Mobile Ultrasonic Diagnostic System

A8T/A8/A7

SERVICE MANUAL

P/N 4720-0024-01A

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 Human safety................................................................................. 1-4
1.4 Operating Environment.................................................................. 1-4
1.5 Transport and storage.................................................................... 1-5
1.6 Electrical Requirements................................................................. 1-5
1.7 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 Measurements and Calculations.................................................... 2-2
3 System Configuration & Function ......................................3-1
3.1 Front End Board (FED).................................................................. 3-2
3.2 CPU Board .................................................................................... 3-2
3.3 Keyboard / Control Panel............................................................... 3-2
3.4 COM Board.................................................................................... 3-2
3.5 Power Supply Board ...................................................................... 3-3
4 Principle of the System .......................................................4-1
4.1 Operation Theory........................................................................... 4-1
4.2 Technical Specifications ................................................................. 4-2
4.3 Probes ........................................................................................... 4-5
5 Assemble / Disassemble the System .................................5-1
5.1 Internal Configuration .................................................................... 5-1
5.2 Assembly /Disassembly of the System .......................................... 5-3
6 Malfunction Analysis ...........................................................6-1
6.1 FED Subsystem Malfunction.......................................................... 6-1
6.1.1 Image looks too coarse................................................. 6-1
6.1.2 Noise on the image ....................................................... 6-1
6.2 CPU Board Malfunction ................................................................. 6-2
6.3 Power Supply Board Malfunction................................................... 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
7.1.3 Transport....................................................................... 7-2
7.2 Transducer..................................................................................... 7-3
7.2.1 Maintenance ................................................................. 7-3
7.2.1.1 Use endocavity transducer .................................... 7-5

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7.2.2 Cleaning ........................................................................7-6
7.2.3 Disinfection....................................................................7-6
7.3 Service Guideline ...........................................................................7-7
7.3.1 Service Guideline ..........................................................7-7
7.3.2 Service responsibility ....................................................7-8
7.3.3 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 chapter.
To ensure the safety of the operator and patient, please read the relevant
details in this chapter carefully before operating this system. Warning and
precaution messages must be followed exactly to avoid system damage or
even personal injury.

This system complies with Type B general equipment, Class I,

EN606601-1:1990+A1:1993+A2:1995 standard.

Take the following precautions before using the ultrasonic

system:
Do not disassemble/modify this system under any circumstances. Only
authorized personals from SonoScape or representatives of SonoScape
should service/upgrade the system.
In case of any malfunction occurs, the ultrasonic system should be turned off
immediately. Inform SonoScape or the local SonoScape representative
nearest to you as soon as possible.
Properly grounding can prevent potential electric shock, ensure that the
three-conductor AC power cord equipped with the system is plugged into an
electrical outlet/receptacle marked with hospital grade. The equipment has an
extra grounding point (located at the lower rear panel). To avoid loss of image
quality, it is compulsory to connect this point to ground (earth).
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.

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The equipment may interfere with other high frequency devices (e.g. medical
lasers). Extra safety measures must be taken if other HF devices have to be
used nearby.
The installation shall be performed by personnel authorized by the
manufacturer only. Do not attempt to install the system by yourself
The system shall be used by a qualified operator or practitioner or under the
supervision of a qualified person.
The equipment must not be used in the presence of inflammable gases (e.g.
anesthetic gases and nitrous oxide) to avoid explosion hazard.
Turn off the system completely by unplugging the power supply cord before
cleaning. Protect the system from drip water or other liquid that could short
electric circuits inside the system.
Acoustic coupling gel should be applied to obtain high quality image. To
ensure the safety of patient, only legally marketed coupling gel, which is
biocompatible and complies with related standard, should be used.
At the end of the life time of this product, please contact your local
representative or SonoScape for disposal.

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1.2 Warning Signs

Signs Description

Insulated patient application part (Type BF)

Dangerous electric voltage

Attention! Follow these instructions, to avoid system

damage or personal injury.

Off (Mains power switch OFF)

On (Mains power switch ON)

Potential equilibrium connection

Alternating current

It’s strictly prohibited to use the equipment in the

presence of inflammable gases.

Direct current

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1.3 Human safety

This product should be used only with valid reasons. Keep the power levels
and the exposure time as low as possible, as long as a satisfactory diagnosis
can be achieved. The ALARA (As Low As Reasonably Achievable) guideline
must be observed.

Keep the transducers clean. The transducers shall be cleaned and

disinfected before scanning another patient. For intracavitary probes, high
level disinfection is required.

Press the Freeze key to start freeze mode 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 on the body for a prolonged period of time.

1.4 Operating Environment

¾ Environmental requirements for operation:

z Relative humidity: 30％～75% no condensation

z Ambient temperature: 10℃ ～ 40℃

z Barometric pressure: 700～1060hPa

¾ Strong EM field may interfere with the system. To avoid degradation

of image quality, shield the system or keep it far away from the
strong EM radiation source.

¾ The keyboard / control panel is only for operating the system. Do not
put any booklets or any other devices on the keyboard / control
panel.

¾ When the system is not in use, be sure to turn off the power supply.
Cover the trolley with a dust cover.

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1.5 Transport and storage

¾ Environmental Conditions for Transportation:

z Relative humidity: ≤80%, no condensation

z Ambient temperature: -5℃ ~ 40℃

z Barometric pressure: 700 ~ 1600hPa

1.6 Electrical Requirements

¾ Power Requirements: 110-220V~, 50/60Hz,

¾ Power Consumption: 150 VA (Max.)

¾ Mains input voltage: the input fluctuation should be within ±10%，

otherwise the system may be damaged.

¾ Grounding to earth: Before connecting the mains power cable,

connect the extra grounding point on the system to a dedicated
safety ground point/device.

NOTE:
Please follow the above requirements to provide the suitable power
supply to the system.

The requirements of power supply may vary in different

regions/countries. Please refer to the symbols on the rear panel of
the system for the detailed requirements.

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1.7 Electrical Safety Classification

The equipment conforms with the following regulations for electrical safety,
¾ IEC 60601-1: 1988+A1:1991+A2:1995, Medical Electrical Equipment
Part 1: General Requirements For Safety, Class I, BF, continuous
operation
¾ IEC 60601-2-37: 2001 + A1:2004 + A2:2005, Medical Electrical
Equipment Part 2-37: Particular Requirements For The Safety Of
Ultrasonic Medical Diagnostic And Monitoring Equipment
¾ Degrees of protection against harmful liquid: IPX0 for the SSI-8000
system and IPX7 for the accompanied probes.
¾ The equipment conforms with the following EMC/EMI standards:
IEC60601-1-2: 2001＋A1: 2004, Class A (CE)

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2 General Information

2.1 The Characteristic of the Products

The system is a high performance, full digital, mobile ultrasonic diagnostic

system. Employing the most advanced full digital ultrasound design in the
industry and utilizing the VLSI (very large scale integration), the system
provides excellent imaging performance and is capable of producing
information rich images. A variety of accessories are available: external USB
2.0 support, Ethernet image sharing and etc. The system’s reliable
performance relies on the embedded Linux system loaded with professional
application packages. Thanks to the windows style interface, the system is
customizable and easy to operate.

A high-performance industrial-grade LCD is used on the systems. Compared

to the normal LCD, it can display high resolution images and has abundant
gray scale levels. The light weight of the LCD also helps reducing the system
weight significantly.

2.2 Applications

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

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

z Vascular (cerebrovascular, peripheral vascular)
z Abdominal (liver, spleen, gallbladder, kidney, and etc.)
z Obstetrics/Gynecology
z Cardiac
z Urology

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WARNING：
This ultrasonic diagnostic system is not intended for ophthalmic
use or any use causing the acoustic beam to pass through the eye.
Operation Modes

z B Mode
z B/M Mode
z M Mode
z THI Mode
z Dual B Mode
z Quad B Mode

2.3 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 etc.

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3 System Configuration & Function

This system consists of the main unit (host) and probes.

The main unit consists of a CPU board, a FED (or Front End) board, a
keyboard panel, a monitor inventor board, a power supply board and a LCD
monitor.

The configuration is shown as in Fig. 1.

Fig. 1

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3.1 Front End Board (FED)

The FED board is the main signal process board.

Three 156-pin probes can be plugged to the system at the same time and
with one of them being active. The FED board sends high voltage drive
signals to the probe elements and also picks up echo signals from these
elements. The FED board amplifies the echo signals and extracts useful
information through digital signal processing.

3.2 CPU Board

The CPU board is the core control unit of the system.

The CPU board processes the digital echo signals from the FED board and
generates graphic and text information. The information are then displayed on
the LCD. The CPU board also controls the data ports, such as Ethernet port,
RS232 port, S-video and C-video port, Dual USB port.

3.3 Keyboard / Control Panel

Almost all user operations, from selecting menu items to adjusting imaging
parameters, from file management to Ethernet sharing, and etc., are
performed through the keyboard. There are 65 hard keys, one gain control
knob, one function knob, one menu knob, 8 TGC control sliders, one trackball
and two customizable function keys.

3.4 COM Board

The COM board provides the CPU board with power supply which is sourced
from the power supply board.

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3.5 Power Supply Board

A switching mode power supply (SMPS) is installed inside the system to

provide the startup and operating voltages for all other circuit boards.

Pin Assignments of DC Output of Power Supply board

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4 Principle of the System

4.1 Operation Theory

The digital beam former at the FED board sends out transmit pulses at a
certain frequency. These pulses, after being processed, will be transmitted to
the corresponding element crystals. The crystals convert the electronic
signals into ultrasonic vibrations. Vibrations of many such crystals produce
ultrasound beam focusing in certain directions. The ultrasound waves
propagate into the human body are reflected by the tissues. When the echoes
are picked up by the crystals on the transducer, they carry information of the
tissues and the locations of reflections. To extract this information from the
echoes, they are converted back to electric signals, are sent for processes
like electric signals for pre-amplification, AD conversion, digital signal
processing and etc. Finally the CPU generates the video signals and the
tissue characteristics are ultimately displayed on the LCD monitor.

The Linux system embedded in the CPU board is the central part of the
system. In addition to generate ultrasound images, it is also responsible for
the following tasks:
• responding to keyboard activities, i.e. execution of user commands
entered by keyboard inputs.
• miscellaneous measurements and calculations.
• data communications (input and output through IO ports) with
accessories.

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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 socket: 3
z Scanning range:
Convex array: depth over 300mm
Linear array: depth 123mm, width 46mm
Micro-convex array: max. angle 180°, max. Depth 320mm at 2.0MHz
z Grayscale: 256
z Dynamic range: 30-165 dB;
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 Support biplane probe
z Line density: low, high;
z Edge enhancement: 8 steps;
z Grayscale curve: 21 types;
z Persistence: 8 steps;
z Chroma: 16 types;
z Frequency: 5 steps;
z Focal 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: 1.2, 1.5, 2.0,
3.0, 4.0, 5.0, 6.0 and 8.0;
z M mode: sweep speed in steps: 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, FPS, gain,
grayscale curve, left/right invert, up/down invert , image rotation,
sweep angle/width, depth, line density, zoom in, focus number, focus
position, focus distance, biopsy guide line position and angle, sound
power, croma;
z Diagnostic mode: cardiac, liver, kidney, muscular-skeletal,
gynecological, obstetric, thyroid, carotid, breast and pancreas; and
customized diagnostic modes
z Cine and storage:
512 frames in B mode;
Mass storage ability can store up to 2000 images in BMP format, or
10000 images in JPG format.
Cine speed adjustable: high, medium or low;
Measurements during cine playback is supported.
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 than 100 types; Support Dual-Body Mark and
Quad-Body Mark
z Annotation: rich predefined 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, ANGLE, UT,
OFD, CI, AFI, FGC、HIP
GYN measurement: UT, ENDO, OVARY, FOLLICLE, CERVIX,
UT-L/CX-L;
Cardiac measurement: MV, LV, AO, EDV, ESV, EF, CO, SV, FS, ET
URO measurement: RUV, PV, PSV, Left Kidney, Right Kidney;
Other measurement: Thyroid
z Report: OB, GYN, cardiac report, URO,small part, growth curve,
histogram

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z Build-in workstation;
z Display: 15-inch industrial-grade LCD, the user can adjust the
monitor through system menu;
z Based on Linux operation system;
z Multilingual user interface: Simplified Chinese/ Traditional Chinese/
English/ Russian/ Spanish/ French/ Italian;
z Input Methods: Chinese/ English;
z Video output format: composite video, S-Video, VGA;
z Output ports: LAN, 4×USB2.0, composite video, VGA, S-Video, video
printer controller socket.
z Input port: footswitch;
z DVD-RW (Optional);
z Optional peripherals: footswitch, video printer, USB video printer,
USB disk, mobile hard disk, network device, VCR;
z DICOM function: (Optional);
z File output format:
Image: BMP, JPG, AVI, DCM;
Report: .RPT, .pdf;
z Software update: USB update;
z Power in: 100－240V～, 50/60Hz auto adaption;
z External dimension: L×W×H ≤ 529×747×1352（mm）
z Net weight: Approx. 50Kg;
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 C352/3.5MHz/R50mm, Convex Abdominal/GYN/OB

3 C543/5.0MHz/R40mm, Convex Abdominal

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

5 L746/7.5MHz/50mm, Linear Small Parts

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

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

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

9 6V4/6.5MHz/R13mm, TV, Micro-convex Transvaginal

10 6V5/6.5MHz/R13mm, TV, Micro-convex Transvaginal

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

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5 Assemble / Disassemble the System

5.1 Internal Configuration

Internal hardware configurations of the system are shown in the two figures
on the next page.

Part list

Item number in the

Name
figures

1 FED Board

2 CPU Board

3 COM Board

4 Power Supply Board

5 Keyboard

6 TrackBall

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Fig 5.1-1

Fig 5.1-2

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5.2 Assembly /Disassembly of the System

Fig 5.2-1 Cable Routing

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Fig 5.2-2 Connections

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9
2

1
2
4
2
2

3
8
7

2
6
2
3

Fig 5.2-3 Disassemble the system

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1. Remove the LCD monitor and its support arm ( Fig 5.2-3)
Be sure to lock the wheels of the trolley before dissembling the system.
1. Working from the rear, remove the screws (2).
2. Remove the plastic cover (6).
3. Remove the screws (3).
4. Holding the monitor and the base of monitor support arm, pull the monitor
support arm horizontally backwards to detach it from the trolley.

Fig 5.2-4 Disassemble the LCD monitor

2. Disassemble the LCD monitor (Fig 5.2-4)

1. Working from the back of the LCD monitor, remove the screws (2).
2. Remove the front frame (1). Be aware of that the monitor controller cables
are attached to the front frame.
3. Disconnect the data cables at the back of the LCD panel and remove the
LCD panel from the back cover.

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3. Remove the keyboard unit (Fig 5.2-3)
1. Working beneath the keyboard, remove the screws (2).
2. Gently lift the keyboard unit up and disconnect all the cables attached to
it.
3. Remove the keyboard unit from the trolley.

5
I
4

8 7 6
9
2
1

8 10

Fig 5.2-5A Disassemble the keyboard unit (A)

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3
2
1

Fig 5.2-5B Disassemble the keyboard unit (B)

4. Disassemble the keyboard unit (Fig 5.2-5A)

1. Remove the screws (8,9) from the bottom of the keyboard unit.
2. Disconnect cable connecting the trackball with the PCB (7); disconnect
the cable connecting the PCB (7) with PCB (4).
3. Pop up and remove the keycaps of TGC and hard keys (1, 2, 3). Remove
the trackball, PCBs (7, 4).
4. Remove the screws from the back of the PCB ①; remove the PCB (2 in
Fig 5.2-5B).

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Fig 5.2-6 Disassemble the FED Board

5. Disassemble the FED, CPU and power supply boards
1. Remove the front cover (1, 9 in Fig 5.2-3).
2. Remove the metal panel (4 in Fig 5.2-3).
3. Remove the main unit. (5 in Fig 5.2-3).
4. Remove the metal cover (4 in Fig 5.2-6).
5. Remove the FED board (Fig 5.2-6).
6. Remove the metal panel (5 in Fig 5.2-7) beneath the FED board.
7. Remove the power supply board (4 in Fig 5.2-7).
8. Remove the CPU board (3 in Fig 5.2-7).

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Fig5.2-7 Disassemble the Power and the CPU Board

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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 the Customer Service as soon as possible for
troubleshooting.

6.1 FED Subsystem Malfunction

A properly working FED board is essential to produce high quality ultrasound

images. Any malfunction of the FED board will cause degradation of image
quality. Some typical phenomena of poor images and their resolutions are
described in the following subsections.

6.1.1 Image looks too coarse

The possible cause of coarse ultrasound image is the worsening performance

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

6.1.2 Noise on the image

Many factors can cause too much noise on the image; EM interference from
external source or power supply and malfunction of PCB boards inside the
system are the most likely causes.

Power supply, if not properly grounded, can also generate interferences

causing too much noise on the image. To avoid such kind of problem, the
three-conductor power supply cable of the system must be plugged in an
outlet/receptacle with proper grounding, and the extra grounding point
(marked with equipotential symbol) on the rear panel of the system should
also be grounded.

To find out whether the interference is due to external source or internal board
malfunction, check whether the area with too much noise is limited to the
ultrasound image window. Obvious noise on the whole screen implies that the
interference is caused by external source. Excessive noise is limited to
ultrasound image window implies malfunction of PCB boards inside the
system.

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6.2 CPU Board Malfunction

System clock auto resets

If the system automatically resets its clock, it’s an indication that the battery
on the CPU board should be replaced. The battery has a designed lifetime of
5 years. The battery may provide only a fraction of the normal voltage after its
lifetime.

Display problem
If the screen shows artifacts (e.g. some color bars) or shows nothing, follow
procedure below to find out the cause of the problem.

• Check the cables between the monitor and the system, especially the
LVDS signal cable. If no problem is found,
• then check if the input voltage for LCD meets the +12V requirements.
If no problem is found,
• then check the CPU board for any defects.

6.3 Power Supply Board Malfunction

The power supply of the ultrasonic system is self-adaptive for 110V/220V

mains power input.

The output voltages are +5V, +12V, +3.3V, +100V, -100V, and +HVAdjust.
When power failure occurs, the output voltages should be tested. However, if
the power supply cannot start up, inspect the power supply board for any
damages.

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7 System Maintenance

7.1 Main Unit

7.1.1 Maintenance

This ultrasonic diagnostic system has precision instruments inside. To

maintain the quality of system performance, daily maintenance should be
performed. Preventive maintenance procedures, recommended to be
performed once every year, must be carried out by the SonoScape
representatives or any other personnel authorized by SonoScape.

The daily maintenance includes:

z Use dry cloth to clean the system plastic cover and the keyboard;
z Use special soft cloth and cleanser to clean the LCD;
z To ensure good ventilation for the system, clean the dust filter at the
bottom of the system;
z Check if the grounding of the system is good, whether it complies
with relevant safety requirements;

In order to achieve long term stable operation of the system, ensure

that the environmental requirements have been satisfied.

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7.1.2 Installation

The system is a mobile diagnostic device.

Before installation, please pay attention to the following:

z The environment where the system will be in use should meet the
requirements stated in the operator’s manual;
z The package should be in good condition, no obvious damage or
breakage should be present. Take out the system from the package;
z Place the system on horizontal and clean floor.
z The extra grounding point (marked with an equipotential symbol) at
the back of the system should be grounded.

7.1.3 Transport

When moving or transporting the system, take the precautions outlined below
to ensure personal safety and to avoid damaging equipments. After the
system has been moved to a new place, ensure that the system is secured by
locking the four system castors.

Follow these instructions for transporting the system:

1. Turn the system completely off. Unplug the mains power cable.
2. Disconnect all the transducers and put them in their carrying case.
3. Disconnect all peripherals.
4. Hold the handle of the system and move the system to the destined
place.
For long-distance transport, observe these additional precautions
as well:
5. Prepare the system and pack it in the original package. Packing in
the original package can reduce the risk of scratching or collision
damage.
6. Place the system upwards and ensure that it is firmly secured while
inside the vehicle during transport.
7. Environmental requirements should be satisfied, refer to section 1.5
for details.

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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 your local representative .
Apply sufficient amount of coupling gel on the transducer to achieve good
acoustic coupling. Clean and disinfect the transducer after using.

WARMING
Only the supported transducer models produced by SonoScape
should be used with the ultrasonic diagnostic system. Connecting
unsupported transducers may result in electric shock or system
damage.

7.2.1 Maintenance

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

• The probe is very sensitive to vibrations. Handle the probe with care
to prevent any collision damage.
• The system must be in the freeze mode, at the EXAM screen
(preparation mode) or turned off when removing/connecting the
probe.
• Avoid scratching the probe head (acoustic window).
• Clean the probe with soft cloth or wet sponge soaked in potable water.
Do not use solutions containing alcohol or any other organic solvent
(e.g. diluent).
• Do not immerse the probe beyond the binding line. Immersion for
prolonged period of time in liquid beyond the binding line can damage
the probe.
• If any evidence of wear on a probe is discovered, you should stop
using this probe immediately and contact service representative as
soon as possible.
• Avoid winding or stretching the probe cable excessively while using
the probe.
• Turn the switch lock in the indicated direction as shown on the probe
connector when connecting the probe.
• Use only the quality couplant to avoid damaging probe head.

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Fig. 7.2.1 Transducer Illustration

a) Binding line
b) Cable
c) Cable sheath
d) Probe Handle
e) Probe head (acoustic lens)
f) transducer

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7.2.1.1 Use endocavity transducer

Clean and disinfect the endocavity transducer both before and after each use.

Legally marketed probe sheath approved by FDA should be used to cover the
transducer before ultrasound diagnosis. Do not use pre-lubricated condom as
a sheath. The lubricants in these condoms may not be compatible with the
probe construction.

NOTE:
1． Some patients are allergic to latex (natural rubber) contained in
medical devices. FDA recommends that before using the
endocavity transducer for ultrasound diagnosis, the doctor
should identify such patients and prepare to treat allergic
reactions promptly.
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.

Instructions for preparing the endocavity probes:

Warning!
• Use of sterile FDA cleared 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.

1. To prevent disease transmission, wear sterile gloves.

2. Put an adequate amount of coupling gel on the probe head or into
the probe sheath..
3. Insert the transducer into the probe sheath.
4. Cover the probe with the probe sheath up to the user section (probe
handle).
5. Examine the integrity of the probe sheath. If breakage occurs, repeat
from step 1 to replace the sheath with another new one.

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7.2.2 Cleaning

Clean the transducer and the probe handle after each use.

For surface probes, disinfect the transducer periodically. For intracavitary

probes, disinfecting the transducer after each use is required.

Remove coupling gel on the transducer using soft cloth. Wash away any
visible residue with flowing potable water. If the probe surface carries too
much residue, remove all visible residue with wet cloth soaked in mild soap
water. Use wet soft cloth to scrub the surface if dried residue exists.

Air dry or dry with a soft cloth.

NOTE:
1． Before cleaning the transducer, remove the protective cover on
the transducer.
2． During the cleaning of endocavity transducer, it is important to
ensure that all surfaces of the endocavity transducer are
cleaned thoroughly.

7.2.3 Disinfection

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

glutaraldehyde solution) approved by FDA. Prepare, store and use the
disinfectant following its manufacturer’s instructions. It is effective to disinfect
transducers with 2% glutaraldehyde solution, which is recognized as the most
compatible germicide for the transducer.

• Do not use thermal disinfection! Temperatures higher than 66°C

(150°F) will damage the probe.

• Do not use germicide containing ethylene oxide.

Immerse the transducer head in the germicide solution for at least 20 minutes,
but no more than 1 hour. The immersion level should below the binding line.
Immerse beyond the binding line for a prolonged period of time may damage
the probe.

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

disinfection. Make sure that no visible residue should be present. Here are
the transducer disinfection procedures:

Follow the manufacturer’s instructions to prepare, store and use the

germicide. Note that high level disinfection is recommended for surface
probes, and is required for intracavitary probes. You may need to gently rotate
and shake the transducer to remove the air bubbles between the transducer
surface and the germicide solution. Remove the transducer from the
germicide solution after the disinfection. Rinse it thoroughly with clean and
potable water. Dry the probe with soft cloth.

For more detailed probe maintenance information, refer to the Probe User
Manual.

7.3 Service Guideline

7.3.1 Service Guideline

When any malfunction occurs, turn the system off and inform your local
service representative. Kindly provide detailed information on the phenomena
of the malfunction. A failure report with pictures showing the malfunction will
be quite useful and will help to reduce the service time. Our service engineer
will contact you as soon as possible once you reported the malfunction to us.

In case that the fuse is burned out, the customer may replace it by following
instructions provided by our service engineer. The fuse used in this ultrasonic
system is 50T-0160H 250V and is widely available. The user can purchase the
same kind of fuse from the local market. If the fuse is burned out again after the
replacement, DO NOT attempt start up the system again, kindly inform your local
representative immediately for help.

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7.3.2 Service responsibility

This system is sophisticated electronic equipment. Except for simple

maintenance, other services, e.g. repairs and adjustments, should be
performed only by authorized personnel. Do-it-yourself repairs / modifications
invalidate the warranty and the user shall bear the full and exclusive
responsibility of any damages caused by such activities.

7.3.3 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: [email protected]

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