SAEVO FT 412 User manual

Cód.: - Rev.:01 77000001433
FT 412
OWNER´S
MANUAL
English

MANUAL PRESENTATION
Technical Name: Ultrasound device
Trade Name: Ultrasound Diagnostic Equipment
Model: FT 412
Brand: Saevo
Responsável Técnico: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Registration nº: 10069210072
Alliage S/A Industrias Médico Odontológico
Rodovia Abrão Assed, Km 53 - CEP 14097-500
Ribeirão Preto - SP - Brazil
Phone: [phone]

Statement
The manufacturer owns the intellectual property rights to this manual, and also maintains the contents of this manual as
confidential information. This manual is a reference for the operation, maintenance and cleaning of this product and does not
convey any license under the patent rights of the manufacturer, nor the rights of others.
This manual contains the information protected by copyrights or patents. Reproduction, amendment or translation of this
manual in any manner whatsoever without the written permission of the manufacturer is strictly prohibited.
All information contained in this manual is believed to be correct. The manufacturer shall not be liable for errors contained
herein or for incidental or consequential damages in connection with the furnishing, performance or use of this manual. The
manufacturer does not assume any liability arising out of any infringements of patents or other rights of third parties.
This manual is based on the maximum configuration and therefore some contents may not apply to your product.
This manual is subject to change without prior notice and legal obligation.
Manufacturer’s Responsibility
The manufacturer is responsible for the effects on safety, reliability and performance of this product, only if all the following
requirements are met.
●All installation operations, expansions, changes, modifications and repairs of this product are conducted by the
manufacturer authorized personnel.
●The use or application of the product or the use of parts or accessories is approved by the manufacturer.
●The electrical installation of the relevant room complies with the applicable national and local requirements.
●The product is used in accordance with the instructions for use.
Documentation
The manufacturer provides the documentation consisting of various manuals:
●The basic user manual describes the basic functions and operating procedures of the system.
●The advanced user manual provides information about the measurements and calculations available in each mode.
Understand the meanings of the following items clearly before reading this manual.
Item Meaning
!
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in malfunction or damage of
the system.
Indicates a potentially biological hazardous situation which, if not avoided, may result in disease
transmission.
NOTE Indicates precautions or recommendations that should be used in operating the system.
Boldfaced
Word
Indicates controls on the control panel, or on-screen objects such as menu items or keys.

Item Meaning
Click Move the cursor to the controls on the display and press the conrm key on the control panel.
>Select a menu item or a key following the path.

I
Contents
1 Safety ��������������������������������������������������������������������������������������������������������������������������������������������������������������������� 1
1.1 Intended Use ................................................................................................................................................................ 1
1.2 Safety Precautions........................................................................................................................................................ 1
1.2.1 Electrical Safety ............................................................................................................................................... 1
1.2.2 Mechanical Safety............................................................................................................................................ 2
1.2.3 Accessories Caring........................................................................................................................................... 3
1.2.4 Biohazard Considerations ................................................................................................................................ 3
1.3 Acoustic Power Principle............................................................................................................................................. 3
1.3.1 Biological Safety.............................................................................................................................................. 4
1.3.2 ALARA............................................................................................................................................................ 4
1.3.3 Mechanical and Thermal Indices ..................................................................................................................... 4
1.3.4 Transducer Surface Temperature Limits .......................................................................................................... 5
1.3.5 Imaging Functions that Change Acoustic Output ............................................................................................ 5
1.4 Safety Symbols ............................................................................................................................................................ 5
2 System Overview ������������������������������������������������������������������������������������������������������������������������������������������������� 9
2.1 System Configuration .................................................................................................................................................. 9
2.2 Physical Specifications ................................................................................................................................................ 9
2.3 System Components..................................................................................................................................................... 9
2.3.1 Peripheral Device Panel ................................................................................................................................. 10
2.3.2 Control Panel...................................................................................................................................................11
2.3.3 Key Panel ....................................................................................................................................................... 13
2.3.4 Basic Screen................................................................................................................................................... 15
3 Preparing the System����������������������������������������������������������������������������������������������������������������������������������������� 17
3.1 System Assembly ....................................................................................................................................................... 17
3.2 System Moving/Positioning....................................................................................................................................... 18
3.3 Connecting and Powering on the System .................................................................................................................. 18
3.3.1 Using the Mains Supply................................................................................................................................. 18
3.3.2 Using the Battery ........................................................................................................................................... 19
3.3.3 Indicators........................................................................................................................................................ 19
3.4 Powering On/Off the System ..................................................................................................................................... 20
3.5 Adjusting the System ................................................................................................................................................ 21
3.5.1 Adjusting the Monitor Arm............................................................................................................................ 21
3.5.2 Adjusting the Display Monitor ...................................................................................................................... 21
3.6 Connecting the Probe................................................................................................................................................. 22
3.7 Connecting the Peripheral Device.............................................................................................................................. 23
3.7.1 Connecting the Foot Switch........................................................................................................................... 23
3.7.2 Connecting the Video Printer ......................................................................................................................... 23
3.7.3 Connecting the Network Printer .................................................................................................................... 23
3.7.4 Connecting the USB Printer........................................................................................................................... 24
4 Customizing Your System���������������������������������������������������������������������������������������������������������������������������������� 25
4.1 General System Settings ............................................................................................................................................ 25
4.1.1 General Settings ............................................................................................................................................. 25
4.1.2 Display Settings ............................................................................................................................................. 27

Contents
II
4.1.3 Storage Settings.............................................................................................................................................. 28
4.1.4 Defined-Key Settings..................................................................................................................................... 29
4.2 Peripheral Device Settings......................................................................................................................................... 30
4.3 Defining Annotation Library...................................................................................................................................... 31
4.4 Body Mark Settings ................................................................................................................................................... 32
4.5 Measurement Settings................................................................................................................................................ 33
4.5.1 General Measurement Settings ...................................................................................................................... 33
4.5.2 Application Settings....................................................................................................................................... 34
4.5.3 List Settings.................................................................................................................................................... 37
4.6 Report Settings........................................................................................................................................................... 38
4.7 Configuring DICOM.................................................................................................................................................. 39
4.7.1 Storage Service Settings................................................................................................................................. 39
4.7.2 Commitment Settings..................................................................................................................................... 40
4.7.3 DICOM Worklist Settings.............................................................................................................................. 41
4.7.4 MPPS Settings................................................................................................................................................ 42
4.7.5 Print Service Settings ..................................................................................................................................... 43
4.8 Defining System Defaults .......................................................................................................................................... 44
4.8.1 Loading System Defaults ............................................................................................................................... 45
4.8.2 Creating System Defaults............................................................................................................................... 45
4.8.3 Export or Import System Defaults ................................................................................................................. 45
4.9 Viewing System Information ..................................................................................................................................... 46
4.9.1 General Information....................................................................................................................................... 46
4.9.2 Acoustic Output ............................................................................................................................................. 46
5 Preparing for an Exam �������������������������������������������������������������������������������������������������������������������������������������� 49
5.1 Acquiring Patient Information ................................................................................................................................... 49
5.1.1 Beginning a New Patient................................................................................................................................ 49
5.1.2 Retrieving Archived Information ................................................................................................................... 51
5.1.3 Using DICOM Worklist ................................................................................................................................. 52
5.2 Pausing/Resuming an Exam....................................................................................................................................... 52
5.2.1 Pausing an Exam............................................................................................................................................ 52
5.2.2 Resume an Exam............................................................................................................................................ 52
5.3 Completing/Discontinuing an Exam.......................................................................................................................... 52
5.3.1 Completing an Exam...................................................................................................................................... 52
5.3.2 Discontinuing an Exam.................................................................................................................................. 53
6 Acquiring Images ����������������������������������������������������������������������������������������������������������������������������������������������� 55
6.1 Selecting a Probe and an Exam Type......................................................................................................................... 55
6.2 Acquiring B-Mode Images......................................................................................................................................... 57
6.2.1 Entering B Mode............................................................................................................................................ 57
6.2.2 Optimizing B-Mode Images........................................................................................................................... 57
6.3 Acquiring Color Flow Images.................................................................................................................................... 62
6.3.1 CFM Mode..................................................................................................................................................... 62
6.3.2 PDI Mode....................................................................................................................................................... 63
6.3.3 TDI Mode....................................................................................................................................................... 63
6.3.4 Optimizing CFM/PDI/TDI Mode Images...................................................................................................... 64
6.4 Acquiring M-Mode Images....................................................................................................................................... 67
6.4.1 M Mode.......................................................................................................................................................... 67
6.4.2 Anatomical M-Mode...................................................................................................................................... 68
6.4.3 Optimizing M-Mode Images.......................................................................................................................... 69

Contents
III
6.5 Acquiring Spectral Doppler Images........................................................................................................................... 70
6.5.1 PW Mode ....................................................................................................................................................... 70
6.5.2 CW Mode ....................................................................................................................................................... 72
6.5.3 Optimizing Spectral Doppler Images............................................................................................................. 74
6.6 Acquiring Triplex-Mode Images................................................................................................................................ 77
6.6.1 B+CFM/TDI +M............................................................................................................................................ 77
6.6.2 B+CFM/PDI/TDI +PW.................................................................................................................................. 78
6.6.3 B+CFM/PDI+CW .......................................................................................................................................... 80
7 Elastography Imaging���������������������������������������������������������������������������������������������������������������������������������������� 81
7.1 Acquiring Elastography Images................................................................................................................................. 81
7.2 Optimizing Elastography Images............................................................................................................................... 82
7.2.1 Strain Map...................................................................................................................................................... 82
7.2.2 Strain Process................................................................................................................................................. 82
7.2.3 Transparency .................................................................................................................................................. 83
7.2.4 Contrast ......................................................................................................................................................... 83
7.2.5 Persistence ..................................................................................................................................................... 83
7.2.6 Frequency....................................................................................................................................................... 83
7.3 Working with Elastography Images........................................................................................................................... 83
8 3D Imaging ��������������������������������������������������������������������������������������������������������������������������������������������������������� 85
8.1 Acquiring 3D Images................................................................................................................................................. 85
8.2 Working with 3D Images ........................................................................................................................................... 86
8.2.1 Adjusting ROI ................................................................................................................................................ 86
8.2.2 Setting Display Format .................................................................................................................................. 87
8.2.3 Setting Render Mode ..................................................................................................................................... 87
8.2.4 Cropping Reviews with Trace ....................................................................................................................... 88
8.2.5 Moving/Rotating/Magnifying Images............................................................................................................ 88
8.2.6 Optimizing 3D Image..................................................................................................................................... 89
8.2.7 Observing Reviews by the Slice .................................................................................................................... 89
8.2.8 Setting the Scan Mode ................................................................................................................................... 90
8.2.9 Adjusting ZAngle/ZScale .............................................................................................................................. 90
8.2.10 Restoring the Image ......................................................................................................................... 91
8.2.11 Customizing Presets ......................................................................................................................... 91
9 4D Imaging���������������������������������������������������������������������������������������������������������������������������������������������������������� 93
9.1 Acquiring 4D Images................................................................................................................................................. 93
9.1.1 Entering the Real-Time 4D Imaging.............................................................................................................. 93
9.1.2 Acquiring Dynamic 3D Image....................................................................................................................... 94
9.2 Working with 4D Images ........................................................................................................................................... 94
10 Working with Images��������������������������������������������������������������������������������������������������������������������������������������� 95
10.1 Imaging Features........................................................................................................................................................ 95
10.1.1 Imaging Reverse ............................................................................................................................................ 95
10.1.2 Split Screen Display....................................................................................................................................... 95
10.1.3 m-Tuning........................................................................................................................................................ 96
10.1.4 Harmonic Imaging ......................................................................................................................................... 96
10.1.5 Panoramic Imaging ........................................................................................................................................ 97
10.2 Magnifying an Image................................................................................................................................................. 99
10.3 Freezing an Image...................................................................................................................................................... 99
10.4 Using Cine.................................................................................................................................................................. 99

Contents
IV
10.4.1 Reviewing Cine ............................................................................................................................................. 99
10.4.2 Cutting Cine ................................................................................................................................................ 100
10.5 Annotations and Body Marks .................................................................................................................................. 100
10.5.1 Annotating an Image.................................................................................................................................... 100
10.5.2 Body Mark ................................................................................................................................................... 101
10.5.3 Deleting Annotations and Body Marks ........................................................................................................ 101
10.6 Using ECG ............................................................................................................................................................... 101
10.6.1 Basic Procedures of ECG Operation............................................................................................................ 102
10.6.2 Optimizing Parameters................................................................................................................................. 102
10.6.3 Reviewing ECG ........................................................................................................................................... 103
11 Managing Images/Data ���������������������������������������������������������������������������������������������������������������������������������� 105
11.1 Storing an Image ...................................................................................................................................................... 105
11.1.1 Storing 2D Image ......................................................................................................................................... 105
11.1.2 Storing 3D/4D Image ................................................................................................................................... 105
11.2 Viewing an Image .................................................................................................................................................... 105
11.2.1 Viewing a Current Image ............................................................................................................................. 105
11.2.2 Retrieving an Image ..................................................................................................................................... 106
11.3 Sharing Data............................................................................................................................................................. 106
11.4 Backing up Data....................................................................................................................................................... 107
11.4.1 Backing up Data to the USB drive............................................................................................................... 107
11.4.2 Backing up Data to DVD ............................................................................................................................. 107
11.5 Importing Data to the System .................................................................................................................................. 107
12 Working with DICOM����������������������������������������������������������������������������������������������������������������������������������� 109
12.1 Verifying Connectivity............................................................................................................................................. 109
12.2 DICOM Storage ....................................................................................................................................................... 109
12.3 DICOM Print.............................................................................................................................................................110
12.4 DICOM Worklist.......................................................................................................................................................110
12.5 MPPS ........................................................................................................................................................................111
12.6 Storage Commitment ................................................................................................................................................112
12.7 DICOM Queue..........................................................................................................................................................113
13 Probes and Biopsy ������������������������������������������������������������������������������������������������������������������������������������������ 115
13.1 Probe .........................................................................................................................................................................115
13.1.1 Available Probes............................................................................................................................................115
13.1.2 Probe Usage ..................................................................................................................................................116
13.1.3 Cleaning the Probe........................................................................................................................................117
13.1.4 Disinfecting and Sterilizing the Probe ..........................................................................................................118
13.1.5 Disinfecting and Sterilizing the Probe Cable............................................................................................... 120
13.1.6 Storage and Transportation .......................................................................................................................... 121
13.2 Biopsy ...................................................................................................................................................................... 121
13.2.1 Available Biopsy Brackets ........................................................................................................................... 122
13.2.2 Assembling the Biopsy Bracket................................................................................................................... 122
13.2.3 Preparing for a Biopsy ................................................................................................................................. 125
13.2.4 Verifying the Biopsy Bracket....................................................................................................................... 125
13.2.5 Performing a Biopsy .................................................................................................................................... 125
13.2.6 Cleaning the Biopsy Bracket........................................................................................................................ 126
13.2.7 Sterilizing the Biopsy Bracket ..................................................................................................................... 127
13.2.8 Storage ......................................................................................................................................................... 127

Contents
V
14 System Maintenance �������������������������������������������������������������������������������������������������������������������������������������� 129
14.1 Cleaning the System................................................................................................................................................. 129
14.2 Maintenance Checks ................................................................................................................................................ 130
14.3 Troubleshooting ....................................................................................................................................................... 130
14.4 Replacing the Fuse................................................................................................................................................... 131
14.5 Equipment Disposal ................................................................................................................................................. 131
14.6 Precautions for the Reduction of the Environment Impact...................................................................................... 131
14.7 Precautions in Case of Destruction of the System ................................................................................................... 132
14.8 Customer Service ..................................................................................................................................................... 132
Appendix A Specifications���������������������������������������������������������������������������������������������������������������������������������� 133
Appendix B EMC Guidance and Manufacturer’s Declaration ���������������������������������������������������������������������� 134
Appendix C In Situ, Derated, and Water Value Intensities ���������������������������������������������������������������������������� 137
Appendix D Recommended Coupling Gel, Cleaner and Disinfectant ����������������������������������������������������������� 138
D.1 Coupling Gel............................................................................................................................................................ 138
D.2 Cleaner ..................................................................................................................................................................... 139
D.3 Disinfectant .............................................................................................................................................................. 139
Appendix E Acoustic Output Data �������������������������������������������������������������������������������������������������������������������� 140

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1
1 Safety
This chapter describes the important information for operating this ultrasound system. To ensure the safety of both
operator and patient, please read the relevant details in this chapter carefully before using this system.
You should be thoroughly familiar with the precautions provided in this manual. Otherwise, the manufacturer is
not responsible for the effects on safety, reliability and performance of the system.
1�1 Intended Use
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for
evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult),
Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Supercial), Cardiac (pediatric
and adult), OB/Gyn and Urology.
The system also provides the measurement and calculation packages used for clinical diagnosis purposes. For
details, please refer to the advanced user manual.
Contraindication: The system is not intended for ophthalmic use or any use causing the acoustic beam to pass
through the eye.
!
Precautions must be considered in the use of any application. Otherwise, it may result in system damage or serious
injury.
1�2 Safety Precautions
Read and understand all precautions in this manual before attempting to use the system. Keep this manual with the
system at all times. Review the procedures for operation and safety precautions periodically.
1�2�1 Electrical Safety
!
●Only qualified physicians or sonographers can perform ultrasound scanning on human subjects for medical
diagnostic reasons.
●Any unauthorized personnel should not tamper with the main unit of the system.
●Do not service or maintain the system while it is in use with a patient.
●Do not position the system to make it difcult to disconnect the system from the mains supply.
●Do not use the system with flammable anaesthetics (category AP) or flammable anaesthetics with oxidants
(category APG).
●Do not use the system with other equipment such as an electric knife, high-frequency therapy equipment, or a
debrillator. Otherwise, electrical shock may occur.
●Connect the protective earth conductor only before powering on the system. Disconnect the ground wire only
after powering off the system. Otherwise, electrical shock may occur.
●Connect the system to the other electrical equipment by using the potential-equalization lead wire before
connecting the power plug of the system to an electrical outlet.
●Do not place the multiple socket-outlet on the oor.

1 Safety
2 Basic User Manual
●The video printer should be connected to the specic interface by using the cable provided by the manufacturer.
Otherwise, electrical shock may occur.
●Within the environment that is 1.8 meters (6 feet) around a patient, connect peripherals to the auxiliary power
outlet which is capable of isolation protection; or, power the peripherals by the auxiliary output cable or the
isolation transformer complied with EN/IEC 60601-1, or the power input of the same safety level.
●Within the patient environment, when removing the covers or the connectors from the non-medical electrical
equipment without tools during maintenance, calibration or other operations, do not touch the parts of the non-
medical electrical equipment and the patient simultaneously.
●Use only the probes provided by the manufacturer. Otherwise, the system will not perform, and an accident
such as a re may result in the worst case.
●Only the peripherals and accessories provided or recommended by the manufacturer can be used. Using other
devices or accessories may degrade the system performance and even cause electrical shock.
●Do not pour any uid onto the system surfaces, as uid seepage into the electrical circuitry may cause excessive
electrical current leakage or system failure. If any water is spilled onto the system carelessly, stop using the
system and contact the local distributor immediately.
●The AC power plug for the system is a three-prong grounded plug and should never be adapted to any two-
prong outlet or by using an adapter. Connect the AC power plug of the multiple socket-outlet to a hospital-grade
power outlet.
●If the system is transported to the operating environment with a great temperature change, leave it for
approximately 4 hours before powering it on. Ensure that the temperature and humidity inside and around the
system are equivalent before an operation.
●Do not use the system around a strong electric field, a strong electromagnetic field,or the devices which
generate radio waves, such as a radio, cellular telephones, or transceivers. Using the system in an improper
environment may result in malfunction or damage.
●Select the conformed multiple socket-outlet with protective grounding,and ensure that its maximum output
power exceeds the requirement of the system.
●The multiple socket-outlet can only be used to provide power to the recommended peripherals of the system.
●Do not connect other devices to the multiple socket-outlet. Otherwise, the rated output power of the multiple
socket-outlet may be exceeded, and it may result in failure.
●Accessory equipment connected to the analog and digital interfaces must be certied according to the respective
EN/IEC standards (for example, EN/IEC 60950 for data processing equipment and EN/IEC 60601-1 for
medical equipment). Furthermore, all congurations shall comply with the system standards EN/IEC 60601-1.
●Do not use an endocavitary probe on the body surface of a patient. Otherwise, the electromagnetic compatibility
of the probe may be degraded.
●If the non-medical electrical equipment used with the system is supplied by a multiple socket-outlet with
separating transformer, connect the AC power plug of the multiple socket-outlet to a hospital-grade power
outlet. Consult a professional to ensure that the connection complies with the safety standards.
1�2�2 Mechanical Safety
!
●
To avoid possible personnel injury and system damage, move the system slowly and carefully.
●During the movement, the system could cause injury if the casters roll over feet or into shins. Exercise extreme
caution while moving the system for a long distance, and up or down the ramp.
●Lock the foot brakes after arrival.
●Do not place other objects on top of the control panel. Do not sit on the control panel or any other part of the
system.
●Disconnect the foot switch and the power cable before moving the system.

1 Safety
Basic User Manual 3
●Do not knock or shake the system.
●Ensure that the casters are intact and can rotate well before moving the system.
●Always use the handle to move the system.
●Ensure that the foot brakes are released and all cables are away from the casters before moving the system.
1�2�3 Accessories Caring
!
●
Do not use the foot switch in the operating room.
●Use the probe carefully. If any part of the transducer surface is scratched, stop using the probe immediately.
Otherwise, electrical shock may occur.
●After disinfecting the accessories, wash out chemicals or discharge gases thoroughly from the accessories.
Residual chemicals or gases could result in damage to the accessories, and be harmful to human bodies.
●Only trained physicians or sonographers under ultrasound guidance can handle the biopsy needle guides.
During the operation, the operator must observe proper needle insertion sequencing with the needle guide to
avoid undue discomforts, unnecessary risks or injuries to the patient.
●Use the legally marketed probe sheath. Refer to package labeling to determine latex content. Natural rubber
latex may cause anaphylactic reactions in some individuals. Avoid contact with items containing natural rubber
latex. Refer to the FDA Medical Alert, March 29, 1991.
●Use the legally marketed coupling gel in accordance with relevant local regulations. Read and understand all
precautions in the relevant manual of the coupling gel before use.
●Prepare, use, store and dispose the cleaner, disinfectant and sterilant according to the instructions provided by
manufacturers.
●
Do not disconnect the probe during the real-time scan. Otherwise, it may damage the probe and the system.
●Disconnect the probe from the system after freezing an image or powering off the system. Otherwise, the
system or the probe could be damaged.
1�2�4 Biohazard Considerations
●To minimize the risk of cross-contamination or infectious diseases when performing a biopsy, the operator
should wear disposable gloves, protective clothing or protective goggles if it is needed. Follow the working
regulations strictly in case the skin contacts the samples.
●Some disinfectants or sterilants are acid or alkaline. Use them with caution, and prevent hands or clothing
from coming into direct contact with them. Wash hands or eyes immediately in case of any contamination by
disinfectants.
●Dispose of cleaners, disinfectants or solutions in accordance with local standards or regulations.
1�3 Acoustic Power Principle
!
●Perform ultrasound procedures prudently under the guidance of the ALARA (as low as reasonably achievable)
principle. Only expose the patient to the lowest practical transmit power levels in the shortest possible period to
achieve a satisfactory diagnosis.
●Freeze the image at any time if you are not operating the system for a long period of time.
●Do not scan the same part of an patient continuously or expose the patient to prolonged scanning. Doing so may
harm the patient.
●Do not expose the fetus to prolonged scanning in the Doppler mode.
●Although the output power is automatically controlled for the selected applications, high TI values should be
kept to a minimum or avoided in obstetric applications.

1 Safety
4 Basic User Manual
●You should be familiar with the performances and operations of the system, observe the ultrasound output
parameters on the screen at all times.
1�3�1 Biological Safety
Diagnostic ultrasound is recognized as being safe, but the possibility of biological effects exists when using it in
high exposure levels and long exposure times. Thus ultrasound should be used in a prudent manner to provide
medical benet to the patient.
1�3�2 ALARA
It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures that the total energy
level is controlled below a low enough level at which bioeffects are not generated while diagnostic information is
being accumulated. The total energy is controlled by output intensity and total radiation time. The output intensity
necessary for examinations differs depending on the patient and the clinical case.
Not all examinations can be performed with an extremely low level of acoustic energy. Controlling the acoustic
level at an extremely low level leads to low-quality images or insufcient Doppler signals, adversely affecting the
reliability of the diagnosis. However, increasing the acoustic power more than necessary does not always contribute
to an increase in quality of information required for diagnosis, rather increasing the risk of generating bioeffects.
The operator must take responsibility for the safety of the patient and utilize the ultrasound deliberately. Deliberate
use of the ultrasound means that output power of the ultrasound must be selected based on ALARA. Additional
information regarding the concept of ALARA and the possible bioeffects of Ultrasound is available in a document
from the AIUM (American Institute of Ultrasound Medicine) title “Medical Ultrasound Safety”.
1�3�3 Mechanical and Thermal Indices
The display of the system consists of two parts: Thermal Index (TI) and Mechanical Index (MI).
■ MI/TI Explanation
In October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its
Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,Sept.
1988: Vol. 7, No. 9 Supplement), sometimes referred to as the StoweReport, which reviewed available data on
possible effects of ultrasound exposure. Another report “Bioeffects and Safety of Diagnostic Ultrasound” dated
January28, 1993, provides more current information.
●Mechanical Index (MI)
Mechanical bioeffects are threshold phenomena that occur when a certain level of output is exceeded. The
threshold level varies, however, with different types of tissue. The potential mechanical bioeffects varies with
peak pressure and ultrasound frequency. The MI accounts for these two factors. The higher the MI value,
the greater the likelihood of mechanical bioeffects occurring. There is no specic MI value that means that
a mechanical effect is actually occurring. The MI should be used as a guide for implementing the ALARA
principle.
●Thermal Index (TI)
The TI value informs the operator about the conditions that might lead to an increase in temperature on the
surface of the body, within the body tissue, or at the point of focus of the ultrasound beam on bone. That is, the
TI value informs the operator about the potential temperature rise in body tissue. It is an estimate of temperature
increase in body tissue with specic properties. The actual amount of any temperature rise is inuenced by
factors such as tissue type, vascularity, mode of operation and others. The TI value should be used as a guide
for implementing the ALARA principle.
Depending on the examination and type of tissue involved, TI could be one of three types:
−Soft Tissue Thermal Index (TIS) is used when imaging soft tissue only, it provides an estimate of potential
temperature rise in soft tissue.
−Bone Thermal Index (TIB) is used when bone is near the focus of the image as in the third trimester, it
provides an estimate of potential temperature rise in the bone or adjacent soft tissue.

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Basic User Manual 5
−Cranial Bone Thermal Index (TIC) is used when bone is near the skin surface as in transcranial examination,
it provides an estimate of potential temperature rise in the bone or adjacent soft tissue.
■ MI/TI Display
TI and MI values are displayed in real time on the screen. The operator should observe these index values during
examinations and ensure that exposure time and output values are maintained at the minimum amounts needed for
effective diagnosis.
The MI and TI precision is 0.1.
1�3�4 Transducer Surface Temperature Limits
For probes intended for internal applications, e.g. the endocavitary probe or transesophageal probe, the surface
temperature of the probe may change by adjusting system parameters
The maximum surface temperature of the endocavitary probes is 43°C. To protect the patient against the harm of
excessive temperature, the probe stops working automatically when its temperature reaches the limit. The surface
temperature of the probe is displayed on the right side of the screen.
PAT: 37℃
TIP: <28℃
Patient Threshold Temperature
Transducer Tip Temperature
1�3�5 Imaging Functions that Change Acoustic Output
The qualied operator may use the system controls to limit the ultrasound output and to adjust the quality of the
images. The operator should observe the acoustic output display for possible effects.
There are three categories of system controls relative to output. They are controls that have direct effect on the
output, controls that indirectly control output and controls that are receiver controls.
1�4 Safety Symbols
The following table is provided for your identication of important symbols located in labels on the system.
Symbol Meaning
Caution
Dangerous voltage
Pinch hazard
Risk of explosion if used in the presence of ammable anesthetics
Type BF applied part
Main switch OFF
Main switch ON
On/Standby switch

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6 Basic User Manual
Symbol Meaning
Foot switch connector
Protective earth (ground)
Equipotentiality
Alternating current
Degree of IP protection
Non-ionizing electromagnetic radiation
Manufacturer
Date of manufacture
Follow instructions for use
Network port
USB port
Fragile
Keep dry
No stacking
Maximum stacking limit of packages
Maximum of two layers allowed for the monitor
Keep this way upward
Serial number

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Basic User Manual 7
Symbol Meaning
Rechargeable (for battery only)
This symbol indicates that waste electrical and electronic equipment must not be
disposed of as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning
the decommissioning of your equipment.

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9
2 System Overview
This ultrasound system adopts advanced ultrasonic Doppler technologies.
To ensure the performance and availability of this ultrasound system, you should be thoroughly familiar with the
operations of system components, the control panel, the key panel and the basic screen.
2�1 System Conguration
The standard system conguration mainly consists of the following items:
●Main unit
●Probes
●Others: See the Packing List in the packaging box.
2�2 Physical Specications
●System dimensions: approx. 720mm(W)×1372mm(H)×559mm(D)
●System weight: approx. 60kg
2�3 System Components
12
13
14
1
2
3
4
5
6
7
8
9
10
11
15
16
17
18
19
20
21
22
Figure 2-1 System Overview

2 System Overview
10 Basic User Manual
1 LCD Monitor
2 Control Panel
3 Coupling Gel Holder
4 Front Handle
5 Transducer Cable Hanger
6 Probe Port
7 Power Indicator
8 Charging/Discharging Indicator
9 Battery Capacity Indicator
10 Caster
11 Foot Switch Port
12 Pencil Probe Port
13 Probe Holder
14 Cable Hanger
15 Speaker
16 Fan
17 Cable Hanger
18 Dust Filter
19 Peripheral Device Panel
20 DVD Drive (optional)
21 USB Port
22 On/Standby Button
2�3�1 Peripheral Device Panel
1 2 3 4 5 6
7891011
Figure 2-2 Peripheral Device Panel
No� Name Description
1VGA Video Output Used for connecting a video device to acquire VGA signals, such as monitor
or projector.
2 USB Port Used for connecting USB devices.
3 Network Port Used for connecting the DICOM server or the network.
4 S-VIDEO Port Used for connecting a video device to acquire S-VIDEO signals, such as
monitor or projector.
5 Audio Signal Output Used for connecting an audio device.
6 Video Printer Port Used for connecting the video printer.
7 Mains Supply Switch Used for powering on or off the system.
8 Power Input Used for connecting the power cable.
9Equipotential Terminal Used for equipotential connection, balancing the protective earth potentials
between the system and other electrical equipment.
10 ECG Port (optional) Used for connecting the ECG cable.