Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch

(Ultrasound Color Doppler Diagnostic Scanner)User's Manual

Information

Code: CC18-H-002

Revision: SJ

ISSUE DATE: 2019-04

CE Declaration

This product is provided with a CE marking in accordance with the regulations stated in
Council Directive 93/ 42/ EEC of June 14, 1993 concerning Medical Devices. Shenzhen
Lanmage Medical Technology Co., Ltd., is certified by notified body TUV Rheinland
Product Safety GmbH. with notified No.0197 to the EC Commission.

Authorized EC Representative:
Company: Lotus NL B.V.
Address: Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
E-mail: [email protected]
Tel: +31645171879 (English), +31626669008（Dutch）

Manufactured by

Shenzhen Lanmage Medical Technology Co., Ltd.

Address: 1st Floor, Building B Jingchengda Industrial Park,No.4 keji road, Langxin
Community, Shiyan Street, 518000 Bao'an District, Shenzhen China (Hereinafter to
be referred to as: Lanmage)
Shenzhen Lanmage Medical Technology Co., Ltd. is a sub-company of Shenzhen
Landwind Industry Co., Ltd. dedicated to R&D, manufacturing and marketing of
ultrasound imaging, radiology solutions etc.
Lanmage, abbreviated from Landwind Imaging, is a sub-brand of Landwind Medical.
Tel: +86-755- 66869896
Fax: +86-755- 66869896
Postal code: 518000.
Production date: see the machine.
Usage period: 5 years.
Customer service center: 400-888-6452.

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 All rights reserved.
This Manual and the information contained herein are proprietary information of
Shenzhen Lanmage Medical Technology Co., Ltd. No information or any part hereof
can be copied, reproduced, compiled, modified, distributed or transmitted, in any
form or by any means, without the prior written consent of Shenzhen Lanmage
Medical Technology Co., Ltd. This Manual is intended for users who are authorized
to use such Manual as a part of the product purchased from Lanmage Use of this
Manual by unauthorized personnel is strictly forbidden.

Shenzhen Lanmage Medical Technology Co., Ltd. makes no representations or

warranties of any kind concerning the document, express or implied, including,
without limitation, warranties of merchantability and fitness for a particular purpose.
Although every effort has been exerted to ensure the accuracy of the information
contained herein, Shenzhen Lanmage Medical Technology Co., Ltd. assumes no
liabilities for any errors or omissions and reserves the right to modify the product to
improve its reliability, function or design without further notice. Shenzhen Lanmage
Medical Technology Co., Ltd. may modify or improve the product or program
described herein at any time.

The product may contain recycled parts whose performance is equivalent to brand-
new parts or rarely used parts.

Instructions before Use

Users must read and understand the instructions carefully before use. The following warning
symbols are used in this manual. The user must know the meanings of these symbols before
operating the instrument.

Warning: Indicates a danger. Warnings are intended to alert you to the importance of
following the correct operating procedures where risk of injury to the patient or
system user exists. Do not proceed to any further operation until the specified
conditions are fully understood and satisfied.

Caution: Indicates a danger. Cautions are intended to alert you to the importance of
following correct operating procedures to prevent the risk of damage to the system.
Do not proceed to any further operation until the specified conditions are fully
understood and satisfied.

Note: Notes contain special information concerning the proper use of the system

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 and/or additional instructions.

Safety Classification
1. Type of protection against electrical shock: Class I equipment
2. Degree of protection against electrical shock: Type BF equipment
3. Degree of protection against harmful ingress of water: Ordinary equipment
4. Degree of safety of application in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide: Do not use this equipment in
an environment in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
5. Operation mode: Continuous operation

Requirements for the Installation Site

D Install this instrument in an environment with a sound earthling system.

D Never install this instrument in a place beside water and chemicals.
D Never install this instrument in a place vulnerable to harmful conditions, such
as direct sunshine, high temperature, excessive humidity and dust, and it shall
be operated and stored in a place with good air environment, free from
corrosive substances including the salt, alkali and sulfur.
D Avoid the excess inclination, swinging, impact and other unstable elements
during installation.
D Make sure that there are no other instruments producing strong magnetic field
near the Scanner.

Warranty
Please do not disassemble this instrument on your own. The warranty does not
include the following items, even during the warranty period:
1. Disassemble the instrument on your own.
2. Damage or loss resulting from disoperation or improper use (any application
beyond the application scope of this instrument).
3. Damage or loss due to the failure to follow regulations on power supply, installation and
operating conditions.
4. Damage or loss caused by the installation, modification and checkup or repair by an
unauthorized service engineer.
5. Damage or loss caused by natural disasters, such as fires, earthquakes, lightning, and
So on.

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 Environmental

Lanmage designs the ultrasound diagnostic system according to the requirements

of safety and environmental protection. If user does not disassemble the instrument
or perform an improper use, the system will not cause any harm to anyone and
environment. In accordance with the requirement of regulations, if materials that may be
hazardous to the environment must be used, they should be disposed properly.

Warning:

D Do not dispose the waste of ultrasound diagnostic system together with industrial waste
and household garbage.

D According to the local and national environment protection law, the waste generated by
ultrasound diagnostic system must be dispose properly, and the equipment should be
properly processed when it reaches its service life.

D Recycling the recyclable materials by qualified Waste Management, thereby reducing

environment pollution.

For relevant information, please contact the Lanmage service department, or dispose the
waste properly according to local refuse collection method.

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Table of Contents
TABLE OF CONTENTS.........................................................................................................................................5
CHAPTER 1 SAFETY PRECAUTIONS...................................................................................................................9
1.1 Safety Information...............................................................................................................................9
1.1.1 Safety Classification.......................................................................................................................9
1.1.2 Electrical Safety..............................................................................................................................9
1.1.3 Ultrasound Safety Information General......................................................................................12
1.1.4 Mechanical Safety........................................................................................................................18
1.1.5 Acoustic Output Limits.................................................................................................................18
1.1.6 Probe Surface Temperature.........................................................................................................20
1.1.7 Electromagnetic Compatibility....................................................................................................20
CHAPTER 2 INTRODUCTION...........................................................................................................................27
2.1 User’s Manual.....................................................................................................................................27
2.2 Working Theories...............................................................................................................................27
2.3 Intended Use......................................................................................................................................27
2.4 Imaging Modes...................................................................................................................................28
2.5 General View......................................................................................................................................28
2.6 Connectors..........................................................................................................................................31
2.7 Probe...................................................................................................................................................34
2.7.1 Probe Types and Scanning Principles..........................................................................................34
2.7.2 Probe Connection.........................................................................................................................34
2.7.3 Selecting Active Probe..................................................................................................................35
2.7.4 Probe Applications.......................................................................................................................35
2.8 Peripherals..........................................................................................................................................35
2.8.1 List of Peripherals.........................................................................................................................35
2.8.2 Connections of Peripheral Devices...............................................................................................36
2.9 Control Panel......................................................................................................................................36
2.9.1 Control Panel Brightness..............................................................................................................37
2.9.2 Introduction of Control Panel Buttons.........................................................................................37
2.10 System Symbols................................................................................................................................45
CHAPTER 3 STARTING EXAMINATIONS..........................................................................................................47
3.1 System Start-up and Running Sequence Inspection.........................................................................47
3.1.1 System Start-up............................................................................................................................48
3.1.2 System Operation.........................................................................................................................48
3.1.3 System Continuous Operation.....................................................................................................48
3.1.4 System Shutdown.........................................................................................................................49
3.2 Information on the Imaging Screen...................................................................................................49
3.3 Patient Information............................................................................................................................50
3.3.1 New Patient information.............................................................................................................50
3.3.2 Previous patients..........................................................................................................................51
3.4 Probe and Exam Items.......................................................................................................................51
3.5 End Exam............................................................................................................................................52
CHAPTER 4 OPTIMIZING THE IMAGE.............................................................................................................53
4.1 Imaging Mode.....................................................................................................................................53
4.2 B Mode................................................................................................................................................53
4.2.1 B mode Operating Steps..............................................................................................................54
4.2.2 B mode Parameter Settings.........................................................................................................54
4.3 Dual-B Mode.......................................................................................................................................58
4.4 M Mode..............................................................................................................................................60
4.4.1 M mode Operating Methods.......................................................................................................60
4.4.2 M mode Parameter Settings........................................................................................................60
4.5 Color Mode.........................................................................................................................................62
4.5.1 Color mode Operating Methods..................................................................................................62
4.5.2 Color mode Parameter Settings...................................................................................................62
4.6 PDI Mode (Power Doppler Imaging Mode).......................................................................................66
4.6.1 PDI mode Operating Steps...........................................................................................................66
4.6.2 PDI mode Parameter Settings......................................................................................................67
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4.7 Pulse-wave Doppler (PW)..................................................................................................................67
4.7.1 PW mode Operating Steps...........................................................................................................68
4.7.2 PW mode Parameter Settings......................................................................................................69
4.8 4D Mode.............................................................................................................................................73
4.8.1 3D Mode.......................................................................................................................................73
4.8.2 4D Mode.......................................................................................................................................83
4.9 CW imaging model (optional)............................................................................................................83
4.10 LanScape (optional)..........................................................................................................................84
4.13 Tissue Doppler Imaging (TDI) (optional)............................................................................................85
CHAPTER 5 SCAN/DISPLAY FUNCTION...........................................................................................................87
5.1 Image Zoom........................................................................................................................................87
5.2 Image Freeze......................................................................................................................................87
5.3 CINE Mode..........................................................................................................................................88
5.3.1 Cine loop.......................................................................................................................................89
5.3.2 Cine Editing...................................................................................................................................89
5.3.3 Cine Storage..................................................................................................................................90
5.3.4 Thumbnails...................................................................................................................................90
5.3.5 Cine Review..................................................................................................................................91
5.4 Image Annotation...............................................................................................................................92
5.4.1 Mark Annotation..........................................................................................................................93
5.4.2 Text Annotation............................................................................................................................94
5.4.3 Arrow Annotation........................................................................................................................94
5.5 Biopsy.................................................................................................................................................95
5.5.1 Introduction..................................................................................................................................95
5.5.2 Adjustment of Biopsy Guideline..................................................................................................96
5.5.3 Biopsy-supporting Modes............................................................................................................96
5.5.4 Disposable Protective Case..........................................................................................................97
5.5.5 Patient Preparations....................................................................................................................98
5.5.6 Puncture........................................................................................................................................99
CHAPTER 6 MEASUREMENTS AND CALCULATIONS....................................................................................101
6.1 Measurement Overview..................................................................................................................101
6.1.1 Measurement Interface.............................................................................................................101
6.1.2 Caliper Type................................................................................................................................102
6.1.3 Default Measurement Methods and Units................................................................................103
6.1.4 Basic Measurement Procedures................................................................................................103
6.2 General Measurement.....................................................................................................................104
6.2.1 General 2D-mode Measurements and Calculations.................................................................104
6.2.2 General M Mode Measurements and Calculations..................................................................108
6.2.3 General Doppler mode Measurements and Calculations.........................................................110
6.2.4 Measurement Errors..................................................................................................................112
6.3 Special Measurement......................................................................................................................114
6.3.1 Abdominal Measurement..........................................................................................................114
6.3.2 Gynecological Measurement.....................................................................................................117
6.3.3 Obstetric Measurement.............................................................................................................119
6.3.4 Urological Measurement...........................................................................................................126
6.3.5 Vascular Measurement..............................................................................................................128
6.3.6 Small Parts Measurement..........................................................................................................132
6.3.7 Orthopedic Measurement..........................................................................................................134
6.3.8 Cardiology Measurement..........................................................................................................135
6.3.9 Transcranial Measurement........................................................................................................147
6.3.10 Emergency Medicine Measurement........................................................................................148
CHAPTER 7 RECORD OF IMAGES AND REPORTS..........................................................................................151
7.1 Worksheet and Report.....................................................................................................................151
7.1.1 Report Viewing...........................................................................................................................151
7.1.2 Worksheet Viewing....................................................................................................................155
7.2 Storage of Image and Report...........................................................................................................156
7.2.1 Reviewing Image and Report.....................................................................................................156
7.2.2 Export Image and Report...........................................................................................................156

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7.3 Data Transmission............................................................................................................................158
7.4 Add a Printer....................................................................................................................................159
7.4.1 Connected to an Analog Signal Printer.....................................................................................160
7.4.2 Connected to a Digital Signal Printer........................................................................................160
7.5 Report Printing.................................................................................................................................161
7.5.1 Print Preview..............................................................................................................................161
7.5.2 Report Printing...........................................................................................................................161
7.6 DICOM Connection...........................................................................................................................161
7.6.1 DICOM Storage...........................................................................................................................162
CHAPTER 8 PRESET........................................................................................................................................163
8.1 Preset................................................................................................................................................163
8.1.1 Operation methods of preset.....................................................................................................163
8.1.2 System Preset.............................................................................................................................163
8.1.3 Exam Preset................................................................................................................................167
8.1.4 Measure Preset...........................................................................................................................168
8.1.5 Text Preset..................................................................................................................................174
8.1.6 Body Mark Preset.......................................................................................................................175
8.1.7 Network Preset...........................................................................................................................177
8.1.8 Peripheral Preset........................................................................................................................178
8.1.9 Service Preset.............................................................................................................................181
8.1.10 Acquire Settings........................................................................................................................183
CHAPTER 9 MAINTENANCE..........................................................................................................................185
9.1 Caring for the System.......................................................................................................................185
9.1.1 Daily Checklist............................................................................................................................185
9.1.2 Maintenance...............................................................................................................................185
9.2 Cleaning and Disinfecting System Parts..........................................................................................186
9.3 Caring for and Using Probes............................................................................................................188
9.3.1 Using Probes...............................................................................................................................188
9.3.2 Cleaning and Disinfection..........................................................................................................190
9.3.3 Storage........................................................................................................................................191
9.3.4 Protective Case...........................................................................................................................191
9.3.5 Helpful Hints for Endocavity Probes..........................................................................................191
9.3.6 Protect shell................................................................................................................................192
9.3.7 Caring Coupling Agent...............................................................................................................192
Appendix A Specifications........................................................................................................................193
A.1 Working, Storage and Transport Environment and Packaging..................................................193
A.2 Probe Surface Temperature..........................................................................................................194
A.3 Monitor..........................................................................................................................................194
A.4 DVD-Drives....................................................................................................................................194
A.5 Power Supply.................................................................................................................................194
A.6 Imaging Modes.............................................................................................................................195
A.7 Regulatory Compliance.................................................................................................................196

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Chapter 1 Safety Precautions

1.1 Safety Information

1.1.1 Safety Classification

The system complies with IEC 60601-1 (IEC 60601--1) and is classified as follows:
It is classified as class I equipment according to type of protection against electrical shock;
It is classified as type BF applied parts according to degree of protection against electrical
shock;
It is classified as ordinary equipment according to protection against harmful ingress of liquids
or particulate matter;
It is classified as equipment unsuitable for use according to suitability degree for use in a
flammable anesthetic mixture with air, oxygen or nitrous oxide;
It is classified as continuous operation according to mode of operation.

1.1.2 Electrical Safety

The system is provided with a cable which has a removable power plug with a grounding
contact connecting to the grounding part of the cable. Accordingly, the wall outlet should be
connected to the protective earthling systems of the room where the system is to be operated.

Note: To avoid electrical shock, never modify the ultrasound system’s AC power connector
plug as doing so may overload your equipment’s power circuits. To ensure grounding reliability,
connect the system only to an equivalent outlet.

Note: Using an extension cord or multi-socket outlet setup to provide power to the
imaging system or to the system’s peripheral devices, may compromise the system
grounding and cause your system to exceed leakage current limits.

Note: Operators of the instrument shall be qualified service-trained professionals or shall use
the instrument under the supervision of qualified professionals.

Warning: Maintenance is prohibited during equipment use.

Warning: Connect the system only to a sound wall outlet provided with a protective ground
lead and therefore use only a proper power cable. You are not allowed to remove or
disconnect the ground lead, no matter when.

The system is equipped with an equipotential terminal to connect a potential equalizing wire
(a copper wire of at least 4mm²cross-sectional area) to the protective earthling system of the
room where the system is to be operated.
The operating room should be provided with a wall outlet having a grounding contact. The state

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of both wall outlet and wiring in the operating room should be inspected by qualified personnel.

Note: Install the system only in rooms intended for medical use. The system complies with the
IEC 60601-1 Electrical Safety Requirements (IEC 60601-1).

Warning: if the system keeps making alarming sound, please

D Turn off the system, and

D Contact Lanmage client service center

The alarming sound is a warning of non-functioning of the cooling fan. Operation of the
system must be ceased under such condition to avoid malfunction.
Observe the following guidelines to ensure safety:
D Do not remove the cover of the system.

D Operate the system in the room complying with the Sanitary Norms and Rules when
Operating Equipment Producing Ultrasound Transmitted to Operators’ Hands through
Contact, No. 2282 – 80.

D The operating room should at least occupy an area of 20 m 2, and each system should be
installed in a separate room.

D Ensure the following environment is maintained in the operating room: Temperature:

22℃, relative humidity: 40% - 60%, air flow velocity: ≥0.15m/sec

D Check the state of wall outlets in a regular manner;

D Do not remove the plug out of the outlet by pulling the wire;

D Replace mains fuses, and pull the power cable plug out of the wall outlet. Do not install
fuses that do not correspond to the current value specified;

D Do not place any foreign objects into the system components;

D To ensure normal thermal conditions when operating the system, and not to install the
system near space heaters, ovens, etc.;

D When the system is applied on patients, it should not be connected to any peripherals
such as PC and printer, which fail to comply with IEC 60601-1 in terms of electrical safety
features, unless special isolating devices are used complying with the requirements of
IEC 60601-1

Caution: The power characteristics should comply with those of industrial enterprises and/or
health care institutions.

Caution: The system should be provided with an uninterrupted power supply (UPS) in places
where the main power supply is likely to suspend temporarily. Otherwise, the service warranty

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clause will become invalid automatically.

Caution: Do not operate the system near the sources of heat, strong electrical and magnetic
fields such as transformers as well as close to equipment generating high- frequency signals,
for example, electrosurgical units (ESUS)). Failure to comply with this requirement will have a
negative impact on ultrasound image quality and the subsequent diagnosis.

Caution: Do not remove the system hood due to the presence of dangerous voltage. When
the system is being used, the control panel shall be in place. All internal adjustments and
replacements should only be conducted by qualified service-trained Lanmage customer
service professionals.

Caution: Equipment connected to the ultrasound system and located in the patient zone must
be powered from a medically-isolated power source or must be a medically- isolated device.
Equipment powered from a non-isolated source can result in chassis leakage currents
exceeding safe levels. Chassis leakage current created by an accessory or device connected
to a non-isolated outlet may add to the chassis leakage current of the ultrasound system.

Caution: To make electrical or mechanical connection between this instrument and the
equipment of other manufactures, confirm that it complied with the IEC 60601-1 standard, and
recheck the leakage current and other safety indices of the entire set of system, to avoid
possible hazard arising from leakage current overlapping.

Caution: To avoid electrical shock and damage to the ultrasound system, shut down and
disconnect the equipment from the AC power source before cleaning and disinfection.

Caution: Do not use the system in an environment with combustible gases or anesthetic, to
avoid explosions.

Caution: Do not use the system in damp or wet environments. Keep it away from
inflammables and explosives.

Caution: Do not pour any fluid onto the system surfaces, as fluid seepage into the electrical
circuitry may cause excessive leakage current or system failure.

Caution: To avoid the possibility of static shock and damage to the system, avoid using
aerosol spray cleaners on the monitor screens.

Caution: Use the probe with care. Do not use damaged probes. Do not use probes with cracks
or surface crimps, since such probes might have their insulation damaged, which easily

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causes electric shock to patients.

Caution: When the system is displaced to a room with a higher temperature from one with a
lower temperature, it is highly recommended to turn on the system several hours later when
the temperature inside the system has been stabilized.

Caution: Do not attempt to modify the instrument. If it is really necessary to do so, please
notify us or our agent.

Caution: Operators of the instrument shall be qualified service-trained professionals or shall

use the instrument under the supervision of qualified professionals.

Caution: To maintain the safety and functionality of the ultrasound system, maintenance must
be performed every 12 months. Electric safety test must be performed at periodic intervals at
regular intervals as specified by local safety regulations, or as needed.

Caution: Upon the expiration of the service life of the system, please notify your dealer or
Lanmage to handle properly.

Caution: Although the instrument is manufactured according to the existing EMI/EMC

requirement, its use in electromagnetic environments may still cause instantaneous
attenuation of the ultrasound images. If such a phenomenon often occurs, Lanmage
recommends you to check the system operating environment to locate the possible radiation
sources. Such radiation may arise from other electric devices in the same or neighboring room.
Such communication devices as phones and pagers may generate such radiation, and such
devices as radio receivers, TVs or microwave transmitting devices in proximity may also
produce such radiation. If electromagnetic interferences exist, please move the instrument to
another place.

EMC Note: Operating the ultrasound imaging system in close proximity to sources of strong
electromagnetic fields, such as radio transmitter stations or similar installations may lead to
interference visible on the monitor screen. However, the device has been designed and tested
to withstand such interference and will not be permanently damaged.

1.1.3 Ultrasound Safety Information General

Caution: For neonatal head imaging, Lanmage recommends that you exercise special care
during neonatal cephalic scanning to avoid possible damage to the posterior region of the eye.
The ultrasound energy emitted by the probe easily penetrates the fontanels of the infant.

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Caution: To avoid possible damage, without doctor’s guidance, it prohibits from using the
working probe scan the eye directly.

Caution: Lanmage makes every effort to manufacture safe and effective probes. You must
take all necessary precautions to eliminate the possibility of exposing patients, operators, or
third parties to hazardous or infectious materials. These precautions should be considered in
the use of any application that may indicate the need for such care, and during end cavity
scanning; during biopsy or Biopsy procedures; or scanning patients with open wounds.

Caution: To eliminate the possibility of exposing patients, operators, or third parties to

hazardous or infectious materials, handle dangerous or infectious materials all along according
to the medical specifications for handling biohazard castoffs.

Caution: The assessment of biological effects of diagnostic ultrasound on humans is a subject

of ongoing scientific research. This system and all diagnostic ultrasound procedures should be
used for valid reasons, for the shortest period of time, and at the lowest mechanical and
thermal indices necessary to produce clinically acceptable images.

Caution: Do not use the system if irregular and unusual repeated video refreshes occur.
Discontinuous scanning frequency is a hardware fault, please remove it before use.

Caution: Use the diagnostic ultrasound only when there is a good medical reason, minimize
exposure times, and select the lowest scanning power value required to create images that are
suitable for clinical exam.

Caution: When making ultrasonic scanning, the instrument shall be used with ultrasound
coupling agent, and no biologic compatibility problem is found. However, to ensure safety, only
qualified ultrasound coupling agent in compliance with related standard shall be used.

Caution: If error information occurs to the video display, it indicates that a danger happens to
the system; please suspense the use of the system immediately. Record the error information,
turn off the system, and notify your supplier.

Warning: The system is not intended for Trans orbital or other ophthalmologic exams!

Warning: To ensure the safety of examined patients, do not scan the same part of an
examined patient consecutively for a long period of time.

Warning: The values of the mechanical index (MI) and technical index (TI) are not applicable
for ophthalmologic ultrasound. Take special cautions when scanning the head of a fetus to

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avoid damage to the posterior region of the eye.

Warning: To avoid any patient health hazard, use probes to examine only those exam zones,
where a given probe is intended for.

Warning: Take Caution when contrast substances are used to scan heart, abdominal. Cavity
and other organs. Be careful that the lower the MI value is, the less possible ultrasonic
cavitation is.

Warning: Lanmage recommends adhering to the principles of ALARA (as low as reasonably
achievable). In accordance with these principles, a physician shall select the lowest ultrasound
exposure (the lowest ultrasound intensity and exposure time) that produces diagnostically
acceptable information and, in doing so, minimize harmful effect risk.

Warning: Ultrasound power is better transmitted through water than tissues. The actual MI
and TI values may be higher than those displayed on the imaging screen when buffer
materials such as gel pad are used.

Mechanical Index (MI)

Mechanical Index which indicates the potential for mechanical bio effect is calculated as the
peak rare factional pressure (unit: Map) at a tissue damping coefficient of 0.3 dB/cm/MHz
Map divided by the square root of the center frequency of the transmitted field in MHz By
using MI, the risk for mechanical bio effects when acquiring diagnostically acceptable images
will be reduced as much as possible. The higher the MI value is, the higher this risk is.
However, the actual occurrence of bio effects cannot be judged in terms of MI. In all imaging
modes, the system will display MI in real-time.
Please change ultrasound transmission power, mode set, probe type and/or focus position
depth to change MI value.

Thermal Index (TI)

Thermal index (TI) indicates a temperature rise in about 1℃.

The purpose of displaying TI is to warn the user about conditions which may cause
temperature to rise. TI is the ratio of the acoustic signal power to the power causing a
temperature rise in 1°С (value based on the temperature model). There are three thermal
indices which are based on specific temperature model respectively to evaluate the
temperature rise near the surface of and inside soft tissue when the ultrasound beam passes
through soft tissue and focuses on the immediate vicinity of bone:

D Soft tissue thermal index (TIS): indicates the potential temperature rise of soft
tissue when ultrasound beam passes through and focuses on them.

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D Cranial thermal index (TIC): indicates the potential temperature rise of bones near
the beam’s entrance into the body when ultrasound beam passes through the body.

D Bone tissue thermal index (TIB): indicates the potential temperature rise where the
ultrasound beam passes through soft tissue and a focal region is in the immediate
vicinity of bone.

D Both MI and TI are relative indicators which reflect potential temperature rise. The
higher the MI or TI value is, the higher the temperature rise is. They provide a relative
value for applying the concept of ALARA.

Please change the ultrasound transmission power, mode set, probe type, focus number,

Focus position depth, scanning depth and/or other parameters to change TI value.

Mechanical Index and Thermal Index Errors

MI and TI errors are dependent on probe type used and the laboratory measurement errors of
ultrasound intensity.

Mechanical Index and Thermal Index Interpretation

The principal obligation of the user is to ensure the safety of the patient. To organize his work
properly, the user should be well aware of the equipment can be the source of hazard. It is
impossible to evaluate the level of hazard without the correct interpretation of MI and TI.

Ultrasound exposure parameters: thermal index (TI) and mechanical index (MI).

At present, the dependence of the immediate ultrasound bio effects on ultrasound output
parameters such as sound intensity and sound pressure is still under research. Two principal
mechanisms of such dependence have been found, namely, the thermal mechanism and the
mechanical mechanism.

It is known that the likelihood of temperature rise and cavitation is determined by total output,
operation mode, ultrasound beam shape, focus position, frame frequency and time factor. TI
and МI must take all these factors into account and provide the user with information about
possible thermal and mechanical effects in tissues. Since MI and TI which indicate current
output conditions and do not take into account of accumulation effects (especially, heating)
throughout the exam period, it has been found that the likelihood of cavitation tend to rise with
increase in the negative peak pressure in tissues. TI makes it possible to evaluate
approximately the potential temperature rise in a certain location of tissue in the ultrasound
beam path. The approximation of such evaluation is conditioned by a great number of factors
affecting the temperature rise. Under such circumstances, there are no index value which can
provide an exhaustively full evaluation of the actual temperature rise for all possible
conditions and tissue types. It only means that, for a given particular ultrasound beam shape,
TI = 2 (the value that corresponds to a temperature rise in a model specimen of 2°C) reflects
a greater temperature rise in tissue than TI = 1. The temperature rise in the actual tissue,

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however, is not 2°C. Refer to the following for a detail description of the limitation regarding
the use of MI and TI.

It should also be kept in mind that the margin of safety for MI and TI has not been established.
Researches on margin of safety based on bio effects, up to now, are rather fragmentary and
still at the development stage. However, it has been found that the temperature rise in
embryonic or fetal tissue of not below 41°C (i.e., 5°C above the normal temperature) within 5
minutes must be considered potentially hazardous. Potential hazards are also considered
present in cases where ultrasound exams with a sound pressure amplitude near the
pulmonary tissue of a neonate not below 1MPa at MI=0.7 (Pinter mode) or MI=0.5 (Resold
mode) as well as any ultrasound exams at a frequency of above4 MHz with MI=0.5.Moreover,
in the obstetric practice, ultrasound scanning modes in which TI value is higher than 1.0
should be preferably avoided to comply with the reasonable margin of safety recommended
by WFUMB. If an acceptable diagnostic result is unable to be achieved under such conditions,
a short-time output increase is permitted. But, any additional thermal load on the fetus is
impermissible if the body temperature of the mother has gone up.

The models created to forecast TI take into account of the cooling effect of tissue with blood
flowing through it. Therefore, TI value should be maintained at a lower level if the hem
perfusion of the tissue under exam is poor. However, if the organs scanned are known to be
well washed with blood, for example, liver and heart, TI value can be maintained at a higher
level.

In some cases, when the soft tissues to be examined as well as bones behind them are
present in the scanning region, TIB (the thermal index for bone) other than TIS (the soft
tissue thermal index) should be used for a better gauge of temperature rise. Such a situation
occurs in examining the female breast, as well as in vascular exams if a vessel lies on a bone
surface. MI becomes of special importance in examining heart when lungs (the ‘gas-soft
tissue’ boundary) may be in the scanning region. The likelihood of cavitations is especially
high in ultrasound exams with the application of bubble materials. In such exams, the
limitation of the MI should be paid special attention. In summing up, the following should be
emphasized once more:

Note: Monitoring MI is of special importance in the exanimations with the application of a

contrast (bubble) material, scanning heart (the possible presence of lungs in the scanning
region) as well as abdominal exams (the possible presence of intestinal gases in the scanning
region). It is less important to trace MI in the absence of gas-containing cavities in the
scanning region, i.e., in examining most parenchymatous organs, muscles, etc.

Note: Monitoring TI is of special importance in the exanimations of pregnant women

(especially during the first trimester); embryo’s skull and vertebral column; a patient having

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body temperature rising; any tissue with poor hems perfusion; as well as any ophthalmologic
exams. Where ribs or other bones are present in the scanning region, TIB should be preferably
used instead of TIS. It is of less important to trace TI in examining tissues with good hem
perfusion such as liver and spleen, in scanning heart as well as in vascular exams.

Note: In a scanning mode, a temperature rise in the surface of soft tissue is always higher than
that in bone deep. But this is not the case sometimes, and Caution should be therefore taken
in interpreting TI values in both B mode and Doppler mode for second and third trimesters of
pregnancy.

Note: In cavities filled with liquid, ultrasound power could not be absorbed to such substantial
extent as expected from model calculations. So the values of MI and TI can often be
underestimated when ultrasonic scans through a full urinary bladder or amniotic fluid.

Note: TI is not intended for use in ophthalmologic practice and cannot be used in assessing
thermal effects in ophthalmologic exams.

Note: In a scanning mode, TI values give an idea about tissue heating near the probe surface
which is only based on an absorbed ultrasound beam power but take no account of a
temperature rise in tissue due to contact with the surface heated up by the probe , though this
temperature rise can be rather significant.

Note: The displayed TI values are averaged values and should not, therefore, be interpreted
as the actual temperature rise (unit: °C). TI and MI calculation models are based on many
simplifications of an actual situation. Therefore, it should be born in mind, in some especially
unfavorable situations; the actual temperature rise can be three times as much as the
displayed TI value.

Note: Unlike X-Ray beams, an unfavorable bioeffect of ultrasound on tissues only manifests in
situations where it exceeds certain threshold value. For instance, temperature of a scanned
tissue portion that goes up within a range of 37°C to 41°C is acceptable for a rather prolonged
period while a temperature elevation of up to 45°C is impermissible: no cavitations effect and
therefore, no bioeffect would occur below the threshold level.

Note: A preferable exam approach, in terms of safety, would appear as follows: first, set the
lowest index and then increase it until a satisfactory image or a Doppler signal is produced.
Exposure time is another important parameter. Lanmage recommends that you select the
lowest possible exposure time that produces diagnostically acceptable information.
Maximal values of each index and corresponding control parameters
Refer to Appendix B for the maximal values of each index and corresponding control
parameters. The index values are given for each of the probes used in accordance with IEC
60601-2-37 (GB 9706.9) standard.
Maximal acoustic parameters and corresponding control parameters

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Refer to Appendix B for nominal values of each index and corresponding control parameters
for each of the probes used in accordance with IEC 61157 (GB 16846) standard.

1.1.4 Mechanical Safety

Warning: Be aware of wheels and control panel, especially when you moved the machine.
Depending on its configuration and accessories, the weight of the system could be over 88
kilograms, it might cause bodily injury when the machine roll over a foot or press against tibia.
The control panel can be turned right or left, Land wind recommends pushing but not pulling
when moving the machine. Beware especially when moving on a slope.

Warning: Use only the probe cable holder provided by Lanmage.

Caution: Ensure all probe cables are safe. Avail of the cable management system for ensuring
the probe cables are free from damage. When moving the diagnostic equipment or attempting
to go over obstacles, don’t use the probe cable hook to lift up or pull the system.

Note: The wheels of the system are installed with brakes. The wheels can be locked with
stepping down on brakes, and freed when the brakes are lifted. The brakes should be released
when moving the system.

Note: If the system does not function properly after moving, please contact your supplier
immediately. The installation of each component within the system can be relied upon and can
suffer relative great force, but excessive force could cause malfunction to the system.

Note: In the process of machine use, pay attention to the load bearing of each part. Being
overweight may damage the machine parts. The main load-bearing components: keyboard
panel 5kg, probe hook 1kg, probe placed rack 2kg, 2kg storage basket.

1.1.5 Acoustic Output Limits

Transmission Power
The system is provided with the function of displaying ultrasound power. The mechanical and
thermal indices enabling ultrasound power transmitted to the patient to be monitored and
limited.
The range of power transmission (scanning signal amplitude) is -18dB～0dB. The selection
Of 0dB (or 100%), in conjunction with other controls or functions of the system, sets the
maximum sound intensity and the mechanical index of each probe where:

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≤720mW / cm2, MI≤1.9

Use the power transmission presets of the system.
Please refer to Table 1.1 for the possible transmission power values.

Table 1.1 Possible Transmission Power Values

0 -6dB -12dB -18dB(-15dB)

100% 50% 25% 12% (18%)

The system ensures the real-time displaying of scanning parameters on the field of the active
probe in all imaging modes.
The real-time display of output power provides the user with the relevant information
related to ultrasound intensity.

Warning: The use is responsible for selecting the signal level used. To adjust transmission
power applied to the patient through the probe, use the respective keys on the system
control panel. Please refer to the introduction to keys in Chapter 2 System Controls for the
application of available keys. Rotate [Select] and move the cursor to select [A. Power],
and click to adjust the transmission power. As the fundamental function of the system, it
determines the transmission power of all probes and modes in the period of real-time
scanning. However, it is not the only factor to influence MI and TI.
The range and, in particular, the maximum value of MI and TI vary with probes. In addition, MI
and TI preset values are provided for each type of diagnostic exam.

Imaging Functions That Change Acoustic Output

Warning: Monitor the real-time display of MI and TI all times.

Note: In addition to rotate [Select] and move the cursor to select [A. Power], and click to adjust
the transmission power, the acoustic output may be affected by such functions or system
controls as follows:
D Power ON/OFF;
D Pulse repetition frequency (PRF) of transmitter emission in PW-mode;
D PRF in Color-mode;
D Exam zone (Zone);
D Focusing, the number of focuses and focus position depth;
D Freeze Mode;
D Imaging depth;
D Color beam density;
D Color sensitivity;
D Color window size in color mapping modes;
D System presets (See Chapter 8 Preset);
D Probe type;
D using a gel pad;

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D Operating mode.

1.1.6 Probe Surface Temperature

The maximum surface temperature of the probe applied to the patient’s body and operating at
the same time of emitting shall not exceed 41°C.

Caution: Be extremely careful! Never to operate a probe whilst emitting without contacting the
patient’s body.
The surface temperature of a probe which is being operated but makes no contact with the
patient’s body may rise until the emission function is cut off automatically (the Freeze Mode
will be automatically activated in 5 minutes).

Caution: A description of the means used to limit the surface heating of INVASIVE
TRANSDUCER ASSEMBLIES to no more than 43 °C in the event of a SINGLE FAULT
CONDITION

1.1.7 Electromagnetic Compatibility

EMC is defined as the ability of the product, equipment or diagnostic system to function with
the requirements in an electromagnetic environment and yet without producing any
unbearable electromagnetic interference to any equipment in such environment.

EMI is defined as the ability of the product, equipment or diagnostic system to function
satisfactorily despite the existence of EMI.

Electromagnetic radiation is the ability of the product, equipment or diagnostic system to

channel the unbearable EMI into the usage environment.

The digital colored ultrasound diagnosis system is made with the existing EMC requirements.
The use of this diagnostic system in a place where magnetic field exists may cause
momentary degradation of ultrasound image. If this phenomenon occurs in high frequency,
the user is recommended to run a check on the environment where the system is in use, in
order to ascertain the possible radiation source. The radiation may come from the same room
or adjoining room where other electrical equipment are in use, or it may also come from
portable and radio-frequency-generated telecommunication equipment such as cell phones or
pagers, or wireless equipment, televisions or microwave transmission equipment in the
vicinity. In case EMI may cause interference to this diagnostic system, it may become
necessary to move the system to another location. The Ultrasound Color Doppler Diagnostic
Scanner has complied with international CISPR 11 standards in radiation and transmission of
EMI. Due to achieving such standards, this diagnostic system can be used in all facilities
(except civil use or the public low voltage supply network that directly connects to buildings
intended for civil use).

EMC Tests includes all n that pertains to the relevant electromagnetic radiation and

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interference resistance of the diagnostic equipment. They ensure the operating environment
of the diagnostic equipment can fulfill all the prescribed conditions set out in the reference
information. The system functions may be lowered if operating the equipment in an
environment that fails to fulfill these conditions.

Preferable operation conditions and electromagnetic compatibility levels of digital colored

Doppler diagnostic scanner is given in Table 1.2 and 1.3.The system is designed to be
operated in the designed electromagnetic environment.

Table 1.2 —Electromagnetic emissions

Guidance and manufacturer’s declaration — electromagnetic emissions
The models Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner are intended for
use in the electromagnetic environment specified below. The customer or the user of
the Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch series scanner should assure that they
are used in such an environment.
Emissions test Compliance Electromagnetic environment —guidance

The models Mirror 2 Touch/Mirror 5 Touch/Mirror 8

Touch scanner use RF energy only for their
RF
Group 1 internal function. Therefore, the RF emissions are
emissions
very low and are not likely to cause any
CISPR 11
interference in nearby electronic equipment.

The models Mirror 2 Touch/ Mirror 5 Touch/ Mirror 8

RF
Class A Touch scanners are suitable for use in all
emissions
CISPR 11 establishments other than domestic, and may be
Harmonic used in domestic establishments and those directly
Emissions Class A connected to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for domestic
purposes, provided the following warning is needed.
Warning: The models Mirror 2 Touch/Mirror 5
Touch/Mirror 8 Touch scanners are intended for use
by healthcare professionals only. The models Mirror
Voltage 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner
Fluctuations/ flicker may cause radio interference or may disrupt the
Complies
emissions operation of nearby equipment. It may be necessary
IEC 61000-3-3 to take mitigation measures, such as re-orienting or
relocating the models Mirror 2 Touch/Mirror 5
Touch/Mirror 8 Touch scanners or shielding the
location.

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Table 1.3 Guidance and declaration —Electromagnetic immunity

Guidance and Declaration — electromagnetic immunity

The models Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner are intended for use in the
electromagnetic environment specified below. The customer or the user of the Mirror 2 Touch/Mirror 5
Touch/Mirror 8 Touch scanner should assure that it is used in such an environment.

IEC 60601 Electromagnetic environment

Immunity test Compliance level
test level — guidance

Floors should be wood, concrete or

Electrostatic ±8kV contact ±8kV contact
ceramic tile. If floors are covered with
discharge (ESD) ±2kV, ±4kV, ±8kV, ±2kV, ±4kV, ±8kV,
synthetic material, the relative
IEC 61000-4-2 ±15kV air ±15kV air
humidity should be at least 30%.

±2kV for power ±2kV for power

Electrical fast
supply lines supply lines
transient/burst
±1kV for signal ±1kV for signal
IEC 61000-4-4 Mains power quality should be that
input/output lines output lines
of a typical commercial or hospital
±0.5 kV, ± 1 k V ±0.5 kV, ± 1 k V environment.
Surge line to line; line to line;
IEC 61000-4-5 ±0.5 kV, ± 1 k V,± 2 ±0.5 kV, ± 1 k V,± 2 k
k V line to ground V line to ground

<5% UT <5% UT
Mains power quality should be that
(>95% dip in UT) (>95% dip in UT) For
of a typical commercial or hospital
for 0.5 cycle 0.5 cycle
environment. If the user of the Mirror
Voltage dips, short <5% UT <5% UT
2 Touch/ Mirror 5 Touch/ Mirror 8
interruptions and (>95% dip in UT) (>95% dip in UT)
Touch scanner requires continued
voltage variations for 1 cycles for 1 cycles
operation during power mains
on power supply 70% UT 70% UT
interruptions, it is recommended that
input lines (30% dip in UT) (30% dip in UT)
the Mirror 2 Touch/Mirror 5 Touch/
IEC 61000-4-11 for 25/30 for 25/30
Mirror 8 Touch scanner be powered
cycles cycles
<5% UT <5% UT from an uninterruptible power supply
or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5/6 sec for 5/6 sec

Power frequency magnetic

Power frequency
Fields should be at levels
(50/60 Hz)
30 A/m 30 A/m characteristic of a typical location in
Magnetic field
a typical commercial or hospital
IEC 61000-4-8
environment.
Note：UT is the a.c. mains voltage prior to application of the test level.

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Table 1.4 —Guidance & Declaration-electromagnetic immunity concerning

Conducted RF & Radiated RF
Guidance and Declaration — electromagnetic immunity
The models Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner are intended for use in the
electromagnetic environment specified below. The customer or the user of the Mirror 2 Touch/Mirror 5
Touch/Mirror 8 Touch scanner should assure that it is used in such an environment.

Complianc Electromagnetic environment

Immunity test IEC 60601 test level
e level — guidance

Portable and mobile RF communications

equipment should be used no closer to any
part of the Mirror 2 Touch/Mirror 5
Touch/Mirror 8 Touch scanner, including
cables, than the recommended separation
distance calculated from the equation
3Vrms 3Vrms applicable to the frequency of the
150kHz to 80MHz 150kHz to 80MHz transmitter. Recommended separation
Conducted RF Distance
１２
IEC 61000-4-6 d=[3.5/V3]×P /

6 Vrms in ISM 6 Vrms in ISM

bands bands
１２
d=1.2× P / 80MHz to 800 MHz
１２
d=2.3×P / 800MHz to 2.7GHz
3V/m 3V/m
Where P is the maximum output power
Radiated RF 80MHz to 2.7GHz 80MHz to 2.7GHz
rating of The transmitter in watts (W)
IEC 61000-4-3 according to the transmitter manufacturer
385MHz-5785MHz 385MHz-5785MHz
and d is the recommended separation
Test Test
distance in meters (m).
specifications for specifications for
Field strengths from fixed RF
ENCLOSURE ENCLOSURE
transmitters, as determined by an
PORT IMMUNITY PORT IMMUNITY
electromagnetic site survey, a should be
to RF wireless to RF wireless
less than the
communication communication
compliance level in each frequency range. b
equipment equipment
Interference may occur in the vicinity of
Symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption
and reflection from structures, objects and people
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner is
used exceeds the applicable RF compliance level above, the Mirror 2 Touch/Mirror 5
Touch/Mirror 8 Touch scanner should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 1.5 Recommended separation distance between portable and mobile RF

communications equipment and the models Mirror 2 Touch/Mirror 5 Touch/Mirror 8
Touch scanner
Recommended separation distances between portable and mobile RF communications
equipment and the Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner
The Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner are intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the Mirror
2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Mirror 2 Touch/Mirror 5 Touch/Mirror 8 Touch scanner as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output m
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W ２ １２ １２
d = 1.2 ×PV d =1.2× P / d = 2.3 × P /
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Note: The production and usage of this equipment may emit some radio frequency energy.
Equipment may cause radio frequency interference for other medical and non- medical
equipment and radio communication. To prevent to produce such interference, this product
has passed the tests that confirmed its compliance with electromagnetic compatibility (EMC)
requirements of IEC 60601-1-2, which is from European standard (EN60601-1-2). The IEC
standard used for European norms in Europe. But the company does not guarantee would
never have interference in individual installation environment.

Note: If found the equipment emerge interference which can be determined through open and
close the equipment. Users (or qualified maintenance personnel) should take the following one
or more measures to solve interference problems:

D Adjusting the affected equipment direction or location.

D Add the distance between this equipment and the affected equipment.
D Using other power supply (not affected equipment used) for this equipment.
D Contact the after-sales maintenance personnel of the Lanmage Company in time.

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Note: For the following caused circumstances of EMC interference, the manufacturer shall not
be responsible for: Using the other Internet cables which not recommended. Apart or refit the
equipment without permission.

Note: All of the enclosure should be closed when operate system, ensure the intactness of the
machine before system operating, it may affect the system EMC performance in the enclosure
open operating system.

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Chapter 2 Introduction

2.1 User’s Manual

User’s Manual, introduces the system basic performance, safety precautions, imaging mode,
measurements and calculations, and maintenance of probe and system.

This manual contains all the necessary and sufficient information for securely operating the
system and the after-sales service personnel of Lanmage will provide advanced training for
operators within the valid period of agreement. Before you try to use this system, please
make sure you have read and understood all of the information contained in this manual.

Note: Please always keep this manual being placed next to the device, and periodically review
relevant operation procedures and security considerations.

2.2 Working Theories

Under the system control signal, the transmitting circuit will generate transmitting actuating
signal that will be formed into transmitting high-voltage pulse via the high voltage driver, this
group of high-voltage pulse is sent to the array element of the corresponding probe via the
multiplexer T/R switch, resulting in the ultrasound of specific frequency, delay and intensity.

The ultrasonic echo signals that are reflected back by the human tissues are received by the
same set of array elements and converted into the echo electrical signals, which will directly
enter the high-speed analog-to-digital converter (ADC) via pre-amplification and pretreatment
of gain compensation, and ADC will carry out the signal sampling and generate the digital
signal in quantization.

The sophisticated dynamic delay of digital echo signal can be realized by using the
programmable logic devices, and then carry out beam synthesis. The beam synthesis is
composed of dynamic focusing, dynamic aperture and dynamic iodization as well as other
processing procedures.

The signals of beam synthesis adopt dynamic filtering, amplitude detection, second sampling,
dynamic range conversion, time and space filtering, frame processing as well as other signal
and image processing technologies so as to improve the image resolution; the processed
image data will be sent to the host control system via digital scan conversion to achieve real-
time image display and interaction.

2.3 Intended Use

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Touch series Ultrasound Color Doppler Diagnostic Scanner is intended to be used in the
ultrasound diagnostic of the human body. It is applicable for adults, pregnant women,
pediatric patients and neonates.

It is used for ultrasound diagnosis on tissue organs, which is applicable to Abdomen,

gynecology and obstetrics, urology, blood vessels, small organs, such as heart, emergency
treatment and pediatric diagnosis.

2.4 Imaging Modes

This system is able to support the measurements in B Mode, M Mode, Color Mode, PDI
Mode, PW Mode and THI Mode, etc.

2.5 General View

This system is configured in standard version. Its front view and left view are shown in the
figures below.

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Front view of the system

1. Monitor (LCD) 2. Control panel 3.Probe cable hook

4.Probe connection port 5. Wheel 6. Probe Holder

7. Gel Bottle Holder 8. Storage basket 9. Host

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Back view of the system

1. Monitor brightness adjustment button 2. Input/output Port

3. Power Supply Panel 4. DVD R/W drive

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2.6 Connectors

I/O Panel:

Serial number Icon Name

1 USB Port

2 Ethernet Connection Port

3 DVI Output

4 VGA Output

5 Audio Input

6 Composite video input

7 S-video Input

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Serial number Icon Name

8 RS-232-C Serial Port

9 VGA Input

10 Audio Output

11 Composite video Output

12 S-video Output

13 Printer Port

14 Printer Remote Port

Power supply panel:

1. Power switch 2. Power input jack 3. Fuse

4. Grounding terminal 5. Auxiliary output 150VA 6. Auxiliary output 20VA

Monitor Keys:
Keys in the rear of the monitor can directly adjust the settings of monitor brightness and
contrast. You can use the menu options to adjust the other settings of the monitor.

Note: Language settings of the monitor menu are separate from language settings of the
ultrasonic system.

Note: The manufacturer defaults the settings of monitor brightness, contrast and backlight
control as imaging presets defined by the manufacturer. Adjusting monitor brightness, contrast

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and backlight control may have an impact on the image optimization effects arising from
preset values defined by the manufacturer.
In order to guarantee consistency in the process of image reproduction, you should adjust
brightness and contrast of the image monitor before adjusting print quality of the installed
recording equipment.
The monitor has the functions of automatic adjustment, contrast adjustment, brightness
adjustment, backlight control, reset and exit, as shown in the figure below, through which you
can adjust these controls to match your preferences, and make it in line with the lighting
conditions of the room.

The back wall of the system is respectively attached with a nameplate (top) for full-digital
color ultrasonic diagnosis system and a label for system warning (bottom), on which relevant
information about the system is noted.

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2.7 Probe

2.7.1 Probe Types and Scanning Principles

This system mainly uses the following electronic scanning ultrasonic probes: convex
array probe (e.g.C2-5) and linear array probe (e.g.L5-10).
The following figure shows the overall view of the ultrasonic probe configured in the
system and its scanning principles.

Overall view of electronic scanning probe and its scanning principles

A) Convex array probe; B) Linear array probe
All probes have more than one frequency spot. Probe is an applied part of the system,
and users can connect four probes on the ultrasonic imaging system, but there is only
one probe to be activated at the same moment. Probe configurations are based on your
contract of purchase, as shown in the following table.
Model Type Center Frequency
C1-5 Convex Probe 3.5 MHz
C2-5 Convex Probe 3.5 MHz
L5-10 Linear Probe 7.5 MHz
L4-13 Linear Probe 7.5 MHz
EC4-9 Endocavity Probe 6.5MHZ
C4-9MC Micro Convex Probe 6.5 MHz
C4-9ER Convex Probe 6.5 MHz
P2-3 Phased array Probe 2.5 MHz
P1-4 Phased array Probe 2.5 MHz
4C2-5n Convex Probe 4 MHz

2.7.2 Probe Connection

Note: Before connecting or disconnecting the probe, make sure that "Freeze" mode is
enabled!

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Plug the probe connector into a free socket. Turn the probe lock-lever to lock position.
Ensure that the probe sits tight. Four probes can be simultaneously connected to the
system: one is connected to Port A, one to Port B and other to Port C and D. There is a
label attached on the probe connector, listing the probe name, serial number, and etc.

2.7.3 Selecting Active Probe

Press [Probe] on the control panel to enter probe selection menu. The system will list the
probe connected to the system. If the probe port is not connected with a probe, the probe
area will display a blank; if there is only one probe connected to the system, the system
will default this probe as the active probe.

2.7.4 Probe Applications

Note: Please make sure that the ultrasonic probe is always applied in accordance with the
intended uses that are prescribed for the related exam items in the following table.

Probe

Exam Subjects C1-5 P2-3 EC4-9

L5-10 L4-13 4C2-5n C4-9MC
C2-5 P1-4 C4-
9ER
Abdomen + + + +

Gynecology + + + +

Obstetrics + + +

Urology +

Carotid artery + +

Peripheral arterial + +

Intravenous +

small organs + +

Heart +

pediatric

musculoskeletal + +
* Including probes in the Item of the basic system.
** Not including probes in the Item of the basic system. They can be available if required
by customers.

2.8 Peripherals

2.8.1 List of Peripherals

The system is configured with the following peripherals:

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D Foot switch (optional);
D Printer (optional).

Note: Please choose the printers recommended by the personnel working in the Lanmage
Customer Service Center, and connect the printer with the system.

2.8.2 Connections of Peripheral Devices

The signal cables of peripheral device shall be connected to the port on the I/O panel of
the system.

Note: when you connect additional peripherals, please observe the following requirements:
when you need to connect this system to the equipment produced by any other
manufacturers for electrical connection or mechanical connection, make sure they conform
to IEC 60601-1 standards, and re-examine leakage current and other safety performance
indicators of the whole system, so as to avoid potential dangers caused by leakage current
overlay.

You can connect this system with LAN of the medical institutions with a category-5 twisted
pair wire (not included in the kit of the system).
Caution: If the system is connected with LAN, the warranty and after-warranty services shall
be implemented in accordance with the independent service agreement signed between the
operating organization and Lanmage.

Caution: Please be careful when you connect this system with LAN (i.e. Ethernet). To do
this kind of connection, consult Lanmage Customer Service Center. Any person who
connects this medical unit with other devices shall take responsibilities for such connection
safety.

Caution: To connect this system with LAN, the network administrator shall be responsible
for the correct settings and antivirus security for the network connection. If necessary,
consult Lanmage Customer Service Center.

2.9 Control Panel

The ultrasound diagnostic system is equipped with keys, trackball, knobs, TGC (time gain
compensation) slider controls and toggles. You can access system settings, exam area
and patients' exam results by using these buttons on the control panel. The logically
arranged buttons and knobs will surely facilitate your work.

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2.9.1 Control Panel Brightness

The system provides two levels of brightness on the control panel: when the ultrasonic
imaging system is in use, the control panel shows white backlight; when a knob or button
is active, the active knob or button becomes blue Backlight. Buttons without active
functions have no backlight.

2.9.2 Introduction of Control Panel Buttons

2.9.2.1 Function keys

1. Power button and TGC Slider Control

Power button

To switch on/off the system.

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TGC/LGC Slider Control

Located at the bottom left side of the system control panel, TGC/LGC slide controls are to
control gain by ultrasound scanning depth.

2. Patient Exam Process

Patient

Enter the new patient interface, that you can input a new patient information; also you can
view or edit the current and previous patient’s information.

Probe

Enter the probe and exam selection interface which displays a list of probes and exams,
including available system-defined exam types and user-defined settings.

Review

Enter the interface to review, select and save the patient's basic information and image
information.

Report

Enter the Patient Report interface to display the reports about corresponding exam items of

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the patient, and execute the functions of print preview, print, export, and page turning.

End Exam

End the current patient exam, and start a new patient exam.

3. Parameter adjustment knob:

Parameter adjustment knob

Using the Parameter adjustment knob to activate, adjust the key options displayed at the
bottom of the screen. There are 5 parameters of the Parameter adjustment knob,
corresponding to the 5 column parameters below the screen.
Press the parameter adjusting key to switch between the first and the second line of the
corresponding parameters. Rotate the parameter adjustment knob can adjust the
corresponding parameters.

4. Image Operation Controls

Press [B] knob to enter B mode for grayscale imaging. If a combination mode or other
imaging mode is activated, pressing [B]knob will allow the system to exit the current mode or
function and return to B mode.

Rotating [B] knob can change the total gain of B mode. Clockwise rotating can increase gain;
and counter-clockwise rotating can decrease gain.

Gain value will be displayed in the imaging parameter area on the top left corner of the
screen.

Press[C] to enter the color flow imaging mode. Clockwise rotating [C] knob to increase total
gain of Color mode while counter- clockwise rotating to decrease it.

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Note: in the PDI mode, rotating [C] knob can change the total gain of power mode. Gain
value will be displayed in the imaging parameter area on the top left corner of the screen.

Pressing [D] knob can display a Doppler Sampling line and a Sampling gate in the B-mode
image. According to the system presets, pressing [D] knob for the first time can also enable
the display of Doppler spectrum. For pulsed Doppler, pressing PW knob again can enable the
system to display B/PW modes and give out Doppler sound signals. Rotating [D] knob can
change the total gain of PW mode. Clockwise rotating [D] knob can increase gain; and
counter-clockwise rotating [D] knob can decrease gain. In 3D/4D mode, rotate the knob to
rotate the image around the Z axis.

Pressing [M] knob can display M-mode cursor in the image of B mode. Roll the trackball to
place the cursor on the desired area. Press [M] knob again to display B/M mode.

Rotating [M] knob to change the total gain of M mode. Clockwise rotating [M] knob can
increase gain; and counter-clockwise rotating [M] knob can decrease gain. Gain value will be
displayed in the imaging parameter area on the top left corner of the screen. In 3D/4D mode,
rotate the knob to rotate the image around the Y axis.

Steer/Angle

Angle value is displayed in the imaging parameter area on the top left corner of the screen.
The system can also display the angle values greater than 1° on the image screen. When the
angle is greater than or equal to 60°, the system will highlight angle values in red.

In the PW mode (when the Angle function is activated), rotating [Steer/Angle] can adjust the
Doppler angle.

When using a linear array probe, you can press [Steer/Angle] to switch functions of angle and
steering in the process of Doppler imaging. The system will highlight cine and image in green
under the control of the trackball, so as to tell users which function is activated.

In 3D/4D mode, rotate the knob to rotate the image around the x axis.

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4D

It is only used for 4D probe, press [4D] key to enter the pre-acquisition interface of 3/4d mode,
and activate this control to observe 3d image, as well as to conduct various kinds of rendering,
cutting, rotation and other processing of 3d image.

CW

Press the activation of continuous wave Doppler imaging. Is suitable for the purpose of heart
ultrasound (the CW mode is only available under the phased array probe).

Depth/Zoom

Rotate the knob to change imaging depth; Press the knob to activate a zoom window, and
start amplification; We can Zoom the image no matter in real-time state or freeze state ,Press
again to exit zoom mode.

Depth value is displayed on the left lower corner of the image.

Focus

Press this button to change the number of focuses in the image, and rotate this button to
position the focus.

5. Controls around the trackball:

Trackball

The trackball can position the image body mark, measuring mark and text. You can also use
trackball in combination with the Set key on the control panel.

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The System will tell users which functions are controlled by the trackball, for which the
method is: the system highlights the selected image body mark, measuring mark and text in
green, and/or lists their active functions on the bottom left of the screen.

You can use the system presets to adjust the moving speed of the trackball.

Update

In a mixed-mode imaging process, you can switch between frozen display and real-time
display.

For example, if a B-mode image is in a frozen state, while Doppler spectrum is in a real- time
state, after you press [Update], the system will display real-time 2D images, and freeze the
Doppler spectrum.

When performing a measurement, pressing [Update] can circularly view the measuring mark
for editing

Caliper

Press [Caliper] to activate General Measurement function. The system will display the
measurement options for selected imaging mode and exam. Press the [Cancel] on the
touchscreen to exit the measurement function.

Measure

Press [Measure] to activate the specialized measurement function;

When the measurement function is activated, the system will display the specialized
measurement options for the selected imaging mode and exam.

Press [Freeze] on the control panel or the [Cancel] on the touchscreen to exit the
measurement function. The measurement results can be exported to the patient report.

Cursor

Activate the cursor, the cursor can move in the entire screen.

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Clear

Clear the contents of the screen

Set

Used to confirm selection of a specific function or command. For example, you can use it to
lock the caliper, select a menu or body mark, including measuring values in the patient report
or delete a measurement from the worksheet.

When it is used along with the trackball, the Confirm function is similar to the mouse click
based on Windows technology.

Freeze

Freeze the image, scan or spectrum on the screen. If images or scans is frozen, press
[Freeze] to restore to real-time Imaging.

System presets can change the response of the Freeze key. When you press [Freeze], other
functions will be activated.

User-defined keys

F1, F2, F3, F4 keys are user-defined function keys. The default function of each key can be
preset in the system settings. See chapter 8 preset for more information.

6. Storage Controls:

Save

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Press to save images, the images displayed in the thumbnail area. You can use system
presets to set the area for image storage.

2.9.2.2 Touchscreen common buttons

You can use the touchscreen keyboard to Input patient data, Select exam, Annotate clinical
images and Configure system preset. Some of the common use buttons are:

Keyboard

Press to dial out the soft keyboard for inputting content. The touchscreen keyboard layout is
similar to standard computer keyboard. Some special function key are listed as below:
Help Press to display online help to view the user's manual.

Capture Press to access the screen for saving, deleting, and overwriting quick
settings (used for imaging settings of certain types of probes and exams)
work Press to display the screen of DICOM work queue to view the sending
queue status of DICOM images.
Full Press to display the image in full screen size, press again to exit.
Screen
Clear Press to clear all annotations, arrows, body marks and measurements on
the screen.

Mark

Press the [Mark] key to display a list of the available body marks of the selected exam type.
Click on the body icon on the touchscreen to select the appropriate body mark.

Text

Press to activate the annotation function and place the text cursor on the image screen. Enter
the texts through the keyboard or by selecting the terms in the annotation list.

Arrow

Press to Place an arrow on the image area of the screen.

Backspace key

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Press to Exit the current display mode, function or page, and reactivate the previous mode,
function or page.

Cursor

Press to show/hide cursor.

Preset

Press to enter system setting interface. Use the system presets to modify and customize the
system

2.10 System Symbols

Symbol Description

Alternating current

Type BF Applied Part

Caution.

Equipotential Connection

ON (power)

OFF (power)

Footswitch Connector

Contrast control

Monitor brightness Control

Probe port

Probe anti-flooding（host not applicable）

USB port

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Refer to the instruction manual

General warning sign

Bar code

Grounding mark

Manufacturer (This symbol shall be accompanied by the

name and address of the manufacturer.)
Authorized representative in the European Community (This
symbol shall be accompanied by the name and address of the
authorized representative in the European Community.)

Date of manufacture

Serial number

CE marking

Dangerous voltage

Pushing prohibited when the wheels are locked.

Danger: An explosive danger may occur if it is used in the

presence of flammable anesthetics

No heavy load

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Chapter 3 Starting Examinations

3.1 System Start-up and Running Sequence Inspection

The system should be used in a medical room with an ambient temperature of 5ºC~40ºC.

Lanmage recommends not installing this system in the vicinity of X-ray equipment, ultrasonic
and microwave frequency therapy equipment.

Warning: This system will generate, receive and radiate RF electromagnetic waves. If it is not
installed or used strictly in accordance with the system installation and operating instructions, it
may have a detrimental impact on other devices, and may also interfere with itself.

We encourage users to take the following measures to exclude interferences (by switching

"ON/OFF" the system to identify interferences):

D To changes the direction or position of the device;

D To improve the isolation between the system and the equipment;
D The socket connected to this system is different from those to other devices;
D If you need help, please contact Lanmage’ Customer Service Center.

Install the system monitor and avoid its screen being exposed to local lighting and direct
sunlight as well as other light sources.

This system shall be installed, assembled, customized an adjusted by the personnel from
Lanmage Customer Service Center. Lanmage Customer Service Center can also provide
services upon the expiry of warranty in accordance with the independent service agreements
signed between the operation institutions and Lanmage. After transport or storage, please
contact Lanmage Customer Service Center for any questions about the system's basic
information about re-storage, installation and assembly.

Before being installed at the scheduled location, the system shall be unpacked, and stored in
the environment at the temperatures below 5ºC. After being placed for at least two hours at
the room temperature, turn on/off the system and ultrasonic probe.

Caution: Before moving the system from one place to another place, first open the lock on the
caster brake, and lock the caster near the step or ramp.

Caution: This system shall be always installed on a level surface; therefore, the casters must

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be locked. Any failure in following these requirements may cause overturning or rolling of the
system.

Caution: In the process of using the machine, rotate the monitor slowly, not too large. When the
rotation Angle reaches the limit, stop rotating in the same direction.

3.1.1 System Start-up

Caution: Before starting this system with mains power supply for the first time, please make
sure that voltage and frequency are in line with the technical specifications described on the
nameplate on the back panel of the system.

Start the system, and perform the following steps:

D Make sure that the system has been connected with the feeder line of the monitor, and
has been properly connected to the three-hole socket with protective grounding in 100-
240V 50Hz;
D After being connected to the mains power supply, adjust the electric switch "POWER"

D On the back panel to "I" for starting, and press on the top left corner of the control
panel;

D Turn on the printer and load paper into it.

3.1.2 System Operation

When you start the system, the logo of Lanmage will appear, and after several seconds of
program loading, the system will automatically enter the main interface, and the image is
defaulted as B Mode.

Note: If the system loading fails, an error message will prompt. In this case, please contact the
personnel in Lanmage Customer Service Center.

Warning: Users are not allowed to install other software without authorization.

3.1.3 System Continuous Operation

This system can continuously run for 12 hours. If you need to shut down the system in the
running process, turn on the system after 20 seconds.

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Note: Due to the compatibility issues arising out of the English operating system, the system will
come to occasionally stop responding, which can be resolved by restarting the system, and the
system needs to put on a patch so as to completely solve the problem.

3.1.4 System Shutdown

After ensuring the system data has been completely saved, return the menu to main interface,

and press on the left corner of the control panel. The prompt information of "Do you want
to shut down?" pops up and the system will be automatically off in several seconds after
confirmation.

Caution: When the machine is downloading, you cannot shut down the system; otherwise, this
could cause the failure of software downloading. If you need to shut down the system, please
wait until the operating system has finished the downloading.

3.2 Information on the Imaging Screen

Information that is displayed on the imaging screen consists of two categories: symbol
information and image information. The locations for various display areas of these two types
of information are shown in the following diagrams.

1. Hospital name;
2. Current patient name and ID number;
3. Mechanical index (MI) , thermal index for soft-tissue (TIS),System time and date (the
time does not go when being frozen);
4. Thumbnails area;

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5. Gray scale (right); color scale will occur on the left of gray scale in Color Doppler Blood
Flow Imaging (color mode) or Power Doppler Blood Flow Imaging (PDI mode).
6. Scale and focus marking;
7. Option buttons from left to right: Page-down, Page-down, save to a USB Disk or CD,
Sent to the report and Delete images;
8. From left to right are network connection, CD, USB flash drive icon, System time, change
case display, and System language;
9. Soft menu ;
10. Image display area;
11. Display the current custom key preset;
12. Active Probe Type, inspection subject, Scanning and Processing Parameters;
13. Probe direction signs. Freeze indication

3.3 Patient Information

Press [Patient] on the control panel, and the patient information interface pops up, which
includes patient general information and exam information about the current patient and
search menu.

3.3.1 New Patient information

1. Press the [Patient] button on the control panel;

2. Roll the trackball to [New Patient] and select the information box, press [Set], and input
patient information by using the keyboard;

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3. Select the information edit boxes of the remaining patients in the same operation, and
the operator shall enter patient information as detailed as possible.
4. Click [Apply] to save the settings, and click [OK] to return to main interface.

3.3.2 Previous patients

D If you have saved this patient's information, you do not need to re-enter the information,
and just click ▼ in the [Search], and select one of the information to input in the [Search
Key] for searching, press [New Patient] after exporting the information, then you can re-
establish the patient's information exam.

D If you have saved the patient information, and would like to continue the last exam, you
can search the patient according to the method above, then double-click the patient list
information, and press [Set] to resume the last exam.

D If the patient's information is incorrect and has to be re-established, you can move
the arrow to the appropriate setting area for modification; to clear all the information,

D Click the [Delete Exam] button below, then re-enter the information.

3.4 Probe and Exam Items

Four probe icons and corresponding probe measurement item menus will occur after
pressing the [Probe] key on the control panel, and the models and appearances of these
probes connected with the system are respectively in line with the interface, of which the
probe model in blue background is the default active probe, and the exam items followed with

[﹡] are the default exam items of this probe. When the port is not connected with a probe,

the corresponding probe area will be displayed in blank.

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Click the probe icon, select the desired probe and return to the main interface; the user can
also click the [Exam Name] of the corresponding probe, and the main interface will carry out
the measurement to the exam item of the current probe.

User can also select desire probe and exam item on the touchscreen.

Note: If the port is connected with a probe, and the corresponding area is still displayed in
blank, please contact the appropriate service personnel for inspection.

3.5 End Exam

Before examining a new patient, press <End Exam> to end the exam of the previous patient,
update the patient ID and information, to avoid mixing data of the next new patient.

Click the [End/Exam] to see whether the current patient check menu is finished and the
current patient will be checked. You can use the system preset, select whether the "end
check" prompt message will pop up and the state after the check.

To end an exam, you can do one of the following:

D Press [End Exam] on the control panel.
D Click [New Patient] on the Patient screen to end the last patient exam and clear the
patient information.
D Click [New Exam] on the Patient screen to end the last exam and clear the exam data.

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Chapter 4 Optimizing the Image

4.1 Imaging Mode

D 2D Mode B THI 2B (Dual-mode) 4 B Split mode

D C Mode Color PDI Directional PDI

D M Mode M

D Doppler Mode PW CW

Note: When operating in M mode, Color mode, PDI mode or PW mode, you can exit from these
mode interfaces by pressing the B button, B mode will be displayed.

4.2 B Mode

B mode is the most commonly used imaging mode in two dimensional imaging modes, which
has the measurement functions to display two-dimensional images and provide related soft-
tissue anatomy structure; in B mode, the images are displayed in gray scale.

To enter B mode, press [B] on the control panel. B mode is the default mode when the
system is on.

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4.2.1 B mode Operating Steps

General exam steps in B mode are as follows:

D Record the related information of the patient, and verify the system settings
(probe settings and B-mode preset)

D Place the patient in the appropriate position and put the machine in place for the
patient to receive a comfortable exam and for the operator to control the machine more
easily and carry out the exam to the patient.

D Collect all of the data.

4.2.2 B mode Parameter Settings

The B-mode parameters can be set in the soft menu of main interface:

There are 5 parameters of the Parameter adjustment knob, corresponding to the 5 column
parameters below the screen. Press the parameter adjusting key to switch between the first
and the second line of the corresponding parameters. Rotate the parameter adjustment knob
can adjust the corresponding parameters.

In the image above, when you change the parameters of the B mode menu bar, the
parameter area on the top left of main menu will display the corresponding indicator changes
(as shown below):

In B mode, to optimize the specific image scanning parameters above, you can make the

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following adjustments:

Gn (Gain)

Operation: rotate [B] knob on the control panel to adjust.

Function: to set the brightness of a two-dimensional image. This knob decides the coefficients
of the increasing amplitudes of echo signals. All incoming echo signals make use of the
sample gain for amplification non-relevant with the depth.
You can also use TGC slider knobs to make compensations for gain through depth
(Sensitivity time control), so as to select gain for different images in different depths by means
of separate methods. In this way, you can determine the accurate attenuation compensation
of echo signal according to the entering time (depth of emission non- uniformity). The
standard position of the slider knob is located in the central position. This position
corresponds to the propagation time compensation of echo signal.

F (Frequency)

Operation: Rotate [frequency] corresponding knob to change frequency range.

Function: For special types of patients, you can change the frequency parameters so as to
achieve the best possible optimization effects.

DR (Dynamic Range)

View the soft menu [DR], rotate the corresponding adjustment knob to adjust the contrast of
grayscale images.

Persist

Operation: View the soft menu [Persist], and rotate the corresponding adjustment knobs to
adjust.
Function: This function is used to superimpose average adjacent B images, So as to optimize
the image and remove noise. Persistence increasing may lead to signal missing.

LanSRI

Operation: activate the soft menu [LanSRI], rotate the corresponding adjustment knob to
change the image edge.
Function: Optimize the clarity of image edge.

R/S (Line Density)

Operation: View the soft key menu [R / S], then rotate the corresponding adjustment knob to
change the size of the line density.
Function: Adjust the balance between the image line density (resolution) and the frame rate.
Increasing the line density increases resolution and decreases frame rate.

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Colorize

Operation: View the soft menu [Colorize] and rotate the corresponding knob to adjust.
Function: Change the color of the image.

Scanning Area

Operation: View the soft menu [FOV], press and rotate the corresponding function key to
change the size of the desired area.
Function: Adjust the scanning area to the minimum reasonable size for maximum frame
frequency.

Rejection

Operation: rotate the corresponding adjustment knob to change the rejection range.
Function: Select a level below which echoes will not be amplified (an echo must have certain
minimum amplitude before it will be processed)

Smooth

Operation: View the soft menu [Smooth], rotate the corresponding adjustment knob to change
the smoothness.
Function: This function is to reject image noise and to make images smooth.

Map (Grayscale Map)

Operation: View the soft menu [Map], rotate the corresponding adjustment knob to adjust.
Function: This function applies the gray correction to obtain the optimum images, but it would
be easy to affect the information in B mode.

Note: Before making other adjustments, please choose the grayscale map, because there is
mutual dependence among grayscale map, gain and dynamic range. If you change the
grayscale map, you have to reset gain and dynamic range.

Focus

Operation: Press [Focus] key on the control panel.

Function: Selection of focal area has determined the depth range for the purpose of having
the best shape in this ultrasonic beam. The position of focal area can be represented with the
arrow on the right side of the image.

Scanning Depth

Operation: Press [Depth / Zoom] on the control panel;

Function: rotate this key, and you can set the depth range of the echo image in a certain

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desired area. Only real-time depth adjustments are allowable. Changing echo image depth
will cause the changes of depth proportion, MI/TIS/TIB/TIC and other indexes as well as
frame rate.

You can rotate the menu button to change B-mode image display, Functions of specific
parameters and methods of operation are as follows:

Functions of specific parameters and methods of operation are as follows:

Acoustical Power

Operation: Click on the left and right button on the touchscreen [A Power] icon, click the right
button to increase the acoustical power, and click the left button to reduce the acoustical
power.

Up/Down Flip and Left/Right Flip

Operation: Click on the touchscreen [U/D flip], [L/R flip] button to flip the image upside down,
or left to right.

Trapezoidal Imaging

Operation: Click on the touchscreen [Trapezoidal], to open trapezoidal imaging, and click
again to close the trapezoidal imaging.
Function: Activate sector sensor format for linear sensor.

Split mode

Operation: Click on the touchscreen double real time button, open the 2B real time Button
Blue highlight, the two images on the left and right of the screen will be displayed in real time;

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press the button again, real time 2B is closed in.

LanTissue

Operation: Click on the left and right button on the touchscreen [LanTissue] and there will be
four options to adjust, namely General, Liquid, Fat and muscle.

4B Mode

Operation: Click the touchscreen [4B] button to open the 4B mode, and the continuous click
screen image display area will appear four images in turn. One of the four images is in real
time, and the rest are in a frozen state.

THI (Tissue Harmonic Imaging)

Operation: Press the [THI] user custom key (preset needed) on the control panel or click the
touchscreen [THI] button.
Function: Enhance near-field and mid-field resolution to improve the imaging contrast, and at
the same time enhance far-field of Biopsy. To enter/exit the secondary (tissue) harmonic
mode.

Com-Frequency

Click the "Com-Frequency" menu of the touchscreen to turn on or off the frequency
composition function.

4.3 Dual-B Mode

To enter the non-real time 2B mode, press the B button on the system panel, click on
the [Dual] button on the touchscreen, and appear on the left of the image a B MODE image,
and

click on the touchscreen again on the[Dual] button screen to show a B mode image on the
right. At this point, the image on the left is frozen and the right is real time. The image
parameters can be adjusted the same as the B mode.

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4.4 M Mode

M mode is a movement mode used to identify the motion pattern of objects under the
ultrasonic beam. It is most commonly used to view the motion mode of the heart.

4.4.1 M mode Operating Methods

1. Press [M] on the control panel to enter B/M mode; a green sampling line will occur, and
rotate the trackball to change the direction of sampling line, and locate the sampling line
on the non-display B-mode area;
2. Press [M] again on the control panel to enter M mode. The position of the sampling line
can also be changed by moving the trackball.
3. If necessary, you can preset the M mode, such as adjustment of scanning speed, gain,
focal position and others M-mode imaging settings.
4. Press [Freeze]; then press [measure] to image measurements.
5. Press [M] again to exit M mode.

4.4.2 M mode Parameter Settings

In M mode, the parameters (as shown below) displayed in the soft menu are different from B
mode, which can be adjusted just similar to B mode:

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Sweep

Operation: rotate the corresponding adjustment knob to increase or decrease the scanning
speed.
Function: Scan Speed is used to change the speed of the time line in M mode.

Edge

Operation: View the soft menu [Edge], and rotates the corresponding function knob to adjust.
Function: Optimizes the clarity of image edge.
In the main menu of M mode (as shown below), you can also set acoustical power, screen
layout and others.

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4.5 Color Mode

Color mode is a Doppler mode for inputting the color-coded qualitative information associated
with the relative speed and direction of the fluid movement.

4.5.1 Color mode Operating Methods

1. Press [C] on the control panel, and a green sampling box will pop up, and change the
position of the sampling box by rotating the trackball.
2. Press [Set], and the green box will be displayed in a dotted line; rotate the trackball
to adjust the size of the box. Press [Set] again to confirm the size of the box.
3. Set the color blood flow parameters through the system preset or directly set up on the
touchscreen.
4. Record color blood flow images.
5. Press [C] or [B] to exit color mode.

4.5.2 Color mode Parameter Settings

The parameters of color mode can be adjusted by the soft menu, as shown below:

Set the parameters in the following figure to optimize images through the menu above.

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In color mode, the methods for setting the images shown in the figure above:

Gn (Gain)

Operation: You can change the gain by rotating [C] on the control panel, in which left/right
adjustment is to decrease/increase gain.
Function: Gain can amplify the overall echo intensity processed in the color-mode window or
spectrum Doppler timeline, and its value will vary depending on the probes and applications.
Gain has no effects on power output. But increasing gain will lower the power output level to
so as to produce images in equal quality.

Scale

Operation: rotate the corresponding adjustment knob to reduce/increase scale.

Function: Scale will affect the output energy, frame rate and wall filter.

LanFlow

Operation: rotate the corresponding adjustment knob to change the color blood flow.
Function: This function is used for image optimization by providing adjustment on parameters,
including scales and filters.

R/S (Line Density)

Operation: rotate the corresponding adjustment knob to adjust the linear density.
Function: Line density helps to optimize color blood flow or spatial resolution in order to get
the best color images, which will be greatly helpful for high-frame-rate fetal heartbeats, adult
heart applications and clinical radiology applications. Changes of line density will also change
the volume density and frame rate, and at the same time, it will Change thermal index and/or
mechanical index, or may also affect the output display.

Baseline

Operation: rotate the corresponding function key to move the baseline.

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Function: In the Color Mode, you can move the baseline so as to avoid aliasing in the
direction of blood flow (similar to the baseline displacement in pulse Doppler mode). By
moving the baseline, you can expand the speed range in one of the directions. The zero line
of color scale will also make corresponding displacement. The maximum and minimum blood
speed will be respectively displayed on the top and bottom of the color scale.

Persist (Frame Correlation)

Operation: Press and rotate the corresponding adjustment knob to adjust.

Function: Frame correlation can determine the persistent time of color data in the sampling
box, and the persistent color data will remain on the screen until the persistent time has
expired or the system has detected a higher rate of blood flow.

Filter (Wall Filter)

Operation: Press and rotate the corresponding adjustment knob to adjust the size of the filter
(Hz in unit).
Function: filter the speed signal of lower-speed blood flow so as to remove the fake images
resulting from breathing and other activities of patients.

Priority

Operation: Press and rotate the corresponding adjustment knob can change its size.
Function: Color priority can be used to choose whether to display arbitrary pixel color or
threshold value of B mode data, and color priority increase will lead to displaying more color
pixel information on the B mode image.

Smooth
Operation: Press and rotate the corresponding adjustment knob to adjust.
Function: This function is to reject image noise and to make images smooth.

Map

Operation: rotate the corresponding adjustment knob of map to change the color of the maps.
Function: Color-scale map refers to the color range that is allocated to the desired color or
power area, and the color-scale map is based on the flow rate of color flow imaging and the
flow intensity of power mode.
For color imaging, color changes mean the changes of flow rate. A dark color means a lower
rate while a light color means a higher flow rate, and these maps have the red and blue
colors to indicate the flow direction, while the color flow rate and deviated maps use green
shadows to indicate the flow disorders

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A. Power

Please see the methods of B mode.

Color Flip

Operation: Click on the touchscreen [Invert], turn the color invert function, the color on the
right side of the image will turn upside down, and the color in the collection box will also turn
over. Then click the [Invert] key to turn off the color invert.

Split Mode

Operation: The image area will be displayed in real time with two same images, in which the
image sampling box is displayed in the right area, and the left is the B pattern image without
color flow. The image can be compared conveniently.

Sensitivity

Operation: Click on the left and right direction buttons on the [Sensitivity] icon of the
touchscreen. The [Sensitivity] option will display L, M, and H letters, where H has the highest
resolution and L has the lowest.

Function: By using this function, you can change the scanning operation frequency of color
Doppler imaging to adjust the sensitivity. Sensitivity increase will lead to decrease of frame
rate, while sensitivity reduction will lead to increase of frame rates (See frame display area on
the bottom right of the image for more details).

Peak

Operation: Click on the left and right arrow keys on the touchscreen [peak] icon, and the 1sec,
2sec, 3sec, off characters will appear on the peak capture icon.
Function: When the ultrasonic system continues accumulation, and displays the peak color

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rate associated with flow rate in the selected time, there will be a phenomenon of persistent
peak in order to designate the time period for collecting the color rate of flow peak; when you
select 1sec, the system will maintain the peak for 1 second.

4B

Operation: Click the touchscreen [4B] button to open the 4B mode, and the continuous click
screen image display area will appear four images in turn. One of the four images is in real
time, and the rest are in a frozen state.

4.6 PDI Mode (Power Doppler Imaging Mode)

PDI mode is a color blood flow imaging technology, which is used to reflect the Doppler signal
intensity resulting from flow, rather than the frequency shift of signals. By using this
technology, the ultrasonic system can map the color flow based on the amount of the moving
reflectors, rather than take into account their speeds. As PDI does not affect the speed, thus
there will be no aliasing.

4.6.1 PDI mode Operating Steps

1. Preset one of the custom key as PDI function fast key, press to activate PDI; or Press[C]
to activate color mode and then click the touchscreen menu [PDI] to enter PDI mode.
2. The method of setting PDI mode sampling box is the same as that of Color mode;
3. Optimize images through parameter preset or interface settings;
4. Record the data.

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4.6.2 PDI mode Parameter Settings

You can also set the parameters of the following image directly on the main interface:

These parameters will be displayed on the left side of the screen, as shown below:

For the relevant adjustment functions in PDI mode, the user can refer to the operating
methods of Color mode, which will not be repeated here.

4.7 Pulse-wave Doppler (PW)

Doppler can provide the measurement data on the rates of the moving tissues and fluids, and
PW mode can receive the echo signals that are given out from the flow in the preset direction
and depth; carry out the spectral analysis on the echo signal, and work out values of flow
parameters according to the analysis.

Under normal circumstances, flow is not uniform, but consists of mixed blood cells in different
rates and directions. Therefore, the contents are displayed with a combination of spectrum in
different grayscale values. Strong signals will be displayed relatively brighter, but weaker
signals are shown in the different levels of gray.

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4.7.1 PW mode Operating Steps

1. Press [D] for the first time, then a green sampling line and deviation angle appear (Click
on [Setting]→ click [Exam Preset] on the left of the screen, and this step will be omitted

if "No cursor M/D display" is checked);

2. Press [D] for the second time, and two images will occur respectively on the top and
bottom, in which on the top is the B-mode image, and on the bottom is the transverse
section of the sampling line;
3. Set the image parameters through [Setting] or the toggle so as to optimize images;
4. Record the data.
5. Press [D] for the third time to exit the PW mode.
Instructions for PW-mode images:

1. Sampling line
2. Blood flow angle Indicator

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3. Sampling gate

Sampling Line

Function: When activating Doppler in the B mode, [Sampling line] will be displayed in the B-
mode image and this cursor is the graphical indication of the acoustical line.

Blood-flow Angle Indicator

Function: The indicator is represented as the angle between Doppler-mode sampling line and
the calibration indicator, which will be displayed when there is a Doppler sampling line, and
the indicator means the blood-flow direction, and the specific angle deflection is displayed on
the top left corner of the image.

Sampling Gate

Function: For the B-mode images, Doppler-mode sampling line moves the sampling gate,
and the gate is located on a specific position. Rotate the function toggle to change the size of
the gate. Changing sampling gate will change heat index and/or mechanical index.
Please note that it may affect output display.

Steps for angle of deflection;

1. Press [D], and the sampling line, sampling gate and blood-flow angle indication will
appear as shown in the figure above;
2. Press [D] again, and two images will appear on the top and bottom; rotate the trackball to
adjust the sampling depth and sampling line position of the image above;
3. Rotate [Sampling gate] corresponding adjustment knob to change the size of the gate
frame;
4. Rotate [Angle] corresponding adjustment knob, and there will be three angle settings
including 0, 60 and -60, and you can use [Steer/Angle] if you would like to slightly adjust
the angle, which can be steered to the left with the maximum of 89° and to the right with
the minimum of -89°.
After determining the sampling position, size and direction, you can carry out the PW- mode
measurements to the following images.

4.7.2 PW mode Parameter Settings

You can use the soft menu to set a specific parameter, and its value will be displayed on the
left of the screen, as shown below:

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Functions of specific parameters and setting methods are as follows:

Gn (Gain)

Operation: Use the rotary knob [D] to change the amplitude of Doppler signal and their
display brightness on the imaging screen.
Function: The selected gain shall be matched with the signal amplitude and the used
grayscale. In this case, make sure that spectrum diagram does not appear on a lot of noise.
When rotating the control in a clockwise direction, the entire spectrum diagram becomes
brighter. When rotating the control in a counter-clockwise direction, the entire spectrum
diagram becomes darker.

DR (Dynamic Range)

Operation: rotate the corresponding adjustment knob to adjust.

Function: Affect the amount of the displayed Doppler amplitude data.

Filter

Operation: Press and rotate the corresponding adjustment knob to adjust the size of the filter.
Function: Remove the noises that are caused by cardiovascular or heart wall movements. It
will be at the price of lowering the sensitivity of flow.

PRF (Pulse Repetition Frequency)

Operation: Press the corresponding function keys on the soft menu [PRF].you shall Press the
corresponding function key to switch the settings between [Filter] and [PRF], and the system
will automatically update the speed scale.
Function: Regulate the speed scale so as to accommodate faster/slower rates of blood flow.
The PRF is based on the speed scale.

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Baseline

Operation: you shall use the toggle [Baseline]. Moving the baseline on the spectrogram can
extend the speed range in one direction, while the speed range displayed in another direction
is reduced.
Function: As the leveling line corresponding to the zero velocity and zero Doppler frequency
on the spectrum diagram.

Spectrum Invert

Operation: Invert the spectrum curve in the vertical direction without affecting the baseline
position, press the touchscreen [Invert].
Function: The function key [Invert] will be displayed on the top left of the screen, and [+] and
[-] on the speed scale will be accordingly inverted. By doing this, you can also change the
speed (frequency) calibration. In the initial state, the area above the baseline means the
blood-flow movement towards the direction of the probe, while the area below the baseline
means the blood-flow movement away from the probe. If the inverting function is enabled, the
area above baseline means the blood-flow movement away from the probe, while the area
below baseline means the blood-flow movement towards the probe.

Functions of specific parameters and setting methods are as follows:

Rejection

Function: The noise and interference caused by the spectrum of Doppler signal can be
properly controlled by pressing the left and right buttons on the touchscreen.

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Sweep

Operation: Click on the touchscreen [sweep] icon on the left and right button to adjust.
Function: The scan speed can control the updating frequency of the spectrum, and the scale
will be displayed on the bottom of the screen.

Full Screen

Operation: Click on the touchscreen [Full D] icon, open the full screen display of PW mode,
and facilitate the careful and clear observation of images.

Duplex

Operation: Duplex and Triplex sync are in the same menu. Click on the touchscreen
[Triplex/Duplex] icon to open the dual sync function, and there are B mode and PW mode in
real time. When the double sync closes, the B mode is frozen, and the PW time line is
activated. Dual synchronous active mode: B+PW.

Triplex

Operation: After the Color (PDI) mode is opened, press [D] button and click the icon of the
touchscreen [Triplex/Duplex] to activate the three synchronous mode of real-time B, Color
and PW. In this mode, the adjustment of image optimization is roughly the same as that in B,
Color (PDI) and PW mode.
Three synchronous and active modes: B+ Color+ PW, B+PDI+PW.

Automatic Spectrum Envelope

Operation: Click the left and right buttons on the icon of [Automatic Envelope] on the
touchscreen, and Off, Up, Down and Both appear successively. The red-green line appears
above the baseline when Up, and the red-green line appears below the baseline when Down.
Both red and green lines appear above and below the baseline. The largest is green and the
average is red

Format

Operation: Clicking on the left and right knobs on the touchscreen [Format] icon, V1:1, V1:2,
V2:1, and H2:3 appear in turn, and the proportion of the two images is different. You can use
it according to your own habits.

Adjust Doppler Volume

Operation: PW mode click on the touchscreen [volume] icon on the left and right button to
increase or decrease the volume.
Function: The loudspeakers in the monitor can make sounds in Doppler mode. The system

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uses different acoustical signals to indicate the flow direction that flows towards or away from
the sensor; in general, the flow towards the sensor is displayed above the Doppler baseline,
and gives out sounds from the loudspeaker on the right side, while the flow away from the
sensor is displayed below the baseline, and make sounds from the loudspeaker on the left
side.

Note: In inverting the Doppler, the acoustical signals will also be inverted.

4.8 4D Mode
The 4D imaging mode includes both static 3D and real-time 4D imaging

4.8.1 3D Mode

4.8.1.1 3D Mode Operating Steps

1. Click [4D] on the control panel to enter the pre-collection interface, and click [3D] on the
touchscreen to enter the 3D pre-collection interface.

2. Click [set] key and the green box is shown as dotted line. Rotate the track ball to adjust
the size of the box.

3. Move the track ball, and the sampling box moves within the image sector. The location of
the sample box is determined by the user as required.

4. Select one of the [resolution priority], [speed priority] and [penetration priority] as the 3D

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image preset in the [imaging preset] of the touchscreen. Selecting different presets will
affect the parameter values.

5. Select one of [Render], [Multi Slice], [Niche] and [Free Line] as the default 3D image in
[imaging mode], and select different imaging mode parameter types.

6. According to the prompt, press [Update] to enter the 3D view interface.

7. Press [Update] again to return to the 3D pre-collection status.

8. Press the button of [B] and [4D] to exit 3D mode and enter the state of B real-time
imaging.
3D pre acquisition interface mode parameters are shown below:

Scanning angle
Operation: Rotate the corresponding knob of [scanning Angle]. Function：
Set the Angle of probe scan.
Quality
Operation: Rotate the corresponding knob of [Quality].
Function: The image quality under the state of 4D image can be adjusted. Currently,
adjustable gears include Hi2, Hi1, Mid and Low. The quality ranges from high to Low.

Frequency
Operation: Check the knob corresponding to the soft menu [frequency] and rotate the
parameter adjustment knob to change.
Function: For special patient type, change the frequency parameters to achieve the best
optimization effect.
Dynamic
Operation: Check the corresponding knob of soft menu [dynamic range] and rotate the
corresponding parameter adjustment key to change.
Function: Can increase or decrease the contrast of gray image.
If the pre-collection parameters are changed, corresponding indicators will be displayed in the
parameter area on the left of the main screen
Resolution priority
Operation: Click the [resolution priority] button on the pre-set of the subject check on the
touchscreen, and the button is highlighted. The subject check is changed to resolution priority
at the parameter on the left.
Function: Optimum volume imaging effect. The system will automatically adjust the image
parameters according to the selected style. This option is recommended for regular 3D
features.
Speed priority
Operation: Click the preset [speed priority] on the touchscreen to check the subject. The

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button is highlighted. The parameter on the left will change the subject to speed priority.
Function: Optimum volume imaging effect. The system will automatically adjust the image
parameters according to the selected style. This option is recommended for general 4D
functionality.

Through the priority

Operation: Click the [penetration priority] preset at the subject check on the touchscreen, the
button is highlighted, and the subject check at the parameter on the left is changed to
penetration priority. Function: optimum volume imaging effect. The system will automatically
adjust the image parameters according to the selected style. This option is recommended for
patients who have a larger body, a deeper site to be examined, and difficult ultrasound
penetration.

4.8.1.2 3D Mode Parameter Settings

The parameter value can be displayed on the left side of the screen. The specific parameter
setting method is as follows:

Render
Operation: In the touchscreen, press [Render] to enter the Render page.
Function: Will render mode to various types of image rendering, the diagram below:

The Render main page is shown below:

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Parameter：
Render
Operation: Click [Render mode] on the touchscreen to select different image processing
modes.
Function: Define rendering mode, including surface, depth, the simulation model, the
maximum, minimum, perspective the six kinds of patterns.

One
Operation: Click the [One] in the view on the touchscreen.
Function: Select the one view. After entering the 3D view interface, only 3D images will be
displayed on the screen.

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Dual
Operation: Click [Dual] in the view on the touchscreen and highlight the button.
Function：Select [Dual] view and enter the 3D view interface. The screen displays cut
surface +3D image.

Quad
Operation: Click the [Quad] in the view on the touchscreen and highlight the button.
Function：Select "Quad" view, and after entering the 3D view interface, the screen will
display all the cut and 3D images.

ROI
Operation: Click the [ROI] button, which is highlighted. Press [Set] to move the track ball and
change the ROI size of the selected window. Press [Set] again to move the track ball and
change the position of the upper edge of the ROI box.
Function: Enable the volume adjustment for the reconstruction of the box. Volume rendering.

Reset
Operation: Click the [Reset] button to reset the image.
Function: After the image has gone through the [ROI] operation, click the [Reset] button to
restore the image to its original shape.

4DTint 2
Operation: Rotate the soft menu [4DTint 2] to adjust.
Function: Adjust the false colorize effect of the image.

Magic editor
Operation: Click [magic edit] and the touchscreen enters the magic edit page, as shown in
the figure below.

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1. Move the trackball, move the cursor to the desired position, and press [Set]. Move the
trackball again and mark the part that needs cutting. Press [Set] and the demarcation is
cut out.
2. If not satisfied with cutting, in cancellation, click on the [Last] / [All] button, can be
cancelled for cutting action.
3. If the cutting is complete, click on the [Back] menu, exit the magic edit page. Function: To
cut image of each spare part of the image.

Ref. imge
Operation: click the button [A] / [B] / [C] / [3D]. The button is highlighted and the number in
the window turns green on the display screen.
Function: Select the reference image A, B, C or 3D.

Quick Rotate
Operation: Click [clockwise 90 °] / [90 ° anticlockwise] / [180 °] / [reset] menu, menu
highlighting, restore the original state.
Function: Rotate the 3D image; if the 3D image is rotated (including X/Y/Z axis rotation),
[reset] returns the 3D image to its original state.

Threshold
Operation: Click the left and right direction button on the [threshold] button on the
touchscreen for adjustment.
Function: Gray value threshold definition for the reconstruction of gray value and regarded as
noise. Opacity define a threshold for distinguishing the stringency Degrees, low opacity value

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makes the surface look stiff, high opacity value makes the image reconstruction with a
transparent appearance.

Smoothness
Operation: Rotate the soft menu [smooth] to adjust.
Function: adjust the 3 d data smoothing effect.

CurvePos
Operation: Rotate the parameter adjustment key corresponding to [Curve Pos], rotate
left/right, and reduce/increase the curve Pos value.
Function: Grey value of the input signal calibration and compensation, get the ideal output.

Curve Bias
Operation: Rotate the parameter adjustment knob corresponding to [Curve Bias], rotate
left/right, and reduce/increase the curve Bias value.
Function: Change the visibility of the input signal with “Curve Pos" desired output.

3D background
Operation: Rotate the parameter adjustment knob corresponding to [3D background], rotate
left/right, reduce /increase the 3D background value.
Function: For 3D rendering imaging window with a certain gray value of background color.

Glossy Parameters
Operation: Press the parameter adjustment button corresponding to the [Polishing
parameter], the soft menu is highlighted, turn left/right, and reduce/increase the lighting
parameter.
Function: Make the rendering reconstruction object can be unable to move ahead on the
light to illuminate. This parameter is used to adjust the effect of the light source.

2D smoothness
Operation: Press the [2D smooth], the soft menu is highlighted, turn left/right, and
reduce/increase 2D smooth.
Function: Surface shows through the smooth treatment improved; at the same time keep
the details in the image.

2D threshold
Operation: Press the parameter adjustment knob corresponding to [2D threshold] soft menu
highlights, turn left/right, reduce/increase 2D threshold. Function: If you choose to render
mode, generally need to adjust the minimum threshold to identify surface boundary. All
color values below this level are ignored in the render calculation.

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2D background
Operation: Press the parameter adjustment knob corresponding to [2D background[2D
background]soft menu highlights ，turn left/right, reduce/increase 2D background.
Function: For 2D plane imaging window combined with the background color of the grey
value.

Multi Slices
Operation: Click [Multi Slices] in imaging mode and highlight the button.
Function: An intuitive display 3D data set patterns. The data in the data set is displayed in
layers parallel to each other. The overview image is orthogonal to the parallel plane,
showing the parts of the volume that are shown in the parallel plane. This visualization
approach is consistent with the approach used by other medical systems, such as CT or
MRI, in presenting data to users. The distance between parallel planes can be adjusted to
suit the requirements of a given data set. In addition, you can set the number of planes.

The MultiSlice main page is shown below：

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Parameter：
Format
Operation: Click the [View Format] button on the touchscreen for adjustment.
Function: Switch interface display format.

Niche
Operation: Click the [Niche] in the rendering of the touchscreen and highlight the button.
Function: The perpendicular part of section A, B, C editing to 3D section view. The niche
shadow is named because this view shows something like inserting a spatial figure into the
volume. Niche model will have special parameters are as follows:

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The Niche main page is shown below:

Parameter：
Niche restoration

Operation: Rotate the soft menu [Niche restoration].

Function: all Niche regulation operation is reset to its original state

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4.8.2 4D Mode

4.8.2.1 4D Mode Operating Steps

The basic operation steps of 4D mode are the same as that of 3D mode. Only the selection
of [3D] and [4D] on the touchscreen should be replaced by the selection of [4D]. Details can
be seen in 4.9.1.1 "3D Mode Operating Steps.

4.8.2.2 4D Mode Parameter Settings

4D mode is to add time parameters on 3D mode to reflect the changes of 3D image in real
time. For detailed parameter Settings, see the section “3D Mode Parameter Settings”.

4.9 CW imaging model (optional)

CW Mode Operating Steps

Allow the examination of blood flow data along the sampling line of the Doppler model, rather
than the blood flow data at any given depth. Collect samples along the entire Doppler beam
to quickly scan the heart.。

1. Press [CW] for the first time, show a green sampling line
2. Press [CW] for the second time, and two images will occur respectively on the top and
bottom, in which on the top is the B-mode image, and on the bottom is the CW spectrum ;
3. Press [freeze] to image;
4. Press [Measure] to perform imaging measurements;
5. Press [CW] for the third time to exit the CW mode, enter B real-time imaging status
For more information about controls, refer to the "PW Doppler" optimization control
specification

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4.10 LanScape (optional)

LanScape provides panoramic imaging of anatomy that would otherwise be too large to
display on a single image. Panoramic imaging is performed by moving the probe longitudinal
along a structure: i.e. following the Median Nerve, showing the two Thyroid lobes on one
screen or generating the Achilles tendon.

LanScape acquisition

Configure the programmable key F2 as LanScape before the scan: press the [Setup] key to
enter preset menu, select [system preset], then select [User defined], then configure [User
defined F2] as LanScape.
To acquire a LanScape scan

1. Optimize the B-Mode image. Ensure even gel coverage.

2. Press the F2 programmable key. Set appropriate values in the soft menu.
3. To start acquiring the image, press [Update] key.
4. Scan evenly. When you scan, scan slowly and in a uniform motion lengthwise, end-to-
end (with or against the probe orientation marker).
5. To complete the scan, press [Update] key or Freeze (or allow the scan to auto
complete).
The LanScape is then displayed, scaled to fit entirely on the screen.
6. Perform measurements and record images.
The quality and usefulness of LanScape images is affected by transducer motion. Incorrect
technique can contribute to image distortion. Guidance and precautions for uniform motion:
D Continuous contact is required throughout the length of the extended image. DO NOT lift
the transducer from the skin surface.
D Always keep the transducer perpendicular to the skin surface. DO NOT rock the
transducer.

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Image

D Keep the motion within the same scan plane, if possible. DO NOT slide the transducer
laterally.
D Lateral turning (change in direction to follow anatomical structure) can be accommodated
with slower motion. DO NOT make abrupt changes in direction.
D The system accommodates a reasonable range of motion velocity. DO NOT make abrupt
changes in speed of motion. Deeper scans generally require reduced speed.

4.13 Tissue Doppler Imaging (TDI) (optional)

Tissue Doppler Imaging (TDI) measures the velocity of myocardial motion using Doppler
rinciples. While the usual Doppler echocardiography measures the velocity of blood flow
using the Doppler signals from the fast moving blood cells, which are of low amplitude, tissue
Doppler measures low velocity, high amplitude signals from the myocardial tissue Motion. TDI
function is available only when phased array probe plugged to the system.
Two TDI modes are available
PW Tissue Doppler（PTD）
Color 2D Tissue Doppler (CTD)

TDI operating methods

Configure any of the programmable keys as TDI (take F3 for example) before the scan: press
the [Setup] key to enter preset menu, select [system preset], then select [User defined], then
configure [User defined F3] as TDI.
In Color Doppler mode, press [TDI] key, CTD mode will be active; In PW mode, press [TDI]
key, PTD mode will be active;

TDI starting mode preset

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Click on the [Setup] on the touchscreen→ Click [Exam Preset] on the left of the screen, and
then you can setup [TDI staring mode].

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Chapter 5 Scan/Display Function

5.1 Image Zoom

[Dept/Zoom] is used to zoom the desired area, and the system will accordingly adjust the
imaging parameters to help us view the small parts of the image. There are two types of
imaging zoom, namely real-time imaging zoom (front-end zoom) and freeze imaging zoom
(back-end zoom).

Real-time imaging zoom

1. Press [Dept/Zoom] to activate the green zoom window;

2. Move the trackball and change the position of the zoom window; Press [Set] to determine
the size of the desired area;
3. Then press [Dept/Zoom] again to zoom the window; rotate [Depth/Zoom] to adjust the
magnification, clockwise for magnification, and counter-clockwise for magnification;
4. Press [Dept/Zoom] again to exit the partial zoom.

Freeze imaging zoom

1. Press the [Freeze] button and rotate the [Dept/Zoom] knob to enable the overall
magnification;
2. Rotate [Dept/Zoom] knob to adjust the magnification;
3. Move the trackball to adjust the position of the desired magnified area;
4. Press [Dept/Zoom] again to exit the overall magnification
Zoom the image to change its frame frequency, which will frequently change heat index and
position of focal area may also be changed, and it could lead to peak intensity in different
positions in the acoustic area, and MI may also be changed.

Note: It may affect output display. Setup

5.2 Image Freeze

Freezing real-time images would stop all the movements, and be allowed to measure, remark,
save and print images.
When you turn on the system, the system will be defaulted as the real-time state, and press
[Freeze] to switch between real-time image state and freeze image state.
In the frozen state, the system can respond to different functions according to preset. The
method of viewing the preset is:

Click on the [Setting] on the touchscreen → Click [Exam Preset] on the left of the screen, and

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then you can select [Freeze Response].
When you use a pedal switch, you can also use the pedal switch to freeze the image, and the
specific settings are:

Click on the [Setting] on the touchscreen → Click [Peripheral Preset] on the left of the screen

* Click[Pedal Switch] of the sub-menu above the screen to carry out relevant settings
for left-foot pedal switch and right-foot pedal switch.

5.3 CINE Mode

Cineloop and images will be continuously stored in the system so that users can
automatically and manually play cine and images. The data in the cine can be available until
new data has been captured; the cine can either be stored in the system memory or be filed.
Cine mode is very helpful for great concerns about the images in the special period of
Cardiac cycle and viewing short cine fragments.

You can enter the cine mode by selecting the [Freeze Response] of the [Exam Preset]
module to Cine. In Cine mode, "ring Indicator" will be displayed on the bottom right of the
screen (as shown below):

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No. Name Explanation

1 Left CINE marking indicating the start of CINE data;

Indicating the position of the current frame on the CINE data
2 Frame indicator
cycle;
3 Right CINE marking Indicating the end of CINE data;
Indicating the speed of CINE data playback, which can be
set to 1, 2, 4, 1/8, 1/4, 1/3, 1/2 and 2/3, of which 1 means
4 Speed indicator
equal to the scan speed; you can adjust the speed in the Soft
menu.
Indicating the frame number of the current frame and the
5 Frame counter
total frames stored in the cine buffer zone;
6 CINE Time Current data time and time of the total storage data.

5.3.1 Cine loop

There are two ways to review Cine loops, one is frame-by-frame review, and the other is
automatic cine loop:

Frame-by-frame review:

1. Press [Freeze] to move the trackball for viewing the cine loop frame by frame.
2. Press [Freeze] again to exit the CINE mode, remove memory area and start the real-
time imaging.

Automatic cine loop:

1. Press [Freeze] and click the touchscreen [Cine] for automatic cine loop.
2. Click [Cine] again to stop playing;
3. Press [Freeze] to exit the cine mode, clear memory area and start the real-time imaging.

5.3.2 Cine Editing

In the CINE mode, we can not only use the method above to carry out the CINE review, but
also view the cineloop in a certain time period, and edit the cine by using the function keys in
the soft menu.

Cine editing can also be made through the touchscreen. The editing method is:
1. Press [Freeze] to start cine mode;
2. Roll the trackball to locate the starting point of the frame indicator, and Click on the
touchscreen [Begin].
3. Roll the trackball again to locate the end point of the frame indicator, and Click on the
touchscreen [End].

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4. If you are still not satisfied, you can click [Reset] to restart the cine editing.
5. Click [Cine] or manually rotate the trackball to view the Cine data of the new area; Click
on menu [Speed] to adjust the speed of the automatic cine loop, and the speed will be
displayed on the indicator of the cine icon.

5.3.3 Cine Storage

Cine storage can be divided into static memory and dynamic memory. Static memory
involves the frame-by-frame image while dynamic memory is the video clips. These two types
of memory are workable in both real-time and frozen states.
The method is: Click on [Image Save] or [Cine Save] on the touchscreen to display the
images or cine on the right thumbnail of the screen.

5.3.4 Thumbnails

In order to distinguish between images and cine in the thumbnail, there will be displayed
between cine and images. By using the icon below the thumbnail, we can flip up and down,
store, transmit and delete the images.

Flip the thumbnail display area to the next page;

Flip the thumbnail display area to the previous page;

Store the selected images and cine in the thumbnail to U Disk;

Transmit the selected images in the thumbnail to the report;

Delete the selected images and cine in the thumbnail.

Specific operations:

1. Click on [Image Save] or [Cine Save] on the touchscreen, and the image or cine can be
seen in the thumbnail area in order.
2. Press the [Pointer] on the touchscreen, and use the trackball to move the cursor. Place
the cursor on the selected thumbnail, press [Set], and the selected image will occur in a
yellow box.
3. Use the trackball and [Set] to select multiple images, and click the icon to store, transmit
and delete images.
4. Select the thumbnail and double-press [Set] to view the big image, and Click [Freeze] to
exit the larger image;
5. Press [Set] again in the selected thumbnail to cancel the selection.

Note: Cineloop will occupy a great portion of the system memory. Therefore, in order to avoid
system memory overflows, it is recommended to output the recorded cine into CD or U Disk,

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and then delete the recorded contents from the database in accordance with the sequences.

Note: In order to store images in the thumbnail into the preview area, you must establish a
new patient; otherwise, the images cannot be viewed in the Review.

5.3.5 Cine Review

Press [Review] on the control panel to enter the review menu, as shown below:

D The images that are saved in the thumbnail will be stored in the D disk of the system by
default. The green area below is the currently used capacity and prompt of D disk so as
to avoid image(s) from failing to be saved due to memory overflow.
D When there are a larger number of patients, we can find a patient through [Search Key];
D Click the menu below the screen to carry out the following actions such as, "select all',
[Unselect all] [send], [cancel], [delete Exam], [Hide] and so on.
D Click the menu [Image Screen] on the right to enter the interface [Image Review];
When clicking [Image Screen], you will enter the interface [Image Review], as shown below:

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D On the upper left is the system's image default saving path, folder and storage time.
D You can view the image size in line with the operator's habits and page layout, and
double-press [Set] to view the single-frame image, click on the "Freeze" key to exit
display;
D Click the button below the image to transmit the selected image(s) to a U disk and/or
CD, and carry out other actions such as "select all', "delete", "send to report", "send to
DICOM", Page up and Page down, etc...
D Click the exam screen to return to the [Review] interface;

5.4 Image Annotation

The Annotation function can allow us to enter free text notes and insert pre-defined
annotation into the imaging display information. It can also provide marks, arrows and texts,
thus you can respectively enable [Mark], [Arrow] and [Text] on the touchscreen to make
annotations for image(s).

Images with an annotation can be:

1. Saved in the system database (Please press [Save] on the control panel);
2. Printed (See "Print" in Chapter 7).

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5.4.1 Mark Annotation

Press [Mark] on the touchscreen, for which the icon is displayed on the lower right corner of
the image, and a human icon is displayed in the area on the right of the icon; to change a
mark, you can do this through the touchscreen (as shown below), of which the settings of
human icon are based on the current exam item.

The operating method of Mark is as follows:

1. Click on the touchscreen [mark] button to activate the marks annotation function. Click
on the body mark in the marks display area to select the target mark. The selected
target is displayed in the lower right corner of the image.
2. To change the marks of the examination title, click the current examination account
button to enter the examination account selection interface.
3. Operate the following soft menu to rotate Probe and delete the marks.

4. The first individual marks and the volume library can be set using a preset system.

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5.4.2 Text Annotation

Press [Text] on the touchscreen to enable the text annotation. You can select the body mark
characters displayed on the [Text] page of the touchscreen, or use the touchscreen keyboard
to freely input text. Detailed operation can be carried out by rotating the corresponding knob.

Methods of text annotation:

1. Click [Text] on the touchscreen to enable the text annotation;

2. Click on the text, select the desired text;
3. Move the trackball again and move the cursor to the desired image, then press [Set].
4. Use the text to carry out the functions of deleting (move the cursor to the front of the text),
hiding/showing, screen clearing, text word library on/off, cursor reset, starting point
setting and so on; you can also use Preset for character color and size settings.
If you use the keyboard to freely input text, you need to click the touchscreen [keyboard]
button to open the touchscreen keyboard. After the cursor stays at the ideal image position,
tap the keyboard to enter characters, and then press the [Set] key to confirm.

Operating methods for annotation preset:

Press [Setting] → Click [Text Preset] on the left of the screen → [Text
Properties] on the sub- Menu of the screen to preset relevant information for annotation.

5.4.3 Arrow Annotation

Press [Arrow] on the touchscreen, and a green arrow icon will occur on the screen, and you

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can see corresponding parameter settings on the screen.

Operating methods for arrow annotation:

1. Press [Arrow] to enter the arrow annotation;

2. Move the trackball to place the arrow on the desired target;
3. Rotate the [Select] key to rotate the direction of the arrow; or press the toggle for 30° or
90° rotation, and press [Set].
4. Click [Next] to enable the next arrow and repeat the steps above; click [Delete] and
5. [Delete All] to remove individual or all arrows.

5.5 Biopsy

5.5.1 Introduction

The function of Biopsy can help the doctors to accurately locate the transducer and the
ancillary Biopsy needle in the process of Biopsy; this is because the Biopsy guideline
displayed on the imaging screen is just pointed to the preset path of the Biopsy needle.

Note: Biopsy is of high risk to the patients and the doctors, thus the user must comply with the
correct needling sequences when using the Biopsy stand and its accessories so as to avoid
unnecessary risks to the patients.

Note: The Biopsy guideline displayed on the screen is used for reference only. The user must
verify the exact puncturing position in the operations of biopsy, tapping and aspiration, etc.

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5.5.2 Adjustment of Biopsy Guideline

Each Biopsy function shall be properly adjusted before use. You can set the puncturing
probe, angle, Biopsy line size and other relevant functions according to the following
steps: Press [Setting] on the keyboard → Click [System Preset] on the left of the
screen → Click

[Biopsy] on the sub-menu of the screen, then you can carry out the default settings to the
relevant Biopsy functions.

Note: The Biopsy line shall be demonstrated by the representative or user from Customer
Service Center, and if the probe or biopsy bracket is replaced, the Biopsy program must be
repeated.

Note: Before Biopsy, make sure the track that the Biopsy needle enters is in line with the guide
line displayed on the imaging screen, which can be pre-tested in a water tank filled with 47℃

water. For an individual user, each type of probe needs to make only one debugging.

5.5.3 Biopsy-supporting Modes

Modes that support Biopsy include:

D B mode

D Color mode

D PDI mode

D THI mode

The Biopsy function can only be used in the real-time state. Enable the Biopsy function by
taking B mode as an example:
1. Press [B] to enter the B mode;
2. Press the [Biology] button on the keyboard, and a dotted Biopsy guideline in a certain
angle will occur in the image, and the angle mark [Biology] will occur on the top right of
the screen;
3. To adjust the angle, press [Biopsy] again, and the Biopsy line angle will be changed and
the angle mark [Biology2] will occur;
4. Then press [Biopsy], followed by Biopsy 3, Biopsy 4, Biopsy 5 and Exit Biopsy.

Note: Before Biopsy, make sure that the track of pointer is consistent with the guideline on the
screen.

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Fine tuning function of moving the biopsy guide line steps:

1. When enter the biopsy, Click [Calibration] to active the Fine tuning function;
2. Press [Move left] on the touchscreen can left move the biopsy guide line; [Move right]
can right move the guide line; [Move up] can up move the guide line; and [Move down]
down move the guide line.
3. Roll the [Steer/Angle] knob to change the biopsy guide line angle.
4. Press [Calibration] again to exit the fine tuning function.

5.5.4 Disposable Protective Case

The probe needs to use a disposable case in the process of Biopsy.

Note: All medical institutions must provide a disposable case for the probe so as to prevent
infection. Currently, it is recommended to use formal and standard disposable cases without
containing any pyrogen or other pathogenic agents.

Note: Each of the probes is provided with an independent case, which shall be consisted of
protective shell and cable as well as fixed ring. The sterile probes shall be placed in the
biopsy-dedicated probe device; in addition to the above, the case shall be equipped with
relevant biopsy-dedicated accessories.

Note: The latex contained in the product is likely to cause a latex-allergic patient to suffer from
a strong allergic reaction.

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Note: Do not use condoms containing lubricants to protect the case, as this may damage the
probe. Condom lubricants are not compatible with the probe materials.

Note: Do not use any expired probe case; before use, please be sure of the service life of the
case.

5.5.5 Patient Preparations

Preparations for patients shall be followed in accordance with the routine operation steps of
Biopsy. Any exam or Biopsy under the ultrasonic diagnostic system shall be carried out by
the personnel with corresponding qualifications or professional training or under their
guidance.
Needle track testing:
1. Connect the biopsy bracket with the sensor;
2. Connect the sensor to the system, and activate the sensor;
3. set the system to the proper depth required by a centesis;
4. Click [Biopsy] on the keyboard to start the Biopsy function;
5. To adjust the angle, click [Biopsy] again;
6. Submerge the sensor head into the de-aerated water, and insert the needle into the
guider;
7. Based on the needle track testing with a guide line displayed on the image screen,
the guider can be put into use after verification.

Note: Only the doctors experiencing with full testing are qualified to carry out a centesis.
Appropriate preventive measures must be taken and a sterile environment must be provided.

Note: The Biopsy function cannot be used for IVF and chorionic tissue test and umbilical cord
blood sampling and so on.

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5.5.6 Puncture

Note: Before centesis, make sure that the puncturing path of the needle-holder is consistent
with the guideline on the screen. It can be tested by putting it into a water tank filled with 47℃

water.

Note: Do not use the guide needle that has been tested whether the puncturing path is
consistent with the guide line on the screen, or use the guide needle that is used for
positioning the puncturing path. Make sure that a new guide needle is used for every Biopsy.

Note: There are several guide lines that are commonly used for Biopsy and do not make any
Biopsy before the guide line is completely determined.

Note: When setting the guide line, we do not take into account the bending or deformation of
the Biopsy needle.

Note: The intersection of Biopsy guide line on the screen and the offset of the probe scanning
central axis (depth) are able to be calculated, which can be tested in the water tank filled with
47℃ water.

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Chapter 6 Measurements and Calculations

6.1 Measurement Overview

When the system is carrying out the measurement, you can press the trackball button on the
control panel (Please refer to Control Panel in Chapter 2); there are two types of
measurements and calculations: general measurement and special measurement.

Note: In order to guarantee the desired area from any miscalculation due to the measurement
value in the measuring process, and therefore we should adjust the parameters so as get the
best image quality for measurement.

Note: In order to obtain accurate Doppler blood flow measurements, we should keep the
sampling angle at 60 degrees, as Doppler angle lower or higher than 60 degrees is prone to
misdiagnosis arising from reading errors.

Note: If the image is not frozen or the measurement mode is changed in the measuring mode,
the measurements and calculations data will disappear from the screen, and the General
measurement data will not be saved (Special measurement data will be saved in the
worksheet and the report)

Note: If the system is suddenly shut down in the measuring process, the measurement data
will not be saved.

In general, the user can carry out the functions of measurements and calculations in the real-
time, zoomed or frozen image, but in M mode and PW mode, the measurement function
cannot be implemented in the real-time image, for which the image shall be frozen first.

6.1.1 Measurement Interface

As shown in the following figure, we need to have a detailed understanding of the following
four areas/menus in the measurement process:

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1. Special Measurement main menu: from top to bottom: measurement item, page turning
display of measurement item (this option will occur in the case there is a single page),
special measuring Item, worksheet, report and cursor shows state.
2. Image measuring area: Use the trackball and [Set] to activate the measurement display
of the caliper.
3. General measurement menu: Click the soft menu to select the measurements of the
corresponding general items.
4. Measurement result display area: Move the cursor to the top column and press [Set],
and rotate the trackball to press [Set] to move the measurement results to your
preferential area. This area can support 8 groups of data display, and the data after the
eighth group will automatically overwrite the previous measurement data.

6.1.2 Caliper Type

The caliper is a measuring mark used to indicate the starting point and the end point. Some
caliper groups need multiple measurements to calculate a value, and a group of measured
data will use the same caliper number for marking, and an image can display eight calipers
at most. The mark will also be displayed in the result box; different measuring methods will
have different calipers displayed on the image, which can be distinguished by referring to the
list table.

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Caliper Type Description Mode

B mode: distance, tracing length,
++ To indicate the starting point
area, angle, volume, stenosis rate,
×× and end point of each pair of marks
A/B ratio
To draw the starting position for a
M mode: time, HR
vertical dotted line, capable of
PW mode: time, HR, PI (automatic),
marking the horizontal position or
PI (manual), flow
spacing

PW mode: velocity, resistance index,

To indicate the vertical and
acceleration, velocity ratio
horizontal positions.
M mode: distance, slope, A/B ratio

6.1.3 Default Measurement Methods and Units

D In different imaging modes, there are different default measuring methods. Please refer
to relevant chapters of "Measure Preset" for the system default imaging measurement
methods.
D Some General measurements have more than one measuring method, for example, the
area method includes elliptical method and tracing method; please see relevant chapters
of "Measure Preset" for its default settings.
D When the system is measuring different General measurement items, the measurement
units are also different; please see Chapter 8 of "Measure Preset" for their default units;
you can change the unit settings, if necessary.
The users can set the default measuring method and unit in the Preset according to their
preferences:
Press [Setting] on the touchscreen → Click [Measure Preset] on the left of the screen →
Click [General] and [Caliper] on the sub-menu above the screen, and the user can make the
default settings to the general measurement methods above.

6.1.4 Basic Measurement Procedures

In general, the basic measurement procedures are as follows:

1. Enter the required measurement mode, and press [Measure] or [Caliper] to
activate specialized measurement or general measurement. ;
2. press the parameter knob to select a general measurement item or use [trackball] to
select a Special Measurement;
3. Use the trackball and [Set] to measure the desired area of the image; and press [Save]
to save the image;
4. Results of the measurements will be displayed on the measurement result box;
5. If you want to modify results, you can re-measure this item when the data is presented
with a color highlight in the measurement result area; and then press [Caliper] return
measurement state.
6. If you want to remove the measuring scale and measurement result in the image, press
[Clear] on the keyboard to clear the screen (but the measurement data will be saved to

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the report and worksheet);
7. Click [Cancel] on the touchscreen or press [Freeze] to exit the measurement.
8. After the measurement is completed, the Special Measurement results will be saved to
the report and the worksheet for viewing and editing.

6.2 General Measurement

General measurements and calculations refer to all the measurements and calculations that
are able to be carried out in the exam items, under which there are different general
measurement items in each type of imaging modes. The specific methods of general
measurements are displayed in the soft menu, and general measurements and calculations
include the measurements and calculations of general 2D mode (including modes of B, Color,
THI and PDI), general M mode and Doppler mode (including PW mode).

6.2.1 General 2D-mode Measurements and Calculations

In 2D mode, you can set its measurement method in the Preset or select:

6.2.1.1 Distance Measurement

Function: measuring the distance between two respective points on the ultrasonic image.
Measurement methods:
1. Enter B mode and press [Caliper].
2. Rotating menu [Distance] to select distance measurement.
3. Roll the trackball to place the caliper on the image, and position the first measurement
mark and press [Set].
4. Roll the trackball to move the caliper and position the second measurement mark,
then press [Set] to measure the distance between two points of the image, meanwhile,
the measurement result will be displayed in the result box of the imaging screen.
5. Click [Cancel] on the touchscreen or press [Freeze] to exit the measurement.

6.2.1.2 Tracing Length Measurement

Function: To use the manual tracing to calculate the distance. In general, B mode tracing
length measurement is used for measuring non-linear distance.

Measurement methods:

1. Press[Caliper] to enable the measurement function;

2. Rotating menu [Trace Length];
3. Roll the trackball to position the first measurement mark, and press [Set], then the

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system will fix this position.
4. Roll the trackball again to position the second measurement mark, and press [Set] to
complete the measurement, then the system will record the measuring results to the
result box on the screen.

6.2.1.3 Area Measurement

There are two type of area measurements, namely elliptical method and tracing method, and
users can use the system preset to select the default measurement method, or Press the
menu [Area], then elliptical and tracing options will occur for selecting.

Making an ellipse measurement

Function: To measure the circumference and area of a closed area through the elliptical
method. When two diameters D1 and D2 used in the measurement are almost equal, the
formula for calculating circumference is very accurate. When the image needs to measure
the circumference, and the ratio between two diameters exceeds 2:1, it is recommended to
use the tracing method so as to ensure the accuracy of the measurements.

Measurement methods:

1. Activating general measurement function;

2. Press menu [Area] and select [Ellipse];
3. Roll the trackball to position the first measurement mark, and press [Set]; roll the
trackball again, and the system will display an ellipse, press [Set] to position an axis of
the ellipse.
4. Roll the trackball again, the system will adjust the shape of the ellipse along its second
axis; press [Set], the system will display the measuring data to the result box.
5. Roll the trackball again, and press [Set] to position the ellipse on the image. If you are
not satisfied in the process of measurement, you can return to the previous step and
press [Set] to revise the measurements.

Making a Trace Area Measurement

Function: calculating the area/circumference by manual tracings.

1. Activating measurement function;
2. Press menu [Area] and click [Trace];
3. Roll the trackball and press [Set] to position the first measurement mark, Roll the
trackball again , the system will display the second measurement mark;
4. Roll the trackball and the mark line will establish a tracing by following the trackball;
press [Set] to position the second mark, and the system will display the circumference
and area of the tracing in the measurement result.

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6.2.1.4 Angle Measurement

Function: To measure the angle between two intersecting planes on the ultrasonic plane, of
which the larger angle isα, and the smaller angle isβ, and these two angles will be displayed
in the result box.
1. Press menu [Angle] to select the angle measurement.
2. Roll the trackball to place the caliper on the image, and position the first measurement
mark and press [Set];
3. Roll the trackball to move the caliper to position the second measurement mark, then
press [Set] and a line segment will occur;
4. Roll the trackball to position the third measurement mark and press [Set];
5. Roll the trackball to move the caliper to position the fourth measurement mark, then
press [Set] and another line segment will occur;
6. The measurement angle between these two line segments will be displayed in the result
box.

6.2.1.5 Stenosis Rate Measurement

Stenosis rate measurement consists of diameter stenosis rate and area stenosis rate, which
can be set in the Preset or through the soft menu; refer to distance measurement and ellipse
area measurement for its measuring method, which will not be repeated here.

6.2.1.6 Volume Measurement

Press the menu [volume] and five volume measurement methods will occur, as shown below:

Ellipse + Distance method

Measurement methods:

1. Activating general measurement function;

2. Press menu [Volume], and press the toggle to select [Ellipse+ Distance].
3. Roll the trackball to position the first measurement mark, and press [Set], then the
system will fix the mark; roll the trackball again, and the system will display an ellipse,
press [Set] to position an axis of the ellipse.
4. Roll the trackball again, and the system will adjust the shape of the ellipse along its
second axis; press [Set].
5. Roll the trackball again to position the ellipse on the image and press [Set] to fix the
position. If you are not satisfied in the process of measurement, you can return to the
previous step and press [Set] to revise the measurements.
6. Roll the trackball again and move the caliper to position the starting point of the line

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segment, then press [Set];
7. Roll the trackball again. Move the caliper to position the end point of the line segment,
then press [Set] to complete the measurement; the measuring results will be displayed in
the result box.

Formula:

π(D1×D2xD3)
V=
6

Elliptic long axis D1, Elliptic short axis D2, Segment line D3. Formula unit: mm.

1-Distance Method

Function: The system uses a single distance measurement to calculate the volume.
1. Activating measurement function;
2. Press menu [Volume] and then press [1-Distance];
3. Roll the trackball to position the first measurement mark, and press [Set], then the
system will fix this position, and display the second mark;
4. Roll the trackball to position the second measurement mark, and press [Set]. The system
will fix this mark, and the measuring results will be displayed in the measuring result box.

Formula:
3
（π ×D ）
V=
6

D=length of the Segment, Formula unit: mm

2-Distance Method

Function: The system uses two distance measurements to calculate the volume. Use the
caliper to respectively measure the length and the depth. The measuring results are
successively displayed in the result box of the imaging screen. After the measurement is
completed, the measuring results will be displayed in the result box.

Formula:

(π×D1×D22)
V=
6

Segment length D1, D2, Formula unit: mm

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3-Distance Method

Function: Use the caliper to measure the three distances of D1 length, D2 width and D3
thickness of elliptical-similar object. The results of these linear measurements will be
accordingly displayed in the result box of the imaging screen. After the thickness is measured,
the volume will be displayed in the result box.

Formula:

π×(D1×D2xD3)
V=
6

Segment length D1, D2, D3, Formula unit: mm

1-Ellipse Method

Function: Use the ellipse method to calculate the volume, and please refer to the Ellipse Area
Method for specific measurement methods. After the measurement is completed, the volume
will be displayed in the result box.

Formula:

(8×A2)
V=
3π×D

Segment length D, ellipse area A, Formula unit: mm.

6.2.1.7 A/B Ratio Measurement

A/B ratio measurement consists of distance ratio, area ratio and volume ratio, which is a
measurement to calculate the ratio between two measurements; users can set this method in
the Preset, or select this method in the soft menu; refer to the measurement methods of
distance, area and volume for its measuring methods, which will not be repeated here.

6.2.2 General M Mode Measurements and Calculations

In the measurement of M mode, if you want to conduct a system preset, please refer to the
method of B mode Measure Preset;

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6.2.2.1 Distance Measurement

Function: To measure the distance between two vertical points on the M mode. Measurement
methods:
1. Enter M mode, and press [Freeze] to freeze the image;
2. Press [ Measure] on the touchscreen, and rotate the menu [Distance] to measure
the distance;
3. A dotted line will occur; rotate the trackball to adjust the position of the starting
point, then press [Set];
4. Rotate the trackball again to fix the vertical dotted lines, and align the end points on the
dotted line, press [Set] to locate the vertical line segment; the measuring results will be
displayed in the result box;
5. If you want to re-position the points, press [Update] to revise the results.

6.2.2.2 HR Measurement

Function: To measure the HR between two vertical dotted lines on the M image.
1. Click menu [HR] and a dotted line will occur; rotate the trackball to position the dotted
line and press [Set];
2. Move the trackball and another dotted line will occur, press [Set] to position the dotted
3. Line. The HR measurements between two points will be displayed in the result box.
Formula:
60×n
HR =
T
T is the length of time represented by the line segment length, n is the number of cardiac
cycles, Formula unit: s.

6.2.2.3 Slope Measurement

Function: To calculate the slope via measuring the distance between the two points of M
mode ultrasound image.
Measurement methods:
Rotate menu [Slope], and refer to Distance Measurement for the methods of slope
measurement, which will not be introduced in details here.

6.2.2.4 Time Measurement

Function: To measure the time interval between two respective points of the M mode image.
1. Select [Time] to switch to the measurement for time interval;
2. A dotted line occurs; roll the trackball and press [Set] to position the dotted line as the
starting point of the time interval;
3. Move the trackball and another dotted line will occur, press [Set] to position the end point
of the time interval. The time interval between two respective points will be displayed in
the result box.

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6.2.2.5 A/B Ratio

A/B ratio measurement consists of distance ratio and time ratio measurements; please refer
to distance measurement and time measurement above for specific operating methods, and
the results will be displayed in the result box.

6.2.3 General Doppler mode Measurements and Calculations

You can carry out the following general measurements in Doppler mode:

6.2.3.1 Velocity

Function: This measurement is used to calculate speed.

1. Enter PW mode , and press [Freeze ] , then press [Measure] to enter the PW
measurement mode;
2. Rotate menu [Velocity] to switch to the flow velocity measurements;
3. A measuring cursor arising from the intersection of vertical line and horizontal line occurs,
and roll the trackball to adjust the position of focus, press [Set] to position the focus, and
the velocity measurement will be displayed in the result box.

6.2.3.2 PI (Auto)

1. After entering PW measurement mode, Rotate menu [PI Auto] to select automatic tracing
measurement;
2. A tracing caliper occurs on the screen, press [Set] to position the caliper and fix the
starting point;
3. Move the trackball to position the end point, and press [Set] for positioning;
4. 4The system will automatically fix these two calipers and find out the maximum value
between the two points. In addition, a caliper will automatically occur, and rotate the
trackball and press [Set] to confirm the second caliper; after the measurement is
completed, the measuring results will be displayed in the result box.

6.2.3.3 PI (Manual)

1. After entering PW measurement mode, Rotate menu [PI Manual] to select the manual
tracing measurement;
2. A tracing caliper occurs on the screen, press [Set] to position the caliper and fix the
starting point;
3. Move the trackball for the maximum spectrum value required by manual tracing, and
press [Set] to position the end point.
4. A caliper will occur, and rotate the trackball to set the second caliper; after the

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measurement is completed, the measuring results will be displayed in the result box.

6.2.3.4 Acceleration Measurement

Function: To measure the ratio between acceleration or deceleration time; it is composed of

two measurement marks: distance mark and velocity mark, so as to calculate the peak
velocity (Vmax), Time (T) and acceleration.
Measurement method:
1. Rotate menu [Acceleration] and switch to the corresponding measurement.
2. Roll the trackball to place the caliper on the starting point, and press [Set];
3. Roll the trackball to place the caliper on the end point, and press [Set];
4. The measuring results will be displayed in the result box.

6.2.3.5 Velocity Ratio Measurement

Function: To measure the velocities of two respective points (V1, V2) and calculate the
velocity ratio (V1/V2, V2/V1, (V1-V2)/V1).
Refer to Acceleration Measurement for measuring methods.

6.2.3.6 HR Measurement

Function: To depict a cardiac cycle through the measurement mark displayed in the form of
vertical line, based on which the HR can be determined.
1. Measurement methods:
2. Rotate menu [HR].
3. Roll the trackball to place the caliper on the starting point of the cardiac cycle on the
spectrum, and press [Set];
4. Roll the trackball to place the caliper on the end point of the cardiac cycle, and press
[Set];
5. The measuring results will be displayed in the result box.

6.2.3.7 RI (Resistance Index) Measurement

Function: This measurement is used to calculate the resistance index, measuring the peak
systole (PS) and the velocity of end diastole (ED) as well as their velocity rate.
Refer to Velocity Measurement for its measuring methods.

6.2.3.8 Flow Volume Measurement

Flow Volume measurement consists of D-Flow and A-Flow, of which D-Flow is diameter flow
measurement and A-Flow is area flow measurement; you can select the default
measurement method in the Preset or in the soft menu.
The preset method is: Click the menu [Setting] on the touchscreen → Click [Measure Preset]
on the left of the screen → Click [General Measurement] on the sub-menu above the
screen, and the user can make the default settings to the flow measurement method.

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Making a Diameter Flow Volume Measurement

Function: Diameter flow is an estimated value of the flow that is calculated based on the
vascular diameter. Diameter flow needs to carry out the measurement of vascular diameter
in B mode with Doppler velocity tracing.

Measurement methods:

1. Rotate menu [Flow Volume], in which there are [D-Flow] and [A-Flow], then select [D-
Flow];
2. Place the cursor in the starting point of PW mode image, and press [Set];
3. Roll the trackball to place the cursor on the end point, and press [Set];
4. Roll the trackball and move the caliper to the B mode image, then select the starting
point and press [Set];
5. Roll the trackball to place the caliper on the end point, and press [Set];
6. The measuring results will be displayed in the result box.

Making an Area Flow Volume Measurement

Function: Area flow is an estimated value of the blood flow that is calculated based on the
area. Area flow also needs to carry out the area measurement in B mode with Doppler
velocity tracing.

Measurement methods:

D Rotate menu [Flow], in which there are [D-Flow] and [A-Flow], then select [A-Flow];
D Place the cursor in the starting point of PW mode image, and press [Set];
D Roll the trackball to place the cursor on the end point, and press [Set];
D Roll the trackball and move the caliper to the B mode image for area measurement
(Refer to Area Measurement in 2D-mode General measurement for details).
D The measuring results will be displayed in the result box.

6.2.3.9 Time Measurement

Function: To be used to measure the time interval between two vertical measurement marks.
Refer to Velocity Measurement for its measuring methods.

6.2.4 Measurement Errors

Although the system has a very high accuracy of scan and measurement, users should also
be aware of the errors arising from ultrasonic signal characteristics and scanning structure,
organization and physiological characteristics of liquids.
In order to ensure the best possible measurement accuracy, the image zoom proportion shall
be used for measurement.
In order to improve lateral resolution, select the proper probe according to the depth range of

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the measurement structure.
During the measuring process, the following measurement errors shall be taken into account:
D Distance measuring error: ± 3% or less;
D Circumference measuring error: ± 3% or less;
D Area measuring error: ± 6% or less;
D Volume measuring error: ± 9% or less;
D When the ultrasonic beam axis is aligned with the blood flow, the measuring error of flow
velocity shall be within ±5%.
The measuring errors are acquired from assessment to the testing targets in the laboratory
environment.
In the process of diagnosis, the measurement data of the ultrasonic systems must be used in
combination with other clinical data, and no diagnosis shall be made only in terms of
measurement data. When the data are acquired by using the ultrasonic system, other factors
shall also be taken into account. Analysis of these factors has shown that the accuracy of
measurement and further calculation depend on the quality image to a large extent. In turn,
the image quality depends on system design and skills of operators as well as their
understandings of system features.
The ultrasound imaging algorithms are based on the sound velocity in the 1540 m/s tissues.
However, in different tissues, sound velocity may be different. In soft tissue, the error is
usually by 2%, and sometimes even reaches 5%, particularly when a fat tissue occurs in the
measured area.
In order to ensure the best measurement precision, please align the probe carefully and keep
the sound beam aligned with the direction of flow.

Note: The calculation precision of blood flow parameters depends on:

D System design and signal processing algorithms used in the system;

D Quality of reflection signals, including signal-to-noise ratio and Doppler change;
D Skills of the users, whether they can correctly adjust the probe in line with the direction
of the exam item and select the system parameters;
D All of these above will affect the quality of reflection signals and the suitability of
processing algorithms.
Due to the above and other factors, the aggregate error of such an absolute measurement
like flow velocity sometimes even reaches ± 50% or higher. Even in ideal laboratory
environment, it is very difficult to achieve an error within ± (5-10) %.
Therefore, we should try our best to avoid absolute measurement, but give priority to the
relative measurements such as resistance index and plasticity index, etc., of which the errors
are around 10%.
In the absolute measurement, angle between beam axis and flow direction is very important.
If the angle exceeds 60°, the measurement error will increase dramatically. Even if the
angle

is less than 60°, the error also depends on the parallel positioning accuracy between flow

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direction line and actual flow direction performed by an operator. The calculation precision of
the average velocity will be greatly affected by the relative position of sampling volume and
blood vessel. The sampling volume must be large enough so as to be able to "ensonify" the
entire sample volume. The sampling volume must be aligned with the blood vessel axis.
Users must receive trainings from skilled experts so as to ensure proper use of the Doppler
ultrasonic diagnostic system.

6.3 Special Measurement

Special Measurements and calculations refer to the measurements and calculations of

various specific exam items, including abdomen Renal, abdominal blood vessel, pediatric
abdomen, gynecology, obstetrics, early pregnancy, middle and late pregnancy, fetal heart,
urinary tract, prostate, blood vessel, Carotid, peripheral arteries, vein, Small Parts, thyroid,
mammary glands, testes, orthopedics, cardiology, pediatric cardiology, Transcranial,
emergency and other measuring items. The system will store the measuring and calculating
results into the worksheet and report.
Special Measurement shares a similar operating method with general measurement, but the
specific measurement items can be selected from the main menu, for which the specific
operating steps are as follows:
1. Press [Patient] to input relevant patient information;
2. Press [Probe] to select the measuring items under the corresponding probe;
3. Enter the desired measurement mode, and press [Measure] (press [Freeze] first
and then [Measure] in M mode and PW mode);
4. Move the trackball to the measurement items on the left, and click on the touchscreen to
select the measurement items; the corresponding measurement methods will be
displayed in the soft menu of the screen.
5. Rotate the trackball to the desired area of the image and press [Measure] for
measurement; the system will be defaulted to measure the next item after completing the
current item, in front of which the icon √ will be displayed; if all the items are measured,
the system will continue to carry out the measurements again;
6. The latest eight data of the measuring results will be displayed in the measurement result
display area;
7. Click the worksheet and report on the left, and view the measuring results; all of the
measurements will be saved into the worksheet, while the latest measurement data
will be saved in the report.
We will introduce the measuring Items, measurement methods, measurement steps, formula
and export reports of the items above respectively in 2D mode, M mode and PW mode.

6.3.1 Abdominal Measurement

Preparations before measurement:

1. Check whether the current probe is suitable for abdominal measurement;

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2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Press [Probe] to select the items of abdominal measurement.

6.3.1.1 Abdominal Measurement in 2D Mode

In 2D mode, abdominal measurement is divided into general measurement and Renal,

abdominal blood vessel and Pediatric abdominal measuring Items, all of which are measured
through the distance method, and the specific measurement items include:

D Liver: R Live Max, R Live W,R Live D,L Live L,L Live D,CBD,CHD,
D Gall bladder: GB L,GB W,GB Wall- D,
D Pancreas: Pancr. Head, Pancr. Corus, Pancr. Tail, Pancr. Duct,
D Spleen: SP-L,SP-D,SP-W;
D Right kidney: RK-L, RK-D, RK-W;
D Left kidney: LK-L, LK-D, LK-W;
D ABD-Vascular:Ao, CHA, Celiac Axis, SMA, Splenic A, Rt Renal A, Lt Renal A, IVC,Portal
D V, Hepatic V, SMV, Splenic V, Rt Renal V, Lt Renal V.
D Ped-ABD: R Live Max, R Live W,R Live D,L Live L,L Live D,CBD,CHD,GB L,GB W,GB
Wall- D, Pancr. Head, Pancr. Corus, Pancr. Tail, Pancr. Duct, SP-L,SP-D, SP-W; Right
kidney: RK- L, RK-D, RK-W; Left kidney: LK-L,LK-D,LK-W;

Measurement methods:

1. Press [B] to enter the B mode measurement;

2. Press [Measure] and the abdominal measuring items will be displayed in the main menu
on the left; rotate the trackball to select the corresponding item and press [Set], then
move the trackball to the image for distance measurement (the measurement method is
displayed in the soft menu);
3. The measurement result is displayed in the result box; click the main menu or the
4. [Report] to view the report or worksheet.

Formula for Renal:

Calculation Item Input Parameter Formula

3-Distance π(D1×D2xD3)
Renal volume V=
(length, width and height) 6

6.3.1.2 Abdomen Measurement in Doppler Mode

In Doppler mode, you can carry out the measurements to each part of abdominal entire
sample volume, and the concrete measurement items and methods are:
D RI , PS and ED of Ao, CHA, Celiac Axis, SMA, Splenic A, Rt Renal A, Lt Renal A;

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D PV of IVC, Portal V, Hepatic V, SMV, Splenic V, Rt Renal V, Lt Renal V;
Among them, the measurement methods of the arteries above are PI (automatic); RI
measurement methods are: RI;
PS measurement methods are: V (velocity); ED measurement methods are: V (velocity); PV
measurement methods are: V (velocity).

Measurement methods of PI (Auto), RI, PS, ED and PV:

1. Press [D] to enter the PW mode, press [Freeze] and press [Measure] to enter the PW
measurement interface;
2. On the left occurs the abdominal menu items; click on the touchscreen or trackball to
select the measurement item; (refer to general Measurement for specific measurement
methods that are displayed in the soft menu)
3. A vertical line will be displayed on the system screen; move the trackball to position the
starting point of the vertical line and press [Set], then move the trackball to position the
vertical line and press [Set] (taking RI as an example);
4. The measurement values will be displayed in the result box.

6.3.1.3 Abdominal Measurement Report

The report includes patient information, measurements, images, description and conclusion
of the measurement result made by doctors.

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6.3.2 Gynecological Measurement

Preparations before measurement:

1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Press [Probe] to select gynecological measurement.

6.3.2.1 Gynecological Measurement in 2D Mode

In B mode, users can carry out the gynecological measurements that are listed in the menu:
D Uterus: UT-L, UT-D, UT-W ,Endo, Cervix,
D Rt Ovary: OV-L, OV-D, OV-W;
D Lt Ovary: OV-L, OV-D, OV-W;

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D Rt Follicle:#1~#15;
D Lt Follicle:#1~#15;
D CRL, Yolk Sac,
GS
Among them, Uterus, Rt Ovary, Lt Ovary, CRL, Yolk Sac, GS use the distance method for
measurement:
1. Place the caliper on the starting point, and press [Set];
2. Roll the trackball to place the caliper on the end point, and press [Set];
3. The measuring results will be displayed in the result box.
4. Measurement steps for Follicle:
5. Place the caliper on the starting point, and press [Set];
6. Roll the trackball to place the caliper on the end point, and press [Set], then a line
segment occurs;
7. Place the caliper on the starting point, and press [Set];
8. Roll the trackball to place the caliper on the end point, and press [Set], then a line
segment occurs;
9. The measuring results will be displayed in the result box.

Gynecological 2D mode calculation

When you measure the long diameter, thick diameter and wide diameter of the uterus and
ovaries in the measurement results, the system will carry out the volume measurement
according to the formula in the following table.

Calculation Item Input Parameter Formula

3-Distance (long diameter

Uterine Volume D1, thick diameter D2 and UT − Vol = 0.5236 × D1 × D2 × D3
wide diameter D3)

Ovarian Volume 3-Distance (D1, D2, D3) OV − Vol = 0.5236 × D1 × D2 × D3

6.3.2.2 Gynecological Measurement in Doppler Mode

In Doppler mode, users can conduct the measurements of UT A, Rt OV A, Lt OV A; the

measurement method is PI (automatic), and the operating steps are:
1. Press [Probe], and select [GYN] to return to the main interface;
2. Press the PW mode, and press [Freeze], then press [Measure] to enter the
measurement interface;
3. The gynecological measurement option will pop up in the main interface, and select the
measurements;
4. A vertical line occurs, and rotate the trackball and [Set] to position the vertical line; then a
second vertical line occurs, rotate the trackball and press [Set] to position the vertical line;
5. The system will automatically fix these two vertical lines and work out the maximum
value between the two points. A caliper will automatically occur, and rotate the trackball
and press [Set] to position the second caliper, then the measurement is completed.

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6. The measurements will be displayed in the result box, and saved to the worksheet and

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report.

6.3.2.3 Gynecological Report

The report includes patient information, measurements, images, description and conclusion
of the measurement results made by doctors, allowing users to view the conditions of the
patient; the report is as follows:

6.3.3 Obstetric Measurement

Preparations before measurement:

1. Check whether the current probe is suitable for obstetric measurement;
2. Check whether the system date is the current date;
3. Press [Patient] to input the patient information, and confirm last menstrual period,

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selection of single birth or multiple births as well as other cases;
4. Press [Probe] to select OB-1 or OB-2/3, OB in the obstetric measurement.
5. Press [Setting] on the key → Click [Measure Preset] on the left of the screen → Press
[Measure] on the sub-menu above the screen to preset the related obstetric
measurements and reference author as well as other information.

6.3.3.1 Obstetric Classification

There are two exam types of obstetric application, including early obstetric exam and
standard obstetric exam, both of which have formula to calculate the menstrual age and fetal
weight and to speculate the growth ratio of fetus. Each type of exam can support
measurements of multiple births.
D Early obstetric exam is mainly targeted at the measurements of pregnant women in the
first trimester.
D Standard obstetric exam is mainly targeted at the measurements of intermediate 3
months and last 3 months.

6.3.3.2 Estimation of Fetal Weight and Gestational Age

Estimation of fetal weight:

When the system carries out related obstetric measurements, it will automatically calculate
the fetal weight and gestational age, of which EFW1 and EFW2 are the estimated fetal
weights (g).
The fetal weight can be calculated through the following methods:
D Shepard
D Hansmann
D Merz
D Hadlock1
D Hadlock 2
D Hadlock 3
D Hadlock 4
By default, the system will use Hadlock 2 to estimate the fetal weight, and if the user wants to
select other methods, click [Worksheet] to select the calculation method of fetal weight in the
drop-down list in EFW1 or EFW2, or can make settings in the Preset; the operating methods
are:
Press [Setting] on the keyboard → Click [Measure Preset] on the left of the screen → Click
[EFW/CUA] under the sub-menu [Measure] above the screen to select the calculation method
of fetal weight and gestational age.

Gestational age calculation:

Enter the last menstrual period in the obstetric report or patient information menu in
accordance with the following steps:

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1. Move the cursor to the last menstrual period ▼ and a date list occurs (as shown below);
2. Click or to change the menstrual period, and press [Set] to select the appropriate
date;
3. After entering the last menstrual period, the system will automatically calculate the
clinical expected date of confinement through corresponding methods.
4. Click [Worksheet] to select the reference author of gestational age from the drop- down
menu of [CUA Based on].

The reference author and corresponding estimating formula can be seen from the following
table:

Reference Author Estimating Formula and Measuring Item

Hadlock1 CUA(BPD, HC) = 10.32+0.009*HC2+1.3200*BPD+0.00012*HC3

Hadlock2 CUA(BPD, AC) = 9.57+0.524*AC+0.1220*BPD2

Hadlock3 CUA(BPD, FL) = 10.50+0.197*BPD*FL+0.9500*FL+0.7300*BPD

Hadlock4 CUA(HC, AC) = 10.31+0.012*HC2+0.3850*AC

Hadlock5 CUA(HC, FL) = 11.19+0.070*HC*FL+0.2630*HC

Hadlock6 CUA(AC, FL) =10.47+0.442*AC+0.3140*FL2 - 0.0121*FL3

CUA(BPD, HC, AC) = 10.58+0.005*HC2
Hadlock7
+0.3635*AC+ 0.02864*BPD*AC
Hadlock8 CUA(BPD, HC, FL) = 11.38+0.070*HC*FL+0.9800*BPD

Hadlock9 CUA(BPD, AC, FL) = 10.61+0.175*BPD*FL+0.2970*AC+0.7100*FL

Hadlock10 CUA(HC, AC, FL) = 10.33+0.031*HC*FL+0.3610*HC+0.0298*AC*FL

Hadlock11 CUA(BPD, HC, AC, FL)=10.85+0.060*HC*FL+0.6700*BPD+0.1680*AC

6.3.3.3 Measurement of Single Birth and Multiple Births

1. Press [Patient] to enter the basic information of patients, and enter the number of fetus in
the patient information, in which the user can enter 4 at most, meaning a maximum of
four fetuses can be measured at the same time;
2. Press [Measure] and four letters A, B, C and D will appear on the top of main menu, of

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which the system will highlight the letter of the designated fetus under measurement, and
A is the default letter.
3. To carry out measurements of multiple births (take twins for example), the user can
define the fetuses as A and B; to measure A, roll the trackball to select A and press [Set]
to measure the following items; to measure B, select B and press [Set] to measure the
following items.

6.3.3.4 Obstetric Measurement in 2D Mode

In B mode, in accordance with the classification of obstetrics, the obstetric measurements

consist of three measuring Items, namely early pregnancy, middle/late pregnancy and fetal
heart:
D General: GS, CRL, BPD, HC, AC, FL.AFI:Q1, Q2, Q3, Q4, NT, OFD, ASD, ATD,
FTA , APTD, TTD, HL, C Lav, Ulna, Tibia, Radial, FIB, FT, Ear, BN, Placenta D, TC, HeartC,
CTAR, THD, Rt Renal L, Lt Renal L, Rt RAP, Lt RAP, Cervix Len, TCD, Cist Magna, HW,
OOD(Outer Orbital Diameter), IOD(Outer Orbital Diameter), Umb VD;
For the measurements above, except that HC, AC, FTA, TC, CTAR and Heart C the area
measurements and heart chest area ratio is the area ratio measurement, all of the others are
distance method measurements, for which the measurement steps are as follows:
1. Roll the trackball to place the first caliper on the starting point to be measured;
2. Press [Set];
3. Roll the trackball to place the second caliper on the end point to be measured;
4. Press [Set];
5. The measuring results will be displayed in the result box of the imaging screen.
The operating methods to use the elliptical area method to measure HC, AC, FTA, TC and
heart C are:
1. Press [Patient] to enter and save the patient information, and press [Probe] to select the
obstetric measurement item and return to main interface;
2. Press B mode and press [Measure] to enter the measurement interface;
3. The obstetric items pop up in the main menu, and select the measurement of Head
Circumference (taking HC measurement for example);
4. The area method measurement will occur in the menu: rotate the trackball and press [Set]
to position the starting point of the ellipse; and rotate the trackball and press[ Set] again
to position an axis of the ellipse; then rotate the trackball and press [Set] to position the
other axis of the ellipse; and finally rotate the trackball to select the position of ellipse and
press [Set] for positioning;
5. The measurements will be displayed in the result box, and saved to the worksheet and
report.
6. The measurement of CTAR can refer to the ellipse area method above, and another an
ellipse needs to be drawn for calculating the area ratio in the process of the
measurement.

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6.3.3.5 Measurement Item and Calculation of Fetal Heart

There is a measurement kit for fetal heart in the obstetric submenu, and measurement items,
descriptions and measurement methods are listed in the following table.

Measurement Item Description Measurement methods

AoD Arch Diameter of aortic arch Distance

Asc AoD Diameter of ascending aorta Distance

Desc AoD Diameter of descending aorta Distance

Interventricular septum dimension at
IVSd Distance
end systole
Left ventricular internal dimension at
LVIDd Distance
end systole
Left ventricular posterior wall dimension
LVPWd Distance
at end systole
Interventricular septum dimension at
IVSs Distance
end systole
Left ventricular internal dimension at
LVIDs Distance
end systole
Left ventricular posterior wall dimension
LVPWs Distance
at end systole
LVOT Diam Left ventricular outflow tract diameter Distance

PA Pulmonary artery Distance

Right ventricular dimension at end
RVDd Distance
systole
RVOT Diam Right ventricular outflow tract diameter Distance

CTAR Heart-chest area ratio Area ratio

Cardiac Axis Cardiac axis Angle

Measurement method from fetal heart aortic arch diameter to right ventricle outflow tract
diameter:
1. Press [Exam/Item] to select the fetal heart measurement Item in the obstetric menu or
directly click [OB]; and click [Measure] to select [AoD Arch] in the main menu (taking AoD
Arch for example);
2. Place the third caliper on the starting point of D1 segment;
3. Press [Set];
4. Roll the trackball to place the second caliper on the end point of D1 segment;
5. Press [Set];
6. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report. If you want to continue with the following measurements, please
repeat steps 2-5.
7. Measurements of CTAR can refer to the measurement of ellipse area method of head
circumference, while another an ellipse shall be also measured, and the measurements
will be displayed in the result box.

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Fetal heart formula

The table below shows the formula of fetal heart measurement in 2D mode and M mode, and
the calculation results will saved to the report and worksheet.

Measuremen Desired
Description Unit
t Item Measuremen
t
left ventricular end-systole volume and
Left ventricular end-diastole volume are
estimated by measuring the distance from
left ventricular internal diameter (LVID).
Teichholz Volume method:
EDV = 7(LVIDd3/1000)/(2.4 + LVIDd/10) ESV
= 7(LVIDs3/1000)/(2.4 + LVIDs/10) LVIDd
EDV &ESV mL
Cube: EDV = LVIDd³/1000 LVIDs
ESV = LVIDs³/1000
Gibson:
EDV = 0.52(0.98*LVIDd/10 +
5.90)* LVIDd2/100
ESV = 0.52(1.14*LVIDs/10 +
4.18)* LVIDd2/100
Ejection fraction refers to the ratio
EF between stroke volume and end- diastolic EDV ESV %
volume: EF=SV/EDV*100
Systolic percentage refers to the
LVIDd
FS systolic percentage of LV size: FS=[(LVIDd- %
LVIDs
LVIDs)÷LVIDd]*100
Stroke volume refers to the ventricular
SV ejection volume in a cardiac cycle or EDV ESV mL
ventricular systolic phase: SV=EDV-ESV

6.3.3.6 Obstetric Measurement in M Mode

In M mode, you can view the routine fetal heart rate and fetal heart measurement Item, which
has been listed in the table above (excluding FHR and fetal heart measurement items), and
will not be repeated here.

6.3.3.7 Obstetric Measurement in Doppler Mode

In Doppler mode, you can carry out the measurements of Umb A, MCA, FHR and fetal heart
measuring Items measuring Item will be listed in the table below along with the description of
measurement items and measurement methods. Please refer to corresponding general
measurement items in Doppler mode for its operating methods.

Measurement Item Description Measurement methods

Preload Index RI
Time interval between beginning and
Tel Index a Time
end of mitral valve filling
Time interval between beginning and
Tel Index b Time
end of aortic flow
Left ventricular outflow tract
LVOT Max Velocity
maximum velocity

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LVET Left ventricular ejection time Time

Asc Ao Vmax Ascending aorta maximum velocity Velocity

Ao Arch Vmax Aortic arch maximum velocity Velocity

Desc Ao Vmax Descending aorta maximum velocity Velocity

DA Vmax Arterial duct maximum velocity Velocity

RVOT Vmax Right ventricle maximum velocity Velocity

RVET Right ventricle ejection time Velocity

PA Pulmonary artery Velocity

FHR Fetal heart rate Time

6.3.3.8 Obstetric Graph and Report

In the main menu of obstetric measurements, there are worksheets and reports as well as
obstetric graphs; click graphs to view the growth curve of the fetus.

D From the graph, you can view the corresponding obstetric measurement items and the
selected growth curve of the reference authors, and these reference authors can be set
in the Preset; Preset of reference author: press [Setting] on the touchscreen → Click
[Measure Preset] on the left of the screen → Click the sub-menu [Measure] on the
screen, and then click [Graph] for setting.
D There are three curves in the obstetric graph, respectively showing the maximum value,
normal value and minimum value of the measurement item of the fetus. Red point

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represents the position of the current measurement value. The fetal growth can be
judged by viewing the growth curve.
D Click the [single]or [Quad] below the graph to carry out image switching and selection of
multiple births, as well as other functions such as graph print previewing, printing, page
up and page down, switching to worksheet or report, etc.

6.3.3.9 Obstetric Report

On the basis of routine report, obstetric report is included with LMP, EDD (LMP), EDD (CUA),
GA (LMP), CUA, selection of single birth/multiple births and CUA Based on, so as to allow us
to calculate the subsequently input data.

6.3.4 Urological Measurement

Preparations before measurement:
1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Press [Probe] to select urological measurement.

6.3.4.1 Urological Measurement in 2D Mode

In B mode, users can carry out any of the following urological measurements:
D Right kidney: RK L,RK D,RK W;

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D Left kidney: RK L,RK D,RK W;
D Right Adrenal: Adrenal L, Adrenal D, Adrenal W;
D Left Adrenal: Adrenal L, Adrenal D, Adrenal W;
D Bladder: Bladder-V, Residual;
D Prostate: Prostate-L, Prostate-D, Prostate-W;
In the measurements above, the measurement methods of long diameter, thick diameter and
wide diameter are distance measurements, and refer to Distance Measurement in the chapter
of “General Measurement” for specific methods; we will make measurements on bladder size
and residual urine volume in volume measurement method, which has been introduced to
include five methods in the chapter of “Volume Measurement”, and users can set specific
methods through Preset:
Press [Setting] on the touchscreen→ Click [Measure Preset] on the left of the screen →Click
the sub-menu [General Measurement] on the screen, and the user can select the volume
measurement method for preset in [Default Measurement Method].

Measurement methods of Bladder-V and Residual:

1. Press [Measure];
2. A measurement items will occur on the left, menu [Bladder-V]
3. and then press [Set], or click on the touchscreen for selection;
4. Relevant volume measurements will be displayed in the soft menu (for example, 1-
Ellipse), which can be selected here or preset as above;
5. Rotate the trackball and press [Set] to position the starting point of the ellipse; and rotate
the trackball and press[ Set] again to position an axis of the ellipse; then rotate the
trackball and press [Set] to position the other axis of the ellipse; and finally rotate the
trackball to select the position of ellipse and press [Set] for positioning;
6. The system will display the measuring values of bladder size in the result box; in case of
pressing [Measure], the system will measure the next residual urine by following the
measurement items; repeat steps 3 -4.

Urological calculation in 2D mode

Calculation Item Input Parameter Formula

Vol = 0.7 ×
Bladder-V 3-Distance
D1×D2×D3or Vol =
(π×D1×D2×D3)/6
3-Distance
Prostate-V (long diameter, wide Vol =(π×D1×D2×D3)/6
diameter and thick diameter)

6.3.4.2 Urological Measurement in Doppler Mode

In Doppler mode, users can carry out the following urological measurements: Rt Renal A: RI
(Resistance Index), PS (Peak Systole), ED (End Diastole);

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Lt Renal A: RI (Resistance Index), PS (Peak Systole), ED (End Diastole);
Specific measurement methods may refer to the chapter of “Abdominal Measurement in
Doppler Mode”.

6.3.4.3 Urological report

In the urological measurements, the final data of each measurement item will be saved to the
report, and the report format is as follows:

6.3.5 Vascular Measurement

Preparations before measurement:

1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Press [Probe] to Select Vascular, Carotid, P-Arterial or Venous Exam.

6.3.5.1 Vascular Measurement in 2D Mode

In B mode, users can carry out the vascular measurements in the main menu, including
measurement Items of Carotid, P-Arterial and Venous, and divide them into right side and left
side in the measuring process according to the vascular parts of human bodies. Users can
conduct the following Carotid measurements:

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Aortic artery
Description Measurement methods
Measurement
Item
CCA-Prox Common Carotid - Prox D-%stenosis/A-%stenosis

CCA-Mid Common Carotid -Mid D-%stenosis/A-%stenosis

CCA-Dist Common Carotid -Dist D-%stenosis/A-%stenosis

ICA Internal Carotid D-%stenosis/A-%stenosis

ECA External Carotid D-%stenosis/A-%stenosis

VA Vertebra artery D-%stenosis/A-%stenosis

D P-Arterial: CIA, EIA, CFA, PFA, PFA-Prox, PFA-Mid, PFA-Dist, POPA, TRUNK, ATA,
PTA, PERA, DP- A, Subc A, Axil A, Brachial A, Radial A, Ulnar A;
D Venous: CIV, EIV, CFV, GSV, FV, SFV, DFV, Pop V, LSV, Subc V, Axill V, Brachial V,
CephV, Basilar V;
P-Arteries and Carotid arteries are under fractional shortening measurements; veins are
under distance method measurements. Fractional shortening is divided into diameter
fractional shortening and area fractional shortening, and users can select them through the
toggle or in the Preset.

Determining a Diameter Percent Stenosis

A Diameter Percent Stenosis shall compare the diameters in the same blood vessel, and
after acquiring two diameters in the same blood vessel, the system will automatically carry
out the calculations in terms of the following formula:
D1−D2
%Steno = ×100

D1

D1, larger diameter; D2, smaller diameter

Operating steps of diameter fractional shortening to measure arteries:
1. Press [Probe] to view the Carotid measuring Item or directly click the vascular item; after
pressing [Measure], select “Carotid“ in the main menu (taking Carotid for example); to
measure the left Carotid, click [Left] on the top of the menu;
2. Place the third caliper on the starting point of D1 segment;
3. Press [Set];
4. Roll the trackball to place the second caliper on the end point of D1 segment;
5. Press [Set];
6. Roll the trackball to place the third caliper on the starting point of D2 segment;
7. Press [Set];
8. Roll the trackball to place the fourth caliper on the end point of D2 segment
9. Press [Set].
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10. The measurements will be displayed in the result box of the screen, and saved to the

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worksheet and report. If you want to continue with the following measurements, please
repeat steps 2-9.

Determining an Area Percent Stenosis

An Area Percent Stenosis shall compare the cross-sectional areas in the same blood vessel,
and after carrying out two tracings in the same blood vessel, the system will automatically
carry out the calculations in terms of the following formula:
A1−A2
%Steno = ×100

A1
A1, larger area; A2, smaller area.
Operating steps of area fractional shortening to measure arteries:
1. Press [Measure] to enter the measurement interface;
2. Measurement items will pop up in the main menu, and select the measurement item of
Carotid (taking Carotid measurement for example);
3. Click [A-%stenosis] in the soft menu:
4. Rotate the trackball and press [Set] to position the starting point of the ellipse;
5. Rotate the trackball and press[ Set] again to position an axis of the ellipse;
6. Then rotate the trackball and press [Set] to position the other axis of the ellipse;
7. And finally rotate the trackball to select the position of ellipse and press [Set] for
positioning;
8. After the measurement of an ellipse is completed, repeat steps 4-7 to complete the
measurement of another ellipse;
9. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report. If you want to continue with the following measurements,
10. Please repeat steps 3-8.

Vein measurement through Distance Method

Operating steps of measuring veins through Distance Method:

1. Press [Probe] to view the vein measuring Item or directly click the vascular item; after
pressing [Measure], select “vein“ in the main menu (taking common iliac vein for
example); to measure the common iliac vein, click [Left] on the top of the menu;
2. Place the first caliper on the starting point of line segment;
3. Press [Set];
4. Roll the trackball to place the second caliper on the end point of line segment;
5. Press [Set];
6. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report. If you want to continue with the following measurements, please
repeat steps 2-5.

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6.3.5.2 Vascular Measurement in Doppler Mode

In Doppler mode, users can carry out the vascular measurements including RI (resistance

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index), PS (peak systole) and ED (end diastole) of Carotid measuring Item and peripheral
artery measuring Item(refer to Vascular Measurement in 2D Mode in Chapter 6). The system
will divide the blood vessel measurement into the left side and right side according to the
vascular parts of human bodies; See the left menu interface for measurement.

Abbreviations for veins:

CIV Common Iliac Vein

EIV External Iliac Vein
CFV Common Femoral Vein
GSV Great Saphenous Vein
FV Femoral Vein
SFV Superficial Femoral Vein
DFV Deep Femoral Vein
Pop V Popliteal Vein
LSV Little Saphenous Vein
Subc V Subclavian Vein
AxillV Axillary Vein
Brachial V Brachial Vein
CephV Cephalic Vein
Basilar V Basilar Vein
RI measurement method is: RI;
PS measurement methods are: velocity
ED measurement methods are: velocity
PV measurement methods are: velocity
Measurement methods of RI, PS, ED and PV:
1. Press [D] to enter the PW mode, press [Freeze] and press [Measure] to enter the PW
measurement interface;
2. On the left occurs the vascular menu; rotate [Select] or trackball to select the
measurement item;
3. A vertical line will be displayed on the system screen; move the trackball to position the
starting point of the vertical line and press [Set], then move the trackball to position the
vertical line and press [Set];
4. The measurements will be displayed in the result box, and saved to the worksheet and
report. If you want to continue with the following measurements, please repeat Step 3.

6.3.5.3 Vascular Report

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6.3.6 Small Parts Measurement

Preparations before measurement:
1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Check whether the measurement mode is correct.

6.3.6.1 Small Parts Measurement in 2D Mode

In 2D mode, users can carry out the measurements of Small Parts including thyroids, breasts
and testicles, and the system will divide the measurements into left thyroid and right thyroid,
left breast and right breast, and left testicle and right testicle according to the position of Small
Parts.
Users can conduct the following measurements:
D Thyroid: Thyroid-L, Thyroid-D, Thyroid-W, Isthmus H;
D Breast:Breast-D,Mass1,Mass2,Mass3;
D Testicle: Testicle-L, Testicle-D, Testicle-W;

Thyroid Measurement:

Users can conduct the following measurements on thyroid volume:

1. To measure thyroid right lobe size, click [Right] in the measurement items of the main
menu, and use the distance method to measure the length, thickness and width of the
right lobe, then the system will automatically calculate the right lobe volume in

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accordance with the formula listed in the table below.
2. In order to measure thyroid left lobe size, please refer to the measurement method of
thyroid right lobe size.
3. After measuring the sizes of two lobes of the thyroid, the total sum is the size of the
whole thyroid. The results will be saved to the worksheet and report.

Specific operating procedures:

1. Click the thyroid measuring Item in the Small Organ menu of [Probe] or directly click the
Small Organ item; after clicking [Measure], select “Thyroid“ in the main menu; to
measure the left thyroid, click [Left] on the top of the menu;
2. Place the first caliper on the starting point of line segment;
3. Press [Set];
4. Roll the trackball to place the second caliper on the end point of line segment;
5. Press [Set];
6. Roll the trackball to place the third caliper on the starting point of line segment;
7. Press [Set];
8. Roll the trackball to place the fourth caliper on the end point of line segment;
9. Press [Set];
10. Roll the trackball to place the fifth caliper on the starting point of line segment;
11. Press [Set];
12. Roll the trackball to place the sixth caliper on the end point of line segment;
13. Press [Set];
14. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report.

Breast Measurements:

Click the Breast Measuring Item under the Small Part menu of [Probe] or directly click the
Small Organ item, and select “Breast” to measure breast thickness, Mass 1, Mass 2 and
Mass 3 through the distance method; refer to “Thyroid Measurements” for its operating
methods, which will not be repeated here.

Testicular Measurements:

Click the Testicle Measuring Item under the Small Part menu of [Probe] or directly click the
Small Organ item, and select “Testicle” to measure long diameter, thick diameter and wide
diameter through the distance method, then the system will automatically calculate the
testicular size; refer to “Thyroid Measurements” for its operating methods, which will not be
repeated here.

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Calculation Item Input Parameter Formula

3-Distance (length，
Thyroid - volume Vol = 0.479 × D1 × D2 × D3
thickness，width )

3-Distance (length，
Testical - volume Vol = 0.523598775 × D1 × D2 × D3
thickness，width )

6.3.6.2 Small Parts measurement report

Small Parts measurement report is shown in the figure below.

6.3.7 Orthopedic Measurement

Preparations before measurement:
1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Press [Probe] to select Orthopedics exam.

6.3.7.1 Orthopedic Measurement in 2D Mode

In B mode, users can carry out the measurements on R Hip Angle and L Hip Angle. The
measurement method is angle method.
Orthopedic steps through angle measurement method:

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1. Press [Measure] in the corresponding mode;
2. On the left occurs the orthopedic menu; click on the touchscreen or trackball to select the
measurement item;
3. Place the caliper on the starting point of line segment, and press [Set];
4. Roll the trackball to place the second caliper on the end point of line segment, and press
[Set].
5. Place the third caliper on the starting point of line segment, and press [Set];
6. Roll the trackball to place the fourth caliper on the end point of line segment, and press
[Set];
7. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report. If you want to continue with the following measurements, please
repeat steps 3-6.

6.3.7.2 Orthopedic Report

6.3.8 Cardiology Measurement

Cardiology measurements include general cardiology measurement and ped-cardiology
measurement, and ped-cardiology measurement is the same with general cardiology
measurement, thus you can refer to relevant measurements of general cardiology.
Preparations before measurement:
1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;

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3. Press [Patient] to input the information of the patient;
4. Press [Probe] to select cardiac Exam.

6.3.8.1 Cardiology Measurement in 2D Mode

In 2D mode, users can carry out the measurements of cardiac area listed in the main menu,
and the following table has listed the measurement items, descriptions and measurement
methods of cardiac measurements defined in the system, and the measuring results will be
displayed in the corresponding measurement worksheet and patient report.
Measuremen
Measurement Item Description
t methods
MV Mitral Valve
Distance from E point to septal separation,
EPSS that is, distance from mitral valve anterior lobe Distance
in diastole to ventricular septum.
MVA(Trace) Mitral Valve Area Trace/Ellipse
MV Diam Mitral Valve Diameter Distance
AV/LA Aortic Valve / Left Atrium
RV Diam Right Ventricle Diameter Distance
AO Aorta Distance
ACS Acute Coronary Syndrome Distance
LA Diam Left Atrium Diameter Distance
AV Aortic Valve
LVOT Diam Left ventricular outflow tract diameter Distance
AV Area Aortic Valve Area Trace/Ellipse
Mod.Simpson
Left ventricular short axis area
LVAd sax PM Trace/Ellipse
at papillary muscle level at end diastole
Left ventricular short axis area
LVAd sax MV Trace/Ellipse
at mitral valve level at end
diastole
Left ventricular length at end
LVLd apical Distance
diastole, apical
Left ventricular short axis area at
LVAs sax PM Trace/Ellipse
papillary muscle level at end systole
Left ventricular short axis area
LVAs sax MV Trace/Ellipse
at mitral valve level at end
Left ventricular length at end
LVLs apical Distance
diastole, apical
Single plane Method
Left ventricular area at end diastole,
LVAd apical Trace/Ellipse
apical
Left ventricular length at end
LVLd apical Distance
diastole, apical
Left ventricular area at end diastole,
LVAs apical Trace/Ellipse
apical
Left ventricular length at end
LVLs apical Distance
diastole, apical
Bi plane Method
Left ventricular area at end diastole,
LVAd apical Trace/Ellipse
apical

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Measuremen
Measurement Item Description
t methods
Left ventricular short axis area
LVAd sax MV Trace/Ellipse
at mitral valve level at end
diastole
Left ventricular internal dimension
LVIDd Distance
at end diastole
Left ventricular long-axis area at end
LVAs apical Trace/Ellipse
systole, apical
Left ventricular short axis area
LVAs sax MV Trace/Ellipse
at mitral valve level at end
Left ventricular internal dimension
LVIDs Trace/Ellipse
at end systole
Teichholz
Diastole Diastole
Right ventricular anterior
RVAWd Distance
wall thickness at end
Right ventricular dimension at end
RVDd Distance
systole
Interventricular septum dimension
IVSd Distance
at end systole
Left ventricular internal dimension
LVIDd Distance
at end systole
Left ventricular posterior
LVPWd Distance
wall dimension at end
Systole Cardiac systole
Interventricular septum dimension
IVSs Distance
at end systole
Left ventricular internal dimension
LVIDs Distance
at end systole
Left ventricular posterior
LVPWs Distance
wall dimension at end

Note: The black font refers to the measuring Items of the following measurement items.

As shown in the table above, the measurement Item mainly includes Distance Method and
Trace/Ellipse Method, and operations of Distance Method are:
1. Press [Probe] to select [Cardiac], and enter B mode;
2. Press [Measure] and select MV measurement Item in the main menu (taking mitral valve
for example), and then click [MV] to display the measurement items of mitral valve;
3. Place the first caliper on the starting point of line segment;
4. Press [Set];
5. Roll the trackball to place the second caliper on the end point of line segment;
6. Press [Set];
7. Roll the trackball to place the third caliper on the starting point of line segment;
8. The measurements will be displayed in the result box, and saved to the worksheet and
report.

Operations in elliptical area measurement are:

1. Click B mode and press [Measure] to enter the measurement interface;

2. The cardiac measurement items pop up in the left menu, select the MV measurement

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Item (taking mitral valve for example); then click [MV] to display the measurement items
of mitral valve, and click [MVA];
3. The area method measurement occurs in the soft menu: press the toggle to select
[Ellipse] measurement;
4. Rotate the trackball and press [Set] to position the starting point of the ellipse; and rotate
the trackball and press[ Set] again to position an axis of the ellipse; then rotate the
trackball and press [Set] to position the other axis of the ellipse; and finally rotate the
trackball to select the position of ellipse and press [Set] for positioning;
5. The measurements will be displayed in the result box, and saved to the worksheet and
report.

Operations of tracing area method measurements are:

1. The cardiac measurement items pop up in the left menu, select the MV measurement
Item (taking mitral valve for example); then click [MV] to display the measurement items
of mitral valve, and click [MVA];
2. The area method measurement occurs in the soft menu: press the toggle to select [Trace]
measurement;
3. Place the first caliper on the starting point of line segment;
4. Press [Set];
5. Roll the trackball to display the tracing line, and press [Set] after locating the position of
end point;
6. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report.

Cardiology calculations in 2D mode

When the measurements are completed, the system will perform the 2D mode calculation,
and the calculation results will be displayed on the screen and saved to the cardiac
worksheet and report, of which the calculation and description of the measurement items will
be listed in the table below for reference.
Calculati
Desired Calculating
on Item Description
Measuremen Result
t
AO/LA Aorta / Left Atrium AO
Cardiac index refers to the cardiac output per
square meter of body surface area (BSA): CI
= CO÷BSA.
If the height is expressed in cm, the weight
CI will be expressed in kg: BSA=0.007184 x HR, BSA EDV
(cardiac (weight0.425) x (height0.725) ESV L/min/m2
index) If the height in expressed in feet/ inches, the
weight will be expressed in pounds:
BSA=0.007184 x (weight x 0.454)0.425
x (height x 2.54)0.725
CO (Cardiac Cardiac output refers to the effective
EDV ESV HR L/min
Output) left ventricular ejection volume per unit time:

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CO= [(EDV – ESV) ÷ 1000] (HR).

EDV, ESV End-diastolic volume, End-systolic volume

Ejection fraction refers to the ratio between
EF (ejection
stroke volume and end- diastolic volume: EDV ESV %
fraction)
EF=100 [(EDV 1.2.2003) - ESV EDV].
Systolic percentage refers to the systolic
FS (fractional LVIDd
percentage of LV size: FS = 100[(LVIDd - %
shortening) LVIDs
LVIDs) ÷ LVIDd].
Stroke volume refers to the ventricular
SV ejection volume in a cardiac cycle or LVIDd
ml
(stroke ventricular systolic phase: LVIDs
volume) SV = EDV-ESV.
Cardiac index is used to measure the
SI
(stroke
standardized stroke volume in terms of SV BSA ml/m2
BSA (body surface area): SI=SV ÷ BSA.
index)
Left ventricular function assessment in 2D mode

The following table lists the cardiac measurement calculation formulas in Simpson Bi- Plane,
single-plane, dual-plane, Teichholz (2D), Mod Simpson for your reference.
Calculatio Desired Calculating
Description
n Item Measureme Result
Use the end-diastolic and end-systolic disk in LVLd
the apical four-chamber view to measure and SV ml
LVLs
Simpson BP estimate volumes. EDV(mL)= π * CO L/min
4chEDV,
(Simpson LVLd(mm)/20 *Σ (r2i(mm)*r4i(mm))/1000 EF %
ESV
Bi- Plan) ESV(mL)= π * LVLs(mm)/20 * SI mL/m2
2chEDV,
Σ(r2i(mm)*r4i(mm))/1000 CI n/a
ESV

Use the end-diastolic and end-systolic single-

plane tracing in the two-chamber or four-
chamber view to measure and estimate
volumes. EDV ml ESV
In addition, you also need to carry out the LVAd apical ml SV ml
distance measurement on the long- axis LVAs apical CO L/min
Single-plane
dimension in the apical view in LVLd EF %
end-diastole and end-systole: EDV= (8 ÷ (3 LVLs SI mL/m2
π)) * (LVAd long-axis apical (cm2)) 2/LVLd CI n/a
apical (mm) *10
EDV= (8 ÷ (3 π)) * (LVAs long-axis apical
(cm2)) 2/LVLs apical (mm) *10

Use the apical and sax MV end-diastolic and

end-systolic dual-plane tracing to measure
and estimate volumes.
In addition, you also need to perform the LVAd apical
EDV ml ESV
distance measurements on LVIDd and LVIDs: LVAs apical
ml SV ml
EDV =(8÷(3π))* LVAd long-axis LVAd sax
Dual-plane CO L/min
apical(cm2) * MV LVAs
EF %
LVAd short-axis MV(cm2)/ LVIDd(mm) * sax MV
SI mL/m2
10 LVLd LVLs
CI n/a
ESV =(8÷(3π))* LVAs long-
axis apical(cm2) *
LVAs short-axis MV(cm2)/ LVIDs(mm) * 10

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Use the distance measurement to

estimate volumes from left ventricular internal
EDV ml ESV
diameter (LVID):
ml SV ml
EDV(mL) = 7 *(LVIDd(mm) * LVIDd(mm)
LVIDd CO L/min
Teichholz (2D) * LVIDd(mm)
LVIDs EF %
/ 1000) / (2.4 + LVIDd(mm) / 10) ESV(mL) = (7
SI mL/m2
* LVIDs(mm) * LVIDs(mm) *
CI n/a
LVIDs(mm)
/ 1000) / (2.4 + LVIDs(mm) / 10)
EDV (mL) = LVLd apical(mm)/9 *
LVLd apical
(4*LVAd sax MV(cm2) +
LVLs apical EDV ml ESV
2*LVAd sax PM(cm2) + SQRT (LVAd sax
LVAd sax ml SV ml
MV(cm2) *
MV LVAs CO L/min
Mod Simpson LVAd sax PM(cm2)) /10)
sax MV EF %
ESV (mL) = LVLs apical(mm)/9 * (4*LVAs sax
LVAd sax SI mL/m2
MV(cm2) +2*LVAs sax PM(cm2)
PM LVAs CI n/a
+ SQRT (LVAs sax MV(cm2) *LVAs sax
sax PM
PM(cm2)) /10)

6.3.8.2 Cardiac Measurement in M Mode

In M mode, users can carry out the measurements of MV, AV/LA and LV, and the following
table has listed the measurement items, descriptions and measurement methods of cardiac
measurements defined in the system, and the measuring results will be displayed in the
corresponding measurement worksheet and patient report.
Measurement Measurement
Description
Item methods
MV Mitral valve

CE amp E-wave amplitude Distance

CA amp A-wave amplitude Distance

Mitral valve leaflet excursion in
DE Excursion Slope
anterior diastole
DE amp DE-wave amplitude Distance
Distance from E point to septal
EPSS separation, that is, distance from mitral valve Distance
anterior lobe in diastole to ventricular septum
Mitral valve early diastolic closing
EF Slope Slope
velocity
AV/LA

RV Diam Right Ventricle Diameter Distance

AO Aorta Distance

ACS Acute Coronary Syndrome Distance

LA Diam Left Atrium Diameter Distance

LVET Left Ventricular Ejection Time Time

LVPEP Left Ventricular Pre-ejection Period Time

Teichholz

Diastole

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Right Ventricular Anterior Wall

RVAWd Distance
Thickness at end diastole
Right Ventricular Dimension at end
RVDd Distance
diastole
Interventricular Septal Size at end
IVSd Distance
diastole
Left Ventricular Internal Dimension
LVIDd Distance
at end diastole
Left Ventricular Posterior Wall
LVPWd Distance
Dimension at end diastole
Systole
Interventricular Septum Dimension
IVSs Distance
at end systole
Left Ventricular Internal Dimension
LVIDs Distance
at end systole
Left Ventricular Posterior
LVPWs Distance
Wall Dimension at end
systole
HR Heart Rate HR
D The table above includes the methods of Distance, Slope, Time and HR in the process of
cardiac measurement, and the operating methods are:
1. Press [M] to enter the M mode, and press [Measure] to enter the M mode measurement
interface;
2. On the left occurs the cardiac menu options; click on the touchscreen or trackball to
select the measurement item; the appropriate measurement methods are displayed in
the soft menu;
3. A vertical line will be displayed on the system screen; move the trackball to position the
starting point of the vertical line and press [Set], then move the trackball to position the
vertical line and press [Set];
4. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report. If you want to continue with the following measurements, please
repeat Step 3.

Cardiac calculation in M Mode

When the measurements are completed, the system will perform the M mode calculation, and
the calculation results will be displayed on the screen and saved to the cardiac worksheet
and report, of which the calculation and description of the measurement items will be listed in
the table below for reference.
Calculation Desired
Description Unit
Item Measuremen
Cardiac index refers to the cardiac output t
per square meter of body surface area
(BSA):
CI (cardiac CI = CO÷BSA. HR, BSA L/min/m
index) If the height is expressed in cm, the weight will EDV ESV 2
be expressed in kg:
BSA=0.007184 x (weight0.425) x
(height0.725)

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If the height in expressed in feet/inches, the

weight will be expressed in pounds:
BSA=0.007184 x (weight x 0.454)0.425 x (height
x 2.54)0.725
Cardiac output refers to the effective left
CO (Cardiac EDV
ventricular ejection volume per unit time: CO= L/min
Output) ESV HR
[(EDV – ESV) ÷1000] (HR).
Cubed Volume Method:
EDV = LVIDd3
ESV = LVIDs3
Teichholz Volume Method:
EDV = 7(LVIDd3 / 1000) / (2.4+LVIDd/10) ESV =
LVIDd
EDV, ESV 7(LVIDs3 / 1000) / (2.4+LVIDs/10) Gibson ml
LVIDs
Volume Method:
EDV =π/ 6*(0.98*LVIDd/10+5.90) * LVIDd/
10*LVIDd/10
ESV =π/ 6*(1.14*LVIDs/10+4.18) * LVIDs/
10*LVIDs/10
CA amp
CA/CE CA/CE=CA amp (mm) / CE amp (mm)
CE amp
Ejection fraction refers to the ratio between
EF (ejection
stroke volume and end-diastolic volume: EF = EDV ESV %
fraction)
100[(EDV-ESV)÷EDV]
LA
AO/LA Aorta / Left Atrium Ratio
AO
Stroke volume refers to the ventricular
SV ejection volume in a cardiac cycle or ventricular
EDV ESV ml
(stroke systolic phase:
volume) SV = EDV-ESV.
Cardiac index is used to measure the
SI standardized stroke volume in terms of BSA
(stroke (body surface area):
SV BSA ml/m2
index) SI=SV ÷ BSA.
HR (heart
HR = 60÷(R-R interval) HR cycle bpm
rate)

6.3.8.3 Cardiac Measurement in Doppler Mode

In Doppler mode, users can carry out the measurements of MV, AV, TV and PV, and the
following table has listed the measurement items, descriptions and measurement methods of
cardiac measurements defined in the system, and the measuring results will be displayed in
the corresponding measurement worksheet and patient report.
Measuremen Measuremen
Description
t Item t method
MV (Mitral Valve)

Distance from E point to septal separation, that

EPSS is, distance from mitral valve anterior lobe in Distance
diastole to ventricular septum.

E Dur E-wave duration Time

A Dur A-wave duration Time

IVRT Isovolumic relaxation time Time

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Measuremen Measuremen
Description
t Item t method
MV E pt Mitral valve E point Velocity

MV A pt Mitral valve A point Velocity

MVA

PHT Pressure half-time Pressure half-time

MVA(Trace) Mitral valve area Trace

CO Cardiac output

MV VTI Mitral valve velocity time integral PI (Manual)

MC diam Mitral valve diameter Distance

HR Heart rate HR

LVIMP Left ventricular

intramyocardial pressure
LVET Left Ventricular Ejection Time Time

MV C.O dur Mitral valve close/open duration Time

Tel index

Tel Index a Time interval between beginning Time

and end of mitral valve filling
Tel Index b Time interval between beginning Time
and end of aortic flow
AV Aortic Valve

AV Vmax Aortic valve maximum velocity Velocity

LVOT Vmax Left ventricular outflow tract Velocity

maximum velocity
IVRT Isovolumic relaxation time Time

AVA(VTI)

AV VTI Aortic valve velocity time integral PI (Manual)

LVOT VTI Left ventricular outflow tract velocity PI (Manual)

time integral
LVOT diam Left ventricular outflow tract diameter Distance

AVA(trace) Aortic valve area

AV area Aortic valve area Trace

VSD Ventricular septal defect

VSD Vmax Ventricular septal defect maximum Velocity

velocity
LVSTI Left ventricular systolic time intervals

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Measuremen Measuremen
Description
t Item t method
LVET Left Ventricular Ejection Time Time

LVPEP Left Ventricular Pre-ejection Period Time

HR Heart rate HR

TV Tricuspid valve

TV VTI Tricuspid valve velocity time integral

TV E pt Tricuspid valve E point Velocity

TV A pt Tricuspid valve A point Velocity

RVIMP Right ventricular intramyocardial pressure

RVET Right ventricle ejection time Time

TV C.O dur Tricuspid valve close/open duration Time

PV Pulmonary valve

PV Vmax Pulmonary valve maximum velocity Velocity

RVET Right ventricle ejection time Time

RV Act Right ventricular acceleration time Time

RV PEP Right ventricular pre-Ejection period Time

CO Cardiac output

PV VTI Pulmonary valve velocity time PI (Manual)

integral
PV diam Pulmonary valve diameter Distance

HR Heart rate HR

Users can refer to the operations described in general measurement chapters.

Cardiac special calculation in Doppler mode

When the measurements are completed, the system will perform the PW mode calculation,
and the calculation results will be displayed on the screen and saved to the cardiac
worksheet and report, of which the calculation and description of the measurement items will
be listed in the table below for reference.
Desired
Calculation Item Description Unit
Measuremen
A/E= mitral valve A t
Mitral valve A point Mitral valve A
point (m/s)/mitral valve N/A
and E point ratio (A/E) point (Distance)
E point (m/s)
Mitral valve E point and A E/A=MV E pt(m/s) / MV A Mitral valve E N/A

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Desired
Calculation Item Description Unit
Measuremen
point ratio (E/A) pt (m/s) point t(Distance)
Mitral valve maximum MV PGmax(mmHg)=(MV Mitral valve maximum
pressure gradient (MV PG mmHg
max) Vmax(m/s))2*4 velocity

Mitral valve mean pressure MV PGmean(mmHg)=(MV Mitral valve mean

mmHg
gradient (MV PG mean) Vmean(m/ s))2*4 velocity
Aortic valve maximum AV PG max(mmHg)=(AV Aortic valve
pressure gradient (AV PG mmHg
max) Vmax(m/s))2*4 maximum velocity

Aortic valve mean pressure AV PG mean(mmHg)=(AV Aortic valve

mmHg
gradient (AV PG mean) Vmean(m/s))2*4 mean velocity
Pulmonary valve maximum PV PGmax(mmHg)=(PV Pulmonary valve
pressure gradient (PV PG maximum mmHg
max) Vmax(m/s))2*4 velocity
Pulmonary valve mean PV PGmean(mmHg)=(PV Pulmonary valve mean
pressure gradient (PV PG mmHg
mean) Vmean(m/s))2*4 velocity

Left ventricular outflow LVOT

Left ventricular outflow
tract maximum pressure PGmax(mmHg)=(LVOT mmHg
tract maximum velocity
radiant (LVOT PG max) Vmax(m/ s))2*4
Left ventricular outflow LVOT
PGmean(mmHg)=(LVOT Left ventricular
tract mean pressure mmHg
outflow tract mean
gradient (LVOT PG mean) Vmean(m/ s))2*4
velocity
Ventricular septal defect VSD Ventricular
maximum pressure PGmax(mmHg)=(VS septal defect maximum mmHg
gradient (VSD PGmax) D Vmax(m/s))2*4 velocity
Tricuspid valve maximum TV PGmax(mmHg)=(TV
Tricuspid valve
pressure gradient (TV mmHg
PGmax) Vmax(m/s))2*4 maximum velocity

Tricuspid valve mean TV PGmean(mmHg)=(TV Tricuspid valve mean

pressure gradient (TV mmHg
PGmean) Vmean(m/s))2*4 velocity

Left ventricular
LVIMP=(MV C-O dur(ms) MV C.O duration LV
intramyocardial pressure --
– LVET(ms)) / LVET(ms) ejection time (ET)
(LVIMP)
Right ventricular
RVIMP=(TV C-Odur(ms) – TV C.O duration LV
intramyocardial pressure --
RVET(ms)) / RVET(ms) ejection time (ET)
(RVIMP)
The measurement
Heart rate (HR) HR = 60/R-R interval. bpm
covers a cardiac cycle
Left ventricular outflow
MVA(VTI)( cm2) = tract diameter Left
Mitral valve area (Velocity
π*(LVOT diam(mm)/2/10)2 ventricular outflow tract
time integral) cm2
[MVA (VTI)] *(LVOT VTI (cm) / MV VTI velocity time integral
(cm)) Mitral valve velocity
time integral
Left ventricular
AVA(VTI)(cm2) = π*(LVOT
outflow tract diameter
Aortic valve area diam(mm)/2/10)2 Left ventricular
(velocity time integral) * outflow tract velocity cm2
[AVA (VTI)] (LVOT VTI(cm) / AV time integral Aortic
VTI(cm)) valve velocity time
Left ventricular ((LVOT integral
LVOT Diam

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Desired
Calculation Item Description Unit
Measuremen
outflow tract cardiac index Diam)2*0.785*(LVOT LVOTt VTI HR
(LVOT CI) VTI)*(HR)/1000)/ BSA
Ratio between left
ventricular pre- ejection LVPEP
LVSTI=LVPEP/ET LVPEP LVET
period and left / ET
ventricular ejection time
3.14/4*(LVOT
Mitral valve area (velocity LVOT Diam
time integral)[MVA (VTI)] Diam)2*(LVOT VTI)/(MV LVOT VTI MV VTI
VTI)
Mitral valve area
MVA(P
(Pressure half-time) [MVA 220/(MV PHT(ms) MV PHT
HT)
(PHT)]
Ratio between right
ventricular pre- ejection RVPEP/
RVSTI=RVPEP/ET RVPEP ET
period and right ventricular ET
ejection time
Please refer to Appendix D for professional contents of cardiac measurement.

6.3.8.4 Cardiac Measurement Report

The following figure is the worksheet and report of cardiac measurement, in which you can
view the measurement results. If you are not satisfied with the result, you can enter the
worksheet to revise and save the data, which will be saved into the report.

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6.3.9 Transcranial Measurement

Preparations before measurement:
1. Check whether the probe is suitable for the current measurement item;
2. Check whether the system date is the current date;
3. Press [Patient] to input the information of the patient;
4. Press [Probe] to select transcranial measurement.

6.3.9.1 Transcranial Measurement in 2D Mode

In 2D mode, uses can carry out the transcranial measurements, the following table has listed
the measurement items, descriptions and measurement methods of transcranial
measurements.

Measurement Item Description Measurement method

MCA middle cerebral artery Distance

ICA.Siphon carotid siphon Distance

ACA.A1 anterior meningeal artery A1 Distance

ACA.A2 anterior meningeal artery A2 Distance

ACoA anterior communicating artery Distance

PCA.P1 posterior cerebral artery P1 Distance

PCA.P2 posterior cerebral artery P2 Distance

PCoA posterior communicating artery Distance

PCA posterior cerebral artery Distance

Basilar A basilar artery Distance

Vert A vertebral artery Distance

Transcranial measurement through Distance Method;

1. Press [Measurement], and roll the trackball to the transcranial measurement items and
select [MCA] (taking MCA for example);
2. Place the first caliper on the starting point of line segment, and press [Set];
3. Roll the trackball to place the second caliper on the end point of line segment, and press
[Set].
4. The measurements will be displayed in the result box of the screen, and saved to the
worksheet and report. If you want to continue with the following measurements, please
repeat steps 2-3.

6.3.9.2 Transcranial Measurement in Doppler Mode

In Doppler mode, uses can carry out the transcranial measurements, and the measurement
items and methods can refer to the chapter of Transcranial Measurement in 2D Mode.

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Steps for transcranial measurements:

1. In PW mode, press [Freeze] and then press [Measure];

2. roll the trackball to the transcranial measurement items and select [MCA] (taking MCA for
example);
3. Place the first caliper on the starting point of line segment, and press [Set];
4. Roll the trackball to place the second caliper on the end point of line segment, and press
[Set].
5. The measurements will be displayed in the result box, and saved to the worksheet and
report. If you want to continue with the following measurements, please repeat steps 2-3.

6.3.9.3 Transcranial Report

6.3.10 Emergency Medicine Measurement

Preparations before measurement:
D Check whether the probe is suitable for the current measurement item;
D Check whether the system date is the current date;
D Press [Patient] to input the information of the patient;
D Press [Probe] to select EM measurement.

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6.3.10.1 EM Measurement in 2D Mode

In 2D mode, uses can carry out the EM measurement in the main menu, and the
measurement method is the Distance Method.
EM measurements include: GB Wall-D, CBD, Ao, EDV, ESV, GS, CRL, BPD, BI Trans D, BI
Trans W, BI Sag D, and BI Sag L;

Steps of EM measurement through Distance Method:

1. Press [Measurement], and roll the trackball to the EM measurement items and select
[GB Wall-D](taking gallbladder wall thickness for example);
2. Place the first caliper on the starting point of line segment, and press [Set];
3. Roll the trackball to place the second caliper on the end point of line segment, and press
[Set].

4. The measurements will be displayed in the result box, and saved to the worksheet
and report. If you want to continue with the following measurements, please repeat steps 2-3

6.3.10.2 EM Measurement in M Mode

In M mode, uses can carry out the fetal heart rate of EM measurement in the main menu, and
the measurement method is the Time Method; refer to Fetal Heart Rate in Obstetric
Measurement.

6.3.10.3 EM Report

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Chapter 7 Record of Images and Reports

7.1 Worksheet and Report

Different from general measurements (distance, circumference, volume, time, slope, HR,
velocity and angle), data of Special measurements will be saved into the worksheet and
report, and distributed to various report database according to different exam items; different
reports of exam items are divided into general report and branch report, and gynecological,
obstetric, early pregnancy, middle/late pregnancy and cardiac exam items are categorized
into the branch report, which are added with some other menus on the basis of general report;
here by taking general report as an example, we will make an introduction to the branch
reports in terms of the specific measurement items in Chapter

7.1.1 Report Viewing

Users can access to report and worksheet through two ways:

1. Press [Report] on the control panel to enter the report, and then click [Worksheet] on the
screen to enter the worksheet; Then press [Report] on the control panel to exit the
worksheet and report.
2. Press [Measure] on the control panel to enter the measurement menu, and the buttons of
[Worksheet] and [Report] will occur below the measurement items, then click the button
to enter the interface;

Then press [Report] on the control panel to exit the worksheet and report. Report is divided
into five parts, namely Patient Information, Measurements, Images, Description and
Conclusion, which is displayed in three sections; click [Page up] or [Page down] to view the
complete report; here we will come to understand the contents of these three sections.

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The interface in Section One is shown below:

D The system will set the Report Database as the database of the current measurement
item by default;

D The basic information filled by users in the patient-Information interface will be displayed
in [Patient Information];

D For measurement data, you can click [Worksheet] to enter the worksheet for editing; in
case there are a large number of data, you can move the roll bar on the right of the
screen for viewing.

D Users can perform the functions such as image print, print preview, select images, export,
access to worksheet and page turning.

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Section Two is shown in the figure below:

D You can click [Select Images] and in the thumbnail of main interface to select images in
the report. However, a maximum of four images can be simultaneously displayed in the
report.
D Users can enter relevant comments below each image.
D Click [Select Image] to pop up the interface below, and the left image is the one saved in
the current measurement item by clicking [Save], while the cine images in Cine Save
cannot be displayed in this interface:

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Parameter Description

Available Images The left column shows the images saved in the hard disk;

The right column shows the images that are selected into the
Selected Images
report;

Select all images in the left column to add to the report,

which are displayed in the [Selected Images]; if there are more
than four images uploaded to the left column, the report will only
show the first four images;

Select an image in the left column to the report;

Delete a selected image from the right column;

Move the selected image up to a location;

Move the selected image down to a location.

Section Three is shown in the following figure, in which users can enter the Patient’s
case description and conclusions:

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If you want to check out the complete report, please click [Print Preview].

7.1.2 Worksheet Viewing

The worksheet can be entered in the same way as report, and you can change or delete data
in the worksheet and repeat measurements and save the final measurement result to the
report; as shown below, press [Report] to enter the report interface:

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7.2 Storage of Image and Report

In the measurement process, Press [Save] on the control panel or click [Image Save] or [Cine
save] to display images or cine in the thumbnail, which will be automatically saved to the
system's Hard disk. We can also save the images (including images and cine to an optical
disk (CD/DVD) or USB disk.
When the measurement is completed, patient reports and graphs can also be exported to an
optical disk or USB disk;

7.2.1 Reviewing Image and Report

If you want to view the patient's images and reports, you can perform the following operations:
1. First press [Patient] to enter the interface Patient Information, and search the
desired patient in the patient information list, and press [Set] to exit;
2. This patient's images will be displayed in the thumbnail of the main interface, or press
the [Review] button to enter the Reviewing interface; search the patient in the patient
information list, and lick [Image Screen] on the interface to view the images.
3. Press [Report] and then click [Worksheet] to view patient report and worksheet.

7.2.2 Export Image and Report

7.2.2.1 Export to USB

When you insert a U disk, the icon will appear on the bottom right of the screen, then
you can store images into the U disk, and export the reports and images; click [Export] or

the thumbnail to pop up the export dialog box (as shown below):

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D The default display of U disk is the letter following the name of the last disk of hard drive,
for example, if the system is named to D disk, the default optical drive is E disk and
displayed as CD/DVD E, then the first inserted U disk will be automatically identified as
USB F disk, and the second will be USB G disk, likewise; click [▼] on the right of hard
drive to select the location of data storage.
D When a data is stored, the system will automatically name the file and displayed in the
[File Name], and users can change the name by clicking.
D The list below the file name is the files in the U disk; double-click the folder to enter and

view the files. Click to return to operation.

D Users can save images and reports by selecting different formats, for reports, there are
PDF, HTML and RTF; for images, there are JPEG, BMP and TIFF.
D Press [Set], and the data will be uploaded to the U disk and a prompt for successfully
sending data to the removable storage device will be displayed.

Note: It is recommended to use the 512M Netac U265 or 1G Netac U208 matched by
Lanmage; The system supports FAT32 file format, and before the U disk is used, it shall be
formatted into FAT32 on the computer. The system update can only be used by the customer
service staff of the company. All the consequences caused by the user's unauthorized
operation shall be undertaken by the user.

7.2.2.2 Export to CD/DVD

When you insert a CD/DVD, the icon will appear on the bottom right of the screen,

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through which you can burn the reports and images; click [Export] in the menu or the

thumbnail to pop up the export dialog box, then you can select CD/DVD E from the drop-
down drive list, and modify the file names and data formats; after the changes are finished,
press [Set] to pop up the following dialog box:

D The system will automatically create a folder, click [Burn] to save the desired files into
this folder.
D You can view the burning progress through [Progress], and click [Close] when the
burning is completed.
D Close Media: When clicking [Close Media], the system will not perform a second
burning after the optical disk finishes its burning.
D Eject When Finished: When clicking [Eject When Finished], the CD/DVD burning is
finished and will be automatically ejected.

7.3 Data Transmission

Press [Review] to enter the Reviewing interface, and then click [Data Transfer] to enter the
interface of data transmission, as shown below:

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Export: to export the patient information on the Local HD to an optical disk (CD/DVD)
or USB disk.

1. Click [Export], and the patient information list on the first row will pop up the patient data
stored in the system;
2. On the bottom left corner occurs from [Local HD] to [], and click the drop-down list of [] to
select the export device;
3. Click [Select All]or select single patient information as required;
4. Then click [Data Transfer] to transmit the patient data from the system to the removable
device.

Import: to import patient information from an optical disk (CD/DVD) or USB device to
the Local HD.

1. Click [Import], and the patient information list on the second row will pop up the patient
data stored in the system;
2. On the bottom left corner occurs from [] to [Local HD], and click the drop-down list of [] to
select the import device;
3. Patient data in the import device will be displayed in the patient information list in the first
row;
4. Click [Select All] or select single patient information as required;
5. Then click [Data Transfer] to transmit the patient data from the removable device to the
system.

7.4 Add a Printer

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D This system can be directly connected to a printer for analog signal printing (the system
supports the analog printer models SONY UP-897MD/Mitsubishi P93).
D It can also connected with a printer for digital signal printing (this system supports the
digital printer models HP LaserJet 5200LX PCL 6).

7.4.1 Connected to an Analog Signal Printer

If the system is configured with an analog signal printer, please observe the following steps:
Before settings, please read carefully and have a profound understanding of the user's
manual of the provided printer models.
Connect a cable of the printer with Video Output on the back panel of the ultrasonic system,
and connect the other cable to Remote Port of the printer; press [Print] on the printer or press
[Print] on the ultrasonic system to print images and data.

7.4.2 Connected to a Digital Signal Printer

The system can be connected to a digital signal printer directly through USB or LAN.

Connected to a local printer

1. The system will automatically install the driver programs required for the optional printer,
and users can add the printer according to their needs.
2. Press [Setting] on the touchscreen, and click [Peripheral Preset], then click [Printer]
above the sub-menu to pop up the printer menu.
3. Click [Add printer] to pop up the Add Printer Wizard menu, and when you are prompted
to do so, you can select the local printer connected to your computer in the menu [Local
or Network Printer], and click [Next].
4. The menu [Printer Port] will pop up for selection, and select the USB port in the drop-
down list, then click [Next];
5. The menu [Install Printer Software] will pop up, and select the printer manufacturer in the
list of [Manufacturer] on the left, then select the printer model on the right, and click
[Next];
6. The menu [Use the Current Driver Program] will pop up, and select the driver program,
then click [Next];
7. If you have been prompted to complete the printer adding, the added printer model will
appear in the list.

Connected to a network printer

1. Click [Setting] on the touchscreen, and click [Peripheral Preset] on the left, then click
[Printer] above the sub-menu to pop up the printer menu.
2. Click [Add printer] to pop up the Add Printer Wizard menu, and when you are prompted
to do so, you can select the network printer connected to your computer in the menu
[Local or Network Printer], and click [Next];

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3. The menu [Designate a Printer] will pop up, and you will be prompted to determine the
printer connected to Internet, Home or Office Network and to enter the printer model,
then click [Next].
4. If you have been prompted to complete the printer adding, the added printer model will
appear in the list.

7.5 Report Printing

7.5.1 Print Preview

In the Report interface, click [Print Preview] to preview the report (as shown below), and
users can zoom the report and carry out paging layout and display according to the content
size.
After confirming there are no errors in the report, click [Cancel] to exit the preview interface.

7.5.2 Report Printing

1. Click [printer] in the preset interface, we can choose the Print type from the down list of
[Print Key Destination] (Please see the detail in Chapter 8).
2. Press [Report] on the control panel or enter the Report interface, then click [Print].

7.6 DICOM Connection

Connect the ultrasonic system with the hospital network with a network cable, and connect
the system to the DICOM server for testing; the images (DICOM server storage non
supporting videos) in the ultrasonic system can be stored into the DICOM server after it is
successfully tested; refer to Network Preset in Chapter 8 for specific methods.

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7.6.1 DICOM Storage

1. Press [Review] on the control panel to enter the Reviewing interface, and select the
desired patient in the Patient Information,
2. Then click [Image Screen] to pop up the interface [Image Review}, and select the desired
image(s), then click [Send to DICOM], and a pop-up message will prompt whether they
are successfully uploaded.
3. If you want to view the uploaded data in details, you can return to the main interface and
press [Work queue] on the touchscreen keyboard to pop up [DICOM JOB SPOOLER] for
viewing the details of uploaded images, as shown below.
4. Press [Work queue] again to return to the main interface.

In the DICOM Job Spooler, you can carry out the operations to the uploaded images, such as
refresh, delete, and resend, select an uploading location, hide and select all, etc.

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Chapter 8 Preset

8.1 Preset

Press [Setting] on the touchscreen to enter the preset interface, through which users can
preset the system parameters according to their own needs for faster and accurate data
measurement. The preset menu includes System Preset, Exam Preset, Measure Preset, Text
Preset, Body Mark Preset, Peripheral Preset and Service. We can change the settings
according to our needs.

8.1.1 Operation methods of preset

1. Press [Setting] on the touchscreen to enter the preset interface;

2. Each function module menu is listed on the left of the menu, and use the trackball in
combination with the [Set] key to enter the corresponding module menu for parameter
selecting, editing (you can use the keyboard for input) and revising; click [Reload Factory]
to restore to the default settings;
3. Click [Apply] to save settings, and [OK] to save settings and exit the interface and
[Cancel] to exit the interface.
Save changes in each module; if the changes are not saved, and when it is switched to
another module, a prompt will pop up.

8.1.2 System Preset

System Preset includes the four sub-menus, namely Region Setting, General Setting, Biopsy
Setting, and User defined.

8.1.2.1 Region Setting

Click [System Preset] on the left, and click [Region] on the top of sub-menu, then the
following menu below pops up, including Hospital Information, Language, Time and Weight
Format Settings;

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Parameter Description

Enter the hospital name in the keyboard, and press Ctrl + space
Hospital Name
key to switch language input.
Select the appropriate language from the drop-down list:
Language
Chinese, English;

Time Format Time format selection: 12 h, 24 h

Date Format Date format selection: YY/MM/DD, MM/DD/YY, DD/MM/YY;

System Date Input system date and select calendar;

System Time Input system time for and select time;

Weight & Height Select measurement units: Metric System, American System
Unit Format (Metric system available only)

Surface Area Formula Set the surface area formula: East, West (East available only)

Note: After the language is switched, the system will restart to enable the new language;
Please save the data before switching the language.

8.1.2.2 General Setting

Click the[General Settings]above the sub-menu, through which we can set Patient
Management, Trackball Movement, Storage, Probe Default Setting, Doppler Volume and
Screen Saver, etc.

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Parameter Description
Select: when saving images, and if there is no patient
information, the system will automatically create a patient ID,
Save the images when
which will be displayed in the report and on the main screen;
without patient info
Unselect: When saving images, and if there is no patient
information, it will prompt to create a new patient.
Select: When a new patient is created, it will automatically
generate a patient ID (date + current patient number, for
Auto generated ID example, 20101122), which can also be edited;
Unselect: To create a new patient, you can manually enter the
patient ID.
Available ports when starting the system: Port1, Port 2 and Port
3;
Active probe port
If the preset port is not installed with the probe, the system will
automatically identify the next port in sequence;
Trackball travel speed Select trackball movement speed: high, medium and low.
Doppler Audio Volume Regulate Doppler audio volume: 1% to 100 %.
Select the image area to be stored: image area 800×600
Image Size
Full screen 1920x 1080
Edit the stored cine time, and support backward
Cine Store Time
storage. Storage Time: 0 ~ 120 s, Default Value: 60 s.
Select: When there is no system operation exceeding the
Enable Screen save setting time, the system will enter the screensaver status.
Unselect: The screen saver function is not enabled;
Screen saver Type Select the screen-saver type: black screen, text3D ;
Screen saver Waiting Select the screensaver waiting time from the drop-down menu
(min): 5, 10, 15, 15, 20 and 25.

8.1.2.3 Biopsy Setting

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Click [Biopsy/Litho] above the sub-menu to pop up the menu for relevant Biopsy Settings;

Parameter Description

Probe Type N/A

Bracket Type N/A

Default Angle N/A

Angle 1, Angle 2 and

N/A
Angle 3

Initial Position N/A

Select: activate Biopsy depth marking every 0.5 cm.

Enable 0.5cm Markers
Unselect: no depth marking.

Biopsy Guide Line size Select the size of Biopsy guide wire: small, medium and large

8.1.2.4 User Defined

Click [User Defined] above the sub-menu for the user-defined settings. You can carry out
the following shortcut settings through the customized key functions on the control panel.

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There are four customized function keys on the right of the control panel, and you can carry
out the following shortcut settings in this interface: None, Biopsy Guide, Acquire Set, Litho,
Digital Printing, Analog Printer, image save, cine save,2B, 4B, PDI, LanScape, TDI, A mode,
LVivoEF, ECG, Print.

8.1.3 Exam Preset

Click [Exam Preset] to pop up the Exam Preset menu, through which you can carry out
settings of general measurements on exam items, Doppler/M Mode and End exam settings,
etc.

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Exam Item Description

Exam Item N/A
Select [Freeze Response] and the system will enter: Cine, Text,
Freeze Response
Mark and Measure;
ON: In 2B imaging mode (real-time/non-real-time), there is no gap
Seamless Dual between two images;
OFF: there is a gap between two images;
TGC curve options on the right of image in the main interface:
TGC Display Always ,
Instantaneous, Close
TGC invert
Select: flip; Unselect: no flip
with
Images
Thermal Select thermal index: TIS, TIC, or TIB.
index When TIS/TIC/TIB is ≥ 0.4, thermal index will be displayed
Display Select：Press [Capture] or [acquire set] shortcut key to save
Quick save with acquire current parameters as default.
Set Unselect: press [Capture] or [acquire set] to enter acquire setting
interface.
HPRF Enable Select: add HPRF menu in PW mode. And vice versa.
Select: immediately display M mode/PW mode imaging, no
Bypass M/D cursor displaying sampling line; Unselect: display the sampling line and
the corresponding imaging mode can be displayed by pressing
the M/PW button.
Frequency: the frequency spectrum scale shows the frequency
Doppler
value;
Frequency/
Velocity: the frequency spectrum scale shows the velocity value.
Velocity
Region: to create a new patient;
Status after Live Scanning: to clear the patient information, and reserve the
End Exam probe and exam settings of the previous exam, then enter B
mode imaging.
Select: when the exam is completed, the system will pop up a
dialog box to confirm whether to end the patient exam, and the
Confirmation when
Patient Information menu will pop up after the selection of the
exam ends
user;
Unselect: directly access to the Patient Information menu.

8.1.4 Measure Preset

Click [Measure Preset] and then click the menu above the interface to pop up the general
measurement settings, Special measurement setting and parameter setting. The items in
bold font are the system default settings.

8.1.4.1 General Setting

Click [General Settings] to pop up the General Setting menu, through which you can carry
out settings for caliper and measuring results, and select the units on general measurement.

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Parameter Description
Caliper Size Caliper size setting: large, medium, small;
Caliper Pattern "+" and "X " display option;
Measurement Result Measurement result background display:
Background Display: transparent; Non-display: non-transparent
Result Font Size Measurement result font size: small, medium, large
Result Font Color Final measurement result font color: white, yellow, blue
Distance Units of general distance measurements and distance-type
measurement results: mm, cm
Circumference Units of general circumference measurements and
circumference-type measurement results: mm, cm
Area Units of general area measurements and area-type measurement
results: mm2, cm2, m2
Volume Units of general volume measurements and volume-
type measurement results: mm3, cm3, L
Velocity Units of general velocity measurements and velocity-type
measurement results: mm/s, cm/s, m/s
Time Units of general time measurements and time-type measurement
results: ms, s
Slope Units of general slope measurements and slope-
type measurement results: mm/s, cm/s, m/s
Acceleration Units of general acceleration measurements and
acceleration- type measurement results: mm/s, cm/s2, m/s2

8.1.4.2 General Measurement Settings

Click [Caliper] to display the measurement method options in various modes.

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Parameter Description
Default B mode measurements Value: distance, Trace
B mode
length, area, angle, volume, stenosis rate, A/B ratio
Default M mode measurements Value: distance, HR, slope, time,
M mode
A/B ratio;
Default PW mode measurements Value: velocity, PI (Auto),
PW mode
acceleration, velocity rate, HR, RI, PI (Manual), flow, time;
Area Methods of setting default area measurement: ellipse, trace;
Methods of setting default volume measurement: 1-distance, 1-
Volume
ellipse, 2-distance, 3-distance, ellipse + distance;
Methods of setting default stenosis rate measurement: D-
%stenosis
%stenosis, A- %stenosis;
Methods of setting default B-mode ratio measurement: D ratio,
B mode Ratio
area ratio and volume ratio;
Methods of setting default M-mode ratio measurement: D ratio,
M mode Ratio
time ratio;
Flow volume Methods of setting default flow measurement: A-flow, D-flow.

8.1.4.3 Measurement Settings

Click [Specialist Measure] to pop up the Special Measurement interface, through which we
can edit the measurement items in B mode, M mode and PW mode, and save the settings to
the measurement menu and report.

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Selection methods of measurement items in the imaging mode:

1. Click ▼ on the right of [Exam mode] to select the desired measurement item;
2. Then click B, M and PW to enter the measurement items in the imaging mode, on the
left of which are the optional items, and on the right are the selected items; the system
will set all of the measurement Items in [Exam Item] as the selected items by default;
3. If you want to cancel a measurement, you can use the trackball and [Set] to select

4. [Select item], then press on the right to delete it; to add a new measurement item,

you can click , and the item will be selected to [Select item];

5. Click to move the selected item to the upper location; click to move the
selected item to the lower location;
6. Click [OK] to save the measurement item settings and return to main interface; click
[Apply] to save settings; click [Cancel] to return to the main interface without saving
settings.

8.1.4.4 Obstetric Measurement Settings

When the three measurement Items, namely obstetrics, early pregnancy and late pregnancy
are selected in the measurement item, the system will add four more parameter settings,
including Ratio, EFW/CUA (fetal weight/ultrasonic compound gestational age), Graph
(growth curve graph) and OB table (gestational age/fetal growth curve), you can select a
reference author behind the obstetric measurement item; please refer to Appendix E for
more details.

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Gestational Age (GA) Table

Measurement items Author

Default B mode measurements Value: distance, Trace
B mode
length, area, angle, volume, stenosis rate, A/B ratio
GS Tokyo, Osaka
CRL Hadlock, Robinson, Hansmann, Lasser, Tokyo, Osaka, JSUM,
ASUM
BPD Hadlock, Merz, Lasser, Rempen, Tokyo, Osaka, JSUM, ASUM
OFD ASUM
ASD Merz
ATD Merz
HC Hadlock, Lasser
AC Hadlock, Merz, Lasser, JSUM
FTA Osaka
FL Hadlock, Merz, Jeanty, Tokyo, Osaka, JSUM
HL Jeanty, Osaka
Ulna Jeanty
Tibia Jeanty
BN Jeanty, Tongsong
FT Mercer
HC/AC Campbell
FL/AC Hadlock
FL/BPD HadLock
GS Tokyo, Rempen
CRL Hadlock, Rempen, Robinson, Hansmann, Tokyo, Osaka, JSUM,
ASUM

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Measurement items Author

BPD Hadlock, Merz, Lasser, Rempen., Hansmann, Tokyo, Osaka,
JSUM, ASUM, Chitty
OFD ASUM, Chitty, Hansmann
HC Hadlock, Merz, Hansmann, Chitty, ASUM
AC AUSM, Hadlock, Merz, Jeanty, JSUM, Chitty.
A×T Tokyo, JSUM
FTA Osaka
FL Hadlock, Merz, Jeanty, Hansmann, Tokyo, Osaka, JSUM, ASUM
HL Jeanty, Merz, Hansmann, Osaka, ASUM
Ulna Jeanty, Merz, Hansmann
Tibia Jeanty, Merz, Hansmann
FT Mercer
Renal L Bertagnoli, Hansmann
RAP Bertagnoli, Hansmann
Clav Yarkoni
TC Chitkara

8.1.4.5 Parameter Settings

Click [Other Parameters] to pop up the measurement and report settings, as shown below:

Parameter Description
Heart Select the default measurement item of mean cardiac cycle,
Cycles values: 1, 2, 3, 4 and 5;
Average
Measure Select the action upon completion of a measured value: None ,
Sequence Repeat, Next;
Data value after selecting the measurement data: Average,
Data Average
Direct;
Graph Format Set the default method of growth curve display: single, Quad;

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8.1.4.6 Probe

To customize the order of exam sections for each probe.

8.1.5 Text Preset

8.1.5.1 Text Library Settings

Click [Text Preset] and then click [Text Library] to enter the Text library setting.

Operation methods for annotation library setting:

1. Click ▼on the right of [Exam Mode] to select the item; The exam items are set in the
default exam mode on the right of annotation library, and users can select the
annotation library on their own, in which the measurement items will appear on the right
of annotation box.
2. If you want to cancel the annotation of an item, you can use the trackball and [Set] to
select the annotation item, then click [Delete] on the right or click [Delete All] to delete
the whole annotation library of the current item; if you want to add an item annotation,

click to select the annotation library on the left; when clicking , all the items in the
annotation library of the current item will be added.
3. You can manually enter the annotation on the upper-right corner, and click [Add] to add
the annotation into the annotation library; select the annotation and click [Modify] to
revise the annotation in the annotation library;

4. Click to move the selected item to the upper location; click to move the
5. selected item to the lower location;

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6. Click [OK] to save the measurement item settings and return to main interface; click
[Apply] to save settings; click [Cancel] to return to the main interface without saving
settings.

8.1.5.2 Text Property Settings

Click [Text Property] to carry out settings of annotation attribute.

Parameter Description
Text Font Size Annotation text font size: 10, 12, 14, 18, 20; unit: Pound(s)
Set annotation text font and arrow color, and values are: yellow,
Text Color
red, blue, orange, white and purple;
When selected, it will automatically wrap when the text length
Word Wrapping exceeds the image boundary; otherwise it needs to wrap
manually;
Arrow Size Set the arrow size: small, medium, large
erase Text Image Select the text, and the annotation will be erased when the image
is Unfrozen is frozen; otherwise the erasing function will not be performed.
Retain while When selected, upon entering and exiting the timeline mode, the
Entering or Leaving system will reserve the annotation on the monitor display;
Time Line Mode otherwise it will not reserve the annotation;

8.1.6 Body Mark Preset

8.1.6.1 Mark Library Settings

Click [Body Mark Preset] on the right and click [Mark Library] to pop up the body mark library;
please refer to the setting methods of annotation library described in the previous section.

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8.1.6.2 Mark property Settings

Click [Mark property] to conduct settings of body mark attribute, including: displaying or non-
displaying the probe marking, erasing the annotation when the image is unfrozen, copied to
the sliding side with multiple images and displaying or non-displaying body mark background,
etc.

Parameter Description
When selected, the probe mark will be displayed in the body
Probe Mark Display
mark; otherwise it will not be displayed.
Copy to active When selected, the body mark will be erased when the image is
side in multiple unfrozen; otherwise it will not be erased.
image

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Parameter Description
When selected, the system will copy the body mark to the active
Erase When Image
images in the multiple images; otherwise it will only appear on the
is unfrozen
current image.
Body Mark Select the body mark background display: transparent and non-
Backgroun Transparent.
d
8.1.7 Network Preset

8.1.7.1 TCP/IP Settings

Click [Network Preset] on the left menu and then click [Local TCP/IP]; the system can input
IP connection network, and can also enter the host name of the ultrasonic system, IP
address, and set DICOM, including the following parameters in the table below:

Parameter Description
Host Name Host name of the ultrasonic system
IP Address IP address of the ultrasonic system host
Subnet Mask Subnet mask of the ultrasonic system host
Gateway Default gateway of the ultrasonic system host
AE Title Application entity title of local DICOM service
Port Store service port number (local port number). 104 by default
Largest PDU packet size and range: 16k to 64k. If the settings are
PDU
beyond this range, the system will set 32k by default.

8.1.7.2 Storage Server Settings

Click [Storage Server] above the menu to pop up the DICOM server settings.

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Operation methods of connecting storage server:

1. Connect the system to the hospital network with a network cable;

2. Click [Local TCP/IP], and we can automatically obtain or manually input IP address for
the ultrasonic system according to various network connection and based on our needs;
3. Enter AE Title, Port and PDU of DICOM of the ultrasonic system;
4. Then click [Storage Server] to input AE Title, IP Address and Port of DICOM of the
storage server. The IP address is the IP address of the server, and the port is generally
104 by default;
5. Click [Add], and the server will be displayed in the server list;
6. Select the added server in [Server List], and then click [Verify] to test the connection
between ultrasonic host and storage server, and pop up relevant prompts.
Re-add, modify and delete the server:

D Re-add: the ultrasonic system can be connected with multiple servers, and when you
want to connect the system to other servers, you can modify AE title, IP address and
port of DICOM, then click [Edit];
D Modify: If you want to modify the servers in the list, select the desired storage server
entries in the list; after modification, click [Edit] for modifying and saving;
D Delete: Select a storage server entry in the list, and click [delete] to remove the server.

Note: The server Settings of Worklist, MPPS, storage commitment, and printing
interface are the same as above.

8.1.8 Peripheral Preset

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8.1.8.1 Printer Setting

Click [Peripheral Preset] on the right and click [Printer] on the top of the screen.

Printing device selection: In accordance with differences of peripheral signal ports, the
printers can support:
D Numeric Print: to print numerically (including picture and text print and digital video
print):
D Analog Print: to print analog videos.
D Disk Storage and DICOM Storage: When choose this and return the interface, press
[print], the Image will be stored in Disk and send to DICOM.
Add Printer: click the button to enable "Add Printer Wizard". You can add the printer driver
from the system or optical disk according to your needs; after the completion of adding, the
list will show the added printer model and status information (see Chapter 6 Add Printer).
Remove Printer: select a printer from the printer list, and click [Delete] to remove the printer.

8.1.8.2 Output Setting

Click [Output] on the top the screen to carry out relevant output settings.

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Parameter Description
You can set two types of video signal output sizes:
Output size
Full-screen (1920* 1080); image area (800 * 600).
Output Format Select the standard for video printer output. PAL, NTSC
After video reserve is started, and if the video output is full-
screen, the image area remains unchanged, and non-image video
Video Invert signal will be reverse; if [image area] is selected, the video
inverse will be automatically restricted to close, that is, the video
reserve would only be enabled in full- screen output.

8.1.8.3 Foot Switch Settings

Click [Foot Switch] on the screen menu to carry out settings of None, Freeze, Image Save,
Cine Save, Print and so on to left pedal and right pedal.

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This system can connect a USB footswitch to replace some control panel keys. Before
connect you need to setup the footswitch as below:
Connect the footswitch to a computer, and insert the footswitch driver to define the key.
Define CTRL+ SHIFT+ Left key as left pedal, CTRL+ SHIFT+ right key as right pedal.
D Connect the footswitch
1. Connect the footswitch to the USB port of the system.
2. Preset the footswitch function as shown above the figure.
3. Step on the footswitch in the main surface to perform the function.

8.1.8.4 DICOM Print

To set DICOM print detailed Settings, such as orientation, layout, copies, magnification, etc.

8.1.9 Service Preset

Click [Service Preset] on the left menu to preset the system setting management, user
management and system information.

8.1.9.1 Preset Management

Click [Preset Management] on the top of the screen to carry out import and export
management of the preset data.

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Export Preset Data

1. You can select one or more of the preset data to export to the system;
2. Select one or more of the preset data to be exported in the export list;
3. Click [Export] to pop up the dialog box [Export Setting];
4. Choose the location and the file naming rule is: YYMMDD-HHMMSS.dat, and users can
click [File Name] in the export preset menu to revise the file name, which cannot be
opened for revising.
5. Click [OK] to complete export and return to preset interface.
Import Preset Data

Preset data import and export are the two opposite processes, therefore identify the location
of the files for data import, and click [Set] after data import, then the system will restart to
carry out preset data settings according to the imported data.
Export user data

1. select Log / patient Data / All Data

2. select the location to be stored
3. click the [Export] button to pop up the export completed prompt box
4. click [OK] to complete the export, return to the preset interface

Note: Before importing preset, please save the measurement data; otherwise the system
restart will lose data.

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8.1.9.2 Admin

If Enable user access control is check, user access control is activated, user name and
password will be needed to enter system operation.

8.1.9.3 System configuration

To view the current device identifier, import product key and system configuration
information.

8.1.9.4 System Information

Click [System Information] on the top of the screen to view software and hardware
version information of the current system.

8.1.10 Acquire Settings

The acquire setting can be access through touchscreen keyboard [Capture] or user define
key on the control panel.
D Click [keyboard] on the touchscreen, then press [Capture] on the touchscreen keyboard.
D Click [Setting] on the touchscreen, then <User Defined> to set one of the user defined
key function as acquire set.
Click [Capture] on the touchscreen keyboard, or press the preset user define key on the
keyboard to pop up the [Acquire Set] interface, which is similar to [Probe], which is the exam
of system configuration while the Acquire setting is the custom exam created by users.

Note: In system preset, note whether ‘quick save acquire set’ is selected, see <8.1.3
Exam Preset>. If selected, Click [Capture] or the user define key can only save the current
parameters as the default setting of current exam mode.

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Customize Exam Method:

1. Users can press [Probe] to carry out selection of items.

2. In the course of exam, you can regulate imaging parameters through the software so as
to achieve a satisfactory image quality;
3. Click [Capture], or press the user define key to enable the capture of imaging condition
and input the corresponding name of acquire setting, then press [Save] to save the
imaging conditions; which can be displayed in the interface of [Probe], and can be used
as the imaging condition by users. Likewise, measurement library, annotation library
and mark body library related to exam can be accordingly copied to the new exam item.
4. When clicking [Active], the system will pop up a message to prompt whether to set it as
the default setting; when clicking [Delete], you can only delete the User Defined, but
cannot delete system exam; click [Cancel] to return to the main interface without saving
settings.

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Chapter 9 Maintenance

9.1 Caring for the System

It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic
operation on a daily basis. Each day, prior to using the system, performs the steps of the
Daily Checklist.
All exterior parts of the system, including the control panel, keyboard and probe, should be
cleaned and/or disinfected as necessary or between uses. Clean each component to
remove any surface particles. Disinfect the components to kill vegetative organisms and
viruses.

9.1.1 Daily Checklist

Complete the following each day before using the system:

D Visually inspect all probes. Do not use a probe which has a cracked, punctured, or
discolored casing, or a frayed cable.
D Visually inspect all power cables. Do not turn on the power if a cable is frayed or split, or
shows signs of wear. Contact your dealer for replacement of the power cable if a cable
is frayed or split, or shows signs of wear.
D Verify that the trackball, TGC sliding controls, and other controls on the control panel
are clean and free from gel or other contaminants.

Once the system is powered on:

D Visually check the on-screen displays and lighting.

D Make sure the monitor displays the current date and time.
D Verify that the probe identification and indicated frequency are correct for the active
probe.

9.1.2 Maintenance

Note: To maintain the safety and functionality of the ultrasound system, maintenance must
be performed every 12 months. Electric safety test must be performed at periodic intervals
according to the local safety regulations or as needed.

Repair:

For the repair or replacement of system equipment parts, please contact Lanmage or your
dealer.

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Lanmage Authorized Care:

Installers and operators must observe any statutory regulations that govern the installation,
operation, inspection and maintenance of this equipment.
To ensure the safety of patients, operators, and third parties, you must check this equipment
every 12 months, and replace any component if necessary. This maintenance must be
performed by a qualified Lanmage authorized representative. It is important to inspect the
equipment more frequently if it is operated under extraordinary conditions. Check and
maintenance must be performed at specified intervals to avoid any part becoming hazardous
due to wear. Contact the Lanmage service department for information regarding the required
maintenance. As manufacturers and installers of ultrasound equipment, Lanmage cannot
assume responsibility for the safety properties, reliability, and/or performance of the
equipment if:
D Installations, extensions, readjustments, modifications, additions, or repairs are carried
out by persons not specifically authorized by Lanmage.
D Components that affect the safe operation of the system are replaced by parts not
authorized by Lanmage.
D The electrical installation of the room where the equipment is located does not meet the
power and environment requirements specified in this manual.
D The equipment is not used in accordance with the operation instructions.
D The probe is non-factory configuration.
D The system is operated by persons who do not receive good education or training.
Lanmage suggests that you request any person that performs maintenance, or repairs, to
provide you with a certificate showing:
D The nature and extent of the work performed
D Changes in rated performance
D Changes in working ranges
D Date of service
D Name of the person or firm performing the service
D Signature of the person performing the service
Lanmage refuses any responsibility whatsoever for repairs performed without the express
written consent of the Lanmage.

9.2 Cleaning and Disinfecting System Parts

If the system is in operation, you should regularly (daily) clean the system.
Before cleaning and disinfecting the system, check to make sure that the system is turned
off and unplugged. Regularly clean the external surfaces of the system parts with a soft cloth.
Wipe the system body with a water-moistened cloth or cotton swab. Where required, you
can wash system components with soapy water.
When cleaning, avoid any excessive watering of the system parts cleaned and the entry of
liquid solutions inside the system via vents. If this is the case, allow the system to dry for the

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appropriate time before you turn the system on.
Clean the external filters located on the fans of the back panel of the system once a month.
Replace them if required with those from the spare parts kit.
Perform the maintenance of the components of the system by such methods and in such
time as directed in their service documentation.
If a printer is included in the system, check the cartridge state and replace it if required.
Inspect periodically the paper bin and the paper feed roll.

Cleaning and Disinfecting the System:

Note: To avoid electrical shock and damage to the ultrasound system, always power off and
disconnect the equipment from the AC power source before cleaning and disinfection.

Note: Do not pour any fluid onto the system surfaces, as fluid seepage into the electrical
circuitry may cause excessive leakage current or system failure.

Note: remove gel residuals out of the probe after each use!

Note: To avoid the possibility of static shock and damage to the system, avoid the use of
aerosol spray cleaners on the monitor screens.

To clean the system surfaces:

1. Power off the ultrasound system and disconnect it from the power source.
2. Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to
widen the surface of the ultrasound system. Take particular care to clean the areas near
the trackball and the slide controls. Ensure these areas are free of gel and any other
visible residue.
3. After cleaning, use a clean, lint-free cloth to dry the surface.
4. After cleaning, reconnect the ultrasound system to the power supply.

To remove and clean the holders for probes and coupling agent (gel):

Use neutral cleaning agent to clean the surfaces of the holders for probes and coupling
agent, and then use a piece of lint-free cloth to dry them.

To clean the trackball

Note: Do not drop or place foreign objects inside the trackball assembly. This may affect the
trackball’s operation and damage the system.

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1. Trackball bezel2. Trackball

Disassemble the trackball

1. Rotate the trackball bezel clockwise and lift up to remove the trackball bezel from the
trackball assembly.
2. Remove the trackball out of the trackball assembly.

Cleaning

D Clean the bezel and trackball with a cotton swab or lint-free pad moistened with mild
detergent solution.
D Clean the inside of the trackball assembly, using a cotton swab moistened with mild
detergent solution.
D Allow the trackball components to completely dry before reassembly.

Reinstall the trackball and replace the trackball bezel

1. Place the trackball inside the trackball assembly.

2. Place the trackball bezel over the trackball.
3. Use the bezel fastener to aim at the trackball slot, Press down and counterclockwise the
bezel until it snaps into position.

9.3 Caring for and Using Probes

9.3.1 Using Probes

Before you begin using the system, inspect all the probes on a daily basis. Do not use the
probe with cracks in the probe or connector shell, or cuts, gouges or swelling of lens
material or in the event of signs of damage to the cable.
Immediately clean and disinfect the probe after each use to avoid the infection of patient and
operator during exam.
Cuts in the probe cable or cracks in the probe or connector shell can destroy the electrical
safety features of the probes.

Caution: Ensure surfaces of the probe are always disinfected during procedures requiring

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disinfection.

Caution: To minimize the risk of cross contamination and infectious diseases, Endocavity and
intraoperative probes must be cleaned and high-level disinfected after each use.

Caution: The outer surfaces of an Endocavity or intraoperative probe should be checked to

ensure there are no unintended rough surfaces, sharp edges, or protrusions that may cause
a safety hazard.

Caution: Probes are sensitive devices——irreparable damage may occur if they are dropped,
knocked against other objects, cut, or punctured. Do not attempt to repair or replace any part
of a probe.

Caution: To avoid cable damage, do not roll the system over probe cables.

Caution: Do not use probe sheaths containing oil-based coatings or petroleum-or mineral oil-
based ultrasonic coupling agents. Use only water-based ultrasonic coupling agent.

Caution: Take extreme care when handling or storing probes. They must not be dropped,
jarred, or knocked against other objects. Do not allow probes to come into contact with any
sharp-edged or pointed object.

Caution: Do not attempt repairing or modifying probe Parts!

Caution: Maintenance and repair should only be carried out by the duly authorized personnel.
Do not attempt opening the probe or connector. This could void your warranty!

Caution: All probes, no matter what their design is, are sensitive to strikes. And therefore,
handle them with care. Pay attention to any cracks, through which a current-conducting liquid
can enter the probes!

Caution: Prevent twisting, kinking, and looping of the probe cables, as well as protect them
from exposure to mechanical factors, in particular, from getting to under equipment wheels or
feet!

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Caution: Damage to the probe due the above causes could void your warranty!

Caution: The system and probes should be inspected regularly for damages by the duly
authorized personnel!

Warning: Damages to the probe or probe cable can affect safe operation of the system and
therefore, repair them immediately!

You should inspect periodically the probes on the following signs of damage (pins shouldn’t
be bent or damaged).When you are not using the probe, place it in the probe holder located
on the side on your system to assure safe, convenient storage.
To improve acoustic contact, use only a special ultrasound transmission gel. Never use the
following substances to improve acoustic contact:
1. Mineral oils;
2. Mineral oil based gels;
3. Gels containing lotions or any softeners;

9.3.2 Cleaning and Disinfection

Cleaning

Remove gel residuals out of the probe after each use. Where required, wipe the probe and
cable with a water-moistened gauze pad. Wipe the probe by any of the recommended
disinfectant. Remove disinfectant solutions residuals out of the probe with a water-
moistened gauze pad. Do not allow the disinfectant solution drying up on the probe. Do not
wipe the working surface of the probe with hard material, do not use a stiff brush to clean the
probe, and do not scrape gel residuals with sharp tools.

Disinfection

You should disinfect the probe after the probe lens contacts affected tissues, mucous
membranes and blood. The essential disinfection level of the ultrasound probe is defined by
tissue type, probe contacted with.
D Unplug the probe.
D Sterilize the probe with isopropanol in terms of requirements.
To prevent probe damage, follow the immersion depth guidelines for each probe type.

Caution: To avoid electrical shock and damage to the system, disconnect the probe prior to
cleaning or disinfecting.

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Caution: Do not immerse the probe cable or the connector housing in liquid and prevent them
from soaking!

Caution: Do not immerse the probe in a disinfectant for more than 1 hour! Wipe the residual of
disinfector solution, if any, from the probe with a clean cloth which dips bolder water. Then cool
the probe to room temperature. Forbid to air dry the disinfector solution on the probe. After
disinfection, wipe the probe with a dry clean cloth. When cleaning, avoid any the

Caution: Never sterilize the probe with sterilization techniques such as gas or heat sterilization
techniques. It can cause the serious probe damages!

Caution: Do not use abrasive cleaning agents, organic solvents such as benzene, isopropyl
alcohol, or phenol-based substances, or cleaning agents containing organic solvents to
clean or disinfect probes. These substances can damage the probes.

Caution: Do not use a spray cleaner on a probe, as this may force cleaning fluid inside the
housing and damage the probe.

Caution: All probes should be cleaned and disinfected prior to their use on each patient.
Endocavity and intraoperative probes require high-level disinfection prior to use.

9.3.3 Storage

Store the probes in a clean and dry environment. Extreme temperature or humidity may
damage the probes.

9.3.4 Protective Case

Due to the mechanical sensitivity of probes, Lanmage recommends that you always use the
probe case when you ship a probe or transport it from one place of exam to another. The
case is specially designed to protect the sensitive parts of the probe. Be sure that all parts of
the probe are properly placed inside the case before you close the lid.

9.3.5 Helpful Hints for Endocavity Probes

Before use, place an adequate amount of ultrasound transmission gel at the tip of the probe.
Place the disposable sheath (contraceptive) over the probe.
After each use, remove the sheath (contraceptive) and place it to a special container for
further disposal.

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Caution: You must follow the disinfectant manufacturer’s instructions

Caution: Do not immerse the probe in a disinfectant for more than 1 hour!

Caution: Do not use abrasive cleaners, substances based on acetone, phenol, ethyl alcohol,
de-chlorinating agents and organic solvents to clean and sterilize the probe!

9.3.6 Protect shell

Because of the mechanical sensitivity of the probe, it is recommended that you use the
probe box when you transport the probe or move from one inspection site to another. The
box is specially designed to protect sensitive parts of the probe. Before you cover the top of
the probe box, make sure all parts of the probe are correctly placed in the box

9.3.7 Caring Coupling Agent

Caution: Before use, examine the coupling agent for any material flaws. Thinning, bulging, or
brittleness of the material indicates damage. Any product showing flaws should not be used.

Do not store coupling agent below 5°C nor above 57°C. Coupling agent has a limited shelf
life. Before use, examine these products for any material flaws. Some packaging may list an
expiration date. Any product showing flaws, or whose expiration date has passed, should
not be used.

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Appendix A Specifications

A.1 Working, Storage and Transport Environment and Packaging

Storage Environment Requirements:

D Temperature: -20°C ~ + 55°C

D Relative Humidity: 10% to 90% (non-condensing)
D Atmospheric Pressure: 500hPa ~ 1060hPa

Working Environment Requirements:

D Temperature: 5 °C ~ 40 °C
D Relative Humidity: 30% to 85% (non-condensing)
D Atmospheric Pressure: 700hPa ~ 1060hPa

Transport Environment Requirements

D Temperature: -20°C ~ + 55°C

D Relative Humidity: 10% to 90% (non-condensing)
D Atmospheric Pressure: 500hPa ~ 1060hPa

Protective Measures:

D Liquid Protection: This system does not have the function of liquid protection;
D Heat Protection: There are two fans installed on the back of the system host for heat
protection.

Packaging and Size:

D Size: 995х590х1380 mm³ (machine);

1050x700x1580 mm³ (including
packaging).
D Weight: 95 kg (N.W.); 139kg (G.W.)

Note：

1. Far away from equipment with strong electric and magnetic field and high voltage;
2. Avoiding the exposure of the screen in direct sunlight; light shielding indoors for easy
observation; good ventilation and anti-dust measures;
3. Operate system in the environment GB/T14710-93 specifying for.

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A.2 Probe Surface Temperature

Probe Type Surface Temperature（℃）

You can set two types of video signal output sizes:
Output size
Full-screen (1920* 1080); image area (800 * 600).
C1-5 Convex
≤ 41;
Probe C2-5 Convex
Probe Convex Probe
4C2-5n ＜41;
P1-4 Phased-array ＜41;
probe P2-3 Phased-
array
EC4-9probe
Endocavity Probe ＜41.
C4-9ER Convex Probe
C4-9MCConvex Array ＜41.
L5-10 Linear Probe ＜41.
L4-13 Linear Probe

A.3 Monitor

Monitor: High-resolution 21.5”TFT LCD, no interlaced scan.

Resolution: 1920 x 1080 pixels.
Synchronization: Horizontal:30 Hz to 70 Hz; Vertical:50 Hz to 85 Hz.
Controlled tilt/rotation: Tilt angle: Up/down 90; Rotation angle: Left/right 90°.
Safety classification: Class 1 in accordance with EN60601-1.

A.4 DVD-Drives
Reading speed: 48x (7.2 Mb/s); Caching: 2M;
CD/DVD-R and CD/DVD-RWWriting
drive : speed: CD-R: 48x (7.2 Mb/s); CD-RW: 32x (4,8 Mb/s); DVD+/-R 20X D
Access time:100 ms

A.5 Power Supply

Mains voltage: 100-240V~，50/60HZ，5.5-2.5A

Power supply
Standard power supply
requirements
: Max. rated power requirements: 500 VA
including regular and additional equipment connected to
Power requirement:
outlets on a circuit, and consuming in the aggregate not more
than 220VA
Monitor, Printer, AUX voltage: 100-120V~，50/60HZ，5.5-4.5A
200-240V~ ，50/60HZ，3.0-2.5A.
Outlets: Output power: Monitor 100 VA;
Printer :100VA; Acoustic system :20 VA
Acoustic system 20 VA AUX 20 VA.

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A.6 Imaging Modes

A.6.1 B Mode

Imaging Mode B, real-time 2B, non-real-time 2B,4B

Frequency 2.5MHz~5 MHz
DR 30~120
Persist 0~4
Maximum Scan Depth 31cm
R/S 0~3
Colorize 0~15
Fov 19.2~36.1fps
Rejection 0~5
Smooth 0~3
LanSRI 0~4
Map A~P
Flip U/D,L/R
LanTissue Normal, Liquid, Fat, Muscle
Frame counter 1055

A.6.2 M Mode

Imaging Mode B/M, Full-M

Frequency 2.5MHz~5 MHz
DR 30~120
Sweep 1~7
LanSRI 0~3
Colorize 0~15
Map A~P
Rejection 0~5

A.6.3 Color Mode

Imaging Mode Color, 4B, Real-time 2B

Frequency 2.2MHz~2.6 MHz
PRF 3.97KHz~175.07Hz
LanFlow L,M,H
R/S 0~3
Map A~H
Persist 0~4
Filter 0~4
Smooth 0~3
Invert Available
Sensitivity L,M,H
Peak off,1,2,3

A.6.4 PDI Mode

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 Appendix A
Imaging Mode PDI, 4B, Real-time 2B
Frequency 2.2MHz~2.6 MHz
PRF 5.44KHz~239.90Hz
LanFlow L,M,H
R/S 0~3
Map A~H
Persist 0~4
Filter 0~4
Priority 0~4
Smooth 0~3
Sensitivity L,M,H

A.6.5 PW Mode

Imaging Mode B/PW, Full-PW

Frequency 2.2MHz~2.6 MHz
PRF 15.87KHz~732.49Hz
Gate 0.5~20
Colorize 0~11
DR 30~60
Filter 0~4
Angle -60~60
Invert Available
Map A~H
Rejection 0~5
Sweep 1~7
Auto Trace Off, Up, Down
Tri Plex/Duplex On, Off
Format V1:1,V1:2,V2;1,H2:3

A.7 Regulatory Compliance

Number of
Item Scope Name of standard
standard
Medical electrical equipment – Part 1:
General
1 IEC 60601-1 General requirements for basic safety and
,
essential performance.
Safety
Medical electrical equipment --Part 1-2:
General requirements for basic safety and
General
2 IEC 60601-1-2 essential performance- Collateral standard:
, EMC
Electromagnetic disturbances - Requirements
and tests

Medical electrical equipment –Part 1-6:

General
3 IEC 60601-1-6 General requirements for basic safety and
,
essential performance –Collateral standard:
Usability
Usability.
General Medical device –Part 1: Application of usability
4 IEC 62366-1
, engineering to medical devices
Usability

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Number of
Item Scope Name of standard
standard

Medical Electrical Equipment Part 2-37:

Particular Requirements for the basic safety and
5 Safety IEC 60601-2-37
essential performance of Ultrasonic Medical
Diagnostic and Monitoring Equipment

General, Medical device software – Software life-cycle

6 IEC 62304
Software processes.
Standard means for the reporting of the acoustic
Acoustic
7 IEC 61157 output of medical diagnostic
output
ultrasonic equipment
Risk
Medical devices- Application of risk
8 managem IEC ISO 14971
management to medical devices.
ent
Medical devices - symbols to be used with
9 Labeling IEC ISO 15223-1 medical device labels, labeling and
information to be supplied.

Informatio Information Supplied by the Manufacturer for

10 IEC 1041
n Medical Devices
Biological evaluation of medical devices—Part
Biological 1：Evaluation and testing within a risk
11 IEC ISO 10993-1
evaluation management process.

Biological Biological evaluation of medical devices-- Part

12 IEC ISO 10993-5
evaluation 5:Tests for in vitro cytotoxicity

Biological IEC ISO 10993- Biological evaluation of medical devices-- Part

13
evaluation 10 10:Tests for irritation and skin sensitization

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