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SERVICE MANUAL

Service Manual SONOACE X8


www.samsung SAMSUNG MEDISON.com

Contents
Chapter 1 General Information

 System Information 1-1

 System Specifications 1-2

 System Configurations 1-5

 Screen Configuration 1-9

Chapter 2 Safety

 Safety Signs 2-1

 Symbols 2-2

 Electrical Safety 2-4

 System Organization 2-8

 Environmental Protection 2-19

Equipment Protection 2-20

 Safety for USB device 2-21

Service Manual SONOACE X8


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Contents
Chapter 3 Maintenance

 System Maintenance 3-1

 Service Manual questions or Comments 3-1

 System Surfaces 3-2

 Administration of Information 3-3

 Probe Management 3-4

 Biopsy Guide Adapter and Needle Guide 3-9

 Trouble Shooting Trees 3-11

Chapter 4 Installation

 Before Installation 4-1

Connecting peripherals 4-3

 Peripheral Device 4-5

 Probe 4-6

 Optional Function 4-7

Service Manual SONOACE X8


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Contents
Chapter 5 Performance Tests

 Wiring and Cautions 5-1

 Initial Setup 5-2

 Initialization and Monitor Tests 5-3

 Functional Tests 5-4

Chapter 6 System Organization

•System Organization 6-1

•Probe Select Assembly Board (PSA) 6-3

•Beamformer Board (BF) 6-5

•Back End Board (BE) 6-8

•PC Module 6-11

•Key Matrix PCB 6-13

Service Manual SONOACE X8


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Contents
Chapter 7 Disassembly

 Overview 7-1

 Disassembly 7-2

Chapter 8 Parts

 Ordering Parts 8-1

 Part Number 8-2

 Part Pictures 8-3

Chapter 9 Probe

 Probe Specification 9-1

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C hapter 1

General Information

System Information 1-1

System Specifications 1-2

System Configurations 1-7

Screen Configurations 1-9

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General Information Chapter 1 1-1

General Information

System Information
The SONOACE X8 is a high-resolution color ultrasound scanner with high penetration and a
variety of measurement functions.

Features and Advantages of SONOACE X8

1. High-end Digital Beam Forming – The SONOACE X8 utilizes the newly developed
Digital Beam forming technology.
2. A variety of applications – The SONOACE X8 is optimized for use in a variety of
ultrasound departments, including general, abdomen, obstetrics, gynecology, vascular,
extremity, pediatric, cardiac, breast, urology, and etc.
3. Various diagnostic Modes - 2D Mode, M Mode, Color Doppler Mode, Power Doppler
Mode, PW Spectral Doppler Mode, CW Spectral Doppler Mode, etc.
4. 3D images can be obtained.
5. Measurement and Report Functions – Besides the basic distance, area, circumference
and volume measurement functions, the SONOACE X8 also provides application-
specific measurement functions. The report function collates measurement data.
6. Review of Scanned Images – The SONOACE X8 displays Cine images of 2048 frames
and loop images of 8192 lines.
7. SonoView - This is a total ultrasound image management system, which allows a user to
archive, view and exchange documents.
8. Digital Imaging and Communication in Medicine (DICOM) Function - This is used to
archive, transmit and print DICOM images through a network.
9. Peripheral/Accessory Connection – A variety of peripheral devices including VCRs and
printers can be easily connected to the SONOACE X8.

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System Specifications

Height: 1278mm (with monitor)


Physical Width: 510mm
Dimensions Depth: 885mm
Weight: more than 101kg (with monitor)

2D imaging mode
M imaging mode
Color Doppler Imaging (CDI) mode
Power Doppler Imaging (PDI) mode
Directional Power Doppler Imaging (DPDI) mode
Power Pulse Inversion Imaging (PPII) mode
Pulse Wave (PW) Spectral Doppler imaging mode
Imaging modes
Continuous Wave (CW) Spectral Doppler imaging mode
3D imaging mode
Dual modes
Quad modes
Combined modes
Simultaneous mode
Zoom

Gray Scale 256 (8 bits)

Transmit focusing, maximum of eight points (four points


Focusing simultaneously selectable)
Digital dynamic receive focusing (continuous)

Curved Linear Array


C2-5EL
C3-7EP
C4-9/10ED
Linear Array
HL5-12ED
L5-12EC
L5-12/50EP
Phased Array
P2-4AH
P3-5AC
P3-7AC
Endocavity Curved Linear Array
Probes
NER4-9ES
NEV4-9ES
Volume Probe
3D2-5EH
3D2-5EL
3D2-6ET
3D4-8EK
3D4-8ET
3D4-9ES
3D5-9EK
CW
CW2.0
CW4.0

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General Information Chapter 1 1-3

Probe connections 4 probe connectors (including CW probe connector)

Monitor 17 inch LCD monitor

VHS and SVHS VCR left and right audio


Microphone
Rear Panel B/W printer video and remote control
Input / Output VGA monitor
Connections Parallel port
USB
LAN

Cine loop memory (maximum 2048 frames)


Image Storage
Image filing system

General, Obstetrics, Gynecology, Extremity, Urology, Breast. Renal,


Vascular, Pediatric, Abdomen, Cardiac, Neonatal, Fetal Echo,
Application Carotid, Varicose, Fetal Abdominal, OB-Early, Small organ, Intra-
operative, Cephalic, Peripheral-vascular, Muscular-skeletal, Trans-
rectal, Trans-vaginal, Contrast Agent

Electrical
100-120V/200-240VAC, 10A, 50/60Hz
Parameters

Obstetrics
Gynecology
Cardiology
Measurement Fetal Echo
Packages Vascular (Carotid, Upper Extremity, Lower Extremity, Varicose)
Urology
Radiology
* Refer the Chapter 5 for additional information

TGC control
Mode-independent gain control
Acoustic power control (adjustable)
Signal processing Dynamic aperture
(Pre-processing) Dynamic apodization
Dynamic range control (adjustable)
Image view area control
M-mode sweep speed control

Frame average
Edge Enhancement / Blurring
Signal processing Gamma-scale windowing
(Post-processing) Image orientation (left/right and up/down, rotation)
White on black/black on white
Zoom

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Trackball operation of multiple cursors


2D mode: Linear measurements and area measurements using
Measurement elliptical approximation or trace
M mode: Continuous readout of distance, time, and slope rate
Doppler mode: Velocity and trace

VCR
Video Page Printer
Color Video Page Printer
USB Video Printer
USB Color Video Printer
Inkjet Printer
Auxiliary Laser Printer
USB MO Driver
USB Wireless LAN
Foot Switch
USB Flash Memory Media
Microphone
Monitor

Operating: 700hPa to 1060hPa


Pressure Limits
Storage: 700hPa to 1060hPa

Operating: 30% to 75%


Humidity Limits
Storage & Shipping: 20% to 95%

Operating: 10 OC ~ 35OC
Temperature Limits
Storage & Shipping: -25OC ~ 60OC

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General Information Chapter 1 1-5

System Configurations

Main Body

The console consists of two parts – the inner unit and the outer unit. The inner section is
responsible for ultrasound image generation. The outer section is designed to support the use
of other devices and includes monitor and probe connection sockets, the probe holder,
storage devices like HDDs, storage space for peripheral devices and the system power
switch.

[Figure 1-1] Main Body

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Control Panel

The control panel can be used for controlling the system. It consists of the following four sections:
1. Function keys for mode selection and scanning, located on the right side of the control panel.
2. Function keys for annotation and measurements, located around the Trackball.
3. Menu selection buttons, located on the left side of the control panel.
4. An alpha-numeric keyboard, located at the top of the control panel.

[Figure. 1-2] Control Panel

The user can manipulate the control panel using ① Slide, ② Button, ③Trackball, ④ Dial-Button,
⑤ Dial, and ⑥ Up/Down Switch. The dial-button can be used both as a dial and a button.

Kinds of Controls and the Operations


Slide
Slide increases a value if it is pushed to the right and decreases a value if pushed to the left.
The TGC Slide is an example.

Button
As one of most general controls, you have only to press the button to start a desired operation.
The [Set] button is an example. This is a button worked by toggle. That is, one press of button
turns the function on, and one more press of button turns the function off.

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General Information Chapter 1 1-7

Trackball
The trackball is a control to move a cursor on the screen.

Dial-Button
The dial-button is designed to add to the convenience of use and to reduce the complexity of
the control panel. It also functions as a dial, which changes a value by turning to the left or
right, and as a button, which operates by pressing. The [Menu] dial-button is an example. This
dial-button is to execute the currently selected menu item. Turning the dial-button to the right,
you can select the upper menu items of the current menu. Turning to the left, you can select
the lower menu items.

Dial
The dial is the control that increases or decreases the value upon turning to the right or left,
respectively. The [Gain] dial is an example.

Up-Down Switch
The up-down switch is a control that increases a value while it is up and decreases a value
while it is down. The [Scale] switch is an example. When you switch it up or down, the
focusing point ascends or descends, respectively.

For more information on the buttons with multiple functions, see Operation
Note manual.

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General Information Chapter 1 1-8

Monitor
A color VGA monitor is provided, to display ultrasound images and other information.
The monitor is connected with the Main Body along with an axis, freely movable in any direction.

Probe
The probe generates ultrasound waves and obtains constitutive data for ultrasound images.
Refer to “Chapter 12. Probes” for further information.

Peripheral Devices
Peripheral devices like VCR, Echo-printer, Microphone, Foot Switch or lamp are connected to
the main body.

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General Information Chapter 1 1-9

Screen Configurations
The monitor screen of this system displays ultrasound images, diverse information and user
operation menus. As shown below, the screen configuration is mainly divided into Title, Image
Area, Menu, Feedback Area and Flexible Soft Menu.

[Figure 1-3] Screen Configurations

Title
The Title displays Logo, Patient Information, Name of hospital, Application, Frame Rate and
Depth, Probe Information, Acoustic Output Information, Date and Time.

[Figure 1-4 Title]

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General Information Chapter 1 1-10

Menu

The menu is divided into 3 kinds: Image adjustment menu, Measurement menu, and Utility
menu. Use Menu dial-button to select an item from the menu.

[Figure 1-5 Menu]

Image Area
The ultrasound image, image information, annotation, and measurement are displayed in
the image area.

[Figure 1-6 Image Area]

Thumbnails Area
Saved images, by pressing the Save button on the control panel, are displayed in the
thumbnails area.
Click a thumbnail with a pointer to enlarge.

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General Information Chapter 1 1-11

[Figure 1-7 Thumbnails Area ]

User Information Area


User information area provides a variety of information necessary for system use e.g. current
system status, bodymarkers, and so on.

[Figure 1-8 User Information Area ]

Flexible Soft Menu

[Figure 1-9 Flexible Soft Manu ]

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C hapter 2

Safety

Safety Signs 2-1

Safety Symbols 2-2

Electrical Safety 2-5

System Organization 2-8

Environmental Protection 2-19

Equipment Protection 2-20

Safety for USB device 2-21

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Safety Chapter 2 2-1

Safety

Safety Signs
Please read this chapter before using an SAMSUNG SAMSUNG MEDISON ultrasound
system. It applies to the ultrasound system, probes, recording devices, and any optional
equipment.

SONOACE X8 is intended for use by, or by the order of, and under the supervision of a
licensed physician qualified to direct the use of the device.

Safety signs in This manual are classified like below.

It describes the precautions necessary to prevent user hazards of great


Danger urgency. If a DANGER is ignored, it might cause users a fatal injury such
as loss of life.

It is used to indicate the presence of a hazard that can cause serious


Warning personal injury, or substantial property damage if a WARNING is ignored.

Caution It is used to indicate the presence of a hazard that can cause equipment
damage if a CAUTION is ignored.

It is a piece of information not related to any hazard, but useful in installing,


Note operating and maintaining the system.

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Safety Chapter 2 2-2

Symbols
The international Electro technical Commission (IEC) has established a set of symbols for
medical electronic equipment, which classify a connection or warn of potential hazards. The
classifications and symbols are shown below.

Isolated patient connection (Type BF applied part).

Power switch (It supplies/cuts the power for product)

OFF (It cuts the power for some part of product)

ON (It supplies the power for some part of product)

This symbol identifies a safety note. Be sure you understand the function
of this control before using it. The control function is described in the
appropriate operation manual.

Identifies equipotential ground.

Indicates dangerous voltage over 1000 VAC or over 1500 VDC.

Identifies the point where the system safety ground is fastened to the
chassis. Protective earth connected to conductive parts of Class I
equipment for safety purposes.

Output port for VGA or Parallel port

ECG port

Isolated patient connection (Type BF applied part).

Power switch (It supplies/cuts the power for product)

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Safety Chapter 2 2-3

Input/Output (I/O) port used for RS232C

Left and right Audio / Video input

Left and right Audio / Video output

Print remote output

Foot switch connector

ECG connector

USB connector

MIC input port

Protection against the effects of immersion.

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Safety Chapter 2 2-4

Electrical Safety

This equipment has been verified as a Class I device with Type BF applied part. For maximum
safety observe these warnings:

Shock hazards may exist if this system, including all externally mounted
Warning recording and monitoring devices, is not properly grounded.

In a hospital, doctors and patients are subjected to dangerous, uncontrollable compensating


currents. These currents are due to the potential differences between connected equipment and
touchable conducting parts as found in medical rooms. The safe solution to the problem is
accomplished with consistent equipotential bonding. Medical equipment is connected with
connecting leads made up with angled sockets to the equipotential bonding network in medical
rooms.

Equipotential
Connection Lead Terminal
(Socket)

Main Body
Equipotential
Connector

Earth in Medical Room

Do not remove the protective covers on the system; hazardous voltages


are present inside. Cabinet panels must be in place while the system is in
Warning use. All internal adjustments and replacements must be made by a qualified
SAMSUNG MEDISON Customer Service Department.
Do not operate this system in the presence of flammable gases or
anesthetics. Explosion can result.

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Safety Chapter 2 2-5

 To avoid risk of electrical shock hazards, always inspect all the probes
before use; check the face, housing, and cable before use. Do not use, if the
face is cracked, chipped, or torn, the housing is damaged, or the cable is
abraded.
 To avoid risk of electrical shock hazards, always disconnect the system
from the wall outlet prior to cleaning the system.
 All patient contact devices, such as probes, ECG leads must be
removed from patient contact prior to application of a high voltage
defibrillation pulse.
 To avoid risk of electrical shock, do not use any probe that has been
immersed beyond the specified cleaning or disinfection level. See ‘Chapter
11. Maintenance’ in this manual.
 Conductive parts of electrodes shall not contact other conductive parts
including earth.
 To avoid risks of electrical shock and fire hazards, inspect the system
power cord and plug on a regular basis. Ensure that they are not damaged
Warning in any way.
 To avoid risk of electrical shock hazards, accessory equipment connected
to the along the digital interfaces must be certified according to the
representative IEC standards (I.e. IEC60950/EN60950 for data processing
equipment and IEC60601-1/EN60601-1 for medical equipment).
Furthermore all configurations shall comply with the system standard
IEC60601-1-1/EN60601-1-1. Everybody who connects additional equipment
to the signal input part or signal output part configurations a medical system,
and is therefore responsible that the system complies with the requirement
of IEC60601-1-1/EN60601-1-1. If in doubt, consult the SAMSUNG
MEDISON Customer Service Department.
 Do not touch the SIP/SOP and patient simultaneously. It may cause a
leakage current exceeding the maximum allowable values.
Do not perform any changes or repairs on the ECG-amplifier, the connecting
cables or the patient cable. A defective patient cable must be exchanged.
Only authorized service personnel must perform necessary repairs.

 This device is not intended to provide a primary ECG monitoring function,


therefore, does not have means of indicating an inoperative
electrocardiograph.
 Do not use ECG electrodes for HF surgical equipment. It can cause the
Warning hazard of burns in the event of defect in HF surgical equipment.
 Do not use ECG electrodes during the operation of a cardiac pacemaker
or other electrical stimulators. It can cause any safety hazard to a patient.
Do not use ECG leads and electrodes in an operating room.

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Safety Chapter 2 2-6

■ Although your system has been manufactured in compliance with existing


EMI/EMC requirements, use of this system in the presence of an
electromagnetic field can cause momentary degradation of the ultrasound
image. If this occurs often, SAMSUNG MEDISON suggests a review of the
environment in which the system is being used, to identify possible sources
of radiated emissions. These emissions could be from other electrical
devices used within the same room or an adjacent room. Communication
devices such as cellular phones and pagers can cause these emissions. The
existence of radio, TV, or microwave transmission equipment located nearby
can cause emissions. In cases where EMI is causing disturbances, it may be
necessary to relocate your system.
■ E lectrostatic discharge (ESD), commonly referred to as a static shock, is
Caution a naturally occurring phenomenon. ESD is most prevalent during conditions
of low humidity, which can be caused by heating or air conditioning. During
low humidity conditions, electrical charges naturally build up on individuals
and can create static shocks. An ESD condition occurs when an individual
with an electrical energy build-up comes in contact with objects such as
metal doorknobs, file cabinets, computer equipment, and even other
individuals. The static shock or ESD is a discharge of the electrical energy
build-up from a charged individual to a lesser or non-charged individual or
object. The level of electrical energy discharged from a system user or
patient to the ultrasound system can be significant enough to cause damage
to the system or probes. The following precautions can help to reduce ESD:
anti-static spray on carpets; anti-static spray on linoleum; anti-static mats; or
a ground wire connection between the system and the patient table or bed.

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Safety Chapter 2 2-7

EMC Test Reports

Guidance and manufacturer’s declaration - electromagnetic immunity

The EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an environment.

IEC 60601 Electromagnetic


Immunity test Compliance level
Test level environment -guidance

Electrostatic ±6kV Contact ±6kV Contact Floors should be wood,


discharge (ESD) concrete or ceramic tile.
±8kV air ±8kV air If floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity should
be at least 30%.

Electrical fast ±2kV for power ±2kV for power Mains power quality
transient/burst supply lines supply lines should be that of a typical
± 1kV for ± 1kV for commercial or hospital
IEC 61000-4-4 input/output lines input/output lines environment.

Surge ±1kV differential ±1kV differential Mains power quality


mode mode should be that of a typical
IEC 61000-4-5 ±2kV common ±2kV common commercial or hospital
mode mode environment.

Voltage dips, <5% Uт <5% Uт Mains power quality should


short (>95% dip in Uт) (>95% dip in Uт) be that of a typical
interruptions and for 0.5cycle for 0.5cycle commercial or hospital
environment. If the user of
voltage 40% Uт 40% Uт
the EUT image intensifier
variations on (60% dip in Uт ) (60% dip in Uт )
requires continued
power supply for 5 cycle for 5 cycle operation during power
input lines 70% Uт 70% Uт mains interruptions,
(30% dip in Uт) (30% dip in Uт) it is recommended that the
IEC 61000-4-11 for 25 cycle for 25 cycle EUT image intensifier be
<5% Uт <5% Uт powered from an
(<95% dip in Uт ) (<95% dip in Uт ) uninterruptible power supply
for 5 s for 5 s or a battery.

Power frequency 3 A/m 3 A/m Powerfrequency


(50/60Hz) magnetic
magnetic field fields should be at levels
characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.

NOTE Uт is the a.c. mains voltage prior to application of the test level.

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Safety Chapter 2 2-8

System Organization
This section contains information about biological safety and a discussion of the prudent use of
the system. A list of precautions related to biological safety follows; observe these precautions
when using the system.

 Do not use the system if an error message appears on the video


display indicating that a hazardous condition exists. Note the error code,
turn off power to the system, and call your local Customer Service
Department of SAMSUNG MEDISON.
Warning n Do not use a system that exhibits erratic or inconsistent updating.
Discontinuities in the scanning sequence are indicative of a hardware
failure that must be corrected before use.
n Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle.
n Use only acoustic standoffs that have been approved for use by
SAMSUNG MEDISON.

 The system limits the maximum temperature of contact as 41 degree


Celsius, and the output of ultrasonic waves observes American FDA
regulations respectively.
Warning  Power protection fuse prevents the probe and the system from current
overflow. Should the power protection circuit sense any current overflow,
the probe current will be shut off to prevent the probe surface from
overheating; the output of ultrasound waves will be limited.

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Safety Chapter 2 2-9

 Sheaths are recommended for clinical application of an invasive nature,


including intraoperative, transrectal, transvaginal, and biopsy procedures.
SAMSUNG MEDISON does not supply sheaths so that you should
purchase appropriate ones on your own.
 Some sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals, Refer to the FDA Medical Alert,
March 29, 1991, reprinted here.
Warning  In neurosurgical applications, sterilized probes should be used with
sterile gel and a sterile pyrogen-free sheath.
 If the sterile sheath becomes compromised during neurosurgical
applications involving a patient with Creutzfeldt-Jakob disease, the probe
cannot be sterilized with any sterilization method.
 Sheaths are disposable and must not be reused.
 If an installed sheath is cut or contaminated prior to use, the probe
should be cleaned and disinfected, and a new sterile sheath installed.

ALARA Education Program

The guidance for the use of diagnostic ultrasound is defined by the “as low as reasonably
achievable” (ALARA) principle. The decision as to what is reasonable has been left to the
judgment and insight of qualified personnel. No set of rules can be formulated that would be
sufficiently complete to dictate the correct response to every circumstances. By keeping
ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize
ultrasonic bioeffects.

Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographer’s
responsibility to control total energy transmitted into the patient. The sonographer must
reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and
limit exposure time, an ultrasound system provides controls that can be manipulated during the
exam to optimize the results of the exam.

The ability of the user to abide by the ALARA principle is important. Advances in diagnostic
ultrasound not only in the technology but also in the applications of that technology, have
resulted in the need for more and better information to guide the user. The output indices are
designed to provide that important information

There are a number of variables, which affect the way in which the output display indices can be
used to implement the ALARA principle. These variables include values, body size, location of
the bone relative to the focal point, attenuation in the body, and ultrasound exposure time.
Exposure time is an especially useful variable, because the user controls it. The ability to limit
the index values over time supports the ALARA principle.

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Safety Chapter 2 2-10

Applying ALARA
The system-imaging mode used depends upon the information needed. B-mode and M-mode
imaging provide anatomical information, while Doppler, Power, and Color imaging provide
information about blood flow. A scanned mode, like B-mode, Power, or Color, disperses or
scatters the ultrasonic energy over an area, while an unscanned mode, like M-mode or
Doppler, concentrates ultrasonic energy. Understanding the nature of the imaging mode being
used allows the sonographer to apply the ALARA principle with informed judgment.
Additionally, the probe frequency, system set-up values, scanning techniques, and operator
experience allow the sonographer to meet the definition of the ALARA principle.

The decision as to the amount of acoustic output is, in the final analysis, up to the system
operator. This decision must be based on the following factors: type of patient, type of exam,
patient history, ease or difficulty of obtaining diagnostically useful information, and the potential
localized heating of the patient due to probe surface temperatures. Prudent use of the system
occurs when patient exposure is limited to the lowest index reading for the shortest amount of
time necessary to achieve acceptable diagnostic results.

Although a high index reading does not mean that a bioeffect is actually occurring, a high index
reading should be taken seriously. Every effort should be made to reduce the possible effects
of a high index reading. Limiting exposure time is an effective way to accomplish this goal.

There are several system controls that the operator can use to adjust the image quality and
limit the acoustic intensity. These controls are related to the techniques that an operator might
use to implement ALARA. These controls can be divided into three categories: direct, indirect,
and receiver control.

Direct Controls
Application selection and the output intensity control directly affect acoustic intensity. There are
different ranges of allowable intensity or output based on your selection. Selecting the correct
range of acoustic intensity for the application is one of the first things that occur in any exam.
For example, peripheral vascular intensity levels are not recommended for fetal exams. Some
systems automatically select the proper range for a particular application, while others require
manual selection. Ultimately, the user has the responsibility for proper clinical use. The
SAMSUNG MEDISON system provides both automatic or default and manual or user-
selectable settings.

Output has direct impact on acoustic intensity. Once the application has been established, the
output control can be used to increase or decrease the intensity output. The output control
allows you to select intensity levels less than the established maximum. Prudent use dictates
that you select the lowest output intensity that is consistent with good image quality.

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Safety Chapter 2 2-11

Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity. These controls
affect imaging mode, pulse repetition frequency, focus depth, pulse length, and probe
selection.

The choice of imaging mode determines the nature of the ultrasound beam. B-mode is a
scanning mode, Doppler is a stationary or unscanned mode. A stationary ultrasound beam
concentrates energy in a single location. A moving or scanned ultrasound beam disperses the
energy over an area and the beam is concentrated on the same area of a fraction of the time
as that of an unscanned mode.

Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a
specific period of time. The higher the pulse repetition frequency, the more pulse of energy in a
period of time. Several controls affect pulse repetition frequency: focal depth, display depth,
sample volume depth, color sensitivity, number of focal zones, and sector width controls.

Focus of the ultrasound beam affects the image resolution. To maintain or increase resolution
at a different focus requires a variation in output over the focal zone. This variation of output is
a function of system optimization. Different exams require different focal depths. Setting the
focus at the proper depth improves the resolution of the structure of interest.

Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse,
the greater the time-average intensity value. The greater the time-average intensity, the
greater the likelihood of temperature increase and cavitations. Pulse length or burst length or
pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample
volume increases the pulse length.

Probe selection indirectly affects intensity. Tissue attenuation changes with frequency. The
higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. A
higher probe operating frequency requires more output intensity to scan at a deeper depth. To
scan deeper at the same output intensity, a lower probe frequency is required. Using more
gain and output beyond a point, without corresponding increases in image quality, can mean
that a lower frequency probe is needed.

Receiver Controls
Receiver controls are used by the operator to improve image quality. These controls have no
effect on output. Receiver controls only affect how the ultrasound echo is received. These
controls include gain, TGC, dynamic range, and image processing. The important thing to
remember, relative to output, is that receiver controls should be optimized before output is
increased. For example; before increasing output, optimize gain to improve image quality.

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Additional Considerations
Ensure that scanning time is kept to a minimum, and ensure that only medically required
scanning is performed. Never compromise quality by rushing through an exam. A poor exam
require a follow-up, which ultimately increase time. Diagnostic ultrasound is an important tool in
medicine, and, like any tool, it should be used efficiently and effectively.

Output Display Features


The system output display comprises two basic indices: a mechanical index and a thermal index.
The thermal index further consists of the following indices: soft tissue (TIs) and bone (TIb). One of
these three thermal indices will be displayed at all times. Which one depends upon the system
preset or user choice, depending upon the application at hand.

The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1

The thermal index consists of the three indices, and only one of these is displayed at any one
time.
Each probe application has a default selection that is appropriate for that combination. The TIb or
TIs is continuously displayed over the range of 0.0 to maximum output, based on the probe and
application, in increments of 0.1.

The application-specific nature of the default setting is also an important factor of index behavior.
A default setting is a system control state which is preset by the manufacturer or the operator.
The system has default index settings for the probe application. The default settings are invoked
automatically by the ultrasound system when power is turned on, new patient data is entered into
the system database, or a change in application takes place.

The decision to display one or the other of the three thermal indices should be based on the
following criteria:

Appropriate index for the application: TIs is used for imaging soft tissue; and TIb for a focus at or
near bone.

Mitigating factors that might create artificially high or low thermal index readings: location of fluid
or bone, or blood flow. For example, is there a highly attenuating tissue path so that the actual
potential for local zone heating is less than the thermal index displays.

Probe modes versus unscanned modes of operation affect the thermal index. For scanned
modes, heating tends to be near the surface; for unscanned modes, the potential for heating
tends to be deeper in the focal zone.

Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indices are kept to
a minimum and that exposure time is limited without compromising diagnostic sensitivity.

Mechanical Index (MI) Display


Mechanical bioeffects are threshold phenomena that occur when a certain level of output is
exceeded. The threshold level varies, however, with the type of tissue. The potential for
mechanical bioeffects varies with peak pressure and ultrasound frequency. The MI accounts for
these two factors. The higher the MI value, the greater the likelihood of mechanical bioeffects
occurring. There is no specific MI value that means that a mechanical effect is actually occurring.
The MI should be used as a guide for implementing the ALARA principle.

Service Manual SONOACE X8


Safety Chapter 2 2-13
Thermal Index (TI) Display
The TI informs the user about the potential for temperature increase existing at the surface
of the body, within the body tissue, or at the point of focus of the ultrasound beam on bone.
The TI is an estimate of temperature increase in body tissue with specific properties.
The actual amount of any temperature rise is influenced by factors such as tissue type,
vascularity, mode of operation and others. The TI should be used as a guide for
implementing the ALARA principle.
The bone thermal index (TIb) informs the user about potential heating at or near the focus after the
ultrasound beam has passed through soft tissue or fluid, for example, at or near second or third
rimester fetal bone.
The cranial bone thermal index (TIc) informs the user about the potential heating of bone at or near
the surface, for example, cranial bone.
The soft tissue thermal index (TIs) informs the user about the potential for heating within soft
homogeneous tissue.
You can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous system setups.
TIc is displayed when you select a transcranial application.
Mechanical and Thermal indices Display Precision and Accuracy
The MI and TI precision is 0.1 unit on the system.
The MI and TI display accuracy estimates for the system are given in the Acoustic Output Tables
manual. These accuracy estimates are based on the variability range of probes and systems,
inherent acoustic output modeling errors and measurement variability, as described below.
The displayed values should be interpreted as relative information to help the system operator
achieve the ALARA principle through prudent use of the system. The values should not be
interpreted as actual physical values in interrogated tissue or organs. The initial data that is used to
support the output display is derived from laboratory measurements based on the AIUM
measurement standard. The measurements are then put into algorithms for calculating the
displayed output values.
Many of the assumptions used in the process of measurement and calculation are conservative in
nature. Over-estimation of actual in situ exposure, for the vast majority of tissue paths, is built into
the measurement and calculation process. For example:
– The measured water tank values are derated using a conservative, industry standard, attenuation
oeffect of 0.3dB/cm-MHz.
– Conservative values for tissue characteristic were selected for use in the TI models.
Conservative
values for tissue or bone absorption rates. Blood perfusion rates. Blood heat capacity, and tissue
thermal conductivity were selected.
– Steady State temperature rise is assumed in the industry standard TI models, and the
assumption is made that the ultrasound probe is held steady in one position long enough for steady
state to be reached.
A number of factors are considered when estimating the accuracy of the display values:
hardware variations, estimation algorithm accuracy and measurement variability. Variability among
probes and systems is a significant factor. Probe variability results from piezoelectric crystal
efficiencies, process-related impedance differences, and sensitive lens focusing parameter
variations. Differences in system pulser voltage control and efficiencies is also a contributor to
variability. There are inherent uncertainties in the algorithms used to estimate acoustic output
values over the range of possible system operating conditions and pulser voltages. Inaccuracies in
laboratory measurements are related to differences in hydrophone calibration and performance,
positioning, alignment and digitization tolerances, and variability among test operators.
The conservative assumptions of the output estimation algorithms of linear propagation, at all
depths, through a 0.3dB/cm-MHz attenuative medium is not considered in the accuracy estimate
for the display. Neither linear propagation, nor uniform attenuation at the 0.3dB/cm-MHz rate, occur
in water tank measurements or in most tissue paths in the body. In the body, different tissues and
organs have dissimilar attenuation characteristics. In water, there is almost no attenuation. In the
body, and in particular, in water tank measurements, non-linear propagation and saturation losses
ccur as pulser voltages increase.
The display accuracy estimates are based on the variability range of probes and systems, inherent
acoustic output modeling errors, and measurement variability. Display accuracy estimates are not
based on errors in, or caused by measuring according to, the AIUM measurement standards, nor
the effects of non-linear loss on the measured values.

Service Manual SONOACE X8


Safety Chapter 2 2-14

Control Effrcts

Control affecting the indices


As various system controls are adjusted, the TI and MI values may change. This will be most
apparent as the POWER control is adjusted; however, other system controls will affect the on-
screen output values.

POWER
Power controls the system acoustic output. Two real-time output values are on the screen: a TI
and a MI. They change as the system responds to POWER adjustments.
In combined modes, such as simultaneous Color, B-mode and pulsed Doppler, the individual
modes each add to the total TI. One mode will be the dominant contributor to this total. The
displayed MI will be from the mode with the largest peak pressure.

B mode Controls

B-mode size
Narrowing the sector angle may increase frame rate. This action will increase the TI. Pulser
voltage may be automatically adjusted down with software controls to keep the TI below the
system maximums. A decrease in pulser voltage will decrease MI.

ZOOM
Increasing the zoom magnification may increase frame rate. This action will increase the TI.
The number of focal zones may also increase automatically to improve resolution. This action
may change MI since the peak intensity can occur at a different depth.

Persistence
A lower persistence will decrease the TI. Pulser voltage may be automatically increased. An
increase in pulser voltage will increase MI.

Focal no.
More focal zones may change both the TI and MI by changing frame rate or focal depth
automatically. Lower frame rates decrease the TI. MI displayed will correspond to the zone will
the largest peak intensity.

FOCUS
Changing the focal depth will change MI. Generally, higher MI value will occur when the focal
depth is near the natural focus of the transducer.

Service Manual SONOACE X8


Safety Chapter 2 2-15

Color and Cintrols

Color Sensitivity
Increasing the color sensitivity may increase the TI. More time is spent scanning the color image.
Color pulses are the dominant pulse type in this mode.

Color Sector Width


Narrower color sector width will increase color frame rate and the TI will increase. The system may
automatically decrease pulser voltage to stay below the system maximum. A decrease in pulser
voltage will decrease the MI. If pulsed Doppler is also enabled then pulsed Doppler will remain the
dominant mode and the TI change will be small.

Color Sector Depth


Deeper color sector depth may automatically decrease color frame rate or select a new color focal
zone or color pulse length. The TI will change due to the combination of these effects. Generally, the
TI will decrease with increased color sector depth. MI will correspond to the peak intensity of the
dominant pulse type, which is a color pulse. However, if pulsed Doppler is also enabled then pulsed
Doppler will remain the dominant mode and the TI change will be small.

SCALE
Using the SCALE control to increase the color velocity range may increase the TI. The system may
automatically adjust pulser voltage to stay below the system maximums. A decrease in pulser
voltage will also decrease MI.

SEC WIDTH
A narrower B-mode sector width in Color imaging will increase color frame rate. The TI will increase.
MI will not change. If pulsed Doppler is also enabled, then pulsed Doppler will remain the dominant
mode and the TI change will be small.

M-mode and Doppler Controls

Speed
M-mode and Doppler sweep speed adjustments will not affect the MI. When M-mode sweep speed
changes, TI changes.

Simultaneous and Update Methods


Use of combination modes affects both the TI and MI through the combination of pulse types. During
simultaneous mode, the TI is additive. During auto-update and duplex, the TI will display the
dominant pulse type. The displayed MI will be from the mode with the largest peak pressure.

Sample Volume Depth


When Doppler sample volume depth is increased the Doppler PRF may automatically decrease. A
decrease in PRF will decrease the TI. The system may also automatically decrease the pulser
voltage to remain below the system maximum. A decrease in pulser voltage will decrease MI.

Service Manual SONOACE X8


Safety Chapter 2 2-16

DOPPLER, M-
M-MODE, and COLOR Imaging Controls

When a new imaging mode is selected, both the TI and MI may change to default
settings. Each mode has a corresponding pulse repetition frequency and maximum
intensity point. In combined or simultaneous modes, the TI is the sum of the contribution
from the modes enabled and MI is the MI for the focal zone and mode with the largest
derated intensity. The system will return to the previously selected state if a mode is
turned off and then reselected.

Probe
Each probe model available has unique specifications for contact area, beam shape,
and center frequency. Defaults are initialized when you select a probe. SAMSUNG
MEDISON factory defaults vary with probe, application, and selected mode. Defaults
have been chosen below the FDA limits for intended use.

DEPTH
An increase in B-mode depth will automatically decrease the B-mode frame rate. This
would decrease the TI. The system may also automatically choose a deeper B-mode
focal depth. A change of focal depth may change the MI. The MI displayed is that of the
zone with the largest peak intensity.

Application
Acoustic output defaults are set when you select an application. SAMSUNG MEDISON
factory defaults vary with probe, application, and mode. Defaults have been chosen
below the FDA limits for intended use.

Acoustic Output and Measurement

Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)
from ultrasound exposure have been studied by various scientific and medical institutions. In
October 1987, the American Institute of Ultrasound in Medicine(AIUM) ratified a report
prepared by its Bioeffects Committee(Bioeffects Considerations for the Safety of Diagnostic
Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as
the Stowe Report, which reviewed available data on possible effects of ultrasound exposure.
Another report “Bioeffects and Safety of Diagnostic Ultrasound,” dated January 28, 1993
provides more current information.

The acoustic output for this system has been measured and calculated in accordance with the
December 1985 “510(K) Guided for Measuring and Reporting Acoustic Output of Diagnostic
Ultrasound Medical Devices,” except that the hydrophone meets the requirements of “Acoustic
Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA UD 2-1992)

Service Manual SONOACE X8


Safety Chapter 2 2-17

All intensity parameters are measured in water. Since water does not absorb acoustic energy,
these
water measurements represent a worst case value. Biological tissue does absorb acoustic
energy.The true value of the intensity at any point depends on the amount and type of tissue
and
the frequency of the ultrasound that passes through the tissue. The intensity value in the tissue.
The
intensity value in the tissue, In Situ, has been estimated by using the following formula:
In Situ = Water [ ]
where: In Situ e −=
( 0.In
23alf ) Intensity Value
Situ
Water = Water Value Intensity
e = 2.7183
a = Attenuation Factor
Tissue a(dB/cm-MHz)
Brain .53
Heart .66
Kidney .79
Liver .43
Muscle .55
l = skin line to measurement depth (cm)
f = Center frequency of the transducer/system/mode combination(MHz)
Since the ultrasonic path during an examination is likely to pass through varying lengths and
types
of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used
for
general reporting purpose; therefore, the In Situ value which is commonly reported uses the
formula:
In Situ (derated) = Water [ ]
Since this value is not the true In Situ intensity, the term “derated” is used.
The maximum derated and the maximum water values do not always occur at the same
operating
condition; therefore, the reported maximum water and derated values may not be related by
the In
Situ (derated) formula. For example: a multi-zone array transducer that has maximum water
value
intensities in its deepest zone. The same transducer may have its largest derated intensity in
one if
its shallowest focal zones.
e − (0.069lf )

Service Manual SONOACE X8


Safety Chapter 2 2-18

Acoustic Output and Measurement

The terms and symbols used in the acoustic output tables are defined in the following
paragraphs.

ISPTA.3 the derated spatial-peak temporal-averge intensity


(milliwatts per square centimeter).
ISPPA.3 the derated spartial-peak pulse-average intensity
(watts per square centimeter). The value of IPA.3 at the position of global
maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global
maximum MI is reported.
MI the Mechanical Index. The value of MI at the position of ISPPA.3,
(MI@ISPPA.3) may be reported instead of MI(global maximum value)
if ISPPA.3 is 190W/cm2
Pr.3 the derated peak rarefactional pressure (megapascals) associated with the
transmit pattern giving rise to the value reported under MI.
WO the ultrasonic power (milliwatts). For the operating condition giving rise to
ISPTA.3, WO is the total time-average power; for the operating condition
subject to reporting under ISPPA.3, WO is the ultrasonic power associated
with the transmit pattern giving rise to the value reported under ISPPA.3
fC the center frequency (MHz). For MI and ISPPA.3, fC is the center frequency
associated with the transmit pattern giving rise to the global maximum value
of the respective parameter. For ISPTA.3, for combined modes involving
beam types of unequal center frequency, fC is defined as the overall range of
center frequencies of the respective transmit patterns.
ZSP the axial distance at which the reported parameter is measured
(centimeters).
x-6,y-6 are respectively the in-plane (azimuthal) and out-of-plane (elevational)
-6 dimensions in the x-y plane where Zsp is found (centimeters).
PD the pulse duration (microseconds) associated with the transmit pattern
giving
rise to the reported value of the respective parameter.
PRF the pulse repetition frequency (Hz) associated with the transmit pattern
giving
rise to the reported value of the respective parameter.
EBD the entrance beam dimensions for the azimuthal and elevational planes
(centimeters).
EDS the entrance dimensions of the scan for the azimuthal and elevational planes
(centimeters).

Service Manual SONOACE X8


Safety Chapter 2 2-19

Environmental Protection

The equipment and accessories are to be disposed of safely after the life span
of them and national regulations must be observed.
The lithium battery in PC is to be replaced by a SAMSUNG MEDISON’s service
Caution man or its authorized dealer.
The waste sheaths are to be disposed of safety and national regulations must
be observed.

Service Manual SONOACE X8


Safety Chapter 2 2-20

Equipment Protection
Follow these precautions to protect your system:

Excessive bending or twisting of cables on patient-applied parts may cause


failure or intermittent operation of the system.
Improper cleaning or sterilization of a patient-applied part may cause permanent
damage.
Do not submerge the cables of patient-applied parts in solution. The cables are
not liquid-tight beyond the applied part/cable or cable/connector interfaces.
Do not use solvents such as thinner or benzene, or abrasive cleaners on the
system, probes or peripheral devices.
The system has been designed for 100-120Vac and 200-240Vac; you
should select the input voltage of monitor, printer and VCR. Prior to
Caution connecting an OEM power cord, verify that the voltage indicated on the power
cord matches the voltage rating of the OEM device.
An isolation transformer protects the system from power surges. The isolation
transformer continues to operate when the system is in standby.
In general, only the area of the probe acoustic window is watertight (IPX7).
Except where specified in specific cleaning instructions, do not immerse the
remainder of a probe in any liquid.
For optimal performance, your SAMSUNG MEDISON ultrasound system should
be connected to a circuit dedicated solely for the ultrasound system.
Use only the foot switch, which SAMSUNG MEDISON supplies, and check the
SAMSUNG MEDISON logo symbol on it.

Service Manual SONOACE X8


Safety Chapter 2 2-21

Safety for USB devices


Follow these cautions before using USB devices

Before you equip USB devices, Please shut down the system.
Caution In case of USB MO Driver, do not use with other USB storing devices.

Service Manual SONOACE X8


C hapter 3

Maintenance
System Maintenance 3-1

Service Manual Questions or Comment 3-1

System Surfacex 3-2

3-3
Administration of Information

Probe Management 3-4

Biopsy Guide Adapter and Needle Guide 3-9

Trouble Shooting Trees 3-11

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-1

Maintenance
System Maintenance
Installation Replacement
Avoid humidity.
Avoid direct sunlight.
Avoid places with extreme temperature variations.
Optimal conditions for the system are temperatures of 10° ~ 35° C and humidity of 30% ~ 75%.
Avoid heat sources.
Avoid dusty and unventilated areas.
Avoid places where the system is likely to be exposed to vibration or impacts.
Avoid places where the system is likely to be exposed to chemical substances or gases.

Service Manual Questions or Comments


If you have questions about the service manual, or you discover an error in the manual, contact
SAMSUNG MEDISON Ultrasound service Department. Service Area Managers are as follows

Customer Assistance
Various support locations around the world can provide customers with technical assistance
regarding the ultrasound
system. Customers should contact the sales office where they purchased the system or the
nearest SAMSUNG MEDISON distributor
office. Office addresses and telephone numbers are in the system user documentation.

SAMSUNG MEDISON Service Department, Discusser & SAMSUNG MEDISON


Bldg.,
1003, Daechi-dong, Gangnam-gu,Seoul, Korea
(822) 2194-1000 or (822) 2194-1074
www.SAMSUNG MEDISON.com

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-2

SYSTEM SURFACES
The exterior surfaces of most SAMSUNG MEDISON ultrasound systems can
be disinfected using a recommended disinfectant with a wipe method.
You can use the following procedure to disinfect system surfaces on these
systems.

Always use protective eyewear and gloves when cleaning and disinfecting
Warning any equipment.

Caution Use only recommended disinfectants on system surfaces.

Cleaning
Turn off the system and disconnect the system power cord from the wall outlet.
Use a soft cloth lightly dampened in a mild soap or detergent solution to clean exterior surfaces
on the system.

Disinfection
The following disinfectants are recommended because of both its biological effectiveness (as
qualified through the FDA 510(k) process) and its chemical compatibility with SAMSUNG
MEDISON ultrasound product materials.

Solutions Country Type Active ingredient FDA510

Cidex USA Liquid Gluteraldehyde K924434

Cidex Plus USA Liquid Gluteraldehyde K923744

Mix the disinfection solution compatible with your system according to label instructions for solution strength.
A disinfectant qualified by the FDA 510(k) process is recommended.

Wipe the system surfaces with the disinfection solution, following disinfection label instructions for wipe
durations, solution strengths, and disinfectant contact duration. Ensure that the solution strength and duration
of contact are appropriate for the intended clinical application.

Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-3

Administration of Information
You may lose information files on user setting or patients, because of
Caution shock on the product or internal error. Thus, back-up on a regular
basis.

User Setting
User Setting Back up
lients may not back-up the user setting of the product.
Contact the SAMSUNG MEDISON Customer Service Department to attain support to back-
up.
Write down and Save information on user setting to prevent the possible loss of files before
Back-up.
Nevertheless, clients may back up the user setting on GA Table used in obstetrics diagnosis.
ofurther information please refer to “Chapter 4. Before Scanning”.

Patient Information
Patient information Back-up
Clients may back up diagnosis using SonoView software. For further information, please refer
to “Chapter 9. Image management” in this manual.

The system automatically saves basic information of patients. Should you wish to reinstall the
system due to system error, please ask the SAMSUNG MEDISON Customer Service
Department to retrieve the basic information and diagnosis images stored in the system

Software
The software of the product may be updated to enhance performance.
Clients may not change the software; attain support from SAMSUNG MEDISON Customer
Service Department to update the software.

Minor software updates may be carried out without any prior notice of the
Caution manufacturer.

Should errors occur in the operating system (Windows), and you desire to upgrade the
operating system, please follow the specifications of the operating system manufacturer.

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-4

Probe Management

Warning Always use protective eyewear and gloves when cleaning and disinfecting
probes and biopsy guide adapters.

Probes must be cleaned after each use. Cleaning the probe is an


essential step prior to effective disinfection or sterilization. Be sure to
follow the manufacturer’s instructions when using disinfectants.
Caution
Do not allow sharp objects, such as scalpels or cauterizing knives, to
touch probes or cables.

When handling a probe, do not bump the probe on hard surfaces.

Probe is the most important factor in image quality. Optimal imaging cannot be attained without the
correct probe. The system is optimized for use based on your probe selection.

Do not use a surgeon’s brush when cleaning probes. The use of even soft
brushes can damage the probe.
Caution During cleaning, disinfection, and strilization, orient the parts of the probe that
must remain dry higher than the wetted parts until all parts are dry. This will
help keep liquid from entering non-liquid-tight areas of the probe.

Disconnect the probe from the system.

Remove any sheaths, biopsy guide adapters, or biopsy needle guides(biopsy guide adapters are re-
usable portion of the biopsy guide and can be sterilized.)

Discard sheaths(sheaths are single-use item)

Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any
particulate matter or body fluids that remain on the probe or cable.

To remove remaining particulates, rinse with water up to the immersion point.

Wipe with a dry cloth; or wipe with a water-dampened cloth to remove soap residue, and then wipe
with a dry cloth.

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-5

Disinfection or Sterilization

Sterilize the device only for vaginal and rectal probing. A 10-6 reduction in pathogens should be
reached following the sterilization procedures in this manual and using the following SAMSUNG
MEDISON recommended solutions. The following disinfectants are recommended because of both its
biological effectiveness (as qualified through the FDA 510(k) process) and its chemical compatibility
with SAMSUNG MEDISON ultrasound product materials.

If a pre-mixed solution is used, be sure to observe the solution expiration


date.

The type of tissue it will contact during use dictates the level of disinfection
Warning required for a device. Ensure that the solution strength and duration of
contact are appropriate for disinfection or sterilization. Be sure to follow the
manufacturer’s instructions.
In neurosurgical application, sterilized probes should be used with a
pyrogen-free sheath.

Using a non-recommended disinfection solution, incorrect solution strength,


or immersing a probe deeper or for a period longer than recommended can
damage or discolor the probe and will void the probe warranty.

Do not immerse probes longer than one hour, unless they are sterilizable.
Caution Probes may be damaged by longer immersion times.
Sterilize probes using only liquid solutions. Using autoclave, gas(EtO), or
other non-SAMSUNG MEDISON-approved methods will damage your
probe and void your warranty.

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-6

Information of Detergent, Disinfectant, and Ultrasound Gel

•Use an appropriate one with following tables. The information is also listed on the SAMSUNG
MEDISON web site. (http://www.SAMSUNG MEDISON.com)

Disinfectants

Sekusept Extra
2,3)

2)
T-Spray Ⅱ

Sani-Cloth

2)

Omnicide
Cidex Plus

Wavicide
Cidex OPA

Nuclean
Metricide
T-Spray

Names

3)
-01
Type Spray Wipe Liquid

Quaternary
Active Ingredient Glutaraldehyde
Ammonium (N-Alkyl)

C2-5EL ● ● ● ● ● ● ● ● ● ●
CA
C3-7EP ● ● ● ●

HL5-12ED
LA L5-12EC
L5-12EP/ 50mm
P2-4AH ● ● ● ● ●
PA
P3-5AC ● ● ● ★ ● ● ● ● ●

NER4-9ES
EC
NEV4-9ES
3D2-5EL
3D2-6ET
3D 3D4-7EK x x x ● x x x x
3D4-8ET

3D5-8EK x x x ● x x x x

CW2.0 ● ● ● ★ ● ●
CW
CW4.0

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-7

Mix the disinfection solution (or sterilization solution, for sterilizable probe) compatible with your
probe according to label instructions for solution strength. A disinfectant qualified by the FDA
510(k) process is recommended.

Immerse the probe into the disinfection solution (or sterilization solution, for sterilizable probe) as
shown in the figure below for your probe.

Follow the instructions on the disinfection (or sterilization, for sterilizable probe) label for the
duration of probe immersion. Do not immerse probes longer than one hour, unless they are
sterilizable.

Using the instructions on the disinfectant or sterilization label, rinse the probe up to the point of
immersion, and then air dry or towel dry with a clean cloth. (Or a sterile clothe, for sterilizable
probe).

Examine the probe for damage such as cracks, splitting, fluid leaks, or sharp edges or projections.
If damage is evident, discontinue use of the probe and contact SAMSUNG MEDISON Customer
Service Department.

[Figure 3-1] Disinfection of Probes

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-8

Disinfectants Cleaner Gel

3)

alcohol(70%)
Gigasept FF

Aquasonics
Isoproppyl
Gigasept AF

Metrizyme
Klenzyme
Sporox II
Names

Vircon
Milton

Enzol

3)
100
Type Liquid NA Liquid

Hydrogen Peroxide

Succindialdehyde,

Propylene Glycol
Dodeylphenoleth

Xylene Sulfonate
oxylate, Sodium
Formaldehyde

Bersteinsaure
Hypochlorite

Proteolytic
Enzymes
Sodium

Alcohol
Gel
NA

Active Ingredient

C2-5EL ● ● ● ● ● ● ● ● ● ●
CA
C3-7EP x ● ● ● ●

HL5-12ED
LA L5-12EC
L5-12EP/ 50mm
P2-4AH ● ● ● ●
PA
P3-5AC ★ x x x ★ ● ● x ● ●

NER4-9ES
EC
NEV4-9ES
3D2-5EL
3D2-6ET
3D 3D4-7EK x x x x x ●

3D4-8ET

3D5-8EK x x x x x ●

CW2.0 ● ● x x ● ● ● x ● ●
CW
CW4.0

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-9

Biopsy Guide Adapter And Needle Guide

The external surfaces of reusable biopsy guide adapters can be sterilized using one of the
following procedures. A 10-6 reduction in pathogens should be reached by following the sterilization
procedures in this manual.

Always use protective eyewear and gloves when cleaning and disinfecting
Warning probes and biopsy guide adapters.

Biopsy guide must be cleaned after each use. Cleaning the biopsy guide
adapter is essential steps prior to effective disinfection or sterilization. Be sure
to follow the manufacturer’s instructions when using disinfectants.

Biopsy guide and cables should not contact with sharp things like scalpel.
Caution
When handling a biopsy guide, do not bump it on hard surfaces.

Do not use bleach to clean or sterilize the biopsy guide adapter. Using bleach
on the adapter may cause damage and will void your warranty.

Cleaning and sterilization of stainless steel biopsy guide

Cleaning
After use, remove the biopsy guide assembly from the probe.
Disassemble the biopsy guide into its component parts, if applicable.
Using a small brush and water, scrub each part to remove trapped material from the
biopsy guide adapter.
Rinse with water to remove remaining particulates.

Sterilization
Sterilize the biopsy guide adapter by autoclaving (Steam) or using gas (Ethylene Oxide).
After sterilization, follow the proper post-sterilization procedure for the sterilization
method used.
Inspect the biopsy guide adapter for damage such as cracks, rust or breakage. If damage
is evident, discontinue use of the biopsy adapter and contact SAMSUNG MEDISON
Customer Service Department.

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-10

Cleaning and sterilization of plastic biopsy guide adapter.

Cleaning
After use, remove the biopsy guide assembly from the probe.
Disassemble the biopsy guide into its component parts, if applicable. Discard the single-use
parts. These parts cannot be resterilized.
Using a small brush and water, scrub each part to remove trapped material from the reusable
components.
Rinse with water to remove remaining particulates.

Sterilization

Reusable plastic biopsy guide adapters can be sterilized only by using a


Caution chemically compatible cold-sterilization solution. Sterilization by autoclaving
or by using gas or radiation will permanently damages these parts.

Sterilize the components by using a chemically compatible cold-sterilization solution. A


sterilant qualified by the FDA 510(k) process is recommended. Ensure proper contact time
(usually 10 hours) and solution temperature used.

After sterilization, follow the proper post-sterilization procedure for the sterilization method
used.

Inspect the components for damage such as cracks, rust or breakage. If damage is evident,
discontinue use of the biopsy adapter and contact SAMSUNG MEDISON Customer Service
Department.

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-11

Trouble Shooting Trees

System does not Power On / Boot up

No
Is the system plugged in ? Pulgged In !

Yes

No
Is fuse normal ? Change Fuse

Yes

Is there AC at the wall


No
Check the power line in
outlet ?
hospital

Yes

Check the Power Supply

[Figure 3-2] Tree of System does not power on

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-12

Noise in Image format

Yes
Noise is appear in image format Keep the system away from those
electrical devices

No

Is there any electrical


devices that affect the
system ?

Use another room's wall outlet

Check Probes

[Figure 3-3] Tree of noise in Image format

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-13

Track Ball

The trackball is low sensitive !

Yes
Does the trackball move
at all ? Remove the ball from the trackball unit,
and clean it.

No

Replace the trackball unit

[Figure 3-4] Tree of track ball check

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-14

Unable to record to VCR

Unable to record to VCR !

No
Is the VCR properly Check that all signal. ang power supply cable
connected ? connections to the VCR unit are OK.

Yes

No
Is the VCR tape put into Put the tape into the device and rewind it.
the drvice ?

Yes

No
Is recording unable even Check the signal cable connections
by manual operation ? between VCR and rear panel

Yes

No
VCR output of system
O.K ? Replace DSC B/D

Yes

Replace VCR

[Figure 3-5] Tree of unable to record to VCR

Service Manual SONOACE X8


Equipment Maintenance Chapter 3 3-15

Unable to use Printer

Unable to use Printer

No Check that all signal. power supply cable


Is the printer properly
connections between printer and system
connected ?
are O.K.

Yes

No
Are there print papers
left ? Insert the printer papers

Yes

No
Is proper configuration for
the print key set ? Configure the print key

Yes

Is printing unavailable No
even by manual Check the signal cable
operation ?

Yes

No
Still no image on the print
out Printer O.K

Yes

Video output of system No


O.K ? Replace the PCC B/D

Yes

Replace the printer

[ Figure 3-6] Tree of unable to use printer

Service Manual SONOACE X8


C hapter 4

Installation
Before Installation 4-1

Connecting peripherals 4-3

Peripheral Device 4-5

Probe 4-6

Optional Function 4-7

Service Manual SONOACE X8


Installation Chapter 4 4-1

Installation

Before installation
Pre--installation
Pre
Upon arrival, inventory the shipment with the carrier’s driver:
Carefully inspect the packing material for obvious signs of damage such as crushed,
punctured,
torn, broken, wet or rattling packages.
Idamage is not evident, sign and stamp a bill of lading “condition of contents unknown subject
tinspection.”
Idamage is evident, contact your Purchasing Department for action, have the carrier’s driver
indicate the damage on the damage on the freight bill, and sign all copies of the bill.
During formal inspection, you should :
Open all packages within 15 days of receipt for a complete inspection of the consignment.
Report concealed damage to the carrier within 15 days of receipt or the carrier may not accept
liability.

UNPACKING INSTRUCTIONS

The SA8000SE Ultrasound system and its accessories are shipped in two cartons.
To unparck the unit

To unpack the unit


Remove or cut the binder tape.
Carefully lift the main console, Probe box from the carton and place it on a flat, secure surface.
Take out the accessory and set it in safe place
Save all shipping materials in case the unit requires additional transportation

SAMSUNG MEDISON or local distributor will make available on request


circuit diagrams, components partlist, descriptions, calibration instructions or
Caution other information which assist your appropriately qualified technical
personnel to repair those parts of equipment which are designed by
SAMSUNG MEDISON as repairable

Service Manual SONOACE X8


Installation Chapter 4 4-2

Moving the product

The product is heavy, but fragile to shock, thus be cautious when you are moving the product,
especially walking down the stairs carrying it.

When you are moving the product, note the following.

Do not lift up the product to move it. You should have at least 4 adults to move the product
carefully to avoid any injury.
Make sure that peripheral devices such as monitor are securely fastened to the system. Put
away accessories such as the probe before moving the product.
The wheels are designed to move back/forth; to move the product left/right, please make short,
multiple back/forth movements gently pushing it to the direction you wish to turn.
Move the product slowing after having checked if the wheel locks are loose

Product Installation

Avoid humidity.
Avoid direct sunlight.
Avoid severe temperature change. The optimal conditions for the product are temperature of
10° ~ 35° Celsius and humidity of 30% ~ 75%.
Avoid placing the product near heat sources.
Avoid places with poor ventilation.
Avoid vibration.
Avoid chemical substance.

Placing the product near a generator, Roentgen devices or broadcast cables


Caution may result in noise and abnormal visual images. Using the power source
with other electric devices may also induce noise.

Keep the following in mind when using the product.


Do not insert anything, especially metal piece, into the product.
Do not attempt repairs yourself: disassembling voids the warranty.
Do not block the ventilation slot.
Plug in the AC cord after the whole components are connected properly: otherwise, damage to
the product may occur.
When unplugging the power cord, make sure to grip the plug, not the cord.

Service Manual SONOACE X8


Installation Chapter 4 4-3

Connecting Peripherals

Rear Pannel

A monitor and other peripheral devices like printer, VCR, etc. are connected via the rear panel at the
back of the system.

[Figure 4-1] Rear Panel

VGA (Output)
Print out VGA signal with monitor.

PARALLEL (Output)
Devices such as standard PC printers are connected via the parallel port on the rear panel. To use
Dynamic MR (optional), connect the Dongle.

USB (Input/Output)
USB peripheral devices are connected via the USB port. There is another USB port in the front panel to
connect the USB storage device.

Service Manual SONOACE X8


Installation Chapter 4 4-4

LAN (Input/Output)
DICOMCAUTION
can be connected via the LAN port. Patient information is transferred to another

AUDIO (Input/Output)
It is possible to input and output Audio signal.

You cannot use Audio Input in the Front Panel at the same time, but you
Caution can use Output at the same time.

VHS (Input/Output)
Connect with VCR through VHS system.

You cannot use VHS Input in the Front Panel at the same time, but you
Caution can use Output at the same time.

S-VHS (Input/Output)
Connect with VCR through S-VHS system..

You cannot use S-VHS Input in the Front Panel at the same time, but you
Caution can use Output at the same time.

PRINTER (Output)
Connect with Echo printer.

PRINT REMOTE (Output)


It is used to print remotely by connection with Echo
printer.

MIC (Input)
Connect with microphone.

Probe holder

A probe holder is mounted at the left and right side of the control panel.

Service Manual SONOACE X8


Installation Chapter 4 4-5

Peripheral Device

Note Refer to the operation manual of peripheral device about its operating.

Internal Peripheral Device


These are peripheral devices mounted in the system.

DVD-Multi
Hard Disc Drive

External Peripheral Device

These are peripheral devices that can be connected for use when needed and are connected via the
USB port located at the rear panel.

The following products are recommended:


Video Cassette Recorder (VCR), Panasonic MD835, Sony SVO-9500MD
Video Page printer : Mitsubishi M90E, Sony UP-895MD, Sony UP-897MD
Color Video Page printer : Mitsubishi CP910E, Mitsubishi CP910U
USB Video printer : Mitsubishi CP93DW, Sony UPD897
USB Color Video printer : Mitsubishi CP900DW, Sony UPD21MD
Inkjet Printer : HP1200, HP6540, HP6840, HP6940, HP6980
Laser Printer : HP1320, HP2550
USB Magnetic Optical (MO) Disk Drive : 1.4G External USB Optical Disk
USB Wireless LAN : 3COM 3CRUSB10075, Linksys 2.4GHz Wireless-G USB Network Adapter
Foot Switch : Leftt: Dual Left / Right , Right: Freeze / Unfreeze
Others : Flash Memory media , Microphone

Service Manual SONOACE X8


Installation Chapter 4 4-6

Probe
Probes are devices that generate ultrasound waves and process reflected wave data for the
purpose of image formation.

Connecting Probes

Be sure to connect or disconnect probes when the power is off to ensure the safety of the
system and the probes.

Equip probes to the probe connectors on the front panel of the system. A maximum of three
probes can be connected at one time. The CW probe should only be connected to its own
connector.
Turn the connector-locking handle clockwise.

[Figure 4-2] Probe Connector

Service Manual SONOACE X8


Installation Chapter 4 4-7

Optional Function

This product has the following optional functions:

3D
3D XITM
CW Function
Cardiac Measurement
Dynamic MRTM
DICOM
DICOM SR
Spatial Compound

For further information about optional functions, please refer to the relevant chapters in this manual.

Service Manual SONOACE X8


C hapter 5

Performance Tests

Wiring and Cautions 5-1

Initial Setup 5-2

Initialization and Monitor Tests 5-3

Functional Tests 5-4

Service Manual SONOACE X8


Performance Tests Chapter 5 5-1

Performance Tests

Wiring and Cautions

Warnings
Never open the safety cover of this equipment. Internal parts of the equipment are supplied
with high voltage electricity. All internal repairs and part replacements must be carried out only
by the SAMSUNG MEDISON Customer Service Department.
Electrostatic Discharge (ESD), generally known to be caused by shocks of static charges, can
occur in natural conditions. ESD occurs most commonly in dry conditions, such as during
operation of heaters or air conditioners. ESD also occurs when contacting metal door handles,
file cabinets, computer parts or even another person. Static charges and ESD are produced
when electrically charged materials release electricity to charge less charged materials. It is
possible that the static charges released by the system user or the patient may damage the
ultrasonographic system or the probe.
Always observe the following guidelines to prevent damages by ESD:
1. Spray anti-static charge spray over the carpet or the linoleum.
2. Use anti-static charge mats.
3. Ground the system and the patient’s table or bed.

Service Manual SONOACE X8


Performance Tests Chapter 5 5-2

Initial Setup
Initial setup includes both the hardware setup and the software setup. The system coordination
is done in accordance with the COA (Customer Order Acknowledgement). This test must be
conducted after a proper inspection of the equipment installation as described in Chapter 4.
-Do not inspect the equipment functionality with items not recommend by SAMSUNG
MEDISON Co., Ltd.

Service Manual SONOACE X8


Performance Tests Chapter 5 5-3

Initialization and Monitor Tests


1. If the equipment is not powered on yet, use a hospital power cord of 15 amps or higher.
2. Insert printer paper and a video tape appropriate for the product specification.
3. Properly connect the probe to the two probe connectors.
4. Power on the system. Upon power-up, the internal program begins the initialization process.
5. After the system initialization process and the self-test are complete (about 3 to 5 minutes),
the 2D mode screen will be displayed.
6. Using the System Setup items, you can verify the versions of the software applied to the
current equipment on the monitor screen.
7. Select a probe to apply another 2D image.
8. Check the following on the monitor
- Adjust brightness and contrast of the monitor from minimum through maximum and check
for any distortions.
- Verify that the image is displayed in the center of the screen. Verify the horizontal and
vertical resolutions.
- Check for any problems around each corner.

Service Manual SONOACE X8


Performance Tests Chapter 5 5-4

Functional Tests
Follow the procedure above to test the system functions. If there is any problem with the
system, conduct the test again.
If the test is successful, check the following:
- Is the image displayed exactly in the center of the monitor screen?
- Are all the lights on the control panel working?
- Are all the toggle switches, slides, and the trackball working?
If there is any problem, follow the “Initial Setup” procedure again.

Service Manual SONOACE X8


Performance Tests Chapter 5 5-5

General System Confidence Test


Run Diagnostics on the system to view information for the main check points and the main
tests within the PCB.

User Interface Tests


Run User Interface Tests to check the functionality of the User Interface for the Operating
System. Control Panel functions can also be implemented on the screen. While this test is in
progress, other tests can also be run. For information on the keys and their functions, see
Seby Operation Manual.

2D Image Test
1. Power off the system. The system will shut down in 10 to 20 seconds. Then power on the
system again.
2. Select Curved Array Probe.
3. Apply 2D Phantom Image.
4. Apply the POWER function at 100%.
5. Adjust the TGC gain to produce the 2D image with the least noise. Reduce gain while
maintaining the image on the far side.
6. Adjust the horizontal and vertical placement so that the phantom image is in the appropriate
location.
7. Once the phantom is placed in the appropriate location, adjust the axial and lateral functions
so that the image does not disappear and noise is not produced.
8. After the phantom image adjustment is complete, adjust the focus of all holes within each
phantom structure.
9. Use the menu keys to conveniently implement various images.
 2D
Direction, Application, M line, Density, Focus +, -, 2D, THI, DEPTH,
FOCAL POS TSI OPT, ZOOM, POWER, TGC, DUAL
 COLOR
Direction, M line, Density, Maps, COLOR, THI, DEPTH, FOCAL POS,
ZOOM POWER, TGC, DUAL
 M-mode
Direction, Application, Density Format, M, THI, DEPTH, FOCAL POS ZOOM,
POWER, TGC
10. In PW Mode, the menu items can be used to obtain optimal images as well.
 PW Doppler
PWD,ANGLE, Simultaneous, SV Size +-, VOLUME, FILTER,
SWEEP BASELINE, SCALE, INVERT
 PW Doppler + Color or CPA
COLOR or CPA

Service Manual SONOACE X8


Performance Tests Chapter 5 5-6

Freehand 3D Test
1. Power off the system. The system will shut down in 10 to 20 seconds. Then power on the
system again.
2. Select Curved Array Probe.
3. Click the “3D” button to obtain a 3D image.
4. Adjust X, Y, Z, RECT.L, MAG, and TH.L to obtain the desired image.
5. When the image is obtained, press the Freeze button to view the 3D image on the monitor
screen.
6. Press the 2D button to return to the normal mode.

CW Static Probe Test


This test can be run only when the Doppler Phantom is in use.
1. Power off the system. The system will shut down in 10 to 20 seconds. Then power on the
system again.
2. Connect the CW probe, and select it. Use Default for Application.
3. Adjust the Doppler gain to obtain the desired Doppler image.
4. After using the Doppler images, click the 2D button to return to the previous screen.

ECG Test
This test can be run only when the ECG Module is available.
1. Install the ECG Module on the system.
2. Adjust the settings to 1mV amplitude and 60BPM rate.
3. Select the Phased Array Probe, and set Application to Default.
4. Turn on ECG. The ECG Trace will be displayed at the bottom on the monitor.
5. Adjust the ECG Gain to obtain an optimized ECG Trace.

Service Manual SONOACE X8


Performance Tests Chapter 5 5-7

Image Save Test


1. Power off the system. The system will shut down in 10 to 20 seconds. Then power on the
system again.
2. Select any probe.
3. Click the STORE button to save the image.
4. Click the END EXAM button.
5. Click the REVIEW menu within SONOVIEW to view the saved image.

B & W Printer Tests


This test can be run only when a B/W Printer is installed.
1. If a printer is installed, ensure that it is loaded with paper. If not, load the appropriate paper.
2. Use the Freeze button to obtain a 2D image.
3. Click the Printer button to print out the image on the screen. If the quality of the printed
image is not satisfactory, adjust the brightness and contrast of the printer.

VCR Tests
This test can be run only when a VCR is installed.
1. If a VCR is installed, ensure that it is loaded with a tape. If not, insert a blank tape.
2. Switch between 2D Mode and PW Mode for recording to a VCR.
3. Rewind the recorded tape.
4. After rewinding, click the Utility -> VCR -> Play menu. Then press the Play button on the
VCR to play the recorded video. If there is noise on the screen or in the sound, replace the
VCR and run the test again.
5. Click the Utility -> VCR -> STOP menu to return to the previous screen.
* The VCR input must be set to external input.

Service Manual SONOACE X8


Performance Tests Chapter 5 5-8

Color Printer Tests


This test can be run only when a color printer is installed.
1. If a printer is installed, ensure that it is loaded with paper. If not, load the appropriate paper.
2. Use a phantom to obtain a good 2D image.
3. Select C-Mode, and adjust the color gain to obtain a good C-Mode image.
4. When the image is obtained, press the CAPTURE and PRINT buttons to print out the image.
5. If the quality of the color printout is not satisfactory, adjust the color and brightness menu
items on the printer (bri, con, tint, color, etc.) and run the test again.

End of Testing
When all the tests are successful, you may proceed to use the equipment. If a problem was
discovered during the tests, restart the system and run the tests again.
If the problem persists, please contact SAMSUNG MEDISON Customer Support.

Service Manual SONOACE X8


C hapter 6
System Organization
System Organization 6-1

Probe Select Assembly Board (PSA) 6-3

Beamformer Board (BF) 6-5

Back End Board (BE) 6-8

PC Module 6-11

Key Matrix PCB 6-13

Service Manual SONOACE X8


System Organization Chapter 6 6-1

System Organization

System Organization

Overview
The SA X8 system consists of ten main parts.
- Frame structure that constitute the basic framework
- LCD Monitor Module
- AD Power & DD Power Module
- Key Control Unit
- PSA Module
- Beamformer (BF) Board
- Continuous Wave Doppler (CW) Board
- Back End Board
- PC Module (Software DSC)
- Motor Board

Control, signal process, signal analysis and all other functions are processed by the internal
Pentium processor, and the processed images e transferred using accessories (MOD, CD-RW,
FDD, etc.).
For best performance, the system includes an industrial PC with a 64-bit CPU and a main
memory of 2 GB.
Also, for system stability, the SA X8 uses Windows OS.

Service Manual SONOACE X8


System Organization Chapter 6 6-2

SA8000SE Functional Block Diagram

System (H/W)
BF

DVI Splitter / Rear Main Monitor


BE(MID) (DVI)
Sub Monitor
(DVI/D-Sub)
PCIF VHS/S-VHS

Estimate Data (Raw Data) VGA Card

PC (S/W)
PC (S/W)
DirectX
PC Memory

Pre Filter Scan Conversion Post Filter UI (Marker)

[ Figure 6-1] SA8000SE Functional Block Diagram

Service Manual SONOACE X8


System Organization Chapter 6 6-3

Probe Select Assembly (PSA)


Figure 6-2 is a simple block diagram of the PSA PCB.
The PSA contains three probe connectors. When a probe is selected in the user menu, a
connector of the probe become select. The PSA acts as a gateway that connects the probes
and the system. It reads the probe ID upon booting and sends the data to the CW PCB. Then
the CW PCB decodes the data and transmits it to the CPU.

Universal 128
HDI S/H
connector 1 HVSW
X 24 from BF Board

Universal 128
HDI S/H Latching
connector 2 Relays

4
4128
Universal
Probe select
HDI S/H Relay
from CW Board
connector 3 Control

Connectivity
Sensor
No Probe

Probe ID
Probe ID

[ Figure 6-2] Probe Select Assembly Block Diagram

Service Manual SONOACE X8


System Organization Chapter 6 6-4

Probe Select Assembly (PSA)

[ Figure 6-3] PSA board

Service Manual SONOACE X8


System Organization Chapter 6 6-5

Beamformer (BF board)


Figure 6-4 is a functional block diagram of the Beamformer PCB.
The Beamformer consists of 1 PCB. It generates transmission pulses in order to operate the
probe elements. The received echo signals are sent through the filter for eliminating noise.
Then the signals are amplified to specific levels by the PREAMP and are converted to digital
signals for digital beamforming.
The delay them of time digital signals are controlled by the FIFO and then are summed
together by the BFIC. This process is called beamforming.
In addition, the Beamformer also performs Dynamic Apodization, Multi Beam Receiving, TGC
and other functions for improving the image quality.

Board Specification
 64ch TX Pulsers (MHIC0202: 32 units)
 64ch Limiter
 64ch TGC Amp (Four channel TGC Amp, AD8334: 8 units)
 64ch A/D Converter (Eight Channel A/D Converter, TI5122: 8 units)
 Synthetic Aperture Support
 Dual Line Receiving Support
 RX Dynamic Aperture Function
 RX Apodization Function (supports curves for different modes)
 Trapezoidal Imaging Support
 TX Focal Point Support
 Board version included in Board

Service Manual SONOACE X8


System Organization Chapter 6 6-6

Beamformer Functional Block Diagram

Amplifies the 3.3V Since the BFIC


signals to 5V so operates at 3.3V,
that the Pulser IC the TX_out
Amplifies the 5V can recognize the signals do not
signals to 80V, signals properly. exceed 3.3V.
which is sufficient
for operating the
probes.
Pulser Pulse
(64CH) Signal TX_out
MHIC0202 Buffers

BF IC
To
(64CH) BE BD
MCB024B
TGC after
amplifying the
echo signals A/D
to 50dB. conversion.

TGC LFP
Limiter & &
(64CH) PreAmp ADC
(64CH) (64CH)

HV (80V) Digital
elements are Beamforming
removed from the
received signals.

TGC를 위한
Generates
TGC curve
TGC curve for
TGC. 발생

TGC curve /reference generator & Buffer

[ Figure 6-4] Beamformer Functional Block Diagram

Service Manual SONOACE X8


System Organization Chapter 6 6-7

Beamformer board

[ Figure 6-5] Beamformer board

Service Manual SONOACE X8


System Organization Chapter 6 6-8

Back End (BE board)


The Back End board consists of three main parts: 2D process,Doppler& Color process, DMA &
RTC part

DSP Part
The DSP Part consists of a 2D mode part, a Spectral Doppler Part, and a Color Doppler Part.
The 2D mode part receives the beamformed output signals, generates B/W signal (2D image)
data and sends it to the DSC Part.
The Spectral doppler mode part separates the RF signals received for Doppler direction
separation into I (Inphase) signals and Q (Quadrature) signals. Then it uses the clutter filter to
remove the clutter noise in which is a kind o wall noise from vein wall out of the signals. The
signals with wall noise removed are sent to the PCC Board for the Doppler Sound process,
and they are sent to the FFT circuit, where the basic Doppler elements Power, Velocity, and
Variance are analyzed.
The Color Doppler mode part receives the I signals and Q signals, removes the wall noise and
adds colors by using Color Flow Mapping.

Audio Sound Part Components and Functions


The Audio Sound Part is the last device that processes Doppler Sound for the Spectral
Doppler.
The Audio Sound Part consists of the D/A converter (which converts digital signals into analog
signals), a filter (LPF) (which removes the noise from Doppler signals), and the Power Amp
(which amplifies the audio to sufficient output levels).

Service Manual SONOACE X8


System Organization Chapter 6 6-9

Back End board Functional Block Diagram

HOST interface
PDSP
With RTC From ECG

From B/F

Doppler DSP
#0
SRAM

MCB 025 ECG


#0 RTC
Convert
SRAM Doppler DSP
#1
DSP
FPGA
SRAM

MGA 025
#1 B data To PC
SRAM

C data DMA CTR


DMA & RTC
D data FPGA DMA DATA
SRAM

MGA 025
#2
SRAM Sound data

From CW

SDRAM SDRAM SDRAM


#0 #2 #5

SDRAM
#0 SDRAM SDRAM
Configuration #1 #3
CPLD MCB026
SDRAM
#1
To REAR
Analog Sound Part Doppler Sound
SDRAM SDRAM

[ Figure 6-6] Back End Board Block Diagram

Service Manual SONOACE X8


System Organization Chapter 6 6-10

Back End Board

[ Figure 6-7] Back End board

Service Manual SONOACE X8


System Organization Chapter 6 6-11

PC Module
The PC Module consists of three main parts: PC Part, VM Part, and S/W DSC Part.

PC Part Components and Functions


The PC Part consists of the PC Module, which is the central part of the system, and the PC
Interface which controls the data and signals of the PC and the System. The PC Part controls
the entire PC Module and manages the data input and output.

S/W DSC Part


The DSC Part is an image filter circuit that improves image quality. It consists of the scan
conversion part—which writes the received scan line data and reads the monitor by the h-sync
cycle, frame memory part, and zoom and freehand 3D path parts.
The DSC Part sums data from 2D mode and Spectral Doppler mode produced by different
paths together as one set of common data.
It facilitates various functions such as Digital Scan Conversion and Frame Average, 3D (DMA),
Cine, RTC, Read Zoom, and Edge Enhance along with Memory.

Video Manager Part Components and Functions


The Video Manager Part is the last device that the signals go through before being sent as
display signals.
The Video Manager Part consists of the DAC (which converts digital signals into analog
signals), the Encoder (which converts digital signals into VCR signals), and the Decoder
(which allows the external video signals to be displayed on the system).

Service Manual SONOACE X8


System Organization Chapter 6 6-12

PC Carrier PCB

[ Figure 6-8] PC Module

Service Manual SONOACE X8


System Organization Chapter 6 6-13

Key Matrix board

Key Matrix Components and Functions


SA X8 K/M board constitutes the Key Matrix that supports the UI (User Interface). When the
user clicks a function button, the associated command is sent to the system, so that the
system can perform the associated operation. It acts as a bridge between the user and the
system.

[ Figure 6-9] Key Matrix PCB

Service Manual SONOACE X8


System Organization Chapter 6 6-14

Key Matrix Functional Block Diagram

+3.3V

SR[8.. 15]
Key Matrix
Key
control SC[0..7]
CPLD
XC 95144
TQ 144
Power Control Signal

DAT A[ 0..7]
SD[0..7 ]
SA[0. .7]

BD- 336-
TGC

MAX239
Key
ADC SD[ 0..7]
0808 Power Control

uP Foot s/w
89c51
Alpha Numeric
Key

+5VA Connector

TTXA,B
PS2
Track TTYA,B Mouse
HT 82M39A
Ball

TBR,TBL

POWER PS2
+5V , + 12V PORT

ALPHA/ NUM
ERIC
PORT

[ Figure 6-10] Key Matrix Block Diagram

Service Manual SONOACE X8


C hapter 7

Disassembly

Overview 7-1

Disassembly 7-2

Service Manual SONOACE X8


Disassembly Chapter 7 7-1

Disassembly

Overview

Overview
This chapter contains instructions for disassembling and assembling the SA X8 system.
The system must be disassembled only by the SAMSUNG MEDISON after-sales personnel.
Please read the safety instructions in Chapter 2 before proceeding.

High voltage power exists within the system. The system must be
disassembled only by the SAMSUNG MEDISON after-sales personnel.
Warning If working on the system with power on, do not use the anti-static wrist
band while being grounded to the system chassis.

Service Manual SONOACE X8


Disassembly Chapter 7 7-2

Disassembly

SA8000SE Front and Back

[ Figure 8-1] SA X8 Front [ Figure 8-2] SA X8 Back

Service Manual SONOACE X8


Disassembly Chapter 7 7-3

Disassembling the Front Panel

You must remove the front cover in order to disassemble the main board

Pull filter under the front of the console


to away from the product

Use the screwdriver(+) to remove the


two screws.

Hold the bottom part of the front cover and pull it out.

Disassembling the PSA ASSY

Use the screwdriver(+) to remove the ten screws.

Hold the PSA assy and pull it out.

Service Manual SONOACE X8


Disassembly Chapter 7 7-4

Disassembling the system board

This is system with the PSA assy removed

Disassemble the CW Board, BF Board


and BE Board in order

CW Board

BF Board

BE Board

DC-DC Power

Use the screwdriver(+) to remove the two screws.

Disassemble the cover of DC-DC Power

Use the screwdriver(+) to remove the


two screws.
Disassemble the DC-DC Power

Service Manual SONOACE X8


Disassembly Chapter 7 7-5

Disassembling the ECG Module

Use the screwdriver(+) to remove the three screws.


Disassemble the ECG Module

Disassemble the cable connected to the ECG


Module

Hold the ECG Module and pull it out.

Service Manual SONOACE X8


Disassembly Chapter 7 7-6

Disassembling the Back Panel

This illustration shows removal of


the handle

Hold the handle and pull it out.

Use the screwdriver(+) to remove the


two screws.

PC Module

MOTOT Board

HDD
Hold the bottom part of the back
cover and pull it out.

This is system with the back cover removed

Service Manual SONOACE X8


Disassembly Chapter 7 7-7

Disassembling the Motor board and HDD.

Use the screwdriver(+) to remove the fore


screws.
Disassemble the HDD

Use the screwdriver(+) to remove the two


screws.

Hold the Motor board and pull it out.

Disassembling the PC Module

Disconnect all connectors on the PC Module.

Use the screwdriver(+) to remove the one


screw.

Hold the PC Module and pull it out.

Service Manual SONOACE X8


Disassembly Chapter 7 7-8

Rear board panel

VGA card

PCIIF board
DVIF board

Use the screwdriver(+) to remove the screw.


Disassemble the Rear board panel, VGA, PCIIF board and DVIF board.

Disassembling the AC-


AC-DC Power module

Use the screwdriver(+) to remove the four screw.

Hold the Power cover and pull it out.

Use the screwdriver(+) to remove


the tow screw.

Hold the AC-DC Power module and


pull it out.

Service Manual SONOACE X8


Disassembly Chapter 7 7-9

Disassembling the control panel

Hold all the knobs and pull it out.

Use the screwdriver(+) to remove


the fourteen screw.

Disconnect all connectors on the Control panel

Use the screwdriver(+) to remove


the thirty two screw.

Service Manual SONOACE X8


C hapter 8

Parts

Ordering Parts 8-1

Part Numbers 8-2

Parts Pictures 8-3

Service Manual SONOACE X8


Parts Chapter 8 8-1

Parts

Ordering Parts
This chapter contains information on the SA X8 parts.
Please refer to the SA X8 Compatibility Matrix to check the replacement parts and their
software versions for each system configuration (main PCBs and specific hardware parts).
For installing and verifying system parts, please refer to the figures and part tables in this
chapter.
Part numbers are indicated in the corresponding tables.
Prior to ordering parts, please verify whether the existing parts can be replaced according to
the current service policy.

Service Manual SONOACE X8


Parts Chapter 8 8-2

Part Numbers

PART PART NAME PART DESCRIPTION

BD-345-PSA P6A PSA BD

BD-345-CW P6A CW BD

BD-345-BF P6A BF BD

BD-345-BE P6A BACK END BD

BD-345-KM P6A KEY MATRIX BD

BD-345-MOTH P6A MOTHER BD


BOARD
BD-345-MTR P6A MOTOR B/D

BD-345-PCIF P6A PC INTERFACE BD

BD-345-DVIF P6A DIGITAL VIDEO INTERACTIVE BD

BD-345-LCDIF P6A LCD INTERFACE BD

BD-345-RPU P6A REAR PANEL UPPER BD

BD-345-RPL P6A REAR PANEL LOWER BD

AY-PC/MOTH-345 PC MOTHER ASSY X8

HDD-250G-SEAGATE SEAGATE 250G HDD


PC MODULE
PC-DVD/RW-GSAH30N DVD-R,+R,+RW,-RW, CD-R, CD-RW

AY-345-PWR-PC SAX8 PC POWER ST-250MAK

MONITOR A373-012A LCD MONITOR ASSY X8

POWER AY-345-PWR-ADM P6A POWER AY AC-DC MODULE


SUPPLY AY-345-PWR-DDM P6A POWER AY DC-DC MODULE

TRACK BALL 335-C-010A TRACKBALL YEL UNIT 58MM TAMAGAWA

A260-130A KBD ALPHA ASSY X8


KEYBOARD
260-Z-046A ALPHA NUMERIC KBD X4

COVER A229-004A ARM ASSY X8

AY-SPEAK-345 SPEAKER ASSY X8

A213-059A SPEAKER X8
ELECTRIC AY-FAN-345-PC X8 PC FAN ASSY

AY-FAN-345-RACK X8 RACK FAN ASSY

AY-345-ECG ECG ASSY X8

Service Manual SONOACE X8


Parts Chapter 8 8-3

Part Pictures
Board

Name BD-345-PSA Name BD-345-CW

Description PROBE SELECT ASSY Description CW BOARD

Name BD-345-BF Name BD-345-BE

Description BEAMFORMER BOARD Description BACK END BOARD

Service Manual SONOACE X8


Parts Chapter 8 8-4

Name BD-345-KM Name BD-345-LCDIF

Description KEY MATRIX BOARD Description LCD INTERFACE BOARD

Name BD-345-PCIF Name BD-345-DVI


DIGITAL VIDEO INTERACTIVE
Description PC INTERFACE BOARD Description
BOARD

Service Manual SONOACE X8


Parts Chapter 8 8-5

Name BD-345-RPU Name BD-345-RPL

REAR PANEL LOWER


Description REAR PANEL UPPER BOARD Description
BOARD

Name BD-345-MTR

Description MOTOR BOARD

Service Manual SONOACE X8


Parts Chapter 8 8-6

PC

Name AY-PC/MOTH-345 Name AY-345-PWR-PC

Description PC MOTHER ASSY Description PC POWER ST-250MAK

Name HDD-250G-SEAGATE Name PC-DVD/RW-GSAH30N

DVD-R,+R,+RW,-RW, CD-R,
Description SEAGATE 250G HDD Description
CD-RW

Service Manual SONOACE X8


Parts Chapter 8 8-7

MONITOR & POWER

Name A373-012A Name A229-004A

Description LCD MONITOR ASSY Description ARM ASSY

Name AY-345-PWR-ADM Name AY-345-PWR-DDM

Description POWER AY AC-DC MODULE Description OWER AY DC-DC MODULE

Service Manual SONOACE X8


Parts Chapter 8 8-7

KEYBOARD & TRACK BALL

Name A260-130A Name 260-Z-046A

Description KBD ALPHA ASSY Description LPHA NUMERIC KBD

Name 335-C-010A

TRACKBALL YEL UNIT 58M


Description
M TAMAGAWA

Service Manual SONOACE X8


C hapter 9

PROBE

Specification 10-9

Service Manual SONOACE X8


Probe Chapter 9 9-1

PROBE

Specification
This section summarizes probe specifications for the SA X8 Ultrasound System.

Probe Specifications
This section includes information on the part ordering process used by the field service
engineers.

Center
Probe Frequency Application Preset
(Mhz)

Abdomen General, Renal, Aorta, Appendix

C2-5EL 3.2 OB General, Fetal Heart, Early

Gynecology General, Uterus, Adnexa, Endometrium

Abdomen General, Renal, Aorta, Appendix

C3-7EP 5 OB General, Fetal Heart, Early

Gynecology General, Uterus, Adnexa, Endometrium

Small Parts General, Thyroid, Breast, Testicle, Superfical

Vascular General, Carotid, Arterial, Venous


HL5-12ED 7.5
Muskuloskeletal General, Shoulder/Knee, Hand/Foot, Elbow/Wrist

Pediatric Abdomen General, Abdomen

Small Parts General, Thyroid, Breast, Testicle, Superfical

Vascular General, Carotid, Arterial, Venous


L5-12EC 7.5
Muskuloskeletal General, Shoulder/Knee, Hand/Foot, Elbow/Wrist

Pediatric Abdomen General, Abdomen

Small Parts General, Thyroid, Breast, Testicle, Superfical

Vascular General, Carotid, Arterial, Venous


L5-12/50EP 7.5
Muskuloskeletal General, Shoulder/Knee, Hand/Foot, Elbow/Wrist

Pediatric Abdomen General, Abdomen

Service Manual SONOACE X8


Probe Chapter 9 9-2

Center
Probe Frequency Application Preset
(Mhz)

Abdomen General, Renal, Aorta, Appendix

3D2-5EL 3.5 OB General, Fetal Heart, Early

Gynecology General, Uterus, Adnexa, Endometrium

Abdomen General, Renal, Aorta, Appendix

3D2-6ET 3.5 OB General, Fetal Heart, Early

Gynecology General, Uterus, Adnexa, Endometrium

Abdomen General, Renal, Aorta, Appendix

3D4-8ET 4.5 OB General, Fetal Heart, Early

Gynecology General, Uterus, Adnexa, Endometrium

OB General, Fetal Heart, Cervix

NER4-9ES 6.5 Gynecology General, Uterus, Adnexa, Endometrium

Urology General, Prostate, Bladder

OB General, Fetal Heart, Cervix

NEV4-9ES 6.5 Gynecology General, Uterus, Adnexa, Endometrium

Urology General, Prostate, Bladder

Abdomen General, Renal, Aorta, Appendix

3D5-8EK 6.5 OB General, Fetal Heart, Cervix

Gynecology General, Uterus, Adnexa, Endometrium

Abdomen General, Renal, Aorta, Appendix

3D5-9EK 6.5 OB General, Fetal Heart, Early

Gynecology General, Uterus, Adnexa, Endometrium

Cardiac General, Aortic arch


Pediatric Cardiology General, Aortic arch
P2-4AH 3
Abdomen General, Renal, Aorta
TCD General
Cardiac General, Aortic arch
Pediatric Cardiology General, Aortic arch
P3-5AC 4
Abdomen General, Renal, Aorta
TCD General

CW2.0 2 Cardiac General, Cardiac

CW4.0 4 Cardiac General, Cardiac, Pediatric Cardiac

Service Manual SONOACE X8


SONOACE X8 SERVICE MANUAL
English

www.SAMSUNG MEDISON.com

Date: February 2007


Publisher: Customer Support Dept., SAMSUNG MEDISON Co., Ltd.
Address : Discusser & SAMSUNG MEDISON Bldg.,
1003 Daechi-dong, Gangnam-gu, Seoul, Korea
Tel : 02.2194.1000
Fax : 02.2194.1071

Service Manual SONOACE X8

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