Fukuda Denshi PaoLus UF-760AG User manual

FULL DIGITAL
DIAGNOSTIC ULTRASOUND
IMAGING EQUIPMENT
UF-760AG
Ver.01
Instructions for Use
Keep this guide near the unit for future reference.
Complementary information can be found in the system operation manual.

The device bears the CE label in accordance with the provisions of Medical Device Directive 2007/
47/EC.
THE PERSONS RESPONSIBLE FOR PLACING DEVICES
ON THE EC MARKET UNDER MDD 2007/47/EC.
NAME : FUKUDA DENSHI UK
ADDRESS: 13 WESTMINSTER COURT, HIPLEY STREET
OLD WOKING, SURREY GU22 9LG, UK
This “Instructions for Use” Guide provides you all required information for safe oper-
ation of the device. For more details please refer to the Operation Manual of the unit.
Copyright © 2011 by Fukuda Denshi Co., Ltd.
No part of this document may be copied or reproduced in any form without the prior written permis-
sion of Fukuda Denshi Co., Ltd.
Printed in Japan.
Caution
Note for U.S. Customers:
`Federal law restricts this device to be sold by or on the order of a physician.
Info:
`Only physicians or persons instructed by physicians are allowed to use this equipment.
`The information contained in this document is subject to change without notice due to
improvements in the equipment.
EC REP
This Instructions for Use Guide is for the UF-760AG Version 01.

1
1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.1 Welcome! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Copyright. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3 Compliance with standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.4 Cautions on Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.4.1 Symbols and meanings of warning labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.4.2 Before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.4.3 Important Warning Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
1.4.4 Warning Labels on the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
1.5 Acoustic Output and Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
2 SYSTEM INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1 Basic description of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1.1 Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
2.1.2 Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
2.1.3 Rear View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
2.2 Connecting the power cord and the ground wire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.2.1 Power cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
2.2.2 Ground wire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
2.3 Connecting probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.4 Power ON and Power OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.5 Control Panel Tour . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6 Relocation / Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.7 Menu Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.8 Configuring my preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.8.1 How to get started? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
2.8.2 How to change general system settings?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
2.8.3 How to install a new printer? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
2.8.4 How to assign functions to the REC keys?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
2.8.5 How to connect my system to a network? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
2.8.6 How to configure my Measurement list? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
2.8.7 How to set Obstetric curves by default?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
3 STARTING AN EXAM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.1 Managing Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.1.1 Searching for a patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3.1.2 Accessing an old study. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3.2 Starting an Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.2.1 Enter a new patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.2.2 Selecting Probe and Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.3 Making an Examination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.3.1 Screen display tour. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
3.3.2 Adjusting brightness and contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
3.3.3 Working in B/M-mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
3.3.4 Working in PW/CW-mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
3.3.5 Working in CFM mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
3.3.6 Working in 3D/4D mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3.3.7 Working with EasyOptim (option). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
3.3.8 Working with Spatial Compounding (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

2
3.4 Image Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
3.5 Review the study content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
3.6 Create a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
3.7 Printing Images/Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
4 ANNOTATIONS AND MEASURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.1 Annotations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2 Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.2.1 B-mode basic measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
4.2.2 M-mode basic measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
4.2.3 PW/CW-mode basic measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
5 MANAGING PATIENT DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.1 Import/Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 Backup and Recovery Tool. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.2.1 Patient Database Backup and Restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
5.2.2 Backup and Restore of User Preferences and setups . . . . . . . . . . . . . . . . . . . . . . . .5-4
6 MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.1 Check Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2 Cleaning and Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2.1 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
6.2.2 Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
6.3 Product recycling and disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
A APPENDIX A: Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.1.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.1.2 Display Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.1.3 System Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.2 Ultrasound Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.2.1 B-mode (2D). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.2.2 M-Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.2.3 Spectral Doppler Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.2.4 Color Doppler and Power Doppler Modes, Color M mode. . . . . . . . . . . . . . . . . . . . A-3
A.2.5 ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.3 Database, Measurements, Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.3.1 Archiving and Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.3.2 Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.3.3 Annotations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.3.4 Input/Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
A.4 Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
A.4.1 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
A.4.2 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
A.4.3 Regulations and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
A.4.4 Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
A.5 Probes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

Contents of this chapter:
Welcome!!
Copyright
Compliance with standards
Cautions on Safety
Acoustic Output and Patient Safety
Introduction 1
UF-760AG Instructions for Use

1-2 Welcome!
1 INTRODUCTION
Thank you for purchasing the UF-760AG system.
Intended readers:
Medical Doctors and clinicians using the equipment.
Thank you for purchasing the UF-760AG.
Your instrument is equipped with the following features:
• Multi-beam processing and frequency compound imaging technology
• Advanced tissue echo cancellation for superb Color Doppler and Power Doppler
• Smart harmonic imaging and three axis filtering for excellent image quality
•High brightness LCD monitor
• High sensitivity wide band probes
• Simple operability
The information contained in this publication may not be used for any purpose other than that for
which it was originally supplied. The publication may not be reproduced in part or in whole without
the written consent of FUKUDA DENSHI. FUKUDA DENSHI may not be held liable for any error con-
tained in this publication or any damage related to use of equipment. FUKUDA DENSHI reserves the
right to revise this publication. Amendments may therefore be made without prior notice.
UF-760AG, manufactured by FUKUDA DENSHI, fully complies with the Council Directive 2007/47/
EC concerning medical devices and bears the CE mark.
FUKUDADENSHI hasdefinedUF-760AGasUltrasounddiagnosticequipmentinClassIIa according
to Annex of the directive.
The UF-760AG is in compliance with:
•MDD
• Japanese pharmaceutical affairs law
• German K.V. regulation
• IEC 60601-1 Class I Type BF (electrical Safety)
• IEC 61157 (Acoustic power reporting)
• IEC 60601-2-37
• JIS T0601-1
• FDA 510(k)
1 INTRODUCTION
1.1 Welcome!
1.2 Copyright
1.3 Compliance with standards

1
1 INTRODUCTION
Cautions on Safety 1-3
The following signs indicate the extent of injury or damage due to incorrect handling of the equipment
without observing the warning precautions.
1.4 Cautions on Safety
1.4.1 Symbols and meanings of warning labels
Danger:
`Failure to follow this message can result in death or serious injury of the patient or operator,
or cause imminent danger of fire.
Warning:
`Failure to follow this message can result in death or serious injury of the patient or operator,
or create a fire hazard.
Caution:
`Failure to follow this message can cause injury to the patient or operator, or may cause dam-
age to the equipment.
For your information:
`Information, to make your work easier.
`mark is indicated on the main unit of the equipment for protecting it from damage.
1.4.2 Before Use
Caution:
`Never use the equipment unless you are a skilled operator.
`According to the description of the different techniques of the system and the different appli-
cations, the user can be only a physician with graduate medicine school or a trained sonogra-
pher.
`The real patient population is composed of any person needing an harmless and non real
invasive examination (invasive examinations are only made through natural orifices). This
person, healthy or not, can be an adult or a child.
`Ultrasound examination can be performed for different purposes and on different body parts.
`Be sure of not exceed the time and quantity required for diagnosis or medical treatment.
`Always monitor the unit and the patient to make sure they are normal.
Caution:
Observe the following when installing the system:
`Install the unit in a place where it is not exposed to water and in a place free from excessive
atmospheric pressure, humidity, ventilation, sunlight, etc., which may affect the performance
of the unit.
`Install the unit in a stable place.
`Make sure the unit is properly grounded.
`Do not remove the protective cover from the equipment.
`Do not modify the equipment.
`Do not reproduce the equipment.
`Do not allow alcohol, water or other liquids to enter the device interior.
`Do not use the system near an MRI.
Caution of Power Voltage:
`The equipment must be operated with the specified input power voltage.
Maintenance and inspection
`Maintenance and inspection are essential for finding signs of physical damage to the equip-
ment, connectors, and all cables.

1-4 Cautions on Safety
1 INTRODUCTION
For your information:
`For more detailed information about Cautions on Safety please refer to UF760AG Operation
Manual (Chapter 1 “INTRODUCTION” on page 1-1) to ensure a safe and proper manipula-
tion of the system.
1.4.3 Important Warning Items
Warning:
Connecting the Power Cord
`Be sure to connect the power cord to a medical-use 3-pin receptacle.
`If potential equalization is required, connect the potential equalization terminal of the equip-
ment and the terminal for potential equalization with the ground wire (equalization of the
ground potential).
`Use a power cord that is approved for use in your area.
Power ON
`Do not use the equipment with a defibrillator.
`If the equipment is used with an electro-surgery, check the connection of the counter elec-
trode plate otherwise skin burns can occur.
Physiological Signal Display
`The ECG module is not designed for electrocardiography or monitoring. Do not use it for
diagnosis.
Connecting a Patient Cable
`Inspect the patient cable before using the equipment.
`If a cardiac pacemaker or other electrically stimulant equipment is connected to the patient,
danger to the patient may result.
Power OFF
`Do not turn OFF the power while you are accessing the USB memory or the HDD.
For your information:
`For more detailed information about Cautions on Safety please refer to UF760AG Operation
Manual (Chapter 1 “INTRODUCTION” on page 1-1) to ensure a safe and proper manipula-
tion of the system.
1.4.4 Warning Labels on the instrument
Warning:
`Do not break, damage or obliterate the warning labels attached to the equipment.

1
1 INTRODUCTION
Acoustic Output and Patient Safety 1-5
Thermal Index (TI)
TI is determinate by the ratio of the total acoustic power to the acoustic power required to raise the
tissue temperature by 1°C. In addition, and due to the fact the temperature increases greatly different
according to tissue structures, three kinds of TI are distinguished: TIS (Soft-tissue Thermal Index),
TIB (Bone Thermal Index) and TIC (Cranial-bone thermal Index).
Although the output power is automatically controlled for the selected applications, high TI values
should be kept to a minium or avoided in Obstetric applications. WFUMB (World Federation for Ul-
trasound in Medicine and Biology) guidelines state that a temperature increase of 4°C for 5 minutes
or more should be considered as potentially hazardous to embryonic and fetal tissue.
Mechanical Index (MI)
The mechanical bioeffects are the result of compression and decompression of insonated tissues
with the formation of micro bubbles that may be referred as cavitations.
MI is an index that shows the possibility of appearing cavitations based on acoustic pressure. It is
important to keep the MI value low when both gases and soft tissues are encountered, in cases like
lung exposure in cardiac scanning or bowel gas in abdominal scanning.
Display of TI and MI values
TI and MI values are displayed in real time in the lower left part of the screen. The operator should
monitor these index values during examinations and ensure that exposure time and output values
are maintained at the minimal amounts needed for effective diagnosis.
The TI and MI values are displayed in increments of 0.2. Index values below 0.4 are displayed by the
system as <0.4. To optimize ALARA, index values that are equal or higher than 0.4, are displayed
even if the maximal index value does not exceed 1.0.
Maximum Ultrasound Output
The UF-760AG meets FDA Track 3 requirements and the maximum ultrasound output with real time
displayed of TI and MI indexes is limited as follows:
ALARA (As Low As Reasonably Achievable)
This principle mandates that ultrasound output power and exposure time are kept to the minimum
requiredwithout compromising diagnostic capability or resolution. While therehavebeennoreported
incidents of serious bioeffects in humans for diagnostic ultrasound levels, itis known that an increase
of tissue temperature may occur and that can lead to possible cavitations.
1.5 Acoustic Output and Patient Safety
Intended Use ISPTA.3 MI
Vascular; Cardiac; Abdominal and Ob/Gyn ap-
plications 720 mW/cm21.9
Ophthalmic application is not supported by UF-760AG.
For your information:
`ISPTA.3: Spatial peak time average intensity with consideration given to attenuation.

1-6 Acoustic Output and Patient Safety
1 INTRODUCTION