Sonoscape A6T User manual

A6T/A6/A5 Portable Ultrasonic Diagnostic System
4701-0040-01A
I
1System Safety ......................................................................1-1
1.1 Safety Overview .................................................................... 1-1
1.2 Warning Signs ....................................................................... 1-3
1.3 Biological safety .................................................................... 1-4
1.4 Ultrasound Safety.................................................................. 1-4
1.5 Operating Environment ......................................................... 1-4
1.6 Transport and storage ........................................................... 1-5
1.7 Electrical Requirements......................................................... 1-5
1.8 Electrical Safety Classification............................................... 1-6
2System Description .............................................................2-1
2.1 General.................................................................................. 2-1
2.2 Application............................................................................. 2-1
2.3 Contraindication .................................................................... 2-2
2.4 System Configuration ............................................................ 2-2
2.4.1 Configuration.................................................................. 2-2
2.4.2 Standard Configuration................................................... 2-3
2.4.3 Optional Accessories...................................................... 2-3
2.4.4 Optional Peripherals....................................................... 2-3
2.5 Technical Specifications ........................................................ 2-5
2.6 System Principle.................................................................... 2-8
3System Operation ................................................................3-1
3.1 Operation Notice ................................................................... 3-1
3.2 Transducer Connection ......................................................... 3-1
3.3 System Power ON/OFF......................................................... 3-2
3.4 General Operation................................................................. 3-3
3.4.1 Keyboard Operation ....................................................... 3-3
3.4.2 User Interface................................................................. 3-6
3.4.3 System Setting ............................................................... 3-7
3.4.3.1 General Setting ................................................ 3-8
3.4.3.2 Dicom Setting................................................... 3-9
3.4.3.3 Formula Select............................................... 3-10
3.4.3.4 Formula Define .............................................. 3-12
3.4.3.5 Comment Setting ........................................... 3-14
3.4.4 Patient Information ....................................................... 3-17
3.4.3.6 Disk Management .......................................... 3-18
3.4.3.7 LCD Setting.................................................... 3-22
3.4.5 BodyMark ..................................................................... 3-23
TABLE OF CONTENTS

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3.4.6 How to use biopsy ........................................................3-24
3.4.7 Report...........................................................................3-25
3.4.8 Use the peripherals ......................................................3-26
3.4.8.1 USB device ....................................................3-26
3.4.8.2 Footswitch ......................................................3-27
3.4.8.3 Video Out .......................................................3-27
3.4.8.4 Network Device ..............................................3-27
3.5 Imaging................................................................................3-28
3.5.1 Basic operation.............................................................3-28
3.5.2 Parameter Adjust .......................................................... 3-29
3.6 Measurement.......................................................................3-32
3.6.1 B mode basic measurement.........................................3-33
3.6.1.1 Distance Measurement ..................................3-33
3.6.1.2 Angle measurement .......................................3-34
3.6.1.3 Ratio measurement ........................................ 3-35
3.6.1.4 Area/Circumference measurement ................3-36
3.6.1.5 Volume measurement (2-Axis, 3-Axis) ...........3-38
3.6.2 B mode special measurement ......................................3-40
3.6.2.1 Basic OB measurement .................................3-41
3.6.2.1.1 GS (Gestational Sac) measurement .......3-41
3.6.2.1.2 CRL measurement ..................................3-42
3.6.2.1.3 BPD (Biparietal Distance) measurement.3-43
3.6.2.1.4 HC (Head Circumference) measurement 3-43
3.6.2.1.5 AC measurement ....................................3-44
3.6.2.1.6 FL (Femur Length) measurement ...........3-45
3.6.2.1.7 OFD measurement ...............................3-46
3.6.2.1.8 CER measurement.................................. 3-47
3.6.2.1.9 AFI (Amniotic Fluid Index) measurement 3-47
3.6.2.1.10 Report .....................................................3-48
3.6.2.2 High-level OB measurement ..........................3-49
3.6.2.2.1 APAD measurement................................ 3-49
3.6.2.2.2 AA (Abdominal Area) measurement ........ 3-50
3.6.2.2.3 HL (Humerus Length) measurement .......3-51
3.6.2.2.4 THD measurement..................................3-52
3.6.2.2.5 FTA (Fetal Trunk Area) measurement .....3-53
3.6.2.2.6 OOD measurement .................................3-53
3.6.2.2.7 TIBIA measurement ................................3-54
3.6.2.2.8 ULNA measurement................................3-54
3.6.2.2.9 Input Last Menstrual Period (Input LMP).3-55

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3.6.2.2.10 Fetal Growth Curve (FGC)...................... 3-55
3.6.2.2.11 Fetal Biophysical Profile (FBP) ............... 3-56
3.6.2.3 GYN measurement ........................................ 3-60
3.6.2.3.1 UT measurement .................................... 3-61
3.6.2.3.2 Endo measurement ................................ 3-62
3.6.2.3.3 L.Ovary (Left Ovary) measurement......... 3-63
3.6.2.3.4 R.Ovary (Right Ovary) measurement...... 3-64
3.6.2.3.5 L.Follicle (Left Follicle) measurement ..... 3-65
3.6.2.3.6 R. Follicle (Right Follicle) measurement . 3-66
3.6.2.3.7 CX (Cervix) measurement ...................... 3-67
3.6.2.3.8 CX-L /UT-L.............................................. 3-68
3.6.2.4 Cardiac measurement.................................... 3-68
3.6.2.4.1 LV function .............................................. 3-69
3.6.2.4.2 Right Ventricle inner diameter (RV)......... 3-76
3.6.2.4.3 Pulmonary Artery inner diameter (PA)..... 3-77
3.6.2.4.4 Left Ventricular Mass (LV Mass) ............. 3-77
3.6.2.4.5 Left Ventricle Mass Weight Index............ 3-78
3.6.2.5 Small Part measurement ............................... 3-79
3.6.2.5.1 URO measurement (RUV) ...................... 3-79
3.6.2.5.2 Prostate measurement (PSV) ................. 3-80
3.6.2.5.3 Thyroid measurement (THY) .................. 3-82
3.6.3 M mode measurement ................................................. 3-83
3.6.3.1 Distance Measurement .................................. 3-83
3.6.3.2 Time measurement ........................................ 3-84
3.6.3.3 Slope measurement....................................... 3-84
3.6.3.4 HR measurement........................................... 3-85
3.6.3.5 LV function measurement (LV) ....................... 3-86
3.6.2.5.1 TEICHHOLZ ........................................... 3-86
3.6.2.5.2 CUBE...................................................... 3-87
3.6.2.5.3 GIBSON.................................................. 3-88
3.6.3.6 Mitral Valve measurement (MV)..................... 3-88
3.6.3.7 Aortic valve measurement (AO) ..................... 3-90
3.6.3.8 Ejection Time (ET) ......................................... 3-92
3.6.3.9 TEI measurement .......................................... 3-92
3.7 Other Operation................................................................... 3-93
3.7.1 Save ............................................................................. 3-93
3.7.2 Saving exam mode....................................................... 3-93
3.7.2.1 Saving image file............................................ 3-94
3.7.3 Cineloop ....................................................................... 3-95

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3.7.3.1 Single image cineloop ....................................3-95
3.7.3.2 Continuous cineloop.......................................3-95
3.7.3.3 M mode cineloop............................................3-96
3.7.3.4 Review images...............................................3-96
3.7.4 Clipboard ......................................................................3-96
3.7.5 Software Upgrade.........................................................3-97
4Transducer ...........................................................................4-1
4.1 Use transducer ......................................................................4-1
4.2 Use biopsy guide ...................................................................4-1
4.3 Transducer Specifications......................................................4-2
5System Maintenance ...........................................................5-1
5.1 Main Unit ...............................................................................5-1
5.1.1 Maintenance ...................................................................5-1
5.1.2 Installation ......................................................................5-2
5.1.3 System Transport ...........................................................5-2
5.2 Transducer.............................................................................5-3
5.2.1 Maintenance ...................................................................5-3
5.2.1.1 Use endocavity transducer...............................5-5
5.2.2 Cleaning .........................................................................5-6
5.2.3 Disinfection.....................................................................5-6
5.3 Service Method......................................................................5-7
5.3.1 Service Method...............................................................5-7
5.3.2 Service responsibility......................................................5-8
5.3.3 Service contact information ............................................5-8
Appendix A Descriptions of Signs .................................... A-1
Appendix B Principle for Using Acoustic Power.............. B-1
Appendix C The information of Representatives ................... C-1
Appendix D Maximum Acoustic Output Report ..................... D-1

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Caution
This manual contains necessary information to operate the system safely.
Please read this manual before attempting to use the system.
This system has been designed with safety consideration of the operators
and the patients. However, to ensure the system reliability and safety, please
pay attention to the following:
zThis system shall be operated only by or under the guidance
of a qualified person.
zThis system complies with Type B general equipment, Class
I of EN606601-1:1990+A1:1993+A2:1995 standard.
zDo not modify this system in any way. Necessary
modifications can be made only by the manufacturer or its
designated agents.
zThis system is fully adjusted at the factory. Do not adjust
any fixed adjustable parts.
zIn the event of a malfunction, turn off the power supply
immediately and inform the manufacturer or its designated
agents.
zThe power cable of the system must be connected to a
grounded power socket. Do not remove the ground cable for
any reason.
zOnly the devices comply with
EN606601-1:1990+A1:1993+A2:1995 standard can be
connected with the system, either electronically or
mechanically. 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.
zThe system has no any specialized design when it is
configured with high-frequency operation devices. The
operator shall use caution in these types of applications.

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zThe system is designed to provide medical information on
clinical diagnosis for doctors. The doctors shall be
responsible for determining diagnostic results, while the
manufacturer shall not assume any responsibility for such
diagnostic process.
zPlease back up the important data of the system to external
storage media, such as a U disk or a DVD.
zThe manufacturer shall not be responsible for any loss of
stored data in the system due to any malfunction.
Due to functional update, this user’s manual may be slightly different from the
system you are using.
Regulatory Requirement
This product complies with regulatory requirements of the following
European directive 93/42/EEC concerning medical devices.

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1 System Safety
1.1 Safety Overview
Safety measures for the operator and the patient are discussed in this section.
To ensure the safety of the operator and patient, please read the relevant
details in this chapter carefully before operating this system. Meanwhile, in
this manual the description on warning means that any violation of the
relevant rules may result in personal injury or even risk of life to the operator
or the patient.
The following precautions should be adhered to:
1. This system complies with Type B general equipment, Class I,
EN606601-1:1990+A1:1993+A2:1995 standard. Please follow
Section 1. “System Safety” in the user’s manual to operate this
system properly.
2. Do not modify this system in any way. Necessary modifications
can be made only by the manufacturer or its designated agents.
3. This system is fully adjusted before delivery from the factory. Do
not adjust any fixed adjustable parts.
4. If any disorder occurs during operation, please turn off the power
supply immediately and inform our designated contact persons or
us.
5. The power cable of the system should be connected to a
grounded power socket, and the ground cable should not be
removed.
6. Only the devices comply with
EN606601-1:1990+A1:1993+A2:1995 standard can be
connected with the system, either electronically or mechanically.
It is required to recheck the leakage current and other safety
performance indexes of the whole system to avoid any potential
hazard to the system resulted from leakage current
superposition.

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7. When it is configured with high-frequency operation devices, no
special protective measures are supplies for the system. The
operator should be vigilant to such application.
8. The installation shall be performed by personnel authorized by
the manufacturer only. Do not attempt to install the system by
yourself
9. Service shall be performed by service engineer authorized by the
manufacturer only.
10. The system shall be used by a qualified operator or under the
supervision of a qualified person.
11. The system is not designed to be operated in the presence of
flammable substances. Such an environment could cause an
explosion.
12. Power down the system before cleaning. Protect the system
from water or other liquids that could drip into the system.
13. To ensure the safety of the patient, continuous scanning and
imaging for a long period on the same part of the patient is
prohibited.
14. When the system is used for ultrasound scanning, it shall be
used with ultrasound gel without problem in biological
compatibility. To ensure safety, only qualified ultrasound gel in
compliance with related standard can be used.
15. At the end of the life time of this product, please contact your
local agent or our company for disposal.

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1.2 Warning Signs
Signs Description
Type B Applied Part symbol classified as electric shock
prevention
Dangerous voltage
Attention; To secure system safety, wherever this sign is
found in the system or documents please refer to relevant
instructions in the user’s manual.
OFF (The power disconnected from the unit)
ON (The power connected to the unit)
Equi-potentiality sign; The terminal shall be connected
with the corresponding connection terminal of other
devices, to ensure the equation of electric.
Alternating current
Operating the system in the presence of flammable gas is
prohibited; Otherwise it may cause an explosion.
Direct current

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1.3 Biological safety
This product 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 acceptable
diagnostically image.
1.4 Ultrasound Safety
Keep the transducers clean. The transducers shall be cleaned before
scanning another patient.
Patients should always be exposed to the lowest transmit power for the
shortest time. Freeze the system or keep the probe away from the patient if
no scanning is performed. Do not scan the patient with the probe at a fixed
position of the body for a long time; Please refer to Appendix C for acoustic
report of the system.
1.5 Operating Environment
¾The unit should be operated within the parameter outline below:
zRelative humidity: 30%~75% non-condensing
zAmbient temperature: 10℃~40℃
zAtmosphere Pressure: 700~1060hPa
¾Strong radiation source or powerful electromagnetic waves, e.g.
electromagnetic waves from radio broadcasting, may result in
image ghosting or noise. The system shall be isolated from such
radiation source or electromagnetic waves.
¾Do not put anything on top of the main unit.
¾When the system is not in use, be sure to turn off the power
supply. Cover the main unit with a dust cover. The system shall
be operated in the environment without dust.

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1.6 Transport and storage
¾The following transport and storage environmental conditions are
within system tolerances:
zRelative humidity: 20%~90%non-condensing
zAmbient temperature: -20℃~40℃
zAtmosphere Pressure: 700~1060hPa
1.7 Electrical Requirements
¾Power Requirements: 100-240V~, 50/60Hz
¾Power Consumption: 130 VA
¾Main unit voltage: With a fluctuation range of less than ±10%,
otherwise the system may be damaged.
¾Grounding: Before connecting the power cable, connect the
attached ground protection cable to a special grounding device.
NOTE:
Please follow the above requirements for power supply to the system.
The requirements of power supply may vary in different areas. Please
refer to the symbols at the rear panel of the system for the detailed
requirements.

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1.8 Electrical Safety Classification
¾This safety standard of this system complies with Type B, Class I
EN606601-1:1990+A1:1993+A2:1995;
¾It belongs to continuous operation (for more than 8 hours)
according to operation mode;
¾According to the classification on harmful liquid
protection(Main unit:IPX0 Transducers:IPX4)
¾The system should NOT be used under the condition with the
inflammable mixture of anesthesia gas and air, or oxygen and
nitrous oxide;
¾This equipment meets the requirements for EMC/EMI
IEC60601-1-2 Class A (CE);
¾The system shall be added with a ground device protection.
During operation, please make sure that the system is connected
to an extra grounding device. Otherwise it may be interfered by
alternating current and affected in imaging quality.

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2 System Description
2.1 General
The system is a full digital portable B/W diagnostic ultrasound system with
high performance. With the most advanced full digital ultrasound design in the
industry, the system is configured with high performance super large scale
integration, and human tissue ultrasound information can be acquired to its
best capability; In combination with professional built-in Linux computer
system, rich data ports, professional application packages and standard
Windows style interface, the system is featured with high performance, as
well as powerful software function and easy operation.
A high-performance industrial-grade LCD is used on the systems. Other than
the traditional systems, clear image display and abundant gray scales can be
found on this system, meanwhile the system weight is reduced significantly.
Moreover, the professional built-in operation system and the standard PC
ports enable the user to perform system upgrade and maintenance without
effort, while maintaining the advantages of its technologies.
2.2 Application
The system, with electronic scanning ultrasound diagnostic capabilities, is
suitable for all kinds of clinical diagnosis. It can work with many multi-freq
transducers, and can apply to general organs. Its main applications are as
follows:
zSmall parts (breast, thyroid, testes, etc.)
zVascular (cerebrovascular, peripheral vascular)
zAbdominal (liver, spleen, gallbladder, kidney, etc.)
zGynecological
zCardiac
zUrological
zMusculo-skeletal

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2.3 Contraindication
No Contraindication. But the system is not intended for OPHTHALMIC use or
any use that causes the acoustic beam to pass through the eye(s).
2.4 System Configuration
2.4.1 Configuration
The system consists of a main unit and transducer(s).
1. RS232 Port
2. LAN Port(DICOM Port)
3. VGA Port
4. S-Video Port
5. Double USB Port

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2.4.2 Standard Configuration
zHost 1pc
zPower cable 1 pc
zConfigurable transducers (models and quantity are subject to
customer requirements. See Section 4.3 for transducer models. )
zProtective ground cable 1 pc
zFuse 1.6A/250V 2 pcs
zS-terminal cable 1 pc
zBNC video cable 1 pc
zUSB2.0 cable 1 pc
zVGA video cable 1 pc
zUltrasound gel 1 bottle
2.4.3 Optional Accessories
zDVD Combo
zFootswitch
zBiopsy guide
zTrolley
zSpecial backpack
zConfigurable transducers (See Section 4.3 for transducer
models.)
2.4.4 Optional Peripherals
zUSB2.0 memory stick
zUSB2.0 mobile hard disk
zUSB2.0 DVD-RW

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zUSB2.0 video printer
zComposite video printer
zNetwork printer
zVCR
1. REMOTE Control Port
2. S-Video Port
3. Foot Switch
4. Ground Pole
5. Power Connector with Fuse-box
6. Power Switch
7. Probe Connectors

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2.5 Technical Specifications
zAll digital beam former
zDynamic receive focusing, dynamic aperture, dynamic
apodization;
zTransducer: multiple-frequency transducer, 5-frequency,
frequency range 2.0-12.0MHz;
zProbe connector: 2 slots
zScanning range:
Convex array: Max depth300mm
Linear array: depth 123mm, width 46mm
Micro-convex array: Max angle 180°, during 2.0MHz, max
Depth 320mm
zGrayscale: 256
zDynamic range: 108dB;
zImaging mode: THI , B , B+B , B+M , M , 4B;
zScanning lines: 256 lines in B mode max. 256 lines in M mode
max;
zLine density: low, high;
zEdge enhancement: 8 steps;
zGrayscale curve: 16 types;
zPersistence: 8 steps;
zChroma: 8 types;
zFrequency: 5 steps;
zFocusing method: dynamic focusing, variable aperture;
zFocus number: Max 4, focus number and depth controllable
zFrame rate: max 60 frames;
zGain control: gain 0~255, encoder adjust; 8-TGC; independent

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gain control for B and M modes;
zZoom factor: max. 8.0, local zoom function;
zM mode: sweep speed 1,2,3,4,5s;
zM mode video invertion;
zBiopsy guide line: on/off, position and angle adjustment;
zUser adjustable parameters: dynamic range, frequency, GSC,
persistence, gain, grayscale curve, left/right invert, up/down
invert, image rotation angle, sweep angle/width, depth, line
density, zoom factor, focus number and position, biopsy guide
line, acoustic power, chroma pitcure;
zDiagnostic mode: applications such as cardiac, liver, kidney,
muscular-skeletal, gynecological, obstetric, thyroid, carotid,
breast and pancreas; exam mode preset by the user;
zCine and storage:
In B mode, 256 frames with high line density, or 512 frames
with low density; 128s in M mode;
A flash can store up to 2000 images in bmp format, 10000
images in JPG format after power off.
Cine speed adjustable: high, medium, low;
Measurement when reviewing images;
zClipboard function: the latest reviewed images (up to 32 images)
can be shown at the bottom right of the screen;
zBody mark: not less than 80 type;
zAnnotation: rich annotations, the user can add new annotations;
zMeasurement:
Basic measurement: distance, ratio, area (ellipse),
circumference, angle, volume, time, slope, heart rate
OB measurement: BPD, CRL, FL, AC, HC, GS, VOL, ANG
LE, UT, OFD, CI, AFI, FGC

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Cardiac measurement: MV, LV, AO, EDV, ESV, EF, CO, SV,
FS, ET
Other measurement: RUV, PV, and so on
zReport: cardiac report, vascular report, OB/GYN, growth curve,
urology;
zDisplay: 12-inch industrial-grade LCD, the user can adjust the
monitor through system menu;
zBuilt-in Linux system;
zStandard PS2-port keyboard, backlight display, high-brightness
control, keyboard with beeper prompt;
zMultiple language operation interface: Simplified Chinese/
Traditional Chinese/ English/ Russian/ Spanish/ French/ Italian;
zInput in Chinese/ English;
zVideo out format: composite video, S-Video, VGA;
zOutput ports: LAN, 2×USB2.0, composite video, VGA, S-Video,
print control;
zInput port: footswitch;
zDVD-RW (Option);
zOptional peripherals: footswitch, video printer, USB video printer,
USB disk, mobile hard disk, network device, VCR;
zDICOM function: (Option);
zFile output format:
Image: BMP, JPG, AVI,DCM;
Report: .RPT;
zSoftware update: USB update by the user or update through
Flash replacement;
zPower in: 100-240V~, 50/60Hz auto adaption;
zExternal dimension: 336×180×346mm(L×W×H

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zNet weight: 6.5Kg;
zEnvironmental requirement:
Operation Storage and Transport
Ambient temperature: 10℃~40℃-20℃~55℃
Relative humidity: 30%~75% 20%~90%
Atmospheric pressure: 700~1060hPa 700~1060hPa
2.6 System Principle
The fundamental operating principle of diagnostic ultrasound system is:
through the transducer, electric excitation signals are converted into acoustic
signals, which are propogated, attenuated and reflected in the patient’s body.
Then the echos from the body are converted into electric signals through the
transducer. Going through complicated signal processing circuit, a scanned
tomographic image is displayed on the monitor.
The block diagram of the system is displayed below:
Fig.2-6a Block Diagram
This manual suits for next models
2
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