascular and OB-GYN applications, the Worksheet tab displays
the labeled measurements performed in an interactive report or on
Anatomical Data.

The OB-GYN Worksheet displays Exam information, Fetus condition

information and the labeled measurements performed in the OB-GYN
application on an interactive report.

OB Estimated Fetal Weight percentile and Growth Percentile data

are used to interpret and manage fetal growth. EFW percentile data
is presented along with the calculated EFW as determined by using
data from peer-reviewed publications and the gestational age. Growth
percentile data is presented along with fetal measurements as determined
by using data from peer-reviewed publications and the gestational age.
The display of this data allows the clinician to assess fetal growth and
manage the pregnancy.

Be careful to confirm the patient name and ID before starting an

examination for a new patient.
Check the date format before entering date of birth, Last Menstrual Period
(LMP), Estimated Date of Delivery (EDD), Date Of Conception (DOC)
and Ovulation Date. Incorrect entry of these parameters will result in an
incorrect Gestational Age (GA).

Enter the EDD and GA in the patient's medical record for backup.

Check the "Activate OB calcs" button on the Patient Data Entry page
(PDE) in order to perform obstetric calculations.

It is necessary to specify which OB author is to be used for each particular

measurement to calculate the GA and get an Estimated Fetal Weight
(EFW).

A diagnosis can not be only based on one measurement or data. Be careful

to always consider the overall clinical evaluation of the patient, including
the medical record.

Depending on fetal position, some measurements may be incorrect. Be

careful to always consider the overall clinical evaluation of the patient,
including the medical record.

The system provides fetal measurements for up to five fetuses. Be careful

not to confuse the fetuses during measurements.

For each measurement performed, you can select either the first,
last, average, minimum, maximum or specifically one of the five
measurements that are allowed to be displayed, using the selector feature
in the Measurements tab of the Report.

Be careful when deleting measurements, as this will affect the selector

result.

Deviations from the normal values of measurements must be judged

based on the graphs and literature.

1. Perform obstetrical labeled measurements

2. The Measurements appear in the report together with the indication
of the percentile and Z-score (based on the selected reference table,
author and date)
The OB trending allows you to assess the evolution of the fetus as a
function of time, for exams that are stored on the system.

Make sure the "Activate OB calcs" option is checked in the Patient Data
Entry in order to use percentiles and Z-scores.

1. Enter patient data in the Patient form

Make sure at least the Patient Fist Name, Last Name and Date of
Birth match the previous exams so that the system recognize the same
patient.
2. At the bottom of the Patient form, a window displays the previous
exams for the same patients
3. Select the previous data for the current patient
4. The previous data for the current patient is imported in the system
5. Start the exam and perform the current measurements
6. Save images as needed
7. Press Report
8. For each measurement, the data of the previous exam(s) and the
current exam are displayed on a same graph

The Vascular Worksheet displays the labeled measurements

performed in the vascular application and presets on Anatomical Data.

You can add some information to each worksheet such as scan quality
or clinical findings.

1. Click on the text field next to the corresponding label

The keyboard automatically opens up

2. Type text to enter additional information
You can add labeled measurement results, annotations, plaque shapes
and arrows to each worksheet.

1. Press Toolbox on the touch screen

A window opens up on the main display
2. Click on the information you want to add.

1. Press Annotate in the tool box

An annotation box is displayed on the worksheet.

2. Use the keyboard to edit it
3. Click on the annotation and use the Trackball to move the
annotation box if needed.
4. Double-click on the annotation box to rotate it if needed

Arrows are displayed around the annotation box.

5. Use the TouchRing to rotate the annotation box
6. Press Select to validate.

1. Click on the plaque shape you want to add in the tool box
2. Click on the plaque shape and use the Trackball to move it if needed
3. Press Select to validate.
4. Double-click on the plaque shape to resize or rotate it if needed
Arrows are displayed around the plaque shape.
5. Use the TouchRing to rotate the plaque shape
6. Press Select to validate.

1. Click on an element on the worksheet to link it to the Anatomical Data

with an arrow
2. Press Add arrow in the tool box
3. Click on the added arrow
4. Use the Trackball to move the tip of the arrow to the selected
location on the Anatomical Data
5. Press Select to validate.

1. Click on the element you want to remove

2. Press Toolbox on the touch screen
3. Click on Remove on the tool box.

The Carotid worksheet provides the SRU1 and NASCET2 criteria at the
bottom of the worksheet.

Click on the elements that apply to the findings to add them to the
worksheet.

The Liver Worksheet provides you with a summary table of all Q-

Box Liver labeled measurements performed on the liver, with detailed
information for each Q-Box measurement.

1
Society of Radiologists in Ultrasound
2
North American Symptomatic Carotid Endarterectomy Trial
In order to obtain this Q-Box Liver Worksheet:

1. After a SWE acquisition, press Meas. on the control panel

2. Select the Liver SWE measurement package on the touch screen
3. The list of available Q-Box Liver SWE labeled measurements appear
on the right side of the screen
4. Use any of the labeled measurements
5. Press Save Image
6. Press Report
7. Click on the Worksheet tab

The Liver Worksheet also provides you with the capability to select a
publication to visualize SWE statistics for reference.

Those measurements are not from the exam. They are extracted from the
selected publication and are shown for reference only.

1. Click on the arrow to visualize the list of available publications

2. Click on the publication of interest
3. The related table is displayed below and will appear in the final report.
The Conclusion tab in the Report Builder is a free-form text entry
screen.

Enter any final information or conclusions about the exam here.

You can choose to show the conclusion in the final report by using the
Show/Hide Info icons:

• Selecting the Show Info icon will designate that conclusion to

appear in the final report
• Selecting the Hide Info icon will designate that conclusion to not
appear in the final report
Press Generate Report to generate the desired report in .pdf.

Use the pointer and the TouchRing™ to navigate between pages .

If you are satisfied with the report preview, you can print a hard copy
of the report.
Touch the Print Report button on the touch screen to send the report
to a configured printer.
If a hard-copy printer is not available, the Report will not be sent.

An option allows you to export the report as DICOM images. This can
be used in particular when your PACS does not support viewing of pdf.

1. Press System Config.

2. Open the Administration tab
3. Open the Devices sub-tab
4. Add or edit an existing DICOM store
5. In the Advanced Options tab, enable the Report Export
6. In the drop-down list, select the Ultrasound image option
7. Click on OK to validate
You can capture and save a single image, or a clip sequence.

Clips can be captured retrospectively or prospectively.

The captured frame or clip sequence is saved in the patient study, and a
thumbnail is available in the live imaging display and the Review display.

During capture, an icon is displayed at the bottom of the display.

When the capture is complete, a thumbnail of the image is displayed.

1. Press Freeze
2. Press Save Image
The image appears in the thumbnail strip on the right side of the
screen.

The Aixplorer® allows you to capture retrospective clips.

1. Press Freeze.
2. Press Save Clip when frozen to save the images in the clip sequence
just acquired.
When the capture is complete an audible beep will confirm that the
clip was saved.
The clip appears in the thumbnail strip on the right side of the screen.

Do not press Review until you hear the beep.

The Aixplorer® allows you to capture prospective clips in live imaging.

1. Press Save Clip during live imaging initiates a prospective clip

capture.

Prospective clip capture will automatically complete after the duration

specified in the System Configuration.

When capture is complete an audible beep will confirm that the clip
was saved.
2. Press Save Clip again or Freeze to stop the capture.

Do not change the scaling of the image during the prospective clip
capture, especially the following settings:
• Digital Zoom
• Display Format
• Dual Top/Bottom
• Wide Image mode

On a DICOM review workstation, changing the scaling of the image

may result on possible inaccurate measurements performed afterwards
on DICOM prospective clips.
3. The clip appears in the thumbnail strip on the right side of the screen.

Do not press Review until you hear the beep.

Pressing Save Image while acquiring a prospective clip does not stop
the prospective clip acquisition.

See Chapter 8, Customizing the System [377].

To set up the duration of a prospective clip capture:

Choose the desired duration of prospective clip captures from the

available options:

2 sec, 5 sec, 10 sec, 15 sec, 30 sec, 1, 2, 3, 4, 5 min

Trim allows you to discard frames from the start or end of a prospective
or retrospective clip.

1. Press Trim on the touch screen.

The trackball is arbitrated to Trim End.

2. Move the Trackball towards the beginning of the clip to discard the
required frames from the end of the clip

The trackball is arbitrated to Trim Start

3. Move the Trackball towards the end of the clip to discard the
required frames from the start of the clip
4. Turn Trim off to cut the trimmed frames out.
5. Press Save Clip to save a new clip without the trimmed out frames.

If needed, press Trim Reset to return the Trim Start and Trim End
frames to the start and end of the acquisition, respectively.
During or after an exam, use Review to examine and compare images
acquired in the exam. Multiple exams for one patient may be reviewed.
In Review, you can look at the images or clip sequences that have been
stored.

Stored images can be viewed, sent, printed, searched and backed up.

Image analysis can also be performed in Review.

Images that are stored on the ultrasound system hard-drive can be sent to
a DVD, USB media, or on DICOM-compatible devices on a network.

In Review mode, a variety of tasks may be completed, including

performing measurements and playing clip sequences.

In Review mode, measurements on images in the current exam can be

performed.

An image must first be displayed in full size.

Measurements made in Review on the current exam can be saved in the

report.

Measurements made in Review on prior exams cannot be saved.

To display the measurement controls on the Review Exam touch screen,

press Meas. Clear all measurements from an image by touching Erase
all on the Review Exam touch screen.
Press Review to enter Review mode.
The display that appears depends on whether an exam is active on the
system.
If an exam is in progress, pressing Review opens the Review Exam
display.
If there is not an exam currently in progress when Review is selected,
the Patient Directory will be displayed.

If an automatic deletion is set up in the system configuration, you can

lock some exams to prevent them from being automatically deleted.

To return to live imaging, press Review again.

The Patient Directory is a list of exams that are stored on the selected
disk drive.

The Patient Directory includes options that allow the user to sort, view,
and transfer exams.

If no current exam is in progress when Review is started, Patient

Directory is displayed.

In the Patient Directory, exams are organized in a table containing several

columns.

Each column header describes the contents of that column using either
text or an icon.

Click on a column header to sort the list by this column.

The Exam Status column displays the number of times an exam has been
continued (if any).
If an exam is currently in progress, pressing Review opens the Review
Exam display with images loaded from the current exam.
If no exam is in progress, pressing Review opens the Patient Directory
display, which lists previous exams.
To review previous exams, first select an exam in the Patient Directory.
Multiple exams of the same patient may be selected and loaded for
review.
To select all exams click Select All
Click Display Selected to load the selected exams for viewing

The Review Exam display is used for viewing and comparing exam
images in the selected layout.

Thumbnail images for the current or selected exam appear on the right
side of the display.

The touch screen display provides access to other review functions.

You can print images from the image review.

1. Click on each image you want to print in the desired order

2. Click on Print

In Review small images, called thumbnails, can be viewed.

Thumbnails are located on the right side of the Review Exam display.
Touch Previous thumbnail and Next thumbnail on the Touch
Screen to navigate through thumbnails of images. This will display the
previous or the next image in full screen review mode.
Putting the pointer over a thumbnail makes it expand to a larger
dimension.
Clicking on the thumbnail image will make it expand to its real size.
Clicking on the garbage icon over a thumbnail deletes that image.

In Review, two images from different exams of the same patient may be
compared.

1. Select the two exams in the Patient Directory

2. Click Display Selected.
3. Click on the patient name on the left side
Thumbnails of the two exams will appear.
4. Select the two images to be reviewed and touch Compare.
The two images appear side by side. They can be reviewed at the
same time and measurements and annotations can be performed.
For environmental purposes, print only when necessary.

Use digital devices for storage.

You can print to an integrated printer (option) or to printers on a network.

The system allows you to configure print controls and printers.

You can print live or frozen images during an exam.

1. Acquire the desired image

2. Press Save Image on the control panel

Images will be printed according to the printers that are associated and
configured (see Chapter 8, Customizing the System [377]).

You can configure the S key to both save and print in the system
configuration.

From the review exam display, you can print stored single and multi
frame images, one at a time, from 1 to 15 images per page.

1. Press Review
2. Select an exam
3. Press Display Selected
4. In the Review Exam display, select images you want to print
 The print order will follow the selection order.
Click on the images you want to print in the order you want them
printed

5. Select which printer to use with the appropriate knob on the touch
screen
6. Select the desired layout with the next knob
7. Touch Print.

In order to configure the network, you must connect the network cable at
the back of Aixplorer® to a local area network first.

In the Review Exam display, you can send single-frame images from the
system to DICOM-printers.

1. Press Review
2. Select an exam
3. Touch Display Selected
4. In the Review Exam display, select one or more images
5. Touch Export to DICOM
6. In the Send To dialog box, select a DICOM printer
7. Click OK to print the selected images

To configure your DICOM Printer, seethe section called

“Devices” [392]
You can print images from the image review.

1. Click on each image you want to print in the desired order

2. Click on Print
In Review, specific images can be pushed to DICOM printers (optional)
and servers on a network, to a CD/DVD, or to a USB device.

The format can be chosen before sending images or clips.

To send an enlarged image to a printer or USB device, see Chapter 8,

Customizing the System [377].

In the Review Exam display, images can be pushed from the system to
DICOM compatible printers and servers on a network. Also, images can
be sent to the DVD drive on the system.

1. In the Review Exam display, select one or more images

2. Touch Export to DICOM or Export as JPEG/H264
3. In the Send To dialog box, select a destination
In the Send To dialog box, the total space, as well as the free space
available on the device are displayed for a USB device.
 Check the Image de-identification checkbox in the Send To dialog
box to send the image(s) with identification fields cleared from the
database and the image.

4. Click OK to send the selected images

The exams will be exported into folders organized by patient name.

To eject a CD/DVD:

1. Click on the appropriate icon (CD or DVD)

2. Follow the instructions that appear on the screen

If you need to manually eject the CD/DVD, insert a paper clip in the hole
located right next to the CD/DVD player.

To eject a USB device:

1.
Wait until the symbol (exporting data to USB) is replaced by
in the notification icons area
2. Remove the USB device

Ensure that both the user and the patient do not place hands or any other
body parts on or in the USB port

At anytime, you can check the export status, by clicking on the

appropriate notification icon on the left side of the screen.

For information on icons, refer to the section called “Notification

Icons” [167].
With the Aixplorer®, you have the capability to manage your own
clinical trials by exporting data in 2 different formats.

The User’s Club format allows you to export anonymized images and
measurements together in order to post them in your clinical study (User’s
Club tool).

The Excel format allows you to export un-anonymized measurements

in order to utilize the data in a spreadsheet.

The Excel file will contain all the measurements that have been
performed during the exams.

For several measures realized with the same measurement tool, the
average and the median values will be automatically calculated and
displayed.

To export data:

1. Plug a USB device

2. Press Review to access the Patient Directory
3. Select the exam(s) you want to export
4. Touch Clinical Data Export on the touch screen
5. Select an export format
6. Select your device
7. Press Start
The systems exports your data in the selected format on your USB device.

For more information on the User’s Club: www.aixplorerclub.com

[http://www.aixplorerclub.com]
The DICOM Structured Report is a document architecture designed for
encoding and exchanging clinical information and findings in the context
of Radiology imaging.The DICOM SR is supported for OB-GYN and
Vascular clinical applications on the Aixplorer®.

For the OB-GYN application it uses the NEMA’s Template ID 5000 OB-
GYN Ultrasound Procedure Report.

For the Vascular application it uses the NEMA's Template ID 5100

Vascular Ultrasound Procedure Report.

One image/clip acquired within the OB-GYN or Vascular clinical

application will trigger the creation of a DICOM SR report.

By default, the Aixplorer® will not generate DICOM structured Reports

at the end of the exam.

In order to activate the DICOM SR feature:

1. Press System Config.

2. Open the Device Settings tab
3. Open the System DICOM options sub-tab
4. Check the Generate Structured Reports checkbox

1. In the System Configuration, click on the Devices sub-tab of the

Administration tab
2. Click on Edit Selected
3. Click on the Advanced options of your DICOM store device
4. Select the Enable Export of SR checkbox of your choice

1. In the System Configuration, click on the Devices sub-tab of the

Administration tab
2. Click on the DICOM Removeable media
3. Click on Edit Selected
4. Select the Enable Export of SR checkbox of your choice

When the export of SR is enabled for one or several DICOM Store

devices, a DICOM SR file will be sent automatically at the end of the
exam to this/these configured DICOM Store devices.

During a live examination, and if the export of SR is enabled for one

or several DICOM Store devices, you may send on demand updated
versions of the DICOM SR report to this/these configured DICOM Store
devices.

1. Press Review or Report on the control panel

2. Press Send SR on the touch screen

1. When an exam is ended, click on Review

2. Select the exam for which you want to send the SR, and press
Display Selected
3. In the Review Image List, click on the DICOM SR icon
4. Press Export to DICOM on the touch screen
5. Select the device and click on OK

You can configure all your DICOM exportation settings. See the section
called “Devices” [392]
The Patient Directory allows you to delete exams from the system.

If an exam is accidentally deleted, and the exam has been archived to a

DVD, the archived exam can be re-loaded.

In the Review Exam display, stored images from an exam can be deleted.

This is only possible, however, when Send Images/Clips in Print/

Network setups is set to At End of Exam.

When an image is deleted, it remains temporarily in the Review Exam

display with an X marked through it.

1. Select the images to be deleted

2. Touch Delete Selected on the touch screen
3. Click on Delete in the confirmation box

1. In the Patient Directory, select one or more exams. To select all exams,
touch Select All
2. Click Delete Selected
3. Click on Delete in the confirmation box
Prior to, or during an exam, a query may be performed to find patient
exams located on a remote workstation, external USB media, or CD/
DVD.

Qualified images can be extracted from these exams and retrieved by the
Aixplorer®.

Once retrieved, the images can be browsed, and an appropriate image can
be selected for Review.

A retrieved image may also be displayed in a side-by-side manner next

to a live image in the current exam.

Important: The Query and Retrieve feature requires the Aixplorer®

system is connected to a network hosting a DICOM compliant image
archive workstation.

If there is no current exam, a query may be performed for any number of

studies from the workstation.

These studies can be retrieved by the Aixplorer® in preparation for

upcoming new exams.

If there is a current exam in progress, the query will attempt to find prior
exams of the current patient (if the automatic Q/R was configured).

Valid types to be retrieved are as follows:

• DICOM Ultrasound images

• DICOM Ultrasound images extracted from ultrasound clips
• DICOM images from a variety of modalities: Computed Radiography
(CR), Computed Tomography (CT), Magnetic Resonance (MR),
Nuclear Medicine (NM), Secondary Capture (SC), X-Ray
Angiographic (XA), Radio Fluoroscopy (RF), Mammography (MG)
Please consult your workstation user's manual, the workstation DICOM
conformance statement or your workstation/PACS administrator for
assistance with secondary captures.

Any retrieved exam can be displayed along with a live image in a current
exam.

However, if there are mismatches in patient identification characteristics

between the current exam and the retrieved exam, a warning will be
displayed.

For more information on DICOM, have a look at our DICOM

Conformance Statement and IHE Statement on our website:

http://www.supersonicimagine.com/dicom

http://www.supersonicimagine.com/ihe

Refer to the section called “Notification Icons” [167] for Query-

Retrieve notification icon.

Displaying a patient with a different patient identification to that in the

current exam must be done with caution.

This feature is provided in the event of a patient name change, or hospital

ID change.

The operator assumes all risk when performing query retrieve operations
on Aixplorer®.

Retrieved images can be very helpful when used for reference

comparison to the same feature of interest in the live ultrasound image.

Use caution when reviewing retrieved images on Aixplorer®, as they

may be compressed or displayed at a lower level of image quality than
observed on the PACS workstation.
Images retrieved and displayed on the Aixplorer® are not intended to be
used for sole diagnosis.

You may also push studies from your PACS workstation to your
Aixplorer® system.
If configured, the system can perform an automatic query of various
types of exams for a given patient.
When the exam is started for a given patient, press Save Image to
save a first image for this patient.
The system automatically performs a query on the selected patient.
Press the Q/R button on the control panel to view the queried exams.
See Chapter 8, Customizing the System [377] for more details.

Press the Q/R button to initiate an exam query.

The query dialog box will appear.

Click on the tab on which you want to query:

• Patient Name (Name)

• Patient ID (ID)
• Accession Number (Accession)

Use the appropriate filters to manage the query then press Query.
A list of matching exams will be displayed.

1. Press the Q/R button to initiate an exam query.

2. Click on the Import from Media button
3. A browser window appears
4. Select the location of data to be imported

You may select a folder containing DICOM data, a specific DICOM

file or a DICOMDIR file to import.

5. Click on OK to confirm
If configured, the system performs an automatic retrieve of the last
acquired series for each of the selected modalities.

After a query is performed, the system will return a list of matching

exams.

Exams are displayed in a table with the following attributes:

• Patient Name
• Patient ID
• Date of Birth
• Modality
• Number of Images
• Date/Time

To see more information about a particular study, place the pointer over
a study and a tool-tip box will appear with additional information.

Use Select to choose exams from the query list.

A checkmark will appear next to selected exams.

If you would like to query again, choose the New Query button at the
bottom of the menu.

Press the Retrieve button to retrieve the selected exams.

These exams will be transferred to the Aixplorer® system.

Exams containing large numbers of images or long ultrasound loops may

take a long time. It is best to perform a query and retrieve operation prior
to the start of an exam.

When the selected exams have been retrieved, RETRIEVED appears

next to each line.

You may send DICOM data from a PACS or a DICOM modality to the
Aixplorer®.

The Q/R notification icon will be displayed to indicate data have been
pushed on the Aixplorer®

Click on the notification icon or press the Q/R button on the control panel
to see the received exams.

Double-press Select on an image to display it in full screen.

The retrieve image will be displayed in the right pane.

You can navigate through the retrieved images by using the buttons at
the top of the pane:

• Previous will go to the previous image

• Next will advance to the next image.

You can also use the TouchRing to navigate through the retrieved
images.

The full screen icon will enlarge the retrieved image to the side of the
full screen, temporarily hiding the live or frozen image from the current
exam.

All system controls will operate as usual on the current live or frozen
image.

System controls will not effect the retrieved image.

To quit viewing retrieved images, press the Q/R button on the control
panel.

Make sure all the images you need are saved.

After the exam is complete, end the exam as follows:
Press End Exam on the control panel.

You have the possibility to continue an exam that was ended.

1. Press End Exam to make sure there is no exam in progress

2. Press Review
3. From the Patient Directory, select the exam you want to continue
4. Press Continue on the touch screen
The system has re-opened the closed exam and is in B-mode. The
thumbnails of the previous session(s) of the same exam are displayed
on the right side.

The time limit to re-open an exam may be configured in the System/

Display tab of the System Configuration.

Press End Exam to close the exam.

Your system can be customized in several ways to make it more useful
for your needs.
Presets designed specifically for the exams you perform can be created,
and system settings can be changed to optimize your workflow.
System configuration allows you to configure the entire system, its
applications, and additional options.

To access system configuration, touch Syst.Config. on the touch

screen while in any active imaging mode.
Any changes made to the system configuration are automatically saved,
unless otherwise specified.
Touch Exit on the touch screen to exit system configuration.

The system configuration is divided in 7 tabs:

• System/Display
• Device Settings
• Administration
• Presets
• Measurements
• Research (optional)
• System Diagnostics

Refer to each section for detailed information.

The System/Display tab is divided in 3 tabs:

• System
• Regional parameters
• Exam

In this section, you can :

• Enter the institution name and address

• Choose the patient name order
• Display/not display the sonographer's name in the image header
• Select the Thermal Index (TI) to display on the imaging screen
• Upload from a USB media and insert a logo which will be displayed
on the report header or choose the default logo to be displayed on the
report header
 To change the logo to be displayed in the printed report:
1. Make sure the «Display logo in report» checkbox is checked
2. Do one of the following:
• Select «Use the default logo» if you want to use the Aixplorer® logo
• Select «Use the custom logo» if you want to use your own logo
• Then plug a USB device with the logo you want to use into the
system
• Then click on the logo to browse for your own logo

• Enable/disable the screen saver, and configure it

• Calibrate the touch screen

To calibrate the touch screen:

1. Press “touch screen calibration - calibrate now”
2. Press each calibration point that appears on the touch screen until
it disappears

• Set the illumination intensity of the control panel

• Activate a sound while for the following functions:
• After each Save Image/Clip
• For the touch screen Keyboard
• When the system boots up
• Set the function assigned to the TouchRing™ while in B mode
• Assign a function to the programmable key (’S’ Button on the control
panel)
• Assign a function to each side of the foot switch (available as an option)
This section refers to the regional settings and language configuration of
the system.

In this section, you can:

• change the system interface language

• set the keyboard language
• change the date and time format
• adjust the system’s date and time.

To set date and time:

1. Select a time zone from the drop down list

2. Do one of the following:
• Enter a Network Time Protocol (NTP) server (by default, you can
enter ntp.ubuntu.com), and click on “Synchronize with NTP” in the
Automatic setting box
• Pick a date and set the time in the Manual setting box, then click
on “Apply manual changes”
In this section, you can:

• Customize your scanning preferences:

• Adjust some preferences for the Color and PW modes
• Steering Angle Step defines the incremental step for the steering
of the color box
• PW Fine Angle Step defines the incremental step for the Fine
Angle Correction in PW
• Choose to automatically invert the color flow map with the
steering direction
• Customize the knob rotation direction for the steering angle, focal
zone and depth
• Configure the duration of the Manual TGC auto display on the
touchscreen after activating the Auto TGC. By default, the auto
display is off.
• Customize some Freeze options:
• Set time for the live mode’s auto freeze
• Choose the action to perform after freezing the image:
• only freeze
• display body markers
• display annotations
• display measurements
• Configure the limit duration of the prospective clip capture, for
contrast mode and for the other modes.
• Customize the way the measurements are displayed
• Customize the Continue exam mode (see the section called
“Continuing an Exam” [376])
• Choose to have a warning popup when saving an image for an
anonymous patient
• Choose if you want the Focal Zone Management to be manual or
automatic.
• Choose to activate or deactivate the Adaptive TGC mode
• Choose to enable looping in clips
• Customize the rotation direction for the Depth and Focus knobs
The Device Settings tab is divided in 3 tabs:

• Media settings
• Media association
• System DICOM options

In this section, you can configure all the media already added and
associated.

Click on Media Settings to see the list of active devices.

For DICOM Stores devices, a menu allows you to define the method to
send the data :

• Send after acquisition

• Send on end exam
• Send manually

You can also define printing parameters for DICOM printers, Reports
Printers, and Image printers, as well as JPEG/AVI Removable
Media Export parameters (Compression level, export LUTs (Look Up
Tables),...)

A dedicated "WorkList Settings" menu is available for the DICOM

Modality Worklist servers. You can set the way of querying the Modality
Worklist SCP:

• By Modality
• By AE Title
• By Date

and set the maximum reponses you want to receive from the Modality
Worklist server(s) when this device is available and configured in the
Administration part.
In this section, you can associate any media added in the tab
Administration.

This section allows you to add an active device to the working

configuration.

You can choose from the device list which has been pre-configured in
the Administration part of the System Configuration.

To associate a device:

1. Navigate to the bottom of the screen where you will find the “available
devices” list.
2. Click on the type of device, a list will be displayed.
3. Select the specific device you would like to associate.
4. Click on “associate”. The device will appear at the top of the screen
in the “associated devices” list.

You can associate one or several DICOM WorkList Servers, to be able

to query several WorkList servers at the same time.
You can remove a device from the associate list by selecting it and click
on the ‘unlink’ button.
In this section, you can adjust the DICOM parameters.

In the Main DICOM Options part, you can enter all the DICOM
parameters that identify the ultrasound system on a DICOM network.

You can also configure the system so that it will not communicate with
unknown hosts, and choose if you want the system to generate Structured
Reports or not.

In the Modality Worklist Options part, you can configure the way the
Modality Worklist is refreshed with the “polling option”:

• Choose “Manual” to refresh the Worklist only manually

• Choose “Automatic” to set up a time to automatically refresh the
Worklist
• Choose “Smart” to automatically refresh the Worklist each time you
press End Exam on the control panel.

You can also choose to use the Off-line mode, so that when the network
is disconnected, you still have access to the last refresh of the Worklist,
by default this mode is on.

You can also set your workflow preference for the end of the exam:

• Display the Modality Worklist

• Display the Patient Data Entry
Finally, you can select the way of querying the Worklist when pressing
End Exam in the "Query preference" drop-down list:

• Enable the Broad Query option

• Enable the Patient Query option
• Maintain the last selected option

In the Store SCP Options part, you can choose the deletion method and
if you want to retrieve the multiframe images.

In the Q/R SCU options part, you can configure the Query/Retrieve
parameters.

You can also configure the automatic query and automatic retrieve by
selecting the queried fields and modalities.
The Administration tab is divided in 5 tabs:

• Devices
• Network configuration
• Network tools
• Disk maintenance
• Medical Staff

Image compression may result in the loss of image information.

While low levels of image compression are generally acceptable in

medical imaging, using high levels of lossy compression may result in
image degradation.

It is the responsibility of the user to set and maintain the degree of image
compression which is diagnostically acceptable in exported images.

If you are uncertain as to what degree of compression is acceptable,

consult the literature, or use the system default compression.
Devices refers to the initial devices configuration.

A list of device types that can be added is displayed on the left side of the
screen, according to the options purchased:

• Add DICOM Store1

• Add DICOM Modality Worklist1
• Add DICOM Modality Performed Procedure Step (MPPS)1
• Add DICOM Printer1
• Add DICOM Query/Retrieve1
• Add image Printer

Use the recommended driver for the selected printer.

Click on the appropriate button on the left to add a device and configure
its parameters.

Click on a device in the middle of the screen to view and configure its
parameters.

1
Available only if the DICOM option has been purchased
When adding any DICOM device using the DICOM network connection,
the following Basic Options must be fulfilled :

• Station Name, IP Address, Port Number and Application Entity Title

(AET)

To edit an existing DICOM Store device, select it on the devices list then
click on Edit Selected.

On the Basic Options tab you can configure your DICOM device.

On the Advanced Options tab you can manage your exportation settings.

1. In the General Export Settings you can choose :

• if you want the patient's name to be shown or hidden on the exported
files
• the types of data you want to enable for exportation (single or multi
frames, PDF reports, DICOM SR)
 • the Look Up Table (LUT) you want to apply on the exported
images/video clips
• the type of character encoding
2. In the Pictures and Clips Settings you can define :
• the transfer syntax with pre-set image compressions
• the compression quality of the images
• the support of Color or Monochrome modes at the exportation
• the level of image size reduction
• the duration of the retrospective clip

You can configure all these options the same way for any DICOM
Removable Media.

In the Commit Option tab you can choose to ask for a commitment from
the storage service.

When all the desired options have been set, press OK to save the changes.

The nine available LUTs are pre-set filters acting on specific Brightness
and Contrast settings of the exported images and/or clips.

They are used to make the images appear on a DICOM Review

workstation Monitor as they appear on the Aixplorer® Monitor.

Applying a too bright or too contrasted LUT can have outcomes on the
quality of the images informations.

It is the user's responsibility to carefully adjust all imaging parameters

to avoid image saturation and obtain optimal quantitative time-intensity
data.
To edit an existing DICOM Printer, select it on the devices list then click
on Edit Selected.

On the Basic Options tab you can configure your DICOM Printer.

On the Advanced Options tab you can manage your printing settings :

• adjust the brightness and contrast

• choose the media type you will print on
• define the priority, the destination and the magnification type
• define the color and density of the borders and empty spaces of the
document
• precise the session label, the configuration information and the
smoothing type
• define the reduction percentage of document

When all the desired options have been set, press OK to save the changes.
This section concerns the network configuration of Aixplorer®. The
system shall be connected to the network through an ethernet cable.

The system can be configured with a specific IP address and network

setting, with a cable connected or can be automatically configured in
DHCP mode.

For any network configuration, the MAC address is displayed and once
connected, the network status is also displayed (especially important for
the DHCP configuration).

The Aixplorer® network connection is only opened for DICOM and

network printer service.

The system does not require a minimum data rate to perform on the
network.

In case of network connection failure, the data can be exported using a

DICOM removable media or the embedded printer.

Integrating the Aixplorer® to a network with other connected devices

may result in unpredictable risks. Nevertheless, the restricted access to
the system prevents the user from using an antivirus solution.

The Aixplorer® may be connected to the hospital WIFI network.

Check the section called “Notification Icons” [167] for a desciption of

WIFI icons.
The WIFI connection is not guaranteed in all geographies, and depends
on the characteristics of the network.

The WIFI dongle is the Linksys AE3000, FCC/IC certified (FCC ID:
Q87-AE3000).

Tests performed by external accredited lab are according to the following

standards:

• RF measurements according to EN 300 328: WLAN 2.4GHz, IEEE

Std. 802.11b/g/n
• MC measurements according to FCC part 15B
• European directive RED

Operating frequency range: 2412 ~ 2462MHz 5745 ~ 5825MHz (not

active)

The Aixplorer® may be connected to the hospital WIFI network.

1. Plug the WIFI dongle on the Aixplorer®

Select a device whose temperature range is compatible with

Aixplorer®'s use.
2. Open the WIFI Configuration sub-tab of the Administration tab
3. Enter your Admin password and click on Unlock
4. Select the appropriate network and security

Only encrypted wireless networks are available (WPA with password)

You may connect to a hidden network. It will appear as Hidden

Network. After selecting the hidden network, you will have to enter
the SSID.

5. Enter the network password and click on Add.

Make sure to correctly configure the WIFI network before sending data.

Make sure the WIFI dongle is correctly plugged

Make sure to connect your Aixplorer® to a secured wireless network

The wired connection has the priority over the wireless connection. It
is therefore not possible to connect to a WIFI network if an Ethernet
connection is detected.

If a network cable is connected to the Aixplorer® and an Ethernet

connection is detected while the Aixplorer® is connected to a WIFI
network, the WIFI connection will be automatically deactivated.

You may also modify WIFI connection parameters or delete a WIFI

network with the Admin password.

Please contact a SuperSonicImagine representative.

1. Select the appropriate WIFI network in the list

2. Click on Connect

The selected WIFI connection will remain active as long as it is not

deactivated (Disconnect button) or the system is not switched off.

Check the section called “Notification Icons” [167] for a desciption of

WIFI icons.
Once you have configured the network (see the section called “Ethernet
Configuration” [397]), you have access to network tools:

• Ping
• Traceroute
• Dig and Reverse Dig
• MTR
• Duplicate address detection DAD
• IPcalc

Contact your local SuperSonic Imagine Service Representative for

further instructions on the use of these tools.
This section concerns all of the options to manage the studies contained
on the system hard drive.

You can also back up and restore some elements from your system.
1. Plug a USB device on which you want to back up some elements from
your system
2. Press the Backup/Restore button
3. Enter the password
4. Press OK
5. Select your USB device
6. Select the elements you want to back up
7. Press Start

1. Plug the USB device on which you backed up some elements of your
system
2. Press the Backup/Restore button
3. Enter the password
4. Press OK
5. Select the USB device on which you backed up some elements of your
system
6. Select the Restore tab
7. Select the back up file you want to restore on the left
8. Select the elements you want to restore on the right
9. Press Start
You can format a plugged USB device directly from the Aixplorer®.

1. Plug the USB device you want to format

2. Press the Format USB Device button
3. Enter the password
4. Press OK
5. Select the USB device you want to format
6. Press Format
7. A warning message is displayed. Press Continue to format the
device
8. When the operation is completed, a message is displayed
9. Press Close
This section allows you to manage the list of physicians and sonographers
that you can choose from in the Patient Data Entry.

In the list at the bottom of the screen, click on a name to display the related
informations in the appropriate fields above the list.

To add a name:

1. Click on New on the right side of the list

2. Enter the appropriate data

The new name is automatically saved. They can be selected from the
Patient Data form.
A Preset is a group of settings that optimizes the system for a specific
type of exam. Presets establish many initial settings, such as gain value,
color map, filter, TissueTuner™, Flow Optimizations, etc… When the
system is turned on, the default Preset is active. Before beginning an
exam, be sure that the appropriate Preset is active. You can choose
from several default Presets. These default Presets cannot be deleted.
Several Presets per transducer/application combination can be created
and stored, depending on the number of buttons available on the
individual transducer touch screen.

The Presets tab is divided in 3 tabs:

• Annotations
• Bodymarkers
• Presets

It allows you to customize annotations and bodymarker packages, as well

as imaging presets.
This section allows you to edit the annotation library for the current
language.

To edit the annotation library:

1. Select a package
2. Select the page you want to edit by using the navigation controls,
located above the annotation grid:
• First page/Last page
• Previous page/Next page
• Add page
• Remove page
3. To create a new package, click on New Package and enter a name
in the pop-up window.
4. To duplicate an existing package, click on Duplicate Package
and enter a new name in the pop-up window. A new package will
be created with all the annotations from the initial package without
modifying it.
5. To change the name of an annotation, click on it and change it in the
pop-up window
6. To create a new annotation on an empty button, click on the empty
button and enter its name in the pop-up window
7. To remove an annotation from a group, select Free Annot (the
first color box on the left side) and click on the annotation you
 want to remove from its group. The annotation button becomes
“transparent” (no color) and will not be replaced by another one
8. To move an annotation from one group to another, click on the new
group color you want to apply, and click on the annotation. The
annotation will change color
9. To change a rotary knob label or create a new one, click on the Edit
Title button located next to the knob you want to edit, and change it
in the pop-up window
10.To delete a rotary knob value, click on the value and then click on the
- button next to it
11.To add a rotary knob value, type the new value in the box and click
on the + Add to the list button next to it
12.To move a rotary knob value within the list, click on it and then click
on the arrows next to it
This section allows you to edit the body marker libraries and to customize
some options related to body markers.

You can choose to remove the body marker every time you unfreeze the
image by checking the “Remove body marker on unfreeze” option.

You can choose to remove the probe marker from the body marker every
time you unfreeze the image by checking the “Remove probe marker on
unfreeze” option.

You can set up a time out for the body marker touch screen. At the end of
this time out, the body marker touch screen will be automatically closed.

In this section, you can customize the body marker library for each preset.
1. Select the package you want to modify on the right part

You can navigate through the different pages of the library by using the
following buttons:

• First displays the first page of the library

• Previous displays the previous page of the library
• Next displays the next page of the library
• Last displays the last page of the library

You can add and remove pages for the selected library by using the Add
and Remove buttons.

1. Click on the body marker you want to remove

2. Click on the Remove button below the arrow

1. Click on the body marker you want to move

2. Click on the appropriate arrow

1. Click on the body marker you want to set as the default body marker
for the library
2. Click on Set as default below the arrows

The selected body marker will be displayed by default every time you
press Body Marker on the control panel for the selected preset.
All the available libraries on the system are displayed on the left part.

1. Select the appropriate package

The available body markers are displayed below.

2. Click on the body marker you want to add to your library
3. Click on the Add button

The selected body marker will be added at the first available space in
your library.

Note: all changes are automatically saved.

You can reset a body marker library for a given preset as it was by default
by clicking on Reset to default.

1. Click on New and enter the name of the package in the pop-up
window.
2. Choose bodymarkers in the library and add them to your package.
Refer to the section called “To add a body marker to a
package” [411]

1. Click on Duplicate and enter a new name in the pop-up window.

A new package will be created with all the bodymarkers from the
initial package without modifying it.

To add a bodymarker from another package, select the appropriate

package and proceed as for adding a bodymarker.
Once you have set the system to a desired configuration, you may want
to make a Preset.

1. Press Probe on the control panel

2. Touch New Preset
A dialog box will appear on the main display.
3. Select the application in which you want to save the preset
4. Select an annotation library for your new preset
5. Select a body marker library for your new preset
6. Select a measurement library for your new preset
7. Using the keyboard, enter a name for your new Preset.
8. Select OK.
9. Press Probe on the control panel to verify your Preset.

The user-created presets appear in light blue on the touch screen.

The factory presets appear in dark blue on the touch screen.

In the Presets sub-tab, you can manage imaging presets.

1. Select the appropriate probe and application on the left side of the
screen.

The available presets for this probe and this application will appear.

Selected Presets lists the presets as they will appear on the touch screen.

1. Click on the preset you want to add from the Available Presets list on
the left
2. Click on the right arrow to add it to the Selected Presets list

Selected Presets lists the presets as they will appear on the touch screen.

1. Click on the preset you want to remove from the Selected Presets list
2. Click on the left arrow to add it to remove it
1. Select the preset that you want to modify in the Selected Presets list.
2. You can move a preset within the list with the Up and Down buttons.

They will be displayed in the same order on the touch screen preset
page.

To reset a factory preset to the default configuration, click on Reset.

1. Select the small annotation tab on the right side of the screen.

You will see the available packages box on the left of the Add button
and the selected packages box on the right.

The selected packages are those already available in the preset.

2. To add an annotation package, select the appropriate package in the
available packages box and click on Add.

It will appear in the selected packages box.

3. In the selected packages box you can remove a package by clicking
on Remove.
4. You can also move a package within the list using the Up and Down
buttons.
5. To edit the annotation package, select a package in the selected
packages box and click on Edit Package.

1. Select the small bodymarker tab on the right side of the screen.
 You will see the available packages box on the left of the Add button
and the selected packages box on the right.

The selected packages are those already available in the preset.

2. To add a bodymarker package, select the appropriate package in the
available packages box and click on Add.

It will appear in the selected packages box.

3. In the selected packages box you can remove a package by clicking
on Remove.
4. You can also move a package within the list using the Up and Down
buttons.
5. To edit the bodymarker package, select a package in the selected
packages box and click on Edit Package.

1. Select the small measurement tab on the right side of the screen.

You will see the available packages box on the left of the Add button
and the selected packages box on the right.

The selected packages are those already available in the preset.

2. To add a measurement package, select the appropriate package in the
available packages box and click on Add.

It will appear in the selected packages box.

3. In the selected packages box you can remove a package by clicking
on Remove.
4. You can also move a package within the list using the Up and Down
buttons.
5. To edit the measurement package, select a package in the selected
packages box and click on Edit Package.
1. Do one of the following:
• Press Probe on the control panel, then touch Manage Presets
on the touch screen
• Touch Syst. Config. on the touch screen, then click on
Presets and Presets
2. Choose the probe and the application
The list of user-defined Presets appears.
3. Click on the Preset you want to rename and click on Rename
A popup menu appears
4. Enter a new name
5. Click on OK to validate

You can delete the Presets you created. The factory presets cannot be
deleted.

1. Do one of the following:

• Press Probe on the control panel, then touch Manage Presets
on the touch screen
• Touch Syst. Config. on the touch screen, then click on Presets
and Presets
2. Choose the probe and the application

The list of user-defined Presets appears.

3. Click on the Preset you want to delete and click on Remove.

A popup menu appears.

4. Click on OK to validate
The Measures tab is divided in 4 tabs:

• Measures
• Labels and Calculations
• Packages
• Obstetrics

This section allows you to customize the measurement tools.

1. Select a measurement in the left list

2. You can modify the unit and the precision. Click on the unit or the
precision you want to modify and select the appropriate unit in the
drop down list.
3. Check the measurements that you want to be displayed on screen and/
or included in the report.
This section allows you to configure each labeled measurement
individually.

1. Select the appropriate package

2. Select the labeled measurement you want to customize

You may use the white area as a search box to easily find a labeled
measurement in the list.

Click on the broom icon to erase the text in the search box.

The information and options related to this labeled measurement

appear on the right.
3. You can modify the unit and the precision. Click on the unit or the
precision you want to modify and select the appropriate unit in the
drop down list.
4. With the drop down, you can choose the measurements that you want
to be displayed on screen and/or included in the report.
For Internal Carotid Artery and Common Carotid Artery labeled
measurements, you may uncheck the Display Prox/Mid/Dist
labels checkbox to hide the segment labels. Only Internal Carotid
Artery and Common Carotid Artery generic labels will appear in the
labeled measurement list.
This section allows you to configure your own labeled measurements
packages.

The left side box contains all the labels available on the system.

The right side box contains the labels available for the selected
application, as it appears on the main display when you press Meas. on
the control panel.

You can edit the labels that are available for a given application.

To add a labeled measurement to a package:

1. Select the package you want to modify on the right side of the screen
2. Select the package that contains your labeled measurement on the left
side of the screen. You can select All to see the labeled measurements
available on the system.
3. Select the labeled measurement you want to add from the left side list
4. Click on Add

To remove a labeled measurement from a package:

1. Select the package on the right side of the screen

2. Select the labeled measurement you want to delete from the right side
list
3. Click on Remove

To move a labeled measurement within the list in a package:

1. Select the package

2. Select the labeled measurement you want to move from the right side
list
3. Click on Move up or Move down until it reaches the desired place

To rename a package:

1. Select the package on the right side of the screen

2. Click on Rename
3. Enter a new name in the pop-up window

To reset a package to its default configuration:

1. Select the package on the right side of the screen

2. Click on Reset

To create a new package:

1. Click on New
2. Enter a name in the pop-up window and click on OK
3. You can then add labeled measurements to the new package. It will
be available in the presets.

To duplicate a package:

1. Click on Duplicate
2. Enter a name in the pop-up window and click on OK

A new package will be created with all the labeled measurements.

The Obstetrics section is divided in 3 parts:

• GA - EFW (Gestational Age - Estimated Fetal Weight)

• Fetal Growth and EFW Percentiles
• Tables and Equations

Be careful to confirm the patient name and ID before starting an

examination for a new patient.

Check the date format before entering date of birth, Last Menstrual Period
(LMP), Estimated Date of Delivery (EDD), Date Of Conception (DOC)
and Ovulation Date. Incorrect entry of these parameters will result in an
incorrect Gestational Age (GA).

Enter the EDD and GA in the patient's medical record for backup.

Check the "Activate OB calcs" button on the Patient Data Entry page
(PDE) in order to perform obstetric calculations.

It is necessary to specify which OB author is to be used for each particular

measurement to calculate the GA and get an Estimated Fetal Weight
(EFW).

A diagnosis can not be only based on one measurement or data. Be careful

to always consider the overall clinical evaluation of the patient, including
the medical record.

Depending on fetal position, some measurements may be incorrect. Be

careful to always consider the overall clinical evaluation of the patient,
including the medical record.

The system provides fetal measurements for up to five fetuses. Be careful

not to confuse the fetuses during measurements.

For each measurement performed, you can select either the first,
last, average, minimum, maximum or specifically one of the five
measurements that are allowed to be displayed, using the selector feature
in the Measurements tab of the Report.
Be careful when deleting measurements, as this will affect the selector
result.

Deviations from the normal values of measurements must be judged

based on the graphs and literature.

This section allows you to customize the information you want to display
on screen:

• LMP (Last Menstrual Period)

• GA by LMP
• AUA (Average Ultrasound Age)
• DOC (Date of Conception) by AUA
• EDD (Estimated Delivery date) by AUA

In this section, you can also specify the table you want to use for each
OB calculation.

For each OB calculation (whose name is displayed in the Result

Box name column), the type of calculation is described in the
Association Type column.

1. Click on the Author reference name to select another author.

In this tab, you can select which table to use for the fetal growth and EFW
percentiles.

1. Click on the author/date in order to change it

2. Select the new author/date on the list

In this section, you can visualize the reference tables for OB as tables or
graphs.
1. Select the Author, Type and Year of publication
2. In the right part, click on Graph to visualize the graph, Table to
visualize the table and About to visualize the document references.

You have the capability to import tables that have been created for
Aixplorer®.

1. Plug a USB device on a computer

2. On this USB device, create a folder called ObTables (case sensitive)
3. Copy the table(s) provided by SuperSonic Imagine in the created
ObTables folder

Do not rename the file provided by SuperSonic Imagine.

4. Correctly disconnect the USB device from your computer
5. Plug the USB device on Aixplorer®
6. Open the System Configuration menu
7. Click on the Measurements tab
8. Click on the Obstetrics sub-tab and then the Tables and
Equations section
9. Click on Import Table at the bottom right of the screen

The following pop-up window is displayed:

10.Click on the arrow to select your USB device from the list
11.If tables are correct on the USB device, a green checkmark will be
displayed

If one or several tables are displayed with a red dot, the system did
not recognize them.

The Import Tables button will be grayed out.

a. Plug your USB device on your computer
b. Delete all tables from your USB device
c. Copy correct tables on your USB device and restart the above
procedure.

12.Click on Import Table on the pop-up window

13.Configure the imported tables as needed

A re-installation of the same software version would remove all imported

tables.

It is possible to delete all imported tables from Aixplorer®.

1. Open the System Configuration menu

2. Click on the Measurements tab
3. Click on the Obstetrics sub-tab and then the Tables and
Equations section
4. Click on the Delete all imported tables button at the bottom
right of the screen
The Diagnostic tab is intended to be accessed by service personnel only.

Password access to the some of the contents is required to perform system

diagnostic tests.

This section is only for field service engineers.

A password is not required to access some basic system information, as

follows:

• Product version
• Software version
• File format version
• Cart number
• Serial number
• Panel firmware
• List of enabled options

In addition, 3 buttons are available:

• Reset Panel
• Clear logs
• Export logs to USB

In this tab you also have access to the remote service.

The Super Sonic Imagine Remote Service Solution enables the
monitoring of the Aixplorer® Ultrasound System.

Two ways are defined to communicate with Aixplorer® :

• the user of the Remote Service web interface communicates in real-

time with the system
• both tasks to perform and results are pushed on the remote server by
the User of the Remote Service web interface and Aixplorer® when
connected.

A manual system logs upload on the Remote Service website allows a

third way to recover data from the system.

You can refer to the Remote Service Solution User's Guide for further
informations.
Refer to the user’s manual of your specific printer for guidance on how
to properly change printer paper and toner.

You can perform the maintenance operations as described in this chapter.

Cleaning of the Aixplorer® ultrasound system should occur at regular
intervals, or more frequently as needed.

SuperSonic Imagine provides the following recommended cleaning

intervals as guidelines:

Part Recommended
Cleaning Frequency

System Display Monitor Weekly, or as needed

System Control Panel Daily, or between patients

Touchscreen Display Daily, or between patients

System Exterior:
Weekly, or as needed
chassis and Handles
Inspect weekly;
Air Filters clean monthly;
replace annually

Transducers:
Between patients
cleaning and disinfection
It is prudent to continually survey the system for maintenance
needs. Contact your SuperSonic Imagine Sales or Service authorized
representative for further details.

If you have any questions regarding basic maintenance, or prefer to have

maintenance service performed, contact your authorized SuperSonic
Imagine Service representative.

Always press the On/Off switch, turn off the power switch at the back
of the machine, and disconnect the system from the wall outlet before
performing maintenance or cleaning the system.

It is recommended that gloves and protective eyewear are used when

cleaning the system.

Do not spray any cleaning agents directly onto the system. They may leak
into the system, damaging the system and voiding the warranty.

Do not allow standing liquid to collect around the control panel keys.

Do not allow liquid to drip inside the system chassis.

The exterior of the system should be periodically cleaned with a soft
cloth, lightly moistened with water and a gentle soap. This includes the
system chassis, control panel and handles. Be sure to clean any unused
gel from the surface of the control panel after system use.

The products below have been tested and found to be compatible with
SuperSonic Imagine Aixplorer®.

Solution Manufacturer Cleaner/ Active ingredient

Disinfectant
Sani-Cloth Active PDI Cleaner Quat. Ammonia

Disinfectant
Sani-Cloth Af3 PDI Cleaner Quat. Ammonia

Disinfectant

A clean, soft cotton cloth dampened with an ammonia-based window

cleaner should be used to clean the Monitor display. Do not use paper
towels, as these may scratch the display monitor. The cleaning agent
should be sprayed onto the cloth, not directly onto the display surface.
Take care not to get any cleaning agent into the housing of the system.
This may lead to system damage.

A clean, soft cotton cloth dampened with an ammonia-based window

cleaner should be used to clean the Touch Screen display. Do not use
paper towels, as these may scratch the display monitor. The cleaning
agent should be sprayed onto the cloth, not directly onto the display
surface. Take care not to get any cleaning agent into the housing of the
system. This may lead to system damage.

The Aixplorer® ultrasound system is equipped with air filters. These

should be inspected every week and cleaned as needed. At first switch
on of the system after the first day of the month, the system displays an
icon as a reminder to check the air filters. Please refer to the following
air filter cleaning procedure, and click OK on the pop-up window.

The air filters are located:

• in a slot at the rear side of the system

• in a slot at the bottom side of the system.

To remove the rear air filter, open the cover on the back. To remove the
side air filter, open the left side cover with a pen. It is recommended
that air filters be cleaned monthly or more frequently if a significant
accumulation of dust or debris is noted.

Air filters may be removed, washed with mild soap and rinsed
thoroughly with water. Allow the filters to air dry before re-installing in
the system. Spare air filters are provided for immediate use. Additional
air filters can be ordered from SuperSonic Imagine Customer Service.
1. Remove the air filter cover by pulling the bottom of the cover towards
you.
2. Inspect the filter, and if it is dirty, replace it with a spare
3. Depending on the condition of the air filter, use either a vacuum
cleaner or soap and water to clean the dirty filter
4. Thoroughly dry the cleaned filters before re-installing

Before performing maintenance or cleaning, always press the On/Off

switch, turn off the power switch at the back of the machine, and then
disconnect the system from the wall outlet.

Increased internal temperature can be caused by dirty air filters.

Failure to keep the air filters clean can result in the system becoming
unavailable during critical use.

Never install an air filter that is not completely dry.

Turn off power before you remove the air filters.

Do not turn power on without air filters installed.

Cleaning the Scanning Window

Reading performance may degrade if the scanner's window is not clean.

If the window is visibly dirty, or if the scanner isn't operating well, clean
the window with a soft cloth or lens tissue dampened with water (or a
mild detergent - water solution). If a detergent solution is used, rinse with
a clean lens tissue dampened with water only.

Cleaning the Scanning Housing

The HS-1M is IP54 rated when the cable is attached. This means that
liquids and dusts will not penetrate into the housing. However, the
scanner should not be submerged in water or other liquids. It is also good
practice to dampen the cleansing cloth vs. spraying the scanner directly.

The HS-1M housing is compatible with the following medical grade

cleaners:

• Sani-Cloth® HB
• Sani-Cloth® Plus
• Hydrogen Peroxide
• CaviWipes™
• 409® Glass and Surface Cleaner
• Windex® Blue
• Clorox® Bleach (100%)
• Isopropyl Alcohol
• Gentle dish soap and water

Do not submerge the HS-1M in water.

Do not use abrasive wipes or tissues on the HS-1M's window - abrasive
wipes may scratch the window.

Never use solvents (e.g., acetone, benzene, ether, or phenol-based agents)

on the housing or window - solvents may damage the finish or the
window.
Use care when handling and cleaning ultrasound transducers.

Do not use a damaged or defective transducer.

Do not immerse or allow liquid to penetrate a transducer which has had

its face or cable sheath compromised.

Failure to follow these precautions can result in serious injury and

equipment damage.

Follow these precautions to avoid injury and equipment damage.

Inspect the transducer prior to cleaning for damage or degeneration to the

lens, housing, cable and connector.

Do not use or apply liquid cleaning agents to a damaged or defective

transducer.

Do not immerse the transducer into any liquid beyond the level specified
for that transducer.

Never immerse the transducer connector or transducer adapters into any

liquid.

Transducer damage can result from contact with inappropriate coupling

or cleaning agents.

Use only cleaning agents which have been approved for the specified
transducer.

Do not soak, immerse, or maintain prolonged contact with solutions

containing alcohol, bleach, ammonium chloride compounds or hydrogen
peroxide.
The level of disinfection required for a device is dictated by the type of
tissue it will contact during use. Ensure the solution strength and duration
of contact are appropriate for the intended clinical use of the transducer.

Always use protective eyewear and gloves when cleaning, disinfecting

or sterilizing any equipment.

Be sure to observe the expiration date of the solution.

Avoid disinfectant contact with the connector label.

Biological hazards may exist if ultrasound transducers are not properly

cleaned, disinfected or sterilized.

This is especially true if the transducer comes in contact with mucous

membranes or bodily fluids.

Proper cleaning and disinfection are necessary to prevent disease

transmission and infection control.

It is the responsibility of the equipment user to verify and maintain the

effectiveness of the infection control procedures in use.

For any procedures where the transducer may come in contact with bodily
fluids or mucous membranes, the use of a legally marketed, sterile, non-
pyrogenic transducer sheath is recommended.

Only use disposable sheaths. Sheaths are never to be reused.

Use caution when using disinfectant products.

Wear rubber gloves and protective eyewear.

Always follow the manufacturer’s instructions.

In order for liquid chemical disinfectants to be effective, all visible

residues must be removed during the cleaning process.

For effective cleaning, follow the instructions accompanying the cleaner

or disinfectant product.
Care should be taken to avoid applying disinfectant agents to the cable-
housing junction.

Do not allow any fluids to enter the cable-housing junction.

Do not use any alcohol or alcohol-based products on the transducer cable.

If the transducer shows signs of damage such as cracks, splitting,

delamination of the face or cable damage, discontinue use of the
transducer and contact your authorized SuperSonic Imagine Service
representative for assistance.

Cleaning and disinfection is a two step process: a cleaning step followed

by a disinfection step.

Cleaning is intended to remove all foreign matter (blood, tissue, protein,

scanning gel, etc.) from the device.

The level of disinfection required for a device is dictated by the type

of tissue it will contact during use. There are three classifications: non-
critical, semi-critical, and critical. These are based on the degree of risk
of infection involved in the use of the device.

Non-critical applications are those where the device contacts only intact
skin; semi-critical applications are those where the device contacts mucus
membranes or minor skin breach; critical applications are those where the
device enters a normally sterile environment, sterile tissue or vasculature.

Ultrasound transducers used for non-critical applications generally need

only to be cleaned and low-level disinfected between patient uses.
Transducer used in semi-critical application should be cleaned and high
level disinfected after use even if a sheath was used.

Transducers used in critical applications should be sterilized and the use

of a sterile sheath is recommended. Transducer used in critical application
should be cleaned and sterilized after use even if a sheath was used.

The SuperSonic Imagine Aixplorer® transducers are intended for use

in non-critical and semi-critical imaging applications. The transducer
must be thoroughly cleaned and disinfected after each use. In general,
only low-level disinfection is required for non-critical applications of the
SuperSonic Imagine Aixplorer® transducer.

For semi-critical applications, high-level disinfection is required and only

one of the high-level disinfectants chosen from the list below should be
used.

High-level disinfection for semi-critical is recommended, carefully

following the manufacturer’s instructions with regard to application and
contact time as indicated on the product label.

1. After every patient exam, carefully wipe the face and housing of the
ultrasound transducer to remove any traces of ultrasound coupling gel.
2. Inspect the transducer for any signs of damage such as cracks,
splitting, delamination of the face or cable damage. If any damage is
noted, do not proceed with the cleaning or disinfecting procedures and
call your authorized SuperSonic Imagine Service representative for
assistance.
3. Wipe the transducer face, housing and cable with a water-moistened
soft cloth. The use of a mild soap, low-level cleaner or enzymatic
cleaner (from the table below) is acceptable.
4. If stubborn material has dried on the face or housing of the transducer,
carefully scrub the transducer using water moistened gauze, sponge
or surgeon’s soft bristle brush. Wipe away any material with a water-
moistened soft cloth.
5. Rinse the transducer thoroughly with water. Do not allow water to
access the cable-housing junction.
6. Air dry or dry using a soft dry cloth.

1. Always clean the transducer prior to disinfection. (See steps above.)

2. When using an FDA or CE -cleared (as appropriate) disinfecting
agent, carefully follow the instructions provided by the manufacturer
of the product.
3. For low-level disinfection, the lens and housing of the transducer may
be wiped with any of the cleaners/low level disinfectants
listed in the associated transducer table.
4. For high-level disinfection, the transducer may be wiped or soaked
using one of the disinfectants listed in the associated transducer
table.
5. Air dry or dry using a soft dry cloth.
6. Re-inspect the transducer for any signs of damage such as cracks,
splitting, delamination of the face or cable damage before putting the
transducer back into use.
 The table below lists indicates the product compatibility ("YES") with
the Aixplorer® probes.

Only use compatible products with Aixplorer® probes.

Solution/ Manufacturer Cleaner/ Active ingredient SL15-4 SE12-3 SEV12-3 SLV16-5 XC6-1
system Disinfectant SL18-5 XP5-1
SL10-2 SLH20-6
SMC12-3
SC6-1
Alkaspray Alkapharm Cleaner Isopropyl alcohol YES
GSA Alkylamine
(Cidalkan) Disinfectant
Alkazyme Alkapharm Cleaner Quat. Ammonia YES

Disinfectant
Anioxyde Anios Disinfectant Peracetic acid YES YES
1000
Cidex OPA Advanced Disinfectant Orthophtalaldehyde YES YES YES YES YES
(DISOPA Sterilization
in Japan) Products

Cidex Plus Advanced Disinfectant Orthophtalaldehyde YES

Sterilization
Products
Cidezyme Johnson Cleaner Proteolytic enzymes YES YES YES
and
Johnson
Enzol Advanced Cleaner Proteolytic enzymes YES
Sterilization
Products

Disinfectant Succindialdehyde,
Gigasept FF Schuller&Mayr YES YES YES
dimethoxy-
tetrahydrofuran
KlenZyme Steris Cleaner Proteolytic enzymes YES

Linget’Anios Anios Cleaner Ethanol YES YES YES

Solution/ Manufacturer Cleaner/ Active ingredient SL15-4 SE12-3 SEV12-3 SLV16-5 XC6-1
system Disinfectant SL18-5 XP5-1
SL10-2 SLH20-6
SMC12-3
SC6-1
Disinfectant Digluconate de
chlorhexidine
Alkylamino-
alkylglycine

MetriZyme Metrex Cleaner Proteolytic enzymes YES

Mikrobac Bode Disinfectant Benzyl-C12-18- YES YES

Tissues alkyldimethyl-
ammonium
chlorides didecyl-
dimethyl-
ammonium chloride
Milton Milton Disinfectant Sodium YES
Hypochlorite
Opaster Anios Disinfectant Orthophtalaldehyde YES
Anios
Sani-Cloth PDI Cleaner Quat. Ammonia YES
Active
Disinfectant
Sani- PDI Disinfectant Quat. Ammonia YES
Cloth HB
Sani- PDI Disinfectant Quat. Ammonia YES
Cloth Plus
Sporox Reckitt & Disinfectant Hydrogen Peroxide YES
Colman
Sporox II Reckitt & Disinfectant Hydrogen Peroxide YES
Colman
Steranios Anios Disinfectant Glutaraldehyde YES YES

Steranios Anios Disinfectant Orthophtalaldehyde YES YES

OPA
Super PDI Disinfectant Quat. Ammonia YES
Sani Cloth
T-Spray Disinfectant
Pharmaceutical Quat. Ammonia YES
Innovations
Inc.
Solution/ Manufacturer Cleaner/ Active ingredient SL15-4 SE12-3 SEV12-3 SLV16-5 XC6-1
system Disinfectant SL18-5 XP5-1
SL10-2 SLH20-6
SMC12-3
SC6-1
Transeptic Parker Cleaner Chlorhexidine YES
spray laboratories Gluconate,
Isopropyl Alcohol
Tristel Duo Tristel Disinfectant Chlorine dioxide YES YES
Solutions
Limited
Tristel Solo Tristel Disinfectant Hexamethylene- YES
Solutions biguanide
Limited
Trophon Nanosonics High-level Hydrogen peroxide YES YES
mist generated
disinfectant in a disinfection
chamber
Wavicide 01 MCC Disinfectant Glutaraldehyde YES

For endocavity probes, make sure the cleaner/disinfectant is compatible

with mucosa.

Some cleaner/disinfectant products may cause coloration or discoloration

of the probe housing. This coloration/discoloration does not affect the
image quality of the probe.

The above cleaner and disinfectant products have been tested and found
to be compatible with SuperSonic Imagine Aixplorer® transducers
material solely. Questions regarding efficacy, instructions for use, and
proper handling should be directed to the manufacturer. Please check
whether the recommended products are approved for use in your country.
The use of a non-approved cleaner or disinfectant which results in
damage to the probe will void the warranty. The use of products outside
of those on this list is to be done at the user’s and patient’s own risk.
If soaking a transducer is required, the SL15-4, SL18-5, SL10-2, SC6-1,
SMC12-3 transducers may only be immersed in liquid to a level of 3cm
(1.18 in.) above the cable-strain relief junction. The SEV12-3, SLV16-5,
XP5-1, XC6-1, SLH20-6 and SE12-3 transducers may be immersed in
liquid to a level of 1m (39.37in.) above the cable-strain relief junction.
See figure below.

According to the IEC 60529 standard, all Aixplorer probes are IPX7
according to the figure below.

Never immerse the probe connector. Never immerse the cable-connector

junction. Do not leave the transducer immersed longer than required for
disinfection. See figure below.
Additional information regarding cleaning and disinfection of ultrasound
transducers can be found in the following references:

Chemical Sterilization and high-level disinfection in health care facilities.

ANSI/AAMI ST58:2005 Sterilization and Disinfection of Medical
Devices: General Principles. Centers for Disease Control, Division of
Healthcare Quality Promotion.

http://www.cdc.gov/ncidod/hip/sterile/sterilgp.htm (5-2003) [http://

www.cdc.gov/ncidod/hip/sterile/sterilgp.htm%20(5-2003)]

ODE Device Evaluation Information—FDA Cleared Sterilants and

High Level Disinfectants with General Claims for Processing Reusable
Medical and Dental Devices.

http://www.fda.gov
If you encounter difficulty in the operation of the system, use the
information in this section to help correct the problem.

If the problem is not covered here, contact your Customer Support

Representative.

The troubleshooting table below contains a list of symptoms and the

action to take to correct the problem.

Symptom Corrective action

System does not power on Ensure that the system is plugged in
to a functioning outlet, and that the
circuit breaker on the rear power is set.
Turn on power.
Image quality is poor Take care of ambient light
Adjust gain, TGC and Auto TGC
Try with an other probe
Adjust position of LCD screen
to improve viewing angle
If there is no change, contact your
customer service representative.
Error message appears on screen Note the error and contact your
customer service representative.
System does not recognize the transducer Disconnect, reconnect and
reselect the transducer.
If there is no change, contact your
customer service representative.
DVD does not work Find another DVD disk to store data.
If there is no change, contact your
customer service representative.
The system does not Ensure that the system is plugged in
start, the fans do not spin to a functioning outlet, and that the
circuit breaker on the rear power is set.
Turn on power.
If there is no change, contact your
customer service representative.
The main monitor does not turn on Check the cables at the
(fans run and control panel is on) back of the monitor
Reboot
If there is no change, contact your
customer service representative.
The touch screen display is Reboot.
off when the system is ready
 Symptom Corrective action
If no change, contact your
customer service representative.
The control panel is off Reboot.
If no change, contact your
customer service representative.
The system displays a banner Reboot.
indicating a HW problem If banner stay on, contact your
customer service representative.
“GRUB error” is displayed at boot time. Internal hard drive
failure. Service is needed.
Contact your customer
service representatives
Splash screen is up but the progress bar Operating system is
has not moved for more than 5 minutes damaged. Service is needed.
Contact your customer
service representative.
A broom icon appears in This icon appears once a month, it is
the icon area of the screen to remind you to check the air filters.
Stop the system and verify the filters
Click on the icon
A pop-up window appears
Click yes on the pop-up window
The icon disappears
Artefact, white cone(s) in the B-mode, Reboot the system.
and/or colored cone(s) on the color If there is no change, contact you
flow image, starting from the skin line customer service representative.
The table below provides the maximal temperature that may be reached
for each transducer.

Table 11.1. Maximal temperature for each transducer

Tranducer name Maximal temperature Test Method
SL15-4 21.5°C Still air
SL18-5 21.5°C Still air
SC6-1 43°C Still air
XC6-1 47.5°C Still air
SE12-3 Max increase = 3.6°C Simulated use
SEV12-3 Max increase = 4.8°C Simulated use
SLV16-5 39.1° Still air
SL10-2 25.4°C Still air
SMC12-3 44.9°C Still air
XP5-1 48.1°C Still air
SLH20-6 40.1°C Still air

The following symbols are used in the acoustic reporting tables below:

Symbol Term
acoustic working frequency

attenuated pulse-average intensity

spatial-peak, temporal-average intensity

attenuated spatial-peak,
temporal-average intensity
MI mechanical index
number of pulses per ultrasonic scan line
P output power
Symbol Term
bounded-square output power

attenuated peak-
rarefactional acoustic pressure
peak-rarefactional acoustic pressure

prr pulse repetition frequency

srr scan repetition rate
TI thermal index
TIB bone thermal index
TIC cranial-bone thermal index
TIS soft-tissue thermal index
depth for bone thermal index

depth for mechanical index

depth for peak attenuated
pulse intensity integral
depth for soft-tissue thermal index
The SuperSonic Imagine Aixplorer® system complies with IEC
60601-2-37 standard.

The following table summarizes the transducer/mode combinations for

which the global maximum displayed MI or TI is greater than 1.0.
 Table 11.2. Transducer/mode combinations for which the global maximum displayed MI or TI is greater than 1.0

Operating Transducers
Mode
SL15-4 SL18-5 SC6-1 SE12-3 SLV16-5 SL10-2 SMC12-3 XP5-1 SLH20-6 XC6-1 SEV12-3
B-mode

Pulsed
Doppler
Color
Doppler
Amplitude
Doppler
Directional
Color
Doppler
SWE™
Mode
B-Mode
+ Pulsed
Doppler
Harmonic
Imaging
B-mode
+ 3D
Color
+ 3D
SWE™
+ 3D
M-mode
The reported expanded uncertainty for the display of mechanical and
thermal indices is based on a standard uncertainty multiplied by a
coverage factor k=2, providing a coverage probability of approximately
95%.

At the above uncertainty level, the accuracy result for the Mechanical
Index (MI) is +/-19.3% and the accuracy result for the Thermal Index
(TI) is +/-53.1%.

Acoustic Quantity Measurement Uncertainty

Power (P) +/- 53.1 %
Pressure ( ) +/- 19.3 %

Intensity ( at max MI) +/- 53.1 %

Center frequency ( ) +/- 1 %

For each transducer/mode combination in the table above which is

checked, a detailed acoustic output table has been provided on the
following pages.

The probes for which TIC is marked with (b) are not intended for
transcranial or neonatal cephalic uses.
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 (a) (a) (a)
Index components value # - # -
at (MPa) CD:
3.55
B: 3.82
(mW) # # #
(mW) # #

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
1.6
B: 1.41
(cm) -

(MHz) CD: # # #
7.38
B: 5.25
prr (Hz) CD:
176
B: 16
srr (Hz) 14

CD: 11
B: 1
at (W/cm²) CD: 26
Other information
B: 310
at (mW/cm²) CD:
123
B: 12
at (mW/cm²) CD:
279
B: 21
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (MPa) CD:
4.41
B: 4.59
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

Condition 1: UpExtVeinous, B mode Fundamental, Focal zone 22 mm,

GEN, Acoustic Power 0 dB
 Operating Mode: B + SWE
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 3.29 3.29 4.5*
Index components value P: 0.24 P: 1.62 P: 0.24 P: 1.99
F: 2.51 F: 0.73 F: 2.51 F: 0.51
B: 0.38 B: 0.38 B: 0.38 B: 0.38
P: 2.62
F: 2.1
B: 0.36
at (MPa) P: 4.05
F: 2.93
B: 3.76
(mW) P: 212 P: 212 P: 272
F: 70.3 F: 70.3 F: 131
B: 16.6 B: 16.6 B: 16.6
(mW) P: 19.1 P: 19.1
F: 42.4 F: 42.4
B: 7.4 B: 7.4
Associated (cm) P: 1.79
acoustic parameters F: 2.4
(cm) P: 1.79
F: 1.5
(cm) B: 1.41
(cm) P: 1.92
F: 1.35
(MHz) P: 6 P: 5 P: 5 P: 5
F: 5.63 F: 7.5 F: 7.5 F: 5.63
B: 5.25 B: 7.63 B: 7.63 B: 7.63

prr (Hz) P: 2
F: 84
B: 24
srr (Hz) 2
Other information
P: 1
F: 42
B: 12
at (W/cm²) P: 452
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 288
B: 310
at (mW/cm²) P: 383
F: 27
B: 34
at (mW/cm²) P: 490
F: 49
B: 52
at (MPa) P: 5.42
F:
B: 7.63
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

* Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

Condition 1: General, SWE Box position 20 mm, PEN, Acoustic Power

0 dB

Condition 2: Breast, SWE Box position 45 mm, RES, Acoustic Power

0 dB
 Operating Mode: B + Trivu

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 4.19 4.19 4.5*
Index components value P: 0.24 P: 1.62 P: 0.24 P: 1.99
F: 2.51 F: 0.73 F: 2.51 F: 0.51
CDF: CDF: CDF: CDF:
0.9 0.26 0.89 0.18
B: 0.38 B: 0.38 B: 0.38 B: 0.38
P: 2.62
F: 2.1
CDF:
0.75
B: 0.36
at (MPa) P: 4.05
F: 2.93
CDF:
2.93
B: 3.76
(mW) P: 212 P: 212 P: 272
F: 70.3 F: 70.3 F: 131
CDF: 25.1 CDF: 70.3 CDF:
B: 16.6 B: 16.6 46.8
B: 16.6
(mW) P: 21 P: 21
F: 24 F: 24
Associated CDF: 8.57 CDF: 8.57
acoustic parameters B: 11.1 B: 11.1
(cm) P: 1.79
F: 2.4
CDF:
2.4
(cm) P: 1.79
F: 1.5
CDF:
1.52
(cm) B: 1.41
(cm) P: 1.92
F: 1.35
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
CDF:
1.35
(MHz) P: 6 P: 5 P: 5 P: 5
F: 5.63 F: 7.5 F: 7.5 F: 5.63
CDF: CDF: 7.5 CDF: 7.63 CDF:
5.63 B: 7.63 B: 7.63 5.63
B: 5.25 B: 7.63

prr (Hz) P: 1
F: 420
CDF:
160
B: 24
srr (Hz) 2

P: 1
F: 420
CDF:
160
B: 12
at (W/cm²) P: 452
F: 288
CDF:
288
Other information B: 310
at (mW/cm²) P: 383
F: 27
CDF:
10
B: 34
at (mW/cm²) P: 490
F: 49
CDF:
19
B: 52
at (MPa) P: 5.42
F: 3.65
CDF:
3.65
B: 4.59
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

P: Push component; F: Flat component; CDF: Flat Color Doppler

component; B: B component

* Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

Condition 1: General, SWE Box position 20 mm, PEN, Acoustic Power

0 dB

Condition 2: Breast, SWE Box position 45 mm, RES, Acoustic Power

0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.4 1.09 2.44 1.84
Index components value 0.85 0.78 0.86 2.44
at (MPa) 3.2

(mW) 43.6 32.7 20.3

(mW) 43.6 32.7

(cm) 0.84
Associated
acoustic parameters (cm) 1.35

(cm) -
(cm) 1.29

(MHz) 5.125 5.38 5.25 5

prr (Hz) 1064

srr (Hz) -
1

Other information at (W/cm²) 243

at (mW/cm²) 549

at (mW/cm²) 881

at (MPa) 3.89

Condition 1 MI

Operating control Condition 2 TIS

conditions Condition 3 TIB
Condition 4 TIC

Condition 1: General, Focal zone 22 mm, SV 1.5 mm, Scale 8 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 68 mm, SV 2 mm, Scale 65 cm/s,

Acoustic Power 0 dB

Condition 3: General, Focal zone 52 mm, SV 2 mm, Scale 65 cm/s,

Acoustic Power 0 dB
Condition 4: General, Focal zone 7 mm, SV 0.5 mm, Scale 65 cm/s,
Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.6 (a) (a) (a)
Index components value # - # -
at (MPa) CD:
2.88
B: 3.34
(mW) # # #
(mW) # #

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
1.4
B: 1.43
(cm) -

(MHz) CD: # # #
7.5
B: 5.25
prr (Hz) CD:
288
B: 70
srr (Hz) 18

CD: 16
B: 4
at (W/cm²) CD:
Other information 311
B: 41
at (mW/cm²) CD: 94
B: 15
at (mW/cm²) CD: 96
B: 54
at (MPa) CD:
4.41
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
B: 4.59
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

Condition 1: B: Thyroid, B mode Harmonic, Focal zone 14 mm, PEN,

SuperCompound on, HD/FR med, Acoustic Power 0 dB

COL: Breast, Focal zone 14 mm, PEN, HD/FR med, Acoustic Power 0dB
 Operating Mode: B + SWE
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 2.84 3.21 4.0
Index components value P: 0.24 P: 1.61 P: 0.24 P: 1.99
F: 1.64 F: 0.91 F: 1.64 F: 0.91
B: 0.31 B: 0.31 B: 0.31 B: 0.31
P: 2.62
F: 1.37
B: 0.26
at (MPa) P: 3.99
F: 2.54
B: 3.34
(mW) P: 125 P: 125 P: 125
F: 79 F: 79 F: 79
B: 7.3 B: 7.3 B: 11.6
(mW) P: 9.9 P: 9.9
F: 79 F: 79.9
B: 9.7 B: 7.3
Associated (cm) P: 1.79
acoustic parameters F: 2.34
(cm) P: 1.79
F: 1.34
(cm) B: 1.37
(cm) P: 1.42
F: 1.55
(MHz) P: 5 P: 5 P: 5 P: 5
F: 7.5 F: 7.5 F: 7.5 F: 5.63
B: 5.25 B: 7.63 B: 7.63 B: 7.63

prr (Hz) P: 2
F: 624
B: 70
srr (Hz) 1
Other information
P: 2
F: 624
B: 70
at (W/cm²) P: 21.9
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 10.5
B: 41
at (mW/cm²) P: 471
F: 99
B: 15
at (mW/cm²) P: 490
F: 221
B: 54
at (MPa) P: 5.2
F: 3.8
B: 4.6
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

P: Push component; F: Flat component; B: B component

Condition 1: PUSH and FLAT: Breast, SWE Box position 20 mm, Std,
Acoustic Power 0 dB

B: Thyroid, B mode Harmonic, Focal zone 14 mm, PEN,

SuperCompound on, HD/FR med, Acoustic Power 0 dB

Condition 2: PUSH and FLAT: Breast, SWE Box position 45 mm, Std,
Acoustic Power 0 dB

B: Thyroid, B mode Harmonic, Focal zone 14 mm, PEN,

SuperCompound on, HD/FR med, Acoustic Power 0 dB
 Operating Mode: B + Trivu

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 3.06 3.43 4.3
Index components value P: 0.24 P: 1.61 P: 0.24 P: 1.99
F: 1.64 F: 0.91 F: 1.64 F: 0.91
CDF: CDF: CDF: CDF:
0.39 0.22 0.39 0.22
B: 0.31 B: 0.31 B: 0.31 B: 0.31
P: 2.62
F: 1.37
CDF:
0.30
B: 0.26
at (MPa) P: 3.99
F: 2.54
CDF:
2.54
B: 3.34
(mW) P: 125 P: 125 P: 125
F: 79 F: 79 F: 79
CDF: 18.8 CDF: 18.8 CDF:
B: 7.3 B: 7.3 18.8
B: 11.6
(mW) P: 9.9 P: 9.9
F: 79 F: 79.9
Associated CDF: 11.1 CDF: 11.1
acoustic parameters B: 9.7 B: 7.3
(cm) P: 1.79
F: 2.34
CDF:
2.34
(cm) P: 1.79
F: 2.34
CDF:
2.34
(cm) B: 1.37
(cm) P: 1.42
F: 1.55
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
CDF:
1.55
(MHz) P: 5 P: 5 P: 5 P: 5
F: 7.5 F: 7.5 F: 7.5 F: 5.63
CDF: CDF: 7.5 CDF: 7.5 CDF:
7.5 B: 7.63 B: 7.63 7.5
B: 5.25 B: 7.63

prr (Hz) P: 2
F: 624
CDF:
200
B: 70
srr (Hz) 1

P: 2
F: 624
CDF:
200
B: 70
at (W/cm²) P: 21.9
F: 10.5
CDF:
10.5
Other information B: 41
at (mW/cm²) P: 471
F: 99
CDF:
32
B: 15
at (mW/cm²) P: 490
F: 221
CDF:
71
B: 54
at (MPa) P: 5.2
F: 3.8
CDF:
4.6
B: 4.6
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

P: Push component; F: Flat component;CDF: Color Doppler Flat

component; B: B component

Condition 1: PUSH and FLAT: Breast, SWE Box position 20 mm, Std,
Acoustic Power 0 dB

B: Thyroid, B mode Harmonic, Focal zone 14 mm, PEN,

SuperCompound on, HD/FR med, Acoustic Power 0 dB

Condition 2: PUSH and FLAT: Breast, SWE Box position 45 mm, Std,
Acoustic Power 0 dB

B: Thyroid, B mode Harmonic, Focal zone 14 mm, PEN,

SuperCompound on, HD/FR med, Acoustic Power 0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.5 0.92 2.21 1.4
Index components value 0.91 0.65 0.91 2.18
at (MPa) 3.3

(mW) 36.4 36.4 21.8

(mW) 5.94 5.94

(cm) 1.1
Associated
acoustic parameters (cm) 1.35

(cm) -
(cm) 1.41

(MHz) 5.125 5.38 5.37 5.125

prr (Hz) 1093

srr (Hz) -
1

Other information at (W/cm²) 186

at (mW/cm²) 536

at (mW/cm²) 801

at (MPa) 4.24

Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3 TIC
Condition 4

Condition 1: General, Focal zone 22 mm, SV 1 mm, Scale 8 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 68 mm, SV 0.5 mm, Scale 110 cm/s,
HPRF on, Acoustic Power 0 dB

Condition 3: General, Focal zone 2 mm, SV 1.5 mm, Scale 190 cm/s,
Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.6 2.38 2.38 (b)
Index components value CD: - CD: -
1.92 1.92
B: 0.46 B: 0.46
at (MPa) CD:
2.35
B: 2.38
(mW) CD: 277 CD: 277 #
B: 60 B: 60
(mW) CD: 218 CD: 218
B: 52.4 B: 52.4

Associated (cm) -
acoustic parameters (cm) -

(cm) CD:
1.23
B: 2.36
(cm) -

(MHz) CD: CD: 2.44 CD: 2.44 #

3.06 B: 1.88 B: 1.88
B: 2.19
prr (Hz) CD: 99
B: 9
srr (Hz) 9

CD: 11
B: 1
Other information at (W/cm²) CD:
164
B: 118
at (mW/cm²) CD: 35
B: 5
at (mW/cm²) CD: 46
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
B: 8
at (MPa) CD:
2.69
B: 3.17
Condition 1 MI TIS TIB #

Operating control Condition 2 #

conditions Condition 3 #
Condition 4 #

CD: Color Doppler mode; B: B mode

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition1: General, B mode Fundamental, Focal zone 22 mm, GEN,

Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.6 2.77 3.03 (b)
Index components value P: 0.62 P: 0.45 P: 0.57 P: 1.3
F: 1.69 F: 0.27 F: 1.69 F: 1.27
B: 0.46 B: 0.46 B: 0.46 B: 0.46
at (MPa) P: 2.55
F: 1.29
B: 2.38
(mW) P: 56 P: 57 #
F: 365 F: 365
B: 60 B: 60
(mW) P: 52 P: 48
F: 126 F: 126
B: 52 B: 52
Associated (cm) P: 2.42
acoustic parameters F: 3.25
(cm) P: 5.25
F: 3.25
(cm) B: 2.36
(cm) P: 1.2
F: 1.34
(MHz) P: 2.5 P: 2.5 P: 2.5 #
F: 2.81 F: 2.81 F: 2.81
B: 2.19 B: 2.31 B: 2.31
prr (Hz) P: 1
F: 42
B: 6
srr (Hz) 1

P: 1
Other information
F: 42
B: 6
at (W/cm²) P: 10
F: 55
B: 415
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) P: 53
F: 5.2
B: 4.7
at (mW/cm²) P: 50
F: 5.5
B: 7.9
at (MPa) P: 2.38
F: 1.09
B: 2.37
Condition 1 MI #

Operating control Condition 2 TIS #

conditions Condition 3 TIB #
Condition 4 #

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

Condition 1: General, SWE Box position 45 mm, Std, Acoustic Power

0 dB

Condition 2: General, SWE Box position 75 mm, Std, Acoustic Power

0 dB

Condition 3: General, SWE Box position 70 mm, Std, Acoustic Power

0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.0 3.74 4.5 (b)
Index components value 3.74 2.1 2.42 4.5
at (MPa) 1.52

(mW) 332 246 #

(mW) 349 226

(cm) 2.57
Associated
acoustic parameters (cm) 5.8

(cm) -
(cm) 2.91

(MHz) 2.19 2.25 2.25 #

prr (Hz) 3787

srr (Hz) -
3787

Other information at (W/cm²) 276

at (mW/cm²) 549

at (mW/cm²) 876

at (MPa) 1.51

Condition 1 MI

Operating control Condition 2 TIS

conditions Condition 3 TIB
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, Focal zone 48 mm, SV 1.5 mm, Scale 65 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 180 mm, SV 3.0 mm, Scale 65 cm/s,
Acoustic Power 0 dB
Condition 3: General, Focal zone 180 mm, SV 10.0 mm, Scale 65 cm/
s, Acoustic Power 0 dB
 Operating Mode: M mode

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.0 (a) 4.5* (b)
Index components value # # 0.66 4.5
at (MPa) 1.77

(mW) # 68.6 #
(mW) # 59

(cm) #
Associated
acoustic parameters (cm) 3.65

(cm) -
(cm) 1.47

(MHz) 3 # 2.0 #

prr (Hz) 1000

srr (Hz) -
1

Other information at (W/cm²) 141

at (mW/cm²) 145

at (mW/cm²) 231

at (MPa) 1.98

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

* Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

Condition 1: GYN, Focal zone 18 mm, Acoustic Power 0 dB

Condition 2: GYN, Focal zone 180 mm, Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 4.5* 4.5* (b)
Index components value CD: - CD: -
4.73 4.73
B: 0.21 B: 0.21
at (MPa) CD:
2.77
B: 2.38
(mW) CD: 648 CD: 648 #
B: 27 B: 27
(mW) CD: 473 CD: 473
B: 21.2 B: 21.2

Associated (cm) -
acoustic parameters (cm) -

(cm) CD:
4.05
B: 4.46
(cm) -

(MHz) CD: CD: 2.06 CD: 2.06 #

2.75 B: 2.69 B: 2.69
B: 2
prr (Hz) CD:
140
B: 28
srr (Hz) 14
CD: 10
B: 2
Other information
at (W/cm²) CD:
252
B: 186
at (mW/cm²) CD:
486
B: 50
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) CD:
1213
B: 97
at (MPa) CD:
2.78
B: 2.37
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

CD: Color Doppler component; B: B component

* Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

Condition 1: B: Renal, B mode Harmonics, Focal zone 86 mm, GEN,

MED, Acoustic Power 0 dB

COL: GenOb, Box position 110mm, RES, MED, Acoustic Power 0dB

Condition 2: B: Thyroid, B mode Fundamental, Focal Zone 64 mm, PEN,

HD, Super Compound on, Acoustic Power 0 dB

COL: Liver, Box position 140mm, PEN, HD, Acoustic Power 0dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7** 4.5* 4.5* (b)
Index components value P: 0.52 P: 0.27 P: 0.2 P: 0.61
F: 4.02 F: 1.56 F: 4.02 F: 3.19
B: 0.96 B: 0.96 B: 0.96 B: 0.96
at (MPa) P: 2.52
F: 1.88
B: 2.38
(mW) P: 42.4 P: 16.5 #
F: 440 F: 440
B: 77.7 B: 77.7
(mW) P: 38.6 P: 14.7
F: 330 F: 330
B: 75 B: 75
Associated (cm) P: 3.96
acoustic parameters
F: 4.89
(cm) P: 3.9
F: 4.89
(cm) B: 4.46
(cm) P: 4.44
F: 4.18
(MHz) P: 1.8 P: 2.83 P: 2.83 #
F: 2.75 F: 2.5 F: 2.5
B: 2.0 B: 2.1 B: 2.1
prr (Hz) P: 1
F: 42
B: 6
srr (Hz) 1
P: 1
Other information F: 42
B: 6
at (W/cm²) P: 158
F: 126
B: 186
at (mW/cm²) P: 258
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 7.6
B: 10.9
at (mW/cm²) P: 465
F: 17.3
B: 1.8
at (MPa) P: 3.14
F: 2.76
B: 3.23
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

*Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

***: Highest MI of the each composing mode is higher than 1.7, however,
the system controls the voltage in order limit the MI to 1.7.

Condition 1: PUSH and FLAT: General, SWE Box position 55mm, Res,
HD, Acoustic Power 0 dB

B: Renal, B mode Harmonics, Focal zone 86 mm, GEN, MED, Acoustic

Power 0 dB

Condition 2: PUSH and FLAT: General, SWE Box position 85mm, Res,
HD, Acoustic Power 0 dB

B: Thyroid, B mode Fundamental, Focal Zone 64 mm, PEN, HD, Super

Compound on, Acoustic Power 0 dB

Condition 3: PUSH and FLAT: General, SWE Box position 35mm, Res,
HD, Acoustic Power 0 dB

B: Thyroid, B mode Fundamental, Focal Zone 64 mm, PEN, HD, Super

Compound on, Acoustic Power 0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.6 2.88 4.5* (b)
Index components value 2.88 2.05 1.81 4.98
at (MPa) 2.37

(mW) 282 209 #

(mW) 269 172

(cm) 2.57
Associated
acoustic parameters (cm) 4.95

(cm) -
(cm) 3.47

(MHz) 2.19 2.25 2.2 #

prr (Hz) 748

srr (Hz) -
1

Other information at (W/cm²) 229

at (mW/cm²) 543

at (mW/cm²) 658

at (MPa) 3.08

Condition 1 MI

Operating control Condition 2 TIS

conditions Condition 3 TIB
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

* Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

Condition 1: General, Focal zone 32 mm, SV 3.0 mm, Scale 13 cm/s,

Acoustic Power 0 dB
Condition 2: General, Focal zone 180 mm, SV 1 mm, Scale max,
Acoustic Power 0 dB

Condition 3: General, Focal zone 86 mm, SV 7.5 mm, Scale max,

Acoustic Power 0 dB
 Operating Mode: M Mode

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.8 3.51 (b)
Index components value 1.8 1.26 1.43 3.51
at (MPa) 2.38

(mW) 244 94 #
(mW) 187 75

(cm) 4.33
Associated
acoustic parameters (cm) 4.37

(cm) -
(cm) 4.46

(MHz) 2.0 2.0 1.81 #

prr (Hz) 1000

srr (Hz) -
1

Other information at (W/cm²) 50

at (mW/cm²) 299

at (mW/cm²) 500

at (MPa) 2.37

Condition 1 MI

Operating control Condition 2 TIS

conditions Condition 3 TIB
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition1: Abdominal, B mode Harmonics, Focal zone 32 mm, RES,

MED, Acoustic Power 0 dB

Condition2: Abdominal, B mode Harmonics, Focal zone 180 mm, GEN,

MED, Acoustic Power 0 dB
Condition3: Abdominal, B mode Harmonics, Focal zone 66 mm, GEN,
MED, Acoustic Power 0 dB
 Operating Mode: 2D + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 (a) (a) (b)
Index components value # - # -
at (MPa) CD:
3.27
B: 3.6
(mW) # # #
(mW) # #

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
0.79
B: 0.74
(cm) -

(MHz) CD: # # #
6.63
B: 4.75
prr (Hz) CD:
275
B: 25
srr (Hz) 25

CD: 11
B: 1
at (W/cm²) CD:
Other information 250
B: 310
at (mW/cm²) CD: 31
B: 8
at (mW/cm²) CD: 67
B: 8
at (MPa) CD:
3.23
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
B: 3.16
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

CD: Color Doppler component; B: B component

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, B mode Fundamental, Focal zone 22 mm, PEN,

FR, Color Pen Med, Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 1.63 2.38 (b)
Index components value P: 0.46 P: 0.2 P: 0.4 P: 1.16
F: 0.67 F: 0.5 F: 0.67 F: 0.71
B: 0.5 B: 0.5 B: 0.5 B: 0.5
at (MPa) P: 3.38
F: 2.25
B: 3.36
(mW) P: 92 P: 92 #
F: 42.8 F: 42.8
B: 32.1 B: 32.1
(mW) P: 77.9 P: 74.9
F: 31.3 F: 31.3
B: 23.2 B: 23.2
Associated (cm) P: 1.85
acoustic parameters F: 1.97
(cm) P: 1.95
F: 1.97
(cm) B: 0.74
(cm) P: 1.75
F: 0.5
(MHz) P: 4.35 P: 4.1 P: 4.1 #
F: 5 F: 4.5 F: 4.5
B: 4.13 B: 4.25 B: 4.25

prr (Hz) P: 1
F: 42
B: 20
srr (Hz) 1

P: 1
Other information
F: 42
B: 20
at (W/cm²) P: 246
F: 253
B: 311
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) P: 142
F: 8.3
B: 17.6
at (mW/cm²) P: 238
F: 9.5
B: 27.5
at (MPa) P: 4.35
F: 2.43
B: 4.29
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

Condition 1: General, SWE Box position 20 mm, Std, Acoustic Power

0 dB

Condition 2: General, SWE Box position 40 mm, Std, Acoustic Power

0 dB

Condition 3: General, SWE Box position 35 mm, Std, Acoustic Power

0 dB
 Operating Mode: PW Doppler
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.2 (a) 2.92 (b)
Index components value # # 1 2.92
at (MPa) 2.62

(mW) # 46.6 #
(mW) # 46.6

(cm) #
Associated
acoustic parameters (cm) 0.9

(cm) -
(cm) 2.1

(MHz) 4.63 # 4.5 #

prr (Hz) 2396

srr (Hz) -
1

Other information at (W/cm²) 272

at (mW/cm²) 296

at (mW/cm²) 611

at (MPa) 3.62

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, Focal zone 48 mm, SV 0.5 mm, Scale 31 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 22 mm, SV 3.0 mm, Scale 31 cm/s,

Acoustic Power 0 dB
 Operating Mode: M mode

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.6 (a) (a) (b)
Index components value # # # #
at (MPa) 3.32

(mW) # # #
(mW) # #

(cm) #
Associated
acoustic parameters (cm) #

(cm) -
(cm) 2.1

(MHz) 4.5 # # #

prr (Hz) 1000

srr (Hz) -
1

Other information at (W/cm²) 0.37

at (mW/cm²) 222

at (mW/cm²) 425

at (MPa) 1.98

Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: Early On, Focal zone 22 mm, GEN, Acoustic Power 0 dB

 Operating Mode: 2D + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.65 (a) (a) (b)
Index components value - - - -
at (MPa) CD:
3.02
B: 4.2
(mW) - - -
(mW) - -

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
0.76
B: 0.48
(cm) -

(MHz) CD: - - -
6.63
B: 6.75
prr (Hz) CD:
185
B: 40
srr (Hz) 40

CD: 5
B: 1
at (W/cm²) CD:
Other information
232
B: 584
at (mW/cm²) CD: 67
B: 42
at (mW/cm²) CD:
671
B: 65
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (MPa) CD:
2.9
B: 4.2
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

CD: Color Doppler component; B: B component

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

B: Prostate, B mode Fundamental, Focal zone 30 mm, GEN, Acoustic

Power 0 dB

COL : General, Focal Zone 14 mm, RES, Med, Acoustic Power 0 dB

 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.2 2.23 (a)
Index components value P: 0.26 P: 0.16 P: 0.3 P: 1.0
F: 1.08 F: 1.0 F: 1.1 F: 1.2
B: 0.05 B: 0.05 B: 0.05 B: 0.05
at (MPa) P: 3.47
F: 1.25
B: 1.65
(mW) P: 13.6 P: 15.5 -
F: 83.6 F: 83.6
B: 2.3 B: 2.3
(mW) P: 13.6 P: 13.6
F: 50.9 F: 50.9
B: 1.8 B: 1.8
Associated (cm) P: 1.76
acoustic parameters F: 1.97
(cm) P: 2.16
F: 1.97
(cm) B: 0.48
(cm) P: 2.16
F: 0.5
(MHz) P: 4.1 P: 4.1 P: 4.1 -
F: 4.38 F: 4.38 F: 4.38
B: 6.75 B: 4.25 B: 4.25

prr (Hz) P: 1
F: 786
B: 40
srr (Hz) 1

P: 1
Other information
F: 786
B: 40
at (W/cm²) P: 157
F: 240
B: 584
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) P: 147
F: 160
B: 42
at (mW/cm²) P: 266
F: 154
B: 66
at (MPa) P: 4.58
F: 2.25
B: 4.22
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3
Condition 4

(a) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

Condition 1: B: Prostate, B mode Fundamental, Focal zone 30 mm, GEN,

Acoustic Power 0 dB

F: General, Acoustic Power 0 dB.

P: General, SWE Box position depth 2 mm, SWE Box size depth 32 mm.

Condition 2: B: Prostate, B mode Fundamental, Focal zone 30 mm, GEN,

Acoustic Power 0 dB

F: General, Pen, Acoustic Power 0 dB.

P: General, SWE Box position depth 9.5 mm, SWE Box size depth 37
mm.

Condition 3: B: Prostate, B mode Fundamental, Focal zone 30 mm, GEN,

Acoustic Power 0 dB

F: General, Acoustic Power 0 dB.

P: General, SWE Box position depth 2 mm, SWE Box size depth 32 mm.
 Operating Mode: PW Doppler
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.38 (a) 2.92 (b)
Index components value - - 0.84 2.51
at (MPa) 2.92

(mW) - 39.4 -
(mW) - 39.4

(cm) #
Associated
acoustic parameters (cm) 0.9

(cm) -
(cm) 2.04

(MHz) 4.5 - 4.5 -

prr (Hz) 724

srr (Hz) 1
1

Other information at (W/cm²) 435

at (mW/cm²) 447

at (mW/cm²) 883

at (MPa) 3.9

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, SV Position depth 40 mm, SV size 2 mm, Scale

6.2 cm/s, Acoustic Power 0 dB

Condition 2: General, SV Position depth 50 mm, SV size 2 mm, Scale

170 cm/s (HPRF), Acoustic Power 0 dB
 Operating Mode: M mode

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.37 (a) (a) (b)
Index components value - - - -
at (MPa) 2.93

(mW) - - -
(mW) - -

(cm) -
Associated
acoustic parameters (cm) -

(cm) -
(cm) 2.1

(MHz) 5 - - -

prr (Hz) 1000

srr (Hz) 1
1

Other information at (W/cm²) 300.2

at (mW/cm²) 150

at (mW/cm²) 298

at (MPa) 3.66

Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: GYN, Focal zone 40 mm, PEN, Acoustic Power 0 dB

 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.85 (a) (a) (a)
Index components value # - # -
at (MPa) CD:
3.56
B: 4.59
(mW) # # #
(mW) # #

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
0.54
B: 0.83
(cm) -

(MHz) CD: # # #
6.63
B: 6.38
prr (Hz) CD:
225
B: 15
srr (Hz) 15
CD: 11
B: 1
at (W/cm²) CD:
Other information 435
B: 227
at (mW/cm²) CD: 40
B: 16
at (mW/cm²) CD: 52
B: 23
at (MPa) CD:
3.83
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
B: 5.46
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses
CD: Color Doppler component; B: B component

Condition 1: GYN, B mode Fundamental, Focal zone 14 mm, RES,

Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.85 1.51 3.09 (b)
Index components value P: 0.3 P: 0.19 P: 0.3 P: 1.17
F: 1.36 F: 1.08 F: 1.36 F: 1.67
B: 0.25 B: 0.25 B: 0.25 B: 0.25
at (MPa) P: 3.3
F: 3.4
B: 4.59
(mW) P: 15.5 P: 15.5 #
F: 86.3 F: 86.3
B: 7.67 B: 7.67
(mW) P: 15.5 P: 15.5
F: 65 F: 65
B: 7.38 B: 7.38
Associated (cm) P: 1.72
acoustic parameters
F: 1.87
(cm) P: 1.2
F: 1.87
(cm) B: 0.85
(cm) P: 1.79
F: 0.53
(MHz) P: 4.1 P: 4.1 P: 4.1 #
F: 5.63 F: 4.5 F: 4.5
B: 6.38 B: 7.13 B: 7.13
prr (Hz) P: 1.8
F: 77
B: 7
srr (Hz) 1.8
P: 1
Other information F: 43
B: 4
at (W/cm²) P: 401
F: 269
B: 658
at (mW/cm²) P: 480
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 17
B: 8
at (mW/cm²) P: 465
F: 21
B: 11
at (MPa) P: 4.38
F: 2.98
B: 5.46
Condition 1 MI TIS TIB

Operating control Condition 2

conditions Condition 3
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

Condition 1: General, SWE Box position 40 mm, PEN, Acoustic Power

0 dB
 Operating Mode: PW Doppler
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.63 (a) 2.21 (b)
Index components value # # 0.86 2.21
at (MPa) 1.95

(mW) # 40.1 #
(mW) # 40.1

(cm) #
Associated
acoustic parameters (cm) 2.1

(cm) -
(cm) 1.81

(MHz) 4.5 # 4.5 #

prr (Hz) 724

srr (Hz) -
1

Other information at (W/cm²) 401

at (mW/cm²) 113

at (mW/cm²) 218

at (MPa) 4.47

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, Focal zone 30 mm, SV 1.5 mm, Scale 6 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 60 mm, SV 2.5 mm, Scale 10 cm/s,

Acoustic Power 0 dB
 Operating Mode: M mode

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.85 (a) (a) (b)
Index components value # # # #
at (MPa) 4.59

(mW) # # #
(mW) # #

(cm) #
Associated
acoustic parameters (cm) #

(cm) -
(cm) 0.83

(MHz) 6.38 # # #

prr (Hz) 1000

srr (Hz) -
1

Other information at (W/cm²) 658

at (mW/cm²) 255

at (mW/cm²) 360

at (MPa) 5.46

Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: GYN, B mode Fundamental, Focal zone 14 mm, GEN,

Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 (a) (a) (b)
Index components value # - # -
at (MPa) CD:
4.12
B: 4.6
(mW) # # #
(mW) # #

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
1.28
B: 0.63
(cm) -

(MHz) CD: # # #
7.5
B: 7.75
prr (Hz) CD:
150
B: 15
srr (Hz) 15

CD: 10
B: 15
at (W/cm²) CD:
Other information 517
B: 896
at (mW/cm²) CD:
123
B: 2
at (mW/cm²) CD:
279
B: 2.5
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (MPa) CD:
5.53
B: 5.61
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

CD: Color Doppler component; B: B component

Condition 1: General, Bmode Harmonics, Focal zone 22 mm, RES,

Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 3.13 3.13 (b)
Index components value P: 0.24 P: 1.62 P: 0.24 P: 1.99
F: 2.51 F: 0.73 F: 2.51 F: 0.51
B: 0.38 B: 0.38 B: 0.38 B: 0.38
at (MPa) P: 4.05
F: 3.31
B: 5.37
(mW) P: 212 P: 212 #
F: 70.3 F: 70.3
B: 16.6 B: 16.6
(mW) P: 19.1 P: 19.1
F: 42.4 F: 42.4
B: 7.4 B: 7.4
Associated (cm) P: 1.79
acoustic parameters
F: 2.4
(cm) P: 1.79
F: 1.52
(cm) B: 0.66
(cm) P: 1.92
F: 1.24
(MHz) P: 6 P: 5 P: 5 #
F: 7.5 F: 7.5 F: 7.5
B: 7.75 B: 7.63 B: 7.63
prr (Hz) P: 2
F: 84
B: 24
srr (Hz) 2
P: 1
Other information F: 42
B: 12
at (W/cm²) P: 452
F: 312
B: 896
at (mW/cm²) P: 392
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 13.6
B: 9.3
at (mW/cm²) P: 450
F: 21
B: 11
at (MPa) P: 5.42
F: 4.08
B: 5.61
Condition 1 MI

Operating control Condition 2 TIS TIB #

conditions Condition 3
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

Condition 1: General, SWE Box position 20 mm, PEN, Acoustic Power

0 dB

Condition 2: Breast, SWE Box position 45 mm, PEN, Acoustic Power

0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.4 1.09 2.69 (b)
Index components value 1.09 0.77 0.9 2.69
at (MPa) 3.18

(mW) 45.9 35.9 #

(mW) 45.9 35.9

(cm) 1.1
Associated
acoustic parameters (cm) 1.1

(cm) -
(cm) 0.5

(MHz) 5 5 5.25 #

prr (Hz) 837

srr (Hz) -
1

Other information at (W/cm²) 378

at (mW/cm²) 487

at (mW/cm²) 574

at (MPa) 3.49

Condition 1 MI

Operating control Condition 2 TIS

conditions Condition 3 TIB
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, Focal zone 7 mm, SV 5.0 mm, Scale 6 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 68 mm, SV 2.5 mm, Scale 54 cm/s,

Acoustic Power 0 dB
Condition 3: General, Focal zone 52 mm, SV 1 mm, Scale 54 cm/s,
Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.23 1.23 (a)
Index components value CD: - CD: -
1.06 1.06
B: 0.17 B: 0.17
at (MPa) CD:
4.06
B: 4.11
(mW) CD: 21.2 CD: 21.2 -
B: 8.02 B: 8.02
(mW) CD: 19.3 CD: 19.3
B: 6.8 B: 6.8

Associated (cm) -
acoustic parameters (cm) -

(cm) CD:
1.29
B: 1.03
(cm) -

(MHz) CD: CD: 9 CD: 9 -

7.38 B: 5.63 B: 5.63
B: 6
prr (Hz) CD:
118
B: 6
srr (Hz) 19

CD: 6
B: 1
Other information
at (W/cm²) CD:
610
B: 749
at (mW/cm²) CD:
166
B: 101
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) CD:
354
B: 156
at (MPa) CD:
5.49
B: 4.95
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

(a) This probe is not intended for transcranial or neonatal cephalic uses

CD: Color Doppler component; B: B component

Condition 1: B: Breast, Bmode THI, Focal zone 68 mm, GEN, Acoustic

Power 0 dB

CD: Breast, Focal Zone 22 mm, GEN, Med, Acoustic Power 0 dB.
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 (a) 1.38 (b)
Index components value - P: 0.25 P: 0.65 -
F: 0.6 F: 0.56
B: 0.17 B: 0.17
at (MPa) P: 4.12
F: 3.69
B: 4.11
(mW) - P: 9.33 -
F: 43.5
B: 8.02
(mW) - P: 9.49
F: 17.2
B: 6.8
Associated
acoustic parameters (cm) -
(cm) P: 1.72
F: 2.54
(cm) B: 1.03
(cm) P: 1.25
F: 1.18
(MHz) P: 5.63 - P: 5.63 -
F: 7.5 F: 7.5
B: 6 B: 7.63
prr (Hz) P: 1
F: 624
B: 6
srr (Hz) 1
P: 1
F: 624
Other information
B: 19
at (W/cm²) P: 228
F: 353
B: 749
at (mW/cm²) P: 328
F: 187
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
B: 101
at (mW/cm²) P: 511
F: 353
B: 159
at (MPa) P: 4.96
F: 4.9
B: 4.95
Condition 1 MI

Operating control Condition 2 TIB -

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push component; F: Flat component; B: B component

Condition 1: B: Breast, Bmode THI, Focal zone 68 mm, GEN, Acoustic

Power 0 dB

F: Breast, Acoustic Power 0 dB.

P: Breast, std, SWE Box position depth 7.5 mm, SWE Box size depth
10.2 mm.

Condition 2: B: Breast, Bmode THI, Focal zone 68 mm, GEN, Acoustic

Power 0 dB

F: Breast, Acoustic Power 0 dB.

P: Breast, std, SWE Box position depth 26 mm, SWE Box size depth
10.2 mm.
 Operating Mode: PW Doppler
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.6 (a) 1.88 (b)
Index components value - - 0.64 1.73
at (MPa) 3.67

(mW) - 23.6 -
(mW) - 23.6

(cm) -
Associated
acoustic parameters (cm) 1.09

(cm) -
(cm) 1.15

(MHz) 5 - 5.75 #

prr (Hz) 837

srr (Hz) 1
1

Other information at (W/cm²) 632

at (mW/cm²) 487

at (mW/cm²) 574

at (MPa) 4.38

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: Breast, SV Position depth 20 mm, SV size 1.5 mm, Scale

6 cm/s, Acoustic Power 0 dB

Condition 2: Breast, SV Position depth 64 mm, SV size 0.5 mm, Scale

93 cm/s, Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.02 1.02 1.2
Index components value CD: - CD: -
0.93 0.93
B: 0.1 B: 0.1
at (MPa) CD:
3.28
B: 3.2
(mW) CD: 46.6 CD: 46.6 CD:
B: 3.7 B: 3.7 46.6
B: 3.7
(mW) CD: 44.4 CD: 44.4
B: 3.7 B: 3.7
Associated (cm) -
acoustic parameters
(cm) -

(cm) CD:
2.08
B: 1.98
(cm) -

(MHz) CD: CD: 4.5 CD: 4.5 CD:

3.75 B: 5.25 B: 5.25 4.5
B: 3.75 B: 5.25
prr (Hz) CD:
330
B: 30
srr (Hz) 30
CD: 11
Other information B: 1
at (W/cm²) CD: 41
B: 449
at (mW/cm²) CD:
274
B: 4.3
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) CD:
487
B: 5.6
at (MPa) CD:
3.58
B: 3.68
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

CD: Color Doppler mode; B: B mode

Condition 1: Abdomen, B mode Fundamental, Focal zone 52mm, PEN,

FR, Scale 6 cm/s, Acoustic Power 0 dB

Condition 2: LowExtVenous, Focal zone 68 mm, GEN, FR, box max

high, Scale 72 cm/s, Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 1.71 3.17 2.19
Index components value P: 0.61 P: 0.36 P: 0.62 P: 1.27
F: 0.8 F: 1.25 F: 1.97 F: 1.8
B: 0.1 B: 0.1 B: 0.1 B: 0.1
at (MPa) P: 3.34
F: 2.54
B: 3.42
(mW) P: 31.2 P: 31.2 P: 6.5
F: 109.9 F: 109.9 F:
B: 3.67 B: 3.67 109.9
B: 3.67
(mW) P: 31.2 P: 31.2
F: 38.3 F: 38.3
B: 3.67 B: 3.67
Associated
acoustic parameters (cm) P: 1.9
F: 2.1
(cm) P: 1.9
F: 2.1
(cm) B: 1.98
(cm) P: 1.88
F: 1.95
(MHz) P: 4.1 P: 4.1 P: 4.1 P: 4.1
F: 4.38 F: 4.38 F: 4.38 F: 4.38
B: 3.75 B: 5.25 B: 5.25 B: 5.25
prr (Hz) P: 1
F: 48
B: 6
srr (Hz) 1
P: 1
Other information
F: 48
B: 6
at (W/cm²) P: 243
F: 196
B: 449
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) P: 288
F: 83
B: 7
at (mW/cm²) P: 314
F: 155
B: 11
at (MPa) P: 3.76
F: 3.26
B: 4.09
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push mode; F: Flat mode; B: B mode

Condition1: General, SWE Box at 35mm, Std, B mode Harmonics, Pen,

Acoustic Power 0 dB

Condition2: General, SWE Box at 50mm, Std, B mode Fundamental,

Gen, Acoustic Power 0 dB
 Operating Mode: B + Trivu
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 2.13 3.77 2.86
Index components value P: 0.61 P: 0.36 P: 0.62 P: 1.27
F: 0.8 F: 1.25 F: 1.97 F: 1.8
CDF: CDF: CDF: CDF:
0.27 0.42 0.66 0.6
B: 0.1 B: 0.1 B: 0.1 B: 0.1
at (MPa) P: 3.34
F: 2.54
CDF:
2.54
B: 3.42
(mW) P: 31.2 P: 31.2 P: 6.5
F: 109.9 F: 109.9 F:
CDF: 36.63 CDF: 36.63 109.9
B: 3.67 B: 3.67 CDF:
36.63
B: 3.67
(mW) P: 31.2 P: 31.2
F: 38.3 F: 38.3
CDF: 12.8 CDF: 12.8
B: 3.67 B: 3.67
Associated (cm) P: 1.9
acoustic parameters
F: 2.1
CDF:
2.1
(cm) P: 1.9
F: 2.1
CDF:
2.1
(cm) B: 1.98
(cm) P: 1.88
F: 1.95
CDF:
1.95
(MHz) P: 4.1 P: 4.1 P: 4.1 P: 4.1
F: 4.38 F: 4.38 F: 4.38 F: 4.38
CDF: 4.38 CDF: 4.38
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
CDF: B: 5.25 B: 5.25 CDF:
4.38 4.38
B: 3.75 B: 5.25
prr (Hz) P: 1
F: 480
CDF:
160
B: 6
srr (Hz) 1
P: 1
F: 48
CDF:
160
B: 6
at (W/cm²) P: 243
F: 196
CDF:
196
Other information B: 449
at (mW/cm²) P: 288
F: 83
CDF:
27.7
B: 7
at (mW/cm²) P: 314
F: 155
CDF:
51.7
B: 11
at (MPa) P: 3.76
F: 3.26
CDF:
3.26
B: 4.09
Condition 1 MI
Operating control Condition 2 TIS TIB TIC
conditions
Condition 3
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Condition 4

(b) This probe is not intended for transcranial or neonatal cephalic uses

P: Push mode; F: Flat mode; F: Color Doppler Flat mode; B: B mode

Condition1: General, SWE Box at 35mm, Std, B mode Harmonics, Pen,

Acoustic Power 0 dB

Condition2: General, SWE Box at 50mm, Std, B mode Fundamental,

Gen, Acoustic Power 0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.2 1.7 4.5 2.7
Index components value 1.7 1.22 0.58 4.5
at (MPa) 2.34

(mW) 93.3 33.1 29.9

(mW) 93.3 33.1

(cm) 1.31
Associated
acoustic parameters (cm) 1.96

(cm) -
(cm) 2.28

(MHz) 3.75 3.75 4.125 3.75

prr (Hz) 628

srr (Hz) -
1

Other information at (W/cm²) 275

at (mW/cm²) 381

at (mW/cm²) 697

at (MPa) 2.99

Condition 1 MI

Operating control Condition 2 TIS

conditions Condition 3 TIB
Condition 4 TIC

Condition 1: General, Focal zone 52 mm, SV 2.5 mm, Scale 6 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 68 mm, SV 1.5 mm, Scale 80 cm/s,

Acoustic Power 0 dB

Condition 3: General, Focal zone 68 mm, SV 4.0 mm, Scale 80 cm/s,

Acoustic Power 0 dB
Condition 4: General, Focal zone 7 mm, SV 0.5 mm, Scale 80 cm/s,
Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 (a) (a) (a)
Index components value # - # -
at (MPa) CD:
3.67
B: 3.42
(mW) # # #
(mW) # #

(cm) -
Associated (cm) -
acoustic parameters
(cm) CD:
2.08
B: 1.98
(cm) -

(MHz) CD: # # #
5.38
B: 4.25
prr (Hz) CD:
275
B: 25
srr (Hz) 25
CD: 11
B: 2
at (W/cm²) CD:
Other information 296
B: 3.9
at (mW/cm²) CD:
152
B: 24
at (mW/cm²) CD:
222
B: 46
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (MPa) CD:
3.64
B: 5.12
Condition 1 MI

Operating control Condition 2

conditions Condition 3
Condition 4

CD: Color Doppler mode; B: B mode

(a) The maximum index value is less than 1

Condition1: General, B mode Fundamental, Focal zone 22 mm, GEN,

Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.8 1.46 2.25 2.31
Index components value P: 0.12 P: 0.08 P: 0.12 P: 0.37
F: 1.93 F: 1.18 F: 1.93 F: 1.44
B: 0.2 B: 0.2 B: 0.2 B: 0.2
at (MPa) P: 3.34
F: 2.85
B: 3.74
(mW) P: 6.32 P: 6.32 P: 6.32
F: 102.7 F: 102.7 F:
B: 11.49 B: 11.49 102.7
B: 10.8
(mW) P: 6.32 P: 6.32
F: 80.93 F: 80.93
B: 10.17 B: 10.17
Associated
acoustic parameters (cm) P: 1.72
F: 2.18
(cm) P: 1.72
F: 2.18
(cm) B: 2.19
(cm) P: 1.79
F: 2.36
(MHz) P: 4.1 P: 4.1 P: 4.1 P: 4.1
F: 5 F: 4.88 F: 4.88 F: 4.88
B: 4.25 B: 5.25 B: 5.25 B: 5.25
prr (Hz) P: 1
F: 42
B: 6
srr (Hz) 1
P: 1
Other information
F: 42
B: 6
at (W/cm²) P: 63
F: 232
B: 3.9
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) P: 146
F: 11
B: 4
at (mW/cm²) P: 135
F: 10
B: 7
at (MPa) P: 3.55
F: 2.29
B: 5.12
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

P: Push mode; F: Flat mode; B: B mode

Condition 1: General, SWE Box at 35mm, Std, B mode Harmonics, Pen,

Acoustic Power 0 dB

Condition 2: General, SWE Box at 50mm, Std, B mode Fundamental,

Gen, Acoustic Power 0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.3 1.84 3.97 2.85
Index components value 1.84 1.36 1.84 3.97
at (MPa) 2.75

(mW) 88.5 88.5 88.5

(mW) 88.5 256.7

(cm) 1.16
Associated
acoustic parameters (cm) 2.06

(cm) -
(cm) 0.92

(MHz) 4.5 4.5 4.5 4.5

prr (Hz) 724

srr (Hz) -
1

Other information at (W/cm²) 269

at (mW/cm²) 157

at (mW/cm²) 172

at (MPa) 2.43

Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

Condition 1: General, Focal zone 22 mm, SV 1.0 mm, Scale 6 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 68 mm, SV 2.0 mm, Scale max,

Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 3.08 3.08 4.5*
Index components value CD: - CD: -
2.02 2.02
B: 1.06 B: 1.06
at (MPa) CD:
1.85
B: 2.28
(mW) CD: 149 CD: 149 CD:
B: 109 B: 109 149
B: 109
(mW) CD: 105 CD: 105
B: 93 B: 93
Associated (cm) -
acoustic parameters
(cm) -

(cm) CD:
4.84
B: 3.61
(cm) -

(MHz) CD: CD: 2.42 CD: 2.42 CD:

2.4 B: 2.4 B: 2.4 2.42
B: 1.9 B: 2.4
prr (Hz) CD:
248
B: 8
srr (Hz) 8
CD: 8
Other information B: 4
at (W/cm²) CD:
202
B: 168
at (mW/cm²) CD:
185
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
B: 13
at (mW/cm²) CD:
419
B: 45
at (MPa) CD:
2.93
B: 2.4

Operating control Condition 1 MI

conditions Condition 2 TIS TIB TIC

CD: Color Doppler component; B: B component

* Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

Condition 1: TCD. B: mode Harmonics, Focal zone 30 mm, GEN,

Acoustic Power 0 dB. CD: Focal zone 40 mm, RES, Acoustic Power 0
dB.

Condition 2: TCD. B: mode Fundamental, Focal zone 100 mm,

GEN,Acoustic Power 0 dB. CD: Focal zone 100 mm, RES, Acoustic
Power 0 dB
 Operating Mode: PW Doppler
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.5 3.56 4.5* ** 4
Index components value 1.73 1.78 0.92 2.4
at (MPa) 1.64

(mW) 283 144 283

(mW) 190.7 198.5

(cm) 2.77
Associated
acoustic parameters (cm) 6.46

(cm) -
(cm) 5.42

(MHz) 1.875 1.9 1.95 1.9

prr (Hz) 1704

srr (Hz) -
1

Other information at (W/cm²) 104.2

at (mW/cm²) 479

at (mW/cm²) 849

at (MPa) 2.168

Condition 1 MI
Operating control
Condition 2 TIS TIC
conditions
Condition 3 TIB

*: Sum of TI from worst case of each composing mode is higher than 4.5,
however, the system controls the voltage in order to limit the TI to 4.5

**: Specific firing configuration that leads to an extrapolation of

acoustical parameters. Therefore an additional error factor has been taken
into account on the final TI value which is why the sum the Index
components values is not equal to the Maximum index value.

Condition 1: General, Focal zone 34 mm, SV 1.5 mm, Scale 35 cm/s,

Acoustic Power 0 dB
Condition 2: General, Focal zone 140 mm, SV 1.5 mm, Scale 60 cm/s,
Acoustic Power 0 dB

Condition 3: General, Focal zone 80 mm, SV 0.5 mm, Scale 90 cm/s,

Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.33 1.33 1.4
Index components value CD: - CD: -
0.87 0.87
B: 0.46 B: 0.46
at (MPa) CD:
4.81
B: 4.59
(mW) CD: 11.3 CD: 11.3 CD: 20
B: 17.4 B: 17.4 B: 12.8
(mW) CD: 11.3 CD: 11.3
B: 17.4 B: 17.4

Associated (cm) -
acoustic parameters (cm) -

(cm) CD:
0.97
B: 1.02
(cm) -

(MHz) CD: CD: 8.5 CD: 8.5 CD:

8.38 B: 7.38 B: 7.38 7.38
B: 7.13 B: 7.38
prr (Hz) CD:
132
B: 24
srr (Hz) 12
CD: 11
Other information B: 2
at (W/cm²) CD: 41
B: 449
at (mW/cm²) CD:
509
B: 226
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) CD:
898
B: 50
at (MPa) CD:
6.36
B: 5.76
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3 TIC
Condition 4

CD: Color Doppler mode; B: B mode

Condition 1: General, B mode Harmonics, Focal zone 14 mm, RES,

Acoustic Power 0 dB

Condition 2: General, Focal zone 40 mm, PEN, FR, Scale 72 cm/s,

Acoustic Power 0 dB

Condition 3: General, Focal zone 30 mm, PEN, FR, Scale 72 cm/s,

Acoustic Power 0 dB
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.61 2.01 2.51
Index components value P: 0.11 P: 0.06 P: 0.11 P: 0.3
F: 1.12 F: 1.01 F: 1.12 F: 1.23
B: 0.55 B: 0.55 B: 0.55 B: 0.55
at (MPa) P: 3.17
F: 4.4
B: 4.59
(mW) P: 3.3 P: 3.3 P: 3.3
F: 54.6 F: 54.6 F: 54.6
B: 25 B: 25 B: 25
(mW) P: 3.3 P: 3.3
F: 31.9 F: 31.9
B: 25 B: 25
Associated (cm) P: 1.59
acoustic parameters
F: 1.35
(cm) P: 1.59
F: 1.35
(cm) B: 1.02
(cm) P: 0.96
F: 0.93
(MHz) P: 6.94 P: 6.94 P: 6.94 P: 6.94
F: 7.13 F: 7.38 F: 7.38 F: 7.38
B: 7.13 B: 7.38 B: 7.38 B: 7.38
prr (Hz) P: 1
F: 42
B: 20
srr (Hz) 1
P: 1
Other information F: 42
B: 20
at (W/cm²) P: 234
F: 358
B: 611
at (mW/cm²) P: 94
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 4
B: 25
at (mW/cm²) P: 149
F: 7
B: 50
at (MPa) P: 3.99
F: 5.28
B: 5.76
Condition 1 MI

Operating control Condition 2 TIS TIB TIC

conditions Condition 3
Condition 4

P: Push mode; F: Flat mode; B: B mode

Condition 1: General, SWE Box pos 9 mm, Std, B mode Harmonics, Pen,
Acoustic Power 0 dB

Condition 2: General, SWE Box pos 24 mm, Std, B mode Fundamental,

Gen, Acoustic Power 0 dB
 Operating Mode: PW Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 (a) 1.75 1.2
Index components value # # 0.74 1.75
at (MPa) 1.75

(mW) # 20.6 12.5

(mW) # 20.6

(cm) #
Associated
acoustic parameters (cm) 0.9

(cm) -
(cm) 0.86

(MHz) 7.38 # 7.38 7.5

prr (Hz) 1207

srr (Hz) -
1

Other information at (W/cm²) 675

at (mW/cm²) 260

at (mW/cm²) 416

at (MPa) 4.84

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3 TIC
Condition 4

Condition 1: General, Focal zone 14 mm, SV 0.5 mm, Scale 8 cm/s,

Acoustic Power 0 dB

Condition 2: General, Focal zone 40 mm, SV 4.0 mm, Scale 80 cm/s,

Acoustic Power 0 dB

Condition 3: General, Focal zone 7 mm, SV 4.0 mm, Scale 80 cm/s,

Acoustic Power 0 dB
 Operating Mode: B + CD Doppler

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7 1.88 1.88 -
Index components value CD: - CD: -
1.1 1.1
B: 0.78 B: 0.78
at (MPa) CD:
4.25
B: 4.12
(mW) CD: 22.8 CD: 22.8 -
B: 24.5 B: 24.5
(mW) CD: 27.9 CD: 27.9
B: 23.5 B: 23.5

Associated (cm) -
acoustic parameters (cm) -

(cm) CD:
0.92
B: 0.82
(cm) -

(MHz) CD: CD: 8.5 CD: 8.5 -

6.63 B: 7 B: 7
B: 8.25
prr (Hz) CD:
145
B: 50
srr (Hz) 12
CD: 12
B: 4
Other information
at (W/cm²) CD:
517
B: 826
at (mW/cm²) CD:
367
B: 66
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
at (mW/cm²) CD:
672
B: 85
at (MPa) CD:
4.55
B: 4.95
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3
Condition 4

(a) This probe is not intended for transcranial or neonatal cephalic uses

CD: Color Doppler mode; B: B mode

Condition 1: B: Knee, Bmode THI, Focal zone 4 mm, PEN, Acoustic

Power 0 dB

CD: Breast, Focal Zone 14 mm, PEN, Med, Acoustic Power 0 dB.

Condition 2: B: General, Bmode THI, Focal zone 40 mm, PEN, Acoustic

Power 0 dB

CD: Breast, Focal Zone 68 mm, RES, FR, Acoustic Power 0 dB.
 Operating Mode: B + SWE

TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.7* 1.81 2.47 (a)
Index components value P: 0.07 P: 0.03 P: 0.11 P: 0.26
F: 0.97 F: 0.99 F: 0.97 F: 1.42
B: 0.78 B: 0.78 B: 0.78 B: 0.78
at (MPa) P: 4.92
F: 4.21
B: 4.12
(mW) P: 2.26 P: 2.23 -
F: 54.7 F: 54.7
B: 24.5 B: 24.5
(mW) P: 2.21 P: 3.27
F: 27.7 F: 54.7
B: 23.5 B: 23.5
Associated (cm) P: 1.7
acoustic parameters
F: 1.35
(cm) P: 1.36
F: 1.35
(cm) B: 0.84
(cm) P: 0.94
F: 0.96
(MHz) P: 6.94 P: 6.94 P: 6.94 -
F: 6.88 F: 7.38 F: 7.38
B: 8.25 B: 8.25 B: 8.25
prr (Hz) P: 1
F: 42
B: 50
srr (Hz) 1
P: 1
Other information F: 42
B: 50
at (W/cm²) P: 400
F: 359
B: 826
at (mW/cm²) P: 264
 TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
F: 121
B: 66
at (mW/cm²) P: 409
F: 203
B: 84
at (MPa) P: 6.68
F: 5.22
B: 4.95
Condition 1 MI

Operating control Condition 2 TIS TIB

conditions Condition 3
Condition 4

(a) This probe is not intended for transcranial or neonatal cephalic uses

*: The highest MI from the worst case of the composing mode is higher
than 1.9, however the system

P: Push mode; F: Flat mode; B: B mode

Condition 1: B: Knee, Bmode THI, Focal zone 4 mm, PEN, Acoustic

Power 0 dB

F: Breast, Acoustic Power 0 dB.

P: Knee, std, SWE Box position depth 5.3 mm, SWE Box size depth 10
mm.

Condition 2: B: General, Bmode THI, Focal zone 40 mm, PEN, Acoustic

Power 0 dB

F: Breast, Acoustic Power 0 dB.

B: General, Bmode THI, Focal zone 40 mm, PEN, Acoustic Power 0 dB

 Operating Mode: PW Doppler
TIS TIB
Index Label MI At Below At Below TIC
surface surface surface surface
Maximum index value 1.65 (a) 1.4 (b)
Index components value - - 0.49 1.41
at (MPa) 3.45

(mW) - 13.7 -
(mW) - 13.7

(cm) -
Associated
acoustic parameters (cm) 0.46

(cm) -
(cm) 0.9

(MHz) 7.25 - 7.5 -

prr (Hz) 2006

srr (Hz) 1
1

Other information at (W/cm²) 297

at (mW/cm²) 459

at (mW/cm²) 647

at (MPa) 3.83

Condition 1 MI

Operating control Condition 2 TIB

conditions Condition 3
Condition 4

(a) The maximum index value is less than 1.0

(b) This probe is not intended for transcranial or neonatal cephalic uses

Condition 1: General, SV Position depth 40 mm, SV size 0.5 mm, Scale

10.3 cm/s, Acoustic Power 0 dB

Condition 1: General, SV Position depth 4 mm, SV size 2 mm, Scale 150

cm/s, Acoustic Power 0 dB
Abbott, JG. Rationale and derivation of MI and TI - a review. Ultrasound
in Med. and Biol. 25:431-441; 1999.

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The detailed tables and equations listed below are available
in the Obstetrical References Guide. You may download it at
the following link: http://www.supersonicimagine.com/Aixplorer-R/
Women-s-Healthcare/Obstetrics.

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: L.J. Salomon, M. Duyme, J. Crequat, G. Brodaty, C. Talmant, N.

Fries and M. Althuser - CFEF - Collège Français d'Echographie Foetale,
Paris, France - Ultrasound Obstet Gynecol 2006; 28: 193-198, 2006
Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003
CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the
French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Jeanty: Jeanty P and Romero R, Obstetrical Ultrasound, McGraw-Hill,

1984

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754
ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal
Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986
Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in
Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Chitty: Altman D.G and Chitty L.S, New charts for ultrasound dating of
pregnancy, Ultrasound Obstet. Gynecol, Vol 10, pp 174-191, 1997

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991
Daya: Daya S, Woods S, Ward S, Lappalainen R and Caco R, Early
pregnancy assessment with transvaginal ultrasound scanning, CMAJ,
Vol 144(4), pp 441-446, 1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Chitty: Altman D.G and Chitty L.S, New charts for ultrasound dating of
pregnancy, Ultrasound Obstet. Gynecol, Vol 10, pp 174-191, 1997

Hadlock: Hadlock F.P, Deter R.L, Harrist R.B. and Park S.K, Estimating
fetal age: computer-assisted analysis of multiple fetal growth parameters,
Radiology, 152, pp 497-501, 1984

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986

Jeanty: Jeanty P and Romero R, Obstetrical Ultrasound, McGraw-Hill,

1984

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal

Measurement Standards for an Australian Population, ASUM, 2003

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754
ASUM: ASUM and Campbell Westerway S , Ultrasonic fetal
Measurement Standards for an Australian Population, ASUM, 2003

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986

CFEF: Crequat J, Duyme M and Brodaty G, Fetal growth charts by the

French College of fetal ultrasonography and the Inserm U 155 , Biometry
2000, 28, pp 435-455, 2000

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754

Jeanty: Ultrasonic Evaluation of Fetal Limb Growth, Jeanty et al., June

1982, Radiology 143: 751-754

CFEF: Courbe d'estimation de poids foetal 2014 par le CFEF - Janvier

2015 - Massoud M., Duyme M., Fontanges M., Collège Français
d'Echographie Foetale (CFEF), Combourieu D. - Journal de Gynécologie
Obstétrique et Biologie de la Reproduction - Accepté le 15 janvier 2015
Doubilet: J Ultrasound Med. 1997 Apr

Hadlock: Hadlock FP1, Harrist RB, Martinez-Poyer J, In utero analysis

of fetal growth: a sonographic weight standard, Radiology. 1991 Oct,
181(1):129-33.

Oken (all): BMC Pediatr. 2003, 3:6. Published online 2003 Jul 8.
doi:10.1186/1471-2431-3-3 A nearly continuous measure of birth weight
for gestational age using a United States national reference Emily Oken,
Ken P Kleinman, Janet Rich-Edwards, and Matthew W Gillman

Oken (females): BMC Pediatr. 2003, 3:6. Published online 2003 Jul 8.
doi:10.1186/1471-2431-3-6 A nearly continuous measure of birth weight
for gestational age using a United States national reference Emily Oken,
Ken P Kleinman, Janet Rich-Edwards, and Matthew W Gillman

Oken (males): BMC Pediatr. 2003, 3:6. Published online 2003 Jul 8.
doi:10.1186/1471-2431-3-6 A nearly continuous measure of birth weight
for gestational age using a United States national reference Emily Oken,
Ken P Kleinman, Janet Rich-Edwards, and Matthew W Gillman

Hadlock: Hadlock F.P, Harrist R.B, Carpenter R.J, Deter R.L and Park
S.K, Sonographic estimation of fetal weight. The value of femur length
in addition to head and abdomen measurements, Radiology, 150, pp
535-540, 1984

Merz: Merz E, Goldhofer W and Timor-Tritsch E , Ultrasound in

Gynecology and Obstetrics, Textbook and Atlas, Georg Thieme Verlag ,
1991

Hadlock: Hadlock F.P, Harrist R.B, Sharman R.S, Deter R.L, Park
S.K, Estimation of fetal weight with the use of head, body, and
femur measurements--a prospective study, Am.J.Obstet.Gynecol., 151,
pp 333-337, 1985

Hadlock: Hadlock F.P, Harrist R.B, Sharman R.S, Deter R.L, Park
S.K, Estimation of fetal weight with the use of head, body, and
femur measurements--a prospective study, Am.J.Obstet.Gynecol., 151,
pp 333-337, 1985

Hadlock: Hadlock F.P, Harrist R.B, Sharman R.S, Deter R.L, Park
S.K, Estimation of fetal weight with the use of head, body, and
femur measurements--a prospective study, Am.J.Obstet.Gynecol., 151,
pp 333-337, 1985

Hadlock: Hadlock F.P, Harrist R.B, Sharman R.S, Deter R.L, Park
S.K, Estimation of fetal weight with the use of head, body, and
femur measurements--a prospective study, Am.J.Obstet.Gynecol., 151,
pp 333-337, 1985
Hadlock: Hadlock F.P, Harrist R.B, Carpenter R.J, Deter R.L and Park
S.K, Sonographic estimation of fetal weight. The value of femur length
in addition to head and abdomen measurements, Radiology, 150, pp
535-540, 1984

Hansmann: Hansmann, Hackeloer, Staudach and Wittman, Ultrasound

Diagnosis in Obstetrics and Gynecology, Springer-Verlag, New York,
1986
 Acoustic Power
3D Imaging, 241 B-mode, 183
3D and SWE, 247 CEUS, 257
3D History Loop, 246 Color Modes, 217
3D Measurements, 247 M-mode, 265
Acquisition, 241 PW, 232
Multi Slice (MS), 245 SWE, 205
Multi-Planar Reconstruction Additional Video Devices, 23
(MPR), 242 Air Filters
Cleaning, 434
Recommended Cleaning
Frequency, 431
Absorption, 69
ALARA
Accessories
Applying ALARA with the
Gels, 132
System, 96
Transducer Sheaths, 134
Controlling energy, 81
Accuracy (see Measurements
Controlling exposure time, 81
Accuracy)
Controlling scanning technique,
Acoustic Output Detailed
82
Reporting, 455
Controlling system setup, 82
Mode Summary Table, 459
Effects of operating mode, 84
SC6-1 Transducer, 479
Effects of system capabilities,
SE12-3 Transducer, 495, 501
82
SEV12-3 Transducer, 507
Effects of transducer
SL10-2 Transducer, 524
capabilities, 84
SL15-4 Transducer, 462
Practicing the ALARA
SL18-5 Transducer, 471
Principle, 92
SLH20-6 Transducer, 547
The ALARA Principle, 81
SLH22-6 Transducer, 542
Alarm System, 110
SLV16-5 G3 Transducer, 519
Annotations
SLV16-5 Transducer, 513
Annotation Library, 274
SMC12-3 Transducer, 533
Home position, 274
Symbols, 457
Audio Adjustment, 120
XC6-1 Transducer, 487
XP5-1 Transducer, 538
AutoTGC (see Time Gain Clinical Data Export, 362
Compensation (TGC)) Clips
Play, 177
Color Modes, 209
B-Mode, 179 Color Flow imaging (CFI), 209
Scanning Tips, 199 Color Power imaging (CPI), 209
Baseline Directional Color Power
Color, 216 imaging (dCPI), 210
PW, 234 Scanning TIPS, 227
Beginning an Exam, 156 Color Priority, 218
BI-RADS, 324 Comparing images, 355
Bioeffects and Biophysics of Conformance Standards, 7
Ultrasound Interactions, 57 Contact Us
Biopsy China, 10
Biopsy Guidelines, 186 France, 9
Compatible Biopsy Guides, 144 Germany, 10
Blending, 219 North America, 9
Body Markers, 270 Service, 10
United Kingdom, 9
Continuing an Exam, 376
Cable Holder, 123 Contraindications, 6
Capturing Images and Clips, 349 Contrast Agent, 255
Cavitation Contrast Enhanced Ultrasound
Cavitation and Role of Gas Imaging (CEUS), 251
Bubbles, 73 Scanning TIPS, 260
Factors Generating Cavitation, Contrast Imaging (see Contrast
73 Enhanced Ultrasound Imaging
Types of Cavitation, 74 (CEUS))
CD/DVD Drive, 19 Control Panel
Certifications, 8 Cleaning, 433
Cleaning and Disinfection Cleaning Frequency, 431
Products, 443 How to Move the Control Panel,
Cleaning the System, 431 119
Clinical Application Examples How to Swivel the Control
Abdominal/Pelvic, 104 Panel, 119
Endocavitary (Non obstetrical), Knobology, 149
105 Customizing the System, 377
Musculoskeletal, 103 Administration, 391
Obstetrics, 107 Device Settings, 385
Pediatrics, 109 Measurements, 417
Small Parts, 102 System Diagnostics, 427
Vascular, 106 System/Display, 380
 Electromagnetic Emissions (see
Date and time, setting, 382 Declaration of Electromagnetic
Declaration of Electromagnetic Emissions)
Emissions, 50 Electromagnetic Interference, 45
Declaration of Immunity, 51 Ending an Exam, 163, 376
Depth, 171 Entering Patient Data, 157
DICOM Ethernet
Devices, 392 Configuration, 397
DICOM Conformance
Statement, 369
DICOM options, 389 Fine Angle Correct, 232
DICOM Printer, 357, 396 Flash, 257
DICOM Store, 393 Flash Power, 258
Icons, 167 Flash Suppression, 219
Digital Zoom, 175 Focal Zone (see Focal Zone
Dimensions of the system, 15 Management)
Disinfectants (see Cleaning and Focal Zone Management, 173
Disinfection Products) Foot Rests, 127
Disk Maintenance, 402 Footswitch, 18
Display Format Freeze, 171
M-mode, 266
PW, 233
SWE, 204 Gain, 172
Display unit, 203 Gel
Doppler Line, 230 Gel Holders, 124
Dual imaging, 176 Recommended Gels, 132
Duplex Mode (see Simultaneous Getting Started, 151
Duplex and Triple Modes)
DVD
Drive, location, 19 Handles, 126
How to eject, 360 Hard Drive Maintenance (see Disk
DVI Port, 19 Maintenance)
Dynamic Range Harmonic Imaging, 181
B-mode, 182 Heat Conduction Effect, 70
CEUS, 258 Hide Color, 215
Hide Patient Name, 177
High PRF, 235
Elasticity Range, 203
Electrical Operating
Requirements, 16 Icons (see Notification Icons)
Image Orientation
Left/Right, 176
 Top/Bottom, 176 Ejection Fraction, 286
Imaging Modes, 164 Ellipse, 277
Immunity (see Declaration of Follicle Counting, 284
Immunity) Functionalities, 296
Indications for Use, 6 Hip Angle, 280
Indices as Indicators of Thermal IMT, 281
and Mechanical Effects, 64 Multi Q-Box, 293
Intended Use, 5 PSV/EDV, 288
Invert PW Autotrace, 287
Color, 214 Q-Box, 292
PW, 233 Q-Box Ratio, 292
Q-Box Trace, 293
Trace, 278
Keyboard, 158 Volume, 279
Knobology, 149 Mechanical Index (MI), 65, 86,
166
Mechanisms for Thermal and Non-
Labeled Measurements (see Thermal Bioeffects, 60
Measurements) Modality Worklist, 160
Languages, 382 Monitor
Latex Cleaning, 433
Allergic Reactions, 141 Description, 118
Transducer Sheaths, 134 Display, 166
Left/Right (see Image Orientation Recommended Cleaning
Left/Right) Frequency, 431
Moving the System, 128
MPR (see Multi-Planar
M-Mode, 261 Reconstruction)
Measurements, 275 Multi Slice (MS), 245
% Area Reduction, 283 Active view, 245
% Diameter Reduction, 283 Display, 245
3D Measurements, 247 Navigation, 246
Accuracy, 299 Multi-Planar Reconstruction, 242
B-mode Ratio, 282 Active view, 242
Curved Distance, 197 Display, 242
d:D, 280 Navigation, 243
Depth, 279 Rotation, 243
Distance, 276 MVI, 256
Distance Ratio, 284
Doppler Slope, 289
Doppler Time, 287 Network
Doppler Trace, 289 Tools, 401
Notification Icons, 167
Query and Retrieve, 368

On-Cart Storage, 124

On/Off Radiation Force, 75
Symbols, 40 References, 553
Turning the System On and Off, Reports, 331
151 Generating Reports, 346
Opacity, 204 Report Builder, 333
Output Display Standard, 85 Retrospective Clip, 349
Reviewing an Exam, 352

Panoramic, 193
Patents, iii Safety
Patient Data Electrical Safety, 44
Creating a New Patient, 157 General Equipment Safety, 42
Editing Patient Data, 162 Mechanical Safety, 55
Loading a Patient file from the Safely Performing Ultrasound
Modality Worklist, 160 Examinations with the
Patient Directory, 353 SuperSonic Imagine System, 57
Patient Reports (see Reports) Thermal Safety, 54
Persistence Sample Volume
B-mode, 184 Position, 230
Color, 218 Size, 230
SWE, 206 Scale
Physical Overview, 13 Color, 214
POI, 256 PW, 234
Potential Hazards at High Output Scattering, 71
Levels, 59 Sector Size, 185
Power Sending a Study, 359
Cable, 130 Service, 10, 11
Switch, 151 ShearWave Elastography, 200
Presets, 406 Scanning TIPS, 208
Printers Sheaths
Additional Printer, 21 For the SC6-1, 135
Configuration, 392 For the SE12-3, 136
Integrated Printers, 21 For the SEV12-3, 136
Printing Images, 356 For the SL10-2, 139
Prospective Clip, 350 For the SL15-4, 135
Pulse Repetition Frequency (PRF) For the SL18-5, 135
PRF, 183 For the SLH20-6, 137
Pulsed Wave Doppler (PW), 228 For the SLV16-5, 137
 For the SMC12-3, 140 Auto TGC Offset, 184
For the XC6-1, 135 AutoTGC, 172
For the XP5-1, 139 ManualTouchTGC, 173
Simultaneous Duplex and Triple Timer, 257
Modes, 235 TissueTuner, 182
Smoothing Top/Bottom (see Image
Color, 217 Orientation Top/Bottom)
M-mode, 267 Touch Screen
SWE, 205 Cleaning, 433
Speakers, 120 Description, 170
Speed of Sound (see TissueTuner) Knobology, 150
Steering Transducers
Color, 217 Cleaning and Disinfection, 440
PW, 231 Connecting, 121
Storage Area, 124 Selecting, 155
Storing The System, 35 Sheaths, 134
SuperCompound, 183 Storing, 122
SuperRes, 184 Troubleshooting, 451
SWE (see ShearWave
Elastography)
SWE Optimization, 202 UltraFast Doppler, 219, 220
Sweep Speed, 235 Ultrasound Use, 58
Sweep Speed; M-mode, 266 Upgrades and Updates, 12
Symbols, 40 USB Ports, 17
System Configuration (see
Customizing the System)
System Overview, 115
Velocity Optimization, 215
Velocity Range, 203
Volume Measurements
Temperature, Pressure and 2D, 279
Humidity Limits, 35 3D, 247
TGC (see Time Gain
Compensation (TGC))
Thermal Bioeffects, 66
Thermal Index (TI), 86, 88, 166 Wall Filter
Thumbnails, 354 Color, 215
Thy-RADS, 327 PW, 234
Time and date, setting (see Date Wheel Locks, 127
and time, setting) Wide Image, 185
Time Gain Compensation (TGC), Worklist (see Modality Worklist)
172 Worksheet, 338
Adaptive TGC Mode, 173
Zoom, 174
HD Zoom, 174
 SuperSonic Imagine, S.A.
Les Jardins de la Duranne - Bât. E et F
510 rue René Descartes
F - 13857 Aix-en-Provence, Cedex - France

Telephone: +33 (0)442 99 24 32

Fax: +33 (0)442 52 59 21
Email: contactsFR@supersonicimagine.fr