Piloter Color Diagnostic Ultrasound System

User manual

Intellectual Property Rights

The intellectual property rights of this Operator’s Manual and the corresponding product
belong to Shenzhen Wisonic Medical Technology CO., LTD. (hereinafter referred to as
“Wisonic”).

This Manual contains proprietary information protected by copyright law. Without written
permission of Wisonic, any organization or individual is prohibited to photograph, copy,
modify or print any part of this Manual, or translate into other languages.

However, Wisonic is not liable for any incidental or consequential damages to the actual
performance and use due to errors in this Manual or the provision of this Manual. Wisonic
does not provide license conferred by patent law to any other parties. Wisonic does not
assume legal responsibility for the legal consequences resulting from violating the patent law
and the rights of any third party.
Statement
Wisonic reserves the right of final interpretation to this Manual.

The content of this Manual is subject to change without prior notice.

Only if the following requirements are met, Wisonic will be responsible for the safety,
reliability and performance of the product, i.e.:

 Assembly, expansion, re-adjustment, improvement and repair should only be performed

by qualified personnel approved by Wisonic;

 All the replaced parts and supported accessories and consumables relate to the
maintenance shall be originally from Wisonic or others approved by Wisonic;

 DO NOT make changes or modifications to the software or hardware of this

system

 The electrical equipment complies with relevant standards and the requirements of this
Manual;

 The product is operated in accordance with this Manual.

II
 After-sales Service Unit
Manufacturer Name: Shenzhen Wisonic Medical Technology CO., LTD.

Customer Service Department

Address: 1st Floor & 5th Floor, NO.6 Building, Ping Shan Technology Park, Taoyuan Street,
Nanshan District, 518055, Shenzhen, P.R.China

Postal Code: 518055

Website: www.wisonic.cn

Email: info@ wisonic.cn

Tel: + 86-755-86007788

Fax: +86-755-86007799

EC Authorised Representative Name: Wellkang Ltd

Address: 29 Harley St.,London W1G 9QR, England, United Kingdom

Tel:+44(20)30869438,32876300

Fax:+44(20)76811874

Website: www.CE-marking.eu

III
Preface
Notice
This User Manual is the necessary instructions for the safe use of this product. This Manual
introduces the use, properties, method of operation, safety information and intended use of
the Piloter series ultrasound system in details. Before using the product, please carefully read
and understand the contents of this Manual, and abide by the method of operation stated in
this Manual in order to ensure the safety of patients and operators.

This User Manual is a major component of the product, and should always be placed near the
product for easy reference.

Object of Application

This User Manual is intended for professional clinical staff or personnel with experience in
the use of ultrasound diagnostic equipment. The readers should have knowledge and work
experience in medical procedures, practices and terminology of ultrasound diagnosis.

Illustration

All the illustrations in this user Manual are for reference only. The menus, settings and
parameters of the illustrations may be different from your actual currently use system. The
content varies depending on the software version, preset settings and optional configuration.

IV
 Contents
Contents ............................................................................................................................. V
Intellectual Property Statement ........................................................................................................ XI

1 Introduction ...............................................................................................................1-1
1.1 Product information ..................................................................................... 错误!未定义书签。
Attention ......................................................................................................................................... 1-1
1.2 Warranty ............................................................................................................................... 1-1
Exemptions ................................................................................................................................ 1-1
1.3 Company Contact ................................................................................................................. 1-2
1.4 Important Information ........................................................................................................... 1-3
1.5 About This Manual................................................................................................................ 1-4

2 Safety Precautions ....................................................................................................2-1

2.1 Precaution Levels ................................................................................................................. 2-1
2.2 Safety Classification ............................................................................................................. 2-1
2.3 Important Safety Considerations .......................................................................................... 2-2
2.4 Patient Safety ....................................................................................................................... 2-2
2.5 Personnel Safety .................................................................................................................. 2-4
2.6 General Caution ................................................................................................................... 2-7
2.7 Symbols ................................................................................................................................ 2-7

3 System Overview .......................................................................................................3-1

3.1 Product and Model Code ...................................................................................................... 3-1
3.2 Intended Use ........................................................................................................................ 3-1
3.3 Contraindication.................................................................................................................... 3-1
3.4 Product Specifications .......................................................................................................... 3-1
3.4.1 External Dimensions and Weight.................................................................................. 3-1
3.4.2 Imaging Modes ............................................................................................................. 3-2
3.4.3 Power supply ................................................................................................................ 3-2
3.4.4 Environmental Conditions ............................................................................................. 3-3
3.5 System Configuration ........................................................................................................... 3-3
3.5.1 Standard Configuration ................................................................................................. 3-3
3.5.2 Options .......................................................................................................................... 3-4
3.6 Introduction of Each Unit ...................................................................................................... 3-6
3.7 Extension Module ................................................................................................................. 3-8
3.7.1 Probe Extender ............................................................................................................. 3-8

4 Preparing the System ................................................................................................4-9

4.1 Site Requirement .................................................................................................................. 4-9

V
 4.2 Move/Posit System ............................................................................................................... 4-9
4.3 Power Supply ..................................................................................................................... 4-10
4.3.1 Connecting the External Power Supply ...................................................................... 4-10
4.3.2 Powered by Batteries .................................................................................................. 4-11
4.4 Powering the System ......................................................................................................... 4-11
4.4.1 Power ON ................................................................................................................... 4-11
4.4.2 Power OFF.................................................................................................................. 4-12
4.4.3 Standby ....................................................................................................................... 4-12
4.5 Battery ................................................................................................................................ 4-13
4.5.1 Battery Status.............................................................................................................. 4-14
4.5.2 Checking Battery Performance ................................................................................... 4-14
4.5.3 Battery Disposal .......................................................................................................... 4-15
4.5.4 Recycling Battery ........................................................................................................ 4-15
4.6 Connecting /Disconnecting a Probe ................................................................................... 4-15
4.6.1 Connecting a Probe .................................................................................................... 4-15
4.6.2 Disconnecting a Probe ................................................................................................ 4-16
4.7 Graph /Text printer .............................................................................................................. 4-17
4.8 Video Printer ....................................................................................................................... 4-18
4.9 Monitor Display ................................................................................................................... 4-20
4.9.1 Basic Screen ............................................................................................................... 4-20

5 Preparing for an Exam ..............................................................................................5-1

5.1 Begin an Exam ......................................................................................................................... 5-1
5.2 Begin a New Patient ................................................................................................................. 5-1
5.2.1 New Patient information ........................................................................................................ 5-1
5.2.2 Retrieve Patient information .................................................................................................. 5-5
5.3 Select an Exam and Probe ....................................................................................................... 5-6
5.3.1 Selecting an Exam................................................................................................................. 5-6
5.3.2 User-Defined Exam ............................................................................................................... 5-6
5.3.3 Selecting a Probe .................................................................................................................. 5-7
5.3.4 Ending a Patient Exam .......................................................................................................... 5-8

6 Optimizing Image.......................................................................................................6-1
6.1 Imaging Modes Controls ...................................................................................................... 6-1
6.2 Image Adjustment ................................................................................................................. 6-2
6.3 Optimizing B Mode Image .................................................................................................... 6-3
6.3.1 Typical B Mode Exam Protocol ..................................................................................... 6-3
6.3.2 B Mode Parameters ...................................................................................................... 6-4
6.3.3 Controls ......................................................................................................................... 6-4
6.4 Optimizing M Mode Image ................................................................................................. 6-10

VI
 6.4.1 Typical M Mode Exam Protocol .................................................................................. 6-10
6.4.2 M Mode Parameters ................................................................................................... 6-10
6.4.3 Controls ....................................................................................................................... 6-11
6.5 Color Mode Image .............................................................................................................. 6-12
6.5.1 Typical Color Mode Exam Protocol ............................................................................ 6-12
6.5.2 Color Mode Parameters.............................................................................................. 6-12
6.5.3 Controls ....................................................................................................................... 6-13
6.6 Optimizing Power Mode Image .......................................................................................... 6-17
6.6.1 Typical Power Mode Exam Protocol ........................................................................... 6-17
6.6.2 Power Mode Parameters ............................................................................................ 6-17
6.6.3 Power Mode Image Optimization................................................................................ 6-18
6.7 Optimizing PW/CW Doppler Mode ..................................................................................... 6-18
6.7.1 Typical PW / CW Mode Exam Protocol ...................................................................... 6-19
6.7.2 PW/CW Mode Parameters ......................................................................................... 6-20
6.7.3 Controls ....................................................................................................................... 6-21
6.8 wiNeedle ............................................................................................................................. 6-25

7 wiGuide ......................................................................................................................7-1
7.1 Calibration ............................................................................................................................ 7-1
7.2 Setting .................................................................................................................................. 7-2
7.3 How to use............................................................................................................................ 7-3
7.3.1 Indicator ........................................................................................................................ 7-3
7.3.2 OUT-OF-PLANE Needle Guidance .............................................................................. 7-5
7.3.3 In-Plane Needle Guidance............................................................................................ 7-7

8 Scanning & Display ...................................................................................................8-9

8.1 Display .................................................................................................................................. 8-9
8.1.1 ReadZoom .................................................................................................................... 8-9
8.1.2 Front Zoom ................................................................................................................... 8-9
8.1.3 Dual Display ................................................................................................................ 8-10
8.1.4 FZoom (Full-screen Zoom) ......................................................................................... 8-10
8.1.5 Freezing an Image ...................................................................................................... 8-10
8.2 Using Cine .......................................................................................................................... 8-11
8.2.1 Activating Cine Review ............................................................................................... 8-11
8.2.2 Cine and Monitor Display............................................................................................ 8-11
8.3 Annotating an Image .......................................................................................................... 8-12
8.3.1 Adding Comments ...................................................................................................... 8-12
8.3.2 Comment Menu .......................................................................................................... 8-12
8.3.3 Moving Comments ...................................................................................................... 8-14
8.3.4 Deleting Comments .................................................................................................... 8-14

VII
 8.4 Body Marks......................................................................................................................... 8-14
8.4.1 Menu for Body Marks.................................................................................................. 8-15
8.4.2 Adding Body Marks..................................................................................................... 8-16
8.4.3 Moving Body Marks .................................................................................................... 8-17
8.4.4 Deleting Body Marks................................................................................................... 8-17

9 Measurement .............................................................................................................9-1
9.1 Measurement Accuracy ........................................................................................................ 9-1
9.2 Measurement and Calculation Setup ................................................................................... 9-3
9.2.1 Measurement Menu Setup ........................................................................................... 9-3
9.2.2 Measurement Advanced Setup................................................................................... 9-12
9.2.3 Mode Measurements .................................................................................................. 9-17
9.3 Measure Tools .................................................................................................................... 9-25
9.4 Generic Measurements ...................................................................................................... 9-27
9.5 Abdomen ............................................................................................................................ 9-30
9.6 OB ...................................................................................................................................... 9-35
9.7 Gynecology......................................................................................................................... 9-44
9.8 Small Parts ......................................................................................................................... 9-48
9.9 Cardiology .......................................................................................................................... 9-50
9.10 Vascular .............................................................................................................................. 9-64
9.11 Urology ............................................................................................................................... 9-69
9.12 Pediatrics ............................................................................................................................ 9-74

10 Patient Data Management .......................................................................................10-1

10.1 Patient Information Management ....................................................................................... 10-1
10.1.1 Enter Patient Information ............................................................................................ 10-1
10.1.2 Patient Information Setting ......................................................................................... 10-1
10.2 Image File Management ..................................................................................................... 10-2
10.2.1 Memory Media ............................................................................................................ 10-2
10.2.2 Image File Formats ..................................................................................................... 10-2
10.2.3 Image Storage Preset ................................................................................................. 10-3
10.2.4 Saving Images to the System ..................................................................................... 10-3
10.2.5 Image Review and Analysis ........................................................................................ 10-4
10.2.6 Sending Image File ..................................................................................................... 10-5
10.3 Report Management ........................................................................................................... 10-6
10.4 Patient Data Management (Review) .................................................................................. 10-8
10.4.1 Viewing Patient Information ........................................................................................ 10-8
10.4.2 Searching a Patient .................................................................................................... 10-8
10.4.3 Patient Data Management .......................................................................................... 10-8

11 Cloud Share ............................................................................................................. 11-1

VIII
 11.1 Turn ON or OFF the Cloud ................................................................................................. 11-1
11.2 QR code for Exam share .................................................................................................... 11-2
11.3 View share data with mobile phone .................................................................................... 11-3

12 wiLearn Education Center ......................................................................................12-1

12.1 wiLearn Education Center .................................................................................................. 12-1
12.2 Install & upgrade................................................................................................................. 12-3

13 Setup ........................................................................................................................13-1
13.1 System Preset .................................................................................................................... 13-1
13.1.1 General ....................................................................................................................... 13-1
13.1.2 Image .......................................................................................................................... 13-3
13.1.3 Security ....................................................................................................................... 13-5
13.2 Exam .................................................................................................................................. 13-8
13.2.1 Exam Preset ............................................................................................................... 13-8
13.2.2 Application configuration ............................................................................................. 13-9
13.3 Measure Tool .................................................................................................................... 13-10
13.4 Peripheral Preset .............................................................................................................. 13-11
13.5 Network ............................................................................................................................ 13-14
13.5.1 TCP/IP ...................................................................................................................... 13-14
13.5.2 Network Storage. ...................................................................................................... 13-15
13.5.3 DICOM Local ............................................................................................................ 13-17
13.5.4 DICOM Server .......................................................................................................... 13-17
13.5.5 DICOM Storage ........................................................................................................ 13-18
13.5.6 DICOM Worklist ........................................................................................................ 13-20
13.5.7 DICOM MPPS ........................................................................................................... 13-22
13.5.8 DICOM QR................................................................................................................ 13-23
13.5.9 Storage Commitment ................................................................................................ 13-24
13.5.10 Dicom Print ............................................................................................................... 13-26
13.6 Demo ................................................................................................................................ 13-29
13.6.1 Demo Page ............................................................................................................... 13-29
13.6.2 Demo Play Page ....................................................................................................... 13-30
13.7 Maintenance ..................................................................................................................... 13-31
13.7.1 About ......................................................................................................................... 13-31
13.7.2 Data Manage ............................................................................................................ 13-32

14 Probes and Biopsy ..................................................................................................14-1

14.1 Probe .................................................................................................................................. 14-1
14.1.1 Name and Function of Each Part of the Probe ........................................................... 14-3
14.1.2 Orientation of the Ultrasound Image and the Probe Head ......................................... 14-4
14.1.3 Procedures for Operating ........................................................................................... 14-4

IX
 14.1.4 Wearing the Probe Sheath ......................................................................................... 14-8
14.1.5 Probes Cleaning and Disinfection............................................................................. 14-10
14.2 Biopsy ............................................................................................................................... 14-14

15 System Maintenance ...............................................................................................15-1

15.1 Daily Maintenance .............................................................................................................. 15-1
15.1.1 Cleaning the System ................................................................................................... 15-1
15.1.2 Checking the Probe .................................................................................................... 15-2
15.1.3 Backup of the System Hard Drive............................................................................... 15-2
15.2 Maintenance Checks by Service Engineer ........................................................................ 15-2
15.3 Consumables and Periodic Part Replacement .................................................................. 15-3
15.4 Troubleshooting .................................................................................................................. 15-3

16 Acoustic Output.......................................................................................................16-1
16.1 Concerns with Bioeffects .................................................................................................... 16-1
16.2 Prudent Use Statement ...................................................................................................... 16-1
16.3 ALARA Principle (As Low As Reasonably Achievable) ...................................................... 16-1
16.4 MI/TI Explanation................................................................................................................ 16-2
16.4.1 Basic Knowledge of MI and TI .................................................................................... 16-2
16.4.2 MI/TI Display ............................................................................................................... 16-3
16.5 Acoustic Power Setting ...................................................................................................... 16-4
16.6 Acoustic Power Control ...................................................................................................... 16-5
16.7 Acoustic Output .................................................................................................................. 16-6
16.7.1 Derated Ultrasonic Output Parameters ...................................................................... 16-6
16.7.2 Limits of Acoustic Output ............................................................................................ 16-6
16.7.3 Differences between Actual and Displayed MI and TI ................................................ 16-7
16.8 References for Acoustic Power and Safety ........................................................................ 16-7

17 Guidance and Manufacturer’s Declaration ............................................................17-1

18 Appendix ..................................................................................................................18-8
18.1 OB Reference ..................................................................................................................... 18-8
18.2 Cardiac Reference ........................................................................................................... 18-13

X
©2015 Shenzhen Wisonic Medical Technology Co., Ltd. All rights Reserved.

For this Basic user manual, the issue date is 2018-01.

Intellectual Property Statement

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD (hereinafter called Wisonic)
owns the intellectual property rights to this Wisonic product and this manual. This manual
may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Wisonic, or of others.

Wisonic intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written
permission of Wisonic is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any

other derivative work of this manual in any manner whatsoever without the written
permission of Wisonic is strictly forbidden.

Wisonic, W+, Holo are the trademarks, registered or otherwise, of Wisonic in China and
other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.

XI
 This page was intentionally left blank.

XIIIntroduction
 1 Introduction

Attention
Contents of this manual are subject to change without prior notice.

This manual contains necessary and sufficient information to operate the system safely.
Advanced equipment training may be provided by a factory trained Applications Specialist for
the agreed-upon time period.
Read and understand all instructions in this manual before attempting to use the system. Keep
this manual with the equipment at all times. Periodically review the procedures for operation
and safety precautions.
Disregarding information on safety is considered abnormal use.
Not all features or products described in this document may be available or cleared for sale in
all markets. Please contact your local Wisonic Ultrasound representative to get the latest
information.
NOTE: Please note that orders are based on the individually agreed specifications and may
not contain all features listed in this manual.
NOTE: All references to standards / regulations and their revisions are valid for the time of
publication of the user manual.

1.1 Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions

Wisonic's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting
from the improper use or application of the product or the use of parts or accessories not
approved by Wisonic or repairs by people other than Wisonic authorized personnel.

This warranty shall not extend to:

Introduction1-1
 Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.

1.2 Company Contact

Manufacturer: Shenzhen Wisonic Medical Technology Co., Ltd

E-mail Address: [email protected]

Tel: +86-755-86007788

Fax: +86-755-86007799

1-2Introduction
1.3 Important Information
1. Medical ultrasound images are created by computer and digital memory from the
transmission and reception of mechanical high-frequency waves applied through a
transducer. The mechanical ultrasound waves spread through the body, producing an
echo where density changes occur. For example, in the case of human tissue, an echo is
created where a signal passes from an adipose tissue (fat) region to the liver. The echoes
return to the transducer where they are converted back into electrical signals.
2. These echo signals are highly amplified and processed by several analog and digital
circuits having filters with many frequency and time response options, transforming the
high-frequency electrical signals into a series of digital image signals which are stored in
memory. Once in memory, the image can be displayed in real-time on the image monitor.
All signal transmission, reception and processing characteristics are controlled by the
main computer. By selection from the system control panel, the user can alter the
characteristics and features of the system, allowing a wide range of uses, from obstetrics
to peripheral vascular examinations.
3. Transducers are accurate, solid-state devices, providing multiple image formats. The
digital design and use of solid-state components provides highly stable and consistent
imaging performance with minimal required maintenance. Sophisticated design with
computer control offers a system with extensive features and functions which is
user-friendly and easy to use.

Introduction1-3
1.4 About This Manual
The safety instruction must be reviewed before operation of the
CAUTION: unit.

Piloter series documentation consists of various manuals:

• The user manual provides information needed by the user to operate the system
safely. It describes the basic functions of the system, safety features, operating modes,
measurements/calculations, probes, OB tables, and user care and maintenance.
The Piltoer series include Piloter Exp/T/PE/P/S/B/D/F/R/RE/V/U/SE/i/X and Piloter
totally sixteen model systems.
NOTE: Probe information displayed on screen examples does not necessarily reflect the
probes available on your ultrasound system. Please refer to the Probes chapter for a
listing of available probes and features.
• The Acoustic Power Reference Manual contains Acoustic Output tables.
The Piloter series manuals are written for users who are familiar with basic ultrasound
principles and techniques. They do not include sonographic training or detailed clinical
procedures.
NOTE: The system cover color varies.
NOTE: The screen graphics in this manual are only for illustrational purpose.

1-4Introduction
 2 Safety Precautions

2.1 Precaution Levels

Icon Description
Various levels of safety precautions may be found on the equipment and different
levels of concern are identified by one of the following flag words and icons which
precede the precautionary statement.

Symbol Meaning

Indicates that a specific hazard is known to exist which through

inappropriate conditions or actions will cause serious personal injury or
DANGER
death.
Indicates that a specific hazard is known to exist which through
inappropriate conditions or actions may cause series personal injury or
WARNING
death
Indicates that a potential hazard may exist which through inappropriate
conditions or actions may cause minor personal injury, product
CAUTION
damage, or property damage.

Indicates a potentially hazardous situation that, if not avoided, may

NOTE
result in property damage.

Important information that helps you to operate the system more

Tips
effectively.

2.2 Safety Classification

The type of protection against electric shock:
CLASSⅠEquipment
The degree of protection against electric shock:
Type BF Applied Part

Safety Precautions2-1
 The degree of protection against harmful ingress of water:
The System is ordinary Equipment (IPX0), the probes belong to IPX7, and the
Transducer extender belongs to IPX0.
According to the degree of safety of application in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:

EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC

MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
The mode of operation:
Continuous operation
The installation and use:
Portable Equipment
Mobile Equipment (installed on the trolley)

2.3 Important Safety Considerations

The following topic headings (Patient Safety, and Equipment and Personnel Safety) are
intended to make the equipment user aware of particular hazards associated with the use of
this equipment and the extent to which injury can occur if precautions are not observed.
Additional precautions may be provided throughout the manual.
Improper use can result in serious injury. The user must be thoroughly
familiar with the instructions and potential hazards involving ultrasound
CAUTION:
examination before attempting to use the device. Training assistance is
available from Wisonic Medical Systems if needed.
The equipment user is obligated to be familiar with these concerns and
avoid conditions that could result in injury.

2.4 Patient Safety

The concerns listed can seriously affect the safety of patients
WARNING: undergoing a diagnostic ultrasound examination.

Patient identification

Always include proper identification with all patient data and verify the accuracy of the patient's
name and ID numbers when entering such data. Make sure correct patient ID is provided on all
recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis.

The ultrasound system is not meant to be used for long term storage of patient data or images.
The user is responsible for the data on the system and a regular backup is highly
recommended.

If the system is sent for repair, please ensure that any patient information is backed up and

2-2Safety Precautions
erased from the system before shipping. It is always possible during system failure and repair
to lose patient data. Wisonic is not responsible for the loss of this data.

Diagnostic information

Equipment malfunction or incorrect settings can result in measurement errors or failure to

detect details within the image.

The equipment user must become thoroughly familiar with the equipment operation in order to
optimize its performance and recognize possible malfunctions. Applications training are
available through the local Wisonic representative. Added confidence in the equipment
operation can be gained by establishing a quality assurance program.

Mechanical hazards

The use of damaged probes can result in injury or increased risk of infection. Inspect probes
often for sharp, pointed, or rough surface damage that could cause injury or tear protective
barriers. Become familiar with all instructions and precautions provided with special purpose
probes.

A damaged probe can also increase the risk of electric shock if

conductive solutions come in contact with internal live parts. Inspect
probes often for cracks or openings in the housing and holes in and
around the acoustic lens or other damage that could allow liquid entry.
Electrical Become familiar with the probe's use and care precautions outlined in
Probes and Biopsy.
Hazard:

Ultrasound transducers are sensitive instruments which can easily be

damaged by rough handling. Take extra care not to drop transducers
Caution:
and avoid contact with sharp or abrasive surfaces. A damaged housing,
lens or cable can result in patient injury or serious impairment or
operation.

Safety Precautions2-3
 Ultrasound can produce harmful effects in tissue and potentially result in
patient injury. Always minimize exposure time and keep ultrasound
Caution:
levels low when there is no medical benefit. Use the principle of ALARA
(As Low As Reasonably Achievable), increasing output only when
needed to obtain diagnostic image quality. Observe the acoustic output
display and be familiar with all controls affecting the output level. See
the Bioeffects section of the Acoustic Output chapter in the Advanced
Reference Manual for more information.
The basket of trolley is 5 Kg.

2.5 Personnel Safety

The concerns listed below can seriously affect the safety of equipment
DANGER: and personnel during a diagnostic ultrasound examination.

To avoid injury:
• Do not remove protective covers. No user serviceable parts are
inside. Refer servicing to qualified service personnel.
• Never use any adaptor or converter of a three-prong-to-two-prong
Electrical type to connect with a mains power plug. The protective earth
connection will loosen.
• Do not place liquids on or above the console. Spilled liquid may
Hazard: contact live parts and increase the risk of shock.
•The operator shall not touch adaptor DC output and the patient
simultaneously.
•The user must check that the equipment functions safely and see
that it is in proper working condition before being use
•The operator shall not touch DC output of adapter and the patient
simultaneously.

The system must be supplied from an adequately rated

electrical circuit. The capacity of the supply circuit must be
as specified.
Smoke & Fire

Hazard

2-4Safety Precautions
 For patient and personnel safety, be aware of biological hazards while
performing invasive procedures. To avoid the risk of disease
transmission:
• Use protective barriers (gloves and probe sheaths) whenever possible.
Follow sterile procedures when appropriate.
Biological • Thoroughly clean probes and reusable accessories after each patient
examination and disinfect or sterilize as needed. Refer to Probes and
Biopsy for probe use and care instructions.
Hazard • Follow all infection control policies established by your office,
department or institution as they apply to personnel and equipment.

• To avoid risk of electric shock, this equipment must only be

connected to a supply mains with protective earth
WARNING:
• This equipment contains dangerous voltages that are capable of
serious injury or death.
• If any defects are observed or malfunctions occur, stop operating the
equipment and perform the proper action for the patient. Inform a
qualified service person and contact a Service Representative for
information.
• There are no user serviceable components inside the console. Refer
all servicing to qualified service personnel only.
• The system provides calculations (e.g. estimated fetal weight) and
charts based on published scientific literature. The selection of the
appropriate chart and clinical interpretation of calculations and charts
are the sole responsibility of the user. The user must consider
contraindications for the use of a calculation or chart as described in
the scientific literature. The diagnosis, decision for further
examinations and medical treatment must be performed by qualified
personnel following good clinical practice.

•Only approved and recommended peripherals and accessories

should be used.
WARNING:
•All peripherals and accessories must be securely mounted to the
system

Safety Precautions2-5
 • Do not use this equipment if a safety problem is known to exist. Have
the unit repaired and performance verified by qualified service
CAUTION:
personnel before returning to use.
• Contact with natural rubber latex may cause a severe anaphylactic
reaction in persons sensitive to the natural latex protein. Sensitive
users and patients must avoid contact with these items. Refer to
package labeling to determine latex content and FDA’s March 29,
1991 Medical Alert on latex products.
• Archived data is managed at the individual sites. Performing data
backup (to any device) is recommended.
• DO NOT use high-frequency surgical equipment with the system.
• Do not position the equipment so that it is difficult to operate the
disconnection device.

Do not dispose of electrical appliances as unsorted municipal waste,

Note: use separate collection facilities. Contact your local government for
information regarding the collection systems available. If electrical
appliances are disposed of in landfills or dumps, hazardous substances
can leak into the groundwater and get into the food chain, damaging
your health and well-being.

The WEEE label applies to EU member states only and

may be attached to main unit for system products.

2-6Safety Precautions
2.6 General Caution
•Standard maintenance must be performed by authorized service
personnel for the lifetime of the product (5 years).
CAUTION:
•Proceed cautiously when crossing door or elevator thresholds with the
Docking Cart or Isolation Cart. Use the handle to push/ pull the system,
e.g., do not use the Docking Cart external LCD. Failure to do so may
cause serious injury or system damage.
• The device requires no calibration.
•Manufacturer will provide circuit diagrams, component part lists,
descriptions, calibration instructions to assist to SERVICE
PERSONNEL in parts repair.
•Magnetic and electrical fields are capable of interfering with the proper
performance of the system. For this reason make sure that all external
devices operated in the vicinity of the system comply with the relevant
EMC requirements. Wireless communications equipment such as
wireless home network devices, mobile phones, cordless telephones
and their base stations, walkie-talkies or MRI devices are a possible
source of interference as they may emit higher levels of
electromagnetic radiation.

2.7 Symbols
This system uses the symbols listed in the following table, and their meanings are
explained as well.

No. symbol Description

1 Type-BF applied part

2 Caution!

3 General warning sign (Background color: yellow).

4 Danger, high voltage

Safety Precautions2-7
 No. symbol Description

5 Power switch

6 Transducer port

7 Ethernet port

8 USB port

9 HDMI Connects

10 DC(Direct current)

12 Please refer to the instruction manual

13 Non-ionizing radiation

Do not place the system with the mobile trolley on a sloped surface.
Otherwise the system may slide, resulting in personal injury or the
14
system malfunction. Two persons are required to move the system
over a sloped surface.

15 DO NOT push the system when the casters are locked.

16 Do not sit on the system

2-8Safety Precautions
 No. symbol Description

17 Serial Number

18 Manufacture date

19 Manufacture information

20 Authorized representative in the European Community

This product is provided with a CE marking in accordance with the

regulations stated in Council Directive 93 / 42 / EEC concerning
21 Medical Devices. The number adjacent to the CE marking (0123) is the
number of the EU-notified body certified for meeting the requirements
of the Directive.

Safety Precautions2-9
 3 System Overview

3.1 Product and Model Code

Piloter □

Model code.

Product code.

NOTE: The functions described in the basic user manual may vary depending upon the
specific system you purchased.

3.2 Intended Use

The ultrasonic diagnostic system is applicable for adults, pregnant women, pediatric
patients and neonates. It is intended for use in the abdomen (liver, spleen, gallbladder,
pancreas, kidney), obstetrics and Gynecology, small organs (thyroid and parathyroid
gland, testis, prostate, breast, salivary gland, superficial lymph), and peripheral blood
vessels, heart and vaginal.

3.3 Contraindication
The ultrasonic diagnostic system is not intended for ophthalmic use or any possible ways
that cause the acoustic beam to pass through the eye.

3.4 Product Specifications

3.4.1 External Dimensions and Weight

Main unit external dimensions: 234 mm (H) ×340 mm (L) ×36 mm (W)

System Overview3-1
System weight: 1.9 Kg (including cart)

3.4.2 Imaging Modes

B Mode B

M Mode M

C Mode Color

Power（Dirpower）

D Mode PW Doppler

CW Doppler

Advanced Support for Wisonic's unique Holo (flat wave PW) imaging
Imaging

3.4.3 Power supply

Power MANGO60-19AB-WIS
Adapter

Voltage 100-240V～ (AC adapter)

Frequency 50/60Hz (AC adapter)

Input Power 1.5-0.7A (AC adapter)

Battery LI14I03A

Battery Spec Lithion, 14.4V,2900mAh

Power cord H05VV-F 3G 1.0mm^2/SJT VW-1 300V 1.31mm^2/SJT VW-1 300V

0.824mm^2

3-2System Overview
NOTE: 1. The CE region applied voltage is 220-240V～.

2. Power supply set meet the requirements with local regulations and
has a reliable ground connection.

3. The power cord diameter is at least 0.75 square millimeters.

3.4.4 Environmental Conditions

Operating conditions Storage and transportation conditions

Ambient 0℃～40℃ -20℃～55℃

temperature

Relative 30%～85% (no condensation) 30%～95% (no condensation)

humidity

Atmospheric 700hPa～1060hPa 700hPa～1060hPa

pressure

WARNING: Do not use this system in the conditions other than those
specified.

3.5 System Configuration

3.5.1 Standard Configuration

Main unit
Accessories
 User manuals
 Power adapter and connecting cable

System Overview3-3
3.5.2 Options

3.5.2.1 Probes and Needle-guided Brackets Available

Probe Region
Type Intended Use
model Applied

Abdomen, Gynecologic, Obstetric, Nerve Body

C5-2 Convex
block surface

Abdomen, Gynecologic, Obstetric, Nerve Body

C5-2B Convex
block surface

Abdomen, Gynecologic, Obstetric, Nerve Body

C8-3 Convex
block surface

Small parts, Vascular, Nerve block, Body

L15-4NB Linear
Muscular-Skeletal surface

Small parts, Vascular, Nerve block, Body

L10-5 Linear
Muscular-Skeletal surface

Superficial, Vascular, Nerve block, Body

LH15-6 Linear
Muscular-Skeletal, Small parts surface

Cardiology, Transcranial, Nerve block, Body

P4-1 Phased
abdominal surface

Cardiology, Transcranial, Nerve block, Body

P7-3 Phased
Abdominal surface

EV10-4 Transvaginal Gynecology, Obstetrics, Urology Transvaginal

3-4System Overview
3.5.2.2
3.5.2.3 Options

No. Item

1 CW module (requires to be configured in factory)

2 PW module

3 Trolley

4 Desktop stand

5 Probe extender

6 DICOM Basic

7 DICOM Worklist

8 DICOM MPPS

9 DICOM QR

10 4G Driver module (requires to be configured in factory)

11 wiNeedle

12 wiLearn

13 General application package

14 Anesthesia application package

15 Pain management package

Note: Options listed here may vary country to country, please contact your local distributor
for more detailed info.

System Overview3-5
 Piloter Series complies with IEC60601-1-2:2007, and its RF
WARNING: emission meets the requirements of CISPR11 Class B. in a
domestic environment, the customer or the user should
guarantee to connect the system with Class B peripheral
devices; otherwise RF interference may result and the
customer or the user must take adequate measures
accordingly.

3.6 Introduction of Each Unit

3-6System Overview
 NO. Name Function

1 Touch screen monitor Image display, operator-system interface or control.

2 Storage basket Used to store any small accessories.

3 Holder of Gel Used to store gel.

4 Adapter Used to supply power to the host

5 Cup sleeve of probe Used to store temporary probe

6 Wheel Support and move the system.

7 USB USB port

8 For extended high definition display

9 Ethernet port Connect internet

Power input

10 Main system power input.

System Overview3-7
 NO. Name Function

Connects a probe to the main unit; or connects a

11 Probe port probe extend module.

12 Power on/off the system.

Power

13 AC power input System AC input

14 Desktop stand Support the main unit

3.7 Extension Module

3.7.1 Probe Extender

Be careful：
 For the probe expansion module of the plug, please try to operate in
the system after the freeze, so as to reduce the loss of the probe
extension module life.
 The probe expansion module is connected with the probe, because
the probe cable becomes longer, and the image quality can be
reduced.
 Introduction of components：

The probe is connected with the probe extender ports: it can connect 3 probes.

3-8System Overview
 4 Preparing the System

4.1 Site Requirement

This medical equipment is approved, in terms of the prevention of radio wave interference,
to be used in hospitals, clinics and other institutions which are environmentally qualified.
The use of this equipment in an inappropriate environment may cause some electronic
interference to radios and televisions around the equipment.

Take precautions to ensure that the console is protected from electromagnetic

interference.

Precautions include:

• Operate the console at least 15 feet away from motors, typewriters, elevators, and
other sources of strong electromagnetic radiation.

• Operation in an enclosed area (wood, plaster or concrete walls, floors and ceilings)
helps prevent electromagnetic interference.

• Special shielding may be required if the console is to be operated in the vicinity of

radio broadcast equipment.

Perform regular preventive maintenance.

Notice:
Maintain a clean environment. Turn off, and if possible, disconnect the
system before cleaning the unit.
Never set liquids on the unit to ensure that liquid does not drip into the
control panel or unit.

4.2 Move/Posit System

When moving or transporting the system, follow the precautions below to ensure the
maximum safety for personnel, the system, and other equipment.

Before moving the system

1. Shut down the system.
2. Unplug the power cord (if the system is plugged in).
3. Disconnect all cables from off-board peripheral devices (external printer, etc.) from the
console. To prevent damage to the Power Cord, DO NOT pull excessively on the cord
or make sharp bends while wrapping.
4. Store all probes in their original cases or in soft cloth or foam to prevent damage.

Preparing the System4-9

5. Store sufficient gel and other essential accessories in the special storage case..
The system weighs approximately 1.9kg. To avoid possible injury
CAUTION: and equipment damage:
• Do not let the system strike walls or door frame.
• Limit movement to a slow careful walk.

Transporting the System

Use extra care when transporting the system using vehicles. In addition to the instructions
used when moving the system, also perform the following:
1. Before transporting, place the system in its special storage case.
2. Ensure that the system is firmly secured while inside the vehicle.
3. Secure system with straps or as directed otherwise to prevent motion during transport.

4.3 Power Supply

This system can work normally only when it is connected to the external power supply or
the battery capacity is sufficient.

4.3.1 Connecting the External Power Supply

1. Connect the connector of the power adapter to the adapter port in the system.
2. Use a three-wire cable to connect the adapter with the external power supply.
3. The external power supply system must meet the following requirements:
 Power supply voltage: 100-240V～
 Power supply frequency: 50/60Hz
 Input current: 1.5- 0.7 A
 The model of the power adapter: MANGO60-19AB-WIS

If you have any question about the power adapter, please contact your sales
representative.

NOTE: 1. You must use the specified power adapter.

2. Do not use this power adapter in the conditions other than those specified.

3 The plug (or appliance separable) is used as disconnect to the mains

supply, do not to position the ME EQUIPMENT so that it is difficult to
operate the disconnection device.

4-10Preparing the System

4.3.2 Powered by Batteries
The lithium ion battery provides power when an AC power source is not available. A
battery in the battery bay is standard with the system. Lithium ion batteries last longer
than conventional batteries and do not require replacement as often.

The battery is designed to work with Piloter series systems only.

NOTE:
Only use the batteries authorized by Wisonic.

4.4 Powering the System

4.4.1 Power ON
Connecting and Using the System
To connect the system to the electrical supply:
1. Ensure that the wall outlet is of the appropriate type.
2. Plug the AC adapter connector on the system.
3. Push the power plug securely into the wall outlet.

Use caution to ensure that the power cable does not disconnect during
system use.
CAUTION:
If the system is accidentally unplugged, data may be lost.

DO NOT use the system on plastic foam, paper or similar type surfaces.
The system could overheat and slow down.
WARNING:
Ensure that the system is on a sturdy, heat resistant surface.

To avoid risk of fire, the system power must be supplied from a separate,
properly rated outlet.
Under no circumstances should the AC power plug be altered, changed,
or adapted to a configuration rated less than specified. Never use an
extension cord or adapter plug.
To help assure grounding reliability, connect to a “hospital grade” or
“hospital only” grounded power outlet.

Turning on Power
1. Press the power button in the upper right side on the touch panel.
2. The system enters the work status.
3. The indicator lights on and becomes green.

Preparing the System4-11

4.4.2 Power OFF

You need to follow the correct procedures to power off the system. In addition, after you
upgrade the software or when the system is down, you need to power off and restart it.
If you will not use the system for a long period of time, you shall:
1. Disconnect the power adapter.
2. Disconnect the mains power.
3. Turn off powers of all peripherals connected to the system.
To power off your system normally:
1. When you shut down the system, enter the scan screen and lightly press the Power
On/Off switch at right bottom side of the system for more than 1 sec. The System-Exit
window is displayed.
2. Touch Power Off. The shutdown process takes a few seconds and is completed when the
LED turns from green to off.

NOTE: 1. DO NOT rush shutdown of the system in a direct way. It may destroy the
data.

2. If the system has not fully shut down in 60 seconds, press and hold down
the On/Off switch until the system shuts down.

4.4.3 Standby

Standby definition: in a normal temperature and humidity environment, the system is

connected to the probe and without additional equipment or modules.After a period of time,
the system will freeze, screen dimmed.

To enter standby mode:

1. Lightly press the Power On/Off switch for more than 1 sec. The System-Exit window is
displayed.
2. Touch Standby. The shutdown process takes a few seconds and is completed when the
LED will turn orange.

To quit standby：

Please press the power switch.

When the system is in standby mode and you need to power off, please:

4-12Preparing the System

 Press the power switch to quit standby first. Press the Power On/Off switch for more than
1 sec and then touch Power Off.

NOTE: 1. If you do not use the system for a long time (including storage and
transportation), please turn off the system, otherwise it will cause battery
exhaustion and permanent damage.

2. If you do not use the system for a long time, please do not enter the standby.
You should turn off the system, unplug the power and shut down all
connected devices.

4.5 Battery
The lithium ion battery provides power when an AC power source is not available. A
battery in the battery bay is standard with the system.

The lithium ion technology used in your system’s battery is significantly less hazardous to
the environment than the lithium metal technology used in some other batteries (such as
watch batteries). Used batteries should not be placed with common household waste
products. Contact local authorities for the location of a chemical waste collection program
nearest you.

The battery is designed to work with systems only.

NOTE:
Only use the batteries authorized by Wisonic.

Preparing the System4-13

 •The battery has a safety device. Do not disassemble or alter the
WARNING: battery.
•Charge the batteries only when the ambient temperature is between 0
and 40 degrees C (32 and 104 degrees F) and discharge the batteries
between 0 and 40 degrees C (32 and 104 degrees F).
•Do not short-circuit the battery by directly connecting the negative
terminals with metal objects.
•Do not heat the battery or discard it in a fire.
•Do not expose the battery to temperature over 50 degrees C (122
degrees F). Keep it away from fire and other heat sources.
•Do not charge the battery near a heat source, such as a fire or heater.
•Do not leave the battery in direct sunlight.
•Do not pierce the battery with a sharp object, hit it, or step on it.
•Do not use a damaged battery.
•Do not solder a battery.
•Do not connect the battery to an electrical power outlet.
•If the system is not being used on a monthly basis, the battery needs to
be removed during the lengthy non-use period.

4.5.1 Battery Status

The battery status indicator is located on the main screen, indicating the battery capacity.

When the power capacity is not enough, the icon will flash in order to let the user charge
the system or shut down the system.

4.5.2 Checking Battery Performance

The battery performance may be degraded over time, so you need to check the battery
performance periodically. The checking procedures are shown as follows:

1. Stop the ultrasound exam.

2. Connect the system to the AC power supply to charge the battery until current
capacity is full.
3. Disconnect the system from the AC power supply to power the system by the battery
until the system automatically shuts down.
4. The powering time of the battery indicates the battery performance.

If the powering time of the battery is much shorter than that specified, you may replace the
battery or contact the service personnel.

NOTE: The usage life of the battery is 300 charge / discharge cycles. If the battery is
improperly used, its life may be shortened.

4-14Preparing the System

4.5.3 Battery Disposal

You need to dispose of the battery when it damages or severely degraded.

NOTE: Recycle or dispose of the lithium battery in accordance with all federal, state and
local laws. To avoid fire and explosion hazard, do not burn or incinerate the
battery.

4.5.4 Recycling Battery

When the battery no longer holds a charge, it should be replaced. The batteries are
recyclable. Remove the old battery from the system and follow your local recycling
guidelines.

4.6 Connecting /Disconnecting a Probe

4.6.1 Connecting a Probe

1. Place the probe's carrying case on a stable surface and open the case.
2. Carefully remove the probe and unwrap the probe cord.
Note:
DO NOT allow the probe head to hang free. Impact to the probe head could
result in irreparable damage.
Use the integrated cable management hook to wrap the cord.
Inspect the probe before and after each use for damage or degradation to the
housing, strain relief, lens, seal and connector.
DO NOT use a transducer which appears damaged until functional and safe
performance is verified.
Inspection should be conducted during the cleaning process.
3. Align the connector with the probe port and carefully push into place with the cable
facing downward of the system.
4. Carefully position the probe cord so it is free to move and is not resting on the floor.
5. When the probe is connected, it is automatically be known by the system.

Preparing the System4-15

 The probes, cables and connectors are in proper operating order and
WARNING: free from surface defects, cracks and peeling. Using a defective
probe may cause electric shock.

Fault conditions can result in electric shock hazard. Do not touch the
surface of probe connectors which are exposed when the probe is
CAUTION:
removed. Do not touch the patient when connecting or disconnecting a
probe.

4.6.2 Disconnecting a Probe

Probes can be disconnected at any time. However, make sure image is frozen when
disconnecting the probe.
1. Slide the connector button.
2. Pull the probe and connector straight out of the probe port.
3. Carefully slide the probe and connector away from the probe port.
4. Ensure the cable is free.
5. Be sure that the probe head is clean before placing the probe in its storage box or a
wall hanging unit.

4-16Preparing the System

4.7 Graph /Text printer
Connecting a local printer
As shown in the figure below, a graph /text printer has a power cord and data cable. The
power cord shall be directly connected to a protective grounding wall receptacle as
required.

1. Connect the two USB ports of the printer and the system with the USB cable of the
printer.
2. Power on the system and the printer.
3. Install the printer driver: “Setup→ Peripheral" and touch “Add Printer”, as shown in
the figure:

Preparing the System4-17

1. Select "Add Local Printer" and touch “Next” to enter the screen of browsing driver;
select the desired driver and touch “OK” to install the driver.
 Printers listed have drivers installed already.
 Touch “Property” to see the printer attribute.
2. Touch “OK” to finish the installation.
 Add Network Printer
After the system is connected into a LAN, enter the "“Setup”→“Peripheral” screen.

1. Touch[Add Printer] and select the types of adding network printer

 Search Network Printer
Select "Search Network Printer" and touch “Next” to search for the printer; select
the domain and server in the screen to find the printer.

2. When the network printer is successfully connected, you can see the printer in the list.

Tips: the network printer functions depending on the configured network environment in
the hospital, please consult the network configuration manager in case of failure.

NOTE: When you install the printer’s driver, you must specify the specific path for
installation; otherwise, vague path may result in longer time for searching.

4.8 Video Printer

The system support digital video printers, including B/W printers and color printers.

4-18Preparing the System

 1. USB Cable 2. Power cable

 Connecting a local printer (Sony UP-D897as an example)

1. Place the printer in the proper position.

2. Connect the power cord of the printer to a receptacle. Use a USB cable to connect the
USB port of the system with the USB port of the printer.

3. Load a paper roll, and turn on the system and printer.

4. Install the printer driver (steps are the same as of graph/text printers; please refer to
relevant chapters for details).

Please refer to the accompanying manuals of the printers for more details.

Preparing the System4-19

4.9 Monitor Display

4.9.1 Basic Screen

The following diagram maps out the different areas in the screen:

Information Area
The information area displays manufacturer logo, hospital name, exam date &
time, acoustic power & MI/TI, patient information, probe, current exam mode, and
Operator, etc.

To preset whether gender, age or operator is displayed: Enter

"Setup→System→General" and check "Name", "Patient ID" or "Operator" in the
“Patient Info” box in the upper left corner of the screen.
 Logo
Manufacture logo, displayed in the upper left of the screen.
 Hospital name
Display the hospital name. Hospital name can be set via
"Setup→System→Hospital name".
 Exam time
Displays the exam time, including date and time.
 Acoustic power & MI/TI

4-20Preparing the System

 Display the acoustic power, including the acoustic power, MI (Mechanical Index)
and TI (Thermal Index).
 Patient Information
Displays patient name, ID, etc.Enter the patient information through the "Patient
Info" screen.
 Probe
Display the currently-used probe model, or the default model.
 Exam Mode
Displays the currently used exam type, e.g. Abdomen, is displayed.
 Operator
Displays the operator’s name on the screen. This information is entered through
the “Patient Info” screen.
Imaging Area
The image area displays the ultrasound images, probe mark (or activating window
mark), time line (in M or PW mode), coordinate axis (including depth, time,
velocity/frequency), focal position (located at depth axis in the form of ), besides,
the annotation, body mark, measurement calipers, color bar/grayscale bar are also
displayed here.
Workflow and Imaging Menu Area
 Workflow
Includes Patient, Exam, Scan, Review.

To active a specific workflow point, you need only to touch the icon of desired
function.

 Patient

Where you either input the basic patient information, or record detailed info via
extend the dialog with touch of “Advanced”. After confirmation of patient, system
directly go to the menu of “Scan”.

 Exam

Where you select which probe to perform, and then choose a specific exam
according to your requirement.

 Scan

At unfrozen mode, “Scan” shows the imaging parameter menu for user to adjust.
At frozen mode, “Scan” goes to menu of post application such as “Measure”,
“Comment”, “Bodymark”.

 Review

Preparing the System4-21

 Where you review the history of patient who was examined or under scaning.
And you can also backup or export patient images.

4-22Preparing the System

 5 Preparing for an Exam

5.1 Begin an Exam

Begin an exam by entering new patient information.
The operator should enter as much information as possible, such as:
1. Patient ID
2. Patient name
3. Exam category
4. Exam Information
The patient's name and ID number is retained with each patient's image and transferred with
each image during archiving or hard copy printing.

To avoid patient identification errors, always verify the identification

with the patient. Make sure the correct patient identification appears
CAUTION:
on all screens and hard copy prints.

5.2 Begin a New Patient

Touch the “Patient” on screen.
New Patient should be selected at the beginning of each new patient exam.
End Exam should be used at the end of each exam.
Touch “End Exam”, system automatically stores all patient data, annotations,
measurements, calculations and worksheets of the last exam.
Create a patient
 After enter the patient id and other information, touch “Confirm” on the "Patient
" screen to create a new patient.
Quickly create a patient
 Directly touch “AUTO” on the "Patient” screen, you can quickly generate a new
patient data.

5.2.1 New Patient information

 Touch on each patient information fields will pop up soft keyboard, you can enter
information or select options at this time; After enter the patient information, close
the soft keyboard to finish the input; For the drop-down list, select on options.

Preparing for an Exam5-1

 Detailed information is described as follows:

1. General information
 Patient ID

Once you Input the ID and confirm it, you are only permitted to change it within 24
hours. There are 2 ways to generate the patient ID.

 Temporary ID

Touch “AUTO” on the "Patient Info" screen, will jump to “Scan” interface. Then,
the patient ID can't be edited

 Enter the ID

If you don’t apply auto ID, you need to enter an ID. If you touch OK to confirm
patient ID, it could not be edit again

Attention:

If an ID that is already existed in the system is entered, the system prompts

"Patient exits. Are you sure to load?” you can import the data.
 Name
Input the patient name directly through the pop-up keyboard. Characters of A to Z
and 0 to 9 and “.” are available“\”, “^”, “＝” and “,” are not permitted.
 Gender
Select Male or Female
 DOB (Date of birth):
Not allow to input the birth date of a patient manually. Touch "DOB" to select the
birthday of patient. You can select the desired year, month and day, then touch
“OK” to finish it. The default date is today.
 Age:
 Auto generated age: once the DOB is done, the system can display an
auto-generated age in the field box, the unit can be “Years”, or “Days”. If the
age is less than one year, the system will automatically show the age in days.

 Also, you can manually input the age.

Attention
When you manually input the age, it won't convert to DOB. DOB is still empty at
this time.
 MRN
Submitted to the insurance with a social security number. The combination of
Numbers and letters, or pure Numbers.
 Object:
You can manually input the Object.
 Operator

5-2Preparing for an Exam

 People who is responsible for images acquisition and scanning."\","^","=" and
","are not allowed.
 Study description:
Allow users to input check explanation and annotation manually.

2. Application Type
 Application type
You can select among 10 types: ABD (Abdomen), OB (Obstetrics), GYN
(Gynecology), CARD (Cardiac), VAS (Vascular), URO (Urology), SMP (Small Part),
and PED (Pediatrics), ICU, NERVE.

Select the type tab to input the exam-specific information.

 Exam specified information:

Application
Contents Meaning/Purpose
Type

Unit can be modified in < preset >- < measurement tools >
Height
"unit && formula", choose metric or inch;
Unit can be modified in < preset >- < measurement tools >
ABD Weight
"unit && formula", choose metric or inch;
(Abdomen) BSA (body After the height and weight are inputted, the system will
surface automatically calculate the BSA based on the formula which
area) is set via "Setup→Meas tools ".
LMP (last menstrual period), IVF (in vitro fertilization), BBT
(basic body temperature), DOC (Date of Conception), EDD
(estimated delivery date), the system can automatically
calculate GA and EDD (estimated delivery date); or,
calculates GA and LMP according to the EDD and entered
date.
 LMP: After you enter LMP, the system will calculate
Origin and display GA and EDD.
 IVF: After you enter IVF, the system will calculate
GA and EDD.
OB  BBT: input BBT, the system will calculate the GA
(Obstetric) and EDD.
 DOC: input DOC, the system will calculate the GA
and EDD.
 EDD: input EDD, the system will calculate the GA
and EDD.
Gravida Num of pregnancy.
Ectopic Num of abnormal pregnancy. e.g. extra uterine pregnancy
Gestations Number of embryos (1, 2, 3; 1 is default)
Para Num of delivery
Aborta Num of abortion
LMP Last menstrual period
GYN

Preparing for an Exam5-3

 Application
Contents Meaning/Purpose
Type

(Gynecology) Gravida Num of pregnancy.

Para Num of delivery
Ectopic Num of abnormal pregnancy. e.g. extra uterine pregnancy
Aborta Num of abortion
Unit can be modified in < preset >- < measurement tools >
Height
"unit && formula", choose metric or inch;
Unit can be modified in < preset >- < measurement tools >
Weight
"unit && formula", choose metric or inch;
BSA (body After the height and weight are inputted, the system will
Cardiology surface automatically calculate the BSA based on the formula which
area) is set via "Setup→System Preset→General".
BP Blood pressure.
HR Heart rate
RAP Right Atrium Pressure
BP(L) Input left arm blood pressure.
VAS
(Vascular) BP(R) Input right arm blood pressure.

Serum
/
URO PSA
(Urology) PPSA
/
coefficient

SMP (Small None /

Parts)

PED None /
(Pediatrics)

Same as
ICU /
cardiology

Nerve None /

3. Operating Information
 Accession #: exam number used in DICOM. It should be entered within 16 letters
or characters; “\”is not permitted.
 Perf. Physician: people who is responsible for the exam. "\", "^","＝"and "," are
not allowed.
 Ref. Physician: the people who requires the ultrasound exam. "\", "^", "＝" and ","
are not allowed.
 Comment: exam-specific explanation or remarks.

5-4Preparing for an Exam

4. Functional key
 “Confirm /Update”: touch “Confirm” to save the patient data entered and jump
to "Scan". “Confirm” change to “Update”, when users return to the patient dialog
to edit the information. Touch “Update” to save the modified patient data, it will not
jump to "Scan" at this time.
 “New Patient”: touch to clear the current patient information in the patient
information screen in order to input information of a new patient.
 “Auto” ID: according current status, when there is no patient on board, the
button can be use, if not, it would not be in use .Touch this button to automatically
create a new patient and jump to "Scan".
 Clear All: touch this button will remove all patient information except ID.
 Worklist：After touching “Worklist”, “Worklist” change to “Patient”. Patient
information change into the Worklist list, you can input some patients information
to search the patient on the server.

5.2.2 Retrieve Patient information

The patient data can be obtained in Review from the system SSD or USB memory device.

1. Directly browse

Touch "Review" to enter the Review interface, you can browse directly for patient
information and movie.

2. Set the searching condition

 Directly input key word to search exam you want.
 Touch “Clear”, the system will clear the information you entered, and all the
recorded patient information of the system will be listed out.
3. Select the desired patient information from the list.
 New Exam: click to enter “Patient” screen, meanwhile, the corresponding
patient information is also imported to the new exam. After you edit the patient
information in the Patient Info screen, select OK to start a new exam.
 Patient Info: click to enter “Patient Info” screen, browse the information of
patient.
 Pause Exam: click to stop the activated exam.
 Continue Exam: click to continue an unfinished exam that is carried out within 24
hours.
 Activate Exam: click to continue an exam that is finished within 24 hours.
 Modify: click to enter “Patient Info” screen and continue an exam within 24
hours.
 QR Code: click to show the QR code of patient.

Preparing for an Exam5-5

5.3 Select an Exam and Probe
If the exam mode is changed during a measurement, all
measurement calipers on the image will be cleared. The
CAUTION: data of general measurements will be lost, but the data of
application measurements will be stored in the reports.

5.3.1 Selecting an Exam

1. Press the “Exam” icon.
2. The exam category preset that best describes the desired exam to be performed is
chosen after the exam category is selected. The factory default preset selections are
displayed in Setup->Application Screen.

5.3.2 User-Defined Exam

To set up User-Defined Application Presets,
1. Touch the “Exam” key. The Probe screen appears.
2. Click “Save as” button. A pop-up menu appears:

5-6Preparing for an Exam

3. Type the name of the new application. The new application now appears on the probe
preset screen.

5.3.3 Selecting a Probe

1. Touch the “Exam” key.
2. Select a probe from images listed.

Preparing for an Exam5-7

5.3.4 Ending a Patient Exam
When you have completed the study, touch “End Exam” key, the system automatically
archives the information, clears all patient data and jump to "Patient" interface.

5-8Preparing for an Exam

 6 Optimizing Image

1. Images are displayed on system only for reference.

WARNING: Wisonic is not responsible for the diagnostic results.
Who performs the exam, is responsible for the
diagnostic results.

2. In Dual-B imaging mode, the measurement results of

the merged image may be inaccurate. Therefore, the
results are provided for reference only, not for
confirming a diagnosis.

6.1 Imaging Modes Controls

Key Description

B Button B Mode key: press to enter B Mode.

M Button M Mode key: press to enter M Mode.

PW Button PW Mode key: press to enter PW Mode.

CW Button CW Mode key: press to enter CW Mode.

COLOR
Color Mode key: press to enter Color Mode.
Button

Update
Press to change the currently active window.
Button

Optimizing Image6-1
6.2 Image Adjustment
Before optimizing the image by adjusting image parameters, adjust the brightness and
contrast of the monitor to the best.

Intension Action

Adjust gain

Adjust TGC
To modify the brightness
Adjust AP (do try to adjust gain first before increasing
the acoustic power)

Adjust DR

Adjust Gray Map

To modify gray scale image
effect
Adjust Persistence

Adjust SSI

6-2Optimizing Image
 Intension Action

Decrease depth

Decrease the Focus Num in B mode

To increase frame rate of gray
scale imaging
Decrease the FOV in B mode

Decrease Line Density

Decrease ROI in Color/Power mode

To increase frame rate of color
imaging
Decrease Line Density

Adjust Opt

Adjust Scale
To modify flow images effect
Adjust Sensitivity
(Resolution and sensitivity)
Adjust Line Density

Adjust Smooth

6.3 Optimizing B Mode Image

B-Mode is intended to provide two-dimensional images and measurement capabilities
concerning the anatomical structure of soft tissue.

6.3.1 Typical B Mode Exam Protocol

A typical examination using B-Mode might proceed
1. Record exam-related patient information. Verify system setup (probes and presets).
2. Position the patient and the console for optimum operator and patient comfort. Perform the
scan.
3. Complete the study by collecting all the data.

Optimizing Image6-3
6.3.2 B Mode Parameters
 In B Mode scanning, the image parameter area in the upper left corner of the screen
will display the real-time parameter values as follows:

Display FH 10 40mm FR 25 Z1.00

Parameter Frequency Depth Frame Rate Zoom Rate

 Parameters that can be adjusted to optimize the B Mode image are indicated in the
following.

Adjustment Items

Adjust on the main

Gain, Depth, TGC, Focus Positon, Auto
Screen

wiNeedle, Needle E. Dual, SCI , ExFOV ,Mid Line, Focus Number,

Opt, Dynamic Range, SSI , Chroma, Gray Map, LGC, L/R Invert,
Menu
U/D Invert, Line Density, Persistence, AP, B Steer, Smooth,
Thermal Idx, FOV

6.3.3 Controls
Gain
B-Mode Gain increases or decreases the amount of echo information
Description displayed in an image. It may have the effect of brightening or darkening the
image if sufficient echo information is generated.

Adjusting Slide the slider below the image, Sliding to the right to increase the gain,
and sliding to the right to decrease.

The adjusting range is 0-100.

Gain allows you to balance echo contrast so that cystic structures appear
Benefits echo-free and reflecting tissue fills in.

6-4Optimizing Image
Depth
Depth controls the distance over which the B-Mode images anatomy. To
Description visualize deeper structures, increase the depth. If there is a large part of the
display which is unused at the bottom, decrease the depth.

Adjusting To change depth, use your finger click button on the right of image screen,
touch up one to decrease the depth; touch down one to increase the depth.

The adjustable depth values vary depending upon the probe types.

Depth adjusts your field of view. It increases your field of view to look at larger
Benefits or deeper structures; it decreases your field of view to look at structures near
the skin line.

Impacts Depth increase will cause a decrease in the frame rate.

TGC
TGC amplifies returning signals to correct for the attenuation caused by tissues
Description at increasing depths. TGC slide pots are spaced proportionately to the depth.
The area each pot amplifies varies as well. A TGC curve may appear on the
display, matching the controls that you have set (except during zoom).

Adjusting To increase the gain compensation at an area of interest, slide the TGC
slider to the right.

To decrease the gain compensation at an area of interest, slide the TGC

slider to the left.

About 2s after the adjustment is finished, the TGC curve disappears.

TGC balances the image so that the density of echoes is the same throughout
Benefits the image

Opt. (Frequency)
Frequency mode lets you downshift to the probe's next lower frequency or shift
Description up to a higher frequency.

Adjusting You can select a harmonic frequency or a B mode frequency.

Adjust the frequency value through the “Opt” item in the Menu, “THI”
indicates harmonic frequency.

Values of frequency vary depending upon the probe types.

Select the frequency according to the detection depth and current tissue
characteristics.

Optimizing Image6-5
 This optimizes the probe's wide band imaging capabilities at multiple
Benefits frequencies to image at greater depths.

Acoustic Power

Description Refers to the power of ultrasonic wave transmitted by the probe, the
real-time value of which is displayed in the patient header area in the upper
of the screen.

Adjusting Adjust through the AP item in the Menu

The adjusting range is 10%-100% in increments of 3%.

Benefits Generally, increasing the acoustic power will increase the brightness and
contrast of the image as well as the force of penetration.

Impacts You should perform exams according to actual situation and follow the
ALARA Principle.

Focus
Increases the number of focal zones or moves the focal zone(s) so that you
Description can tighten up the beam for a specific area. A graphic caret corresponding to
the focal zone position(s) appears on the right edge of the image.

Adjusting Adjust the focus number through the Focus Num in the Menu.

Adjust the focus position through the Focus Pos on The main Screen

Focal zones adjust automatically when you adjust the depth.

Focus optimizes the image by increasing the resolution for a specific area.
Benefits Increasing the number of focal zones improves image quality.
Changing the focal number affects the frame rate. The greater number of focal
Impacts zones, the slower the frame rate.

Imaging Display Adjustment

Description More information can be obtained without moving the probe or changing
the sampling position.

You can widen or narrow the size of the sector angle to maximize the image's
FOV (Field region of interest (ROI).
of View)
The system provides four levels of scan range: 50%, 70%, 90%, and
100%.

6-6Optimizing Image
 You can get a much larger field of view when selecting a larger FOV, but
the frame rate will decrease.

B Steer You can slant the B-Mode linear image to the left or the right without moving
the probe. This steering function only applies to linear probe

On Linear and convex probes, ExFOV provides a larger field of view in the far
ExFOV field.

Impacts The FOV position is available only for the convex and phased probes.

The ExFOV function is available only for linear probes and convex.

Line Density
Optimizes B-Mode frame rate or spatial resolution for the best possible image.
Description

Adjusting Adjust through the Line Density item in the Menu.

There are three levels of line density available: L, M, H, UH.

Benefits The higher the line density, the higher the resolution, and the lower the
frame rate.

Dynamic Range
Dynamic Range controls how echo intensities are converted to shades of gray,
Description thereby increasing the adjustable range of contrast.

Adjusting Adjust through the DR item in the Menu

The adjusting range is 30-180 dB in increments of 4 dB.

Dynamic Range is useful for optimizing tissue texture for different anatomy.
Benefits Dynamic Range should be adjusted so that the highest amplitude edges
appear as white while lowest levels (such as blood) are just visible

Optimizing Image6-7
SSI
SSI is an adaptive algorithm to reduce the unwanted effects of speckle (noise)
Description in the ultrasound image. Image speckle usually appears as a grainy texture in
otherwise uniform areas of tissue. Its appearance is related to image system
characteristics, rather than tissue characteristics, so that changes in system
settings, such as probe type, frequency, depth, and others, can change the
appearance of the speckle. Too much speckle can impair image quality and
make it difficult to see the desired detail in the image. Likewise, too much
filtering of speckle can mask or obscure desired image detail. Extra care must
be taken to select the optimal SSI level.

Adjusting Adjust through the SSI item in the Menu.

The system provides 5 levels of SSI effects adjustment, off represents no

SSI is turned on, and the bigger the value the stronger the effect.

Benefits The bigger the value the more clearly the profile of the image.

Persistence
Temporal filter that averages frames together, thereby using more pixels to
Description make up one image. This has the effect of presenting a smoother, softer
image.

Adjusting Adjust through the Persistence item in the Menu.

Benefits Smooths the image.

Impacts Persistence increase may lead to signal missing.

Invert

Description This function provides a better observation for image display.

Invert(U/D To invert the image horizontally or vertically.

Invert and
L/R Invert) Click L/R Invert or U/D Invert in the Menu to invert the image.

When you invert or rotate an image, the “ ” mark will change its position
correspondingly on the screen; the M mark is located in the upper left corner of the
imaging area by default.

6-8Optimizing Image
Impacts The function is available in real-time imaging, freeze or cine review status.

SCI
SCI is available on all linear and convex probes. Multiple focal zones are
Description supported. Steering is optimized by probe. The displayed compound image
depth is equal to the image depth of the non-steered frame.

Adjusting Adjust through the SCI item in the Menu

The combined single image has the benefits of reduced speckle (noise),
Benefits reduced clutter and continuity of specular reflectors and borders. Therefore,
this technique can improve contrast resolution with increased visualization of
low contrast lesions, better detection of calcifications, biopsy needle
visualization, and cystic boundary definition.

Impacts When linear probe is being used, SCI function is not available when
ExFOV function is turned on or B steer is adopted.

Gray Map

Description This function applies the gray correction to obtain the optimum images.

Adjusting Select among the maps through the Gray Map item in the Menu.

Impacts The function is available in real-time imaging, freeze or cine review status.

Chroma
Chroma is the colorization of a conventional B-Mode image or Doppler
Description Spectrum to enhance the user's ability to discern B, M, and Doppler Mode
intensity valuations. Colorize is NOT a Doppler Mode.

Adjusting Turn on or off the function through the Chroma item in the Menu.

Select the Chroma through the Chroma item in the Menu.

The system provides 10 Chroma maps to be selected among.

Impacts The function is available in real-time imaging, freeze or cine review status.

Auto

Description To optimize image parameters as per the current tissue characteristics for
a better image effect.

Optimizing Image6-9
Adjusting Press “Auto” button below the main image screen to turn on the function,
the symbol of which will be displayed in the image parameter area of the
screen.

6.4 Optimizing M Mode Image

6.4.1 Typical M Mode Exam Protocol

A typical examination using M-Mode might proceed as follows:
1. Get a good B-Mode image. Survey the anatomy and place the area of interest near the
center of the B-Mode image.
2. Press M Button.
3. Trackball to position the mode cursor over the area that you want to display in M-Mode.
4. Press M Button.
5. Adjust the Sweep Speed, TGC, Gain, Power Output, and Focus Position, as needed.
6. Press Freeze to stop the M trace.
7. Perform desired measurements.
8. Record the trace and calculations to hard disk and/or hard copy device.
9. Press Freeze to continue imaging.
10. To exit, press M Button.

6.4.2 M Mode Parameters

In M mode scanning, the image parameter area in the upper left corner of the screen
displays the real-time parameter values as follows:

Display 40mm

Parameter Depth

Parameters that can be adjusted to optimize the M mode image are indicated in the
following.

Adjustment Items

Adjust on the main

Gain, TGC, Depth, Focus Position
Screen

6-10Optimizing Image
Adjustment Items

Time Mark, Speed, Chroma, Edge Enhance, Dynamic Range,

Menu
Display Format ,Gray map,

During M mode imaging, B mode parameters can’t be adjusted.

During M mode scanning, frequency and acoustic power of the probe are synchronous
with that of B mode.
Adjustment of the depth, focus position or TGC to the B mode image will lead to
corresponding changes in M mode image.

6.4.3 Controls
Time Mark

Description To show the time mark in M mode image.

Adjusting Turn on or off the function through Time Mark item in the Menu.

Benefits When time mark is displayed on the M mode image, it's much easier to
identify the cardiac cycles and detect more details.

Impacts The function is available in real-time imaging, freeze or cine review status.

Display Format

Description To set the display format of M mode image with B mode image.

Adjusting Adjust through the Display Format item in the Menu.

There are 3 formats available for image display: L/R, V1:1, V1:2.

Benefits Adjust according to the actual situation and obtain a desired analysis
through comparison.

Impacts The function is available in real-time imaging, freeze or cine review status.

Speed

Description Changes the speed at which the timeline is swept.

Adjusting Change the speed through the Speed item in the Menu.

Optimizing Image6-11
 You can speed up or slow down the timeline to see more or fewer occurrences
Benefits over time.

Edge Enhance

Description This function is used to increase image profile, so as to distinguish the

image boundary.

Adjusting Adjust through the Edge Enhance item in the Menu.

Impacts Larger edge enhance may lead to noise increasing.

6.5 Color Mode Image

Color Flow Mode is a Doppler Mode intended to add color-coded qualitative information
concerning the relative velocity and direction of fluid motion within the B-Mode image.

6.5.1 Typical Color Mode Exam Protocol

A typical examination using Color Flow Mode,
1. Follow the same procedure as described under B-Mode to locate the anatomical area of
interest.
2. After optimizing the B-Mode image, add Color Flow.
3. Move the color flow area of interest as close to the center of the image as possible.
4. Optimize the color flow parameters so that a high frame rate can be achieved and
appropriate flow velocities are visualized.
5. Touch “Freeze” to hold the image in memory.
6. Record color flow images as necessary.
7. If more definitive information is needed about flow, utilize the procedures described under
Doppler Mode.

6.5.2 Color Mode Parameters

In Color mode scanning, the image parameter area in the upper left corner of the
screen displays the real-time parameter values as follows:

6-12Optimizing Image
Display F 5.3 45mm FR 17 Z1.15

Parameter Frequency Depth Frame Rate Zoom Rate

Parameters that can be adjusted to optimize the Color mode image are indicated in
the following.

Adjustment Items

Adjust on the main

Gain, Depth, TGC, Auto
Screen

Opt. , Priority, Baseline, Sensitivity, Dual Live, Map, AP, Scale,

Menu
WF, Invert, Line Density, Smooth, Persistence, Steer

In Color mode, acoustic power is synchronous with that of B mode. Adjustment of the
depth or zoom to the B mode image will lead to corresponding changes in Color mode
image.

6.5.3 Controls
Color Gain
Gain amplifies the overall strength of echoes processed in the Color Flow
Description window or spectral Doppler timeline

Adjusting Slide the slider below the image, Sliding to the right to increase the gain,
and sliding to the right to decrease.

Benefits Allows you to control the amount of color within a vessel

ROI Adjustment

Description To adjust the width and position of ROI in Color mode.

Adjusting Put two finger on the ROI and zoom the ROI.

Put one finger on the ROI and move on the screen to change the position.

Impacts The larger the ROI box, the lower the frame rate, and the lower the
resolution and color sensitivity.

Optimizing Image6-13
Opt. (Frequency)
Frequency mode lets you downshift to the probe's next lower frequency or shift
Description up to a higher frequency.

Adjusting Select the frequency value through the Opt item in the Menu.

Values of frequency vary by probes. Select the frequency value according

to the need of the detection depth and the current tissue characteristics.

Benefits The Lower the frequency, the worse the axial resolution, and the better the
force of penetration.

Dual Live

Description This function is used to display B image and Color image simultaneously at
dual images.

Adjusting Click Dual Live in the Menu to turn on or off the function. When the function
is turned on, the window will be automatically switched to the dual windows
(one for B image, and the other for Color image).

Impacts The function is available in real-time imaging, freeze or cine review status.

Steer
You can slant the ROI of the Color Flow linear image left or right to get more
Description information without moving the probe. The Angle Steer function only applies to
linear probes.

Adjusting Adjust through the Steer item in the Menu, rotate to get 1°per increment

Provide a Color Doppler angle suitable for linear probe orientation. Beneficial
Benefits in Peripheral Vascular to image carotid arteries and the arteries and veins of
extremities.

Impacts Steer is available only for linear probes.

Line Density
Optimizes the Color Flow frame rate or spatial resolution for the best possible
Description color image

Adjusting Adjust through the Line Density item in the Menu.

Benefits The higher the line density, the higher the resolution.

6-14Optimizing Image
Impacts Line density changes the vector density and frame rate

Sensitivity

Description This function is an indication of the ability to detect flow, which is used to
adjust the accuracy of color flow.

Adjusting Adjust through the Sensitivity item in the Menu.

Benefits The higher the packet size, the more sensitive indication for low-velocity
flow.

Impacts Increasing the packet size will lead to frame rate decrease.

Persistence

Description Averages color frames.

Adjusting Adjust through the Persistence item in the menu or the Menu.

Smooth

Description This feature is used to reject noise and smooth the image.

Adjusting Adjust through the Smooth item in the Menu.

The system provides 4 levels of smooth function, the bigger the value the
higher the smooth.

Scale

Description Increases/decreases the PRF on the color bar.

To raise/lower the velocity scale, press PRF/Wall Filter until you reach PRF,
Adjusting then adjust PRF up/down.
Aligns the velocity scale to different blood flow velocities. Imaging of higher
Benefits velocity flow requires increased scale values to avoid aliasing. Imaging of
lower velocity flow requires decreased PRF.

Impacts Low velocities may not be identified when a high velocity scale is used.

Optimizing Image6-15
Baseline
Changes the Color Flow or Doppler spectrum baseline to accommodate higher
Description velocity blood flow. Minimizes aliasing by displaying a greater range of forward
flow with respect to reverse flow, or vice versa.

Adjusting To adjust the baseline, adjust Baseline up/down, as necessary.

Impacts The function is available in real-time imaging, freeze or cine review status.

Invert
Let’s you view blood flow from a different perspective, e.g., red away (negative
Description velocities) and blue toward (positive velocities). You can invert a real-time or
frozen image.

Adjusting Turn on or off the function through the Invert item in the Menu.

Impacts The function is available in real-time imaging, freeze or cine review status.

Map
Allows you to select a specific color map. After you have made your selection,
Description the color bar displays the resultant map.

Adjusting Select among the maps through the Map item in the Menu.

Benefits Shows the direction of the flow and highlights the higher velocity flows.

WF (Wall Filter)
Filters out low flow velocity signals. It helps get rid of motion artifacts caused
Description from breathing and other patient motion.

Adjusting Select through the WF item in the Menu.

Benefits Gets rid of excess, unnecessary low frequency signals caused by motion.

Priority

Description This function is used to set levels of the flow display, to display the
grayscale signal or color signal.

Adjusting Select the value through the Priority item in the Menu.

6-16Optimizing Image
Effects The higher the value, color signals are prior to be displayed; while the
lower the value, grayscale signals are prior to be displayed.

6.6 Optimizing Power Mode Image

Power Doppler Imaging (PDI) is a color flow mapping technique used to map the strength of
the Doppler signal coming from the flow rather than the frequency shift of the signal. Using this
technique, the ultrasound system plots color flow based on the number of reflectors that are
moving, regardless of their velocity. PDI does not map velocity, therefore it is not subject to
aliasing.

6.6.1 Typical Power Mode Exam Protocol

1. Select a high-quality image during B mode or B+ Color scanning, and adjust to place
the area of interest in the center of the image.

2. In Color Menu, click the Power button to enter B+Power mode. Use the finger to
change position and size of the Region of Interest (ROI).

3. Adjust the image parameters to obtain optimized images.

4. Perform other operations (e.g. measurement and calculation) if necessary.

6.6.2 Power Mode Parameters

 In Power mode scanning, the image parameter area in the upper left corner of the
screen displays the real-time parameter values as follows:

Display F 5.3 60mm FR 17 Z1.00

Parameter Frequency Depth Frame Rate Zoom Rate

Optimizing Image6-17
Parameters that can be adjusted to optimize the Power mode image are indicated in the
following.

Type Parameter

Adjust on the main

Gain, TGC, Depth, Auto
Screen

Opt. , Priority, Dual Live, Map, Acoustic Power, Scale, Wall Filter,
Menu
Invert, Line Density, Smooth, Persistence, Steer

In Power mode, acoustic power is synchronous with that of B mode. Adjustment of the
depth or zoom to the B mode image will lead to corresponding changes in Power
mode image.

Parameters consistent with those in Color mode and B mode are not to be introduced,
please refer to relevant section of the Color mode and B mode, while special items of the
Power mode are introduced in the following.

6.6.3 Power Mode Image Optimization

Map

Description This feature indicates the display effect of power image. The maps in
Power mode image are grouped into two categories: Power maps and
Directional Power maps.

Adjusting Select the map through the Map item in the Menu.

The Directional Power maps provide information of flow direction.

Impacts The function is available in real-time imaging, freeze or cine review status.

6.7 Optimizing PW/CW Doppler Mode

Doppler is intended to provide measurement data concerning the velocity of moving tissues
and fluids. PW Doppler lets you examine blood flow data selectively from a small region called
the sample volume.

6-18Optimizing Image
6.7.1 Typical PW / CW Mode Exam Protocol
1. Scan B and Color image first, then adjust to place the ROI in vessels interested.

2. Touch “PW”/ “CW” button to enter the sampling state,

 The sampling parameters will be displayed in the image parameter area on the
left part of the screen as follows:

PW Sampling Line Frequency FH10

Adjustment (of B or COLOR)

Frame Rate FR25

Angle Correction Angle 0°

SV Size SV 1mm

SVD SVD 1.4 cm

CW Sampling Line Frequency FH3.4

Adjustment (of B or COLOR)

Frame Rate FR62

Angle Angle 0

CW Focus Depth SVD 8.0 cm

3. Set the SVD in the middle of vessels cavity; adjust the angle and SV size according to
the actual situation.

4. Touch “PW”/ “CW” button again or “Update” button to enter PW/CW Mode and
perform the examination. You can also adjust the SV size, angle and depth in the
real-time scanning.

Optimizing Image6-19
5. Adjust the image parameters during PW/CW mode scanning to obtain optimized
images.

6. Perform other operations (e.g. measurement and calculation) if necessary.

6.7.2 PW/CW Mode Parameters

In PW/ CW mode scanning, the image parameter area in the upper left corner of the
screen displays the real-time parameter values as follows:

PW: CW:

PW Display F 2.0 SV 5 SVD8.0cm Angle 0 FR8

Frequency SV SV Position Angle 60 Duplex or

Parameters size triplex Frame
Rate

CW Display F 2.0 SVD 8.0cm Angle -16°

Parameters Frequency SV Position Angle -16°

Parameters that can be adjusted to optimize the PW/ CW mode image are indicated in the
following.

Adjustment Items

Adjust on the main

Gain, TGC, Depth, Focus Position, Auto
Screen

Invert, SV, WF, Frequency, Duplex/Triplex, Trace Line, Volume,

Menu PW Chroma, Speed, Acoustic Power , T/F Res, Gray Map, Dynamic
Range, Scale, Baseline, Quick Angle, Angle, Time Mark, PW Steer

6-20Optimizing Image
Adjustment Items

WF, Invert, Chroma, Frequency, Speed, Dynamic Range, Audio,

CW Trace Sensitivity, Gray Map, Scale, Baseline, Quick Angle, Angle,
Acoustic Power, Time Mark, T/F Res,

6.7.3 Controls
Scale
Adjusts the velocity scale to accommodate faster/slower blood flow velocities.
Description Higher PRF is generally used for higher velocity blood flow and lower PRF is
generally used for lower velocity blood flow. Velocity scale determines pulse
repetition frequency.
To raise/lower, adjust the PRF on the Menu. The display updates velocity
Adjusting scale parameters after you adjust the velocity scale

Benefits Blood flow information is not cut off due to the effect of aliasing.

Velocity Scale values vary by probe and application. In Triplex, when you
Impacts change the velocity scale in Color Flow, the Doppler Mode velocity scale is
also updated if Triplex is on.

Auto Trace and Parameter

Description This function is used to trace the spectrum and calculate parameters of PW
mode image, and the results of which are displayed in the result window.

Adjusting Click Auto Trace in the Menu, to turn on or off the function.

Select parameters in the dialogue box prompted by clicking Auto Trace

Para.

In real-time scanning, the results displayed are derived from the calculation
of latest cardiac cycle.

In the freezing and cine status, the results displayed are calculated from
the current selected area.

Impact Note: heart rate value obtained by auto calculation may be of deviation,
please adopt manual measurement to get the precise value.

Optimizing Image6-21
Invert

Description Used to set the display scale of spectrum.

Adjusting Turn on or off the function through the Invert item in the Menu.

Impacts Available in real-time imaging, freeze or cine review status.

T/F Res
Adjusts image appearance so that if you select a lower setting, the image
Description appears smoother; if you select a higher setting, the image appears sharper.

Adjusting Adjust through the T/F Res item in the Menu.

WF (Wall Filter)
Insulates the Doppler signal from excessive noise caused from vessel
Description movement.

Adjusting Select through the WF item in the Menu.

Impacts Wall filter may be changed by changes to the velocity scale.

Trace

VMax&VMean& To display maximum speed or average speed, or both in the spectrum.

Both
Click V Max or V Mean in the Menu, to turn on or off the function.
Adjusting
In the spectrum map, maximum speed is displayed in blue curve, while
the average speed is displayed in yellow curve.

Benefits The function is available in real-time imaging, freeze or cine review

status.

Display Format
Changes the horizontal/vertical layout between B-Mode and M-Mode, or
Description timeline only.

Operation Adjust through the Display Format item in the Menu.

There are 3 formats to display the images: V1:1, L/R, V1:2.

6-22Optimizing Image
Benefits The function is available in real-time imaging, freeze or cine review status.

Duplex/ Triplex
Duplex allows two modes to be active at the same time; Triplex allows three
Description modes to be active at the same time.

Adjusting Turn on or off the function through the Duplex/ Triplex in the Menu.

Benefits Allows the user to have multiple modes active at the same time.

Baseline
Adjusts the baseline to accommodate faster or slower blood flows to eliminate
Description aliasing.

Adjusting Adjust through the Baseline item in the Menu.

Benefits Adjust baseline according to the actual situation to change the range of
flow velocity to optimize the image.

Positive value means to enhance the signals above the baseline, and
negative value means to enhance the signals below the baseline.

Impacts The function is available in real-time imaging, freeze or cine review status.

Angle
Estimates the direction and velocity of flow at an angle to the Doppler vector by
Description computing the angle between the Doppler vector and the flow to be measured.

Adjusting Adjust through the Angle item in the Menu.

The adjustable angle range is -89~89° in increments of 1°.

Impacts The function is available in real-time imaging, freeze or cine review status.

Quick Angle

Description To adjust the angle faster in increments of 60°, and the real-time value of
which is displayed on the right part of the spectrum map.

Optimizing Image6-23
Adjusting Adjust through the Quick Angle item in the Menu.

There are 3 angles for quickly adjustment: -60°, 0°, and 60°.

Optimizes the accuracy of the flow velocity. This is especially useful in vascular
Benefits applications where you need to measure velocity

Dynamic Range
Dynamic range controls how echo intensities are converted to shades of gray,
Description thereby increasing the range of contrast you can adjust.

Adjusting Adjust through the DR item in the Menu.

Benefits The more the dynamic range, the more specific the information, and the
lower the contrast with more noise.

Impacts Available in real-time imaging, freeze or cine review status.

Audio

Description Adjust the output volume of the spectrum.

Adjusting Adjust through the Audio item in the Menu.

Benefits Audio helps to identify the feature and status of flow.

PW Steer

Description Adjust the scan angle of PW waves on linear probes

Adjusting Adjust through the PW Steer item in the Menu.

Benefits This feature is used to steer the direction of the beam so as to change the
angle between the beam and flow direction with immobility of the linear
probe.

Impacts Available in real-time imaging, freeze or cine review status.

6-24Optimizing Image
SV

Description To adjust the SV position and size of sampling in PW mode, the real-time
value of SV and SVD are displayed in the image parameter area in the
upper left corner of the screen.

Adjusting Adjust the SV size through the SV item in the Menu.

Benefits The smaller the SV size, the more accurate the result; and more
information can be obtained when selected large SV size.

6.8 wiNeedle
In the image without deflection situation, you can activate wiNeedle parameter in order to
show needle tip and make needle-path clearer.

Attention

 This is optional function. Linear array probe support this function.

 Some parts are mistaken for needle-path, because the location of the
muscle fascia parallel needle-path. Maybe it will make a pseudo image, too.

 If the angle of needle is vertical to transmitting ultrasound beam, the effect

of wiNeedle is better.

entry and exit：

You can Click the wiNeedle button which in B menu to enter or exit out of wiNeedle
interface.

Optimizing Image6-25
7 wiGuide

wiGuide is the special feature for improving needle visualization and placement. It is an
option and only be available in the L15-4NB probe. This function need software license
authorized. wiGuide can provide needle detection and orientation information for in-plane
and out-of-plane approaches.

Caution：

 Probe Condition-check the condition of the probes package on delivery. If

it is damaged, the probe must not be used and repacked. Please contact
your representative.

Warnings:

 The Magnetiser generates a magnetic field that can affect the WiGuide
probe calibration. The Magnetiser must remain at least 1m from a wiGuide
probe at all times.

 The Magnetiser produces a weak magnetic field. It should be kept away

from any device that is sensitive to magnetic fields, for example
pacemakers.

7.1 Calibration
Calibration is a simple process but it is extremely important to hold the probe in the air
making sure it is far away from any metal or magnetic objects. If there are any objects
then the calibration will be poor.

Calibration is required when the Signal Strength Indicator is not at the top of the green
scale as shown in the picture below. Before calibrating the probe hold it still for a couple of
seconds. If the problems persist proceed with the calibration.

wiGuide7-1
Press the calibration button to start the calibration process. While holding the probe in air
press the button and wait for a few seconds until the system indicates the process has
completed.

After this has been done, while keeping the probe in the air, quickly check the Signal
Strength Indicator. It should now be back at the top of the green scale.

7.2 Setting
The display setup allows the user to choose the features from the WiGuide that will be
displayed on and beside the ultrasound image.
Pressing the display SETTINGS button opens a menu from which elements of the display
can be turned on or off.
The following display settings can be changed separately for in-plane injections or
out-of-plane injections：
1. Press the Trajectory toggle button to turn the trajectory display on or off in-plane
and/or out of plane.
2. Press the Position toggle button to turn the Position display on or off in-plane
and/or out of plane.
3. Press the Target toggle button to turn the target display on or off in-plane and/or
out of plane.

The following display settings can be changed only for both in-plane injections and
out-of-plane injections:
1. Press the Alignment Image toggle button to turn the indicator display on or off.
2. Press the Tip Sound toggle button to turn the prompt sound on or off.

7-2wiGuide
7.3 How to use
The WiGuide detects the position and orientation of magnetized needles in the presence
of the probe and displays this information relative to the ultrasound image. Spatial
positioning of the needle, with respect to the ultrasound image, is then updated in real
time.

This guides the operator to better visualize the needle in the ultrasound image during
ultrasound guided needling procedures.

In this case the user should only use Needle Guidance following the recommended
procedure:
1. Scan the patient as normal to find the correct anatomy for needle insertion.
2. Hold the probe steady at this position with minimum motion.
3. Introduce the needle to the desired anatomic target without significant motion of the
probe；
i.e moving+/-1cm in any direction is permissible.

WARNINGS:

 Ensure the magnetiser is at least 1m from the WiGuide probe at all times.

 Ensure there is sufficient lighting to identify the magnetiser needle entry

port when magnetising a needle.

 Verify that Signal Strength Indicator is green or orange at his location.

 The Magnetiser should be handled and disposed of following your

institution's procedures for infectious/bio-hazardous materials, including
any local laws and regulations on its disposal.

 Follow the proper shelf life handling, with special attention to the
expiration dates.

 Risk of needle damage: It is essential that the needle be introduced

carefully into the magnetiser. Failure to do so may result in needle damage.

7.3.1 Indicator
 Depth Indicator

wiGuide7-3
Once the wiGuide is activated and a connection to the needle has been made, the Depth
Indicator is displayed.

The Depth Indicator shows the maximal depth the selected needle can reach during a
procedure .If that depth is outreached the Needle Guidance will temporarily not be able to
display the location of the needle tip ,as it has moved out of the ultrasound image. The
needle tip will be shown again when the needles position is corrected by the user.

Warning：

 The number indicated by Depth indicator only shows the maximum depth for which
needle guidance is supported. Please note that this number is NOT related to the
needles length. The needle can be longer or shorter than the displayed mm.

 Signal strength indicator

The Signal Strength Indicator estimates the level of stray fields in the environment of the
probe. It is always present when WiGuide is activated.
The bars indicate the level of stray fields on a color scale：

1) Green means low stray fields are present, and indicates optimal conditions for the
WiGuide.
2) Orange means moderate stray fields, and indicates poor conditions for the WiGuide.
When in this range extra care must be taken to hold the probe steady.
3) Red means strong stray fields are present which means unworkable conditions for
the WiGuide. When the bar is in the range, the WiGuide will be automatically disabled.
If this happens, move the needle away for a moment, waiting until the indicator
changes to at least yellow, then try again, change location or environment or perform
the procedure with normal ultrasound guided techniques.
4) Blinking：The Indicator blinks when the probe moves, and continues until the probe
remains stable. If the blinking occurs while the indicator is between orange and green,

7-4wiGuide
 the connection to the needle is about to break. The probe must be held steady so the
wiGuide can stabilize.

7.3.2 OUT-OF-PLANE Needle Guidance

Screen controls and display information related to OUT-OF-PLANE WiGuide.

NO. NAME FUNCTION/DESCRIPTION

Alignment image WiGuide A plan view of the area surrounding the probe. In
1 display：active area this area the system may be able to detect the
presence of a needle.
Alignment image WiGuide A plan view of the needle.
2 display：needle Circle represents the hub end of the needle and

wiGuide7-5
 other end is needle tip.
Out-of-plane injections 2A：
When the tip of the needle is IN the ultrasound
image plane then the needle is green.
Out-of-plane injections 2B：
When the tip of the needle is NOT in the
ultrasound image plane then the needle is red.
Alignment image WiGuide A plan view of probe, central white line
3 display：Probe represents ultrasound plane. Note the notch
position is also indicated on the probe which
coincides with the blue square on the top left
hand side of the image.
On image display：Needle Colored lines indicate the estimated projection
4 of a detected needles position onto the
ultrasound plane. Under optimal operating
conditions and expert use there is a high
likelihood that the needle will be positioned
between the two colored lines relative to the
ultrasound image.
On image display：Trajectory Dashed line indicates the needle trajectory
5 should the operator advance the needle forward
from that position.
On image display：Target Box indicates the estimated position at which
6 the needle tip will cross the ultrasound image
plane for out-of-plane injections. Under optimal
operating conditions and expert use there is a
high likelihood that the needle tip will cross the
ultrasound image plane within the box.
OUT-of-plane injections 6A：
When the tip of the needle is IN the ultrasound
image plane then the trajectory is green.
OUT-of-plane injections 6B：
When the tip of the needle is NOT in the
ultrasound image plane then the box is red.
Signal Strength Indicator Indicates stray field characteristics.
7

Depth indicator A connection to the needle has been made.

8 wiGuide can estimate the needle positions up to
the depth displayed.

NOTE：
Needles will only be detected and tracked well when approaches are made if there
is a strong connection. To detect a needle the user must make a connection

7-6wiGuide
between the needle and the probe by moving the needle tip to within 5mm from the
probe

7.3.3 In-Plane Needle Guidance

NO. NAME FUNCTION/DESCRIPTION

2 Off image WiGuide display: A plan view of the needle.

needle
Circle represents the hub end of the needle and
other end is needle tip.

In-plane injections 2C：

When the needle is aligned with the ultrasound

image plane then the needle is colored green.

wiGuide7-7
 In-plane injections 2D：
When the needle is NOT aligned with the
ultrasound image plane then the needle is
colored red.

5 On image display：Trajectory Dashed line indicates the needle trajectory

should the operator advance the needle forward
from that position.

6 On image display：Target Box indicates the estimated position at which

the needle tip is. Under optimal operating
conditions and expert use there is a high
likelihood that the needle tip will be within the
box.

In-plane injections 6C：

When the needle is aligned with the ultrasound

image plane then box is green.

In-plane injections 6D：

When the needle is NOT aligned with the

ultrasound image plane then the box is red.

7 Signal Strength Indicator Indicates stray field characteristics.

8 Depth indicator A connection to the needle has been made.

wiGuide can estimate the needle positions up to
the depth displayed.

7-8wiGuide
 8 Scanning & Display

8.1 Display
Zoom is used to magnify a zoom region of interest (ROI). The system adjusts all imaging
parameters accordingly. You can also zoom frozen images. Zooming an image changes the
frame rate which tends to change thermal indices. The position of the focal zones may also
change which may cause the peak intensity to occur at a different location in the acoustic field.
As a result, the MI (TI) may change.

8.1.1 ReadZoom
To Zoom
At real time scanning or freeze status, use two fingers pinch or spread on the screen
and zoom it.

Zoom Adjustment
 To change the magnification factor (the maximum is 10 times).
Pinch two fingers close to decrease the magnification factor; Spread two fingers
away to increase the magnification factor.

The magnification factor is displayed in Area of Image Parameters. For example,

indicates the current magnification factor is 1.6.
 Move the finger to change the zoom display position.

Exit Zoom
Pinch two fingers close until zoom rate to 1.0 to exit the zoom status.

8.1.2 Front Zoom

With Write Zoom, the ultrasound line density and/or sampling frequency increases, giving a
better resolution.

NOTE：The difference between Read Zoom and Write Zoom can be described in relation to
photography. With a photograph, Read Zoom manipulates the negative and enlarges
the picture; whereas Write Zoom uses a telephoto lens to bring the image closer
before taking the picture.

Scanning & Display8-9

 To Zoom
At real time scanning, click “Front Zoom” in Menu, the system will display the ROI.

Then select the ROI position and the size by use two fingers, then click to enter the
zoom status.
Exit Zoom
Click “Front Zoom”to exit the zoom status

8.1.3 Dual Display

The system supports dual-split display format. However, only one window is active at one
time.
 Dual-split: press “Dual” button in the Menu of B mode to enter the dual-split mode,
and click the probe tag to activate between two windows; press “B” on the
control panel to exit.
Imaging modes support splitting display: B mode, Color mode, Power mode

8.1.4 FZoom (Full-screen Zoom)

Function: to magnify the image in full screen.

1. Open the image (or the under scanning image), Click to enter Full Screen
zoom status. In FZoom status, only image area is shown. You can click anywhere in
the image area, and then system will pop up "Save Img, Save Cine, Freeze, End
Exam, depth" button. If you the image area again, these buttons will disappear.

2. Click to return to normal status.

In FZoom status:

Cannot Measure or Comment the image.

It is not the currently zooming region that is used for video output, image saving and print
functions.

8.1.5 Freezing an Image

Freezing a real-time image stops all movement and allows you to measure and print the
image.
Freeze an image:
1. Manually enter the freeze: click “Freeze” on the screen.
2. Automatically enter the freeze: In the <Setup > - < system Settings > - < image>, set the
"Automatic freeze" time, such as 5 minutes; 5 minutes later without any operation, the

8-10Scanning & Display

machine automatically enter the freeze.

Unfreeze an image: click “UNFREEZE” on the screen to activate image.

NOTE: While the image is frozen, all Power Output is suspended.

Selecting a new probe will unfreezes the image.

8.2 Using Cine

CINE images are constantly being stored by the system and are available for playback or
manual review via CINE.
Timeline data is continually stored at four times the display width of timeline data (and updates
the corresponding B-Mode images).
You can view CINE as a continuous loop via CINE Loop or manually review CINE images
frame by frame via the button controls.
Data in CINE is available until new data is acquired. CINE is stored on the system's memory
and can be archived as well.
CINE is useful for focusing on images during a specific part of the heart cycle or to view short
segments of a scan session.

8.2.1 Activating Cine Review

To activate CINE:
1. Click Freeze Button.
2. Slide the slider below the image region will replay the images.

8.2.2 Cine and Monitor Display

The CINE display (located on the bottom side of the image area) indicates which frame you
are viewing of the whole loop.

 Auto Review
 Review all
In the manual cine review status, click to activate auto cine review.
 Setting Length of Auto Review

You can set a length of cine loop which can be reviewed automatically. After the auto
review region is set, the auto cine review can only be performed within this region;
Scanning & Display8-11
 a) Move Start: Slide the blue button upon the cine slider to set it as start
point.

b) Move End: Slide the blue button below the cine slider to set it as end
point.

c) Click Save Cine in the Menu to save the cine of the selected length.

8.3 Annotating an Image

The comment function provides the capability to type the comments of free text and/or insert
the pre-defined comments from the comment library. It also provides the user with arrow
markers to point to parts of the image.

Press the “Freeze”–“Scan”–“Comment” button to enter comment state.

8.3.1 Adding Comments

1. To initiate comment:
 Press the “Freeze” button, and go to “Scan”–“Comment” page, touch the
pre-defined comments to add them.
 Touch “Keyboard” menu, and type the characters on the soft keyboard.
 Touch the “Arrow” menu to mark with the arrow comment.

Tips: when the system entered comment status, the default characters entered are
capitalized. The indicator is on.

2. Choose comment type at “Scan”-“Comment” page, and add the comments. Then
modify, move or delete the comments added.

3. Exiting comment:
 Exit “Scan”-“Comment” page.
 Touch “Unfreeze” to exit comment and go to scan.

8.3.2 Comment Menu

Use comment menu list to modify comment menu under comment state.
Home position
Move the cursor to the desired location and click Set Home. The current position will
be saved as a home position for next comment. Clear all the comments, and add a
new comment, the comment will be added at home position.

8-12Scanning & Display

 Font Size/Arrow Size
 Under “Comment” Menu, Touch the font size list to choose different size: Small,
Med, and Big.
 Under “Arrow” menu, touch Small, Mid, Big to change the arrow size.
 Under comment menu, select the comment menu list to change the comment
library (the available ones are libraries for all the exams). See the screen below:

When Input the comment, the system displays the customized comment text library for the
current exam.
Set comment language
Under “Comment” menu, switch the language list between English and current
system default language for comment menu.

If the current language is English, this function is not available, the list only contain
English.

Scanning & Display8-13

8.3.3 Moving Comments

Drag the comment to the place where you want, and loose up the finger. And the
comment color is changed to high light green.

8.3.4 Deleting Comments

Deleting a character of a Comment

1. Under comment state, click the comment, and move the cursor after the character
you want to delete.

2. Touch the key on the soft keyboard to delete the character.

Deleting a Comment or an Arrow

1. Under comment mode, touch “Clear” button, the comments will be deleted according
to the adding sequence.
Deleting all the Comments

1. Under comment mode, long press “Clear” button, all the comments will be deleted.
Auto deleting the Comments

1. Go to “Setup”– “System Setup”– “Image” page, and check the function “Unfreeze
Clear”. All the comments will be deleted after a Freeze execution is performed.
Otherwise the comments will be deleted through switch patient, probe or exam mode
only.

NOTE: 1. When no object is selected, Touching the “Clear all” key will clear all
comments, Body marks and all measurements calipers.

2. After powering off, the system will clear all comments on the image.

8.4 Body Marks

An additional way to annotate the image display is with body patterns. Body patterns are a
simple graphic of a portion of the anatomy that is frequently scanned. The body pattern and
probe marker can serve as a reference for a patient and probe positioning when images are
archived or scanned. To activate body patterns, enter a frozen state, and touch
“Scan”–“BodyMark” button.

8-14Scanning & Display

8.4.1 Menu for Body Marks
The body mark Menu displays the settings for the current mode:

Switch body mark library list

1. Under body mark mode, switch body mark library lists, the page will display the body
marks under the menu. See the screen below:

When Input the body mark, the system displays the customized body mark library for the
current exam.

Scanning & Display8-15

8.4.2 Adding Body Marks
To add the body mark:

1. Under frozen state, touch “Scan” –“BodyMark”, switch to the body mark library, and
Touch the body mark you want to add.

To modify the body mark probe:

1. Touch “Probe Mark” Menu, and there are eight different direction probes displayed.
See the picture below. Touch the probe needed to modify the direction of the probe.

2. Touch “Probe Mark” Menu, drag the probe mark to the place where you want to add,
and loose finger to fix position of probe mark.

8-16Scanning & Display

8.4.3 Moving Body Marks
You can move the body mark graphics to any desired position within the image area.

1. Drag the body mark to the new position, the back ground color of the body mark
changes to grey.

2. Release finger, the movement finished.

NOTE: In Dual B Mode, a body mark cannot be moved between the separated image
windows.

8.4.4 Deleting Body Marks

To delete a body mark
1. Under body mark mode, Touch “Clear” button to delete the body mark on the image.

2. Auto deleting the Body Marks

Go to “Setup”– “System Setup”– “Image” page, and check the function “Unfreeze”
or “Clear”. All the Body Marks will be deleted after a Freeze execution is performed.
Otherwise the Body Marks will be deleted through switch patient, probe or exam
mode only.

Scanning & Display8-17

NOTE: In the Body Mark mode, if no object is selected, long Touch the Clear key
will clear all comments, body marks and general measurements from the
screen.

Tips:
 Powering off, preset returning, switching the exam/ patient/ mode/ probe will clear
the body marks.
 Switch the dual window will change to active the body mark of another window.

8-18Scanning & Display

 This page was intentionally left blank.

Scanning & Display8-19

 9 Measurement

Measurements and calculations derived from ultrasound images are intended to supplement
other clinical procedures available to the attending physician. The measurement could be
performed in both Zoom In and cine play mode, and also in frozen mode.

WARNING:
1. Must make sure that the measure target and the image are right, the
measurement area should be effective, otherwise will led a misdiagnosis.
2. When measure the Doppler blood, the probe must not be vertical to the blood
direction, otherwise will led a wrong blood information. And the comment
added must be correct, otherwise will led a misdiagnosis.
3. During the measurement, once unfreeze or changing the operation mode, all
the measurement ruler will be deleted, and the ordinary measurement data will
be lost (application measurement data will be saved in the report).
4. During the measurement, shutdown the machine or press the End Exam
button will led t lost the data.
5. Under the Dual B mode, there is deviation for the measurement. The
measurement could be only used for reference but can’t diagnose.

Measurement Related
1. Measure: Under Freeze mode, go to “Scan” page, and press “Measure” button to start an
ordinary measurement.
2. Calc: Under Freeze mode, go to “Scan” page, and press “Calc” button to start a
application calculation measurement

9.1 Measurement Accuracy

Table 1 Precision of 2D Images
2 1
Parameter Value Range Error

Within ±3%; or when the measured value is

Distance Maximum ≥300 mm 3
less than 40 mm, the error is less than 1.5 mm.

Maximum ≥1126 Within ±7%; or when the measured value is

Area (Trace)
cm2 less than 16 cm2, the error is less than 1.2 cm2.

Measurement9-1
 Parameter Value Range Error

Area (ellipse, Within ±7%; or when the measured value is

Maximum ≥884cm2
circle) less than 16 cm2, the error is less than 1.2 cm2.

Angle 0-180° Within ±3%.

Table 2 Volume Measurements

Parameter Value Range Error

Maximum > Within ±10 %; or when the measured value is less than
Volume
999cm3 64 cm3, the error is less than 6.4 cm3.

Table 3 Time/Motion Measurements

Parameter Value Range Error

Within ±3 %; or when the measured value is

Distance Maximum ≥300 mm
less than 40 mm, the error is less than 1.5 mm.

Time Maximum 8 s Within ±1%.

15-999 beats per

Heart rate Within ±4%.
minute

Table 4 Doppler Velocity Measurement

Parameter Value Range Error

Velocity (PW mode) Maximum ≥2.5 m/s When angle ≤ 60º, ≤5%.

Velocity (CW mode) Maximum ≥2.5 m/s When angle ≤ 60º, ≤5%.

9-2Measurement
NOTE: Within the selected field range, the measurement accuracy is ensured within the
range mentioned above. The accuracy specifications are performance in the
worst conditions, or based on the real test for the system, regardless of acoustic
speed error.

9.2 Measurement and Calculation Setup

Measurements and studies are organized for typical work flows. If you want, you
can change this setup. You can specify which studies are in each exam category,
and which measurements and calculations are in each study. You can change the
measurements that are available on the measurement window. The Clover allows
you to quickly and easily set up your system so that you can work most efficiently.

9.2.1 Measurement Menu Setup

You can make changes to studies and measurements in the "Meas & Calc" screen. To open
the screen:

1. Press Setup.

The system displays the Setup dialog on the monitor display.

2. Select “Meas &Calc “at the top of the screen

The system displays the App Package "Menu" screen.

Measurement9-3
In Menu

The "In Menu" section lists studies and measurements for current use

Selecting an Measure Package for "In Menu"

When you open the "Meas &Calc" screen, it displays the default Measurements Package of
the current exam category. To select the Measure Package you want to work with:

1. Move to the "Application “drop-down menu.

2. Click it

The system displays a list of Measurements Package.

3. Choose the Measurements Package you want.

9-4Measurement
 The "In menu" lists studies and measurements for the selected Measurements Package.

Selecting the measurement mode for "In Menu"

In the "Menu Mode" section of the "Menu" screen, select one of the following:

• 2D (B-Mode)
• MM (M-Mode)
• Dop. (Doppler Mode)

The "In Menu" lists studies and measurements for the selected mode.

Measurement9-5
Selecting a study or measurement

To work with a study or measurement, you must first select it in the "In Menu". The "In Menu"
lists the studies and measurements for a Measurements package. The studies and
measurements are organized in a hierarchy, in the same order that they are organized on the
summary window while doing measurements. The following example shows the highest level
of the OB2/3 Measurements Package. After you select the OB2/3 in "Application" drop-down
menu, The "In Menu" shows all studies and measurements for the OB2/3.

To select a study or measurement:

1. Move to the "In Menu" and highlight the study or measurement
2. Click a measurement.

The following example shows the "In Menu “after the "Fetal Heart" measurement is
expanded. The measurements in study “Fetal Heart" is now displayed.

Expand a study:

1. Move to the "In Menu" and highlight the study “Fetal Heart"

9-6Measurement
2. Click it

The system displays the measurements in study "Fetal Heart"

Specifying Which Measurements Go in Menu or Study

The "Available Items" section is where you specify which items go in a study.

Selecting an Measure Package for Available Items

When you open the "Meas &Calc" screen, "Available Items" displays regular Package. To
select the Available Package you want to work with:

1. Move the finger to the "Package" drop-down menu.

2. Click it

The system displays a list of Measurements Package.

3. Move the finger to highlight the Measurements Package you want.

Measurement9-7
4. Click it.

The "Available Items" lists studies and measurements for the Available Measurements
Package.

Selecting the measurement mode for Available Items

In the "Package Mode" section of the "Menu" screen, select one of the following:

• 2D (B-Mode)
• MM (M-Mode)
• Dop. (Doppler Mode)

The "Available Items” lists studies and measurements for the selected mode.

9-8Measurement
Adding Measurements and Studies

Adding a measurement or a study to "In Menu"

You can add a measurement in a system-defined folder or in a folder you created.

1. In the "In Menu" section, select the study where you want to add the measurement or
study.
• If you don't select any study, the measurement will be added to the top menu
2. In the "Available Items" section, select the measurement or study you want to be added
3. Click"<" between "In Menu" section and "Available Items" section

Adding all measurements in "Available Items" to "In Menu"

You can add a measurement in a system-defined folder or in a folder you created.

Measurement9-9
NOTE: If the Tool field is gray, it cannot be removed.

1. In the "In Menu" section, select the study where you want to add the measurement or
study.
• if you don't select any study, the measurement will be added to the top menu
2. In the "Available Items" section, select the "package “and "Package Mode" you want to
add
3. Click"<<" between "In Menu" section and "Available Items" section

Adding a user-defined study

A measurement study is a Group that includes related measurements.

1. In the "In Menu", in the top menu or select the study where you want to add the study.
2. In the "In Menu" section, Move the finger to the "Add Group"

9-10Measurement
3. Press Set

The system displays a dialog of inputting "Group Name".

Measurement9-11
4. Type the study name, then select "OK"

The study is added

5. To add measurements to the study, see ‘Adding a measurement or a study to "In Menu"

Remove a Study or Measurement from "In Menu"

You can only remove the studies or measurement from "In Menu" which for displaying. You
cannot delete default system studies or measurements in "Available Items".

NOTE: If the Tool field is gray, it cannot be removed.

1. Select the study or measurement in the "In Menu".

2. Select ">" to remove the measurement or study which for displaying.

Remove all Studies and Measurements from "In Menu"

You can only remove the studies or measurement from "In Menu" which for displaying. You
cannot delete default system studies or measurements in "Available Items".

1. In the "In Menu" section, select the "App package" and "Menu Mode" you want to remove
2. Select ">>" to remove all the measurements and studies.

9.2.2 Measurement Advanced Setup

The system allows you to specify application-specific values for certain parameters. You
specify the parameter values on the advanced tab of the Meas&Calc screen.

Enter Advanced Preset

You can make changes to studies and measurements in the Meas&Calc screen. To open the
screen:

1. Press Setup.

The system displays the Setup screen on the monitor display.

2. Select "Meas &Calc “at the top of the screen and click it, select "Advanced" on the
monitor display

The system displays the App Package "Advanced" screen.

9-12Measurement
Selecting an App Package

When you open the Advanced Menu of the "Measure" screen, it displays the default
Measurements Package of the current exam category. To select the Measure Package you
want to work with:

1. Move the finger to the "Application" drop-down menu.

2. Click it.

The system displays a list of Measurements Package.

3. Move the finger to choose the Measurements Package you want.

The "In menu" lists studies and measurements for the selected Measurements Package.

Measurement9-13
Set the Heart Cycle for the Measure Package

To select a value for a Heart Cycle parameter, select it from the Value list.

Heart Cycle: 1, 2, 3, 4 or 5

Set the Artery Measure for the Measure Package

To select a value for an Artery Measure parameter, select it from the Value list.

Artery Measure: 2PT, Trace or S-Auto

9-14Measurement
Set the Units for the Measure Package

To select a value for the Units, select it from the Value list.

You can set units as follows.

Unit Conversion
(coefficient value)

Distance mm x10

cm x1

Area mm2 x100

cm2 x1

Volume mm3 x1000

cm3 x1

Time ms x1000

s x1

Velocity mm/s x100

cm/s x10

m/s x1

Set the Result Items of Doppler for the Measure Package

The system allows you to preset the parameters for manual calculations. You specify the
parameter values in the Doppler frame of the advanced screen.

Measurement9-15
  2-Point

In the 2-Point frame, select the measurements that you want to the system to
show for 2-Point Doppler measurements for the selected study.

The Result Items of 2-Point includes PS, ED, MD, S/D, D/S and RI, of which ED
and MD are mutual exclusive.

 Manual/Semi-Auto Trace

In the Manual/Semi-Auto frame, select the measurements that you want to the
system to show for Manual and Semi-Auto Doppler measurements for the
selected study.

The Result Items of Manual/Semi-Auto includes PS, ED, MD, S/D, D/S TAMAX,

9-16Measurement
 VTI, RI and PI, of which ED and MD are mutual exclusive.

 Auto Trace

In the Auto Trace frame, select the measurements that you want to the system to
show for Auto Trace Doppler measurements for the selected study.

The Result Items of Auto Trace conclude PS, ED, MD, S/D, D/S TAMAX,
TAMEAN, VTI, RI, PI and HR, of which ED and MD are mutual exclusive.

9.2.3 Mode Measurements

B-Mode Measurements

Some basic measurements can be made in B-Mode

• Distance
• Area
• Volume
• Angle
• Depth
• Four Points And Three Lines

Attention：Only Piloter Exp/T/P/S/F/RE/U/i support depth measurement.

Only Piloter、Piloter Exp/T/D/V/U/SE/i support Color Vel measurement.

Only Piloter Exp/S/B/D/R/RE/V/U support CIA Diam measurement.

Only Piloter、Piloter Exp/T/F/R/RE/V/X support Interlobar A measurement.

Distance
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Distance> button.
2. There is a high light green dotted line with two active ring on each end point on the
screen.
3. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
4. To complete the measurement, exit measurement mode or start another
measurement.
Measurement9-17
 The system displays the distance value in the Results Window.

NOTE:
Before you complete a measurement:

• The measure ruler is in active mode, touch “Delete” button, the measure ruler will
be deleted, and the value in result window also will be deleted.

Circumference and area (Ellipse)

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Area> button, click method list and choose <Ellipse>.
2. There is a high light green circle on the screen, there are two vertical intersection lines
inside the circle, and on each end point of the line, and there is an active ring.
3. To measure circumference and area, drag two end point ring of vertical line, these end
point rings could only be moved on the vertical direction.
4. Drag the end point ring on the horizon line, there end point rings could be moved in
any direction.
5. To complete the measurement, exit measurement mode or start another
measurement.

The system displays the distance value in the Results Window.

NOTE:

Before you complete the ellipse measurement:

• To erase the ellipse and the current data measured, touch“Delete” button, the
measure ruler will be deleted, and the value in result window also will be deleted.

Circumference and area (Trace)

1. Under Freeze mode, go to “Scan” page, and press “Measure”button, and press
<Area> button, click method list and choose <Trace>.
2. There is a high light green cross point on the screen.
3. To posit the first point, drag the cross point to the start position of the trace, and loose
up. There will be the second active cross point on the screen.
4. To trace the area, drag the second active cross point along the trace image, and loose
up when finished the trace.
5. The measurement is finished automatically.
6. The trace area is rounded with dotted line, and the circumference and area value are
displayed in the result widow.

9-18Measurement
NOTE

Before you complete the trace measurement:

• To erase measurement rule and measurement data, press “Delete” button.

Volume (Three Dist)

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Volume> button to enter measurement item page.
2. Press <Diam 1> button, the first diam is displayed with two active ring on each end
point. Posit the first diam through drag these two active rings.
3. Press <Diam 2> button, the second diam is displayed with two active ring on each end
point. Posit the second diam through drag these two active rings.
4. Press <Diam 3> button, the third diam is displayed with two active ring on each end
point. Posit the third diam through drag these two active rings.
5. The diam values and volume value will be displayed in the result window.

NOTE:

• Press “Delete” button to delete the added measurement.

Angle
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Angle> button.
2. There are two crossed line on the screen. Through drag or press the end point of the
line to measure the angle.
a. Press the end point of the line
Press any point P on the image, the end point closed to P will be moved to P.
b. Drag the end point of the line
Drag the end point to position P, loose up, the movement is finished.
3. To complete the measurement, exit measurement mode or start another
measurement. And the angle value will be displayed in the result window.

Depth
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Depth> button.
2. There is a high light green cross point on the screen.
3. To measure the depth, there are two methods:
a. Press any point P on the image, the cross point is moved to P, the depth of position

Measurement9-19
P is measured.
b. Drag the cross point to P, and loose up, the depth of position P is measured.
4. To complete the measurement, exit measurement mode or start another
measurement. And the depth value will be displayed in the result window.

Four Points and three lines

The measurement ruler is in cardiac measure library under the directory EF Volume -
Cube/Teicholz

1. Under Freeze mode, go to “Scan” page, and press “Calc” button, and click the
measurement library list, choose Cardiac library. Go to <EF Volume> -<Cube/Teich>
page, and press <Diastole> button.
2. There are three mutual vertical lines displayed on the screen, and there are four active
rings at the end point of the lines, the distance of each line is measurement value of
the Four Points And Three Lines.
3. To measure Four Points And Three Lines, drag the active rings to confirm the
position.
4. To complete the measurement, exit measurement mode or start another
measurement. And the Four Points and Three Lines value will be displayed in the result
window.

M-Mode Measurements

Basic measurements that can be taken in the M-Mode portion of the display are:

• Distance
• Time
• Heart Rate
• Slope
• Four Points And Three Lines

NOTE:

To perform any of these measurements, perform the following steps:

1. In the B-Mode part of the display, scan the anatomy you want to measure.
2. Go to the M-Mode part of the display.
3. Adjust the M-Mode gate
4. Press “Freeze”.

9-20Measurement
Distance

Distance measurement in M-Mode functions the same assistance measurement in

B-Mode. It measures the vertical distance between calipers.

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Distance> button.
2. There are vertical lines with one horizon line connected on the screen, and there are
two active rings at the junctions. The distance between the two rings is the distance.
3. To measure M distance, drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And distance value will be displayed in the result window.

Time
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Time> button.
2. There are vertical lines with one horizon line connected on the screen, and there are
two active rings at the junctions.
3. To measure M time, drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And time value will be displayed in the result window.

Heart Rate
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Heart Rate> button.
2. There are vertical lines with one horizon line connected on the screen, and there are
two active rings at the junctions..
3. To measure M heart rate, drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And heart rate value will be displayed in the result window.

Slope

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Slope> button.

Measurement9-21
2. There are vertical lines with one horizon line connected on the screen, and there is one
active ring at the junctions of the vertical line and horizon line. And there is a active ring on
another vertical. The slope of the two rings is M slope.

3. To measure M slope, drag the two rings to confirm the position.

4. To complete the measurement, exit measurement mode or start another measurement.

And slope value will be displayed in the result window.

Four Points and Three Lines

The measurement ruler is in cardiac measure library under the directory EF Volume -
Cube/Teicholz under M mode.

1. Under Freeze mode, go to “Scan” page, and press “Calc” button, and click the
measurement library list, choose Cardiac library. Go to <EF Volume> -<Cube/Teich>
page, and press <Diastole> button.

2. There is a line with four active rings displayed on the screen, and confirm three lines,
the distance of the line is the measurement value of Four Points and Three Lines.

3. To measure Four Points and Three Lines, drag these active rings to confirm the
position.

4. To complete the measurement, exit measurement mode or start another measurement.

And Four Points and Three Lines value will be displayed in the result window.

Doppler Mode Measurements

Some basic measurements can be made in Doppler-Mode

• Velocity
• Time
• Heart Rate
• Acceleration
• Spectrum
• Cardiac Trace

Note

To perform any of these measurements, perform the following steps:

1. In the B-Mode part of the display, scan the anatomy you want to measure.

9-22Measurement
2. Go to the Doppler Mode part of the display.
3. Adjust the Doppler gate.
4. Press Freeze.

Velocity

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Vel> button.

2. There is a cross point on the screen, the velocity of the cross position is the doppler
velocity.

3. To measure the velocity, there are two methods:

a. Press any position P of the image, the cross point will be moved to P to measure
the velocity.

b. Drag the cross point to position P, and loose up to.

4. To complete the measurement, exit measurement mode or start another measurement.

And Four Points and Three Lines value will be displayed in the result window.

Time
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Time> button.
2. There are vertical lines with one horizon line connected on the screen, and there are
two active rings at the junctions.
3. To measure M time, drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And time value will be displayed in the result window.

Heart Rate
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Heart Rate> button.
2. There are vertical lines with one horizon line connected on the screen, and there are
two active rings at the junctions.
3. To measure M heart rate, drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another

Measurement9-23
 measurement. And heart rate value will be displayed in the result window.

Acceleration
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Accel> button.
2. There are vertical lines with one horizon line connected on the screen, and there is
one active ring at the junctions of the vertical line and horizon line. And there is an
active ring on another vertical. The slope of the two rings is Doppler acceleration.
3. To measure Doppler acceleration, drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And acceleration value will be displayed in the result window.

Spectrum (Two Point)

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Two Point(RI)> button.
2. There are two vertical lines and a horizon line on the screen, and there is one active
ring at the junctions of the vertical line and horizon line. And there is an active ring on
another vertical.
3. To measure Doppler Two Points (RI), drag the two rings to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And two points (RI) value will be displayed in the result window.

Spectrum (Manual Trace)

1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Spectrum> button, and choose <Manual> measure method.
2. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
3. To confirm the start point, drag the cross point and loose up. The horizon line
disappeared.
4. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
5. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

9-24Measurement
Spectrum (Semi-Auto Trace)
1. Under Freeze mode, go to “Scan” page, and press “Measure” button, and press
<Spectrum> button, and choose <semi-auto> measure method.
2. There are two vertical lines and one horizon line displayed on the screen.
3. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.
4. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

9.3 Measure Tools

Measures tool consists of two parts function. Including the basic functions and unit
formula switching function. You can switch different formula according to your
need.

ICA/CCA

ICA/CCA is used to preset the calculation method of flow velocity ratio of ICA (Internal Carotid
Artery) and CCA (Common Carotid Artery). Select one of following in each down-drop lists:

• Prox
• Mid
• Dist

Cardiac Function

Cardiac Function is used to preset the calculation method of EDV and ESV in package
"Cardiology”, select on of following:

• Cube:

Measurement9-25
• Teicholz:

Height/Weight Unit

Height/Weight unit affects the unit of height and weight in Patient information, select one of
following:

• Metric
• English

BSA Formula (Body Surface Are)

BSA is calculated by entering the patient's weight and height by using the "Patient" window, it
will be involved in the calculation of CO (Cardiac Output) in package "Cardiology"

9-26Measurement
BSA Formula can be set to Oriental formula or Western formula, and the following shows the
contents of calculation formula:

Oriental:

Western:

9.4 Generic Measurements

The Generic studies provide you quick access to measurements such as volume,
angle. This section describes generic measurements, organized by mode.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Measure” button.
2. Click the measurement ruler.

Measurement9-27
9-28Measurement
B-Mode Measurements

In B-Mode, the Generic study includes the following measurements:

Type Item Description Method

Measurement Distance / 2D Distance

Area / Ellipse,Trace2D,Spline,CrossLine

Volume / ThreeDist,EllipseDist

Angle / Angle

Depth / Depth

Note: Piloter PE/P/S/B/F/R/RE/X do not support Color vel; Piloter PE/P/S/B/D/U/SE/i do

not support Depth.

M-Mode Measurements

In M-Mode, the Generic study includes the following measurements:

Type Item Description Method

Distance / M Distance

Heart Rate / M Heart Rate

Measurement
Time / M Time

Slope / M Slope

Doppler Mode Measurements

In D-Mode, the Generic study includes the following measurements:

Type Item Description Method

Measurement9-29
 Type Item Description Method

Vel Velocity M Distance

Time / M Heart Rate

Heart Rate / M Time

Acceleration / M Slope
Measurement
2PT(RI) 2 Point(Resistive Index) 2 Point

D-Trace Doppler Trace Manual Trace,

Semi-Auto Trace

Car Trace Cardiac Trace Manual Trace,

Semi-Auto Trace

9.5 Abdomen
Describes how to perform Abdomen measurements and calculations.

Introduction

1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <Abdomen> measurement library, and press the measurement item.

9-30Measurement
B-Mode Measurements
The following measurements are located in the Exam Calcs for the Abdomen exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (Liver, CBD, CHD, Portal V Diam, Gall Bladder study, Renal study,
Pancreas study, Bladder study, Spleen, AA Diam, AA Bif, and CIA Diam) are listed on the
following pages.

Example:
Liver
1. Select “Liver”; there is a high light green dotted line on the screen with two active
rings on the end point of the line.
2. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
3. To complete the measurement, exit measurement mode or start another
measurement.
4. The system displays the Liver value in the Results Window.

Measurement9-31
 Type Item Description Method

Liver Liver

CBD Common Bile Duct

CHD Common Hepatic Duct

Portal V Diam Portal Vein Diameter

GB L Gall Bladder Length

GB H Gall Bladder Height

GB W THK Gall Bladder Wall Thickness

Renal L Renal Length

Renal H Renal Height

Measurement Renal W Renal Width 2D Distance

Cortex Cortex

Panc Duct Pancreas Duct

Panc Head Pancreas Head

Panc Body Pancreas Body

Panc Tail Pancreas Tail

Spleen Spleen

Pre-V BL L Pre-Void Bladder Length

Pre-V BL W Pre-Void Bladder Width

Pre-V BL H Pre-Void Bladder Height

9-32Measurement
 Type Item Description Method

Post-V BL L Post-Void Bladder Length

Post-V BL W Post-Void Bladder Width

Post-V BL H Post-Void Bladder Height

AA Diam Abdomen Aorta Diameter

AA Bif Abdomen Aorta Bif

CIA Diam Common Iliac Artery

Diameter

Note: Only Piloter Exp/S/B/D/R/RE/V/U support CIA Diam measurement.

Doppler Mode Measurements

The following measurements are located in the Exam Calcs for the Abdomen exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (Abd Aorta, Celiac Trunk, SMA, Hepatic A, CBA, Splenic A, Main Renal A,
Arcuate A, Segmental A, Interlobar A, SMV, Renal V, IVC, Portal V, Hepatic V, M Hepatic
V, Splenic V) are listed on the following pages.

Artery Example:
Abd Aorta
1. Select “Abd Aorta”;
2. Click measure methods at measure method list: Two Point, Manual, and Semi-Auto.

2PT (2 Point)

a. Choose “Two Point”.

b. There are two vertical lines and a horizon line on the screen, and there is one active
ring at the junctions of the vertical line and horizon line. And there is an active ring on
another vertical.
c. To measure Doppler Tow Point (RI), drag the two rings to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement.

Manual (Manual Trace)

Measurement9-33
a. Choose “Manual”
b. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
c. To confirm the start point, drag the cross point and loose up. The horizon line
disappeared.
d. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
e. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

S-Auto (Semi-Auto Trace)

a. Choose “Semi-Auto”
b. There are two vertical lines and one horizon line displayed on the screen.
c. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

Type Item Description Method

Abd Aorta Abdomen Aorta

Celiac Trunk Celiac Trunk

SMA Superior Mesenteric Artery

Hepatic A Hepatic Artery

CBA Common Bile Artery

2 Point, Manual Trace,
Measurement
Semi-Auto Trace
Splenic A Splenic Artery

Main Renal A Main Renal Artery

Arcuate A Arcuate Artery

Segmental A Segmental Artery

Interlobar A Interlobar Artery

9-34Measurement
 Type Item Description Method

SMV Superior Mesenteric Vein

Renal V Renal Vein

IVC Inferior Vena Cava

Portal V Portal Vein Peak Velocity

Hepatic V Hepatic Vein

M Hepatic V Middle Hepatic Vein

Splenic V Splenic Vein

9.6 OB
Describes how to perform OB measurements and calculations.

OB calculation package includes OB1, OB2/3.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <OB1> or <OB2/3> measurement library, and press the measurement item.

Measurement9-35
B-Mode Measurements

The following measurements are located in the Exam Calcs for the OB exam category.
Some measurements are only available in certain Exam Calcs. Those specific
measurements are listed on the following pages.

Example:

BPD

To measure BPD, make one distance measurement:

1. Press “BPD”; an active caliper displays.

2. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
3. To complete the measurement, exit measurement mode or start another

9-36Measurement
 measurement.
4. The system displays the BPD value in the Results Window.

Type Item Description Method

GS Gestational Sac Diameter

YS Yolk Sac

CRL Crown Rump Length

NT Nuchal Translucency

PL THK Placental Thickness

BPD Biparietal Diameter

OFD Head Circumference

FL Femur Length

AF1 Amniotic Fluid 1

Measurement 2D Distance
AF2 Amniotic Fluid 2

AF3 Amniotic Fluid 3

AF4 Amniotic Fluid 4

TAD Abdominal Transversal

Diameter

APAD Anteroposterior Abdominal

Diameter

CEREB Cerebral

Cist Magna Cist Magna

LVW Lateral Ventricle Width

Measurement9-37
 Type Item Description Method

HEM Hemisphere Width

EOD External Orbital Diameter

IOD Inter Orbital Diameter

HUM Humerus Length

Ulna Ulna Length

RAD Radius Length

TIB Tibia Length

FIB Fibula Length

CLAV Clavicle Length

Vertebra Length of Vertebrae

Foot Foot Length

Ear Ear Length

APTD Anteroposterior trunk

diameter

TTD Transverse trunk diameter

LVID Left Vetricular Internal

Diameter

RV Right Ventricle

HC Head Circumference

2D Area
AC Abdominal Circumference

9-38Measurement
 Type Item Description Method

FTA Fetal Trunk Cross-sectional

Area

Study AFI /

Fetal Heart /

Calculation AFI Amniotic Fluid AFI=

AF1+AF2+AF3+AF4

FTA Fetal Trunk Area FTA=pi/4*APTD*TTD

M-Mode Measurements
The following measurements are located in the Exam Calcs for the OB exam category. Some
measurements are only available in certain Exam Calcs. Those specific measurements are
listed on the following pages.

Type Item Description Method

Measurement FHR Fetal heart rate M Heart Rate

Doppler Measurements
The following measurements are located in the Exam Calcs for the OB exam category.
Some measurements are only available in certain Exam Calcs. Those specific

Measurement9-39
measurements are listed on the following pages.

Type Item Description Method

FHR Fetal Heart Rate M Heart Rate

Umb A Umbilical Artery

Ductus V Ductus Venous

Placenta A Placenta Artery

Measurement MCA Middle Cerebral Artery

2 Point, Manual Trace,
Semi-Auto Trace
Fetal Aorta Fetal Aorta

Desc Aorta Descending Aorta

Uterus A Uterus Artery

Ovary A Ovary Artery

Artery Example:
Umbilical Aorta
1. Select “Umb Aorta”;
2. Click measure methods at measure method list: Two Point, Manual, and Semi-Auto.

2PT (2 Point)

a. Choose “Two Point”.

b. There are two vertical lines and a horizon line on the screen, and there is one active
ring at the junctions of the vertical line and horizon line. And there is an active ring on
another vertical.
c. To measure Doppler Tow Point (RI), drag the two rings to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement.

Manual (Manual Trace)

a. Choose “Manual”
b. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
c. To confirm the start point, drag the cross point and loose up. The horizon line

9-40Measurement
 disappeared.
d. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
e. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

S-Auto (Semi-Auto Trace)

a. Choose “Semi-Auto”
b. There are two vertical lines and one horizon line displayed on the screen.
c. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

More than one fetus

The System will mark each fetus during process of measurement and calculations. For
example, fetus A marks the first tile, fetus B marks the second tile, and fetus C marks the
third tile.

Measurement9-41
To identify a fetus

For measurements, calculations, to switch the fetus, please do the following operations:

1. Select a measurement of OB mode, press fetus list, and choose the corresponding
fetus.

Ultrasound GA

Ultrasound GA and ultrasound EDD are calculated according to the parameters obtained in
measurements.

•  GA in OB Items
•  AUA (Average Ultrasound Age)

Estimated Fetal Weight Calculation (EFW)

9-42Measurement
EFW is a calculation item. If all tools required for EFW formula have been performed,
EFW will be obtained automatically. The system will recalculate the EFW after new
measurements are completed.

The Fetal Weight formulas are shown in the following table:

Formulas Descriptions Units

EFW item

Hadlock FW = 10^(1.1134+0.05845x AC–0.000604xAC²–0.007365x BPD²+0.000595xBPDxAC+0.1694 g cm

x BPD)

Merz FW = – 3200.40479 + 157.07186 x AC + 15.90391 x BPD² g cm

Shepard FW = 10^(–1.7492 + 0.166 x BPD + 0.046 x AC – 0.002646 x AC x BPD) x 1000 g cm

SD=0.2120*EFW

Campbell FW = e^(–4.564 + 0.282 x AC - 0.00331 x AC²)x 1000 g cm

SD=0.146*EFW SD Type=±2SD

Hadlock4 FW = 10^(1.3596 – 0.00386 x AC x FL + 0.0064 x HC + 0.00061 x BPD x AC + 0.0424 x AC + g cm

0.174 x FL)

SD=0.146*EFW SD Type=±2SD

Hadlock3 FW = 10^(1.326 – 0.00326 x AC x FL + 0.0107 x HC + 0.0438 x AC + 0.158 x FL) g cm

SD=0.148*EFW SD Type=±2SD

Hadlock2 FW = 10^(1.335 – 0.0034 x AC x FL + 0.0316 x BPD + 0.0457 x AC + 0.1623 x FL) g cm

SD=0.146*EFW SD Type=±2SD

Hadlock1 FW = 10^(1.304 + 0.05281 x AC + 0.1938 x FL – 0.004 x AC x FL) g cm

SD=0.154*EFW SD Type=±2SD

Measurement9-43
Tokyo FW = 1.07 x BPD³ + 3.42 x APTD x TTD x FL g cm

Osaka FW = 6.3 + 1.25647 x BPD³ + 3.50665 x FTA x FL g cm

Hansmann FW= (–1.05775 x BPD + 0.649145 x TTD + 0.0930707 x BPD² – g cm

0.020562 x TTD² + 0.515263)x 1000

9.7 Gynecology
Describes how to perform Gynecology measurements and calculations.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <Gynecology> measurement library, and press the measurement item.

B-Mode Measurements

The following measurements are located in the Exam Calcs for the Gynecology exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements are listed on the following pages.

Example:

9-44Measurement
Uterus length, width, and height

Each of these is a standard distance measurement. Typically, length and height are
measured on the sagittal plane while the width is measured on the transverse plane.

To measure uterus length, width, or height:

1. Scan the patient in the appropriate scan plane.

2. Select the Uterus study, then select UT L, UTW, or UT H.

An active caliper displays.

3. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
4. To complete the measurement, exit measurement mode or start another
measurement. The system displays the UTL value in the Results Window.
5. To measure the second and the third measurement, please repeat step 2~4. After
finishing the three measurement, there will be Uterus Volume calculated in the result
window.

Type Item Description Method

UT L Uterine Length

UT W Uterine Width

UT H Uterine Height

Endo Endometrium Thickness

Measurement Ovary L Ovary Length 2D Distance

Ovary W Ovary Width

Ovary H Ovary Height

Cervix L Uterine Cervix Length

Cervix W Uterine Cervix Width

Measurement9-45
 Type Item Description Method

Cervix H Uterine Cervix Height

Follicle1 Follicle1

Follicle2 Follicle2

Follicle3 Follicle3

Follicle4 Follicle4

Follicle5 Follicle5

Follicle6 Follicle6

Follicle7 Follicle7

Follicle8 Follicle8 Follicle

Follicle9 Follicle9

Follicle10 Follicle10

Follicle11 Follicle11

Follicle12 Follicle12

Follicle13 Follicle13

Follicle14 Follicle14

Follicle15 Follicle15

Follicle16 Follicle16

Doppler Mode Measurements

The following measurements are located in the Exam Calcs for the Gynecology exam

9-46Measurement
category. Some measurements are only available in certain Exam Calcs.

Type Item Description Method

Uterus A
2 Point, Manual Trace,
Measurement
Semi-Auto Trace
Ovary A

Artery Example:
Uterus Aorta
1. Select “Uterus Aorta”;
2. Click measure methods at measure method list: Two Point, Manual, and Semi-Auto.

2PT (2 Point)

a. Choose “Two Point”.

b. There are two vertical lines and a horizon line on the screen, and there is one active
ring at the junctions of the vertical line and horizon line. And there is an active ring on
another vertical.
c. To measure Doppler Tow Point (RI), drag the two rings to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement.

Manual (Manual Trace)

a. Choose “Manual”
b. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
c. To confirm the start point, drag the cross point and loose up. The horizon line
disappeared.
d. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
e. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

S-Auto (Semi-Auto Trace)

a. Choose “Semi-Auto”
b. There are two vertical lines and one horizon line displayed on the screen.
c. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

Measurement9-47
9.8 Small Parts
Describes how to perform Small Parts measurements and calculations.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <Thyroid> or <Testis> measurement library, and press the measurement
item.

B-Mode Measurements
The following measurements are located in the Exam Calcs for the Small Parts exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (Thyroid study, Testis study) are listed on the following pages.

Example:
Thyroid length, width, and height
Each of these is a standard distance measurement. Length and height are typically
measured in the sagittal plane. Width is measured in the transverse plane.

9-48Measurement
1. Select the appropriate orientation (side): “Right” or “Left”.
2. Select “Thyroid L, Thyroid W, or Thyroid H”. An active caliper displays.
3. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
4. To complete the measurement, exit measurement mode or start another
measurement. The system displays the Thyroid L value in the Results Window.
5. To measure the second and the third measurement, please repeat step 2~4. After
finishing the three measurement, there will be Thyroid Volume calculated in the
result window.

Type Item Description Method

Thyroid L Thyroid Length

Thyroid H Thyroid Height

Thyroid W Thyroid Width

Measurement Isthmus H Isthmus H 2D Distance

Testicle L Testicle Length

Testicle H Testicle Height

Testicle W Testicle Width

Doppler Mode Measurements

The following measurements are located in the Exam Calcs for the Abdomen exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (STA, ITA) are listed on the following pages.

Artery Example:
STA
1. Select “STA”; an active caliper displays.
2. Click measure methods at measure method list: Two Point, Manual, and Semi-Auto.

2PT (2 Point)

a. Choose “Two Point”.

b. There are two vertical lines and a horizon line on the screen, and there is one active
Measurement9-49
 ring at the junctions of the vertical line and horizon line. And there is a active ring on
another vertical.
c. To measure Doppler Tow Point (RI), drag the two rings to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement.

Manual (Manual Trace)

a. Choose “Manual”
b. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
c. To confirm the start point, drag the cross point and loose up. The horizon line
disappeared.
d. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
e. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

S-Auto (Semi-Auto Trace)

a. Choose “Semi-Auto”
b. There are two vertical lines and one horizon line displayed on the screen.
c. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.

d. To complete the measurement, exit measurement mode or start another

measurement. And spectrum value will be displayed in the result window.

Type Item Description Method

STA Superior Thyroid Artery

2 Point, Manual Trace,
Measurement
Semi-Auto Trace
ITA Inferior Thyroid Artery

9.9 Cardiology
Describes how to perform Cardiac measurements and calculations.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.

9-50Measurement
2. Switch to <Cardiology> measurement library, and press the measurement item.

Measurement9-51
B-Mode Measurements
The following measurements are located in the Exam Calcs for the Cardiology exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements are listed on the following pages.

Example:
LA Diam
1. Select “LA Diam”; an active caliper displays.
2. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
3. To complete the measurement, exit measurement mode or start another
measurement.
4. The system displays the LA Diam value in the Results Window.

Type Item Description Method

Measurement RVAWd Right Ventricle Anterior Wall 2D Distance

9-52Measurement
 Type Item Description Method

end-diastole

RVIDd Right Ventricle Anterior Wall

end-systole

IVSd Interventricular Septal

Thickness at end-diastole

LVIDd Left Ventricular Internal

Diameter at end-diastole

LVPWd Left Ventricular Posterior

wall thickness at
end-diastole

IVSs Interventricular Septal

Thickness at end-systole

LVIDs Left Ventricular Internal

Diameter at end- systole

LVPWs Left Ventricular Posterior

wall thickness at end- systole

LA Diam Left Atrium Diameter

Ao Root Diam Aorta Root Diameter

LVOT Diam Left Ventricular Outflow

Tract Diameter

RVOT Diam Right Ventricular Outflow

Tract Diameter

Ao st junct Aorta ST junct Diameter

Asc Ao Diam Ascending Aorta Diameter

Measurement9-53
 Type Item Description Method

Ao Arch Diam Aorta arch Diameter

Desc Ao Diam Descending Aorta Diameter

MPA Diam Main pulmonary Artery

Diameter

LPA Diam Left pulmonary Artery

Diameter

RPA Diam Right pulmonary Artery

Diameter

LCA Diam Left Coronary Artery

Diameter

RCA Diam Right Coronary Artery

Diameter

IVC Diam Inferior Vena Cava Diameter

IVC Ins Diam Inferior vena cava

inspiration Diameter

IVC Exp Diam Inferior vena cava

expiration Diameter

MV Diam Mitral Valve Diameter

Measurement 2D Distance
EPSS Distance between point E
and Interventricular
Septum when mitral valve
is fully open

AV Diam Aortic Valve Diameter

AV Cusp Sep Aortic Valve Cusp Separation

9-54Measurement
 Type Item Description Method

TV Diam Tricuspid Valve Diameter

PV Diam Pulmonic Valve Diameter

EDA End-Diastole Area

ESA End-Systole Area

MVA Mitral Valve Area

AVA Aortic Valve Area

2D Area
TVA Tricuspid Valve Area

PVA Pulmonic Valve Area

LA Area Left Atrium Area

RA Area Right Atrium Area

Simpson /

Study Mod. Simpson / /

Cube/Teich /

M-Mode Measurements
The following measurements are located in the Exam Calcs for the Abdomen exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements are listed on the following pages.

Type Item Description Method

RVAWd Right Ventricle Anterior Wall

end-diastole
Measurement M Distance

RVIDd Right Ventricle Anterior Wall

Measurement9-55
 Type Item Description Method

end-systole

IVSd Interventricular Septal

Thickness at end-diastole

LVIDd Left Ventricular Internal

Diameter at end-diastole

LVPWd Left Ventricular Posterior

wall thickness at
end-diastole

IVSs Interventricular Septal

Thickness at end-systole

LVIDs Left Ventricular Internal

Diameter at end- systole

LVPWs Left Ventricular Posterior

wall thickness at end- systole

LA Diam Left Atrium Diameter

M Distance
Ao Root Diam Aorta Root Diameter

EPSS Distance between point E

and Interventricular
Septum when mitral valve
is fully open

MV Cusp Sep Mitral Valve Cusp Separation

AV Cusp Sep Aortic Valve Cusp Separation

LVET Left Ventricle Ejection Time

M Time
LVPEP Left Ventricle Pre-Ejection
Period

9-56Measurement
 Type Item Description Method

MV D-E Exc Mitral valve D-E excursion

MV C-O Dur Mitral valve C-O Duration

MV D-E Slope Mitral valve D-E Slope

M Slope
MV E-F Slope Mitral valve E-F Slope

Study Cube/Teich /

Doppler Measurements
The following measurements are located in the Exam Calcs for the Cardiology exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements are listed on the following pages.

Type Item Description Method

MV VTI /

MR VTI /

LVOT VTI /

AV VTI /
Measurement Trace
AR VTI /

TV VTI /

RVOT VTI /

PV VTI /

Measurement MV PHT / PHT

Measurement9-57
 Type Item Description Method

AV(PHT) /

AR PHT /

PVA(PHT) /

MR Vmax /

LVOT Vmax /

AV Vmax /

AAo Vmax /

DAo Vmax /
Single Point Velocity
TV Vmax /

PV Vmax /

MPA Vmax /

RPA Vmax /

LPA Vmax /

MV Dec Time /

AV Acc Time /
Acceleration
AV Dec Time /

PV Acc Time /

Study Operations
Left Ventricular Function

9-58Measurement
A group of measurements is to estimate LV Function at diastole and systole phase under B
and M mode, with calculations list as following:

Calc Item Description Formulas

SV Stroke Volume SV(ml)=EDV(ml)-ESV(ml)

CO Cardiac Output CO(l/min) = SV(ml)×HR(bpm)/ 1000

EF Ejection Fraction EF(%) = SV(ml)/ EDV(ml)

SI SV Index SI(No unit) = SV(ml)/ Body Surface Area

(m2)

CI CO Index CI(No unit) = CO(l/min)/Body Surface

Area (m2)

FS Fractional FS (No unit) = (LVIDd (mm) – LVIDs

Shortening [mm]) / LVIDd (mm)

MVCF Mean Velocity MVCF = (LVIDd(mm) – LVIDs(mm)) /

of Circ Fiber (LVIDd (mm) × LVET (ms) / 1000)
Shortening

Cube

 Study Items

Measure Items Description Method

Diastole Diastole 3 Consecutive Line

Measurement

Systole Systole 3 Consecutive Line

Measurement

LVIDd Left Ventricular 2D Distance

Internal Diameter at
end- diastole

Measurement9-59
LVIDs Left Ventricular 2D Distance
Internal Diameter at
end- systole

 Study Result

Result Description Formulae

IVSd Interventricular Septal /

Thickness at end-diastole

LVIDd Left Ventricular Internal /

Diameter at end-diastole

LVPWd Left Ventricular Posterior wall /

thickness at end-diastole

IVSs Interventricular Septal Thickness /

at end-systole

LVIDs Left Ventricular Internal Diameter /

at end- systole

LVPWs Left Ventricular Posterior wall /

thickness at end- systole

EDV(Cube) End-diastolic Left Ventricular

Volume
EDV(ml)= LVIDd(cm)3

ESV(Cube) End-systolic Left Ventricular

Volume
ESV(ml)= LVIDs(cm)3

SV(Cube) Stroke Volume See LV Function part

CO(Cube) Cardiac Output

EF(Cube) Ejection Fraction

9-60Measurement
FS(Cube) Fractional Shortening

MVCF(Cube) Mean Velocity of

Circumferential Fiber
Shortening

SI(Cube) SV Index

CI(Cube) CO Index

LV Mass(Cube) Left Ventricular Mass LV Mass (g) = 1.04 ×

((LVPWd(cm) + IVSd(cm) +
LVIDd(cm))3- LVIDd(cm)3) -
13.6


Mod. Simpson

 Study Items

Measure Items Description Method

LVLd apical Left Ventricular Long-axis Length at 2D Distance

End-diastole in apical view

LVLs apical Left Ventricular Long-axis Length at 2D Distance

End-systole in apical view

LVAd sax MV Left Ventricular Area at Mitral Valve 2D Area

level at End-diastole in Short-axis view

LVAs sax MV Left Ventricular Area at Mitral Valve 2D Area

level at End-systole in Short-axis view

LVAd sax PM Left Ventricular Area at Papillary Muscle 2D Area

level at end-diastole in short axis view

LVAs sax PM Left Ventricular Area at Papillary Muscle 2D Area

level at end-systole in short axis view

 Study Result

Measurement9-61
Result Description Formulae

EDV End-diastolic A*
Left Ventricular
Volume

ESV End-systolic Left B*

Ventricular
Volume

SV Stroke Volume

CO Cardiac Output

LV Function part See

EF Ejection Fraction
LV Function part

SI SV Index

CI CO Index

A* stands for:

B* stands for:

Operating Procedures

1. In Calc Menu->“EF Volume”->“Mod. Simpson”

2. At view of Apical Long-Aixs, measure

LVLd Apical

LVLs Apical
3. At short-axis view at mitral valve level, measure

LVAd sax MV

LVAs sax MV

4. At short-axis view at papillary muscle level, measure

LVAd sax PM

9-62Measurement
 LVAs sax PM

5. Finally, all results in above table will show up

Mitral Valve Area (MVA)

 Study Items

Measure Items Description Method

LVOT Diam Left Ventricular Outflow Tract Diameter 2D Distance

LVOT VTI Left Ventricular Outflow Tract D Trace

Velocity-Time Integral

MV VTI Mitral Valve Velocity-Time Integral D Trace

 Study Result

Except above measurement result, also the calc result are shown as follow:

Result Description Formulae

MVA Mitral Valve Area

Aortic Valve Area (AVA)

 Study Items

Measure Items Description Method

LVOT Diam Left Ventricular Outflow Tract Diameter 2D Distance

LVOT VTI Left Ventricular Outflow Tract D Trace

Velocity-Time Integral

AV VTI Aortic Valve Velocity-Time Integral D Trace

 Study Result

Except above measurement result, also the calc result are shown as follow:

Measurement9-63
Result Description Formulae

AVA Aortic Valve Area

9.10 Vascular
Describes how to perform vascular measurements and calculations.

Vascular calculation package includes Carotid, LEA, LEV, UEA, UEV, and TCD.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <Vascular> measurement library, and press the measurement item.

B-Mode Measurements
9-64Measurement
The following measurements are located in the Exam Calcs for the Abdomen exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (Vas Diam, Vas Area, Diam Reduction, and Area Reduction) are listed on
the following pages.

Example:
Vas Diam
1. Select “Vas Diam”; an active caliper displays.
2. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position P.
b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
3. To complete the measurement, exit measurement mode or start another
measurement.
4. The system displays the Vas Diam value in the Results Window.

Type Item Description Method

Vas Diam Vascular Diameter

Diam Resid Diameter Residue 2D Distance

Diam True Diameter True

Measurement
Vas Area Vascular Area

Area Resid Area Residue 2D Area

Area True Area True

Diam Reduct. Diameter Reduction Diam Reduct=(Diam

True-Diam Resid)/Diam True
Calculation
Area Reduct. Area Reduction Area Reduct=( Area True-
Area Resid)/ Area True

Doppler Mode Measurements

The following measurements are located in the Exam Calcs for the Abdomen exam

Measurement9-65
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements are listed on the following pages.

Artery Example:
STA
1. Select “CCA”; an active caliper displays.
2. Click measure methods at measure method list: Two Point, Manual, and Semi-Auto.

2PT (2 Point)

a. Choose “Two Point”.

b. There are two vertical lines and a horizon line on the screen, and there is one active
ring at the junctions of the vertical line and horizon line. And there is a active ring on
another vertical.
c. To measure Doppler Tow Point(RI), drag the two rings to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement.

Manual (Manual Trace)

a. Choose “Manual”
b. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
c. To confirm the start point, drag the cross point and loose up. The horizon line
disappeared.
d. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
e. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

S-Auto (Semi-Auto Trace)

a. Choose “Semi-Auto”
b. There are two vertical lines and one horizon line displayed on the screen.
c. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

Type Item Description Method

CCA Common Carotid Artery

2 Point, Manual Trace,
Measurement
Semi-Auto Trace
ICA Internal Carotid Artery

9-66Measurement
 Type Item Description Method

ECA External Carotid Artery

Bulb Bulb

Vert A Vertebral Artery

Subclav A Subclavian Artery

Axill A Axillary Artery

Brachial A Brachial Artery

Ulnar A Ulnar Artery

Radial A Radial Artery

Innomi A Innominate Artery

C.Iliac A Common Iliac Artery

IIA Internal Iliac Artery

Ex.Iliac A External Iliac Artery

CFA Common Femoral Artery

PFA Profound Femoral Artery

SFA Superficial Femoral Artery

Pop A Popliteal Artery

TP Trunk A Tibioperoneal Trunk Artery

Peroneal A Peroneal Artery

P. Tib A Posterior Tibial Artery

Measurement9-67
 Type Item Description Method

A. Tib A Anterior Tibial Artery

Dors. Ped A Dorsalis Pedis Artery

Subclav V Subclavian Vein

Axill V Axillary Vein

Cephalic V Cephalic Vein

Basilic V Basilic Vein

Brachial V Brachial Vein

Ulnar V Ulnar Vein

Measurement Peak Velocity
Radial V Radial Vein

C.Iliac V Common Iliac Vein

IIV Internal Iliac Vein

Ex.Iliac V External Iliac Vein

Femoral V Femoral Vein

CFV Common Femoral Vein

SFV Superficial Femoral Vein

PFV Profound Femoral Vein

Measurement Saph V Saphenous Vein Peak Velocity

SSV Small Saphenous Vein

Pop V Popliteal Vein

9-68Measurement
Operation procedures:
Artery

1. Select desired Artery in Calc Menu

2. Adjust method used for measurement
3. Finish measurement, then related measurement results will appear.

Vein

1. Select desired Vein in Calc Menu

2. Finish measurement, then related measurement results will appear.

9.11 Urology
Describes how to perform Urology measurements and calculations.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <Urology> measurement library, and press the measurement item.

Measurement9-69
B-Mode Measurements
The following measurements are located in the Exam Calcs for the Urology exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (Renal study, Prostate study, Adrenal study, Seminal study, Bladder study)
are listed on the following pages.

Example:
Renal length, width, and height
Each of these is a standard distance measurement. Length and height are typically
measured in the sagittal plane. Width is measured in the transverse plane.
1. Select the appropriate orientation (side): “Right” or “Left”.
2. Select “Renal L, Renal W, or Renal H”. An active caliper displays.
3. To measure the distance, there are two methods:
a. Press any point P on the image, the end which is closed to P will be moved to
position
9-70Measurement
 b. Drag any end point to position P in the image, and loose up, the end point will be
moved to position P.
4. To complete the measurement, exit measurement mode or start another
measurement. The system displays the Renal L value in the Results Window.
5. To measure the second and the third measurement, please repeat step 2~4. After
finishing the three measurement, there will be Renal Volume calculated in the result
window.

Type Item Description Method

Renal L Renal Length

Renal H Renal Height

Renal W Renal Width

Prostate L Prostate Length

Prostate H Prostate Height

Prostate W Prostate Width

Seminal L Seminal Length

Measurement Seminal H Seminal Height 2D Distance

Seminal W Seminal Width

Pre-V BL L Pre-Void Bladder Length

Pre-V BL H Pre-Void Bladder Height

Pre-V BL W Pre-Void Bladder Width

Post-V BL L Post-Void Bladder Length

Post-V BL H Post-Void Bladder Height

Post-V BL W Post-Void Bladder Width

Measurement9-71
 Type Item Description Method

Adrenal L Adrenal Length

Adrenal H Adrenal Height

Adrenal W Adrenal Width

Doppler Mode Measurements

The following measurements are located in the Exam Calcs for the Urology exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (Abd Aorta, Main Renal A, Arcuate A, Segmental A, Interlobar A, Renal V)
are listed on the following pages.

Artery Example:

Main Renal A

1. Select “Main Renal A”; an active caliper displays.

2. Click measure methods at measure method list: Two Point, Manual, and Semi-Auto.

2PT (2 Point)

a. Choose “Two Point”.

b. There are two vertical lines and a horizon line on the screen, and there is one active
ring at the junctions of the vertical line and horizon line. And there is an active ring on
another vertical.
c. To measure Doppler Tow Point (RI), drag the two rings to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement.

Manual (Manual Trace)

a. Choose “Manual”
b. There are one vertical line and one horizon line crossed, and there is a cross point at
the junction.
c. To confirm the start point, drag the cross point and loose up. The horizon line
disappeared.
d. To trace the spectrum, drag the cross point.
Note: To erase the trace line, drag the cross point to the left direction.
e. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

S-Auto (Semi-Auto Trace)

9-72Measurement
a. Choose “Semi-Auto”
b. There are two vertical lines and one horizon line displayed on the screen.
c. To trace the semi-auto spectrum, move the two vertical lines to confirm the position.
d. To complete the measurement, exit measurement mode or start another
measurement. And spectrum value will be displayed in the result window.

Type Item Description Method

Abd Aorta Abdomen Aorta

Main Renal A

2 Point, Manual Trace,

Arcuate A
Semi-Auto Trace
Measurement
Segmental A

Interlobar A

Renal V Peak Velocity

Measurement9-73
9.12 Pediatrics
Describes how to perform Pediatrics measurements and calculations.

Introduction
1. Under Freeze mode, go to “Scan” page, and press “Calc” button to start an
application measurement.
2. Switch to <ORTH> measurement library, and press the measurement item.

B-Mode Measurements
The following measurements are located in the Exam Calcs for the Pediatrics exam
category. Some measurements are only available in certain Exam Calcs. Those specific
measurements (HIP (BA), HIP (AB)) are listed on the following pages.

Example:
Each of these is an angle measurement with tow angles calculated.
HIP (BA), HIP (AB)
1. Select the appropriate orientation (side): “Right” or “Left”.
2. Select “HIP (BA) or HIP (AB)”. An active line displays, and there is a fulcrum on the
line.
3. There are two crossed line on the screen. Through drag or press the end point of the
line to measure the angle.
a. Press the end point of the line
Press any point P on the image, the end point closed to P will be moved to P.
b. Drag the end point of the line

9-74Measurement
 Drag the end point to position P, loose up, the movement is finished.
4. To complete the measurement, exit measurement mode or start another
measurement. And the angle value will be displayed in the result window.

Type Item Description Method

HIP(BA) HIP beta to alpha angle

Measurement 2D Angle
HIP(AB) HIP alpha to beta angle

This page was intentionally left blank.

Measurement9-75
 10 Patient Data
Management

An exam record consists of all information and data of one exam.

An exam record consists of the following information:

 Patient basic information and exam data
 Image files
 Reports

NOTE: 1. DO NOT use the internal hard drive for long-term image storage. Daily
backup is recommended. External storage media is recommended for
image archive.

2. The system patient database space is limited, please back up or clear

patient data in time.

3. Wisonic is not responsible for lost data if you DO NOT follow suggested
backup procedures.

10.1 Patient Information Management

10.1.1 Enter Patient Information

The general patient information and exam information are entered through the Patient Info
screen

After completion of patient information entry, click “Confirm” to save the patient
information to the patient data.

10.1.2 Patient Information Setting

Open “Setup→System→General”, and then set the following in the Patient Info area.
Here, you can select if to display patient ID, name, hospital, age or operator in the screen.
 Setting patient information display

Patient Data Management10-1

10.2 Image File Management
You can store the image files either in the patient database in the system, or to external
memory devices. For a saved image, you can perform operations like image reviewing,
analyzing and demonstration (Demo).

10.2.1 Memory Media

System supported memory media including:

 System hard disk
 USB memory devices: USB flash drive, removable USB hard disk

10.2.2 Image File Formats

The system supports two types of image file formats: system-relevant and PC-compatible.
System-relevant formats:
 Single-frame image file (SFR)
Refers to single-frame static image files not to be compressed; you can perform
measurements and comments adding on this type of files.
 Cine file (Loop)
System-defined multi-frame file format; you can perform manual or auto cine
review, and perform measurements or add comments for the reviewed images.
After you open a stored cine in file, the system automatically enters cine review
status.

The system can save SFR files as well as BMP, JPG, PNG or DCM files, or save loop
cine files as AVI, DCM files. The system can also open SFR, JPG, BMP and Loop
files.

10-2Patient Data Management

 PC-compatible formats:
 Screen file (BMP)
Single-frame file format, used to save the current screen, non-compressed
format.
 Screen file (JPG)
Single-frame file format, used to save the current screen in the compressed
format; you can set the compression ratio.
 PNG: Portable Network Graphic
Single-frame file format, used to save the current screen, non-compressed
format.
 Multi-media files (AVI)
Multi-frame file format, general cine file format.
 Multi-media files (MP4)
Multi-frame file format, general cine file format.
 DICOM files (DCM)
DICOM standard files format, single-frame or multi-frame format, used to record
patient information and images.

10.2.3 Image Storage Preset

Set single frame export format
 Format
You can select the image export format in the “Send To” dialogue box.
Set cine saving length
Open “Setup→System→Imaging”, set the cine saving length in the “Cineloop
capture”.

10.2.4 Saving Images to the System

To save a single-frame image or a cine in the system:

(1) Touch on the screen, and a single frame image will be saved

(2) Touch on the main interface directly, and a cine will be saved.

Patient Data Management10-3

 (3) Touch on the main interface directly, and a cine will be saved.

10.2.5 Image Review and Analysis

You can review and analyze the stored images (only refer to the images stored in the
system default path).

10.2.5.1 Review an Image

You can review all images stored in an exam, and send, delete or analyze the stored
images.
To enter Review:

 Touch to enter Review screen. The system displays the images

stored in this exam of the current patient (if there is no current patient information,
you can review the images of the latest exam).
To exit Review:

Directly click on other pages, such as "Scan".

Basic operations
1. Click on an exam record in the Exam History area. The selected item is highlighted.

2. Open a cine and then you can click Patient to view patient information.

3. Click a thumbnail to view and analyze an image.

The function buttons are described as follows:

 Exam History:
You can select one certain exam from the exam directory to review the images.

 the Review screen default displays the images of the current exam

 If previously examined image is opened, it displays this specific patient's

images.

 Patient Info:
Click to enter the Patient Info screen, you can review or edit the
currently-selected patient information.
 Image operations：
Select: Select multiple images or multiple exams.

Cancel: After clicking the Cancel, the button changes into Select, you can cancel
all the selections by clicking Cancel.
10-4Patient Data Management
 Send To: Click to send the selected image to other location, DICOM server,
printer and etc.

Delete: Click to delete the selected image.

Backup: Click to backup exam.

10.2.5.2 Image Analysis

For the image analysis, you can view, zoom, perform post processing and measurements,
add comments and perform cine (multi-frame) review for a stored image. The operation
steps are the same as those for real-time scanning; please refer to relevant sections for
details.
To enter image analysis:
 In the image scanning status, click “Freeze” to enter the Frozen status; or
 In the Review status, select a thumbnail and click Open or directly click the
selected thumbnail to open the image. Click "Scan" to enter image analysis.
To exit the image analysis:
 Touch “UnFreeze” to exit and enter the real-time scanning status.
 Touch “Review” to exit from the image analysis to the Review status.

10.2.6 Sending Image File

On the image screen, select a stored image thumbnail (Click on the different image to
select more than one at the same time), click “Send” button, the image can be sent to
the external devices.
In the Review screen, click “Send” to send the selected image to the external
devices.

See the figure below.

Patient Data Management10-5

  For external memory devices (e.g. USB memory devices, or network storage
server):

a) PC format transfer: JPG/ AVI, BMP/ AVI, PNG/ AVI. Where a single-frame
image is exported as JPG, PNG or BMP, and the cine file exported as AVI.

b) DCM format transfer: DCM (including single-frame DCM and multi-frame

DCM).

c) You can also select to export report in PDF format.

 For a video printer, send images to the video printer connected with the system.
For a graph/ text printer, send the images to the default graph/ text printer.

10.3 Report Management

Report storage:

The exam reports are stored under the directory of the exam of the patient.

10-6Patient Data Management

 Exporting and sending a report

In the Review screen, click "Send" to send patient data to an external memory device,
you can choose if reports are exported with images. See the figure below.

To export the report:

(1) Check “Include report data” on the screen.

Printing report
Use a connected graph/text printer to print a report. Please refer to “Peripheral
PresePeripheral Preset” for details about default report printer setting.

Patient Data Management10-7

10.4 Patient Data Management (Review)

10.4.1 Viewing Patient Information

Dataflow

Select the data source of patient data, the system patient database is default.

Patient list

Display patient information, image and cine.

Patient Info

Select an exam of a patient, open an image and click Patient to display the patient
information of this exam.

10.4.2 Searching a Patient

(1) Select the data source.

(2) Enter the keyword in accordance with what you want, and the system searches
and displays the results in the patient list.

(3) When you select a patient in the patient list, the images of this patient will be
displayed on the right side of the screen.

10.4.3 Patient Data Management

Send To

The system supports to send data to external memory, or DICOM server or send
images or reports to printers to print.

 Select multiple exams, the “Send " button is used to send exam data or images
of the selected exam.
 Select multiple images, the "Send” button is used for sending selected images.

 Send patient exam data to USB devices, network storage.

 Send images to USB devices, disc, DICOM storage server, DICOM printer,
video printer, text/ graph printer, network storage.

 Send images with report to USB devices, and network storage.

 Format transfer is available when sending images to USB devices, network

storage.

10-8Patient Data Management

 Delete

To delete the selected patient or exam data, click the “Delete” button on the right side
of the patient list. However, you cannot delete patient data being printed, exported or
sent, or delete the current exam.

 Select exams, click “Delete" button to delete the selected exam.

 Select image, click “Delete" button to delete the selected images.
Backup/ Restore

You can back up the selected patient data to the system-supported media in order to
view it on computers, or restore the patient data to the system from an external
media.

Backup: click to export the selected patient data to the system-supported media.

Restore: click to import the patient data from an external media. If no external data
source is connected, then the button is unavailable.

Patient Data Management10-9

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10-10Patient Data Management

 11 Cloud Share

Warning: this system provides the image of cloud sharing services for clinical reference
only, do not for diagnosis, do not responsible for the correctness of the results of the
diagnosis.

This chapter describes how to use the cloud share function, please ensure that the
network can be connected to the internet.

11.1 Turn ON or OFF the Cloud

Click Setup to enter “System-General”, while the Cloud settings is on the bottom right of
corner, check mark the “Cloud Upload” will upload exam data to the internet(details are
shown in Preset chapter)

Cloud Share11-1
11.2 QR code for Exam share
Exam share is upload to cloud, what can be share are:

 Basic Information of patient (includes: Name, Age, Sex)

 Exam Information of patient

 Pictures during the examination

 Measured data, comments, bodymarks in the pictures.

Followings are not support in cloud:

 Full screen picture

 Cine files

After turn On the Cloud Upload and QR Code Display, back to main screen:

1. Create a new patient, scan on body.

2. Click Save Img, and picture will be uploaded to cloud server, then QR Code is
generated at the top right of screen.

3. Review page will show the uploaded image:

11-2Cloud Share
A green cloud shown at the top left corner of the thumbnail indicating the picture uploaded
already.

Note:

1) Only Single Frame image can uploaded.

2) Click can show more function of an exam, Click QR Code can show the QC
code of this exam.

11.3 View share data with mobile phone

After get a QR code:

1. Scan the QC code with mobile phone by the internet browser apps, then can view the
images without any patient information as below:

Cloud Share11-3
2. User can click the thumbnail to enlarge the pictures

3. After zoom in the picture, if want to review more information and report, it need to login
in. Click the log in button:

4. Input correct name and exam date (format 20150101),and the login in click, can
review the report of this exam.

11-4Cloud Share
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Cloud Share11-5
 12 wiLearn Education
Center

12.1 wiLearn Education Center

The function of wiLearn provide varied education resources, to help the users to
study how to scan different objects and operate a biopsy.

Click wiLearn to enter wiLearn page：

The content of wiLearn function are as following：

wiLearn Education Center12-1

 Categories Contents
EMERGENCY ABDOMINAL AORTIC ANEURYSM, FAST, FEEL, PLEURAL
EXAMINATION, PREP
EPIDURAL AND EPIDURAL AND SPINAL
SPINAL
MSK CARPAL TUNNEL, INTERCARPAL SCAPHOLUNATE, KNEE
IN JECTION, SHOULDER1: SHOULDER SCANNING,
SHOULDER 2: BURSITIS, SHOULDER 3: TENDINOSIS,
SHOULDER 4: IMPINGEMENT, SHOULDER 6: INJECTION.
PAIN TREATMENT GREATER OCCIPITAL NERVE BLOCK, ILIONGUINAL
BLOCK, INTERCOSTAL BLOCK, SAPHENOUS NERVE
BLOCK, STELLATE GANGLION BLOCK, SUPRASCAPULAR
BLOCK, TAP BLOCK.
REGIONAL AXILLARY PL. BR., DISTAL N. ISCHIADICUS,
ANESTHESIA INTERSCALENE PL. BR., N. FEMORALIS, PROXIMAL N.
ISCHIADICUS, SAPHENOUS NERVE BLOCK,
SUPRACLAVICULAR PL. BR., TAP.
RESCUE BLOCKS AXILLARY BLOCK, MEDIANUS NERVE, RADIALIS NERVE,
ULNARIS NERVE.
VASCULAR 1.A CENTRAL VEINS EVALUATION, 1.B CENTRAL VEINS,
ACCESS 2.A PVA ARM EVALUATION, 2.B PVA ARM, 3.A PVA
FEMORAL EVALUATION, 3.B PVA FEMORAL VEIN,V.
AXILLARIS, V.FEMORALIS, V.JUGULARIS INTERNA

Double click each content to enter detail operation page, follows each step in the
page to scan or biopsy. Single click the picture or movie will zoom out them, and single
click them again, the picture or movie will be in normal size.

12-2wiLearn Education Center

 12.2 Install & upgrade

Click icon, and pop up install & upgrade button:

wiLearn Education Center12-3

Click install & upgrade button, choose the installing document:

Click OK button to install and upgrade, and pop up the following page:

12-4wiLearn Education Center

After restarting, we finished the install and upgrade function。

Click icon to enter ”setup-maintenance” page, check the version and date of
wiLearn.

wiLearn Education Center12-5

 This page was intentionally left blank.

12-6wiLearn Education Center

 13 Setup

Preset Menus provides the following functionality:

 System. View and update general system configuration settings, and video settings, and
key settings, and authority management.
 Exam. Configure exams under each probe and specific application and user-specific
settings.
 Measure Tool. Set measure related tools and formula.
 Peripheral. Provide settings to printer
 Network. Define connection and communication setup, including exam dataflow
information.
 Demo: Play Demo.
 Maintenance. Customize preset data, look up system info, and provide service related
functions.
To access these functions, Click the setup Icon on the screen then select the appropriate tab
menu to configure.

13.1 System Preset

System setup, support setting page:

Page Meaning/Purpose

To set the hospital name, language, time zone, time format, system
date/time, logo and so on.
General

To set patient information and cloud.

Imaging To set some general parameters in imaging modes.

Security To set the user account control relevant information.

13.1.1 General

General page via “Setup→ System →General”, items are listed as follows:

Setup13-1
 Region Items Meaning/Purpose

Hospital Name Set hospital name

Hospital Logo Load hospital Logo

Location
Department Set department

Language Select display language

13-2Setup
 Region Items Meaning/Purpose

Time format Select time format

Date format Select date format

Time&Date Time zone Select time zone

System date Adjust system date

System time Adjust system time

Hospital name Whether display in the main interface

Patient name Whether display in the main interface

Patient Information Patient ID Whether display in the main interface

Patient age Whether display in the main interface

Operator Whether display in the main interface

Sync Cloud Set cloud sync cloud active

Cloud
QR code display Display QR code on screen

Thumbnail Set Review display Thumbnail

Review
Table Set Review display exams list

13.1.2 Image

Image page via “Setup→System→ Image”.

Setup13-3
 Region Items Description

Prospective time Input time

Cineloop
Capture
Retrospective Input time

When no probe connects, system assign default

Default probe
probe on screen

Image Control & Horizontal Scale Horizontal scale on screen

Display
Unfreeze clear Bodymark, Comment

Auto freeze Set a time to enter freeze

13-4Setup
 Region Items Description

Sleep Set a time to enter sleep mode

HDMI output mode Set the output area size

Brightness Can set the screen brightness

Can set the sound, Beep after “Save” complete,

Volume
QUERTY Keyboard Beep
Others
Beep after "Save
There will be a Beep when Save Img is finished
" complete

QUERTRY
There is a sound when pressing the keyboard
Keyboard Beep

13.1.3 Security

Open the Security page via “Setup→System→ Security”.

Security page provides user to admin the system if in need.

 local account access: to open the local account login page

 cloud account access: to open the cloud account login page

 New: to create a new user

 Delete: to delete a user

 Change password: to change password to a new one

Setup13-5
13.1.3.1 System Login
If access control has been set by the system administrator, you can access the data in the
system only after you log on the system.

You need to enter user name and password in the following cases:

 Before entering the system

 Changing user

As long as the system is in the working status, you can enter the above screens without
entering user name and password repeatedly.

 Log on the system:

(1) If the system requires you to log on the system before you access the data, you
can see the following dialogue box.

13-6Setup
 (2) Select the user name in the drop-down list of User Name.

(3) Enter password and click Login.

2. Log out the system:

(1) To log out the current user and change to another user, click at the upper
right corner of the screen to pop up the following dialogue box:

(2) Click Change User to pop up the Login dialogue box.

(3) Enter the user name and password in the field box.

13.1.3.2 Add/ Delete a User

The system administrator can add and delete a user, while the operator can’t.

Setup13-7
13.1.3.3 Change Password

The system administrator can modify password of all users.

The operator can only modify his/her own password.

There are two ways to modify password: modify it on “Admin” page or on “Session
Manage” dialogue box.

13.2 Exam
Open “Setup-Exam” selection screen to enter Exam Preset screen.

13.2.1 Exam Preset

Preset page via “Setup→Exam→ preset”.

13-8Setup
 Set the default exam mode

Selected a probe, and then select an exam mode, click the default button to set the
exam for the default mode of the probe.

 Delete exam mode

Click the Delete button to delete a customized exam.

 Up/Down

Select an exam mode, click move up or down, this place of exam in the list move up
or down.

13.2.2 Application configuration

Application page via “Setup→Exam→ Application”.

Setup13-9
After an exam mode is selected,

Click a selection in Application list, you can select a new application for the exam
mode in the popped up drop-down list.
Selected a line, click export, this exam mode of data can be send to the U disk.
Click export all, all exams can be exported to the U disk.
Click import, the exam data of the U disk can be import to the machine.

Tips: loading or pasting exam setup data will overwrite previous presets and can't be
reverted.

13.3 Measure Tool

The Measure Tool Config screen is used to set measure related tools and formula.

13-10Setup
 Region Items Description

ICA/CCA Config different measure direction.

Basic
Cardiac Function Config different calculate formula.

Height/Weight
Config measure unit
Units && Units
Formula
BSA Formula Config BSA formula

13.4 Peripheral Preset

The Peripheral Config screen is used to set up printer and Input& Display.

Setup13-11
 Printer setting

The settings of a printer include print service and print driver.

NOTE: If you use the user-defined key to print, the user-defined printer type shall be
consistent with that of the default printer.

 All Printer

 Install: click to start install a new printer.

13-12Setup
  Delete: Delete printer from the list.

 Property: Detailed info about printer

 Text & Graphic Printer

 Default: Make the selected printer as a default printer

 Setting: Pop up the paper printer setting window

 Img Print Layout: Layout for image print setting

 Video Printer

Setup13-13
  Default: Make the selected printer as a default printer

 Setting: Pop up the paper printer setting window

 Print Layout: Horizontal or Vertical

13.5 Network

13.5.1 TCP/IP
Open the TCP/IP page via “Setup → Network → TCP/IP”.

Set the items as followed:

TCP/IP
Name Illustrations
System Name The name of operation system, can only be reviewed but not
be modified
Network Adapter The name of network adapter, including wireless network and
local network.

13-14Setup
 Physical Address The physical address of the network adapter. There is adapter
name before physical address.
IP address The IP address of the adapter, including DHCP and Static.
DNS address The DNS address of the adapter, including DHCP and Static.
OK Save the modifications.
Cancel Cancel the modifications

Wireless Networks
Name Illustrations
SSID The SSID list including all the wireless networks connected
successfully.
Security Type The Security Type of the wireless networks, including Open
system, Shared key, WPA-Personal, and WPA2-Personal.
Encryption Type The Encryption Type of the wireless networks, including TKIP
and AES.
Security key The Security key of the wireless networks.
Connect Check “Connect automatically”, the wireless network will be
automatically connected automatically the next time start up the system.
Remove Click Remove button, there is a confirm page pop out, if choose
Yes button, the password is needed the next time connect the
wireless network.

13.5.2 Network Storage.

Open the Network Storage page via “Setup → Network → NetworkStorage”.

Setup13-15
 The items as followed:
Name Illustrations
Servie Name The name of a network storage.
Device/IP IP address or device name of the network storage server.
Shared Dir The name of shared dir.
User Name User name of the network storage server.
Password Password of the network storage server.

 Create: To create a network storage service.

 Verify: To verify whether the service is available.

 Reset: Clear all the content filled.

 Update: Modify the service content.

 Browse: View the network storage server.

 Delete: Delete a service.

 Set as Default: Set a service to be default service.

 Ping: Test the network to storage server status.

13-16Setup
13.5.3 DICOM Local
Open the DECOM Local page via “Setup → Network → DICOM Local”.

DICOM Local Setting items are described as follows：

Name Description
AETitle Application entity title of the ultrasound system.
The AE title here should be the same with the one of the acceptable
SCU set in the server.
Port DICOM communication port, which should be the same with the
one in the server.
PDU Maximum PDU data package.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13.5.4 DICOM Server

To add or delete DICOM servers, or set IP address and name for the DICOM server.

a) Touch to enter the Setup menu.

b) Select “Network”; select “DICOM Server” to open the screen, as shown in the
figure below.

Setup13-17
 c) DICOM server setting items are described as follows:
Name Description
Device Name of the device supporting DICOM services
The device name is empty or has the same name, does not
support the increase.
IP Address IP address of the server.
IP address where there is an empty, no support for the
increase.
Ping You can ping other machines to verify connection after
entering the correct IP address. Also you can check the
connection of the already added server in the list.
Add Click to add servers to the device list.
Delete Click to delete the selected server(s) in the device list.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13.5.5 DICOM Storage

a) Touch “Setup” to enter the Setup menu.
b) Select “Network”; select “DICOM Storage” to open the screen, as shown in the
figure below.

13-18Setup
 c）DICOM server setting items are described as follows:

Name Description
Device After you set the server(s) in DICOM Server Setting, the name(s) will
appear in the drop-down list, select the name of the storage server.
Service Name The service name is set up here, as the storage service name for the
Station interface.
AETitle Application Entity title, here, it should be consistent with that of the
storage server.
Port Here, the port should be consistent with that of the storage server port.
Maximum Optional range 1-10
Retries
Interval Time(s) Reserved feature.
Timeout（s） Refers to time after which the system will stop trying to establish a
connection to the service. Value: 5－SD.
The step size is 5, and the default is 15.
Cine Region Option：Original、640*480
Compression Option：uncompressed、RLE、JPEG.
Mode
Compression When JPG is selected, the setting is allowed.

Setup13-19
Ratio Option：Lossless、Low、Medium、High。
Color Mode Option：Color、Mixed、Gray。
Allow If SCP supports this function, then select it.
Multi-frame
Max Frame-rate When Allow Multi-frame is selected, the setting is allowed.
Option：25、30、35、All。
Add Click to add servers to the Service List.
Cancel（Up） Empty this time to modify the data set.
Update Select an item in the service list, change the parameters in the above
area, and click [Update] to update the item in the service list.
Delete Click to delete the selected service in the service list.
Default Select one item from the service list, and click the default, which is
called a hook.
Only one item is set to the default service.
Verify Click to verify if the two DICOM application entities are normally
connected.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13.5.6 DICOM Worklist

a) Touch “Setup” to enter the Setup menu.
b) Select “Network”; select “DICOM Worklist” to open the screen, as shown in the
figure below.

13-20Setup
 c）DICOM server setting items are described as follows:
Name Description
Device After you set the server(s) in DICOM Server Setting, the name(s) will
appear in the drop-down list, select the name of the storage server.
Service Name The service name is set up here, as the worklist service name for the
Station interface.
AETitle Application Entity title, here, it should be consistent with that of the
worklist server.
Port Here, the port should be consistent with that of the storage server port.
Maximum Optional range 1-10
Retries
Interval Time(s) Reserved feature.
Timeout（s） Refers to time after which the system will stop trying to establish a
connection to the service. Value: 5－SD.
The step size is 5, and the default is 15.
MaxSearchNum The Maximum exam number to search
Add To create a new Dicom Storage service.
Delete To delete a Dicom Storage service.
Cancel To set all the content to default value.
Update: To modify a Dicom Storage service.
Default: To set a Dicom Storage service to default.
Verify To test the network to a Dicom Storage server.

Setup13-21
13.5.7 DICOM MPPS
a) Touch “Setup” to enter the Setup menu.
B) Select “Network”; select “DICOM MPPS” to open the screen, as shown in the figure
below.

c）DICOM MPPS setting items are described as follows:

Name Description
Device After you set the server(s) in DICOM Server Setting, the
name(s) will appear in the drop-down list, select the name of
the storage server.
Service Name The service name is set up here, as the MPPS service name
for the Station interface.
AETitle Application Entity title, here, it should be consistent with that of
the MPPS server.
Port Here, the port should be consistent with that of the storage
server port.
Maximum Retries The step size is 1,Optional range 1-10.
Interval Time(s) Value: 5－65.The step size is 5, and the default is 15.
Timeout（s） Refers to time after which the system will stop trying to

13-22Setup
 establish a connection to the service. Value: 5－65.
The step size is 5, and the default is 15.
Add Click to add servers to the Service List.
Cancel Empty this time to modify the data set.
Update Select an item in the service list, change the parameters in the
above area, and click [Update] to update the item in the service
list.
Delete Click to delete the selected service in the service list.
Default Select one item from the service list, and click the default,
which is called a hook.
Only one item is set to the default service.
Verify Click to verify if the two DICOM application entities are
normally connected.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13.5.8 DICOM QR
a) Touch “Setup” to enter the Setup menu.
b) Select “Network”; select “DICOM QR” to open the screen, as shown in the
figure below.

c）DICOM QR setting items are described as follows:

Setup13-23
 Name Description
Device After you set the server(s) in DICOM Server Setting, the
name(s) will appear in the drop-down list, select the name of
the storage server.
Service Name The service name is set up here, as the QR service name for
the Station interface.
AETitle Application Entity title, here, it should be consistent with that of
the QR server.
Port Here, the port should be consistent with that of the storage
server port.
Maximum Retries The step size is 1,Optional range 1-10.
Interval Time(s) Value: 5－65.The step size is 5, and the default is 15.
Timeout（s） Refers to time after which the system will stop trying to
establish a connection to the service. Value: 5－65.
The step size is 5, and the default is 15.
Add Click to add servers to the Service List.
Cancel Empty this time to modify the data set.
Update Select an item in the service list, change the parameters in the
above area, and click [Update] to update the item in the service
list.
Delete Click to delete the selected service in the service list.
Default Select one item from the service list, and click the default,
which is called a hook.
Only one item is set to the default service.
Verify Click to verify if the two DICOM application entities are
normally connected.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13.5.9 Storage Commitment

c) a) Touch “Setup” to enter the Setup menu.
d) b) Select “Network”; select “Storage Commitment” to open the screen, as
shown in the figure below.

13-24Setup
 c）Storage Commitment setting items are described as follows:

Name Description
Device After you set the server(s) in DICOM Server Setting, the
name(s) will appear in the drop-down list, select the name of
the storage server.
Service Name The service name is set up here, as the storage commitment
service name for the Station interface.
AETitle Application Entity title, here, it should be consistent with that of
the storage commitment server.
Port Here, the port should be consistent with that of the storage
server port.
Maximum Retries The step size is 1,Optional range 1-10.
Interval Time(s) Value: 5－65.The step size is 5, and the default is 15.
Timeout（s） Refers to time after which the system will stop trying to
establish a connection to the service. Value: 5－65.
The step size is 5, and the default is 15.
Associated Storage Associated with the DICOM storage service.
Service
Add Click to add servers to the Service List.
Cancel Empty this time to modify the data set.

Setup13-25
 Update Select an item in the service list, change the parameters in the
above area, and click [Update] to update the item in the service
list.
Delete Click to delete the selected service in the service list.
Default Select one item from the service list, and click the default,
which is called a hook.
Only one item is set to the default service.
Verify Click to verify if the two DICOM application entities are
normally connected.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13.5.10 Dicom Print

e) a) Touch “Setup” to enter the Setup menu.
f) b) Select “Network”; select “Dicom Print” to open the screen, as shown in the
figure below.

13-26Setup
 c）Dicom Print setting items are described as follows:

Name Description
Device After you set the server(s) in DICOM Server Setting, the
name(s) will appear in the drop-down list, select the name of
the storage server.
Service Name The service name is set up here, as the dicom print service
name for the Station interface.
AETitle Application Entity title, here, it should be consistent with that of
the dicom print server.
Port Here, the port should be consistent with that of the storage
server port.

Setup13-27
 Maximum Retries The step size is 1,Optional range 1-10.
Interval Time(s) Value: 5－65.The step size is 5, and the default is 15.
Timeout（s） Refers to time after which the system will stop trying to
establish a connection to the service. Value: 5－65.
The step size is 5, and the default is 15.
Copies Optional range 1-5.
Setings Option：RGB、MONOCHROME2.
filmOrientation Option：LANDSCAPE、PORTRAIT.
Priority Option：High、Middle、Low.
Film Size Option：8IN×10IN、8_5IN×11IN、10IN×12IN、10IN×14IN、
11IN×14IN、11IN×17IN、14IN×14IN、14IN×17IN、24IN×24IN、
24IN×30IN、A3、A4.
Display Format Option ：STANDARD\1,1 、STANDARD\1,1 、 STANDARD\1,1 、
STANDARD\1,1 、 STANDARD\1,2 、 STANDARD\1,3 、
STANDARD\2,1 、 STANDARD\2,2 、 STANDARD\2,3 、
STANDARD\2,4 、 STANDARD\3,3 、 STANDARD\3,4 、
STANDARD\3,5 、 STANDARD\3,6 、 STANDARD\4,4 、
STANDARD\4,5 、 STANDARD\4,7 、 STANDARD\4,8 、
STANDARD\5,5 、 STANDARD\5,6 、 STANDARD\5,7 、
STANDARD\5,8 、 STANDARD\6,6 、 STANDARD\6,7 、
STANDARD\6,8 、 STANDARD\6,9 、 STANDARD\6,10 、
STANDARD\7,7 、 STANDARD\7,8 、 STANDARD\7,9 、
STANDARD\7,10 、 STANDARD\8,8 、 STANDARD\8,9 、
STANDARD\8,10.
Min Density Set the minimum density to print here.
Medium Type Option：PAPER、CLEAR FILM、BLUE FILM.
Destination Option：MAGAZINE、PROCESSOR.
Max Density Set the maximum density to print here
Trim Option：NO、YES.
Magnification Type Option：NONE、BILINEAR、CUBIC、REPLICATE.
Configuration Info Set the printed properties here.
Add Click to add servers to the Service List.
Cancel Empty this time to modify the data set.
Update Select an item in the service list, change the parameters in the
above area, and click [Update] to update the item in the service
list.
Delete Click to delete the selected service in the service list.
Default Select one item from the service list, and click the default,
which is called a hook.
Only one item is set to the default service.
Verify Click to verify if the two DICOM application entities are
normally connected.
OK Click to save parameter setting.
Cancel Click to cancel parameter setting.

13-28Setup
13.6 Demo
The Demo function is designed for you to play a demo.

13.6.1 Demo Page

Demo page via “Setup→ Demo”, screen is as follows:

Setup13-29
 Normal: Only play all the demo documents one time, and quit demo mode, enter to
scan mode.

 Repeat All: play all demo document by recycling. Until quit demo mode manually.

 Time interval: Could be set from 1-500 minutes, default value is 3 minutes. To
control the play speed.

 Add: to add a demo document to the play list.

 Copy: to add a demo document to the play list, and at the same time copy the
document to E disk.

 Delete: to delete the selected document in the list.

 Delete All: to delete all the document in the list.

 Start Demo: check the item, and press OK button to start playing a demo.

13.6.2 Demo Play Page

Paly a Demo, the controls are as followed:

13-30Setup
 : to continue playing.

 : to pause playing.

 : to go to previous picture.

 : to go to next picture.

 : to delete current picture.

 : to quit demo mode.

13.7 Maintenance
The Maintenance function is designed for you to update the system software or other
special functions. If you require these functions, please contact Wisonic Customer Service
Department or sales representative.

Through the menu, you can perform net update, remote desktop, system test, log
operation, etc.

13.7.1 About

In the Setup menu to enter the system information screen via

“System->Maintenance->About”.

Setup13-31
This screen displays the system software version and versions of other devices. You
cannot edit the information but only view them. The information varies depending upon the
system configurations and version.

13.7.2 Data Manage

In the Setup menu to enter the Data Manage screen via “System->Maintenance->Data
Manage”.

13-32Setup
13.7.2.1 Export

This function is used to write the selected setup data into a disk for backup. The format of
the data file is .zip.

Procedures:

1. Select some or all items in the “Export” field on the left side of the “Data Manage”
screen.

2. Click “Export” to open the Export Data screen.

3. Select the path to save the data.

4. Select the exported file and type as DTA and click OK.

13.7.2.2 Import
This function is used to import the existing setup data to the setup data memory of the
system. The system will reset and operate according to the setup preferences that were
imported.

Procedures:

1. Select an item in the Import field on the right side of the Manage Settings screen.

2. Click Import to open the Load Data screen.

3. Select the imported file and type as DTA.

Setup13-33
4. Click OK, a progress bar will appear and the setup data in DTA format is imported to
the specified path.

5. To restore the factory setup data, click Restore Factory on the right side of the screen.

You can use Export All, Import All, or Load Factory at the bottom of the screen to
export/import all setup data of the system or restore all factory setup data of the system.
The operating methods are the same as those mentioned above.

13-34Setup
 14 Probes and Biopsy

14.1 Probe
The system supports the following probes:

Probe
No. Illustration
Model

1. C8-3

2. C5-2B

3. C5-2

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 Probe
No. Illustration
Model

4. L10-5

5. L15-4NB

6. EV10-4

7. P4-1

8. P7-3

14-2Probes and Biopsy

 Probe
No. Illustration
Model

9. LH15-6

14.1.1 Name and Function of Each Part of the Probe

The basic structures and corresponding functions of probes are basically the same. The
following will take probe C5-2B as an example to illustrate.

No. Name Function

It converts the electrical signal into ultrasound signal,

making the sound beams focus in the given direction;
meanwhile, it will receive the ultrasound signal and then
<1> Probe head convert the received signal into electrical signal.

The lens on the surface is the acoustic lens. Apply

ultrasound gel on the acoustic lens.

File number:H-7100-00-40052 Probes and Biopsy14-3

 No. Name Function

Needle-guided
<2> bracket fix tabs and Used to mount the needle-guided bracket.
grooves

Used to transmit electrical signals between the probe

<3> Probe cable
body and connector.

Used to connect the probe to the ultrasonic diagnostic

<4> Probe connector
system.

Tips:

The probes’ structure marked <2> in the figure above may vary with the matched
needle-guided brackets.

14.1.2 Orientation of the Ultrasound Image and the

Probe Head

The orientation of the ultrasound image and the probe are shown as below. The “Mark”
side of the ultrasound image on the monitor corresponds to the mark side of the probe.
Check the orientation before the examination (Here takes linear probe as an example).

Mark

14.1.3 Procedures for Operating

14.1.3.1 Inspecting probes

Perform After Each Use

14-4Probes and Biopsy

Inspect the probe's lens, cable, casing, and connector. Look for any damage that would allow
liquid to enter the probe. If any damage is found, do not use the probe until it has been
inspected and repaired/replaced by a Wisonic Service Representative.
NOTE: Keep a log of all probe maintenance, along with a picture of any probe malfunction.

14.1.3.2 Environmental Requirements

Probes should be operated, stored, or transported within the parameters outlined below.
Operational Storage and transport
Temperature 0-40 °C -20-55 °C
Humidity 30%-85% (non-condensing) 30%-95% (non-condensing)
pressure 700hPa-1060hPa 700hPa-1060hPa

Ensure that the probe face temperature does not exceed the normal
Caution: 1. operation temperature range

14.1.3.3 Probe Safety

Handling precautions
Ultrasound probes are highly sensitive medical instruments that can
Warning 1 easily be damaged by improper handling. Use care when handling and
. protect from damage when not in use. DO NOT use a damaged or
: defective probe. Failure to follow these precautions can result in
serious injury and equipment damage.
The probe is driven with electrical energy that can injure the patient or user if live internal parts
are contacted by conductive solution:

File number:H-7100-00-40052 Probes and Biopsy14-5

 DO NOT immerse the probe into any liquid beyond the level indicated
Warning by the immersion level diagram. Refer to the immersion illustration in
the Probe Cleaning Process section. Never immerse the probe
: connector or probe adaptors into any liquid.
DO NOT drop the probes or subject them to other types of mechanical
shock or impact. Degraded performance or damage such as cracks or
chips in the housing may result.
Prior to each use, visually inspect the probe lens and case area for
cracks, cuts, tears, and other signs of physical damage. DO NOT use
a probe which appears to be damaged until you verify functional and
safe performance.
You must perform a more thorough inspection, including the cable,
strain relief, and connector, each time you clean the probe.
Before inserting the connector into the probe port, inspect the probe
connector pins. If a pin is bent, do not use the probe until it has been
inspected and repaired/replaced by a Wisonic Service Representative.
DO NOT kink, tightly coil, or apply excessive force on the probe cable.
Insulation failure may result.

Mechanical hazards
A defective probe or excessive force can cause patient injury or probe
Caution: 1. damage:
Observe depth markings and do not apply excessive force when
inserting or manipulating intercavitary probes.
Inspect probes for sharp edges or rough surfaces that could injure
sensitive tissue.
DO NOT apply excessive force to the probe connector when inserting
into the probe port. The pin of a probe connector may bend.

Special handling instructions

Protective barriers may be required to minimize disease transmission.
Caution: 1. Probe sheaths are available for use with all clinical situations where
infection is a concern. Use of legally marketed, sterile probe sheaths
is mandatory for intra-cavitary and intra-operative procedures. Use of
legally marketed, sterile, pyrogen free probe sheaths is REQUIRED
for neurological intra-operative procedures.
Instructions. Custom made sheaths are available for each probe. Each probe sheath kit
consists of a flexible sheath used to cover the probe and cable and elastic bands used to
secure the sheath.
Sterile probe sheaths are supplied as part of biopsy kits for those probes intended for use in
biopsy procedures. In addition to the sheath and elastic bands, there are associated
accessories for performing a biopsy procedure which are included in the kit. Refer to the

14-6Probes and Biopsy

biopsy instructions for the specific probes in the Discussion section of this chapter for further
information.
Reordering. To reorder sheaths, please contact your local distributor or the appropriate
support resource.
Devices containing latex may cause severe allergic reaction in latex
Caution: 1. sensitive individuals
Do not use pre-lubricated condoms as a sheath. In some cases, they
may damage the probe. Lubricants in these condoms may not be
compatible with probe construction.
DO NOT use an expired probe sheath. Before using probe sheaths,
verify whether the term of validity has expired.

Endocavitary Probe Handling Precautions

If the sterilization solution comes out of the endocavitary probe, please follow the cautions
below.
Sterile/sanitary sheaths are to be used on the probe during its actual
Caution: 1. use with patients. Wearing gloves protects the patient and operator.
Sterilant Exposure to Patient (e.g., Cidex)—Contact with a sterilant
to the patient’s skin or mucous membrane may cause an
inflammation. If this happens, refer to the sterilant’s instruction
manual.
Sterilant Exposure from Probe Handle/Connector to Patient (e.g.,
Cidex)—DO NOT allow the sterilant to contact the patient. Only
immerse the probe to its specified level. Ensure that no solution has
entered the probe’s handle before scanning the patient. If sterilant
comes into contact with the patient, refer to the sterilant’s instruction
manual.
Endocavitary Probe Point of Contact—Refer to the sterilant’s
instruction manual.

14.1.3.4 Probe handling and infection control

This information is intended to increase user awareness of the risks of disease
transmission associated with using this equipment and provide guidance in making
decisions directly affecting the safety of the patient as well as the equipment user.
Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the
patient by direct physical contact. Depending on the type of examination, this contact
occurs with a variety of tissues ranging from intact skin in a routine exam to recirculating
blood in a surgical procedure. The level of risk of infection varies greatly with the type of
contact.
One of the most effective ways to prevent transmission between patients is with single
use or disposable devices. However, ultrasound transducers are complex and expensive
devices that must be reused between patients. It is very important, therefore, to minimize

File number:H-7100-00-40052 Probes and Biopsy14-7

 the risk of disease transmission by using barriers and through proper processing between
patients.
Risk of Infection. ALWAYS clean and disinfect the probe between
Caution: 1. patients to the level appropriate for the type of examination and use
FDA-cleared probe sheaths where appropriate.
Adequate cleaning and disinfection are necessary to prevent disease
transmission. It is the responsibility of the equipment user to verify
and maintain the effectiveness of the infection control procedures in
use. Always use sterile, legally marketed probe sheaths for
intra-cavitary and intra-operative procedures.

Disinfect the probe and sterilize the needle-guided bracket

before and after an ultrasound-guided biopsy procedure is
WARNING: performed. Failure to do so may cause the probe and the
needle-guided bracket become source of infection.

14.1.4 Wearing the Probe Sheath

A legally marketed probe sheath must be installed over the probe before performing
intra-cavitary and intra-operative examination. Protective barriers may be required to
minimize disease transmission. Probe sheaths are available for use with all clinical
situations where infection is a concern.

To order probe sheath, contact:

CIVCO Medical Instruments Co.

102 First Street South, Kalona, IA 52247-9589 USA Tel: 1-319-656-4447

E-mail: [email protected]

http://www.civco.com

1. Be sure to cover the probe with a new (unused) probe sheath

CAUTIO to prevent infection during examination. If the package of a
probe sheath is open or broken, the sterilization of the probe
N: sheath may not be sufficient. DO NOT use such a probe
sheath.

14-8Probes and Biopsy

 2. The cover contains natural rubber latex and talc that can
cause allergic reactions in some individuals.

3. DO NOT use an expired probe sheath. Before using probe

sheaths, verify whether the term of validity has expired.

Method (for reference only):

1. Place an appropriate amount of gel 2. Insert the probe into the sheath; make
inside the sheath or on probe face. Poor sure to use proper sterile technique.
imaging may result if no gel is used. Pull cover tightly over probe face to
remove wrinkles and air bubbles,
taking care to avoid puncturing cover.

3. Secure the sheath with enclosed elastic 4. Inspect the sheath to ensure there are
bands. no holes or tears.

File number:H-7100-00-40052 Probes and Biopsy14-9

14.1.5 Probes Cleaning and Disinfection

14.1.5.1 14.1.5.1 Cleaning

After completing each examination, clean and disinfect the probes as required. Please
refer to the follow instructions for cleaning.

WARNING

 Disconnect the probes from the main unit.

 DO NOT immerse the probe connector into liquid such as water or

disinfectant, which may cause electrical shock or system
malfunction.

CAUTION

 Wipe off the gel thoroughly after examination.

 Avoid collision the probe head with hard object in probe cleaning
process.

 When performing cleaning of probe to prevent infection, please

wear sterile gloves.

Please refer to the following instruction and your hospital policy for probe cleaning.

1. Disconnect the probe with the main unit

2. Wear the sterile gloves to prevent infection.

3. Wipe off the ultrasound gel and other foreign matter thoroughly with soft cotton ball
or medical gauze,

4. Wash the probe head with clean water of soapy water(about 3 gallon.) to remove
all remaining foreign matter.

5. After rinsing the probe head clean, dry the probe using a sterile cloth or gauze.
Never dry the probe by heating.

14-10Probes and Biopsy

14.1.5.2 Disinfection

The probe of ultrasonic diagnostic system is direct contact with patient. Different type
examination leads to contact with different body part. The risk of infection depends on the
contact body with the probe. The FDA guidance has indicates that ultrasound probes that
are non-critical devices only need to be cleaned and low-level disinfected between patient
uses. The probes used in semi-critical applications should be cleaned and sterilized or at
least receive high level disinfection after use even if a sheath was used.

WARNING

 Must follow local regulations when using the disinfectant.

 Please refer to the instruction concerning concentration of the

disinfectant solution provided by the disinfectant manufacturer,
and comply with the method of disinfection and dilution and
caution during use, otherwise it may damage the probe.

 Only immerse part of the probe below the sheath joint when immerse
the probe in the solution, observe the graph below carefully to
immerse the probe.

Probe Sheath
Joint

Transducer Immerse graph

 Do not immerse the part of probe connector or the cable near it into
water or disinfectant, otherwise it may cause electric shock or
probe damage.

 Please mind the expiry date of the disinfectant before performing

probe disinfection. Do not use the expired disinfectant.

CAUTION

 Do rinsing the probe with plenty of sterile water to remove residual

chemical on it. Because the chemical may be harmful to human
body.

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  Do not using the high-pressure steam/immersion for probe
sterilization.

 Be sure to use sterile probe, the unsterile probe may become a

source infection.

NOTE

 Clean the probe before performing sterilization. Please use the

disinfection or sterilization solution that recommended in this manual,
because the disinfection have be accomplished chemical and biometric
compatibility verification.

 If not use the manual recommended disinfectant, please refer to the

instructions provided by the chemical manufacturer concerning
concentration of the sterilization solution, method of sterilization and
dilution and cautions during use.

 Wipe off the ultrasound gel thoroughly from the probe head after
completing the examination, otherwise the residual ultrasound gel may
solidify and degrade the image quality.

 Do not make the probe to become overheat (more than 55℃) during

cleaning and disinfections. High temperature may cause the probe

damaged.

 When performing cleaning and disinfection of the probe to prevent

infection, wear the sterile gloves and protective eyewear.

14.1.5.2.1 Disinfection for Surface probe

Be sure to perform disinfection after use of the surface probe, process as follows,

1. Cleaning the probe before disinfection. Please refer to the “1.5 probe cleaning”

2. WISONIC recommends the following solution to disinfect the probe with low level
disinfection.

Chemical Name Solution Manufacturer Type Time of

Name duration

14-12Probes and Biopsy

Chemical Name Solution Manufacturer Type Time of
Name duration

Iso-Propyl
IPA All Spray /sponge 10 minutes
alcohol (70%)

3. Rinse the transducer with plenty of sterile water (about 2 gallons) for at least 1
minute to remove all residues chemical on it, or follow the rinsing method
recommended by the disinfectant manufacturer.

4. Wipe off the water on the transducer with sterile cloth or gauze after rinsing it. Do
not dry the transducer by heating.

14.1.5.2.2 Disinfection for intracavitary probe

Be sure to perform disinfection after use of the intracavitary probe, process as follows,

1. Cleaning the probe before disinfection. Please refer to the “1.5 probe cleaning”

2. WISONIC recommends the following solution to disinfect the probe with high level
disinfection.

Chemical Solution Name Manufacturer Type Time of

Name duration

Ortho-phthal
aldehyde Cidex OPA J&J Solution 12 minutes(25℃)
(0.55%)

1. Rinse the transducer with plenty of sterile water (about 2 gallons) for at least 1
minute to remove all residues chemical on it, or follow the rinsing method
recommended by the disinfectant manufacturer.

3. Wipe off the water on the transducer with sterile cloth or gauze after rinsing it. Do
not dry the transducer by heating

NOTE

1. It is normal phenomenon that the acoustic lens change color after being
repeatedly disinfected.

2. Repeated disinfection may degrade the performance and safety of the probe.
Before examination is performed and after disinfected of the probe, confirm that
the probe is normal. Manually confirm that the appearance of the probe do not
has surface defects, cracks and peeling. If an abnormality is found on the probe,

File number:H-7100-00-40052 Probes and Biopsy14-13

 immediately stop using it and contact WISONIC customer service department or
sales representative.

14.1.6 Storage and transportation

After the examinations are accomplished, please confirm that the probe is normal. The
disinfected probe should be stored in a suitable place so that the next examination can be
conducted smoothly。

1. To prevent the probe from being damage, Do Not store it in location where it
may be exposed to：
 Direct sunlight and X-ray
 Temperature extreme changes
 Dust
 Excessive vibration
 Heat generators

2. Store and transport the probe under the following ambient condition：
 Ambient temperature ：-20℃～55℃
 Relative humidity ：30%～95%（no condensation）
 Atmosphere ：700hPa～1060hPa

3. Be sure to disinfect the probe and keep it in the case to prevent infection
when sent it to WISONIC customer service department or sales
representative for repair.

4. Please disinfect the probe case as necessary.

14.2 Biopsy
Please refer to the corresponding biopsy bracket guide operation manual.

14-14Probes and Biopsy

 This page was intentionally left blank.

File number:H-7100-00-40052 Probes and Biopsy14-15

 15 System Maintenance

Routine system maintenance shall be carried out by the user. Service maintenance will be
provided by Wisonic service engineers while the system is under warranty. System
maintenance after the warranty has expired is the full responsibility of the owner /operator.

1. Only an authorized Wisonic service engineer can perform

WARNIN maintenance not specified in this basic user manual.

G:
2. For the sake of the system performance and safety, you
should perform periodical checks for the system.

15.1 Daily Maintenance

You are responsible for daily maintenance.

15.1.1 Cleaning the System

Before cleaning the system, be sure to turn off the power and
WARNIN disconnect the power cord from the outlet. If you clean the
system while the power is “On”, it may result in electric shock.
G:
 Cleaning the probe

Please refer to the basic user manual of the corresponding transducer or “12 Probe
and Biopsy” chapter to perform cleaning and disinfection.
 Cleaning the probe cable

a) Use soft dry cloth to wipe off stains from the probe cable.

b) If it is difficult to clean the stains thoroughly, use soft cloth dipped with mild
detergent, and then let the cable air dry.
 Cleaning the monitor

Use a soft cloth, apply a glass cleaner directly to the cloth and wipe down the monitor
to remove finger marks, dust and smudges. Then allow the monitor to air-dry.

System Maintenance15-1
NOTE: 1. Do not use hydrocarbon glass cleaner or cleaner for OA (Office Automation)
equipment to clean the monitor. These substances may cause deterioration
of the monitor.

2. Please clean the control panel periodically, otherwise the button may be
blocked by dirt and the system will be buzzing while the button makes no
response.

 Cleaning the control panel, cover and bracket

Use dry soft cloth to clean the surface of the system. If the system is dirty, moisten the
soft cloth with a mild or neutral detergent and wipe off any stains. Use dry soft cloth to
remove any moisture and allow all hard surfaces to completely air-dry.

15.1.2 Checking the Probe

Check the probe connector for crack each time before use. DO NOT use the probe if a
crack is inspected. A thorough inspection to the probe including cable and connector is
required each time when you clean the probe.

15.1.3 Backup of the System Hard Drive

To prevent deterioration or loss of data stored in the system hard drive, create a backup
copy of the hard drive at regular intervals.

15.2 Maintenance Checks by Service

Engineer
The following checks must be performed to ensure and maintain system safety and
performance. Please contact Wisonic Customer Service Department or sales
representative to schedule and carry out these checks.

Check Category Check Item

Interior of the system

Cleaning Peripherals
Ground leakage current
Enclosure leakage current
Electric safety Patient leakage current
Patient leakage current (110% supply voltage on applied part)
Patient auxiliary leakage current

15-2System Maintenance
 Check Category Check Item
Monitor mounting mechanism
Control panel Mounting mechanism for the peripheral devices
Mechanical safety
Check other mechanical structures
Check the probe appearance
Images in each mode Image recording by using the standard
Image recording probe

15.3 Consumables and Periodic Part

Replacement
This system contains some consumables and parts requiring periodic replacement.
Before replacing them, please contact Wisonic Customer Service Department or sales
representative for instructions.

15.4 Troubleshooting
To ensure proper system operation and function, it is recommended that a maintenance
and inspection plan be established to periodically check the safety of the system. If any
system malfunction is experienced, contact Wisonic Customer Service Department or
sales representative.

If any persistent system malfunction is experienced, e.g. an onscreen error message,

blank imaging screen, absent menus, please refer to the following table below. If the
failure cannot be eliminated, please contact Wisonic Customer Service Department or
sales representative.

1 Do not spill water or other liquid into the system while you
CAUTION: perform the cleaning. Otherwise it may result in malfunction
or electric shock.

2 When you want to clean probe connectors and TGC sliders,

contact Wisonic Customer Service Department or sales
representative. Cleaning it yourself may result in malfunction
or degradation of the performance.

System Maintenance15-3
Troubleshooting Table

No. Failure Cause Measure

1 After the power Abnormal power system or Verify that the plug has not
supply is turned incorrect connection of the become loosened or dislodged
on, the power power cord. from the back of the system.
indicator does
not light on.

 The interval between  Turn off the system and

2 When the turnoff and restart is too wait a minimum time of 1
power indicator short – wait a minimum minute, and then restart the
time of 20 seconds. system.
of the monitor is
 The monitor brightness  Adjust the monitor
on and image is
or contrast may be brightness and contrast
blank. improperly set. back to factory defaults.
 The transmission power,  Adjust the transmission
3 The monitor overall gain or TGC power, gain or TGC control.
displays the controls are improperly  Ensure proper probe
set. connection.
characters but
 Verify that a probe is  Unfreeze the image.
no images.
connected and / or fully
connected.
 The system is in the
frozen status.
 The exam mode is not  Select an appropriate
4 The image correct. exam mode.
quality is  The settings of the  Adjust the settings of the
degraded image post processing image via post processing
are not correct. or reset the post processing
 The image presets are to the default values.
inappropriate  Reset the factory default
setups.
 There is too much dirt  Check the control panel for
5 The button is blocking the button the button being blocked
response less and press it several times to
release it.
with the system
 Clean the button.
buzzing

15-4System Maintenance
 This page was intentionally left blank.

System Maintenance15-5
 16 Acoustic Output

This section of the basic user manual applies to the overall system including the main unit,
probes, accessories and peripherals. This section contains important safety information
for operators of the device, pertaining to acoustic output and how to control patient
exposure through use of the ALARA (as low as reasonably achievable) principle. Also this
section contains information regarding the acoustic output testing and the real-time output
display.

Read this information carefully before using the system.

16.1 Concerns with Bioeffects

Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of
injuries to patients caused by diagnostic ultrasound.

It cannot be stated categorically that ultrasound is 100% safe. Studies have revealed that
ultrasound with extremely high intensity is harmful to body tissues.

Diagnostic ultrasound technology has made a great leap forward during the last several
years. This rapid advance has generated concerns about the potential risk of bioeffects
when new applications or diagnostic technologies become available.

16.2 Prudent Use Statement

Although there are no confirmed biological effects on patients caused by exposures from
present diagnostic ultrasound instruments, the possibility exists that such biological
effects may be identified in the future. Thus ultrasound should be used in a prudent
manner to provide medical benefit to the patient. High exposure levels and long exposure
times should be avoided while acquiring necessary clinical information.

16.3 ALARA Principle (As Low As

Reasonably Achievable)
It is required to practice ALARA when using ultrasound energy. Practicing ALARA ensures
that the total energy level is controlled below a low enough level at which bioeffects are
not generated while diagnostic information is being accumulated. The total energy is

Acoustic Output16-1
controlled by output intensity and total radiation time. The output intensity necessary for
examinations differs depending on the patient and the clinical case.

Not all examinations can be performed with an extremely low level of acoustic energy.
Controlling the acoustic level at an extremely low level leads to low-quality images or
insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However,
increasing the acoustic power more than necessary does not always contribute to an
increase in quality of information required for diagnosis, rather increasing the risk of
generating bioeffects.

Users must take responsibility for the safety of patients and utilize ultrasound deliberately.
Deliberate use of ultrasound means that output power of ultrasound must be selected
based on ALARA.

Additional information regarding the concept of ALARA and the possible bioeffects of
Ultrasound is available in a document from the AIUM (American Institute of Ultrasound
Medicine) title “Medical Ultrasound Safety”.

16.4 MI/TI Explanation

16.4.1 Basic Knowledge of MI and TI

The relationship of various ultrasound output parameters (frequency, acoustic pressure

and intensity, etc.) to bioeffects is not fully understood presently. It is recognized that two
fundamental mechanisms may induce bioeffects. One is a thermal bioeffect with tissue
absorption of ultrasound, and another one is a mechanical bioeffect based on cavitations.
Thermal Index (TI) gives the relative index of temperature increase by thermal bioeffect,
and Mechanical Index (MI) gives the relative index of mechanical bioeffect. TI and MI
indices reflect instantaneous output conditions, so they DO NOT consider the cumulative
effects of the total examination time. TI and MI models contain practical simplifications to
complex bioeffects interaction. Then the operator should be aware that the actual worst
case temperature rise may be up to several times higher than the displayed TI value.
 MI (Mechanical Index):

The mechanical bioeffects are the result of compression and decompression of insonated
tissues with the formation of micro bubbles that may be referred to as cavitations.

MI is an index that shows the possibility of the cavitations generation based on acoustic
pressure, and the value in which the peak-rarefactional acoustic pressure is divided by the
square root of the frequency. Therefore MI value becomes smaller when the frequency is
higher or the peak-rarefactional acoustic pressure is lower, it becomes difficult to generate
the cavitations.

16-2Acoustic Output
 MI = Pr, 

fawf CMI

CMI = 1 (MPa/ MHz )

For the frequency 1 MHz and the peak-rarefactional acoustic pressure 1 MPa, MI
becomes 1. It is possible to think MI to be one threshold of the cavitations generation.
Especially, it is important to keep MI value to be low when both gases and the soft tissues
exist together, for such as lung exposure in cardiac scanning and bowel gas in abdominal
scanning.
 TI (Thermal Index):

TI is determined by the ratio of the total acoustic power to the acoustic power required
to raise the tissue temperature by 1 degree C. In addition, because the temperature
rises is greatly different according to tissue structures, TI is divided three kinds: TIS
(Soft-tissue Thermal Index), TIB (Bone Thermal Index) and TIC (Cranial-bone
Thermal Index).
 TIS: Thermal index related to soft tissues, such as abdominal and cardiac
applications.
 TIB: Thermal index for applications, such as fetal (second and third trimester) or
neonatal cephalic (through the fontanel), in which the ultrasound beam passes
through soft tissue and a focal region is in the immediate vicinity of bone.
 TIC: Thermal index for applications, such as pediatric and adult cranial
applications, in which the ultrasound beam passes through bone near the beam
entrance into the body.

Although the output power is automatically controlled for the selected applications, high TI
values should be kept to a minimum or avoided in obstetric applications. WFUMB (World
Federation for Ultrasound in Medicine and Biology) guidelines: state that temperature
increase of 4 degree C for 5 min or more should be considered as potentially hazardous to
embryonic and fetal tissue.

The smaller the MI/TI values, the lower the bioeffects.

16.4.2 MI/TI Display

TI and MI values are displayed in real time in the upper part of the screen. The operator
should monitor these index values during examinations and ensure that exposure time
and output values are maintained at the minimum amounts needed for effective diagnosis.

Under different operating conditions, once there is a situation that a MI value is greater
than 1.0; the start point of displaying MI values is 0.4.

Acoustic Output16-3
In the same way, once there is a situation that a TI value is greater than 1.0, the TI value
will be displayed and the start point is 0.4. You can set which TI item is to be displayed in
the setup.

NOTE: If there is a value of MI or TI exceeds 1.0, you must be careful to practice the
ALARA principle.

The display precision is 0.1.

16.5 Acoustic Power Setting

 Acoustic power adjustment

Touch AP in the Menu to adjust the acoustic power percentage, and its value is displayed
on the corresponding item. The greater the acoustic power percentage, the greater the
current acoustic output.

When the image is frozen, the system stops transmitting acoustic power.
 Default setting of acoustic power

Selection of diagnostic applications is the most important factor for controlling ultrasound
output.

The permissible level of intensity of ultrasound differs depending on the region of interest.
For fetal examinations, in particular, much care must be exercised.

In this system, imaging setups can be created using the ultrasound output set by you. At
this time, the default function is disabled. It is the user’s responsibility for any change to
the default settings.

Default choices

Initial power 10% to 100%*

* Definition of 100%: The maximum acoustic power of a transducer determined by the

increase in transducer surface temperature in the selected mode and the acoustic power
restrictions specified by the FDA.

NOTE: This system automatically returns to the settings whenever changes are made to
the values (when you turn on the power, switch between probes, press <End
Exam>, or select Return in the Setup menu).In the factory default settings, the
Acoustic Output is limited below settings. Following the ALARA restriction, you
are allowed to increase the acoustic power under FDA 510(k) Guidance-Track3
limits and to set it in the image preset screen.

16-4Acoustic Output
The acoustic output of the system has been measured and calculated in accordance with
IEC60601-2-37: 2005, FDA 510(K) GUIDANCE, Acoustic Output Measurement Standard
for Diagnostic Ultrasound Equipment (NEMA UD-2 2004) and the “Standard for Real-Time
Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment (AIUM and NEMA UD-3 2004).

16.6 Acoustic Power Control

The qualified operator may use the system controls to limit the ultrasound output and to
adjust the quality of the images. There are three categories of system controls relative to
output. They are controls that have direct effect on the output, controls that indirectly
control output and controls that are receiver controls.
 Direct Controls

It is possible to control, if necessary, the acoustic output with the Menu control on the
control panel. In this case, the maximum value of the acoustic output never exceeds an MI
of 1.9, TI of 6 and an ISPTA.3 of 720 mW/cm2 in any mode of operation.
 Indirect Controls

The controls that indirectly affect output are many imaging parameters. These are
operating modes, frequency, focal point positions, image depth and pulse repetition
frequency (PRF).

The operating mode determines whether the ultrasound beam is scanning or

non-scanning. Thermal bioeffect is closely connected to M mode, Doppler and Color
mode.

Acoustic attenuation of tissue is directly related to transducer frequency.

The focal point is related to active aperture of transducer and beam width.

For the higher PRF (pulse repetition frequency), the more output pulses occur over a
period of time.
 Receiver Controls

The receiver controls (for example, gain, dynamic range, and image post-processing, etc.)
do not affect output. These controls should be used, when possible, to improve the image
quality before using controls that directly or indirectly affect output.

Acoustic Output16-5
 16.7 Acoustic Output

16.7.1 Derated Ultrasonic Output Parameters

In order to determine the relevant Ultrasonic Output Parameters, a method is used which
allows for the comparison of ultrasound systems which operate at different frequencies
and are focused at different depths. This approach, called "derating" or "attenuating",
adjusts the acoustic output as measured in a water tank to account for the effect of
ultrasound propagation through tissue. By convention, a specific average intensity
attenuation value is used, which corresponds to a loss of 0.3 dB/cm/MHz. That is, the
intensity of ultrasound will be reduced by 0.3 dB/MHz for every centimeter of travel from
the transducer. This can be expressed by the following equation:

I atten  I water 10 (－0.3 / 10  f c  z )

Where Iatten is the attenuated intensity, Iwater is the intensity measured in a water tank (at
distance z), fc is the center frequency of the ultrasound wave (as measured in water), and
z is the distance from the transducer. The equation for attenuating pressure values is
similar except that the attenuation coefficient is 0.15 dB/cm/MHz, or one-half the intensity
coefficient. The intensity coefficient is double the pressure coefficient because intensity is
proportional to the square of pressure.

Although the attenuation coefficient chosen, 0.3 dB/cm/MHz, is significantly lower than
any specific solid tissue in the body, this value was chosen to account for fetal
examinations. In early trimester ultrasound fetal examinations, there may be a significant
fluid path between the transducer and the fetus, and the attenuation of fluid is very small.
Therefore the attenuation coefficient was lowered to account for this case.

16.7.2 Limits of Acoustic Output

In accordance with the FDA Track 3 requirements, the derating (or attenuated) approach
was incorporated into the FDA Acoustic Output Limits, as listed below. The maximum
acoustic output level from any transducer in any operating mode is expected to fall below
these limits.

FDA Maximum Acoustic Output Limits for Track 3 (Attenuated Values)

Application Ispta.3 Isppa.3 MI

(mW/cm2) (W/cm2)
or
Regions
720 ≤ 190 ≤ 1.9
(except eyes)

16-6Acoustic Output
16.7.3 Differences between Actual and Displayed MI
and TI

In operation, the system will display to the operator the Acoustic Output Parameters
Thermal Index, TI, or Mechanical Index, MI (or sometimes both parameters
simultaneously). These parameters were developed as general indicators of risk from
either thermal or mechanical action of the ultrasound wave. They serve to indicate to the
operator whether a particular setting of the system increases or decreases the possibility
of Thermal or Mechanical effect. More specifically, they were designed to assist in the
implementation of the ALARA principle. As an operator changes a given system control,
the potential effect of the change in output will be indicated. However, the Thermal Index
is not the same as temperature rise in the body, for several reasons. First of all, in order to
provide a single display index to you, a number of simplifying assumptions had to be
made. The biggest assumption was the use of the attenuating formula described above,
which is much lower than the actual value for most tissues within the body. Scanning
through muscle or organ tissue, for example, will produce much higher attenuation than
0.3 dB/cm/MHz. There were also significant simplifications made for the thermal
properties of tissue. Therefore, scanning through highly perfused tissue, such as the heart
or vasculature, will produce significantly less thermal effect than that suggested by the
Thermal Index.

Similarly, the Mechanical Index was derived to indicate the relative possibility of
mechanical (cavitation) effects. The MI is based on the derated peak-rarefactional
pressure and the center frequency of the ultrasound wave. The actual peak-rarefactional
pressure is affected by the actual attenuation caused by tissue in the path between the
transducer and the focal point. Again, all solid tissues within the body have higher
attenuation than the proscribed 0.3 dB/cm/MHz value, and therefore, the actual
peak-rarefactional pressure will be lower. Further, the actual peak-rarefactional pressure
will change depending upon the region of the body being scanned.

For these reasons, the TI and MI displays should only be used to assist the operator in
implementing ALARA at the time of the patient examination.

16.8 References for Acoustic Power and

Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993

2. “Medical Ultrasound Safety” issued by AIUM in 1994

Acoustic Output16-7
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,
Revision 3" issued by AIUM/NEMA in 2004

4. "Standard for real-time display of thermal and mechanical acoustic output indices on
diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004

5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic

Ultrasound Systems and Transducers" issued by FDA in 2008.

6. “Medical electrical equipment – Part 2-37: Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment” issued by IEC in 2005.

16-8Acoustic Output
 17 Guidance and
Manufacturer’s Declaration

The system complies with the EMC standard IEC60601-1-2: 2007.

The use of unapproved accessories may diminish system

WARNIN performance.

G:

NOTE: 1 Use of accessories, probes, and cables other than those specified may result
in increased emission or decreased immunity of system.

2 The system should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, system should be observed to verify
normal operation in the configuration in which it will be used.

3 The system needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided
below.

4 Preventing conducted RF immunity. Due to technological limitations, the

conducted RF immunity level are limited to 1Vrms level, conducted RF
interference above 1Vrms may cause wrong diagnosis and measurements.
We suggest that you position system further from sources of conducted RF
noise.

5 Operation of system, in the case that the patient physiological signal is lower
than the minimum amplitude or value specified in the product specifications,
may cause inaccurate results.

6 Portable and mobile RF communications equipment can affects system. See

tables 1, 2, 3, and 4 below.

Guidance and Manufacturer’s Declaration17-1

TABLE 1

GUIDANCE AND WISONIC DECLARATION—ELECTROMAGNETIC EMISSIONS

The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.

ELECTROMAGNETIC ENVIRONMENT
EMISSIONS TEST COMPLIANCE
－GUIDANCE

The system uses RF energy only for its

internal function. Therefore, its RF
RF emissions emissions are very low and are not likely
Group 1
CISPR 11
to cause any interference in nearby
electronic equipment.

RF emissions
Class B
CISPR 11 The system is suitable for use in all
establishments including domestic
Harmonic Emissions
Class A establishments and those directly
IEC 61000-3-2 connected to the public low-voltage
power supply network that supplies
Voltage Fluctuations/ Flicker buildings used for domestic purposes
Emissions
Compliance
IEC 61000-3-3

17-2Guidance and Manufacturer’s Declaration File number:H-7100-00-40052

TABLE 2

GUIDANCE AND WISONIC DECLARATION—ELECTROMAGNETIC IMMUNITY

The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IEC 60601 COMPLIANCE ELECTROMAGNETIC
IMMUNITY TEST
TEST LEVEL LEVEL ENVIRONMENT-GUIDANCE

Electrostatic ±6 kV contact; ±6 kV contact; Floors should be wood,

Discharge(ESD) ±8 kV air ±8 kV air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the
relative humidity should be at
least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should
Transient / burst supply voltage; supply voltage; be that of a typical
IEC 61000-4-4 ±1 kV for commercial or hospital
input/output environment.
voltage
Surge ±1 kV voltage(s) ±1 kV voltage(s) Mains power quality should
IEC61000-4-5 to voltage(s); to voltage(s); be that of a typical
±2 kV voltage(s) ±2 kV voltage(s) commercial or hospital
to earth to earth environment.
Voltage dips, <5% UT (>95% <5% UT for 0.5 Mains power quality should
Short interruptions dip in UT ) for cycle be that of a typical
and voltage 0.5 cycle 40% UT for 5 commercial or hospital
variation on power 40% UT (60% cycles environment. If you require
supply input dip in UT ) for 5 70% UT for 25 continued operation during
voltage cycle cycles power mains interruptions, it
IEC 61000-4-11 70% UT (30% <5% UT for 5 s is recommended that our
dip in UT ) for product be powered from an
25 cycle uninterruptible power supply
<5% UT (>95% or a battery.
dip in UT ) for 5
sec
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 HZ) fields should be at levels
magnetic field characteristic of a typical
location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration17-3

TABLE 3

GUIDANCE AND WISONIC DECLARATION—ELECTROMAGNETIC IMMUNITY

The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
IMMUNITY IEC 60601 COMPLIANCE ELECTROMAGNETIC
TEST TEST LEVEL LEVEL ENVIRONMENT-GUIDANCE
Portable and mobile RF
communications equipment should
be used no closer to any part of the
3 Vrms system, including cables, than the
Conduced RF
150 kHz - 80 3 Vrms recommended separation distance
IEC 61000-4-6
MHz calculated from the equation
applicable to the frequency of the
transmitter. Recommended
separation distance

d = 1.2 x P
d = 1.2 x P 80 MHz to 800 MHz

d = 2.3 x P 800 MHz to 2.5GHz

Where, P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
3V/m
Radiated RF meters (m).
3V/m Field strengths from fixed RF
IEC 61000-4-3 80MHz -
2.5GHz transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level in
each frequency range.
Interference may occur in the vicinity
of equipment marked with the
following symbol:

17-4Guidance and Manufacturer’s Declaration File number:H-7100-00-40052

TABLE 4

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE

RF COMMUNICATION DEVICE AND THE SYSTEM
The system is intended for use in an electromagnetic environment in which radiated RF
disturbance are controlled. The customer or the user of system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communication equipment (transmitters) and system as recommended below,
according to the maximum output power of the communication equipment.
Rated Maximum Separation Distance According to Frequency of Transmitter
Output power of (m)
Transmitter 150kHz -80MHz 80MHz-800MHz 800MHz-2.5GHz
(W) d  1.2 P 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.

Table 5

Main technical parameters of 4G/WIFI

The device includes RF transmitter, each transmitter frequency, modulation type,

frequency characteristic and effective radiated power parameters are provided as follow
to refer

technical parameters

RF
frequency/freque frequency transmit
modulation type
ncy band tolerance power

Guidance and Manufacturer’s Declaration17-5

 885-915MHz 33/30dBm±
2dB≤
3G 1710-1755MHz GMSK/8PSK BPSK ≤0.1ppm 24dBm+1

1920~1980MHz

11b:17±
1.0dBm@11
Mbps;

11g:14±
1dBm@54M
bps
WIFI 2.412GHz~2.483 802.11b :CCK,QPSK,BPSK,
/
5GHz 802.11 g/n:OFDM
802.11n(HT
20),12+/-1d
Bm,

802.11n(HT
40),12+/-1d
Bm

17-6Guidance and Manufacturer’s Declaration File number:H-7100-00-40052

Guidance and Manufacturer’s Declaration17-7
 18 Appendix

18.1 OB Reference

CRL Australasian Society for Ultrasound in Medicine. Policies and Statements D7.
Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

Hadlock FP, Shah YP, Kanon DJ, Lindsey JV. Fetal Crown-Rump Length:
Reevaluation of Relation to Menstrual Age (5-18 weeks) with High-Resolution
Real-Time US. Radiology 1992; 182: 501-505

Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics

and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

TOKYO: Shinozuka N, Okai T, Mizuno M. How to interpret OB/GYN ultrasound

measurement data. Fetal Measurement Obstetrics and Gynecology Chapter
1989; 80: 369-380 – and personal communication

GS Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics

and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

Rempen A. Biometrie in der Frühgravidität (I. Trimenon). DER FRAUENARZT

1991; 32: 425-428

TOKYO: Shinozuka N, Okai T, Mizuno M. How to interpret OB/GYN ultrasound

measurement data. Fetal Measurement Obstetrics and Gynecology Chapter
1989; 80: 369-380 – and personal communication

BPD Australasian Society for Ultrasound in Medicine. Policies and Statements D7.
Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

Hadlock FP, Deter RL, Harrist RB, Park SK. Estimating Fetal Age:
Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology
1984; 152: 497-501

18-8Appendix File number:H-7100-00-40052

 Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics
and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

Jeanty P, Cousaert E, Hobbins JC, Tack B, Bracken M, Cantraine F. A

longitudinal study of fetal head biometry. Am J Perinatol 1984; 1: 118-128;
Dating: Jeanty P et al. Obstetrical Ultrasound. New York: McGraw-Hill Book
Company, 1984; 55-66

Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162; Dating: Merz E. Habilitationsschrift. Mainz University
Women's Hospital 1988

TOKYO: Shinozuka N, Okai T, Mizuno M. How to interpret OB/GYN ultrasound

measurement data. Fetal Measurement Obstetrics and Gynecology Chapter
1989; 80: 369-380 - and

personal communication

HC Australasian Society for Ultrasound in Medicine. Policies and Statements D7.

Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

Hadlock FP, Deter RL, Harrist RB, Park SK. Estimating Fetal Age:
Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology
1984; 152: 497-501

Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics

and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

Jeanty P, Cousaert E, Hobbins JC, Tack B, Bracken M, Cantraine F. A

longitudinal study of fetal head biometry. Am J Perinatol 1984; 1: 118-128

AC Australasian Society for Ultrasound in Medicine. Policies and Statements D7.

Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

Hadlock FP, Deter RL, Harrist RB, Park SK. Estimating Fetal Age:
Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology
1984; 152: 497-501

Appendix18-9
 Jeanty P, Cousaert E, Cantraine F. Normal growth of the abdominal perimeter.
Am J Perinatol 1984; 1: 129-135

Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162; Dating: Merz E. Habilitationsschrift. Mainz University
Women's Hospital 1988

TOKYO: Shinozuka N, Okai T, Mizuno M. How to interpret OB/GYN ultrasound

measurement data. Fetal Measurement Obstetrics and Gynecology Chapter
1989; 80: 369-380 – and personal communication

FL Australasian Society for Ultrasound in Medicine. Policies and Statements D7.

Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

Hadlock FP, Deter RL, Harrist RB, Park SK. Estimating Fetal Age:
Computer-Assisted Analysis of Multiple Fetal Growth Parameters. Radiology
1984; 152: 497-501

Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics

and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

Jeanty P, Cousaert E, Cantraine F, Hobbins JC, Tack B, Struyven J. A

longitudinal study of fetal limb growth. Am J Perinatol 1984; 1: 136-144; Dating:
Jeanty P et al. J Ultrasound Med 1984; 3: 75-79

Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162; Dating: Merz E. Habilitationsschrift. Mainz University
Women's Hospital 1988

TOKYO: Shinozuka N, Okai T, Mizuno M. How to interpret OB/GYN ultrasound

measurement data. Fetal Measurement Obstetrics and Gynecology Chapter
1989; 80: 369-380 – and personal communication

OFD Australasian Society for Ultrasound in Medicine. Policies and Statements D7.
Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

18-10Appendix File number:H-7100-00-40052

 Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics
and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

Snijders RJ, Nicolaides KH. Fetal biometry at 14-40 weeks´ gestation.

Ultrasound Obstet Gynecol 1994; 4: 34-38

APAD Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162

APTD Hansmann M. Ultraschallbiometrie im II. und III. Trimester der

Schwangerschaft. Gynäkologe 1976; 9: 133-155

TAD Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162

TTD Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics

and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986

FTA OSAKA: Mineo A; The diagnosis and Treatment of IUGR. Japanese Journal of
Perinatal Care 1990; 9: 407-422

HUM Australasian Society for Ultrasound in Medicine. Policies and Statements D7.
Statement On Normal Ultrasonic Fetal Measurements. 2007; Dating: Campbell
Westerway S. Personal communication.

Jeanty P, Cousaert E, Cantraine F, Hobbins JC, Tack B, Struyven J. A

longitudinal study of fetal limb growth. Am J Perinatol 1984; 1: 136-144; Dating:
Jeanty P et al. J Ultrasound Med 1984; 3: 75-79

Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162

ULNA Jeanty P, Cousaert E, Cantraine F, Hobbins JC, Tack B, Struyven J. A

longitudinal study of fetal limb growth. Am J Perinatol 1984; 1: 136-144; Dating:
Jeanty P et al. J Ultrasound Med 1984; 3: 75-79

Appendix18-11
 Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches
Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162

TIB Jeanty P, Cousaert E, Cantraine F, Hobbins JC, Tack B, Struyven J. A

longitudinal study of fetal limb growth. Am J Perinatol 1984; 1: 136-144; Dating:
Jeanty P et al. J Ultrasound Med 1984; 3: 75-79

Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162

RAD Jeanty P. Fetal limb biometry. Radiology 1983; 147: 601-602 - and personal
communication

Merz E, Wellek S. Das normale fetale Wachstumsprofil - ein einheitliches

Modell zur Berechnung von Normkurven für die gängigen Kopf- und
Abdomenparameter sowie die großen Extremitätenknochen. Ultraschall Med
1996; 17: 153-162

FIB Jeanty P, Romero R. Critical Reading of the Biometry Literature. In: Hansmann
M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics and
Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986. pages
161-188

CLAV Yarkoni S, Schmidt W, Jeanty P, Reece EA, Hobbins JC. Clavicular

Measurement: A New Biometric Parameter for Fetal Evaluation. Journal of
Ultrasound in Medicine 1985; 4: 467-470

CEREB Hill LM, Guzick D, Fries J, Hixson J, Rivello D. The Transverse Cerebellar
Diameter in Estimating Gestational Age in the Large for Gestational Age Fetus.
Obstet Gynecol 1990; 75: 981-985

EOD Hansmann M, Hackelöer BJ, Staudach A. Ultrasound Diagnosis in Obstetrics

and Gynecology. Berlin, Heidelberg, New York, Tokyo: Springer, 1986; Dating:
Jeanty P et al. J Ultrasound Med 1984; 3: 241-243

Vertebr TOKYO: Shinozuka N, Okai T, Mizuno M. How to interpret OB/GYN ultrasound

measurement data. Fetal Measurement Obstetrics and Gynecology Chapter

18-12Appendix File number:H-7100-00-40052

 1989; 80: 369-380 – and personal communication

EFW Hadlock FP, et al, “Sonographic Estimation of Fetal Weight”, Radiology

1984:150:535-540

Hadlock FP, et al, “Estimation of fetal weight with the use of head, body and
femur measurements: A prospective study” Am. J. Obstet. Gynecol. 1985; 151:
333-337

Shepard MJ, et al, “An Evaluation of Two Equations for Predicting Fetal Weight
by Ultrasound”, American Journal of OB & Gyn, January 1982; 142(1):47-54

Campbell S., Wilkin D. „Ultrasonic measurement of fetal abdomen

circumference in the estimation of fetal weight.” British Journal Obstetrics and
Gynecology; Sept. 1975; 82(9); 689-97

Shinozuka N., Okai T., Kohzuma S., Mukubo M., Shih C.T., Maeda T., et al
“Formulas for Fetal Weight Estimation by Ultrasound Measurements based on
Neonatal Specific Gravities and Volumes” American Journal of Obstetrics and
Gynecology 157: 1140-1145; 1987

Perinatal care Vol. 9 No. 5, 44(414)

Hansmann, Hackeloer, Staudach, Wittmann, "Ultrasound Diagnosis in

Obstetrics and Gynecology," Springer-Verlag, New York, 1986, page 154

18.2 Cardiac Reference

Body Surface Area (BSA):

DuBois, D., DuBois, E.F., "A Formula to Estimate the Approximate Surface Area if
Height and Weight Be Known," Nutrition, Sept-Oct 1989, Vol. 5, No. 5, pp. 303-313.

EDV(S-P Ellipse):

Folland, E.D., et al., "Assessment of Left Ventricular Ejection Fraction and Volumes by
Real-Time, Two-Dimensional Echocardiography," Circulation, October 1979, Vol. 60, No.4,
pp. 760-766

Appendix18-13
ESV(S-P Ellipse):

Folland, E.D., et al., "Assessment of Left Ventricular Ejection Fraction and Volumes by
Real-Time, Two-Dimensional Echocardiography," Circulation, October 1979, Vol. 60, No.4,
pp. 760-766.

Stroke Volume (SV):

Gorge, G., et al., "High Resolution Two-dimensional Echocardiography Improves the

Quantification of Left Ventricular Function", Journal of the American Society of
Echocardiography, 1992, 5: 125-34.

Roelandt, Joseph, Practical Echocardiology, vol. 1 of Ultrasound in Medicine Series, ed.

Denis White, Research Studies Press, 1977, p. 124.

Ejection Fraction (EF):

Pombo, J.F., "Left Ventricular Volumes and Ejection by Echocardiography," Circulation,

1971, Vol. 43, pp. 480-490.

Stroke Volume Index (SI):

Gorge, G., et al., "High Resolution Two-dimensional Echocardiography Improves the

Quantification of Left Ventricular Function", Journal of the American Society of
Echocardiography, 1992, 5: 125-34.

Roelandt, Joseph, Practical Echocardiology, vol. 1 of Ultrasound in Medicine Series, ed.

Denis White, Research Studies Press, 1977, p. 124.

Cardiac Output (CO):

Belenkie, Israel, et al., "Assessment of Left Ventricular Dimensions and Function by

Echocardiography," American Journal of Cardiology, June 1973, Vol. 31

Cardiac output Index (CI):

The Merck Manual of Diagnosis and Therapy, ed. 15, Robert Berkon, ed., Merck and
Co., Rahway, NJ, 1987, p. 378.

18-14Appendix File number:H-7100-00-40052

Schiller, N.B., et al., “Recommendations for Quantification of the LV by
Two-Dimensional Echocardiography,” J Am Soc Echo, Sept.-Oct., 1989, Vol. 2, No. 5,p.
364.

EDV (Simpson):

Weyman, Arthur E., Cross-Sectional Echocardiography, Lea & Febiger, 1985, p.

295.Folland, E.D., et al., "Assessment of Left Ventricular Ejection Fraction and Volumes
by Real-Time, Two-Dimensional Echocardiography," Circulation, October 1979, Vol. 60,
No.4, pp. 760-766

ESV (Simpson):

Weyman, Arthur E., Cross-Sectional Echocardiography, Lea & Febiger, 1985, p.

295.Folland, E.D., et al., "Assessment of Left Ventricular Ejection Fraction and Volumes
by Real-Time, Two-Dimensional Echocardiography," Circulation, October 1979, Vol. 60,
No.4, pp. 760-766

EDV (Simpson SP):

Schiller, N.B., et al., "Recommendations for Quantification of the LV by

Two-Dimensional Echocardiography," Journal of the American Society of
Echocardiography, Sept-Oct 1989, Vol.2, No. 5, p. 364

ESV (Simpson SP):

Schiller, N.B., et al., "Recommendations for Quantification of the LV by

Two-Dimensional Echocardiography," Journal of the American Society of
Echocardiography, Sept-Oct 1989, Vol.2, No. 5, p. 364

EDV (Simpson BP):

Schiller, N.B., et al., "Recommendations for Quantification of the LV by

Two-Dimensional Echocardiography," Journal of the American Society of
Echocardiography, Sept-Oct 1989, Vol.2, No. 5, p. 364

Appendix18-15
ESV (Simpson BP):

Schiller, N.B., et al., "Recommendations for Quantification of the LV by

Two-Dimensional Echocardiography," Journal of the American Society of
Echocardiography, Sept-Oct 1989, Vol.2, No. 5, p. 364

EDV (Cube):

Dodge, H.T., Sandler, D.W., et al., "The Use of Biplane Angiography for the
Measurement of Left Ventricular Volume in Man," American Heart Journal, 1960, Vol. 60,
pp. 762-776.

Belenkie, Israel, et al., "Assessment of Left Ventricular Dimensions and Function by

Echocardiography," American Journal of Cardiology, June 1973, pg. 31.

ESV (Cube):

Dodge, H.T., Sandler, D.W., et al., "The Use of Biplane Angiography for the
Measurement of Left Ventricular Volume in Man," American Heart Journal, 1960, Vol. 60,
pp. 762-776.

Belenkie, Israel, et al., "Assessment of Left Ventricular Dimensions and Function by

Echocardiography," American Journal of Cardiology, June 1973, pg. 31.

Fractional Shortening (FS):

Belenkie, Israel, et al., "Assessment of Left Ventricular Dimensions and Function by

Echocardiography," American Journal of Cardiology, June 1973, Vol. 31.

MVCF:

Colan, S.D., Borow, K.M., Neumann, A., “Left Ventricular End-Systolic Wall
Stress-Velocity of Fiber Shortening Relation: A Load-Independent Index of Myocardial
Contractility,” J Amer Coll Cardiol, October, 1984, Vol. 4, No. 4,pp. 715-724.

Snider, A.R., Serwer, G.A., Echocardiography in Pediatric Heart Disease, Year Book
Medical Publishers, Inc., Littleton, MA, 1990, p. 83.

Teichholz:

18-16Appendix File number:H-7100-00-40052

Teichholz, L.E., et al., "Problems in Echocardiographic Volume Determinations:
Echocardiographic-Angiographic Correlations in the Presence or Absence of Asynergy,"
American Journal of Cardiology, January 1976, Vol. 37, pp. 7-11

LVMW:

John H. Phillips, “Practical Quantitative Doppler Echocardiography” , CRC Press,

1991, .Page 96.

LV MASS-I:

John H. Phillips, “Practical Quantitative Doppler Echocardiography” , CRC Press,

1991, .Page 96.

LA/Ao:

Roelandt, Joseph, Practical Echocardiology, Ultrasound in Medicine Series, Vol.

1,Denis White, ed., Research Studies Press, 1977, p. 270.

Schiller, N.B., et al., “Recommendations for Quantification of the LV by

Two-Dimensional Echocardiography,” J Am Soc Echo, Sept-Oct, 1989, Vol. 2, No. 5,p.
364.

MV CA/CE:

Maron, Barry J., et al., “Noninvasive Assessment of Left Ventricular Diastolic Function
by Pulsed Doppler Echocardiography in Patients with Hypertrophic

Cardiomyopathy, J Am Coll Cardio, 1987, Vol. 10, pp. 733-742.

MV E/A:

Maron, Barry J., et al., "Noninvasive Assessment of Left Ventricular Diastolic Function
by Pulsed Doppler Echocardiography in Patients with Hypertrophic Cardiomyopathy,"
Journal of the American College of Cardiology, 1987, Vol. 10, pp. 733-742.

Appendix18-17
Pressure Half Time (PHT):

Oh, J.K., Seward, J.B., Tajik, A.J. The Echo Manual. Boston: Little, Brown and
Company, 1994, p.59-60

Mitral valve area:

Goldberg, Barry B., Kurtz, Alfred B., Atlas of Ultrasound Measurements, Year Book
Medical Publishers, Inc., 1990, p. 65.

Stamm, R. Brad, et al., “Quantification of Pressure Gradients Across Stenotic Valves

by Doppler Ultrasound,” J Am Coll Cardiol, 1983, Vol. 2, No. 4,pp. 707-718.

Right Ventricular Systolic Pressure:

Stevenson, J.G., "Comparison of Several Noninvasive Methods for Estimation of

Pulmonary Artery Pressure," Journal of the American Society of Echocardiography, June
1989, Vol. 2, pp. 157-171.

Yock, Paul G. and Popp, Richard L., "Noninvasive Estimation of Right Ventricular
Systolic Pressure by Doppler Ultrasound in Patients with Tricuspid Regurgitation,"
Circulation, 1984, Vol. 70, No. 4, pp. 657-662.

18-18Appendix File number:H-7100-00-40052