Portable Ultrasonic System

A6T/A6/A5

SERVICE MANUAL

P/N 4720-0022-01B

Sonoscape Co., Ltd.

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Table of Contents

1 System 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
2 General Information.............................................................2-1
2.1 The Characteristic of the Products................................................. 2-1
2.2 Applications ................................................................................... 2-1
2.3 Operation Modes ........................................................................... 2-2
2.4 Measurements and Calculations.................................................... 2-2
3 System Configuration & Function ......................................3-1
3.1 Digital Beam Former Board(DBF).................................................. 3-2
3.2 CPU Board .................................................................................... 3-2
3.3 Keyboard ....................................................................................... 3-2
3.4 Inventor Board ............................................................................... 3-2
3.5 Power Supply Board ...................................................................... 3-3
4 System Operation Theory ...................................................4-1
4.1 Operation Theory........................................................................... 4-1
4.2 Technical Specifications ................................................................. 4-2
4.3 Probes ........................................................................................... 4-5
5 Assembly /Disassembly of the System..............................5-1
5.1 Internal Conformation .................................................................... 5-1
5.2 Assembly /Disassembly of the System .......................................... 5-3
6 Malfunction Analysis ...........................................................6-1
6.1 Common Malfunction Analysis of DBF Subsystem ........................ 6-1
6.1.1 Image dots become coarse ............................................ 6-1
6.1.2 Noise on the image ........................................................ 6-1
6.2 Malfunction Analysis of CPU Board ............................................... 6-2
6.3 Malfunction Analysis of Power Supply Board................................. 6-2
7 System Maintenance ...........................................................7-1
7.1 Main Unit ....................................................................................... 7-1
7.1.1 Maintenance................................................................... 7-1
7.1.2 Installation ...................................................................... 7-2

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7.1.3 System Transport ...........................................................7-2

7.2 Transducer .....................................................................................7-3
7.2.1 Maintenance ...................................................................7-3
7.2.1.1 Use endocavity transducer.......................................7-5
7.2.2 Cleaning .........................................................................7-6
7.2.3 Disinfection .....................................................................7-6
7.3 Service Method ..............................................................................7-7
7.3.1 Service Method...............................................................7-7
7.3.2 Service responsibility......................................................7-8
7.3.3 Service contact information ............................................7-8

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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

¾ The unit should be operated within the parameter outline below:

z Relative humidity: 30％～75% non-condensing

z Ambient temperature: 10℃ ～ 40℃

z Atmosphere Pressure: 700～1060hPa

¾ Strong 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.

¾ Do not put anything on top of the main unit.

¾ When 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

¾ The following transport and storage environmental conditions are

within system tolerances:

z Relative humidity: 20%~90%

z Ambient temperature: -20℃～55℃

z Atmosphere Pressure: 700～1060hPa

1.7 Electrical Requirements

¾ Power Requirements: 100-240V~, 50/60Hz,

¾ Power Consumption: 130 VA (Max.)

¾ Main unit voltage: With a fluctuation range of less than ±10%，

otherwise the system may be damaged.

¾ Grounding: 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

¾ This safety standard of this system complies with Type B, Class I

EN606601-1:1990+A1:1993+A2:1995;

¾ It belongs to continuous operation (for more than 8 hours) according

to operation mode;

¾ It belongs to IPX0 according to the classification on harmful liquid

protection;

¾ The system should NOT be used under the condition with the
inflammable mixture of anesthesia gas and air, or oxygen and
nitrous oxide;

¾ This equipment meets the requirements for EMC/EMI

IEC60601-1-2 Class A (CE);

¾ The 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 General Information

2.1 The Characteristic of the Products

The system is a high performance full digital portable B/W diagnostic

ultrasound system. With the adoption of 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 thus acquired to its best capability, providing rich
diagnostic information; 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 back end 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
see on this system, meanwhile the system weight is reduced significantly.

Moreover, with the high performance embed operation system and standard
PC ports, user can upgrade and maintenance the system easily, while
maintaining the advantages of its technologies.

2.2 Applications

The system, with electronic scanning ultrasound diagnostic capabilities, is

suitable for all kinds of clinical diagnosis. It can work with many broadband
transducers, good for ultrasound diagnostic exams on general organs. Its
main applications are as follows:

z Small parts (breast, thyroid, testes, etc.)

z Vascular (cerebrovascular, peripheral vascular)
z Abdominal (liver, spleen, gallbladder, kidney, etc.)
z Gynecological
z Cardiac
z Urological

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WARNING：
It is not applicable for ophthalmology or any examination that
ultrasound beam would penetrate through eye.

2.3 Operation Modes

z B Mode

z B/M Mode

z M Mode

z THI Mode

z Dual B Mode

z Quad B Mode

2.4 Measurements and Calculations

z Basic measurement: distance, ratio, area (ellipse), circumference,

angle, volume, time, slope, heart rate
z OB measurement: BPD, CRL, FL, AC, HC, GS, VOL, ANG LE, UT,
OFD, CI, AFI, FGC
z Cardiac measurement: MV, LV, AO, EDV, ESV, EF, CO, SV, FS, ET
z Other measurement: RUV, PV, and so on

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3 System Configuration & Function

This system consists of the main unit and probes.

The main unit is composed of a CPU board, a Digital Beam Former board, a
keyboard panel, a monitor inventor board, a power supply board and a LCD
monitor.

The configuration is shown as Fig. 1.

Fig. 1

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3.1 Digital Beam Former Board(FED)

The FED board is the main signal process board.

By connecting two 156-pin probe sockets on the board at one time, the
system can active one as current operating probe. The FED board send high
voltage drive signal to the probe elements, and at the same time it gets echo
signal form the probe elements, then amplify the echo signals and sampling
them. After a series of DSP process, the digital echo flow formed.

3.2 CPU Board

The CPU board is the system platform.

The CPU board receive the digital echo flow from DBF board, and mix it with
other graphic and character information, then display these on the LCD
screen. And same time, the CPU board control the data ports, such as net
port, RS232 port, S-video and C-video port, Dual USB port, etc. On the CPU
board, there are some flash IC, which burned with the system software data.

3.3 Keyboard

The keyboard is the main user interface of the system.

The keyboard respond the user’s operation commands, such as key-in, TGC
adjustment, knob rotate, and sends these commands to the CPU board.

3.4 Inventor Board

The inventor board can provide the AC power supply for the LCD monitor, and
it joint the CPU board and the system power supply board together.

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3.5 Power Supply Board

The power supply of this unit is switch power supply. It generates all the DC
voltages required for normal operation of all the boards.

Pin Define of Power Supply board DC Output

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4 System Operation Theory

4.1 Operation Theory

The operation principle diagram of the A6T/A6/A5 is as shown in Fig. 1.

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 reflected echo signals 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.

According to the design, the Digital Beam Former sends out transmit pulse
signals at a certain frequency. Going through signal driving and logic switch,
the signals are sent to corresponding ultrasonic element crystal of the
transducer. With the oscillation of crystal, ultrasonic waves are generated.
The combinations of many element signals enable the transducer to send out
a dynamic directional compounded beam. When the beam is propogated and
attenuated in the human body, it is returned to the element crystal, and
changed to electric signals again. Being amplified by the pre-amplifier, the
signals are sent for A/D conversion, through which analog signals are
converted to digital signals, compounded in the beam former, go through
digital signal processings such as filtering, logarithm compression, detection
and form digital beam data stream. The beam data steam is sent to the CPU
board goes through scan transform and video processing. Finally, an
ultrasonic image is displayed on the monitor.

The core of the CPU board is a built-in Linux system. In addition to completing
display of ultrasonic images, it accepts keyboard operation commands from
the user, and changes them to internal executable commands. Moreover, it
will achieve all kinds of measurement and calculation, data input and output of
peripheral ports, and so on. The system can also work with peripheral devices
such as a printer, a network device or an external memory, so as to extend
system functions.

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4.2 Technical Specifications

z Digital beam former

z Dynamic receive focusing, dynamic aperture, dynamic apodization
throughout the course;
z Transducer: broadband multiple-frequency transducer, 5-frequency,
frequency range 2.0-12.0MHz;
z Probe connector: 2
z Scanning range:
Convex array: depth over 280mm
Linear array: depth 123mm, width 46mm
Micro-convex array: max. angle 180°, max. Depth 320mm at 2.0MHz
z Grayscale: 256
z Dynamic range: 158dB;
z Imaging mode: THI , B , B+B , B+M , M , 4B;
z Scanning lines: max. 256 lines in B mode max. 256 lines in M mode;
z Line density: low, high;
z Edge enhancement: 8 steps;
z Grayscale curve: 16 types;
z Persistence: 8 steps;
z Chroma: 7 types;
z Frequency: 5 steps;
z Focus number: max. 4, focus number and depth controllable
z Focusing method: whole-course dynamic focusing, variable aperture;
z Frame rate: max. 60 frames;
z Gain control: gain 0～255, encoder adjust; 8-TGC; independent gain
control for B and M modes;

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z Zoom factor: max. 8.0, local zoom function, in 8 steps:;

z M mode: sweep speed:1, 2, 3, 4, 5s;
z M mode video inversion;
z Biopsy guide line: on/off, position and angle adjustment;
z User adjustable parameters: dynamic range, frequency, GSC,
persistence, enhancement, grayscale curve, left/right invert, up/down
invert, image rotation angle, sweep angle/width, zoom factor, focus
number and position, biopsy guide line;
z Diagnostic mode: applications such as cardiac, liver, kidney,
muscular-skeletal, gynecological, obstetric, thyroid, carotid, breast
and pancreas; exam mode preset by the user;
z Cine and storage:
256 frames in B mode;
A power-down flash can store up to 2000 images in BMP format, or
10000 images in JPG format.
Cine speed adjustable: high, medium or low;
Measurement when reviewing images;
z Thumbnail function: the latest reviewed images (up to 32 images)
can be shown in thumbnail at the bottom right of the screen;
z Body mark: not less 80 type;
z Annotation: rich annotations, the user can add new annotations;
z Measurement:
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
Cardiac measurement: MV, LV, AO, EDV, ESV, EF, CO, SV, FS, ET
Other measurement: RUV, PV, and so on
z Report: cardiac report, vascular report, OB/GYN, growth curve,
urology;

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z Display: 12-inch industrial-grade LCD, the user can adjust the

monitor through system menu;
z Built-in Linux system;
z Standard PS2-port keyboard, backlit display, high-brightness control,
keyboard with beeper prompt;
z Multiple language operation interface: Simplified Chinese/ Traditional
Chinese/ English/ Russian/ Spanish/ French/ Italian;
z Input in Chinese/ English;
z Video out format: composite video, S-Video, VGA;
z Output ports: LAN, 2×USB2.0, composite video, VGA, S-Video, print
control;
z Input port: footswitch;
z DVD-RW (Option);
z Optional peripherals: footswitch, video printer, USB video printer,
USB disk, mobile hard disk, network device, VCR;
z DICOM function: (Option);
z File output format: Image: BMP, JPG, AVI; Report: .RPT;
z Software update: USB update by the user or update through Flash
replacement;
z Power in: 100-240V～, 50/60Hz auto adaption;
z External dimension: L×W×H ≤ 336×180×346（mm）
z Net weight: Approx. 6.5Kg;
z Environmental requirement:

Operation Storage and Transport

Ambient temperature: 10℃～40℃ -20℃～55℃

Relative humidity: 30％～75% 20%~90%
Atmospheric pressure: 700～1060hPa 700～1060hPa

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4.3 Probes

Item Transducer Name/ Model Application

1 C351/3.5MHz/R50mm, Convex Abdominal/GYN/OB

2 C543/5.0MHz/R40mm, Convex Abdominal

3 L745/7.5MHz/50mm, Linear Small Parts

4 L773/7.5MHz/66mm, Linear Small Parts

5 C312/3.5MHz/R15mm, Micro-convex Cardiac

6 C612/6.5MHz/R13mm, Micro-convex Veterinary

7 6V4/6.5MHz/R13mm, TV, Micro-convex Transvaginal

8 EC2/6.5MHz/R10mm, EC, Micro-convex Endocavity

9 BCL10-5,convex&Linear,bin-plane; Transrectal

10 BCC9-4,Convex&convex,bin-plane; Transrectal

11 L745/7.5MHz/50mm, Linear Veterinary

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5 Assembly /Disassembly of the System

5.1 Internal Conformation

Fig 4.1 and Fig4.2 show the internal conformation of the system.

The number is reprsent:

1． FED Board

2． CPU Board

3． Inventor Board

4． Power Supply Board

5． KeyBoard

6． TrackBall

7． LCD

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Fig 4.1

Fig 4.2

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5.2 Assembly /Disassembly of the System

Fig 4.2-1

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1． To disassemble the Keyboard PCB（Fig4.2-1）

a) Take off the potentiometer caps（7）;

b) Pull out knob forcibly（5，6）;
c) Unscrew the self tapping screws from top side;
d) Pull out the keyboard（4）;
e) Remove the cable to the unit and the cable to the trackball;
f) Unscrew the self tapping screws from bottom side（2）;
g) Take off the keyboard PCB （3）and remove the silicon mask;

2． To remove the FED PCB(20)

a) Unscrew 6 screws in the back shell(24);

b) Remove the back shell(24);
c) Unscrew screws(23) on the metal cover(22) and remove metal
cover(22);
d) Unscrew 6 screws(21) on FED board(20);
e) Remove the FED PCB(20);

3． To remove the CPU PCB

After remove the FED PCB;

a) Unscrew the screws on the metal board(18) under the FED board;
b) Remove the metal board(18);
c) Unscrew 2 screws on the CPU PCB;
d) Unscrew the screws of the metal board(17) on the right side;
e) Remove the cables on the CPU PCB;
f) Pull out the CPU PCB from bottom side;

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4． To remove the power supply board

After remove the metal board under the DBF board;

a) Unscrew 4 screws on the power supply board;
b) Pull out the cable on the power supply board;
c) Pull out the power supply board form bottom side;

5． To remove the inventor board(16);

a) Unscrew the screws(14) on the metal board(15) over the inventor

board(16);
b) Unscrew the screws on the inventor board;
c) Pull out the inventor board form top side;

Caution:

You can remove the inventor board without remove the other
boards

6． To disassemble the LCD

a) Pull out the cables on the inventor board;

b) Unscrew the screws on the rotate axis;
c) Pull out the LCD from the front side;

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6 Malfunction Analysis

Besides the failure list blow, there may be other problems due to the
complicated features of the system. If any failure occurs, it is important to note
down the operating environment, operating status and the failure
phenomenon. Then contact a professional service person as soon as
possible to troubleshoot the problem.

6.1 Common Malfunction Analysis of DBF Subsystem

Because the DBF board is directly related to quality of ultrasound images, if

image quality is not good, it may be caused by the DBF board. The bad
quality of images are illustrated as below:

6.1.1 Image dots become coarse

The possible cause of dots becoming coarse is the worsening performance of

the amplifier on the DBF board, or the resonance frequency shifts. Therefore,
it may be caused by the DBF board failure.

6.1.2 Noise on the image

There are many reasons that cause noise on the image, e.g. electromagnetic
interference, power interference and interference from the system itself, etc.
When there is any interference appears on the image, remove the external
interference sources firstly. Only when there is no external interference can a
further confirmation of the system failure is made.

External electromagnetic interference can cause the whole screen (not limited
to the ultrasound imaging area) appears being disturbed. If the failure of the
front end system causes the interference, the interference will only appear on
the ultrasound imaging area. Therefore, whether the interference source is
from external electromagnetic interference can be distinguished.

External power interference may also cause noise on the ultrasound imaging
areas. If the outward power interference is detected, the system ground
terminal should be checked to see whether it is well grounded. In the
meantime, keep away from the power interference source.

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If the noise is caused by system failure, the location of the noise can be
identified roughly according to the noise feature.

1) Noise appears in tower shape, and there are one or more tower
shapes on the image. It is usually the failure of the DBF board;
2) Noise appears irregular, and appears in the whole ultrasound
imaging area.

6.2 Malfunction Analysis of CPU Board

System clock cannot be maintained

If the system clock can not be maintained, change the battery first. The
battery may work for five years, then the voltage of battery may drop;

The screen display confusion

If the screen display some color bar, or nothing displayed, check the cable
between the screen and system, especially the lvds signal cable; Then check
the voltage +12V; If all is ok, the defect may caused by CPU board;

6.3 Malfunction Analysis of Power Supply Board

The power supply board of A6T/A6/A5 can self-adapt with 110V/220V AC

input.

There are several output voltages. They are: +5V, +12V, +3.3V, +100V, -100V,
+HVAdjust. When inspecting power failure, it should be inspected to see
whether there is any obvious damage or default parts firstly. If the system can
still power up, test every voltage firstly.

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7 System Maintenance

7.1 Main Unit

7.1.1 Maintenance

The system is a precise electrical device. To ensure the best performance

and operation of the system, observe proper maintenance procedures. You
warrant safety and effectiveness of the system, it is recommended to conduct
a preventative maintenance for the system once every year, and it shall be
performed by a professional from the manufacturer or an authorized person.

The daily maintenance shall mainly cover:

z Use a piece of dry cloth to clean the system plastic housing and the
keyboard;
z Use special soft cloth and cleanser to clean the LCD;
z Clean and remove the dust from the dust net at the bottom of the
system, so as to ensure that the system is clean inside and the
ventilation is good;
z Check if the grounding of the system is good, whether it complies
with relevant safety requirements;
z Check the operating environment of the system, so as to ensure that
the operation environment is good, which assures long-term stable
running of the system.

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7.1.2 Installation

The system is a portable diagnostic device.

Before installation, please pay attention to the following:

z The environment where the system is in use shall comply with the
requirements in its technical specifications;
z Take out the system from the package; ensure that the system
cosmetic is good, without any obvious damage;
z The system shall be placed on a even platform, without any
irrelevant items around;
z The grounding post at the back of the system shall be connected to
a terminal complying with grounding standard.

7.1.3 System Transport

When moving or transporting the system, take the precautions outlined below
to ensure maximum safety for personnel, the system, and other equipment.
After the system is positioned to a new place, ensure that the system is
placed on a secure level.

Before moving or transporting the system, observe the following:

1. Completely power down the system; plug out the power cord.
2. Disconnect all the transducers, and store all transducers in their
original cases;
3. Disconnect all peripheral devices;
4. Lift the system when all the above items are observed.
5. For long-distance transport, observe the additional precautions
below:
6. Pack the system properly. It is recommended to pack it with its
original package, so as to avoid impact, shock or pressure during
transport;
7. Do not place the system upside down during transport;
8. For environmental requirements on transport, see relevant sections
in this manual.

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7.2 Transducer

Before using the transducer, check if there is any damage in the transducer
housing, cable or connector. If there is, contact the service agent. Using
ultrasound gel on the transducer surface as coupling between the patient and
the transducer. After finishing the exam, conduct necessary cleaning and
disinfection.

WARMING:
Only the manufactured transducer can be used with the system.
Connecting the transducer to any other system may result in
electric shock or damage.

7.2.1 Maintenance

The structure of the convex and the linear transducers is shown in Fig 5-1a.

z The probe may be damaged even by a slight impact. Use it carefully

to avoid shocking or striking against any hard object;
z Ensure that the main unit is in frozen or power-down state while
connecting or disconnecting a probe;
z Be very careful not to scratch the probe head surface (acoustic
lens);
z Use a sponge or soft cloth soaked with water to clean the probe after
use. DO NOT use alcohol or wiper containing alcohol or other
organic solvent like diluent to do the cleaning.
z The probe shall not be inserted into water over the bonding
boundary,or it may lead to potential damage. In this case, please
contact our service immediately;
z If the probe cable is exposed due to scratch, please stop to use it
and contact our service immediately.
z Install the transducer by rotating the locker in the indicated direction,
and avoid to damage the connector;
z Avoid twisting the transducer cable when using the transducer.
z Use qualified acoustic coupling gel only. Avoid damage to the
transducer acoustic lens due to gel with bad quality.

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Fig. 5.2.1 Transducer Figuration

a) Bonding boundary
b) Cable
c) Cable sleeve
d) Handle
e) Probe head (acoustic lens)
f) transducer

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7.2.1.1 Use endocavity transducer

Every time using and after using the transducer, clean the handle of the
endocavity transducer, and disinfect it with chemical disinfectant.

Before using the endocavity transducer for ultrasound exam, cover on the
transducer a condom approved by the FDA. Here is the precaution when
covering a disposable condom:

NOTE:
1． Some patients are allergic to natural rubber of medical device
containing rubber. The FDA recommends that before using the
endocavity transducer for ultrasound exam, the doctor shall
identify such patients and prepare measures against such
allergy immediately.
2． Only water-solubility material or water-solubility jelly is allowed
to use on the transducer head. Derivative from oil or mineral oil
may damage transducer surface.
3． It is strongly recommended to use condoms approved by the
FDA.

Here are the procedures to handle an endocavity transducer:

1. Put on medical disinfected gloves.

2. Take out a condom from its package.
3. Fill appropriate ultrasound coupling gel in the condom.
4. Hold the condom with one hand, and insert the acoustic lens section
of the transducer.
5. Fix the condom at the end of the transducer handle.
6. Check if the condom is broken during this process. If it is, replace
with a new condom, and repeat the steps above.

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7.2.2 Cleaning

Every time using the transducer, clean the transducer handle, and disinfect
the endocavity transducer with chemical disinfectant.

Remove the ultrasound gel on the transducer with soft cloth, and wash away
any residue on the transducer with running water. Then clean the transducer
with warm moderate suds. If necessary, clean the transducer and remove the
visible residue on the surface of the endocavity transducer with soft cloth.

Clean the transducer with sufficient clean drinking water, wash away visible
suds residue on the transducer, and air dry it.

NOTE:
1． Before cleaning the transducer, remove the protective cover on
the transducer (e.g. disposable condom).
2． During the cleaning of endocavity transducer, it is important to
ensure that all surfaces of the endocavity transducer is cleaned
thoroughly.

7.2.3 Disinfection

The transducer shall be disinfected with liquid chemical disinfectant (e.g.

glutaraldehyde solution) approved by the FDA. The solution shall be mixed,
stored and used following its manufacturer’s product instruction. It is effective
to disinfect transducers with 2% glutaraldehyde solution, which is considered
to be the disinfectant most compatible to transducer material.

Do not process the transducer with high-pressure steam or have it contact

any ethylene oxide. In no circumstances shall heat disinfection be applied.
Temperature higher than 150 F (66℃) may damage the transducer.

Immerse the transducer head in the disinfectant for not less than 20 minutes,
but no more than 1 hour. The immersion section shall not exceed the
transducer bonding boundary. The transducer should not be immersed in any
liquid completely, otherwise it may lead to permanent damage.

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To ensure efficacy of the disinfectant, clean the transducer thoroughly before

disinfection. Make sure that not any residue is on the transducer. Here are the
disinfection steps for a transducer:

z According to the precautions for storage, usage and handling of the

disinfectant, follow the supplier’s instruction to prepare the
disinfectant.
z Immerse the cleaned and dried transducer in the prepared
disinfectant following the requirement.
z When the transducer is immersed or placed into the disinfectant,
rotate or shake the transducer section in the disinfectant to clear off
any bubble and ensure a thorough contact between the transducer
and the disinfectant. For high-level disinfection, perform the
disinfection procedure by following the supplier’s suggested
duration.
z Withdraw the transducer from the disinfectant, and the disinfection
for the transducer is finished. Clean off the disinfectant on the
transducer thoroughly with water, and then wipe it up with soft dry
cloth.
z Air dries the transducer.

7.3 Service Method

7.3.1 Service Method

When any abnormality occurs, shut off the power supply and inform our
service engineer of the detailed situation. If possible, send a failure picture to
our service engineer. We will provide prompt service. A detailed failure report
will help us to shorten the service time.

If the fuse is broken, the fuse can be replaced by following our service
engineer’s instruction. The fuse is 50T-0160H 250V. Two fuses of this model
were packed with the system as accessories. The same fuses can be
purchased from the local market. If the same broken fuse issue happens
again after replacement, please inform our service engineer immediately.

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7.3.2 Service responsibility

The system is a sophisticated electronic system. Except for simple

maintenance, for field service, our authorized service contractor or we will
replace the defective parts.

When repair or adjustment of the system is required, please contact us. We

are not responsible for any failure caused by the service conducted by others.

7.3.3 Service contact information

SonoScape Co., Ltd.

9/F, Yizhe Building, Yuquan Road, Nanshan District,
Shenzhen , Guangdong Province, China
Post Code: 518051
Tel: 400-678-8019
Fax: 86-755-26722850
Email: service@sonoscape.net

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