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SERVICE MANUAL
Contents
Chapter 1 General Information
Chapter 2 Safety
Symbols 2-2
Contents
Chapter 3 Maintenance
Chapter 4 Installation
Probe 4-6
Contents
Chapter 5 Performance Tests
Contents
Chapter 7 Disassembly
Overview 7-1
Disassembly 7-2
Chapter 8 Parts
Chapter 9 Probe
General Information
General Information
System Information
The SONOACE X8 is a high-resolution color ultrasound scanner with high penetration and a
variety of measurement functions.
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.
System Specifications
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
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
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: 10 OC ~ 35OC
Temperature Limits
Storage & Shipping: -25OC ~ 60OC
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.
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.
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.
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.
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.
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.
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.
Title
The Title displays Logo, Patient Information, Name of hospital, Application, Frame Rate and
Depth, Probe Information, Acoustic Output Information, Date and Time.
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.
Image Area
The ultrasound image, image information, annotation, and measurement are displayed in
the 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.
Safety
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.
Caution It is used to indicate the presence of a hazard that can cause equipment
damage if a CAUTION is ignored.
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.
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 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.
ECG port
ECG connector
USB connector
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.
Equipotential
Connection Lead Terminal
(Socket)
Main Body
Equipotential
Connector
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.
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.
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.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
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.
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.
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.
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.
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.
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.
Control Effrcts
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.
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.
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.
Speed
M-mode and Doppler sweep speed adjustments will not affect the MI. When M-mode sweep speed
changes, TI changes.
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.
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)
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 )
The terms and symbols used in the acoustic output tables are defined in the following
paragraphs.
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.
Equipment Protection
Follow these precautions to protect your system:
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.
Maintenance
System Maintenance 3-1
3-3
Administration of Information
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.
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.
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.
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.
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.
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.
Probe Management
Warning Always use protective eyewear and gloves when cleaning and disinfecting
probes and biopsy guide adapters.
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.
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.)
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.
Wipe with a dry cloth; or wipe with a water-dampened cloth to remove soap residue, and then wipe
with a dry cloth.
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.
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.
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.
•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
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.
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
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
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.
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
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.
No
Is the system plugged in ? Pulgged In !
Yes
No
Is fuse normal ? Change Fuse
Yes
Yes
Yes
Noise is appear in image format Keep the system away from those
electrical devices
No
Check Probes
Track Ball
Yes
Does the trackball move
at all ? Remove the ball from the trackball unit,
and clean it.
No
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
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
Yes
Installation
Before Installation 4-1
Probe 4-6
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
The product is heavy, but fragile to shock, thus be cautious when you are moving the product,
especially walking down the stairs carrying it.
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.
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.
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.
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.
MIC (Input)
Connect with microphone.
Probe holder
A probe holder is mounted at the left and right side of the control panel.
Peripheral Device
Note Refer to the operation manual of peripheral device about its operating.
DVD-Multi
Hard Disc Drive
These are peripheral devices that can be connected for use when needed and are connected via the
USB port located at the rear panel.
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.
Optional Function
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.
Performance Tests
Performance Tests
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.
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.
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.
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
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.
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.
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.
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.
PC Module 6-11
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.
System (H/W)
BF
PC (S/W)
PC (S/W)
DirectX
PC Memory
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
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
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
Beamformer board
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.
HOST interface
PDSP
With RTC From ECG
From B/F
Doppler DSP
#0
SRAM
MGA 025
#1 B data To PC
SRAM
MGA 025
#2
SRAM Sound data
From CW
SDRAM
#0 SDRAM SDRAM
Configuration #1 #3
CPLD MCB026
SDRAM
#1
To REAR
Analog Sound Part Doppler Sound
SDRAM SDRAM
PC Module
The PC Module consists of three main parts: PC Part, VM Part, and S/W DSC Part.
PC Carrier PCB
+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
Disassembly
Overview 7-1
Disassembly 7-2
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.
Disassembly
You must remove the front cover in order to disassemble the main board
Hold the bottom part of the front cover and pull it out.
CW Board
BF Board
BE Board
DC-DC Power
PC Module
MOTOT Board
HDD
Hold the bottom part of the back
cover and pull it out.
VGA card
PCIIF board
DVIF board
Parts
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.
Part Numbers
BD-345-CW P6A CW BD
BD-345-BF P6A BF BD
A213-059A SPEAKER X8
ELECTRIC AY-FAN-345-PC X8 PC FAN ASSY
Part Pictures
Board
Name BD-345-MTR
PC
DVD-R,+R,+RW,-RW, CD-R,
Description SEAGATE 250G HDD Description
CD-RW
Name 335-C-010A
PROBE
Specification 10-9
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)
Center
Probe Frequency Application Preset
(Mhz)
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