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Medison Sonoace 8000se PDF
Medison Sonoace 8000se PDF
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Contents
Chapter 1 General Information
Chapter 2 Safety
Symbols 2-3
Contents
Chapter 3 Maintenance
Chapter 4 Installation
Before Installation 4-1
Contents
Chapter 5 Performance Tests
Contents
Chapter 7 Setting Up
Chapter 8 Disassembly
Overview 8-1
Disassembly 8-2
Chapter 9 Auxiliaries
Contents
Chapter 10 Configuration
Overview 10-1
Chapter 11 Parts
Chapter 12 Probe
Contents
Chapter 13 Glossary
Terms 13-3
General Information
General Information
System Information
The SA8000SE is a high-resolution color ultrasound scanner with a remarkably high
resolution and deeper penetration, which provides a variety of measuring functions.
1. The SA8000SE has the newly developed Digital Beam forming technology.
2. The SA8000SE has various applications of Abdomen, Obstetrics, Gynecology,
Vascular System, Cardiac, Urology, etc.
3. The SA8000SE provides various diagnostic modes such as 2D Mode, M Mode,
Color Doppler Mode, Power Doppler Mode, PW Spectral Doppler Mode, etc.
4. 3D images can be obtained.
5. Besides the basic measurements of distance, area, circumference and volume,
6. SA8000 SE provides specific measurements in every application It has a function to
report measurement data also.
7. Both a Cine Image of 256 frames and a Loop Image of 4096 lines are provided in
order to examine scanned images.
8. The SA8000SE provides SonoView as an Image Filing tool to control images.
9. The SA8000SEsupports DICOM function to save, transfer and print images through
network.
10. Various peripheral devices such as VCR, printer, etc can be easily connected and
used with the main system.
System Specifications
Height: 1380mm (with monitor)
Width: 530mm
Physical Dimensions
Depth: 870mm
Weight: More than 101kg
2D real-time
Dual 2D real-time
2D/M-mode
Color Doppler
Imaging Mode Pulsed-wave Doppler
Power Doppler
3D-mode
Simultaneous
Real-time zoom
Abdominal
Obstetrical
Peripheral vascular
Gynecological and fertility
Small parts (breast, thyroid, parathyroid, penis, testes)
Abdominal surgery
Renal
Application
Breast
Musculoskeletal
Pediatric
Prostate
Urology
Trans-Rectal
Trans-Vaginal
Freehand 3D
Optimal volume resolution
Various 3D rendering algorithm
- Surface mode
VOLUME MODE - Maximum transparent mode
- Minimum transparent mode
- X-ray mode
MagiCut Plus
3D Orientation Help
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
Gamma-scale windowing
Signal processing
Image orientation (left/right and up/down)
(Post-processing)
White on black/black on white
Real-time zoom
Operating: 10 OC ~ 35OC
Temperature Limits
Storage & Shipping: -40OC ~ 70OC
<Convex Array>
C3-7ED Probe
• Application: General, Abdomen, Fetal Heart, Gynecology,
Obstetrics, Renal
• Number of element: 128
• Center frequency: 4.5MHz
• Convex of radius: 50mm
• FOV: 69.56°
• Doppler TX frequency: 2.8MHz
• Harmonic frequency: 2.2MHz
Biopsy guide available
<Linear Array>
HL5-9ED Probe
• Application: General, Breast, Small Part, Vascular,
Muscuoskeletal
• Number of element: 128
• Center frequency: 7.5MHz
• FOV: 38.4mm
• Doppler TX frequency: 5.6MHz
Scan Heads • Steered angle: 15°
• Trapezoidal imaging
• Biopsy guide available
System Configurations
The SA8000SE system comprises a main body, control panel, probe and peripheral devices.
Main Body
The main body is divided into the inner part that generates ultrasound images and the outer
part, which connects to the other units. The outer part is equipped with probe connectors,
connectors for monitor and the other peripheral devices, input-output devices like HDD, probe
holders, wheels for moving, storage space for peripheral devices and a system power switch.
Control Panel
The control panel is the unit for users to operate the system.
The control panel is largely primarily divided into three parts. On the left side there are function keys
to control menu, scan and control the ultrasound image. On the central part, the function keys for
measurement and annotation after image scanning are arranged around a trackball. On the right
side you can find the function keys to select menu. And On the Alpha-Numeric keyboard there are
manage an image and setup.
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.
Freeze
This button is to turn the image scanning on or off. In freeze state, Cine function, saving,
printing out and measuring the image are available.
Store
This button stores the image or report that are currently being displayed on the screen in the
system database. The stored images and Report can be controlled in SonoView mode.
Echo Print
This button prints out the image viewed on the current Image Area into a configured echo
printer.
2D
In 2D mode, it is possible to examine organs in direction of the depth of scanning in real time.
Because this system includes 2D image basically, except for some special cases, you cannot
turn the 2D off when desired. Therefore, the [2D] button does not work as a toggle although it
gives LED feedback. Instead, it is used as a button to return to the basic 2D mode even from
any other image modes.a
This button is to turn the M Mode on. It is possible to observe one desired line of 2D images as
time goes by. While the M Mode is on, one more press of this button turns it off.
This button is to turn the Color Mode on. Patterns of bloodstream are shown in 2D screen in real
time. While the color mode is on, one more press of this button turns it off.
This button is to turn the PW Spectral Doppler Mode on. It is possible to observe blood vessel or
bloodstream of heart. Spectral Doppler also can be used with 2D mode at the same time. While
the PW Spectral Doppler Mode is on, one more press of this button turns it off.
PD
This button is to turn the Power Doppler Mode on. While the Power Doppler Mode is on, one
more press of this button turns it off.
Dual
This button turns the Dual Mode on. You can compare two 2D images in Dual mode. While the
dual mode is on, one more press of this button turns it off. You can use the [Set] button or [Dual]
button to change the left/right view direction of the activated image in Dual Mode.
Harmonic
This button is to turn the Harmonic Imaging on. While the harmonic imaging is on, one more
press of this button turns it off. This is applicable to the 2D Harmonic Imaging.
CW
This button is to turn the CW Spectral Doppler mode on. While the CW Spectral Doppler Mode
is turned on, one more press of button turns it off.
B Gain
C Gain
This dial is used to control color Gain by turning it. In the PD mode, you can also control PD gain
by turning this dial.
D Gain
Focus
If this switch is up, the focusing point goes up. Conversely, when switch is down the focusing
point goes down.
Depth
If this switch is up, the depth of image is shallow. Conversely switch-down results in a deeper
image.
HD Zoom
If you put up this switch, a Zoom box appears. Change the Zoom size by using the [Change]
button and trackball. And then press [Set] button to apply to image.
You can exit from Zoom mode by pressing the [Exit] button or controlling [Depth] switch.
Zoom
This button is for Read Zoom function. You can control the size and the position of 2D image
by using [Change] button and track ball. If you roll trackball upward, you can check the lower
part of image and roll it downward, you can check the upper part of image. If you roll trackball
leftward, you can check the right part of image and roll it rightward, you can check the left part
of image.
You can exit the Zoom mode by pressing the [Exit] button or [Zoom] button.
Frequency
This button is to change the probe frequency, when you use a probe that supports Multi
Frequency. You can select the frequency of probe by pressing this button several times. The
meanings are below.
Audio
Angle
This dial is to control the angle of Sample Volume in Spectral Doppler Mode. It is also used to
Baseline
This switch is to control the Baseline in Spectral Doppler Mode or Color Doppler Mode. Baseline
ascends with switch-up and descends with switch-down.
Speed
This button is to control the Sweep Speed in Spectral Doppler Mode or M Mode. If you press this
button, the sweep speed changes step by step.
Scale
This switch is to control the speed of blood flow or frequency range in Color Doppler Mode, Spectral
Doppler Mode or Power Doppler Mode. Switch-up expands the range of speed (frequency) and
switch-down reduced the range of speed (frequency).
Filter
This switch is to control the Wall Filter values in Color Doppler Mode, Power Doppler Mode or
Spectral Doppler Mode. Switch-up increases the Wall Filter values and switch-down decreases
the values.
Invert
This button is to invert the top and the bottom of the color bar in Color Doppler Mode. It also
inverts the top and the bottom of the speed (frequency) axis in Spectral Doppler Mode
Steer
This button is to alter the angle of ROI (Region of Interest) in Color Doppler Mode or Power
Doppler Mode. This operation is only available for Linear Probe. This button changes ROI to the
left, the front and then to the right in this order.
TGC Control
You can control the TGC values by depth using six slides.
While controlling the TGC slides, if you make the Gain difference of
Caution two adjacent slides too big, there might appear a line on the image.
Therefore it is not advisable for a user to control the slides in that way.
These are used to measure the image for diagnosis and to annotate it after obtaining the
desired image.
aliper
This button is to measure distance, volume, circumference and area. Select measurement
methods such as Distance, Ellipse, Trace, Hip Joint, and Volume. If you press this button
repeatedly, you can select desired measure method among all the ones supported.
Also, by pressing this button, measure menu appears at Flexible soft menu. Since each
measure menu has more than 2 measure methods, Flexible press soft menu button
Calculator
repeatedly to select your desired measure method. Refer to “Chapter 7. Basic
Measurements”.
This button is to display some menus that can be possibly measured in the selected
Application or Image Mode. Hence you can measure any desired item from the menu.
Refer to “Chapter 8. Measurements by applications”.
Body Marker
This button is to display the list of Body markers. If you select a desired marker, you can
insert the Body marker into the image on the screen.
Indicator
This button is to display an arrow-shaped indicator, so that you can mark the image with the
indicator.
Text
Clear
This button is to delete Text, Indicator, Body Mark, and measurement results on the image.
Trackball
Trackball makes cursor move on the screen. It also searches the image in Cine mode.
Change
Trackball makes cursor move on the screen. It also searches the image in Cine mode.
Exit
This button is to exit a current state of the system and return to a default mode.
Set/Update
This button is to set up the item or value that you have selected using trackball.
In diagnosis mode, this button carries out options, which are available. For example, it is used
to change the left/right view direction of the activated image in dual mode. When you press this
button once, the scanning image is appeared in right side. If you press the button one more
time, the image in the right side will be frozen and the scanning image is appeared in left side.
In Spectral Doppler mode, it is used to hold or scan 2D image.
For measurement, Press this when you complete one measurement and desire one more, and
cursor with other shape will appear.
Menu Control
Controls related to the menu displayed on the screen.
Menu
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.
3D Control
Controls related to diagnosis using 3D image.
3D
The [3D ] button on the alphanumeric keyboard is to display 3D.While the 3D Image Mode
is on, one more press of this button turns it off. 3D mode is unable in Cine mode or not in 2D
mode.
Utility Controls
Controls related to all kinds of utilities supported by SA8000SE.
Utility
The [Utility ] button on the alphanumeric keyboard is to display utility menu.
SonoView
The [SonoView ] button on the alphanumeric keyboard is to operate SonoView, which is an
Image Filing program.
Report
The button on the alphanumeric keyboard is to display one of the Report programs, which
includes measurement results of the currently selected Application.
Setup Controls
Controls related to various setups of the system.
Probe
This button is to display a window to select or change the probe and Application.
Setup
The [Setup ] button on the alphanumeric keyboard is to display a Setup window to setup the
parameters related to the system.
Patient
This button is to display the window to select a patient or input new information of patient.
End Exam
This button is to finish the diagnosis on the current patient and reset the related data.
It is used to input a text and so on. The buttons from 1 to 5 function as Flexible soft buttons in the
diagnosis mode. Some function keys are used for measurement
These are for OB measurements. You can measure immediately only what you select.
These buttons on the alphanumeric keyboard is to execute the corresponding Soft Menu on the
lower part of screen according to the state of the system.
X KEY
During using VCR, you can exit from VCR by pressing X key.
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.
Logo
Patient Information
The Patient’s ID and name are displayed here. The patient’s information can be
given in the patient information window.
Probe Information
The Name of the probe and its frequency information are displayed. You can select the
type of probe in the probe selection window. The probe frequency can be changed by
pressing the [FREQ] button on the control panel. A general or normal frequency is shown as
‘GEN,’ the higher and lower frequencies are shown as ‘RES’ and ‘PEN’, respectively.
Image Area
The ultrasound image, image information, annotation and measurement information are
displayed on the image area.
Ultrasound Image
It is an ultrasound image scanned using a probe. The image format depends on the diagnosis
mode. On the left side of the image, certain markers are displayed like depth marker, focus
marker and gray or color index bar.
Image Information
The information on the ultrasound images such as Gain, Dynamic Range and so on are
displayed. The contents of the image information depend on the kinds of ultrasound image
currently displayed.
Annotation
Annotation is displayed to explain the image. This includes Body mark, Indicator and Text.
Measurement Information
The basic measures of distance, circumference, area and volume are displayed together with the
measurement results from various Applications.
Menus
These consist of Image Control Menu, Measure Menu and Utility Menu.
When you use [Menu] dial-button, Image control menu is displayed on the right side of
screen. If the diagnosis mode is changed, a different menu is displayed. You can select the
corresponding menu turning the [Menu] dial-button on the control panel.
Measure Menu
A different Measure Menu is provided for each Application, and displayed by pressing the
[Calculation] button on the control panel. You can select Measure Menu using the [Menu]
dial-button or trackball on the control panel.
Utility Menus
The Utility Menu is used for the operation of various utilities and system setup. It is
displayed when the [Utility ] button on the alphanumeric keyboards is clicked. You can
also select the Utility Menu using the [Menu] dial-button on the control panel.
The Feedback area shows you all information required for system operation. The feedback area
displays the current state of the system and the item that can be selected.
Option functions
SA8000SE has the following optional functions that can be provided according to you or
perator’s selection.
reehand 3D
onoView
his is the image-filing package by which you can store and manage the scanned images
easily.
ICOM
his is the industrial standard for communication of images and other information between
edical devices on network. Using DICOM option, you can send or print images after
For more detailed information on the above optional functions, refer to the relevant chapters in
is operation manual.
Safety
Symbols 2-3
Safety
Safety Requirements
Classification:
Class I equipment with Type BF applied parts
Ordinary Equipment
Non-AP/APG
Safety Signs
Please read this chapter before using an MEDISON ultrasound system. It applies to the
ultrasound system, probes, recording devices, and any optional equipment.
SA8000SE 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.
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 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.
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
Medison.
Use only acoustic standoffs that have been approved for use by
MEDISON.
T Verify the alignment of the biopsy guide before use. See the “Chapter12.
E Probes” section of this manual.
Note
Before cleaning probes, see the “Chapter12. Probes” section of this
manual.
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.
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
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.
The TI informs the user about the potential for temperature increase existing at the surface
f the body, within the body tissue, or at the point of focus of the ultrasound beam on bone.
he actual amount of any temperature rise is influenced by factors such as tissue type,
ascularity, mode of operation and others. The TI should be used as a guide for
he bone thermal index (TIb) informs the user about potential heating at or near the focus after
the
ltrasound beam has passed through soft tissue or fluid, for example, at or near second or third
he cranial bone thermal index (TIc) informs the user about the potential heating of bone at or
near
he soft tissue thermal index (TIs) informs the user about the potential for heating within soft
omogeneous tissue.
ou can select either TIs or TIb using the TIs/TIb selection on the Miscellaneous system setups.
he MI and TI display accuracy estimates for the system are given in the Acoustic Output
Tables
anual. These accuracy estimates are based on the variability range of probes and systems,
nherent acoustic output modeling errors and measurement variability, as described below.
he displayed values should be interpreted as relative information to help the system operator
chieve the ALARA principle through prudent use of the system. The values should not be
nterpreted as actual physical values in interrogated tissue or organs. The initial data that is
used to
upport the output display is derived from laboratory measurements based on the AIUM
easurement standard. The measurements are then put into algorithms for calculating the
any of the assumptions used in the process of measurement and calculation are conservative
Service Manual SONOACE 8000SE
in
Safety Chapter 2 2-15
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.
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. 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. 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)
ll intensity parameters are measured in water. Since water does not absorb acoustic energy,
these
ater measurements represent a worst case value. Biological tissue does absorb acoustic
− ( 0.23alf )
e value of the intensity at any point depends on the amount and type of tissue
nergy.The true
and
he frequency of the ultrasound that passes through the tissue. The intensity value in the tissue.
The
ntensity value in the tissue, In Situ, has been estimated by using the following formula:
n Situ = Water [ ]
e = 2.7183
a = Attenuation Factor
e −(0.069lf )
Tissue a(dB/cm-MHz)
Brain .53
Heart .66
Kidney .79
Liver .43
Muscle .55
ince the ultrasonic path during an examination is likely to pass through varying lengths and
types
f tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used for
eneral reporting purpose; therefore, the In Situ value which is commonly reported uses the
ormula:
ince this value is not the true In Situ intensity, the term “derated” is used.
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 MEDISON’s service man or
Caution 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
Equipment Management 3-2
Maintenance
Equipment Maintenance
Fuse Replacement
1. Disconnect the plug from the system.
2. Take the fuse out; Press the middle of fuse
3. Insert the fuse holder to the appliance inlet.
4. After installing the new fuse, connect the plug to the system.
Electrical ratings and the others of the fuse are shown in the following table.
Input Ratings Fuse Ratings
100-120VAC 12.5A/250V
200-240VAC 10A/250V
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 Medison distributor
office. Office addresses and telephone numbers are in the system user documentation.
SYSTEM SURFACES
The exterior surfaces of most 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 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
rite down and Save information on user setting to prevent the possible loss of files before
ack-up.
Patient Information
evertheless,
Patient clients may
information back up the user setting on GA Table used in obstetrics diagnosis.
Back-up
Clients may back up diagnosis using SonoView software. For further information, please refer
r further information
to “Chapter please refer toin“Chapter
9. Image management” 4. Before Scanning”.
this manual.
The system automatically saves basic information of patients. Should you wish to reinstall the
system due to system error, please ask the 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 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 (Linux), 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 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
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-MEDISON-approved methods will damage your probe and void
your warranty.
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 Medison Customer Service
Department.
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 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
The following disinfectants are recommended because of both its biological effectiveness
(as qualified through the FDA 510(k) process) and its chemical compatibility with MEDISON
ultrasound product materials.
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 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
Installation
Befor installation
Pre-installation
arefully inspect the packing material for obvious signs of damage such as crushed, punctured,
f damage is not evident, sign and stamp a bill of lading “condition of contents unknown –
subject
o inspection.”
f damage is evident, contact your Purchasing Department for action, have the carrier’s driver
ndicate the damage on the damage on the freight bill, and sign all copies of the bill.
UNPACKING
uring formal inspection,INSTRUCTIONS
you should :
pen
The all packages
SA8000SE within 15
Ultrasound days of
system andreceipt for a complete
its accessories inspection
are shipped of the
in two consignment.
cartons.
To unparck the unit
eport concealed damage to the carrier within 15 days of receipt or the carrier may not accept
To unpack the 15” VGA monitor
iability.or cut the binder tape
Remove
Carefully lift the 15”VGA monitor and place it on a flat, secure surface
Take out the accessory and set it in safe place
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
Lamp Connector
This System provides a lamp for the Alpha Numeric Keyboard at a dark place. The connector
is located under the control panel, and you can turn it on or off by using the switch on its hat.
Front Panel
It is possible to connect with peripheral devices such as VCR, Color video printer, and so on through
Front Panel, which is inside of system rack.
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.
USB Connector
It is possible to connect with Storage devices, Inkjet Printer and so on through USB connector, which
is on left side of system rack.
Please set/set off USB device after turn off the system power completely.
Caution If you set/set off USB device during working, It may cause wrong working
Storage devices
SA8000SE supports many kinds of storage devices like USB MO Driver, USB CD-RW Driver and
Flash Memory Media to backup & restore data of SonoView or Measure packages.
SonoView support: USB MO Driver, USB CD-RW Driver and Flash Memory Media
Measure package support: USB MO Driver, Flash Memory media
Inkjet printers
You can use a Postscript interchange printer for SA8000SE. The connector should be connected to
the USB port of Rear Panel.
Available printers are HP DeskJet880C, HP DeskJet895C, HP LaserJet1200, HP DeskJet6122
and HP DeskJet5550.
It is possible to connect with peripheral devices such as monitor, printer, VCR, and so on through Real
Panel, which is at backside of system.
PARALLEL (Output)
Connect general PC printer through parallel port
RS-232C (Input/Output)
Input or output port for RS-232C
Caution You cannot use RS-232C in the Front Panel at the same time.
LAN (Input/Output)
It enables you to use DICOM. It transfers the patient’s information to other servers through DICOM
CAUTION
Network.
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.
ECG Connector
Connect with ECG Module.
[Figure 4-5] Lead II ECG
Probe holder
This system provides a probe holder at the left side of the control panel. You can put a probe into it.
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 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 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 MEDISON Customer Support.
2D Image Test
Freehand 3D Test
ECG Test
Peripheral Tests
System Organization
System Organization
Overview
The SA8000SE system consists of six main parts.
- Frame structure and boards that constitute the basic framework
- Power Unit
- Control Unit
- Ultrasound emitter and echo signal receiver
- Image signal processor and analyzer
- Image sound implementation part
The output power map for the POWER UNIT is described in the section “Power Unit” later in
this manual.
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 128 MB.
Also, for system stability, the SA8000SE uses Linux OS.
The SA8000SE system consists of a Continuous Wave Doppler (CW) PCB, a Digital
Beamformer (BF) PCB, a Digital Scan Converter (DSC) PCB, and a Power Supply Unit.
Beamformer #1
Probe Select Assembly (PSA)
- BF Control Logic
- 3Probe Connector - Transmit Pulse Generation (16 units)
- Probe Detection - Limiter (32 units)
- Probe ID - TGC Amp (16 Dual TGC amplifier)
- Switching Relay (128 units) - A/D Conversion (16, 8bit)
- Synthetic Aperture Support
- Dual line Receiving Support
CW PCB
PCC PCB
- PC Module
Speaker
- CPU : NS Geode GX1 - 300Mhz
Rear Panel I/O PCBs (R)
- Memory : 128 MB
- HDD : 80Gbytes (Seagate)
- PC Part (LAN, USB, MIC) 1. Rear Panel Left
- CV & Y/C Decoding for change RGC into a signals 2. Rear Panel Middle
- RGC Encoding for change CV & Y/C into a signals 3. Rear Panel Right Speaker
- Doppler Audio Processing (L)
- System PCI BUS
- Video DAC & amplifier
POWER UNIT
Power Output Voltage
The SA8000SE Power Supply is designed to work with 115VAC or 230VAC. Always ensure
that the power toggle switch on the product is set correctly for the wall power outlet.
The INPUT Voltage Selector is used for setting the power and voltage of the product.
The OUTPUT Voltage Selector is used for setting the power supplied directly from the product
to the monitor a printer.
Please refer to the figure below for more information.
1 2 3 4 5 6 7
Voltage Used by
1 +3.3 VDC Computer, Digital Logic, Beamformer
ADM INRUSH
CURRENT
RectificationCIRCUIT DDM (+50V)
AC IN LimiterCIRCUIT
INPUT MAIN
AC90V~264V Input SWITCH OUTLET ON/OFF OUTPUT 1
AC 110/220V
AC IN FILTER Manual Control TRANS CIRCUIT OUTLET 1 (MONITOR)
S/W
CIRCUIT (AC/AC) AC 110V/220V OUTPUT 2
F.G Manual Control S/W
OUTLET 2 (PRINTER)
INPUT
DDM IN
P/B, P/O, P
·S/W, P/G/S
(+50V)
FILTER
±HV REMOTE, OTP CIRCUIT
DDM IN CIRCUIT
(GND)
POWER SECTION
OUTPUT 3
+5.2VA, VD
DC/DC POWER 4
-5.2VD
Universal 128
HDI S/H
connector 1 128 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
Beamformer
Figure 6-7 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
BF IC
Uses 4:1 Mux To
HV Switch
in order to (32CH) DSC
operate all of
4 : 1 Mux the 128 MCB014B
elements with TGC after
the 32 pulsers. amplifying the
echo signals A/D
to 50dB. conversion.
TGC LFP
Limiter & &
(32CH) PreAmp ADC
(32CH) (32CH)
HV (80V) Digital
elements are Beamforming
removed from the
received signals.
TGC를 위한
Generates
TGC curve
TGC curve for
TGC. 발생
Beamformer PCB
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.
DSC Part
The DSC Part consists of the image filter circuit (which improves the image quality), the frame
memory part (which writes the scan line data and displays the monitor on the H-sync), Zoom,
and FreeHand 3D Path.
The DSC Part combines into one screen the information from the 2D / Spectral Doppler / Color
Doppler modes which are generated through different paths.
VM Part
The VM Part converts the digital data into RGC signals for displaying on the monitor and
converts the digital signals into analog signals. It also combines the menu information from the
PC and the image information from the system together for displaying on the screen.
It generates various video output signals in order to support other external devices.
From
BF PCB
MGA016
MGA015
Produces 2D Image
Removes Clutter
Color Produces I and Q signals
Color Mapping Mid
Doppler
Processor
Processor
Produces color
PC Host Control
box (combines the PDSP CPLD
DSP address mapping
existing 4 into 1)
FPGA
기본
Basic 도플러
Doppler Removes Multi Beam
DSP1 Operates DRAM
datadata 처리
process 1.2V로 artifact
at
동작 1.2V
RAM for
Debugging
SDRAM
전용RAM
debugging
Real Time
Performs auto
real- DSP2
기능trace
traceauto
time 담당
NI TO I
Header
SDRAM
Mapping To
I TO NI PCC PCB
SDRAM VM
FPGA
Post Map
Generates
Gray Bar
Image
Color Keying
Post Control V-sync
RGB conversion OSC
SDRAM H-Sync
Field Memory (G)
PC Module
PC Interface
CPU : NS Geode GX1 300MHz
DSC
Memory : 128 MB CPLD
HDD : 80 GB (Seagate) PCI 9054
I RGB data
DSC
NI RGB data
Converts I DSC
Converts signals into
(Y/UV) I 신호를 TDA Converts
SAA7115 SAA7129 Y/UV Digital
signals신호를
(Y/UV) into VCR용의 8775 digitaldata의
data
Decoder Encoder signals for Aalog 변환
RGB포멧으로
RGB signals Y/UV신호로
VCR. DAC into analog
변환 변환 data.
Converts
digital data into
analog data.
Speaker R.L To
Power Amp
LPF Rear
Block
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
HT82 M39A
Ball
TBR,TBL
POWER PS2
+5V , + 12V PORT
ALPHA/ NUM
ERIC
PORT
Setting up
Setting Up
CONTRAST
- + 50
Figure 7-1 Contrast Adjustment
BRIGHTNESS
- + 50
Figure 7-2 Brightness Adjustment
MAIN MENU
EXIT
COLOR
SIZE / CENTER
GEOMETRY
UTILITY
ENTER : MENU SELECT : + / -
Administration Mode
1. In Scan Mode, press ‘CTRL + Enter + A + D + M + I + N + Enter’ to open the
password input window as illustrated below.
2. At the Password input window, hit ‘Silicagel + Enter’ to enter the admin mode.
Network Setting
1. Press the Setup button. When the Setting window is displayed, click the Peripherals Tab.
2. Fill out information ueeded for the Host Setting group items and click Apply.
3. To use DHCP, select Using Dynamic IP Configuration, enter Hostname and click Apply.
C-MOS Setting
PNP/PCI CONFIGRATION
INTERGRATED PERIPHERALS
System Upgrade
1. Insert a storage device into the MO or Fresh Memory USB Port.
2. Click the Upgrade button in the Admin window.
3. Select the device which was the Upgrade file
5. The system will ask whether the file is correct. Hit “y”.
6. When the upgrade is complete, the system will ask whether to update the image user
setting to factory setting.
Disassembly
Overview 8-1
Disassembly 8-2
Disassembly
Overview
Overview
This chapter contains instructions for disassembling and assembling the SA8000SE system.
The system must be disassembled only by the 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 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
Changing Fuse
Auxiliaries
Auxiliaries
Auxiliary Cabling
UP21MD cabling
CP800 cabling
UP895MD cabling
AG-MD835 cabling
Auxiliary Settings
The following setting values are factory setting values.
Sharpness 2
Gamma 2
Paper HD
Smoothing OFF
Contrast 7
Brightness 7
COL:
Load Color: 1
CYN – RED: 0
MAG – RGB: 0
YEL – BLU: 0
Dark: 1
Light: 0
Sharpness: 8
Interpol: OFF
Save Color: 1 [EXEC]
PRN: IN:
Beep: ON Offset: 0
Save User: 1
Function:
COLOR ADJ
R-SUB 0
G-SUB 0
B-SUB 0
CENTER PUSH
ANALOG ADJ
BRT 7
CONT 5
R-SUB 0
B-SUB 0
CENTER PUSH
INPUT
RGB
ADDITIONAL
MULTI OFF
BUZZER TONE1
MODE S
GRAD NOMAL
APT NOMAL
COM OFF
MIRROR OFF
COMMENT [>]
SIZE/TIMMING
H-POSI -2
H-START FRONT
SIZE USER
SAVE PRG -6
SYSTEM SET
PAGE INC ON
CONVERT ON
REMAINING OFF
KEY SET
SIGNAL SET1
FIELD NOMAL
AFC OFF
SYNC EXIT
R-SUB 0
B-SUB 0
SIGNAL SET
DIR NOMAL
AUTO CUT ON
OP MODE 3P
Configuration
Overview 10 – 1
PCB Names 10 - 3
Configuration
Overview
This chapter contains instructions for verifying the main PCB locations for the SEBY system
and their functions.
PCB Names
2. ECG Out
9. Parallel port
Parts
Parts
Ordering Parts
This chapter contains information on the SEBY parts.
Please refer to the SEBY 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
PART PART NAME PART DESCRIPTION
BD-340-BF-0A SEBY B/F B/D
PROBE
Specification 12-1
Information 12-2
PROBE
Specification
This section summarizes probe specifications for the SA8000SE Ultrasound System.
Probe Specifications
This section includes information on the part ordering process used by the field service
engineers.
Information
Probe Information
C3-7ED
Application Abdomen,OB,GYN,Fetal
Heart,Renal
HL5-9ED
Radius of Curvature
Application Pediatric,Cardiac
EC4-9ED
Application General,OB,GYN,Urology
Glossary
Terms 13-3
Glossary
AC Alternating Current
A Amperes
ADC Analog-to-Digital Conversion
Assy Assembly
B/W Black and White
COA Customer Order Acknowledgment
CPU Central Processing Unit
CW Continuous-Wave
DAC Digital to Analog Converter
D/A Digital -to- Analog Converter
DC Direct Current
DICOM Digital Imaging and Communications in Medicine
DR Dynamic Range
DVM Digital Volt Meter
ECG Electro Cardiogram
EMC Electro Magnetic Compatibility
EMI Electro Magnetic Interference
ESD Electrostatic Sensitive Device or Electrostatic Discharge
I-RGB Interlaced Red, Green, and Blue Video
IVT Intra-Vaginal Transducer
Terms
CAUTION:
Message containing caution information to protect the product.
I-RGB:
Interlaced, red, green, and blue video signals. This system includes the rear panel connector
to support video devices that use this type of video signals.
Interlaced:
Interlaced is the current television scanning standard.
One full screen frame is generally made of 525 horizontal lines. The interlaced method scans
262.5 fields, repeatedly deflecting the scanning lines vertically. In other words, one full screen
frame is made by two instances of scanning.
As a result, the screen may flicker at 30 frames per second, but the same screen will not
flicker at 60 frames per second.
QWERTY Keyboard:
Keyboard with the top left keys laid out in the order of QWERTY. It is to the standard
computer keyboard type.
WARNING:
Message containing caution information to protect the user and patient from possible risks
and dangers.
English
Rev : 1.0
Date: March 2005
Publisher: Customer Support Dept., Medison Co., Ltd.
Address: Medison Venture Tower
997-10 Daechi-dong, Gangnam-gu, Seoul, Korea
Tel : 02.2194.1000
Fax : 02.2194.1071