Ultrasound Diagnostic System: Operation Manual

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Ultrasound Diagnostic System

Model
ECO 3 EXPERT

V1.0
Dec 11, 2014

OPERATION MANUAL

Direction: CHUM ECO-001


ECO 3 EXPERT Ultrasound Diagnostic System

Regulatory Requirement

This product conforms to the essential requirements of the


Medical Device Directive 93/42/EEC. Accessories without the CE mark are not
guaranteed to meet the Essential Requirements of the Medical Device Directive.

This manual is a reference for the ECO 3 EXPERT. Please verify that you are using
the latest revision of this document. If you need the latest revision, contact your
distributor.

NOTE:
Important
1.No part of this manual may be reduced, modified, copied or reprinted, in whole or in part,
without written permission from CHISON.
2.The contents of this manual are subject to change without prior notice and without our legal
obligation.
3.Before operating the system, please read and understand this manual. After reading, keep this
manual in an easily accessible place. If you have any question or doubt, please contact CHISON's
authorized service engineer.
4.CHISON‟s Warranty only cover material and parts costs for repair, but do not cover any labor
cost or onsite service cost at end user's side.

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ECO 3 EXPERT Ultrasound Diagnostic System

NOTE:
Important information
1.It is the customer‟s responsibility to maintain and manage the system after delivery.
2.The warranty does not cover the following items, even during the warranty period:
a)Damage or loss due to misuse or abuse with system and probes, for example, drop
the probe, the liquid or the metal part fall into the system.
b)Damage or loss caused by Acts of God such as fires, earthquakes, floods, lightning,
etc.
c)Damage or loss caused by failure to meet the specified conditions for this system,
such as inadequate power supply, improper installation or environmental conditions.
d)Damage or loss caused by non approved transportation by CHISON.
e)Damage or loss due to use the system outside the region where the system was
originally sold.
f)Damage or loss involving the system purchased from a source other than CHISON
or its authorized agents.
3.Do not make changes or modifications to the software or hardware of this system
and probes.
4.During operate the system, if user has any doubt, difficulty or any unclear, please
contact CHISON's authorized service engineer immediately. Please describe the
situation clearly to solve the question in time. Before solve the question, please don‟t
operate the system.
5.This system shall not be used by persons other than fully qualified and certified
medical personnel.
6.It is prohibited to use the device for fetal sex examination, except for necessary
medical needs. The device can only be sold to qualified medical institutions or doctors.
The users shall fully understand and master the devices before operating. The users
shall have got the qualification, and shall comply with the local laws and regulations,
the local religion and customs, etc.
7.The System modified or repaired by people other than CHISON‟s qualified service
engineers, CHISON shall not be liable for the system.
8.The purpose of this system is to provide physicians with data for clinical diagnosis.
It is the physician‟s responsibility for diagnostic procedures. CHISON shall not be
liable for the results of diagnostic procedures
9.This manual contains warnings regarding foreseeable potential dangers, but user
shall always be alert to dangers other than those indicated as well. CHISON shall not
be liable for damage or loss that results from negligence or from ignoring the
precautions and operating instructions described in this operation manual.
10.Due to negligence not following operation manual, CHISON shall not be liable for
the results.
11.Each time before and after ultrasound examination, please check the probe surface,
probe cable and sheath whether they are abnormal, such as cracking, peeling and
deformation. Also check whether the lens is strongly fixed. Abnormal probes may

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ECO 3 EXPERT Ultrasound Diagnostic System

cause electric shock and injure the patient. Once any abnormal, user must stop using
and contact CHISON's authorized service engineer.
12.If the probe is dropped or scratched by hard part, please stop using the probe
immediately. And contact CHISON's authorized service engineer to make sure the
safety and effectiveness is in good condition before use.
13.If there is any liquid or metal to enter to the system, please power off the system
and stop using it immediately. Please first contact CHISON‟s authorized service
engineer to make sure it‟s safe before restart using it.
14.Please don't use solvents (such as paint thinner, benzine, or alcohol) or abrasive
cleansers for cleaning the system (including monitor and probes, etc). It may corrode
the system and probes.
15.While the system or probe is over life time, please refer to operation manual
section 9.4
16.Important data must be backed up on external memory media. CHISON shall not
be liable for loss of data stored in the memory of this system caused by operator error
or accidents.
17.Please put this operation manual with the system to ensure operator and manager
can reach it at any time.
18.LCD display screen may have some dark or light dots, it is normal for the LCD. It
does not mean that LCD screen is defective.

Caution:It is prohibited to use the device for fetal sex examination, except for necessary
medical needs. The device can only be sold to qualified medical institutions or doctors. The users
shall fully understand and master the devices before operating. The users shall have got the
qualification, and shall comply with the local laws and regulations, the local religion and customs,
etc.

Caution: The users should read the operation manual carefully before operating the devices.
Turning on the device means the users have read the operation manual and accept the listed
cautions, warnings, and notes in the manuals. If the users disagree and cannot accept the cautions,
the users can ask for returning the device.

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ECO 3 EXPERT Ultrasound Diagnostic System

Content
Chapter 1 Introduction .............................................................................................................................. 1

1.1 System Overview ...................................................................................................................... 1

1.2 Contact Information ................................................................................................................ 1

Chapter 2 System Safety........................................................................................................................... 2

2.1 Safety Overview ........................................................................................................................ 2

2.2 Electrical Safety ........................................................................................................................ 3

2.3 Labels ........................................................................................................................................ 5

2.3.1 Warning Symbols ............................................................................................................ 5

2.4 Patient Environmental Devices ............................................................................................... 6

2.5 Biological Safety ....................................................................................................................... 8

2.6 Scanning Patients and Education ........................................................................................... 9

2.6.1 Safe Scanning Guidelines ............................................................................................... 9

2.6.2 Understanding the MI/TI Display ................................................................................. 11

Chapter 3 System Introduction ............................................................................................................... 15

3.1 Consol Overview..................................................................................................................... 15

3.2 Physical Specification ............................................................................................................. 15

3.3 System View in Different Views ............................................................................................ 16

3.4 Function Introduction ............................................................................................................ 17

3.4.1 Image Modes................................................................................................................. 17

3.4.2 Accessories.................................................................................................................... 18

3.4.3 Configuration of the System ......................................................................................... 19

3.5 Installation Procedures .......................................................................................................... 19

3.5.1 Environment Condition ................................................................................................. 19

3.5.2 Powering the System..................................................................................................... 21

3.5.3 Probe Installment .......................................................................................................... 22

3.5.4 Accessories Installment ................................................................................................. 22

Chapter 4 Control Panel ......................................................................................................................... 24

4.1 Alphanumeric Keyboard ....................................................................................................... 24

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ECO 3 EXPERT Ultrasound Diagnostic System

4.2 Function Keys/Knob .............................................................................................................. 24

4.2.1 SWITCH ....................................................................................................................... 24

4.2.2 PATIENT....................................................................................................................... 24

4.2.3 PROBE ......................................................................................................................... 24

4.2.4 SETUP .......................................................................................................................... 24

4.2.5 END .............................................................................................................................. 25

4.2.6 BODY MARK .............................................................................................................. 25

4.2.7 COMMENT .................................................................................................................. 25

4.2.8 ARROWS...................................................................................................................... 25

4.2.9 DEL............................................................................................................................... 25

4.2.10 Print............................................................................................................................. 25

4.2.11 Archive ........................................................................................................................ 26

4.2.12 Report ......................................................................................................................... 26

4.2.13 Parameter Control Key ............................................................................................... 26

4.3 Central Control ...................................................................................................................... 26

4.3.1 ENTER ......................................................................................................................... 26

4.3.2 UPDATE ....................................................................................................................... 27

4.3.3 Exit ................................................................................................................................ 27

4.3.4 Cursor ........................................................................................................................... 27

4.3.5 Change .......................................................................................................................... 27

4.3.6 Dist................................................................................................................................ 27

4.3.7 Trace ............................................................................................................................. 27

4.3.8 Calc ............................................................................................................................... 27

4.3.9 MENU........................................................................................................................... 27

4.3.10 Trackball ..................................................................................................................... 27

4.4 The key of Image Mode ......................................................................................................... 28

4.4.1 B.................................................................................................................................... 28

4.4.2 B/B ................................................................................................................................ 28

4.4.3 4B.................................................................................................................................. 28

4.4.4 M ................................................................................................................................... 28

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4.5 Control of Image .................................................................................................................... 28

4.5.1 THI ................................................................................................................................ 28

4.5.2 AIO ............................................................................................................................... 28

4.5.3 CINE ............................................................................................................................. 29

4.5.4 SAVE ............................................................................................................................ 29

4.5.5 Left and Right Invert ..................................................................................................... 29

4.5.6 Up and Down Invert...................................................................................................... 29

4.5.7 STC ............................................................................................................................... 29

4.5.8 GAIN ............................................................................................................................ 30

4.5.9 ANGLE/ZOOM Knob .................................................................................................. 30

4.5.10 DEPTH/FOCUS Knob ................................................................................................ 30

4.5.11 Information Area Indicating Machine Status .............................................................. 30

4.5.12 Indicator Light ............................................................................................................ 30

Chapter 5 Operation and Exam Mode .................................................................................................... 31

5.1 Preparing the System for Use ................................................................................................ 31

5.1.1 The Device Inspection .................................................................................................. 31

5.1.2 Power On ...................................................................................................................... 31

5.2 Choose Exam Mode ................................................................................................................ 31

5.2.1 The Probe Identification................................................................................................ 31

5.2.2 Mode Selection ............................................................................................................. 31

5.3 Patient Data Entry ................................................................................................................. 32

5.4 Image Interface Display ......................................................................................................... 33

5.5 Display Mode .......................................................................................................................... 33

5.5.1 B Mode ......................................................................................................................... 33

5.5.2 B/B Mode...................................................................................................................... 33

5.5.3 4B Mode ....................................................................................................................... 33

5.5.4 B/M Mode ..................................................................................................................... 34

5.5.5 M Mode ........................................................................................................................ 34

5.5.6 PW Mode ...................................................................................................................... 34

5.6 B Image Adjustment .............................................................................................................. 35

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5.6.1 Frequency...................................................................................................................... 35

5.6.2 Dynamic ........................................................................................................................ 35

5.6.3 i-Image .......................................................................................................................... 35

5.6.4 Compound ..................................................................................................................... 35

5.6.5 PW ................................................................................................................................ 36

5.6.6 M Speed Adjustment ..................................................................................................... 36

5.6.7 Gain............................................................................................................................... 36

5.6.8 STC ............................................................................................................................... 36

5.6.9 Depth............................................................................................................................. 36

5.6.10 Focus Pos .................................................................................................................... 36

5.6.11 Angle ........................................................................................................................... 36

5.6.12 ANGLE/ZOOM .......................................................................................................... 36

5.6.13 INVERT ...................................................................................................................... 36

5.6.14 THI .............................................................................................................................. 37

5.6.15 AIO ............................................................................................................................. 37

5.7 B Image Menu Adjustment ................................................................................................... 37

5.7.1 Scan Width .................................................................................................................... 37

5.7.2 Focus Num .................................................................................................................... 37

5.7.3 Persistence .................................................................................................................... 38

5.7.4 Line Density .................................................................................................................. 38

5.7.5 Smooth .......................................................................................................................... 38

5.7.6 Edge Enhance ............................................................................................................... 38

5.7.7 Acoustic Power ............................................................................................................. 38

5.7.8 SRA............................................................................................................................... 38

5.7.9 Utility ............................................................................................................................ 38

5.7.10 Advance ...................................................................................................................... 39

5.7.11 Gray Scale Curve ........................................................................................................ 40

5.8 PW Image Adjustment ........................................................................................................... 40

5.8.1 Steering Angle ............................................................................................................... 40

5.8.2 Freq ............................................................................................................................... 40

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5.8.3 D 2D Map ..................................................................................................................... 40

5.8.4 Enhance ......................................................................................................................... 40

5.8.5 D Gamma ...................................................................................................................... 41

5.8.6 Dynamic ........................................................................................................................ 41

5.8.7 Pixel Ratio..................................................................................................................... 41

5.8.8 Color Map ..................................................................................................................... 41

5.8.9 Audio............................................................................................................................. 41

5.8.10 Acoustic power ........................................................................................................... 41

5.8.11 Invert ........................................................................................................................... 41

5.8.12 Wall Filter ................................................................................................................... 41

5.8.13 Speed........................................................................................................................... 41

5.8.14 PRF ............................................................................................................................. 42

5.8.15 Baseline ....................................................................................................................... 42

5.9 Full Screen Show (need to activate this function in setup) ................................................. 42

5.10 Edit Comment ....................................................................................................................... 42

5.10.1 Overview ..................................................................................................................... 42

5.10.2 Input Characters .......................................................................................................... 42

5.10.3 Input Comment Library Characters ............................................................................ 43

5.10.4 Edit Quick Comments ................................................................................................. 43

5.10.5 Input Quick Comments ............................................................................................... 43

5.10.6 Move Comments ......................................................................................................... 43

5.10.7 Edit Comments ........................................................................................................... 43

5.10.8 Delete Comments ........................................................................................................ 43

5.10.9 Set the Position of Default Comment.......................................................................... 44

5.11 Set Body Mark ...................................................................................................................... 44

5.11.1 General Description .................................................................................................... 44

5.11.2 Body Mark Operation ................................................................................................. 46

5.12 Set the Direction of Arrow ................................................................................................... 46

5.13 Image and Cine Disposition ................................................................................................. 46

5.13.1 The Principle of Cine Storage ..................................................................................... 46

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5.13.2 Manual Loop ............................................................................................................... 47

5.13.3 Automatic Loop .......................................................................................................... 47

5.13.4 Save and Recall Image ................................................................................................ 47

5.13.5 Save and Recall Cine .................................................................................................. 47

5.13.6 Delete images .............................................................................................................. 47

5.13.7 Send images ................................................................................................................ 47

5.14 Image Browse ....................................................................................................................... 48

5.15 Archive Management ........................................................................................................... 48

5.16 Report .................................................................................................................................... 49

5.17 DICOM ................................................................................................................................. 51

5.17.1 DICOM Worklist ......................................................................................................... 51

5.17.2 DICOM Storage .......................................................................................................... 51

5.17.3 DICOM Print .............................................................................................................. 52

5.17.4 DICOM SR ................................................................................................................. 52

Chapter 6 Measurement and Calculation ................................................................................................ 53

6.1 Keyboard for Measurement .................................................................................................. 53

6.1.1 Trackball ....................................................................................................................... 53

6.1.2 [ENTER] ....................................................................................................................... 53

6.1.3 [UPDATE] .................................................................................................................... 53

6.1.4 [DEL] ............................................................................................................................ 53

6.1.5 [Change] ....................................................................................................................... 54

6.1.6 [Exit] ............................................................................................................................. 54

6.1.7 Parameters control key .................................................................................................. 54

6.2 B Mode general Measurement methods ............................................................................... 54

6.2.1 Meas. Distance .............................................................................................................. 54

6.2.2 Ellipse ........................................................................................................................... 54

6.2.3 Trace ............................................................................................................................. 55

6.2.4 Histogram...................................................................................................................... 55

6.2.5 Cross-section Diagram .................................................................................................. 56

6.3 B Fast Measurement .............................................................................................................. 56

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6.4 B General Measurement ........................................................................................................ 57

6.5 ABD Measurement ................................................................................................................. 58

6.6 OB Measurement ................................................................................................................... 59

6.6.1 EDD (estimated date of delivery) Estimation ............................................................... 62

6.6.2 Growth curves ............................................................................................................... 62

6.7 Pediatric Measurement .......................................................................................................... 62

6.7.1 HIP Angle...................................................................................................................... 63

6.8 GYN Measurement ................................................................................................................ 63

6.9 Small Parts Measurement ..................................................................................................... 64

6.10 B Mode Vessel Measurement .............................................................................................. 65

6.11 Urology Measurement .......................................................................................................... 65

6.12 Cardiac Measurement .......................................................................................................... 65

6.13 Normal Measurement in M, B/M mode ............................................................................. 66

6.13.1 Distance ...................................................................................................................... 66

6.13.2 Time ............................................................................................................................ 67

6.13.3 Heart rate..................................................................................................................... 67

6.13.4 Velocity ....................................................................................................................... 67

6.14 General Measurement in M mode ...................................................................................... 67

6.15 M Abdomen Measurement .................................................................................................. 68

6.16 M OB Measurement ............................................................................................................. 68

6.17 M GYN Measurement .......................................................................................................... 68

6.18 M Mode Cardiac Measurement .......................................................................................... 68

6.19 M Urology Measurement ..................................................................................................... 70

6.20 M Small Parts Measurement ............................................................................................... 70

6.21 M Pediatric Measurement ................................................................................................... 70

6.22 PW mode measurement methods ........................................................................................ 70

6.22.1 Velocity ....................................................................................................................... 70

6.22.2 Time ............................................................................................................................ 70

6.22.3 HR ............................................................................................................................... 71

6.22.4 Auto Trace ................................................................................................................... 71

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6.22.5 Manual Trace .............................................................................................................. 71

6.23 PW Fast Measurement ......................................................................................................... 71

6.24 PW Genearl Measurement .................................................................................................. 72

6.25 PW Abdomen Measurement ............................................................................................... 74

6.26 PW OB Measurement .......................................................................................................... 74

6.27 PW GYN Measurement ....................................................................................................... 75

6.28 PW Cardiology Measurement ............................................................................................. 76

6.29 PW Vascular Measurement ................................................................................................. 82

6.30 PW Urology Measurement .................................................................................................. 83

6.31 PW Small parts Measurement ............................................................................................ 83

6.32 PW Pediatric Measurement ................................................................................................ 83

Chapter 7 Preset ...................................................................................................................................... 84

7.1 General setting ........................................................................................................................ 84

7.2 Measurement .......................................................................................................................... 85

7.2.1 General measurement setting ........................................................................................ 85

7.2.2 Measurement formula setting........................................................................................ 86

7.3 Annotation .............................................................................................................................. 92

7.3.1 Annotation Library ........................................................................................................ 92

7.3.2 Edit Annotation ............................................................................................................. 93

7.3.3 Comment and Arrow Option ......................................................................................... 93

7.4 Body marks ............................................................................................................................. 94

7.4.1 Body Marks Library ...................................................................................................... 94

7.4.2 Body mark edition......................................................................................................... 94

7.4.3 Body mark Option ........................................................................................................ 95

7.5 Exam Mode ............................................................................................................................. 95

7.5.1 Exam Mode Edit ........................................................................................................... 95

7.5.2 Exam Mode Selection ................................................................................................... 95

7.5.3 Exam mode selection .................................................................................................... 96

7.6 DICOM ................................................................................................................................... 97

7.6.1 Add/Edit DICOM Function ........................................................................................... 99

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ECO 3 EXPERT Ultrasound Diagnostic System

7.7 NET Work .............................................................................................................................. 99

7.8 System ..................................................................................................................................... 99

7.8.1 System information ....................................................................................................... 99

7.8.2 Upgrade......................................................................................................................... 99

7.8.3 Function Setting .......................................................................................................... 100

7.8.4 Installment setting ....................................................................................................... 100

7.8.5 Video VGA ................................................................................................................. 100

7.8.6 Image function ............................................................................................................ 100

7.8.7 System Maintenance ................................................................................................... 100

7.8.8 USB Video Printer Option .......................................................................................... 100

Chapter 8 System Maintenance ............................................................................................................ 101

8.1 Machine Clean ...................................................................................................................... 101

8.2 Probe Maintenance .............................................................................................................. 101

8.3 Safety Check ......................................................................................................................... 102

8.4 Malfunction Check ............................................................................................................... 103

Chapter 9 Probes................................................................................................................................... 104

9.1 General Description ............................................................................................................. 104

9.2 Care and Maintenance ......................................................................................................... 104

9.2.1 Inspecting Probes ........................................................................................................ 104

9.2.2 Cleaning and Disinfecting ........................................................................................... 105

9.3 Probe Operation Instructions.............................................................................................. 112

9.3.1 Scanning the Patient .................................................................................................... 112

9.3.2 Operating Transvaginal probe ..................................................................................... 113

9.3.3 Cleaning and Disinfecting TV and TR Probes ............................................................ 113

9.4 Service Responsibility .......................................................................................................... 114

Appendix A: The Information of EC Representative ............................................................. 116

Appendix B: Acoustic Output Report Table............................................................................ 117

Appendix C: Guidance and Manufacturer’s Declaration ...................................................... 145

Appendix D: Measurement Results Summary ........................................................................ 149

Appendix E: Display Accuracy and Acoustic Measurement Uncertainties .......................... 151

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ECO 3 EXPERT Ultrasound Diagnostic System

Appendix F: Transducer Maximum Surface Temperature ................................................... 152

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ECO 3 EXPERT Ultrasound Diagnostic System

Chapter 1 Introduction
This manual contains necessary information for safe system operation.
Read and understand all instructions in this manual before operating the system. Always keep this manual with
the equipment, and periodically review the procedures for operation and safety precautions.

1.1 System Overview

Indications for Use


The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for
evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac
(adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and
Transvaginal.

Contraindication
The system is NOT intended for ophthalmic use or any use that causes the acoustic beam to pass through the
eye.

1.2 Contact Information

For additional information or assistance, please contact your local distributor or the appropriate support
resource shown below:
CHISON website: www.chison.com
Service Support CHISON Medical Imaging Co., Ltd.
Tel: 0086-0510-85311707
Fax: 0086-0510-85310726
E-mail: [email protected]

Placing an Order CHISON Medical Imaging Co., Ltd.


Tel: 0086-0510-8531-0593/0937
Fax: 0086-0510-85310726
Email: [email protected]

Manufacturer CHISON Medical Imaging Co., Ltd.


No.228, ChangJiang East Road, Block 51 and 53 Phase 5 Industrial Park,
ShuoFang, New District, Wuxi, Jiangsu, China, 214142

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ECO 3 EXPERT Ultrasound Diagnostic System

Chapter 2 System Safety

2.1 Safety Overview

This section discusses measures to ensure the safety of both the operator and patient. To ensure the safety of
both operator and patient, please read the relevant details in this chapter carefully before operating this system.
Disregarding the warnings or violation of relevant rules may result in personal injury or even loss of life
for operator or patient.

Users should observe the following precautions:


This system complies with Type BF general equipment, and the IEC standard.
Do not modify this system in any way. Necessary modifications must be made only by the manufacturer or
its designated agents.
This system has been fully adjusted at the factory. Do not adjust any fixed adjustable parts.
In the event of a malfunction, turn off the system immediately and inform the manufacturer or its designated
agents.
The power cable of the system should only be connected to a grounded power socket. Do not remove the
ground cable for any reason.
Only connect this system, either electronically or mechanically, with devices that comply with the
EN60601-1 standard. Recheck the leakage current and other safety performance indices of the entire system to
avoid potential system damage caused by leakage from a current superposition.
The system does not incorporate any specialized protective measures in the event it is configured with
high-frequency operation devices. The operator should use caution in these types of applications.
The system should be installed only by personnel authorized by the manufacturer. Do not attempt to install
the system by yourself.
Only an authorized service engineer may perform maintenance.
Only a qualified operator, or someone under qualified supervision, should use the system.
Do not use this system in the presence of flammable substances, otherwise an explosion may occur.
Do not continuously scan the same part of a patient or expose the patient to prolonged scanning; otherwise it
may harm the patient.
When using the system for ultrasound testing, use only qualified ultrasound gel that complies with system
standards.
Do not unplug probe when the system is in active operation. Always go to EXAM screen when need to
remove the probe.
To prevent from arm or neck injury, the operator should not stay at the same position for too long during
patient scanning without taking break.
Do not put liquid on top of the main unit.

NOTE
*The system has built-in screen saver to avoid the tic mark on the display. It is not recommended to constantly
turn on and off the unit.
*To dispose of this product properly, please call your local service department.

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ECO 3 EXPERT Ultrasound Diagnostic System

2.2 Electrical Safety

Type of protection against electric shock


Class I Equipment
CLASS I EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION
only, but includes a protective earth ground. This additional safety precaution prevents exposed metal parts
from becoming LIVE in the event of an insulation failure.

NOTE: The mains supply shall be cut off after disconnecting the power line and the net power.

Degree of protection against electric shock


Type BF Applied part (for Probes marked with BF symbol)
TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular
regard to allowable LEAKAGE CURRENT

Level of protection against harmful ingress of water


Parts of probe likely to come into contact with operator or patient meet the requirements of drip-proof
equipment (IPX1)
Parts of probe intended to be immersed in normal use meet the requirements of watertight equipment (IPX7)
The IP Classification of System is Ordinary Equipment (IPX0)

Safety level when used in the presence of FLAMMABLE ANAESTHETIC

MIXED WITH AIR (or WITH OXYGEN or WITH NITROUS OXIDE):


The Equipment is not suitable for use in the environment with FLAMMABLE ANAESTHETIC MIXED
WITH AIR (or WITH OXYGEN or WITH NITROUS OXIDE)

Mode of operation
Continuous Operation
For maximum safety, always follow these guidelines:
Proper grounding of the system is critical to avoid electrical shock. For protection, ground the chassis with a
three-wire cable and plug, and plug the system into a hospital-grade, three-hole outlet.
Do not remove or circumvent the grounding wire.
Do not remove the protective covers on the system. These covers protect users from hazardous voltages.
Cabinet panels must remain in place while the system is in use. A qualified electronic technician must make all
internal replacements.
Do not operate this system in the presence of flammable gases or anesthetics.
All peripheral devices (unless certified as medical grade) that are connected to the system must be powered
through the electrical outlet through an optional isolation transformer.

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ECO 3 EXPERT Ultrasound Diagnostic System

Notice upon Installation of Product


Separation distance and effect from fixed radio communications equipment: field strengths from fixed
transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast, and TV broadcast transmitter cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the ultrasound system is
used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound system
should be observed to verify normal operation. If abnormal operation is observed, additional measures may be
necessary, such as re-orienting or relocating the ultrasound system or using an RF shielded examination room
may be necessary.
Use either power supply cords provided by or designated by CHISON. Products equipped with a power
source plug should be plugged into the fixed power socket which has the protective grounding conductor.
Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-to-two-prong
converter).
Locate the equipment as far away as possible from other electronic equipment.
Be sure to use only the cables provided by or designated by CHISON. Connect these cables following the
installation procedures (e.g. wire power cables separately from signal cables).
Lay out the main equipment and other peripherals following the installation procedures described in this
manual.

Notice against User Modification


The user should never modify this product.
User modifications may cause degradation in Electrical Safety. Modification of the product includes changes
in:
Cables (length, material, wiring, etc.)
System configuration/components
User modifications may cause degradation in EMC performance. Modification of the product includes changes
in:
Cables (length, material, wiring, etc.)
System installation/layout
System configuration/components
Securing system parts (cover open/close, cover screwing)

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ECO 3 EXPERT Ultrasound Diagnostic System

2.3 Labels

Real panel label

2.3.1 Warning Symbols

Caution, consult accompanying documents. Dangerous electric voltage. Unplug the main plug
This symbol advises the reader to consult the before opening the system!
accompanying documents for important safety related
information such as warnings and pre-cautions that
cannot be presented on the device itself.

Do not use the following devices near this equipment: Be careful of static.
cellular phone, radio receiver, and mobile radio
transmitter, radio controlled toy, etc. Use of these
devices near this equipment could cause this
equipment to perform outside the published
specifications. Keep power to these devices turned off
when near this equipment.

WASTE OF ELECTRICAL AND The CE mark of Conformity indicates this

ELECTRONIC EQUIPMENT (WEEE): This symbol equipment conforms with the Council Directive
is used for Environment Protection, it indicates that 93/42/EEC
the waste of electrical and electronic equipment must
not be disposed as unsorted waste and must be
collected separately. Please contact your local
5
ECO 3 EXPERT Ultrasound Diagnostic System
Authority or distributor of the manufacturer for
information concerning the decommissioning of your
equipment.

AUTHORIZED REPRESENTATIVE
Type-BF applied part
IN THE EUROPEAN COMMUNITY: This symbol is
accompanied by the name and the address of the
authorized representative in the European
Community.

This symbol is followed by the serial MANUFACTURER: This symbol is


number of the device. accompanied by the name and the address of the
manufacturer.

Power On/off.
This symbol signifies that the user manual
CAUTION: This Power Switch cannot isolate Mains
Supply completely. must be read.
Rx only
The “Alternating current” symbol indicates This symbol indicates that in the united states of
that the equipment is suitable for alternating current America, Federal law restricts the device to sale by or
only. on the order of a licensed practitioner or therapist.

This symbol is followed by the manufacturing date of


the device in the form YYYY-MM. CORRECT: The correct connection of the battery
connector
WRONG: The wrong connection of the battery
connector

2.4 Patient Environmental Devices

Left side:
1 LAN port
1 VGA port: External monitor
2 USB ports
1 Footswitch port
1 Power in port

Rear panel:
2 Probe ports
1 USB port
1 Video out port
1 Remote port

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ECO 3 EXPERT Ultrasound Diagnostic System

Acceptable Devices
The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT
ENVIRONMENT.

CAUTION:
DO NOT connect any probes or accessories without approval by CHISON within the PATIENT
ENVIRONMENT.
DO NOT touch patient and devices without IEC/EN 60601-1 approval to avoid the leakage current risk
within the PATIENT ENVIRONMENT.

Unapproved Devices

CAUTION:
DO NOT use unapproved devices.
If devices are connected without the approval of CHISON, the warranty will be INVALID.
The system can‟t be used with HF surgical equipment; otherwise the burns to patient may occur.

Any device connected to this system must conform to one or more of the requirements listed below:
IEC standard or equivalent standards appropriate to devices.
The devices shall be connected to PROTECTIVE EARTH (GROUND).

CAUTION:
Unsafe operation or malfunction may result. Use only the accessories, options and supplies approved or
recommended in these instructions for use.

Peripheral used in the patient environment

The system has been verified for overall safety, compatibility and compliance with the following on-board
image recording devices:
B/W video printer: SONY UP-D711MD
The system may also be used safely while connected to devices other than those recommended above if the
devices and their specifications, installation, and interconnection with the system conform to the requirements
of IEC/EN 60601-1.
Adapter is considered as a part of ME equipment
The connection of equipment or transmission networks other than as specified in the user instructions can
result in an electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections
require verification of compatibility and conformity to IEC/EN 60601-1 by the installer. Equipment
modifications and possible resulting malfunctions and electromagnetic interference are the responsibility of the
owner.
General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking.
There must be adequate mechanical mounting of the device and stability of the combination.
Risk and leakage current of the combination must comply with IEC/EN 60601-1.
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ECO 3 EXPERT Ultrasound Diagnostic System
Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2.

Peripheral used in the non-patient environment


The system has been verified for compatibility, and compliance for connection to a local area network (LAN)
via a wire LAN, provided the LAN components are IEC/EN 60601-1 compliant.

General precautions for installing an alternate off-board, remote device or a network would include:
The added device(s) must have appropriate safety standard conformance and CE Marking.
The added device(s) must be used for their intended purpose having a compatible interface.

2.5 Biological Safety

This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be
used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As
Reasonably Achievable) to produce diagnostically acceptable images. The AIUM offers the following
guidelines:

Clinical Safety Quoted from AIUM

Approved March 26, 1997

Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy
for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in
Medicine herein addresses the clinical safety of such use:
There are no confirmed biological effects on patients or instrument operators caused by exposures from
present diagnostic ultrasound instruments. Although the possibility exists that such biological effects may be
identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic
ultrasound outweigh the risks, if any that may be present.

Heating: Elevating tissue temperature during obstetrical examinations creates medical concerns. At the embryo
development stage, the rise in temperature and the length of time exposed to heat combine to determine
potential detrimental effects. Exercise caution particularly during Doppler exams. The Thermal Index (TI)
provides a statistical estimate of the potential temperature elevation (in centigrade) of tissue temperature.
Three forms of TI are available: Soft Tissue Thermal Index (TIS), Bone Thermal Index (TIB) and Cranial
Bone Thermal Index (TIC).

Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential
temperature increase in soft tissue.
Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB
examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cranial Bone Thermal Index (TIC). Used when bone is near the skin surface as in transcranial examination, it
provides an estimate of potential temperature increase in the bone or adjacent soft tissue.

Cavitations: Cavitations may occur when sound passes through an area that contains a cavity, such as a gas
bubble or air pocket (in the lung or intestine, for example). During the process of cavitations, the sound wave

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ECO 3 EXPERT Ultrasound Diagnostic System
may cause the bubble to contract or resonate. This oscillation may cause the bubbles to explode and damage
the tissue. The Mechanical Index (MI) has been created to help users accurately evaluate the likelihood of
cavitations and the related adverse effects.
MI recognizes the importance of non-thermal processes, cavitations in particular, and the Index is an attempt to
indicate the probability that they might occur within the tissue.

2.6 Scanning Patients and Education

The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe use
of this ultrasound system. Follow these usage guidelines for safe operation:
In order to maintain proper cleanliness of the probes, always clean them between patients.
Always use a disinfected sheath on all EV/ER probes during every exam.
Continuously move the probe, rather than staying in a single spot, to avoid elevated temperatures in one part
of the patient‟s body.
Move probe away from the patient when not actively scanning.
Understand the meaning of the TI, TIS, TIB, TIC and MI output display, as well as the relationship between
these parameters and the thermal/cavitation bioeffect to the tissue.
Expose the patient to only the very lowest practical transmit power levels for the shortest possible time to
achieve a satisfactory diagnosis (ALARA - As Low As Reasonably Achievable).

2.6.1 Safe Scanning Guidelines

Ultrasound should only be used for medical diagnosis and only by trained medical personnel.

Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of the equipment,
in the interpretation of the results and images, and in the safe use of ultrasound (including education as to
potential hazards).

Operators should understand the likely influence of the machine controls, the operating mode (e.g. B mode)
and probe frequency on thermal and cavitation hazards.

Select a low setting for each new patient. Output should only be increased during the examination if
penetration is still required to achieve a satisfactory result, and after the Gain control has been moved to its
maximum value.

Maintain the shortest examination time necessary to produce a useful diagnostic result.

Do not hold the probe in a fixed position for any longer than is necessary. The frozen frame and Cine loop
capabilities allow images to be reviewed and discussed without exposing the patient to continuous scanning.

Do not use endo-cavitary probes if there is noticeable self heating of the probe when operating in the air.
Although applicable to any probe, take particular care during trans- vaginal exams during the first eight weeks
of gestation.

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ECO 3 EXPERT Ultrasound Diagnostic System
Take particular care to reduce output and minimize exposure time of an embryo or fetus when the
temperature of the mother is already elevated.

Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when exposing: an
embryo less than eight weeks after gestation; or the head, brain or spine of any fetus or neonate.

Operators should continually monitor the on-screen thermal index (TI) and mechanical index (MI) values
and use control settings that keep these settings as low as possible while still achieving diagnostically useful
results. In obstetric examinations, TIS (soft tissue thermal index) should be monitored during scans carried out
in the first eight weeks after gestation, and TIB (bone thermal index) thereafter. In applications where the
probe is very close to bone (e.g. trans-cranial applications), TIC (cranial bone thermal index) should be
monitored.
MI> 0.3 there is a possibility of minor damage to neonatal lung or intestine. If such exposure is necessary,
reduce the exposure time as much as possible.

MI> 0.7 there is a risk of cavitations if an ultrasound contrast agent containing gas micro-spheres is being
used. There is a theoretical risk of cavitations without the presence of ultrasound contrast agents. The risk
increases with MI values above this threshold.

TI> 0.7 the overall exposure time of an embryo or fetus should be restricted in accordance with Table 2-2
below as a reference:

Maximum exposure time


TI (minutes)

0.7 60
1.0 30
1.5 15
2.0 4
2.5 1

Table 2-2 Maximum recommended exposure times for an embryo or fetus

Non-diagnostic use of ultrasound equipment is not generally recommended. Examples of non-diagnostic uses
of ultrasound equipment include repeated scans for operator training, equipment demonstration using normal
subjects, and the production of souvenir pictures or videos of a fetus. For equipment of which the safety
indices are displayed over their full range of values, the TI should always be less than 0.5 and the MI should
always be less than 0.3. Avoid frequent repeated exposure of any subject. Scans in the first trimester of
pregnancy should not be carried out for the sole purpose of producing souvenir videos or photographs, nor
should their production involve increasing the exposure levels or extending the scan times beyond those
needed for clinical purposes.

Diagnostic ultrasound has the potential for both false positive and false negative results. Misdiagnosis is far
more dangerous than any effect that might result from the ultrasound exposure. Therefore, diagnostic
ultrasound system should be performed only by those with sufficient training and education.

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ECO 3 EXPERT Ultrasound Diagnostic System

2.6.2 Understanding the MI/TI Display

Track-3 follows the Output Display Standard for systems that include fetal Doppler applications. The acoustic
output will not be evaluated on an application-specific basis, but the global maximum de-rated Ispta must be ≤
720 mW/ cm2 and either the global maximum MI must be ≤ 1.9 or the global maximum de-rated Isppa must be
≤ 190 W/cm2. An exception is for ophthalmic use, in which case the TI = max (TIS_as, TIC) is not to exceed
1.0; Ispta.3 ≤50mW/cm2, and MI ≤ 0.23. Track-3 gives the user the freedom to increase the output acoustic
power for a specific exam, and still limit output acoustic power within the global maximum de-rated Ispta ≤
720 mW/cm2 under an Output Display Standard.

For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display Standard. The diagnostic
ultrasound systems and its operation manual contain the information regarding an ALARA (As Low As
Reasonably Achievable) education program for the clinical end-user and the acoustic output indices, MI and TI.
The MI describes the likelihood of cavitations, and the TI offers the predicted maximum temperature
rise in tissue as a result of the diagnostic examination. In general, a temperature increase of
2.5°C must be present consistently at one spot for 2 hours to cause fetal abnormalities. Avoiding a local
temperature rise above 1°C should ensure that no thermally induced biologic effect occurs. When referring to
the TI for potential thermal effect, a TI equal to 1 does not mean the temperature will rise 1 degree C. It only
means an increased potential for thermal effects can be expected as the TI increases. A high index does not
mean that bioeffects are occurring, but only that the potential exists and there is no consideration in the TI for
the scan duration, so minimizing the overall scan time will reduce the potential for effects. These operator
control and display features shift the safety responsibility from the manufacturer to the user. So it is very
important to have the Ultrasound systems display the acoustic output indices correctly and the education of the
user to interpret the value appropriately.

RF: (De-rating factor)


In Situ intensity and pressure cannot currently be measured. Therefore, the acoustic power measurement is
normally done in the water tank, and when soft tissue replaces water along the ultrasound path, a decrease in
intensity is expected. The fractional reduction in intensity caused by attenuation is denoted by the de-rating
factor (RF),

RF = 10 (-0.1 a f z)

Where a is the attenuation coefficient in dB cm-1 MHz-1, f is the transducer center frequency, and z is the
distance along the beam axis between the source and the point of interest.

De-rating factor RF for the various distances and frequencies with attenuation coefficient 0.3dB cm-1 MHz-1
in homogeneous soft tissue is listed in the following table. An example is if the user uses 7.5MHz frequency,
the power will be attenuated by .0750 at 5cm, or 0.3x7.5x5=-11.25dB. The De- rated Intensity is also referred
to as „.3‟ at the end (e.g. Ispta.3).

Distance Frequency (MHz)


(cm) 1 3 5 7.5
1 0.9332 0.8128 0.7080 0.5957
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ECO 3 EXPERT Ultrasound Diagnostic System
2 0.8710 0.6607 0.5012 0.3548
3 0.8128 0.5370 0.3548 0.2113
4 0.7586 0.4365 0.2512 0.1259
5 0.7080 0.3548 0.1778 0.0750
6 0.6607 0.2884 0.1259 0.0447
7 0.6166 0.2344 0.0891 0.0266
8 0.5754 0.1903 0.0631 0.0158

I‟=I*RF Where I‟ is the intensity in soft tissue, I is the time-averaged intensity measured in water.

Tissue Model:
Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode. Six models are
developed to mimic possible clinical situations.

Thermal Models Composition Mode Specification Application

Large aperture (>1cm2)


1 TIS Soft tissue Unscanned Liver PW
2 TIS Soft tissue Unscanned Small aperture (<1cm2) Pencil Probe
3 TIS Soft tissue Scanned Evaluated at surface Breast color
4 TIB Soft tissue and bone Scanned Soft tissue at surface Muscle color
5 TIB Soft tissue and bone Unscanned Bone at focus Fetus head PW

6 TIC Soft tissue and bone Unscanned/scanned Bone at surface Transcranial

Soft tissue:
Describes low fat content tissue that does not contain calcifications or large gas-filled spaces.

Scanned: (auto-scan)
Refers to the steering of successive burst through the field of view, e.g. B mode.

Unscanned:
Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the transducer is moved
to a new position. For instance, the PW, and M mode.

TI:
TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to raise tissue
temperature by 1°C (Wdeg), TI = W.3/Wdeg.
Three TIs corresponding to soft tissue (TIS) for abdominal; bone (TIB) for fetal and neonatal cephalic; and
cranial bone (TIC) for pediatric and adult cephalic, have been developed for applications in different exams.
An estimate of the acoustic power in milli-watts necessary to produce a 1°C temperature elevation in soft
tissue is:

Wdeg = 210/fc,for model 1 to 4, where fc is the center frequency in MHz.

Wdeg = 40 K Dfor model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture diameter in cm at
the depth of interest.
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ECO 3 EXPERT Ultrasound Diagnostic System

MI:
Cavitation is more likely to occur at high pressures and low frequencies in pulse ultrasound wave in the tissue,
which contains the bubble or air pocket (for instance, the lung, intestine, or scan with gas contrast agents). The
threshold under optimum conditions of pulsed ultrasound is predicted by the ration of the peak pressure to the
square root of the frequency.

MI = Pr‟ / sqrt(fc)
Pr‟ is the de-rated (0.3) peak rare-fractional pressure in Mpa at the point where PII is the
maximum, and fc is the center frequency in MHz. PII is the Pulse Intensity Integral that the total energy
per unit area carried by the wave during the time duration of the pulse. The peak
rare- fractional pressure is measured in hydrophone maximum negative voltage normalized by the
hydrophone calibration parameter.

Display Guideline:
For different operation modes, different indices must be displayed. However, only one index needs to be
shown at a time. Display is not required if maximum MI is less than 1.0 for any setting of the operating
mode, or if maximum TI is less than 1.0 for any setting of the operating mode. For TI, if the TIS and TIB are
both greater than 1.0, the scanners need not be capable of displaying both indices simultaneously. If the index
falls below 0.4, no display is needed. The display increments are no greater than 0.2 for index value less than
one and no greater than 1.0 for index values greater than one (e.g. 0.4, 0.6, 0.8, 1, 2, and 3).

Display and Report

Located on the upper middle section of the system display monitor, the acoustic output display provides the
operator with real-time indication of acoustic levels being generated by the system.

For Scan
Only display and report MI, and start from 0.4 if maximum MI > 1.0, display in increments of 0.2.

Below is a simple guideline for the user when TI exceeds one limit exposure time to 4(6-TI) minutes based on
the „National Council on Radiation Protection. Exposure Criteria for Medical Diagnostic Ultrasound: I.
Criteria Based on Thermal Mechanisms. Report No.113 1992‟.

Operator Control Features:


The user should be aware that certain operator controls may affect the acoustic output. It is recommended to
use the default (or lowest) output power setting and compensate using Gain control to acquire an
image. Other than the output power setting in the soft-menu, which has the most direct impact on the power;
the PRF, image sector size, frame rate, depth, and focal position also slightly affect the output power. The
default setting is normally around 70% of the allowable power depending on the exam application mode.

Controls Affecting Acoustic Output


The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influenced by certain
controls.
Direct: The Acoustic Output control has the most significant effect on Acoustic Output.
Indirect: Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed
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ECO 3 EXPERT Ultrasound Diagnostic System
under the bioeffect portion of each control in the Optimizing the Image chapter.
Always observe the Acoustic Output display for possible effects.

Best practices while scanning


HINTS: Raise the Acoustic Output only after attempting image optimization with controls that have no effect
on Acoustic Output, such as Gain and TGC.

WARNING: Be sure to have read and understood control explanations for each mode used before
attempting to adjust the Acoustic Output control or any control that can affect Acoustic Output.

Use the minimum necessary acoustic output to get the best diagnostic image or measurement during an
examination. Begin the exam with the probe that provides an optimum focal depth and penetration.

Acoustic Output Default Levels


In order to assure that an exam does not start at a high output level, the system initiates scanning at a reduced
default output level. This reduced level is preset programmable and depends upon the exam icon and probe
selected. It takes effect when the system is powered on or New Patient is selected. To modify acoustic output,
adjust the Power Output level on the Soft Menu.

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ECO 3 EXPERT Ultrasound Diagnostic System

Chapter 3 System Introduction

3.1 Consol Overview

Console Overview

3.2 Physical Specification

335mm(Length)×155mm(Width)×350mm(Height)

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ECO 3 EXPERT Ultrasound Diagnostic System

3.3 System View in Different Views

System Front View

System Side View


1. Ethernet 2.VGA 3.USB 4.Footswicth 5.Power in

Console Overview
1. Probe Holder 2.Probe 3.Keyboard

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ECO 3 EXPERT Ultrasound Diagnostic System

System Rear View


1. Probe 2.USB 3.Remote 4. Video Out 5.Battery Holder 6. Probe Holder

3.4 Function Introduction

1.Possess B, B/B, 4B, B/M, M, PW display mode, M, B/M mode possess 4 kinds of scan velocity;
2.Possess many combination of focus, total gain control 8 segments STC;
3.Possess depth scan and image left-right up-down rolling-over function;
4.Possess a lot of imaging technology for example multiple compound imaging (space frequency compound),
multiple frequency, multiple zoom ratio, pan zoom, screen scroll, chroma, harmonic imaging etc;
5.Possess image processing, total gain, dynamic range, frequency, focus number, focus position, zoom,
compound, scan width, line density, smooth, edge enhancement, frame, persistence, gray scale, restrain boost
multi-beam, acoustic power, M velocity;
6.Possess distance proportion circumference volume rate angle histogram in B mode distance time velocity
heart rate measurement function in M mode ;GYN measurement software package, small parts measurement
software package, ventricle function measurement software package and user defined formula;
7.Possess body mark arrow case number display, real time clock display annotation in image user-defined
annotation;
8.Possess multi-language interface display User interface change, shear plate, printing ,DICOM3.0 biopsy
guided functions;
9.It has permanent storage for image and cine and optional 320GB HDD. It can also be connected to
removable storage via USB port. To realize mass storage ,can recall saved image for analysis;
10.Cine loop storage 256frames real time image;
11.Screen rotation function make you adjust screen angle according to users' requirement 0~30°;
12.Output standard PAL or NTSC video signal and VGA signal;
13.Print or export graphic report.

3.4.1 Image Modes


B mode
B/M mode
M mode
2B mode
4B mode

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ECO 3 EXPERT Ultrasound Diagnostic System
PW mode

3.4.2 Accessories

Transducers:

C3-A, 2.5-5.0MHz Convex Array L7M-A, 5.3-10.0MHz Linear Array


Indications for Use: Fetal/OB; Abdominal (GYN & Indications for Use: Pediatric; Small Organ(breast,
Urology); Pediatric; testes, thyroid); Peripheral Vascular, Musculo-skeletal
Conventional & Superficial;

L7S-A, 5.3-11.0MHz Linear Array V6-A, 4.5-8.0MHz Micro-convex Array


Indications for Use: Pediatric; Small Organ(breast, Indications for Use: OB; GYN & Urology;
testes, thyroid); Peripheral Vascular, Musculo-skeletal Transvaginal;
Conventional & Superficial;

R7-A, 5.0-10.0MHz Linear Array MC6-A, 4.5-8.0MHz Micro-convex Array


Indications for Use: Urology; Transrectal; Indications for Use: Abdominal (GYN & Urology);
Pediatric; Small Organ(breast, testes, thyroid);
Cardiac (pediatric);

MC3-A ,2.5-5.0MHz Micro-convex Array


Indications for Use: Abdominal (GYN & Urology); ;
Cardiac (adult & pediatric);

Peripherals
VGA output for external monitor
VIDEO output for B&W video printer
LAN port output
LAN for DICOM and image review station
USB 2.0 for flash drive
Foot switch
AC/DC adapter: MDS-060AAS19 B
Input: 100-250V~1.5-0.75A, 50-60Hz
Output: 19V 3.15A
DELTA ELECTRONICS, INC.
Battery Pack: BT-2500, 4400mAh, DONGGUAN POWER INC
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ECO 3 EXPERT Ultrasound Diagnostic System

3.4.3 Configuration of the System


Configuration ECO 3 EXPERT
Color White
Probe 2(standard)
Maximum memory 8GB
320G HDD Option
Built in battery Standard
PW Standard
Compound, THI, i-Image Standard
Trapezoidal Standard
Chroma Standard
DICOM 3.0 Option
Option: HP LaserJet P2055d, HP
Graphic Printer LaserJet P1102, HP LaserJet Pro 200
color M251n
Seven: C3-A, V6-A, MC3-A, L7M-A,
Probe configuration
L7S-A, MC6-A, R7-A

3.5 Installation Procedures

Note: Please do not turn on the power switch until finishing all the installation and necessary preparation.

3.5.1 Environment Condition


The system should be operated under the following environment.

3.5.1.1 Operation Environment Requirement


Ambient Temperature: 10 ℃~40 ℃
Relative Humidity: 30%~75%RH
Atmospheric Pressure: 700hPa~1060hPa

3.5.1.2 Transport and Storage Environmental Requirement


The following environmental transport and storage conditions are within system tolerances:
Temperature: -5ºC ~ 40ºC
Relative Humidity:≤ 80% non-condensing
Atmosphere Pressure:700hPa ~ 1060hPa

3.5.1.3 Electrical Requirements


Power Consumption: less than 60 VA
Voltage Fluctuation

WARNING

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ECO 3 EXPERT Ultrasound Diagnostic System
Maintain a fluctuation range of less than ±10% of voltage labeling on rear panel of the system, otherwise the
system may be damaged.

Grounding
Before connecting the power cable, connect the attached ground protection cable from Equipotentiality
terminal on system rear panel to a specialized grounding device.

NOTE
Please follow the outlined power requirements. Only use power cables that meet the system
guidelines—failure to follow these procedures may produce system damage.
Line power may vary in different geographic locations. Refer to the detailed ratings on the rear panel of the
system for detailed information.
Battery
To avoid the battery bursting, igniting, or fumes from the battery; causing equipment damage, observe the
following precautions: Do not immerse the battery in water or allow it to get wet. Do not put the battery into a
microwave oven or pressurized container. If the battery leaks or emits an odor, remove it from all possible
flammable sources. If the battery emits an odor or heat, is deformed or discolored, or in a way appears
abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any
questions about the battery, short term (less than one month) storage of battery pack: Store the battery in a
temperature range between 0 degrees C (32 degrees F) and 50 degrees C (122 degrees F).
Long term (3 months or more) storage of battery pack: Store the battery in a temperature range between-20
degrees C (-4 degrees F) and 45 degrees C (113 degrees F); Upon receipt of the ECO and before first time
usage, it is highly recommended that the customer performs one full discharge/charge cycle. If the battery has
not been used for >2 months, the customer is recommended to perform one full discharge/charge cycle. It is
also recommended to store the battery in a shady and cool area with FCC (full current capacity).• One Full
Discharge/Charge Cycle Process:1. Full discharge of battery to let the ECO automatically shut down.2.
Charge the ECO to 100% FCC (full current capacity).3. Discharge of Venue 40 for complete shutdown(takes
one hour for discharge).• When storing packs for more than 6 months, charge the pack at least once during the
6 month timeframe to prevent leakage and deterioration in performance.

3.5.1.4 Operation Space


Please leave enough free space from the back of the system to ensure well ventilation.

Caution: Leave enough free space from the back of the system; otherwise, with the increasing of the
temperature inside the unit, malfunction may occur.

3.5.1.5 System Positioning & Transporting


Moving the System
When moving or transporting the system, take the precautions described below to ensure maximum safety for
personnel, the system and other equipments.

Before Moving the System

Press 3 s, system will forced shut down and completely switch off the system.

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ECO 3 EXPERT Ultrasound Diagnostic System
Disconnect all cables from off-board peripheral devices (external printer, etc.) from the console.

NOTE
To prevent damage to the power cord, DO NOT pull excessively on the cord or sharply bend the cord while
wrapping it.
Store all probes in their original cases or wrap them in soft cloth or foam to prevent damage.
Replace gel and other essential accessories in the appropriate storage case.
Ensure that no loose items are left on the console.

When Moving the System


Carry the system with handle, or put the system on the cart to move it.

NOTE
Walk slowly and carefully when moving the system.
Do not let the system strike walls or doorframe.

Transporting the System


Use extra care when transporting the system in a vehicle. After preparing the system as described above, take
the following additional precautions:
Only use vehicles that are suitable for transport of the system.
Before transporting, place the system in its original storage carton.
Load and unload the system to a vehicle parked on a level surface.
Load the unit abroad the vehicle carefully and over its center of gravity. Keep the unit still and
upright.
Ensure that the transporting vehicle can bear the weight of system plus the passengers.
Secure the system firmly with straps or as directed within the vehicle to prevent movement during transport.
Any movement, coupled with the weight of the system, could cause it to break loose.
Drive carefully to prevent damage from vibration. Avoid unpaved roads, excessive speeds, and erratic stops
or starts.

3.5.2 Powering the System

3.5.2.1 Acclimation Time


After being transported, the unit requires one hour for each 2.5 ºincrement if its temperature is below 10 ºC or
above 40 ºC.

NOTE
Please keep at least 20 to 30 cm spare space away from the back of the system to ensure well ventilation.
Otherwise, with the increasing of the temperature inside the unit, malfunction may occur.

3.5.2.2 Connecting the electric power


After making sure that the AC power supply in hospital is in normal status, and this AC voltage type matches
to the power requirements indicated on the label of system, then please connect the plug of power cord to the
POWER IN socket at the rear panel of the system,and connect the other end of power cord to the AC power
supply socket in hospital.

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ECO 3 EXPERT Ultrasound Diagnostic System
Please use the power cable provided by the manufacturer, other type of power cable is not allowed.

Press 1 s, system boot,

Press and pop up dialog for shut down. Click the enter key then power off.

Or press 3 s, system will forced shut down

CAUTION
Connecting the system to the wrong AC power supply may cause damage to the system and danger to the
operators and animals.

3.5.3 Probe Installment

Caution:Please only use the probes provided by manufacturer for this model, other types of probes are
not allowed to use with this system! Otherwise it may cause the damage to the system and the probe.

CAUTION
Before connecting the probe, please carefully check the probe lens, probe cable and probe connector to see
whether there is anything abnormal, such as cracks, falls off. Abnormal probe is not allowed to connect to the
system; otherwise there is possibility of electricity shock.
Hold the probe connector lock switch, and insert the connector socket vertically.
Release the probe lock switch.
Check the locked probe with one hand to make sure that it‟s not loose, and it‟s securely connected

CAUTION
Only power supply at “turn off” state, can install / take-down the probe, otherwise it will damage the
machine or the probe.
When installing and disassembling probe, please put the probe head inside the probe holder, it can prevent
the probe falling down to the ground.

3.5.3.1 Probe Disassembly


Turn the dead lock switch 90degree in counterclockwise direction, extract probe connector plug vertically.

3.5.4 Accessories Installment

Caution:Please only use the optional parts provided or suggested by manufacturer! Using other
types of optional devices may cause the damage to the system and the connected optional devices.

3.5.4.1 Video printer installment


1.Put video printer stably.
2.Connect cable of video printer to video port in the back of the device. And connect the other side to video
signal output port in the rear side.
3.Connect the printer line to print control port in the printer rear side, and connect the other side to the print

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ECO 3 EXPERT Ultrasound Diagnostic System
control port in the unit rear side.
4.Connect power cable of video printer to power system..
5.Adjust printer parameter preset according to the type of printing paper

Caution: Do not use any other power cable to replace 3-wire power cable manufacturer provides,
otherwise there is danger of electric shock.

Video printer sign introduction

: Video signal input port

:Video signal output port

:Print control port

:Video printer switch

3.5.4.2 Graphic printer installment


Put graphic printer stably, connect printer cable to USB port in the left side of the unit.
Connect the power cable of graphic printer to power system.

Caution:Please see packing list for fundamental configuration!

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ECO 3 EXPERT Ultrasound Diagnostic System

Chapter 4 Control Panel

4.1 Alphanumeric Keyboard

Alphanumeric Keyboard
The alphanumeric keys are used for inputting patient number, name, character and figure etc.

4.2 Function Keys/Knob

4.2.1 SWITCH

Turn on or off the device

4.2.2 PATIENT

Set up a new patient data, input name and other information.

4.2.3 PROBE

Press this key for selecting probe. It can only select the connected probe.

4.2.4 SETUP

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ECO 3 EXPERT Ultrasound Diagnostic System
Press this key to get in or out the system setting page.

4.2.5 END

Press END key to finish the exam.

4.2.6 BODY MARK

Press this key to enter into body mark working status, select the body mark and confirm the probe scanning
position on the screen. It is only available in frozen status.

4.2.7 COMMENT

Press this key to enter into comment status, and add comments in the image area on the screen.

4.2.8 ARROWS

Add arrows icon to the image area.

4.2.9 DEL

Press this key to clear the measurement lines, body mark, and comments.

4.2.10 Print

PRINT1: Print the screen image by video printer connected to the system.
PRINT2: Print the report by printer connected to the system (Only report page works).
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ECO 3 EXPERT Ultrasound Diagnostic System

4.2.11 Archive

File management of system, you can view and edit the patient data.

4.2.12 Report

Produce/ Save/ Recall an examination report.

4.2.13 Parameter Control Key

Increase/decrease the corresponding parameters of the screen, or open/close the function.

5
4.3 Central Control

4
6

3
7

2 8

1 9

10

1. UPDATE 2.EXIT 3.Cursor 4.Change 5.MENU


6. Dist 7.Trace 8.Calc 9.ENTER 10.Trackball

4.3.1 ENTER
This multifunction key is work with trackball. The function switches with the unit status. Such as, set the
cursor position, body mark position, comment position, toggle trackball function, selected the menu, and

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ECO 3 EXPERT Ultrasound Diagnostic System
confirm the input.

4.3.2 UPDATE
This multifunction key is work with trackball. The function switches with the unit status. Such as, call the
annotation and back in measuring.

4.3.3 Exit
Press this key can exit measurement, dialog, and menu.

4.3.4 Cursor
Press this key to show or hide the cursor.

4.3.5 Change
Press this key to change the menu.

4.3.6 Dist
Press this key to enter into distance measurement.

4.3.7 Trace
Press this key to enter into trace measurement, and press [UPDATE] to change between trace and ellipse.

4.3.8 Calc
Press this key to enter into measurement software package.

4.3.9 MENU
Press MENU-knob for second time to select the item and adjust the parameters. Press MENU-knob for third
time to exit from current item. Rotate the MENU- knob to select the item

4.3.10 Trackball
Trackball is the main operation tool on screen. Position calipers in measurement, the function of the trackball
is different under diverse working status.

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4.4 The key of Image Mode

4.4.1 B

Display B mode

4.4.2 B/B

Press this key to enter into 2B mode.

4.4.3 4B

Press this key to enter into 4B mode.

4.4.4 M

Press this key to change the mode between B/M and M.

4.5 Control of Image

4.5.1 THI

Press this key to open or close the THI function.

4.5.2 AIO

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ECO 3 EXPERT Ultrasound Diagnostic System
Only press this key for automatic optimization image.

4.5.3 CINE

Only press this key to save the current cine loop.

4.5.4 SAVE

Only press this key to save the current image.

4.5.5 Left and Right Invert

Press this key to invert the image from left and right.

4.5.6 Up and Down Invert

Press this key to invert the image from up and down.

4.5.7 STC

STC can be used for adjusting gain compensation in different image depth.
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ECO 3 EXPERT Ultrasound Diagnostic System

4.5.8 GAIN
Rotate the knob to adjust the gain of B mode and M mode.

4.5.9 ANGLE/ZOOM Knob


Rotate the knob to adjust the angle or zoom. Press this knob to change the function between angle and zoom.

4.5.10 DEPTH/FOCUS Knob


Press the knob to adjust the depth and function position. Press the knob to change the function between depth
and focus position.

4.5.11 Information Area Indicating Machine Status

Left-to-Right of the up row: hard disk, cable network, USB


Hard disk: press this icon to show the capacity of disc to used save data or USB flash disk in current system
Cable network: show the present situation of cable network; press this icon to show the IP address of current
system.
USB: show whether this system connects USB flash disk or not, press this icon to show USB safely remove
interface.
Left-to-Right of the down row: input method, DICOM Task Sequence, battery gauge
Input method: press this icon to switch Chinese and English input method.
DICOM Task Sequence: press this icon to show DICOM task and its situation ,To terminate the DICOM task,
delete, and so on(Need to activate DICOM)
Battery gauge: show the connecting situation of the battery, just press this icon to show the present State of
charge and discharge, remaining electric quantity and available time.

4.5.12 Indicator Light

From left to right: Adapter Indicator, Charge Indicator, and Sleep Indicator.
Adapter Indicator: when the main unit connects to the adapter with power supply, the indicator lights,
otherwise extinguishes.
Charge Indicator: When the battery is charging, the indicator lights, once the battery is charged, the indicator
goes out.
Sleep Indicator: When the main unit is in sleep mode, the indicator lights, otherwise extinguished.

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ECO 3 EXPERT Ultrasound Diagnostic System

Chapter 5 Operation and Exam Mode


This chapter mainly describes the process of the normal operation of the device, including the preparation
before examination, how to get the image, optimize the image, add comments, body mark and so on.

5.1 Preparing the System for Use

5.1.1 The Device Inspection


(1)The device is placed stability;
(2)The grid voltage AC 100-240V, 50Hz-60Hz;
(3)Cable is properly connected, firm and ground, the adapter is properly connected to the device;
(4)Probe is connected and fixed.

5.1.2 Power On

Long press 1 second to start the machine, wait for the system to enter the user interface, activate the
probe slot into the B mode.

5.2 Choose Exam Mode

5.2.1 The Probe Identification

The system default automatically identifies the current probe type, when the probe is inserted, Press
to switch the probe.

CAUTION: Please connect or disconnect the probe only after the system is freezing, in order to
ensure stability and extend the service life of the probe.

5.2.2 Mode Selection


In probe selection interface, probe and clinical application selection page is displayed, you can choose needed
probe and inspection part, and press the default into the B mode, start scan detection.

NOTE: The system has been set clinical application preset before leaving factory, each probe has its
own preset.
The detailed operation steps of the clinical application preset of the probe, please refer to the preset section.

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5.3 Patient Data Entry

Press the to display the Patient screen

Patient‟s Information Screen


Function Buttons on Patient screen:
[Archive]: Operation on the patient information which has already existed;
[Wordlist]:Recall patient information in worklist. And need to open the DICOM function;
[New Patient]:Create a new patient information identity;
[New Study]:Choose exam applications(OB、GYN、CARD and so on) for the new patient;
[End Study]:Edit patient‟s exam item;
[OK]:Save patient information;
[Cancel]:Cancel the operation of new patient information;
Operation Methods:
(1)Move the Trackball to the position of inputting character, then input patient information by character
keyboard.
(2)Use the Trackball and the [ENTER] key to switch between different input options: ID, patient name,
doctor's name, birthday (It can be automatically calculated when input age), age (It can be automatically
calculated when input birthday), gender.
(3)Select the exam items, and input the regular inspection information.
(4)After inputting the required information, click on the [OK] key to save the patient information, the system
will return to the B mode.
(5)Recall information of the previous patient, you can use the Archive or Worklist to recall patient information
to exam.

CAUTION: Creating a diagnostic record, you should check the accuracy of the patient information
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ECO 3 EXPERT Ultrasound Diagnostic System
before saving measurement or image; otherwise, it will be stored in the wrong patient records. After checking
the patient, press the [END] key to save the patient information in the system.

5.4 Image Interface Display

1
7
9
2 8

10

11 6

3 5

1, Logo 2, Control menu 3, Image status prompt 4, Image parameter area


5, System state prompt 6, Gray curve 7, Image parameter area 8, Gray-scale strip
9, Start point of scanning 10, Image Region 11, Cine loop

5.5 Display Mode

Display Mode: B,2B,4B,M,B/M, they can be shifted by the mode key.

5.5.1 B Mode
Press [B] Mode key, and display the single B Mode image, B Mode is the basic mode for two-dimensional
scanning and diagnosis.

5.5.2 B/B Mode


Press [2B] to display double B mode images side by side. One image is in real-time status; the other is in
frozen status. The real-time image has start scan marker and ruler marker .Press [2B] in B/B mode, the original
active image is frozen while the original frozen image is activated.

5.5.3 4B Mode
Press [4B] to enter into 4B mode, the screen will display four B mode images side by side, but only one image
is in real-time status. Pressing it again can switch the real-time status among four images.
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5.5.4 B/M Mode


Press [B/M] key, a real time B mode image and a real-time M-mode image will be displayed at the same time.
And a sample line will appear in the B mode image area, which indicates the active sample position for M
image on the B image area. Click the position on the B image area to fix the position of sampling line.

5.5.5 M Mode
Press [M] key again, B mode image will disappear; M mode image is still active on the whole screen. M mode
image stands for the tissue movement status at the sampling line. The M mode image varies with time, so it is
mainly used for cardiac applications.

5.5.6 PW 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.
The X axis represents time while the Y axis represents velocity in either a forward or reverse direction.
PW Doppler is typically used for displaying the speed, direction, and spectral content of blood flow at selected
anatomical sites.

PW Doppler can be combined with B mode for quick selection of the anatomical site for PW Doppler
examination. The site where PW Doppler data is derived appears graphically on the B mode image (Sample
Volume Gate). The Sample Volume Gate can be moved anywhere within B mode image.

PW mode Exam Procedure:


Get a good B mode image.
Press [PW] key to display the sample volume cursor and gate.
Position the sample volume cursor by moving the Trackball left and right. Position or re-size the sample
volume gate by moving the Trackball up and down, then press [ENTER] key.
Press [UPDATE] key to display PW Doppler spectrum and the system will run in combined B+Doppler
mode. The Doppler signal can be heard through the speakers.
Optimize the PW Doppler spectrum as necessary.
Ensure that the sample line is parallel to the blood flow.
Press [FREEZE] key to hold the trace in cine memory and stop imaging.
Perform measurements and calculations, as necessary.
Record results with your recording devices.
Press [FREEZE] key to resume imaging.
Repeat the above procedure until all relevant flow sites have been examined.
Replace the probe in its respective holder.

When entering Duplex mode for the first time, the Doppler spectrum is not activated. The Doppler Sample
Volume appears in the default position, and the B mode image or 2D mode are active. Moving the Trackball
will change the Sample Volume position. Press the [ENTER] key to toggle the Trackball function between
Sample Volume Gate position and size. Press the [UPDATE] key after the Sample Volume Gate is defined to
activate the Spectral Doppler mode. Press the [UPDATE] key for second time to toggle back to 2D update and
deactivate the Spectral Doppler.
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ECO 3 EXPERT Ultrasound Diagnostic System

Doppler mode Scanning Hints:


The best Doppler data will be got when the scanning direction is parallel to the direction of the blood flow;
when the scanning direction is perpendicular to the anatomic target, you can get the best B mode image, so you
should keep the balance as you don‟t usually get both an ideal B mode image and ideal Doppler data
simultaneously.
PRF: adjust the velocity scale to accommodate faster/slower blood flow velocity. Velocity scale determines
pulse repetition frequency.
Wall Filter: remove the noise caused by vessel or heart wall motion at the expense of low flow sensitivity.
Baseline: adjust the baseline to accommodate faster or slower blood flows to eliminate aliasing.
Angle: optimize the accuracy of the flow velocity. It estimates the flow velocity in a direction at an angle to
the Doppler vector by computing the angle between the Doppler vector and the flow to be measured. This is
special useful in vascular applications where you need to measure velocity.
Doppler Gain: allow you to control the background information of spectral.
Sweep Speed: control speed of spectral update.

Doppler Sample Volume Gate Position and Size (Trackball and SET)
Move the sample volume on the B mode‟s Doppler cursor. The gate is positioned over a specific position
within the vessel.
To move Doppler cursor position, turn the trackball left or right until positioned over the vessel.
To move sample volume gate position, move the trackball up or down until positioned inside the vessel.
To size sample volume gate, press [ENTER] key to toggle trackball function from sample volume gate
positioning to sizing, then move the trackball to change sample volume gate size.

5.6 B Image Adjustment

5.6.1 Frequency
In real status, press the first line key of [Frequency] to increase the frequency, and press the second line key of
[Frequency] to decrease the frequency.

5.6.2 Dynamic
Dynamic range is used for adjusting the contrast resolution of B mode image and mode image, compressing or
enlarging the display range of gray scale.
At the real-time status, press the first line key of [Dynamic] to increase the Dynamic, and press the second line
key of [Dynamic] to decrease the Dynamic. The range is 30 to 90.

5.6.3 i-Image
In real status, press the corresponding key of [i-Image] to adjust, the range is 0~3.

5.6.4 Compound
In real status, press the corresponding key of [Compound] to adjust, and the range is 0~3.

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ECO 3 EXPERT Ultrasound Diagnostic System
The SRA can‟t be edited after opening the compound.

5.6.5 PW
Display PW mode.

5.6.6 M Speed Adjustment


In real M status, press the corresponding key of [Speed] to adjust M speed, and the range is 1~4.

5.6.7 Gain
In real status, rotate [Gain] knob to adjust the Gain, and the range is 0~255, the step is 5.

5.6.8 STC
STC curves can be used for adjusting gain compensation in different image depth.
Drag the slide of STC to adjust the value.
STC curve will disappear automatically 1 second later after stopping adjustment.

5.6.9 Depth
Press [DEPTH/FOCUS] selection knob until the indicator of [DEPTH] is lit, and then rotate the knob to
change the depth of image.

5.6.10 Focus Pos


Press the [DEPTH/FOCUS] selection knob until the indicator of [FOCUS POS] is lit. Then turn the knob to
change Focus Position.

5.6.11 Angle
Change the angle of sampling line of sampling gate in PW mode.
Press [ANGLE/ZOOM] confirm the light of ANGLE on, the sampling line rotates with the direction.

5.6.12 ANGLE/ZOOM
Press [ANGLE/ZOOM] knob until the indicator of [ANGLE] is lit, and the angle of sample gate will rotate
with the rotation direction.
Press [ANGLE/ZOOM] knob to confirm the ZOOM button is lit, and it will appear the zoom box, rotate the
knob to select the zoom steps.

5.6.13 INVERT
B mode image and B/M mode image can be reversed horizontally and vertically.

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