Preface

Thanks for purchasing ZONCARE-Q9 Full Digital Color Doppler Ultrasonic Diagnostic

system

Please read user manual carefully before using machine in order to operate machine in

correct way.

Please properly keep the instruction for review after reading it.

Product Information:

 Name: Full Digital Colour Doppler Ultrasonic Diagnostic System

 Type: ZONCARE-Q9

 Component:host, monitor, probes, printer and foot switch

 Application:intended for ultrasound evaluation of human subjects

 Manufacturer: Wuhan Zoncare Bio-medical Electronics Co.,Ltd.

 Registered Address: #380, High-tech 2nd road, Eastlake high-tech district, Wuhan,

Hubei, P. R. China.

 Manufacture Address: #380, High-tech 2nd road, Eastlake high-tech district, Wuhan,

Hubei, P. R. China.

 Production Date: See the label

 Operating Life: 10 years

Authorized Representative：

 Company Name: Well kang Limited

 Company Address: The Black Church, St. Mary's Place, Dublin 7, Ireland

 Tel: +353(1)4433560

 Fax: +353(1)6864856

User manual Edition date: 2018.07.16 Version: 1.0

I
Intellectual property
Intellectual property of this user manual and its corresponding products belongs to Wuhan

Zoncare Bio-medical Electronics Co., Ltd. (Hereinafter referred to as “Zoncare”).

Without the written consent of banner company any individual or organization may not copy,

modify, or translation of any part of this specification.

is Zoncare company registered label.

Declaration
Zoncare has the final explanation right to the user manual.

Zoncare is responsible for safety, reliability and performance of this product only in the

condition that:

 Installation operations, expansions, changes, modifications and repairs of this product

are conducted by zoncare authorized personnel;

 Repair involving replacement of parts as well as supporting the use of original

accessories, consumables are Banner Company (original) or approved by the company

of banner

 The electrical installation of the relevant room complies with the applicable national and

local requirements;

 This product is operated under strict observance of this manual.

The warranty and maintenance services

The warranty period of products are subject to the sales contract.

Consumptive material means that after each usage, the material need to change every time

or change regularly, consumptive material didn’t have warranty period.

Warranty period will be calculated from the “Installation date”of product warranty card along

with machine, product warranty card is the only certificate that used for warranty period

calculation. In order to protect your rights, please fill the warranty card when the machine installed

successful and also send copy of warranty card to the service staff and send back to customer

service department of Zoncare company.

If the device is during warranty period, zoncare provide free maintenance service for you. If

beyond warranty period, the company will provide maintenance service under the condition of

II
charging a reasonable fee, spare parts costs and transportation costs. But be attention, the

company will charge maintenance and spare parts fees if the device has some problem caused

by the following reasons:

1. Man-made damage.

2. Improper use.

3. The grid voltage exceeds the scope of the provisions of the product.

4. Irresistible natural disasters.

5. Replacement or use spare parts, accessories, consumables which are without the

company approved or maintained by non-authorized personnel.

6. Other faults do not caused by product itself.

After the warranty period, zoncare can continue to provide paid maintenance services. If you

don't pay or delayed in paying the charge service fees, zoncare will be suspended until you pay

for maintenance service.

After Service Enterprise

Name: Wuhan Zoncare Bio-medical Electronics Co., Ltd.

Address: #380, High-tech 2nd road, Eastlake high-tech district, Wuhan, Hubei, P. R. China.

Zip Code: 430206

Website: http://www.zoncare.com

Tel: +86(27)87770581

Tel /Fax: +86(27)87770203

Warning:The ultrasonic equipment shall be by professional clinicians, or under

the guidance of professional clinicians use. Any unauthorized
personnel, or no trained personnel shall not conduct any operation.

Important Information
Customer shall be solely responsible for the maintenance and management after purchase

it.

Only the professional medical staff that has qualification certificate can use the system.

III
 Quality guarantee does not contain the following content even the product is still during

warranty period.

1. Device purchased from other company or other unauthorized agents and dealers.

2. Error or man-made damage or loss of system.

3. System and operation conditions do not meet the requirements, such as the fluctuation of

power supply or supply is insufficient, incorrect installation etc.

4. Damage or loss caused by irresistible natural disasters or other social factors.

5. Prohibit module disassembling, change the system circuit, electronic device, hardware and

software etc.

6. Under any circumstances, problems, loss or damage caused by the non-appointed staff who

installs or re-install, change, or repair, the company is not liable for responsibility.

7. This system is designed to provide data relevant to the needs of clinical diagnosis for doctors

or hospitals, doctors bear and have responsibilities for the diagnosis process, the company

does not assume any responsibility for the diagnosis process.

8. The doctor who operates the device should back up important data. Loss of data stored

within the system caused by faulty operation, the company does not assume any

responsibility.

9. This manual contains the potential hazard warning about the foreseeable. Stay high alert to

those hazards which are not in the manual.

10. When the system administrator has changed, please hand over to the instructions.

Introduction
User manual introduce the usage ,function and operation method of product. Before using

the machine, please read and understand the content of user manual carefully in order to make

sure that operate machine correctly and ensure safety of patient and operator.

The user manual introduce product in details according to the complete configuration of

machine, So some parts may not suitable for your purchased machine. If any questions, please

contact Zoncare company.

Based on improving parts and device function , stability need, we will make some changes

IV
of device(including hardware and software), At the moment, we will try our best to amend or add

material, but may still have some differences of description, please understand.

Please put user manual near to the machine so that it can obtained on time and conveniently

when need it.

Application
This specification applies to clinical medical professionals reading, the reader should have

related procedures, practices, and terminology knowledge and working experience.

Illustration
To provide all of the illustrations in this manual is only for your reference, the illustrations to

set or data may be with you on the product can see the actual display is not consistent.

V
 Table of Contents

1 Security Declaration.................................................................................................................................. 1
1.1 Safety Classification....................................................................................................................... 1
1.2 Symbol Definition............................................................................................................................ 1
1.3 Safety Symbol................................................................................................................................. 2
1.4 Reference Standards..................................................................................................................... 2
1.5 Summary of Safety......................................................................................................................... 3
1.6 Safety Warning Information...........................................................................................................4

2 Overview..................................................................................................................................................... 8
2.1 Intended Application.......................................................................................................................8
2.2 Contraindication.............................................................................................................................. 8
2.3 Composition.....................................................................................................................................8
2.4 Specifications Parameter...............................................................................................................8
2.4.1 Power Conditions.................................................................................................................8
2.4.2 Environmental Conditions...................................................................................................8
2.5 Boundary Dimension...................................................................................................................... 8
2.6 Software Version.............................................................................................................................8
2.7 Configuration................................................................................................................................... 9
2.7.1 Standard Configuration....................................................................................................... 9
2.7.2 Selectable Probe..................................................................................................................9
2.8 System Parts Introduction............................................................................................................. 9
2.8.1 System Parts........................................................................................................................ 9
2.8.2 Control Panel...................................................................................................................... 11
2.8.3 I/O Interface Board............................................................................................................ 16
2.8.4 Power Socket Port.............................................................................................................17
2.8.5 Keyboard.............................................................................................................................17
2.9 Symbols and Identification.......................................................................................................... 18

3 System Preparations...............................................................................................................................20
3.1 System Placement........................................................................................................................20
3.2 System Movement and Transportation..................................................................................... 20
3.3 External Power Connection and Grounding.............................................................................20
3.3.1 Connections of External Power Supply..........................................................................20

VII
 3.3.2 Connections of Ground Terminal.....................................................................................21
3.4 Probe Connection and Remove............................................................................................... 21
3.4.1 Connecting Probe(s)......................................................................................................... 22
3.4.2 Removing Probe(s)........................................................................................................... 22
3.5 ON/OFF..........................................................................................................................................23
3.5.1 ON........................................................................................................................................ 23
3.5.2 Reboot after Failure...........................................................................................................25
3.5.3 Power Off............................................................................................................................ 25

4 Main Interface...........................................................................................................................................26
4.1 Working Interface..........................................................................................................................26
4.2 Information Area........................................................................................................................... 26
4.3 Parameter& Menu Adjustment Area..........................................................................................27
4.4 TGC Curve Display Area.............................................................................................................27
4.5 Image Area.................................................................................................................................... 27
4.6 Scale and Menu Display Area.................................................................................................... 28
4.7 Status Notice Thumb Area.......................................................................................................... 28
4.8 Menu Status Area.........................................................................................................................28

5 Patient Information.................................................................................................................................. 31
5.1 Enter/Exit Patient Information Input...........................................................................................31
5.2 Overview of Patient Information Input Interface...................................................................... 31
5.3 Patient Information Input............................................................................................................. 33
5.3.1 Basic Patient Information................................................................................................. 33
5.3.2 Patient Detail Information Input....................................................................................... 33
5.4 Exam Type and Probe Selection................................................................................................34

6 Imaging Modes.........................................................................................................................................36
6.1 Imaging modes..............................................................................................................................36
6.2 Changing Operation Mode.......................................................................................................... 37
6.3 Adjusting Image Parameters...................................................................................................... 39
6.4 B Mode........................................................................................................................................... 41
6.4.1 B Mode Operation............................................................................................................. 41
6.4.2 B Mode Parameter............................................................................................................ 41
6.4.3 B Mode Imaging Optimization......................................................................................... 41
6.5 B/M Mode.......................................................................................................................................47
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 6.5.1 B/M Mode Operation......................................................................................................... 47
6.5.2 B/M Mode Parameter........................................................................................................ 48
6.5.3 B/M Mode Imaging Optimization..................................................................................... 48
6.6 C Mode........................................................................................................................................... 49
6.6.1 C Mode Operation............................................................................................................. 50
6.6.2 C Mode Parameter............................................................................................................ 50
6.6.3 C Mode Imaging Optimization......................................................................................... 50
6.7 PD/DPDI Mode..............................................................................................................................54
6.7.1 PD Mode Operation...........................................................................................................55
6.7.2 PD Mode Optimization...................................................................................................... 55
6.7.3 DPDI Mode Operation.......................................................................................................55
6.7.4 DPDI Mode Optimization..................................................................................................55
6.8 PW Mode....................................................................................................................................... 55
6.8.1 PW Mode Operation...........................................................................................................56
6.8.2 PW Mode Parameters.......................................................................................................56
6.8.3 PW Mode Optimization..................................................................................................... 56
6.9 CW Mode....................................................................................................................................... 59
6.9.1 CWMode Operation...........................................................................................................59
6.10 Wfov Imaging.............................................................................................................................. 60
6.10.1 Wfov Imaging Operation.................................................................................................60
6.11 AMM Mode.................................................................................................................................. 61
6.11.1 AMM Mode Operation.....................................................................................................61
6.12 MC Mode..................................................................................................................................... 61
6.12.1 MC Mode Operation........................................................................................................61
6.13 TDI Mode..................................................................................................................................... 62
6.13.1 TDI Mode Operation....................................................................................................... 62
6.13.2 Strain Rate Mode.............................................................................................................62
6.13.3 Strain Rate Mode Operation..........................................................................................63
6.14 Freehand 3D Imaging................................................................................................................ 63
6.14.1 Freehand 3D Operation..................................................................................................63
6.15 3D/4D Imaging............................................................................................................................ 65
6.15.1 3D/4DImaging Summary................................................................................................ 65
6.15.2 3D/4D Imaging Operation.............................................................................................. 65
6.15.3 3D/4D Imaging Parameter Adjustment........................................................................ 66
6.15.4 3D/4D Image Edition.......................................................................................................67
6.15.5 3D/4D Image Measurement...........................................................................................68
IX
7 Cine Loop..................................................................................................................................................70
7.1 Enter/Exit Cine Loop.................................................................................................................... 70
7.2 Storing Images or Cines.............................................................................................................. 70
7.3 Operation of Cine Loop................................................................................................................71
7.3.1 Automatic/Manual Loop....................................................................................................71
7.3.2 Cine Loop Speed Selection............................................................................................. 71
7.4 Cine Loop in different Imaging Modes...................................................................................... 71

8 Measurement and Calculation...............................................................................................................73

8.1 Basic Operation............................................................................................................................ 73
8.1.1 Measurement Basic workflow.......................................................................................... 73
8.1.2 Button Function.................................................................................................................. 74
8.1.3 Measurement Items...........................................................................................................74
8.1.4 Measurement, Calculation and Research..................................................................... 75
8.1.5 Measurement Ruler...........................................................................................................75
8.1.6 Measurement Result Display...........................................................................................76
8.2 Measurement Report................................................................................................................... 76
8.2.1 Report Checking................................................................................................................ 76
8.2.2 Report Edition.....................................................................................................................77
8.2.3 Report Printing................................................................................................................... 78
8.3 2D Regular Measurement........................................................................................................... 78
8.3.1 Distance.............................................................................................................................. 78
8.3.2 Area..................................................................................................................................... 78
8.3.3 Ellipse.................................................................................................................................. 79
8.3.4 Cross................................................................................................................................... 79
8.3.5 Angle....................................................................................................................................80
8.3.6 Distance Ratio....................................................................................................................80
8.3.7 Volume................................................................................................................................ 80
8.3.8 Volume（Ellipse）.............................................................................................................81
8.3.9 Area Ratio........................................................................................................................... 81
8.3.10 Diameter........................................................................................................................... 81
8.3.11 Joint Angle........................................................................................................................ 82
8.3.12 Depth-Distance................................................................................................................ 82
8.4 B/M Regular Measurement......................................................................................................... 82
8.4.1 HR（2）..............................................................................................................................82
8.4.2 Time..................................................................................................................................... 83
X
 8.4.3 Slope....................................................................................................................................83
8.4.4 Distance.............................................................................................................................. 83
8.5 CFIMode Measurement...............................................................................................................83
8.6 PW ModeMeasurement...............................................................................................................84
8.6.1 Heart Rate and Time.........................................................................................................84
8.6.2 Doppler Velocity.................................................................................................................84
8.6.3 PI.......................................................................................................................................... 84
8.6.4 RI..........................................................................................................................................84
8.6.5 PS/ED..................................................................................................................................85
8.6.6 Acceleration........................................................................................................................85
8.6.7 E/A....................................................................................................................................... 85
8.6.8 PW Auto Trace(D)............................................................................................................. 85
8.6.9 M Trace............................................................................................................................... 86
8.7 Abdomen........................................................................................................................................86
8.7.1 ABD Examination Preparation.........................................................................................86
8.7.2 ABD Measurement Workflow...........................................................................................86
8.7.3 ABD Measurement Items................................................................................................. 87
8.7.4 ABD Measurement Operation......................................................................................... 87
8.7.5 ABD MeasurementReport................................................................................................ 88
8.8 Obstetrics.......................................................................................................................................88
8.8.1 OB Examination Preparation........................................................................................... 88
8.8.2 OB Measurement Workflow............................................................................................. 88
8.8.3 OB Measurement Item......................................................................................................89
8.8.4 OB MeasurementFormula................................................................................................ 90
8.8.5 OB MeasurementOperation............................................................................................. 92
8.8.6 OB Measurement Report................................................................................................. 92
8.9 Cardiac........................................................................................................................................... 93
8.9.1 Cardiac Examination Preparation................................................................................... 93
8.9.2 Cardiac Measurement Workflow..................................................................................... 93
8.9.3 Cardiac Measurement Item..............................................................................................93
8.9.4 Cardiac MeasurementOperation..................................................................................... 98
8.9.5 Cardiac Measurement Report........................................................................................112
8.10 Gynecology................................................................................................................................112
8.10.1 GYNExamination Preparation..................................................................................... 112
8.10.2 GYNMeasurement Workflow....................................................................................... 112
8.10.3 GYNMeasurement Items..............................................................................................113
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 8.10.4 GYNMeasurementOperation....................................................................................... 114
8.10.5 GYNMeasurementReport.............................................................................................115
8.11 Urology....................................................................................................................................... 115
8.11.1 Urology ExaminationPreparation................................................................................ 115
8.11.2 Urology Measurement Workflow.................................................................................115
8.11.3 Urology Measurement Items........................................................................................115
8.11.4 Urinary Measurement Operation.................................................................................117
8.11.5 Urinary Measurement Report...................................................................................... 118
8.12 Vascular..................................................................................................................................... 118
8.12.1 Vascular Examination Preparation............................................................................. 118
8.12.2 Vascular Measurement Workflow............................................................................... 118
8.12.3 Vessel measurement options...................................................................................... 118
8.12.4 Vascular Measurement Operation.............................................................................. 119
8.13 Small Organ.............................................................................................................................. 120
8.13.1 Small Organ Examination Preparation...................................................................... 120

9 Text Annotation and Arrow Marks...................................................................................................... 122

9.1 Enter/Exit Text Annotation........................................................................................................ 122
9.2 Add Text Annotation.................................................................................................................. 122
9.2.1 Input annotation............................................................................................................... 122
9.3 Modifying Text Annotation........................................................................................................ 123
9.4 Deleting Annotation....................................................................................................................123

10 Body Mark............................................................................................................................................ 125

10.1 Enter/Exit Body Mark...............................................................................................................125
10.2 Classification of Body Mark.................................................................................................... 125
10.3 Body Mark Operation...............................................................................................................125

11 Image Management............................................................................................................................126
11.1 Work Interface of Image Management................................................................................. 126
11.2 Enter/Exit Image Management.............................................................................................. 127
11.3 Search........................................................................................................................................128
11.4 View............................................................................................................................................128
11.5 New Patient...............................................................................................................................128
11.6 Check Report............................................................................................................................ 128
11.7 Export / Import.......................................................................................................................... 128
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 11.8 Delete.........................................................................................................................................129

12 System Setup.......................................................................................................................................130
12.1 Default Working Interface....................................................................................................... 130
12.2 Enter/Exit Preset...................................................................................................................... 130
12.3 System Parameter Preset.......................................................................................................131
12.3.1 System............................................................................................................................ 131
12.3.2 Imaging........................................................................................................................... 132
12.3.3 DICOM............................................................................................................................ 133
12.3.4 Peripherals...................................................................................................................... 134
12.3.5 Scheme...........................................................................................................................136
12.3.6 License Management................................................................................................... 136
12.3.7 About information.......................................................................................................... 138

13 System Maintenance.......................................................................................................................... 139

13.1 Routine Maintenance...............................................................................................................139
13.1.1 Clean System.................................................................................................................139
13.1.2 Depth of Immersion.......................................................................................................141
13.1.3 Data Maintenance......................................................................................................... 142
13.2 Maintenance..............................................................................................................................142
13.2.1 Maintenance of Operators........................................................................................... 142
13.2.2 Maintenance and Inspection by Maintainers............................................................ 142
13.3 Fault Checking..........................................................................................................................143
13.4 Equipment Modification Instructions..................................................................................... 144

14 Transport and Storage....................................................................................................................... 145

15 Acoustic Power Output Principle...................................................................................................... 146

15.1 Biological Effects...................................................................................................................... 146
15.2 Statement of Cautious Use.....................................................................................................146
15.3 ALARA Principle （As Low As Reasonably Achievable）............................................... 146
15.4 MI/TI Description...................................................................................................................... 147
15.4.1 Basic Information of MI and TI.................................................................................... 147
15.4.2 MI/TI Display Description............................................................................................. 148
15.5 Acoustic Output Control.......................................................................................................... 148

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16 EMC Declaration................................................................................................................................. 149

Appendix A Good Practice for the Pollution Control of Electronic ProductsConformance Statement
........................................................................................................................................................................155
Appendix B Technical Parameters........................................................................................................ 156
Appendix C Acoustic Output Data......................................................................................................... 157

XIV
1 Security Declaration

1.1 Safety Classification

 According to the anti-shock type:

Classification Ⅰ equipment

 According to the extent of the anti-shock:

Applied part, type BF

 According to the harmful into the liquid level of protection

Host: IPX0 (unprotected);

Probe: IPX7 flooding (protection for short periods of time).

 According to the in (with air or oxygen, nitrous oxide) of the presence of mixed inflammable

anesthetic gas use safety degree: Not appropriate in a (with air or oxygen, nitrous oxide) of

the presence of inflammable anesthetic gases mixed use of equipment

 According to the working mode:

Continuous work.

 According to the installation of the equipment and the way of use:

Car type equipment.

1.2 Symbol Definition

In this instruction manual,“ Danger” , “ Warning” , “ Caution”and“Notice” Is used

to represent relevant safety and other important items, the specific meaning they are as follows.

Before reading this manual, please understand and remember the meaning of these words

carefully.

Symbols
Meaning
and words

1
 This symbol indicates urgent danger will happen. If not strictly followed,
Danger they could lead to personal death or serious injury.

Warnin This symbol indicates potential danger will happen. If not strictly
g followed, they could lead to personal death or serious injury.

Cautio This symbol indicates potential danger will happen. If not strictly
n followed, they could cause mild or moderate damage.

Emphasis on important matters needing attention, providing instructions or

Notice
explanation in order to better use this product.

1.3 Safety Symbol

The following symbols may be used in this manual or elsewhere in product labeling
Symbol Description

BF-type parts

Dangerous voltage

Ground wire

”Caution“ means the items that need pay attention to. Before to use system,
please read user manual carefully. This symbol means that please check user
manual for reference in order to prevent safety accidents.

1.4 Reference Standards

1. IEC 60601-1:2005/A1:2012 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance.
2. IEC 60601-1-2:2014General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility-Requirements and tests.
3. EN 62304:2006/AC:2008 Medical device software - Software life-cycle processes.
4. IEC 60601-2-37:2007+AMD1:2015 Medical electrical equipment-Part 2-37: Particular
requirements for the basic safety and essential performance of ultrasonic medical diagnostic
and monitoring equipment.
5. ISO10993-1:2009/AC:2010 Biological evaluation of medical devices –part1: Guidance on
Selection of Tests.
6. EN ISO 13485:2016 Medical devices-quality management system-Requirements for regulatory
purpose.

2
7. EN ISO14971:2012 Medical devices-Application of risk management to medical devices
8. EN1041:2008 Information supplied by the manufacturer with medical devices.
9. EN ISO 15223-1:2016Medical devices - Symbols to be used with medical device labels, label
ling and information to be supplied
10. EN 62366:2008Medical devices - Application of usability engineering to medical devices
11. EN 60601-1-6:2010Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability

<Provisions on the Management of Instructions and Labels of Medical Devices> (CFDA Notice

No.6)

1.5 Summary of Safety

For patient and operator safety, when using this system please strictly observe the

following content. In this instruction manual，the warning instructions, means that if the violation

of related content, may cause and client personal injury to the user, and even life threatening

equipment .users must comply with the following contents:

1. Don't try to any modification to this device, if must change, please contact us;

2. This equipment in the factory has been fully tested, please do not adjust the adjustable

parts of any fixed;

3. The power of the this equipment must be grounded is good, the ground shall not

beremoved or dismantled;

4. When this equipment must be electronic or mechanical connection with other devices,

please confirm its IEC 60601standard, and need to review the system of safety indicators,

such as leakage current;

5. This device does not provide protective measures for high frequency surgical equipment,

please don't use as much as possible;

6. This equipment can only be conducted by the company authorized personnel to install,

please do not install by yourself;

7. This equipment can only be authorized by the company's maintenance engineer for repair;

8. This device may only be operated by professionally qualified staff;

9. Can't use this equipment in a flammable environment, has the potential to explode;

10. This system (including the host, the probe, display) all the components are suitable for use

in patients with environment;

3
 11. Please cut off the equipment at the end of the clean and prevent water and other liquid drip

into the device;

12. In order to ensure the safety of the examine shall not for a long time continuous scanning

imaging for the same part of the client;

13. This equipment when the ultrasonic scanning, need to be used together with the ultrasonic

coupling agent, found no biological compatibility problems, but in order to ensure safety,

must be used to comply with relevant standards of qualified ultrasonic coupling agent;

14. Will affect the operator to adjust sound power device output value, sound power

changes the MI and TI values also subsequently and change (Note:MI said mechanical

index, TI said heat index);

15. This product and all other diagnostic ultrasound products, should be able to obtain the

necessary under the condition of clinical information, use within the shortest possible time.

Power should be set in clinical acceptable image can be obtained under the premise of

using low power as much as possible.

16. Maintain the cleanness of the probe, the inspection on different subjects, must clean the

probe.

17. Must as far as possible in the shortest possible time and small power under the diagnosis

of client.

18. When to stop scanning the system in the frozen state.

19. Avoid probe fixed to the client for a long time to scan a fixed position.

20. This equipment is the acoustic output see appendix acoustic output report.

21. This equipment is scrapped, please inform our company.

1.6 Safety Warning Information

For patient and operator safety, when using this system please strictly observe the following

safety precautions.

Danger: Never in the presence of flammable gases, such as anesthetic gases,

oxygen, hydrogen, and so on) or flammable liquids (such as ethanol, etc. )
use this system; otherwise there is a risk of explosion.

Warning:
1. Using the adapter or multi socket may affect the grounding, the leakage currently

4
 exceeds the safety requirements.
2. Before the power plug inserted into the socket, the ground must be good connected.
In order to avoid electric shock, unplug the grounding conductor in front, the
equipment must be pulled out from the plug socket, so as to avoid electric shock.
3. In the system movement process must guarantee the system ground terminal and
the earth connection,connect the grounding cable must be carried out when the
device is shutdown, otherwise it could lead to an electric shock.
4. Being sure not ground connection to any gas pipeline or water pipe, otherwise it can
cause poor grounding or the detonation danger.
5. Before cleaning the machine , be sure to unplug the power cord , or it may result in
electric shock.
6. This machine does not have any waterproof device, do not use the machine where
may enter water e. Do not spill any liquid onto or into the machine, otherwise there
will be a risk of electric shock. If you accidentally spill liquid on the machine,
immediately shut down and unplug the power plug, if necessary, contact the
company or authorized customers.
7. Using the probes carefully, if the probe head is scratched, please immediately stop
using the probe and contact the company or authorized staff. If using a probe of
scratching, there will be a risk of electric shock.
8. It is forbidden that contact live part of this device or other equipment with the
patient. If this equipment or other equipment breaks down, the patient can have the
electric shock danger.
9. Do not use the probe which is not provided by our company, otherwise it may
damage the host or probe and even cause accidents such as fire.
10. No knocking probes. The fault probe may result in electrical shock.
11. Do not open the enclosure or panel, otherwise it will cause a short circuit or click on.
12. Do not use the equipment simultaneously together with high frequency electric
knife, high frequency therapeutic equipment or devices such as defibrillators.
Otherwise it might shock patients.
13. Precautions during transport: if need to move the unit, hold the handle.
14. All products connect with this ultrasound device must have IEC standards certified.
15. When using intracavity probe, do not activate the probe outside the patient.

Caution:
1. Considerations for clinical examination techniques
 This device may only be operated by professionally qualified staff.
 The operator should not simultaneously contact the patient and the printer.

5
  This manual does not describe clinical examination techniques, must correct
check on the knowledge of professional training and clinical experience.
2. System exceptions caused by radio waves:
 If uses this medical electron system nearby the transmit radio equipment, it
may interface normal operation. Taking in or using devices that can produce
radio waves are forbidden in the room. Such as mobile phone, radio
transceiver and etc.
 If in the vicinity of the system user with the possible radio waves of the
device, you must call for the immediate closure of these devices to ensure
that the system work normally.
3. Considerations for installation and mobile devices:
 Please ensure that the machine mounted horizontally.
 Do not place anything on the monitor for it may drop and cause injury.
 Mobile equipment must be confirmed before peripherals have been fixed
firmly. Otherwise, damage caused by peripherals may be dumped.
4. Do not exert too much vibration on native (such as moving equipment), or
mechanical parts will be damaged.
5. Always keep the machine dry , avoid the machine quickly moved from a cold place
to a warmer place, otherwise there will be condensation or water droplets , causing a
short circuit danger.
6. If the circuit protection works, indicating the machine or peripheral equipment
failure , please contact the company or authorized service staff, do not do it by
yourself.
7. Normal ultrasound check will not have the risk of burns. In order to avoid burning,
do not put the probe at the same place of patient, and reduce the inspection time as
far as possible.
8. The equipment and accessories is not sterilized when delivering. Before using the
probe and puncture, user should refer to this manual to do disinfection and
sterilization.
9. Do not turn off the power switch directly, or disconnect attachments (such as a
printer and so on) the plug, otherwise it will cause damage to the system.
10. Do not power off the system in the process of printing, saving and transferring data,
otherwise can cause the information loss.
11. In the process of operation, improper power failure may lead to damage or failure of
hard disk data.
12. Before using the ultrasonic diagnosis system, please read carefully the ultrasound
output part.

6
Notice:
1. Using the system under strong electric or magnetic fields (such as transformers) environment
is banned, otherwise it will have adversely affect.
2. Near the high frequency device shall be forbidden to use this system, otherwise it will have
adversely affect and even lead to failure.
3. To avoid damage the system, following situation are forbidden:
1) Where is direct sunlight
2) where the sharp change of temperature
3) Where is dusty
4) where easily vibrated
5) where is nearby heat source
6) where is high humidity
4. You need to wait at least 5 minutes when you want to restart the machine. Otherwise may lead
to failure.
5. Prior to insertion probe, the system must be shut down or freeze the image through the power
switch. Otherwise, it may cause system or probe failure.
6. The probe should be thoroughly cleaned after use.
7. The user can record the registration data (such as a hospital patient information, etc.). To
ensure that data is safe, be sure to back-up the information on external storage media,
because abnormal operation or failure may result in losing of the data stored within the
system.
8. Avoid applying force on the control panel (the body relies on), or it may damage the machine.
9. Uses this system in the narrow and small room possibly causes the indoor temperature
ascension, therefore must guarantee ventilates good.
10. When you need to scrap this system or any attachments, please contact our company or
authorized staff. The company will not assume any responsibility to any damage caused by
failure to comply with this provision.
11. With the extension of time, the machine's electrical and mechanical safety performance will be
reduced (such as producing leakage currents or mechanical deformation and wear parts), the
sensitivity and accuracy of the image will be worse. In order to ensure the normal work
performance, must regularly inspect the equipment.

7
2 Overview

2.1 Intended Application

This ultrasound system is intended for ultrasound evaluation of human subjects.

2.2 Contraindication
The product is not suitable for eye examination.

2.3 Composition
The ultrasound system is composed of host, monitor, probes, printer and foot switch.

2.4 Specifications Parameter

2.4.1 Power Conditions
Supply voltage：AC 100V～240V

Supply frequency：50Hz/60Hz

2.4.2 Environmental Conditions

Oerating Environment Storage and transportation environment

Environmental temperature 5℃～+40℃ -20℃～＋55℃

Working Humidity 25%～80% 10%～95%

Atmospheric pressure 70kPa～106kPa 50kPa～106kP

Warning: do not use or operate the equipment outside the specified environmental

conditions.

2.5 Boundary Dimension

Overall dimensions：845mmX565mmX1455mm

Net weight：around 64 ㎏

2.6 Software Version

The software version of this device system is V2.97-2015.

8
2.7 Configuration
2.7.1 Standard Configuration
 System host

 Monitor

 Probe（See productpacking list for details.）

 Accessory（See productpacking list for details）

2.7.2 Selectable Probe

Probe Central Frequency

No Probe Type Used Part Application
Model Frequency Range

Convex probe Abdomen,

1 TC50 3.5MHz 2.0-6.0MHz Body surface Gynecology,
（R=50）
Obstetrics
Transvaginal Gynecology,
2 TC10 6.5MHz 5.0-10.0MHz Transvaginal
probe（R=10） Obstetrics

Linear probe
3 TL40 7.5MHz 5.0-12.0MHz Body surface Superficial organ
（L=40）

Phased array
4 TP16 3.0MHz 2.0-5.0MHz Body surface Cardiac
probe

4D volume
5 TW40 4.0MHz 2.0-6.0MHz Body surface Obstetrics
probe（R=40）

TC50, TC10, TL40, TW40 probe both support B mode, B+B mode, 4B mode, B/M mode, M

mode, Color Doppler (C) , Power Doppler（PD）, Pulse wave Doppler (PW)；Besides, these modes

above TP16 can also support CW mode.

Warning: Transvaginal probe should not be activated in vitro.

2.8 System Parts Introduction

2.8.1 System Parts

9
10
SN Name Function

The display of ultrasonic image and interface of each application

1 Monitor
module

Displays a touch screen menu that changes according to imaging

2 Touch Screen
mode/state

3 Control Panel Used for text annotation, report editing and ultrasonic application

4 Keyboard For text input（Patient information，System setting，Image text）

5 Handle Move machine and adjust console panel/monitor angle

6 Probe Socket Connect probe

7 Wheel Fix or move machine

8 CD/DVD-RW Recording Ultrasound images（Preset port）

9 USB USB

10 Power Switch On/off machine

Heat gel (The temperature ≤ 40 ℃ . When the temperature is above

11 Gel heater 40 ℃, the in-cup temperature controller is disconnected and the heating
cup stops heating)

12 Probe Shield Put probes inside when do not use it

13 Handle seat Move machine

14 Hook Put power cable when do not use it

15 I/O port USB、Video、RS-232 and so on

16 Power port Electric input、output port

2.8.2 Control Panel

11
SN Icon Name Function

1 / Touch screen Show different menus

2 Power switch On / Off system

Touch screen Change value of relevant parameters according to touch

3-7
knob screen
Contrast
8 Reserved key
imaging

12
 Image
9 Open/Close image management interface
management

10 Report Open/Close report interface

11 Elastography Reserved key

12 Spatial imaging Spatial Compounding Imaging

13 3D/4D Activate/cancel 3D/4D

.

1. Press to adjust the angle，like PW sampling angle；

Using linear probe, press to activate or close
14 Angle Angle Trapezoidal imaging
2. Rotating knob adjusting angle，like B scan angle, C
angle，PW sampling angle

Focus Press and rotate the knob repeatedly to change the focus
15 Focus position/Focus position, the number of focal points and the distance
number/interval between focal points.

16 CW Activate （CW）, rotate PW knob to change CW gain.

17 PW Enter PW mode； Rotate PW knob to change PW gain.

Used under B/PW and PW function; Press this button,

18 Angle/PW
adjust value button, justify the sample volume and angle

19 PD Enter PD mode; rotate C knob to change PD gain.

20 C Gain Enter C mode；Rotate knob to change gain.

21 2B/4B Press once to enter 2B and twice to 4B;

22 B gain Enter B mode；Rotate knob to change B gain.

13
23 B+M Enter B+M mode；Rotate knob to change B+M gain.

24 Base line Change PW/CW spectrum baseline

25 PRF Change PW/CW PRF value

26 Shift Shift PW/CW wave direction

27 ROI Angle Use in linear probe

28 Wall filter Adjust wall filter value

29 PRF Shift C wave direction

30 Shift CFM color

31 Frequency Adjust 2D frequency

32 Zoom Up(enlarge)/ down(reduce) image size

33 Depth Change the scanning depth

34 Focus Change focus position and space

35 / TGC Adjust TGC curve

36 Auto Imaging optimization

Press button, enter into body mark function, body mark

37 Body mark form is showing on the left of the screen, system is in
selection and edition status of body mark.

14
38 Arrow Click this button and enter the arrow mark function;

Enter the image management application module;

Browse images and video;
39 File
Export images and video files to external storage device;
DICOM or network transmission images, video files;

40 Set up Open/close settings

Enter into the probe selection; Select and change the

41 Probe
probe according to the mode

Enter the new patient

42 Patient
Check out the new patients to input information and data;

43 Text Open /close annotation

44 Clean (text) Clean text annotation or measurement

Clean last step operation of text annotation or measu

45 Clean
rement

46 Caliper Open /close measurement function

47 Set Confirm function

In B mode, press【 】and then 【 】to B+B mode；

48 Update
In B mode, press【 】twice and then 【 】to 4B mode

49 Q1 Display application measurement

Self define button for operation: Freeze/Save image to U

50 Q2
disk /Save image/Save cine/ Save cine to U disk

Self define button for operation: Freeze/Save image to U

51 Q3
disk /Save image/Save cine/ Save cine to U disk

15
 52 Freeze Freeze and unfreeze image

53 / Save image in freeze. Save cine in real-time.

Used to locate the arrow graphics on the screen, display

54 / Trackball
text cursor, arrow, etc.

This key performs the cancel function and it equivalents

55 / Cancel
of the right button of PC mouse.

2.8.3 I/O Interface Board

SN Name Function

1 RS-232 Serial port

Network ports, connect to the network or connect other equipment

2 RJ-45
support DICOM protocol

3 USB USB

4 VGA VGA signal output

5 HDMI HDMI signal output

6 S-VIDEO S port signal output.

Output video signal, connect video printers, ultrasound workstation,

7 VIDEO
etc.

16
2.8.4 Power Socket Port

No Name Function

1 AC output fuse Fusible fuse wire，SPEC：Φ5×20mm， F2AL250V AC

2 AC input fuse Fusible fuse wire，SPEC：Φ5×20mm，F3.15AL250V AC

3 AC output AC output port

4 Ground stub Ground connect protection

5 AC input AC input port

2.8.5 Keyboard

For text input (i.e.: patient data, system Settings, image text, etc.)

Pop-up keyboard:

Push on the edge of the keyboard, and then automatic pop-up keyboard.

17
 Close the keyboard:

Gently push the keyboard tray, to sliding shaft.

Keyboard consists of Numbers, letters and function keys used for text annotations, and other

specific function same as a computer keyboard function operation

No Button Function

1 Tab Turn to the next operable item

2 Caps lock Enter case switch

Press Shift and press another key to change case or

3 Shift
character

4 Ctrl Combined shortcut

5 Alt Combined button

6 Space key Insert white space

Receiving input data; Moves the cursor to the next line of

7 Enter
text or input field.

8 Esc Exit

2.9 Symbols and Identification

This equipment uses the following symbols and identification, the following list shows the

meaning.

Symbol Refer to

BF application

This symbol for operating instructions related content, to avoid safety

accident

Dangerous voltage

USB port

Ground wire

ON Connected ( power supply)

18
OFF Disconnect (total power)

The name and address of EU authorized representative

Mark of CE

The name and address of the manufacturer

Manufacturing date

Series number

Reference instructions

Indoor use

Electronic product environmental protection period (20 years)

The waste electrical and electronics equipment must not besotting as

urban waste, it should be collected separately. Information about
equipment scrap, please contact the manufacturer's authorized
representative.

Non-ionizing radiation

19
3 System Preparations

3.1 System Placement

Before placing system, please carefully read and understand the safety precautions, to ensure

the safety of personnel and equipment.

1. Turn the power off, pull the plug.

2. Open the two brake casters.

3. Hold the handle and move the machine, place your system to the desired location, locking2

brake casters.

4. Keep minimum 25cm space.

Warning: Must keep enough space behind and by side of machine, or it will effect

machine heat disperse, then damage of machine。

3.2 System Movement and Transportation

In order to prevent the system from accidents during movement and transportation, please pay

attention to the following matters:

1. The system can be moved only when it is power-off.

2. Remove all probes connected to the system and then move it solely;

3. Remove all peripherals connected with the equipment;

4. Correctly pack the equipment better in original factory package

5. During transportation, the system cannot be laid upside down.

3.3 External Power Connection and Grounding

This ultrasound system works by external power.

3.3.1 Connections of External Power Supply

Power connected to the system must meet the following requirements:

1. Voltage: AC 100V-240V.

2. Frequency: 50Hz/60Hz.

20
 3. Power:320 VA

3.3.2 Connections of Ground Terminal

The power cable used in this equipment is single-phase three-core cable.

The grounding terminal should be connected to the protection line of the power supply

grounding. Power grounding protection must be ensured to work properly.

Warning:

1. Do not connect the device using the three core to two core outlet, otherwise may

cause machine damage orelectric shock accident.

2. The system and external equipment connected to system must be connected to

wall outlet, andthe choice ofsocket must meet the requirementsof system name

plate parameters. Use adapter ormulti-purpose socket may affect the ground, may

cause the current leakage exceeds index.

3.4 Probe Connection and Remove

Caution：

1. Before you plug in the probe, you must ensure that the system is frozen or shut

down. Otherwise, it may cause trouble.

2. when the probe is plugged, the probe is placed in the probe protection seat, and the

probe cable is suspended on the probe support, so as to prevent the probe from

accidentally falling and causing damage to the probe.

3. When using the probe, the probe cable should be suspended from the probe

support, so as not to cause distortion and damage to the part of the probe socket.

4. The system can only use the probe provided by our company. Attempts to use

other probes will damage the equipment and probe and cause unforeseen

accidents or failures.

21
3.4.1 Connecting Probe(s)

Warning: Before connecting the probe, be sure to ensure that the probe matches

the surface of the layer. The probe cable and the probe socket are in

normal condition, that is, no cracks or shedding. The possibility of using

a defective probe to cause an electric shock is possible.

1. Turn the probe connector lock switch to the vertical direction, the cable to the right, insert the

probe connector into the probe socket, and press.

2. Turn the lock switch on the probe connector clockwise 90 degrees to the horizontal position

and tighten it, as shown below.

3.4.2 Removing Probe(s)

Lock the probe connector switch 90 degrees counterclockwise to the vertical direction and pull

out the probe connector vertically, as shown in the figure below.

22
 Warning ： Make sure the system is under freeze or shut down before plug or

connectthe probe. Otherwise, it will cause the damage.

3.5 ON/OFF

3.5.1 ON

Warning:
1. In order to ensure the system safe and effective operation, please keep daily
maintenance and maintenance.
2. When found the abnormal situation, immediately shut down, and contact the
manufacturer or agent. Use defective system will damage patients and equipment.

 Check before start up

Before starting, please refer to the following steps or project for inspection and operation.

SN Inspection Item

Whether Power grid voltage comply with the requirement of working

1
conditions.

Temperature, humidity andatmospheric pressure should meet the

2
requirements of the conditions of use.

3 There can be no condensation phenomenon in environment

23
 The system and peripheral equipment may not have the phenomenon such
4 as deformation, destruction, or with stains. If it is found that the stain,
according to the instructions in "cleaning systems" section to clean.

Monitor and control panel components can not have loose phenomenon or a
5
loose screw.

Power cable or probe cables shall not damage, joint connection parts shall
6
not be loose.

According to the probe maintenance instructions executed correctly cleaning,

7
disinfection, sterilization, etc.

8 Shall not be put sundry On the control panel

Check socket and all the visible interface, make sure no any abnormal
9
phenomena, such as damaged or blocked by foreign bodies.

10 There should be no any obstacles near the movement area and vents

11 Clean and tidy working environment and space.

12 Wheel lock must function well

 Boot and after boot inspection

First, check whether the circuit breaker is closed. If not, the closed circuit breakers.

Press the power switch to start the system, after normal boot, interface display images, and

then press freeze, B mode images displayed interfaces.

Check whether the system start up is normal; please refer to the following project to make the

boot after check.

SN Inspection Item
1 Do not have any abnormal sound, smell, or overheating phenomenon.

2 System has no error message.

Cannot exist obvious abnormal sound, discontinuous displays or abnormal dark

3
space exists in the 2D image.

Check whether there is abnormal fever in the probe surface in the process of
4
using the.

5 The function of the button or knob is normal.

6 The system time in accordance with the current time.

24
 Warning:
1. Using unusually hot probe can burn patients;
2. When found the abnormal situation, immediately shut downand contact the
manufacturer or agent. Use defective system will damage patients and
equipment.

3.5.2 Reboot after Failure

When a problem occurs, need to shut down the system, wait at least 5 minutes before you

reboot the system.

1. Screen display abnormal.

2. Screen display an error message, and this information is always displayed.

3. The corresponding operation cannot continue.

3.5.3 Power Off

If long time no use the machine, please shut off the power. Before power off, should try

according to the following steps:

1. Put the probe in the corresponding probe protection shield

2. Press【 】 on console panel, System shutdown, after waiting for system exit, and then

close the power switch of the unit. When not use for a long time, cut off the power supply

circuit breaker panel. Please do not directly cut off the circuit breaker in the case of system

is on, otherwise, will cause unpredictable machine fault.

Warning: Please make sure to cut off the power after turn off the machine.

If the system shutdown process takes for a long time and can't normal shutdown:

Directly close machine power switch to cut off the power supply at the back of the unit, but this

is forced shutdown, this way may lead to loss of data, usually try not to use this way to turn it off.

Warning: Directly close machine power switch to cut off the power supply at the
back of the unit, but this is forced shutdown, this way may lead to loss of
data, usually try not to use this way to turn it off.

25
4 Main Interface
4.1 Working Interface
Working interface is operation menu that showing image, all kinds of parameters and operation
on the screen. Each kind of scanning mode menu and parameters are different. The working
interface main area map are as follows:

Information Area

Parameter
Scale and TGC curve
and menu
Measurement Image Area displaying
adjusting
displaying area area
area

Menu Status Area

Status Notice Area

4.2 Information Area

Display hospital name, system date, time, patient ID, patient name, probe name and current

displaying mode

 Hospital name

Display hospital name. Setting road is “『Setup』→『System』→『Hospital』”

 Patient ID, patient name

Display patient’s ID and name. Press 【Patient】 button, it can input information.

 Probe name

Display current using probe name, probe selection, change can be selected in probe

selection frame.

 Current application mode

Displaying current using current application mode.

26
  System date and time

Display current system date and time. Setting road is “ 『 Setup 』 → 『 System 』 →

『Date/Time』”.

4.3 Parameter& Menu Adjustment Area

 Parameter display

Under real time scanning, parameter will display as following picture (Following picture is

used for sample only)

Display the corresponding parameter in current mode,include acoustic power（P）、Gain（G）

、

Working frequency（Frq）、Depth（D）、Frame range（FR）

、Dynamic range（DR）and so on.

4.4 TGC Curve Display Area

 Show the depth scale and focus number.

 Show or hide TGC curve.

4.5 Image Area

Show each mode of image, but also all kinds of text, measurement scale markers in this main

display area.

Ultrasound image display, shape depends on the width of the selected probe and Settings, also

includes image depth indicator, focus instructions, etc.

Annotation is to help the analysis and explanation of image information, which includes manual

annotation text/ annotation arrows. Image scans position graph information such as the body

position state, probe direction.

Under the conventional measurement state, and a variety of applications, the annotation

27
information is displayed in the image area in the process of measurement.

4.6 Scale and Menu Display Area

 Grey scale

Show gray scale in B and C mode.

 Menu display

Mainly display the standard and application measurement menu、Body mark、Text annotation

and so on,the details as below:

No Mode/Menu Menu Function Adjusting Operation

Press 【ABC】button to show the note.

ABC Display the current application Move the trackball to select the
1
(Text) mode of text annotation. required notes entries, press 【 Set 】
button to confirm.

Press【Body Mark】button to show the

Display the current application Body Mark Selection. Move the
2 Body Mark
mode of body mark. trackball to select the required body
mark, press 【Set】button to confirm.

During Freeze, display the

Move the trackball to select the
base and application
3 Caliper required entries, press【Set】button to
measurement of current
confirm and measure, calculate.
application mode.

Q1 Displays the application Move the trackball to select the

4 (Application measurement items in the required entires,and
measurement) current application mode. measure,calculate

4.7 Status Notice Thumb Area

 After freeze, in the cine relief area,it will show the saved total frame and current frame.

 After saving the images,thumbnail will show in this area.

4.8 Menu Status Area

28
 MI and TIS

The current mechanical index MI of the system is displayed. The soft tissue heat index TIS.

shows different values according to different real-time scanning conditions.

 Software edition

Displays the current version of the software in use.

 System status information and common function shortcut operation buttons

Enter into “Patient ”

Enter into “Report”

Enter into“Set up”

Move to this icon, show the rest storage space,and press it,show the use of different
time,and can derive and clear the reports

1. Press this icon ，management interface will come out：

29
2. Choose the time period，system will calculate the space usage and show by

diagram.

3. Press『Back up』
，Copy the patient report to your assigned content

4. Press『Clearup』
，can clear any report you want,to make sure the enough local

storage.

30
5 Patient Information

Usually, the user do examination for the patient without having to enter patient information. The

system has a built-in patient information management library. In order to realize the functions of

managing, querying and storing data such as patient images, it is recommended that the user input

the patient information as completely as possible before each examination.

Notice: Before checking for a new patient, press the [Patient] button to update the patient ID and

other basic information to avoid confusion in storing patient information.

5.1 Enter/Exit Patient Information Input

 Enter/Exit patient information input

1. Press the [Patient] button or click the touch screen 『Report→Patient』to enter the

interface for patient information input;

2. Click 『Reset』 to update the ID number and clear the information of the previous

patient information interface.

3. Input the patient's basic information (such as patient name, gender, date of birth, etc.),

press 『Ctrl+Shift』to switch the input method.

4. Click to select the inspection categories such as 『General』、『Obs.』或『Car.』 and

input the corresponding information;

5. After the new patient information is finished, click 『Confirm』 to store the new patient

information, exit the new patient interface, and return to the imaging mode. If you click

『 Cancel 』 , the current information entered will not be saved, and the patient

information input interface will be exited.

5.2 Overview of Patient Information Input Interface

Press【Patient】to enter the interface for patient information input.

31
 Control
menu Information input area
area

The layout of the functions of each part of the work interface is as follows:

 Control menu area

Complete patient information input by selecting the appropriate button in the control menu

area

1. Create Default：Users can register new patients by clicking 『Create Default』 without

entering any information;

2. Library： Users can search for saved patient data through the『Library』interface, and

browse report and picture. New checks can be created from the patient information

found;

3. Worklist：The user can find the patient information that has been reserved through the

『Worklist』interface, and create new patient information according to the found patient

information;

4. Reset ： The user can update the ID number by clicking 『 Reset 』 and clear the

information that has been entered into the patient information interface;

5. Confirm：Click 『
“ Confirm』 to save the current edited and entered information and exit;

6. Cancel ： Click 『 Cancel 』 to exit without saving the current edited and entered

information.

 Information input area

Corresponding to the “Classification of New Patient Information”, different input box

interfaces are displayed to complete the information input of various applications, including

basic information, obstetrics, cardiac, abdomen, gynecology, small organs, doctors, and

32
 remarks. Further explanation refers to "input of patient information" later.

5.3 Patient Information Input

5.3.1 Basic Patient Information

In a new patient exam, press【Patient】to enter into Patient Data Input interface shown as below:

Basic patient data input is instructed as follows:

 Name

Please input the patient name by control panel.

 Gender

The optional gender is male and female.

 Birth Date

Please input the patient birth date in the sequence of year, month and day, with which the

system will calculate the patient age.

 Age

The system will automatically calculate and display the patient age according to the birth

date. The user can input or change the age also.

 ID

Click "Reset" to refresh the ID number.

5.3.2 Patient Detail Information Input

Patient data can be completed, details are shown below：

1. General

Select 『General』to display the general information input interface and input the

description information of the general examination, including:

 Description

 Medhistory

 Height

 Weight

2. Obstetrics

33
 Select "Obstetrics", display the obstetrics information input interface, and enter the

description information of the obstetric examination. The information that the obstetrics

may need to input includes:

 LMP：Input the last menstrual date, and the system calculates the gestational age

and expected date of birth based on the entered artificial insemination date.

 GA

 Conceive

 Misscarry

 EDD( expected delivery date )

 Delivery

 ConCnt

3. Cardiac Data:

Select 『Car.』to display the cardiac data input interface to input the description data for

Cardiac exam. Cardiac calculation and application may need the data below:

 Height, Weight

 HR

 SBP, DBP

 BSA：
After entering the height and weight, the system automatically calculates the

body surface area.

4. Doctor information

Information about the attending doctor, the diagnosing doctor, and the operator can be

input from the keyboard.

5. Comments

The attending doctor can fill in the ultrasound diagnosis in the comments.

5.4 Exam Type and Probe Selection

1. Press Probe key, the following interface will pop up, The user can select the application

mode as needed by touch screen.

34
2. The user can directly click the touch screen to select the probe and the corresponding

application mode as needed to complete the switching of the probe

Notice：Do not switch the probe quickly, when the probe switch, when the machine
issued a "crackle" sound, indicating that the probe switch successfully,
otherwise, may lead to abnormal.

35
6 Imaging Modes

Waring: Images provided by this system are only for the references for the
physicians in their diagnosis. For accuracy of the diagnosis results, it’s not
the images but the physicians shall be responsible.

6.1 Imaging modes

This system supports the imaging modes shown in the table below:

Mode Imaging Remarks

B mode

B+B mode

4B mode

FHI Applicable for convex array probes

THI
2D mode
Trapezoidal imaging Applicable for linear array probes

Extended imaging Not applicable for linear array probes

SC（Spatial Composite） Not applicable for phased array probes

B/Mmode

AMM（Anatomical Mmode） Not applicable for intracavity probes

C（Color Doppler）

MC（M Color flow imaging mode）

PD（Power Doppler）

C/B
Color flow
dual C/P（Power）
real-time
Color mode C/DP（Directional
mode Power）
DPDI

TDI (Tissue Doppler) Applicable for phased array probes

SR（Strain Rate） Applicable for phased array probes

PW

CW

36
 Applicable for phased array and linear
Triple
probes

Wfov Applicable for linear array probes

Others Freehand 3D Not applicable for phased array probes

4D

6.2 Changing Operation Mode

Image mode
selection and selection and switching operations
switching
operations
1. Press【B】Knob button to enter into B-mode
2. Other modes, Press【B】Knob button to enter into B-mode.
3. In B-mode, press【 】button or press『Dual』on touch screen,
B, B+B, 4B
then press 【 】button to enter into B+B mode.
4. In Bmode, press【 】twice or press『Quad』on touch screen, then
press【 】button again to enter into 4B mode.

FHI mode
In the B mode, click 『FHI』on the touch screen to activate the
(harmonic
harmonic fusion mode. Click again to return to B mode.
fusion)

1. Select the convex array or linear array probe. In the B mode,

THI mode repeatedly click the touch screen『THI』to switch between the B
(harmonic mode and the reverse phase harmonic (Phase THI).
imaging) 2. Select phased array probe. In B mode, press the touch screen
『THI』to switch between B mode and Filter THI.

Trapezoidal Select the linear array probe. In the B mode, press the【Angle】knob
imaging to enter the trapezoidal image.

Extended In addition to the linear array probe, in the B mode, rotate the
imaging 【Angle】key to adjust the angle of the B mode image sector.

In the B mode, press the【 】key or click the touch screen

SC
『SpatialComp』to enter the spatial composite imaging.

B/M In the B mode, press the [M] key to enter the B/M mode.

37
AMM
In B mode or B/M mode, click on the touch screen『AMM』to enter the
(anatomical M
anatomical M mode (AMM).
mode)
C Press the 【C】knob to enter the C mode.

1. in the color mode, press the touch screen『SideComp』once,

real-time double-display C / B;
Color blood flow 2. press the touch screen『SideComp』twice, real-time double-display
dual real-time C / P (Power);
mode 3. Press the touch screen 『SideComp』three times, and display the
C/DP (Directional Power) in real time.
4. Press the touch screen 『SideComp』again to return to C mode.

MC（M Color
blood flow In color mode, press the [M] key to enter the MC mode.
imaging mode）

When scanning in C mode, press the 【PD】key or click 『Power』

PD
on the touch screen to enter the energy Doppler mode.

When scanning in C mode, press the click 『DirPower』 on the touch

DPDI
screen to enter the directional power Doppler mode.

1. Select the phased array probe. In the B mode, press the 【C】
TDI knob to activate the C mode.
2. Click on the touch screen『Tissue Doppler』to enter the TDI mode.

1. Select the phased array probe. In the B mode, press the【C】knob

SR (strain rate to activate the C mode.
imaging) 2. Click the touch screen『Tissue Doppler』to activate the TDI mode,
imaging) then click the touch screen 『StrainRate』 to activate the SR
mode.

38
 1. In the B or C mode, press the 【PW】 key to move the sampling
line to the position of interest, and then press the【 】key to
activate the PW mode.
2. Press the【 】key repeatedly, the image can be switched in
PW
real-time B/C/D, C/D and D modes;
3. During the scanning process, the trackball is moved, the real-time
B/C image is automatically activated, the moving trackball is
stopped, and the real-time PW spectrum display is started again;

When selecting the phased array probe, in B or C mode, press the

CW
【CW】key to enter the CW imaging mode.

Select the line array probe and click on the touch screen『Wfov』 to
Wfov
enter the wide-field imaging ready state.

In addition to the phased array probe, in the B mode, click on the

Freehand 3D touch screen『Freehand 3D』 to activate the Freehand 3D imaging
mode;

Select the 4D probe. In B mode, press the【 】 key or click the

4D
touch screen『4D/3D』to activate the 3D/4D imaging mode.

6.3 Adjusting Image Parameters

Image parameters are adjusted mainly by touch screen and imaging menu

 Main steps of touch screen control

39
No. Type Remark
1 Mode ID Show current scan mode

2 Mode function menu Click to start

3 ●●● Page turning progress

4 Imaging menu Click to activate the corresponding function

5 ●● Page turning progress

Display different image optimization levels in

6 Parameter menu different modes
Click 『 』or『 』to adjust

Adjusts the available imaging parameters for

Quick parameter the selected mode
7
adjustment menu Turn the corresponding knob on the touch
screen to adjust

Switch menus for scanning, reporting, and

Application menu
8 setting application functions
switching area
Click to start

9 Soft keyboard Click to enter the soft keyboard function;

40
  Control panel operation

1. Modify the parameters by turning the knob

2. Modify the parameters by adjusting the rocker switch up or down.

6.4 B Mode
6.4.1 B Mode Operation
The B mode is the most basic imaging mode, showing an anatomical section of the tissue and

organs in real time.

1. Press the [B] key to enter the B mode.

2. Adjust image parameters to obtain an optimized image.

3. Perform other operations (such as measurements and calculations) if necessary.

6.4.2 B Mode Parameter

In the B mode scan, on the screen imaging parameter area shows the real-time parameter

values as shown below.

Display P Gn Frq D FR DR
Acoustic Frequen Frame Dynamic
Parameter Gain Depth
Power cy Rate Range

6.4.3 B Mode Imaging Optimization

 Gain

The gain value is displayed on the screen in real time.

Turn Gain knob clockwise to increase the gain, and anticlockwise to decrease it.

Increasing the gain makes the image brighter, and enables the users to observe more

echo signals, but more noise will be generated.

 LGC

The Lateral gain is used to adjust the brightness of the symmetrical area on both sides of

the image area. The entire image area is divided into 8 segments in the horizontal direction,

from left to right, each segment corresponding to an LTC slider. Each LGC slider defines a

range of gains, from bottom to top, from lowest to highest.

When B mode is real-time scanning, press the touch screen 『LGC』to pop up the window;
41
 Move the slider vertically by hand or with the trackball, from bottom to top，the gain will

change from low to high;

To make the gain symmetrical and effective, turn on the 『 』, symmetrically the other

side of the slider to adjust synchronously;

Click『Apply』to take effect.

Tip: LGC is suitable for phased array probes.

 TGC

Compensate the attenuation caused by tissue depth increase. Adjust depth gain by

segment.

Adjust by the eight segments of sliders on control panel which respectively correspond to

the segmented image of each depth.

Pull the slider right to increase the gain, imaging in corresponding area turns brighter; while

pull it left to reduce the gain, imaging turns darker.

Adjust the signal gain within a given depth range to make the tissue image echo evenly.

 Extended Imaging

In addition to the linear array probes, other probes can make the window of interest larger or

smaller by adjusting the sector angle.

In addition to the linear array probe, the angle of the sector is displayed in the parameter

display area in degrees (°).

Linear array probe, when the B mode is in real time, press the 【 Angle】 key to turn the

trapezoidal imaging on or off.

Line array probe, when the B mode is in the real-time state, rotate the 【Angle】key to adjust

the B mode image declination;

For other probes, in the B mode, rotate the【Angle】 key to adjust the angle of the B mode

image sector.

Increasing the angle between the sectors, you can see a wider field of view, reduce the angle

between the sectors, and the frame rate becomes faster.

 Focus

42
 Adjust the focus of emitting sound beam, and symbol“ ”of corresponding focus zone is

displayed on the left of imaging.

In B mode real-time scanning, rotate the [Focus] knob or adjust 【 】to change the

focus position, press the [Focus] knob, the focus indicator arrow changes color, rotate the

[Focus] knob or adjust 【 】to change the number of focus, in multiple focus. In the

case, press the [Focus] knob, the focus indicator arrow changes color, and rotate the

[Focus] knob or adjust 【 】to change the focus distance.

The contrast and resolution of the image at the focus will increase, resulting in sharper

image information.

The fewer the number of focus, the higher the frame rate.

 Frequency

Different types of probes has different adjustable imaging frequency.

Adjust by the『Frequency』item of the touch screen.

The higher the frequency, the better the near-field resolution, but the penetrating power

decreases.

 Depth

The image depth range is adjustable and varies depending on the probe model.

The depth is adjusted by the 【 】 rocker switch on the control panel.

The greater the depth, the deeper and deeper the tissue is observed; the smaller the depth,

the shallower the observed tissue.

 Dynamic range

Adjust by the 『DynRanCop』item on the touch screen.

The higher the dynamic range value, the more signals are generated to make the image

display brighter. The lower the dynamic range value, the weaker the signal, but the image

particles can be made larger and less dense.

 Persistence

43
 Frames average refers to the fact that, take a weighted average of adjacent B images to

remove imaging noises and reserve more tissue information, thus making the images

clearer and softer.

Adjust by the 『Persistence』 item on the touch screen. The larger the value is, the more

obvious the effect will be."0" means that the function is turned off.

Too high a frame correlation value can result in blurred motion tissue, especially fast

moving tissue/structure.

 Line Density

It is the scan line density, which is actually the number of scan lines at the time of

beamforming. The number of lines corresponding to the line density position of different

inspection parts and different probes is different.

Adjust by the 『Density』 item on the touch screen.

The higher the line density, the higher the lateral resolution,the longer the scan time, and

the lower the frame rate.

 Speckle Reduction（SRI）

It is caused by the coherent superposition of the signals returned by the organization. SRI

is an image post-processing function that reduces speckle noise, improves contrast

resolution, and does not obscure structural details.

Adjust by the 『SRI』item on the touch screen. A larger value indicates stronger reduction,

and a "0" indicates that the function is turned off.

The right SRI level makes the image sharper, but the level is too high, which can lead to

blurred images, especially for fast moving organizations.

 Acoustic Power

AcousticPower refers to the power of ultrasound wave emitted viatransducer. In clinical

application, please select the suitable acoustic power according to real situation and

Acoustic Power principle “ALARA”.

Adjust by the『AcousticPower』item on the touch screen

When acoustic power increases, the whole brightness of the imaging will increase evenly.

44
 Pseudo Color

Tint function enables imaging by color difference instead of gray scale, which distinguishes

the difference of gray scale more intuitively.

Adjust by the『PseudoColor』item on the touch screen

The numerical value indicates the pseudo color number, and the pseudo color number "0"

represents the default gray scale display.

 Noise Reduction

Noise suppression is mainly used to remove blur caused by factors such as composite

technology and SRI on B-mode images, so that B-mode display is clearer.

Adjust by the『NoiseReduction』item on the touch screen. A larger value indicates stronger

noise suppression, and a "0" indicates that the function is off.

Proper noise reduction levels will make the image clear.

 Edge enhancement

Edge enhancement refers to enhancing the image outline to strengthen the effects of

image edges.

Adjust with the 『 EdgeEnhance 』 item on the touch screen. A larger value indicates a

stronger edge enhancement, and a "0" indicates that the function is off.

Excessive edge enhancement levels can cause image particles to become larger.

 U/D, L/R

By changing the way the image is displayed obtain the best view point.

It enables the image reversing vertically up/down and horizontally left/right.

ByU/D,L/R on touch screen reverse the image or cancel image reversing.

By mark on screen identify the imaging direction. By default, the mark is in the

upper left corner.

 Zoom

Amplify the scan image as a whole.

45
 The whole image can be magnified or shrunk by the【 】 rocking switch on the control

panel.

Real-time images frozen images and movie playback images can be magnified and can be

measured annotated or tagged on the enlarged image.

 Puncture guidance

Puncture guidance function is also called biopsy sampling function. The puncture line and

guide line of the puncture guide must be calibrated before using the puncture guidance

function.

Click the『Biopsy』on touch screen, activate this function.

Adjust『LineNum』on touch screen，change puncture line number

Adjust『Fine TuneD』on touch screen，Fine tuning of guide line distance

Adjust『Fine TuneA』on touch screen，Fine tuning of guide line angle

Adjust『Angle』on touch screen，significantly change the angle of the lead line, which is

used primarily for calibration

Adjust『Exit』, exit the puncture boot function, return B mode.

 B/SRI

In the B mode, click the touch screen『B|SRI』to display the real-time double image and

display the B mode image and the SRI image at the same time.

 Trapezoidal

In B mode, press the [Angle] knob to enter trapezoidal imaging for a larger scan area.

Please note: this adjustment is only available for linear probes.

Adjust by Trapezoidal on longitudinal image parameter menu.

 Spatial Composite

Spatial Composite imaging improves image resolution by acquiring ultrasound images from

multiple different angles to form a single frame image. Spatial composite also contributes

to the visual display of tissue boundaries/edges.

46
 When B mode is real-time scanning, click the touch screen 『SpatialComp』 to adjust the

spatial composite level. A larger value indicates that the angle used for the composite is

larger or the angle is larger. “0” means to turn off the function. The higher level of spatial

synthesis is only available for shallow inspection of line array probes.

Too high a level of spatial composite can blur the image, especially for fast moving

tissues/structures, in which case it is recommended to reduce or turn off spatial composite.

Spatial composite shows a frame image after combining different angles of ultrasound

images, so the composite image size is smaller than the unprocessed image.

 Tissue Harmonic Imaging (THI)

THI obtains images by transmitting two ultrasounds to improve image resolution, especially

midfield resolution.

B mode real-time scanning (convex array or line array probe), repeatedly click on the touch

screen 『THI』, you can switch between B mode and reverse phase harmonic (Phase THI).

In the B mode real-time scanning (phased array probe), click the touch screen 『THI』, you

can switch between B mode and filter type harmonic (Filter THI).

THI will increase the resolution of the midfield image, but will make the near and far field

images not good enough.

 Harmonic Fusion (FHI)

FHI will make the midfield image more clear and delicate, while maintaining the image

quality of near and far fields. Harmonic Fusion (FHI) mode is only available for convex

array probes.

When B mode is real-time scanning,click the touch screen 『FHI』to activate the harmonic

fusion mode. Click again to return to B mode.

6.5 B/M Mode

The B/M mode is used to check the tissue motion and display the amplitude change caused by

the change of the direction of a sound beam selected by the user.

6.5.1 B/M Mode Operation

47
 1. Optimize the B mode image;

2. Press the [M] key to enter the B/M mode.

3. Use the trackball to move the sampling line to the position of interest, and press the [Set] key

to locate the sampling line.

4. Adjust the image parameters to obtain an optimized image;

5. Perform other operations (such as measurements and calculations) if necessary;

6. Press the [M] key again to exit the B/M mode.

6.5.2 B/M Mode Parameter

In the B/M mode scan, the on-screen imaging parameter area displays the real-time parameter

values as shown below.

Display P Gn Frq SS

Parameter Acoustic Power Gain Frequency SpeedV

6.5.3 B/M Mode Imaging Optimization

 M sampling line angle

The M sampling line angle refers to the angle between the M line and the image depth

direction.

When the B/M mode is scanned in real time, the trackball is moved to adjust the M

sampling line position, and rotate『Angle』to change the sampling line angle

The M sampling line angle is displayed in the B/M mode imaging parameter area in units of

"degrees (°)".

 B/M mode gain

Use B mode gain to adjust the brightness of the B/M mode image.

In the B/M mode, turn the [B] key to adjust the brightness of the B/M mode image.

Increasing the gain will bright the image and you can see more received signals. However,

noise may also increase. .

 Sweep speed

48
 This parameter is used to set the scanning speed of B/M mode imaging. The real-time

speed value is displayed in the image parameter area on the right side of the screen.

Adjust the scanning speed by using the 『SweepV』item on the touch screen.

Each value represents a different scanning speed, and a high scanning speed is better for

fast moving tissue. Changes in speed make it easier to identify diseases in the heart cycle.

 Edge enhancement

Edge enhancement refers to enhancing the image outline to strengthen the effects of

image edges.

Adjust with the 『 EdgeEnhance 』 item on the touch screen. A larger value indicates a

stronger edge enhancement, and a "0" indicates that the function is off.

Excessive edge enhancement levels can cause image particles to become larger.

 SV Length

The sample volume length is adjusted to better locate the area of interest.

Adjust by the『SV Length』item on the touch screen.

The size of the sampling gate is in centimeters (cm).

 Display Format

Switch the display mode.

In B/M mode, press 『R/D』on the touch screen to switch the display format to left/right

display. Press 『R/D』on the touch screen again to return to the default up/down display

format. Push the rocker switch【 】up to display it in full screen.

 Map

Adjust and optimize the image grayscale contrast.

Adjust by the『Map』item on the touch screen.

This feature can be used in real time, frozen state.

6.6 C Mode

49
 The C (Color Blood Flow) mode facilitates the observation of color blood flow information

and allows to determine the direction and velocity of blood flow by color. In general, the

color above the baseline of the color bar indicates the blood flow to the probe, and the color

below indicates the blood flow back to the probe; the color is closer to color on the top of

the color bar, the faster the blood flow, the closer the color is to the baseline of the color bar,

the slower the blood flow.

6.6.1 C Mode Operation

1. Optimize the B mode image;

2. Press the [C] key to enter the C mode.

3. Use the trackball and [Set] key to change the position and size of the sampling frame

(ROI).

4. Adjust image parameters during the scanning process to obtain an optimized image;

5. Perform other operations (such as measurements and calculations) if necessary;

6. Press the [B] or [C] key to exit the C mode.

6.6.2 C Mode Parameter

In the C mode scan, the on-screen imaging parameter area displays the real-time parameter

values as shown below.

Display P Gn Frq PRF WF

Acoustic Pulse Repetition
Parameter Gain Frequency Wall Filter
Power Frequency

6.6.3 C Mode Imaging Optimization

 Frequency

In C mode, The system supports multiple frequencies

Click the touch screen『Frequency』, adjust the frequency value.

The lower the frequency, the more energy, the better the penetration and sensitivity. High

frequency and high resolution of blood flow.

 C.Gain

C mode gain is enhanced or reduced overall Doppler signal.

50
 Rotate【C】button，Adjust C mode gain.

Too much gain will cause color noise, and insufficient gain will reduce color flow

information.

 ROI

The function is to adjust the width and position of the color mode ROI.

When the ROI box is a dashed line, slide the trackball to change the size. When the ROI

box is solid, sliding the trackball to change position. Press [set] to switch between solid and

dashed lines.

The larger the ROI frame, the lower the frame rate and the lower the resolution and color

sensitivity.

 PRF

The pulse repetition rate (PRF) is the reciprocal of the pulse repetition period (the interval

between the two pulses). Adjust through the『Scale』item on the touch screen.

High-speed blood flow detection requires a large PRF, otherwise it will cause color

confusion. Low-speed blood flow detection requires small PRF to keep low-frequency

signals unfiltered.

The range of PRF regulation is limited by the depth of scanning. For example, a deep color

ROI does not support high PRF.

 Smooth

Smoothing is a post-processing function used to reduce noise for continuous display of

Doppler spectrum images.

Adjust this function through 『Smooth』item on the touch screen. The greater the value, the

stronger the smoothness."0" indicates that the function is off.

Smoothing reduces color noise and makes color blood flow more continuous.

 Persistent

Frame correlation, also known as afterglow, is a time filter that averages images frame by

frame.

51
 Adjust by 『Persistent』 item on the touch screen. The larger the value is, the stronger the

frame correlation is. "0" means that the function is turned off.

Frame correlation reduces color noise and makes blood flow display continuous, but too

high a level can lead to false color.

 Map

The system provides a variety of color images for better display in different clinical

applications.

Adjust by the『Map』 item on the touch screen. Choose the color of interest.

 Line Density

Linear density determines the quality and information of the image.

Adjust through the 『Density』 on the touch screen.

The higher the linear density, the higher the resolution;

The higher the line density, the lower the frame frequency.

 B-Reject

B reject refers to an amplitude threshold.

Adjust through the 『B-Reject』on the touch screen.

The greater the value, the stronger the tissue inhibition. "0" means maximum tissue

detection.

When the corresponding B value of the detected color pixel region is greater than the

threshold value, the pixel region is shown to be tissue rather than blood flow. B

suppression can prevent the bright tissue boundary (e.g. vascular wall) from being

detected as blood flow. But too low a B inhibition level may remove real blood flow

information, especially in relatively dark imaging areas.

 V- Accept

Velocity passing means a velocity threshold.

Adjusted by the『V-Accept』item on the touch screen

52
 The higher the speed level, the lower the threshold, which means that if the speed of a

pixel is greater than the threshold, the pixel is detected as blood flow. Using low-level

speed is detected as blood flow by preventing rapid movement of tissue, but too low a level

will remove true low-speed blood flow.

 Ensemble Size

The number of sampling packets controls the number of single color blood flow scanning

harness. These scanning harness were processed to calculate blood flow velocity and

other parameters.

Adjusted by the『EnsembleSize』item on the touch screen

Larger sampling packets will show better blood flow sensitivity, but lower frame rates.

Note: in cardiac examinations, small sampling packets such as 6 or 8 can be used to

maintain a high frame rate. For other site checks, a larger number of sampling packets can

be used as long as the frame rate is appropriate (at least 10 frames).

 Flow Priority

Blood flow priority is set for blood flow thresholds for tissue / blood flow detection.

Adjust by the『FlowPriority』on the touch screen.

Large blood flow priority makes it easier to detect blood flow in small blood vessels, but

also increases blood flow noise in tissue movement.

 Wall Filter

Filter low speed signals from tissue motion.

Adjust through the 『Wallfilter』 item on the touch screen.

Excessive wall filtering removes real low-speed blood flow information.

 Frame Rate

Adjust through the『FrameRate』 item on the touch screen.

A high frame rate is usually required in C mode.

 Disply Parameter

53
 Switching C mode display parameters

Select the display speed or variance through the 『 DlyParameter 』 item on the touch

screen.

The current version of the software has two parameters, velocity and variance. Speed is

the display parameter used by the system default check. Variance can show the level of

blood flow disturbance, which is helpful to detect eddy current and even turbulence.

 Double real time

Real-time dual-amplitude display allows both modes to be activated at the same time.

1. Click『SideComp』once，Real-time dual-amplitude display C/B;

2. Click『SideComp』twice，Real-time dual-amplitude display C/P(Power);

3. Click『SideComp』triple，Real-time dual-amplitude display C/DP（Directional Power）

;

4. Click『SideComp』again, go back C mode.

 Reverse

Reverse the direction of the color Doppler image.

Adjust the size through the『ColorInv』 item on the touch screen.

 Angle deflection

Note: This adjustment is only applicable to linear array probes.

Rotate【Angle】to adjust it.

This function is used to adjust the scanning angle of the linear array probe, thus changing

the angle between the emitting beam and the flow direction.

6.7 PD/DPDI Mode

PD (Power Doppler) mode is used to represent the information of the density and velocity of

erythrocytes in the blood flow for a certain period of time, and the color of different brightness

is used to mark it, but it does not reflect the information of the direction of the blood flow.

DPDI (directional Power Doppler) has the advantages of all PD imaging and has the direction

information that is not available in PD imaging. The adjustment of image parameters in

PD/DPDI mode is basically consistent with that in C mode, which can be adjusted with

54
 reference to C mode .

6.7.1 PD Mode Operation

1. In C mode，Click the touch screen『Power』
，enter PD mode.

2. Reference C mode to adjust ROI and optimize image parameters.

3. Press【B】button or click touch screen『Power』

，exit PD mode.

6.7.2 PD Mode Optimization

 Double real time

Real-time dual-amplitude display allows both modes to be activated at the same time.

1. Click『SideComp』once，Real-time dual-amplitude display P/B;

2. Click『SideComp』twice，Real-time dual-amplitude display P/C;

3. Click『SideComp』triple，Real-time dual-amplitude display P/DP;

4. Click『SideComp』again, go back PD mode.

6.7.3 DPDI Mode Operation

1. In C mode，Click the touch screen『Dirpower』
，enter DPDI mode.

2. Reference C mode to adjust ROI and optimize image parameters.

3. Press【B】button or click touch screen『Dirpower』

，exit DPDI mode.

6.7.4 DPDI Mode Optimization

 Double real time

Real-time dual-amplitude display allows both modes to be activated at the same time.

1. Click『SideComp』once，Real-time dual-amplitude display DP/B;

2. Click『SideComp』twice，Real-time dual-amplitude display DP/C;

3. Click『SideComp』triple，Real-time dual-amplitude display DP/P;

4. Click『SideComp』again, go back DPDI mode.

6.8 PW Mode
PW (Pulse Doppler) mode, which is used to study the movement information of blood flowing

along a scanning line in a certain region. The transverse axis of PW spectrum is used to

55
 represent the time, and the longitudinal axis represents the Doppler shift. When the angle

between the sound beam and the blood flow is known, the velocity and flow rate of the blood

flow can be calculated by the amplitude of frequency shift, and the laminar or turbulent

information in the bleeding flow can be judged.

6.8.1 PW Mode Operation

1. Optimizing B or C mode images.

2. Press 【PW】 ,displayed PW sampling line and sampling volume.

3. Slide the trackball change the PW sample volume line position, Adjust the sampling volume

length and he blood flow angle through the touch screen menu 『 SV Length 』 and

『FlowAngle』.

4. Move the sample volume line to the location of interest and press【 】 Doppler to start the

spectrum scanning.

5. Press【 】again and again, and the image can be switched in real-time B / C / D, C / D and

D modes.

6. When only the real-time PW spectrum is displayed, the trackball is moved, the real-time B / P

C image is automatically activated, the exact sampling volume position is easily found, the

moving trackball is stopped, and the real-time PW spectrum display is started again.

7. If necessary, perform other operations (e.g. measurements and calculations)

8. Press 【B】or【PW】button , Exit PW mode

6.8.2 PW Mode Parameters

In PW/CW mode , the imaging parameter area on the screen displays the real-time

parameter values as follows:

Indication P Gn Frq PRF WF SS SV

Sample
Parameters Power Gain Frequency PRF Wall filter SweepV
Volume

6.8.3 PW Mode Optimization

 Gain

PW mode gain adjusts the energy of Doppler signal.

56
 In PW mode, the【PW】 knob is rotated to adjust the gain.

The proper gain makes the spectrum image more clear, but too much gain brings more

background noise.

 Frequency

In PW mode, The system supports multiple frequencies.

Adjust the size through the『Frequency』 item on the touch screen

 SV Length

Adjust the sampling volume to cover the area of interest for Doppler spectrum examination.

Adjust the size through the 『SV Length』 item on the touch screen.

The smaller the sampling volume, the more accurate the result is.

 Flow Angle

To obtain reliable flow velocity, adjust PW blood flow angle to be consistent with the

direction of intravascular blood flow

In PW mode, Adjust this function through 『FlowAngle』item on the touch screen.

 Baseline

Refers to the region of the spectrum where the velocity is zero.

In PW mode, Adjust this function through 『Baseline』item on the touch screen.

 Automatic baseline

Automatic baseline is automatic adjustment of baseline.

In PW mode, Adjust this function through 『AutoBase』item on the touch screen.

 Baseline reversal

Flip the positive or negative of the speed scale and flip the spectrum waveform up or down

at the same time.

In PW mode, Adjust this function through 『BaseRev 』item on the touch screen.

57
 Spectrum full screen

The PW spectrum is displayed on full screen.

In PW mode, Adjust this function through 『FullScreen』item on the touch screen.

 Right/Down Display

Switch display mode

In PW mode, click 『R/D』 on touch screen to switch display format to left / right display,

and click touch screen『R/D』again to return to default upper / lower display format.

 PRF

PRF is the inverse of the time when two sound beams are continuously emitted in Doppler

mode. High PRF is used to display the full spectral waveform of high-speed blood flow

without aliasing. For low-speed blood flow, low PRF is used to ensure that the spectral

display covers the entire range of velocity scales.

In PW mode, Adjust this function through 『PRF』item on the touch screen.

 Wall Filter

Wall filters filter out low-speed signals, for example, signals from tissue movement.

Excessive wall filtering may filter out real low-speed blood flow signals.

In PW mode, Adjust this function through 『WallFilter』item on the touch screen.

 AudioFilter

Audio filtering function is used to filter low-frequency sound.

In PW mode, Adjust this function through 『AudioFilter』item on the touch screen.

The higher the level, the more low-frequency sounds are removed. "0" means that the

feature is turned off.

 Volume

Adjust PW spectrum volume

In PW mode, Adjust this function through 『Volume』item on the touch screen.

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  Smooth

Smoothing is a post-processing function used to reduce noise for continuous display of

Doppler spectrum images.

In PW mode, Adjust this function through 『Smoothing』item on the touch screen.

The greater the value, the stronger the smoothness.

 Sweep Speed

Scanning speed controls the speed of the scan timeline. The higher the scan speed, the

shorter the time to seize the heart cycle, but the spectrum waveform may not show details.

In PW mode , Adjust this function through 『SweepV』item on the touch screen.

The larger the value, the faster the timeline image is refreshed.

 Real-time Envelope

The function automatically envelop the spectrum and calculate the relevant parameters.

In PW mode, Turn this feature on or off through『RealTimeEnvelope』 item on the touch

screen.

6.9 CW Mode
The CW (Continuous Doppler) mode acquires a Doppler spectrum display by continuously

transmitting and receiving ultrasonic signals. Compared to PW Doppler, CW achieves a high

sampling rate in a fixed sampling gate range. CW Doppler is suitable for high-speed blood

flow examinations.

The image parameter adjustment of the CW mode is basically the same as the adjustment of

the PW mode, and can be adjusted by referring to the PW mode.

CW mode is only available for phased array probes.

6.9.1 CW Mode Operation

1. Select the phased array probe, and optimize the image of B or C mode.

2. Press【CW】 key to enter CW imaging mode;

3. Move the trackball left and right to adjust the sampling line angle, move the trackball up

and down to adjust the region of interest, and then start continuous Doppler spectrum

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 scanning;

4. Move the sampling volume line to the position of interest and press the【 】key to start

the Doppler spectrum scanning;

5. Press the 【 】key repeatedly to switch the image in real-time B/C mode and CW mode;

6. When only the real-time PW spectrum is displayed, if you move the trackball, then the

real-time B/C imaging is automatically activated, so that it is easy to find the exact sampling

volume position; if you stop moving the trackball, the real-time PW spectrum display will

start again.

7. Adjust image parameters during the scan to obtain an optimized image;

8. Perform other operations (such as measurements and calculations) if necessary;

9. Press【B】or【CW】to exit the CW mode.

6.10 Wfov Imaging

Wfov Imaging (Panoramic imaging), also known as ultra-wide field of view imaging.

Compared with ordinary ultrasound imaging, panoramic imaging provides a new

perspective for clinical diagnosis, and has important clinical diagnostic significance for

observing large lesions and the relationship between lesions and surrounding tissues.

Panoramic imaging means that a series of two-dimensional images are acquired by the

movement of the probe, and then this series of two-dimensional images are spliced into a

continuous slice image by computer reconstruction.

6.10.1 Wfov Imaging Operation

1. Click on the touch screen『Wfov』to get ready for Panoramic Imaging;

2. Adjust the parameters to get the best image;

3. Click on the touch screen 『StartAcq』 to start Panoramic Imaging, move the probe to

generate WFOV image at a constant speed;

4. Click on the touch screen『View』 to display a wide-view image in full screen.

5. Click on the touch screen『StartWfov』to restart the Panoramic Imaging;

6. Click on the touch screen『Exit』to exit Panoramic Imaging and return to B mode.

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 Notice:
1. To achieve high-quality in Panoramic Imaging, it is required to scan at a constant
speed in only one direction. It is recommended that the operator practice several
times, especially when using Panoramic Imaging for measurements.
2. Panoramic Imaging is only available for line array probes.

6.11 AMM Mode

The traditional B/M mode has only one M sampling line, which has limitations for

examination of moving organization, especially for patients with difficulty in getting imaging.

The anatomical M mode compensates for the inadequacy of the traditionalB/M mode for

patients with difficulty. It provides multiple M-sampling lines that allow you to perform more

efficient motion analysis of B/M mode images at different angles and positions.

6.11.1 AMM Mode Operation

1. In B mode or B/M mode real time scanning, click on the touch screen "Anatomy M" to

activate the Anatomical M mode (AMM);

2. Rotate the【B】key to adjust the AMM mode gain;

3. Click the touch screen『Scan Speed』to adjust the scan speed;

4. Click on the touch screen "PseudoColor" to adjust the pseudo-color;

5. Rotate the【Angle】knob to adjust the angle of the sampling line of interest;

6. Click『Show All』on the touch screen to display all the anatomical lines;

7. Click『Show A』or 『Show B』or 『Show C』on the touch screen to display or hide the

corresponding anatomical M line respectively;

8. Click 『L/R』or 『U/D』 on the touch screen to switch the display mode of the image;

9. Click 『Exit』on the touch screen to exit the anatomical M imaging mode.

6.12 MC Mode
The M Color Flow mode is referred to as the MC mode for cardiac examination applications.

Color flow uses velocity and variance color maps to overlay B/M mode images. The color

blood flow covers the B mode image and the B/M mode timeline.

6.12.1 MC Mode Operation

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 1. Optimize the C mode image when in C mode;

2. Use the trackball and 【Set】 key to change the position and size of the sampling frame

(ROI);

3. Press the 【M】 key to activate the MC mode and the image area displays an M sample

line.

4. Move the trackball to make the sampling line to the location of interest and acquire the

MC image;

5. Rotate the【C】key to adjust the MC mode gain

6. Adjust the image parameters to get a good image;

7. Press the 【B】or 【M】key to exit the MC mode.

6.13 TDI Mode

The Tissue Doppler Imaging mode is referred to as the TDI mode, and the Doppler theory

is used to estimate tissue motion, such as the speed of myocardial motion. The TDI mode

can obtain motion information and generate color-coded images of tissue motion speed.

6.13.1 TDI Mode Operation

1. Select the phased array probe, optimize the B mode image;

2. Press【C】to activate C mode and click the touch screen 『Tissue Doppler』to activate TDI

mode;

3. Use the trackball and 【Set】 key to change the position and size of the sampling frame

(ROI);

4. Turn the【C】knob to adjust the TDI mode gain;

5. Adjust the image parameters to get a good image;

6. Click 『Exit』on the touch screen to exit TDI mode.

Notice:
The C mode deals with blood flow signals, and the TDI obtains information about tissue
motion.

6.13.2 Strain Rate Mode

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 The Strain RateImaging mode is referred to as the SR mode, which is an extension of TDI.

The strain rate is the spatial gradient of the velocity data calculated by TDI. Strain Rate

Imaging shows tissue deformation in the direction of the beam.

6.13.3 Strain Rate Mode Operation

1. Select phased array probe, optimize B mode image, press【C】knob to activate C mode;

2. Click the touch screen『Tissue Doppler』to activate the TDI mode, then click the touch

screen『StrainRate 』to activate the SR mode;

3. 3Use the trackball and 【Set】 key to change the position and size of the sampling frame

(ROI);

4. Turn the【C】knob to adjust the SR mode gain;

5. Adjust the image parameters to get a good image;

6. Click 『Exit』on the touch screen to exit SR mode.

6.14 Freehand 3D Imaging

The Freehand 3D imaging mode provides a way to generate 3D images for inspection

using standard linear array and convex array probes. The process of this 3D imaging is to

obtain a series of frame images (refer to the following figure, moving the probe in parallel at

a constant speed) to reconstruct the volume data, applying the volume rendering technique,

and display the 3D rendered image. The quality of the 3D rendered image is closely related

to the way the probe moves, so the probe is positioned perpendicular to the body surface

and kept moving at a constant speed. Based on this, the Freehand 3D image is for

reference only and is not recommended for clinical diagnosis and measurement.

Parallel scan

6.14.1 Freehand 3D Operation

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1. Select the probe:

Press the 【Probe】 key or select the probe and its inspection site on the touch screen,

optimize the B mode image.

2. Activate Freehand 3D:

Click on the touch screen『Freehand 3D』or press the【3D/4D】button on the control panel

to activate the Freehand 3D imaging mode

3. Adjust the ROI window:

Use the trackball and the【Set】key to adjust the ROI size and position to ensure that the

ROI is large enough to cover the area of interest. For example, to obtain a facial image of

the fetus during an obstetric examination, the ROI should contain amniotic fluid;

4. Start 3D data collection:

Click on the touch screen 『StartAcq』to start 3D data acquisition, move the probe in

parallel at a constant speed to obtain a series of images for generating 3D volume data;

5. Stop 3D data collection:

Click the touch screen『EndAcq』to stop 3D data acquisition, and then the Free-Hand 3D

operation interface will display, on which shows the rendered 3D image;

6. Adjust the 3D view angle:

You can click the 『Rot X』,『Rot Y』or『Rot Z』 menu on the touch screen to rotate the

3D image along the X, Y or Z axis to change the view angle of the 3D image.

7. Save the 3D image:

Press the 【Q】key to save the 3D image.

8. Exit Freehand 3D:

Click on the touch screen "Exit" to exit the Freehand 3D mode.

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6.15 3D/4D Imaging
6.15.1 3D/4DImaging Summary
This feature is only available on machines with a 3D/4D imaging module installed. In the

3D/4D imaging inspection, the volume probe needs to be fixed in one position and cannot

be moved. The mechanical components inside the probe can stably and continuously scan

different positions by swinging, thereby obtaining a series of continuous and stable frame

images.

6.15.2 3D/4D Imaging Operation

1. Select volume probe:

Press the【Probe】 key or select the 4D volume probe on the touch screen, select the

inspection position, optimize the B mode image.

2. Activate 4D Imaging function:

Click on the touch screen 『3D/4D』to activate the 3D/4D imaging mode.

3. Adjust the ROI window:

Use the trackball and the【Set】key to adjust the ROI size and position, as shown below,

to ensure that the ROI is large enough to cover the area of interest. For example, to

obtain a facial image of the fetus during obstetric examination, the ROI should contain

amniotic fluid;

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 4. Optimize image parameters:

a) Click on the touch screen『Persistent』to adjust the frame correlation level;

b) Click on the touch screen『NoiseReject』to adjust the noise reduction level;

5. Adjust the swing angle:

Click on the touch screen『Angle』to adjust the swing angle;

6. Select image quality level:

Click on the touch screen『Quality』to adjust the image quality level. The higher the level,

the better the 3D/4D image quality, but the frame rate is reduced.

7. Start data collection:

a) Click the touch screen 『4D』to start 4D data acquisition;

b) Click the touch screen『3D』to enter the 3D imaging mode of the volume probe;

8. Save image:

When scanning in 4D mode, press the 【Freeze】key to freeze the image; when in 3D

mode the imaging process has been finished and is in freezing state, press the【Q】key to

save the 3D/4D image;

9. Stop 4D data collection:

Press【Freeze】to stop 4D data collection;

10. Exit 3D/4D imaging mode:

Click on the touch screen 『Exit』to exit the 3D/4D imaging function.

6.15.3 3D/4D Imaging Parameter Adjustment

 Adjust view angle

Click on the touch screen 『RotX』,『Rot Y』 or 『RotZ』 to rotate the 3D/4D image along

the X, Y or Z axis, to adjust the 3D/4D image angle of view;

Click the touch screen『Rotate Z 90°』, the 3D/4D image will be flipped 90°;

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  Threshold

Click on the touch screen『Threshold』to adjust the threshold in order to produce a good

appearance of the 3D surface image. Use this feature to remove noise or low-level echoes.

 Transparency

Click on the touch screen 『Transparency』 to adjust the transparency, which affects the

threshold effect. Low transparency can define obvious surface edges, and high

transparency defines more diffusive surfaces.

 Smooth

Click on the touch screen 『Smooth』to adjust the smoothing level. Smoothing removes

noise and smooths uneven surfaces, but too high levels can lose detail.

 Inverse

Click on the touch screen『Inverse』to reverse the brightness of the image.

 Image display

For 3D/4D imaging, click on 『Single Window』,『Double Window』 or 『Four Window』

to change the view to single view, double view or four view display.

 Render Type

For 3D/4D imaging, click on 『 Render Type 』 to select the imaging mode of interest:

『X-Surface』,『Max.』,『Min』
，『X-ray』.

6.15.4 3D/4D Image Edition

The 3D/4D images should be edited, so as to get better images.

1. When the 4D mode image is frozen, or the 3D mode imaging is completed, click on the

touch screen 『Magic Cut（in）』or 『Magic Cut（out）』, use the trackball to select

a closed area on the 4D view, press【Set】key again to delete the image of the selected

area, as shown below;

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 2. When using the trackball to select a closed area on the 4D view, press the【 】key on

the control panel to re-select an area. If you want to modify the deleted part, click on

the touch screen 『Reset』to restore the initial imaging status.

3. Click the touch screen 『RotX』,『RotY』or 『RotZ』to adjust the view angle. Delete

the unnecessary parts according to the above steps, and press the 【Q】key to save

the image.

6.15.5 3D/4D Image Measurement

Measurement methods

The system provides a fast volume measurement tool based on the ellipsoid formula,

which assumes that the object to be measured is an ellipsoid. To calculate the ellipsoid

volume, you need to get its width and height in the section of front view, and then obtain its

thickness in the side view. Or take the width on the section of the front view and then get its

height and thickness in the side view. As shown below.

Get width and height in the section of front view, and thickness in the side view

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 Get width in the section of the front view, height and thickness in the side view

Operation

1. When the 4D image is frozen, press on the touch screen 『Measurement』to activate

the measurement function;

2. In the front view, use the trackball and【Set】key to measure the height and width, and

measure the thickness in the side view, as shown below.

3. After the three lengths are measured, the volume result will be displayed at the top

right of the 4D view.

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7 Cine Loop

When freezing, you can playback the images to make measurements, calculations, text

comments, body marks, etc.

The image playback mode supports manual and automatic playback and can be switched to

either manner. The default image playback mode is manual playback.

7.1 Enter/Exit Cine Loop

 Enter Image Playback

Press the 【Freeze】button to freeze the image, the system automatically enters the manual

playback mode. By moving the trackball, the user can browse through the frames or

automatically cycle through the images.

 Exit Image Playback

In the image playback mode, press the【Freeze】button again to unfreeze the image, return

to the real-time scan work state, and exit the image playback mode.

7.2 Storing Images or Cines

 Store images

1. During the real-time image scanning, to save the image of interest, press the 【Freeze】

key to freeze the image.

2. Press the 【Q】key. The thumbnail of the stored image appears at the bottom of the

screen. The current image is stored in digital form under the current patient.

 Store Cines

1. In real-time scanning state, press the【Q】key, and the video icon will appear in the

lower left corner of the screen to start real-time storage.

2. To end the real-time storage, press the【Q】key again. The stored video is stored in AVI

format under the current patient and displayed in the image storage area at the bottom

of the screen.

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 When storing images and videos, in addition to the 【Q】button, you can also use the【Q2】/

【Q3】buttons. These two buttons can be used to customize one of them to save images/videos.

The path of setting is 『Setup 』→『System』

7.3 Operation of Cine Loop

7.3.1 Automatic/Manual Loop

In the playback mode, the system automatically enters the manual playback mode. By moving

the trackball, the user can browse through the frames or automatically cycle through the images.

7.3.2 Cine Loop Speed Selection

You can speed up or slow down the automatic playback of images as needed.

In the case of image playback, in the lower left corner of the touch screen, the 『speed』 menu

item is displayed, by manipulating『speed』the speed is adjusted for the playback.

The system supports gears of 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2.

When the playback speed is displayed as 0, it means that playback is stopped.

7.4 Cine Loop in different Imaging Modes

 Image playback in B/C/PD mode

In B or C or PD mode, enter image playback, move the trackball, and the stored images will

be displayed on the screen in sequence. Move the trackball to the right, the images are displayed

in ascending order of the number of image frames; move the trackball to the left, and the images

are displayed in descending order of the number of image frames.

A progress bar of playback is shown at the bottom of the screen: the background of the

progress bar indicates the total number of frames stored, and the forward bright blue bar indicates

the current number of frames.

 Image playback in PW mode

In PW mode, enter video playback, move the trackball, and the stored images are displayed on

the screen in sequence. The trackball moves to the left, the image playback progress bar moves to

the left, and the image moves to the right to display the image stored earlier; the trackball moves to

71
the right, the video playback progress bar moves to the right, and the image moves to the left to

display the newly stored image.

A image playback progress bar is shown at the bottom of the screen, the numbers displayed

above are the time corresponding to the currently played PW line and the total duration of the stored

image in playback.

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8 Measurement and Calculation

Measurement operations can be divided into general measurement and application

measurement. The measurement operation is performed in a frozen image.

Warning:
1. Make sure that the measurement target and image are correct, and the measurement
area is valid, otherwise it will lead to misdiagnosis.
2. During the measurement process, all measurement scales and comments on the
image will be cleared when the probe is switched.
3. The measurement result will be lost if an image is unfreezed during the measurement.

4. Press the 【Q】key during measurement. After editing the image, the measurement

result will be saved in the patient report.

Notice:

1. Need select the appropriate part for the measurement.

2. Application measurement can measure frozen images and images of movie playbacked, but

cannot measure saved image format images and AVI format images.

8.1 Basic Operation

8.1.1 Measurement Basic workflow

1. Press 【Patient】[Patient] to fill in patient information.

Patient information includes: patient ID, name, gender, age, date of birth, etc.

The patient information will be used for post-inspection storage, analysis of measurement

data, and generation of inspection reports.

2. Press【Probe】to select the probe and clinical application type.

3. Press【Caliper】 or 【Q1】to enter the normal measurement or application measurement.

4. Move the trackball and select the measurement item from the measurement menu to

measure.

5. Press【Q】to save the image.

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 6. Press【 】to edit the report.

8.1.2 Button Function

Key Function

Caliper Enter/exit normal measurement status

Q1 Enter/exit application measurement status

Select the measurement item in the menu and press 【Set】

Set
to activate the measurement item.

Clean Roll back of the measurement steps, or reversely delete the

(close to【Caliper】) scales corresponding to each measurement operation.

Clean Clear all measurement calipers and result window data on

(close to【 ABC】) the screen.

Edit report

Trackball Move the cursor

8.1.3 Measurement Items

The system provides both normal and application measurements

 Normal Measurement: The measurement items in the normalmeasurement menu, including

basic measurement tools and methods such as distance, area, etc.

 Application Measurement: measurement items in the application measurement menu. Wherein,

different inspection modes correspond to one or more measurement packages, and the

measurement package includes measurement items suitable for respective clinical applications.

For example, the "BPD" measurement item of the obstetric measurement.

Tip: Most of the application measurement items use conventional measurement tools. For

example, BPD in obstetric 2D measurement uses the ‘distance’ tool in 2D conventional

measurement. The only difference is that the special measurement item corresponds

to a certain clinical significance.

The system supports measurement for the following applications:

 Abdomen

74
 Gynecology

 Obstetrics

 Vascular

 Thyroid

 Urinary

 Cardiac

Start measurement item

Start as follows:

1. Move the cursor to the measurement item and press【Set】.

2. If there is a submenu, press【Set】to enter the submenu.

3. In the submenu, click on the item in the menu to start the measurement.

8.1.4 Measurement, Calculation and Research

The measurement items provided by the system are divided into measurement, calculation and

research.

Measurement

The results obtained by calipers are called the measured value, and the corresponding measuring

item is called the measurement.

Calculation

The results that the system automatically calculates by using formulas, which use the results of

measurement or calculations as parameters, are called calculated values, and the corresponding

item is called calculation.

If the measurement items required by the calculation item have all been measured, the system

automatically calculates the calculation item value after completing these measurement items.

When some of these items are measured again, the system recalculates the results.

Research

A combination of measurements and calculations for a specific clinical application.

You can expand and close a study to see the measurements or calculations it contains.

8.1.5 Measurement Ruler

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A measurement ruler is a geometric figure that is drawn on an ultrasound image and consists of

several endpoints and lines or curves.

 Fixed/active endpoint

The endpoints of the measurement caliper are divided into active ones and fixed ones. The active

endpoint is called the measurement cursor.

 Color of caliper

The default color for caliper's endpoint and line segments are yellow when active and white when

fixed.

 Movement of the endpoint of caliper

Use the trackball to move.

 Sequence number of caliper endpoints

Different sequence numbers are displayed on the endpoint and in the result window to distinguish

different measurements.

8.1.6 Measurement Result Display

The measurement results are displayed on the right side of the screen and the results are updated

instantly.

View measurement results:

When the quantity of measurement items exceeds the rage of measurement result window, the

earliest measurement result is no longer displayed according to the principle of FIFO (first in, first

out).

During the measurement process, the measurement results are displayed as follows:

1. Ifthe measurement result is in the clinical range and its specific value is displayed;

2. If the measurement result is in the ultrasound range, but exceeds the clinical range, it will be

shown as “＿＿＿”.

8.2 Measurement Report

8.2.1 Report Checking

The measurement report is used to record the measurement results, and the measurement results

are stored by pressing【Q】after each measurement operation is determined.

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1. Press the【 】key to open the report interface.

2. The report interface displays the default report in the current examination mode;

3. Press the【 】key to exit t

8.2.2 Report Edition

 Add/remove images

If ultrasound images are saved in the current exam, they can be added to the report.

1. Click on the 『+』button on the report page to pop up the dialog box shown below.

Left column: Images saved in the current exam that can be added to the report.

Right column: The image that has been selected and will be added to the report.

2. Select image

Add/remove images, using the following buttons:

『＞』add the single image selected in the left column to the right column.

『＞＞』add all candidate images to the right column.

『＜』remove a single image from the selected right column.

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 『＜＜』Remove all images from the selection.

3. Click 『Set』to confirm the settings.

 Add ultrasound annotation information

Enter relevant information in the『Text』.

8.2.3 Report Printing

You can print the report directly by clicking 『Print』 on the report page.

You can also click 『Preview』to enter the print preview. In the print preview interface, you can:

Print the report:Click on『Print』

Page turning: Click on『Previous』or 『Next』to view other report pages.

Exit preview: Click『Cancel』.

8.3 2D Regular Measurement

8.3.1 Distance

Function: Measure the distance between two points on the ultrasound image.

1. Under the 2D image, press the【Caliper】and the measurement cursor appears on the

screen.

2. Use the trackball to move the cursor to the start point of measurement.

3. Press【Set】to set the starting point of measurement.

4. Use the trackball to move the cursor to the end of the measurement.

5. Press【Set】to set the measurement end point and the measurement result is displayed

in the result window.

8.3.2 Area
Function: Measure the area and perimeter of an enclosed area on an ultrasound image.

The measurement method is by tracing.

1. In the 2D image, press the 【Caliper】key to select『Area』, move the cursor to the

image area, and the measurement cursor appears on the screen.

2. Move the cursor to a point in the measurement area.

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 3. Press【Set】to set the trace start point.

4. Move the cursor along the target area to draw the trace line.

5. Press【Set】, the start and end points of the trajectory line are connected by a straight

line to form a closed measurement area; or when the cursor is close to the start point

of the trace, the trace line automatically closes to determine the measurement area,

and the measurement result appears in the result window.

8.3.3 Ellipse
Function: Measure the area and perimeter of an enclosed area on an ultrasound image.

The measurement method is ellipse.

1. Under the 2D image, press the【Caliper】key to select『Ellipse』, move the cursor to

the image area, and the measurement cursor appears on the screen.

2. Move the cursor to a point in the measurement area.

3. Press【Set】to determine the starting point of the first axis of the ellipse.

4. Move the cursor to the end of the first axis of the ellipse.

5. Press【Set】to determine the end point of the first axis.

6. Move the cursor. The length of the second axis of the ellipse changes as the cursor

moves. Move the cursor to make the ellipse as close as possible to the measurement

area.

7. Press【Set】to determine the ellipse measurement area and the measurement result

appears in the result window.

8.3.4 Cross
Function: Measure the area and perimeter of an enclosed area on an ultrasound image.

The measurement method is a cross

1. Under the 2D image, press the【Caliper】key to select『Cross』, move the cursor to the

image area, and the measurement cursor appears on the screen.

2. Move the cursor to a point in the measurement area.

3. Press【Set】to set the starting point of the first axis.

4. Move the cursor to the end of the first axis.

5. Press【Set】to determine the end point of the first axis.

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 6. Move the cursor to the starting point of the second axis and press【Set】to set.

7. Move the cursor to the end of the second axis.

8. Press 【 Set 】 to set the end point of the second axis to determine the cross

measurement area. The measurement result appears in the result window.

8.3.5 Angle
Function: Measure the angle between two intersecting planes, ranging from 0 to 180°.

1. Under the 2D image, press the【Caliper】key to select 『Angle』, move the cursor to

the image area, and the measurement cursor appears on the screen.

2. Refer to the distance measurement method and set two line segments.

3. After the setting is completed, the angle value automatically appears in the result

window.

8.3.6 Distance Ratio

Function: Measure the ratio between the two distances on the ultrasound image.

1. In the 2D image, press the【Caliper】key to select 『Dist Ratio』, move the cursor to

the image area, and the measurement cursor appears on the screen.

2. Refer to the distance measurement method and set two line segments.

3. After the setting is completed, the distance ratio automatically appears in the result

window.

8.3.7 Volume
Function: Measure the volume of a target object of an ultrasound image. The measurement

method is three distances.

It is applicable to the case where two scanning planes of the target object, which are

perpendicular to each other, are displayed in the Dual B mode, and the volume is

calculated by measuring the lengths of the three axes of the target object, and the

calculation formula is:

π
Volume（cm3）＝ ×D1 (cm) ×D2 (cm) ×D3 (cm)
6

Among them, D1, D2, and D3 are the lengths of the three axes of the target object.

1. Under the 2D image, press the 【Caliper】 key to select 『Volume』, move the cursor

80
 to the image area, and the measurement cursor appears on the screen.

2. Measure the length of the three axes of the target object separately. For the

measurement method, please refer to the distance measurement. In general, the three

distances should not be on the same scanning plane at the same time.

3. After the measurement is completed, the volume value will appear in the result

window.

8.3.8 Volume（Ellipse）
Function: Measure the volume of a target object of an ultrasound image. The measurement

method is an ellipse.

1. Under the 2D image, press the 【Caliper】key to select 『Volume (Ellipse) 』, move

the cursor to the image area, and the measurement cursor appears on the screen.

2. Refer to measurement method of ellipse.

3. After the measurement is completed, the volume value will appear in the result

window.

8.3.9 Area Ratio

Function: Measure the area of two enclosed areas on the ultrasound image and calculate

the ratio. The measurement method is the tracing method.

1. In the 2D image, press the 【Caliper】key to select the 『Area Ratio』and move the

cursor to the image area. The measurement cursor appears on the screen.

2. Measure the area of the two enclosed areas separately, please refer to the area

measurement method.

3. After the measurement is completed, the area ratio will appear in the results window.

8.3.10 Diameter
Function: Measure the diameter of an enclosed area on an ultrasound image.

1. Under the 2D image, press the【Caliper】key to select『Diameter』, move the cursor

to the image area, and the measurement cursor appears on the screen.

2. Reference distance measurement method.

3. After the measurement is completed, the diameter value appears in the result window.

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8.3.11 Joint Angle
Function: Measure the angle between the two joints based on one baseline and two

intersecting line segments. The joint angle measurement always takes an angle less than

or equal to 90°.

1. Under the 2D image, press the【Caliper】 key to select 『Joint Angle』, a yellow line

will appear in the image area, and there will be a point mark on the line.

2. Use the trackball to move the line to the measurement start point, determine the

baseline position, press the 【 Set 】 key to position thebaseline and the baseline is

displayed as a yellow dotted line.

3. The second line appears on the screen. Rotate the 【Angle】knob to adjust the line

angle. Press the【Set】button to position the angle, the α value is displayed in the result

window.

4. The third line appears on the screen. Rotate the【Angle】knob to adjust the line angle.

Press the 【Set】button to position the angle, the β value is displayed in the result

window.

8.3.12 Depth-Distance
1. In two-dimensional images, press the Caliper key to select depth-distance, and the

measurement cursor appears on the screen.

2. Reference distance measurement method.

3. After the measurement is completed, the depth and distance values appear in the

result window.

8.4 B/M Regular Measurement

8.4.1 HR（2）

Function: Heart rate measurement is a measure of the time interval between two heartbeat

cycles on a B/M image and the number of heartbeats per minute.

1. On the B/M image, press the 【Caliper】key and the cursor will appear on the screen.

2. Use the cursor to select two cardiac cycles.

3. After the measurement is completed, the HR value appears in the result window.

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8.4.2 Time
Function: Measure the time interval between two points on the B/M image.

1. On the B/M image, press the【Caliper】key to select『Time』and two vertical lines appear

on the screen.

2. Move the cursor to the measurement start point and press【Set】to confirm.

3. Move the cursor to the end of the measurement.

4. Press【Set】to set the measurement end point and the measurement result is displayed

in the result window.

8.4.3 Slope
Function: Calculate the slope between two points by measuring the distance and time

these two points on the B/M ultrasound image.

1. Under the B/M image, press the 【Caliper】key to select『Slope』and two mutually

perpendicular dashed lines appear on the screen.

2. Use the trackball to move the cursor to the measurement start point.

3. Press【Set】 to set the measurement starting point.

4. Use the trackball to move the cursor to the end of the measurement.

5. Press 【 Set 】 to set the measurement end point, and the measurement result is

displayed in the result window.

8.4.4 Distance
Function: Measure the distance between two points on the B/M image.

1. Under the B/M image, press the 【Caliper】key to select 『Distance』and two vertical

lines appear on the screen.

2. Move the cursor to the measurement starting point and press【Set】to confirm.

3. Move the cursor to the end of the measurement.

4. Press 【 Set 】 to set the measurement end point, and the measurement result is

displayed in the result window.

8.5 CFIMode Measurement

The measurement items in CFI mode are the same as the 2D mode. Please refer to the 2D

83
 mode for measurement operation.

8.6 PW ModeMeasurement

8.6.1 Heart Rate and Time

The heart rate and time measurement operation in PW mode is the same as the B/M mode.

Please refer to the B/M mode for measurement operation.

8.6.2 Doppler Velocity

Function: Measure the flow velocity and maximum differential pressure at a point on the

Doppler spectrum waveform on the Doppler image.

1. On the Doppler spectrum, press the【Caliper】key to select『Velocity(D)』, and the

cursor appears on the screen.

2. Move the cursor to the target position and press the【Set】key. The measurement result

is displayed in the result window.

8.6.3 PI
1. On the Doppler spectrum, press the【Caliper】key to select『PI』and the cursor appears

on the screen.

2. Move the cursor to the measurement start point and press the【Set】key to complete

the Doppler flow rate measurement of the first peak point.

3. Move the cursor to the measurement end point and press【Set】to set the measurement

end point. The measurement result is displayed in the result window.

8.6.4 RI
1. On the Doppler spectrum, press the 【Caliper】key to select 『RI』 and the cursor

appears on the screen.

2. Move the cursor to the measurement start point and press【Set】to confirm.

3. Move the cursor to the end of the measurement.

4. Press【Set】to set the measurement end point, the measurement result is displayed in

the result window.

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8.6.5 PS/ED
Function: The velocity of the contraction peak point (PS) and the end-diastolic velocity (ED)

are measured on the blood flow waveform in the Doppler image and the ratio value is

calculated.

1. On the Doppler spectrum, press the【Caliper】key to select 『PS/ED』and the cursor

appears on the screen.

2. Move the cursor to the contraction peak position and press the【Set】key to complete

the measurement of the contraction peak point.

3. Move the cursor to the end of diastole and press【Set】to complete the end-diastolic

measurement. The ratio value is displayed in the results window.

8.6.6 Acceleration
1. On the Doppler spectrum, press the【Caliper】key to select 『Accel』and the cursor

appears on the screen.

2. Move the cursor to the measurement start point and press【Set】to confirm.

3. Move the cursor to the end of the measurement.

4. Press【Set】to set the measurement end point, and the measurement result is displayed

in the result window.

8.6.7 E/A
1. On the Doppler spectrum, press the【Caliper】key to select 『E/A』and the cursor

appears on the screen.

2. Move the cursor to the measurement start point and press【Set】to confirm.

3. Move the cursor to the end of the measurement.

4. Press【Set】to set the measurement end point, and the measurement result is displayed

in the result window.

8.6.8 PW Auto Trace(D)

Function: The system automatically envelops the spectrum and calculates the relevant

parameters.

1. In the PW mode image, press the 【Caliper】key and the cursor appears on the screen.

85
 2. Find the beginning of a spectrum period and press the【Set】key.

3. Move the trackball to the end of the spectrum period, press the 【Set】key again, and

the measurement result is displayed in the result window.

8.6.9 M Trace
Function: The manual envelope of Doppler spectrum is obtained by drawing one or several

Doppler waves on the D mode image to obtain the clinical index of velocity and pressure

gradient index.

1. In the PW mode, press the 【Caliper】key and the cursor will appear on the screen.

2. Move the cursor to the start of the trace and press the【Set】key to position it.

3. Move the cursor to the right along the boundary of the spectrum to envelop the Doppler

waveform. Roll the trackball to the left to delete the envelope. As so, continuously move

the trackball to the end of a cardiac cycle, press【Set】to locate the measurement end

point. The measurement result is displayed in the results window.

8.7 Abdomen

8.7.1 ABD Examination Preparation

Before the inspection begins, please do the following confirmation and preparation:

1. Verify that the selected probe is suitable for the current inspection.

2. The current date of the check system is correct.

3. Press【Patient】button, input patient information in “Patient ”interface.

4. Switch to the corresponding inspection mode.

8.7.2 ABD Measurement Workflow

1. Press【Patient】button, input patient information in “Patient” interface.

2. Press 【Q1】button, enter into measurement.

If the menu currently displayed does not contain an abdominal measurement item, after

moving the cursor to the menu, select the measurement package with the abdominal

measurement item.

3. Select the measurement item in the measurement menu and make the measurement

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 4. Press 【 】button to edit the report.

8.7.3 ABD Measurement Items

This system provides a variety of abdominal measurement items to choose from under 2d

mode as follows:

Classificat Method of measurement or formula of

Item
ion calculation
Liver

CHD

Portal V Diam

GB wall th

GBH

GBL

CBD

Panc duct
measurem
Panc tail Same as “Distance” measurement in 2D
ent
Panc body

Panc head

Spleen

Aorta Diam

Renal CT

Kid.T

Kid.W

Kid.L

Calculate Kid. Vol See below

8.7.4 ABD Measurement Operation

Measurement term

Take the"Liver" measurement as an example to illustrate the measurement process

1. Select "liver" in the menu.

2. Measure liver 2D routine "Distance" method.

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 Calculation term

Renal volume

Function: measuring thickness of renal cortex, thickness of kidney, width of kidney, length

of kidney, calculation of renal volume

1. Select 『Kidney』from the Measurement menu

2. Measure Renal cortex thickness, renal thickness diameter, renal width diameter, renal

long diameter with 2D “Distance”. The system calculates the renal volume

automatically.

8.7.5 ABD MeasurementReport

During or after the measurement, the report can be edited according to the 【 】of the

control panel.

For the contents of the report, see "8.2 Measurement report"

8.8 Obstetrics

8.8.1 OB Examination Preparation

Before the inspection begins, please do the following confirmation and preparation:

1. Verify that the selected probe is suitable for the current inspection.

2. The current date of the check system is correct.

3. Press【Patient】button, input patient information in “Patient ”interface.

4. Switch to the corresponding inspection mode.

8.8.2 OB Measurement Workflow

1. Press【Patient】button, input patient information in “Patient ”interface.

2. Press 【Q1】button, enter into measurement.

If the menu currently displayed does not contain an obstetrical measurement item,

after moving the cursor to the menu, select the measurement package with the

abdominal measurement item.

3. Select the measurement item in the measurement menu and make the measurement

4. Press 【 】button to edit the report.

88
8.8.3 OB Measurement Item
This system offers a choice of 2D and B/M obstetrics items.

Obstetric 2D measurement

Method of measurement or formula

Classification Item
of calculation
Same as “Distance” measurement in
BPD
2D
HC
Same as “Ellipse” measurement in 2D
AC
FL
AFI
GSLen
GSLen1
GSLen2

Measurement GSLen3
CRL
Same as “Distance” measurement in
OFD
2D
HL
Ulna
NT
Fibular
N.B.L
Radius
Tibia

Measure the longitudinal diameter,

transverse diameter and thickness
GS
diameter of pregnancy sac and
Calculation calculate the mean value.
term
AFI（2） AFI= Depth 1 + Depth 2

AFI= Depth 1 + Depth 2

AFI（4）
+ Depth 3 + Depth 4

89
 Fetal weight is calculated by measuring
fetal parameters using the default fetal
EFW
weight formula. See Fetal weight
Formula.

Head circumference / abdominal

HC/ AC
circumference

Femur length / abdominal

FL/ AC
circumference

FL/ BPD Femur length / biparietal diameter

Measure depth 1 and depth 2, calculate

EFW（2）
AFI= depth 1 + depth 2
Research Measure depth 1, depth 2, depth 3,
EFW（4） depth 4, calculate amniotic fluid index =
depth 1 + depth 2 + depth 3 + depth 4

Obstetrical B / M measurement

Method of measurement or formula

Classification Item
of calculation

Measurement HR（2） Same as “HR” measurement in B/M

8.8.4 OB MeasurementFormula
Gestational age formula

Measurement items Gestational age optional formula

Hadlock1
Hadlock2
Hadlock3
EFW
Hadlock4
Merz1
Merz2

90
 Hadlock1
Hadlock2
Hadlock3
AC
Hadlock4
Merz1
Merz2

Hadlock1
Hadlock2
FL
Hadlock3
Hadlock4
Hadlock2
BPD Hadlock4
Merz1

Hadlock3
HC
Hadlock4

Fetal weight formula

Fetal weight is a calculation. During obstetrical measurement, the system automatically

calculates fetal weight if all the measurements required by the fetal weight formula have been

completed.

In the following formula, EFW-Fetal Weight; BPD-Biparietal Diameter; AC-Abdomen

Circumference; HC- Head Circumference;FL-Femur Length.

Unit
Formula
Formula Description Measureme
name EFW
nt term
EFW=10^(1.304+(0.05281*AC)+(0.1938*FL)-(0.004*A
Hadlock1 g cm
C*FL))
(AC,FL)
SD=0.154*EFW SD Type=±2SD g g

EFW=10^(1.335-(0.0034*AC*FL)+(0.0316*BPD)+(0.04
Hadlock2 g cm
57*AC)+(0.1623*FL))
(AC,FL,BPD)
SD=0.146*EFW SD Type=±2SD g g
EFW=10^(1.326-(0.00326*AC*FL)+(0.0107*HC)+(0.04
Hadlock3 g cm
38*AC)+(0.158*FL))
(AC,FL,HC)
SD=0.148*EFW SD Type=±2SD g g

91
 Hadlock4 EFW=10^(1.3596-(0.00386*AC*FL)+(0.0064*HC)+(0.0
g cm
(AC,FL,HC,B 0061*BPD*AC)+(0.0424*AC)+(0.174*FL))
PD) SD=0.146*EFW SD Type=±2SD g g

Merz1 EFW=-3200.40479+(157.07186*AC)+(15.90391*(BPD^
g cm
(AC, BPD) 2))
Merz2
EFW=0.1*(AC^3) g cm
（AC）

8.8.5 OB MeasurementOperation
Examples of measurement, calculation and research are given below.

Measurement Term

Take the measurement term "HC" as an example, as follows:

1. Select 『HC』 from the measurement menu

2. Refer to 2D conventional "Ellipse" measuring operation method to measure area.

3. The results of the measurements, such as gestational age, expected delivery date, etc.,

are shown in the result window

Calculation Term

Take the calculation item "HC/AC" (Head Circumference/Abdominal Circumference) for

example, as follows:

1. Select "HC" and "AC" in the measurement menu.

2. Measure HC and AC by using 2D routine "ellipse" method in turn.

3. The ratio of HC/AC after measurement is displayed in the result window

Research Item

The "AFI" of the study was measured as follows:

1. Select AFI in the measurement. Enter its submenu

2. Measure the maximum amniotic fluid depth 1, depth 2, depth 3 and depth 4. The

system calculates amniotic fluid index automatically.

8.8.6 OB Measurement Report

During or after the measurement, the report can be edited by 【 】 on the control board.

92
 For the contents of the report, see "8.2 Measurement report"

8.9 Cardiac

8.9.1 Cardiac Examination Preparation

Before the inspection begins, please do the following confirmation and preparation:

1. Verify that the selected probe is suitable for the current inspection.

2. The current date of the check system is correct.

3. Press【Patient】button, input patient information in “Patient ”interface.

4. Switch to the corresponding inspection mode.

8.9.2 Cardiac Measurement Workflow

1. Press【Patient】button, input patient information in “Patient” interface.

2. Press 【Q1】button, enter into measurement.

If the menu currently displayed does not contain an obstetrical measurement item,

after moving the cursor to the menu, select the measurement package with the cardiac

measurement item.

3. Select the measurement item in the measurement menu and make the measurement

4. Press 【 】button to edit the report.

8.9.3 Cardiac Measurement Item

The system provides the following cardiac measurement options:

Cardiac 2D measurement

Classifi Method of measurement

Item Explanation
cation or formula of calculation

End diastolic apex section left Same as “Distance”

LVLd
ventricular long axis measurement in 2D

Measur End diastolic apical left ventricular Same as “Area”

LVALd
ement long axis area measurement in 2D

End of systolic apical section left Same as “Distance”

LVLs
ventricular long axis measurement in 2D

93
 End systolic apical left ventricular Same as “Area”
LVALs
long axis area measurement in 2D

End diastolic left ventricular short

LVIDd
axis Same as“Distance”
End-systolic left ventricular short measurement in 2D
LVIDs
axis

LVAd sax End diastolic mitral valve horizontal

MV left ventricular short axis area

LVAs sax Left ventricular short axis area of

MV mitral valve at end of systolic period
Same as “Area”
LVAPd sax Left ventricular short axis area of the measurement in 2D
PM end diastolic papillary muscle

Left ventricular short axis area of the

LVAPs sax
papillary muscle at the end of the
PM
systolic period

Left ventricular posterior wall

LVPWd
thickness at end-diastolic end

IVSTd Diastolic septal thickness

MPAD Main pulmonary artery diameter

Same as “Distance”
right ventricular end diastolic
RVEDd measurement in 2D
diameter

Right ventricular end-systolic

RVEDs
diameter

LA apical left atrial diameter

LAA(A2C) Left atrial area (two-chamber heart) Same as “Area”

LAA(A4C) Left atrial area (four-chamber) measurement in 2D

Single
plane /
ellipse

Researc Biplane
/ Underneath
h ellipse

Bullet
/
volume

Simpson /

94
 Simpson
/
uniplanar

Simpson
/
biplane

Cardiac B/M measurement

classific Method of measurement or

Item explanation
ation formula of calculation

End diastolic left

LVIDd
ventricular short axis Same as “Distance”
End-systolic left ventricular measurement in 2D/B/M
LVIDs
short axis

CE / Same as “Distance”
CA / measurement in B/M

ACV / Same as “EF” measurement

EFSLP / in B/M

Right ventricular ejection

RV-ET
time

RV-AcT /
Measure
ment Right ventricular Same as “Time”
RV-PEP
pre-ejection time measurement in B/M
Cycle T /

AcT /

DcT /

LAD / Same as “Distance”

AOD / measurement in B/M

left ventricular ejection Same as “Time”

LVET
time measurement in B/M

Left ventricular posterior

Same as “Distance”
LVPWd wall thickness at end
measurement in B/M
diastolic

95
 End diastolic left
LVIDd
ventricular short axis

IVSTd Diastolic septal thickness

The interval between

Same as “Time”
MV C-O dur closure and opening of the
measurement in B/M
mitral valve

Cardiac PW measurement

Method of measurement or
classification Item explanation
formula of calculation

MR-Velocity / Same as “Velocity(D)”

measurement in PW
E-Wave-velocity /

Same as “Distance”
MV-Diameter /
measurement in B/M

Same as “Time” measurement

MV-Dct /
in PW

Same as “Velocity(D)”
A-Wave-velocity /
measurement in PW

Same as “Time” measurement

PHT /
in PW
Measurement Mitral valve velocity Same as “Manual Envelope”
MV VTI
time integral measurement in PW

MV VT /
Same as “Time” measurement
E-Wave-Dur /
in PW
A-Wave-Dur /

Same as “Distance”
LVOP /
measurement in 2D

Aortic valve velocity Same as “Manual Envelope”

AV VTI
time integration measurement in PW

Same as “Velocity(D)”
AoV-Velocity /
measurement in PW

96
 Same as “Time” measurement
AOR-Time /
in PW

AOR-Vmax / Same as “Velocity(D)”

AOR-Ved / measurement in PW

Left ventricular
Same as “Velocity(D)”
LOVT VTI outflow velocity time
measurement in PW
integral

Same as “Distance”
LOVT_D /
measurement in 2D

Same as “Velocity(D)”
LOVT-Vel /
measurement in PW

Tricuspid velocity Same as “Manual Envelope”

TV VTI
time integral measurement in PW

Same as “Velocity(D)”
TV Velocity /
measurement in PW

Tricuspid
Same as “M” measurement in
TR- VTI regurgitation velocity
PW
integral

Pulmonary valve Same as “Velocity(D)”

PV Velocity
velocity measurement in PW

Pulmonary valve Same as “Manual Envelope”

PV- VTI
velocity time integral measurement in PW

Pulmonary valve Same as “Distance”

PV Diameter
diameter measurement in 2D

Pulmonary vein
D-Wave-VTI D-peak velocity time
integral Same as “Manual Envelope”

Pulmonary vein S measurement in PW

S-Wave-VTI peak velocity time
integral

Pulmonary vein Same as “Time” measurement

PW-DcT
deceleration time in PW

97
 Pulmonary vein S2
S2 -Wave-Vel
peak velocity

Pulmonary vein S1
S1 -Wave-Vel
peak velocity

PVA peak velocity of Same as “Velocity(D)”

PVA -Wave-Vel
pulmonary veins measurement in PW

Pulmonary vein
D -Wave-Vel
D-peak velocity

Pulmonary vein PVA

PVA -Wave-Dur
peak time

Right ventricular
RV-ET
ejection time
Same as “Time” measurement
RV-AcT /
in PW
Right ventricular
RV-PEP
pre-ejection time
CycleT /

AcT /
Same as “Time” measurement
DcT /
in PW
left ventricular
LVET
ejection time

8.9.4 Cardiac MeasurementOperation

Measurement term

1. Select the measurement item in the measurement menu

2. Complete the measurement according to the method described in the "Cardiac" form.

Research term

8.9.4.1 Left Ventricle

Left ventricular function measurement assesses left ventricular systolic and diastolic

capacity by measuring a series of clinical parameters, except to calculate end-systolic

volume and end-diastolic volume according to different methods. The following clinical

indexes can also be calculated (not all cardiac function calculation methods can calculate

all the following indexes, which need to be treated specifically according to the parameters

98
 of this index):

Result Explanation Formula

SV stroke volume SV(ml)=EDV(ml)-ESV(ml)

CO cardiac output CO(l/min)=SV(ml)×HR(bpm)/ 1000

EF ejection fraction EF(No unit)= SV(ml)/ EDV(ml)

Stroke volume
SI SI(No unit)= SV(ml)/ surface area (m2)
index
Cardiac output
CI CI(No unit)= CO(l/min)/ surface area (m2)
index
fractional
FS FS (No unit) = (LVIDd(cm) – LVIDs(cm)) / LVIDd(cm)
shortening
Mean peripheral
MVCF MVCF = (LVIDd(cm) – LVIDs(cm)) / (LVIDd (cm) × ET (s))
shortening rate

 SP Ellipse
Research item

Item Explanation Operation

End diastolic apex section

LVLd Same as “Distance” measurement in 2D
left ventricular long axis

End diastolic apical left

LVALd Same as “Area” measurement in 2D
ventricular long axis area
End of systolic apical
LVLs section left ventricular long Same as “Distance” measurement in 2D
axis
End systolic apical left
LVALs Same as “Area” measurement in 2D
ventricular long axis area

M mode heart rate measurement or direct

HR Heart Rate
input

Research Result

Item Explanation Operation

End-diastolic left
EDV /
ventricular volume

99
 end systolic left
ESV /
ventricular volume

SV Per discharge

CO Cardiac Output

EF Ejection Fraction Based on the left Ventricular function

SI Stroke volume index list

Left ventricular output

CI
index

Operating Steps

1. Select 『SP Ellipse』in measurement menu.

2. Measure the following parameter on the long axis of the end diastolic apex:

LVLd， LVALdto get EDV value.

3. Measure the following parameters on the long axis section of the apical at the end of

the systolic period:

LVLs, LVALsto get ESV value.

System will calculate SV,EF.

If height, weight were input, the system will automatically calculate SI.

4. Input HR.

The system will automatically calculate CO and CI.

 BP Ellipse

Research Term
Item Explanation Operation

End diastolic left ventricular short

LVIDd
axis Same as “Distance”
End-systolic left ventricular short measurement in 2D
LVIDs
axis

End diastolic mitral valve

Same as “Area”
LVAd sax MV horizontal left ventricular short
measurement in 2D
axis area

100
 Left ventricular short axis area of
LVAs sax MV mitral valve at end of systolic
period

End diastolic apical left ventricular

LVALd
long axis area

End systolic apical left ventricular

LVALs
long axis area

B/M mode heart rate

HR Heart Rate
measurement or direct input

Research Result

Item Explanation Operation

End-diastolic left ventricular

EDV（BP Ellipse） /
volume

end systolic left ventricular

ESV（BP Ellipse） /
volume

SV （BP Ellipse） Per discharge

CO （BP Ellipse） Cardiac Output

Based on the left Ventricular
EF （BP Ellipse） Ejection Fraction
function list
SI （BP Ellipse） Stroke volume index

CI （BP Ellipse） Left ventricular output index

Operating Steps

1. Select 『BP Ellipse』in measurement menu.

2. Measure the following parameters on the short axis section of the left ventricle:

LVIDd

LVIDs

3. Measure the following parameters on the horizontal short axis section of the mitral

valve:

LVAd sax MV

LVAs sax MV

4. Measure the following parameters on the long axis of the apical section:

LVALd and calculate EDV

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 LVALs and calculate ESV

After measure LVAs apical, the system will calculate SV, EF;

If height, weight were input, the system will automatically calculate SI.

5. Input HR.

The system will automatically calculate CO and CI.

 Bullet

Research term
Item Explanation Operation

End diastolic apex section left

LVLd
ventricular long axis Same as “Distance”
End of systolic apical section left measurement in 2D
LVLs
ventricular long axis

End diastolic mitral valve

LVAd sax MV horizontal left ventricular short
axis area Same as “Area”
Left ventricular short axis area of measurement in 2D
LVAs sax MV mitral valve at end of systolic
period

B/M mode heart rate

HR Heart Rate
measurement or direct input

Research result

Item Explanation Operation

End-diastolic left EDV(ml)= 5/6×LVLd(cm)×LVAd sax

EDV（Bullet）
ventricular volume MV(cm2 )

end systolic left ESV(ml)= 5/6×LVLs (cm)×LVAs sax

ESV（Bullet）
ventricular volume MV(cm2 )

SV （Bullet） Per discharge

CO （Bullet） Cardiac Output

Based on the left Ventricular function list
EF （Bullet） Ejection Fraction

SI （Bullet） Stroke volume index

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 Left ventricular
CI （Bullet）
output index

Operating Steps

1. Select 『Bullet』in measurement menu.

2. Measure the following parameters on the short axis section of the left ventricle:

LVLd

LVLs

3. Measure the following parameters on the horizontal short axis section of the mitral

valve:

LVAd sax MV

LVAs sax MV

4. Measure the following parameters on the long axis of the apical section:

LVAd sax MV and calculate EDV

LVAs sax MV and calculate ESV

And the system will calculate SV、EF;

If height, weight were input, the system will automatically calculate SI.

5. Input HR.

The system will automatically calculate CO and CI.

 Simpson

Research term
Item Explanation Operation

End diastolic apex section left

LVLd
ventricular long axis Same as “Distance”
End of systolic apical section left measurement in 2D
LVLs
ventricular long axis

End diastolic mitral valve

Same as “Area”
LVAd sax MV horizontal left ventricular short
measurement in 2D
axis area

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 Left ventricular short axis area of
LVAs sax MV mitral valve at end of systolic
period

Left ventricular short axis area of

LVAPd sax PM
the end diastolic papillary muscle

Left ventricular short axis area of

LVAPs sax PM the papillary muscle at the end of
the systolic period

B/M mode heart rate

HR Heart Rate
measurement or direct input

Research result

Item Explanation Operation

End-diastolic left
EDV（Simpson） /
ventricular volume

end systolic left

ESV（Simpson） /
ventricular volume

SV （Simpson） Per discharge

CO （Simpson） Cardiac Output

EF （Simpson） Ejection Fraction

Based on the left Ventricular function list
SI （Simpson） Stroke volume index

Left ventricular
CI （Simpson）
output index

Operating Steps

1. Select 『Simpson』in measurement menu.

2. Measure the following parameters on the left ventricular apical long axis view

LVLd

LVLs

3. Measure the following parameters on the left ventricular mitral valve horizontal

short axis section:

LVAd sax MV

LVAs sax MV

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 4. Measure the following parameters on the Left ventricular papillary muscle

horizontal short axis section:

LVAPd sax PM and calculate EDV

LVAPs sax PM and calculate ESV

And the system will calculate SV,EF;

If height, weight were input, the system will automatically calculate SI.

5. Input HR.

The system will automatically calculate CO and CI.

 SimpsonSP

Research term
Item Explanation Operation

End-diastolic (two-cavity /
EDV(A2C/A4C)
four-cavity) volume

End of contraction (two-cavity Simpson measurement

ESV(A2C/A4C) tangent / four-cavity tangent)
capacity

B/M mode heart rate

HR Heart Rate
measurement or direct input

Research result

Item Explanation Operation

End-diastolic
EDV（Simpson SP） left ventricular /
volume
end systolic
ESV（Simpson SP） left ventricular /
volume
SV （Simpson SP） Per discharge

CO （Simpson SP） Cardiac Output

Based on the left Ventricular function list
Ejection
EF （Simpson SP）
Fraction

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 Stroke volume
SI （Simpson SP）
index

Left ventricular
CI （Simpson SP）
output index

Operating Steps

1. Select 『Simpson SP』in measurement menu.

2. Measurement of endocardium：

Measure the end diastolic endocardium and set the position of long axis position to

get EDV.

Measure the end-systole endocardium and set the position of long axis position to

get ESV

And the system will calculate SV, EF.

If height, weight were input, the system will automatically calculate SI.

3. Input HR.

The system will automatically calculate CO and CI.

 Simpson BP

Research term
Item Explanation Operation

End-diastolic left ventricular

EDV(A2C)
volume(Two-cavity tangent plane)

End systolic left ventricular

ESV(A2C)
volume(Two-cavity tangent plane)
Simpson measurement
End-diastolic left ventricular
EDV(A4C)
volume(Four-cavity tangent plane)

End systolic left ventricular

ESV(A4C)
volume(Four-cavity tangent plane)

B/M mode heart rate

HR Heart Rate
measurement or direct input

Research result

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 Item Explanation Operation

End-diastolic
EDV（Simpson BP） left ventricular /
volume
end systolic
ESV（Simpson BP） left ventricular /
volume
SV （Simpson BP） Per discharge

CO （Simpson BP） Cardiac Output

Ejection
EF （Simpson BP）
Fraction
Based on the left Ventricular function list
Stroke volume
SI （Simpson BP）
index

Left ventricular
CI （Simpson BP）
output index

Caution：

In the measurement of left ventricular function by Simpson, the apical

two-chamber section and the apical four-chamber section must be
perpendicular. Otherwise, it will result in incorrect measurement results.

Operating Steps

1. Select 『Simpson BP』in measurement menu.

2. On the apical two lumen section, measure the following parameters:

End diastolic endocardium of left ventricle and setting long axis position to obtain

EDV (A2C)

The endocardium of the left ventricle was contracted at the end of systole, and the

long axis position was obtained to obtain ESV (A2C).

3. On the apical four lumen section, measure the following parameters:

End diastolic endocardium of left ventricle and setting long axis position to obtain

EDV (A4C)

The endocardium of the left ventricle was contracted at the end of systole, and the

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 long axis position was obtained to obtain ESV (A4C).

If height, weight were input, the system will automatically calculate SV, EF, SI.

4. Input HR.

The system will automatically calculate CO and CI.

 Left ventricular myocardium

Left ventricular mass index (LVMI) was calculated by measuring and calculating left

ventricular mass (LV Mass),.

Research term

Item Explanation Operation

Left ventricular posterior wall

LVPWd
thickness at end-diastolic end
Same as “Distance”
End diastolic left ventricular short
LVIDd measurement in 2D
axis

IVSTd Diastolic septal thickness

Operating Steps

1. Select 『LV』in measurement menu.

2. At the end of left ventricular diastole, measure the following parameters:

LVPWd, LVIDd, IVSTd

The system will calculate LV Mass automatically.

If height, weight were input, the system will automatically calculate left ventricular

mass index.

 Left ventricular volume（LA Vol）

Research term
Item Explanation Operation

Same as “Distance”
LA apical left atrial diameter
measurement in 2D

Left atrial area (two-chamber Same as “Area”

LAA(A2C)
heart) measurement in 2D

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 LAA(A4C) Left atrial area (four-chamber)

Operation steps

Refer to the "Research Project" table for the measurement of each item in the

operational steps

 Cube

Research result
Item Explanation Operation

End diastolic left ventricular

LVIDd
short axis Same as “Distance”
End systolic short axis measurement in B/M
LVIDs
diameter

B/M mode heart rate

HR Heart Rate
measurement or direct input

End diastolic left ventricular

EDV（Cube） EDV(ml)=LVIDd(cm)3
volume

End systolic left ventricular

ESV（Cube） ESV (ml)=LVIDs(cm)3
volume

SV （Cube） Per discharge

CO （Cube） Cardiac Output

EF （Cube） Ejection Fraction

According to the “left
Left ventricular shortening Ventricular menu form”
FS（Cube）
rate

SI （Cube） SV index

CI （Cube） CO index

Operating Steps

1. Select 『Cube』in measurement menu.

2. Measure LVIDd and EDV in B/M mode.

3. Measure LVIDs and ESV in B/M mode, the system will calculate SV, EF, FS.

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 4. In B/M mode or directly input HR.

If height, weight were input, the system will automatically calculate SI, CO, CI.

 Teichholz

Research term
Item Explanation Operation

Diastolic ventricular septum

IVSTd
thickness

End diastolic left ventricular

LVIDd
short axis

Left ventricular posterior

LVPWd wall thickness at
end-diastolic end Same as “Distance”
Interventricular ventricular measurement in B/M
IVSTs
septum thickness

End systolic short axis

LVIDs
diameter

Left ventricular posterior

LVPWs wall thickness at end of
systolic

B/M mode heart rate

HR Heart Rate
measurement or direct input

Operating Steps

1. Select 『Teichholz』in measurement menu.

2. Measure IVSTd, LVIDd, LVPWd and EDV in B/M mode.

3. Measure IVSTs, LVIDs, LVPW and ESV in B/M mode, the system will calculate SV,

EF, FS.

4. In B/M mode or directly input HR.

If height, weight were input, the system will automatically calculate SI, CO, CI.

 Cibson

Research term

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 Item Explanation Operation

interventricular septum
IVSTd
thickness at end-diastole

Left ventricular short axis

LVIDd
diameter at end of diastole

left ventricular posterior

LVPWd
wall depth
Same as “Distance”
interventricular septal measurement in B/M
IVSTs
thickness at end-systole

Left ventricle short diameter

LVIDs
at end of contraction

Left ventricular posterior

LVPWs wall thickness at end of
systolic

B/M mode heart rate

HR Heart Rate
measurement or direct input

Operation steps

Please refer to the above table for the measurement method of each project.

Refer to“Teichholz”for operation steps.

 LV TEI

Left ventricular myocardial performance index reflects the overall ventricular systolic

and diastolic function.

Research term
Item Explanation Operation

The interval from closing to

MV C-O dur Same as “Distance”
opening of the mitral valve
measurement in B/M
LVET left ventricular ejection time

Research result

In addition to the measurement results in the above research project, the following

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 research results can be obtained:
Item Explanation Operation

Left ventricular
LV TEI myocardial
performance index

Operation steps

Please refer to the research project table for the measurement method of each project.

8.9.5 Cardiac Measurement Report

During the measurement or after the measurement, the report can be edited according to

【 】on the control board

For the content of the report, see the “8.2 measurement report”.

8.10 Gynecology

8.10.1 GYN Examination Preparation

Before the inspection begins, please do the following confirmation and preparation:

1. Verify that the selected probe is suitable for the current inspection.

2. The current date of the check system is correct.

3. Press 【Patient】button, input patient information in “Patient ”interface.

4. Switch to the corresponding inspection mode.

8.10.2 GYN Measurement Workflow

1. Press 【Patient】button, input patient information in “Patient ”interface.

2. Press 【Q1】button, enter into measurement.

If the menu currently displayed does not contain a gynecology measurement item, after

moving the cursor to the menu, select the measurement package with the gynecology

measurement item.

3. Select the measurement item in the measurement menu and make the measurement

4. Press 【 】button to edit the report

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8.10.3 GYN Measurement Items
The system provides the following 2D gynecological measurement items to choose from

(no measurement in B/M mode)：

Method of measurement or formula of

Clarification Item
calculation

UT T

UT W

UT L

Cervix L

Cervix T

Cervix W

UT_L

CX_L

Lt. Ovary L

Lt. Ovary W

Lt. Ovary T
Measurement Same as “Distance” measurement in 2D
Rt. Ovary W

Rt. Ovary T

Rt. Ovary L

Lt. DOF L

Lt. DOF W

Rt. DOF W

Rt. DOF L

UTB HR

UTB VR

APBU R

Endo L

UT Vol

Calculate Ovary Vol See below

UT_L/CX_L

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8.10.4 GYN MeasurementOperation
Measurement term

The following is an example of a uterine length-diameter measurement process that is the

same for other items.

1. Choose "UT-UT_L" in the measurement menu

2. Using the 2D conventional "Distance" measurement method to measure the length of

uterine diameter.

Calculation term

Uterine volume

Function: measure uterus thickness diameter, uterus width diameter, uterus length

diameter, calculate uterus volume and uterus diameter line.

1. Select 『U』 in the measurement menu

2. Using the 2D conventional "distance" measurement method to measure the uterus

thickness diameter, uterus width diameter, uterine length diameter respectively. The

system automatically calculates the uterine volume and uterine diameter line.

Ovarian Volume

Function: measure the length diameter, width diameter of the ovary, and calculate the

volume.

Note: measure the left and right sides separately.

1. Select "Ovary" in the measurement menu

2. Using the 2D conventional "distance" measurement method to measure the length,

the width and the thickness of ovary. Automatic calculation of ovarian volume by

system.

UT/CX

Function: Measure uterine body, cervix, calculate uterine body/cervix。

1. Choose "UT_L/CX_L" in the measurement menu.

2. Using the 2D conventional "distance" measurement method to measure the palace,

the cervix respectively. The system automatically calculates the value of uterine

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 body/cervix.

8.10.5 GYN MeasurementReport

During the measurement or after the measurement, the report can be edited according to

【 】on the control board

For the content of the report, see the “8.2 measurement report”

8.11 Urology

8.11.1 Urology ExaminationPreparation

Before the inspection begins, please do the following confirmation and preparation:

1. Verify that the selected probe is suitable for the current inspection.

2. The current date of the check system is correct.

3. Press 【Patient】button, input patient information in “Patient ”interface.

Switch to the corresponding inspection mode.

8.11.2 Urology Measurement Workflow

1. Press 【Patient】button, input patient information in “Patient”interface.

2. Press 【Q1】button, enter into measurement.

If the menu currently displayed does not contain a urology measurement item, after

moving the cursor to the menu, select the measurement package with the urology

measurement item.

3. Select the measurement item in the measurement menu and make the measurement

4. Press 【 】button to edit the report

8.11.3 Urology Measurement Items

The system provides 2D urinary measurement items to choose from (no measurement in

B/M mode):

Method of measurement or formula of

Clarification Item
calculation

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 ProstateL

ProstateW

ProstateT

RU L

RU W

RU T

Lt. RenalCT

Lt. Kid.L

Lt. Kid.W

Lt. Kid.T

Rt. RenalCT

Lt. Kid.T

Lt. Kid.W

Lt. Kid.L

Lt.AGL
Measurement Same as “Distance” measurement in 2D
Lt.AGT

Lt.AGW

Lt.AGT

Lt.AGL

Lt.AGW

Lt.Testi.T

Lt.Testi.W

Lt.Testi.L

Rt.Testi.T

Rt.Testi.W

Rt.Testi.L

Lt.Sperm.T

Lt.Sperm.L

Lt.Sperm.W

Lt.Sperm.T

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 Lt.Sperm.W

Lt.Sperm.L

Prostate Vol
Calculation See below
Testi. Vol

8.11.4 Urinary Measurement Operation

Measurement term

The following is an example of "prostate length diameter" measurements. Describe the

measurement process。

1. Choose『Prostate-ProstateL』in the measurement menu

2. Using the 2D conventional "Distance" measurement method to measureProstate

long diameter.

Calculation term

Prostate volume

Function: To measure prostate length, width diameter, thickness diameter, prostate

volume, special antigen value

1. Select 『Prostate』 in the measure menu.

2. Measure the length diameter, width diameter thickness diameter of prostate in 2D

regular "distance" measurement method.

3. The system automatically calculates prostate volume and special antigen value.

Testicular volume

Features: measure the thickness of the testicles, testicular wide Trail, the testis

length-diameter to calculate the volume of the testicles.

Note: measure the left and right sides separately.

1. Select『Testicle』in the measurement menu.

2. Using the 2D conventional "distance" measurement method to measure the diameter

of testis, the width of testis and the length of testis were measured. The system

automatically calculates the testicular volume.

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8.11.5 Urinary Measurement Report
During the measurement or after the measurement, the report can be edited according to

【 】on the control board

For the content of the report, see the “8.2 measurement report”

8.12 Vascular

8.12.1 Vascular Examination Preparation

Before the start of the check, please confirm and prepare the following work:

1. Confirm the selected probe is suitable for the current check.

2. Check the system current date is correct.

3. Press 【Patient】, enter the Patient information.

4. Switch to the corresponding examination mode.

8.12.2 Vascular Measurement Workflow

1. Press 【Patient】, complete Patient information in the“Patient”page.

2. Press 【Q1】, enter measurement.

If the current displayed menu does not contain blood vessel measurement option, move

the cursor to the menu, and select measurement package containing blood vessel

measurement option.

3. Select measurement option in the measurement menu and start measuring.

4. press 【 】 to edit report.

8.12.3 Vessel measurement options

This system provides 2D urinary system measurement options:

Measurement method or Calculation

Category Item
formula

Narrow region diameter Same normal“Distance”measurement as

Normal region diameter 2D
Measurem
ent Narrow region area Same normal“Distance”measurement as
Normal region area 2D

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 IMT(Posterior wall)
Auto measurement
IMT(Anterior wall)

Stenosis percentage(Diameter)=
Stenosis
(Normal diameter-Narrow diameter) /
percentage(Diameter)
Calculation Normal Diameter

Stenosis percentage(Area)=
Stenosis percentage(Area)
(Normal area-Narrow area) / Nomal area

8.12.4 Vascular Measurement Operation

Measurement Items

Narrow region diameter

1. Select 『%DST』in the measurement menu;

2. Measure narrow region diameter with 2D normal“Distance”method.

Narrow region area

1. Select『%AST』in the measurement menu;

2. Measure narrow region area with 2D normal“Area”method.

IMT(Anterior Wall)

1. Select 『IMT(Anterior Wall)』in the measurement menu, a yellow ROI sampling frame

pops up;

2. Move ROI sampling frame to the measured carotid IMT(ROI must contains the intima

needed measurement);

3. Press 【Set】, immediate measurement results show on the screen.

IMT(Posterior Wall)

1. Select 『 IMT(Posterior Wall) 』 in the measurement menu, a yellow ROI sampling

frame pops up;

2. Move ROI sampling frame to the measured carotid IMT(ROI must contains the intima

needed measurement);

3. Press 【Set】, immediate measurement results show on the screen.

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 Calculation Item

Stenosis percentage (Diameter)

Function: With measured vessel narrow region diameter and normal diameter to calculate

stenosis percentage (Diameter)

1. Select 『%DST』in measurement menu;

2. Measure vessel narrow region diameter and normal region diameter respectively with

2D normal “Distance”measurement method. Systematically calculate stenosis

percentage (Diameter).

Stenosis percentage (Area)

1. Select 『%AST』 in the measurement menu;

2. Measure vessel narrow region diameter and normal region diameter respectively with

2D normal “Area”measurement method. Systematically calculate stenosis percentage

(Area).

8.12.5 Vascular Measurement Report

During or after the measurement, press【 】on control panel to edit report.

Please refer to “8.2 Measurement report”for report content.

8.13 Small Organ

8.13.1 Small Organ Examination Preparation

Before the start of the check, please confirm and prepare the following work:

1. Confirm the selected probe is suitable for the current check.

2. Check the system current date is correct.

3. Press 【Patient】, complete Patient information in the“Patient” page.

4. Switch to the corresponding mode.

8.13.2 Small Organ Measurement Workflow

1. Press 【Patient】, complete Patient information in the“Patient” page.

2. Press 【Q1】, enter measurement.

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 If current displayed menu does not contain small organ examination option, move the

cursor to the menu, and select measurement package containing small organ

measurement option.

3. Select measurement option in the measurement menu and start measuring

4. Press 【 】 to edit report.

8.13.3 Small Organ Measurement Items

This system provides 2D small organ measurement options:

Measurement method or Calculation

Category Item
formula

Rt.Thyroid W

Rt.Thyroid L

Measure Rt.Thyroid T Same normal“Distance”measurement as

ment Lt.Thyroid T 2D

Lt.Thyroid W

Lt.Thyroid L

8.13.4 Small Organ Measurement Operation

1. Select measurement item in measurement menu.

2. Complete measurement according item form described method

8.13.5 Small Organ Measurement Report

During or after the measurement, press【 】on control panel and edit report.

Please refer to “8.2 Measurement report”for measurement report

121
9 Text Annotation and Arrow Marks

During the diagnosis, annotations and marks are usually required for ultrasound image so as

to increase its reading feasibility. Annotations such as character input, annotation and arrow mark

can be added and froze on the ultrasound image.

Notice：Please Add Correct Annotation in Case of Misdiagnosis

9.1 Enter/Exit Text Annotation

Press【ABC】or touch 『Text』to enter annotation interface, display screen and touch screen

display auto annotation menu.

Press【ABC】again to close auto annotation menu and exit annotation interface.

9.2 Add Text Annotation

9.2.1 Input annotation

Input characters after the system entering annotation interface, operation procedure is as

following:

1. Move curse to image area and add annotation directly. Press 『 Caps Lock 』 to enter

uppercase character input mode and press it again to enter lowercase character input

mode.

2. Press 『Shift 』and corresponding character key to input the another character on the

character key, same way as keyboard.

3. The inputting annotation color is green, after finishing annotation, slide trackball to the

interesting place and press【Set】to confirm, annotation turns into yellow and fixes on

the interesting place.

9.2.2 Auto-annotationEntries
Annotation needed for ultrasound image can be selected from auto annotation menu on

display screen and touch screen after system entering annotation interface. Annotations are typing

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are in green color, after typing, move trackball to the interested place and press 【Set】to confirm,

as a result, annotation turns into yellow and fixes on the interesting place.

9.2.3 Arrows
 Enter/Exit arrow mark

Press『Arrow』on touch screen to enter arrow mark mode. Slide trackball, there will be an

arrow mark emerging on touch screen, press『Arrow』again to exit arrow mark mode.

Arrow mark is usually used for the place needed annotation or emphasis on ultrasound image.

1. Press『Arrow』, there is an arrow mark emerge on the system default location in the image

frame.

2. Slide trackball and direct arrow mark to the needing place.

3. Slide trackball to adjust arrow mark direction when needed.

4. Press【Set】to complete arrow mark modification operation

5. Repeat above-mentioned steps to continue to add arrow mark.

9.3 Modifying Text Annotation

 Movement

When an annotation needs movement, move the trackball to it and press 【Set】 to activate

the operation. The color of the annotation changes into green from yellow, and one can slide

trackball to move to the interested place and press【Set】to confirm.

 Modify

When an annotation needs movement, move the trackball to it and press 【Set】 to activate

the operation. The color of the annotation changes into green from yellow, Use the left and right

arrow keys on the keyboard and delete keys to select the text to delete and enter the new text.

9.4 Deleting Annotation

 Delete annotation

1. Slide trackball to the annotation

2. Press【 Set 】 twice to activate the annotation. Annotation color changes from yellow to

green.

3. Press 『Back Space』on the keyboard to complete the selected annotation deletion.

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 4. Press 【Clean】(Close to 【Caliper】) to delete annotation one by one.

5. Press【Clean】(Close to 【ABC】) to clean all annotations.

 Delete arrow mark

1. Under arrow mark mode, press 【Clean】(Close to 【Caliper】) to delete arrow mark one

by one.

2. Press 【Clean】(Close to 【ABC】) to delete all arrow marks.

124
10 Body Mark

Body mark involves probing position and probe scanning direction during patient’s examination,

generating assistant effects to images.

10.1 Enter/Exit Body Mark

Press 【Body Mark】, enter body mark mode. Screen and touch screen both display body mark

menu under current application, select body mark and press 【Set】, body mark enter image area.

10.2 Classification of Body Mark

Body mark category is correlative with application mode, namely respectively body mark under

each application mode.

10.3 Body Mark Operation

Body mark operation includes: Body figure selection, probe mark operation

 Body figure selection

Under body mark mode, slide trackball, select the needed body figure, and press 【Set】,

menu display the selected body figure, at the same time, image area renews and display all

the selected body figure. Or select body figure from touch screen.

 Probe mark operation

When the image area display the selected body figure, move cursor to body figure

displaying area, slide trackball to move probe mark to the interesting place. Rotate 【Angle】

can adjust probe mark direction and press 【Set】 to fix.

 Body mark deletion

Press 【Clean】 to delete body mark

125
11 Image Management

This system provides image management function, enable user to review, delete or export the

system internal stored image or video and meet user’s requirement on off-line diagnosis and

off-line presentation on the gained ultrasound image.

11.1 Work Interface of Image Management

Image management interface is as following

Menu Patient List

area

Thumbnail area

Press 【File】or【 】, the interface is as following:

126
 1. Menu area

Menu area can process search, browse, new examination, report review, export, import,

delete, application and cancellation.

2. Patient list

Patient list display current system stored all patient general information, mainly including

patient’s name, gender, age, examination part, image, video and examination date, etc,

3. Thumbnail area

Thumbnail area display all thumbnail of images and videos of the selected patient contained

in the patient list. In order to obviously differentiate image and video, video thumbnail has video

mark frame.

11.2 Enter/Exit Image Management

Press 【File】or【 】in ultrasound working interface to enter image management working

interface.

In image management working interface, slide trackball to 『Cancel』, press 【Set】or press

【File】or【 】to exit image management and return to ultrasound main working interface.
127
11.3 Search
In image management working interface, search condition includes patient name, starting

date and ending date, as following.

Input patient name or starting and ending date, press 『Search』and check patient list area for

the needed patient information.

11.4 View
In image management working interface, select and browse patient information (in highlight)

from the patient list, click 『view』, enter the patient examination information interface and user can

browse.

11.5 New Patient

In image management working interface, when need patient examination, click 『Create』 to

enter patient information interface, input patient information and do patient examination. Please

refer to “Patient”for detailed operation procedures.

11.6 Check Report

In image management working interface, select patient information from the patient list,

patient information area turns into highlight, click 『Report』to enter patient report interface and

user can review patient report. Please refer to “8.2 Measurement report”for detailed operation

procedures.

11.7 Export / Import

Export

In image management working interface, insert USB flash card and there is a USB flash card

icon at screen lower right corner. Select patient image and video needed export, patient

information area turns into highlight, click 『Export』, there will be a scroll progress bar. When the

128
scroll progress bar 100% loaded and disappeared, the patient all image and video export

completed.

Notice ： When image and video file is too big, scroll progress bar processing rate will be

low.Please be patient.

Import

In image management working interface, select patient information from patient list, patient

information area turns into highlight, click 『Import』to selected import file and click 『Confirm』.

When the scroll progress bar 100% loaded and disappeared, the patient all image and video

import completed.

Notice ： When image and video file is too big, scroll progress bar processing rate will be

low.Please be patient.

11.8 Delete
Image management interface, in the list of patients, select deleted patients, the patient

information bar highlighted, click 『Delete』, the color of the font changes from white to orange,

click on the 『Apply』, delete the selected patient information.

When deleting multiple patients, change the color of all patient information fonts from white to

orange, and click on the 『Apply』to delete multiple patients

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12 System Setup

When system is on, user can customize the system setting.

12.1 Default Working Interface

Report edit and printer interface is as following:

Menu area Parameter edit area

Function button area

1. Menu area

Menu area includes system, imaging, DICOM, Peripherals, Theme, License and relative

contents.

2. Parameter edit area

After selecting corresponding parameter menu, parameter edit area will display editing items of

the corresponding menu. User can adjust, modify based on real situation. Please refer to the

following description for the detailed contents.

3. Function button area

During contents modification in parameter edit area, click 『Cancel』 to exit system presetting

interface.

12.2 Enter/Exit Preset

In ultrasound main working interface, press 【Set up】or touch 『Setup→System』 of touch
130
screen to enter parameter presetting working interface.

In parameter presetting working interface, slide trackball to 『Cancel』, press 【Set】, exit

parameter presetting working interface and return to ultrasound main working interface.

12.3 System Parameter Preset

System parameter preset includes system operation status and environment parameter setting

and modification.

12.3.1 System
In ultrasound main working interface, press 【Set up】 to enter system setting interface, as

following.

1. Hospital : Set hospital name;

2. Language: Set system working interface language;

3. ImageSize: User select default image size, including small, middle and large;

4. FreezeTime: When system scan works, user can select the freezing time from drop down

list;

5. ImgType: Store image format setting function;

6. FootSW/Q2/Q3: User can customize Foot switch/Q2/Q3 so as to store image/store image

to USB flash card/store video/store video to USB flash card/Freeze function;

7. 7. LOGO: Display company’s LOGO;

8. Management: Enter system backstage. For system maintenance personnel only;

131
 9. DateTime: Edit current system time;

After editing, modifying presetting parameter of a set of parameter, click 『Save』to store

data.

Click 『Cancel』to exit parameter preset and return to ultrasound main working interface

12.3.2 Imaging
In system presetting interface, click 『 Imaging 』 to enter imaging parameter interface, as

following:

Imaging setting is imaging parameter presetting of selected probe and examination part. For

instance, when doing carotid artery examination with linear probe, user can re-adjust gain value,

which can be stored in imaging setting interface, after save, user can use this gain value in the

following carotid artery examination.

1. presetting value save

1) Select probe and examination part, enter image scan, adjust parameter and gain the

best image;

2) Store the adjusted parameter, click setting interface 『Imaging』and turn into imaging

setting;

3) System automatically recognize scanning mode, probe model of current examination

part, click 『SaveCurPara』will pop up the following message box, click 『OK』to save

current parameter default value, click 『Cancel』to cancel save.

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 2. Save as presetting

Click 『 CurParaSaveAs 』 will pop up following message box. After inputting presetting

name, click 『 OK 』 to save current scanning data as another set of presetting, click

『Cancel』to cancel save

3. Factory reset presetting value

Click 『RestorePreset』to pop up following message box, click 『OK』to restore factory

default scanning value, click 『Cancel』to cancel save

12.3.3 DICOM
In system presetting working interface, click 『DICOM』to enter DICOM as following:

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 DICOM setting is mainly about completing the setting of AE, IP, Port relating with SCU,

Store(SCP), Worklist(SCP). After setting, click 『ConnectVerify』to test connection with SCU port

and SCP port.

Edit, modify the presetting of a set of value, click 『Save』to save data

Click 『 Cancel 』 to exit parameter presetting and return back to ultrasound main working

interface.

12.3.4 Peripherals
In system presetting interface, click 『Peripherals』to enter peripherals parameter interface, as

following.

Peripherals indicates external equipment connecting with ultrasound system

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1. Internet setting

1) Click 『Cur IP』to use system current IP setting and automatically fill in relative internet

values;

2) Click 『 Auto IP 』 to automatically gain IP setting from relative equipment and

automatically fill in relative internet values;

3) Click 『Set IP』to apply internet parameter into system network setting.

2. Printer setting: message box shows all the system installed printer, select printer and click

『SetPrinter』to set the selected printer as ultrasound default printer

3. Multiple Screen setting: Add external screen, video working station, etc will return setting

such as display location and definition of main screen and touch screen and main screen

setting back to system default mode, under which circumstance, re-settings are needed.

1) Click 『 MulScrSet 』 , setting interface pops up. Setting interface will pop up

automatically as ultrasound software will detect screen setting alternation.

2) Setting interface will appear on each connected screen with same effect. The bottom

of each screen will display the screen model number and serial number so as to

differentiate each screen.

3) Auto setting: There will be count down after setting interface popping up, auto setting

will start after count down finished.

4) Manual setting: Click screen type at the bottom of screen thumbnail to

set“MainScreen ”、“Touchscreen”or“Peripheral” and click 『Apply』to complete setting.

5) Touch screen will normal be unable to operate correctly after multiple screen setting.

Click 『Calibration touch screen』to reset touch screen corresponding.

4. Touch screen setting: Add external screen and video working station will possibly lead to

touch screen corresponding invalid, please process resetting.

1) Click 『Touchscreen』, message box pops up

2) Click 『set』, notice in one screen:

3) Operate according to instruction until notice switching into touch screen. Use finger to

touch the notice area and system will notice setting completion, or directly exit

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 information interface

12.3.5 Scheme
In system presetting interface, click 『Scheme』to enter setting interface:

Theme setting is mainly about system UL interface layout and control color setting

12.3.6 License Management

Ultrasound function import license and ultrasound software upgrading file

1. Import permission

If new functions are needed or currently function time needs change, and valid permission

files have been gained, License management interface input valid permission file

1) Click 『Import License』

2) Select the needed input permission file from the message box, such as

3) If permission file is valid, authorized functions will be added into ultrasound system,

image as following:

Notice: UID serial numbers are needed for 4D function activation( Temporary open

management and permanent open management). UID serial number extraction and setting

process is “『Connect the U disk』→『System』→『license』→『Product UID 』→『Save UID』

”,

USB flash care root directory generates lic_xxxxx file.

136
 Warning: Please do not apply this tool to generating other factory adopted similar

program licence. The unmatched licence may lead product malfunction, even

devastation

2. Software upgrading

Software upgrading will inherit the existing licence. New version software will be provided in

installation package method. Inset USB flash card into system

1) Click 『Upgrade』;

2) Select installation package and execute the file;

3) Process installation package according to installation instruction and complete upgrading;

4) Upgrading software will be automatically effective in next ultrasound system reboot.

3. Software rollback

After installing upgrading software, Licence management interface will appear 『RollBack』
,

with which, software will rollback to the previous version if need to check the previous

software version,

1) Click 『RollBack』;

2) Message box pops up;

137
 3) Click 『OK』to return to the previous version. It will be valid if restarted.

12.3.7 About information

In system presetting interface, click 『About』 to enter system information interface. System

information mainly display ultrasound system software and hardware modular information serving

after-sales service.

138
13 System Maintenance

The daily machine maintenance shall be conducted by both the end user and the service

engineer. The end user shall take the full responsibility for the machine’s maintenance after the

purchase of the machine.

Notice:
1. The maintenance, if not specified in this manual, shall be conducted only by the
service engineer.
2. The end user shall check the machine regularly to ensure its performance and safety.

13.1 Routine Maintenance

The daily machine maintenance shall be conducted by the end user.

13.1.1 Clean System

Notice: You must power off the machine and unplug the power cable before the cleaning.
You may experience electrical shock if the cleaning is conducted while the machine
is on.

1. Probe Cleaning

 The Probe is fragile electronics and it may be damaged even with slight impact, so please

be careful while using it and ensure it is not being hit and hit any hard object.

 Please ensure the machine is in FREEZE status or POWERED OFF before

connecting/disconnecting the probe.

 No scratch on the surface of the probe.

 You may use wet sponge or soft cloth with water to clean the probe after each use. DO

NOT use ethanol or any organic solvent for the cleaning.

 Please follow the direction indication to lock the probe while connecting it to the machine.

 Please avoid distorting or twisting the cable while using the probe.

 Please use the qualified medical ultrasound coupling gel or it may cause possible damage

to the probe.
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 Warning:
1. The probe must be disconnected from the machine during cleaning and
disinfection.
2. The probe can only be immersed not exceeding the bond line of the head part and
the handle part, during cleaning and disinfection.

 Cleaning

The surface of the probe shall be cleaned by soft cloth with water after each use.

The probe may be cleaned by soft cloth with neutral detergent first and then with water to

remove the detergent, if the probe is seriously contaminated.

The probe must be dried by clean and dry cloth after the cleaning.

Warning: DO NOT use ethanol or any organic solvents to clean the probe.

Notice:
1. The protection glass and gloves must be worn during the cleaning and the disinfection.
2. Please remove all the protections on the probe (e.g. condom).
3. It is important to clean the whole surface of the transvaginal probe thoroughly during its
cleaning.

 Disinfection and Sterilization

The probe must be disinfected or sterilized by liquid disinfection chemicals, eg, CIDEX. And all

these solutions shall be mixed, stored and used following the product instruction of the

manufacturer.

The probe head shall be immersed into the disinfectant for more than 20 minutes but cannot

exceed 1 hour, and the water line shall be below the bond line of the probe head part and the

probe handle part.

The probe shall be cleaned by the water and dried by soft cloth after the disinfection.

Warning: DO NOT use high pressure steam to handle with the probe or contact
the probe with ethylene oxide. It is prohibited to disinfect the probe by

140
 heating. The temperature over 66℃ will damage the probe. The probe
shall not be fully immersed into any liquid but only below the bond line
of the head part and the handle part.

2. Cleaning of the Probe Socket

 The stains on the probe socket may be removed by soft dry cloth.

 If the stains still exist, the probe socket can be cleaned by a soft and wet cloth with neutral

detergent and air dried.

3. Cleaning of the Monitor

 The stains on the monitor may be removed by soft cloth.

 If the stains still exist, the monitor can be cleaned by a soft and wet cloth with warm water

and air dried.

4. Cleaning of Control Panel and the Cover

 The surface of the machine must only be cleaned by dry and soft cloth. And the neutral

detergent may be used to remove the stains and dirt on the machine, and then dried with

soft cloth or air dried.

13.1.2 Depth of Immersion

The probe can only be immersed not exceeding the bond line of the head part and the handle

part; Or it may be malfunctioning. In case if you have encountered this situation, please reach the

manufacturer immediately. The immersing depth of various probes are shown below:

141
13.1.3 Data Maintenance
Data management, backing up the data to external media, which can ensure the data security,

shall be conducted regularly. The unnecessary data stored in the machine shall be deleted timely

after each successful backup. Or it may impact the system performance.

Warning: The data erased can not be recovered, so please operate with caution.

13.2 Maintenance

13.2.1 Maintenance of Operators

The probe must be cleaned timely after each operation by the end user.

Below listed maintenance check shall be conducted on a quarterly basis:

1. Cleaning of the Machine.

2. The normal operation of each key part (Display, Control Panel).

3. The crack of the probe which might be soaked into conductive liquid.

4. The cable and the plug of the probe.

13.2.2 Maintenance and Inspection by Maintainers

Below listed check must be conducted to ensure the machine’s performance and safety. And

142
please reach the manufacturer when conduct the check.

Type Item
Internal of the Machine
Cleaning
Accessories
Ground Impedance
Earth Leakage Current
Electrical Safety
Shell Leakage Current
Body Leakage Current
Monitor Parts
Control Panel
Mechanical Safety Accessories
Other Mechanical Parts
Visual Appearance of the Probe
Image Record Image Quality of Each Mode

13.3 Fault Checking

To ensure that the machine works properly, it is recommended that the user make

maintenance and periodic inspection plans, regularly check the safety performance of the machine,

if its abnormal, please contact the manufacturer.

If there is no image after the system boots, or there is menu display but no image, please refer

to the table below for checking. If the trouble can not be excluded, please contact the manufacturer.

Warning: do not sprinkle water or liquid into the equipment during cleaning.
Otherwise, it may cause trouble or electric shock.

Troubleshooting：

SN Fault Phenomenon Exclusion Method

After the power switch is turn down,

1 Check power supply system and cables.
the power indicator is not lighted.

1. after shutdown, wait for at least 5

The power light is on, but the image minutes untilnext boot.
2
can not be displayed. 2. adjustthe "contrast" or "Brightness"
button on the monitor.

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 1. Check whether the power supply is
disturbed by other equipment.
2. Environmental check，check whether
There is intermittent stripe
there is electromagnetic interference in
3 interference and snowflake
the space around the machine.
interference on the display screen.
3. Check whether the plug and socket of
the power supply and probe are in good
contact.

The screen has no information, but 1. Adjust TGC、GAIN;

4 the device has a running sound; the 2. Clean the screen surface (use dry, soft
display on the screen is not clear. cloth wipes monitor screen).

1. There are much dust in the fan. Dust

Turn on the machine, the image is can be removed by brush.
5
normal, but the fan doesn't turn. 2. Maybe fan has been damaged, replace
fans.

13.4 Equipment Modification Instructions

Under the conditions permitted by relevant laws, the company reserves the right to retain

product design and specifications.

If the specification is inconsistent with the equipment, the material object shall prevail.

144
14 Transport and Storage

During transportation, the product should be placed upward to avoid rain and mechanical

collision. The stacking layers are not more than 2 layers. The storage limit temperature of the

product is -20 ℃ ～ ＋ 55 ℃ , relative humidity is 10%~95%, atmospheric pressure is 50kPa ~

106kPa,, no corrosive gas and good ventilation.

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15 Acoustic Power Output Principle

This chapter aims at the whole system (including the main engine, probe, accessories and

peripheral equipment), aiming to provide operators with sound output related information and how

to use the ALARA principle to control radiation time and other important safety information.

Please read the chapter carefully before using.

15.1 Biological Effects

Ultrasound is generally believed to be safe for diagnosis, and so far no human damage has

been reported.

In spite of this, we can not arbitrarily believe that all ultrasonic waves are absolutely safe.

Studies have confirmed that high intensity ultrasound is harmful to human tissue.

In recent years, with the long-term development of ultrasound diagnostic technology, more and

more people are concerned about the application of ultrasound and the potential risk of biological

effects caused by ultrasound diagnostic technology.

15.2 Statement of Cautious Use

Although it has not been clearly established that diagnostic ultrasound devices can cause

biological effects in the human body, it is still possible to prove the existence of biological effects in

future applications. We must use ultrasound carefully, play its clinical role, and avoid long-term use

of high-intensity ultrasound while obtaining the necessary clinical information.

15.3 ALARA Principle （As Low As Reasonably Achievable）

When using ultrasound, the ALARA principle should be followed, and the lowest level of energy

that does not lead to biological effects should be used as far as possible on the premise of obtaining

diagnostic information. The magnitude of ultrasonic energy depends on the intensity and time of

exposure. Different patients and clinical cases need different ultrasonic intensity.

Not all tests can be done by exporting very low energy ultrasonic waves. Ultrasound with very

low energy can only produce low quality images and weak Doppler signals, thus affecting the

reliability of diagnosis. However, the use of more than the actual need for sound power does not

help to improve the quality of diagnostic information, but will increase the risk of biological effects.
146
 Users must be responsible for the patient's safety by purposefully using ultrasound, that is,

selecting the output power of the ultrasound according to the ALARA principle.

For further information on ALARA principles and the potential biological effects of ultrasound,

refer to the Safety of Medical Ultrasound document published by the American Academy of

Ultrasound Medicine (AIUM).

15.4 MI/TI Description

15.4.1 Basic Information of MI and TI

The relationship between ultrasound output parameters (such as frequency, sound pressure

and sound intensity) and biological effects has not yet been clarified, but it is generally recognized

that there are two possible causes of biological effects. One is the thermal effect, which refers to the

absorption of ultrasound by tissues; the other is the mechanical effect including cavitation effect.

Thermal index (TI) represents the index of temperature rise caused by thermal effect, and

mechanical index (MI) represents the index of mechanical effect. TI and MI reflect instantaneous

output and do not consider the cumulative effect of inspection time.

a) MI (mechanical index):

The mechanical effect is the result of the formation, enlargement, vibration and collapse of

microbubbles in tissue under the action of sound waves, which is called cavitation effect. MI

indicates the possibility of cavitation effect of sound pressure. The MI value is obtained by dividing

the peak negative pressure by the square root of the frequency, so the higher the frequency or the

lower the peak negative pressure, the smaller the MI value, and the less likely the cavitation effect is.

When the frequency is 1MHz and the negative pressure is 1Mpa, the MI value is 1. MI can be

regarded as a threshold of cavitation effect. When gas and soft tissue exist at the same time, the MI

value should be set to a lower value.

b) TI (thermal index):

TI is determined by the ratio of total acoustic power to the sound power required to raise the

tissue temperature by 1 degrees centigrade. In addition, the tissue structure of different temperature

rise is different, so TI is divided into three categories: TIS (soft tissue thermal index), TIB (bone

147
thermal index), TIC (skull thermal index).

WFUMB (World Union for Ultrasound Medicine and Biology) states that radiation with a

5-minute temperature rise of 4 degrees Celsius may cause potential damage to embryos and fetal

tissues.

15.4.2 MI/TI Display Description

Real time display at the bottom left of the screen. Operators should monitor these exponential

values during the inspection process and ensure that radiation time and sound output values are

kept as low as possible while obtaining effective diagnostic information.

Notice: if MI or TI shows more than 1.0, users should follow the ALARA principle carefully.

The accuracy of MI and TI is 0.1

15.5 Acoustic Output Control

The output of sound is ultimately dependent on the operator of the equipment. Qualified

operators should minimize the output of sound while obtaining effective diagnostic images. Two

types of operation control affect the change of sound output: direct control and indirect control.

a) direct control:

Direct control of sound output is based on the "sound power" on the touchscreen to regulate

the size of the sound output. Typical values of acoustic output in specific application areas are

shown in Appendix C. In any mode, the maximum acoustic output value should not exceed the

acoustic output limit value (MI limit value is 1.9, Ispta.3 limit value is 720Mw/cm2).

b) Indirect control:

Indirect control of acoustic output is mainly caused by control of image correlation parameters.

These controls include operation mode, probe and its frequency, focus, image depth and pulse

repetition rate.

148
16 EMC Declaration

EMC refers to a performance that a product, a device or a system can work properly and doesn’t

cause unsustainable electromagnetic disturbance to any objects in its environment.

Resistance to electromagnetic interference makes products, equipment or systems can work in the

presence of electromagnetic interference (EMI).

EMI and EMS have been thoroughly considered at the beginning of designing the Full Digital Colour

Doppler Ultrasonic Diagnostic System.

The Full Digital Colour Doppler Ultrasonic Diagnostic System is designed and produced according

to present EMC standard and related requirements. Using the system in electromagnetic field may

cause performance changes or degradations like unstable output. If it happens frequently, it’s suggested

to inspect the system’s operating environment to confirm possible disturbance origins. Those

disturbances may originate from other electrical devices in the same room or the room nearby, or from

portable and mobile RF communication equipment like cellphones, interphones etc, or from radio

equipment, TV or microwave transmission equipment. If the Full Digital Colour Doppler Ultrasonic

Diagnostic System is interfered by EMI, it shall be moved to other places or associated measures shall

be taken to prevent it from EMI.

The product meets the requirement of EMC standard EN60601-1-2:2007.

NOTICE:

1. Except the parts and cables sold by the equipment’ manufacturer as internal components spares, using

those unauthorized parts and cables might increase emission or reduce noise immunity of Full Digital

Colour Doppler Ultrasonic Diagnostic System.

2. The device should not be kept close to other devices or stacked. If it must be close, please observe and

verify it works properly under its practical configuration.

3. Prevent electromagnetic interference (conductive anti-interference). Due to technical restriction,

electrical level of conductive noise immunity is limited to 1Vrms. Higher than the limit will cause

interference to images displayed by this equipment, thus affecting the diagnosis and measurement.

This equipment is suggested to keep away from conductive noise source.

4. Operating the equipment under the condition that the patient’s physiological signal is below the

minimum amplitude value or the minimum value will lead to inaccurate consequences.
149
 5. Portable and mobile communication equipment will affect the performance of this equipment.

Explain

 If operated and used in the electromagnetic environmentdescribed as anti-electromagnetic

interference below, the Full Digital Colour Doppler Ultrasonic Diagnostic System will work
safely and provide below basic functions:
1) Keyboard will function.
2) The ultrasound image will be showed on the monitor when transducer is used.

Electromagnetic emission guidelines and statements

The equipment shall be used in the prescribed electromagnetic environment, and the customer or user
shall ensure that the equipment is used in the electromagnetic environment specified below:
Emission Test Conformity Electromagnetic Environment Guidelines

The device USES rf energy only for its internal functions,

Frequency Emission
Group 1 so its rf emission is low and the likelihood of interference
CISPR11
with nearby electronic devices is small.
Radio-frequency
ClassA
Emission CISPR11
Harmonic Emission The equipment is suitable for use in all facilities that are
Not Applicable
IEC61000-3-2 not directly connected to the public low voltage supply
Voltage Fluctuation network for residential and residential housing.
/Scintillation Emmision Not Applicable
IEC61000-3-3

An approved annex to the electromagnetic standard:

The attachment of the Full Digital Colour Doppler Ultrasonic Diagnostic System may affect its

radiation quantity.These attachments, listed in this section for Full Digital Colour Doppler Ultrasonic

Diagnostic System, have been tested in accordance with international standards to confirm compliance

with radiation standards.Please use only the attachments listed in this section.

When connecting the attachment with the Full Digital Colour Doppler Ultrasonic Diagnostic System,

the user should ensure the electromagnetic compatibility of the Full Digital Colour Doppler Ultrasonic

Diagnostic System.Unless otherwise specified, please use only the EMC standard equipment.

No. Name Cable Length（m） Shielding or Not

1 AC Input Power Cord 1.7 No
2 Equipotential Conductor 1.4 No
3 Power Adapter Cable 1.2 No
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 No. Name Cable Length（m） Shielding or Not
4 TC50 Probe Cable <3 Yes
5 TL40 Probe Cable <3 Yes
6 TC10 Probe Cable <3 Yes
7 TP16 Probe Cable <3 Yes
8 TW40 Probe Cable <3 Yes

Warns
 This equipment is only used by professional medical staff.The equipment/system may cause radio
interference or disrupt the operation of nearby equipment.Mitigation measures may be necessary,
such as recalibrating the direction, resetting the device or shielding the appropriate site.

Guidelines and statements on electromagnetic immunity

The equipment shall be used in the prescribed electromagnetic environment, and the customer or user
shall ensure that the equipment is used in the electromagnetic environment specified below.

Immunity Electromagnetic Environment

IEC60601Test Level Conformity Level
test Guidelines

The ground must be wood, concrete or

ESD ±6 kV Contact ±6 kV Contact tile.
IEC61000- Discharge Discharge If the ground is covered with synthetic
4-2 ±8 kV Air Discharge ±8 kV Air Discharge materials, the relative humidity is at
least 30%.
EFT
Network power quality must be a typical
IEC61000- ±2 kV Power Cable ±2 kV Power Cable
commercial or hospital environment.
4-4

Surge ±1 kV Wire to Wire ±1 kV Wire to Wire

Network power quality must be a typical
IEC61000- ±2 kV Wire to ±2 kV Wire to
commercial or hospital environment.
4-5 Ground Ground

＜5％U（Drop＞95％
T ＜ 5 ％ UT （ Drop ＞ Network power quality must be a typical
Voltage
UT）0.5 Cycle 95％UT）0.5 Cycle commercial or hospital environment.If
Drop, Short
40 ％ UT （ Drop 60 ％ 40％UT（Drop 60％ the Full Digital Colour Doppler
Interruption
UT）5 Cycle UT）5 Cycle Ultrasonic Diagnostic System needs to
and Voltage
70 ％ UT （ Drop 30 ％ 70％UT（Drop 30％ keep running during the outage of the
Change
UT）25Cycle UT）25 Cycle network power supply, we recommend
IEC61000-
＜5％U（Drop＞95％
T ＜ 5 ％ UT （ Drop ＞ that UPS power supply with
4-11
UT）5s 95％UT）5s uninterrupted power supply.

151
PFMF The labor frequency magnetic field
（50/60Hz） should have the characteristic of the
3 A/m 3 A/m
IEC61000- labor frequency magnetic field in typical
4-8 commercial or hospital environment.
Notice 1：UTrefers to the network voltage before applying the test voltage.

Guidelines and statements on electromagnetic immunity

The equipment is expected to be used in the electromagnetic environment specified below, and the
purchaser or user shall ensure that it is used in this electromagnetic environment.
IEC60601 Conformity
Immunity test Electromagnetic Environment Guidelines
Test Level Level

Portable and mobile radio communication devices

should not be more than the recommended
separation distance near any part of the Full
Digital Colour Doppler Ultrasonic Diagnostic
System including cable. The calculation of the
distance and the transmitter frequency
Radio 3 V （ Virtual
corresponding to the formula should be used.
Frequency Value） 3V （ Virtual
Recommended isolated distance:
Transmission 150k ～ Value）
d = 1.2
IEC61000-4-6 80MHz

d = 1.2 80 MHz～800 MHz

d = 2.3 800MHz～2.5GHz
In the formula
P——the maximum output rated power of the
transmitter provided by the transmitter
manufacturer；unit (W)
d——Recommended isolated distance, unit (m)
The field strength of the stationary rf transmitter is
determined by the investigation of the
electromagnetic field, and the frequency range
should be lower than that of the electric flat.
Radiofrequency 3V/m
It may be affected by equipment which
Radiation 80MHz ～ 3 V/m
marked by below sign when nearby them.
IEC61000-4-3 2.5GHz

152
Notice 1：If frequency is beyond 80MHz and 800MHz, the formula for high-frequency section should be
adopted.
Notice 2：These guide may not be suitable for all situations, the propagationof electromagnetic wavewill
be effected by buildings, objects and the absorption and reflection of the body.

*Stationary transmitter field, such as wireless cellular/cordless phones and ground mobile radio base
station, amateur radio, am and FM radio and television broadcasting, etc., the field intensity in theory
can not be predicted.In order to evaluate the electromagnetic environment of the fixed radio frequency
transmitter, the investigation of electromagnetic field should be considered.If the field of the Full Digital
Colour Doppler Ultrasonic Diagnostic System is higher than the frequency of the above application, the
test should be verified to verify its normal operation.If abnormal performance is observed, additional
measures may be necessary, such as redirection and resetting of the equipment.
*If the frequency is from150kHz to80MHz, the field strength should be lower than 3V/m.

The Recommended Isolation Distance Between Portable and Mobile RFCommunication

Equipment and This Equipment

Full Digital Colour Doppler Ultrasonic Diagnostic System is used in the electromagnetic environment of
radiofrequency radiation disturbance.According to the maximum output power communication
equipment, Full Digital Colour Doppler Ultrasonic Diagnostic System of buyers or users can by
maintaining aportable and mobile radio frequency communication equipment (transmitter) and the
minimum distance between the equipmentprevent electromagnetic interference.

The Distance between the Different Frequencies of the Transmitter(m)

Maximum Rated
Output Power of
150 kHz～ 80 MHz 80 MHz～ 800 MHz 800 MHz～ 2.5 GHz
Transmitter（W）
d= 1.2 d = 1.2 d = 2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.20 1.20 2.30

10 3.80 3.80 7.30

100 12.00 12.00 23.00

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The recommended isolated distance, d(m) of those transmitter maximum rated power output not list
above can be determined by the corresponding column in the formula.Here P is the maximum output
rated power provided by the transmitter manufacturer.
Notice 1: If frequency is beyond 80MHz and 800MHz, the formula for high-frequency section should be
adopted.
Nitice2: These guidelines may not be suitable for all situations, and electromagnetic communication is
affected by the absorption and reflection of buildings, objects and bodies.

154
 Appendix AGood Practice for the Pollution Control of
Electronic ProductsConformance Statement

Names and contents of hazardous substances in the product

Hazardous Substances or Elements

Hexavalent Poly
Parts Lead Mercury Cadmium Polybrominated
chromium brominated
（Pb） （Hg） biphenyl ethers
（Cd） biphenyls
（Cr6+） （PBDE）
（PBB）
Plastic shell ○ ○ ○ ○ ○ ○
Metal rack ○ ○ × × ○ ○
Silicone
○ ○ ○ ○ ○ ○
keyboard
Trackball × ○ ○ ○ ○ ○
Wire rod × ○ ○ ○ ○ ○
PCBA × ○ ○ ○ ○ ○
Hard disk ○ ○ ○ ○ ○ ○
○: It indicates that contents of hazardous substances in the all homogeneous materials of the
part are below the limits specified in local standard.
×: It indicates that the content of hazardous substances in at least one homogeneous material of
the part is beyond the limits specified in local standard.
For the products on sale day, the table shows electronic information products by our supply
chain may contain these substances.
Notice: Sold products may or may not contain all of the listed parts.

WARNING: When the service life of the equipment is exceeded, all the wastes (used
batteries, circuit boards, fragile electronic components, etc.) may cause
harm. They should be disposed in accordance with local regulations, rather
than disposed haphazardly.

155
Appendix B Technical Parameters

1. Slice thickness

Probe Types Nominal frequency(MHz) Slice Thickness(mm)

Convex probe TC50 3.5 ≤10

Phased array probeTP16 3.0 ≤10

Linear probeTL40 7.5 ≤10

Transvaginal probeTC10 6.5 ≤10

Volume probeTW40 4.0 ≤10

2. M-mode performance indicators: time display error shall be 10% orless.

3. Reading error of color ultrasound blood flow shall be within ±10%.

4. Other performance parameters of this system shall comply with the requirements of

IEC60601-2-37:2007.

156
Appendix C Acoustic Output Data

Probe Nominal Maximum

Order Operating Control Condition
Types Frequency (MHz) Temperature

1 TC50 3.5 41℃

2 TP16 3.0 40℃

For details, please see “Operating

3 TL40 7.5 38℃ Control Conditions” in Acoustic
Output Report)

4 TC10 6.5 40℃

5 TW40 4.0 41℃

157
 Acoustic Power Output Report Tables
Model: B Probe: Convex probe TC50

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤ Aaprt＞
can
1cm² 1cm²
Maximum Index Value 0.80 0.83 - - - -
pra (MPa) 1.25
P (mW) 35.3 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters Z at maxIp (cm) 4.48
deq(zb) (cm) -
fawf (MHz) 3.15 2.95 - - - -
X (cm) 1.58 - - - -
Dim ofAaprt
Y (cm) 1.31 - - - -
td (µsec) 0.16
prr (Hz) 46
Other
pr at max Ipi (MPa) 2.19
Information
deq at max Ipi (cm) -
Ipa,α at max MI (W/cm²) 34.16
Focus 1 1 - - - -

Operating Focus setting 45mm 45mm - - - -

Control Scanning angle - - - - - -
Conditions Rate of work 5 5 - - - -
Frequency (MHz) 3.5 3.5 - - - -
Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

Remark: B-Mode shares the same emitter with B+B and 4B mode. Therefore, the acoustic output of

B-Mode applies for that of B+B and 4B mode.

158
 Model: B/M Probe: Convex probe TC50

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤ Aaprt＞
can
1cm² 1cm²
Maximum Index Value 0.50 0.10 - 0.10 0.30 -
pra (MPa) 1.25
P (mW) 30.3 - 1.44 -
Min. of
(mW) 8.75
[Pα(zs),Ita,α(zs) ]
zs (cm) 2.44
Associated zbp (cm) 2.44
Acoustic
zb (cm) 4.20
Parameters
z at max Ipi,α (cm) 4.48
deq(zb) (cm) 0.33
fawf (MHz) 2.96 2.95 - 2.96 2.96 -
Dim of X (cm) 1.58 - 1.59 1.59 -
Aaprt Y (cm) 1.30 - 1.30 1.30 -
td (µsec) 0.16
prr (Hz) 46
Other
pr at max. Ipi (MPa) 3.10
Information
deqatmax.Ipi (cm) 0.32
Ipa,αat max.MI (W/cm²) 40.12
Focus 1 1 - 1 1 -
Focus setting 45mm 45mm - 45mm 45mm -
Operating
Scanning angle - - - - - -
Control
Speed 2 - - 2 2 -
Conditions
Rate of work 5 5 - 5 5 -
Frequency (MHz) 3.5 3.5 - 3.5 3.5 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for
transcranial or neonatal head, it is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide
any information about MI and TI.

159
 Model: C/PD Probe: Convex probe TC50

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤ Aaprt＞
an
1cm² 1cm²
Maximum Index Value 0.70 0.50 - - - -
pra (MPa) 1.31
P (mW) 68.2 - - -
Min. of
(mW) -
[Pα(zs),Ita,α(zs) ]
zs (cm) -
Associated
zbp (cm) -
Acoustic
zb (cm) -
Parameters
z at max Ipi,α (cm) 4.47
deq(zb) (cm) -
fawf (MHz) 2.50 2.50 - - - -
X (cm) 1.49 - - - -
Dim of Aaprt
Y (cm) 1.20 - - - -
td (µsec) 1.10
prr (Hz) 4000
Other
pr at max. Ipi (MPa) 1.88
Information
deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 36.14
Focus 1 1 - - - -
Focus setting 45mm 45mm - - - -
Operating
Scan angle - - - - - -
Control
Conditions M Speed - - - - - -
Rate of work 5 5 - - - -
Frequency(MHz) 2.5 2.5 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

160
 Model: PW Probe: Convex probe TC50

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤ Aaprt＞
an
1cm² 1cm²
Maximum Index Value 0.30 0.80 - 1.29 0.50 -
pra (MPa) 0.48
P (mW) 68.2 - 152.91 -
Min. of
(mW) 10.15
[Pα(zs),Ita,α(zs) ]
zs (cm) 2.81
Associated zbp (cm) 4.69
Acoustic
zb (cm) 2.81
Parameters
z at max Ipi,α (cm) 4.20
deq(zb) (cm) 9.27
fawf (MHz) 2.50 2.50 - 2.50 2.50 -
X (cm) 6.30 - 6.30 6.30 -
Dim of Aaprt
Y (cm) 1.30 - 1.30 1.30 -
td (µsec) 2.46
prr (Hz) 4000
Other
pr at max. Ipi (MPa) 1.27
Information
deqatmax.Ipi (cm) 3.82
Ipa,αat max.MI (W/cm²) 32.25
Focus 1 1 - 1 1 -
Focus setting 45mm 45mm - 45mm 45mm -
Operating
Scan angle - - - - - -
Control
M Speed 67.8 67.8 - 67.8 67.8 -
Conditions
Rate of work 5 5 - 5 5 -
Frequency(MHz) 2.5 2.5 - 2.5 2.5 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for
transcranial or neonatal head, it is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide
any information about MI and TI.

161
 Model: B Probe: Phased array probe TP16

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤ Aaprt＞
can
1cm² 1cm²
Maximum Index Value 0.91 0.80 - - - -
pra (MPa) 1.45
P (mW) 42.0 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters z at max Ipi,α (cm) 4.58
deq(zb) (cm) -
fawf (MHz) 2.15 2.15 - - - -
X (cm) 0.83 - - - -
Dim of Aaprt
Y (cm) 1.45 - - - -
td (µsec) 0.49
prr (Hz) 32.5
Other
pr at max. Ipi (MPa) 2.47
Information
deqat max.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 33.21
Focus 1 1 - - - -

Operating Focus setting 55mm 55mm - - - -

Control Scan angle - - - - - -
Conditions Frame frequency 5 5 - - - -
Rate of work 2.5 2.5 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for
transcranial or neonatal head, it is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide
any information about MI and TI.

Remark: B-Mode shares the same emitter with B+B and 4B mode. Therefore, the acoustic output of

Mode B applies for that of B+B and 4B mode.

162
 Model: B/M Probe: Phased array probe TP16

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤1 Aaprt＞
can
cm² 1cm²
Maximum Index Value 0.60 0.20 - 0.06 0.37 -
pra (MPa) 1.56
P (mW) 42.1 - 6.5 -
Min. of
(mW) 4.66
[Pα(zs),Ita,α(zs) ]
zs (cm) 1.85
Associated zbp (cm) 1.86
Acoustic
zb (cm) 4.92
Parameters
z at max Ipi,α (cm) 5.26
deq(zb) (cm) 0.16
fawf (MHz) 2.25 2.25 - 2.25 2.25 -
X (cm) 0.83 - 0.83 0.83 -
Dim of Aaprt
Y (cm) 1.46 - 1.45 1.45 -
td (µsec) 0.496
prr (Hz) 65
Other
pr at max. Ipi (MPa) 2.40
Information
deqatmax.Ipi (cm) 0.15
Ipa,αat max.MI (W/cm²) 40.12
Focus 1 1 - 1 1 -
Focus setting 55mm 55mm - 55mm 55mm -
Operating
Scan angle - - - - - -
Control
Conditions M Speed 2 - - 2 2 -
Rate of work 5 5 - 5 5 -
Frequency(MHz) 2.5 2.5 - 2.5 2.5 -
Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

163
 Model: C/PD Probe: Phased array probe TP16

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤ Aaprt＞
can
1cm² 1cm²
Maximum Index Value 0.60 0.40 - - - -
pra (MPa) 1.50
P (mW) 10.3 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters z at max Ipi,α (cm) 5.25
deq(zb) (cm) -
fawf (MHz) 2.00 2.00 - - - -
X (cm) 0.85 - - - -
Dim of Aaprt
Y (cm) 1.44 - - - -
td (µsec) 0.496
prr (Hz) 5000
Other
pr at max. Ipi (MPa) 2.49
Information
deqat max.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 181.80
Focus 1 1 - - - -
Focus setting 55mm 55mm - - - -
Operating
Scan angle - - - - - -
Control
Conditions Speed(cm/s) - - - - - -
Rate of work 5 5 - - - -
Frequency(MHz) 2.5 2.5 - - - -
Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

164
 Model: PW Probe: Phased array probe TP16

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤1 Aaprt＞
can
cm² 1cm²
Maximum Index Value 0.20 0.10 - 0.86 0.80 -
pra (MPa) 0.53
P (mW) 10.3 - 72.93 -
Min. of [Pα(zs),Ita,α(zs) ] (mW) 7.36
zs (cm) 4.60

Associated zbp (cm) 2.49

Acoustic zb (cm) 4.66
Parameters z at max Ipi,α (cm) 4.39
deq(zb) (cm) 6.13
fawf (MHz) 2.65 2.65 - 2.65 2.65 -
X (cm) 0.85 - 0.85 0.85 -
Dim of Aaprt
Y (cm) 1.44 - 1.44 1.44 -
td (µsec) 2.291
prr (Hz) 6000
Other pr at max. Ipi (MPa) 1.05
Information deqatmax.Ipi (cm) 2.77
Ipa,αat max.MI (W/cm²) 22.57
Focus 1 1 - 1 1 -
Focus setting 55mm 55mm - 55mm 55mm -
Operating
Scan angle - - - - - -
Control
Conditions M Speed 60.3 60.3 - 60.3 60.3 -
Rate of work 5 5 - 5 5 -
Frequency(MHz) 2.5 2.5 - 2.5 2.5 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

165
 Model: B+C+PW Probe: Phased array probe TP16

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.22 0.00 - 0.8631 0.02 1.77
pra (MPa) 0.38
P (mW) 0.07 - 117.32 117.32
Min. of
(mW) 0.00
[Pα(zs),Ita,α(zs) ]
zs (cm) 4.66
Associated
zbp (cm) 2.49
Acoustic
Parameters zb (cm) 4.66 4.66
z at max Ipi,α (cm) 6.39
deq(zb) (cm) 7.78
fawf (MHz) 2.50 2.50 - 2.50 2.50 2.50
X (cm) 1.54 - 1.54 1.54 1.54
Dim of Aaprt
Y (cm) 1.40 - 1.40 1.40 1.40
td (µsec) 3.06
prr (Hz) 5000
pr at max. Ipi (MPa) 0.63
Other
Information deqatmax.Ipi (cm) 635.20
Ipa,αat max.MI (W/cm²) 37.24
Focus 1 1 - 1 1 1
Focus setting 55mm 55mm - 55mm 55mm 55mm
Operating
Scan angle - - - - - -
Control
Conditions Speed(cm/s) 60.3 60.3 - 60.3 60.3 60.3
Rate of work 5 5 - 5 5 5
Frequency(MHz) 2.5 2.5 - 2.5 2.5 2.5
Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it is
not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

166
 Model: CW Probe: Phased array probe TP16

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.22 - - 0.167 0.40 0.24
pra (MPa) 0.05
P (mW) - - 16.13 16.13
Min. of
(mW) 8.60
[Pα(zs),Ita,α(zs) ]
zs (cm) 3.64
Associated
zbp (cm) 2.55
Acoustic
Parameters zb (cm) 3.66 3.66
z at max Ipi,α (cm) 6.39
deq(zb) (cm) 3.16
fawf (MHz) 2.50 - - 2.50 2.50 2.50
X (cm) - - 1.63 1.63 1.63
Dim of Aaprt
Y (cm) - - 1.40 1.40 1.40
td (µsec) 4.00
prr (Hz) 10000
pr at max. Ipi (MPa) 0.07
Other
Information deqatmax.Ipi (cm) 0.51
Ipa,αat max.MI (W/cm²) 40.56
Focus 1 - - 1 1 1
Focus setting 55mm - - 55mm 55mm 55mm
Operating
Scan angle - - - - - -
Control
Conditions Speed(cm/s) 56.5 - - 56.5 56.5 56.5
Rate of work 5 - - 5 5 5
Frequency(MHz) 1.6 - - 1.6 1.6 1.6
Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it is
not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

167
 Model: B Probe: Linear probe TL40

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤ Aaprt＞
can
1cm² 1cm²
Maximum Index Value 1.00 1.10 - - - -
pra (MPa) 2.91
P (mW) 34.2 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters z at max Ipi,α (cm) 1.92
deq(zb) (cm) -
fawf (MHz) 6.90 6.90 - - - -
X (cm) 0.96 - - - -
Dim of Aaprt
Y (cm) 0.50 - - - -
td (µsec) 0.228
prr (Hz) 27
Other
pr at max. Ipi (MPa) 4.39
Information
deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 43.3
Focus 1 1 - - - -

Operating Focus setting 20 mm 20 mm - - - -

Control Scan angle - - - - - -
Conditions Frame frequency 5 5 - - - -
Rate of work 7.5 7.5 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

Remark: B-Mode shares the same emitter with B+B and 4B mode. Therefore, the acoustic output of

Mode B applies for that of B+B and 4B mode.

168
 Model: B/M Probe: Linear probe TL40

TIS TIB

Index Label MI Non-scan TIC

Non-sc
Scan Aaprt≤1 Aaprt＞ an
cm² 1cm²
Maximum Index Value 0.70 0.10 0.10 - 0.10 -
pra (MPa) 1.99
P (mW) 3.91 2.3 2.3 -
Min. of
(mW) -
[Pα(zs),Ita,α(zs) ]
zs (cm) -
Associated zbp (cm) -
Acoustic
zb (cm) 1.91
Parameters
z at max Ipi,α (cm) 1.91
deq(zb) (cm) 0.26
fawf (MHz) 6.25 6.25 6.25 - 6.25 -
Dim of X (cm) 0.97 0.97 - 0.97 -
Aaprt Y (cm) 0.50 0.50 - 0.50 -
td (µsec) 0.228
prr (Hz) 254
Other
pr at max. Ipi (MPa) 4.34
Information
deqatmax.Ipi (cm) 0.26
Ipa,αat max.MI (W/cm²) 113.89
Focus 1 1 1 - 1 -
Focus setting 20mm 20mm 20mm - 20mm -
Operating
Scan angle - - - - - -
Control
Conditions Speed 2 - 2 - 2 -
Rate of work 5 5 5 - 5 -
Frequency(MHz) 7.5 7.5 7.5 - 7.5 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

169
 Model: C/PD Probe: Linear probe TL40

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 1.00 0.30 - - - -
pra (MPa) 1.12
P (mW) 34.5 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters z at max Ipi,α (cm) 1.93
deq(zb) (cm) -
fawf (MHz) 5.50 5.50 - - - -
X (cm) 0.55 - - - -
Dim of Aaprt
Y (cm) 0.51 - - - -
td (µsec) 0.228
prr (Hz) 8000
Other
pr at max. Ipi (MPa) 4.23
Information
deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 137.89
Focus 1 1 - - - -
Focus setting 20mm 20mm - - - -
Operating
Scan angle - - - - - -
Control
Conditions Speed - - - - - -
Rate of work 5 5 - - - -
Frequency(MHz) 5.0 5.0 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

170
 Model: PW Probe: Linear probe TL40

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.50 0.60 - 0.37 0.20 -
37
pra (MPa) 1.02
P (mW) 10.5 - 18.54 -
Min. of
(mW) 6.14
[Pα(zs),Ita,α(zs) ]
zs (cm) 2.40
Associated zbp (cm) 2.77
Acoustic
zb (cm) 2.20
Parameters
z at max Ipi,α (cm) 2.03
deq(zb) (cm) -
fawf (MHz) 4.97 4.97 - 4.97 4.97 -
X (cm) 0.93 - 0.93 0.93 -
Dim of Aaprt
Y (cm) 0.61 - 0.61 0.61 -
td (µsec) 1.119
prr (Hz) 5000
Other pr at max. Ipi (MPa) 1.76
Information deqatmax.Ipi (cm) 0.57
Ipa,αat max.MI (W/cm²) 57.24
Focus 1 1 - 1 1 -
Focus setting 20mm 20mm - 20mm 20mm -
Operating
Scan angle - - - - - -
Control
Conditions Speed 44.1 44.1 - 44.1 44.1 -
Rate of work 5 5 - 5 5 -
Frequency(MHz) 5.0 5.0 - 5.0 5.0 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

171
 Model: B+C+PW Probe: Linear probe TL40

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤1 Aaprt＞
can
cm² 1cm²
Maximum Index Value 0.50 0.60 - 0.37 0.00 0.39
pra (MPa) 1.02
P (mW) 0.02 - 29.03 29.03
Min. of
(mW) 9.61
[Pα(zs),Ita,α(zs) ]
zs (cm) 2.40
Associated
zbp (cm) 2.77
Acoustic
Parameters zb (cm) 2.40 2.40
z at max Ipi,α (cm) 2.03
deq(zb) (cm) 3.76
fawf (MHz) 4.98 4.98 - 4.98 4.98 4.98
X (cm) 3.84 - 3.84 3.84 3.84
Dim of Aaprt
Y (cm) 0.70 - 0.70 0.70 0.70
td (µsec) 1.93
prr (Hz) 4000
pr at max. Ipi (MPa) 1.77
Other
Information deqat max.Ipi (cm) 0.93
Ipa,αat max.MI (W/cm²) 38.13
Focus 1 1 - 1 1 1
Focus setting 20mm 20mm - 20mm 20mm 20mm
Operating Scan angle - - - - - -
Control Speed(cm/s) 35.3 35.3 - 35.3 35.3 35.3
Conditions
Rate of work 5 5 - 5 5 5
Frequency(MHz) 5.0 5.0 - 5.0 5.0 5.0

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3:If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI

172
 Model: B Probe: Transvaginal probe TC10

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.50 0.60 - - - -
pra (MPa) 1.38
P (mW) 14.2 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -
Associate zbp (cm) -
d Acoustic
zb (cm) -
Parameter
s z at max Ipi,α (cm) 2.77
deq(zb) (cm) -
fawf (MHz) 6.00 6.00 - - - -
X (cm) 0.65 - - - -
Dim of Aaprt
Y (cm) 0.70 - - - -
td (µsec) 0.283

Other prr (Hz) 60.7

Informatio pr at max. Ipi (MPa) 2.27
n deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 80.89
Focus 1 1 - - - -

Operating Focus setting 25mm 25mm - - - -

Control Scan angle - - - - - -
Conditions Frame frequency 5 5 - - - -
Rate of work 6.5 6.5 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

Remark: B-Mode shares the same emitter with B+B and 4B mode. Therefore, the acoustic output of

Mode B applies for that of B+B and 4B mode.

173
 Model: B/M Probe: Transvaginal probe TC10

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.50 0.10 0.07 - 0.10 -
pra (MPa) 1.36
P (mW) 14.3 2.4 2.4 -
Min. of
(mW) -
[Pα(zs),Ita,α(zs) ]
zs (cm) -
Associated zbp (cm) -
Acoustic
zb (cm) 2.72
Parameters
z at max Ipi,α (cm) 2.76
deq(zb) (cm) 0.45
fawf (MHz) 5.23 5.23 5.23 - 5.23 -
X (cm) 0.66 0.66 - 0.66 -
Dim of Aaprt
Y (cm) 0.71 0.71 - 0.71 -
td (µsec) 0.292
prr (Hz) 250
Other
pr at max. Ipi (MPa) 2.26
Information
deqatmax.Ipi (cm) 0.43
Ipa,αat max.MI (W/cm²) 86.79
Focus 1 1 1 - 1 -
Focus setting 25mm 25mm 25mm - 25mm -
Operating
Scan angle - - - - - -
Control
Conditions Speed 2 - 2 - 2 -
Rate of work 5 5 5 - 5 -
Frequency(MHz) 6.5 6.5 6.5 - 6.5 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

174
 Model: C/PD Probe: Transvaginal probe TC10

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤1 Aaprt＞
can
cm² 1cm²
Maximum Index Value 0.50 0.20 - - - -
pra (MPa) 1.32
P (mW) 4.5 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters z at max Ipi,α (cm) 2.82
deq(zb) (cm) -
fawf (MHz) 5.13 5.72 - - - -
X (cm) 0.66 - - - -
Dim of Aaprt
Y (cm) 0.71 - - - -
td (µsec) 0.290
prr (Hz) 4000
Other
pr at max. Ipi (MPa) 2.15
Information
deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 88.23
Focus 1 1 - - - -
Focus setting 25mm 25mm - - - -
Operating
Scan angle - - - - - -
Control
Conditions Speed - - - - - -
Rate of work 5 5 - - - -
Frequency(MHz) 5.0 5.0 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

175
 Model: PW Probe: Transvaginal probe TC10

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤ Aaprt＞
an
1cm² 1cm²
Maximum Index Value 0.10 0.20 - 0.40 0.30 0.48
pra (MPa) 0.65
P (mW) 4.5 - 4.5 4.5
Min. of
(mW) 7.52
[Pα(zs),Ita,α(zs) ]
zs (cm) 2.42
Associated zbp (cm) 0.99
Acoustic
zb (cm) 2.42
Parameters
z at max Ipi,α (cm) 3.89
deq(zb) (cm) 2.47
fawf (MHz) 5.25 5.25 - 5.25 5.25 5.25
X (cm) 0.60 - 0.60 0.60 0.60
Dim of Aaprt
Y (cm) 0.71 - 0.71 0.71 0.71
td (µsec) 1.321
prr (Hz) 6100
Other pr at max. Ipi (MPa) 0.53
Information deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 2.77
Focus 1 1 - 1 1 1
Focus setting 25mm 25mm - 25mm 25mm 25mm
Operating
Scan angle - - - - - -
Control
Conditions Speed 60.3 60.3 - 60.3 60.3 60.3
Rate of work 5 5 - 5 5 5
Frequency(MHz) 5.0 5.0 - 5.0 5.0 5.0

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

176
 Model: B Probe: Volume probe TW40

TIS TIB
Non-scan
Index Label MI Non-s TIC
Scan Aaprt≤1 Aaprt＞
can
cm² 1cm²
Maximum Index Value 0.65 070 - - - -
pra (MPa) 1.05
P (mW) 30.5 - - -
Min. of [Pα(zs),Ita,α(zs) ] (mW) -
zs (cm) -

Associated zbp (cm) -

Acoustic zb (cm) -
Parameters z at max Ipi,α (cm) 4.50
deq(zb) (cm) -
fawf (MHz) 3.62 3.62 - - - -
X (cm) 1.38 - - - -
Dim of Aaprt
Y (cm) 1.12 - - - -
td (µsec) 0.45
prr (Hz) 37
Other
pr at max. Ipi (MPa) 1.94
Information
deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 32.58
Focus 1 1 - - - -

Operating Focus setting 60mm 60mm - - - -

Control Scan angle - - - - - -
Conditions Rate of work 5 5 - - - -
Frequency(MHz) 4.0 4.0 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

Remark: B-Mode shares the same emitter with B+B and 4B mode. Therefore, the acoustic output of

Mode B applies for that of B+B and 4B mode.

177
 Model: B/M Probe: Volume probe TW40

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.70 0.10 - 0.12 0.40 -
pra (MPa) 1.05
P (mW) 64.4 - 12.4 -
Min. of
(mW) 6.75
[Pα(zs),Ita,α(zs) ]
zs (cm) 1.44
Associated zbp (cm) 1.36
Acoustic
zb (cm) 6.38
Parameters
z at max Ipi,α (cm) 4.45
deq(zb) (cm) 0.33
fawf (MHz) 3.45 3.45 - 3.45 3.45 -
X (cm) 1.58 - 1.59 1.59 -
Dim of Aaprt
Y (cm) 1.30 - 1.30 1.30 -
td (µsec) 0.469
prr (Hz) 41
Other
pr at max. Ipi (MPa) 3.10
Information
deqatmax.Ipi (cm) 0.32
Ipa,αat max.MI (W/cm²) 32.58
Focus 1 1 - 1 1 -
Focus setting 60mm 60mm - 60mm 60mm -
Operating
Scan angle - - - - - -
Control
Conditions Speed 2 - - 2 2 -
Rate of work 5 5 - 5 5 -
Frequency(MHz) 4.0 4.0 - 4.0 4.0 -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

178
 Model: C/PD Probe: Volume probe TW40

TIS TIB
Non-scan
Index Label MI Non-sc TIC
Scan Aaprt≤1 Aaprt＞
an
cm² 1cm²
Maximum Index Value 0.50 0.40 - - - -
pra (MPa) 1.05
P (mW) 48.2 - - -
Min. of
(mW) -
[Pα(zs),Ita,α(zs) ]
zs (cm) -
Associated zbp (cm) -
Acoustic
zb (cm) -
Parameters
z at max Ipi,α (cm) 4.47
deq(zb) (cm) -
fawf (MHz) 2.25 2.25 - - - -
X (cm) 1.59 - - - -
Dim of Aaprt
Y (cm) 1.30 - - - -
td (µsec) 0.465
prr (Hz) 3000
Other
pr at max. Ipi (MPa) 3.23
Information
deqatmax.Ipi (cm) -
Ipa,αat max.MI (W/cm²) 14.55
Focus 1 1 - - - -
Focus setting 60mm 60mm - - - -
Operating
Scan angle - - - - - -
Control
Conditions Speed - - - - - -
Rate of work 5 5 - - - -
Frequency(MHz) 2.5 2.5 - - - -

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

179
 Model: PW Probe: Volume probe TW40

TIS TIB
Non-scan
Index Label MI Non-sca TIC
Scan Aaprt≤ Aaprt＞
n
1cm² 1cm²
Maximum Index Value 0.40 1.00 - 2.73 0.70 2.14
pra (MPa) 0.80
P (mW) 68.2 - 228.04 228.04
Min. of
(mW) 6.22
[Pα(zs),Ita,α(zs) ]
zs (cm) 3.27
Associated zbp (cm) 4.69
Acoustic
zb (cm) 3.27
Parameters
z at max Ipi,α (cm) 5.54
deq(zb) (cm) 11.68
fawf (MHz) 3.32 3.32 - 3.32 3.32 3.32
X (cm) 6.40 - 6.40 6.40 6.40
Dim of Aaprt
Y (cm) 1.20 - 1.20 1.20 1.20
td (µsec) 2.237
prr (Hz) 3600
Other
pr at max. Ipi (MPa) 1.50
Information
deqatmax.Ipi (cm) 5.74
Ipa,αat max.MI (W/cm²) 52.57
Focus 1 1 - 1 1 1
Focus setting 60mm 60mm - 60mm 60mm 60mm
Operating
Scan angle - - - - - -
Control
Conditions Speed 73.4 73.4 - 73.4 73.4 73.4
Rate of work 5 5 - 5 5 5
Frequency(MHz) 2.5 2.5 - 2.5 2.5 2.5

Note 1: For the mode which does not produce the largest value of TIS, it is not necessary to provide any
information of TIS formula.
Note 2: For any transducer assembly which is not intended to be used for transcranial or neonatal head, it
is not necessary to provide any information about TIC.
Note 3: If it meets exemptions of 51.2aa) and 51.2dd) for the equipment, it is not necessary to provide any
information about MI and TI.

No. 3510000389

180