Diagnostic Ultrasound System: Instruction Manual

DIAGNOSTIC ULTRASOUND
SYSTEM
Instruction Manual
Safety Instruction
(volume 1/2)
Instruction manuals consist of this
manual, Power Data Book, How to
Use and Measurement.
Before using this system, please read
this manual.
MN1-5853 rev.2
Copyright©Hitachi Aloka Medical, Ltd. All rights reserved.
Microsoft, Windows and Windows Media are either registered trademarks or trademarks of Microsoft Corporation in
the United States and/or other countries. McAfee logo and product names of McAfee are registered trademarks or
trademarks of McAfee, Inc. or its subsidiaries in the United States and other countries. All brand name, product name,
and system name are registered trademarks or trademarks of their respective owners. In this manual, ™ and ® are
omitted.
VS-FlexGrid Pro copyright©1999-2000 Videosoft Corporation. Portions of this software are based in part on the work
of the Independent JPEG Group.
MN1-5853 rev.2
Introduction
Introduction
This is an instruction manual for F31, a diagnostic ultrasound system.
Read the manual carefully before using the system. Take special note of the items in Chapter 1,
"Safety Precautions" of Safety Instruction manual.
Keep this manual securely for future reference.
Symbols Used in this Document
The following items are important in preventing harm or injury to the operator of the equipment
and the patient. There are 4 levels of harm/damage that can be caused by ignoring instructions
or displays and using the equipment incorrectly: "Danger", "Warning", "Caution", and "Note".
These types are indicated by the following symbols.
Indicates an imminently hazardous situation which, if not avoided, will result

in the death or serious injury of the operator of the equipment.
Indicates a hazardous situation which, if not avoided, may result in death or

serious injury.
Indicates a hazardous situation which, if not avoided, may result in slight or

moderate injury, or property damage.
Indicates a request concerning an item that must be observed in order to

prevent damage or deterioration to the equipment and also to ensure effective
use.
Cautions of cautions shows the following graphics.
This mark means the corresponding item is "alerted".
This mark means the corresponding item is "prohibited".
This mark means the corresponding item is "required".
MN1-5853 rev.2 3
Introduction
About the F31
The F31 is intended to be used by doctors and other qualified personnel in fracture diagnostics
and hemodynamic diagnostics.
However, this equipment is not designed to be used in ophthalmic ultrasound diagnosis, as its
sound intensity is not compliant with ophthalmic restrictions established by the FDA.
Only physicians and other qualified personnel should operate this equipment for diagnostic
purposes. Read section 1-1 of the Safety Instruction manual.
1) PRECAUTIONS Concerning the Use/Management of the F31
• Do not disassemble, repair or remodel this equipment or optional features without our
consent.
NOTE: Disassemble is removing the parts or options from the equipment using
tools.
NOTE: Remodel is installing or connecting the unspecified parts or equipment,

including replacement of power cord.
• Assemble of the equipment or optional accessories shall be performed by our third party
certified. Please contact one of our offices listed on back cover.
Assemble is installing and connecting the parts or optional accessories in the main
equipment using tools.
• Transporting this equipment (via automobile/ship) shall be performed by a third party

certified by the manufacturer. Please contact one of our offices listed on back cover.
• Please conduct routine cleaning and inspection of the equipment. Refer to Chapter 5 of the
Safety Instruction for details.
• Ensure that the output level of the scan conforms to the required duration of diagnosis.
• If any malfunction or abnormality is discovered during operation of the equipment, remove
the probe from the patient immediately and discontinue use. If any abnormality is observed
in the patient, provide proper care as quickly as possible. Refer to Chapter 4 of the Safety
Instructions for more information on dealing with the equipment appropriately. If the
malfunction is not listed in Chapter 4 of the Safety Instructions, contact one of our offices
listed on back cover.
2) PRECAUTIONS for the F31 Installation
This equipment is a medical electrical equipment that intended for use in hospitals,
research facilities. The equipment should be installed in accordance with the following
guidelines.
• Install in accordance with Chapter 3 of the Safety Instructions.
• Install in an environment that conforms to the operating environments indicated in section
2-2-1 of the Safety Instructions.
• Install in an environment that ensures electromagnetic compatibility, in accordance with
section 1-2-6 of the Safety Instructions, "Guideline for Electromagnetic Compatibility",
and Item 1-3, "Electromagnetic compatibility".
4 MN1-5853 rev.2
Introduction
NOTE: The electromagnetic compatibility (EMC) is ability of device to function satisfactorily in its
electromagnetic environment without introducing intolerable electromagnetic disturbance to
anything in that environment.
Classification of F31
• Protection against electric shock (ME equipment): class I • ME equipment

• Protection against electric shock (Applied parts): type BF Applied Parts
– Probe/scanner applied parts and parts treated as applied parts:

Refer to the following diagram (Probe/Scanner Pattern Diagram) and table.
B C A
connector
connector
C A
Figure:Probe/Scanner Pattern Diagram

Above illustrates a surface/intraoperative probe. Below shows a coelomic probe.
Applicable part Parts treated as applied

of body Applied part parts B - C length
Surface of body Ultrasonic irradiation area (D) A to B 100 cm
Intraoperative Ultrasonic irradiation area (D) A to B 20 cm
Endocavity A to C A to C -
– ECG
The 2-meter length of the ECG cable extending from the ECG electrodes is treated as
applied part (see diagram below).
2 meters
ECG electrodes
connector
ECG patient lead
• Protection against electric shock (Defibrillation-proof applied parts): Not suitable

• Protection against harmful ingress of water or particulate matter
– equipment: IPX0 (Ordinary equipment)

– Probe applied part: IPX7 (Watertight equipment)
• Suitability for use in an oxygen rich environment: Not suitable
• Method (s) of sterilization: Not suitable for sterilization/disinfection with medicinal
solution, gas or radiation.
• Mode of operation: Continuous operation
MN1-5853 rev.2 5
Introduction
Terms used in the book
Example Method Intended
Press ENTER. Press the specified switch on the operation panel Switches on the
(ENTER in the example). operation panel
(including the Rotary
Encoder)
Turn Rotary Encoder. Rotate a switch such as Rotary Encoder to the • Rotary Encoder
left and right. • Multi Gain
To the left: counterclockwise direction • B Gain
To the right: clockwise direction • DEPTH/ZOOM
Select Preset key. Press the specified key (Preset in the example) Keyboard
on the keyboard.
Select Set-Up. 1 Using trackball, move the pointer on the • Buttons or items on
button (Set-Up in the example). the screen
2 Press ENTER. • Thumbnails
• Toggle buttons
On:
Off:
• Radio buttons
On:
Off:
Preset (Set-Up > Menus in the bracket are shown hierarchy of the Tree View.
(Application) > 1 Press PRESET key.
Menu-Function) 2 Move the pointer to the Set-Up and press ENTER.
3 Move the pointer to the preset ((Application) in the example) and press
ENTER. Repeat until a specified preset is displayed.
Warning regarding the software used for this instrument
Regarding the software installed in this instrument, the following is prohibited.
1) Reselling, assigning, or transferring the software itself

2) Reverse engineering, reverse compiling, or reverse assembling
3) Modification, alteration or translation
4) Creating copies or duplicates
5) Leasing to third parties
6 MN1-5853 rev.2
Introduction
License Agreement
Microsoft Software License Terms
Notes on Microsoft Software License Terms
This ultrasound diagnostic system uses Windows operating system, a product of Microsoft
Corporation in the United States.
Details regarding Windows license terms are described in the following pages. Please read these
terms before using the ultrasound diagnostic system.
Terminology that appears in the license terms is defined as follows;
• "This device" refers to the ultrasound diagnostic system.

• "This software" refers to Windows.
• "[OEM]" refers to Hitachi Aloka Medical Corporation.
• "Other software" refers to the ultrasound diagnostic system software and other related
software.
For the Microsoft Software License Terms, the following restrictions are given priority to
ensure safe and stable operation of the ultrasound diagnostic system. Confirm all of the
following;
• Only Windows functions, updates, add-on software, Internet-based services, and support
services authorized by Hitachi Aloka Medical Corporation can be used.
• Internet-related services cannot be used except for Sentinel customer service.
• Terminal services, file services, print services, Internet information services, and Internet
connection sharing and telephony services cannot be used.
• The remote boot feature cannot be used.
• Remote access technologies such as Remote Desktop cannot be used.
• Windows Update Agent (Software Update Services) cannot be used.
• Backup copies of Windows cannot be made.
For inquiries to Hitachi Aloka Medical Corporation regarding these license terms, please
contact service support.
MN1-5853 rev.2 7
Introduction
Windows XP Embedded and Windows Embedded Standard Runtime
These license terms are an agreement between you and [OEM]. Please read them. They apply
to the software included on this device. The software also includes any separate media on which
you received the software.
The software on this device includes software licensed from Microsoft Corporation or its
affiliate.
The terms also apply to any Microsoft.
• Updates
• Supplements
• Internet-based services
• Support services
for this software, unless other terms accompany those items. If so, those terms apply. If you
obtain updates or supplements directly from Microsoft, then Microsoft, and not [OEM], licenses
those to you.
As described below, using some features also operates as your consent to the transmission of
certain standard computer information for Internet-based services.
By using the software, you accept these terms. If you do not accept them, do not use or copy
the software. Instead, contact [OEM] to determine its return policy for a refund or credit.
If you comply with these license terms, you have the rights below.
1) Use Rights.
You may use the software on the device with which you acquired the software.
2) Additional Licensing Requirements and/or Use Rights.
a) Specific Use. [OEM] designed this device for a specific use. You may only use the software
for that use.
b) Other Software. You may use other programs with the software as long as the other
programs.
– Directly support the manufacturer’s specific use for the device.

– Provide system utilities, resource management, or anti-virus or similar protection.
Software that provides consumer or business tasks or processes may not be run on the
device. This includes email, word processing, spreadsheet, database, scheduling and
personal finance software. The device may use terminal services protocols to access such
software running on a server.
c) Device Connections.
– You may use terminal services protocols to connect the device to another device run-
ning business task or processes software such as email, word processing, scheduling
or spreadsheets.
– You may allow up to ten other devices to access the software to use.
8 MN1-5853 rev.2
Introduction
• File Services
• Print Services
• Internet Information Services
• Internet Connection Sharing and Telephony Services
The ten connection limit applies to devices that access the software indirectly through
“multiplexing” or other software or hardware that pools connections. You may use
unlimited inbound connections at any time via TCP/IP.
3) Scope of License.
The software is licensed, not sold. This agreement only gives you some rights to use the
software. [OEM] and Microsoft reserve all other rights. Unless applicable law gives you
more rights despite this limitation, you may use the software only as expressly permitted
in this agreement. In doing so, you must comply with any technical limitations in the
software that allow you to use it only in certain ways. For more information, see the
software documentation or contact [OEM]. Except and only to the extent permitted by
applicable law despite these limitations, you may not;
• Work around any technical limitations in the software.

• Reverse engineer, decompile or disassemble the software.
• Make more copies of the software than specified in this agreement.
• Publish the software for others to copy.
• Rent, lease or lend the software.
• Use the software for commercial software hosting services.
Except as expressly provided in this agreement, rights to access the software on this
device do not give you any right to implement Microsoft patents or other Microsoft
intellectual property in software or devices that access this device.
You may use remote access technologies in the software such as Remote Desktop to
access the software remotely from another device. You are responsible for obtaining any
licenses required for use of these protocols to access other software.
• Remote Boot Feature. If the [OEM] enabled the device Remote Boot feature of the
software, you may.
i) use the Remote Boot Installation Service (RBIS) tool only to install one copy of the
software on your server and to deploy the software on licensed devices as part of the
Remote Boot process.
ii) use the Remote Boot Installation Service only for deployment of the software to
devices as part of the Remote Boot process.
iii) download the software to licensed devices and use it on them.
For more information, please refer to the device documentation or contact [OEM].
• Internet-Based Services. Microsoft provides Internet-based services with the software.

Microsoft may change or cancel them at any time.
MN1-5853 rev.2 9
Introduction
i) Consent for Internet-Based Services. The software features described below connect
to Microsoft or service provider computer systems over the Internet. In some cases,
you will not receive a separate notice when they connect. You may switch off these
features or not use them. For more information about these features, visit
http://www.microsoft.com/windowsxp/downloads/updates/sp2/docs/privacy.mspx.
By using these features, you consent to the transmission of this information. Microsoft
does not use the information to identify or contact you.
ii) Computer Information. The following features use Internet protocols, which send to
the appropriate systems computer information, such as your Internet protocol address,
the type of operating system, browser and name and version of the software you are
using, and the language code of the device where you installed the software.
Microsoft uses this information to make the Internet-based services available to you.
• Web Content Features. Features in the software can retrieve related content from
Microsoft and provide it to you. To provide the content, these features send to
Microsoft the type of operating system, name and version of the software you are
using, type of browser and language code of the device where the software was
installed. Examples of these features are clip art, templates, online training,
online assistance and Appshelp. These features only operate when you activate
them. You may choose to switch them off or not use them.
• Digital Certificates. The software uses digital certificates. These digital
certificates confirm the identity of Internet users sending X.509 standard
encrypted information. The software retrieves certificates and updates certificate
revocation lists. These security features operate only when you use the Internet.
• Auto Root Update. The Auto Root Update feature updates the list of trusted
certificate authorities. You can switch off the Auto Root Update feature.
• Windows Media Player. When you use Windows Media Player, it checks with
Microsoft for
• Compatible online music services in your region

• New versions of the player
• Codecs if your device does not have the correct ones for playing content.
You can switch off this feature. For more information, go to:
http://microsoft.com/windows/windowsmedia/mp10/privacy.aspx.
10 MN1-5853 rev.2
Introduction
• Windows Media Digital Rights Management. Content owners use Windows

Media digital rights management technology (WMDRM) to protect their
intellectual property, including copyrights. This software and third party
software use WMDRM to play and copy WMDRM-protected content. If the
software fails to protect the content, content owners may ask Microsoft to revoke
the software’s ability to use WMDRM to play or copy protected content.
Revocation does not affect other content. When you download licenses for
protected content, you agree that Microsoft may include a revocation list with the
licenses. Content owners may require you to upgrade WMDRM to access their
content. Microsoft software that includes WMDRM will ask for your consent
prior to the upgrade. If you decline an upgrade, you will not be able to access
content that requires the upgrade. You may switch off WMDRM features that
access the Internet. When these features are off, you can still play content for
which you have a valid license.
iii) Misuse of Internet-based Services. You may not use these services in any way that
could harm them or impair anyone else’s use of them. You may not use the services
to try to gain unauthorized access to any service, data, account or network by any
means.
4) Windows Update Agent (also known as Software Update Services). The software on the
device includes Windows Update Agent (“WUA”) functionality that may enable your
device to connect to and access updates (“Windows Updates”) from a server installed
with the required server component. Without limiting any other disclaimer in this
Micrososoft Software License Terms or any EULA accompanying a Windows Update,
you acknowledge and agree that no warranty is provided by MS, Microsoft Corporation
or their affiliates with respect to any Windows Update that you install or attempt to install
on your device.
5) Product Support. Contact [OEM] for support options. Refer to the support number
provided with the device.
6) Backup Copy. You may make one backup copy of the software. You may use it only to
reinstall the software on the device.
7) Proof Of License. If you acquired the software on the device, or on a disc or other media,
a genuine Certificate of Authenticity label with a genuine copy of the software identifies
licensed software. To be valid, this label must be affixed to the device, or included on or
in [OEM]’s software packaging. If you receive the label separately, it is not valid. You
should keep the label on the device or packaging to prove that you are licensed to use the
software. To identify genuine Microsoft software, see http://www.howtotell.com.
8) Transfer to a Third Party. You may transfer the software only with the device, the
Certificate of Authenticity label, and these license terms directly to a third party. Before
the transfer, that party must agree that these license terms apply to the transfer and use of
the software. You may not retain any copies of the software including the backup copy.
9) Not Fault Tolerant. The software is not fault tolerant. [OEM] installed the software on
the device and is responsible for how it operates on the device.
MN1-5853 rev.2 11
Introduction
10) Restricted Use. The Microsoft software was designed for systems that do not require
fail-safe performance. You may not use the Microsoft software in any device or system
in which a malfunction of the software would result in foreseeable risk of injury or death
to any person. This includes operation of nuclear facilities, aircraft navigation or
communication systems and air traffic control.
11) No Warranties for the Software. The software is provided “as is”. You bear all risks of
using it. Microsoft gives no express warranties, guarantees or conditions. Any warranties
you receive regarding the device or the software do not originate from, and are not
binding on, Microsoft or its affiliates. When allowed by your local laws, [OEM] and
Microsoft exclude implied warranties of merchantability, fitness for a particular purpose
and non-infringement.
12) Liability Limitations. You can recover from Microsoft and its affiliates only direct
damages up to two hundred fifty U.S. Dollars (U.S. $250.00). You cannot recover any
other damages, including consequential, lost profits, special, indirect or incidental
damages. This limitation applies to;
• Anything related to the software, services, content (including code) on third party internet
sites, or third party programs.
• Claims for breach of contract, breach of warranty, guarantee or condition, strict liability,
negligence, or other tort to the extent permitted by applicable law.
It also applies even if Microsoft should have been aware of the possibility of the damages.
The above limitation may not apply to you because your country may not allow the
exclusion or limitation of incidental, consequential or other damages.
13) Export Restrictions. The software is subject to United States export laws and regulations.
You must comply with all domestic and international export laws and regulations that
apply to the software. These laws include restrictions on destinations, end users and end
use. For additional information, see www.microsoft.com/exporting.
12 MN1-5853 rev.2
Introduction
McAfee Embedded Control
The terms of this license agreement constitute the entire agreement between you and Hitachi
Aloka Medical, Ltd. Please carefully read through the terms of the license agreement listed
below. These license terms apply to the software included on this system. They also apply when
the software has been installed on other media.
This system includes software provided under a license agreement with McAfee, Inc. and its
subsidiaries (hereafter referred to as "McAfee"). These license terms also apply to any McAfee
• Updates
• Supplements
• Support services
for this software, except where these are accompanied by other terms, in which case those terms
apply.
By using this software, you agree to accept these terms. If you do not accept these terms, please
do not use the software. Instead, contact Hitachi Aloka Medical, Ltd. to determine their return
policy for a refund or credit.
If you comply with these license terms, you are entitled to the rights listed below
Software License Agreement
Hitachi Aloka Medical, Ltd. (hereafter referred to as "we" or "us") grants you permission to use
the software (the software program and its related documentation are hereafter collectively
referred to as "the software") provided for under this agreement subject to the following terms.
The use of this software is deemed as acceptance of all of the terms of this license agreement.
If you do not accept them, please do not use the software.
1) Intellectual Property
All copyright and other intellectual property rights inherent to the software belongs to the
software developer and the software is protected by the copyright laws, and any other
applicable rules and regulations, of the country in which it is used. You must therefore
handle the software in the same manner as any other copyrighted work.
2) Granted Usage Rights
a) The user is granted a non-exclusive right to use the software subject to the terms of this
agreement.
b) This software has been designed for a specific purpose. You may use it only for that
purpose.
MN1-5853 rev.2 13
Introduction
3) Scope of License
This software is licensed, not sold. This agreement only gives you limited rights to use
the software. We and the developer of this software reserve all other rights. You must
comply with any technical limitations in the software that only allow you to use it in
certain ways. Except and only to the extent otherwise permitted by applicable laws, you
may not;
a) Work around any technical limitations in the software.

b) Reverse engineer, decompile or disassemble the software.
c) Make copies of the software.
d) Publish the software for others to copy.
e) Rent, lease or lend the software.
4) Limitations
a) Unless expressly permitted by this license agreement, you may not copy or alter the
software, in part or in whole.
b) You may not remove copyright notices or notices of other rights from the software or
related documentation.
c) This software is not designed for life-sustaining purposes or systems that involve a high
level of risk and must therefore not be used in nuclear facilities, aircraft control or air traffic
control systems, life supporting systems, weapons or similar systems.
5) Limited Warranty
a) We and the developer of this software (hereafter referred to as "we" or "us") assume no
liability whatsoever to any person or entity for damages or losses allegedly caused by the
use of the software or the failure to use the software, including business interruptions, data
loss, financial loss or loss of anticipated profit, loss of business information, legal expenses,
technicians’ fees, court expenses or other financial damages that have been incurred as a
result of the use of the software, even if we had been directly or indirectly advised of the
possibility of such damages beforehand. This software is provided "as is" and we make no
claims with regard to its fitness for any purpose. The software may not be free from errors
and we do not guarantee uninterrupted operation. By using this software, you acknowledge
that you are aware of and accept the fact that file changes potentially caused by a computer
virus infection may lead to unforeseen changes in these files as a result of the processes
used to remove said viral infection.
b) We provide no warranty with respect to the software except in the cases stated in paragraph
c) below.
c) If we produce a bug fix for the software within a period of less than six months after a
customer’s initial purchase of the software , we will provide said customers with the revised
software, or software intended to rectify the bug (such software is hereafter referred to as
"revised software") or provide information regarding such revisions. However, the
determination of the need for providing revised software or information regarding such
revised software, as well as when and how it is provided, is entirely at our discretion. The
revised software provided to customers is regarded as part of this software. The above
exception is the sole warranty that we provide for the recording media of the software.
14 MN1-5853 rev.2
Introduction
6) Liability Limitations
Our and the software developer's (hereafter referred to as "we," "us" or "our") liability
and the customer's avenues of recourse are described below.
a) We accept no liability whatsoever for damages incurred by the customer in the use of the
software. However, this may not be the case in the event that liability is found to be
attributable to us.
b) However, even in the event that we are found to be liable for damages due to the above
paragraph a) or applicable laws and/or regulations, our liability to you is limited to no more
than half of the price that you paid for this software within the 12 months prior to the action
or event giving rise to liability and we accept no liability for damages (normal damages)
normally arising from failure, negligence or illegal activities deemed to exceed commonly
accepted norms and/or special or indirect damages of any kind arising from data loss, loss
of business opportunities and/or loss of revenue, even if we had been advised of the
possibility of such damages beforehand.
7) Other Details
a) You must comply with all laws and regulations of the country of export and all applicable
international laws and regulations when exporting the software (including related
documentation) from the country of export. This software includes software created in the
United States and must therefore comply with the Export Administration Regulations
(EAR) of the United States.
b) This license agreement is proof of the right to use this software and must therefore be
retained by the customer.
MN1-5853 rev.2 15
Contents
1 Safety Precautions
1-1 Purpose of Use ...................................................................................................................... 1-1
1-2 Precautions for Use ............................................................................................................... 1-2
1-2-1 Warnings and Safety Notice .................................................................................................... 1-3
1-2-2 Labels ...................................................................................................................................... 1-6
1-2-3 Precautions concerning acoustic power ................................................................................ 1-11
1-2-4 Precautions for Use in Conjunction with Drugs ..................................................................... 1-12
1-2-5 Precautions for Use in Conjunction with Other Medical Devices........................................... 1-13
1-2-6 Guideline for Electromagnetic Compatibility.......................................................................... 1-14
1-3 Electromagnetic compatibility .............................................................................................. 1-16
1-3-1 Guidance and manufacturer’s declaration - electromagnetic emissions ............................... 1-16
1-3-2 Essential performance........................................................................................................... 1-17
1-3-3 Guidance and manufacturer’s declaration - electromagnetic immunity................................. 1-18
1-3-4 Guidance and manufacturer’s declaration - electromagnetic immunity................................. 1-19
1-3-5 Recommended separation distances between portable and mobile RF communications
equipment and the F31 .........................................................................................................1-20
1-4 Electrostatic Discharge (ESD) Guidelines ........................................................................... 1-21
2 Specifications and Parts Name

2-1 Principle of Operation ............................................................................................................ 2-1
2-2 Specifications ......................................................................................................................... 2-3
2-2-1 Environmental Conditions ....................................................................................................... 2-6
2-2-2 Power Requirements ............................................................................................................... 2-6
2-2-3 Classification of F31 ................................................................................................................ 2-7
2-3 Parts Names .......................................................................................................................... 2-8
2-3-1 Exterior .................................................................................................................................... 2-8
2-3-2 Operation Panel .................................................................................................................... 2-11
3 Preparation for Use

3-1 Installing the equipment ......................................................................................................... 3-1
3-2 Connecting Peripheral Instruments ........................................................................................ 3-3
3-2-1 Connecting/Removing a Probe ............................................................................................... 3-4
3-2-2 Connect the Physiological Signal Connector .......................................................................... 3-6
3-2-3 Connecting with Other Instruments ......................................................................................... 3-8
3-3 Moving the equipment .......................................................................................................... 3-11
3-3-1 Isolate from the supply main ................................................................................................. 3-11
3-3-2 Moving equipment ................................................................................................................. 3-12
16 MN1-5853 rev.2
3-4 Storing the Instrument .......................................................................................................... 3-15
3-5 Inspection Before Using ....................................................................................................... 3-16
3-5-1 External Inspection ................................................................................................................ 3-16
3-5-2 Operation Check ................................................................................................................... 3-17
3-5-3 Modifying the Date and Time ................................................................................................ 3-18
3-5-4 Specifying the Hospital Name ............................................................................................... 3-19
3-5-5 Volume Control...................................................................................................................... 3-19
3-6 Screen Display ..................................................................................................................... 3-20
3-6-1 Character Display .................................................................................................................. 3-20
3-6-2 Graphic Display ..................................................................................................................... 3-22
3-7 Adjusting the Operation Panel ............................................................................................. 3-24
3-7-1 Adjusting the Operation Panel............................................................................................... 3-24
3-7-2 Adjust the Orientation of the Operation Panel....................................................................... 3-25
3-7-3 Adjusting the Brightness of the Operation Panel Switch ....................................................... 3-25
3-7-4 Changing the Labeling of the Operation Panel Switches ...................................................... 3-26
3-7-5 Changing the color of the trackball ........................................................................................ 3-27
3-8 Adjusting the Monitor ........................................................................................................... 3-28
3-8-1 Adjusting the Orientation of the Monitor ................................................................................ 3-28
3-8-2 Adjusting the Brightness of the Monitor................................................................................. 3-29
3-9 Viewing the instruction manual on the CD-ROM ................................................................. 3-30
3-10 The Flow of the preparation to the study ............................................................................. 3-31
3-10-1 Operating Mode..................................................................................................................... 3-31
3-10-2 Freezing image/Unfreezing image ........................................................................................ 3-32
3-10-3 Measuring on a ultrasound image ......................................................................................... 3-32
3-10-4 Printing images or Storing images ........................................................................................ 3-32
4 Troubleshooting
4-1 Messages ............................................................................................................................... 4-1
4-2 Dialog messages ................................................................................................................... 4-2
4-3 Assistance messages ............................................................................................................ 4-9
4-4 Other problems .................................................................................................................... 4-11
4-4-1 Image Display and Image Degradation ................................................................................. 4-11
5 Maintenance
5-1 After Using the Instrument ..................................................................................................... 5-1
5-1-1 State of the Instrument and Accessories................................................................................. 5-2
5-2 Cleaning ................................................................................................................................. 5-3
5-2-1 Clean the Instrument ............................................................................................................... 5-4
5-2-2 Cleaning the Air Filter .............................................................................................................. 5-5
5-2-3 Cleaning the Trackball............................................................................................................. 5-6
5-2-4 Cleaning Endo-cavity Probe Holder(Horizontal)...................................................................... 5-7
MN1-5853 rev.2 17
5-3 Maintenance .......................................................................................................................... 5-9
5-3-1 Daily check: For Using the Instrument for a Long Period ...................................................... 5-10
5-3-2 Checking the Measurement Accuracy................................................................................... 5-11
5-3-3 Safety Inspection................................................................................................................... 5-18
6 Accessories and Options

6-1 Instrument and Accessories ................................................................................................... 6-1
6-2 Options ................................................................................................................................... 6-1
6-2-1 Recording Devices .................................................................................................................. 6-2
6-2-2 Functional Expansion Units ..................................................................................................... 6-2
6-2-3 Other Accessories ................................................................................................................... 6-3
6-2-4 Softwares ................................................................................................................................ 6-3
7 Probes
7-1 Caution in the Handling of Probes ......................................................................................... 7-1
7-1-1 Caution about Handling of Probes .......................................................................................... 7-1
7-1-2 Cautions about Cleaning and Storage .................................................................................... 7-3
7-2 Probe specifications ............................................................................................................... 7-5
7-2-1 Convex Sector Probes ............................................................................................................ 7-6
7-2-2 Linear Probes .......................................................................................................................... 7-8
7-2-3 Phased Array Sector Probes ................................................................................................... 7-9
7-3 Clinical Measurement Range ............................................................................................... 7-10
8 Acoustic Output Safety Information

8-1 Acoustic output index ............................................................................................................. 8-1
8-2 Interaction between ultrasound and tissue ............................................................................ 8-3
8-2-1 Possible Biological Effects ...................................................................................................... 8-4
8-3 Derivation and Meaning of MI/TI ............................................................................................ 8-6
8-3-1 Mechanical Index (MI) ............................................................................................................. 8-7
8-3-2 Thermal Index (TI) ................................................................................................................... 8-7
8-4 Setting condition influencing device output ............................................................................ 8-9
8-5 Recommendation on ALARA principle ................................................................................. 8-10
8-6 Default Setting ..................................................................................................................... 8-11
8-7 Acoustic output Limits .......................................................................................................... 8-11
8-8 Measurement uncertainties .................................................................................................. 8-12
8-8-1 Protocol for calculating the measurement uncertainties........................................................ 8-12
8-8-2 Results of measurement uncertainties .................................................................................. 8-15
8-9 References ........................................................................................................................... 8-22
18 MN1-5853 rev.2
1-1 Purpose of Use
1-1 Purpose of Use
In the diagnostic ultrasound system, ultrasound images are produced as follows;

Ultrasound wave pulses released from the transducer are reflected from the internal body
system. Reflected waves are transmitted back to the transducer, and ultrasound images are
produced with the reflected image on the monitor. You can distinguish internal body systems
because the acoustic impedances vary among the internal organs.
Ultrasound images are used for various diagnoses of the internal body system.
This F31 is intended to be used by doctors and other qualified persons for performing slice
diagnoses and blood circulation diagnoses in the following parts of the human body.
• Thorax
• Abdomen
• Perineum and pelvis
• Lower limbs
• Back
• Upper limbs
• Head
• Neck
Do not use it for any applications other than those stated above.
Do not use this equipment for performing ultrasound diagnosis of the eyes.
The acoustic power from this equipment exceeds the upper ophthalmological limits
indicated in the U.S. FDA standards.
Do not use it for any application that is not covered in the instruction manual of the probe.
There is a risk of injuries or burns to the patient or oprator. There is a risk of electrical shock,
breakdown or other accidents.
MN1-5853 rev.2 1-1

1-2 Precautions for Use
Before using this device, please read this manual. Be especially sure to read "1. Safety
Precautions".
Keep this manual securely for future reference.
The following items are important in preventing harm or injury to equipment operator or patient.
There are four levels of harm/damage that can be caused by ignoring instructions/displays or
using the equipment incorrectly: "Danger," "Warning," "Caution," and "Note."
Indicates an imminently hazardous situation that will result in the death of

or serious injury to the equipment operator.
Indicates a hazardous situation that could result in death or serious injury.
Indicates a hazardous situation that may result in slight or moderate injury,

or property damage.
Indicates a request concerning an item that must be observed in order to

prevent damage or deterioration to the equipment and also to ensure
effective use.
Cautions use the following graphics.
This mark means the corresponding item is "alerted".
This mark means the corresponding item is "prohibited".
This mark means the corresponding item is "required".
1-2 MN1-5853 rev.2

1-2-1 Warnings and Safety Notice
• Do not use this device in a flammable atmosphere.

This device is not suitable for use in a flammable environment. It could cause an explosion.
• Do not disassemble, repair or remodel the equipment or optional features without our
consent.
Electric shock or other accidents could result.
Please contact one of our offices listed on back cover.
• Clean, disinfect and sterilze the probes as described in their documentation, before using
them.
• Wear medical gloves during inspection, and wash your hands after inspection.
• Destroy the probes used on patients with Creutzfeld-Jacob disease.
At present, there are no known methods available to properly clean and sterilize probes
exposed to Creutzfeld-Jacob disease.
There is a risk of infection of the patient and the examiner.
• If anything unusual occurs when this instrument is used, take the probe away from the
patient immediately, and stop using the instrument.
If the patient’s condition is abnormal, provide appropriate medical treatment.
When using this instrument, watch to make sure that it is functioning normally, and that the
patient is not abnormally affected.
• DO NOT connect any probes or options to the F31 not specified in this manual.
There is a risk of injuries or burns to the patient or oprator. There is a risk of electrical shock,
breakdown or other accidents.
• DO NOT assemble transport the equipment or its options via automobile or ship.
Electric shock or other accidents could result.
For assemble or transport the equipment and its options, please contact one of our offices
listed on back cover.
Place instrument in the following location.
• Place the instrument on a flat horizontal surface with sufficient stability and minimal
vibrations.
• DO NOT place the instrument on a precarious or uneven surface.
• Avoid locations with water or other liquids, avoid places salt-sulfur and avoid exposure to
direct sunlight.
These locations may cause injuries such as burns to the patient or examiner.
MN1-5853 rev.2 1-3

• Scan for the minimum length of time necessary for the diagnosis, and at the lowest suitable
output.
There is the possibility that the patient’s internal tissues could be affected.
• Hold the probe tightly so as no to slip, especially when using ultrasound gel or others.
Place the unused probe in the probe holder.
Otherwise, the probe may slip out of your hands and hit a patient or a examiner.
• Do not use unreasonable force while inserting a probe into a body cavity.
It may cause injuries to the patient.
• Coat the probe with an ultrasound medium before using.
• When the probe is not in use even during an examination, freeze the image.
Use of an ultrasonic beam into the air without coating the probe with an ultrasound medium,
may cause the surface temperature to rise. It could cause burns to the patient or examiner.
If you find that a probe is unusually warm, please contact one of our offices listed on back
cover.
• DO NOT touch the exposed sockets of the probe’s connector, or USB connector sockets.
• DO NOT touch the patient with parts other than the applied probe.
Doing so may cause electric shock or short circuits.
• Always use the instrument in a dried state.
Avoid rapid temperature change which may cause condensation.
Using the instrument where condensation occurs or when splashed with, can cause electric
shock or short-circuiting.
Let the instrument to stand for a while in a newly installed location to allow it become
acclimated to the environment before switching it ON.
Should you spill liquid on the instrument, contact one of our offices listed on back cover.
• DO NOT cover the vent.
If the temperature gets hot, there is a risk of short-circuiting or other accidents.
• Return the monitor at the front, and then fold the monitor.
• DO NOT close the monitor by force. DO NOT put anything on the monitor.
There is a risk of injury or damage to the monitor. And you may pinch your fingers.
• Perform regular maintenance and inspection as described in this manual.
If components of the equipment deteriorate due to years of use, there is a risk for degrading its
performance, breaking down, emitting smoke or ignition. If you notice any problems, please
contact one of our offices listed on back cover.
1-4 MN1-5853 rev.2

Safety precautions about Power Plug and Cable
Use the power cable provided, and plug it directly into the wall receptacle (hospital grade).
The use of cables, adaptors or extension cords to extend or branch the power connection may
cause a short circuit, ground leakage or fire.
• DO NOT damage, modify or sever the power cable and plug.
• DO NOT twist, bundle, forcibly bend, pull, or place heavy objects on the cable.
Damaging the power cable and plug may cause electric shock or short circuits.
Should you discover deformations or abnormalities in the power cable or plug, stop using the
device immediately.
Using the device with a damaged cable or plug may cause a loose connection or fire.
Please contact one of our offices listed on back cover for servicing.
Routinely disconnect the power cable plug from the outlet for washing.
Use a dry cloth to wipe off any dust or moisture that accumulates on the power cable plug.
Failure to do so may cause electric shock or short-circuits.
For extended periods of disuse, disconnect the power plug from the outlet.
Turning the power switch OFF does not completely shut off power to the equipment.
MN1-5853 rev.2 1-5

1-2-2 Labels
Many marks are used on this equipment.
NOTE: Labels that have a combination and (mainly connector sockets) includes
following safety caution:
DO NOT touch to the connector pins.

There is risk of deterioration and failure of parts sensitive to static electricity. For details, See
“Electrostatic Discharge (ESD) Guidelines” on page 1-21.
NOTE: Refer to the probe documentation for more information on probe labels.
The following label indicates the risk of being pinched in spaces or openings. Symbols are
located in places to indicate the relevant risks at that site.
Be careful of catching your fingers.

There is a risk of injury of your hands or fingers.
1-6 MN1-5853 rev.2

Labels from an anterior view
1)
2)
3)
4)
5)
1) USB connector
2) Swinging method and range of the operation panel.

Pull this lever slightly and the operation panel can be swing within the
range of ±15°.
Pull this lever full and the operation panel can be swing within the
range of ±45°.
3) Probe connector. The number is a connector number.
4) Foot switch connector
IPX8: Protected against the effects of continuance immersion in water

Indicated the optional foot switch (MP-2614B, MP-2345B).
5) Method of adjusting the height of the operation panel.
Adjust the height of the operation panel while stepping on this
up-and-down pedal of the panel.
MN1-5853 rev.2 1-7

Labels on the Rear of the Instrument
1)
2)
3) 3)
4)
5)
1) Method of folding the monitor and moving caution.
Before moving, prepare following the instruction

manual( → p.3-11). Move the instrument by grasping
the handle at the back of the instrument.
2) Warning sign (Refer to the next page.) and
manufacturer information.
2011
This instrument complies with
Directive 93/42/EEC relating to
Medical Device.
Date of manufacture.
Number under the mark means the
manufacturing year.
Do not dispose the instrument as
2'8 general waste.
Comply with a local regulation.
Manufacturer
3) Kinds of connectors for the physiological Type BF Applied parts

signal
1-8 MN1-5853 rev.2

4) Show the name of manufacturer and model, and etc.
5) Equi-potential terminals
Each marks on label 2) means following;
Safety Warning sign.
Dangerous Use the power cable provided, and plug it directly into the wall receptacle (hospital
Voltage grade).
There is the risk of short circuiting or ground leakage.
Explosion Do not use this instrument in a flammable atmosphere.

It may cause an explosion if used in such an atmosphere.
CAUTION Scan for the minimum length of time necessary for the diagnosis, and at the lowest
Acoustic suitable output.
Poser There is the risk of that the patient’s internal tissues could be affected.
CAUTION Be careful of catching your fingers.

pinch There is a risk of injury of your hands or fingers.
No Do not disassemble, repair (including replacement of power cord) or remodel this

Modification instrument.
There is a risk of unexpected accidents or electrical shock.
Please contact one of our offices listed on back cover for servicing.
DO NOT DO NOT use portable radio communication devices (e.g. cellular phones and
use cellular radiotransceiver) near this instrument.
phone Effects can include noise in images, disruption of physiological signals, and artifacts on
the screen.
DO NOT Do not push the side of the equipment. Do not exert excessive force on the equipment.
pushing Doing so may cause the equipment to fall, which may cause injury or damage to other
equipments.
MN1-5853 rev.2 1-9

DO NOT DO NOT sit on the equipment.

sitting Doing so may cause the equipment to fall, which may cause injury or damage to other
equipments.
Follow the Follow the instruction manual to operate this instrument.

instruction If avoided, may result in injury, property damage, or the equipments trouble.
manual
1-10 MN1-5853 rev.2

1-2-3 Precautions concerning acoustic power
The tissues of the human body consist of soft tissues, water, bone, and other tissues. Ultrasound
energy is progressively absorbed and attenuated by the body as it penetrates it, hence tissues
located behind water, which causes only a small degree of attenuation, receive a relatively large
amount of ultrasound energy. Also, it is necessary to be careful of bioeffects due to heat in the
vicinity of tissues, such as bone, that readily convert ultrasound energy into heat.
Particularly, a fetus at the bone formation stage is exposed to a high risk of damage due to
heating because almost all of the ultrasound energy passes through the amniotic fluid without
being attenuated. Even in the case of a fetus prior to bone development, the cells are active,
hence there is a possibility of growth being affected, even when the temperature rise is low.
Mechanical bioeffects such as vibration and cavitation occur when the body is exposed to
ultrasound energy for a long period. You can reduce the risk of damage to the tissues by
interrupting the ultrasound energy before it reaches the level at which tissue damage occurs.
To this end, it is necessary to obtain a grasp of the functions of the instrument, acquire
familiarity with the method of operating it, and understand the parameters that affect the
acoustic power. Also, get into the habit of always freezing the image as soon as you have
obtained the necessary diagnostic information.
Scan for the minimum length of time necessary for the diagnosis, and at the lowest suitable
output.
Select the optimum setting for the region to be examined while observing the acoustic power
index.
Ultrasound energy is converted into heat in the body while being attenuated. Particularly,
there is a possibility of heat being generated in bone and the cranium compared to soft tissue.
DO NOT select doppler modes for routine fetal examinations.

Doppler modes in fetal examinations are only to be used where clinically indicated, such as in
known or suspected high risk pregnancies.
MN1-5853 rev.2 1-11

1-2-4 Precautions for Use in Conjunction with Drugs
• Precautions for use in Conjunction with an ultrasound contrast agent

If you wish to use an ultrasound contrast agent, be sure to use only a substance that has
been approved for use for that purpose. See the specific package insert for the contrast
agent being used for details.
Watch to make sure that the patient is not abnormally affected during the exams using the
ultrasound contrast agent.
Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agents
have been observed in the diagnostic range of Mechanical Index (MI) values.
See the specific package insert for the contrast agent being used for details.
• Precautions for use in conjunction with general drugs

If you perform an ultrasound examination after having the patient ingest a general drug,
the ultrasound may affect the pharmacological effect of the drug.
Before using a general drug, carefully read the instructions provided, and any cautionary
notes.
1-12 MN1-5853 rev.2

1-2-5 Precautions for Use in Conjunction with Other Medical Devices
• Equalize the potential between this instrument and other instrument

This equipment has a potential equalization terminal. The potential equalization terminal
is on the back panel. For equalizing the potential, connect between the potential
equalization terminals.
• Use in conjunction with devices which use high frequencies
High-frequency surgical instruments may be used to deliberately apply an
electromagnetic field or electric current of high frequency to the patient.
This instrument has not been equipped with any means to protect the patient from burn
injury from any of its parts when it is used together with a high-frequency surgical
instrument.
• Use in conjunction with a cardiac defibrillator
Do not use a cardiac defibrillator while a physiological signal is on display.
Keep probes and physiological electrodes away from a patient body surface when a
cardiac defibrillator is used.
• When using this instrument together with other electronic medical appliances, position it
and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as possible from
other appliances and their cables.
Note that electromagnetic radiation from this instrument may cause other electronic
medical instruments nearby to function abnormally. If such interference occurs, stop using
the other instrument together with this one.
• Keep probes, body parts and puncture instruments away from the course of high-frequency
currents.
Failure to observe the following precautions could result in burns to the patient or the
examiner. With these radiated high frequencies, the device may be affected with
interference when it is drawing monochrome or color images.
Operate the device with caution paying attention to the positions of the counter electrode
plates and the connecting cord against the probe.
• Do not apply excessive force for insersion.
Damage an insulating membrane and the patient or the examiner could be burned. Use an
attachment with the electrode to allow suitable guidance of the puncture.
• Do not use in conjunction with a cardiac defibrillator.
It may cause the instrument break down.
MN1-5853 rev.2 1-13

1-2-6 Guideline for Electromagnetic Compatibility
The electromagnetic compatibility (EMC) is the ability of a device to function satisfactorily in

its electromagnetic environment without introducing intolerable electromagnetic disturbance to
anything in that environment.
Medical devices, communications devices, radio and TV broadcasting antennae and similar
devices can both emit electromagnetic waves and receive interference from them. A diagnostic
ultrasound system can receive electromagnetic disturbance emitted by electromagnetic energy
sources. Effects can include noise in images, disruption of physiological signals, and artifacts
on the screen.
To prevent electromagnetic disturbances, considerations must be made for the following: 1)
electromagnetic environment, 2) use of portable and mobile RF communications equipment, 3)
use in conjunction with other medical devices.
IMPORTANT: The doctor must consider whether electromagnetic disturbance could cause any
artifacts which affect images or diagnoses.
1) Electromagnetic environment
For the purposes of preventing electromagnetic interference, this instrument is intended
for use in hospitals, research institutions and similar facilities. Install in an environment
that conforms to the operating environments and in accordance to section 1-3.
• Position this instrument as far away as possible from a radio receiver, TV set, and it’s cables
and antenna. The electromagnetic radiation from this instrument may cause the disturbance
to a radio receiver, TV set, etc.
• If the instrument is to be used near a motor (elevator, pump room, etc.), power transmission
line or wireless instrument, it is necessary to electrostatically shield it.
• When the mains power quality is not satisfied, the instrument can be froze by power supply
fluctuation. If the instrument is froze, refer to Chapter 4 ( → p.4-11).
2) Use of portable and mobile RF communications equipment
Do not use portable radio communication devices (e.g. cellular phones or radio
transceivers) near this instrument. Use of portable and mobile RF communications
equipment such as cellular phones, transceivers, and amateur radio instrument can affect
the operation of this device.
1-14 MN1-5853 rev.2

3) Use in Conjunction with Other Medical Devices

When this system receives electromagnetic disturbances, effects can include noise in
images, disruption of physiological signals, and artifacts on the screen. Position this
instrument and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as
possible from other medical electrical instrument.
• Check that the instrument is not affected by electromagnetic disturbance emitted from any
other device and that electromagnetic disturbances emitted by this instrument does not have
adverse effects on any other devices.
• Use in conjunction with high-frequency surgical equipment, this instrument may be
affected with interference when it is drawing monochrome or color images.
• If electromagnetic radiation from this instrument causes the abnormal operation to other
medical electrical instrument nearby, stop using immediately. Do not use this device in
conjunction with such effected instrument.
MN1-5853 rev.2 1-15

1-3 Electromagnetic compatibility
The electromagnetic compatibility (EMC) of this device is in conformity with IEC 60601-1-2:
Ed.3 which is the international standard for EMC of medical instruments. This standard
prescribes the testing of the level of electromagnetic energy emanating from equipment
(electromagnetic emission) and the tolerance of the equipment for electromagneic disturbance
(electromagnetic immunity).
Testing of our ultrasound diagnostic devices has confirmed that they emit no electromagnetic
energy.
1-3-1 Guidance and manufacturer’s declaration - electromagnetic emissions
The F31 is intended for use in the electromagnetic environment specified below. The customer
or the user of the F31 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions Group 1 The F31 uses RF energy only for its internal
CISPR11 function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B The F31 is suitable for use in all

CISPR11 establishments, including domestic
establishments and those directly connected
Harmonic emissions Class A
to the public low voltage power supply
IEC61000-3-2 network that supplies buildings used for
domestic purposes.
Voltage fluctuations/flicker emissions Complies
IEC61000-3-3
1-16 MN1-5853 rev.2

1-3-2 Essential performance
The ultrasound diagnostic devices has been validated to IEC60601-1-2: Ed.3. Testing indicates
no electromagnetic wave interference is being transmitted or received. For the description of
each essential performance, refer to the specifications or chapter 2.
Essential performance contents refer
Scan Area Scanning range of B mode image TBF switch (How to Use)
Flow Area Display in color on the Flow mode image Screen Display → p.3-20
Marker Scale marks (distance, time and flow velocity) display Screen Display → p.3-20
Velocity Range Display range (scale mark) of flow velocity in the Vel Range (D) menu (How to Use)
Doppler image display
M cursor Detect the M mode and the baseline of the Doppler CURSOR switch (How to Use)
D cursor pattern of the B mode image
Sample Volume Volume of the sample gate that extracts the signals Sample Volume menu (How to Use)
from the B mode image in the PW Doppler mode
Image Frequency Switch the transmitting/receiving frequencies of the Image Freq menu (How to Use)
probe of the B, D, M, Flow, THE or BbH mode
Focus Number of the focal point and each focal point TBF switch (How to Use)
position
Acoustic Power Control the acoustic power 8. Acoustic output Safety Information
ACOUSTIC POWER key (How to Use)
Frame Rate Combination of Line Density for black & white and Frame Rate menu (How to Use)
color images, in the Flow or the Power Flow mode.
Image Select Image quality setting of Doppler spectrum image Image Select (D) menu, Image Select (Flow)
menu,
Preset: IP Select (D), IP Select (Flow), IP Select
(Power)
Average (Flow) Number of transmissions used to display blood flow Average (Flow) menu,
Preset: Flow, Power Flow, eFlow, Tissue Flow,
Tissue Power Flow (How to Use)
Puncture, Display Puncture Guideline Puncture menu, Biopsy Select menu,

Biopsy Select Preset: Graphics (How to Use)
Message Warning messages indicating the correct method of 4. Message

operation, and an alarm tone.
Angle Correction Correct the flow velocity value corresponding to the Angle Correct menu,
angle of incidence of the Doppler beam Preset: Doppler, Tissue Doppler (How to Use)
Heart Rate Display Compute and display the heart rate from detected Display of physiological signals, Physio menu,
R-wave (HR***) Preset: Physio (How to Use)
MN1-5853 rev.2 1-17

1-3-3 Guidance and manufacturer’s declaration - electromagnetic immunity
The F31 is intended for use in the electromagnetic environment specified below.The customer
Immunity test IEC60601 test level Compliance level Electromagnetic environment-guidance
Electrostatic discharge (ESD) ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
IEC 61000-4-2 ±8 kV air ±8 kV air tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrorical fast transient/burst ± 2 kV for power supply ± 2 kV for power supply Mains power quality should be that of a
IEC 61000-4-4 lines lines typical commercial or hospital enviroment.
±1 kV for input/output lines ±1 kV for input/output lines
Surge ±1 kV line (s) to line (s) ±1 kV line (s) to line (s) Mains power quality should be that of a
IEC 61000-4-5 ±2 kV line (s) to earth ±2 kV line (s) to earth typical commercial or hospital
environment.
Voltage dips, short interruptions < 5% UT < 5% UT Mains power quality should be that of a
and voltage variations on power (> 95% dip in UT) (> 95% dip in UT) typical commercial or hospital
supply input lines environment.
0.5 cycle 0.5 cycle
IEC 61000-4-11 If the user of the F31 requires continued
< 40% UT < 40% UT operation during power mains interruptions,
(> 60% dip in UT) for 5 (> 60% dip in UT) for 5 it is recommended that the F31 be powered
cycles cycles from an uninterruptible power supply or a
battery.
< 70% UT < 70% UT
(> 30% dip in UT) for 25 (> 30% dip in UT) for 25
cycles cycles
< 5% UT < 5% UT
(> 95% dip in UT) for 5s (> 95% dip in UT) for 5s
Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic fields should be
magnetic field at levels characteristic of a typical location
IEC 61000-4-8 in a typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
1-18 MN1-5853 rev.2

1-3-4 Guidance and manufacturer’s declaration - electromagnetic immunity
The F31is intended for use in the electromagnetic environment specified below. The customer
Compliance
Immunity test IEC60601 test level level Electromagnetic environment-guidance
Portable and mobile RF communications equipment

should be used no closer to any part of the F31, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Conducted RF 3 Vrms V1 = 3V Recommended separation distance

IEC61000-4-6 150 kHz to 80 MHz
d= ( )
3.5
V1
P
Radiated RF 3 V/m E1 = 3 V/m

IEC61000-4-3 80 MHz to 2.5 GHz d= ( )
3.5
E1
P
: 80 MHz to 800 MHz
d= ( )
7
E1
P
: 800 MHz to 2.5 GHz
where P is the maximum output power rating of

thetransmitter in watts (W) according to the
transmittermanufacturer and d is the recommended
separationdistance in metres (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipmentmarked
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 the F31 is used exceeds the applicable RF compliance level above, the F31
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the F31.
b: Over the frequency range 150 kHz to 80 MHz, fields strength should be less than [V1] V/m.
MN1-5853 rev.2 1-19

1-3-5 Recommended separation distances between portable and mobile RF

communications equipment and the F31
The F31 is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the F31can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the F31 as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter

m
Rated maximum
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter
W
d= ( )
3.5
V1
P d= ( )
3.5
E1
P d= ( )
7
E1
P
0.01 0.116 0.116 0.233
0.1 0.369 0.369 0.738
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (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 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.
1-20 MN1-5853 rev.2

1-4 Electrostatic Discharge (ESD) Guidelines
This guideline includes descriptions to prevent any deterioration and trouble on the part being
sensitive to static electricity.
This instrument can be installed in accordance with “The electromagnetism adaptability
guideline” mentioned in this book. After installing the instrument, connect the probes or
conduct maintenance and inspection of the instrument in accordance with the following.
Electrostatic discharge (ESD) guidelines;
• Do not install the device on a floor covered with a carpet or synthetic materials.
The floor materials on which the device is installed shall be of wood, concrete or ceramic
tile. When installing the device on the floor covered with carpet or synthetic materials, it
is requested the floor materials be grounded.
• Keep the humidity of the installed place higher than 30%.
• When connecting probes, foot switch, and cables to the respective connectors of the
device, do not touch the connecting pins.
When servicing or conducting any maintenance on the device, turn the device off but
leave the power cord plugged in.
Explain the meaning of the ESD warning symbol and provide the training on
the protective procedure of ESD mentioned above.
• ESD warning symbol ( ) : Keep your hand away from the connector pins.
Indicates that the device is subject to deterioration or malfunction due to sensitivity to
static electricity by electrostatic discharge.
MN1-5853 rev.2 1-21

1-22 MN1-5853 rev.2

2-1 Principle of Operation
When a block of continuously arranged multiple transducers transmit and receive

near-simultaneously, all ultrasonic waves emitted from the individual transducers are combined
to provide the same effect as if a single ultrasound beam were released from the center of the
multiple transducers. After the first beam is transmitted and received in this fashion, the
transducers of the above-mentioned block are shifted by one position, then transmitted and
received to provide the second ultrasound beam. This means that the center of the second beam
is shifted from the center of the first beam by one transducer. Shifting the transducer block and
repeatedly transmitting and receiving in this manner makes it possible to obtain multiple
ultrasound beams. Aligning these beams makes planar scanning possible. Furthermore, by
creating a time lag in beam transmitting and receiving operations, the beams can be made to
converge to an acoustic focal point. Continuously setting focus time lag based on the arrival
time of ultrasonic waves enables globally-focused beams.
The ultrasound beam obtained by the above-mentioned method is converted by a digital scan
converter into a video signal to display images on a monitoring device.
This product can display a single or combined images in the following image display modes.
• B mode displays a tomographic view obtained by multiple ultrasound beams generated

as described above.
• M mode obtains ultrasound beams in the same direction repeatedly and displays them on
a screen in sequential and parallel arrangement to display temporal changes in echoes in
a single direction in the test subject.
• D (Doppler) mode has two modes: PW Doppler mode and CW Doppler mode.
PW Doppler mode displays information continuously on blood flow at a sample point
detected by the pulse Doppler method.
In contrast, the CW Doppler mode displays information on blood flow continuously
using ultrasound beams in a single direction detected by the CW Doppler method.
• Color Doppler mode detects information on blood flow itself that is, direction and
velocity of blood flow as well as their deviations by receiving ultrasonic waves in the
same direction and detecting the difference. The information can be displayed in color
and superimposed on the B mode or M mode display.
MN1-5853 rev.2 2-1

Three types of electronic scanning are described below.
• Linear scanning system:

In this system, the probe emits ultrasound beams in a straight line (linear) to obtain and
display a tomographic view of a test subject.
• Convex scanning system:
In this system, the probe emits ultrasound beams radially to obtain and display a
tomographic view of a test subject.
• Sector scanning system:
In this system, the probe emits ultrasound beams in a fan shape (i.e., sector of a circle) to
obtain and display a tomographic view of a test subject.
Combined electronic scanning system
• Trapezoidal scan:
This combines the linear scanning system and the sector scanning systems to obtain and
display a tomographic view of the test subject.
2-2 MN1-5853 rev.2

2-2 Specifications
2-2 Specifications
Scanning method: Electronic sector scan,

Electronic convex scanning,
Electronic linear scanning
Modes: B mode
M mode
D mode (PW and CW modes)
Flow mode
Power Flow mode, Directional Power Flow mode
eFlow mode, Directional eFlow mode
TDI mode
Acoustic Power: 0% to 100%, continuously changeable
Preset function: User settings: 45 kinds (Factory default settings: 33 kinds)

Number of probe connectors: For electronic scanning probes: 3
Image display: Direction of slice image display: Longitudinal inversion,
lateral inversion,
90 degrees rotation.
Image depth: 0.5 cm to 30 cm (36 steps, probe dependent)
Accuracy of display: ±5% or less
(2.5% or less at a shallower depth point than range 6 cm)
Physiological signal display: ECG, DC IN
Measurement function: Basic measurement
Application Cardiac Measurement,
measurement: Vascular Measurement,
Abdominal Measurement,
Obstetrical Measurement,
Gynecological Measurement,
Urological Measurement,
Small Parts Measurement
Viewing monitor: 15-inch flat-panel LCD (Tilt and swivel are possible)
Input/Output Signals Data input/output: USB, RS232C

• Composite: 1 channel
• Y/C input: 1 channel (for DVD recorders)
• Y/C output: 1 channel (for DVD recorders)
Analog audio input for DVD recorders: 1 channel
Analog audio output for DVD recorders: 1 channel
DVD control signal: 1 channel
DVI-D digital: 1 channel
Cine memory function: Search, Scroll, Store, Review, Loop playback
MN1-5853 rev.2 2-3

2-2 Specifications
Image data format: Moving image: • VideoClip (DICOM RGB [RLE/Normal], JPEG)
• AVI
• Line
Still image: • DICOM (Palette, RGB [RLE/Normal], JPEG)
• Tiff
• BMP
• JPEG
Dimensions: 430 mm (Width), 580 mm (Depth), 1195 mm to 1445 mm (Height)
Weight: 65 kg ±10% (main unit only), 85 kg ±10% (with all options included)
Service life: 7 years
Clinical Measurement Accuracy
Measurement Feature General Tolerance Round-off Tolerance
Distance in B-mode ±3% ±0.01 cm < 10 cm distance

±0.1 cm > 10 cm distance
Area by trace in B-mode ±6% ±0.01 cm2 < 100 cm2 area
±0.1 cm2 > 100 cm2 area
Circumference by trace in ±6% ±0.01 cm < 10 cm distance

B-mode ±0.1 cm > 10 cm distance
Area by ellipses in B-mode ±5% ±0.01 cm2 < 100 cm2 area
±0.1 cm2 > 100 cm2 area
Volume in B-mode ±7% ±0.01 cm3 < 100 cm3 area

Excursion in M-mode ±3% ±0.01 cm < 10 cm distance
±0.1 cm > 10 cm distance
Time in M-mode ±3% ±0.01 ms < 1000 ms time

±0.1s > 10 ms time
Heart rate ±1 BPM or 5% ±1 beat per minites
2-4 MN1-5853 rev.2

2-2 Specifications
B Mode
Display gray scale: 256 levels
Scanning area: 100% to 25%, continuously variable
Zoom: Write zoom (real-time): Max. 6 times

Read zoom: Max. 16 times
Depth range selections: 0.5 cm to 30 cm (probe dependent)
Frame rate (Line density): 9 selections

Contrast: 23 levels (Dynamic range: 36dB to 96dB)
STC: 8 levels slide-bar
B Gain: 10 dB to 90 dB
AGC: 16 steps
Relief: 4 steps
FTC: On/Off
Frame correlation: 16 steps (Auto/Manual)
Smoothing: 16 steps
Steered liner scanning: ±30°, 5° steps
Post Process: Echo enhance curve: 5 kinds, Rejection: 64 steps
View Gamma: 5 kinds
M Mode
Sweep methods 7 steps
Gain B Gain ± 30 dB
Contrast 23 levels (Dynamic range: 36dB to 96dB)
AGC 16 steps
Relief 4 steps
FTC On/Off
Free Angular M-mode (FAM): Up to 3 M-mode cursors can be set omni-directionally on real-time
at any position on a B-mode image.
D Mode PW CW
Display patterns: Power spectrum Power spectrum
Max. velocity range: ±6.23 cm/s to ±398.44 cm/s ±24.90 cm/s to ±796.88 cm/s
Angle collection: ±80°, Automated angle correction possible
Sample volume: 0.5 mm to 20 mm
Doppler gain: 0 dB to 50 dB (128 steps)
Flow Mode (Color Doppler)

Display patterns: Velocity, Velocity+variance, Variance, Power Flow, eFlow, TDI
MN1-5853 rev.2 2-5

2-2 Specifications
Flow Mode (Color Doppler)

Velocity: ±127 levels
Variance: 16 levels
Power Flow, eFlow: 128 levels (Directional: ±127 levels )
Color are size: 100% to 15%, continuously variable
Flow Gain: 0 dB to 31.75 dB (128 steps)
Steered liner scanning: ±30°, 5° steps
Color coding: Abdomen, Vascular, Cardiology, Other, User : Each has 5 kinds
2-2-1 Environmental Conditions
Storage environment and

Environmental Conditions Working environment moving / transport environment
Ambient temperature 10°C to 40°C -10°C to 50°C
Relative humidity 30% to 75% (non condensing) 10% to 90% (non condensing)
Atmospheric pressure 700 hPa to 1060 hPa 700 hPa to 1060 hPa
Altitude < 3000 m -
2-2-2 Power Requirements
Conditions
Rated supply voltages or voltage ranges: 100V to 120V, 200V to 240V
Rated frequency or rated frequency range: 50 Hz / 60 Hz
Power input: 700 VA

Power output: 330 VA
2-6 MN1-5853 rev.2

2-2 Specifications
2-2-3 Classification of F31
• Protection against electric shock: class I ・ ME equipment

• Protection against electric shock (Applied parts): type BF applied parts
– Probe/scanner applied parts and parts treated as applied parts:

Refer to the following diagram (Probe/Scanner Pattern Diagram) and table.
B C A
connector
connector
C A
Fig. 1: Probe/Scanner Pattern Diagram
Above illustrates a surface/intraoperative probe. Below shows a coelomic probe.
Applicable part Parts treated as applied

of body Applied part parts B - C length
surface of body Ultrasonic irraditaion area (D) A to B 100 cm
Intraoperative Ultrasonic irraditaion area (D) A to B 20 cm
Endocavity A to C A to C －
– ECG
Parts treated as applied parts: 2m from ECG electrode of the ECG patient cable (consult
following diagram)
2 meters
ECG electrodes
connector
ECG patient lead

• Protection against electric shock (Defibrillation-proof applied parts): Not suitable
• Protection against harmful ingress of water or particulate matter
– equipment: IPX0 (Ordinary equipment)
– Probe applied part: IPX7 (Watertight equipment)
• Suitability for use in an oxygen rich environment: Not suitable
• Method (s) of sterilization: Not suitable for sterilization/disinfection with medicinal
solution, gas or radiation.
• Mode of operation: Continuous operation
MN1-5853 rev.2 2-7

2-3 Parts Names
2-3 Parts Names
2-3-1 Exterior
1)
2)
3)
8)
4)
5) 9)
10)
6)
7) a)
a) Endo-cavity Probe Holder

(horizontal storage, option,
11)
attached example in the left side
of the device)
1) Viewing monitor
2) USB connector (used for connecting to the USB flash memory (stick type only))
NOTE: In some cases, it may not be possible to connect unusually-shaped USB flash
memory products. Check whether your USB flash memory can be connected before trying
to use it.
3) POWER switch
4) Operation panel
5) Handle (uses to adjust the position and the height of the operation panel. Or use to lift the
equipment to negotiate step)
6) Cable hook (for probe cables)
7) Operation panel up-and-down pedal
8) Cable hanger
9) Probe holder
10) Side pocket
2-8 MN1-5853 rev.2

2-3 Parts Names
11) Casters
a) a) Unlock lever
b) Lock lever
b)
Rear
1)
2)
3)
4)
5)
6)
7)
8)
1) Handle (uses to carry the instrument about)

2) Physiological signal Panel
3) Filter
4) Cable hook ( for power cable)
5) Cable clip (for power cable)
6) Circuit breaker
○ : OFF
｜ : ON
7) Power socket (there is the protective earth terminal)
8) Equi-potential terminals
MN1-5853 rev.2 2-9

2-3 Parts Names
Front
1)
2)
3)
4)
1) Lever for locking the operation panel to the home position

2) Electronic probe connector (in order, from top)
3) Cable hook (for probe cables)
4) Foot switch connector
Used for connecting to the optional foot switch (MP-2345B, MP-2614B).
Monitor
1)
1) Tilting button
Use for closing the monitor.
2-10 MN1-5853 rev.2

2-3 Parts Names
2-3-2 Operation Panel
(1) (8)
R
(9)
(2)
(3) (10)
(4)
(5)
(11)
(6)
(12)
(7)
(13)
panel switch names contents
(1) POWER The white light indicates that the power is ON.
The orange light indicates STAND BY mode.
(2) Keyboard Keyboard → p.2-14
(3) MENU Displays the Function menu on the screen.

Switching the menu.
(4) NEW PATIENT Returns to the initial settings. Displays the ID input screen.
(5) Trackball Function Switches between the Focus and Scan Area (Flow Area).
(TBF) Starts the Search function in the freeze mode.
(6) BODY MARK Displays the Body Mark menu on the Function menu.
Switches the Body Mark menu display between show and hide.
(7) Trackball Move the pointer or cursor.
(8) Illuminance sensor Photo chromatic sensor of the operation panel switch, keyboard and
trackball.
MN1-5853 rev.2 2-11

2-3 Parts Names
panel switch names contents

(9) STC Adjusts sensitivity at the display depth corresponding to the value.
(10) Rotary Encoder 1 to

Select the menu or change the set value.
Rotary Encoder 5
(11) PRINT Records images to a recording instrument connected to this

instrument. You can record images by pressing and holding down
this switch.
(12) FREEZE Press: Switches between the real time display and the still image
display.
Turn: Works as the B GAIN knob to adjust B Gain.
(13) Rotary Encoder Used for measuring or linking to the trackball to provide
supplementary control.
Switches
(factory default) contents
B Displays the B mode.
B/B Displays the B/B mode.
Selects the active screen when two or more images (B/B, B/M, etc.) are
displayed.
SELECT If one of the displays was shown in real time such as B/B mode, the real time
display can be switched. If both images are displayed in real time, such as in
the B/M or the B/D mode, only the M or D mode image can be switched and
displayed in real time.
USER1 Activates the function assigned by navigating the preset to Custom SW preset.
STORE Save a still or moving image on the screen.
Sets measurement, preset, comment input, review, Flow Area setup, etc.
ENTER
This switch can be assign to other function as SEND on Custom SW2 preset.
+ (Caliper) Starts the measurement menu assigned to this switch.
Displays the cursor.

CURSOR
Deletes the cursor from the screen.
Cancels the selected operation. Or, goes back to the previous step if
CANCEL
measurement was in progress.
M Displays in the B/M mode.
Displays in the B/PW mode.

D
When it is pressed and held down, it displays in the B/CW mode.
2-12 MN1-5853 rev.2

2-3 Parts Names
Switches
(factory default) contents
Displays a B mode image or an M mode image in FLOW.

F
When it is pressed and held down, it displays in the eFlow mode.
Changes the display depth of the image when the white light is on.
DEPTH/ZOOM
Zooms up the B mode image when the orange light is on.
MULTI GAIN Adjusts sensitivity in the M, D or FLOW modes according to the switching
between these modes.
MN1-5853 rev.2 2-13

2-3 Parts Names
Keyboard
W E R
Key contents
(Measurement) Displays the measurement menu.
Review Displays the Review.
Full Displays the M mode image only during the B/M mode display and the D mode
image only during the B/D mode display.
F4 to F7 Function keys.
F8 Function keys. The factory default setting is EXT.
F9 to F11 Function keys.
Preset Displays the Preset screen.
Probe Displays the Probe menu.
Acoust Power Adjusts the Acoustic Power.
F14, F15 Function keys.
ID Displays the ID input screen without returning to the initial settings.
Comment Enters comments on the screen or ends comment input.
F16 Function key (SEND key as factory default).

It can be assigned as SEND or ENTER.
2-14 MN1-5853 rev.2

3-1 Installing the equipment
Install the instrument in accordance with the following procedures.

For eliminating heat and isolating from power supply at once, the following amounts of open
space are required.
100V to 120V
Power outlet in the wall Power plug
200V to 240V
Power outlet in the wall Power plug
≧ 30 mm ≧ 30 mm
• Install the instrument according to the “Guidelines for Electromagnetic Compatibility”

stated in this manual.
• Insert the power plug into the power outlet (hospital grade) which fits the shape of the
power plug.
• Install the instrument no more than 3 meters away from a power outlet in the wall.
• To cut off the power, disconnect the power plug from the power outlet.
MN1-5853 rev.2 3-1

Place instrument according to the following.

• Place the instrument on a flat horizontal surface with sufficient stability and minimal
vibrations.
• DO NOT place the instrument on a precarious or uneven surface.
• Avoid locations with water or other liquids, and avoid exposure to direct sunlight.
These locations may cause injuries such as burns to the patient or examiner.
• Always use this in dried state.
• Avoid rapid temperature change which may cause condensation.
Using it with condensation or water droplets on it could cause short circuiting or ground
leakage. Leave the instrument to stand for a while in the newly installed location to allow it to
become acclimated to the environment before switching it ON.
1. Fix all casters.

Checking items after moving the instrument
• Check to ensure that there are no scratches or cracks on the enclosure.
• If the temperature is different from the new and the previous installation location, leave the
instrument to stand for a while in the new installed location to allow it to become
acclimated to the environment.
2. Ensure that there are no loose parts, damage, or signs of wear on the instrument.
3. Insert the power plug of the power cable provided into the hospital grade power outlet.
4. Connect the peripheral instrument and probes.
NOTE: Do not place anything on the top surface.
5. Turn on the POWER switch.
Reference:
Environmental Conditions → p.2-6

Electromagnetic compatibility → p.1-16
Connecting/Removing a Probe → p.3-4
Connecting with Other Instruments → p.3-8
Connect the Physiological Signal Connector → p.3-6
Safety precautions about Power Plug and Cable → p.1-5
3-2 MN1-5853 rev.2

3-2 Connecting Peripheral Instruments
Connect peripheral instruments such as probes and the ECG lead cord in accordance with the
following procedures.
When conducting a diagnosis, take care, as described in the electrostatic discharge (ESD)
guidelines, to avoid deterioration and failure of parts sensitive to static electricity.
• DO NOT connect any probes or options to the equipment which is not specified in this
manual.
The patient or the operator may be exposed to burns, electric shock or other injury. There is a
risk of the instrument breaking down.
• DO NOT damage, modify or server the probe cable.
• DO NOT twist, bundle, forcibly bend, or place heavy objects on the probe cable.
There is the risk in electrical shock and other accidents.
• If you find the instrument or a probe to be defective, stop using it immediately.
The patient or the operator may be exposed to burns, electric shock or other injury.
For repair of the instrument or a probe, please contact one of our offices listed on back cover.
• DO NOT touch to the exposed sockets of probe connectors, physiological signal cable
connectors, or USB connector sockets.
• DO NOT touch to the patient with parts other than applied parts and parts treated as such.
Doing so may cause electric shock or short circuitis.
All non-medical equipment connected to the diagnostic ultrasound system must comply with
the respective IEC or ISO standards (e.g. IEC 60950-1 for data processing equipment).
Furthermore all configurations shall comply with the requirements for medical electrical
systems (see clause 16 of the IEC 60601-1: Ed.3, respectively).
There is the possibility that local laws and regulatory requirements take priority over the
above mentioned requirements. For details, please consult one of our offices listed on back
cover.
Reference:
Electrostatic Discharge (ESD) Guidelines → p.1-21
MN1-5853 rev.2 3-3

3-2-1 Connecting/Removing a Probe
Place the Endo-cavity probe on the special probe holder (horizontal) mounted with the special
adapter, Endo-cavity Probe Holder Adapter.
If a probe other than an Endo-cavity probe is placed on the special probe holder, the probe
may fall out and be damaged.
Before placing the probe horizontally on the special probe holder, remove any attached
balloon.
There is a risk of infection of the patient and the examiner.
Ensure the probe in accordance with the following items.
• The probe is possible to connect with the instrument.

• The pins on the probe connector are not bent.
Probes are stored on the probe holder. When storing an endo-cavity probe horizontally, push it
firmly all the way into the probe adapter.
Example of vertical storage Example of horizontal storage
Gray-painted: adapter
3-4 MN1-5853 rev.2

Connecting a Probe to the Instrument
1. Press FREEZE to freeze the image.

2. Turn the lock lever counterclockwise to the RELEASE position.
3. Insert the connector of the electronic type probe into the electronic probe connector on
the instrument.
RELEASE LOCK
lock lever
4. Turn the lock lever clockwise to the LOCK position.
RELEASE LOCK
lock lever
If the lock lever is difficult to turn, reinsert the connector.

5. Use the cable hook to adjust the probe cable to a convenient length. Adjust the position
and length of the probe cable so that it does not rub or scrape the floor.
Remove the Probe
1. Press FREEZE to freeze the image.

2. Turn the lock lever counterclockwise to the RELEASE position.
3. Remove the probe from the instrument.
MN1-5853 rev.2 3-5

3-2-2 Connect the Physiological Signal Connector
Connection terminals related to physiological signals are found on the rear surface of the main
unit.
NOTE: When the ECG cord and ECG cord from ECG monitor are connected, external signal from
ECG monitor is prior to displayed.
If an external signal is not necessary, release this cable from DC-IN connector.
The minimum amplitude of the ECG input necessary for conditioning the ECG
signal is ECG 50μV.
The signal which is lower than this level may cause inaccurate results.
Connect the ECG Lead Cord
The ECG lead is a second limb lead.
connection points ECG cable
1) Right arm Red (R)

1)
2) Right leg Black (RF)
3) left leg Green (F)
2) 3)
● Insert the connector of the ECG lead cord firmly into the connector on the panel
with the groove on the connector faces upward.
● Before connecting the ECG lead cord to the patient, insert the three jacks of the
ECG lead cord into the corresponding ECG electrodes.
3-6 MN1-5853 rev.2

Connect the ECG Monitor Cable
When connecting another ECG monitor to this instrument, the ECG signals obtained by it can
be displayed on the images.
• Use only an ECG monitor that conforms to IEC60601-1 together with this instrument.
• For handling and safety inspection on the ECG monitor to be used with this instrument,
refer to the instruction manual of the ECG monitor.
Electric shocks and electromagnetic interference could result.
DO NOT use the monitor if the instruction manual states that it must not be used together
with diagnostic ultrasound system or similar medical electronic instrument.
Refer to the document of the ECG monitor.

NOTE: Read "Precautions for Use in Conjunction with Other Medical Devices" before connecting
the ECG monitor to this instrument.
1. Connect the cable from the ECG output connector of the ECG monitor to the DC IN
connector of the ECG.
MN1-5853 rev.2 3-7

3-2-3 Connecting with Other Instruments
All non-medical equipment connected to the diagnostic ultrasound system must comply with the
respective IEC or ISO standards (e.g. IEC 60950-1 for data processing equipment).
Furthermore, all configurations shall comply with the requirements for medical electrical systems (see
clause 16 of the IEC 60601-1: Ed.3, respectively).
There is the possibility that local laws and regulatory requirements take priority over the above
mentioned requirements. For details, please consult one of our offices listed on back cover.
USB Flash Memory
Connecting USB flash memory to the USB connector.
• Use a USB flash memory stick that is shorter than 55 mm excluding the connector, with
a height from the bottom to the connector of less than 4.5 mm.
In some cases, it may not be possible to connect unusually-shaped USB flash memory
products. Check whether your USB flash memory can be connected before trying to use
it.
55 mm max.
connector
USB Flash Memory

4.5 mm max.
NOTE: Abstain from using the strap. It can prevent operation by getting tangled with the cable of
the probe.
Equipotential Terminal
The device is equipped with an equipotential terminal on the back panel. Use this terminal as
the equipotential conductor when interconnecting or grounding with other equipment.
3-8 MN1-5853 rev.2

Foot Switch
Connect the optional foot switch (MP-2345B, MP-2614B).
1. Insert the power plug into the power outlet. After the instrument is starting, freeze the
image.
2. Insert the connector of the foot switch.
3. Set the function for the foot switch using the preset.
Connecting network devices
The EMC of this device is in conformity with the IEC 60601-1-2:Ed.3 which is the international
standard for EMC with medical instruments. The following instructions are applicable, when
connecting network devices to the diagnostic ultrasound system.
The instructions are provided in order for the entire system with network devices to meet
IEC60601-1 Ed.3 Electrical Safety Standard.
All configurations shall comply with the requirements for medical electrical systems (see clause
16 of the IEC 60601-1:Ed.3, respectively). There is the possibility that local laws and regulatory
requirements take priority over the above mentioned requirements. For details, please consult
one of our offices listed on back cover.
• Connectable network devices

All non-medical network devices connected to the diagnostic ultrasound system,
including hubs, work stations and personal computers, must comply with IEC60950-1
standard and must be Class I devices.
• Connectable network cables
– Connectors:LAN cable connector
– LAN cable: Straight (in case of hub-use),
LAN cable: Cross (when connecting to PC directly)
– Maximun cable length: 20 m
• Installtion and Network connections
– Non-medical devices must be kept at least 1.5 meters away from a patient.
– When connecting the diagnostic ultrasound system with computer devices located out side
of the ultrasound examination room, a separation device (network hub) must be used
in-between.
MN1-5853 rev.2 3-9

DO NOT use any cable which in not specified or longer than the maximum length.
Electromagnetic interference could result.
If the IT network has been changed, it may be open to new and unacceptable
risks, so additional risk management is required.
The IT network configuration changes
• IT network configuration changes
• Connection of additional devices to the IT network
• Removal of devices from the IT network
• Updates or upgrades to devices connected to the IT network
3-10 MN1-5853 rev.2

3-3 Moving the equipment
DO NOT transport the equipment or its options via automobile or ship.

There is a risk of unexpected accidents or electrical shock.
Transporting this equipment (via automobile/ship) shall be performed by a third party
certified by the manufacturer. Please contact one of our offices listed on back cover.
3-3-1 Isolate from the supply main
DO NOT unplug the power cable from the outlet during shutdown.
The instrument may break down.
After the equipment is shutdown, unplug the power cable from outlet.
1. Press POWER switch to turn off.

2. If necessary, move the equipment to more easily unplug the cable.
3. Unplug the cable from outlet.
MN1-5853 rev.2 3-11

3-3-2 Moving equipment
Move the instrument by grasping the handle at the back of the instrument with both hands.
Do not grasp the instrument at a point other than the handle when moving or lifting it, as this
may result in damage.
DO NOT close the monitor that is turned to sideways.
DO NOT close by force. DO NOT put anything on.
There is a risk of injury or damage to the monitor. And you may pinch your fingers or cables.
Move the instrument keeping distance that it does not come in contact with people, peripheral
equipment, walls, posts, doors and the like.
Move the instrument carefully at a long distance, tilt it, or move it along a passageway that has
stairs.
The instrument may fall or topple over and there is a risk injury or damage to peripheral
equipment or other devices.
The instrument is heavy and does not stop easily once it starts moving.
DO NOT apply an unreasonably large force to the instrument in the horizontal direction.
The instrument may fall or topple over and there is a risk injury or damage to the instrument.
Avoid places with moisture when moving.

Electric shocks and short circuit could result.
3-12 MN1-5853 rev.2

1. Prepare the moving.

Power cable
a Isolate from the supply main → p.3-11
b Lightly coil the power cable and hang it on the power cable hook at the back of the
equipment.
Peripheral instruments that are not fixed

Disconnect those that are not fixed, place it in its case or wrap it in a soft cloth or protective
material.
Peripheral instruments that are fixed
Bunch the cables of the peripheral instrument so that they do not protrude from the instrument or
get caught beneath the casters. When you lower the operation panel or close the monitor, adjust the
cable lines so that they do not pinch.
Probes
Store the probes on the probe holder. For carrying the probe in the Endo-cavity Probe Holder, lay
the probe down horizontally. Do not carry the probe in the vertical position. For instruction how to
secure the probe horizontally refer to “Connecting/Removing a Probe” on page 3-4.
2. Move the operation panel to the lowest position ( → p.3-24).
If the optional devices are installed, lower the operation panel carefully so that it do not hit
on the optional devices.
3. Close the monitor.
a Turn the monitor at the front and correct tilt.
b Hold the tilt button and close the monitor to stop point.
Do not put anything on the monitor or between the monitor and the operation panel.
OK
MN1-5853 rev.2 3-13

4. Release the lock lever of the caster.
a)
a) Unlock lever
b) Lock lever
b)
LOCK LOCK release
5. Grasp the handle on back side firmly when moving the instrument.
Moving across an area with uneven floor levels

Use the handle to lift the instrument over the uneven surface.
6. Fine adjust the position of the instrument at an installed location.

7. Once the position and orientation of the instrument is fixed, lock the casters.
References:
Isolate from the supply main → p.3-11
Adjusting the Operation Panel → p.3-24
3-14 MN1-5853 rev.2

3-4 Storing the Instrument
3-4 Storing the Instrument
When not using the instrument for a long period, store the instrument after carrying out the
preparations for storage. If the storage conditions are unsatisfactory, the instrument may break
down or fail to function satisfactorily. Store the instrument in accordance with the following
procedures.
• Store the instrument under the condition suitable for storing.
1. Disconnect and remove all peripheral instrument and probes.

Peripheral instrument
Place the peripheral instrument in its case or wrap it in a soft cloth or protective material and store
it separately.
Bunch the cables of the peripheral instrument together when storing them.
2. Depress lock levers and fix the instrument.
3. Cover the instrument with a cloth.
References:
Environmental Conditions → p.2-6
Connect the Physiological Signal Connector → p.3-6
Connecting with Other Instruments → p.3-8
MN1-5853 rev.2 3-15

3-5 Inspection Before Using
Perform the external inspection of the instrument and probes before starting the instrument.
After starting the instrument, ensure that the instrument operates normally on the screen.
• If you find the equipment, probes, peripheral instruments or options (recording devices) to
be defective, stop using it immediately.
There is a risk of injury of the patient. For service, probes, or options, please contact one of
our offices listed on back cover.
• Before using a probe, clean, disinfect and sterilize it according to the instruction manual
provided for the probe.
Use of contaminated probes or puncture adapters carries the risk of infection.
For cleaning, disinfecting and safety inspection, refer to the probe documentation.
3-5-1 External Inspection
Perform the following external inspection before using the instrument.
1. Perform the external inspection of the instrument and probe.

Check items for the external inspection
Ensure that there are no scratches, cracks, depressions, change of color on the following parts.
• Enclosure or panel (including vent and air filters)
• Power cable, plugs
• ECG lead cord
External inspection of the probe
Refer to the instruction manual of the probe, inspect the probe to be used.
• Ensure that the probes are cleaned, disinfected and sterilized.
• Ensure that the needle guide adapter and needle are sterilized.
• Ensure that there are no holes, depressions, cracks, deformation on the applied parts.
• Ensure that there are no scratches, cracks, change of color on the cable and the connector.
2. Adjust the monitor in a better position to see.
3. Connect the probe.
4. Confirm that there is an adequate supply of consumables.
• Refill new ultrasound gel.
• Refer to each instruction manual, replace printing paper.
3-16 MN1-5853 rev.2

3-5-2 Operation Check
1. Turn ON the power switch on the instrument.

→ The instrument is set up in 90 seconds, then a B mode image appears.
2. Check the screen display.

check of display
• Images and characters are displayed on the screen.
• Ensure that current time and date are displayed.
If the date and time display is incorrect, a primary battery has run down. Stop using the
instrument, then contact one of our offices listed on back cover.
• Ensure that the connected probe, the image display and the frequency match each other.
When no probes are connected, ensure that "NO PROBE" is displayed.
MN1-5853 rev.2 3-17

3-5-3 Modifying the Date and Time
1. Select the Preset key.

2. Select Set-Up.
→ The preset setting selection list is displayed.
3. Select Common Preset.
→ The Common 1 screen is displayed.
4. Enter the date in the Date field from the keyboard. Alternatively, select the date from the
pull-down list.
Selecting the date from the pull-down list
a Select ▼ to the right of the Date field.
b Select the date from the displayed calendar.
The highlighted date indicates the selected date.
5. Modify the time in the Time field.

a Select HH, MM, or SS to modify the time.
b Enter the time from the keyboard. Alternately, use ▲ / ▼ located at the right end of
theTime field to modify the time.
6. Select Exit to close the Common1 screen.

7. Select Exit.
3-18 MN1-5853 rev.2

3-5-4 Specifying the Hospital Name
1. Select the Preset key.

2. Select Set-Up.
3. Select Common Preset.
→ The Common 1 screen is displayed.
4. Enter the hospital name using up to two 20-character lines in the Hospital Name field.
5. Select Exit to close the Common1 screen.
6. Select Exit.
→ Input data appears to the left of the patient identification information at the top of the
screen.
3-5-5 Volume Control
Sets the audio volume of the Doppler sound, the beep sound of ECG R-waves, and external
input volume.
1. Switch to Image Func Other page.

2. Adjust Audio Volume.
When Audio Volume is set to “0”, it is muted.
Down Up
MN1-5853 rev.2 3-19

3-6 Screen Display
3-6 Screen Display
There are three kinds of displayed information.
• Information that is always displayed.

• Information concerning condition settings for the probe used and ultrasound image.
• Information for patient identification and comments concerning the ultrasound image
Display area for ID.
3-6-1 Character Display
(3)
(1) (4)
(2)
(5)
(7)
(6)
(8)
(1) Hospital Name

(2) Display area for ID, Name, etc
(3) Current date and time
(4) Automatic display area 1
MI=0.53 Mechanical index is displayed in all mode.
TIS<0.4 Thermal index (TIS, TIB or TIC)
Set the display type from Thermal Index in the menu or preset (Preset
Set-Up Menu > Graphics, Information).
71% Acoustic output setting
31 Hz Number of frames per a section.
1 Screen number (1 or 2)
60° Corrected value of doppler angle (is displayed when the Angle Correct
is ON).
3-20 MN1-5853 rev.2

3-6 Screen Display
300/300 Indicates the number of images taken into the cine memory or the
displayed frame number. (when image is frozen)
(5) Automatic display area 2
2.11MR Frequency of the selected probe.
R17.0 Indicates the display depth as a centimeter.

G70 Indicates the image gain.
D66 Indicates the dynamic range.
A1 AGC (Value is not displayed when AGC is Off.)
(6) Automatic display area 3 (2 line)
Sonographer Sonographer’s name entered on the ID screen (displayed only when it is
entered)
2:Abdomen Running preset number and name
Probe:9123 Selected probe name
AIP Indicates that AIP is in operation.
BbH Indicates that Broadband Harmonics is in operation.
SCI Indicates that Spatial Compound Imaging is in operation.
(7) Automatic display area 4 (2 line)
Punc:##° Puncture angle at Puncture Guideline (when puncture guideline is
displayed)
S.V.:##.#mm Sample volume (when sample volume mark is displayed)
Depth:##.#cm Sample depth (when sample volume mark is displayed)
(8) Status bar Indicates used memory space on the HDD.
Status bar color and used disk memory space
HDD Blue indicates that used memory space ranges from 1% to 70%.
HDD
HDD Yellow indicates that used memory space ranges from 71% to
90%.
HDD
HDD Red indicates that used memory space ranges from 91% to 100%.
NOTE: You will be unable to store images if the used memory
space reached 100%. Delete unnecessary data from the
HDD.
MN1-5853 rev.2 3-21

3-6 Screen Display
3-6-2 Graphic Display
(2) (3)
(1)
(4)
(5)
(1) Thumbnail area

Displays the stored images in thumbnail view.
(2) Gray scale bar (gradation of B mode images)
(3) Active mark: An active mark on viewing monitor screen coincides with the front direction mark
on the probe.
Active state: Image on which operations can be performed when two or more images are
displayed.
Non-active state
(4) Focus mark: Indicates the set focal points.
(5) Scale mark: The scale length changes according to the displayed range.
Displayed range Scale (small) Scale (large)

R0.5 to R2.0 0.1 cm 0.5 cm
R2.5 to R6.0 0.5 cm 1.0 cm
R7.0 to R29.0 1.0 cm 5.0 cm
R30 5.0 cm 10.0 cm
3-22 MN1-5853 rev.2

3-6 Screen Display
(6)
(7)
Graphical information displayed in color mode
(6) Color map: This image is a color representation of the set flow velocity and dispersion set by
color coding.
Set the display position from Scale Bar Position in the preset (PRESET Set-Up > Graphic
Information).
(7) Flow area: Flow or Power Flow display area.
MN1-5853 rev.2 3-23

3-7 Adjusting the Operation Panel
Adjust the height, horizontal and vertical position and orientation of the operation panel.
• DO NOT lift the instrument by the operation panel. Do not apply an excessive force to the
instrument.
The instrument could break down.
Adjust the height of the operation panel by holding the handle.
• Adjust the position and orientation of the monitor and operation panel by keeping a
sufficient distance between the instrument and the peripheral equipment, walls and people.
There is risk of injury or damage.
Warn the doctor or patient before adjusting the position and orientation of the operation panel.
3-7-1 Adjusting the Operation Panel
Adjust the height, horizontal and vertical position and orientation of the operation panel.
1. Lock the front casters.

2. Adjust the height of the operation panel by holding the handle with both hands while
stepping on the up-and-down pedal of the panel.
3. Release the up-and-down pedal of the operation panel to fix the operation panel in place.
3-24 MN1-5853 rev.2

3-7-2 Adjust the Orientation of the Operation Panel
1. Check that there is not anything such as a cable in the swing area of the operation panel.
If there is something such as a cables in the swing area, it may be pinch.
2. Adjust the position of the operation panel grasping the handle and keeping pull the lever
for locking the operation panel to the home position.
Arrow: Lever for locking the

operation panel to the home
position
15° 15°
45° 45°
Swing area:
Swing area
Pull this lever slightly and the operation panel can be swing within the range of ±15°. Pull this lever
full and the operation panel can be swing within the range of ±45°.
3-7-3 Adjusting the Brightness of the Operation Panel Switch
NOTE: At the factory settings, Panel LED Brightness is not in the function menu.To display it on
the function menu, assign it in preset to Set-Up > (Application) > Menu-Function.
Adjusting the brightness of the operation panel switch.
1. Display the corresponded function menu.

2. Select Panel LED Brightness from the menu.
3. Select brightness.
When Low, Med, High or is selected
Keyboard (except function keys assigned a function) is auto-photo chromatic.
MN1-5853 rev.2 3-25

3-7-4 Changing the Labeling of the Operation Panel Switches
You can change the functions assigned to the operation panel switches using the preset.
You can customize the switch labeling to match the changes in the assigned functions.
1. Use the supplied tool (for attaching/removing switch cups) to hook the slots of the switch
cup.
2. Pull up the tool and remove the switch cup.
step1.
step2. tool
step1. step1.
3. Change the switch label.

a Remove the switch label.
b Place a new switch label aligning its notches with the protrusions on the rubber cap.
Customize Key Sheet
4. Attach the switch cup aligning its notches with the protrusions on the rubber cap.
CAP
3-26 MN1-5853 rev.2

3-7-5 Changing the color of the trackball
You can customize the color of the trackball for each application (preset).
1. Select Preset key.

2. Select Set-Up.
→ The preset setting selection list is displayed.
3. Select Preset from the Name list.
→ Preset Set-Up Menu of the selected preset is displayed.
4. Select Display2.
→ The following screen is displayed.
5. Change the T.B. Color.

6. Select Exit.
→ This finalizes the changed settings and returns to the preset setting selection list.
Select Cancel to discard the changed settings and return to the preset setting selection list.
7. Select Exit.
MN1-5853 rev.2 3-27

3-8 Adjusting the Monitor
Adjust the height, orientation and brightness.
Take care not o pinch your fingers when adjusting the monitor position or orientation.
You may pinch your fingers or hands and cause injury.
• Prevent the monitor from tangling with the probe cable.
It may cause damage to the monitor or the area of the monitor that was hit.
If the monitor is damaged and the liquid substance inside it touches your skin, wipe it away,
wash with running water for 15 minutes or longer, and consult a doctor. If the liquid gets in
your eye, wash it with running water for 15 minutes or longer and consult a doctor
immediately.
3-8-1 Adjusting the Orientation of the Monitor
To adjust the orientation of the monitor, Grasp the monitor frame with both hands.
Gradient: Swing area: Height: it cannot be adjusted.

10° to the front, 150° to the left, 180° to the right
30° to the back
10° 30°
180°
150°
3-28 MN1-5853 rev.2

3-8-2 Adjusting the Brightness of the Monitor
Adjust the Brightness of the Monitor.
Adjusting the Brightness of the Monitor (Menu)
NOTE: At the factory settings, Monitor Contrast, Monitor Brightness, or Monitor Back Light are not
in the function menu.To display them on the function menu, assign them in preset to Set-Up >
(Application) > Menu-Function.
1. Display the corresponded menu.

2. Adjust Monitor Contrast, Monitor Brightness or Monitor Back Light.
Monitor setting items on the function menu
• Monitor Contrast : 0 to 20
• Monitor Brightness : 0 to 20
• Monitor Back Light: 0 to 20
Adjusting the Brightness of the Monitor
You can set three types as combinations of Monitor Brightness, Monitor Contrast, Monitor
Backlight, Panel LED Brightness. You can select the type for applying to the application.
Setting combinations of Brightness
1. Select PRESET key.

2. Navigate the preset to Set-Up > Common Preset > Common3.
3. Set each items of LCD/Panel Setup.
Set the combination type using the preset
1. Select PRESET key.

2. Navigate the preset to Set-Up > (Application) > Display 2.
3. Select a type from LCD/Panel Setup.
MN1-5853 rev.2 3-29

3-9 Viewing the instruction manual on the CD-ROM
3-9 Viewing the instruction manual on the CD-ROM
NOTE: Adobe Reader version 7.0 or higher is necessary to display the manuals on the CD-ROM.
If Adobe Reader is not installed on your computer, please download Adobe Reader from the
Home page of Adobe Systems Incorporated.
1. Insert the supplied CD-ROM into the CD-ROM drive.

2. Open the DVD/CD drive.
The instruction manuals consists four books.
• Safety Instruction: provides instructions for the safe use of the instrument and how to
avoid hazards.
• How to Use: describes functions for adjusting, displaying and recording images.
• Measurement: describes measurement methods on an ultrasound image and viewing
reports.
• Power Data Book: provides acoustic output tables of probes.
Example of instruction manuals

on the CD-ROM.
(Figure is different from
composition of the instruction
manuals.)
Gray area in the above figure shows (parts of ) the name of the instrument.
3. Double-click an instruction manual
→ A selected instruction manual is displayed.
NOTE: Paper size of the instruction manuals on the CD-ROM is Letter. Before printing,
check your printer property.
3-30 MN1-5853 rev.2

3-10 The Flow of the preparation to the study
Perform the following procedure of the study.

For inputting a patient information, displaying image, and acquiring images, refer to the How
to Use manual.
1. Perform the external inspection of the instrument and probes.

Ensure that there are no scratches, cracks, depressions, change of color.
2. Insert the power plug into the power outlet (hospital grade).
3. Connect a probe to the probe connector on the instrument.
4. Press POWER to turn on, and then check the screen display.
5. Press NEW PATIENT, and then input a patient information.
6. Coat the ultrasonic irradiation area of the probe and area to be examined of a patient with
an ultrasound medium.
7. Apply the probe to the examined area of a patient, and then display an image.
8. When the images are acquired necessary for the diagnosis, and then press FREEZE.
3-10-1 Operating Mode
B mode 1 Press B or B/B.

2 Adjust an image.
• Using DEPTH/ZOOM, adjust size of a tomographic view.
• Using B GAIN or STC knob, adjust the sensitivity.
M mode 1 Press M.
2 Using trackball, move the M cursor on the B mode image.
3 Using MULTI GAIN, control balance of the sensitivity between B mode and M mode.
PW mode 1 Press D.
2 Using trackball, move the Sample Volume on the B mode image.
3 Adjust an image.
• Using Vel Range (D) on the Function menu, adjust the range of the flow velocity.
• Using MULTI GAIN, adjust the sensitivity.
CW mode 1 Press and hold down the D.
2 Using trackball, move the Sample Volume on the B mode image.
3 Adjust an image
• Using Vel Range (D) on the Function menu, adjust the range of the flow velocity.
MN1-5853 rev.2 3-31

Flow mode 1 Press B, B/B, or B/M, and then press F.

(Color 2 Adjust an image.
Doppler) • Using Vel Range (D) on the Function Menu, adjust the range of the flow velocity.
3-10-2 Freezing image/Unfreezing image
● Press FREEZE.
3-10-3 Measuring on a ultrasound image
1. Press Measurement key.

2. Select the measurement item on the measurement menu.
3. Measure according the selected item. (Refer to the Measurement manual.)
3-10-4 Printing images or Storing images
● To Store a still Image

a Press FREEZE to stop an image.
b To print, press PRINT. To store (save), press STORE.
● To store a moving image

a Press FREEZE to unfreeze an image.
b Press STORE to start storing a moving image.
c To stop storing, press STORE.
A moving image is acquired for time for heart beats depending the preset setting.
3-32 MN1-5853 rev.2

4 Troubleshooting
4-1 Messages
4 Troubleshooting
4-1 Messages
There area two types of messages that displayed on the screen.
1) Dialog messages
Dialog messages show the equipment is processing or that an error has occurred.
Operation is suspended.
2) Assistance messages
Assistance messages show additional information to assist in operation. Operation is not
interrupted.
MN1-5853 rev.2 4-1

4 Troubleshooting
4-2 Dialog messages
4-2 Dialog messages
Message Causes Actions

Back up file Reset You select delete the data that is preset or • Continue
will destroy any data saved. Delete the data.
on this system.
• Cancel
Do you still wish to
continue? Return to the previous screen without deleting the data.
• If no response in made within 10 seconds, the display
returns to the previous screen.
Hard disk Access The data cannot be written to the hard disk Please contact one of our offices listed on back cover.
error. in the Preset Control.
Hard disk requires • OK
being diagnosed. Return to the previous screen without writing the data.
This Application is When copying preset data from an external • OK
not supported. media, there are preset data of masked Return to the previous screen without writing the data.
application.
Error: HD free space is insufficient in the Preset Delete unnecessary data in hard disk, and retry.
Disk full. Please Control.
delete data. • OK
Return to the previous screen without writing the data.
Disk access error: The data of HD is crashed and has been 1 Select OK.
System parameter has initialized. 2 Stop using the instrument.
been initialized.
3 Please contact one of our offices listed on back cover.
Please contact
service for
assistance.
Sending images to The image is being transmitted to the The message disappears after transmitting the data.
storage. network from the Review.
Storing Data: **% The image is being saved to the external The message disappears after transmitting the data.
media from the Review (% shows the
progress of saving).
Cannot find study The study information cannot be found. Select Retry, and change the search criteria.
information.
• Retry
Cannot find series The series information cannot be found.
information. Search the patient data.
DICOM image file not The DICOM image file cannot be found. • Cancel
found. Return to the previous screen without searching.
Searching...Please During searching the information. The message disappears after searching, and the search
wait. result is displayed.
4-2 MN1-5853 rev.2

4 Troubleshooting
4-2 Dialog messages

Unable to open list The image that is searched in the Review Select Retry.
file ******** cannot be opened (******** shows file If this message is redisplayed for the images, the image file
name). could be breakdown.
Unable to load image The image that is searched in the Review • Retry
information. cannot be displayed. Open the file after searching.
• Cancel
Return to the previous screen.
Unable to read image The information of the image that is • Retry
information. searched in the Review cannot be Redisplay the image information after searching.
displayed. • Cancel
Unable to build image The image data that is loaded in the Review Return to the previous screen.
information. cannot be built.
In progress. Please DICOM file is being converted to BMP or The message disappears after converting, and the
wait. TIFF. completion message appears.
Process completed. Converting DICOM file to BMP or TIFF The message disappears after 2 seconds.
completed.
Network The communications in the network have a 1 Check the network configurations (Common Preset >
configuration error. problem. DICOM-Store, Send).
2 If necessary, reset the configurations.
• Retry
Retransmit the data.
• Cancel
Return to the previous screen without transmitting the
data.
Printer The DICOM printer in the network has a 1 Check the network configurations (Common Preset >
configuration error. problem. DICOM-Printer).
2 If necessary, reset the configurations.
• Retry
• Cancel
data.
Disk crashed. The removable disk is crashed. Reconnect the removable disk.
If redisplayed, change the removable disk.
• OK
Error: The disk is write-protected. 1 Select OK.
Disk write 2 Replace the writable removable disk.
protected.
• OK
MN1-5853 rev.2 4-3

4 Troubleshooting
4-2 Dialog messages

Removable disk is not The instrument contains a write-protected 1 Select OK.
ready. disk. 2 Replace the writable disk in the disk drive and select
Retry.
• OK
Error: There is no disk in the disk drive. Replace the writable disk in the disk drive and select
No disk, or disk Retry.
The instrument contains an unformatted
unformatted.
disk. • Retry
Reload the data on the disk.
• Cancel
ERROR: Space of the removable disk is insufficient. Replace with the new removable disk and select Continue.
Disk Full!!
Or, adjust data volume to removable disk volume.
• Continue
Write the data.
• Cancel
Verification SCP not The image was transmitted to the SCP that Check the network connection and the network
supported. does not have a server function. configurations of the equipment.
• Retry
Retransmit the image.
• Cancel
data.
Printer A communication error occurs in the Check the network connection and the network
communication error. printer. configurations of the equipment.
• Retry
• Cancel
data.
Network A communication error occurs in the Check the network connection and the network
communication error. network. configurations of the equipment.
• Retry
• Cancel
data.
4-4 MN1-5853 rev.2

4 Troubleshooting
4-2 Dialog messages

There are images not Carried out Print Queue or NEW • Print
printed in the PATIENT, when data exist in the printer Print the data in the printer buffer, move to the next
printer buffer. buffer. operation.
Do you print them or
delete? • Delete
Delete the data in the printer buffer, move to the next
operation.
• Cancel
The patient of this Select the another patient’s Line image Select whether replay a selected image.
image is different replay.
from the patient • OK
during the Erase a display image and replay a selected image.
examination at • Cancel
present.
A current image is displayed without replay a selected
Do you finish an
examination, and may image.
I erase an image?
An image is Select the Line image replay.
transferred to
cinememory.
The image preserved
in cinememory is
erased.
Patient data base An error when it accessed database of a 1 Select OK.
access error. patient in Review. 2 Check the network configuration of the equipment and
connection of the selected database.
• OK
Error: (In the case of Disk on Store Media.) Replace with the new removable disk and select Continue.
Insufficient disk
The writing capacity of Disk is insufficient. Or, adjust data volume to removable disk volume.
space. Please insert
new disk. The message disappears after five seconds.
Error: (In the case Net on Store Media.) Check the network connection and the network
Network configurations of the equipment.
A communication error occurred with the
communication error.
server. The message disappears after five seconds.
Error: • Too many images were stored in the case Delete unnecessary data in hard disk, and retry.
Disk full;Please of Cine on Store Media (capacity over of
The message disappears after five seconds.
delete images. HD).
• Space of the Hard disk or CD-R Buffer is
insufficient.
MN1-5853 rev.2 4-5

4 Troubleshooting
4-2 Dialog messages

Remote *******. The worklist servers (HIS, RIS) in the Check the network connection and the network
******* does not hospital cannot transmit the data. configurations of the equipment.
support Worklist.
• Retry
• Cancel
data.
No worklist records A new worklist cannot be found. Check the network connection and the network
found. configurations of the equipment.
Showing old records.
• Retry
• Cancel
data.
Please enter The patient ID is not entered when the 1 Select OK.
‘PATIENT ID’. search starts. 2 Input a patient ID on the ID screen.
• OK
Loading Patient. Searching the patient ID in the ID screen. The message disappears after searching.
Copying Patient. The patient data is being retrieved from the The message disappears after retrieving.
search list.
Writing Patient. The patient data is being written to the HD. The message disappears after writing.
Receiving Patient. The patient data is being received from the The message disappears after receiving.
HIS and RIS.
Cannot find patient The patient data cannot be found. Select Retry, and change the search criteria.
information.
• Retry
Search the patient data.
• Cancel
Return to the previous screen without searching.
Echo check to C echo check started. The message disappears after two seconds, or after
*******: ******* checking.
started.
Echo check to C echo check ended. Select server have its functions corresponding DICOM or
*******: ******* is active.
successful.
• OK
4-6 MN1-5853 rev.2

4 Troubleshooting
4-2 Dialog messages

Echo check to An error occurred at the time of C echo Selected server doesn’t have its functions or is not active.
*******: ******* check. Please contact your network administrator.
failed.
• OK
Ping check to Ping check started. The message disappears after two seconds, or after
*******: ******* checking.
started.
Ping check to Ping check ended. TCP/IP is active.
*******: *******
successful. • OK
Ping check to An error occurred at the time of Ping check. TCP/IP is not active. Please contact your network
*******: ******* administrator.
failed.
• OK
Invalid probe The connected probe is not suitable for this When the probe is removed, the message disappears.
connected. instrument. NOTE: Connect the probe to the equipment which is
specified this manual.
It can't be stored When storing static images on the DICOM • OK
palette image. Palette format and in the case that the Change the RGB setting and save.
When Store is done, a images on the Palette settings with 3 or
color can't be • Cancel
more differences in 4B modes are saved.
reproduced. Return to the previous screen without saving the setting.
Do you change it to
RGB?
Station name Station names are overlapped. Check the network configuration.
overlaps.
• OK
Invalid data format. There is an error in the header information • OK
of an outside media. Return to the previous screen.
File access error! USB flash memory was removed during Data currently being copied in the instrument can be
A part of the data copying to USB flash memory. displayed as a thumbnail, but cannot be opened or copied.
may not be accessed. Restart the instrument to recopy the data.
Reboot is necessary
to access to the • OK
relevant data. Return to the previous screen.
NOTE:Do not remove the USB flash memory during
accessing.
HARDWARE ERROR A malfunction has been detected in Note message details and contact one of our offices listed
**************** instrument hardware. on back cover.
• OK
MN1-5853 rev.2 4-7

4 Troubleshooting
4-2 Dialog messages

SYSTEM ERROR A malfunction has been detected in Note message details and contact one of our offices listed
**************** software. on back cover.
• OK
Data error of this A malfunction has been detected in probe Restart the instrument.
probe was found. parameters. If this message persists, record message information and
shut down and reboot
When this message appears, power contact one of our offices listed on back cover.
the system.
transmission is shut off immediately.
If this message is
displayed again,
contact our
distributor or Aloka
Office, please show
this message.
Disk Space of Hard disk is 10% or less after Delete unnecessary data from the HDD.
decreased;Please storing images. • OK
delete images.
Or Space of Hard disk is 1% or less after Return to the previous screen.
storing images.
4-8 MN1-5853 rev.2

4 Troubleshooting
4-3 Assistance messages
Message Cause and action

Invalid Function: This The software for operating the menu or switches is
function is inoperable. not ready to operate.
In progress. Please wait. The calculation is in progress. The message
disappears after calculating, and the completion
message appears.
Process completed. The calculation completed.
The message disappears after five seconds.
Press <ENTER> key to rotate When the ENTER key is pressed, the fetus mark
Fetus mark. rotates.
Conform press <ENTER> key. The message appears during the use of Body Mark
Quit<Cancel> key. Location.
Printer Error: The recorder is powered OFF, or when the BUSY
Check printer power. signal does not return in the specified time.
Paper Empty: The EMPTY ERROR is transmitted from the external
Check printer paper. printer.
The data exists in the printer buffer, carry out Print

Queue or NEW PATIENT.
Sending images to printer. The image is being transmitted to the PC printer.
STORE Capacity:Free space ***% The data is saved in the memory.
Free space shows remaining capacity of the store
memory as percentage of the remaining capacity of
the hard disk.
NOTE: Since the status bar indicates how much
HDD space is in use, the display may differ from
the indication of free space.
<FREEZE> the image. The non functional switch or menu for movie was
Then try again. selected.
Accept this images or cycle : Confirming whether it is saved to hard disk after
Press STORE sw replaying Loop an object image in saving operation.
Retry : Press Cancel sw
• CANCEL
Cancel saving the image.
• STORE
Save the image.
MN1-5853 rev.2 4-9

4 Troubleshooting
Message Cause and action

A part of the image couldn't be In the case that Auto Loop is On, and when the
acquired. taking-in quantity of the Cine does not reach the
Accept this images or cycle : settings of heartbeat and the time for taking-in.
STORE sw, Retry :Cancel sw
• CANCEL
Cancel taking the image into the cine memory.
• STORE
Take the image into the cine memory.
A part of the image couldn't be In the case that Auto Loop is Off, and when the
acquired. taking-in quantity of Cine does not reach the settings
of heartbeat and the time for taking-in.
• CANCEL
Cancel taking the image into the cine memory.
• STORE
Take the image into the cine memory.
It failed in the store of this During or starting the image acquisition, the R wave
images! could not be detected.
Not Connected. No connection is established at the time of selection
by the probe name.
System in AUTO-FREEZE. When it is FREEZE automatically after having left
Press <FREEZE> key to resume. unattended during the time setting subsequent to
Timer Freeze by pre-setting on the state of FREEZE
OFF.
Backup data file not found. The backup file cannot be loaded during
maintenance.
Network library initialization The network library failed to be initialized.
error.
Detection Error: The R wave could not be detected in five sec or more.
R-wave of ECG is not detected.
When the R wave signal is detected, the message
disappears.
Range Limit: You attempted to set continuous or step real time
Selection is not available. settings using the trackball or Rotary Encoder and
the values are beyond the limits.
Cannot register. You have attempted to register new words over the
If you delete an unnecessary limit of the user’s dictionary when the learning
word, you can register newly. function is off.
UST-987series: Displayed when you select UST-987-7.5,

UST-987-7.5/UST-995-7.5/UST-M UST-995-7.5, UST-MC11-8731.
C11-8731.
The name of the probe on the screen is displayed as
"UST-987series".
4-10 MN1-5853 rev.2

4 Troubleshooting
4-4 Other problems
4-4 Other problems
Case Cause Action
The equipment is froze. Runaway software. 1 Unplug the power cord from the outlet.
2 Let stand for a few minutes. Connect the
Power supply fluctuation.
power plug into the outlet again.
3 Press the POWER switch to turn on.
The date and time on screen Date and time is not set or Adjust the date and time on Common
are not correct. has shifted. Preset.
Internal battery is drained. Please contact one of our offices listed on

back cover.
The equipment is shutdown The fan is break down. Please contact one of our offices listed on
during start-up. back cover.
The equipment is started
shutdown without warning.
4-4-1 Image Display and Image Degradation
Check the status of POWER switch and monitor screen.

When there is not improvement in that you performed the procedure based on followings, please
contact one of our offices listed on back cover.
check points
POWER Monitor Monitor

switch (graphic) (image) Cause Action
No －－ No connection of the power Reconnect the power plug into the power
cable. outlet.
No －－ Circuit breaker is tripped. Check the condition of the circuit breaker

of the connected power outlet.
Yes No No The fan is break down. Please contact one of our offices listed on
back cover.
Yes No No Screen Saver Display Press the FREEZE switch to switch the
Type is Power Saving display to real time.
Monitor.
Yes No No EXT (external input) is Turn off EXT.

turned on.
Yes Yes No Gain is lowered. Adjust the setting with the B Gain knob.
Yes Yes No No connection of the probe. Reconnect the probe.
MN1-5853 rev.2 4-11

4 Troubleshooting
4-4 Other problems
check points
POWER Monitor Monitor

switch (graphic) (image) Cause Action
Yes Yes No Acoustic power is lowered. Adjust the setting with the Acoustic
Power knob.
Yes Yes No The still image is displayed Press the FREEZE switch to switch the
(The FREEZE switch is display to real time.
ON)
4-12 MN1-5853 rev.2

5 Maintenance
5-1 After Using the Instrument
5 Maintenance
When all today’s studies is finished, isolate the instrument from the supply main. If you skip the
actions after using the instrument, the instrument is damaged or the performance of the
instrument is degraded. Take adequate steps as follows:
DO NOT unplug the power cable from the outlet during shutdown.
The instrument may break down.
After the equipment is shutdown, unplug the power cable from outlet.
1. Freeze the image.

2. Backup the images.
a Transfer all images in the buffer of the internal memory or CD-R to the USB flash memory,
DVD, or CD-R.
b Delete unnecessary images in the buffer of the internal memory or CD-R.
3. Remove recording medium from recording devices.

4. Isolate from the supply main.
a Press the POWER for one second or more to light orange the POWER.
b If necessary, disconnect the power plug from the wall outlet after shutdown in complete.
c Take care that the power cable which is disconnected does not get entangled.
5. Wipe off ultrasound medium remaining on the probes and the ECG electrodes.
6. Remove cables and plugs as necessary.
a Take care that the ECG lead cord does not get entangled.
b Remove the unfixed probes.
MN1-5853 rev.2 5-1

5 Maintenance
7. Clean the instrument.

Parts that must be cleaned at least once a week
• Power Plug (disconnect from the outlet and clean), The area around the device
• Operation panel, External instrument (include probe holders)
• Monitor
• Filter
Parts that must be cleaned as necessary
• Foot switch
• Printer
• Track ball
8. Store the instrument under conditions suitable for storing.
5-1-1 State of the Instrument and Accessories
1) State of the instrument
• Check that the operation panel is cleaned.

• Check that the External instrument (include probe holders) and the foot switch are cleaned.
• Check that the monitor is cleaned.
• Check that the instrument is stored under the condition suitable for storing.
• Check that the power plug is cleaned.
• Check that the casters are locked.
• Check that the instrument is covered by a cloth to protect the dust.
2) State of the probe
• Check that it is cleaned.

• Check that the probe is placed in the probe holder or its case.
• Check that the probe is stored under the condition suitable for storing.
3) State of the ECG lead cord
• Check that those are cleaned.

• Check that those are bunched to prevent from entangling, or placed in the probe holder or
its case.
4) State of peripherals
• Check that the head of the printer head is cleaned.
5-2 MN1-5853 rev.2

5 Maintenance
5-2 Cleaning
5-2 Cleaning
Upon completion of the operation, clean and inspect the instrument after turning off the power
using the following procedure. If you neglect to carry out this procedure, a breakdown may
occur or the instrument may fail to function correctly the next time you carry out an
examination.
DO NOT sterilize or disinfect the equipment with medicinal solution or gas.

Doing so may damage the equipment.
DO NOT spill liquid on the surface or interior of the instrument.

Doing so may cause electric shock and/or short circuits.
Should you spill liquid on the instrument, contact one of our offices listed on back cover.
Clean, disinfect, and sterilize probes with each examination.

Infections may spread via probes.
Refer to the probe’s documentation for information on handling, cleaning, disinfection,
sterilization, and inspection methods.
MN1-5853 rev.2 5-3

5 Maintenance
5-2 Cleaning
5-2-1 Clean the Instrument
Clean the instrument after turning off the power of the instrument and peripherals.
DO NOT clean the instrument with organic solvents such as alcohol or commercial
LCD cleaners.
1. Turn off the power of the instrument.

2. Clean the instrument and peripherals.
Operation panel, enclosure, probe holder, and foot switch
Clean them with a soft, dry cloth. If they are very dirty, remove the dirt in the following procedure.
a Immerse a soft cloth in a weak solution of a neutral detergent, and wring water out of it.
b Wipe the instruments with it softly and clean the dirt.
c Wipe off the detergent.
Monitor
Immerse a soft cloth in water and wring out, wipe the monitor with it softly.
Installation location and Power plug
Clean and remove moisture.
If you use the instrument in a dusty location, the ventilation may deteriorate which can cause
malfunction of the instrument.
Probes
Cleaning, disinfection, and sterilization methods vary according to the probe.
Refer to probe documentation.
Cleaning recording devices
Refer to the peripheral device’s documentation.
Refer to printer documentation for information on printer head cleaning.
5-4 MN1-5853 rev.2

5 Maintenance
5-2 Cleaning
5-2-2 Cleaning the Air Filter
1. Take out each filter as shown in the figure below.

Location of the filters
Filter
2. Vacuum-clean the filter.

3. Wash it with running water.
4. Swish water off, dry the filter completely in a shaded area.
5. Check the front and back of the filter and reinstall it to the original location.
NOTE: Push the filter in completely.
MN1-5853 rev.2 5-5

5 Maintenance
5-2 Cleaning
5-2-3 Cleaning the Trackball
1. Turn the ring to the left.
2. Remove the trackball and put in on a soft cloth.
3. Clean the ring and the trackball with a soft cloth.

4. Clean three places (arrows on the figure below) with a cotton bud.
If the ruby balls are very dirty;

Remove the dirt with a cotton bud that has been immersed in a weak solution of a neutral detergent.
5. Replace the trackball and replace the ring.
5-6 MN1-5853 rev.2

5 Maintenance
5-2 Cleaning
5-2-4 Cleaning Endo-cavity Probe Holder(Horizontal)
This is a optional probe holder that is put the endo-cavity probes. The probe holder and the
adaptor can respectively be removed from the instrument. If necessary, clean it.
Cleaning Endo-cavity Probe Holder(Horizontal)
1. Remove the Endo-cavity Probe Holder.
(2)
(2)
(1)
a Pull (1) tab in the direction of arrow and draw it upward to remove the tab.
b Pull (2) tab in the direction of arrow and draw it upward to remove the tab.
2. Clean it with a soft, dry cloth.

If dirt is heavy
If washing in water
a Rinse the probe holder in running water.
b Wash off ultrasound medium and other substances adhering to the probe holder using a
sponge or gauze.
c Wipe off moisture.
3. Set the probe holder.
(1) (1)
(2)
a Match (1) tab position. Push the probe holder until you hear with a click.
b Match (2) tab position. Push the probe holder until you hear with a click.
MN1-5853 rev.2 5-7

5 Maintenance
5-2 Cleaning
Cleaning Endo-cavity Probe Holder Adapter
1. Remove the adapter.

a Remove the adapter from the back of the probe holder.
b Remove the adapter from near side of the probe holder.
a b
2. Clean it with a soft, dry cloth.

IF dirt is heavy
If washing in water
a Rinse the probe holder in running water.
b Wash off ultrasound medium and other substances adhering to the adapter using a sponge
or gauze.
c Wipe off moisture.
3. Set the adapter.
a b
a Insert the tumour of the adapter into the hole of the probe holder.
b Set the back of the adapter to the probe holder.
5-8 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
5-3 Maintenance
Perform regular inspections to ensure the safe use of the instrument and maintain performance.
There are three kinds of inspections: daily inspections (pre-use inspections/post-use
inspections), measurement accuracy inspections, and safety inspections. Safety inspections are
performed by a technician qualified to conduct safety inspections on electric medical
equipment. If a technician is unavailable, one of our service representatives may be requested
for a fee. For more information on service representatives, contact one of our offices listed on
back cover.
When conducting an inspections, in accordance with the attention points related to the following
electrostatic discharges (ESD), be careful not to invite any deterioration and trouble on the part
being sensitive to static electricity. See “Electrostatic Discharge (ESD) Guidelines” on page
1-21.
If you find the instrument or a probe to be defective, stop using it immediately.

If you continue to use an instrument or probe that is defective, you risk causing injury to the
patient. For repair of the instrument or a probe, please contact one of our offices listed on
back cover.
MN1-5853 rev.2 5-9

5 Maintenance
5-3 Maintenance
5-3-1 Daily check: For Using the Instrument for a Long Period
The equipment may fail to function correctly or may become damaged as a result of
deterioration of parts and consumables. In order to prevent this, you must maintain and inspect
the instrument before or after use, and do periodically.
NOTE: Inspect the probes in accordance with the instruction manual for the probe.
Daily check points
• Check to ensure that there is no dust on the power plug.

• Check to ensure that neither the monitor nor the monitor arm is loose.
• Check to ensure that the Brightness and Contrast settings on the monitor are correct.
• Check to ensure that the Brightness and Contrast settings on the printer are correct.
• Check to ensure that the mounting base is not loose and also that the peripheral
instrument is fixed securely.
Monthly Inspection
• Check to ensure that the casters are locked securely.

• Check to ensure that none of the screws fixing the operation panel and handles are loose.
• Check to ensure that there are no cracks, dents or other enclosure signs of damage on the
instrument.
If you find any loose parts, cracks, dents or other signs of damage on the instrument, make a
suitable indication on the instrument, such as attaching a “BROKEN” tag to it, then contact
one of our offices listed on back cover.
Operate the instrument within its service life (seven years).

A system used over the service life may not provide sufficient perfomence.
5-10 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
5-3-2 Checking the Measurement Accuracy
At least once a year, carry out the following measurements using an ultrasound phantom in
order to check the measurement accuracy and calculation accuracy, and keep a record of the
results.
1) Distance measurement accuracy (horizontal and vertical directions)

2) Resolution and sensitivity (horizontal direction and vertical direction)
3) Doppler measurement accuracy
Preparation for Checking the Measurement Accuracy
• Prepare the following items to inspect.
a) Ultrasound phantom
An ultrasound phantom is made of a substance which resemble those of human body
tissues. It is used for checking the performance of probes and the diagnostic ultrasound
system, and also for adjusting the image settings. It contains parts of different densities and
targets separated by known distances. Some phantoms contain a mechanism for performing
Doppler measurement.
b) Probe connected to the instrument and the accompanying document
c) Measurement accuracy inspection data sheet
d) A record of the previous inspection (If you have it)
1. Copy the measurement accuracy inspection data sheet and write the necessary items.
2. Connect the probe to be used for inspecting the instrument.
3. Press the POWER switch to turn on the power of the instrument.
4. Change the settings of the preset so that they are the same as those used for the previous
inspection. Select the optimum preset for the probe connected to the instrument.
If there is no record of the previous inspection;
Select the optimum preset for the probe connected to the instrument.
5. Record the preset and paste it to the data sheet, or record the preset to a DVD, indicate
details identifying the DVD at the place on the data sheet where the record is to be pasted.
Record the following preset screens.
• Image-B, M1
• Doppler1
• Doppler2
• Flow
MN1-5853 rev.2 5-11

5 Maintenance
5-3 Maintenance
Checking the Distance Measurement Accuracy
Using the ultrasound phantom, determine the horizontal direction and vertical direction
distances.
1. Activate the B mode.

2. Set all of the STC knobs to the center position.
3. Refer to the instruction manual of the probe and adjust the DEPTH/ZOOM switch so as
to obtain the optimum display depth for the inspection.
4. Apply the probe to an ultrasound phantom.
5. Adjust the various switches so that the values conform to R (display depth), G (gain), C
(contrast) and DVA (acoustic power) of the previous record.
Adjust the GAIN, CONTRAST, and ACOUSTIC POWER switches so as to obtain the optimum
image.
7. Calculate the distance measurement accuracy in the horizontal direction.
a Measure the distance between targets separated by a known distance in the horizontal
direction.
b Print the record of the preset screen and paste it to the data sheet. If you recorded the preset
screen to a DVD, indicate details identifying the DVD at the place on the data sheet where
the record is to be pasted.
c Calculate the distance measurement accuracy.
→ Compare it with the record of the previous inspection to judge that it is abnormal if there is
any obvious difference in measurement values.
8. In the same way, calculate the distance measurement accuracy in the vertical direction.
5-12 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
Inspection of the Resolution and Sensitivity
1. Activate the B mode.

2. Set all of the STC knobs to the center position.
3. Refer to the instruction manual of the probe and adjust the DEPTH/ZOOM switch so as
to obtain the optimum display depth for the inspection.
4. Apply the probe to an ultrasound phantom.
5. Adjust the various switches so that the values conform to R (display depth), G (gain), C
(contrast) and DVA (acoustic power) of the previous record.
Adjust the GAIN, CONTRAST, and ACOUSTIC POWER switches so as to obtain the optimum
image.
7. Print the record of the preset screen and paste it to the data sheet. If you recorded the
preset screen to a DVD, indicate details identifying the DVD at the place on the data
sheet where the record is to be pasted.
Inspection of the Doppler Measurement Accuracy
Perform an inspection of the flow velocity measurement accuracy. Next, using an ultrasound
phantom that has a Doppler measurement mechanism (Hereafter called Doppler phantom),
determine the flow velocity by Doppler measurement. Record the measurement results for each
measurement.
Preset settings:
• Select Setup > Flow of the preset setup, set Color for Display Priority.
• Do not change the setting during inspecting.
MN1-5853 rev.2 5-13

5 Maintenance
5-3 Maintenance
Inspect the flow velocity measurement accuracy
1. Display a B/D mode image.

2. Place the probe against the Doppler phantom.
3. Set the velocity of the flow of the Doppler phantom to the recorded velocity of the
previous inspection.
4. Adjust the D gain to the recorded value of the previous inspection.
If you do not have a record of the previous inspection;
Set the D gain so that you obtain the optimal image.
5. Move the Doppler cursor to the area where the blood flows, and display the Doppler
signal.
7. Measure the velocity of the flow.
Inspect the Doppler sensitivity
1. Display a B/flow mode image.

2. Place the probe against the Doppler phantom.
3. Set the velocity of the flow of the Doppler phantom to the recorded velocity of the
previous inspection.
4. Set the flow gain to the recorded value of the previous inspection, and record the result
on the data sheet.
If you do not have a record of the previous inspection;
Set the D gain so that you obtain the optimal image.
5-14 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
Measurement Accuracy Inspection Data Sheet
Manufacturing
Diagnostic ultrasound system Model No. No.
Manufacturing
Probes Model No. No.
Manufacturing
Other peripheral instruments Model No. No.
Inspection date Inspector

Dep./Signature
Image 1 Control preset screen Pasting position Particulars of ultrasound phantom

(control No.,date of purchase, S/N, etc.)
Distance measurement accuracy
Horizontal direction Image pasting position Vertical direction Image pasting position
Known distance between targets: a cm Known distance between targets: a cm
MN1-5853 rev.2 5-15

5 Maintenance
5-3 Maintenance
Distance measurement accuracy
Measured distance: b cm Measured distance: b cm
Distance measurement accuracy % Distance measurement accuracy %

|b-a|÷a×100 ＝ |b-a|÷a×100 ＝
Resolution
Image pasting position
Doppler measurement accuracy
Position for pasting Doppler control preset image Details identifying the Doppler phantom
(control No.,date of purchase, S/N, etc.)
5-16 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
Doppler measurement accuracy
Position for pasting Flow Control preset image Velocity of flow of phantom
Velocity of flow (m/s):
Position for pasting B/D mode image Position for pasting B+ flow mode image
D gain knob FLOW gain knob
MN1-5853 rev.2 5-17

5 Maintenance
5-3 Maintenance
5-3-3 Safety Inspection
A safety inspection is performed by a person who is licensed to carry out safety inspections on
electrical medical instrument at least once a year. And the record of inspection results must be
stored.
If there is no qualified person at the customer's place, our serviceman will carry out this
inspection for a service charge. If you require a serviceman, contact one of our offices listed on
back cover.
Perform the following inspection, and confirm that the measured values are no greater than the
values in the table.
Standard values for periodic safety inspection (Extracted from IEC 60601-1)
Normal Single fault
Item condition condition
1) Earth leakage current 0.5 mA max 10 mA max
2) Enclosure leakage current 0.1 mA max 0.5 mA max
3) Patient leakage current from the patient connection (d.c.) 0.01 mA max 0.05 mA max
Patient leakage current from the patient connection (a.c.) 0.1 mA max 0.5 mA max
Total patient leakage current from the patient connection (d.c.) 0.05 mA max 0.1 mA max
Total patient leakage current from the patient connection (a.c.) 0.5 mA max 1.0 mA max
4) Patient leakage current on the patient connection(s) N/A 5 mA max
Total patient leakage current on the patient connection(s) N/A 5 mA max
5) Impedance for protective contact to earth 0.1Ω max -
Check the power circuits (including power outlets) in the hospital (e.g. measure the
protective earth impedance) at least once a year.
5-18 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
Safety Inspection procedure
1) Earth leakage current

Perform a leakage current test according to Fig.13 of IEC 60601-1: Ed.3 by using the
measurement power supply circuit shown in Fig.F.1 of IEC 60601-1: Ed.3.
This instrument does not have FE (Functional earth terminal). PE (Protective earth
terminal) of this instrument corresponds to leakage current measurement terminal.
Protective earth terminal is located on the rear panel.
2) Touch current
Perform a leakage current test according to Fig.14 of IEC 60601-1: Ed.3 by using the
measuring supply circuit shown in Fig.F.1 of IEC 60601-1: Ed.3.
Signal input and output points of this instrument are protectively earthed except
connectors of ECG lead. Do not apply a voltage to these signal input or output points.
Check the leakage at any part of the enclosure apart from connectors. To do this, apply
two sheets of metal foil of maximum dimensions 20 × 10 cm to arbitrary parts of the
enclosure, then measure the leakage current between one metal foil and earth, and also
between the two metal foils.
3) Patient leakage current from the patient connection to earth
Perform a leakage current test according to Fig. 15 of IEC 60601-1: Ed.3 by using the
measurement power supply circuit shown in Fig. F.1 of IEC 60601-1: Ed.3.
When using multiple probes at the same time, put the probe on selection into a salt
solution and measure a leakage current between the ground and the salt solution.
Do not immerse the probes past the “maximum immersion point” indicated in the
instruction manual for each probe.
Short all three of the ECG lead jacks, and measure the leakage current between the
shorted part and ground.
4) Patient leakage current via the patient connection(s) of an F-type applied part to earth
caused by an external voltage on patient connection(s)
Perform a leakage current test according to Fig. 16 of IEC 60601-1: Ed.3 by using the
measurement power supply circuit shown in Fig. F.1 of IEC 60601-1: Ed.3.
When using multiple probes at the same time, put the probe on selection into a salt
solution and measure a leakage current between the outside voltage and the salt solution.
Do not immerse the probes past the “maximum immersion point” indicated in the
instruction manual for each probe.
Short all three of the ECG lead jacks, and measure the leakage current between the
shorted part and ground.
MN1-5853 rev.2 5-19

5 Maintenance
5-3 Maintenance
When using an ECG lead cable or multiple probes, measure total leakage current. As a
result of the above measurements, the patient contact for measurement is a combination
of three electronic probes with high measurement values, a Doppler probe (if available),
and an ECG cable.
5) Impedance for protective contact to earth
Measure the impedance between the protective earth contact and accessible metal part
which is protectively earthed of the instrument according to clause 8.6.4 a) of IEC
60601-1: Ed.3.
When the specification of arbitrary metal part is difficult, GND side of unconnected
connector is recommended.
NOTE: When measuring the impedance for, do not bring the probe of the tester into contact
with the signal line pins of the connector. This is because the measuring current may
cause damage to the signal line circuit.
6) In addition to measurings
When conducting an IEC 60601-1 Ed.3 test, as indicated in Figure 17, "Measurement of
patient leakage current due to external voltage on the signal input/output part, causing
patient to ground out,” contact one of our offices listed on back cover.
5-20 MN1-5853 rev.2

5 Maintenance
5-3 Maintenance
DIAGNOSTIC ULTRASOUND SYSTEM Safety Inspection Data Sheet
Diagnostic
ultrasound system Model: S/N:
Probe Model: S/N:
Other peripheral
Instruments Model: S/N:
Position and name of

Inspected date inspector
Earth leakage current All possible combinations of positions of switches S5: normal/reverse S12: close/open
Normal condition Allowable: 0.5 mA S1 CLOSE
Single fault condition Allowable: 10 S1 OPEN

mA
Touch current All possible combinations of positions of switches S5: normal/reverse S12: close/open
Measuring points Between enclosure and earth Between two points of

enclosure
Normal condition S1 CLOSE

Allowable: 0.1 mA S7 CLOSE
Single fault condition S1 OPEN

Allowable: 0.5 mA S7 CLOSE
S1 CLOSE
S7 OPEN
Patient leakage current All possible combinations of positions of switches S5: normal/reverse S13: close/open
from the patient
Measuring points Probe ECG lead Total patient
connection to earth
cord leakage current
DC: Normal condition S1 CLOSE

Allowable value: 0.01 mA max S7 CLOSE
Total leakage current: 0.05 mA
DC: Single fault condition S1 OPEN

Allowable value: 0.05 mA S7 CLOSE
Total patient leakage current : 0.1 mA
S1 CLOSE
S7 OPEN
AC: Normal condition S1 CLOSE

AC: Single fault condition S1 OPEN

S1 CLOSE
S7 OPEN
MN1-5853 rev.2 5-21

5 Maintenance
5-3 Maintenance
Diagnostic
ultrasound system Model: S/N:
Probe Model: S/N:
Other peripheral
Instruments Model: S/N:
Position and name of

Inspected date inspector
Patient leakage current All possible combinations of positions of switches S5: normal/reverse S9: normal/reverse S13: close/open
via the patient
connection(s) of an
F-type applied part to
earth caused by an Single fault condition S1 CLOSE
external voltage on the Allowable value: 0.5 mA
patient connection(s) Total patient leakage current : 5.0 mA
Impedance for Allowable value: 0.1 Ω

protective contact to
earth
the patient leakage All possible combinations of positions of switches S5: normal/reverse S9: normal/reverse S13: close/open
current from patient
connection(s) to earth
caused by an external
voltage on a signal DC: Normal condition S1 CLOSE
input/output part Allowable value: 0.01 mA max S7 CLOSE
Total leakage current: 0.05 mA
DC: Single fault condition S1 OPEN

S1 CLOSE
S7 OPEN
AC: Normal condition S1 CLOSE

AC: Single fault condition S1 OPEN

S1 CLOSE
S7 OPEN
5-22 MN1-5853 rev.2

6-1 Instrument and Accessories
6-1 Instrument and Accessories
Parts name Parts No. value
Main Unit USI-163 1
Power Code 100V to 120V: CP-121 1
200V to 240V: CP-117
Instruction Manual (with CD-ROM) MN-CD-F31-E 1
6-2 Options
• DO NOT assemble the instrument or its options without our authorization.

Electric shocks and unexpected accidents could result.
A person recognized by our company assemble the instrument and option when it is delivered
to the user’s premises.
• Connect only options specified by this instruction manual to this equipment.
Failure to observe the following precautions could result in injuries or burns to the patient or
the examiner, or electric shocks and other accidents could result.
MN1-5853 rev.2 6-1

6-2 Options
6-2-1 Recording Devices
Model Name Code Number Remarks
DVD Recorder
DVD Recorder DVO-1000MD SONY
DVO-1000MD connection kit PM-F37-H005
Mounting rack of DVO-1000MD MP-FX-F37-5
Printer
Power Cable (B/W printer) L-CABLE-405-12
Digital B/W printer UP-D897 SONY
Digital B/W printer P95DW MITSUBISHI
Mounting rack of B/W printer MP-FX-F37-1
Digital Color printer UP-D25MD SONY
Mounting rack of Color printer MP-FX-F37-2 for UP-D25MD
Power Cable (Color printer) L-CABLE-807-10C0
USB Cable (B/W printer and Color printer) L-CABLE-889-10C0
Digital Color printer CP30DW MITSUBISHI *1

Mounting rack of Color printer MP-FX-F37-3 for CP30DW
Color printer, DVD recorder simultaneous connection rack
(Standard type) MP-FX-F37-6 for UP-D25MD
(Wide type) MP-FX-F37-7 for CP30DW
*1. It can be connected to a supply mains having voltage 120V. Or it can be connected to a supply mains having voltage
between 220V and 240V.
6-2-2 Functional Expansion Units
Physiological signal display unit PEU-F37
Performance Acceleration Unit EU-9143
Peripheral equipment connection unit EU-6056
6-2 MN1-5853 rev.2

6-2 Options
6-2-3 Other Accessories
1-point foot switch MP-2345B
3-point foot switch MP-2614B
Instruction Manuals MN-P-F31-E Bound volumes
Overlay sheet MP-SH-F37-1
For probe holder, please consult one of our offices listed on back cover.
6-2-4 Softwares
Extend Field of View software SOP-F31-1
Real Time Dop Auto Trace software SOP-F31-3
Free Angular M mode software SOP-F31-5
Flow Profile Measurement software SOP-F31-7
DICOM Network Communication software SOP-F31-10
DICOM Structure Report software SOP-F31-21 SOP-F31-10 is necessary.
Spatial Compound Imaging software SOP-F31-22
AIP software SOP-F31-24
Flow 3D software SOP-F31-35 EU-9143 is necessary.
Freehand 3D software SOP-F31-37

Auto IMT Measurement software SOP-F31-38
Auto NT Measurement software SOP-F31-42
McAfee Embedded Control software SOP-F31-48 McAfee

For install this software,
please contact one of our
offices listed on back cover.
SIP software SOP-F31-52
Reference:
Probe specifications → p.7-5
MN1-5853 rev.2 6-3

6-2 Options
6-4 MN1-5853 rev.2

7 Probes
7-1 Caution in the Handling of Probes
7 Probes
The handling of probes differs by the type of probe. For details, refer to the instruction manual
for the probe. The following are common cautions for probes.
7-1-1 Caution about Handling of Probes
These probes are precision instruments. Handle them carefully not to damage probes.
• Caution in handling
– Store the probe in the probe holder when not in use.

– Hold the probe tightly so that it doesn’t slip especially when using ultrasound gel or other
lubricants.
– Avoid stretching or bending the cable.
Avoid getting the cable pinched under the casters.
– Connect the probe in accordance with this manual and the instruction manual for the probe.
• In order to prevent burns or injury
– Hold the probe tightly so that it doesn’t slip especially when using ultrasound gel or other
lubricants.
– Before using, coat probe adequately with ultrasound gel.
– Do not use unreasonable force while inserting a probe into a body cavity.
– As standard practice, freeze the image when the probe is not in use, even during an
examination.
For ultrasound gel, please contact our office on the back cover.
• In order to prevent infection
– Keep the probes clean and dry.

Do not allow ultrasound gel, water or any other foreign matter to dry on the probes.
– Clean, disinfect and sterilize the probe after using.
– Probes used on patients with Creutzfeld-Jacob disease must be destroyed in order to prevent
inadvertent transmission of this disease.
At present, there are no known methods available to properly clean and sterilize probes
exposed to Creutzfeld-jacob disease.
MN1-5853 rev.2 7-1

7 Probes
References:
Cautions in Performing a Puncture Operation
By installing a puncture adapter, you can carry out a puncture operation. For details, refer to the
instruction manuals for the probe and the puncture adapter.
• External inspection
– Ensure that the probe are sterilized.

– Ensure that the needle is not bent.
– Be sure to check the needle echo using a water tank.
• Caution when installing the puncture adapter
– Be sure that the puncture adapter and the needle have been sterilized before using them.
– Installing the puncture adapter to the probe in accordance with the instruction manuals for
the probe and the puncture adapter.
• Precautions for performing a puncture operation
– A puncture operation must only be performed by a skilled physician.

– While performing a puncture operation, ensure that it is functioning normally, and that the
patient is not abnormally affected.
– If anything unusual occurs when a puncture operation is performed, take the probe away
from the patient immediately, and stop using the instrument.
If the patient’s condition is abnormal, provide appropriate medical treatment.
• To avoid puncturing an area that is not intended to be punctured
– The puncture guideline indicates the direction of puncture needle insertion.

– Use the puncture guideline displayed on screen only as a guide for puncture needle
insertions.
When a puncture adapter has puncture angles, be sure to check a puncture angle on the
screen that is corresponded with current puncture angle.
– Be sure to check the needle echo before using the probe.
If sound velocity of the tissue is not 1,530 m/s, displayed puncture guideline could be
shifted from needle echo.
– Be sure to check the part of the puncture path that is not visible on the screen, and ensure
that it is safe to proceed.
There may be a blood vessel or other organ in the puncture path that is not visible on the
screen.
– Verify the bending and direction of the puncture needle with the puncture needle echo that
is displayed on the monitor.
7-2 MN1-5853 rev.2

7 Probes
Caution about handling the Transesophageal Echo cardiogram probes
The transesophageal echocardiogram probe is used for observing the cardiac ultrasonic wave by
touching the tip of the probe to the esophagus paries, after inserting the probe through the
esophagus by a doctor or other qualified personnel.
• Connect the probe in accordance with this manual and the instruction manual for the
probe.
• Use, clean, disinfect or store in accordance with the instruction manual for the probe.
• Prior to using the transesophageal echocardiogram probe, lower the ultrasonic wave
output with the ACOUSTIC POWER.
During an examination, maintain the output as low as possible.
7-1-2 Cautions about Cleaning and Storage
The safety inspection, cleaning, disinfection and sterilization for each probe differs depending
upon the type of probe. The following are the basic outline of them. For details, refer to the
instruction manual for the probe.
Cleaning, Disinfection and Sterilization
NOTE: DO NOT immerse the probes past the maximum immersion point. For details, refer to the
instruction manual for the probe.
● Clean the probe

a Turn off the power to the instrument.
b Wipe off any ultrasound gel or cream on the probe.
c Clean the probe’s surface in accordance with the instruction manual for the probe.
● Disinfect and sterilize the probe

Method of disinfection and sterilization
They differ depending upon the type of probe. For details, refer to the instruction manual for the
probe.
Probe cover
Refer to the Transducer User’s Manual for sterilization information and the fitting of disposable
sterile probe covers.
MN1-5853 rev.2 7-3

7 Probes
Safety Inspection
After using the probe, inspect the outside of it. If any abnormalities are noted on the probe,
immediately stop using it and contact one of our offices listed on back cover.
• There must be no scratches, holes, cracks or dents on the ultrasonic radiation surface.
• There must be no scratches, holes, cracks or dents on the top of the probe.
• There must be no scratches, cracks or dents on the probe cables.
• There connector must be free of holes, dents, cracks and deformation.
Storage
Store the probe under the following storage environment.
• Ambient temperature: -10 ℃ to 50 ℃

Condensation may occur when storing the instrument in a place, such as a warehouse,
where the temperature and/or humidity varies markedly. Avoid using where condensa-
tion occurs.
• Relative humidity: 10% to 90%
• Atmospheric pressure: 700 hPa to 1060hPa
7-4 MN1-5853 rev.2

7 Probes
7-2 Probe specifications
Use probes only for their intended purpose.

Failure to observe the precautions could result in injuries or burns to the patient or the
examiner. Do not use them incorrectly.
In the probe of intraoperative applications, there is one that can be used for neurosurgery. For
details, refer to the instruction manual for the probe.
Connect probes to this instrument which are specified in this section.

There is a possibility that you are emitting an acoustic beam of an output that is incorrect for
the particular application, or electric shocks and other accidents could result. Do not connect
an unspecified probe.
Table 7-1: Probe List

Convex Sector Probes Linear Probes Phased Array Sector Probes
UST-676P UST-984-5 UST-5413 UST-5298
UST-987-7.5 UST-995-7.5 UST-5299
UST-9123 UST-9124
UST-MC11-8731
NOTE: Please refer to the document supplied with the probe for information on the probe’s
standard configuration and options.
MN1-5853 rev.2 7-5

7 Probes
7-2-1 Convex Sector Probes
Model UST-676P UST-984-5 UST-987-7.5 UST-995-7.5

Intended Uses Transrectal Transvaginal, Intraoperative Intraoperative
Gynecological
Transvaginal Fetal Neonatal Cephalic Small Organ,
Peripheral
Vascular
Applicable part of body Endocavity Endocavity Intraoperative Intraoperative
Surface max. temp. < 43 ℃ < 43 ℃ < 43 ℃ < 43 ℃

Scan Angle or Width 178° 118° 65° 65°
Curvature Radius 9 mm 14 mm 20 mm 20 mm
Operating Mode B, M, B/M, B, M, B/M, B, M, B/M, B, M, B/M,

(PWD: PW Doppler B/PWD, PWD, B/PWD, PWD, B/PWD, PWD, B/PWD, PWD,
M/CD, CD, M/CD, CD, M/CD, CD, M/CD, CD,
CWD: CW Doppler
B/CD/PWD B/CD/PWD B/CD/PWD B/CD/PWD
CD: Flow Mode)
Image Frequency 6.1 MHz 4.8 MHz 7.5 MHz 7.5 MHz
Operating Temp. 10 ℃ to 40 ℃ 10 ℃ to 40 ℃ 10 ℃ to 40 ℃ 10 ℃ to 40 ℃
Remarks
T.H.E Yes – – –
BbH Yes – – –
eFlow Yes – Yes Yes
CW doppler – – – –
Trapezoid – – – –
Spatial Compound – – – –
TDI – – – –
EFV – – – –
Freehand 3D – – – –
7-6 MN1-5853 rev.2

7 Probes
Model UST-9123 UST-9124 UST-MC11-8731

Intended Uses Abdominal Transvaginal, Intraoperative
Gynecological
Gynecological, Fetal Small Organ,
Fetal Peripheral
Vascular
Applicable part of body Surface of body Endocavity Intraoperative
Surface max. temp. < 43 ℃ < 43 ℃ < 43 ℃

Scan Angle or Width 59° 178° 65°
Curvature Radius 60 mm 9 mm 20 mm
Operating Mode B, M, B/M, B, M, B/M, B, M, B/M,

(PWD: PW Doppler B/PWD, PWD, B/PWD, PWD, B/PWD, PWD,
CWD: CW Doppler M/CD, CD, M/CD, CD, M/CD, CD,

B/CD/PWD B/CD/PWD B/CD/PWD
CD: Flow Mode)
Image Frequency 3.5 MHz 6.1 MHz 7.2 MHz
Operating Temp. 10 ℃ to 40 ℃ 10 ℃ to 40 ℃ 10 ℃ to 40 ℃
Remarks
T.H.E – Yes –
BbH Yes Yes –
eFlow Yes Yes Yes
CW doppler – – –
Trapezoid – – –
Spatial Compound Yes – –
TDI – – –
EFV Yes – –
Freehand 3D Yes – –
MN1-5853 rev.2 7-7

7 Probes
7-2-2 Linear Probes
Model UST-5413
Intended Uses Peripheral
Vascular
Small Organ
Applicable part of body Surface of Body
Surface max. temp. < 43 ℃

Scan Angle or Width 38 mm
Curvature Radius N/A
Operating Mode B, M, B/M,

(PWD: PW Doppler B/PWD, PWD,
CWD: CW Doppler M/CD, CD,

B/CD/PWD
CD: Flow Mode)
Image Frequency 7.2 MHz
Operating Temp. 10 ℃ to 40 ℃
Remarks
T.H.E –
BbH Yes
eFlow Yes
CW doppler –
Trapezoid Yes
Spatial Compound Yes
TDI –
EFV Yes
Freehand 3D Yes
7-8 MN1-5853 rev.2

7 Probes
7-2-3 Phased Array Sector Probes
Model UST-5298 UST-5299

Intended Uses Cardiac Pediatric Cardiac Adult
Pediatric
Applicable part of body Surface of Body Surface of Body
Surface max. temp. < 43 ℃ < 43 ℃

Scan Angle or Width 90° 90°
Curvature Radius N/A N/A
Operating Mode B, M, B/M, B, M, B/M,

(PWD: PW Doppler B/PWD, PWD, B/PWD, PWD,
CWD: CW Doppler M/CD, CD, M/CD,

B/CD/PWD, B/CD/PWD,
CD: Flow Mode)
CWD, B/CWD, CWD, B/CWD,
B/CD/CWD B/CD/CWD
Image Frequency 4.1 MHz 2.9 MHz
Operating Temp. 10 ℃ to 40 ℃ 10 ℃ to 40 ℃
Remarks
T.H.E Yes Yes
BbH – Yes
eFlow Yes Yes
CW doppler Yes Yes
Trapezoid – –
Spatial Compound – –
TDI Yes Yes
EFV – –
Freehand 3D – –
MN1-5853 rev.2 7-9

7 Probes
7-3 Clinical Measurement Range
7-3 Clinical Measurement Range
The following is the maximum measurement range per each measurement feature which can be
expected with the this equipment.
Area Area Velocity Time Heart

Distance (Trace, (Ellipse, Circumference Volume Excursion Doppler Interval Rate
PROBE (max, cm) cm2) cm2) (Trace, cm) (cm3) (cm) (cm/s) (s) (BPM)
UST-676P 32.5 469.9 999.9 89.3 999.9 17.0 398.4 9.73 12 - 998
UST-984-5 32.5 469.9 999.9 89.3 999.9 17.0 99.5 9.73 12 - 998
UST-987-7.5 22.9 234.1 999.9 63.1 999.9 12.0 289.9 9.73 12 - 998
UST-995-7.5 22.9 234.1 999.9 63.1 999.9 12.0 289.9 9.73 12 - 998
UST-5298 45.9 936.5 999.9 99.9 999.9 23.9 99.5 9.73 12 - 998
UST-5299 57.3 999.9 999.9 99.9 999.9 29.9 637.6 9.73 12 - 998
UST-5413 22.9 234.1 999.9 63.1 999.9 12.0 318.8 9.73 12 - 998
UST-9123 57.3 999.9 999.9 99.9 999.9 29.9 637.6 9.73 12 - 998
UST-9124 32.5 469.9 999.9 89.3 999.9 17.0 398.4 9.73 12 - 998
UST-MC11-8731 22.9 234.1 999.9 63.1 999.9 12.0 289.9 9.73 12 - 998
7-10 MN1-5853 rev.2

8-1 Acoustic output index
With this device, output indices about the potential for ultrasound induced biological effect to
the tissue are displayed. The displayed indices are the four forms. Of these, mechanical index,
MI shows the mechanical bioeffect in tissue, and thermal indices, TIs show the thermal
bioeffect in tissue provided three forms according to tissue models.
• Mechanical index: MI
Mechanical index (MI) provides an on-screen indication of the relative potential for
ultrasound to induce an adverse bioeffect by a non-thermal mechanism such as
cavitation.
The mechanical bioeffect is caused by the motion of tissue induced when ultrasound
pressure waves pass through or near a gaseous body. The majority of the mechanical
interactions relate to the generation, growth, vibration and possible collapse of
microbubbles within the tissue. This behavior is referred to as cavitation.
Because the thermal bioeffect is not so significant in the mode of B, B/M, and M
respectively, the mechanical index becomes important.
The mechanical index is displayed on all modes.
In other imaging modes, the thermal bioeffect is also important.
• Thermal index: TI
– Soft tissue Thermal Index : TIS

The soft tissue thermal index provides information on temperature increase within soft
homogeneous tissue (heart, first trimester fetal and abdominal scans). TIS can be displayed
on all modes.
– Bone Thermal index: TIB
The bone thermal index (TIB) provides information on temperature increase of bone at or
near the focus when the beam passes through soft tissue (second and third trimester fetal
and neonatal cephalic through the fontanels scans).
TIB can be displayed on all modes and at the time of transducer use. In addition, with scan
modes including B mode imaging, the value of TIB becomes equal to the value of TIS.
– Cranial Bone Thermal index : TIC
The cranial bone thermal index (TIC) provides information on temperature increase of bone
at or near the surface, such as may occur during pediatric and adult cranial scan, in which
the ultrasound beam passes through bone near the beam entrance into the body.
TIC can be displayed on all modes.
MN1-5853 rev.2 8-1

The demarcation between safe levels and levels that the potential for biological effects exist is
important for the operators. The WFUMB (World Federation for Ultrasound in Medicine and
Biology) gives some guidelines.
For example, "Embryonic and fetal in situ temperature above 41 ℃(4 ℃above normal
temperature) for 5 min or more should be considered potentially hazardous.", etc.
On the other hand, the indices provide us an indication of the conditions which are more likely
than others to produce thermal and/or mechanical bioeffect in comparison with other physical
quantities such as the peak rarefactional acoustic pressure or its intensity.
For example, TI values above a certain upper level of the range (more than 1.0) might be better
to avoid in obstetric applications. Such a restriction allows a reasonable safety margin
considering the WFUMB recommendation that a temperature increase of 4 ℃for 5 min or more
should be considered as potentially hazardous to embryonic and fetal tissue.
However if particular clinical results cannot be obtained with lower values, increased output
may be warranted, but particular attention to limit the exposure time should be made. Any extra
thermal load to the fetus when the mother has a fever is also unwise, and again note should be
made to avoid high TI values.
The following list shows an indication of importance of maintaining low values of MI/TI in
clinical use by IEC 60601-2-37.
Table 8-1: Relative importance of maintaining low exposure indices in various scanning
situations
Of greater importance Of less importance
MI • With contrast agents • In the absence of gas bodies:

• Cardiac scanning (lung exposure) i.e. in most tissue imaging
• Abdominal scanning (bowel gas)
TI • First trimester scanning • In well-perfused tissue:
• Fetal skull and spine For example, Liver and spleen
• Patient with fever • In Cardiac scanning
• In any poorly perfused tissue • In vascular scanning
• If ribs or bones are exposed: TIB
CAUTION:It has been thought that cavitation is hard to occur with the diagnostic ultrasound
because it contains as high as several MHz to several dozen MHz frequencies.
However, according to the animal experiments, it is reported that the tissues where originally air
bubbles exist such as lung and bowel are easy to receive the damage of petechia in low acoustic
pressure.
Also according to the animal experiments, ultrasonically induced lung damage in the fluid-filled
lungs of fetuses is not to be expected.
From these facts, it is requested to be careful for using contrast agent to inject air bubbles
intentionally.
8-2 MN1-5853 rev.2

8-2 Interaction between ultrasound and tissue
When ultrasound propagates through human tissue, there is a potential for tissue damage.
During an exam, though ultrasound images are produced with "receiving" a part of the energy
of the transmitted ultrasound wave by the transducer, which energy is reflected from the
irradiated tissue, much of the ultrasound energy is absorbed by body tissue. Ultrasound
generated by the transducer is a physical pressure wave with typical frequencies range from 2
MHz (megahertz, or millions of cycles per second) to 10 MHz. In ultrasound irradiation, the
energy absorbed in the tissue may cause some biological effects.
These mechanisms are classified as mechanical action and thermal action, respectively.
Mechanical bioeffects are due to the pressure waves causing mechanical or physical movement
of the tissues and tissue components. These components such as cells, fluids, etc., oscillate. If
conditions are met, it is possible that these oscillations may affect the structure or function of
living tissues. At present, mechanical effects are thought to be instantaneous in nature, and
closely relate to the peak-rarefactional (peak-negative) acoustic pressure of the ultrasound
pulse.
An extreme example of the mechanical effects of ultrasound is shock - wave lithotripsy, where
focused ultrasound waves are used to break apart kidney stones.
The second type of bioeffect, the thermal bioeffect, is due to the tissues absorbing the energy of
the ultrasound beam. When an acoustic wave transmits through the body tissue, the energy of a
sound wave is attenuated. There are two main causes for attenuation: Absorption and scattering.
Absorption is the conversion of ultrasonic energy into heat; whereas, scattering is the
redirection of the ultrasound away from the direction it was originally traveling. Absorption of
acoustic energy by tissue results in the generation of heat in the tissue. This is what is referred
to as the thermal mechanism. Unlike mechanical bioeffect, thermal bioeffect is thought to be
temporal in nature, and relate to a tissue volume, perfusion rate, exposure time, and duty factor
(ratio of the duration of transmitting pulse to the pulse repetition period).
Among the physiological effects known to occur due to tissue heating are abnormalities in cell
physiology or the low rate of DNA synthesis and increased possibility for the retardation of
growth of systems such as the heart, brain and skeleton of the fetus.
MN1-5853 rev.2 8-3

8-2-1 Possible Biological Effects
Mechanical bioeffect
Mechanical bioeffect is occurred by the oscillation of a pressure wave when ultrasound wave is
transmitted to the body system. This pressure wave acts on microscopic gas bubbles and other
"nucleation sites" in tissue.
These nucleation sites, although presently poorly understood, are believed to serve as starting
points for the development of gas bubbles. Because gas is much more compressible than fluid,
the microscopic gas bubbles can expand and contract greatly in comparison to the immediately
surrounding tissues and fluid. The large change in size may damage tissues.
Though mechanical bioeffect contain cavitation (ultrasonically activated behavior of micro
bubbles and other "nucleation sites" in tissue), acoustic radiation force and microstreaming, etc,
cavitation is thought to be most important.
There are two categories of cavitation: Non-inertial (once termed Steady-state) cavitation and
Inertial (once termed Transient) cavitation.
Non-inertial cavitation arises from the repeated expansion and contraction of the micro bubbles
in response to the varying pressures in ultrasound pulses. This oscillation can lead to a
phenomenon known as "micro streaming", where the oscillation of gas bubbles in tissue leads
to motion in the fluid around the gas bubbles. This phenomenon has shown that micro streaming
has the possibility of causing disruption of cell membranes.
During inertial cavitation, pre-existing bubbles or cavitation nuclei expand from the pressure of
the ultrasonic field and then collapse in a violent implosion. Although this phenomenon occurs
on the microscopic level, it has been demonstrated to produce extremely high temperatures and
pressures in the immediate vicinity, which can lead to cell death.
The potential for mechanical bioeffects is related to the peak negative (rarefactional) pressure
of the ultrasound wave and its frequency. Higher values of negative pressure (if amplitude wave
becomes large) increase the potential for mechanical bioeffect. Higher frequencies decrease the
potential for mechanical bioeffect.
At this time, there is no solid evidence that cavitation occurs in human tissue with the output
intensities available on current ultrasound diagnostic systems. However, mechanical effects are
theoretically possible.
8-4 MN1-5853 rev.2

Thermal bioeffect
Thermal bioeffect occurs over longer periods of time, where absorption of the ultrasound energy
results is heating of tissues. Excessive heating can lead to disruptions in cellular processes and
structures, especially in developing fetal tissues. As stated above, the energy which is producing
image by receiving reflected energy from the body's internal tissues by the transducer is very
limited out of the total energy transmitted to the body system. The residual energy must be
absorbed by the tissues. With this absorption, heat is developed mainly in two areas such as at
the surface of the body where ultrasound beam enters and in the vicinity of the focus of the
beam.
Because of difference in their physical properties, different tissues absorb ultrasound energy at
different rates. Absorption coefficient is affected by the ultrasonic power (energy per unit of
time), the volume of tissues involved and its perfusion rate, or the amount of blood flow through
the target tissues. Bone tissue, with its higher density and lower perfusion rate than those of soft
tissues, absorbs more ultrasound energy.
Bone tissue at the surface will absorb the largest portion, and has the highest susceptibility to
heating from ultrasound exposure. Bone tissue not at the surface, but at the focus point of the
beam, will also absorb a higher portion of energy. Soft tissues absorb the least. Because tissue
absorbs ultrasound energy at different rates, a single model to describe all of the different
properties of different tissues is not available. Currently, there are three different models to
describe thermal bioeffects in tissue. The three models are
• Soft tissues
• Bone at focus and
• Bone at the surface
The type of ultrasound beam also influences the potential for thermal bioeffect. In non-scanning
mode (example: D-mode), as the position and direction of an ultrasound beam converging
energy are fixed, the ultrasound energy of high-density occurs for a comparatively small tissue
volume. This tends to increase the thermal bioeffects in the tissue.
In addition, in B mode, as the position and direction of ultrasound beam are variable, the energy
of ultrasound is scattered in a comparatively large volume of tissues so that the perfusion rate
becomes high and the process of heat becomes not so significant.
At this time, there is no solid evidence that the temperature elevation with currently available
ultrasound diagnostic systems is harmful to the human body.
MN1-5853 rev.2 8-5

8-3 Derivation and Meaning of MI/TI
In 1992, AIUM (The American Institute of Ultrasound in Medicine) and NEMA (National
Electrical Manufacturers Association) published the voluntary standard "TI/MI output display
standard" (AIUM/NEMA: Standard for real-time display of thermal and mechanical acoustic
output indices on diagnostic ultrasound equipment). This standard has established the method
calculating and displaying indices relatively indicating the possibility of mechanical and
thermal bioeffect. IEC 60601-2-37 "Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment" employs the same
indices. Therefore the user can control the acoustic output while confirming the indices are
real-time displayed on the majority of modern diagnostic ultrasound equipment.
These indices, the thermal index (TI) and the mechanical index (MI), provide unitless numbers
giving information on the likelihood of an adverse biological effect resulting from the current
ultrasound examination. The indices were designed so that if either index exceeded a predefined
value, there was a potential for harm. When the value of index exceeds 1.0, the user should
assess if the examination could be performed with a lower acoustic output, or consider
mitigating factors in reevaluating the risk-benefit analysis. Mitigating factors include the
absence of gas-containing structures, anatomical sites that would be particularly invulnerable to
damage and the perfusion rate in the region being examined. Also, the duration of the
examination should be kept to a minimum to avoid any unnecessary exposure. However there
is another risk that must be considered: the risk of not doing the ultrasound exam and either not
having the enough information necessary to diagnose. It is also important to recognize that the
potential harm from misdiagnosis can have greater consequences than that of
ultrasound-induced bioeffect.
8-6 MN1-5853 rev.2

8-3-1 Mechanical Index (MI)
Scientific evidence suggests that mechanical or nonthermal bioeffect, like cavitation, are a
threshold phenomenon, occurring only when a certain level of output is exceeded. However the
threshold level varies depending on the tissue. The potential for mechanical effects is thought
to increase as peak-rarefactional acoustic pressure increases, but to decrease as the ultrasound
frequency increases.
Therefore the mechanical index MI is defined as:
CMI = 1 MPa MHz-1/2

pr, αfawf-1/2 pr : attenuated peak-rarefactional acoustic pressure (MPa)
MI =
CMI
fawf: acoustic working frequency (MHz)
CMI is a standardization coefficient, and it is 1 [MPa MHz-1/2]. Therefore, MI is unitless.

The MI becomes important at a gas/soft tissue interface, for example in cardiac scanning where
the lung surface may be exposed. Most critically, however, is with the use of contrast materials
containing gas bubbles when most attention should be paid to limit MI.
As the ultrasound goes through the fluid such as amniotic fluid or bladder with very little
decrease, the sound pressure received by the tissues might be high even if the value of MI is low.
8-3-2 Thermal Index (TI)
TI is defined that the ratio of attenuated acoustic power at a specified point, Pα [mW] to the
attenuated acoustic power required to raise the temperature at that point in a specific tissue
model by 1 ℃, Pdeg [mW].
Pα Pα : attenuated output power

TI =
Pdeg
TI is unitless as well as MI.

There are three thermal indices are used for different combinations of soft tissue and bone in the
area to be examined, namely, TIS (soft tissue), TIB (bone) and TIC (cranial bone). The purpose
of the thermal indices is to keep users aware of conditions that may lead to a temperature rise
whether at the surface, within the tissues, or at the point where the ultrasound is focusing on
bone. Each thermal index estimates temperature rise under certain assumptions.
• For scanning mode, the position of the maximum heating is assumed to be at the surface
of the probe for all tissue models.
• For non-scanning mode, if bone is not present, the maximum heating is likely to occur
between the surface of the probe and the focus of the ultrasonic beam.
MN1-5853 rev.2 8-7

• For non-scanning mode, if bone is present and located near the focus of the ultrasonic
beam, the maximum heating is likely to occur at the surface of the bone. When doing
diagnoses of the fetus that are developing neural tissues, such as the brain and spinal
cord, that may be in a region of heated bone, it is recommended to display TIB and pay
attention to its value.
When you are undecided which TI should be displayed, it is preferable to refer the following
chart to decide where the bones are located in the region at which is irradiated by ultrasound.
Table 8-2: Thermal Index categories and models
Scanning mode Non-scanning mode
TIS:
Soft tissue thermal
Probe Probe
index
Tissue surface
Tissue surface
Before a focus
Soft tissue
Soft tissue
TIB:
Bone thermal index
Probe
Soft tissue Bone surface
Bone
TIC:
Cranial-bone thermal
Probe Probe
index
Bone Bone
Bone surface Bone surface
Soft tissue Soft tissue
8-8 MN1-5853 rev.2

8-4 Setting condition influencing device output
8-4 Setting condition influencing device output
It is necessary to understand the setting condition of the ultrasonic diagnostic equipment

influencing MI/TI to use the indicated information of MI/TI more effectively. MI is calculated
using the peak rarefactional (negative) acoustic pressure. TI is proportional to the time averaged
value whereas MI is proportional to instantaneous value. The following table shows diagnosis
device control settings to influence MI/TI.
Some parameters such as the pulse repetition frequency are not displayed on a screen of the
device. Therefore it is recommended to read carefully the instruction manual (Safety
Instruction) in use.
Table 8-3: Ultrasound Diagnostic System setting condition to influence MI/TI
*1 Settings condition to influence MI/TI in continuous wave doppler (CWD) are only drive voltage and electric focus.
*2 Gain do not influence MI/TI for processing gain after receiving.
System Control Settings*1 Switch or function MI TI

COMMON Drive Voltage Acoustic Power Yes Yes
Electric focus Focus Yes Yes
Gain *2 Gain ― ―
B Pulse repetition frequency Depth/Zoom ― Yes

Residual Echo Reject Yes Yes
Drive frequency Image Freq ― Yes
Number of scanning lines Frame Rate ― Yes
Scan Area Yes Yes
M Pulse repetition frequency Depth/Range ― Yes
Drive frequency Image Freq Yes Yes
Imaging mode (wave) BbH, T.H.E. Yes Yes
PW Pulse repetition frequency Velocity Range ― Yes
High PRF ― Yes
Pulse duration Image Freq ― Yes
Imaging mode (wave) TDI Yes Yes
Mflow Pulse repetition frequency Velocity Range ― Yes
High PRF ― Yes
Imaging mode (wave) TDI Yes Yes
MN1-5853 rev.2 8-9

8-5 Recommendation on ALARA principle
System Control Settings*1 Switch or function MI TI

Flow Pulse repetition frequency Depth/Zoom ― Yes
Velocity Range ― Yes
Number of scanning lines Frame Rate ― Yes
Flow Area ― Yes
Average (Flow) ― Yes
Imaging mode (wave) eFlow, Power, TDI Yes Yes
8-5 Recommendation on ALARA principle
ALARA stands for "As Low As Reasonably Achievable". Following the ALARA principle
means that total acoustic output is kept as low as reasonably achievable, while diagnostic
information being optimized. This guiding philosophy is the same as in the use of X-ray
equipment.
For example, when the mechanical index (MI) is considered,
• Selection of appropriate probe

• Selection of drive frequency (higher frequency is lower in MI value)
• Selection of electronic focus
• Lower Drive voltage
• Adjust Gain (Higher Gain)
Keep in mind these points during examination. In addition, be more careful before using a
contrast agent.
When Thermal Index(TI) is considered,
• Selection of appropriate TI
• Appropriate image adjustment (raise the gain, etc.)
• Reduction of TI value (reduce transmission voltage, lowering pulse repetition frequency,
widen the scan width in the case of scan mode)
• Shorten exposure time
8-10 MN1-5853 rev.2

8-6 Default Setting
8-6 Default Setting
In order to avoid unintentional high acoustic output, the acoustic output is limited by default
setting in the following cases (it becomes a low value):
• Power On
• Select the type of examination (Application) with the preset feature
• Switching the probe
• NEW PATIENT Function Operation (ID input)
Default setting (Low value) limits the acoustic output less than DVA% = 70%, Ispta, α < 94
mW/cm2, MI<1.0, or TI<3.0 whichever less.
8-7 Acoustic output Limits
The values of spatial peak temporal average intensity (Ispta, α), mechanical index (MI) and
thermal indices (TIs) do not exceed 720 mW/cm2, 1.9 and 6 respectively for other than fetal
examination.
There are cases that the mechanical index (MI) and the thermal index (TI) are more than 1 by
the type of probe and the mode of image display. At that time, it displays the value in real time.
For fetal examination, the mechanical index (MI) and thermal indices (TIs) do not exceed 1.0
and 3.0 respectively.
MN1-5853 rev.2 8-11

8-8 Measurement uncertainties
8-8-1 Protocol for calculating the measurement uncertainties
The protocol for calculating the measurement uncertainties follows the methods used in NEMA
UD 2-2004.
The reporting of an acoustic output quantity requires the specification of the measurement mean
and a quantitative estimate of the uncertainty associated with the measurement. Uncertainty is
expressed in terms of confidence limits or tolerance limits. A 95% confidence limit defines a
range of values that will contain the true mean (or some other specified quantity) 95% of the
time. A 95% tolerance limit defines a range of values that will contain a specified percentage of
all values 95% of the time.
An important feature of this approach is the incorporation of the Type A and Type B
terminology in classifying the components of measurement uncertainty, as recommended by the
International Organization for Standardization (ISO, 1993), and adopted by the American
National Standards Institute (ANSI/NCSL, 1997). These new terms replace the previous terms:
"random uncertainty" and "systematic uncertainty". Type A and Type B uncertainties are
distinguished on the basis by which their numerical values are estimated.
Type A uncertainties are those that are evaluated by statistical treatment of repeated
measurements, and Type B are those that are evaluated by other means. An important reason
for the new classification is to provide an internationally accepted procedure for mathematically
combining individual components of uncertainty into a single total uncertainty regardless of
whether arising from random or systematic effects.
Basic to this approach is representing each component of uncertainty by an estimated standard
deviation, termed standard uncertainty. Its symbol is ui and is equal to the positive square root
of the estimated variance ui2 .
For a Type A uncertainty component, ui equals the statistically estimated standard deviation.
Statistical methods involve the analysis of multiple replications to estimate population
parameters, such as the mean and the standard deviation.
Type B evaluations are based on scientific judgment using all of the relevant information, which
may include:
• previous measurement data,

• experience with the relevant materials and instruments,
• manufacturer's specifications,
• data provided national standards laboratories,
• uncertainty data taken from handbooks.
It should be noted that Type A evaluations of uncertainty based on limited data are not
necessarily more reliable than soundly based Type B evaluations (Taylor and Kuyatt, 1994).
8-12 MN1-5853 rev.2

Type A Evaluated Uncertainty
A Type A standard uncertainty, uA, of a measured quantity is equal to the standard deviation of
the sample mean, which is commonly called the standard error. It is given by,
Sx (1)
u A=
√n
where Sx is the sample standard deviation and n is the number of repetitions. As indicated in
equation(1), a Type A uncertainty is reduced by performing additional measurements. This
results from the increase in the size of the denominator. Ideally, the measurements should be
repeated a sufficient number of times to yield a reliable estimate of the standard error.
Type B Evaluated Uncertainty
A Type B evaluation of uncertainty is performed after all adjustments for correctable systematic
errors have been made. The statistical distributions of all remaining systematic errors are
combined to produce an overall statistical distribution. Unless there is information to the
contrary, the individual probability distributions are considered independent rectangular
distributions, each possessing a variance equal to ai2/3, where ai is the semi-range limit for the
ith uncertainty component. Because of the independence of the individual distributions, the
total variance equals the sum of the individual variances. Thus, for n rectangularly distributed
uncertainty components, the total variance, σ2, is given by
σ 2 = σ 12+ σ 22 + … + σ n2 (2)
and the Type B standard uncertainty, uB, is then
uB = √σ2 = a12 + a22 + ... + an2 (3)

√ 3
MN1-5853 rev.2 8-13

Combined Uncertainty
The combined or total uncertainty of a measured quantity includes both Type A and Type B
evaluated components of uncertainty. It is computed after all blunders have been removed from
the data base, and after all possible systematic corrections have been made. The combined
uncertainty, uC, of a measured quantity is given by
(4)
uC = √uA2 + uB2
The ISO (1993) advocates using the combined standard uncertainty as the parameter for
expressing quantitatively the uncertainty of the result of a measurement and in giving the results
for all international comparisons of measurements. Although uC can be universally used to
express the uncertainty of a measurement result, in many commercial, industrial, and regulatory
applications, and when health and safety are concerned, it is often desirable to provide a
measure of uncertainty that includes a larger proportion of the distribution of values that could
be reasonable attributed to the measurand. This is provided by multiplying the combined
standard uncertainty by a coverage factor k to yield the expanded uncertainty U. That is,
U = k • uC (5)
The result of a measurement is then conveniently expressed as
x=x±U (6)
The value of the coverage factor k is chosen based on the level of confidence required for any
given application. In general, k will be in the range of 2 to 3. NIST has adopted a policy of
setting k = 2, unless stated otherwise (Taylor and Kuyatt, 1994). In ultrasonic exposimetry, k is
usually set to the value of t.975, at the appropriate number of degrees of freedom, in order to
provide a 95% level of confidence about the expected value of the measurand. Whatever the
value of k chosen, it must be clearly stated in the final specification of the uncertainty.
8-14 MN1-5853 rev.2

8-8-2 Results of measurement uncertainties
Now we would like to offer the results of measurement uncertainties of our products. 4 units of
ALOKA SSD-4000 and 6 units of UST-9123 for 4 times repeated acoustic output
measurements (e.g. total power (P), pulse-intensity integral (Ipi), peak-rarefactional acoustic
pressure (pr), acoustic working frequency (fawf)). Though this product model may be different
from the model specified in this manual, we believe we can obtain the similar results from
different set of console and probes. The results were analyzed using a two-way crossed analysis
of variance with repeated measurements.
In this analysis it is assumed that the consoles and transducers are independent and that all
repeated measurements are independent. It is also assumed that all preliminary steps, such as
correcting for systematic errors, have been performed.
There are six transducers (p = 6), four consoles (q = 4) and four times (r = 4) repeated
measurements.
p : transducers
COMPUTATIONAL SET UP FOR q : consoles
r : repetetions
consoles (j =1, 2,..., q)

1 2 ... q
transducers (i =1, 2,..., p)
1 m11, s11 m12, s12 ... m1q, s1q m1 .
2 m21, s21 m22, s22 ... m2q, s2q m2 .

Si .
.. .. .. .. ..
. . . . .
p mp1, sp1 mp2, sp2 ... mpq, spq mp .
m. 1 m. 2 ... m. q m
S. j
ijth cell mean

r
1 (7)
mij = r 3 xijk
k=1
ith transducer mean

q
mi• = q 3 mij
1 (8)
j=1
jth console mean

p
1 (9)
m•j = p 3 mij
i =1
overall mean
p q
1 (10)
m = pq 33 mij
i =1 j =1
standard deviation of ijth cell

r
(11)
√3
S ij = x ijk - m ij) 2/ (r - 1)
k =1
MN1-5853 rev.2 8-15

standard deviation of transducer

p
(12)
S i• =
√ 3 m i• - m) 2/ (p - 1)
i =1
standard deviation of console

q
(13)
S •j = √ 3 m •j - m ) 2/ (q - 1)
ij=1
Using equation (8), (9) and (10), transducer mean, console mean and overall mean are calculated
respectively. The standard deviation calculated using equation (11) is expressed in percentage to overall
mean value.
The variability inherent in the measurement technique is quantified by Smeas, the square root of the
variance attributed solely to the measurement technique. That is,
1 p q (14)
S meas = pq 33 S ij2
√ i=1 j=1
The transducer variability is quantified by Strans, which is given by
1 (15)
S trans = S i• - rq S meas2
√
And the console variability is quantified by Scons, which is given by
S cons = S •j - 1 S meas2 (16)

√ rp
The total variability is quantified by Stotal, which is given by
S total =√ S trans2+S cons2 +S meas2 (17)

The variance of the measurand is given by
σˆ x2 = S total2 (18)
And the variance of the measurand mean is given by
S trans2 S cons2 S meas2 (19)

σˆ x2 = p + q + rpq
The Type A standard uncertainty is the square root of the variance of the measurand mean. That is,
(20)
u A2 = √σˆ x2
The type B uncertainty is given by
uB = √σ2 = a12 + a22 + ... + an2 (21)

√ 3
Then the combined uncertainty will be
(22)
uC = √uA2 + uB2
The expanded uncertainty, U, for the purposes of ultrasonic exposimetry should be set for a level of
confidence of 95%. Thus, k should be set equal to 2.07, the value of t.975 with pq - 1 = 23 degrees of
freedom (from Table 1 of UD 2-2004 Appendix A). Then,
U = k • uC = t .975 ( pq - 1) • uC (23)
And the ultrasound power should be reported as
Power = m ± U (24)
8-16 MN1-5853 rev.2

An upper 95% tolerance limit is computed using an expanded uncertainty in which the coverage factor
is an appropriately chosen tolerance coefficient and the Type A component of the combined uncertainty
equals √ σˆ x2 , instead of √σˆx2 .
Thus, for an upper 95% tolerance limit for 99% of power values is given by,
uC = √uA2 + uB2 = √σ㰖 x 2 + uB2 (25)
k should be set to the value of K.99 for pqr - 1 = 95 degrees of freedom.Then the expanded uncertainty is
U = k • uC = K .99 ( pq - 1) • uC (26)
And the upper tolerance limit is expressed as
Power ≤ m + U (27)
MN1-5853 rev.2 8-17

Uncertainty evaluation of total power : P
The standard deviation obtained from mean value of 6 transducers by eq. (12), Si.: 6.44%
The standard deviation obtained from mean value of 4 consoles by eq. (13), S.j: 2.57%
The standard deviation derived from measurement technique by eq.(14), Smeas: 1.01%
The standard deviation due to the transducer variability by eq. (15), Strans: 6.43%
The standard deviation due to the console variability by eq. (16), Scons: 2.56%
The total standard deviation calculated by eq. (17) Stotal: 7.00%
The type A uncertainty by eq. (20), uA: 2.92%
Uncertainty components for type B uncertainty evaluation

The error due to reading the balance scale, a1 : ±2%
The error due to the reference source, a2: ±4%
The error derived from alignment of the transducer, a3: - 5%
The error derived from not coupling directly between the transducer and water, a4: - 3%
The error derived from not enough thickness of the absorbing target, a5: - 5%
The type B uncertainty by eq. (21), uB: 5.13%

The combined uncertainty by eq. (22), uC: 5.91%
confidence of 95%. Thus, k should be set equal to 2.07, the value of t.975 with pq-1 = 23 degrees of
freedom (from Table 1 of UD 2-2004, Appendix A).
The expanded uncertainty by eq. (23), U 12.22%
P = m ± 12.22 % (95% C.I.)
An upper 95% tolerance limit is computed using an expanded uncertainty in which the coverage factor is
an appropriately chosen tolerance coefficient and the Type A component of the combined uncertainty
equals √σˆx2 and not √σˆx2 as before.
The upper 95% tolerance limit for 99% of power values, uC: 8.68%
The coverage factor, k should be set to the value of K.99 for pqr - 1=95 degrees of freedom. Since a
value for K.99 for 95 degrees of freedom is 2.69, then the coverage factor k = 2.69
The expanded uncertainty for the upper 95% tolerance limit by eq. (26), U 23.38%
P ≤ m + 23.38 %
8-18 MN1-5853 rev.2

Uncertainty evaluation of pulse-intensity integral: Ipi

The error derived from voltage measurement of the oscilloscope, a1: ± 3%
The error derived from time measurement of the oscilloscope, a2: ± 2%
The error derived from calibration of the hydrophone, a3: ± 8.6%
The error derived from alignment of the hydrophone, a5: - 4%
The error derived from the effect of spatial averaging over the aperture of the a6: - 16.6%
hydrophone,
The error derived from the effect of non-linear distortion, a7: - 6%
The error derived from the directivity of the hydrophone a8: - 4%

The expanded uncertainty, U, for the purposes of ultrasonic exposimetry should be

set for a level of confidence of 95%. Thus, k should be set equal to 2.07, the value of
t.975 with pq-1 = 23 degrees of freedom (from Table 1 of UD 2-2004, Appendix A).
Ipi = m ± 25.62 % (95% C.I.)

The upper 95% tolerance limit for 99% of Ipi values by eq.(25), uC: 13.39%
value for K.99 for 95 degrees of freedom is 2.69, then the coverage factor k = 2.69.
The expanded uncertainty for the upper 95% tolerance limit by eq. (26), U 36.03%
Ipi ≤ m + 36.03 %
MN1-5853 rev.2 8-19

Uncertainty evaluation of peak-rarefactional acoustic pressure: pr

The error derived from voltage measurement of the oscilloscope, a1: ± 1.5%
The error derived from calibration of the hydrophone, a3: ± 4.3%
The error derived from alignment of the hydrophone, a5: - 2%
The error derived from the effect of spatial averaging over the aperture of the a6: - 8%
hydrophone,
The error derived from the effect of non-linear distortion, a7: - 3%
The error derived from the directivity of the hydrophone a8: - 2%

pr = m ± 13.19 % (95% C.I.)

The upper 95% tolerance limit for 99% of pr values by eq.(25), uC: 7.08%
value for K.99 for 95 degrees of freedom is 2.69, then the coverage factor k = 2.69.
The expanded uncertainty for the upper 95% tolerance limit by eq.(26), U 19.05%
pr ≤ m + 19.05 %
8-20 MN1-5853 rev.2

Uncertainty evaluation of acoustic working frequency: fawf


fawf = m ± 2.39 % (95% C.I.)
MN1-5853 rev.2 8-21

8-9 References
8-9 References
1) Barnett S.B., et al, International recommendations and guidelines for the safe use of
diagnostic ultrasound in medicine, Ultrasound Med Biol 26, No.3, 2000, P. 355-366
2) IEC 60601-2-37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment, 2007
3) Carstensen EL, Gracewski S, Dalecki D: The search for cavitation in vivo. Ultrasound
Med Biol 26: 1377-1385, 2000
4) Nyborg WL: Biological effects of Ultrasound : Development of safety Guidelines. Part
2 : General Review. Ultrasound Med Biol 27 : 301-333, 2001
5) Apfel RE, Holland CK: Gauging the likelyhood of cavitation from short-pulse low-duty
cycle diagnostic ultrasound. Ultrasound Med Biol 17 : 179-185, 1991
6) AIUM / NEMA: Standard for real-time display of thermal and mechanical acoustic
output indices on diagnostic equipment, UD-3 Rev. 2, 2004a
7) AIUM / NEMA: Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment, UD-2 Rev.3, 2004b
8) Abbott JG: Rationale and derivation of MI and TI. Ultrasound Med Biol 25 : 431-441,
1999
9) AIUM: Medical Ultrasound Safety, 2009
10) BMUS: Guidelines for the safe use of diagnostic ultrasound equipment, 2009
11) WFUMB: Conclusions and Recommendations on Thermal and Non-thermal
Mechanisms for Biological Effects of Ultrasound. Report of the 1996 WFUMB
Symposium on Safety of Ultrasound in Medicine. Barnett, S. B (ed). Ultrasound in
Medicine and Biology, Vol 24, suppl 1, 1998
8-22 MN1-5853 rev.2

Recycling or Disposal
Recycle or dispose of this equipment properly according to your organizational rules and your
local laws.
This symbol on the equipment or on its packaging indicates that this equipment shall not be
treated as household waste. Instead it shall be handed over to the applicable collection point
for the recycling of electrical and electronic products. By ensuring this equipment is disposed
of correctly, you will help prevent potential negative consequences for the environment and
human health, which could otherwise be caused by inappropriate waste handling of this
equipment. The recycling of materials will help to conserve natural resources.
The equipment contains a primary battery (lithium battery). You should recycle or dispose of
this equipment properly according to your organizational rules and your local laws. For more
detailed information about recycling of this equipment, please contact one of our offices listed
on back cover, or your household waste disposal service.
MN1-5853 rev.2
6-22-1 Mure, Mitaka-Shi, Tokyo, 181-8622 Japan
Tel: +81-422-45-6049
URL: http://www.hitachi-aloka.com
Overseas Offices:
Hitachi Medical Ultrasound Logistics,

Zweigniederlassung der Hitachi Medical Systems Europe Holding AG
Carl-Zeiss-Strasse 5, D-72555 Metzingen, Germany
Distributor
MN1-5853 rev.2 010200 20140326

Diagnostic Ultrasound System: Instruction Manual

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DIAGNOSTIC ULTRASOUND

Symbols Used in this Document

Indicates an imminently hazardous situation which, if not avoided, will result

Indicates a hazardous situation which, if not avoided, may result in death or

Indicates a hazardous situation which, if not avoided, may result in slight or

Indicates a request concerning an item that must be observed in order to

Cautions of cautions shows the following graphics.

This mark means the corresponding item is "alerted".

This mark means the corresponding item is "prohibited".

This mark means the corresponding item is "required".

About the F31

1) PRECAUTIONS Concerning the Use/Management of the F31

NOTE: Remodel is installing or connecting the unspecified parts or equipment,

• Transporting this equipment (via automobile/ship) shall be performed by a third party

• Protection against electric shock (ME equipment): class I • ME equipment

– Probe/scanner applied parts and parts treated as applied parts:

Figure:Probe/Scanner Pattern Diagram

Applicable part Parts treated as applied

ECG patient lead

• Protection against electric shock (Defibrillation-proof applied parts): Not suitable

– equipment: IPX0 (Ordinary equipment)

Terms used in the book

Example Method Intended

Warning regarding the software used for this instrument

Regarding the software installed in this instrument, the following is prohibited.

1) Reselling, assigning, or transferring the software itself

Microsoft Software License Terms

Notes on Microsoft Software License Terms

• "This device" refers to the ultrasound diagnostic system.

Windows XP Embedded and Windows Embedded Standard Runtime

– Directly support the manufacturer’s specific use for the device.

• Work around any technical limitations in the software.

• Internet-Based Services. Microsoft provides Internet-based services with the software.

• Compatible online music services in your region

• Windows Media Digital Rights Management. Content owners use Windows

McAfee Embedded Control

Software License Agreement

a) Work around any technical limitations in the software.

c) Make copies of the software.

d) Publish the software for others to copy.

e) Rent, lease or lend the software.

2 Specifications and Parts Name

3 Preparation for Use

6 Accessories and Options

8 Acoustic Output Safety Information

1-1 Purpose of Use

In the diagnostic ultrasound system, ultrasound images are produced as follows;

MN1-5853 rev.2 1-1

1-2 Precautions for Use

Indicates an imminently hazardous situation that will result in the death of

Indicates a hazardous situation that could result in death or serious injury.

Indicates a hazardous situation that may result in slight or moderate injury,

Indicates a request concerning an item that must be observed in order to

Cautions use the following graphics.

This mark means the corresponding item is "alerted".

This mark means the corresponding item is "prohibited".

This mark means the corresponding item is "required".

1-2 MN1-5853 rev.2

1-2-1 Warnings and Safety Notice