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Portable Digital Color Doppler Ultrasound System

Release Date: December, 2015

Caution!
Federal law restricts this device to sale by or on the order of a physician. Please read the user
manual carefully prior to use.

Note:
This manual is subject to change without prior notice and without legal obligation attached!
Sonoscape provides the documentation consisted of basic and advanced user manuals.

Manufacturer Contact Information:


4/F, 5/F, 8/F, 9/F & 10/F, Yizhe Building, Yuquan Road, Nanshan, Shenzhen, 518051,
Guangdong, China
Tel: +86-755-26722890
Fax: +86-755-26722850
E-mail: sonoscape@sonoscape.net
Website: http://www.sonoscape.com
Portable Digital Color Doppler Ultrasound System

P/N: 4710.00334 2015-12-28


Portable Digital Color Doppler Ultrasound System

Contents
Chapter 1 Introduction .................................................................................... 1
Chapter 2 Safety .............................................................................................. 3
2.1 Safety Overview .............................................................................................. 3
2.2 Description of Symbols and Signal Words Used ............................................. 4
2.2.1 Symbols ................................................................................................ 4
2.2.3 Signal words ......................................................................................... 6
2.3 Messages ........................................................................................................ 6
2.4 Adverse Effects and Precautions .................................................................... 7
2.5 Biological Safety .............................................................................................. 7
2.6 Scanning Patients and Education ................................................................... 8
2.6.1 Safe Scanning Guideline ...................................................................... 8
2.6.2 Understanding the MI/TI Display ........................................................ 10
2.7 Environmental Requirements ........................................................................ 13
2.8 Electrical Requirements ................................................................................ 14
2.9 Electrical Safety ............................................................................................ 15
2.10 Cautions for Using Accessories ..................................................................... 16
2.11 Environmental Protection .............................................................................. 17
2.12 System Transportation .................................................................................. 17
2.12.1 Moving the System ............................................................................. 17
2.12.2 Transporting the System..................................................................... 17
Chapter 3 System Specifications ................................................................ 19
3.1 Intended Use ................................................................................................. 19
3.2 Standard System Configuration .................................................................... 19
3.3 Physical Specifications .................................................................................. 19
3.4 System Components ..................................................................................... 20
3.4.1 Front View .......................................................................................... 20
3.4.2 Side View............................................................................................ 20
3.4.3 Rear View ........................................................................................... 21
3.4.4 Control Panel ...................................................................................... 22
3.5 Keyboard Description .................................................................................... 22
Chapter 4 Starting the System ..................................................................... 27
4.1 Probe Connection ......................................................................................... 27
4.2 Powering On and Off ..................................................................................... 27
4.2.1 Using AC Supply................................................................................. 28
4.2.2 Using Battery ...................................................................................... 30
4.2.3 LED Indicators .................................................................................... 31
4.2.4 Powering on ....................................................................................... 32
4.2.5 Powering off........................................................................................ 33
4.3 Peripheral Device .......................................................................................... 33
4.3.1 Footswitch Connection ....................................................................... 33
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4.3.2 Video Printer Connection .................................................................... 34
4.3.3 Network Printer Connection ................................................................ 34
4.3.4 USB Printer Connection ..................................................................... 35
4.4 Patient Information ........................................................................................ 36
4.4.1 Creating New Patient.......................................................................... 36
4.4.2 Patient Exam List................................................................................ 45
4.4.3 DICOM Q/R ........................................................................................ 49
4.4.4 DICOM Queue .................................................................................... 51
4.4.5 PPS Screen ........................................................................................ 52
4.4.6 Patient Exam Import/Export ................................................................ 52
4.5 Starting Ultrasound Diagnosis ....................................................................... 55
4.6 Main Screen .................................................................................................. 56
Chapter 5 System Setup ............................................................................... 57
5.1 General Setting ............................................................................................. 57
5.1.1 General ............................................................................................... 57
5.1.2 Display ................................................................................................ 59
5.1.3 Menu .................................................................................................. 60
5.1.4 Storage ............................................................................................... 61
5.2 Peripheral ...................................................................................................... 62
5.3 Comment....................................................................................................... 63
5.4 Bodymark ...................................................................................................... 64
5.5 Measure ........................................................................................................ 65
5.5.1 General ............................................................................................... 65
5.5.2 Menu .................................................................................................. 67
5.5.3 Formula .............................................................................................. 68
5.6 Report ........................................................................................................... 69
5.7 DICOM .......................................................................................................... 70
5.7.1 DICOM Image Storage ....................................................................... 70
5.7.2 DICOM Storage Commitment ............................................................. 72
5.7.3 DICOM Worklist .................................................................................. 73
5.7.4 DICOM MPPS .................................................................................... 74
5.7.5 DICOM Print ....................................................................................... 75
5.7.6 DICOM Q/R ........................................................................................ 77
5.8 Remote Service ............................................................................................. 78
5.9 System Information ....................................................................................... 79
Chapter 6 B Mode .......................................................................................... 81
6.1 Starting B Mode ............................................................................................ 81
6.2 Parameter Adjustment ................................................................................... 82
6.2.1 Focal Number ..................................................................................... 83
6.2.2 Focal Span ......................................................................................... 84
6.2.3 Chroma ............................................................................................... 84
6.2.4 Frequency .......................................................................................... 84
6.2.5 Acoustic Output Power ....................................................................... 84
6.2.6 Line Density ........................................................................................ 85

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6.2.7 Sector Width and Position .................................................................. 85
6.2.8 Dynamic Range .................................................................................. 85
6.2.9 Grayscale curve.................................................................................. 86
6.2.10 Persistence ......................................................................................... 86
6.2.11 μScan Function .................................................................................. 86
6.2.12 Compound Imaging ............................................................................ 87
6.2.13 Trapezoidal Imaging ........................................................................... 87
6.2.14 L-R Reverse ....................................................................................... 87
6.2.15 U-D Reverse ....................................................................................... 87
6.2.16 Rotation .............................................................................................. 88
6.2.17 Biopsy................................................................................................. 88
6.2.18 B Gain ................................................................................................ 88
6.2.19 Focus.................................................................................................. 89
6.2.20 Depth .................................................................................................. 89
6.2.21 Time Gain Compensation (TGC) ........................................................ 90
6.3 Other B Mode Operations ............................................................................. 91
6.3.1 Frozen Mode ...................................................................................... 91
6.3.2 Image Magnification ........................................................................... 91
6.3.3 Image Reverse (Left/Right) ................................................................ 92
6.3.4 Image Reverse (Up/Down) ................................................................. 93
6.3.5 Dual Display Format ........................................................................... 93
6.3.6 Quad Display Format.......................................................................... 94
6.3.7 Tissue Harmonic Imaging (THI) .......................................................... 95
6.3.8 Panoramic Imaging............................................................................. 95
Chapter 7 CFM Mode .................................................................................... 97
7.1 Starting CFM Mode ....................................................................................... 97
7.2 Parameter Adjustment ................................................................................... 98
7.2.1 Frequency .......................................................................................... 99
7.2.2 CFM Power ........................................................................................ 99
7.2.3 Resolution .......................................................................................... 99
7.2.4 Wall Filter.......................................................................................... 100
7.2.5 B Reject ............................................................................................ 100
7.2.6 Persistence ....................................................................................... 100
7.2.7 Color Map ......................................................................................... 100
7.2.8 Flow Invert ........................................................................................ 101
7.2.9 CFM Gain ......................................................................................... 101
7.2.10 Pulse Repetition Frequency ............................................................. 101
7.2.11 Steer ................................................................................................. 102
7.3 Other CFM Mode Operations ...................................................................... 102
7.3.1 Frozen Mode .................................................................................... 102
7.3.2 Image Magnification ......................................................................... 103
7.3.3 B+CFM Real Time Dual Format ....................................................... 103
7.3.4 Quad Display Format........................................................................ 103
Chapter 8 DPI Mode (Doppler Power Imaging) ......................................... 105
8.1 Starting DPI Mode ....................................................................................... 105

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8.2 Parameter Adjustment ................................................................................. 106
8.2.1 Frequency ........................................................................................ 107
8.2.2 DPI Power ........................................................................................ 107
8.2.3 Resolution ........................................................................................ 107
8.2.4 Wall Filter.......................................................................................... 107
8.2.5 B Reject ............................................................................................ 107
8.2.6 Color Map ......................................................................................... 107
8.2.7 Persistence ....................................................................................... 107
8.2.8 DPI Gain ........................................................................................... 107
8.3 Other DPI Mode Operations ........................................................................ 107
Chapter 9 TDI Mode .................................................................................... 109
9.1 Starting TDI Mode ....................................................................................... 109
9.2 Parameter Adjustment ..................................................................................110
9.2.1 Frequency .........................................................................................110
9.2.2 Power ................................................................................................110
9.2.3 Resolution .........................................................................................110
9.2.4 B Reject .............................................................................................110
9.2.5 Color Map ..........................................................................................110
9.2.6 Persistence ........................................................................................110
9.2.7 TDI Gain ............................................................................................110
9.3 Other TDI Mode Operations ......................................................................... 111
Chapter 10 M Mode ........................................................................................ 113
10.1 Starting M Mode ...........................................................................................113
10.1.1 Inactivated M Mode ...........................................................................113
10.1.2 Activated M Mode ..............................................................................114
10.2 Parameter Adjustment ..................................................................................114
10.2.1 Display Format ..................................................................................115
10.2.2 Sweep Speed ....................................................................................115
10.2.3 Steer M ..............................................................................................115
10.2.4 Chroma ..............................................................................................115
10.2.5 Smoothness ......................................................................................116
10.2.6 Video Invert .......................................................................................116
10.3 Other M Mode Operations ............................................................................116
10.3.1 Frozen Mode .....................................................................................116
10.3.2 M Line................................................................................................117
10.3.3 Dual Display ......................................................................................117
Chapter 11 PW Mode ..................................................................................... 119
11.1 Starting PW Mode ........................................................................................119
11.1.1 Inactivated PW Mode ........................................................................119
11.1.2 Activated PW Mode ...........................................................................119
11.2 Parameter Adjustment ................................................................................. 120
11.2.1 Frequency ........................................................................................ 121
11.2.2 PW Power ........................................................................................ 121
11.2.3 Sweep Speed ................................................................................... 121

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11.2.4 Dynamic Range (DYN) ..................................................................... 121
11.2.5 Wall Filter (WF) ................................................................................. 121
11.2.6 Chroma ............................................................................................. 121
11.2.7 Display Format ................................................................................. 121
11.2.8 Flow Invert ........................................................................................ 121
11.2.9 Video Invert ...................................................................................... 121
11.2.10 2D Refresh ....................................................................................... 122
11.2.11 Baseline ............................................................................................ 122
11.3 Other PW Mode Operations ........................................................................ 122
11.3.1 Frozen Mode .................................................................................... 122
11.3.2 Spectral Doppler Line ....................................................................... 123
11.3.3 Sample Volume Gate........................................................................ 123
11.3.4 Flow Cursor ...................................................................................... 123
11.3.5 Baseline ............................................................................................ 123
11.3.6 Dual Display ..................................................................................... 124
Chapter 12 Miscellaneous Functions .......................................................... 125
12.1 Annotation ................................................................................................... 125
12.1.1 Textual Annotation ............................................................................ 125
12.1.2 Arrow Annotation .............................................................................. 126
12.2 Bodymark .................................................................................................... 126
12.3 Save and Review ........................................................................................ 128
12.4 Customize Exam Mode ............................................................................... 130
12.4.1 Create New Exam Mode .................................................................. 130
12.4.2 Edit Exam Mode ............................................................................... 131
12.4.3 Import/Export Exam Mode ................................................................ 132
12.5 Print ............................................................................................................. 132
12.6 ECG Module................................................................................................ 132
12.6.1 Basic Procedures of ECG Operation ................................................ 133
12.6.2 Optimizing Parameters ..................................................................... 134
12.6.3 Reviewing ECG ................................................................................ 134
Chapter 13 4D ................................................................................................ 135
13.1 Inactivated 4D ............................................................................................. 136
13.1.1 Enter Inactivated 4D ......................................................................... 136
13.1.2 ROI ................................................................................................... 137
13.1.3 Parameter Adjustment ...................................................................... 137
13.1.4 Exit ................................................................................................... 137
13.2 Activated 4D Mode ...................................................................................... 138
13.2.1 Enter Activated 4D Mode .................................................................. 138
13.2.2 4D Menu ........................................................................................... 140
13.2.3 Rotate Image .................................................................................... 142
13.2.4 Zoom ................................................................................................ 143
13.2.5 Print .................................................................................................. 143
13.2.6 Exit ................................................................................................... 143
13.3 Frozen 4D Mode ......................................................................................... 143
13.3.1 Enter Frozen 4D Mode ..................................................................... 143

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13.3.2 Parameter Adjustment ...................................................................... 143
Chapter 14 Probes ........................................................................................ 147
14.1 Probe........................................................................................................... 147
14.1.1 Available Probes............................................................................... 147
14.1.2 Probe Usage .................................................................................... 148
14.1.3 Cleaning the Probe ........................................................................... 149
14.1.4 Disinfecting and Sterilizing the Probe ............................................... 149
14.1.5 Disinfecting and Sterilizing the Probe Cable ..................................... 152
14.1.6 Storage and Transportation .............................................................. 153
Chapter 15 System Maintenance ................................................................. 155
15.1 Manufacturer Responsibility ........................................................................ 155
15.2 Cleaning the System ................................................................................... 155
15.3 Maintenance Checks ................................................................................... 156
15.4 Data Backup................................................................................................ 157
15.5 Troubleshooting........................................................................................... 157
15.6 Equipment Disposal .................................................................................... 157
15.7 Customer Service ........................................................................................ 158
Appendix A 159
EMC Guidance and Manufacturer's Declaration ................................................ 159
Appendix B 165
In Situ, Derated, and Water Value Intensities ..................................................... 165
Appendix C 167
Principle for Using Acoustic Power .................................................................... 167
Appendix D 169
Acoustic Output Data ........................................................................................... 169

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Chapter 1 Introduction

This equipment is a full digital color Doppler ultrasound system for general application.
The high performances of this system from the advanced ultrasound Doppler imaging
technologies include full digital beam-former, wide dynamic range, multi-beam processing, etc.
The ergonomic user-friendly design enables user to customize the system according to the
specific application, and the graphic exam icon assures you familiar with the system in few
minutes.

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Chapter 2 Safety

2.1 Safety Overview


This section discusses measures to ensure the safety of both the operator and patient.
To ensure the safety of both operator and patient, please read the relevant details in this
chapter carefully before operating this system. Disregarding the WARNINGS or violation of
relevant rules may result in personal injury or even loss of life for operator or patient.
Users should observe the following PRECAUTIONS:
 This system complies with Type BF general equipment, and the IEC60601-1
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 IEC60601-1 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.
 In the environment that patient is 1.8 meters (6 feet) around, connect peripherals to
the auxiliary power outlet which is capable of isolation protection, or power the
peripherals by auxiliary output cable or isolation transformer complied with IEC
60601-1 or the power input of the same safety level.
 Leave at least 20cm at the back and both sides of the ultrasound system for
ventilation. Otherwise, the temperature rise could cause failures.
 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.

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 Do not use this system in the presence of flammable substances or an explosion may
occur.
 Connect the earth conductor only before powering on the system. Disconnect the
grounding cable only after powering off the system. Otherwise, there is a danger of
electric shock.
 Do not continuously scan the same part of a patient or expose the patient to
prolonged scanning. Doing so may harm the patient.
 Do not expose the fetus to prolonged scanning in the Doppler mode.
 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.
 Do not place other objects on top of the control panel. Do not sit on the control panel
or other part of the ultrasound system.
 Do not knock or shake the ultrasound system.
 For proper disposal of this product, please contact our service department.

2.2 Description of Symbols and Signal Words Used

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

Symbol Description

Caution

Warning: dangerous voltage

OFF (Mains power switch OFF)

ON (Mains power switch ON)

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“ON” / “OFF” (push-push)


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

Protective earth (ground)

Equipotentiality

Alternating current

Type BF Applied Part

Degree of IP protection

Non-ionizing electromagnetic radiation


NOTE: Ultrasound scanner transmits acoustic waves

Date of manufacture

Follow instructions for use

Network Port

Control port of color video printer

USB Port

Video Input

Video Output

Fragile.

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Keep dry.

Maximum stacking limit of packages. Maximum of two layers


allowed!

Keep this way upward.

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.

Indoor use only.

2.2.3 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.

2.3 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 7 days, the message appears on the
preparation mode screen. System function will not be affected until 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.

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Auto Freeze 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 Freeze mode if there has been no user
activity for 10 minutes. The user may resume the scan by pressing the Freeze key
to return to the real time scan, no prerequisite action is required.

2.4 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 the respective applications.

2.5 Biological Safety


This product, as with all diagnostic ultrasound equipment, should be used only for valid
reasons and should be used both for the shortest period of time and at the lowest power
settings necessary (ALARA-As Low As Reasonably Achievable) to produce diagnostically
acceptable images.
The AIUM offers the following guidelines:
Clinical Safety Quoted from AIUM
Approved March 26, 1997
Diagnostic ultrasound has been in use since the late 1950s. Given its known
benefits and recognized efficacy for medical diagnosis, including use during
human pregnancy, the American Institute of Ultrasound in Medicine herein
addresses the clinical safety of such use:
There are no confirmed biological effects on patients or instrument operators
caused by exposures from present diagnostic ultrasound instruments. Although
the possibility exists that such biological effects may be identified in the future,
current data indicate that the benefits to patients of the prudent use of diagnostic
ultrasound outweigh the risks, if any that may be present.
Heating:
Elevating tissue temperature during obstetrical examinations creates medical concerns. At the
embryo development stage, the rise in temperature and the length of time exposed to heat
combine to determine potential detrimental effects. Exercise CAUTION particularly during
Doppler/Color exams.

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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.

2.6 Scanning Patients and Education


The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility
for the safe use of this ultrasound system. Follow these usage guidelines for safe operation:
 In order to maintain proper cleanliness of the 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).

2.6.1 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
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.

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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 2-1 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 2-1Maximum 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
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

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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.

2.6.1.1 Temperature Display for Transducers Intended for Internal Use

For transducers intended for internal applications, e.g. the endocavitary transducers, the
transducer tip temperature is displayed on upper of the screen. 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.

2.6.2 Understanding the MI/TI Display


Track-3 follows the Output Display Standard for systems that include fetal Doppler applications.
The acoustic output will not be evaluated on an application-specific basis, but the global
maximum de-rated ISPTA must be ≤ 720 mW/cm² and either the global maximum MI must be ≤
1.9 or the global maximum de-rated ISPTA 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/cm²under an Output Display Standard.
For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display Standard.
The diagnostic ultrasound systems and its user manual contain the information regarding an
ALARA (As Low As Reasonably Achievable) education program for the clinical end-user and
the acoustic output indices, MI and TI.
The MI describes the likelihood of 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.

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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
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 Model
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

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

Soft tissue
Describes low fat content tissue that does not contain calcifications or large gas-filled spaces.
Scanned: (auto-scan)
Refers to the steering of successive burst through the field of view, e.g. B and color mode.
UnScanned
Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the
transducer is moved to a new position. For instance, the PW, CW and M mode.
TI
TI is defined as the ratio of the In Situ acoustic power (W.3) to the acoustic power required to
raise tissue temperature by 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

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

Display Guideline
For different operation modes, different indices must be displayed. However, only one index
needs to be shown at a time. Display is not required if maximum MI is less than 1.0 for any
setting of the operating mode, or if maximum TI is less than 1.0 for any setting of the operating
mode. For TI, if the TIS and TIC are both greater than 1.0, the scanners need not be capable

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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
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.

2.7 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

Transportation 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.

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2.8 Electrical Requirements


AC adapter:
Input: 110-240V AC, 2.7-1.2A, 50/60Hz
Output: 17.5V DC, 10A
Main Unit: 17.5V DC, 10A
Lithium battery: 14.8V DC, 10400mAh
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.

 Please ensure that the power requirements are satisfied. Only use power
cables that meet the system guidelines—failure to follow these procedures
may result in system damage.
 Voltage level may vary in different regions. For details, please check the
voltage rating label on the rear panel of the system.

AC adapter

Caution!
 Use the AC adapter approved by the manufacturer only.
 AC adapter can get very hot if being used in poorly ventilated area.
Maintain good ventilation for heat dissipation. Do not put any items on the
AC adapter or the power cable.
 Make sure that the power cable is not entangled and avoid stepping on the
cable.
 Do not place the adapter in its carrying case during use.
 To ensure proper grounding, connect the AC adapter to a receptacle/outlet
marked with “hospital grade”.

Battery

Caution!
 To assure the best performance of the system, it is recommended to
replace the battery pack every three years.
 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-circuit the battery by directly connecting the system with
metal objects.

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 The temperature of the battery can be high right after discharging
completes. To protect it from overheat damage, it will not be charged
immediately after being connected to an AC power supply.
 During long time storage of the battery, a discharge-charge cycle should
be performed in every 3 months.
 Do not discard the battery in fire.
 Do not remove the battery pack from the system.
 Do not put foreign metal or other conductive parts inside the system to
avoid electric shock.
 Protect the battery from rain and do not immerse the battery in water.
 Do not place the system on an uneven surface during use.
 Do not heat or burn the battery.
 Do not use the system near any source which produces significant amount
of heat, such as fire and heater.
 Do not charge or discharge the battery under direct sunlight.
 Do not destroy or disassemble the battery. Do not solder the battery.
 This battery pack should only be used with the ultrasound system which it
has been designed for.
 Do not use the battery in strong electric field.

For more information about the AC adapter and the battery, read Section 4.2.

2.9 Electrical Safety


Only trained health-care professionals should operate this system. This equipment complies
with the following standards:
 The equipment conforms with the following regulations for electrical safety,
IEC 60601-1, Medical electrical equipment Part 1: General requirements for
basic safety and essential performance, Class I, BF, continuous operation
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:
IEC 60601-2-37:2007 and 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 electric 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.

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 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
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.

2.10 Cautions for Using Accessories


 Any accessories 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 Part1: General
requirements for basic safety and essential performance.)
 There is a cleared list of sterilants and high-level disinfectants for use inprocessing
reusable medical and dental devices on FDA website. That list can be consulted to find
agents that may be useful for probe disinfection. Please refer to the following URL for
FDA-Cleared Sterilants and High Level Disinfectants:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingl
e-UseDevices/ucm133514.htm

 Contact with natural rubber latex may cause a severe anaphylactic reaction in persons
sensitive to the natural latex protein. The operator and patients must avoid contact with
these items. Refer to package labeling to determine latex content and FDA’s March 29,
1991 Medical Alert on latex products.

 For cleaning and disinfection 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.
 Do not use the footswitch in the operating room.

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2.11 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 the manufacturer 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.
Disposal of battery
To dispose and recycle the ultrasound system and the battery properly, contact the
manufacturer representative for instructions.

2.12 System Transportation

2.12.1 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 cable.
3. Disconnect all cables attached to the system.
4. To prevent damaging the power cable, 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.

2.12.2 Transporting the System


Use extra care when transporting the system in a vehicle. After preparing the system as
described above, take the following additional PRECAUTIONS:
 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 requires some time to reach thermal equilibrium with the
environment.

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Decrease or increase this time period (4 to 5 hours for 10℃ difference) according to the initial
temperature difference of the system and the environment.

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Chapter 3 System Specifications

3.1 Intended Use


The SonoScape device is a general-purpose ultrasonic imaging instrument 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,
Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and
Urology.

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

3.2 Standard System Configuration


The standard system configuration mainly consists of the followings items:
 Footswitch
 Standard accessory package
 Transducer cable hanger
 ECG package
 AC power cable
 Basic user manual
 Advanced user manual

3.3 Physical Specifications


LCD monitor: 15’’ color display

Weight (system alone, without docking cart): approximately 9.8kg

Dimensions: 400mm(L)×360mm(W)×398mm(H)

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3.4 System Components

3.4.1 Front View

Figure 3-1 Front View


1. Monitor 2. Probe Holder

3.4.2 Side View

Figure 3-2 Side View

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1. Audio Output Port 3. Two USB Ports 5. VGA Port
2. S-Video Output Port 4. Network Port (DICOM)
Information for using S-Video and composite video
 This system supports both S-Video (2 in Figure 3-2) and composite video (5 in
Figure 3-3) output.
 In order to use the composite video output, make sure the S-Video port is
disconnected, and connect the composite connector before the system startup.
 In order to use the S-Video output, make sure the composite video output port is
disconnected before the system startup.
Dust covers
 Some IO sockets are covered using dust covers.
 To remove the dust cover for S-Video, rotate and pull it out.

3.4.3 Rear View

Figure 3-3 Rear View


1. Probe Port 1 5. Composite Video Output Port
2. Probe Port 2 6. ECG Port
3. Video Printer Port 7. Grounding Terminal
4. Foot Switch Port 8. AC Adapter Port

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3.4.4 Control Panel
The control panel is shown in the following figure. It consists of hard keys, knobs, a trackball,
flip switches and TGC slide pots.

Figure 3-4 Control Panel

3.5 Keyboard Description


Key Description

Power On/Off button


Press it to start or shut down the system.

Exam key
Press it to select the probe and exam type in the
application mode screen.

Patient key
Press it to add a new patient, edit or retrieve the patient
information.

Dual display key


Press it to activate the dual display format.

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L/R key
Press it to reverse the image left or right.

U/D key
Press it to reverse the image up or down.

Annotation key
Press it to annotate an image with typed words..

Arrow key
Press it to add arrow on the ultrasound image..

Bodymark key
Press it to add the body mark on the ultrasound image.

3D & 4D key
Press it to activate 3D or 4D imaging mode.

m-Tuning key
Press it to adjust the angle of frequency spectrum and
optimize the image automatically.

Save key
Press it to save the images and cines.

Report key
Press it to enter the Report screen.

Video Print key


Press it to print the current screenshot if the video
printer is successfully connected..

Print key
Press it to print the current screenshot if the network
printer is successfully connected..

Delete key
Press it to delete the last annotation, bodymark or
measurement marker.

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Clear key
Press it to clear all measurement markers and
annotations from the screen.

AUDIO knob
Rotate it to adjust the volume in PW mode.
Or, rotate it to select one menu item when the menu
pops up.

MENU key
Press it to display the menu.

D GAIN knob
Rotate it to adjust the gain value in the color/TDI/DPI
mode..

GAIN knob
Rotate it to adjust the gain value in the B/M mode.

ANGLE knob
Rotate it to adjust the angle.

B Mode key
Press it to enter the B mode.

THI key
Press it to activate the Tissue Harmonic Imaging.

CDI key
Press it to enter the color Doppler mode.

DPI key
Press it to enter the DPI mode.

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PW key
Press it and then press the Update key to activate the
PW mode.

CW key
Press it and then press the Update key to activate the
CW mode..

M Mode key
Press it and then press the Update key to activate the
M mode.

Quad display key


Press it to activate the quad display format.

Freeze key
Press it to freeze an image in the real time scan. Press it
again to restore to the real time scan.

FOCUS switch
Flip it up or down to adjust the position of the focus. .

DEPTH switch
Flip it up or down to adjust the scan depth.

STEER switch
Flip it to left or right to adjust the angle of the sampling
line.

PRF switch
Flip it to up or down to adjust the velocity range of the
image.

BASELINE switch
Flip it to up or down to adjust the position of the
baseline.

Trackball
Use it to move the cursor.

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Update key
in spectral Doppler mode or M mode, press this key to
start/stop PW/CW and M traces.

Set key
Press it to confirm the current operation.

Zoom key
Press it to zoom in or out the image..

Distance key
Press it to activate the distance measurement.

Trace key
Press it to activate the trace measurement.

Ellipse key
Press it to activate the ellipse measurement..

Calc
Press it to activate the measurement menu.

TGC slide pot


Use these 8 TGC slide pots to adjust the gain value of
the specific area on the image.

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Chapter 4 Starting the System

4.1 Probe Connection

Caution
 Use the probe manufactured by the manufacturer only. Otherwise, the diagnosis
cannot be performed.
 Do not disconnect the probe in the real time scan. Otherwise, the system may be
damaged.

Instructions:
1. Insert the probe connector into the probe port.
2. Switch the probe lock clockwise to vertical direction to lock the probe.
If the probe cable is too long, hang it on the probe cable hanger. .

4.2 Powering On and Off


The system can be supplied power by mains supply or built-in rechargeable battery.
When the adapter is connected to the mains supply, the battery is charged until full.

Warning
Review Section 2.8 and Section 2.9 for the detailed electrical requirements and for the
electrical safety.

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Important!

Read messages below and carefully before starting up your system. In


order to avoid unnecessary electric hazards, it's recommended to connect the grounding
terminal to earth even when operating with the battery.
Information for power supply status can be found in Section 2.8.
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.

4.2.1 Using AC Supply

Warning
 The AC adapter is specifically designed for use with this ultrasound system. Do not
use it for other purposes.
 The accompanying AC adapter can only be used for power supply or battery
recharging of the system. Other usages may damage the adapter or even cause an
electric shock.
 Do not connect the DC output plug of the adapter to the system when no mains
supply is available, especially when the system is powered on. Otherwise, the
system may shut down and lock automatically for safety protection.
 When the system shuts down and locks automatically due to misoperation, connect
the adapter to the mains supply to unlock the system for normal use.
 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.
Follow the steps below to connect the adapter.

1. Ensure that the mains supply is within the required range of 110–240V~ 50/60Hz.

2. Connect the grounding terminal at the rear panel to the protective ground using the
grounding cable.
3. Connect one end of the adapter to the system and connect the other end to the mains
supply firmly.

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Correct: tight connection

Incorrect: loose connection

Figure 4-1 Connecting the DC output plug

Warning
 Do not hang the adapter in the air. Place it on the ground or other well ventilated
platform instead.

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Figure 4-2 AC Power Supply

4.2.2 Using Battery


When the adapter is connected to the mains supply, the battery is charged until full.
When the adapter is disconnected, the system is supplied power by the battery.
A fully charged battery can work continuously for more than 1 hour.
It is recommended to connect the grounding terminal of the system to the protective ground
before use.
To start operating the system using only the battery, you need to press and hold down the
Power on/off button for at least 2 seconds
Battery charging time (from depletion to full):
When the system is off:
approximately 2.5 hour.
When the system is on:
approximately 12 hours.
Information about disposing the battery
To dispose the ultrasound system and the battery properly, contact the manufacturer
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 its power source automatically.

Caution

 The battery can only be used with the series system of the manufacturer. .

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 Please charge the battery every 3 months if the battery is not used for a long time.
 Waste battery should be handled carefully. Do no throw it into fire or water.

Warning
Please pay attention to the following cautions when operating this system:
 Do not disassemble the battery from the system.
 Do not short-circuit the battery by directly connecting the system with metal objects.
 Do not immerse the battery in water or allow it to get wet.
 Do not place the system on unstable location.
 Do not heat or burn the battery.
 Do not use the battery near the heat source or the fire.
 Do not use or charge the battery near the fire or under the sunlight.
 Do not destroy the battery or solder it directly.
 Do not use the battery with other devices.
 Do not use the battery in electrostatic environment.

4.2.3 LED Indicators

Battery Discharging Battery Charging Mains Supply


Indicator Indicator Indicator

Figure 4-3 LED Indicators


Three LED indicators, shown in Figure 4-3, indicate the power supply status of the system.

: Indicates the battery discharging status.

: Indicates the battery charging status.

: Indicates the connecting status of the mains supply.

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The indications of each status indicator are shown in Table 4-1.

Table 4-1 Status Indicator

Status Indicator Name Mains Supply Battery

Battery Yellow, charging


Charging Off
Indicator Green, fully charged

Mains Supply
Always green Off
Indicator

Green, full capacity

Yellow, low capacity


Battery
Discharging Off
Blinking yellow, extremely
Indicator
low capacity, and the
system is going to power
off and buzzer alarms.

4.2.4 Powering on

Warning
 Please confirm the follow items before powering on the system.
 Ensure that the specification of mains supply is consistent with that of the adapter.
 Ensure that the grounding terminal at the rear panel of system is connected to the
protective ground properly.
 If you have any question about connecting the grounding terminal, ensure that the battery
is used for supplying power.
 If μscan function is available for the system, ensure that USB drive is not connected to
the system before startup. Otherwise, the μscan function may be damaged.
Ensure power supply is correctly connected as described in Section 1 and Section 4.2.2.
Press the Power on/off button on the control panel to power on the ultrasound system. If no
mains supply is available, press and hold the Power on/off button for 2 seconds to power on
the system with battery.
The system displays the boot-up progress bar and the keyboard will be illuminated.
About one minute later, the Exam screen appears as shown below.

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Figure 4-4 Exam Screen

4.2.5 Powering off


To power off the system, press the Power on/off button on the control panel. The system
shuts down automatically.

4.3 Peripheral Device

4.3.1 Footswitch Connection

Warning

 To avoid falling or damage of the footswitch, do not place the footswitch on the
ultrasound system.
 Do not use the footswitch other than those provided by the manufacturer. Otherwise,
the ultrasound system or the footswitch malfunctions could result.
Connect the footswitch to the footswitch port of the ultrasound system as the figure shown
below.

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4.3.2 Video Printer Connection

Connect the video printer to the ultrasound system by the S-VIDEO cable, BNC cable and
Remote Control cable provided by the manufacturer. You can refer the installation method as
the above figure shown. The video printer is ready to work immediately without any
configurations after a successful connection.

4.3.3 Network Printer Connection


 Printer Setup

1. Connect the printer to the ultrasound system.

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2. Press OK on the control panel menu of the printer.

3. Press the left or right key to select Network Confi, and then press OK to confirm.

4. Press the left or right key to select TCP IP Confi, and then press OK to confirm.

5. Press the left or right key to select Manual, and then press OK to confirm.

6. An IP address is displayed, change it to 192.168.254.183 by pressing the left or right key,


and then press OK.

7. If the IP address is correct, use the left or right key to select Yes, and then press OK. If
the IP address is incorrect, use the left or right key to select No, and then press OK.
Repeat Step6 to enter a correct address.

8. After setting IP address, set the subnet mask to 255.255.255.0 and default gateway to
192.168.254.183 in the same way as described above.

 Ultrasound System Setup

1. Copy the driver file deskjet.ppd provided by the manufacturer into the directory of the
USB drive.

2. Connect the drive to the ultrasound system, and then start up the ultrasound system.

3. Choose System Settings -> Peripheral -> Add -> Net Printer.

4. Enter the IP address of the printer, and then click Test to verify the printer connection.

5. Enter the port number and printer model, and then select the driver file from the
drop-down list in the USB drive.

6. Click Next Step to add the desired printer.

7. Click Exit by using the trackball.

4.3.4 USB Printer Connection


1. Copy the driver file deskjet.ppd provided by the manufacturer into the directory of the
USB drive.

2. Connect the drive to the ultrasound system, and then start up the ultrasound system.

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3. Choose System Settings -> Peripheral -> Add -> USB printer -> Search to add the
desired printer.

4. Click Exit by using the trackball.

4.4 Patient Information


You can start an exam without entering any patient information. However, the patient’s name
and ID is closely related with each patient’s image. To avoid patient identification errors, you
should always verify the identification with the patient.

4.4.1 Creating New Patient


Press the Patient key on the control panel to display the New Patient screen.

Figure 4-5 New Patient Screen

1. Enter relevant patient information

Patient ID 64 characters at most can be input. This entry is required and can
be generated automatically.

Last Name 20 characters at most can be input.

First Name 20 characters at most can be input.

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DOB Enter the date of birth of the patient. The age of the patient will be
calculated automatically.

Age Only digit is allowed.

Sex Select Female, Male or Unknown.

Accession 64 characters at most can be input.

Weight Three characters at most can be input.

Height Three characters at most can be input.

BSA Select Eastern or Western.

BP Enter the blood pressure of the patient in mmHg or kPa. Only digit
is allowed.

Comments 512 characters at most can be input.

NOTE:
 Patient ID is an important identification of the patient. Once it is saved, you cannot
modify it.
 If the system is connected to a worklist server (such as HI S/RI S), you can click the
Worklist button to select a patient from a worklist
 You can view the exam images of the patient by clicking the Patient List button. For
details, refer to 4.3.2 Patient Exam List.
 After entering height and weight of the patient, the system automatically calculates
the body surface area (BSA) using the preset formulas, (Weight and height are
expressed in kilograms and centimeters respectively.
 You must enter height and weight for the current patient when you select Cardiology
as the exam type. BSA will be automatically calculated in accordance with BSA set in
the General Settings menu.
 You must enter LMP or EDD for the current patient when you select Obstetrics as
the exam type. AUA will be automatically calculated.

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 Acquire Patient Information from Worklist

In the New Patient screen, click the Worklist button to open the Worklist screen.

Figure 4-6 Worklist Information Screen


1) Search for the archived information
Enter the search requirements, such as Patient ID, First/Last Name, Sex, Exam
Date/Time or Age, and then click Search to search the desired one.
 If no search requirement is input, click Search to view all patient information saved
on the server.
 Click Reset to clear all requirements input.
2) Select the desired information
 Select the patient information and click Select to start the patient exam.
 If multiple exams have been performed for a patient, you can select multiple exam
cases and click Group Case to load these exam cases to the local system.
3) Exam the desired patient.
Enter the New Patient screen, input the relevant patient information and select the
desired application part to start the exam.
NOTE:
Patients list can be loaded only when valid DICOM worklist server addresses have
been correctly provided. For details, refer to 5.7.3 DICOM Worklist.

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2. Select Exam Type

Abdominal (ABD) Refer to Section 4.3.1.1.

Obstetrical (OB) Refer to Section 4.3.1.2.

Gynecology (GYN) Refer to Section 4.3.1.3.

Cardiac Refer to Section 4.3.1.4.

Vascular Refer to Section 4.3.1.5.

Urology Refer to Section 4.3.1.6.

Small Parts (SMP) Refer to Section 4.3.1.7.

Pediatrics (PED) Refer to Section 4.3.1.8.

Musculoskeletal (MSK) Refer to Section 4.3.1.9.

Nerve Refer to Section 4.3.1.10.

Orthopedic (Ortho) Refer to Section 4.3.1.11.

Other Refer to Section 4.3.1.12.

3. Enter the exam information for the selected exam type.

4. Enter other relevant information.

Description 64 characters at most can be input.

Chief Complaint 64 characters at most can be input.

Past History 64 characters at most can be input.

Referring M.D. 64 characters at most can be input.

Performing M.D. 64 characters at most can be input.

Sonographer 64 characters at most can be input.

Comments 512 characters at most can be input.

5. Click OK to display a dialog box.

6. Click Complete to save the patient information and exit the New Patient screen.

You can also click Discontinued to discontinue the exam after selecting the reason of
discontinuing from the corresponding drop-down list.

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4.3.1.1 Exam Type –Abdominal

No information specific to abdominal exam is required.

4.3.1.2 Exam Type – Obstetrical (OB)

Obstetrical Exam Information:

Date Select LMP or IVF and enter the corresponding date.

EDD Click to select the estimated date of confinement.

Age(wks/days) Gestational age should be less than 44 weeks and 6 days.

Gravida Two characters at most can be input.

Para Number of deliveries. Two characters at most can be input.

Aborta Number of abortions. Two characters at most can be input.

Ectopic Number of ectopic pregnancies. Two characters at most can be


input.

Fetus Select from 1, 2, 3 or 4.

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Date of LMP/IVF, EDD and gestational age are correlated. Enter one of them
and the other two would be calculated automatically.
When LMP is selected,

• EDD = LMP + 280 days

• Age =Current date−LMP + 14 days

• LMP = EDD − 280 days

When IVF is selected,

• EDD = IV F + 266 days.

• Age = Current date −LMP days

• LMP = EDD − 266 days

4.3.1.3 Exam Type –Gynecology

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Gynecology Exam Information:

Date Select LMP or IVF and enter the corresponding date.

Gravida Two characters at most can be input.

Para Number of deliveries. Two characters at most can be input.

Aborta Number of abortions. Two characters at most can be input.

Ectopic Number of ectopic pregnancies. Two characters at most can be


input.

Menopausal Tick the check box for menopausal patient.

4.3.1.4 Exam Type – Cardiac

Cardiac Exam Information:

Heart Rate (bpm) Heart rate in beats per minute. Four characters at most can be
input.

RAP Right atrium pressure in mmHg or kPa. Only digit is allowed.

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4.3.1.5 Exam Type – Vascular

Vascular Exam Information:

Left BP Blood pressure in mmHg or kPa. Only digit is allowed.

Right BP Blood pressure in mmHg or kPa. Only digit is allowed.

Left Upper Limb BP Blood pressure in mmHg or kPa. Only digit is allowed.

Right Upper Limb BP Blood pressure in mmHg or kPa. Only digit is allowed.

Left Down Limb BP Blood pressure in mmHg or kPa. Only digit is allowed.

Right Down Limb BP Blood pressure in mmHg or kPa. Only digit is allowed.

Left/Right ABI Ankle brachial index. Four characters at most can be input.

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4.3.1.6 Exam Type – Urology

Urology Exam Information:

PSA Prostate-specific antigen. Four characters at most can be input.

PPSA Coefficient Four characters at most can be input.

PPSA coefficient in ng/ml2,is used for estimating the PSA level for a prostate
with a specified volume.
Estimated PSA = Prostate Volume × 0.15 ng/ml/g

4.3.1.7 Exam Type – Small Parts (SMP)

No information specific to small parts exam is required.

4.3.1.8 Exam Type – Pediatrics (PED)

No information specific to pediatrics exam is required.

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4.3.1.9 Exam Type –Musculoskeletal (MSK)

No information specific to musculoskeletal exam is required.

4.3.1.10 Exam Type –Nerve

No information specific to nerve exam is required.

4.3.1.11 Exam Type –Orthopedic (Ortho)

No information specific to orthopedic exam is required.

4.3.1.12 Exam Type –Other

No information specific to other exams is required.

4.4.2 Patient Exam List


After entering patient information following Section 4.3.1, press the Patient key to open the
Patient Exam List screen.

NOTE:
 If the system is connected to a worklist server (such as HI S/RI S), you can click the
Worklist button to select a patient from a worklist. For details, refer to the section of
Acquire Patient Information from Worklist.
 Functions of Worklist, MPPS and DICOM can only be used after DICOM is set. For details,
refer to 5.7 DICOM.

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The Patient Exam List screen includes three main sections,
1. Search
2. Exam functions
3. Patient operations

Search
1. Search for the desired information
Select one search requirement, such as Patient ID, and input the relevant information in
the text box.
 If no search requirement is input, click Search to view all patient information saved on
the system.
 Click Reset to clear the search requirement input.
2. Click Search to start search using the above defined search requirement.
3. Double click the patient information to view all exam types of the patient.

Patient operations
Two user interfaces are provided for patient operations: Patient Review and Exam Review.

Figure 4-7 Patient Review Screen

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View View all exams performed for the selected patient.

New Exam Start a new exam for the selected patient.

Delete Patient Delete the selected patient information.

Figure 4-8 Exam Review Screen

Suspend Exam Suspend the currently active exam.

New Exam Create a new exam for the current patient.

Close Exam Click this button and select Yes. Provide information in the PPS
window to close the exam. See Figure4-12.

View Image Review the images or cines of the selected examination. See
Figure 4-9.

Delete Exam Delete the selected exam. An active exam can be deleted only
after being closed.

DICOM Send Send the images or cines of the selected examination to DICOM
server.

DICOM Print Print all images or cines of the selected examination through
DICOM.

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View Image
In the Figure 4-9 View Image screen, press the Set key to select an image. The selected
images will be highlighted with a yellow frame. Buttons at the left side will become active and
user operations are allowed.

Figure 4-9 View Image Screen

Exam Click on this drop-down box to select other exams performed for
the same patient.

All List both images and reports for this exam.

Image List only images for this exam.

Report List only reports for this exam.

Layout Change the layout of the displayed images: 1×1, 2×2, 3×3 or
4×4.

Select All Select all images in the preview window.

Delete Delete the selected images.

Preview Select the image to preview. Or, press the Freeze key to quit the
preview.

DICOM Send Send the selected images to a DICOM server.

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DICOM Print Print the selected images through DICOM.

Print Print the selected images

Export Export to a connected USB device. If more than one USB drives
is connected, select the desired one from the drop-down box.
The format of exported report can be chosen from HTML or PDF.

PC Select the format for exported images or cines.


 For images: JPEG, BMP, TIFF
 For cines: AVI, WMV

Exit Click this button to exit the View Image screen.

Exam Operations
 Click Current Patient to highlight the current exam item if current patient exists.
 Click New Patient to enter the New Patient screen.
 Click DICOM Q/R to enter the DICOM Q/R screen.
 Click DICOM Queue to enter the DICOM Queue screen and check the sending status.
 When the current exam item is highlighted, click PPS to enter the PPS screen, and then
add MPPS information.
 End the exam, and click Import/Export to import or export the patient information.

4.4.3 DICOM Q/R


Patient information can be viewed or queried on the DICOM Q/R screen. Patient information
includes the basic information and image information.

Figure 4-10 DICOM Q/R

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1. Enter the query criteria, and click Query to search the desired patient information.
2. Select the desired patient, and click Query.
 If the desired patient is successfully searched, it will be marked by OK in the Service
Status column.

 If the desired patient failed to be searched, it will be marked by Failed in the Service
Status column. You should check the connection between the ultrasound system and
the Q/R server under such condition.
3. Click Exit, and view the searched patient information in the Patient Exam List screen.

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4.4.4 DICOM Queue
The DICOM Queue records all detailed logs for the DICOM services in following four
categories: image storage, committed storage, MPPS and DICOM print. The log includes
initiation time, image size, result, service status and the returned messages for each service
request.

Figure 4-11 DICOM Queue Screen

Refresh Refresh the log of the DICOM queue.

All Select Select all logs.

Resend Fail Restart the selected fail record.

Resend Resend selected DICOM queue.

Delete Delete selected logs.

Exit Close and exit the DICOM Queue screen.

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4.4.5 PPS Screen
PPS Screen can be opened only when the current exam is active and highlighted.
The PPS Screen includes detailed examination information and scheduled operation
procedure information.

Figure 4-12 PPS Queue


Click Append to add MPPS status for the current exam.
MPPS records the procedures of examinations. The system sends MPPS messages to the
DICOM server when an examination starts, completes or terminates.

4.4.6 Patient Exam Import/Export


The system is set in default that those images will be added into the patient exams database
when exam is active. You can export the patient information to the USB drive or CD/DVD drive
or import it to the system. Import/export function can be performed only when current exam is
closed.
 Patient Information Export
1. Connect the USB drive or DVD drive to the system.
2. Press the Patient key on the control panel to display New Patient screen.
3. Click Patient List -> Patient Review -> Export Screen to display Export Screen.

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Figure 4-13 Export Screen


4. Select patient information to be exported, multiple patients can be selected.
5. Select a storage device in the Export drop-down box,
6. Select the export format from SYSTEM, PC or DICOMDIR.
If PC format is selected, you may further select image format (JPEG, BMP, TIFF) and cine
format (AVI, WMV).
7. Export the patient information.
 If USB drive is connected, click Patient Export to export the selected patient
information to the USB drive.
 If CD/DVD drive is connected, click Burn to export the selected patient information to
the CD/DVD drive.
 Click View to view all exam types of the selected patient or export the selected exam
type separately.
8. Click Delete Patient to delete the selected patient information.

 Patient Information Import


NOTE:
Only patient information file with SYSTEM format can be imported into the system.
1. Connect the USB drive or DVD drive to the system.
2. Press the Patient key on the control panel to display New Patient screen.
3. Click Patient List -> Patient Review -> drop-down box under Import/Export to select the
import device.
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4. Click Import Screen to display the Import Screen.

Figure 4-14 Import Screen


5. Select the patient information to be imported and then click Patient Import.
 Click View to view all exam types of the selected patient or import the selected exam
type separately.
 Click Exit to return to the Patient Exam List screen. The imported patients will be
listed in the Patient Review screen.
 Click Delete Patient to delete selected patient information.

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4.5 Starting Ultrasound Diagnosis


Power on the system and the system enters to Exam screen. Press the Exam key to return
Exam screen. Move the cursor on an application mode icon and press the Set key to start a
real time scan.

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4.6 Main Screen

SonoScape SonoScape HealthCare 2012/02/20 14:39:12


1
20120220_144215 MI/TI 0.6/0.3 C344/Liver

0 5 4
2D
FPS 35
2 D/G 72dB/13
GN 40
PWR 70%
FRQ 4.0MHz 5
D 20.3cm

3 1
0

7
1
5

2
0

The main screen contains the following eight function zones:


1. System information: includes manufacturer logo, hospital name, system time, patient
information, application mode and etc.
2. Image parameters: includes current imaging mode, frame rate, acoustic power, scan depth
and etc.
3. Menu for imaging adjustment
4. TGC, grayscale and color map
5. Horizontal scale and depth scale
6. Depth scale
7. Clipboard (visible when activated)
8. Ultrasound image
9. Status indication bar: includes hints and connection status of peripheral device or network.

Caution
If no operation is performed in 30 minutes, the system automatically exits the real time scan
and returns to the Exam screen, and the probe stops transmitting signals to avoid long time
continuous work.

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Chapter 5 System Setup

Press the Exam key on the Exam screen to enter the System Setting screen.
The general setting and configurations for peripherals, comments, bodymark, measurements,
report, DICOM and remote service can be set in the System Setting screen. System
information can also be found here.

5.1 General Setting


Click the General tab on top left to open the general setting page. It includes the following four
sections: General, Display, Menu and Storage.

5.1.1 General
General configurations include the following:

Hospital Name Enter the hospital name. 30 characters at most can be


input.

Language Click the drop-down box and select the language of the
user interface. Click Apply to change the display language
immediately.

Auto Freeze Response Select the function to be activated once the Freeze key is
pressed in a real time scan.

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Cine, Measurement, Bodymark, Comment or Arrow can
be selected.

Trackball Sensitivity Adjust the trackball sensitivity. Five levels are available,
and the larger the number the higher the sensitivity.

Date Format Adjust the date format.

Time Format Adjust the time format.

Date/Time Setting Click this button to adjust the time zone, system date and
time.

Font Size Adjust the font size for the comment, measurement results,
imaging mode parameters and title bar.

Volume Turn the AUDIO knob to adjust the system volume.


Alternatively, select the intended volume level and press
the Set key.

Apply Click this button to apply any modifications.

Load Default Click this button and select Yes to load the system default
setting.

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5.1.2 Display

TGC Curve Display Set the display method of TGC curve. You can choose
from Always Display, Timeout Hide or Hide.

Patient Name Tick it to display the patient name on the Exam screen.

Patient DOB Tick it to display the date of birth of the patient on the
Exam Screen.

Sonographer Tick it to display the sonographer on the Exam screen.

Open Clipboard On Freeze Tick it to open clipboard automatically after pressing the
Freeze key in a real time scan.

Show Auto Create Patient Tick it to prompt you that patient ID will be generated
ID Prompt Message automatically if you do not enter one when inputting
patient information.

Frequency Display Set it to Center or Range.

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5.1.3 Menu

Add selected item(s) from Available list to Selected list.

Remove selected item(s) from Selected list to Available


list.

Move the item upward in the Selected list.

Move the item downward in the Selected list.

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5.1.4 Storage

Store Region Use the drop-down box to select the region of the
screen to be stored: Full Screen, Ultrasound Image,
or Top Right of Screen.

Store Frame Set the maximum number of frame for cine.

Store to USB Disk Tick it; after you connect the USB drive to the system,
the saved images/cines are synchronously stored to the
USB drive.

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5.2 Peripheral

Video Mode Select output video mode: VGA or TV. The TV mode
contains: NTSC or PAL.

IP Address Only numerical values from 0-255 are allowed.

Netmask Only numerical values from 0-255 are allowed.

Default Gateway Only numerical values from 0-255 are allowed.

DNS Server Only numerical values from 0-255 are allowed.

DICOM AE Title 16 characters at most can be input.

Default Printer Select the desired printer from the drop-down list, and click
Set to save it as the default printer.

Add Printer Click Add, select Net Printer or USB printer in the pop-up
Add Printer dialogue box, and then click Search to search
for the desired printer. Click Next Step to add the desired
printer to the drop-down list of Default Printer.

Media/Position/Scaling Select the size of paper and the position to be printed out
and the print magnification.

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5.3 Comment

Add selected item(s) from Available list to Selected list.

Add all items from Available list to Selected list.

Remove selected item(s) from Selected list to Available


list.

Remove all items from Selected list to Available list.

Move the selected item to the top of the list.

Move the selected item upward in the Selected list.

Move the selected item downward in the Selected list.

Move the selected item to the bottom of the list.

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Edit Comment Item Enter comments in the Edit Comment Item textbox,
and click Add to Lib to add the comment. Or, click
Delete to delete the comment from the Available list.

Display Language Click the drop-down list to select the current system
language.

Clear Annot on Unfreeze If it is ticked, all annotations will be removed when the
image is unfrozen.

5.4 Bodymark

Add selected item(s) from Available list to Selected


list.

Remove selected item(s) from Selected list to


Available list.

Move the selected item to the top of the list.

Move the selected item upward in the Selected list.

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Move the selected item downward in the Selected


list.

Move the selected item to the bottom of the list.

Default Display Position Select the default location for bodymark.

Clear Bodymark on Unfreeze If it is ticked, all bodymarks will be removed when


the image is unfrozen.

5.5 Measure

5.5.1 General

Unit Select the measurement units to be used from


Metric or Imperial.

Heart Rate Cycle Select from 1-6.

GA Calc Select the method for GA calculation.

Shortcut Key Ten shortcut keys on the keyboard can be set

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for OB or Cardiac calculations.

Unfreeze Measure If it is set to On, you can perform the


measurement in the real time mode.
If it is set to Off, the image is frozen when you
perform the measurement.

Measure Line Size Set it to 1, 3, 5, 7, 9, 11 or 13.

Unfreeze Clear Measure Result If it is set to On, all measurement results are
cleared in the real time mode after you perform
the measurement in the frozen mode.
If it is set to Off, all measurement results
cannot be cleared in the real time mode after
you perform the measurement in the frozen
mode.

Auto trace on cine playback status If it is set to On, an auto trace appears and the
system automatically measures and calculates
it when you manually review the cine in the
frozen PW/CW mode.
If it is set to Off, no auto trace appears and the
system cannot automatically measures and
calculates it.

Measure Results Font Size Set it from 12-20.

Show OB Age If it is set to On, OB age will be calculated


according to the date of last menstrual period
or tube baby and displayed in the measured
result box.
If it is set to Off, OB age will not be calculated.

Show EDD If it is set to On, EDD will be calculated


according to the date of last menstrual period
and displayed in the measured result box.
If it is set to Off, EDD will not be calculated.

RUV RATIO Select the ratio of residual urine measurement


to be used from 0.7 or 0.52.

Follicle Measurement Select the measurement method to be used


from Double Caliper or Three Caliper

Show SD If it is set to On, the deviation range between


CUA and EFW will be displayed in the
measured result box and measurement report.

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If it is set to Off, the deviation range will not be
displayed.

5.5.2 Menu

Imaging Mode Click the B, C, M or PW tab to select the imaging mode.

Exam Mode Select the measurement package from the drop-down list.

Move the selected item upward in the list.

Move the selected item downward in the list.

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5.5.3 Formula

BSA Body surface area calculation formula.

AC Abdomen circumference calculation formula.

APTD Anterior-Posterior Thigh Diameter calculation formula.

BPD Biparietal diameter calculation formula.

CER Cerebellum Diameter calculation formula.

CHD Chorion Diameter calculation formula.

CRL Cerebellum Diameter calculation formula.

DS Yolk sac calculation formula.

Fibula Fibula length calculation formula.

FL Femur length calculation formula.

GS Gestational sac calculation formula.

HC Head circumference calculation formula.

EFW Estimated fetal weight calculation formula.

Humerus Humerus length calculation formula.

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LV Lateral ventricle calculation formula.

OFD Occipito-frontal diameter calculation formula.

OOD Outer Ocular Diameter calculation formula.

Radius Radius length calculation formula.

TAD Trans-Abdominal Diameter calculation formula.

Tibia Tibia length calculation formula.

Ulna Ulna length calculation formula.

Apply Click this button to apply any modifications.

Load Default Click this button and select Yes to discard all
modifications and load the system default setting.

5.6 Report

Logo Click <- or -> to select the logo displayed on screen.

Title1/2/3 Enter manually in the corresponding textboxes. 50


characters at most can be input..

Context/Title/SubTitle Set the font size respectively from 14-26.

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Background Color/ Set the color.


Text Color

Display Items For Report Tick the desired items, enter the descriptions in the
corresponding textboxes, and then the corresponding
items will be displayed in the report.

PreView Click this button to preview the report format.

5.7 DICOM
This device complies with the Digital Imaging and Communications in Medicine (DICOM)
standard which is widely accepted as the standard for data storage and communication among
hospitals and organizations.
DICOM configurations can be divided into the following categories: Image Storage, Storage
Commitment, Worklist, MPPS, printing and Q/R.

5.7.1 DICOM Image Storage

Service List Select the desired service name from the


drop-down list. Click Add to add the server, and
click Delete to delete the server.

Remote Host Name 16 characters at most can be input.

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IP Address Only numerical values from 0-255 are allowed.

DICOM AE Title 16 characters at most can be input.

Port Number Five characters at most can be input.

Ping Click this button to test the network connectivity.

Echo Click this button to test whether the remote sever


exists.

Connect Timeout Two characters at most can be input.

Repeat Count Two characters at most can be input.

Dimse Timeout Two characters at most can be input.

Acse Timeout Two characters at most can be input.

Send After Every Image Saved Tick this item, the image will be sent to the remote
server every time when it is saved in the
ultrasound system.

Send At End of Exam Tick this item, the image will be sent to the remote
server after the exam is completed.

Compression Select an image type and the compression level


for the image type.

Quality% Set the compression quality ratio to 0-99.

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5.7.2 DICOM Storage Commitment

Service List Select the desired service name from the drop-down
list.

Remote Host Name 16 characters at most can be input.

IP Address Only numerical values from 0-255 are allowed.

DICOM AE Title 16 characters at most can be input.

Port Number Five characters at most can be input.

Ping Click this button to test the network connectivity.

Echo Click this button to test whether the remote sever


exists.

Connect Timeout Two characters at most can be input.

Repeat Count Two characters at most can be input.

Dimse Timeout Two characters at most can be input.

Acse Timeout Two characters at most can be input.

Synchronously Receive Tick this item, the system synchronously receives


N-EVENT-REPORT Message message with the storage server.

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5.7.3 DICOM Worklist

Service List Select the desired service name from the drop-down
list.

Remote Host Name 16 characters at most can be input.

IP Address Only numerical values from 0-255 are allowed.

DICOM AE Title 16 characters at most can be input.

Port Number Five characters at most can be input.

Connect Timeout Two characters at most can be input.

Repeat Count Two characters at most can be input.

Dimse Timeout Two characters at most can be input.

Acse Timeout Two characters at most can be input.

Max. Result Set the maximum number of patient information can be


sent to the ultrasound system.

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5.7.4 DICOM MPPS

Service List Select the desired service name from the drop-down list.

Remote Host Name 16 characters at most can be input.

IP Address Only numerical values from 0-255 are allowed.

DICOM AE Title 16 characters at most can be input.

Port Number Five characters at most can be input.

Connect Timeout Two characters at most can be input.

Repeat Count Two characters at most can be input.

Dimse Timeout Two characters at most can be input.

Acse Timeout Two characters at most can be input.

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5.7.5 DICOM Print

Service List Select the desired service name from the drop-down
list.

Remote Host Name 16 characters at most can be input.

IP Address Only numerical values from 0-255 are allowed.

DICOM AE Title 16 characters at most can be input.

Port Number Five characters at most can be input.

Connect Timeout Two characters at most can be input.

Format Select the print format from the drop-down list.

Priority Set the printing job priority.

Medium Select the print medium..

Orientation Set the print orientation.

Film Size Set the film size.

Film Destination Specifies the film destination.


Set it to MAGAZINE, image will be stored in a film
magazine.

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Set it to PROCESSOR, image will be processed in a
film processor.

Magnification Set the method used for magnifying images during the
print.

Copies Sets the number of copies to print.

Smoothing Type Specifies the value of magnification interpolation for the


printer.

Trim Specifies whether a trim box should be printed around


each image.

Border Specifies the color of the border to fills the gap between
the images.

Empty Image Set the color of the empty images.

Color Specifies whether to print the images in color or


grayscale.

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

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

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


labels.

Configure Information Specifies special image quality settings.

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5.7.6 DICOM Q/R

Service List Select the desired service name from the drop-down list.

Remote Host Name 16 characters at most can be input.

IP Address Only numerical values from 0 to 255 are allowed.


NOTE:
Click Ping to test the network connectivity.

DICOM AE Title 16 characters at most is allowed.


NOTE:
Click Echo to test whether the ultrasound system is
connected successfully to the Q/R server.

Port Number Five characters at most can be input.

Connect Timeout Two characters at most can be input.

Repeat Count Two characters at most can be input.

Dimse Timeout Two characters at most can be input.

Acse Timeout Two characters at most can be input.

Max. Result Four characters at most can be input.

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5.8 Remote Service


Remote service helps you to solve the abnormity or malfunction occurred in system upgrade or
usage. You can get assistance from after-sales or technical personnel of the manufacturer by
applying it.
To enable remote service,
1. Connect the ultrasound system to the network by using an Ethernet cable.
2. Make settings on the Peripheral menu to ensure the ultrasound system is successfully
connected to the remote server. For details, refer to Section 5.2 Peripheral.
3. Click the Service tab in the System Setting menu to display the following screen.

4. Click Start Remote Service, and the ultrasound system is automatically connected to the
remote server.
 A hint pops up if the ultrasound system is connected successfully.
 Check the network if the ultrasound system fails to be connected.
You should contact after-sales or technical personnel for assistance after applying remote
service.

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5.9 System Information


You can view the current hardware version, the software version and the control number on
this menu. The Control Number is a unique number for the ultrasound system.

Update Click it and select to update the system from network or


USB drive.

Network Set the IP address of the server. Only numerical values


from 0 to 255 are allowed. The system automatically
determines the connectivity to the update server. Press
Confirm to start updating.

Memory Disk Select this option to update using USB drive.

Restore Factory Setting Restore the system to factory setting.

Export Sysinfo Click this button to export the system information to


USB drive.

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Chapter 6 B Mode

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

6.1 Starting B Mode


Select any application part in the Exam screen and press the Set key. The system enters the

B mode by default. You can press to exit other imaging mode and start real time B
mode scan.
B mode interface is shown in Figure 6-1.

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Figure 6-1 B Mode Screen

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6.2 Parameter Adjustment


The B mode operation for the current ultrasound image is independent of the display format
(single, dual or quad).

Press in a real time B mode scan to open B mode menu which includes the following
items.

Real time B mode menu

Focal Number 1

Focal Span 1

Chroma 0

Frequency 8MHz

Power 60

Line Density High

Sec. Width 4.6

DYN 72

GSC 13

Persist 4

Off
μscan

Compound Off

Trapezium Off

L-R Reverse Left

U-D Reverse Up

Rotation 0

Biopsy Off

Biopsy Angle

Biopsy Offset

ECG >>

LGC Left 0

LGC Right 0

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Press in real time B mode to freeze the scan. Press to open the menu
which shows the following items.

Frozen B mode menu

Chroma 3

μscan Off

GSC 3

L-R Reverse Left

U-D Reverse Up

 Instructions:
 Use the trackball to select the menu item.

 Press or rotate anticlockwise to decrease the value.

 Press or rotate clockwise to increase the value.

 If the menu displays items over one page, click PRE or NEXT to turn pages.

 Press to open or close the menu.

6.2.1 Focal Number


Focus refers to the specified area which the transmitted and received ultrasound beam
accumulates. The number of focus is relevant with the image resolution and frame rate. Focus
optimizes the image by increasing the resolution for a specific area. This parameter can only
be adjusted in real time B mode.
Instructions:
1. Open the menu, and use the trackball to select Focal Number.

2. Rotate to decrease/increase the focal numbers.

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6.2.2 Focal Span
When there are multiple focal zones, distance between focal zones can be adjusted as follows:
1. Open the menu, and use the trackball to select Focal Span.

2. Rotate to decrease/increase the space between focal zones.

6.2.3 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.
Instructions:
1. Open the menu, and use the trackball to select Chroma.

2. Rotate to change the chroma setting.

6.2.4 Frequency
The transducer is capable of generating a broadband signal with a certain start frequency and
a certain bandwidth. The higher frequency that is set, the higher the resolution, and the lower
the penetration are.
Instructions:
1. Open the menu, and use the trackball to select Frequency.

2. Rotate to change the frequency range.


NOTE:
The frequency range is displayed at the 2D Image Info area (as FRQ).

6.2.5 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.
Instructions:
1. Open the menu, and use the trackball to select Power %.

2. Rotate to change the value of the acoustic output power.


NOTE:
 The acoustic output power is displayed on the top left screen as PWR.

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 You can decrease the acoustic power indices (MI, TI) by reducing the output power of the
transducer.

6.2.6 Line Density


Line density refers to the amount of ultrasound beam that makes up the image. Increasing the
value of line density improves the resolution and decreases frame rate. Therefore, you have to
balance the frame rate and the image quality when adjusting the line density.
A higher line density is useful in obtaining very high resolution, such as thyroid, testicles. A
lower line density is useful in fetal heart beat, adult cardiac applications and in clinical
Radiology applications.
Instructions:
1. Open the menu, and use the trackball to select Line Density.

2. Rotate to change the line density setting.

6.2.7 Sector Width and Position


Sector width (for linear probes) or sector angle (for curved and phased probes) is used to
adjust the frame rate. You can adjust the sector width or angle to get more information without
moving the probe.
To change the sector width:
1. Open the menu, and use the trackball to select Sec. Width.

2. Rotate to decrease/increase the sector width.


To move the sector position:
1. Open the menu, and use the trackball to select Sec. Position.

2. Rotate to move the imaging sector to the left or right.

6.2.8 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.
Instructions:
1. Open the menu, and use the trackball to select DYN.

2. Rotate to decrease/increase the value of Dynamic Range.

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NOTE:
Dynamic Range is displayed on the top left screen as D/G (D for dynamic range).

6.2.9 Grayscale curve


Due to the difference between the anatomical structures, different organs produce different
grayscale distribution on the ultrasound image. GSC compensates grayscale mapping for
some organs and makes better discrimination for these organs. 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 frozen mode.
Instructions:
1. Open the menu, and use the trackball to select GSC.

2. Rotate to decrease/increase the value of Grayscale Curve.


NOTE:
Grayscale Curve is displayed on the top left screen as D/G (G for grayscale curve)..

6.2.10 Persistence
Persistence is used to average consecutive frames to provide a smoother appearance with
less noise. Use lower persistence values for fast-moving organs or tissues and higher
persistence values for smoother appearance.
Instructions:
1. Open the menu, and use the trackball to select Persist.

2. Rotate to decrease/increase the value of Persistence value.


NOTE:
Persistence value is displayed on the top left screen as I/P (P for persistence).

6.2.11 μScan Function

μScan is used to improve the image quality.


Instructions:
1. Open the menu, and use the trackball to select μScan.

2. Rotate to change the μScan value.

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

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6.2.12 Compound Imaging
Compound imaging is used to acquire a series of overlapping image frames from substantially
differing spatial directions and combining these images to reduce speckle and improve
contrast resolution.
Instructions:
1. Open the menu, and use the trackball to select Compound.

2. Rotate to increase or decrease the value.

6.2.13 Trapezoidal Imaging


Trapezoidal imaging is used to enlarge the imaging area when performing a real time scan by
using the linear transducers.
Instructions:
1. Open the menu, and use the trackball to select Trapezium.

2. Rotate to turn On or Off the Trapezoidal Imaging function.


NOTE:
Only the linear transducers are available for trapezoidal imaging.

6.2.14 L-R Reverse


Use this function to reverse the image orientation left to right without rotating the probe head.
For details, refer to Section 6.3.2.
Instructions:
1. Open the menu, and use the trackball to select L-R Reverse.

2. Rotate to reverse the image left to right.


Or, press the L/R key on the control panel to reverse the image.
NOTE:
Image orientation can be changed in real time mode as well as in frozen mode.

6.2.15 U-D Reverse


Use this function to reverse the image up to down without rotating the probe head.
Instructions:
1. Open the menu, and use the trackball to select U-D Reverse.

2. Rotate to reverse the image.

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NOTE:
Image orientation can be changed in real time mode as well as in frozen mode.

6.2.16 Rotation
Rotation function can rotate the image to a certain angle. The options contain 90°, 180°, and
270°.
Instructions:
1. Open the menu, and use the trackball to select ROT.

2. Rotate to select rotation angle.

6.2.17 Biopsy

Biopsy Gun
Biopsy Type Gun
Biopsy Angle -1.0
Biopsy Offset 40. 0
You can enable or disable the biopsy feature in the real time mode. When Biopsy is set to
Needle, two biopsy guide lines appear. When Biopsy is set to Gun, only one biopsy guide line
appears.
Instructions:
1. Open the menu, and use the trackball to select Biopsy.

2. Rotate to make settings of Biopsy, Biopsy Type, Biopsy Angle and Biopsy
Offset.
NOTE:
 The adjustment ranges of Biopsy Offset and Biopsy Angle vary with the probes.
 You should calibrate the biopsy guideline each time before performing biopsy. Do not use
a needle guide if the path of the needle is not accurately indicated by the on-screen
guidelines. The path of the needle must display within the guidelines.
 The values of Biopsy Offset and Biopsy Angle restore to defaults after system reboot.

6.2.18 B Gain

The B mode gain (2D gain), determines the amplifying factors for the received echoes. The
echoes are amplified with the same gain value regardless of depth. The GAIN knob adjusts
the overall brightness of the 2D image.

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Instructions:
 Turn the GAIN knob clockwise to increase the 2D gain, the ultrasound image gets
brighter.
 Turn the GAIN knob counterclockwise to decrease the 2D gain, the ultrasound image
gets darker.
 Open B mode menu, rotate the Audio knob to select LGC L or LGC R, and then
rotate the knob again to adjust the brightness of the left or right part on the image.
NOTE:
 The gain value is displayed on the top left screen as GN.
 B gain can only be adjusted in real time B mode.

6.2.19 Focus
The focal zone determines the depth range for optimizing the concentration of the ultrasound
beam. Multiple focal zones are possible. The focus identified by a red triangle displays in the
right corner of the image.
If multiple focal zones are present, they are shifted with the same amount of depth.
Instructions:

 Flip downward to shift the focal zones to deeper locations.

 Flip upward to shift the focal zones to shallower locations.

6.2.20 Depth
The depth 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.
Instructions:

 Flip upward to decrease the depth range of the 2D image and the ultrasound

image is magnified.

 Flip downward to increase the depth range of the 2D image and the size of

image is reduced to display the entire ultrasound image.


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 left side of the ultrasound image.

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 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).

6.2.21 Time Gain Compensation (TGC)


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

Use the TGC slide pot to adjust the gain which allows compensation for attenuation

of the echoes over time (depth). TGC balances the image so that the density of echoes is the
same throughout the image.
Instructions:
 Move the slide pot to the left to decrease the gain at the corresponding depth.
 Move the slide pot 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.
 Modifications of TGC values cannot be saved if you shift to use another imaging mode.
 TGC curve disappears when the TGC slide pot is inactive for more than several seconds.

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6.3 Other B Mode Operations

6.3.1 Frozen Mode

During a real time B mode scan, press to freeze an image. Press this key again
to restore to real time scan.

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6.3.2 Image Magnification


You can magnify an interest region on the imaging area.

NOTE:
The image can also be magnified in the frozen mode.

To magnify an image:
1. Press the Zoom key on the control panel to enable this feature.

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2. Position and adjust ROI.


 Position ROI by using the trackball.
 Press the Set key on the control panel, and adjust ROI size by using the trackball.
 Press the Set key again to re-position ROI.
3. Press the Zoom key to magnify the image.
A size multiplier is displayed on the screen, and you can press M, PW or CW to view the
desired image.
4. Press the Zoom key to disable the feature.

6.3.3 Image Reverse (Left/Right)


This function reverses the image left or right, without the need to rotate the transducer itself.

The orientation marker corresponds to the first element of the transducer. See figure
below.

Press and the image will be reversed once.

0
S S 0

5
5
1
1
0
0
1
1
5
5

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6.3.4 Image Reverse (Up/Down)
This function reverses the image up or down. It is most useful in intracavitary examinations.

The orientation marker corresponds to the first element of the transducer. See figure
below.

Press and the image will be reversed once.

0
S
15
5
10
1
0
1 5
5 S
0

6.3.5 Dual Display Format


The dual display of ultrasound images facilitates the comparison of ultrasound images
performed at different time.

1. In a real time B mode, press to activate the dual display. The screen splits into

two parts and displays a real time ultrasound image on the left and a frozen one on the
right, as shown in the following figure.

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1
15
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2. Press , the image on the left is frozen, and the image on the right will be in a
real time B mode.

3. Press again, the image on the left will be in a real time B mode, and the image
on the right will be frozen. The active image (real time image) will be marked with a green
orientation marker.

4. Press again to exit dual display format.

6.3.6 Quad Display Format


The quad display of ultrasound images facilitates the comparison of ultrasound images
performed at different time.

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

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S 0 S 0

5 5

1 1
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2. Press each time to activate the images on top-left, top-right, bottom-left and
bottom-right in order and freeze the other three images. The active image (real time
image) will be marked with a green orientation marker.

3. Press to exit the quad display format.

6.3.7 Tissue Harmonic Imaging (THI)


Tissue Harmonic Imaging (THI) uses the harmonic frequencies generated by tissue. The
fundamental transmit frequency results in a harmonic frequency echo. The harmonic
frequency received from the tissue is a multiple of the fundamental transmit frequency. The
fundamental and any accompanying artifacts are missing from the harmonic frequency that the
system receives. The artifact reduction, and the concomitant reduction in haze and clutter,
increases contrast resolution and improves border delineation. THI is useful in
difficult-to-image patients.

Press to enable the THI mode, THI appears at the top right corner of the screen.
Optimize the image just as the way you did in the B mode.

To disable the THI mode, press again. THI disappears from the screen.

NOTE:
 Compared to the B-mode imaging, THI improves image resolution but decreases the
depth. Therefore, you should make an optimal balance when choosing an imaging mode.
 THI is mainly used with phased array transducers in cardiology application. THI is
available only for selected probes.

6.3.8 Panoramic Imaging


In non-panoramic imaging mode, you can only observe the sectional ultrasonic image of the
body surface where the probe is scanning. When you move the probe, the new sectional
ultrasonic image will replace the previous one, which makes it difficult to observe the whole
anatomical structure and its surrounding tissue.
Panoramic imaging displays individual images stitched in one image and shows the
relationship to adjacent structures. Therefore, panoramic imaging enables you to review and
measure a larger anatomical structure.
NOTE:
Only linear and curved transducers in B mode are available for panoramic imaging.

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Suggestions for preparing panoramic imaging:
 Panoramic imaging is only available performed with linear or curved probes.
 Apply adequate amount of coupling gel along the intended path of the scan.
 Do not shake, rotate or tilt the probe during the scan.
 Ensure the probe remains to be contact with the skin perpendicularly during the
scan.
 Do not change the scan direction or move the probe backwards and forwards.
 When the scan depth increases, generally it is required to decrease the scan speed.
Operation instruction:
1. Acquire a B-mode image in high quality.
2. Press the alphanumeric key P to enter the real time panoramic mode.
3. Acquire an image in the real time panoramic mode, and the mosaic image appears on the
screen in real time.
4. After acquiring the image, press the Freeze key to freeze it, and then the panorama
appears on the screen.
5. Review and edit the image
 Press the Zoom key, use the trackball to review the magnified image. Press the
Zoom key again to return to the panorama.
 Perform measurement, add body marks and annotations and etc.
6. Press the Freeze key to exit panoramic mode and return to the frozen B mode.
7. Press the Freeze key again to return to the real time B mode.

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Chapter 7 CFM Mode

Color Flow imaging adds the color-coded qualitative information in the B-Mode image. Color
Flow imaging is helpful to see the flow, the relevant qualitative information and the flow
velocity.

7.1 Starting CFM Mode

Press in the real time B mode to activate the CFM mode. The CFM sample box

appears on the active 2D image. Press again to return to the real time B mode.

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4000.0 10
PRF
0
WF 600
GN 141
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PWR 60%
FRQ 2.5MHZ 15

Figure 7-1 CFM Mode Screen

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7.2 Parameter Adjustment


The CFM mode operation for the current ultrasound image is independent of the display format
(single, dual or quad). CFM mode parameters and settings can be adjusted through the CFM
mode menu or directly by using the knobs / flip switches.

Press in a real time CFM mode to activate the CFM menu which includes the
following items.

Real time CFM mode


menu

Frequency 8MHz

Power% 60%

Resolution

WF 600

B Reject 26

Persist 4

C. Map 4

Flow Invert Off

Press in real time CFM mode to freeze the scan. Press to open the
menu which shows the following items.

Frozen CFM mode menu

B Reject 26

C. Map 4

Flow Invert Off

 Instructions:
 Use the trackball to select the menu item.

 Press or rotate anticlockwise to decrease the value.

 Press or rotate clockwise to increase the value.

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 If the menu displays items over one page, click PRE or NEXT to turn pages.

 Press to open or close the menu.

7.2.1 Frequency
Frequency optimizes the penetrability and the sensitivity of the color flow.
Higher frequency delivers better display of low flow velocities, but the penetration depth is
reduced.
Lower frequency delivers better display of high flow velocities, but the penetration depth is
increased.
Instructions:
1. Open the menu, and use the trackball to select Frequency.

2. Rotate to change the frequency.


NOTE:
The CFM frequency value is displayed on the bottom left screen as FRQ.

7.2.2 CFM Power


Similar to the acoustic output power in the B mode, the value of the output power in the CFM
mode should be kept as low as reasonably achievable.
Instructions:
1. Open the menu, and use the trackball to select Power %.

2. Rotate to change the value of the acoustic output power.


NOTE:
The acoustic output power in the CFM mode is displayed on the bottom left screen as PWR.

7.2.3 Resolution
Use this function to adjust the resolution power of the image.
Instructions:
1. Open the menu, and use the trackball to select Resolution.

2. Rotate to decrease/increase resolution value.

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7.2.4 Wall Filter
Wall Filter intends to eliminate the low frequency noise generated by movements of blood
vessel walls.
Instructions:
1. Open the menu, and use the trackball to select WF.

2. Rotate to decrease/increase the value.


NOTE:
 The current Wall Filter value is displayed on the bottom left screen as WF.
 The Wall Filter is adjustable within a range which depends on the current PRF value.

7.2.5 B Reject
Set 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 frozen mode.
Instructions:
1. Open the menu, and use the trackball to select B Reject.

2. Rotate to adjust the B Reject value.

7.2.6 Persistence
Persistence is used to average consecutive frames to provide a smoother appearance with
less noise. Use lower persistence values for fast-moving organs or tissues and higher
persistence values for smoother appearance.
Instructions:
1. Open the menu, and use the trackball to select Persist.

2. Rotate to decrease/increase persistence value.


NOTE:
The persistence value is displayed on the bottom left screen as C/P (P for persistence).

7.2.7 Color 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 frozen mode.
Instructions:
1. Open the menu, and use the trackball to select C. Map.

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2. Rotate to adjust the color map method.

7.2.8 Flow Invert


Flow invert is used to view blood flow from a different perspective.
When Flow Invert is set to Off, red pixels represent flow to the probe; blue pixels represent
flow away from the probe.
When Flow Invert is set to On, blue pixels represent flow to the probe; red pixels represent
flow away from the probe.
Instructions:
1. Open the menu, and use the trackball to select Flow Invert.

2. Rotate to enable or disable the Flow Invert function.


NOTE:
You can also press i key on the keyboard to enable or disable the function.

7.2.9 CFM Gain

Properly adjust the CFM gain (or Doppler gain) to ensure that the color flow is
continuous but no color speckle is present.
Rotate the D GAIN knob clockwise / anticlockwise to increase / decrease the CFM gain.
NOTE:
The CFM gain value is displayed on the bottom left screen as GN.

7.2.10 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. Increasing the PRF
range also changes the velocity scale shown on color wedge.

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

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NOTE:
 Different PRF values should be applied according to the flow velocity distribution in
different ograns when performing a scan.
 If the PRF value is too low, aliasing occurs on the spectrum map, parts of the spectrums
display in the opposite directions. If the PRF value is too high, the spectrum map will
display too small to see it clearly and the velocity resolution is also too low.

7.2.11 Steer
The direction of the acoustic beam transmitted by linear transducers can be adjusted in a
real time scan. This function is useful to minimize the angle between the acoustic beam and
the blood flow and enhances accuracy of the calculation data.
Instructions:

 Flip left to rotate the acoustic beam clockwise.

 Flip right to rotate the acoustic beam anticlockwise.

7.3 Other CFM Mode Operations

7.3.1 Frozen Mode

Press to freeze an image in the real time CFM mode scan. Press this key again
to restore to real time scan. The frozen CFM mode screen is displayed as follows.

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7.3.2 Image Magnification


See Section 6.3.2.

7.3.3 B+CFM Real Time Dual Format


Dual display format facilitates you to compare the two images in the B mode and CFM mode.

To activate B+CFM real time dual format mode, press twice in a real time CFM
mode. The left part of screen displays the image in real time B mode, and the right part of the
screen displays the image in real time CFM mode.

To return single display CFM mode, press again.

7.3.4 Quad Display Format


Quad display format facilitates you to compare the images which are acquired at different
times.

1. In a real time B mode, press on the keyboard to activate the quad display format.
The image is reduced to a quarter of its original size and moved to the top left to leave
space for displaying other images, as shown below.

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2. Press to freeze the real time scan and unfreeze the other images in a
clockwise direction.

3. Press again to exit the quad display format.

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Chapter 8 DPI Mode (Doppler Power Imaging)

DPI (Doppler Power Imaging) is a color flow imaging technology which adds the flow signal in
the Color-mode image. DPI uses the number and amplitude of red blood cell going through in
the flow to create the color-coded imaging. The flow with slow velocity and small rate could be
displayed in DPI. Therefore, the flow with a higher sensitivity can be detected without
overlaying any flows with high velocity.
The direction of flow, the flow velocity and flow properties cannot be reflected in the DPI-Mode
image.

8.1 Starting DPI Mode

Press in the real time B mode to activate the DPI mode. The DPI sample box
appears in the active 2D image.

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Figure 8-1 DPI Mode Screen

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8.2 Parameter Adjustment

Press in a real time DPI mode to activate the DPI menu which includes the following
items.

Real time DPI mode menu

Frequency 8MHz

Power% 60%

Resolution

WF 600

B Reject 23

Persist 4

C. Map 3

Press in a real time DPI mode to freeze the scan. Press to open the
menu which shows the following items.

Frozen DPI mode menu

C. Map 3

B Reject 26

 Instructions:
 Use the trackball to select the menu item.

 Press or rotate anticlockwise to decrease the value.

 Press or rotate clockwise to increase the value.

 If the menu displays items over one page, click PRE or NEXT to turn pages.

 Press to open or close the menu.

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8.2.1 Frequency
See Section 7.2.1.

8.2.2 DPI Power


See Section 7.2.2.

8.2.3 Resolution
See Section 7.2.3.

8.2.4 Wall Filter


See Section 7.2.4.

8.2.5 B Reject
See Section 7.2.5.

8.2.6 Color Map


See Section 7.2.7.

8.2.7 Persistence
See Section 7.2.6.

8.2.8 DPI Gain


See Section 7.2.9.

8.3 Other DPI Mode Operations


See Section 7.3.

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Chapter 9 TDI Mode

NOTE: TDI mode is supported only by phased array transducers working in cardiac
applications.
Based on Doppler Principle, TDI is used to form the 2D image by acquiring the low frequency
but high amplitude signal. The signal is adjusted and output from the wall filter.
When TDI mode is used in cardiac application, the system detects the low frequency signal
reflected from the cardiac muscle and form the image of its movement. The direction and
speed of the cardiac muscle movement can be viewed.

9.1 Starting TDI Mode

Press in the real time B mode to activate TDI mode. The TDI sample box appears in
the active 2D image.

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Sample Box 2D Image

Figure 9-1 TDI Mode Screen


To adjust the position of the sample box:
1. Press the Set key and move the trackball to adjust the size of the sample box,
2. Press the Set key again to adjust the position of the sample box.

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9.2 Parameter Adjustment

Press the key in the real time TDI mode to open TDI mode menu which includes the
following items.

Frequency 2.5

Power 60

Resolution High-4

B Reject 255

Persist 0

Color Map 0

Press the key in the real time TDI mode to freeze the image. And press the
key again to open the following menu:

Color Map 0

9.2.1 Frequency
See Section 7.2.1.

9.2.2 Power
See Section 7.2.2.

9.2.3 Resolution
See Section 7.2.3.

9.2.4 B Reject
See Section 7.2.5.

9.2.5 Color Map


See Section 7.2.7.

9.2.6 Persistence
See Section 7.2.6.

9.2.7 TDI Gain


See Section 7.2.9.

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9.3 Other TDI Mode Operations


See Section 7.3.

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Chapter 10 M Mode

M mode is generally used with 2D imaging, and is helpful for cardiac applications. In the M
mode, you can position the M-line in the 2D image on the anatomy of interest, and then learn
about the tissue motion along that line in an M-mode trace. In M-mode, y-axis is used to
display the position or depth of the tissue, and x-axis is the time scale.

10.1 Starting M Mode

10.1.1 Inactivated M Mode

Press in a real time B/CDI/DPI/PW/CW scan to enter the inactivated M mode,


and the screen is divided into two displays. The M line displays on the 2D ultrasound image,
and the M trace displays on the lower of the screen. You can use the trackball to move the M
line.

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Figure 10-1 M Mode Screen

Press to open the menu which includes the following items.

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Real time M mode menu

Display Format V1/1

Sweep Speed 4.0s/f

10.1.2 Activated M Mode

Press in the inactivated M mode to enter the M mode scan. The M mode trace
displays on the lower half of the screen.

10.2 Parameter Adjustment

Press in the inactivated M mode to display the following menu.

Display Format V1/1

Sweep Speed 4.0s/f

Steer M Off

Press in the real-time M mode to display the following menu.

Sweep Speed 4.0s/f

Display Format V1/1

Chroma 0

Smoothing 1

Video Invert Off

Press in the real-time M mode to freeze the image, and press to


display the following menu.

Display Format V1/1

Chroma 0

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10.2.1 Display Format
Use this function to change the layout of the B+M mode ultrasound image. There are 5
different layout formats available.
Instructions:
1. Open the menu, and use the trackball to select Display Format.

2. Rotate to change the Display Format.

10.2.2 Sweep Speed


Use this function to adjust the speed of sweeping in the M mode. The larger the sweep speed
is set, the faster the M trace is updating.
Instructions:
1. Open the menu, and use the trackball to select Sweep Speed.

2. Rotate to change the sweep speed.

10.2.3 Steer M
Use this function to adjust the M line to be perpendicular to the anatomical plane.
Instructions:
1. Open the menu, and use the trackball to select Steer M.

2. Rotate to turn on or off the Steer M on the display.


3. Use the trackball to move the M line.
NOTE:
 If Steer M is set to 1, 2 or 3, you can press the Set key to toggle among the M lines.
 For some probes, if Steer M is set to 1, 2 or 3, you can press the Update key to toggle
among the M lines.

10.2.4 Chroma
Similar to the chroma setting in the B mode, this function gives the effect of changing the M
trace color. The chroma value is adjustable in the real time mode as well as the freeze mode.
Instructions:
1. Open the menu, and use the trackball to select Chroma.

2. Rotate to change the chroma value.

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10.2.5 Smoothness
Smoothness enhances the time-continuity and resolution of M trace by adjusting parameters
of time-relevance. Larger smoothness produces better image resolution but reduces
refreshing time. This parameter is adjustable only in real time mode.
Instructions:
1. Open the menu, and use the trackball to select Smooth.

2. Rotate to change the Smooth value.

10.2.6 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 it to on.
Instructions:
1. Open the menu, and use the trackball to select Video Invert.

2. Rotate to enable or disable the function.

10.3 Other M Mode Operations

10.3.1 Frozen Mode

Press in a real time scan to start the M cine mode.

Press again to resume the real time scan.

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10.3.2 M Line
In the M inactivated or real time mode, the M line displays at the default position of the B mode
ultrasound image. You can use the trackball to move the M line.

10.3.3 Dual Display


The dual display of ultrasound images facilitate the comparison of ultrasound images
performed at the different time.

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Instructions:

1. Press in the real-time M mode to activate the dual display. The screen is divided

into two displays with a real time ultrasound image on the left and a frozen image on the
right.

2. Press to freeze the image on the left and activate the image on the right.

3. Press again to freeze the image on the right and activate the image on the left.
The activated image is marked with a green orientation marker.

4. Press again to exit the display.

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Chapter 11 PW Mode

Pulsed Wave Doppler (PW) is a Doppler mode that measures velocity in a PW sample volume
and displays that information in a spectral trace with audio output.

11.1 Starting PW Mode

11.1.1 Inactivated PW Mode

Press in a real time B/CDI/DPI/PW/CW scan to enter the inactivated PW mode,


and the screen is divided into two displays. The spectral Doppler line displays on the 2D
ultrasound image, and the PW trace displays on the lower of the screen.

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PRF 5500.00 100
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DYN 140
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Figure 11-1 PW Mode Screen

11.1.2 Activated PW Mode

Press to activate the PW trace which will be updated on the lower half of the screen.

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11.2 Parameter Adjustment

Press in the inactivated PW mode to display the following menu.

Display Format V1/1

Sweep Speed 4.0s/f

2D Refresh Off

Press in the real-time PW mode to display the following menu.

Frequency 2.5MHz

Power 70%

Sweep Speed 4.0s/f

DYN 140

WF 4

Chroma 0

Display Format V1/1

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Spect Invert Off

Video Invert Off

2D Refresh Off

11.2.1 Frequency
See Section 7.2.1.

11.2.2 PW Power
See Section 7.2.2.

11.2.3 Sweep Speed


See Section 10.2.2.

11.2.4 Dynamic Range (DYN)


See Section 6.2.8.

11.2.5 Wall Filter (WF)


See Section 7.2.4.

11.2.6 Chroma
See Section 10.2.4.

11.2.7 Display Format


See Section 10.2.1.

11.2.8 Flow Invert


You can use the flow invert function in the PW to invert the spectral display in relation to the
flow direction.
Instructions:
1. Open the menu, and use the trackball to select Spect Invert.

2. Rotate to enable or disable the function.

11.2.9 Video Invert


This function has the effect of changing the background of the spectral display.
Instructions:
1. Open the menu, and use the trackball to select Video Invert.

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2. Rotate to enable or disable the function.

11.2.10 2D Refresh
2D refresh is used to synchronously display two real time scans in the 2D and the PW modes.
Instructions:
1. Open the menu, and use the trackball to select 2D Refresh.

2. Rotate to enable or disable the function.

11.2.11 Baseline
Baseline represents the position of zero velocity or frequency. The velocity range in one
direction can be increased or decreased by adjusting the baseline.
Baseline is used to unwraps the alias during color flow imaging, and display higher velocities
without reversal of colors.
Instructions:

Flip to move the baseline up or down. Note that when the baseline is adjusted
incorrectly spectral trace may produce overlapping phenomena.
NOTE:
If the baseline is adjusted incorrectly, overlapping phenomena may be produced on the PW
trace.

11.3 Other PW Mode Operations

11.3.1 Frozen Mode

Press in a real time PW scan to start the spectral Doppler cine mode.

Press again to resume the real time scan.

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14s

11.3.2 Spectral Doppler Line


Use the trackball to move the spectral Doppler line in the inactivated or real time PW mode.

11.3.3 Sample Volume Gate


Use the trackball to move the spectral Doppler line in the inactivated or real time PW mode.
Press the Set key, use the trackball to change the sample volume gate, and then press the Set
key to confirm.

11.3.4 Flow Cursor


Rotate the ANGLE knob to adjust the angle of flow cursor in the inactivated or real time PW
mode.

11.3.5 Baseline

Flip upward to move the baseline towards the positive direction, and the velocity
range in the color map varies with the adjustment.

Flip downward to move the baseline towards the negative direction, and the
velocity range in the color map varies with the adjustment.

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11.3.6 Dual Display
The dual display of ultrasound images facilitate the comparison of ultrasound images
performed at the different time.

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200 200
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PRF 5500.00 100 100
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PWR 70%
DYN 140
SV 3.1 -100

Instructions:

1. Press in the real-time PW mode to activate the dual display. The screen is

divided into two displays with a real time ultrasound image on the left and a frozen image
on the right.

2. Press to freeze the image on the left and activate the image on the right.

3. Press again to freeze the image on the right and activate the image on the left.
The activated image is marked with a green orientation marker.

4. Press again to exit the display.

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Chapter 12 Miscellaneous Functions

12.1 Annotation
The annotation function allows the user to add textual comments or arrows on the ultrasound
image.

12.1.1 Textual Annotation

Press in any mode to enter the editing status. You can enter texts directly using the
alphanumeric keyboard or select an annotation string from the annotation library.
 To modify annotation

Press to start the annotation mode, the cursor is changed to |. Move the
trackball to highlight the annotation item to be modified, edit the item directly using the
alphanumeric keyboard.
 To move annotation

Press to start the annotation mode, the cursor is changed to |. Move the
trackball to highlight the annotation item to be moved, drag the item directly to the new
location.
 To insert annotation

Press to start the annotation mode, the cursor is changed to |. Move the
trackball to a location where the new annotation will be added and type using the
alphanumeric keyboard to add the new annotation.
 To delete annotation

Press to start the annotation mode, the cursor is changed to |. Move the

trackball over the annotation item to be deleted and press .


 To clear annotation

Press to start the annotation mode, the cursor is changed to |. Press

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to remove all annotation items added on screen.

12.1.2 Arrow Annotation

Press in any mode to enter the editing status.

 Use the trackball to move the trackball, rotate to rotate the direction of the
arrow.
 Press the up or down keys on the alphanumeric keyboard to change the size of the arrow.

 Press again to exit the editing mode.

 To remove the arrow added on screen, first enter the annotation mode, move the trackball

to select the arrow and press .

12.2 Bodymark

Press in any mode to add body marks on screen.

 To select body mark


Move the cursor to select a symbol, the selected symbol will be highlighted with a blue frame.

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Press to add the selected symbol on the ultrasound image.

 To move body mark

Move the cursor over the symbol and press . Press again or press to

confirm movement.

 To rotate probe mark

Rotate to rotate the direction of the probe mark.

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 To delete probe mark

Press or to remove the body mark.

Press on the dual or quad display to remove the body mark in the real-time

mode. Press to delete all body marks.

NOTE:
Body mark can only be deleted when it is being edited.

12.3 Save and Review


The system can save multi-frame cine clips or single frame image to local hard drive. Data can
be saved locally on system or remotely through DICOM.
 To save image

Press in the frozen mode to save the single frame image. A thumbnail is

displayed on the clipboard.

 To save all Frames as cine

Press to freeze the image. Hold in the frozen mode to save


multi-frame cine. A thumbnail is displayed on the clipboard.

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 To save selected frames as cine

Press in the real-time mode to freeze the image. Use the trackball to move the

red marker to the start and end positions and press to select the frames. Hold

to save multi-frame cine.

 To review image or cine


 To review the current image or cine
 To review through the clipboard
1. Press the space key in the frozen mode to open the clipboard.
2. Rotate the ANGLE knob to select the desired image or cine, press the Set
key to confirm.
3. Press the Freeze key to resume the real time scan.

 To review through the Exam screen


1. Press the Patient key when performing an exam.
2. Select the desired patient and click View.
3. Click View Image to select the current image or cine.
4. Press the Set key twice to review the image or cine.

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 To retrieve the image or cine


1. Press the Patient key when an exam is not performed.
2. Select the desired patient and click View.
3. Click View Image to select the current image or cine.
4. Press the Set key twice to review the image or cine..

12.4 Customize Exam Mode


Many application/exam modes have been predefined on the system. The user can customize
imaging parameters and save the customized exam mode which will be displayed as exam
icons on the EXAM screen.

12.4.1 Create New Exam Mode


1. Select a probe and an exam type.
2. Adjust imaging parameters in the real-time mode.
3. Press the S key to display the following dialogue box.

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4. Enter name for the new exam mode and click .

5. Click New to create a new exam mode.

12.4.2 Edit Exam Mode


You can adjust the layout of the application mode screen. Moreover, the customize exam
mode (except system exam mode) can also be deleted.
1. Press the E key on the probe selection screen to display the following window.

NOTE:
An exam type suffixed with s is a system application preset, suffixed with u is a customized
application preset.
2. Select an exam type from Local Disk.
3. Click Up or Down to move the exam mode up or down.

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4. Click Save to complete.
 Click Delete to remove the exam mode.
 Click Reset to restore the default exam mode.
 Click Exit to quit the screen.

12.4.3 Import/Export Exam Mode


NOTE:
Customize exam mode (except system exam mode) can be exported.
1. Press the E key on the probe selection screen.
2. Select a probe and the disk.
3. Select an exam type from Local Disk.
4. Perform the following operations.

 Click to export the select exam mode to the USB drive.

 Click to export all exam mode of the selected transducer to the USB drive.

 Click to import a selected exam mode from the USB drive to local
system.

 Click to import all exam modes from the USB drive to local system.
5. Click Exit to quit the screen.

12.5 Print
This device supports video/thermal printing, USB printing and DICOM printing. Connection
through proper I/O port is necessary to use the printing function.
Instructions:

 Press to print the current screen using a video printer.

 Press to print the current screen.

NOTE:
Consult the printer user guide for installation and usage instructions.

12.6 ECG Module


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

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The ECG module provided by this ultrasound system is for collecting and displaying 3-lead
ECG trace.

Warning
 This ECG module is not suitable for intracardiac use or direct cardiac contact.
 This ECG module provides 3-channel ECG signals, and cannot be used for diagnosis
and monitoring.
 To avoid electric shock, ensure the ECG cable is intact and be correctly connected.
 Conductive parts of electrodes and connectors for ECG should not contact other
conductive parts including earth/grounding.
 Power off the ultrasound system if the patient is found to use the pacemaker or
implantable cardioverter-defibrillators, because the ultrasound system may interfere
with these devices.

12.6.1 Basic Procedures of ECG Operation


Perform the steps as follows:
1. Power off the ultrasound system, and connect the ECG cable to the specific port of the
ultrasound system.
2. Power on the ultrasound system, and attach the ECG electrodes on the patient’s body (as
shown in the following figure).

3. Make the relevant settings of the ECG module. For details, refer to Section 12.6.2
Optimizing Parameters.
4. Freeze the images and review them. For details, refer to Section 12.6.3 Reviewing ECG.
5. Exit the ECG mode, and remove ECG electrodes from the patient.

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12.6.2 Optimizing Parameters
Press the Menu key on the control panel, use the trackball to select ECG, and rotate the Menu
knob to display the submenu of the ECG module.
ECG ON/OFF Display or hide the ECG waveform.
ECG GAIN Set the amplitude of the ECG waveform.
Choose from: 1, 2, 3, 4, 5, 6
ECG POSITION Set the vertical position of the ECG waveform.
Choose from: 1, 2, 3, 4, 5, 6, 7, 8
ECG INVERT Enable or disable the waveform inversion function.
Choose from: On or Off
R-TRIGGER Enable or disable the R-trigger function.
Set it to ON, R-TRIGGER pops up when detecting abnormal ECG
waveforms.

NOTE:
Only phased probes are available for this feature.
TRIGGER DELAY Delay of trigger after the 2D refresh.
FRAME COUNT Image frames transferred per second.
FRAME INTERVAL Interval between 2D image refresh.

12.6.3 Reviewing ECG


Press the Freeze key on the control panel to freeze an image, and the ECG waveform is
frozen at the same time. You can view the ECG waveform frame by frame using the trackball.

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Chapter 13 4D

The images of 3D mode are 2D images, while the images in the 4D mode are images of 3D
mode adding time dimension. The probe scans for a period to acquire images, and then the
images are processed by the system.
The system supports 3D and 4D imaging features, and the relevant work flow is shown as
follows:

 To enter the inactivated 4D mode


Connect the 4D probe to the system, select an exam type on the Exam screen to enter the

real-time 2D mode, and then press to enter the inactivated 4D mode.


 To enter the 3D mode from the inactivated 4D mode

Press in the inactivated 4D mode, the system will form several frames of tissue
slices scanned by the 4D probe into a frame of 3D image.
 To enter the real-time 4D mode from 3D mode

Press in the 3D mode to enter the real-time 4D mode.

 To return to the real-time 2D mode from the 3D mode

Press in the 3D mode to return to the real-time 2D mode.


 To select a display format in the inactivated 4D mode
Press 1, 2, or 4 key in the inactivated 4D mode to select a display format.
 To return to the real-time 2D mode from the real-time 4D mode

Press in the real-time 4D mode to return to 2D real-time mode.

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 To select a display format in the real-time 4D mode

Press in the real-time 4D mode to enter the frozen 4D mode.

 To return the real-time 4D mode from the frozen 4D mode

Press in the frozen 4D mode to return to the real-time 4D mode.

 To return to the real-time 2D mode from the frozen 4D mode

Press in the frozen 4D mode to return to the real-time 2D mode.


 To save and review images
You can save 2D images, cines and 3D images. In 2D mode, 3D images can be reviewed
in the 2D mode.

13.1 Inactivated 4D
You can acquire 4D image by adjusting ROI in the inactivated 4D mode, or open the menu to
adjust parameters.

13.1.1 Enter Inactivated 4D

Press in a real time B mode to enter the inactivated 4D mode.

Figure 13-1 Inactivated 4D

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13.1.2 ROI
2D image, ROI and sample line are displayed in the inactivated 4D mode. You can adjust ROI
and sample line to generate 4D image.
 To adjust ROI
1. Use the trackball to position ROI.
2. Press the Set key, and use the trackball to adjust the size of ROI.
 To adjust sample line
1. Press the Update key to position the sample line.
2. Press the Update key again to adjust the size of the sample line.

13.1.3 Parameter Adjustment


Press the MENU key in the inactivated 4D mode to open the menu, use the trackball to select
the menu items, and then rotate the MENU knob to change the value.
 Sweep Angle
It determines the sweep angle of the transducer. Change the Sweep angle to adjust the
sweep range of the Y slice, and the range is between 20 and 75, every 5 a level.
 Image quality
It determines the quality of the image, including three levels: low, middle, high.
 Stability
It determines the stability of the image while entering 4D mode.

13.1.4 Exit
 Press the Freeze key in the inactivated 4D mode, the probe starts to work, and the
system enters the frozen 4D mode. This frozen image is of high quality.
 Press the 3D key in the inactivated 4D mode to return to the B mode.
 Press the Exam key to exit the inactivated 4D mode.

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13.2 Activated 4D Mode

13.2.1 Enter Activated 4D Mode


Press the alphanumeric keys 1, 2, 4 to respectively activate single display, dual display and
quad display.
Single Display:

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Dual Display:

NOTE:
The slice in the red frame is X slice.
Quad Display:

NOTE:
The slice in the red frame is X slice, in the green frame is Y slice, and in the blue frame is Z
slice.

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13.2.2 4D Menu
Press the MENU key in the inactivated 4D mode to open the menu, use the trackball to select
the menu items, and then rotate the MENU knob to change the value.
 Adjust Slice
Adjust slice to observe the slice of a part of the image.
1. Open the menu, and use the trackball to select Adjust Slice.

2. Rotate the trackball to move the cursor upon a slice, press to select the slice.

3. Rotate to adjust the position of the slice on the axis.


 ROI Show
Adjust this value to open the ROI on the image and slices. With Crop function together,
they can crop images.

1. Use the trackball to move the cursor on a slice of dual or quad display, press
to select the slice.
2. Use the trackball to position ROI.

3. Press , and use the trackball to adjust the size of ROI.

4. Press again, and use the trackball to position ROI.

 Crop
This function only can be used on condition that the ROI Show is turned on.
It determines whether crop the image with the ROI. If the value of the Crop is on, the
parts outside the ROI would be cut off, only the image inside the ROI would be kept.

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 Render Mode
This function sets the render method of the image. The default render mode is Vol
(Volume rendering).
1. Open the menu, and use the trackball to select Render Mode.

2. Rotate to select the mode.


 X Rotate/Y Rotate/Z Rotate
This function makes the 4D image rotate around the desired axis.
1. Open the menu, and use the trackball to select X Rotate, Y Rotate or Z Rotate.

2. Rotate to make the image rotated on the desired axis.


 Zoom
Adjust this item to zoom in and out the 4D image.
1. Open the menu, and use the trackball to select Zoom.

2. Rotate to zoom in or out the image.


 L-R Move
Adjust this item to move the image leftwards or rightwards.
1. Open the menu, and use the trackball to select L-R Move.

2. Rotate to move the image.

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 U-D Move
Adjust this item to move the image upwards or downwards.
1. Open the menu, and use the trackball to select U-D Move.

2. Rotate to move the image.


 Restore
Adjust this item to restore the image.
1. Open the menu, and use the trackball to select Restore.

2. Rotate to restore the image.


 Opacity Offset
Adjust this item to change the transparency of the image. The adjusting range is from 15
to 50.
1. Open the menu, and use the trackball to select Opacity Offset.

2. Rotate to adjust the transparency.


 Brightness
Adjust this item to change the brightness of the image. The adjusting range is from 1 to
100.
1. Open the menu, and use the trackball to select Bright.

2. Rotate to adjust the brightness.


 Color Map
Adjust this item to change the color of the image. 5 colors can be selectable: 0, 1, 2, 3, 4.
1. Open the menu, and use the trackball to select Color Map.

2. Rotate to change the value.


 Stability
Adjust this item to enable or disable the function.
1. Open the menu, and use the trackball to select Stability.

2. Rotate to enable or disable the function.

13.2.3 Rotate Image


4D image can be rotated from any angle.

Use the trackball to move the cursor on an area of the 4D image, press to select this
area, and then use the trackball again to rotate the this area from any angle.

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13.2.4 Zoom
Zoom in or out the image with the shortcut key.

Use the trackball to move the cursor on an area of the 4D image, press to select this
area, and then use the trackball to zoom out or zoom in the image.

13.2.5 Print

After connecting the system to the printer, press to print a current screen shoot.

13.2.6 Exit
In the 4D real-time mode,

 Press to exit the real-time 4D mode and return to the frozen 4D mode.

 Press to exit 4D real-time mode and return to B mode.

 Press to exit the real-time 4D mode and return to the application screen.

13.3 Frozen 4D Mode


4D probe stops working in the frozen 4D mode. You can observe, review, save and calculate
images.

13.3.1 Enter Frozen 4D Mode

Press in the real-time 4D mode to enter the frozen 4D mode.

Press in the inactivated 4D mode, the system automatically enters the frozen
mode and the image is of high quality.

13.3.2 Parameter Adjustment

Press in the frozen 4D mode to open the menu, rotate to select the menu items,

and then rotate to change the value.


 Adjust Slice/ROI Show/Crop/Render Mode/X Rotate/Y Rotate/Z Rotate/Zoom/L-R
Move/U-D Move/Restore/Opacity Offset/Bright/Color Map/Stability/Free Rotate
See Section 14.2.2 - 14.2.4.
 Trace Cut
This function allows users to draw slice line manually to crop the image by any shapes.

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 If the value of Trace Cut is In, it would cut off the image inside the slice line.
 If the value of Trace Cut is Out, it would cut off the image outside the slice line.

1. Move the cursor on the 3D image, and press .


2. Use the trackball to trace along the desired object.

3. Press again to acquire the image.

Press or to select the image, and you can rotate or zoom in or out the
image.

Caution
 Trace Cut function only can be used on condition that the ROI Show is turned off,
otherwise the Trace Cut menu item would be gray.
 Undo Cut function only can be used on condition that the Trace Cut is turned on,
otherwise the Undo Cut menu item would be gray.
 Selecting Undo Cut would restore the image to the last operation of Trace Cut. Users
can restore the image from operating Trace Cut for 15 times.
 Volume Review
The system would save the data of 6 frames before entering the frozen 4D mode. You can
observe those data of 6 frames through this function. The value of the Volume Review
ranges from 0 to 5, corresponding to those data of 6 frames saved in the 4D real-time
mode.
1. Open the menu, and use the trackball to select Volume Review.

2. Rotate change the value.


 Cine Review
Set Cine Review to On, the cine loop bar appears on the left lower corner.

The total frame number and the current frame are marked out in the bar.
Move the trackball left or right to view frame by frame.

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 Sweep Angle

Caution
The value of the three menu items (Sweep Angle, Image quality and Stability) would affect
the scanning method in real-time mode after canceling the frozen mode.
If you change the value of Sweep Angle in the frozen 4D mode, after entering the
real-time 4D mode, the value of Sweep Angle would also be changed.
1. Open the menu, and use the trackball to select Sweep Angle.

2. Rotate to change the value.


 Image Quality
If you change the value of Image quality in the frozen 4D mode, after entering 4D
real-time mode, the value of Image quality would also be changed.
1. Open the menu, and use the trackball to select Image quality.

2. Rotate to change the value.


 Multi Slice
See Section 16.2.11.
 Save
1. Press the Save key on the keyboard, and saving dialogue box appears;
2. Move the trackball to select the desired type.
3. Press the Set key to save image, cine or volume.
And then the saved image or volume data appears on the clipboard.
 Review
You can review the image using the following two methods according to actual needs:
Method 1:
1. In non-3D mode, press the Freeze key.
2. Press the space key on the keyboard, and then clipboard appears on the lower left of
the screen.
3. Rotate the ANGLE knob to select the image you need to review.
4. Press the Set key to review the selected image/cine.
Method 2:
1. Press the Patient key to enter patient information interface.
2. Click Patient Review tab on Patient screen.
3. Select the target patient, click View to enter the Exam Review screen.
4. Click Exam Type -> View Image to enter View Image screen.
Thumbnail images of this patient are displayed on the screen.

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5. Preview or retrieve images:
 Select one or more images, click Review to open the selected images.
 Click All Select -> Review to review all the images.
Select an image, press the Set key twice to view this image and perform relative
measurement.

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Chapter 14 Probes

You should be thoroughly familiar with the operations of the probes before using them. To
ensure the performance and availability of the probes, you should also periodically check,
clean, disinfect or maintain them.

NOTE:
A general instruction for the probes is provided in this manual. For details, refer to the relevant manuals.

14.1 Probe
This ultrasound system supports a wide range of probes which make the system remarkably versatile.

14.1.1 Available Probes


The available probes are listed as follows:

Model Application

2P1, 5P1, C611, C362, C344, C354, VC6-2,


Body surface
L741, L742, L743

6V1, 6V3, EC9-5 Intracavitary

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14.1.2 Probe Usage

Warning
 Do not use the probes other than those provided by the manufacturer. Otherwise,
the ultrasound system cannot be performed, and an accident such as a fire may
result in the worst case.
 Use the probe carefully. If any part of the transducer surface is scratched,
immediately stop using the probe. Otherwise, there is a danger of electric shock.
 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.
 Use the legally marketed coupling gel in accordance with the relevant local
regulations. Read and understand all precautions in the relevant manual of the
coupling gel before using it.
 Special concerns before probe usage:
Inspect the probe before each use. In case the following damage is found, stop
using the probe immediately.
 Cracks on the probe handle (user section).
 Cracks on the transducer surface (applied section).
 Scratches on the transducer surface (acoustic window surface).
 Swell of the acoustic window material.
 Cracks or wear on the probe cable.
 Cracks on the probe connector or any other kinds of visible damage.
 Deformed pins or broken pins exist inside the probe connectors.
 Body surface probe usages
1. Wear medical sterile gloves.
2. Orient the probe
3. Perform a scan.

 Endocavitary probe usages


1. Wear medical sterile gloves.
2. Wear the probe sheaths.
a. Remove the packaging and unfold the probe sheath.
b. Apply an appropriate amount of coupling gel to the inside of the sheath and
onto the face of the probe.
c. Hold the probe and unroll the sheath onto the probe.
d. Pull the probe sheath tightly over the face of the probe to remove wrinkles.
e. Secure the sheath to the probe with the adhesive tapes or elastic bands
provided.
f. Remove the sheath from the probe, and dispose of the sheath in
accordance with the local laws and regulations.

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3. Orient the probe
Check the probe orientation mark before the scan.
The image acquired from the mark side of the probe is displayed on the monitor.
4. Perform a scan.

14.1.3 Cleaning the Probe

Warning
 To avoid probe damages, do not bump the probe on hard surfaces during the
cleaning.
 To avoid the electric shock, disconnect the probe from the ultrasound system
before the cleaning.
 To avoid the potential disease transmission, you should wear medical sterile
gloves and protective goggle during the cleaning.
You should clean the probe after each use.
Perform the following steps to clean the probe.
1. Disconnect the probe from the ultrasound system, and remove the probe sheath from
the probe.
2. Use a lint-free soft cloth dampened with mild soapy water to wipe the probe.
 If the probe carries blood, body fluid or dried stains, you should wipe it with
enzymatic cleaner.
NOTE:
Follow the manufacturer’s instructions to make up the enzymatic cleaner.
 If there are stains on surface or grooves of the probe, you should use a brush
dampened with portable water to remove them.
3. Rinse the probe with the fresh running water to remove the residual cleaner
completely.
4. Dry the probe with a lint-free soft cloth dry cloth.

14.1.4 Disinfecting and Sterilizing the Probe

Warning
 Use the liquid disinfectant/sterilant that meets the local laws and regulations.
 If you use the recommended disinfectant/sterilant, ensure its level and the probe
soak period meets the requirements. Otherwise, the probe could be damaged
and your warranty might be void. If you have other use or needs, ensure the level
of the make-up disinfectant/sterilant and the probe soak period are suitable for
the intended clinical application.

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 Do not use the expired disinfectant/sterilant.
 Store the probe in a sterile environment, and mention its expiry date before use.
 Do not disinfect or sterilize the probe through autoclaving or contact with
ethylene oxide.
 Do not use thermal disinfection/sterilization. Temperatures higher than 66°C
(150°F) will damage the probe.
 Not allow any disinfectant/sterilant to be air-dried on the probe.
 Disinfection Levels
To choose an appropriate disinfectant, you first must determine the required level of
disinfection, based on the probe applications.

Level of
Classification Definition Application
Disinfection

Device enters otherwise Intraoperative,


Critical sterile tissue (intraoperative Sterilization biopsy use or blood
applications) contacting probe

Device contacts mucous


Endocavitary
Semi-critical membranes High
probe
(intracavity applications)

Noncritical Device contacts intact skin Medium or low Body surface probe

 Soak Requirements
Do not immerse the probe beyond its junction line.
NOTE:
Disinfectants listed in this manual are recommended because of their chemical
compatibility with product materials, not their biological effectiveness. For the biological
effectiveness of a disinfectant, refer to the guidelines and recommendations of the
disinfectant manufacturer, Association for Practitioners in Infection Control, U.S. Food and
Drug Administration, and U.S. Centers for Disease Control.

 To disinfect the body surface probe


You should disinfect the surface probe after each use.
Perform the steps as follows:
1. Clean the probe.
For details, refer to Section 14.1.3 Cleaning the Probe.
2. Perform the medium-level disinfection to the surface probe as shown in Table
14-1 until the recommended disinfection period expires.

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NOTE:
If you do not use the recommended disinfectant, follow the manufacturer’s instructions to
make up it.

3. Rinse the probe with the fresh running water to remove the residual cleaner
completely.
4. Dry the probe with a lint-free soft cloth dry cloth.

Table 14-1 Recommended Method for Medium-level Disinfection

Active Level for Active Contact Contact


Disinfectant Manufacturer
Ingredients Ingredient Type Period

70%
Isopropyl All Isopropyl alcohol 70% Spray/Wipe <10 minutes
alcohol

T-spray II Pharm. Inc. Quat.Ammonia / Spray/Wipe <10 minutes

T-spray Pharm. Inc. Quat.Ammonia / Spray/Wipe <10 minutes

 To disinfect the endocavitary probe


You should disinfect the endocavitary probe before and after each use.
Perform the steps as follows:
1. Clean the probe.
For details, refer to Section 14.1.3 Cleaning the Probe.
2. Perform the high-level disinfection to the endocavitary probe as shown in Table
14-2 until the recommended soak period expires.

NOTE:
If you do not use the recommended disinfectant, follow the manufacturer’s instructions to
make up it.

3. Rinse the probe with the running sterile water to remove the residual disinfectant
completely.
4. Dry the probe with a lint-free soft cloth dry cloth.
Table 14-2 Recommended Method for High-level Disinfection

Active Level for Active Contact Contact


Disinfectant Manufacturer
Ingredients Ingredient Type Period

Cidex™ Activated 45-50


J&J Glutaraldehyde 2.4% Soak
Dialdehyde Solution minutes

Resert XL HLD STERIS 2.0% H2O2 2.0% Soak 8 minutes

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 To sterilize the probe
You should sterilize the intraoperative, biopsy use or blood contacting probe after
each use.
Perform the steps as follows:
1. Clean the probe.
For details, refer to Section 14.1.3 Cleaning the Probe.
2. Sterilize the probe as shown in Table 14-3 until the recommended soak period
expires.

NOTE:
If you do not use the recommended sterilant, follow the manufacturer’s instructions to
make up it.

3. Rinse the probe with the running sterile water to remove the residual sterilant
completely.
4. Dry the probe with a lint-free soft cloth dry cloth.
Table 14-3 Recommended Method for Sterilization

Active Level for Active Contact Contact


Sterilant Manufacturer
Ingredients Ingredient Type Period

Cidex™ Activated
J&J Glutaraldehyde 2.4% Soak 10 hours
Dialdehyde Solution

14.1.5 Disinfecting and Sterilizing the Probe Cable

Warning
 Do not immerse the probe connector or handle into disinfectant or sterilant.
 To avoid potential disease transmission, you should wear medical sterile gloves
and protective goggle during the disinfection or serialization.
 Do not immerse the probe cable into alcohol or isopropyl alcohol at any
concentration for a long period. Avoid any contact with iodine or phenols.
 Daily Disinfection
Perform the steps as follows:
1. Use a lint-free soft cloth dampened with mild soapy water to wipe the probe
cable.
2. Perform the medium-level disinfection to the probe cable as shown in Table 14-4
until the recommended disinfection period expires.

NOTE:
If you do not use the recommended disinfectant, follow the manufacturer’s instructions to
make up it.

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3. Rinse the probe cable with the fresh running water to remove the residual
disinfectant completely.
4. Dry the probe with a lint-free soft cloth dry cloth.

Table 14-4 Recommended Method for Medium-level Disinfection

Active Level for Active Contact Contact


Disinfectant Manufacturer
Ingredients Ingredient Type Period

T-spray II Pharm. Inc. Quat.Ammonia / Spray/Wipe <10 minutes

T-spray Pharm. Inc. Quat.Ammonia / Spray/Wipe <10 minutes

 Sterilization

If the probe cable contacts with any blood or body fluid you should sterilize it. For
details, refer to the information about probe sterilization.

14.1.6 Storage and Transportation


Store and transport the probe to ensure the probe is in a good condition.
 To transport the probe
1. Ensure the probe is cleaned and disinfected before the transportation.
2. Place the probe fully into the carrying case, and carefully wind the cable.
3. Ensure no parts of the probe left outside the carrying case before the package.
4. Pack the carrying case with sponge, and place it in a carton.

 To store the probe


The following items are recommended to be performed for the storage.
 Always store the probe in the probe holder or the specific package.
 Ensure the probe holder or the specific package is clean.
 Do not expose it in direct sunlight or environmental temperature of sudden
changes.
 Store the probe alone to avoid any impact on the probe head.
 Carefully wind the probe cable.
 Dry the probe before the storage.

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Chapter 15 System Maintenance

To maintain the safety and functionality of the ultrasound system, you should periodically
perform the maintenance for the ultrasound system and accessories.
 To avoid electrical shock and damage to the ultrasound system, power off and unplug
the system from the AC power outlet before cleaning.
 To maintain the safety and functionality of the ultrasound system, maintenance must
be performed at least every 6 months. Electrical safety tests must also be performed
at regular intervals as specified by local safety regulations.

15.1 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 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 user manual.

15.2 Cleaning the System


 To clean the system surface
1. Power off and unplug the ultrasound system from the AC power outlet.
2. Dampen a lint-free soft cloth with 75% alcohol.
3. Use this lint-free soft cloth to clean the surfaces of the monitor screen, the touch
screen, the control panel, the keyboard and the main unit. Take special care and
avoid scratching the screens.
4. Use a cotton swab to remove solids from between keys and controls.
5. In case of blood or any infectious, use a lint-free soft cloth dampened with 70%
isopropyl alcohol.

 To clean the trackball


1. Power off and unplug the ultrasound system from the AC power outlet.
2. Press the bulges in the ring by both hands.
3. Turn the ring anticlockwise until the ring lifts.

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4. Take out the ring and ball (careful not to drop the ball) from the control panel.
5. Use a lint-free soft cloth dampened with 75% alcohol to clean the trackball.
6. Use a cotton swab dampened with 75% alcohol to remove stains from the ring.
7. Place the trackball and the ring back to the control panel, press the bulges in the
ring by both hands and turn the ring clockwise to install the trackball.

15.3 Maintenance Checks


To maintain the safety and functionality of the ultrasound system, the following
maintenance checks must be performed by the service personnel at least every 6 months.
1. Electric Safety

 Integrity of power cable

 Protective conductor resistance

 Ground line leakage current

 Enclosure leakage current

 Patient leakage current

 Patient auxiliary leakage current


2. Battery Safety
Check the intactness and performance of the battery if the battery is frequently used
or not used for 6 months.

 Battery Integrity
No bulging, cracks, damage, leakage or corrosion.

 Battery Performance
a. Power on the system by using the AC adapter to fully charge the battery.
b. Disconnect the system from the AC adapter to power on the system by the
battery until the system automatically shuts down.
c. The powering time of the battery indicates the battery performance. If the
powering time of the battery is much shorter than 30 minutes, you should
replace the battery or contact Service Department of the manufacturer.
3. Mechanical Safety

 Appearance of the system enclosure

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 Appearance of the control panel and the key panel

NOTE:
The surfaces of the control panel or the key panel may be abrasive because of the split
liquid or other cleaning spray. Take care to find the potential problem when performing the
maintenance checks.

 Connectivity of interfaces
4. Image Recording

 Images in each mode

 Image recording using the standard probe

15.4 Data Backup

Caution

To avoid data loss due to unexpected system breakdown or software update, you are
highly recommended to make periodical data backup.
Please follow these procedures to make backups:
1. Connect a USB drive to the ultrasound system and press the Patient key.
2. Choose the patient file, select Patient Export, and press the Set key to confirm.

15.5 Troubleshooting
A1: The ultrasound system cannot be started up.
Q1: Check whether the ultrasound system is plugged in, and the main power switch is
located to position.
A2: No images are displayed on the LCD monitor.
Q2: Check whether the power supply cable and video cable are well connected.
A3: The LCD monitor displays abnormal.
Q3: Check whether you select an appropriate probe and compatible exam type, or
optimize imaging parameters correctly. For details, refer to Chapter 6.
A4: The measurement cannot be performed after pressing the Calc key on the control
panel.
Q4: Ensure you pressing the Calc key in the frozen mode.
If the above problems still exist, please contact Customer Service Department of the
manufacturer for help.

15.6 Equipment Disposal


You should dispose of the main unit, the probe or other accessories in accordance with
the local laws or regulations.

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For the detailed disposal information, consult the manufacturer or the local distribution.
The manufacturer is not responsible for any system content or accessories that have been
discarded improperly.

15.7 Customer Service


Only the service personnel of or authorized by the manufacturer can service the
ultrasound system. Any feedbacks or inquires concerning our product or service should
be directed to the following address.
Address: 4/F, 5/F, 8/F, 9/F & 10/F, Yizhe Building, Yuquan Road, Nanshan, Shenzhen,
518051, Guangdong, China
Zip Code: 518051
Tel: +86-755-26722890
Fax: +86-755-26722850
E-mail: service@sonoscape.net

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Appendix A

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.

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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

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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 % UT(>95 %
<5 % UT(>95 % dip dip in UT) for 0.5 Mains power quality should be
in UT) for 0.5 period period that of a typical commercial or
hospital environment. If the
40 % UT(60 % dip 40 % UT(60 % dip
user of the EQUIPMENT
Voltage dips and in UT) for 5 periods in UT) for 5
requires continued operation
Short 70 % UT(30 % dip periods
during power mains
interruptions in UT) for 25 70 % UT(30 % dip
interruptions, it is
IEC 61000-4-11 periods in UT) for 25
recommended for the
<5 % UT(>95 % dip periods
EQUIPMENT to be powered
in UT) for 250 <5 % UT(>95 % from an uninterruptible power
periods dip in UT) for 250 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.

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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.

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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

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Appendix B

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 Value Intensity
e = 2.7183
a = Attenuation Factor
Tissue = a (dB/cm-MHz)
Amniotic Fluid = 0.006
Brain = 0.53
Heart = 0.66
Kidney = 0.79
Liver = 0.43
Muscle = 0.55
l = Skin line to measurement depth (cm)
f = Center frequency of the transducer/system/mode combination (MHz)
Since the ultrasonic path during an examination 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 which is commonly reported
uses the formula:
In Situ derated = Water [e-0.069lf]
Since this value is not the true In Situ intensity, the term “derated” is used.

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Appendix C

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.

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

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Appendix D

Acoustic Output Data

Please consult the accompanying CD.

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