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Regulatory Requirement

This product complies with regulatory requirements of the following European


directive 93/42/EEC as amended by 2007/47/EC concerning medical devices.

Note:
Some options are not available on some models!
This manual is subject to change without prior notice or without legal obligation
attached!
Contents

Contents ................................................................................................................... i
Chapter 1 System Safety and Maintenance ................................................. 1
1.1 Safety Overview ................................................................................................ 1
1.2 Description of Symbols and Signal Words Used............................................... 2
1.2.1 Symbols .................................................................................................. 2
1.2.2 Signal words ........................................................................................... 4
1.3 Messages .......................................................................................................... 4
1.4 Adverse Effects and Precautions ...................................................................... 5
1.5 Biological Safety ................................................................................................ 5
1.6 Scanning Patients and Education ..................................................................... 6
1.6.1 Safe Scanning Guideline ........................................................................ 6
1.6.2 Understanding the MI/TI Display ............................................................ 8
1.7 Environmental Requirements .......................................................................... 12
1.8 Electrical Requirements................................................................................... 12
1.9 Electrical Safety ............................................................................................... 13
1.10 Cautions for Using Accessories....................................................................... 14
1.10.1 Foot Switch ........................................................................................... 14
1.10.2 Optional Printers ................................................................................... 14
1.10.3 Transducer Maintenance ...................................................................... 14
1.11 Environmental Protection ................................................................................ 18
1.12 System Transportation..................................................................................... 18
1.12.1 Moving the System ............................................................................... 18
1.12.2 Transporting the System....................................................................... 19
Chapter 2 System Specifications ............................................................... 21
2.1 Indications for Use and Contraindication ........................................................ 21
2.1.1 Indications for Use ................................................................................ 21
2.1.2 Contraindication .................................................................................... 21
2.2 System Overview ............................................................................................. 21
2.3 Probes and Accessories .................................................................................... 23
2.2.1 Physical Specifications ......................................................................... 24
2.4 Concept of Operation ...................................................................................... 24
2.4.1 Control Panel ........................................................................................ 24
2.4.2 Diagnosis Area Layout of Touch Screen .............................................. 26
Chapter 3 Starting the System .................................................................... 31
3.1 Probe Connection ............................................................................................ 31
3.2 Power On and Off ............................................................................................ 31

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3.2.1 Using AC Supply ................................................................................... 32


3.2.2 Using Battery ........................................................................................ 33
3.3 Patient Information .......................................................................................... 35
3.3.1 Retrieve Patient Information ................................................................. 36
3.3.2 View Image Information ........................................................................ 37
3.4 Start Ultrasound Diagnosis .............................................................................. 39
3.5 Adjusting LCD Monitor..................................................................................... 40
3.6 Main Screen Layout......................................................................................... 40
3.7 Imaging Parameters and Presets .................................................................... 42
Chapter 4 System Setup ............................................................................. 45
4.1 Exam History ................................................................................................... 46
4.2 System Settings ............................................................................................... 47
4.2.1 General Setting ..................................................................................... 47
4.2.2 Set Printer ............................................................................................. 49
4.2.3 Set Calculation Menu ........................................................................... 50
4.2.4 Set Measurement Method .................................................................... 51
4.2.5 Annotation Edit ..................................................................................... 53
4.2.6 Define Quick Key .................................................................................. 53
4.2.7 Load Default ......................................................................................... 55
4.2.8 DICOM Setting...................................................................................... 57
4.3 System Information.......................................................................................... 63
4.4 Touch Screen Setting ...................................................................................... 64
4.5 System Information of Touch Screen .............................................................. 66
Chapter 5 B Mode ........................................................................................ 67
5.1 B Mode Image Information .............................................................................. 68
5.2 B Mode Operation ........................................................................................... 68
5.2.1 B Gain ................................................................................................... 69
5.2.2 Time Gain Compensation (TGC) .......................................................... 69
5.2.3 Depth .................................................................................................... 70
5.2.4 Focal Number ....................................................................................... 70
5.2.5 Focus Position ...................................................................................... 70
5.2.6 Focal Span ............................................................................................ 71
5.2.7 Tissue Acoustic Characteristics ............................................................ 71
5.2.8 Dynamic Range .................................................................................... 72
5.2.9 Grayscale curve .................................................................................... 73
5.2.10 Persistence ........................................................................................... 74
5.2.11 Chroma ................................................................................................. 74
5.2.12 Sector Width/Angle ............................................................................... 74
5.2.13 Sector Position...................................................................................... 74
5.2.14 Line Density .......................................................................................... 75
5.2.15 Compound Imaging .............................................................................. 75
5.2.16 Frequency Range ................................................................................. 75
5.2.17 Image Orientation (Left/Right) .............................................................. 75
5.2.18 Image Orientation (Up/Down) ............................................................... 76
5.2.19 Adaptive Image Fusion (AIF) ................................................................ 76
5.2.20 μScan Function ..................................................................................... 76
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5.2.21 Acoustic Output Power ......................................................................... 77


5.2.22 Trapezoidal Imaging ............................................................................. 77
5.2.23 Steer ..................................................................................................... 78
5.2.24 ECG ...................................................................................................... 78
5.2.25 Biopsy ................................................................................................... 79
5.2.26 Zoom ..................................................................................................... 80
5.2.27 Image Rotate ........................................................................................ 80
5.2.28 Dual Display Format ............................................................................. 80
5.2.29 Quad Display Format ............................................................................ 83
5.3 Tissue Harmonic Imaging (THI)....................................................................... 83
5.4 Cine Mode Operation ...................................................................................... 84
5.4.1 Cine Review.......................................................................................... 85
5.4.2 Cine Playback ....................................................................................... 85
5.4.3 Selecting Image Sequence................................................................... 86
5.4.4 Frozen Dual Display Mode (2B) ........................................................... 86
5.4.5 Zoom ..................................................................................................... 87
5.4.6 Grayscale Curve (GSC)........................................................................ 87
5.4.7 Chroma ................................................................................................. 87
5.4.8 Image Orientation (Left/Right) .............................................................. 87
5.4.9 Image Orientation (Up/Down) ............................................................... 87
5.4.10 Panoramic (Optional)............................................................................ 87
5.4.11 3D ......................................................................................................... 90
5.4.12 Saving Image/Cine ............................................................................... 90
Chapter 6 Color Mode ................................................................................. 91
6.1 Starting Color Mode......................................................................................... 91
6.2 Color Image Information .................................................................................. 91
6.3 Color Mode Operation ..................................................................................... 92
6.3.1 Adjust Color Sample Box...................................................................... 93
6.3.2 Color Gain ............................................................................................. 93
6.3.3 Depth .................................................................................................... 93
6.3.4 Time Gain Compensation (TGC) .......................................................... 93
6.3.5 Focus Position ...................................................................................... 93
6.3.6 ECG ...................................................................................................... 93
6.3.7 Pulse Repetition Frequency ................................................................. 93
6.3.8 Color Power .......................................................................................... 94
6.3.9 Steer ..................................................................................................... 94
6.3.10 Wall Filter (WF) ..................................................................................... 94
6.3.11 Persistence (Persist) ............................................................................ 94
6.3.12 Color Map (C Map) ............................................................................... 95
6.3.13 Baseline ................................................................................................ 95
6.3.14 Sector Width/Angle ............................................................................... 95
6.3.15 Sector Position...................................................................................... 95
6.3.16 B Reject ................................................................................................ 95
6.3.17 Frequency ............................................................................................. 95
6.3.18 Image Orientation (Left/Right) .............................................................. 96
6.3.19 Image Orientation (Up/Down) ............................................................... 96

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6.3.20 Flow Invert ............................................................................................ 96


6.3.21 Line Density .......................................................................................... 96
6.3.22 2B.......................................................................................................... 96
6.3.23 4B.......................................................................................................... 96
6.3.24 Display Switch ...................................................................................... 96
6.3.25 Zoom ..................................................................................................... 96
6.3.26 THI ........................................................................................................ 97
6.4 Cine Mode ....................................................................................................... 97
6.4.1 Cine Review.......................................................................................... 98
6.4.2 Cine Playback ....................................................................................... 98
6.4.3 C Map ................................................................................................... 98
6.4.4 B Reject ................................................................................................ 98
6.4.5 Flow Invert ............................................................................................ 98
6.4.6 Baseline ................................................................................................ 98
6.4.7 Image Orientation (Left/Right) .............................................................. 98
6.4.8 Image Orientation (Up/Down) ............................................................... 98
6.4.9 2B.......................................................................................................... 98
6.4.10 Zoom ..................................................................................................... 98
Chapter 7 DPI Mode (Doppler Power Imaging) .......................................... 99
7.1 Starting DPI Mode ........................................................................................... 99
7.2 DPI Image Information................................................................................... 100
7.3 DPI Mode Operation ...................................................................................... 100
7.3.1 Adjust DPI Sample Box ...................................................................... 101
7.3.2 DPI Gain ............................................................................................. 101
7.3.3 Depth .................................................................................................. 101
7.3.4 Time Gain Compensation (TGC) ........................................................ 101
7.3.5 Focus Position .................................................................................... 101
7.3.6 ECG .................................................................................................... 101
7.3.7 Steer ................................................................................................... 101
7.3.8 Pulse Repetition Frequency ............................................................... 102
7.3.9 Wall Filter ............................................................................................ 102
7.3.10 Persistence ......................................................................................... 102
7.3.11 Color Map & Directional DPI .............................................................. 103
7.3.12 DPI Power ........................................................................................... 103
7.3.13 Sector Width/Angle ............................................................................. 103
7.3.14 Sector Position.................................................................................... 103
7.3.15 B Reject .............................................................................................. 104
7.3.16 Frequency ........................................................................................... 104
7.3.17 Image Orientation (Left/Right) ............................................................ 104
7.3.18 Image Orientation (Up/Down) ............................................................. 104
7.3.19 Line Density ........................................................................................ 104
7.3.20 2B........................................................................................................ 104
7.3.21 4B........................................................................................................ 104
7.3.22 Display Switch .................................................................................... 105
7.3.23 Zoom ................................................................................................... 105
7.3.24 THI ...................................................................................................... 105

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Content

7.4 Cine Mode Operation .................................................................................... 105


7.4.1 Cine Review........................................................................................ 106
7.4.2 Cine Playback ..................................................................................... 106
7.4.3 Color Map ........................................................................................... 106
7.4.4 B Reject .............................................................................................. 106
7.4.5 Image Orientation (Left/Right) ............................................................ 106
7.4.6 Image Orientation (Up/Down) ............................................................. 106
7.4.7 2B........................................................................................................ 106
7.4.8 Display Switch .................................................................................... 106
7.4.9 Zoom ................................................................................................... 106
Chapter 8 TDI Mode (Tissue Doppler Imaging) ........................................ 107
8.1 Starting TDI Mode.......................................................................................... 107
8.2 TDI Image Information ................................................................................... 108
8.3 TDI Mode Operation ...................................................................................... 108
8.3.1 Adjust TDI Sample Box ...................................................................... 109
8.3.2 TDI Gain.............................................................................................. 109
8.3.3 Depth .................................................................................................. 110
8.3.4 Time Gain Compensation (TGC) ........................................................ 110
8.3.5 Focus Position .................................................................................... 110
8.3.6 ECG .................................................................................................... 110
8.3.7 Pulse Repetition Frequency ............................................................... 110
8.3.8 Wall Filter ............................................................................................ 110
8.3.9 Persistence ......................................................................................... 111
8.3.10 Color Map ........................................................................................... 111
8.3.11 TDI Power ........................................................................................... 111
8.3.12 Baseline .............................................................................................. 112
8.3.13 Sector Width ....................................................................................... 112
8.3.14 Sector Position.................................................................................... 112
8.3.15 B Reject .............................................................................................. 112
8.3.16 TDI Frequency .................................................................................... 112
8.3.17 Image Orientation (Left/Right) ............................................................ 113
8.3.18 Image Orientation (Up/Down) ............................................................. 113
8.3.19 Flow Invert .......................................................................................... 113
8.3.20 Line Density ........................................................................................ 113
8.3.21 2B........................................................................................................ 113
8.3.22 4B........................................................................................................ 114
8.3.23 Display Switch .................................................................................... 114
8.3.24 Zoom ................................................................................................... 114
8.3.25 THI ...................................................................................................... 114
8.4 Cine Mode Operation .................................................................................... 114
8.4.1 Cine Review........................................................................................ 115
8.4.2 Cine Playback ..................................................................................... 115
8.4.3 C Map ................................................................................................. 115
8.4.4 B Reject .............................................................................................. 115
8.4.5 Flow Invert .......................................................................................... 115
8.4.6 Baseline .............................................................................................. 116

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Content

8.4.7 Image Orientation (Left/Right) ............................................................ 116


8.4.8 Image Orientation (Up/Down) ............................................................. 116
8.4.9 2B........................................................................................................ 116
8.4.10 Display Switch .................................................................................... 116
8.4.11 Zoom ................................................................................................... 116
Chapter 9 M Mode....................................................................................... 117
9.1 Activate the M Trace Display ......................................................................... 117
9.1.1 Adjust M Cursor .................................................................................. 117
9.2 B+M Mode Operation, M Trace Inactive........................................................ 118
9.2.1 2B........................................................................................................ 119
9.2.2 Display Format.................................................................................... 119
9.2.3 Steer M ............................................................................................... 119
9.3 Color +M Mode Operation, M Trace Inactive ................................................ 121
9.4 M Mode Image Information ........................................................................... 122
9.5 M Mode Operation, M Trace Active ............................................................... 122
9.5.1 M Gain ................................................................................................ 123
9.5.2 Sweep Speed ..................................................................................... 123
9.5.3 Power .................................................................................................. 123
9.5.4 Chroma ............................................................................................... 123
9.5.5 Video Invert ......................................................................................... 124
9.5.6 M Process ........................................................................................... 124
9.5.7 Display Format.................................................................................... 124
9.5.8 ECG .................................................................................................... 124
9.5.9 2B........................................................................................................ 124
9.5.10 Display Switch .................................................................................... 124
9.5.11 Image Orientation (Up/Down) ............................................................. 124
9.6 Dual Display Format ...................................................................................... 125
9.7 Cine Mode Operation .................................................................................... 125
9.7.1 Cine Review........................................................................................ 126
9.7.2 Chroma ............................................................................................... 126
9.7.3 Video Invert ......................................................................................... 126
9.7.4 Display Format.................................................................................... 126
9.7.5 2B........................................................................................................ 127
9.7.6 Display Switch .................................................................................... 127
9.7.7 Image Orientation (Up/Down) ............................................................. 127
9.7.8 Cine Playback ..................................................................................... 127
Chapter 10 Spectral Doppler Mode ............................................................ 129
10.1 Spectral Doppler Image Information ............................................................. 129
10.2 Adjusting Sample Volume and Blood Flow Cursor ....................................... 130
10.3 PW Mode ....................................................................................................... 131
10.3.1 Activate the PW spectral display ........................................................ 131
10.3.2 PW Mode Operations with PW Spectrum Inactive ............................. 131
10.3.3 PW Mode Operation with PW Spectrum Active ................................. 134
10.4 Dual Display Format ...................................................................................... 138
10.5 CW Mode ....................................................................................................... 139
10.5.1 CW Mode Operation with CW Spectrum Inactive .............................. 139
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10.5.2 CW Mode Operations with CW Spectrum Active ............................... 140


10.6 Spectral Doppler Cine Mode Operation ........................................................ 143
10.6.1 Cine Review........................................................................................ 143
10.6.2 Cine Playback ..................................................................................... 143
10.6.3 Chroma ............................................................................................... 143
10.6.4 Display Format.................................................................................... 143
10.6.5 Video Invert ......................................................................................... 144
10.6.6 Dual Display Format (2B) ................................................................... 144
10.6.7 Display Switch .................................................................................... 144
10.6.8 Flow Invert .......................................................................................... 144
10.6.9 Baseline .............................................................................................. 144
10.6.10 Image Orientation (Up/Down) ............................................................. 144
Chapter 11 3D Mode (Optional) .................................................................. 145
11.1 Starting 3D Mode ........................................................................................... 145
11.2 3D Mode Operation ....................................................................................... 146
11.2.1 Display Format.................................................................................... 147
11.2.2 Adjust ROI Box ................................................................................... 148
11.2.3 Clear ROI ............................................................................................ 148
11.2.4 Restore ROI ........................................................................................ 149
11.2.5 Crop (Clear and Restore Region Outside ROI Box) .......................... 149
11.2.6 Rotate and Zoom ................................................................................ 149
11.2.7 Move L-R ............................................................................................ 149
11.2.8 Move U-D ............................................................................................ 149
11.2.9 Render Mode ...................................................................................... 149
11.2.10 Trace Cut ............................................................................................ 150
11.2.11 Undo Cut ............................................................................................. 150
11.2.12 Clip Plane ........................................................................................... 150
11.2.13 Opacity Offset ..................................................................................... 151
11.2.14 Opacity Slope ..................................................................................... 151
11.2.15 Multi-Slice ........................................................................................... 151
11.2.16 Color Map ........................................................................................... 151
11.2.17 Scan Method....................................................................................... 151
11.2.18 Z Scale ................................................................................................ 151
11.2.19 Z Angle ................................................................................................ 151
11.2.20 Ellipse ................................................................................................. 151
11.2.21 Threshold ............................................................................................ 152
11.2.22 Save Frame ........................................................................................ 152
Chapter 12 4D Mode*(Optional) .................................................................. 153
12.1 Starting 4D Mode ........................................................................................... 153
12.2 4D Mode Operations ..................................................................................... 153
12.2.1 Adjustment of Sample Box & Cut Off Line ......................................... 155
12.2.2 Cine Review........................................................................................ 156
12.2.3 Rescan ................................................................................................ 156
12.2.4 Image Quality...................................................................................... 156
12.2.5 Stabilization ........................................................................................ 156
12.2.6 Sweep Angle ....................................................................................... 156
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12.2.7 Volume Review ................................................................................... 157


12.2.8 ROI Mode ........................................................................................... 157
12.2.9 Hide ROI ............................................................................................. 157
12.2.10 Crop .................................................................................................... 157
12.2.11 Clear ROI ............................................................................................ 157
12.2.12 Restore ROI ........................................................................................ 157
Chapter 13 Annotation and Body Mark ...................................................... 159
13.1 Body Marks .................................................................................................... 161
Chapter 14 Transducers .............................................................................. 163
14.1 Transducer Information ................................................................................. 163
14.1.1 Supported Transducers ...................................................................... 163
14.1.2 Acoustic Output .................................................................................. 163
14.2 Environmental Requirements ........................................................................ 164
14.3 Preparation and Usage of Transducers ........................................................ 164
14.3.1 Inspection ........................................................................................... 164
14.3.2 Transducer Connection ...................................................................... 164
14.3.3 Preparation for Scanning .................................................................... 165
14.3.4 Scanning ............................................................................................. 166
14.4 Probe Maintenance: Cleaning and Disinfection ............................................ 166
14.4.1 Probe immersion level ........................................................................ 166
14.4.2 Cleaning Instructions .......................................................................... 166
14.4.3 Disinfection Instructions...................................................................... 167
Chapter 15 System Maintenance ................................................................ 169
15.1 Guidance for Service ..................................................................................... 169
15.2 Manufacturer Responsibility .......................................................................... 169
15.3 Contact Information ....................................................................................... 170
Appendix A Acoustic Output Data ..................................................................... 171
Appendix B EMC Guidance and Manufacturer's Declaration........................... 172
Appendix C In Situ, Derated, and Water Value Intensities ................................ 178
Appendix D Principle for Using Acoustic Power .............................................. 179
Appendix E Information of EU Representative ................................................. 181

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Chapter 1 System Safety and Maintenance

1.1 Safety Overview

This section discusses measures to ensure the safety of both the operator and the patient.
To ensure the safety of both the operator and the 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 the operator or the patient.
Users should observe the following PRECAUTIONS:
 This system complies with Type BF general equipment, and the EN60601-1
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.
 Not to position this equipment to make it difficult to operate the disconnection device.
 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 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 or an explosion may
occur.
 Do not continuously scan the same part of a patient or expose the patient to

1
1. System Safety and Maintenance

prolonged scanning. Doing so may harm the patient.


 When using the system for ultrasound testing, use only qualified ultrasound gel that
complies with system standards.
 Do not use the switch at the back of the unit for normal shut down. Always use the
power-on button in the keyboard area.
 Do not unplug probe when the system is in active operation. Doing so may damage
the probe. 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.
 For proper disposal of this product, please contact our service department.

1.2 Description of Symbols and Signal Words Used

1.2.1 Symbols
The following symbols are utilized on the product or the label and package thereof.

Symbol Description

General warning sign

Warning: dangerous voltage

OFF (Mains power switch OFF)

ON (Mains power switch ON)

“ON” / “OFF” (push-push)


NOTE: Each position, "ON" or "OFF", is a stable position.

Protective earth (ground)

Equipotentiality

Alternating current

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1. System Safety and Maintenance

Type BF Applied Part

Degree of IP protection.

Non-ionizing electromagnetic radiation.


NOTE: Ultrasound scanner transmits acoustic waves.

Manufacturer information (including the name and the address


of the manufacturer).

Date of manufacture..

Consult operating instructions.

Network Port

Control port of color video printer

USB Port

Video Input

Video Output

Fragile.

Keep dry.

Maximum stacking limit of packages. Maximum of two layers


allowed!

Keep this way upward.

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1. System Safety and Maintenance

Indicates the presence of hazardous substance(s) above the


maximum concentration value(s) as set in SJ/T11364-2006.
“20” indicates the number of years during which the hazardous
substance(s) will not leak or mutate so that the use of this
product will not result in any severe environmental pollution,
bodily injury, or damage to any assets.

Serial Number.
NOTE: Unique number for the ultrasound system.

This symbol indicates that waste electrical and electronic


equipment must not be disposed of as unsorted municipal
waste and must be collected separately. Please contact an
authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.

Follow instructions for use.

1.2.2 Signal words


The following signal words are used throughout the user manual.

Signal words Description

Warning! Follow these instructions to avoid personal injury or


system damage.

Caution! Follow these instructions to avoid system damage.

Note Follow these instructions to obtain additional helpful


information.

1.3 Messages

All the messages generated by this ultrasound system are self-explanatory. However, you may
encounter the following situations.
License renewal

When the validity of the license is less than 10 days, the message on the above right
appears on the preparation mode screen. System function will not be affected until
4 Basic Operator’s Manual
1. System Safety and Maintenance

the license is expired, in which case the message on the above left will appear when
the user clicks an application mode icon. Please contact us for license renewal.
Auto quit ultrasound scan
In order to protect the operator or the patient from accidentally receiving excessive
acoustic energy, the system automatically stops the real time scan (no on-screen
message will be provided) and returns the preparation mode if there has been no
user activity for 30 minutes. The user may resume the scan from the preparation
mode, no prerequisite action is required.

1.4 Adverse Effects and Precautions

This ultrasound system, same as all other diagnostic ultrasound system in the market, should
be used only for clinically appropriate reasons, for the shortest period of time and at power
settings as low as reasonably achievable (ALARA).
The American Institute of Ultrasound in Medicine (AIUM) principle of As Low As Reasonably
Achievable (ALARA) is recommended during selection of the output of ultrasound power. Try
not to aim probe at the same spot in tissue for a long period of time unless it is necessary for
diagnostic purpose. This system, as a basic imaging system with the Doppler and Color
Doppler feature generates acoustic power that is below pre-enactment levels, which are
generally considered to be safe for respective applications.

1.5 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

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1. System Safety and Maintenance

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/Color 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: TIS, for soft tissue
exposures; TIB, for instances when bone lies near the beam focus; and TIC, for the heating of
bone situated close to the transducer.
Cavitation:
Cavitation 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 cavitation,
the sound wave 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 cavitation and the related adverse effects.

1.6 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 transducers, always clean them
between patients.
 Always use a new 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).

1.6.1 Safe Scanning Guideline


1. Ultrasound should only be used for medical diagnosis and only by trained medical
personnel.
2. 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).
3. Operators should understand the likely influence of the machine controls, the
operating mode (e.g. B-mode, color Doppler imaging or spectral Doppler) and probe
frequency on thermal and cavitation hazards.
4. Select a low setting for each new patient. Output should only be increased during the

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examination if penetration is still required to achieve a satisfactory result, and after


the Gain control has been moved to its maximum value.
5. Maintain the shortest examination time necessary to produce a useful diagnostic
result.
6. Do not hold the probe in a fixed position for any longer than is necessary. It should be
removed from the patient whenever there is no need for real-time imaging or spectral
Doppler acquisition. The freeze frame and Cine loop capabilities allow images to be
reviewed and discussed without exposing the patient to continuous scanning.
7. Do not use endo-cavity 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.
8. Take particular care to reduce output and minimize exposure time of an embryo or
fetus when the temperature of the mother is already elevated.
9. 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.
10. 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 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 cavitation if an ultrasound contrast agent containing gas
micro-spheres is being used. There is a theoretical risk of cavitation 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 1.1 below as a reference.

TI Maximum exposure time (minutes)


0.7 60
1.0 30
1.5 15
2.0 4
2.5 1
Table 1.1 Maximum recommended exposure times for an embryo or fetus
11. Non-diagnostic use of ultrasound equipment is not generally recommended.
Examples of non-diagnostic uses of ultrasound equipment include repeated scans

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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.
12. 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 should be performed only by
those with sufficient training and education.

1.6.1.1 Temperature Display for Transducers Intended for Internal Use

For transducers intended for internal applications, e.g. the intracavitary or transesophageal
transducers, the transducer tip temperature is displayed on the screen. Refer Figure 1.1 for
the location of the temperature display. To protect the patient against the harm of excessive
temperature, the system automatically turns off the transducer when the temperature of the
transducer reaches a threshold temperature, which has a maximum value of 43℃.

1.6.2 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 operator’s 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.

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Figure 1.1 Transducer tip temperature display

The MI describes the likelihood of cavitation, 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 move 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.

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,
=
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

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

Thermal
Composition Mode Specification Typ. App
Models

1TIS Soft tissue Unscanned Large aperture (>1cm²) Liver PW

2TIS Soft tissue Unscanned Small aperture (<1cm²) Pencil probe

3TIS Soft tissue Scanned Evaluated at surface Breast color

Soft tissue
4TIB Scanned Soft tissue at surface Muscle color
and bone

Soft tissue
5TIB Unscanned Bone at focus Fetus head PW
and bone

Soft tissue
6TIC Unscanned/Scanned Bone at surface Trans cranial
and bone

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

Refers to the steering of successive burst through the field of view, e.g. B and color mode.

Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the

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transducer is moved to a new position. For instance, the PW, CW and M mode.

TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to
raise tissue temperature by 1oC (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 milliwatts necessary to produce a 1℃ temperature
elevation in soft tissue is:
Wdeg = 210/f c
for model 1 to 4, where fc is the center frequency in MHz.

Wdeg = 40·K·D
for model 5 and 6, where K (beam shape factor) is 1.0, D is the aperture diameter in cm at the depth of
interest

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 ratio of the peak pressure to the square root of the frequency.
MI = P /
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.

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 TIC 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, 3).
Display and Report in Different Mode
For B-Scan Mode
Only display and report MI, and start from 0.4 if maximum MI > 1.0
For Color Mode
Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0
For Doppler Mode

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Only display and report TIS or TIB and start from 0.4 if maximum TI > 1.0
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 might 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 icon.

1.7 Environmental Requirements

The environmental requirements for using the ultrasound system are listed below.
Operation
Temperature: 10°C~40°C
Relative Humidity: 30%~75%, no condensation
Atmospheric Pressure: 700~1060hPa

Transport and Storage

Temperature: -20°C~55°C

Relative Humidity: 20%~90%, no condensation


Atmospheric Pressure: 700~1060hPa

Strong radiation sources or powerful electromagnetic waves (e.g. electromagnetic waves from
radio broadcasting) may result in image ghosting or noise. The system should be isolated from
such radiation sources or electromagnetic waves.

1.8 Electrical Requirements

Power Supply Requirements


110~240 V AC, 2.7-1.2A, 50/60Hz
Main unit voltage
Maintain a fluctuation range of less than ±10%, or the system may be damaged.
Grounding
Before connecting the power cable, connect the attached ground protection cable to a
specialized grounding device.

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 Please ensure that the power requirements are satisfied. Only power cable
complying with the system guidelines can be used—failure to follow these
procedures may result in system damage.
 Voltage level may vary in different geographic locations. Adjust the voltage
rating on the rear panel according to your local voltage level.
 Use only the power button on the side panel to turn on or off the unit. Mains
power switch on the rear panel should be always ON unless prior to
transport, maintenance, or service of the equipment.

1.9 Electrical Safety

Only trained health-care professionals can operate this system. This equipment complies with
the following standards:
 The equipment conforms with the following regulations for electrical safety,
EN 60601-1 (IEC 60601-1), Medical electrical equipment Part 1: General
requirements for basic safety and essential performance, Class I, BF, continuous
operation
EN 60601-2-37:2008 (IEC 60601-2-37:2007), Medical Electrical Equipment Part
2-37: Particular Requirements for the Basic Safety and Essential Performance of
Ultrasonic Medical Diagnostic and Monitoring Equipment
 The equipment conforms with the following EMC/EMI standards:
EN 60601-2-37:2008 (IEC 60601-2-37:2007) and EN 60601-1-2:2007 (IEC
60601-1-2: 2007), Class A
 Degrees of protection against harmful liquid:
For the main system: IPX0
For the transducer: IPX7, from the acoustic window to the junction
line (Figure 13.1);
and IPX1 for other parts that may contact with
the patient, excluding the transducer connector.

For maximum safety, adhere to these guidelines:

 Proper grounding of the system is critical to avoid electrical shock. For protection,
ground the system with a three-conductor cable, and plug the system into a
hospital-grade receptacle or outlet.
 Do not remove or entangle the grounding wire.
 Do not remove the protective covers of the system. These covers protect users from
hazardous voltages. Only authorized service technicians can make replacements of
the parts inside the system.
 Never use this system while inflammable gas is present!
 Devices must be powered from a receptacle marked “hospital grade” before being
connected to the system directly. In case “hospital grade” receptacles are not

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1. System Safety and Maintenance

available, use isolation transformers instead.


 Operators and patient must not contact any exposed metal terminals of the plugs.
 Duration of continuous physical contact with any applied parts of this ultrasound
system must not exceed 4 hours.

1.10 Cautions for Using Accessories

 Any accessories, provided by other manufacturers other than SonoScape, to be


connected either electrically or mechanically to this ultrasound system must comply
with the specified IEC standards (IEC 60950 Information Technology Equipment -
Safety and IEC 60601-1 Medical electrical equipment Part 1: General requirements
for basic safety and essential performance.)
 For cleaning, disinfection and sterilization of accessories, please follow the
instructions provided by the manufacturers.
 Installation and service of accessories shall be performed according to the
requirements of the manufacturers.
 Disposal of the accessories at the end of the product life shall follow the guidance of
the manufacturers.
 The accessories provided with the ultrasound system, e.g. the foot switch and the
printer, are safe to operate in patient environment. Other accessories or devices not
listed in the list of supported accessories must not be used. You may contact us for
the updated version of the list.

1.10.1 Foot Switch


The foot switch paddle must not be used in the operating room.

1.10.2 Optional Printers


Ensure that the outlets used by the printer have the protective grounding conductor before
connecting the printer to the ultrasound system.
Consult SonoScape for guidance about the installation and service of the printers.

1.10.3 Transducer Maintenance


The transducers/probes provided with the system are durable and have reliable performance.
These precision instruments should be inspected daily and handled with care. Please observe
the following PRECAUTIONS:
 Do not drop the transducer on the hard surface. This can damage the transducer
elements and compromise the electrical safety of the transducer.
 Avoid kinking or pinching the transducer cable.
 Use only approved ultrasound coupling gels.
 Follow the instructions for cleaning and disinfecting the probes.
Disinfecting Surface Transducers

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 Disconnect the transducer from the system.


 Wipe all surfaces with isopropyl alcohol solution and air dry.
 Clean all surfaces of the probe and cable with soft cloth.
 Allow the transducer to air dry prior to storage or further use.
The following statement from AIUM outlines instructions for cleaning the intracavitary
transducer:
Guidelines for Cleaning and Preparing Endocavitary Ultrasound Transducers
between Patients from AIUM
Approved June 4, 2003
The purpose of this document is to provide guidance regarding the cleaning and
disinfection of transvaginal and transrectal ultrasound probes.
All sterilization/disinfection represents a statistical reduction in the number of
microbes present on a surface. Meticulous cleaning of the instrument is the essential key
to an initial reduction of the microbial/organic load by at least 99%. This cleaning is
followed by a disinfecting procedure to ensure a high degree of protection from
infectious disease transmission, even if a disposable barrier covers the instrument during
use.
Medical instruments fall into different categories with respect to potential for
infection transmission. The most critical level of instruments are those that are intended
to penetrate skin or mucous membranes. These require sterilization. Less critical
instruments (often called “semi-critical” instruments) that simply come into contact with
mucous membranes such as fiber optic endoscopes require high-level disinfection rather
than sterilization.
Although endocavitary ultrasound probes might be considered even less critical
instruments because they are routinely protected by single use disposable probe covers,
leakage rates of 0.9% - 2% for condoms and 8%-81% for commercial probe covers have
been observed in recent studies. For maximum safety, one should therefore perform
high-level disinfection of the probe between each use and use a probe cover or condom
as an aid in keeping the probe clean.
There are four generally recognized categories of disinfection and sterilization.
Sterilization is the complete elimination of all forms or microbial life including
spores and viruses.
Disinfection, the selective removal of microbial life, is divided into three classes:
 High-Level Disinfection -Destruction/removal of all microorganisms except bacterial
spores.
 Mid-Level Disinfection - Inactivation of Mycobacterium Tuberculosis, bacteria, most
viruses, fungi, and some bacterial spores.
 Low-Level Disinfection - Destruction of most bacteria, some viruses and some fungi.
Low-level disinfection will not necessarily inactivate Mycobacterium Tuberculosis or
bacterial spores.
The following specific recommendations are made for the use of intracavitary ultrasound

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1. System Safety and Maintenance

transducers.
Users should also review the Centers for Disease Control and Prevention document on
sterilization and disinfection of medical devices to be certain that their procedures conform to
the CDC principles for disinfection of patient care equipment.
1. CLEANING
 After removing the probe cover, use flowing water to remove any residual from the
probe.
 Use a damp gauze pad or other soft cloth and a small amount of mild non-abrasive
soap water to thoroughly clean the transducer.
 Use a soft bristle brush for cleaning if the residue has dried onto the probe surface.
Rinse the transducer thoroughly with running water, and allow to air dry or dry with a
soft cloth.
2. DISINFECTION
1) Use liquid chemical germicide for disinfection. In order for the germicide to be
effective, clean the probe thoroughly to remove all visible residues.
2) Using high level liquid disinfectant will ensure further statistical reduction in microbial
load. Because of the potential invisible breakage of the probe sheath, additional high
level disinfection with chemical germicide is necessary.
Examples of such high level disinfectants include but are not limited to:
 2.4-3.2% glutaraldehyde products (a variety of commercially available products
including “Cidex,” “Metricide,” or “Procide”).
 Non-glutaraldehyde agents including Cidex OPA (o-phthalaldehyde), Cidex PA
(hydrogen peroxide & peroxyacetic acid).- 7.5% Hydrogen Peroxide solution.
 Common household bleach (5.25% sodium hypochlorite) diluted to yield 500
parts per million chlorine (10 cc in one liter of tap water). This agent is effective,
but generally not recommended by probe manufacturers because it can damage
metal and plastic parts.
 Other agents such as quaternary ammonium compounds are not considered high
level disinfectants and should not be used. Isopropanol is not a high level
disinfectant when used as a wipe and probe manufacturers generally do not
recommend soaking probes in the liquid.
 The FDA has published a list of approved sterilant and high level disinfectants for
use in processing reusable medical and dental devices. That list can be consulted
to find agents that may be useful for probe disinfection.
3) You should consult the manufacturer’s instructions to prepare, store and use the
disinfectant.
Consult SonoScape if you are not sure about the compatibility of these agents
with the probes. Many of the chemical disinfectants are potentially toxic and
many require adequate precautions, such as proper ventilation, personal
protective devices (gloves, face/eye protection, etc.) and rinsing before
reusing the probe.

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3. PROTECTIVE SHEATHS
1) The transducer should be protected with a probe sheath. If condoms are used, they
should be non-lubricated and non-medicated.
2) Practitioners should be aware that condoms have been shown to be less prone to
leakage than commercial probe covers, and have a six-fold enhanced AQL
(acceptable quality level) when compared to standard examination gloves. They
have an AQL equal to that of surgical gloves.
3) Users should be aware of latex-sensitivity issues and have available
nonlatex-containing barriers.
4. ASEPTIC TECHNIQUE
1) For the protection of the patient and the health care worker, all endocavitary
examinations should be performed by the operator wearing gloves properly
throughout the ultrasound diagnostic process.
2) Gloves should be used to remove the condom or other barrier from the transducer
and to wash the transducer as mentioned above.
3) As the probe sheath is removed, care should be taken not to contaminate the probe
with secretions from the patient. At the completion of the procedure, hands should be
thoroughly washed with soap and water.

 Obvious rupture in condom integrity does NOT require modification of this


protocol.
 These guidelines take into account possible probe contamination due to
ruptures in the barrier sheath.
 In summary, high level disinfection of the endocavity probes should be
carried out routinely. Protective barrier is required for every examination to
avoid potential disease transmission.
 For all chemical disinfectants, PRECAUTIONS must be taken to protect
workers and patients from the toxicity of the disinfectant.
Reference:
Amis S, Ruddy M, Kibbler CC, Economides DL,MacLean AB. Assessment of condoms as
probe covers for transvaginal sonography. J Clin Ultrasound 2000; 28:295-8.
Rooks VJ, Yancey MK, Elg SA, Brueske L. Comparison of probe sheaths for endovaginal
sonography. Obstet. Gynecol 1996; 87:27-9.
Milki AA, Fisch JD. Vaginal ultrasound probe cover leakage: implications for patient care.
Fertil Steril 1998; 69:409-11.
Hignett M, Claman P. High rates of perforation are found in endovaginal ultrasound probe
covers before and after oocyte retrieval for in vitro fertilization-embryo transfer. J Assist
Reprod Genet 1995; 12:606-9.
Sterilization and Disinfection of Medical Devices: General Principles. Centers for Disease
Control, Division of Healthcare Quality Promotion.
http://www.cdc.gov/ncidod/hip/sterile/sterilgp.htm (5-2003).

Basic Operator’s Manual 17


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ODE Device Evaluation Information–FDA Cleared Sterilants and High Level Disinfectants
with General Claims for Processing ReusableMedical and Dental Devices,March 2003.
http://www.fda.gov/cdrh/ode/germlab.html (5-2003).

Caution!
 These transducers are not designed to withstand thermal disinfection.
Exposure to temperatures higher than 66℃ (150°F) will cause permanent
damage.
 Do not immerse the probe beyond its binding line.
 To clean the transducer, refer to the relevant instructions in the probe’s
manual.

1.11 Environmental Protection

In order to protect the environment, the disposal of waste products, residues, etc. and of the
ultrasound system and accessories at the end of their expected service life should follow these
guidelines:
Disposal of System
Contact SonoScape or our representatives nearest to you for proper disposal
instructions.
Disposal of Accessories
Contact the manufacturers of these products for proper disposal instructions.
Disposal of Waste Products and Residues
Ultrasound coupling gel is water-solvable; residue of the gel can be removed with
medical tissue wipes and disposed as general medical waste.

1.12 System Transportation

1.12.1 Moving the System


When moving or transporting the system, take the PRECAUTIONS listed below.
Before moving the system:
1. Completely power off the system.
2. Unplug the power cord.
3. Disconnect all cables attached to the system.
4. To prevent damaging the power cord, do not pull, stretch or bend it excessively.
5. Store the probes in their carrying cases or wrap them in soft cloth or foam to prevent
damage.
6. Store gel and other essential accessories in the appropriate storage cases.

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1.12.2 Transporting the System


Be exceptionally careful when transporting the system in a vehicle. After preparing the system
as described above, take the following additional PRECAUTIONS:
 Before transporting, prepare and pack the system in the original package.
 Secure the system firmly with straps (or as directed otherwise) within the vehicle to
prevent excessive vibrations during transport.
 Drive carefully to prevent vibration damage. Avoid unpaved roads, excessive speeds.
After being transported, the system needs some time to reach thermal equilibrium with the
environment. Decrease or increase this time period (4 to 5 hours for 10℃ difference)
according to the initial temperature difference between the system and the environment.

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20 Basic Operator’s Manual


Chapter 2 System Specifications

2.1 Indications for Use and Contraindication

2.1.1 Indications for Use


This general-purpose ultrasonic imaging instrument is intended for use by a qualified physician
for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid),
Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular,
Musculoskeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and
Urology.

2.1.2 Contraindication

The system is not intended for OPHTHALMIC use or any use that causes the acoustic
beam to pass through the eye.

2.2 System Overview

Figure 2-1: Overview of S11 system

21
2. System Specifications

Figure 2.2: Front view of S11 system

1 LCD monitor 2 Probe cup


3 Touch screen 4 Slide switch of touch screen

Figure 2.3: Side view of S11 system

1 Audio out 2 S-video port


3 Two USB ports 4 Ethernet port (DICOM port)
5 VGA out 6 Power switch

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2. System Specifications

Figure 2.3: Side view of S9 system


1 Probe lock 2 Probe connection port
3 Power input 4 ECG port
5 BNC video out 6 Foot switch socket
7 Equipotential pin 8 USB port
9 Printer socket 10 Rating Label

Warning!

To remove the dust cover of S-VIDEO, please rotate it first and then pull it out.

2.3 Probes and Accessories

Supported Transducers: see Table 13.1.


Supported Peripherals and Accessories
◇ Video printers
◇ Network printers
◇ PC/workstation for accessing/reviewing ultrasound images
◇ USB2.0 removable disk drives
◇ Foot switch
◇ ECG electrodes and ECG cable
◇ Ultrasound coupling gel
◇ Cart
◇ Battery Pack

Basic Operator’s Manual 23


2. System Specifications

2.2.1 Physical Specifications


Weight (system alone, without docking cart):
approximately 13.5kg
Dimensions (with lid closed L x W x H):

400mm x 350mm x 230mm

2.4 Concept of Operation

2.4.1 Control Panel

Figure 2.4: Control panel view

Key Description

Menu Tap this key to enter system menu.

Audio Tap its left half to turn down the Doppler sound volume, right half to turn it up.

Keyboard Tap this key to activate virtual keyboard of the touch screen. There are
setting options for the touch screen above the virtual keyboard.

Angle Indented for adjusting direction in real time imaging process, and changing
related parameters in system setting interface.

Bodymark Tap this key to select a bodymark and add it to the freeze image.

m-Tuning Tap this key during scanning to make the system automatically
adjust various parameters to obtain high quality image.

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2. System Specifications

Arrow Insert an arrow symbol on the ultrasound image.

Delete Remove the most recently inserted annotations or Bodymarks, or redefine


the route of trace.

Annot Add texts or predefined annotation items to the freeze ultrasound image.

Clear Clear up all the calculations, bodymarks and annotations.

TGC Slide the TGC control to change the gain in the corresponding 2D depth.

File Tap this key to open REVIEW interface and check or review patient
information.

Report Intended for opening report interface.

Print Tap this key to activate the web printer.

Video Used to activate the video printer and print the current screenshot.
Print
Save Tap this key to save ultrasound images.
Frame
Save Cine Tap this key to save ultrasound video.

Exam Start diagnosis for a new patient. Press this key and then all the calculation,
imaging as well as relevant information will be correlated with this patient.

End Exam Tap this key to stop diagnosing of the current patient.

Patient Tap this key to access the Patient Information interface, and create, modify,
search, review related patient information.

Calc Tap this key to activate the calculation menu.

Distance Measure the distance between two points.

Area Tap this key and move the trackball to draw a trace on the ultrasound image;
press SET to close the trace.

Clipboard Intended for activating the clipboard and select images or playback cine on it.

Doppler gain: Rotate this knob to adjust gain of Color/DPI/PW/CW/TDI


mode.

B/M mode gain: Rotate this knob to adjust B/M mode gain.

Set: This key serves as the confirmation key. Used to set, fixate markers
and activate buttons/items marked by the cursor.

Trackball: Use the trackball to move the cursor.

Update: Press this key to activate M imaging in M mode, or activate PW/CW


spectral imaging under PW/CW mode.

Basic Operator’s Manual 25


2. System Specifications

Depth: Rotate this knob to adjust scanning depth.

Freeze: Freeze or unfreeze the ultrasound image

2.4.2 Diagnosis Area Layout of Touch Screen


Functions included here are: selecting a probe and then choosing certain diagnosis mode
under this probe, selecting and adjusting imaging parameters, inserting texts, annotation and
bodymark, selecting measurement/calculation package, etc.. Usually there are the following
four interfaces:

2.4.2.1 Diagnosis Mode Selection Interface

Figure 2.5: Diagnosis mode selection interface

Diagnosis mode selection interface: select the proper probe and then choose exam
mode under this probe (See figure 2.5). It’s the default initial interface after the system
starts up. Press Exam key to return to this interface under other interfaces.

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2. System Specifications

2.4.2.2 Imaging Mode Selection Interface

Figure 2.6: Imaging mode selection interface

Imaging mode selection interface: select scanning mode, adjust parameters. To enter this
interface, select certain exam mode in the interface described above (See Figure 2.6).
The controls displayed in the Imaging mode selection interface vary according to the system
status. During a real time scan, the touchscreen controls are displayed similar to Figure 2.6.

Note:
Availability of the various controls depends on both the system status
and the currently active transducer.

In real time scanning, the functions of the touchscreen and the function knobs are introduced
below.
Imaging mode keys are displayed in the first row. To activate an imaging mode, tap the
corresponding imaging mode key. To exit the current imaging mode, tap the corresponding
imaging mode key again.
General imaging controls are located on the second and third rows, they set the imaging
mode related options to on or off. Some options having sub-options, when activated, display
the controls of the sub-options on the fourth row. The value of the sub-options can be
decreased/increased by tapping the left/right part of the corresponding soft key.
Imaging parameters controls are located on the fifth and sixth rows (the two bottommost
rows). To adjust a parameter, tap to highlight the control key and use the respective function
knob to change the value.

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2. System Specifications

2.4.2.3 Annotation selection interface

Figure 2.7: Bodymark

Annotation selection interface: select texts or insert bodymarks. Tap Annot . or

Bodymark . key to enter this interface ( See Figure 2.7).

2.4.2.4 Measurement Selection Interface

Measurement selection interface: choose calculation/measurement package as well as

measurement items. Tap Calc to enter this interface (See Figure 2.8).

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2. System Specifications

Figure 2.8: Measurement selection interface

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2. System Specifications

30 Basic Operator’s Manual


Chapter 3 Starting the System

3.1 Probe Connection

Caution!
 Prior to connecting or disconnecting a probe freeze the image or
enter the preparation mode (EXAM screen).
 It is unnecessary to switch the unit off.
 If a probe is disconnected while it is active scanning, a software
errormay occur. In this case switch the ultrasound system OFF
and later ON (perform a restart).

Instructions:
1. Flip the switch above the probe connector
socket to the left
2. Plug the probe into the probe socket.
3. Flip the switch to the right to lock the
probe socket.
4. If the cable is too long, you may hang it
on the cable hook at the right side panel.

3.2 Power On and Off

Warning!
Review Section 1.8 and Section 1.9 for the detailed electrical requirements
and for the electrical safety.

31
3. Starting the System

Important! Read messages below and carefully before starting up your


system. In order to avoid unnecessary electric hazards, it’s recommended to connect the
equipotential point to earth even when operating with the battery.

3.2.1 Using AC Supply


The ultrasound system can be powered by means of two different power sources:
- the AC power through the AC adapter, and
- the battery.
Turn on and off the system:

1. Press the power button on the left side of system to turn on the system,

the backlight of the keyboard will be on and it takes about 1 minute for the system to
enter the preparation mode (EXAM screen).

2. To turn off the system, press the power button on the left side of the system.

Information for power supply status can be found in Section 3.2.3.


Use the battery only during emergency or when no reliable AC power supply is available. With
the external AC power supply available, it is always recommended to use the AC supply
instead of the battery.

Warning!
 The AC adapter is specifically designed for the SonoScape S8 ultrasound system, do not
use it with other equipments. To avoid electric hazard and system damage, use only the
AC adapter approved by SonoScape with the S8 ultrasound system.
 AC adapter can get very hot if being used in poorly ventilated area. Maintain good
ventilation for heat dissipation. Do not cover the AC adapter or the power cable with any
other items.
 Make sure that the power cable is not entangled.

1. Connect the equipotential point at the rear panel to safety ground (earth).
2. Attach the connector of the power cable to the AC adapter firmly.
3. Ensure that the mains voltage level is within the required range.
4. Connect the mains power plug into a wall outlet. To achieve the reliable grounding, ensure
to use a power outlet marked with “hospital grade” or the equivalent. Warning: To avoid risk
of electric shock, this equipment must only be connected to a supply mains with protective
earth.
5. Secure the DC output plug into the power supply socket on the ultrasound system. The LED
POR will be illuminated. Refer to the illustration in Figure 3.1 for proper connection.
6. Ensure that all the connections are appropriate and press the power button on the control

32 Basic Operator’s Manual


3. Starting the System

panel to turn the system on.

Figure 3.1: Connecting the DC output plug

Note:
 If battery is in use, to switch the power supply to AC source,
follow Section3.2.2.

Warning!
The adaptor is not allowed to be hung in the air. Place it on the ground or
other well ventilated platform instead.

Figure3.2: Correct way of placing the adaptor

3.2.2 Using Battery


The battery serves as a power source when no AC power supply is available. A fully
charged battery can provide power for the system for up to 1.5 hours. To start operating the

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3. Starting the System

system using only the battery, you need to long-press the power button (press and hold
down the power button for at least 2 seconds).
Battery charging period (from exhausted to full):
When the system is off:
approximately 2.5 hours.
When the system is on:
approximately 12 hours.

Warning!
 This battery is designed to be an integral part of the ultrasound system.
Attempting do-it-yourself removal of the battery not only voids the warranty but
also violates the regulations, and is discouraged by IEC 60601-1.
 Do not short the metal pins on the connectors by metal objects.

Information of disposing the battery:


To dispose and recycle the ultrasound system and the battery properly, contact SonoScape
representative for instructions.

Turn on the system without connecting the AC adapter to use the battery as the source.
Disconnect the output plug of the AC adapter from the system while it is on, and the system
uses battery as the source automatically.
You may charge the battery while the system is off by connecting the AC adapter to the
system.
You may also charge the battery without turning off the system.
Instructions for charging battery with system on:
1. Connect the equipotential point at the rear panel to safety ground (earth).
2. Attach the connector of the power cable to the AC adapter firmly.
3. Connect the power plug of the AC adapter to the outlet marked with “hospital grade”.
4. Connect the DC output plug into the power supply socket on the ultrasound system.
The system automatically charges the battery and takes the AC supply as source.

Caution!
 Make sure to follow the above steps. Connecting the DC output plug of the AC
adapter, which has no AC input, into the system can trigger protection
mechanism which automatically shuts down the system.
 If auto-shutdown due to mis-operation occurs, connect to the AC source and
restart the system.
 Charge the battery only when the ambient temperature is between 0°C and
45°C.
 When you hear the beep sound and the LED BAT is blinking, it means that the
battery power is almost depleted. You should save your data and turn off the

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3. Starting the System

system or connect the system to an AC power source immediately.

Note:
 Once the system is turned on, the control panel will be
illuminated. It takes about 1 minute for the system to enter the
preparation mode (EXAM screen).

Caution!
DO NOT plug in any external USB drive before the system startup completes,
otherwise the μSCAN function might be interrupted.

3.3 Patient Information

Patient information can be accessed in the Patient Information window.

Press the Patient key to open the PATIENT INFORMATION window. See Figure 3.3

Figure 3.3: Patient information

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3. Starting the System

Click the text box and insert or edit the corresponding patient information.

Note:
 Text fields next to EDD, BSA, and GA are calculated by the
system using other patient data, they are not editable.
 A valid patient profile should at least include patient ID and
patient name.
 Click the New Patient button to reset all entries for the current
patient! Click the Cancel button to exit without saving.
 Click the New Exam button to close or pause the current
exam for the patient, and start new exam mode for the patient.
 Click the Pause Exam button to pause the exam for the
current patient. To open the paused exam again, click the
Exam History button.

Click the OK button to save the current patient information.

Note:
 For a newly created patient profile, the file folder for this
patient is stored in the File Manager.
 The ultrasound images and calculation results will be saved to
the corresponding patient folder.

An existing patient profile can be searched by Name, ID or Accession Number.

Note:
 Click the Exam History button to list previously diagnosed
patients. Tick ID, Name or Date. Type in the first few letters of
the ID, Name or Date you are searching for. The matched
patient profiles will be listed below. Click the patient name to
select it. Please refer to the subsection 5.1 Exam History for
more details.

3.3.1 Retrieve Patient Information


To retrieve the information from other server, click the Worklist button in the PATIENT
INFORMATION interface, as shown as Figure 3-1.

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3. Starting the System

Figure 3-1: Worklist

1. Click the Query button without entering any information to check all patients'
information on the worklist server.

2. Move the trackball to place the cursor on the desired text box and press the Set

key, and then enter related information, such as Name, ID, Accession Number, and
Required procedure ID.
3. Click the Query button to search the matched patient records.
4. Click the desired record, click the Start Exam button to start diagnosis.
5. Click the Clear button to clear information in the search text box; Click the Back
button to return the PATIENT INFORMATION interface; Click the Exit button to exit
the current interface.

Note:
If the ultrasound system is connected to a worklist server, you may
select a patient profile from the worklist. Please refer to the subsection
4.2.8.3 DICOM Worklist Server.

3.3.2 View Image Information


Select an exam record in the EXAM HISTORY interface, and then click the Review button to

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3. Starting the System

access the REVIEW interface as shown in Figure 3-2:

Figure 3-2: Review

SELECT ALL Select all images.

STORE TO DICOM Save the selected image into DICOM server.

STORE TO USB Save the selected image to USB disk

DELETE Delete the selected image.

PRINT Print the selected image by DICOM.

View the report in the REVIEW interface.


 When click one image, the INSERT PICTURE item
REPORT
appears under the REPORT item. Click INSERT PICTURE
to add the selected image to the report.

Exit Exit the REVIEW interface.

Use the trackball to move the cursor on the image or clip, double press the Set key to view

the magnified image and play the clip.

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3. Starting the System

3.4 Start Ultrasound Diagnosis

At system initial interface (diagnosis mode selecting interface), tap a transducer icon on the
touchscreen to select the transducer. The predefined diagnosis modes under the transducer
are listed in the lower part of the touch screen. Please Refer to Figure 3-3.

Figure 3-3: System initial interface on the touchscreen.

Tap an application icon to start a real time scan. Although not required, it is recommended to
follow the work flow shown in Figure 3-4.
The system will automatically freeze the ultrasound image if there is no user activity within 30
minutes.

Figure 3-4: A typical work flow

Usage of the Exam key:

1. During an ultrasound scanning process, press the Exam key, the touchscreen will

Basic Operator’s Manual 39


3. Starting the System

display the diagnosis modes.


2. To scan in another diagnosis mode, tap the corresponding diagnosis mode icon.

3. To return to the previous scanning session, tap the Cancel soft key.

Usage of the End Exam key:

1. During an ultrasound imaging, press the End Exam key, the following message

will appear,
2. Click cancel to CANCEL and continue the exam for the current patient.
3. Click OK to end the exam for the current patient. Then another message will pop up:

Please select exam status:


Complete Discontinue
Choose “Complete”, exam for the patient will be ended and marked as “Completed”
in Exam History Interface .
Choose “Discontinue”, exam for the patient will be ended and marked as
“Discontinue” and marked as “Discontinued” in Exam History Interface
4. Enter the PATIENT INFORMATION window again. Select another patient profile or
create a new patient profile. Click OK to close the PATIENT INFORMATION window
and start a new exam.

3.5 Adjusting LCD Monitor

After switching on the system through the slide switch on the front side of the touch screen,
and then adjust the angle of the LCD Monitor with two hands holding its two sides

3.6 Main Screen Layout

The user interface of the application mode is shown in Figure 3-5, items in the figure are
explained in Table 3.1.

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3. Starting the System

Figure 3-5: Application mode screen

1 Logo 11 Spectral Doppler Image Info, or M


Mode Image Info, or
Imaging/Calculation Menu

2 Facility Name 12 THI and PW/CW status

3 Patient ID 13 Cine playback progress indicator

4 Probe 14 Ultrasound Image area

5 Patient Name 15 Clipboard

6 Date and Time 16 Measurement results

7 Mechanical Index 17 Gray scale/Spectrum wedge


Thermal Index

8 Diagnostic/Application mode icon 18 Depth scale and focus

9 2D Image Info

10 Color Image Info

Table 3.1: Application mode interface

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3. Starting the System

3.7 Imaging Parameters and Presets

The default values of the imaging parameters for each imaging mode depend on the
transducer, the application mode and the imaging mode. These parameters include scan
depth, persistence, line density and etc, and they can be adjusted with the knobs, flip switches,
slider controls, and/or menu items during the real-time scan. For details about these
parameters and how to change their values, please refer to the chapters describing the various
imaging modes in this manual.
Modifications of the imaging parameters are kept only during the current application mode,

which can be terminated by pressing the Exam key, creating or selecting another patient

profile, or turning off the system. In this case, when the user enters the same imaging mode,
the parameters are reset to default values.
The user can save the modifications of imaging parameters in a new preset by creating a new
application mode containing the modified parameters. The instructions are provided below.
1. Tap a transducer icon on the touchscreen at the preparation mode.
2. Select an application mode icon for this transducer. The modifications shall be based
on this application mode.
3. Tap the corresponding imaging mode buttons to enter the imaging mode whose
parameters to be modified.
4. Keep the system in the real time mode, and use knobs, slider controls, and/or menu
items to change the imaging parameters as necessary.
5. If necessary change parameters in other imaging mode(s), but do not exit the current
application mode.

6. Tap the Save Frame or Save Cine soft key after parameters are changed and

then the following dialog window appears.

7. Tap the Y key and User preset menu will appear (or tap N to cancel), then click

Create New Exam.

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3. Starting the System

8. Type the name for the new application mode, click Create Exam.
9. Click Exit to return to the Exam interface, where the new created application mode
will be shown.

Caution!
 To ensure the system does not start at a high acoustic output
level, the system is initialized at a reduced default output level in
all default imaging modes.
 When adjusting the imaging parameters, prudent use of the
ultrasound system requires the user to monitor the mechanical
and thermal indices displayed on the top right corner of the
screen closely and ensure no parameters are set to values that
leads to extra ultrasound doze with no obvious medical benefits.

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3. Starting the System

44 Basic Operator’s Manual


Chapter 4 System Setup

After the system start up, the LCD monitor displays desktop background picture, and the
touchscreen displays the selection interface for transducers and diagnosis mode as shown in
Figure 4-1.

Figure 4-1: Initial interface

At the preparation mode, tap the menu key in the touch screen, the menu in Figure 4-2
appears on the main screen. Move the trackball over System Settings and click it to enter
system setting interface. In this interface you can perform general setting, printer setting,
measurement menu setting, calculation menu setting, annotation edit, shortcut key defining,
load default, DICOM setting, etc..

Figure 4-2: System menu

45
4. System Setup

4.1 Exam History

Move the trackball to select the Exam History item and press Set . The Exam History

interface is shown as Figure 4-3. It contains Search section, Record section, and Review
section.

You can also access the interface by tapping the Patient key, and then click the Exam

History key.

Figure 4-3: Exam history

Search the desired patient information according to ID, Name


Search Section
or Date.

View each of patient ID, Name, Exam Date/Time, Type,


Record Section
Status, and Commit.

Preview Section After select a patient record, you can view the saved images.

1. Select an item from ID, Name or Date. Enter words in the String frame, and then
click the Search button to search. Then the matched patient records will be listed in
the Record section.
Click the Reset button to delete the string typed ealier and enter new searched
information again.
2. Select a record, and then click the following buttons as desired:
 Click the New Exam button to create a new exam.

46 Basic Operator’s Manual


4. System Setup

 Click the Continue button to continue the last exam.


 Click the Review button to preview the patient images.
 Click the Delete button to delete the patient record.
 Click the Store button to save the record to USB or DICOM sever.
 Click the Print button to print the record.
 Click the Commit button to check with DICOM sever that the record is stored
successfully or not.
 Click the Exit button to exit the current interface.

4.2 System Settings

Select the System Setting item and press the Set key to open the interface for configuring

the system. Click the Exit button to exit the System Setting interface.

4.2.1 General Setting

Figure 4-4: General settings

Click on the General Setting tab, the following configurations are available. You may need to

click the and buttons to find some items.

To change the setting of an item, use the trackball to move the cursor on the related tab, and

press the Set key. Use the left or the right direction key of the keyboard to change the value.

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4. System Setup

Item Explanation

Set Date/Time Set the current date and time.

Facility Name Enter the facility name.

Language Set the language of the user interface.

Screen Saver Turn on or off the screen saver.

Trackball Sensitive Adjust the sensitivity for tracking the trackball movement.

Set the date format employed by the system to dd/mm/yyyy,


Date Format
yyyy/mm/dd or mm/dd/yyyy.

If this option is ON, letters are entered capitalized by default.

Caps Lock Touch the Shift soft key and tap the alphabetic soft key to input

a lower case letter.

Set the size of the printed image. The range of this setting is 1 to
Print Size 6. With 6 the image size is scaled to 6 times as large as the
image size with 1.

Set the file format for saving multiple frames as video clips.
Clip Format
Currently the System, MP4 and AVI formats are supported.

Set the file format for saving a single frame. The system currently
Still Format
supports the System, JPEG, BMP and TIFF formats.

Set the idle time duration before the system starts the screen
Screen Save
saver. The range is 1 to 60 minutes.

Color of ROI Set the color of the region of interest box.

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4. System Setup

4.2.2 Set Printer

Figure 4-5: Set printer

Item Explanation

Printer Driver Select the printer driver to match the actual printer in use.

Video Invert Invert the RGB-color brightness when printing.

When need to install a new printer driver, tap this button, connect
Insert Driver the flash driver that contains the needed printer driver, and tap
this button again as the system instructes.

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4. System Setup

4.2.3 Set Calculation Menu

Figure 4-6: Set calculation menu

Tap the Set Calculation Menu to configure the calculation menu that appears during
ultrasound imaging.
Instructions:

 Move the cursor over an imaging mode button ( 2D, PW, or M) and press the Set

key.

 Tap Keyboard key to activate the soft keyboard and tap the up or down direction

key of the keyboard to select a calculation item.

 Press the Update key to hide or unhide the selected item in the corresponding

imaging mode.

 When an item contains submenu, tap the Menu key to open or close the

submenu.

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4. System Setup

4.2.4 Set Measurement Method

Figure 4-7: Set measurement method

Click the Set Measurement Method tab to configure the measurement items.
Instructions:

 Move the cursor over the parameter box, and press the Set key.

 Use the left or right direction key of keyboard to change the parameter. Information
about some items is provided below.

Sets the BSA calculation formula applicable for Western or


BSA Setting
Eastern people.

Measure Method Sets the measure equation to Trace or Ellipse.

Set it to Icon Driven and only the items related to the


application/diagnosis mode will be displayed in the calculation
Package menu. Set it to All Package and all the available items will be
shown in the calculation menu, irrespective of the
application/exam mode.

Continue DIST Set this option to ON and you only need to tap the Distance

key once to perform multiple distance measurements. Tap this

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4. System Setup

key again to stop distance measurement.

Changes the behavior of the auto-trace measurement function

(executed by tapping the Ellipse key twice) in a frozen

PW/CW mode. Set it to AUTO and no user intervention is


Dop Auto
required during the measurement; Set it to SEMI-AUTO, the user

will be required to provide the positions of (去掉) some critical

points during the measurement.

Set it to ON to allow the system to auto adjust the focal depth


Focal Auto
when the scan depth changes.

BPD Method Sets the formulae employed for calculating items such as BPD,
FL Method
*
CRL Method FL and so on. Click the button to edit the formula or create

AC Method a new formula. Note that predefined formulae are not editable.

Explanation of BSA:

When BSA setting is Eastern, the calculation formula applied is


BSA = WT0.425 X HT0.725 X 0.007358.
When BS setting is Western, the calculation formula applied is
BSA = WT0.425 X HT0.725 X 0.007184.
In the two formulae above, WT means weight (kg), and HT means height (cm). In patient
information interface, BSA value is automatically calculated by the system after WT and HT
are entered. BSA value is applied in some calculation items, such as SI (stroke index), CI
(cardiac index), etc..

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4. System Setup

4.2.5 Annotation Edit

Figure 4-8: Annotation edit

User can modify the predefined annotation strings. Press the Annotation Edit tab, the
available annotations and the possible operations are listed on the right half of the screen.
Instructions:

 Move the cursor over a string, press Set twice to start editing it. You need to click

the Save button to save the modification.

 Click the button to turn the list one page up; click the button to turn the
list one page down.
 Enter texts in the text box next to String:, click the Insert button and the texts will be
added into the annotation list.
 Click the Delete button to remove the selected string immediately.

4.2.6 Define Quick Key


The numeric keys on the alphanumeric soft keypad can be assigned as shortcut keys for
performing measurements.

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4. System Setup

Figure 4-9: Define quick key

Click the Define Quick Key tab to define the shortcut keys. The D. Key column shows the
numeric keys; the Define Measurement column shows the measurements attached to these
keys.

Move the cursor over one box in Define Measurement column and press Set , tap the box

Tap Keyboard key to open the soft keys, and use left or right direction key to select certain

measurement item. In freeze mode, the operator can tap this numeric key to get this
measurement.

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4. System Setup

4.2.7 Load Default

Figure 4-10: Load default

4.2.7.1 Load and Delete General Setting

Note:
The profiles under Load and Retrieve tabs store only the
configurations for General Setting.

Click the Load tab and select a setting name. The following prompt message appears,

Load new setting?


continue (Y/N).
Delete setting: [DEL]

Type the Y key to load the setting or type the N key to cancel. Press the Delete key to

delete the setting.


To save the current system setting as a new setting, click the Create tab (Figure 4-11). Type in
the name for the setting, and click the CONFIRM button.

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4. System Setup

Figure 4-11: Create user setting

4.2.7.2 Backup and Restore User Setting

To back up or retrieve the user setting and preset, click the Retrieve tab (Figure 4-12). Make
sure a writable USB drive has been connected before proceeding.
User setting contains the configurations of general setting, printer setting, user defined OB
table and measurement formula table.

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4. System Setup

Figure 4-12: Back up or load the user setting and data

 Click Copy user setting to USB to back up the current user setting to an external
USB drive.
 Click Copy USB user setting to system to restore the backup copy of the user
setting from the USB drive.

4.2.7.3 Backup and Restore User Preset

User preset contains the user defined application/exam modes. These application modes are
created by following instructions in Section 3.7 and used as user presets of imaging
parameters.
 Click Copy user preset to USB to backup the user defined application modes to USB
drive.
 Click Copy USB user preset to system to restore the backup copy of user defined
application modes from the USB drive.

Caution!
Restore backup from the USB drive overwrites the patient data on the
system as well.

4.2.8 DICOM Setting


This system conforms to the Digital Imaging and Communications in Medicine (DICOM)
standard, which is the industrial standard for the communication and management of patient
data among the devices in the hospital.
Click the DICOM Settings tab to modify network, DICOM and print setting.

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4. System Setup

Figure 4-13: DICOM Setting: Local

4.2.8.1 Local System and Network Printer

Click the Local tab and configure as follows.


Set DHCP Uses the Dynamic Host Configuration Protocol (DHCP). If this option is selected,
the system startup time will increase about half a minute.
Static IP Uses the following static IP information which shall be provided by the user,
IP Address Sets the IP address of the local system.
NetMask Sets the netmask address of the local system.
Gateway Sets the gateway address of the local system.
Printer IP Sets the IP address of the network printer.
AE Title Sets the Application Entity (AE) title of the local system.
Ping IP Addr. Type an IP address and click the Ping button to test the connectivity of
the system to the IP address.

Caution!
Reboot the system to allow the modification to take effect.

4.2.8.2 DICOM Storage Server

Figure 4-14: DICOM Setting: Store

Click the Store tab and configure the DICOM Storage server profile.
To select a DICOM Storage server profile from the list, click the profile ID to highlight it and

58 Basic Operator’s Manual


4. System Setup

click the Set Default button.


To delete a DICOM Storage server profile from the list, click the profile ID to highlight it and
click the Delete button.
To add a DICOM Storage server profile, follow these instructions,
Server Name Sets the DICOM storage server name.
IP Address Sets the IP address of the DICOM storage server.
Port Sets the port number of used by the DICOM server.
AE Title Sets the Application Entity (AE) title of the DICOM server.
Timeout (sec) Specifies a time period after which the ultrasound system will stop
trying to establish a connection to the server. will be displayed once the test
completes.
Save Click this button to save the modification.
Echo Click this button to test the connectivity to the server. A summary will be
displayed when the test completes.

4.2.8.3 DICOM Worklist Server

Click the Worklist tab to configure the worklist server profile.

Figure 4-15: DICOM Setting: Worklist server

To select a worklist server profile from the list, click the profile ID to highlight it and click the
Set Default button.
To delete a worklist server profile from the list, click the profile ID to highlight it and click the
Delete button.
To add a worklist server profile, follow these instructions,
Server Name Sets the worklist server name.

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4. System Setup

IP Address Sets the IP address of the worklist server.


Port Sets the port number of used by the worklist server.
AE Title Sets the Application Entity (AE) title of the worklist server.
Timeout (sec) Specifies a time period after which the ultrasound system will stop
trying to establish a connection to the server.
Max Results Specifies the maximum number of patient records the system is
allowed to retrieve when searching the patient database.
Save Click this button to save the modification.
Echo Click this button to test the connectivity to the server. A summary will be
displayed once the test completes.

4.2.8.4 DICOM Print Server

Click the Print tab to configure the DICOM print server profile. Click or to view
settings on other pages.

Figure 4-16: DICOM Setting: Print

To select a DICOM print server profile from the list, click the profile ID to highlight it and click
the Set Default button.
To delete a DICOM print server profile from the list, click the profile ID to highlight it and click
the Delete button.
Save Click this button to save the modification.
Echo Click this button to test the connectivity to the server. A summary will be displayed once
the test completes.
To configure a DICOM print server profile, see below.

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4. System Setup

Server Name Sets the DICOM print server name.

IP Address Sets the IP address of the DICOM print server.

Port Sets the port number of used by the DICOM print server.

AE Title Sets the Application Entity (AE) title of the DICOM print server.

Specifies a time period after which the ultrasound system will stop
Timeout (sec)
trying to establish a connection to the server.

Format Sets the number of prints to print on each page.

Priority Sets the print job priority: HIGH, MEDIUM, or LOW.

Medium Select the print medium: PAPER, BLUE FILM or CLEAR FILM

Copies Sets the number of copies to print.

Orientation Specifies whether to print the image LANDSCAPE or PORTRAIT.

Film Size Specifies the dimension of the film size.

Specifies the film destination: MAGAZINE—for storing in a film


Destination
magazine; PROCESSOR—for processing in a film processor.

Specifies the method used for magnifying images at the printing


Magnification process. The value can be set from REPLICATE, BILINEAR, CUBIC
or NONE.

Smooth Type Specifies the value of magnification interpolation for the printer.

Trim Specifies whether a trim box should be printed around each image.

Min. Density Specifies the minimum density level of the film.

Max. Density Specifies the maximum density level of the film.

Specifies the color of the border (BLACK or WHITE) which fills the
Border
gap between the images.

Empty Image Specifies whether to print Black or White empty images.

Color Specifies whether to print the images in color or grayscale.

Film Label Specifies a name to be applied to a group of the film labels.

Config. Info Specifies special image quality settings.

4.2.8.5 DICOM MPPS Server

Click the MPPS tab to configure the DICOM MPPS server profile.

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4. System Setup

Figure 4-17: DICOM Setting: MPPS server

To select a MPPS server profile from the list, click the profile ID to highlight it and click the
Set Default button.
To delete a MPPS server profile from the list, click the profile ID to highlight it and click the
Delete button.
To add a MPPS server profile, follow these instructions,
Server Name Sets the MPPS server name.
IP Address Sets the IP address of the MPPS server.
Port Sets the port number of used by the MPPS server.
AE Title Sets the Application Entity (AE) title of the MPPS server.
Timeout (sec) Specifies a time period after which the ultrasound system will stop
trying to establish a connection to the server.
Save Click this button to save the modification.
Echo Click this button to test the connectivity to the server. A summary will be
displayed once the test completes.

4.2.8.6 DICOM Commit Server

Click the Commit tab to configure the DICOM commit server profile.

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4. System Setup

Figure 4-18: DICOM Setting: commit server

To select a commit server profile from the list, click the profile ID to highlight it and click the
Set Default button.
To delete a commit server profile from the list, click the profile ID to highlight it and click the
Delete button.
To add a commit server profile, follow these instructions,
Server Name Sets the MPPS server name.
IP Address Sets the IP address of the MPPS server.
Port Sets the port number of used by the MPPS server.
AE Title Sets the Application Entity (AE) title of the MPPS server.
Timeout (sec) Specifies a time period after which the ultrasound system will stop
trying to establish a connection to the server.
Report Event Select report event status: ASYNCHRONOUS or SYNCHRONOUS
Save Click this button to save the modification.
Echo Click this button to test the connectivity to the server. A summary will be
displayed once the test completes.

4.3 System Information

Select the System Information tab and press Set to view the system information. Both the

hardware and the software version numbers can be identified here. Among them, the Control
Number is a unique number for the system; and the Software Version number designates the
current software version.

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4. System Setup

Caution!
In the System Information interface, input password and enter system
diagnostics or software change interface. Only authorized service
personals can perform this action.

4.4 Touch Screen Setting

Tap Keyboard key and enter system soft keyboard interface, as shown in Figure 4.19. In the

upper part of this interface, there are keys through which can be used to adjust brightness and
skin of touch screen, as well as set touch screen, enter System Setting interface, Patient
Information interface, and Report interface.

Figure 4.19: Soft keyboard interface of touch screen

Tap Default Brightness key to recover system default setting of touch screen brightness;

Slide control Main Screen to adjust brightness of the main screen;

Slide control Touch Screen to adjust brightness of the touch screen;

Tap Change Skin to change the skin of the touch screen;

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4. System Setup

Tap【SetUp】to enter touch screen setting interface for more adjusting options;
Tap【Menu】,【Patient】,【Report】to enter System setting, Patient Information, and Report
interfaces respectively;

Tap Exit to exit soft keyboard interface.

In touch screen setting interface, the operator can adjust touch screen’s skin, font color and
brightness, brightness of touch screen and the main screen, as well as touch screen volume.

Figure 4.20: Touch screen setting interface

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4. System Setup

4.5 System Information of Touch Screen

Long-tap Keyboard to enter system information interface of touch screen, which includes

USB device mark, touch adjust, touch screen version and system update information.

Figure 4.20: System information interface of touch screen

Tap Touch Screen to enter touch screen calibration interface. Tap icons to calibrate. If

success, the system will return to the previous interface automatically, otherwise, calibrating
icons will appear again;

Tap Version to check version information of touch screen;

If the system is connected with a USB device contained touch screen software of this system,

the USB device mark will be highlighted, and tap System Update to update touch screen.

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Chapter 5 B Mode

B mode imaging is intended to provide information of anatomical structure of soft tissues.

Figure 5.1: B mode

Starting B Mode

Tap an application icon at the preparation mode


to start a real time scan, and the system will
automatically start B mode scanning unless
system is applying a special probe.

When the system is in other imaging modes, you

can press the B mode soft key to exit the

current mode and return to B mode.

67
5. B Mode

5.1 B Mode Image Information

B mode image information is shown on the top left corner of the screen (also refer to Figure
3-5). It shows some parameters important for the diagnosis. The table below shows the
meaning of the items listed in the 2D Image Info area.

FPS Number of frames per second


D/G Dynamic range (DYN)/gray scale curve
GN 2D gain
I/P Adaptive Image Fusion/Persistence
PWR Acoustic output power (%)
FRQ Frequency range (MHz)
D Depth

5.2 B Mode Operation

The B mode operation is performed through soft keys of touch screen.


In real time B mode, the soft-controls available on the touch screen are shown in Figure 5-1.

Figure 5-1: Touch screen controls in real time B mode

Usually, relevant controls of imaging parameters, such as Persist , Chroma , can be

adjusted by the following ways:

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5. B Mode

Tap left half of the soft key to decrease value of the corresponding parameter or inactivate this
function. Tap right half of the soft key increase value of the corresponding parameter or
activate this function.

5.2.1 B Gain
The B mode gain (2D gain), determines the amplifying factors for the received echoes and the
brightness of the ultrasound image. The echoes are amplified with the same gain value
regardless of depth.

Turn the B mode knob clockwise to increase the 2D gain, the ultrasound image gets

brighter.

Turn the B mode knob counterclockwise to decrease the 2D gain, the ultrasound image gets

darker.

Note:
 The gain value is displayed on the screen at the 2D Image
Info area (GN).
 It is possible to change the B Gain only when B mode is
active, independent of additional modes.

5.2.2 Time Gain Compensation (TGC)


 The TGC are adjustable during the real time scan regardless of the imaging mode (B,
Color …) and display format (single, dual, quad).
 Use the TGC slide control to adjust the gain that allows compensation for attenuation of
the echoes over time (depth).
 Move the slide control to the left to decrease the gain at the corresponding depth; move
the slide control to the opposite direction to increase the gain at the corresponding depth.

Note:
 The default TGC compensation corresponds to the middle
positions at which the slide controls are.
 Before a slide control is moved, the TGC is kept to its default
value independent of the slider positions.
 TGC curve disappears when the TGC sliders is inactive for
more than several seconds.

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5. B Mode

5.2.3 Depth

The depth range is adjustable during the real time scan regardless of the
imaging mode (B, CDI, PW/CW, …) and display format (single, dual, quad).

The depth knob controls the depth range of the ultrasound image. The system
automatically adjusts the frame rate (FPS) and acoustic power indices (TI, MI ...)
according to the depth.

 Turn the knob clockwise to increase the depth range of the 2D image and the
size of image is reduced to display the entire ultrasound image.

 Turn the knob counterclockwise to decrease the depth range of the 2D image
and the ultrasound image is magnified.

Note:
 The range of the scanning depth depends on the probe type.
Depth is represented in unit of cm.
 The depth scale is shown on the right side of the ultrasound
image.
 The current depth is displayed at the 2D Image Info area and
represented by D.

5.2.4 Focal Number


 The focal zone determines the depth range for optimizing the concentration of the
ultrasound beam.
 Multiple focal zones are possible. The red triangle marker ( ) for focal zone is displayed
at the depth scale.
 Use Focal menu to select number of focal zones. Number of focal zones is determined by
the probe in use and scanning depth.
To change the number of focal zones using soft keys:

 Tap the right side of the Focal Number soft key to increase the number.

 Tap the left side of the Focal Number soft key to decrease the number.

5.2.5 Focus Position


The focus position determines optimization depth of the ultrasonic beam.
To change the depth position(s) of the focal zone(s):

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5. B Mode

 Tap the right side of the Focal Pos , key on the touchscreen to increase the depth

of focal zone(s).

 Tap the left side of the Focal Pos , key on the touchscreen to decrease the depth

of focal zone(s).

Note:
 The focal depth is adjustable during the real time scan
regardless of the imaging mode (B, Color, DPI, TDI) and
display format (single, dual, quad).
 If multiple focal zones are present, they are shifted with the
same amount of depth.

5.2.6 Focal Span


When multiple focal points exist, you can change focal span (the distance between the
adjacent focal points) if needed:

 Tap the right side of Focal Span key on the touch screen to increase the value.

 Tap the left side of Focal Span key on the touch screen to decrease the value.

Note:
 The maximum number of focal zones depends on the probe in
use.
 Increasing the focal number decreases the frame rate and
increases the acoustic power indices.
 Increasing the focal zone depth increases the acoustic power
indices.

5.2.7 Tissue Acoustic Characteristics


The speed of ultrasound depends on the tissue it is passing through. Tissue acoustic
characteristics specify the ultrasound speed used for measurements and calculations. Adjust
this parameter to tune the focusing to the best.
To change the Tissue Acoustic Characteristics,

 Tap the right side of the Tissue Acoustic key on the touchscreen to increase the

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5. B Mode

value.

 Tap the left side of the Tissue Acoustic key on the touchscreen to decrease the

value.

Note:
 The calculations that depends on the ultrasound velocity
varies with the value of TISSUE ACOUSTIC.
 For your reference, Table 5.1 provides the sound speeds in
miscellaneous tissues/organs/materials.

5.2.8 Dynamic Range


Dynamic Range increases the adjustable range of contrast by enhancing the intensities of
parts of the grayscale. It is useful for optimizing the ultrasound image texture.

 Tap the right side of the DYN key on the touchscreen to increase the value.
ue
Aco
 Tap the left side of the DYN
ustickey on the touchscreen to decrease the value.
ue
Aco
ustic

Note:
Dynamic Range is displayed at the 2D Image Info Area on the screen
(The D in D/G).

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5. B Mode

Tissue Type Phase Velocity (m/s)


Air 330
Soft tissue (average) 1540
Bone, skull 2770 +/- 185
Brain Fresh 1460
Breast in vivo 1510 +/- 5
Breast Fat 1420
Breast Mass 1600
Fat, fresh 1450
Kidney 1560
Liver, fresh 1570
Blood 1570
Lung, fresh 658
Muscle 1580
Uterus 1630
Tendon 1750
Collagen 1675
Water (20°C) 1480
Table 5.1: Sound speeds in the different materials

5.2.9 Grayscale curve


Brightness of each pixel is determined by the amplitude of the corresponding echo. Grayscale
curve (GSC) adjusts the images by changing how the amplitude is converted to brightness.
The GSC is adjustable in the real time mode as well as the freeze mode. Different imaging
mode has different GSC, and there are 7 kinds of GSC to be selected by the user.
Using soft keys:

 Tap the right side of the GSC key on the touchscreen to increase the value.
ue
Aco
 Tap the left side of the GSC
ustickey on the touchscreen to decrease the value.
ue
Aco
ustic

Note:
Grayscale Curve is displayed at the 2D Image Info area on the screen
(The G in D/G).

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5. B Mode

5.2.10 Persistence
Adjust the persistence value to remove speckles from 2D images and enhance the
smoothness of the image.
Using soft keys:

 Tap the right side of the Persist key on the touchscreen to increase the value.

 Tap the left side of the Persist key on the touchscreen to decrease the value.

Note:
Persistence value is displayed at the 2D Image Info area on the screen
(The P in I/P).

5.2.11 Chroma
The echo amplitudes are converted to pixels with different brightness. The chroma value (color
tone and saturation) is mapped to the pixels. There are 13 map combinations available.
The chroma value is adjustable in the real time mode as well as the freeze mode.
Using soft keys:

 Tap the right side of the Chroma key on the touch screen to increase the value.

 Tap the left side of the Chroma key on the touch screen to decrease the value.

5.2.12 Sector Width/Angle

User can increase the frame rate of the image by adjusting Sec.Width and Sec.Pos

while allowing the region of interest remains in the imaging area.


The following operation adjusts the sector width (for linear transducers) or sector angle (for
curved transducers),

 Tap the right side of the Sec.Width key on the touch screen to increase the value;

 Tap the left side of the Sec.Width key on the touch screen to decrease the value.

5.2.13 Sector Position


To move the sector position,

 Tap the right side of the Sec.Pos key on the touchscreen to increase the value.

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5. B Mode

 Tap the left side of the Sec.Pos key on the touchscreen to decrease the value.

5.2.14 Line Density


LINE DENSITY can be set to Low, Medium or High. Higher line density can provide better
horizontal resolution, but also reduces the frame rate.

 Tap the right side of the Line Density key on the touch screen to increase the

value.

 Tap the left side of the Line Density key on the touch screen to decrease the value.

5.2.15 Compound Imaging

In real time scanning, there are three options under Compound : OFF, 1, 2. But it varies

according to the probe.

 Tap the Compound key on the touch screen to set the option to ON;

 Tap the Compound key on the touch screen again to set the option to OFF.

5.2.16 Frequency Range


The transducer is capable of generating a broadband signal with a certain start frequency and
a certain bandwidth. The higher the frequency is set, the higher the resolution will be and the
lower the penetration is.

 Tap the right side of the Frequency key on the touch screen to increase the value.

 Tap the left side of the Frequency key on the touch screen to decrease the value.

Note:
The frequency range is displayed at the 2D Image Info area FRQ.

5.2.17 Image Orientation (Left/Right)


Change of the image orientation is possible with all imaging modes (real-time or frozen)
independent of the display format (single, dual, quad).
Use this function to alternate the image orientation between left and right without rotating the
scan head itself. The orientation marker ( ) corresponds to the position of the first element of
the array on the transducer.

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5. B Mode

Tap the key on the touch screen to alternate the image orientation between left and

right.

Note:
Image orientation can be changed in real time mode as well as in
frozen mode, and so it is in dual or quad mode.

5.2.18 Image Orientation (Up/Down)


Use this function to alternate the image up/down orientation without having to rotate the
transducer itself.

 Tap the key on the touch screen to flip the image vertically.

Note:
Image orientation can be changed in real time mode as well as in
frozen mode, and so it is in dual or quad mode.

5.2.19 Adaptive Image Fusion (AIF)


Adaptive image fusion provides choices of optimization methods for improving image quality
through boundary enhancement, image smoothing and system optimization.

 Tap the right part of the Adapt. Fusion key on the touchscreen to increase the

value.

 Tap the left part of the Adapt. Fusion key on the touchscreen to decrease the

value.

Note:
Adaptive Image Fusion is displayed at the 2D Image Info Area on the
screen (The I in I/P).

5.2.20 μScan Function

The μScan function allows the transducer to see in more than one direction, eliminates
artifacts from the ultrasound image, improving image quality.

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5. B Mode

Note:
The μScan function is available when a valid μScan dongle has been
installed to the system.

 Tap the right part of the μScan key to turn on the μScan function and adjust its value.

 Tap the left part of the μScan key to turn off the μScan function.

5.2.21 Acoustic Output Power


The acoustic output power of the transducer should be set to the minimum value as long as
well-evaluable information can be provided. Always keep the power level and the exposure
time as low as reasonably achievable.

 Tap the right part of the Power% key on the touchscreen to increase the value.

 Tap the left part of the Power% key on the touchscreen to decrease the value.

Note:
 The acoustic output power is displayed at the 2D Image Info
Area on the screen (PWR).
 You can decrease the acoustic power indices (MI, TI) by
reducing the output power of the transducer.

5.2.22 Trapezoidal Imaging

Note:
The Trapezoidal Imaging is only available with linear transducers. The
TRAPEZOID item is hidden for other types of probes.
Please turn off Compound 2 function before you turn on Trapezoid.

 Tap the Trapezoid key on the touch screen to turn on the option.

 Tap the Trapezoid key again on the touch screen to turn off the option.

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5. B Mode

5.2.23 Steer
When using linear transducers, the direction of the acoustic beam can be adjusted using this
function.

 Tap the right or the left side of the Steer key on the touch screen to adjust the

direction of the ultrasound beam.

Note:
Steer key only applies to linear transducers.

5.2.24 ECG
Using an optional ECG module (Type BF), 3-channel ECG signals are provided in cardiac
applications. During an cardiac application, you can configure the ECG-control so that the
ECG trace is displayed at the bottom of the screen.
The ECG cable has three color-coded ECG electrode connectors, i.e., LL (left leg, red), LA (left
arm, black), and RA (right arm, white).

Caution!
The ECG module of this ultrasound system is for collecting and
displaying 3-lead ECG trace. It is NOT a replacement for cardiac
diagnosis or monitoring devices.

Tap the ECG key on the touch screen, the ECG sub-controls (Figure 5-2) appears. Tap

ECG again to hide the ECG sub-controls.

Figure 5-2: ECG

Functions of the ECG sub-controls are described below.


 ECG ON/OFF: Turn on/off the ECG trace display.

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5. B Mode

 ECG GAIN: Adjust the ECG gain (1~4 levels).

 ECG POSITION: Adjust the location of the ECG trace on the screen.
 ECG INVERT: Invert the display of ECG trace.
 R-TRIGGER: Tap this key to turn on or off the R-wave. When turned on, two more
soft-controls for R-wave appears.

5.2.25 Biopsy

When using transducers supporting biopsy operation, tap the Biopsy key on the touch

screen turns on or off the display of biopsy guide lines.

Figure 5-3: Biopsy controls

 Tap Biopsy and set the option to ON to activate the display of the biopsy guide
1
lines . Two more biopsy options appear.

 Tap the Biopsy again to turn off the display of biopsy guide lines.

Figure 5-4: Biopsy guide lines

1
For some transducers, you can be required to select the biopsy bracket model.

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5. B Mode

You may adjust Biopsy offset and Biopsy angle according to actual need. Before starting

biopsy, you shall calibrate the biopsy bracket first. Please refer relevant user manual of 穿刺架

and probes for operating method of biopsy and biopsy bracket calibration.

Note:
 Ranges of accommodation for biopsy offset and angle depend on
the model of transducers.
 Before starting biopsy, you must calibrate biopsy needle and biopsy
guide line. If the two do not coincide in position, biopsy cannot be
done.
 After the system restart, values of biopsy offset and angle will
recover to factory settings.

5.2.26 Zoom
The zoom function enlarges a selected area of the ultrasound image.
The zoom function is also available in cine mode.

 Tap the Zoom . key on the touchscreen, a zoom box is displayed on the image.

 Use the trackball to adjust the size of the zoom box. Press the key and move
the trackball to change the position of the zoom box.

 Tap the Zoom . key again to magnify the area enclosed in the zoom box.

 Tap Zoom . again to return the normal image display.

5.2.27 Image Rotate


The image rotate function can rotate the image to certain of angle. The options contain 90°,
180°, and 270°.

 Tap the right or left side of Image Rotate . to change the rotation angle.

5.2.28 Dual Display Format

5.2.28.1 Frozen+Real Time Display Format

In the real time mode (B, Color, DPI, TDI), tap the key on the touchscreen to activate
the dual display. The image is reduced to half of its original size and moved to the left to leave
space for displaying the other image.

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5. B Mode

Tap the key to freeze the current image and unfreeze the other image.

You may change the imaging mode for the selected image by pressing the corresponding key

( Color , TDI , DPI , …).

Tap the key to toggle the image orientation between left and right.

Tap the key to toggle the image orientation between up and down.

Figure 5-5: Dual display: real time B + frozen B

Press again to

 Exit the dual display mode if both images are in B mode;


 If one is or both of them are in color mode (Color, DPI, or TDI), real time dual display
mode (Section 5.2.28.2) will be activated. In this case, both of the two images are
displayed in real time.

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5. B Mode

5.2.28.2 Real Time Dual Display Format

Note:
The real time dual display format can also be activated by tapping the
2B. key twice at a real time color mode (B, Color or TDI).

Note: In single real time Color mode, you may also enter real time dual mode by double

tapping soft key.

Tap the key on the touch screen to change the left/right image orientations for the

image.

Tap the key on the touch screen to alternate the up/down image orientation for the
image.

You may alternate imaging mode of the current real time image by tapping B , Color ,

DPI TDI
or soft keys.

Tap the key again to exit the dual color mode display.

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5. B Mode

Figure 5-6: Dual display: real time Color + real time B

5.2.28.3 Frozen Dual Display Mode

Freeze
Press the key to freeze both images and the system enters frozen dual display mode.

Use this function to review different images of the same patient. Way of operation is as
following:

In 2D imaging mode, such as B, Color, you may tap to enter dual display mode.

Tap key to determine the position where you want the targeted image display, and

press the key to freeze both images and the system enters frozen dual display mode.

Press again to exit this mode.

5.2.29 Quad Display Format

In a real time B or color mode, tap key on the touchscreen to activate the quad display.
The image is reduced to a quarter of its original size and moved to the top left to leave space
for displaying other images.

Tap the key to freeze the current image and activate the display on the next quadrant
(clockwise).
Changing the imaging mode for the selected image is possible by tapping the corresponding

key ( B ,. Color . DPI , TDI .).

Tap on the touch screen to change the left/right image orientation for the selected

image.

Tap on the touch screen to alternate the up/down image orientation for the selected
image.

Tap the key again to exit the quad display.

5.3 Tissue Harmonic Imaging (THI)

Tissue reflects echoes with the received frequency (which is the ‘fundamental frequency’) as
well as the harmonics. In THI mode, these harmonics are also picked up and analyzed.
THI gives better grayscale contrast compared to the standard B mode imaging, and also helps
removing artifacts from the image. This imaging technique has been proved very useful for

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5. B Mode

difficult-to-image patients.

In real time B, Color, DPI mode, tap the THI soft key to enable the THI mode, and THI as a

mark will appear at the lower left corner of the screen.

To disable the THI mode, tap the THI key again.

Note:
 THI is available only for selected probes.
 The system automatically optimizes certain parameters (B
mode gain and frequency, and acoustic output power) upon
enabling THI.

5.4 Cine Mode Operation

During the real time B mode scan, press the Freeze key to freeze the image and start the

cine mode. Recent image frame sequence will be cached and ready for review.
In the frozen mode, the cine playback status (more in Section 5.4.2) is displayed on the screen;
maximum number of frames the system can cache depends on the settings of scan depth, line
density and zoom.
If there are cine clips saved in the same patient folder, these clips will be displayed at the
bottom of the screen. See Section 5.4.1.
The cine mode operation is independent of the display format (single, dual, quad).

Note:
All measurements results, annotations and body marks on the screen
will be cleared upon pressing the Freeze key.

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5. B Mode

Figure 5-7: Touchscreen controls in frozen B mode

Figure 5-8: Cine playback status

5.4.1 Cine Review


If ultrasound examinations have been performed for the same patient and there are clips
saved in the patient folder, these clips are displayed at the bottom of the screen.
 In a frozen or real time mode, the cine with clips appears on the lower part of screen
automatically.

 Press the T-Ball key, move the trackball to highlight a cine clip and press the

Set key to open the clip.

 Now you may perform zoom, playback or measurement with the cine clip.

5.4.2 Cine Playback


When the image is frozen, the cine status bar shows the total number of frames stored and the
position of the current frame.

5.4.2.1 Play/Stop

Play/Stop
 Tap the soft key to start the cine auto playback;

Play/Stop
 Tap the soft key again to stop the playback.

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5. B Mode

5.4.2.2 Loop Speed

This option controls the cine playback speed.

1. Tap the right side of the Loop Speed soft key to increase the loop speed;

2. Tap the left side of the Loop Speed soft key to decrease the loop speed.

5.4.2.3 Start

Tap the Start key to move the frame marker to the start of the cine.

5.4.2.4 End

End
Tap the key to move the frame marker to the end of the cine.

5.4.2.5 Frame by Frame

Use this function to review the cine frame by frame.

Frame by Frame
1. Tap the right side of the soft key to review the next frame;

Frame by Frame
2. Tap the left side of the soft key to review the previous frame.

5.4.3 Selecting Image Sequence


Sometimes such as when saving a cine clip or preparing for 3D rendering, it is convenient to
be able select only a sequence of image frames. So only the selected image sequence will be
processed.
Follow these steps to select an image sequence:
1. In the cine mode, use the trackball to locate the image frame to be marked as the
start of the sequence, press the Set key.
2. Use the trackball to locate the image frame to be marked as the end of the sequence
and press the Set key. The selected sequence will be highlighted on the cine
playback status bar.

5.4.4 Frozen Dual Display Mode (2B)


Use this function to compare two cine clips collected at different time.

Freeze
1. In a real time 2D mode, e.g. B or Color mode, press the key to freeze the

image.
Cine clips belonging to the same patient are listed at the bottom of the screen.

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5. B Mode

2. Tap the soft key to enter the frozen dual display format.

3. Tap the soft key to switch to the next display.

2
4. Move the trackball to select a cine clip and press the key; The selected cine
clip will be opened and displayed.

5. Tap the soft key again to exit the dual display mode.

5.4.5 Zoom
Refer to Section5.2.26.

5.4.6 Grayscale Curve (GSC)


Refer to Section 5.2.9.

5.4.7 Chroma
Refer to Section 5.2.11.

5.4.8 Image Orientation (Left/Right)

For the function and operation of refer to Section5.2.17.

5.4.9 Image Orientation (Up/Down)

For the function and operation of refer to Section 5.2.18.

5.4.10 Panoramic (Optional)


With panoramic imaging, the system combines frames of B mode images and constructs a
panoramic image providing wider views.
To construct a useful panoramic image, the sonographer need to scan the patient to collect the
required images first. During the scan, the movement of the transducer should be kept in a
way that the movement is parallel to the surface of the scan head.
Some training and practice are necessary for acquiring satisfying panoramic images.

1. Perform an ultrasound scan to acquire the images and press the Freeze key to

freeze the image.

2. Tap the Panoramic . soft key, the screen shows Please wait ….

3. When the system starts to construct the panoramic image, the message “Press CLR

2
You may need to press the T-Ball key change the function of the trackball.

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5. B Mode

to Cancel” appears. You may tap the Clear key to abort the process.

Figure 5-9: Panoramic imaging (processing)

Once the process completes, the screen shows the panoramic image. You can use the
Picture-In-Picture function as below,

1. Tap the Toggle PIP . soft key to activate the Picture-In-Picture function. When

activated, the image is enlarged to fit the height, you may need to use the trackball to
view other parts of the image.

2. Tap the Toggle PIP . soft key again to turn off the Picture-In-Picture function.

3. Tap Quit . to exit the panoramic imaging mode.

Caution!
Measurements performed on panoramic images not properly acquired
can give incorrect results.

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5. B Mode

 Panoramic imaging is most suitable when the region of interest is significantly larger
than a single frame B mode image. It is suggested to move the transducer slowly and
steadily and keep the movement perpendicular to the scan plane, and ensure the
trace of the movement remains in a single plane.
 When performing the scan, monitor the real time image to ensure the above
requirements are satisfied.

Figure 5-10: Picture-In-Picture

Suggestions for preparing panoramic imaging


 Add adequate amount of coupling gel along the intended path of
the scan. Ensure the movement is slow and steady.
 When scanning for panoramic imaging, ensure the transducer
remains in contact with the patient skin.
 Keep the transducer in contact with the patient skin and
perpendicular to the skin surface. Do not shake, rotate or tilt the
transducer during the scan.
 If possible, keep the movement perpendicular to the scan plane
and do not move the transducer laterally.
 Do not change scan direction or move the transducer backward.
 Some variation of the scan speed is allowed but do not change
the speed suddenly. When the scan depth increases, generally it
is required to decrease the scan speed.

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5. B Mode

5.4.11 3D
Refer to Chapter 11.

5.4.12 Saving Image/Cine

If One Key Save (Subsection 4.2.1) is set to ON, press Save Frame to save the current

frame as a single image press Save Cine for more than 3 seconds to save all frames as a

cine. Press to return to real time mode


When One Key Save is set to OFF:

 To save a frame as an image, press Save Frame in frozen mode, move the trackball

to select 1 , and press the Set key. A name automatically generated by time and

the image is saved.


 To save a cine sequence, mark the start and end positions of the sequence, press

Save Frame in cine mode, move the trackball to select 2 , and press the Set

key. A name automatically generated by time and the cine sequence is saved.
If patient information has been entered, the image or cine will be saved under this patient
profile. If not, they will be saved to general directories.
Instructions:
You can format of images when saving them through 【Still Format】 item of General Setting
(Please refer to Section 4.2.1). Open 【Review】interface, click 【Save to USB】 and then
choose【PC】and save it to the flash driver, and you can check the image in PC. You may also
choose 【DICOM】 and then the image will be sent to SCU or flash driver in DICOM format
automatically.
As for the cine file, you can set its saving format through 【Clip Format】 item of General
Setting (Please refer to Section 4.2.1). Open 【Review】interface, click 【Save to USB】 to
save it to the flash driver and then you may review it on PC.

90 Basic Operator’s Manual


Chapter 6 Color Mode

In Color Flow Mode (CFM/ Color), velocity information is represented as a color-coded overlay
on top of a 2D B mode image.

6.1 Starting Color Mode

Tap Color soft key to enter Color Flow Mode.

Tap this soft key again to exit this mode and return to the previous imaging mode.

Figure 6-1: Color mode

6.2 Color Image Information

The color image information for the Color mode ultrasound is displayed at the Color Image Info

91
6. CFM Mode

area (refer to Figure 3-5 for the70


The meanings for the items are shown in the info area as explained in the table below.

PRF pulse repetition frequency


WF wall filter value
GN Doppler gain, D gain
C/P Color Map setting/persistence value
PWR acoustic output power (%)
FRQ transmitted frequency (MHz)

6.3 Color Mode Operation

The Color mode operation is performed using touch screen soft keys and is independent of the
display format (single, dual or quad).
In real time Color mode, the soft-controls available on the touch screen is shown in Figure.

Figure 6.2: Touch screen controls in real time Color mode.

Tap the left or right haft of the key to adjust value of related parameters. Usually, tap the left
half to decrease the value or turn off relevant function. Tap the right half to increase the value
or turn on relevant function.

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6. CFM Mode

6.3.1 Adjust Color Sample Box


Follow the instructions below to adjust the sample box.
 Use the trackball to change the position of the sample box.

 Press the Set key. Use the trackball to change size of the sample box.

 Press the Set key again to re-adjust the position of the sample box.

6.3.2 Color Gain


Properly adjust the Color gain to ensure that the color flow is continuous but no color speckle
is present.

Turn the knob clockwise/counterclockwise to increase/decrease the Color gain.

6.3.3 Depth
Scan depth can be adjusted in the same manner as in B mode, see Section 5.2.3.

6.3.4 Time Gain Compensation (TGC)


The time gain compensation adjusts the brightness of the 2D background, see Section 5.2.2.

6.3.5 Focus Position


Focus position can be adjusted in the same manner as in B mode, see Section 5.2.5.

6.3.6 ECG
See Section 5.2.24.

6.3.7 Pulse Repetition Frequency


The Pulse Repetition Frequency sets the velocity range of the color flow display.

 Tap the right side of the PRF soft key to increase the value;

 Tap the left side of the PRF soft key to decrease the value;

Note:
 The current PRF value is display at the Color Image Info area
(PRF).
 The system automatically adjusts the Wall Filter setting upon
changing the PRF value.

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6. CFM Mode

6.3.8 Color Power


The acoustic output power in the Color mode should be kept as low as reasonably achievable.

Power%
Tap the left/right side of the soft key to decrease/increase the Color power value.

The decreasing or increasing unit is 10%.

Note:
 The acoustic output power in the Color mode is displayed on
the screen at the Color Image Info area (PWR).

6.3.9 Steer
For linear transducers, the Color sample box can be sheered to a certain angle. This function
is only available for linear probe.

Steer
 Tap the right side of the soft key to sheer the sample box to the right;

Steer
 Tap the left side of the soft key to sheer the sample box to the left.

6.3.10 Wall Filter (WF)


Wall Filter intends to eliminate the low frequency noise generated by movements of blood
vessel walls. The WF shall be sophisticated enough to be able to eliminate noise.

WF
 Tap the right side of the soft key to increase the value;

WF
 Tap the left side of the soft key to decrease the value;

Note:
 The current Wall Filter value is displayed at the Color Image
Info area (WF).
 The Wall Filter is adjustable within a range that depends on
the current PRF value. The higher the WF value is, the less
noise the Color image generates, and thus the clearer the
Color mode image is. However, some low rate flow may also
be eliminated. And the lower the WF value is, the more color
noise the Color image generates.

6.3.11 Persistence (Persist)


Similar to the persistence in the B mode, adjust the persistence value to enhance the

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6. CFM Mode

smoothness of the color image. Its value is dependant of the transducer in use, for instance,
L741 has six default values.

Tap the right/left side of the Persist . soft key to increase/decrease the persistence value.

6.3.12 Color Map (C Map)


Use this function to select the method for the color-coding of blood flows.
The Color Map setting is adjustable in the real time mode as well as the freeze mode.

Tap the left or right side of the C Map .soft key to change the color map setting.

6.3.13 Baseline
Baseline corresponds to the position of zero velocity. The velocity range in one direction can
be increased by adjusting the baseline. Maximum velocities in both directions are displayed at
the ends of the Spectral Wedge..

Tap the right or left side of Baseline .to move the baseline towards positive or negative

direction.

6.3.14 Sector Width/Angle


This function adjusts the sector width (for linear transducers) or sector angle (for curved
transducers) of the background grayscale image.
See Section 5.2.12 for operation instructions.

6.3.15 Sector Position


This function adjusts the sector position of the background grayscale image.
See Section 5.2.13 for operation instructions.

6.3.16 B Reject
This function sets the display priorities of the color and 2D grayscale pixels. Larger B Reject
value suppresses more grayscale pixels.
The B Reject value is adjustable in the real time mode as well as the freeze mode. Its floating
range is 0~255.

Tap the left/right side of the B Reject soft key to decrease/increase the value.

6.3.17 Frequency
This function is used to adjust the frequency of the acoustic beam used for acquiring color flow
information.

Tap the left/right side of the Frequency soft key to decrease/increase the acoustic frequency.

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6. CFM Mode

6.3.18 Image Orientation (Left/Right)


Refer to Section 5.2.17.

6.3.19 Image Orientation (Up/Down)


Refer to Section 5.2.18.

6.3.20 Flow Invert


The Flow Invert in Color mode inverts the color display in relation to the direction of flow. The
Spectral Wedge also inverts around the baseline.
The Flow Invert setting is adjustable in the real time mode as well as the freeze mode.
 Tap the Invert soft key to enable flow invert;
 Tap the Invert soft key again to disable the flow invert.

Note:
 When Finv is set to off: red pixels represent flow to the
transducer; blue pixels represent flow away from the
transducer.
 When Finv is set to on: blue pixels represent flow to the
transducer; red pixels represent flow away from the
transducer.

6.3.21 Line Density


This function determines the line density of the color image. Lower line density provides higher
frame rate but also makes the color pixels larger, so the user should keep balance between
frame rate and image quality.

Tap the left or right side of the Line Density soft key to change the line density setting.

6.3.22 2B
Refer to Section 5.2.28.

6.3.23 4B
Refer to Section 5.2.29.

6.3.24 Display Switch


Refer to Section 5.2.28.

6.3.25 Zoom
Refer to Section 5.2.26.

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6. CFM Mode

6.3.26 THI
The tissue harmonic imaging in Color mode affects the background grayscale image only. See
Section 5.3.

6.4 Cine Mode

Press the Freeze key during the real time Color scan to freeze the image and start the cine

mode. Recent image frames are cached and ready for review.
In the frozen mode, the cine playback status (more in Section 5.4.2) is displayed on the screen;
maximum number of frames the system can cache depends on the settings of scan depth, line
density and zoom.
If there are cine clips saved in the same patient folder, these clips will be displayed at the
bottom of the screen. See Section 5.4.1.
The cine mode operation is independent of the display format (single, dual, quad).
In Color cine mode, touchscreen controls are shown in Figure 6-2.

Figure 6-2: Touchscreen controls in frozen Color mode

Tap the left or right haft of the key to adjust value of related parameters, such as Trance .,
cut
Color Map .Usually, tap the left half to decrease the value or turn off relevant function. Tap the

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6. CFM Mode

right half to increase the value or turn on relevant function.

Note:
All measurements results, annotations and body marks on the screen
will be cleared upon playing cine.

6.4.1 Cine Review


To review other cine clips belonging to the same patient, see Section 5.4.1.

6.4.2 Cine Playback


Please refer to Section 5.4.2.

6.4.3 C Map
Refer to Section 6.3.12.

6.4.4 B Reject
Refer to Section 6.3.16.

6.4.5 Flow Invert


Refer to Section 6.3.20.

6.4.6 Baseline
Refer to Section 6.3.13.

6.4.7 Image Orientation (Left/Right)


Refer to Section 5.2.17.

6.4.8 Image Orientation (Up/Down)


Refer to Section 5.2.18.

6.4.9 2B
Refer to Section 5.2.28.

6.4.10 Zoom
Refer to Section 5.2.26.

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Chapter 7 DPI Mode (Doppler Power
Imaging)

Doppler Power Imaging (DPI) mode is especially useful in displaying very low flow velocities.

7.1 Starting DPI Mode

Tap the DPI soft key to activate the DPI mode. The DPI sample box appears in the
active 2D image.

Tap the DPI soft key again to deactivate the DPI mode.

Figure 7-1: DPI mode

99
7. DPI Mode

7.2 DPI Image Information

The DPI image information is displayed at the Color Image Info area (see Figure 3-5).
The meaning for the items shown in the info area is explained in the table below.

PRF pulse repetition frequency


WF wall filter value
GN Doppler gain, D gain
C/P Color Map setting/persistence value
PWR acoustic output power (%)
FRQ transmitted frequency (MHz)

7.3 DPI Mode Operation

The DPI mode operation for the current ultrasound image is independent of the display format
(single, dual or quad).
In real time DPI mode, the soft-controls available on the touchscreen is shown in Figure 7-2.

Figure 7-2: Touchscreen controls in real time DPI mode

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7. DPI Mode

Tap the left or right haft of the key to adjust value of related parameters. Usually, tap the left
half to decrease the value or turn off relevant function. Tap the right half to increase the value
or turn on relevant function.

7.3.1 Adjust DPI Sample Box


Follow the instructions below to adjust the sample box.
 Use the trackball to change the position of the sample box.

Set
 Press the key. Use the trackball to change size of the sample box.

Set
 Press the key again to re-adjust the position of the sample box.

7.3.2 DPI Gain


Properly adjust the DPI gain to ensure that the color flow is continuous but no color speckle is
present.

Turn the knob clockwise/counterclockwise to increase/decrease the DPI gain.

Note:
 The DPI gain value is displayed on the screen at the Color
Image Info area (GN).
 It is possible to change the DPI Gain only when the DPI mode
is active.

7.3.3 Depth
Scan depth can be adjusted in the same manner as in B mode, see Section 5.2.3.

7.3.4 Time Gain Compensation (TGC)


The time gain compensation adjusts the brightness of the 2D background, see Section 5.2.2.

7.3.5 Focus Position


Focus position can be adjusted in the same manner as in B mode, see Section 5.2.5.

7.3.6 ECG
See Section 5.2.24.

7.3.7 Steer
For linear transducers, the DPI sample box can be sheered to a certain angle.

 Tap the right side of the Steer soft key to sheer the sample box to the right;

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7. DPI Mode

 Tap the left side of the Steer soft key to sheer the sample box to the left.

7.3.8 Pulse Repetition Frequency


The Pulse Repetition Frequency sets the velocity range of the color flow display.
The range of the PRF depends on the probe and the application mode.

Flip the PRF switch up/down to increase/decrease the PRF range.

Note:
 The current PRF value is display at the Color Image Info area
(PRF).
 The system automatically adjusts the Wall Filter setting upon
changing the PRF value.

7.3.9 Wall Filter


WF Wall Filter intends to eliminate the low frequency noise generated by movements of blood
vessel walls. The WF shall be sophisticated enough to be able eliminate noise.

Flip the WF switch up/down to increase/decrease the Wall Filter value.

Note:
 The current Wall Filter value is displayed at the Color Image
Info area (WF).
 The Wall Filter is adjustable within range 25Hz~750Hz and it
depends on the current PRF value.
 The Wall Filter is adjustable within a range that depends on
the current PRF value. The higher the WF value is, the less
the noise in the CFM image, and thus the clearer the Color
mode image is. However, some low rate flow may also be
eliminated. And the lower the WF value is, the more color
noise the CFM image generates.

7.3.10 Persistence
Similar to the persistence in the B mode, adjust the persistence value to enhance the
smoothness of the DPI image.

Tap the right/left side of the Persist soft key to increase/decrease the persistence value.

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7. DPI Mode

7.3.11 Color Map & Directional DPI

Tap the left or right side of the C Map/DDPI .soft key to adjust the color map setting. Similar

to the Color Map in the Color mode, this function select the method for the color-coding of the
display of blood flow.
Directional DPI displays the direction of flow while in Doppler Power Imaging. This function is
very useful when there are requirements in applications where sensitivity and directional
information are both required. Red represents flow toward the transducer; Blue represents flow
away from the transducer.
In the real time DPI mode, you can use this soft key to enable directional DPI. When enabled

the icon appears.

Note:
 Note that enabling Directional DPI is only possible during the
real time DPI scan.
 Adjusting Color Map setting is also possible in the freeze
mode.

7.3.12 DPI Power


The value of the output power in the DPI mode should be kept as low as reasonably
achievable. The decreasing or increasing unit is 10%

 Tap the right side of the Power% .soft key to increase the acoustic output power;

 Tap the left side of the Power% . soft key to decrease the acoustic output power;

Note:
The acoustic output power in the DPI mode is displayed on the screen
at the Color Image Info area (PWR).

7.3.13 Sector Width/Angle


This function adjusts the sector width (for linear transducers) or sector angle (for curved
transducers) of the background grayscale image.
See Section 5.2.12 for operation instructions.

7.3.14 Sector Position


This function adjusts the sector position of the background grayscale image.

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7. DPI Mode

See Section 5.2.13 for operation instructions.

7.3.15 B Reject
This function sets the display priorities of the color and 2D grayscale pixels. Larger B Reject
value suppresses more grayscale pixels.
The B Reject value is adjustable in the real time mode as well as the freeze mode. Its floating
range is 0~255.

Tap the left/right side of the B Reject soft key to decrease/increase the value.

7.3.16 Frequency

Use the Frequency soft key to adjust the frequency of the acoustic beam used for acquiring

color flow information.

Tap the left/right side of the Frequency soft key to decrease/increase the acoustic

frequency.

Note:
The DPI frequency value is displayed on the screen at the Color Image
Info area (FRQ).

7.3.17 Image Orientation (Left/Right)


Refer to Section 5.2.17.

7.3.18 Image Orientation (Up/Down)


Refer to Section 5.2.18.

7.3.19 Line Density


This function, similar to the Line Density in Color mode, adjusts the line density in displaying
the flow in the DPI sample box.

 Tap the left or right side of the Line Density .soft key to change the line density

setting.

7.3.20 2B
Refer to Section 5.2.28

7.3.21 4B
Refer to Section 5.2.28

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7. DPI Mode

7.3.22 Display Switch


Refer to Section 5.2.28.

7.3.23 Zoom
Refer to Section 5.2.26.

7.3.24 THI
The tissue harmonic imaging in Color mode affects the background grayscale image only.
See Section 5.3.

7.4 Cine Mode Operation

Press the Freeze key during the real time DPI scan to freeze the image and start the cine

mode. Recent image frames are cached and ready for review.
In the frozen mode, the cine playback status (more in Section 5.4.2) is displayed on the screen;
maximum number of frames the system can cache depends on the settings of scan depth, line
density and zoom.
If there are cine clips saved in the same patient folder, these clips will be displayed at the
bottom of the screen. See Section 5.4.1.
The cine mode operation is independent of the display format (single, dual, quad).
In DPI cine mode, touchscreen controls are shown in Figure 7-3.

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7. DPI Mode

Figure 7-3: Touch screen controls in frozen DPI mode

Tap the left or right haft of the key to adjust value of related parameters, such as B Reject ,

C Map/DDPI .Usually, tap the left half to decrease the value or turn off relevant function. Tap

the right half to increase the value or turn on relevant function.

Note:
All measurements results, annotations and body marks on the screen
will be cleared upon pressing the Freeze key.

7.4.1 Cine Review


To review other cine clips belonging to the same patient, see Section 5.4.1.

7.4.2 Cine Playback


Please refer to Section 5.4.2.

7.4.3 Color Map


Please refer to Section 7.3.11.

7.4.4 B Reject
Please refer to Section 7.3.15.

7.4.5 Image Orientation (Left/Right)


Please refer to Section 5.2.17.

7.4.6 Image Orientation (Up/Down)


Please refer to Section 5.2.18.

7.4.7 2B
Please refer to Section 5.2.28.

7.4.8 Display Switch


Please refer to Section 5.2.28.

7.4.9 Zoom
Please refer to Section 5.2.26.

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Chapter 8 TDI Mode (Tissue Doppler
Imaging)

Tissue Doppler Imaging (TDI) captures the wall motion of vessels and creates a color image
displaying the tissue motion and rate direction. TDI is a cardiography technique, so it can only
be used in cardiology application modes.
Like conventional Doppler mode, TDI also uses Doppler principle. However, in TDI mode high
amplitude (high intensity), low frequency tissue motion is quantified. In contrast, in the
conventional Doppler mode low amplitude (low intensity), high frequency blood motion is
quantified.

Caution!
Users can determine the imaging mode according to practical need.
TDI mode is supported only by phased array transducers working in
cardiac applications.

8.1 Starting TDI Mode

Tap the TDI soft key to activate the TDI mode. The TDI sample box appears in the
active 2D image.

Tap the TDI soft key again to deactivate the TDI mode.

107
8. TDI Mode

Figure 8.1: TID mode

8.2 TDI Image Information

The meanings for the items in the info area are explained in the table below.
PRF pulse repetition frequency
WF wall filter value
GN Doppler gain, D gain
C/P Color Map setting/persistence value
PWR acoustic output power (%)
FRQ transmitted frequency (MHz)

8.3 TDI Mode Operation

The TDI mode operation for the current ultrasound image is independent of the display format
(single, dual or quad).
In the real time TDI mode, available controls are shown in Figure 8-1.

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8. TDI Mode

Figure 8-1: Touch screen controls in real time TDI mode

8.3.1 Adjust TDI Sample Box


Follow the instructions below to adjust the sample box.
 Use the trackball to change the position of the sample box.

 Press the Set key. Use the trackball to change size of the sample box.

 Press the Set key again to re-adjust the position of the sample box.

8.3.2 TDI Gain


Properly adjust the TDI gain to ensure that the color flow is continuous but no color speckle is
present.

TDI gain is adjustable using the knob. Turn the knob


clockwise/counterclockwise to increase/decrease the TDI gain.

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8. TDI Mode

Note:
 The TDI gain value is displayed on the screen at the Color
Image Info area (GN).
 It is possible to change the TDI Gain only when the TDI mode
is active.

8.3.3 Depth
Scan depth can be adjusted in the same manner as in B mode, see Section 5.2.3.

8.3.4 Time Gain Compensation (TGC)


The time gain compensation adjusts the brightness of the 2D background, see Section 5.2.2.

8.3.5 Focus Position


Focus position can be adjusted in the same manner as in B mode, see Section 5.2.5.

8.3.6 ECG
See Section 5.2.24.

8.3.7 Pulse Repetition Frequency


The Pulse Repetition Frequency sets the velocity range of the display.
The range of the PRF depends on the transducer and the application mode. Increasing the
PRF range also changes the velocity scale appearing on the color wedge.

Frequency
Tap the left/right side of the soft control to decrease/increase the PRF range.

Note:
 The current PRF value is display at the Color Image Info area
(PRF).
 The system automatically adjusts the Wall Filter setting upon
changing the PRF value.

8.3.8 Wall Filter


Wall Filter should be adjusted to remove the random color speckle but also keep the enough
amount of color display.

Tap the left/right side of the WF soft control to decrease or increase the Wall Filter value.

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8. TDI Mode

Note:
 The current Wall Filter value is displayed at the Color Image
Info area (WF).
 The Wall Filter is adjustable within a range which depends on
the current PRF value.

8.3.9 Persistence
Similar to the persistence in the B mode, adjust the persistence value to enhance the
smoothness of the color image.

Tap the left/right side of the Persist soft key to decrease/increase the persistence value.

Note:
The persistence value is displayed on the screen at the Color Image
Info area (the P in C/P).

8.3.10 Color Map

The C Map soft key adjusts the color-coding of color pixels. This function is intended for

color coding to optimize flow imaging scanning, and especially appeals to low rate flow. Color
map is also available in frozen mode.
The Color Map setting is adjustable in the real time mode as well as the freeze mode.

Tap the left or right side of the C Map soft key to change the color map setting.

Note:
The Color Map method is displayed on the screen at the Color Image
Info area (the C in C/P).

8.3.11 TDI Power


The acoustic output power in the TDI mode should be kept as low as reasonably achievable.

Tap the left/right side of the Power soft key to decrease/increase the TDI power.

The decreasing or increasing unit is 10%.

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8. TDI Mode

Note:
The acoustic output power in the TDI mode is displayed on the screen
at the Color Image Info area (PWR).

8.3.12 Baseline
Shifting the baseline increases the velocity range in one direction, the zero position also
moves as a result. The maximum velocities in both directions are displayed at the ends of the
Spectral Wedge.

Tap the left/right side of the Baseline soft key to move the baseline in the negative/positive

flow direction.

8.3.13 Sector Width


This function adjusts the sector width of the background grayscale image.
See Section 5.2.12 for operation instructions.

8.3.14 Sector Position


This function adjusts the sector position of the background grayscale image.
See Section 5.2.13 for operation instructions.

8.3.15 B Reject
This function sets the display priorities of the color and 2D grayscale pixels. Larger B Reject
value suppresses more grayscale pixels.
The B Reject value is adjustable in the real time mode as well as the freeze mode. Its floating
range is 0~255.

Tap the left/right side of the B Reject soft key to decrease/increase the value.

8.3.16 TDI Frequency

Frequency
Use the soft key to adjust the frequency of the acoustic beam used for

acquiring color flow information.

Frequency
Tap the left/right side of the soft key to decrease/increase the acoustic

frequency.

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8. TDI Mode

Note:
The TDI frequency value is displayed on the screen at the Color Image
Info area (FRQ).

8.3.17 Image Orientation (Left/Right)


Refer to Section 5.2.17.

8.3.18 Image Orientation (Up/Down)


Refer to Section 5.2.18.

8.3.19 Flow Invert


The Flow Invert in TDI mode inverts the color display in relation to the direction of flow. The
Spectral Wedge also inverts around the baseline.
The Flow Invert setting is adjustable in the real time mode as well as the freeze mode.

 Tap the Invert soft key to enable flow invert;

 Tap the Invert soft key again to disable the flow invert.

Note:
 When it is set to off: red pixels represent flow to the
transducer; blue pixels represent flow away from the
transducer.
 When it is set to on: blue pixels represent flow to the
transducer; red pixels represent flow away from the
transducer.

8.3.20 Line Density


This function determines the line density of the color image. The higher the Line Density value
is, the higher the lateral resolution of the color image, but the lower the FPS. So you have to
balance well FPS and image quality.

Tap the left or right side of the Line Density soft key to change the line density setting.

8.3.21 2B
Refer to Section 5.2.28.

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8. TDI Mode

8.3.22 4B
Refer to Section 5.2.28.

8.3.23 Display Switch


Refer to Section 5.2.28.

8.3.24 Zoom
Refer to Section 0.

8.3.25 THI
The tissue harmonic imaging in TDI mode affects the background grayscale image only.
Please see Section 5.3.

8.4 Cine Mode Operation

Press the Freeze key during the real time TDI scan to freeze the image and start the cine

mode. Recent image frames are cached and ready for review.
In the frozen mode, the cine playback status (more in Section 5.4.2) is displayed on the screen;
maximum number of frames the system can cache depends on the settings of scan depth, line
density and zoom.
If there are cine clips saved in the same patient folder, these clips will be displayed at the
bottom of the screen. See Section 5.4.1.
The cine mode operation is independent of the display format (single, dual, quad).
In TDI cine mode, touchscreen controls are shown in Figure 8-2.

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8. TDI Mode

Figure 8-2: Touch screen controls in frozen TDI mode

Note:
All measurements results, annotations and body marks on the screen
will be cleared upon pressing the Freeze key.

8.4.1 Cine Review


To review other cine clips belonging to the same patient, see Section 5.4.1.

8.4.2 Cine Playback


Please refer to Section 5.4.2.

8.4.3 C Map
Please refer to Section 8.3.10.

8.4.4 B Reject
Please refer Section 8.3.15.

8.4.5 Flow Invert


Please refer Section 8.3.19.

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8. TDI Mode

8.4.6 Baseline
Please refer Section 8.3.12.

8.4.7 Image Orientation (Left/Right)


Please refer Section 5.2.17.

8.4.8 Image Orientation (Up/Down)


Please refer Section 5.2.18.

8.4.9 2B
Please refer to Section 5.2.28.

8.4.10 Display Switch


Please refer Section 5.2.28.

8.4.11 Zoom
Please refer Section 5.2.26.

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Chapter 9 M Mode

M mode can be used alone, but it is normally used in duplex modes with B, Color, or DPI
mode.

Note:
Not all transducers are capable of Color+M or DPI+M modes.

Tap the M soft key to activate the M mode imaging. The screen splits into two parts . One
3

part displays a 2D image with a straight line – i.e. the M cursor – across the image; the other

part is initially blank until the key is pressed, it will then display the M trace that shows
the movement information of the tissue along the M cursor.

9.1 Activate the M Trace Display

After entering the M mode, the M trace is initially not active. Press to start the M
sampling process. The M trace is displayed on the screen and updating.

Press again to stop M sampling process and the M trace stops updating.

9.1.1 Adjust M Cursor


The M cursor is placed at the middle of the image by default. Move the trackball to place the
cursor over the region of interest.

3
The default display format in M and spectral Doppler modes is set with Display Format in General
Setting (Section 4.2.1).

117
9. M Mode

Note:
You may move the M cursor while the M trace is updating. In this case,
the system automatically stops updating the M trace when there is
trackball activity, and resumes updating when there has been no
trackball activity for more than 0.5s.

9.2 B+M Mode Operation, M Trace Inactive

In the B+M duplex mode, when the M trace is not active, the touchscreen controls are
displayed as in Figure 9-1.

Figure 9-1: Touch screen controls in real time B+M mode with M trace inactive

Most controls in Figure 9-1 work in the same way as in B mode. Refer to instructions for B

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9. M Mode

mode operations (Section 5.2) to use these soft controls.

Note:

The soft key in M mode activates M dual display format.

Usage of Dis Format and Steer M are introduced in the following subsections.

9.2.1 2B
To activate the dual display format in the M mode, See Section 9.6.

9.2.2 Display Format

1. Tap the left or right side of the Dis Format soft key to change the layout of the 2D

image and the M trace on the screen. There are six display formats available: V1/2,
V1/3, V2/3, H1/2, H1/4 and O1/4. Examples using these display formats are shown in
Figure 9-2.
2. The default display format in M and PW/CW modes can be modified, see Section
4.2.1.

9.2.3 Steer M
This function is only available in B+M duplex mode.

With Steer M , multiple M cursors can be inserted into the 2D image. Follow instructions

below to add additional M cursor lines.

 Tap the right/left side of the Steer M soft key to increase/decrease the number of

M cursors.
 When there are multiple M cursors, the active cursor is highlighted in cyan. To choose

another M cursor as the active one, press Set .

 Move the trackball to position the active M cursor.

 Turn the Adjust knob to change the angle of the M cursor.

 Use the LEFT/RIGHT keys to change the angle of the M mode cursor.

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9. M Mode

Note:
 The Steer M function is primarily for cardiology application
and may not be available in other application modes.
 If multiple M cursors are present, only the last selected M
cursor (in cyan) will be active upon activating the CFM+M,
DPI+M or TDI+M duplex mode.

Figure 9-2: Display format

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9. M Mode

9.3 Color +M Mode Operation, M Trace Inactive

The touch screen controls in Color+M mode are shown in Figure 9-3.
In Color +M (or DPI+M, TDI+M) duplex mode, when the M trace is inactive, all the touchscreen

controls except (Section 9.6) works in the same way as in Color (or DPI, TDI) mode.
For the function and usage of these soft keys, please refer to the real time Color (or DPI, TDI)
operations.

Figure 9-3: Touch screen controls in real time Color+M mode with M trace inactive

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9. M Mode

9.4 M Mode Image Information

The M mode image information is displayed at the lower left part of the screen. The following
settings are displayed.

MPR M Process setting


SR sweep speed of M trace
GN M mode gain
PWR acoustic output power (%)

9.5 M Mode Operation, M Trace Active

In B+M real time duplex mode, press to start the M mode sampling. The M trace is
displayed and updating. The touchscreen controls are shown in Figure 9-4.
When the M mode sampling process is active, operations in B+M and Color +M modes are
very similar. The following instructions are based on the B+M mode.

Figure 9-4: Touch screen controls in real time B+M mode with M trace active

Tap the left or right haft of the key to adjust value of related parameters. Usually, tap the left
half to decrease the value or turn off relevant function. Tap the right half to increase the value
or turn on relevant function.

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9. M Mode

9.5.1 M Gain
The M gain controls the overall brightness of the M trace.

Turn the knob to adjust the M gain.

Note:
The M gain is displayed at the M mode image information area as GN.

9.5.2 Sweep Speed

Use the Sweep Speed soft key to adjust the M trace updating rate. There are totally six

choices: 0, 1, 2, 3, 4, 5.

Tap the right/left side of the Sweep Speed soft key to increase/decrease the sweep speed,

the scale of the time axis also changes.

Note:
The current sweep speed is displayed at the M mode image
information as SR.

9.5.3 Power
The acoustic power should be set as low as reasonably achievable.

Tap the right/left side of the Power% soft key to increase/decrease the acoustic power for M

mode imaging.

Note:
The M mode acoustic output power is displayed at the M mode image
information area as PWR.

9.5.4 Chroma

The Chorma changes the colors of the M trace. Each chroma value corresponds to a color

scheme for displaying the M trace.

Tap the left or right side of the Chorma soft key to change the chroma value.

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9. M Mode

The chroma is also adjustable in the freeze mode.

9.5.5 Video Invert


This function inverts the M trace display in relation to brightness. In the black/white M trace

display, black and white will be swapped upon setting Video Invert to on.

Tap the Video Invert soft key to set it to on, tap it again to set it to off.

9.5.6 M Process
This function changes the methods for detection processing for the M trace display.

Tap the right or left side of the M Process soft key to change its value to AVE (average) or

PEK (peak).

Note:
The M PROCESS setting is displayed at the M mode image information
as MPR.

9.5.7 Display Format


See Section 9.2.2.

9.5.8 ECG
See Section 5.2.24.

9.5.9 2B

Tap to activate the dual display format in the M mode, see Section 9.6.

9.5.10 Display Switch

With the dual display format, the soft key activates the next image and freezes the
current image, see Section 9.6.

9.5.11 Image Orientation (Up/Down)

Tap the soft key to flip both the M trace and the 2D image in the vertical direction.

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9. M Mode

Note:
The Up/Down soft key also works in the frozen mode and with dual
display format.

9.6 Dual Display Format

Dual display format facilitates the comparison of images acquired at different time and/or with
different imaging modes.

Real Time + Frozen Dual Display

1. In the real time or frozen M mode, tap the soft key while the M trace is
active to activate the dual display format. The screen splits into to symmetrical parts,
with one part (active) displaying a real time M mode image, the other part displays a
frozen M mode image.

2. Tap to freeze the active image and put the other images in the real time scan.

3. You may use the soft key to flip the active image in vertical direction.

Frozen Dual Display

1. With the dual display format, press the key to freeze the active image; images
on both sides are in the frozen mode.
2. If there are other cine clips stored in the patient folder, you can use the trackball to

select a clip and press Set to review the cine clip.

3. Tap again to exit the dual display.

9.7 Cine Mode Operation

If the M trace is not updating, after pressing in the real time B+M or Color +M mode, the
operations are the same as in B or Color mode.

If the M trace is updating (active), after pressing in the real time B+M or Color+M mode,
the touchscreen shows the soft controls in Figure 9-5.

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9. M Mode

Figure 9-5: Touchscreen controls in frozen B+M mode with M trace active

Tap the left or right haft of the key to adjust value of related parameters, such as Chroma ,

Dis Format .Usually, tap the left half to decrease the value or turn off relevant function. Tap

the right half to increase the value or turn on relevant function.

9.7.1 Cine Review


See Section 5.4.1.

9.7.2 Chroma
See Section 9.5.4.

9.7.3 Video Invert


See Section 9.5.5.

9.7.4 Display Format


See Section 9.2.2.

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9. M Mode

9.7.5 2B

Use the soft key to activate the dual display format, see Section 9.6.

9.7.6 Display Switch


See Section 9.6.

9.7.7 Image Orientation (Up/Down)

Tap the soft key to flip both the M trace and the 2D image in the vertical direction.

9.7.8 Cine Playback


Please refer to Section 5.4.2.

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9. M Mode

128 Basic Operator’s Manual


Chapter 10 Spectral Doppler Mode

Pulsed Wave Doppler (PW) and Continuous Wave Doppler (CW) are collectively called
Spectral Doppler mode.

Figure 10-1: B +PW duplex mode

10.1 Spectral Doppler Image Information

Spectral Doppler image information is displayed on the lower left part of the screen.

129
10. Spectral Doppler Mode

PRF pulse repetition frequency


WF wall filter value
GN spectral Doppler gain, D gain
FRQ transmitted frequency (MHz)
PWR acoustic output power (%)
DYN dynamic range
SV sample volume size

10.2 Adjusting Sample Volume and Blood Flow Cursor

Adjustment of the sample volume gate and the blood flow cursor is possible during the real
time PW scan.

Instructions for adjusting the sample volume:

 Move the trackball horizontally to rotate the spectral cursor.


 Move the trackball vertically to move the sample volume gate up or down along the
spectral cursor.

 Press Set and move the trackball to change the size of the sample volume.

Note:
 Moving the trackball while the spectral display is active will
temporarily stop the spectrum from updating; you may change
the sample volume position and size. When there is no
trackball activity for more than 0.5s, the spectrum continues
updating.
 The horizontal axis displays the time scale; the vertical axis
displays the velocity scale.

Refer to Section 10.3.3.12 to adjust blood flow cursor.

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10. Spectral Doppler Mode

10.3 PW Mode

Tap the PW soft key to start the pulsed wave (PW) Doppler mode.
4
In PW mode, the screen splits into two asymmetrical parts . One part displays a 2D image with
a straight line, viz. spectral Doppler cursor, across the image; on the spectral Doppler sample
line, there are two parallel short lines representing the sample volume. The sample volume
indicates the location where the spectral sampling is performed.
The blood flow cursor is located at the sample volume gate. When measurements related to
blood flow velocities are performed, make sure the blood flow cursor is aligned parallel to the
flow direction.

After pressing Update , the other part of the screen will show the PW spectral display which

contains the velocity information of the blood flows in the sample volume.

10.3.1 Activate the PW spectral display

In the PW mode, press Update to activate the PW spectral display, the PW spectrum starts

to update. Press Update again to deactivate the spectral display, the PW spectrum stops

updating.

10.3.2 PW Mode Operations with PW Spectrum Inactive


In the PW duplex mode with B, Color or DPI mode, when the PW spectrum is not active, the
operations are the similar to the operations in the B, Color or DPI mode.
Touchscreen controls in the B+PW mode are shown in Figure 10-2. Most soft keys also appear
in the B mode, refer to B mode operations (Section 5.2) for the functions and usages of these
keys.

Note:

Function of the soft key in B+PW mode and that in


corresponding 2D mode are a little different.

4
The default display format in M and spectral Doppler modes is set with Display Format in General
Setting (Section 4.2.1).

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10. Spectral Doppler Mode

Figure 10-2: Touch screen controls in real time B+PW mode with PW spectral trace inactive

Touch screen controls in the Color+PW mode are shown in Figure 10-3. Most soft keys also
appear in the Color mode, refer to Color mode operations (Section 6.3) for the functions and
usages of these keys.

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10. Spectral Doppler Mode

Figure 10-3: Touch screen controls in real time Color+PW mode with PW spectral trace
inactive

In the spectral Doppler mode, the functions and usage of Steer , 2D Refresh and

Dis Format are introduced below.

10.3.2.1 2D Refresh

1. Tap the 2D Refresh soft key to set it to on; when the Doppler spectral display is

active, the 2D image will remain in the real time. (B+PW duplex or B+ Color+PW
triplex)

2. Tap the 2D Refresh soft key again to set it to off; when the Doppler spectral

display is active, the 2D image will be frozen.

10.3.2.2 Display Format

See Section 9.2.2.

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10. Spectral Doppler Mode

10.3.2.3 Steer Angle

When using linear transducers, the spectral Doppler cursor can be rotated so that the angle
between the cursor and the acoustic beam is offset from zero.

Tap the right or left side of Steer to rotate the spectral Doppler cursor clockwise or

counterclockwise.

10.3.3 PW Mode Operation with PW Spectrum Active

Press the Update key to activate PW spectral display. When the PW spectrum is active,

the touchscreen shows the soft controls as in Figure 10-4. Operations for the PW-duplex
modes with B, Color and DPI modes are the same.

Figure 10-4: Touchscreen controls in real time B+PW mode with PW spectral trace active

Tap the left or right haft of the key to adjust value of related parameters, such as Power% ,

Chroma .Usually, tap the left half to decrease the value or turn off relevant function. Tap the

right half to increase the value or turn on relevant function.

10.3.3.1 Pulse Repetition Frequency (PRF)

The Pulse Repetition Frequency sets the velocity range of the spectral display.

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10. Spectral Doppler Mode

The range of the PRF depends on both the transducer and the application mode.

Tap the right or left side of Frequency to increase or decrease the PRF range.

You may also refer to section 5.2.16.

Note:
 The current PRF value is displayed at the Spectral Doppler
Image Info area as PRF.
 The system automatically adjusts the Wall Filter setting upon
changing the PRF value.

10.3.3.2 High Pulse Repetition Frequency (HPRF)

Tap the right side of Frequency continuously to increase the PRF value, when a certain

value is reached, the High Pulse Repetition Frequency (HPRF) is automatically enabled. One
or more sample volume gates appear at shallower positions on the 2D image.

Note:
The HPRF is not supported by linear transducers.

10.3.3.3 Wall Filter (WF)

Wall Filter intends to eliminate the low frequency noise generated by movements of blood
vessel walls. The WF shall be sophisticated enough to be able eliminate noise.

Tap the right or left side of WF to increase or decrease the filter strength.

Note:
 The current Wall Filter value is displayed at the Spectral
Doppler Image Info area as WF.
 The Wall Filter is adjustable within a range that depends on
the current PRF value.

10.3.3.4 PW Gain

The Doppler gain controls the overall brightness of the spectral display.

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10. Spectral Doppler Mode

When the spectral Doppler display is active, you can turn the knob to adjust the Doppler
gain if necessary.

Note:
The spectral Doppler gain value is displayed at the Spectral Doppler
Image Info area as GN.

10.3.3.5 Display Format

See Section 9.2.2.

10.3.3.6 Steer Angle

Use Steer to adjust the spectral Doppler cursor for linear transducers. See Section 10.3.2.3.

10.3.3.7 Flow Invert

You can use the flow invert function ( Invert in either PW or CW mode to invert the spectral

display in relation to the flow direction.

Tap Invert to enable the flow invert; tap Invert again to disable the flow invert.

When Flow Invert is enabled, Invert indicator appears on top right of the spectrum and the PW
spectrum inverts around the baseline.

10.3.3.8 Frequency

The spectral Doppler frequency controls the transmit frequency.

Tap the right or left side of Frequenc . to increase or decrease the frequency.
y

Note:
The spectral Doppler frequency value is displayed on the screen at the
Spectral Doppler Image Info area (FRQ)

10.3.3.9 Sweep Speed

The Sweep Speed soft key adjusts the refreshing rate of the spectral display.

Tap the right or left side of Sweep Speed to increase or decrease the sweep speed.

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10. Spectral Doppler Mode

10.3.3.10 Baseline

Baseline corresponds to the position of zero velocity. The velocity range in one direction can
be increased by adjusting the baseline. Maximum velocities in both directions are displayed on
the vertical axes of the Doppler spectrum.

Tap the right or left side of Baseline to move the baseline towards positive or negative

direction.

10.3.3.11 PW Power

The value of the output power in the PW mode should be kept as low as reasonably
achievable.

Tap the right or left side of the Power% soft key to increase or decrease the output power.

Note:
The acoustic output power in the PW mode is displayed on the screen
at the Spectral Doppler Image Info area as PWR.

10.3.3.12 Angle Correction

Use Angle to adjust the direction of the blood flow cursor.

1. Tap the left/right half of soft key Angle to adjust the flow direction cursor.

Note:
It’s only necessary to use the angle correction when making
velocity-related measurements.

10.3.3.13 Dynamic Range (DYN)

The dynamic range (DYN) function intends to enhance part of the grayscale spectral display.

Tap the right side of DYN to increase the dynamic range; tap the left side of DYN to

decrease the dynamic range.

10.3.3.14 Chroma

Similar to the chroma setting in the B mode, Chroma changes the color of spectral display.

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10. Spectral Doppler Mode

Tap the right or the left side of Chroma to change chroma setting.

The chroma is adjustable in the real time mode as well as the frozen mode.

10.3.3.15 Video Invert

This function has the effect of changing the background of the spectral display.

Tap Video Invert to turn it on; tap Video Invert again to turn it off.

The background of the spectral display is


 dark, when Video Invert is Off;
 bright, when Video Invert is On.

10.3.3.16 ECG

See Section 5.2.24.

10.3.3.17 2B

Tap to activate the dual display format in the PW mode, see Section 10.4.

10.3.3.18 Display Switch

With the dual display format, the key activates the next image and freeze the current
image, see Section 10.4.

10.4 Dual Display Format

Dual display format facilitates the comparison between images acquired at different time
and/or with different imaging modes.

Real Time + Frozen

1. In the real time or frozen spectral Doppler mode, tap to activate the dual
display format. The screen splits into two parts; the active image is in the real time
PW mode, the other part shows a frozen image.

2. Tap to freeze the current image and make the next image active and in real
time mode.

3. You may tap to flip the image vertically.

Dual Frozen Mode

1. Press Freeze to freeze the current image; both images are now in frozen mode.

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10. Spectral Doppler Mode

2. If there are other cine clips stored in the patient folder, you can use the trackball to

select a clip and press Set to review the cine clip.

Tap again to exit the dual display format.

10.5 CW Mode

Only phased array transducers are capable of the CW mode.

In a real time mode, tap the CW soft key to activate the CW mode.

With the default Display Format setting, the screen splits into two parts. The upper part
displays a 2D image, the lower part will display the CW spectrum.

Figure 10-5: Touch screen controls in real time B+CW mode with CW spectral trace inactive

10.5.1 CW Mode Operation with CW Spectrum Inactive


When the Doppler spectrum is inactive, the operations in B+CW, Color+CW, and DPI+CW
mode operations are very close to the operations in B, Color and DPI modes respectively.

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10. Spectral Doppler Mode

Touch screen controls in the B+CW mode are shown in Figure 10-5. The instructions for the B
mode operations can be found in Chapter 5.
Touch screen controls in the Color+CW mode are shown in Figure 10-6. The instructions for
Color mode operations can be found in Chapter 6.

Note:

The soft key activates the PW dual display format. See


Section 10.4.

Usage of 2D Refresh and Dis Format soft keys can be found in Section 10.3.2.1 and

Section 9.2.2 respectively.

Figure 10-6: Touch screen controls in real time Color+CW mode with CW spectral trace
inactive

10.5.2 CW Mode Operations with CW Spectrum Active


When the CW spectrum is active, the operations in B+CW and Color+CW modes are the same,

140 Basic Operator’s Manual


10. Spectral Doppler Mode

touchscreen controls are shown in Figure 10-7.

Figure 10-7: Touch screen controls in real time B+CW mode with CW spectral trace active

10.5.2.1 Sweep Speed

See Section 10.3.3.9.

10.5.2.2 Flow Invert

See Section 10.3.3.7.

10.5.2.3 Baseline

See Section 10.3.3.10.

10.5.2.4 Pulse Repetition Frequency (PRF)

See Section 10.3.3.1 and HPRF in Section 10.3.3.2.

10.5.2.5 Wall Filter (WF)

See Section 10.3.3.3.

10.5.2.6 Dynamic Range (DYN)

See Section 10.3.3.13.

10.5.2.7 Frequency

See Section 10.3.3.8.

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10. Spectral Doppler Mode

10.5.2.8 Power

The value of the output power in the CW mode should be kept as low as reasonably
achievable.

Tap the right or left side of the Power% soft key to increase or decrease the output power.

Note:
The acoustic output power in the CW mode is displayed on the screen
at the Spectral Doppler Image Info area as PWR.

10.5.2.9 CW Gain

The Doppler gain controls the overall brightness of the spectral display.

When the spectral Doppler display is active, you may turn the knob to adjust the
Doppler gain.

Note:
The spectral Doppler gain value is displayed at the Spectral Doppler
Image Info area as GN.

10.5.2.10 Video Invert

See Section 10.3.3.15.

10.5.2.11 Chroma

See Section 10.3.3.14.

10.5.2.12 Display Format

See Section 9.2.2.

10.5.2.13 Dual Display Format (2B)

See Section 10.4.

10.5.2.14 Display Switch

With the dual display format, tap to activate the next image and freeze the current

image, see Section 10.4.

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10. Spectral Doppler Mode

10.6 Spectral Doppler Cine Mode Operation

In the PW/CW duplex mode with a 2D mode, if the spectral display is not active, press

Freeze to freeze the image, the operations are the same as in the corresponding 2D mode.

When the spectral display is active, press Freeze to freeze the image, operations for

PW/CW duplex modes are the same. The touch screen controls are shown in Figure 10-8.

Figure 10-8: Touch screen controls in frozen B+CW mode with CW spectral trace active

10.6.1 Cine Review


See Section 5.4.1.

10.6.2 Cine Playback


Please refer to Section 5.4.2.

10.6.3 Chroma
See Section 10.3.3.14.

10.6.4 Display Format


See Section 9.2.2.

Basic Operator’s Manual 143


10. Spectral Doppler Mode

10.6.5 Video Invert


See Section 10.3.3.15.

10.6.6 Dual Display Format (2B)


See Section 10.4.

10.6.7 Display Switch

With the dual display format, tap soft key to activate the next image and freeze the
current image, see Section 10.4.

10.6.8 Flow Invert


See Section 10.3.3.7.

10.6.9 Baseline
See Section 10.3.3.10.

10.6.10 Image Orientation (Up/Down)

Tap soft key to flip both the spectral display and the 2D image vertically.

144 Basic Operator’s Manual


Chapter 11 3D Mode (Optional)

Note: 3D mode is optional function.

3D ultrasound allows the user to see width, height and depth of the anatomical structure. In
this case, the echoes are processed by a sophisticated computer program resulting in a
reconstructed three dimensional volume image of internal organs or fetus.

11.1 Starting 3D Mode

Prior to the activation of 3D mode, the 2D images must be acquired. These 2D images can be
collected using normal transducers with B mode.
Experience or training is required to obtain the satisfactory 2D images for the 3D rendering.

After acquiring a sufficient amount of 2D image frames in the B mode, press Select the

5
image sequence to be processed for 3D rendering. Tap the 3D soft key to start the 3D

mode. The image area of the screen will be divided into four parts, see Figure 11-1.
The 3D mode display (Figure 11-1) is divided into four quadrants and includes cross-sectional
views of the anatomical structure:
 Plane A shows the longitudinal image.
 Plane B shows the transversal image.
 Plane C shows the horizontal image.
 Volume display: the surface or partial-transparent view of the 3D structure is
displayed at the last quadrant.

5
See Section 5.4.3.

145
11. 3D Mode

Figure 11-1: 3D Mode

11.2 3D Mode Operation

The touch screen shows the soft controls as in Figure 11-2 in the 3D mode.
Some functions are mutually exclusive, the functions not available are displayed as grayedout
soft keys.
Tap the left or right haft of the key to adjust value of related parameters, such as

Trance cut , Color Map .Usually, tap the left half to decrease the value or turn off relevant

function. Tap the right half to increase the value or turn on relevant function.

146 Basic Operator’s Manual


11. 3D Mode

Figure 11-2: Touchscreen controls in 3D mode

11.2.1 Display Format


By default, the 3D mode uses the quad display mode as shown in Figure 11-1.

Other display formats are possible: tap Full Disp.3D , Dual Display and Quad Display

on the touch screen to activate the single, dual, and quad display respectively.
Single and dual display formats in the 3D mode are illustrated in Figure 11-3.

Basic Operator’s Manual 147


11. 3D Mode

Figure 11-3: Single & dual display in the 3D mode

11.2.2 Adjust ROI Box


The 3D image can be rotated, resized or moved.
Move the cursor over the 3D image,

Press key, and use the trackball to rotate the 3D image;

Tap Zoom key, and use the trackball to resize the 3D image;

Tap left or right haft of soft keys Rotate X , Rotate Y , Rotate Z and make the image to

rotate to X, Y, Z directions respectively.

Tap the right half of Auto Rotate key to make the image rotate clockwise and set maximum

rotate angle. The image will automatically rotate clockwise from its original angle to the
maximum angle, and then continue to rotate counterclockwise to its original angle, and repeat
this action automatically. Tap the left half to decrease the biggest angle or inactivate
auto-rotate.

Tap the left or right half of Move L-R ., and Move U-D soft keys to adjust the position of the

image.

Note:
The maximum angle of auto rotation can be set as 45°, 90°, 180°,
270°, or 360°.

11.2.3 Clear ROI

Tap Clear ROI .to clear the existing ROI.

148 Basic Operator’s Manual


11. 3D Mode

11.2.4 Restore ROI

This function is available only when Clear ROI .is activated.

Tap Restore ROI to restore the ROI.

11.2.5 Crop (Clear and Restore Region Outside ROI Box)

Tap Crop to highlight it so as to activate this function.

There are totally two cropping modes: in and out. Choose in to keep data within the cropping
area and choose out to keep data outside it.

11.2.6 Rotate and Zoom


The volume image displayed on the screen can be rotated and magnified.
Move the cursor over the volume image.
Refer to section 11.2.2

11.2.7 Move L-R

Tap the left or right side of the Move L-R soft key to move the volume display horizontally.

11.2.8 Move U-D

Tap the left or right side of the Move U-D soft key to move the volume display vertically.

11.2.9 Render Mode

Three render modes ( Render Mode .) are available: Volume Rendering (Vol), X-ray,

Maximum Intensity Projection (MaxIP).

Vol Mode: displays the MaxIP Mode: displays the X-ray Mode: displays the
contour of the internal samples with the highest average gray values of the
organs or fetus. intensity along the echoes along the
ultrasound beam. ultrasound beam.

Basic Operator’s Manual 149


11. 3D Mode

11.2.10 Trace Cut

Use Trace Cut to remove areas inside or outside a closed trace. Practically this function can

be used to remove the region obstructing the region of interest.

Figure 11-4: Trace Cut

To use Trace Cut:

 Tap Trace Cut to set its value to In.

 Use the trackball to draw a trace on the volume image.

 Press Set to close the trace and hide the region inside the trace.

 To hide the region outside the trace, set Trace Cut to Out and repeat the above

steps.

Note:
To unhide the region removed by Trace Cut, tap Undo Cut.

11.2.11 Undo Cut

The Undo Cut soft key restores the part of the volume image removed by Trace Cut .

11.2.12 Clip Plane

Enable the soft key Clip Plane to remove part of the volume display on one side of a plane

and display the cross section.

Tap Clip Plane to set it to on,

150 Basic Operator’s Manual


11. 3D Mode

1. Move the cursor over the volume image and press .


2. Use the trackball to move the plane clipping the volume display.

11.2.13 Opacity Offset

Tap the left or right half of Opacity Offset to change the acquisition of 3D image.

11.2.14 Opacity Slope

Tap the left or right half of Opacity Slope to change the acquisition of 3D image.

11.2.15 Multi-Slice

Use Multi-Slice to view multiple cross sections of the 3D structure.

11.2.16 Color Map

Use Color Map to choose the color scheme for mapping the amplitudes of echoes to the

grayscale pixels.

11.2.17 Scan Method

The soft key Scan Method should be set to Linear Motion (Lin) or Sector Motion (Sec)

according to the transducer movement.

11.2.18 Z Scale

For Scan Method = Lin, the Z Scale tunes the 3D display.

11.2.19 Z Angle

For Scan Method = Sec, the Z Angle tunes the 3D display.

11.2.20 Ellipse

Tap Ellipse and move the cursor over plane X, Y, or Z.

Press to determine the starting point, and press again to determine the end
point of the short axis. Move the trackball to change the length of the long axis, and press

to decide long axis length. And then you will get four results: EA, EP, Ea and Eb.

Basic Operator’s Manual 151


11. 3D Mode

11.2.21 Threshold

Tap left or right half of soft key Threshold to alternate its value.

11.2.22 Save Frame

Tap Save Frame , and saving menu will appear. Click【Save IMAGE】or【Save VULOME】

according to actual need.

152 Basic Operator’s Manual


Chapter 12 4D Mode*(Optional)

The 4D imaging is part of the optional 4D package.

4D imaging enables the display of the real time 3D anatomical structure.

12.1 Starting 4D Mode

Connect and select a volume transducer, tap an application mode icon to start with B mode
imaging. The touchscreen shows the controls for the B mode operations together with a

soft key, see Figure 5-1.

Tap to activate the 4D mode. A 2D image with a sample box and a yellow cut off line

appears, see Figure 12-2. The touchscreen controls are displayed as in Figure 12-1.

Some controls are accessible after tapping the flip-page soft key .
Some soft controls are grayed out, their functions are either excluded by activation of other
functions or not available at the current transducer status.

12.2 4D Mode Operations

Tap Full Disp.3D , Dual Display or Quad Display to start the real time 3D image

rendering, the main screen shows the 2D and/or 3D images in dual, quad or full screen 3D

display mode (refer to Figure 11-1 and Figure 11-3). Press Freeze to pause the motor.

Most controls shown in the 4D mode touchscreen also appears in the 3D mode touchscreen.
Their functions are identical. Refer to Chapter 11 for the operation of these functions.
The following three touch screen controls are specific to 4D mode:

1. Full Disp.2D ,displays a full screen real time 2D image. Adjusting the sample box

and cut off line is only possible in full display 2D mode. For more information, see
Section 12.2.1.

2. Cine Review , works when the transducer motor is not running, it reviews the 3D

153
12. 4D Mode*

images acquired. For more information, see Section 12.2.2.

Figure 12-1: Touchscreen controls in 4D mode

3. Rescan ,is intended for acquiring the volume display with higher resolution. For

more information, see Section 12.2.3.

4. Stabilization ,enhances the stability of the volume display.

5. Sweep Angle ,used to set the angle of volume transducer.

6. Image Quality , sets the image quality of the volume display. See Section 12.2.4.

154 Basic Operator’s Manual


13. Annotation and Body Mark

12.2.1 Adjustment of Sample Box & Cut Off Line

Figure 12-2: 4D mode: sample box and cut off line

Note:
 In the 4D mode, only the FULL DISP.2D screen shows the
sample box and the cut off line.
 Only the data in the area enclosed by the sample box and the
cut off line are collected for 3D rendering.

In Figure 12-2, only the data in the shaded area will be collected for rendering the real time
volume display.

Move the sample box by following these steps.

 Move the trackball to change the position of the sample box;

 Press Set ; use the trackball to change the size of the sample box.

 If necessary, press Set again, then use the trackball to move the sample box.

Adjust the cut off line by following these steps.

 Press and use the trackball to move the cut off line vertically;

 Press and use the trackball to change the position of the control point.

 If necessary, press again, then use the trackball to move the cut off line.

Basic Operator’s Manual 155


12. 4D Mode*

12.2.2 Cine Review

Tap Cine Review to review the image frames captured when the motor was running. The

previews of the 3D structure are displayed at the bottom of the screen; see Figure 12-3.

Figure 12-3: Cine review in 4D mode

12.2.3 Rescan

This Rescan function attempts to obtain the volume display with a higher resolution by

performing a rescan. By default, it is set to off.

Press when the motor is running, i.e., during the real time volume data acquisition,
 when Rescan is set to off, the motor will stop immediately;
 when Rescan is set to on, the motor continues running for a while, attempting to
obtain the volume display with a higher resolution.

12.2.4 Image Quality

This Image Quality sets the image quality for the volume display. It can be set to Low, Med,

or High. The higher the image quality is, the lower the time response.

12.2.5 Stabilization
Use this function to improve the stability of display of the 3D structure.

12.2.6 Sweep Angle

Tap the left or right side of Sweep Angle to adjust the value of sweep angle.

156 Basic Operator’s Manual


13. Annotation and Body Mark

12.2.7 Volume Review

Tap the left or right side of Volume Review to adjust its value.

12.2.8 ROI Mode

Tap soft key ROI Mode to highlight it, and ROI mode will be on. Tap it again to turn it off.

12.2.9 Hide ROI

Tap soft key Hide ROI to highlight it and then the ROI will be hidden.

12.2.10 Crop

Tap Crop to highlight it so as to activate this function.

There are totally two cropping modes: in and out. Choose in to keep data within the cropping
area and choose out to keep data outside it.

12.2.11 Clear ROI

Tap Clear ROI .to clear the existing ROI.

12.2.12 Restore ROI

This function is available only when Clear ROI .is activated.

Tap Restore ROI to restore the ROI.

Basic Operator’s Manual 157


Chapter 13 Annotation and Body Mark

Annotation and body mark symbols can be added onto the ultrasound image in both real time
mode and frozen mode.

Note:
When exiting an application modse, the annotations and body marks
added onto the image will be cleared automatically.

Tap the Annot key to start inserting annotation.

Figure 13-1: Annotation

The system predefines a large list of annotation items. User can also modify/add predefined
annotation items at Annotation Edit (see Section 0).

To insert annotations:

159
13. Annotation and Body Mark*

1. Tap the Annot key. The annotation items are displayed on the touchscreen as soft

keys.
2. Tap an application mode key on the first row to view the available annotation items
for this application.
3. Use the trackball to move the cursor to an appropriate position on the ultrasound
image.
4. Tap the soft key of an annotation item to add the annotation at the place of the
cursor.
To change the location of an annotation item added on screen, move the cursor over the item

and press the Set key. Use the trackball to move the item to a another location and press

the Set key.

Keyboard
5. To add manual text on the image, tap the key to open the open

keypad and enter text.


6. Repeat the above steps to add more annotations if needed.

7. Press Annot again or tap the Exit key to exit the annotation screen.

To delete an annotation:

1. Use the trackball to move the cursor over the item to be deleted, an underline
appears below the item.

2. Press the Delete key to delete the item.

3. To remove all annotations, calculation results and body mark symbol from the screen,

please press the Clear key.

Note:
When using the Save key to save an ultrasound image, the added
annotations will be kept on the image.

160 Basic Operator’s Manual


13. Annotation and Body Mark

13.1 Body Marks

Figure 13-2: Bodymark

For the documentation of the ultrasound diagnosis, a collection of graphic body marks is
available.

5. Tap the BodyMark key. The available body mark symbols are displayed as icons on

the touchscreen.
6. Tap an application mode key on the first row to access the available body mark symbols
for this application.
7. Use the trackball to move the cursor to the desired position, tap a body mark symbol to
add the symbol onto the image.

8. Tap the ANGLE key to adjust the angle of probe maker ( ). Press the Set key to

fix the probe marker.

To delete body mark:

1. Tap the Delete key to delete the item.

2. To remove all annotations, calculation results and body mark symbol from the screen,

please Tap the Clear key.

Basic Operator’s Manual 161


13. Annotation and Body Mark*

Note:
When using the Save key to save an ultrasound image, the added body
mark will be kept on the image.

162 Basic Operator’s Manual


Chapter 14 Transducers

This ultrasound system supports a wide range of transducers which make the system
remarkably versatile. Transducer information and the guidance for the use and maintenance of
the transducers are introduced in this chapter.

Caution!
Review to Chapter 1, especially Section 1.4 and Section 1.6, for safe
use of the transducers.

14.1 Transducer Information

14.1.1 Supported Transducers


The following transducers are supported by this ultrasound system:

C344, C322, VC6-2, L741, L742, L752, 2P2,

3P1, 5P2, 6V3, 6V1

Table 14.1: Supported transducers

Caution!
To avoid electric shock or damage the equipment:
1. Use only the supported transducers with this ultrasound
system.
2. Do not use the SonoScape transducers on other ultrasound
systems.

14.1.2 Acoustic Output


The acoustic output powers for the supported transducers are listed in the Acoustic Output
Tables in the companion CD-ROM of this manual.
163
15. System Maintenance

14.1.2.1 Explanation of “In Situ”

For any specified spatial peak intensity in water, the estimated “In Situ” spatial peak intensity at
the same distance from the transducer can be made from the following equation:

Where It is the estimated “In Situ” intensity, Iw is the measured intensity in water, f is the
ultrasonic frequency (or the center frequency of the pulse) in MHz and z is the distance from
the face of the transducer assembly to the point of measurement in cm.

14.2 Environmental Requirements

The transducers should be used with that the following environmental requirements has been
satisfied.

Operation Storage and transport


Relative humidity 30%~75%, no condensation 20%~90%, no condensation
Ambient temperature 10°C~40°C -20°C~55°C
Barometric pressure 700hPa~1060hPa 700hPa~1060hPa

14.3 Preparation and Usage of Transducers

14.3.1 Inspection
After each use, or before first use or after long-time storage of the transducer, the transducer
must be examined for any damages listed in the table below. Stop using the transducer if any
damage is found. Contact your representative for servicing asap.

Possible damage types


Cracks on the transducer handle (user section).
Cracks on the transducer head (applied section).
Scratches on the transducer head (acoustic window surface).
Swell of the acoustic window material.
Cracks or wear on the transducer cable.
Cracks on the transducer connector or any other kinds of visible
damage.
Deformed pins or broken pins exist inside the transducer connectors.

14.3.2 Transducer Connection


Refer to Section 3.1 for the instructions on transducer connection.

164 Basic Operator’s Manual


14. System Maintenance

14.3.3 Preparation for Scanning

Caution!
Transducers are NOT provided in sterile condition. It is the user’s
responsibility to ensure proper disinfection before use.
 An effective acoustic coupling does not require inordinate pressure,
but it does require coupling gel and patient contact.
 Check the expiration date of the probe sheath and the coupling gel.
Never use expired probe sheath and coupling gel.
 Latex or natural rubber contained inside medical equipments or
accessories can cause severe allergic reactions in some individuals.
It’s suggested by FDA that the user should identify the latex-sensitive
patients and be prepared to treat allergic reactions promptly.
 Only water-soluble coupling gel should be applied to the probe head
surface. Avoid contact with the mineral oil.

14.3.3.1 For surface transducers

Put an adequate amount of coupling gel either on the transducer head (acoustic window) or
the patient skin.
If disease transmission is a concern, use of the sterile probe sheath is highly recommended.
Refer to instructions below to use the probe sheath as a barrier between the patient and the
transducer surface.

14.3.3.2 For intracavitary transducers

Note: The transducers are provided in non-sterile condition from the manufacturer.

Intracavitary transducers should be cleaned and


disinfected both before and after usage.

1. To prevent disease transmission, wear sterile gloves.


2. Put an adequate amount of coupling gel on the probe head or into the probe sheath.
3. Insert the transducer into the probe sheath.

Use of legally marketed probe sheath is required for


intracavitary operations. If lubricant is used, it must
be water-soluble. Do not apply coupling gel directly
on the patient skin.
4. Cover the transducer with the probe sheath up to the user section (probe handle).
5. Examine the integrity of the probe sheath. If breakage occurs, repeat from step 1 to
replace the sheath with another new one.

Basic Operator’s Manual 165


15. System Maintenance

14.3.4 Scanning
Refer to Chapter 3 to turn on the system and start an ultrasound diagnosis.

14.4 Probe Maintenance: Cleaning and Disinfection

Clean the transducer and the probe handle after each use.
For surface transducers, disinfect the transducer periodically. For intracavitary transducers,
disinfecting the transducer after each use is required.
Keep a log of maintenance (inspection, cleaning and disinfection) and malfunction.

14.4.1 Probe immersion level

Figure 14-1: Surface transducers

Figure 14-2: Intracavitary transducer

For surface transducers, do not immerse the probe beyond its junction line (refer to Figure
14-1).
For intracavitary transducers, the allowed immersion level is shown in Figure 14-2.

14.4.2 Cleaning Instructions

Caution!
 DO NOT use solutions containing alcohol, mineral oil for
cleaning or disinfecting transducers.
 Wear medical sterile gloves to prevent potential disease
transmission. Wear protective goggle if necessary.
 DO NOT apply solutions containing ethyl oxides on the probe.

1. Disconnect the probe from the ultrasound system. Remove the biopsy guide if it is
attached to the probe.

166 Basic Operator’s Manual


14. System Maintenance

2. Remove all the coupling gel and clean the probe with soft cloth and flowing potable
water.
3. If the probe surface carries too much residue, remove all visible residue with wet
cloth soaked in mild soap water. Use wet soft cloth to scrub the surface if dried
residue exists. Remove all soap water residue with damp cloth soaked in potable
water.
4. Air dry or dry with a soft cloth.

14.4.3 Disinfection Instructions


The level of disinfection is directly related to the duration of contact with the germicide. High
6
level of disinfection is recommended for surface transducers and required for intracavitary
transducers. Legally marketed liquid chemical germicides (e.g. Cidex) are highly
recommended. Prepare and use the germicides following the manufacturer’s instructions.

Caution!
 DO NOT use high pressure steam to disinfect the probe.
 DO NOT use thermal disinfection! Temperatures higher than
66°C or 150°F will damage the probe.

1. Ensure that all visible residues have been removed.


2. Prepare the germicide solutions according to the manufacturer’s instructions. Please
also follow the manufacturer’s instructions for storage and disposal of the germicide.
3. Immerse the probe head into the germicide for a time interval specified by the
germicide manufacturer. The immersion level should be kept below the junction line.
High-level disinfection is recommended for surface transducers and required for
intracavitary transducers. Note that you may need to rotate and shake the transducer
in order to remove the air bubbles between the transducer surface and the germicide
solution.
4. After removing the probe from the germicide solution, rinse it thoroughly with clean,
potable water to remove all visible germicide. Dry the probe with sterile soft cloth.

6
Refer to the germicide manufacturer’s instruction to perform high-level disinfection.

Basic Operator’s Manual 167


Chapter 15 System Maintenance

We recommend the user to perform the following maintenance operations:


 Clean the probes and probe holders daily to remove coupling gel, dust, and etc.
 Clean the system (keyboard, monitor, and etc.) regularly.

Caution!
 Switch the system off before cleaning.
 Damp cloth soaked in mild soap water is allowed.
 Protect the system, especially the electric parts, from drip water.
 Do not apply acetone/alcohol or use abrasives on the system or
the transducer surfaces.

15.1 Guidance for Service

In case of any malfunctions, turn off the system and disconnect the power supply. Contact your
SonoScape representative for service. Mention the detailed phenomena of the malfunction to
the service personnel to help identifying the cause of the problem.

Caution!
There are no user replaceable parts inside the system. Any kind of
do-it-yourself repairs invalidate the warranty. Contact your representative
for service instead.

15.2 Manufacturer Responsibility

The manufacturer assumes the responsibility with regard to safety, reliability and performance
of this product only under the following conditions,
 all installation, hardware and software upgrades, modifications and repairs of this

169
15. System Maintenance

product are performed or instructed by authorized personnel;


 operation, transport and storage of this product are under the required environmental
conditions;
 the product is operated in accordance with this operator’s manual.

15.3 Contact Information

Any feedbacks or inquires concerning our product or service should be directed to the
following address.

Contact Information:

Address: Yizhe Building, Yuquan Road, Nanshan,


Shenzhen, P.R. China
Zip Code: 518051
Tel: 86–400–678–8019
Fax: 86–755–26722850
Website: http://www.sonoscape.com
E-mail: service@sonoscape.net

170 Basic Operator’s Manual


Appendix A Acoustic Output Data

Please refer to enclosed CD disk to this user manual.

171
Appendix B EMC Guidance and
Manufacturer's Declaration

This product complies with the EMC standard IEC 60601-1-2:2007.

Note:
 The system should not be used adjacent to or stacked with other equipment. If the
adjacent or tacked use is necessary, the system should be observed to verify normal
operation in the configuration in which it will be used.
 The system needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided below.
 Preventing conducted RF immunity. Due to technological limitations, the conducted RF
immunity level are limited to 1Vrms level, conducted RF interference above 1Vrms may
cause wrong diagnosis and measurements. We suggested that you position the system
further from sources of conducted RF noise.
Portable and mobile RF communications equipment can affects this system.

172
B. EMC Guidance and Manufacturer's Declaration

Electromagnetic emissions
The EQUIPMENT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EQUIPMENT should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

The EQUIPMENT uses RF energy only for its internal


RF emissions function. Therefore, its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any interference in nearby
electronic equipment.

RF emissions
Class B
CISPR 11

Harmonic The EQUIPMENT is suitable for use in all


emissions Class A establishments, including domestic establishments
IEC 61000-3-2 and those directly connected to the public low-voltage
power supply network that supplies buildings used for
Voltage
domestic purposes.
fluctuations/
Complies
flicker emissions
IEC 61000-3-3

Basic Operator’s Manual 173


B. EMC Guidance and Manufacturer's Declaration

Electromagnetic immunity
The EQUIPMENT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EQUIPMENT should assure that it is used in such an environment.

IEC 60601 test Compliance Electromagnetic


Immunity test
level level environment - guidance

Floors should be wood,


±2 kV, ±4 kV, ±6 ±2 kV, ±4 kV, ±6
Electrostatic concrete or ceramic tile. If floors
kV Contact kV Contact
discharge (ESD) are covered with synthetic
±2 kV, ±4 kV, ±8 ±2 kV, ±4 kV, ±8
IEC 61000-4-2 material, the relative humidity
kV Air kV Air
should be at least 30%.

Electrical fast Mains power quality should be


±2 kV for power ±2 kV for power
transient/burst that of a typical commercial or
port port
IEC 61000-4-4 hospital environment.

Mains power quality should be


Surge ±1 kV line to line ±1 kV line to line
that of a typical commercial or
IEC 61000-4-5 ±2 kV line to earth ±2 kV line to earth
hospital environment.

<5 % U (>95 % T

<5 % U (>95 % dip


T dip in U ) for 0.5
T
Mains power quality should be
in U ) for 0.5 period
T period that of a typical commercial or
hospital environment. If the
40 % U (60 % dip T 40 % U (60 % dip
T

user of the EQUIPMENT


Voltage dips and in U ) for 5 periods
T in U)T for 5
requires continued operation
Short 70 % U (30 % dip T
periods
during power mains
interruptions in U)
T for 25 70 % U (30 % dip
T
interruptions, it is
IEC 61000-4-11 periods in U)T for 25
recommended for the
<5 % U (>95 % dip periods
T
EQUIPMENT to be powered
in U) T for 250 <5 % U (>95 % T
from an uninterruptible power
periods dip in U ) for 250
T
supply.
periods

Power frequency Power frequency magnetic

(50Hz) fields should be at levels


3 A/m 3 A/m characteristic of a typical
magnetic field
location in a typical commercial
IEC 61000-4-8 or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

174 Basic Operator’s Manual


B. EMC Guidance and Manufacturer's Declaration

Electromagnetic immunity
The EQUIPMENT is intended for use in the electromagnetic environment specified below. The
customer or the user of the EQUIPMENT should assure that it is used in such an environment.

IEC 60601 test Compliance Electromagnetic


Immunity test
level level environment - guidance

Portable and mobile RF


communications equipment should
be used no closer to any part of
the EQUIPMENT, including cables,
than the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance

d = 3.5 p

d = 1.2 p 80 MHz to 800 MHz


3 Vrms
Conducted RF 150 kHz to 80 1 Vrms
d = 2.3 p 800 MHz to 2.5 GHz
IEC 61000-4-6 MHz
Radiated RF 3 V/m 3 Vrms where P is the maximum output
IEC 61000-4-3 80 MHz to 2.5 power rating of the transmitter in
GHz watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined by an
a
electromagnetic site survey, should
be less than the compliance level
b
in each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Basic Operator’s Manual 175


B. EMC Guidance and Manufacturer's Declaration

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the EQUIPMENT is used
exceeds the applicable RF compliance level above, the EQUIPMENT should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the EQUIPMENT.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

Recommended separation distances between portable


and mobile RF communications equipment and the EQUIPMENT
The EQUIPMENT is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the EQUIPMENT can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the EQUIPMENT as recommended below,
according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter


Rated maximum
output m
power of transmitter 150 kHz to 80 MHz 800 MHz to 2.5 GHz
80 MHz to 800 MHz
W d = 3.5 p d = 1.2 p d = 2.3 p

0.01 0.35 0.12 0.23

0.1 1.11 0.38 0.73

1 3.50 1.2 2.3

10 11.07 3.8 7.3

100 35.00 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people

176 Basic Operator’s Manual


B. EMC Guidance and Manufacturer's Declaration

Basic Operator’s Manual 177


Appendix C In Situ, Derated, and Water
Value Intensities

All intensity parameters are measured in water. Since water does not absorb acoustic
energy, theses water measurements represent a worst case value. Biological tissue does
absorb acoustic energy. The true value of the intensity at any point depends on the
amount and type of tissue and the frequency of the ultrasound passing through the
tissue. The intensity value in the tissue, In Situ, has been estimated using the following
formula:
In Situ = Water[e-(0.23alf)]
where:
In Situ = In Situ intensity value
Water = Water intensity value
e=2.7183
a=attenuation factor
tissue=a(dB/cm-MHz)
brain=0.53
heart=0.66
kidney=0.79
liver=0.43
muscle=0.55
l=skinline to measurement depth in cm
f=center frequency of the transducer/system/mode combination in MHz
Since the ultrasonic path during the exam is likely to pass through varying lengths and
types of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor
of 0.3 is used for general reporting purposes; therefore, the In Situ value commonly
reported uses the formula”
In Situ (derated) = Water[e-(0.069alf)]
Since this value is not the true In Situ intensity, the term ‘derated’ is used to qualify it.

178
Appendix D Principle for Using Acoustic
Power

ALARA

Please observe ALARA (As Low As Reasonably Achievable) principle when using
ultrasound. So far there is no confirmed evidence to prove that ultrasound has obvious
harm to humans, but the users shall be cautious when using ultrasound. Provided that
sufficient diagnostic information is acquired, try to shorten the time to examine the patient
with the probe on one body position. The ultrasound power and acoustic intensity are
relevant to scanning time. The user shall observe ALARA principle to select an
appropriate ultrasound power for the exam based on his exam needs.

Ultrasound Effects

Ultrasound effect shall include heating and cavitation.

Heating effect: Ultrasound in nature is mechanical wave. During its propagation in


human body, the human tissues are oscillated, heat is generated, and human tissue
temperature rises. Be vigilant to damage due to the heating effect, and always follow
ALARA principle.

Cavitation: Cavitation can occur when sound passes through an area that contains small
bubbles. With ultrasound impact on these small bubbles, temperature and pressure
around the space of the bubbles will increase, or even oscillate and explode, which may
result in physical or chemical effects on the surrounding tissues.

Relevant Parameters
The main parameters related to acoustic power are: transmit frequency, transmit focus number,
transmit voltage, transmit angle, element pitch, etc. These parameters vary subject to exam
modes. Follow ALARA principle to select the appropriate power for scanning.

A multiplicative factor applied to accoustic output parameters intended to account for ultrasonic
attenuation of tissue between the source and a particular location in the tissue. In the
calculation of all mechanical, the average ultrasonic attenuation is assumed to
be 0.3dB/cm-MHz along the beam axis in the body.

179
D. Principle for Using Acoustic Power

References for Acoustic Power and Safety

(1) “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993

(2) “Medical Ultrasound Safety” issued by AIUM in 1994

(3) “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound

Systems and Transducers” issued by FDA in 2008

180 Basic Operator’s Manual


Appendix E Information of EU
Representative

SONOMED
Via Luigino Tandura, 74-00128 Rome, Italy
Tel: +39-06-5082160
Fax: +39-06-5084752
http://www.sonomed.com

181

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