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Contents
Chapter 1

General Information

System Information

1-1

Product Specifications

1-2

Product Components

1-7

Display Screen

1-22

Option Function

1-26

Chapter 2

Safety

Safety Specifications

2-1

Safety Instructions

2-2

Symbols

2-3

Electrical Safety

2-5

System organization

2-9

Environmental Protection

2-20
2-21

Equipment Protection

2-22

Safety for USB device

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SONOACE 8000SE

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Contents
Chapter 3

Maintenance

Equipment Management

3-1

Service Manual questions or Comments

3-1

System Surfaces

3-2

Administration of Information

3-3

Probe Management

3-4

Biopsy Guide Adapter and Needle Guide

3-7

Trouble Shooting Trees

3-9

Chapter 4

Installation

Before Installation

4-1

Connecting peripherals

4-3

System Appearance

4-8

Foot S/W Installation

4-10

Probe Hanger Installation

4-13

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Contents
Chapter 5

Performance Tests

Wiring and Cautions

5-1

Initial Setup

5-2

Initial and Monitor Tests

5-3

Functional Tests

5-4

Chapter 6

System Organization

System Architecture

6-1

Power Unit

6-3

Probe Select Assembly Board (PSA)

6-6

Beamformer Board (BF)

6-8

Digital Scan Converter Board (DSC)

6-11

PC Carrier Board (PCC)

6-14

Key Matrix PCB

6-17

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Contents
Chapter 7

Setting Up

Main Monitor Setting

7-1

Administration Mode

7-2

Network Setting

7-3

C-MOS Setting

7-4

System Upgrade

7-7

Chapter 8

Disassembly

Overview

8-1

Disassembly

8-2

Chapter 9

Auxiliaries

Auxiliary Cabling

9-1

Auxiliary Settings

9-4

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Contents
Chapter 10

Configuration

Overview

10-1

Verifying Main PCB Locations

10-1

PCB Names

10-3

Rear I/O Connector Panel PCB Detail

10-7

Chapter 11

Parts

Ordering Parts

11-1

Part Number

11-2

Part List

11-3

Chapter 12

Probe

Probe Specification

12-1

Probe Information

12-2

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Contents
Chapter 13

Glossary

Acronyms and Abbreviations

13-1

Terms

13-3

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SONOACE 8000SE

C hapter 1
General Information
System Information

1-1

Product Specifications

1-2

Product Components

1-7

Display Screen

1-21

Option Screen

1-26

Service Manual

SONOACE 8000SE

General Information

Chapter 1

1-1

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.

The SA8000SE has the following features and advantages:

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.

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Chapter 1

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System Specifications
Physical Dimensions

Imaging Mode

Gray Scale

Height: 1380mm (with monitor)


Width: 530mm
Depth: 870mm
Weight: More than 101kg
2D real-time
Dual 2D real-time
2D/M-mode
Color Doppler
Pulsed-wave Doppler
Power Doppler
3D-mode
Simultaneous
Real-time zoom
256 shades of gray, 8 bits
65,536 colors, 8 bits for each RGB component

Channels

32 digital channels

Focusing

Dynamic transmit focusing, maximum of eight points (four points


simultaneously selectable)
Digital dynamic receive focusing (continuous)

Probe connections

2 probe connectors,
3 probe connectors for option. (including CW probe connector,
CW probe is going to be supported.)

Monitor

Rear Panel Input


Connections

15" high resolution non-interlaced color monitor


Resolution: 640x480x16bit
Brightness control with quick return to a pre-set calibrated level
Contrast control with quick return to a pre-set calibrated level
Degauss control
High brightness & contrast
VHS and S-VHS VCR left and right audio
ECG
Microphone
Keyboard
VHS and SVHS VCR left and right audio
Patient monitor video and 9V dc power
B/W printer video and remote control
VGA monitor
Parallel port
Lamp
USB

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General Information

Image Storage

Application

Electrical Parameters

1-3

Cine loop memory (maximum 256 frames)


Image filing system
Abdominal
Obstetrical
Peripheral vascular
Gynecological and fertility
Small parts (breast, thyroid, parathyroid, penis, testes)
Abdominal surgery
Renal
Breast
Musculoskeletal
Pediatric
Prostate
Urology
Trans-Rectal
Trans-Vaginal
100-120V/200-240VAC, 12.5/10A, 50/60Hz

VOLUME MODE

Freehand 3D
Optimal volume resolution
Various 3D rendering algorithm
- Surface mode
- Maximum transparent mode
- Minimum transparent mode
- X-ray mode
MagiCut Plus
3D Orientation Help

Harmonic mode

Harmonic/Pulse Inversion

FRAME RATE

Max. up to about 100 fps

TIME GAIN
COMPENSATION

Chapter 1

Eight Slide Pot Controls


Reassigned on HRZ, Depth and U/D Invert Adjustments

DEPTH SELECTION

From 2 to 24 cm

DOCUMENTATION
CAPABILITIES

On-board VCR controls


On-board printing device control
Selective printing on two connected printers
SonoView Lite
DICOM 3.0

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General Information

Optional Devices

Measurement

Peripheral Signals

Chapter 1

1-4

Video Cassette Recorder (VCR)


Panasonic AG-MD 830 SVHS (NTSC & PAL)
Video Page Printer
Mitsubishi M90E B/W page printer
(120V/240V, NTSC/PAL, 3" x 4" format)
Color Video Page Printer
Mitsubishi CP700U color page printer (120V NTSC)
Mitsubishi CP700E color page printer (240V PAL)
Foot Switch
The functions of Left & Right Foot Pedals can be selected in
Setup Mode.
Freeze, Update, Record, Print, Store, 3D, ECG Trigger On/Off
Trackball operation of multiple cursors
2D: Linear measurements and area measurements using
elliptical approximation or trace
M-mode: Continuous readout of distance, time, and slope rate
Doppler: Velocity and trace
RGB Sync (Out)
NTSC/PAL
Red: 1.0 Vpp / 75 ohms
Green: 1.0 Vpp / 75 ohms
Blue: 1.0 Vpp / 75 ohms
Composite Sync: TTL
S VHS (In/Out)
NTSC/PAL
Chrominance: 0.286Vpp/75 ohms/unbalanced
Luminance: 1.0Vpp/75 ohms/unbalanced
VHS (In/Out)
NTSC/PAL
1.0 Vpp/75ohms/unbalanced
Video Patient Monitor (Out)
Video Signal
NTSC/PAL
1.22Vpp/75ohms/unbalanced
Audio R/L(In/Out) : ports
VGA(Out) : 2 ports
RS-232C(In/Out) : 1 port (COM1)
DICOM(In/Out) : 2 ports 10-Base Type
USB port(In/Out) : 2 ports (Ver. 1.0)
Microphone(In) : 1 port
Printer B/W(Out) : 1.0Vpp/75 ohms/unbalanced
Print Remote(Out) : Echo printer trigger

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General Information

Signal processing
(Pre-processing)

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

Signal processing
(Post-processing)

Frame average
Gamma-scale windowing
Image orientation (left/right and up/down)
White on black/black on white
Real-time zoom

Auxiliary

Operating: 700hPa to 1060hPa


Storage: 700hPa to 1060hPa

Humidity Limits

Operating: 30% to 75%


Storage & Shipping: 10% to 95%

CPU module

1-5

Black-and white printer


Color printer
VCR
Monitor
Foot switch

Pressure Limits

Temperature Limits

Chapter 1

Operating: 10 OC ~ 35OC
Storage & Shipping: -40OC ~ 70OC

Main host CPU: CPU card including Geode processor,


Hard drive: 80 GB
RAM size: 128MBytes
Linux based OS
VGA/LAN/Sound functions, and Interfacing function to
CD R/W (Optional)

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1-6

<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

Scan Heads

<Linear Array>
HL5-9ED Probe
Application: General, Breast,
Muscuoskeletal
Number of element: 128
Center frequency: 7.5MHz
FOV: 38.4mm
Doppler TX frequency: 5.6MHz
Steered angle: 15
Trapezoidal imaging
Biopsy guide available

Small

Part,

Vascular,

<Endocavity Curved Linear Array>


EC4-9ED Probe
Application: General, Obstetrics, Gynecology, Urology
Number of element: 128
Center frequency: 6.5MHz
Convex of radius: 19.4mm
FOV: 150.34
Doppler TX frequency: 5.13MHz
Biopsy guide available

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1-7

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.

[Figure 1-1] Main Body

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1-8

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.

[Figure. 1-2] Control Panel

Kinds of Controls and the Operations


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

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

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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.

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Control on the Control Panel

[Figure 1-3] Controls on the Control panel

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.

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Image Mode & Gain Control

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

M
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.

C
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.

D
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.

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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
This dial is used to control 2D Gain by turning it.

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
This dial is used to control Doppler Gain by turning it.

Focus
If this switch is up, the focusing point goes up. Conversely, when switch is down the focusing
point goes down.

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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.
GEN

General frequency

RES

High frequency

PEN

Low frequency

Color & Doppler Image Controls

Audio
This slide is to control the sound volume in Spectral Doppler Mode.

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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.

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TGC Control

You can control the TGC values by depth using six slides.

Caution

While controlling the TGC slides, if you make the Gain difference of
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.

Measurement and Annotation controls


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
repeatedly to select your desired measure method. Refer to Chapter 7. Basic
Calculator
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.

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Indicator
This button is to display an arrow-shaped indicator, so that you can mark the image with the
indicator.

Text
This button is to input a text on the image.

Clear
This button is to delete Text, Indicator, Body Mark, and measurement results on the image.

Measurement and Annotation controls


Controls related to trackball operation.

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.

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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.

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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.

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Alpha numeric Keyboard

[Figure 1-4] Alphanumeric keyboards


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

Measurement buttons in the Keyboards

These are for OB measurements. You can measure immediately only what you select.

Flexible Soft Button Control

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.

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

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

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

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

[Figure 1-5] Screen Configurations

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

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Logo
The Medison Logo is displayed here.

Patient Information
The Patients ID and name are displayed here. The patients information can be
given in the patient information window.

Name of Hospital and Application


The name of the hospital and the selected application are displayed. The name of the
hospital can be set in the system setup window, and the application can be selected in the
probe selection window.

Frame Rate and Depth


The Frame rate and the present diagnosis depth are displayed. The frame rate depends
on the diagnosis mode. In image control menu, you can change the frame rate. The [Depth]
switch on the control panel is used to adjust the diagnosis depth.

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.

Acoustic Output Information


MI (Mechanical Index) and TI (Thermal Index) are displayed.

Date and Time


The Date and Time currently set up in the system are displayed. You can change the date
and time using the system setup window.

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

[Figure. 1-6] 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.

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Menus
These consist of Image Control Menu, Measure Menu and Utility Menu.

Image Control Menu

[Figure 1-7] Image Control Menu 2D mode


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

[Figure 1-8] Measure Menu - OB


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.

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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.

[Figure 1-9] Utility Menus

Feedback Area

[Figure 1-10] Body mark Feedback


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.

Flexible Soft Menus


Flexible Soft Menu is always displayed on the screen. Displayed items depend on the system
state.

[Figure 1-11] Flexible Soft Menus

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Option functions
SA8000SE has the following optional functions that can be provided according to you or
perators selection.

reehand 3D
It makes Surface Rendering - 3D image, which is from 2D image, by Volume Rendering
ethod. It is showed in 3D View.

onoView
his is the image-filing package by which you can store and manage the scanned images
easily.

ICOM
DICOM is the abbreviation of Digital Imaging and Communications in Medicine.
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
onnecting your ultrasound equipment and PACS.

For more detailed information on the above optional functions, refer to the relevant chapters in
is operation manual.

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C hapter 2
Safety
Safety Specifications

2-1

Safety Instructions

2-2

Symbols

2-3

Electrical Safety

2-5

System organization

2-9

Environmental Protection

2-20

Equipment Protection

2-21

Safety for USB device

2-22

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Safety

Chapter 2

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Safety
Safety Requirements
Classification:
Class I equipment with Type BF applied parts
Ordinary Equipment
Non-AP/APG

Electromechanical safety standards met:


IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1General Requirements for Safety.
IEC/EN 60601-1-1 Safety requirements for medicalelectrical systems.
IEC/EN 60601-1-2 Electromagnetic compatibility -Requirements and tests.
IEC 61157 Declaration of acoustic output parameters.
ISO 10993-1 Biological evaluation of medical devices.
UL 2601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.
CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

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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.
Safety signs in This manual are classified like below.

Danger

It describes the precautions necessary to prevent user hazards of great


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

Warning

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


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

Caution

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


damage if a CAUTION is ignored.

Note

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


installing, operating and maintaining the system.

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

Isolated patient connection (Type BF applied part).

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

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

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


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

Indicates dangerous voltage over 1000 VAC or over 1500 VDC.


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

Output port for VGA or Parallel port

ECG port

Isolated patient connection (Type BF applied part).

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

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

Left and right Audio / Video input

Left and right Audio / Video output

Print remote output

Foot switch connector

ECG connector

USB connector

MIC input port

Protection against the effects of immersion.

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

Warning

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

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


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

Equipotential
Connection Lead
(Socket)

Equipotential
Connector

Terminal

Main Body

Earth in Medical Room

Warning

Do not remove the protective covers on the system; hazardous


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

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Warning

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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
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.

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


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

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Caution

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Although your system has been manufactured in compliance with existing


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

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EMC Test Reports


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

Immunity test

Electrostatic
discharge (ESD)

IEC 60601
Test level

Compliance level

6kV Contact

6kV Contact

8kV air

8kV air

2kV for power


supply lines
1kV for
input/output lines

2kV for power


supply lines
1kV for
input/output lines

Mains power quality


should be that of a typical
commercial or hospital
environment.

1kV
differential
mode
2kV common
mode

1kV differential
mode
2kV common
mode

Mains power quality


should be that of a typical
commercial or hospital
environment.

<5% U
(>95% dip in U)
for 0.5cycle
40% U
(60% dip in U )
for 5 cycle
70% U
(30% dip in U)
for 25 cycle
<5% U
(<95% dip in U )
for 5 s

<5% U
(>95% dip in U)
for 0.5cycle
40% U
(60% dip in U )
for 5 cycle
70% U
(30% dip in U)
for 25 cycle
<5% U
(<95% dip in U )
for 5 s

Mains power quality should


be that of a typical
commercial or hospital
environment. If the user of
the EUT image intensifier
requires continued
operation during power
mains interruptions,
it is recommended that the
EUT image intensifier be
powered from an
uninterruptible power supply
or a battery.

3 A/m

3 A/m

Powerfrequency
magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11

Power frequency
(50/60Hz)
magnetic field

Electromagnetic
environment -guidance

IEC 61000-4-8

Floors should be wood,


concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.

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

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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.

Warning

Do not use a system that exhibits erratic or inconsistent updating.


Discontinuities in the scanning sequence are indicative of a hardware
failure that must be corrected before use.
Perform ultrasound procedures prudently. Use the ALARA (as low as
reasonably achievable) principle.
Use only acoustic standoffs that have been approved for use by
MEDISON.

The system limits the maximum temperature of contact as 41 degree


Celsius, and the output of ultrasonic waves observes American FDA
regulations respectively.

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

Note

T
E

Verify the alignment of the biopsy guide before use. See the Chapter12.
Probes section of this manual.
Before cleaning probes, see the Chapter12. Probes section of this
manual.

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Sheaths are recommended for clinical application of an invasive nature,


including intraoperative, transrectal, transvaginal, and biopsy procedures.
MEDISON does not supply sheaths so that you should purchase
appropriate ones on your own.
Some sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals, Refer to the FDA Medical Alert,
March 29, 1991, reprinted here.

Warning

In neurosurgical applications, sterilized probes should be used with


sterile gel and a sterile pyrogen-free sheath.
If the sterile sheath becomes compromised during neurosurgical
applications involving a patient with Creutzfeldt-Jakob disease, the probe
cannot be sterilized with any sterilization method.
Sheaths are disposable and must not be reused.
If an installed sheath is cut or contaminated prior to use, the probe
should be cleaned and disinfected, and a new sterile sheath installed.

ALARA Education Program


The guidance for the use of diagnostic ultrasound is defined by the as low as reasonably
achievable (ALARA) principle. The decision as to what is reasonable has been left to the
judgment and insight of qualified personnel. No set of rules can be formulated that would be
sufficiently complete to dictate the correct response to every circumstances. By keeping
ultrasound exposure as low as possible, while obtaining diagnostic images, users can minimize
ultrasonic bioeffects.
Since the threshold for diagnostic ultrasound bioeffects is undetermined, it is the sonographers
responsibility to control total energy transmitted into the patient. The sonographer must
reconcile exposure time with diagnostic image quality. To ensure diagnostic image quality and
limit exposure time, an ultrasound system provides controls that can be manipulated during the
exam to optimize the results of the exam.
The ability of the user to abide by the ALARA principle is important. Advances in diagnostic
ultrasound not only in the technology but also in the applications of that technology, have
resulted in the need for more and better information to guide the user. The output indices are
designed to provide that important information
There are a number of variables, which affect the way in which the output display indices can be
used to implement the ALARA principle. These variables include values, body size, location of
the bone relative to the focal point, attenuation in the body, and ultrasound exposure time.
Exposure time is an especially useful variable, because the user controls it. The ability to limit
the index values over time supports the ALARA principle.

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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.

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Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity. These controls
affect imaging mode, pulse repetition frequency, focus depth, pulse length, and probe
selection.
The choice of imaging mode determines the nature of the ultrasound beam. B-mode is a
scanning mode, Doppler is a stationary or unscanned mode. A stationary ultrasound beam
concentrates energy in a single location. A moving or scanned ultrasound beam disperses the
energy over an area and the beam is concentrated on the same area of a fraction of the time
as that of an unscanned mode.
Pulse repetition frequency or rate refers to the number of ultrasound bursts of energy over a
specific period of time. The higher the pulse repetition frequency, the more pulse of energy in a
period of time. Several controls affect pulse repetition frequency: focal depth, display depth,
sample volume depth, color sensitivity, number of focal zones, and sector width controls.
Focus of the ultrasound beam affects the image resolution. To maintain or increase resolution
at a different focus requires a variation in output over the focal zone. This variation of output is
a function of system optimization. Different exams require different focal depths. Setting the
focus at the proper depth improves the resolution of the structure of interest.
Pulse length is the time during which the ultrasonic burst is turned on. The longer the pulse,
the greater the time-average intensity value. The greater the time-average intensity, the
greater the likelihood of temperature increase and cavitations. Pulse length or burst length or
pulse duration is the output pulse duration in pulsed Doppler. Increasing the Doppler sample
volume increases the pulse length.
Probe selection indirectly affects intensity. Tissue attenuation changes with frequency. The
higher the probe operating frequency, the greater the attenuation of the ultrasonic energy. A
higher probe operating frequency requires more output intensity to scan at a deeper depth. To
scan deeper at the same output intensity, a lower probe frequency is required. Using more
gain and output beyond a point, without corresponding increases in image quality, can mean
that a lower frequency probe is needed.

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

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

Output Display Features


The system output display comprises two basic indices: a mechanical index and a thermal index.
The thermal index further consists of the following indices: soft tissue (TIs) and bone (TIb). One of
these three thermal indices will be displayed at all times. Which one depends upon the system
preset or user choice, depending upon the application at hand.
The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1
The thermal index consists of the three indices, and only one of these is displayed at any one
time.
Each probe application has a default selection that is appropriate for that combination. The TIb or
TIs is continuously displayed over the range of 0.0 to maximum output, based on the probe and
application, in increments of 0.1.
The application-specific nature of the default setting is also an important factor of index behavior.
A default setting is a system control state which is preset by the manufacturer or the operator.
The system has default index settings for the probe application. The default settings are invoked
automatically by the ultrasound system when power is turned on, new patient data is entered into
the system database, or a change in application takes place.
The decision to display one or the other of the three thermal indices should be based on the
following criteria:
Appropriate index for the application: TIs is used for imaging soft tissue; and TIb for a focus at or
near bone.
Mitigating factors that might create artificially high or low thermal index readings: location of fluid
or bone, or blood flow. For example, is there a highly attenuating tissue path so that the actual
potential for local zone heating is less than the thermal index displays.
Probe modes versus unscanned modes of operation affect the thermal index. For scanned
modes, heating tends to be near the surface; for unscanned modes, the potential for heating
tends to be deeper in the focal zone.
Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indices are kept to
a minimum and that exposure time is limited without compromising diagnostic sensitivity.

Mechanical Index (MI) Display


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

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hermal Index (TI) Display


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 TI is an estimate of temperature increase in body tissue with specific properties.
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
mplementing the ALARA principle.
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
imester fetal bone.
he cranial bone thermal index (TIc) informs the user about the potential heating of bone at or
near
he surface, for example, cranial bone.
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.
Ic is displayed when you select a transcranial application.

echanical and Thermal indices Display Precision and Accuracy


he MI and TI precision is 0.1 unit on the system.
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
isplayed output values.
any of the assumptions used in the process of measurement and calculation are conservative
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Control Effrcts
Control affecting the indices
As various system controls are adjusted, the TI and MI values may change. This will be most
apparent as the POWER control is adjusted; however, other system controls will affect the onscreen output values.

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

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

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

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

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

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

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Color and Cintrols


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

Color Sector Width


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

Color Sector Depth


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

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

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

M-mode and Doppler Controls


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

Simultaneous and Update Methods


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

Sample Volume Depth


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

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DOPPLER, 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. 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.

Acoustic Output and Measurement


Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)
from ultrasound exposure have been studied by various scientific and medical institutions. In
October 1987, the American Institute of Ultrasound in Medicine(AIUM) ratified a report
prepared by its Bioeffects Committee(Bioeffects Considerations for the Safety of Diagnostic
Ultrasound, J Ultrasound Med., Sept. 1988: Vol.7, No.9 Supplement), sometimes referred to as
the Stowe Report, which reviewed available data on possible effects of ultrasound exposure.
Another report Bioeffects and Safety of Diagnostic Ultrasound, dated January 28, 1993
provides more current information.
The acoustic output for this system has been measured and calculated in accordance with the
December 1985 510(K) Guided for Measuring and Reporting Acoustic Output of Diagnostic
Ultrasound Medical Devices, except that the hydrophone meets the requirements of Acoustic
Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA UD 2-1992)

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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 )

nergy.The true
e value of the intensity at any point depends on the amount and type of tissue
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 [

here: In Situ = In Situ Intensity Value


Water = Water Value Intensity
e = 2.7183
a = Attenuation Factor

e (0.069lf )

Tissue

a(dB/cm-MHz)

Brain

.53

Heart

.66

Kidney

.79

Liver

.43

Muscle

.55

= skin line to measurement depth (cm)


= Center frequency of the transducer/system/mode combination(MHz)

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:
n Situ (derated) = Water [

ince this value is not the true In Situ intensity, the term derated is used.

Manual
he maximum derated and the maximum water values Service
do not always
occurSONOACE
at the same 8000SE

Safety

Chapter 2

2-19

Acoustic Output and Measurement


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

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


(milliwatts per square centimeter).

ISPPA.3 the derated spartial-peak pulse-average intensity


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

Service Manual

SONOACE 8000SE

Safety

Chapter 2

2-20

Environmental Protection

Caution

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 MEDISONs service man or
its authorized dealer.
The waste sheaths are to be disposed of safety and national regulations
must be observed.

Service Manual

SONOACE 8000SE

Safety

Chapter 2

2-21

Equipment Protection
Follow these precautions to protect your system:

Caution

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


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

Service Manual

SONOACE 8000SE

Safety

Chapter 2

2-22

Safety for USB devices


Follow these cautions before using USB devices

Caution

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

Service Manual

SONOACE 8000SE

C hapter 3
Maintenance
Equipment Management

3-2

Information Management

3-3

Probe Management

3-4

Biopsy Guide Adapter and Needle Guide

3-7

Trouble Shooting Trees

3-9

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-1

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

Service Manual Questions or Comments


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

Service Manager

Phone

Email

America

Joon Ryu

82-2-2194-1255

joon@medison.com

Asia

James Park

82-2-2194-1231

James@medison.com

China

Annie Ahn

82-2-2194-1252

anonyoo@medison.com

Europe I

DJ Kim

31-23-799-0705

ball@medison.com

Europe II

Ronny Ko

82-2-2194-1256

ronny@medison.com

Europe III

Joey Lee

82-2-2194-1257

joey@medison.com

Japan

Peter Jung

82-2-2194-1173

27print@medison.com

Middle East/Africa

Dennis Lim

82-2-2194-1243

dennis@medison.com

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.
MEDISON Service Department, Medison Venture Tower
997-10, Daechi-dong, Gangnam-gu,Seoul, Korea
(822) 2194-1000 or (822) 2194-1074
www.medison.com

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-2

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.

Warning

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

Caution

Use only recommended disinfectants on system surfaces.

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

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

Solutions

Country

Type

Active ingredient

FDA510

Cidex

USA

Liquid

Gluteraldehyde

K924434

Cidex Plus

USA

Liquid

Gluteraldehyde

K923744

Mix the disinfection solution compatible with your system according to label instructions for solution strength.
A disinfectant qualified by the FDA 510(k) process is recommended.
Wipe the system surfaces with the disinfection solution, following disinfection label instructions for wipe
durations, solution strengths, and disinfectant contact duration. Ensure that the solution strength and duration
of contact are appropriate for the intended clinical application.
Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label.

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-3

Administration of Information
Caution

You may lose information files on user setting or patients, because of


shock on the product or internal error. Thus, back-up on a regular
basis.

User Setting
User Setting Back up
ients may not back-up the user setting of the product.
ontact the Medison Customer Service Department to attain support to back-up.
rite down and Save information on user setting to prevent the possible loss of files before
ack-up.
Patient
Information
evertheless,
clients may
back up the user setting on GA Table used in obstetrics diagnosis.
Patient
information
Back-up
Clients may back up diagnosis using SonoView software. For further information, please refer
r further information
please refer toinChapter
4. Before Scanning.
to Chapter
9. Image management
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.

Caution

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

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-4

Probe Management
Warning

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

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


essential step prior to effective disinfection or sterilization. Be sure to
follow the manufacturers instructions when using disinfectants.

Caution

Do not allow sharp objects, such as scalpels or cauterizing knives, to


touch probes or cables.
When handling a probe, do not bump the probe on hard surfaces.

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

Caution

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

Disconnect the probe from the system.


Remove any sheaths, biopsy guide adapters, or biopsy needle guides(biopsy guide adapters are reusable portion of the biopsy guide and can be sterilized.)
Discard sheaths(sheaths are single-use item)
Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any
particulate matter or body fluids that remain on the probe or cable.
To remove remaining particulates, rinse with water up to the immersion point.
Wipe with a dry cloth; or wipe with a water-dampened cloth to remove soap residue, and then wipe
with a dry cloth.

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-5

Disinfection or Sterilization
Sterilize the device only for vaginal and rectal probing. A 10-6 reduction in pathogens should be
reached following the sterilization procedures in this manual and using the following 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.

Solutions

Country

Type

Active ingredient

FDA510

Cidex

USA

Liquid

Gluteraldehyde

K924434

Cidex Plus

USA

Liquid

Gluteraldehyde

K923744

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


date.

Warning

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

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


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

Caution

Do not immerse probes longer than one hour, unless they are sterilizable.
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.

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-6

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.

[Figure 3-1] Disinfection of Probes

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-7

Biopsy Guide Adapter And Needle Guide


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

Warning

Always use protective eyewear and gloves when cleaning and disinfecting
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 manufacturers instructions when using disinfectants.

Caution

Biopsy guide and cables should not contact with sharp things like scalpel.
When handling a biopsy guide, do not bump it on hard surfaces.
Do not use bleach to clean or sterilize the biopsy guide adapter. Using bleach
on the adapter may cause damage and will void your warranty.

Cleaning and sterilization of stainless steel biopsy guide


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

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

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-8

Cleaning and sterilization of plastic biopsy guide adapter.


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

Sterilization

Caution

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


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

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.

Solutions

Country

Type

Active ingredient

FDA510

Cidex

USA

Liquid

Gluteraldehyde

K924434

Cidex Plus

USA

Liquid

Gluteraldehyde

K923744

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


sterilant qualified by the FDA 510(k) process is recommended. Ensure proper contact time
(usually 10 hours) and solution temperature used.
After sterilization, follow the proper post-sterilization procedure for the sterilization method
used.
Inspect the components for damage such as cracks, rust or breakage. If damage is evident,
discontinue use of the biopsy adapter and contact Medison Customer Service Department.

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-9

Trouble Shooting Trees


System does not Power On / Boot up

No
Is the system plugged in ?

Pulgged In !

Yes
No
Is fuse normal ?

Change Fuse

Yes
Is there AC at the wall
outlet ?

No
Check the power line in
hospital

Yes

Check the Power Supply

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

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-10

Noise in Image format

Yes
Noise is appear in image format

Keep the system away from those


electrical devices

No

Is there any electrical


devices that affect the
system ?

Use another room's wall outlet

Check Probes

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

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-11

Track Ball

The trackball is low sensitive !

Does the trackball move


at all ?

Yes
Remove the ball from the trackball unit,
and clean it.

No

Replace the trackball unit

[Figure 3-4] Tree of track ball check

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-12

Unable to record to VCR

Unable to record to VCR !

No
Is the VCR properly
connected ?

Check that all signal. ang power supply cable


connections to the VCR unit are OK.

Yes

No
Is the VCR tape put into
the drvice ?

Put the tape into the device and rewind it.

Yes

No
Is recording unable even
by manual operation ?

Check the signal cable connections


between VCR and rear panel

Yes

No
VCR output of system
O.K ?

Replace DSC B/D

Yes

Replace VCR

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

Service Manual

SONOACE 8000SE

Equipment Maintenance

Chapter 3

3-13

Unable to use Printer


Unable to use Printer

Is the printer properly


connected ?

No

Check that all signal. power supply cable


connections between printer and system
are O.K.

Yes

Are there print papers


left ?

No
Insert the printer papers

Yes

Is proper configuration for


the print key set ?

No
Configure the print key

Yes

Is printing unavailable
even by manual
operation ?

No
Check the signal cable

Yes

Still no image on the print


out

No
Printer O.K

Yes

Video output of system


O.K ?

No
Replace the PCC B/D

Yes
Replace the printer

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

Service Manual

SONOACE 8000SE

C hapter 4
Installation
Before Installation

4-1

Connecting peripherals

4-3

System Appearance

4-8

Foot S/W Installation

4-10

Probe Hanger Installation

4-13

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-1

Installation
Befor installation
Pre-installation
pon arrival, inventory the shipment with the carriers driver.

arefully inspect the packing material for obvious signs of damage such as crushed, punctured,
orn, broken, wet or rattling packages.
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 carriers 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
all packages
within 15
days of
receipt
for a complete
inspection
of the
consignment.
The
SA8000SE
Ultrasound
system
and
its accessories
are shipped
in two
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 15VGA monitor and place it on a flat, secure surface
Take out the accessory and set it in safe place

To unpack the unit


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

Caution

MEDISON or local distributor will make available on request circuit diagrams,


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

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-2

Moving the product


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

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

Caution

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


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

Keep the following in mind when using the product.


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

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-3

Connecting Peripherals

[Figure 4-1] 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.

[Figure 4-2] Lamp switch On/Off

Service Manual

SONOACE 8000SE

Installation

Chapter 4

Caution

Do not assemble or disassemble it while it is turned on. It may cause


malfunction of the system. Also, if you drop the illuminator or shove it by
force, it may be broken down.

Caution

If raindrops or water drops spatter on the illuminator, or a high percentage


of humidity is shown, please do not operate it. Because you many be in
danger of an electric shock.

4-4

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.

[Figure 4-3] Front Panel

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

Caution

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

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

Caution

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

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

Caution

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

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-5

PRINTER (Output)
Connect with Echo printer.

PRINT REMOTE (Output)


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

Foot Switch Connector


A connector, which connects with foot switch, is on the front and lower part of system.

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
In case of USB MO Driver, do not use other devices with it.

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.

Caution

Please entrust the Medison Customer Service Department with the


installation of the printer and driver.

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-6

Foot Switch Connector


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.

[Figure 4-4] Rear Panel

VGA1 / VGA2 (Output)


Print out VGA signal with monitor.

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.

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-7

LAN (Input/Output)
It enables
you to use DICOM. It transfers the patients information to other servers through DICOM
CAUTION
Network.

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

Caution

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

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

Caution

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

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

Caution

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

PRINTER (Output)
Connect with Echo printer.

PRINT REMOTE (Output)


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

MIC (Input)
Connect with microphone.

ECG Connector
Connect with ECG Module.

[Figure 4-5] Lead II ECG

Service Manual

SONOACE 8000SE

Installation

Chapter 4

4-8

Probe holder
This system provides a probe holder at the left side of the control panel. You can put a probe into it.

Service Manual

SONOACE 8000SE

C hapter 5
Performance Tests
Wiring and Cautions

5-1

Initial Setup

5-2

Initial and Monitor Tests

5-3

Functional Tests

5-4

Service Manual

SONOACE 8000SE

Performance Tests

Chapter 5

5-1

Performance Tests
Wiring and Cautions
Warnings
Never open the safety cover of this equipment. Internal parts of the equipment are supplied
with high voltage electricity. All internal repairs and part replacements must be carried out only
by the 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 patients table or bed.

Service Manual

SONOACE 8000SE

Performance Tests

Chapter 5

5-2

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

Service Manual

SONOACE 8000SE

Performance Tests

Chapter 5

5-3

Initialization and Monitor Tests


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

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Performance Tests

Chapter 5

5-4

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

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Performance Tests

Chapter 5

5-5

General System Confidence Test


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

User Interface Tests


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

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

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Performance Tests

Chapter 5

5-6

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

CW Static Probe Test


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

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

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Chapter 5

5-7

Image Save Test


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

B & W Printer Tests


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

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

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Chapter 5

5-8

Color Printer Tests


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

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

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Performance Tests

Chapter 5

5-9

Performance Test Checklist


Test Item

Result

Remark

Initialization and Monitor Tests


General System Confidence Test
User Interface Tests
2D Image Test
Freehand 3D Test
CW Static Probe Test
ECG Test
Image Save Test
Peripheral Tests

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SONOACE 8000SE

C hapter 6
System Organization
System Architecture

6-1

Power Unit

6-3

Probe Select Assembly Board (PSA)

6-6

Beamformer Board (BF)

6-8

Digital Scan Converter Board (DSC)

6-11

PC Carrier Board (PCC)

6-14

Key Matrix PCB

6-17

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System Organization

Chapter 6

6-1

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.

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Chapter 6

6-2

SA8000SE Functional Block Diagram


Beamformer #1
Probe Select Assembly (PSA)
- BF Control Logic
- Transmit Pulse Generation (16 units)
- Limiter (32 units)
- TGC Amp (16 Dual TGC amplifier)
- A/D Conversion (16, 8bit)
- Synthetic Aperture Support
- Dual line Receiving Support

- 3Probe Connector
- Probe Detection
- Probe ID
- Switching Relay (128 units)

CW PCB
- Generate Main Clock 61.6MHz
- Transmit Power Control

Digital Scan Converter (DSC)


- Quadrature Demodulation
- Generate I, Q signals for Spectral Doppler and Color Doppler
- Log compression and envelope detection
- Gain and Dynamic Range Setting
- Generate Gray Scale data
- Wall Filtering and FFT for Spectral Doppler
- Generate Spectral Data
- Generate Doppler Audio signal
- Wall Filtering and Mean Velocity Estimation for Color Doppler
- Post Processing for Color Doppler
- Generate Color Doppler data
- Generate TGC data for Beamformer Board
------------------------------------------------ Generate all major control signals
- Perform Real Time Control and generate signal
- A/D conversion for ECG
- Cine memory
- Perform Azimuth & Axial interpolation
- Write San Line data in Frame memory
- Read data from Frame memory synchronized with monitor H - Sync
- Read Zoom & Edge Enhancement
- Free Hand 3D Data Path
------------------------------------------------ Image Grabber
- Interlace & Non - Interlace video signal output
- Video color keying

ECG Module
- ECG Isolation Amplifier
- ECG Gain Control

PCC PCB
- PC Module
- CPU : NS Geode GX1 - 300Mhz
- Memory : 128 MB
- HDD : 80Gbytes (Seagate)
- PC Part (LAN, USB, MIC)
- CV & Y/C Decoding for change RGC into a signals
- RGC Encoding for change CV & Y/C into a signals
- Doppler Audio Processing
- System PCI BUS
- Video DAC & amplifier

HDD
(80GB)
Primary Master

Control Panel
- Mode toggle switch
- Track Ball
- TGC Volume

Rear Panel I/O PCBs


1. Rear Panel Left
2. Rear Panel Middle
3. Rear Panel Right

Speaker
(R)

Speaker
(L)

Alphanumeric Keyboard
System Monitor
&
Peripherals

[ Figure 6-1] SA8000SE Functional Block Diagram

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System Organization

Chapter 6

6-3

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.

[ Figure 6-2] Power Supply Output

Part Name

Description

Power Code

Power supply cable

Fuse Holder

Holds 2 fuses

Input Voltage Selector

Main power setting switch


(100V/220V)

Main Power Switch

Main power switch

Output Voltage Selector

Sub-power setting switch


(100V/220V)

Output Voltage

Sub-power directly supplied by the


product for monitor and printer

Power Cooling Fan

Power cooling fan

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Remarks

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System Organization

Chapter 6

6-4

Power Supply Output Voltages


Voltage

Used by

+3.3 VDC

Computer, Digital Logic, Beamformer

+5VDC

Computer,HDD,Digital Logic.Beamformer, K/B

-5VDC

Computer, Beamformer

+12.2VDC

Computer,HDD,Digital Logic,Beamformer, Fan

-12.2VDC

Computer,HDD,Digital Logic,Beamformer, PSA

+10 ~ 80 VDC (+HV)

Beamformer

-10 ~ 80 VDC (-HV)

Beamformer

0 ~ 5 VDC

Acoustic power control

Power Supply Output Voltages

ADM

INRUSH
CURRENT
LimiterCIRCUIT

AC IN
AC90V~264V Input SWITCH
AC IN

CIRCUIT

(+50V)
DDM IN

TRANS

OUTLET ON/OFF
CIRCUIT

(AC/AC)

AC 110V/220V
Manual Control S/W

DDM

DDM IN

AC 110/220V
Manual Control
S/W

FILTER

F.G

DDM (+50V)

RectificationCIRCUIT
MAIN

INPUT

OUTPUT 1
OUTLET 1 (MONITOR)

OUTPUT 2
OUTLET 2 (PRINTER)

Auxiliary Power
(+5V, +15V)
INPUT
P/B, P/O, P
S/W, P/G/S
FILTER
HV REMOTE, OTP CIRCUIT
CIRCUIT

(GND)

POWER SECTION

OUTPUT 3

DC/DC POWER 1

+5.2VA
97V

DC/DC POWER 2

HV
+12.2VA, VD,VMOT

DC/DC POWER 3

-12.2VA,VD
FAN(ADM.DDM)
+5.2VA, VD

DC/DC POWER 4

-5.2VD

DC/DC POWER 5

+3.5VD

DC/DC POWER 6

+3.5VA

[ Figure 6-3 Power Supply Distribution Diagram

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System Organization

Chapter 6

6-5

Power Supply Unit

[ Figure 6-4] Power Supply Unit

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SONOACE 8000SE

System Organization

Chapter 6

6-6

Probe Select Assembly (PSA)


Figure 7-4 is a simple block diagram of the PSA PCB.
The PSA contains three probe connectors. When a probe is selected in the user menu, a
connector of the probe become select. The PSA acts as a gateway that connects the probes
and the system. It reads the probe ID upon booting and sends the data to the CW PCB. Then
the CW PCB decodes the data and transmits it to the CPU.

Universal
HDI S/H
connector 1

128

Universal
HDI S/H
connector 2

128

from BF Board

128

Latching
Relays

4
4128

Universal
HDI S/H
connector 3

Relay
Control

Probe select
from CW Board

Connectivity
Sensor
No Probe
4
Probe ID
Probe ID

[ Figure 6-5] Probe Select Assembly Block Diagram

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SONOACE 8000SE

System Organization

Chapter 6

6-7

Probe Select Assembly (PSA)

[ Figure 6-6] PSA Unit

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System Organization

Chapter 6

6-8

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
32ch TX Pulsers (MHIC0201: 16 units)
32ch Limiter
32ch TGC Amp (Dual channel TGC Amp, AD8332: 16 units)
32ch A/D Converter (Dual Channel A/D Converter, AD9288-40: 16 units)
Bipolar TX Pulses
Synthetic Aperture Support
Dual Line Receiving Support
RX Dynamic Aperture Function (16 step max.)
RX Apodization Function (supports curves for different modes)
Trapezoidal Imaging Support
TX Focal Point Support (4 max.)
Board version included in Board

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System Organization

Chapter 6

6-9

Beamformer Functional Block Diagram

Amplifies the 5V
signals to 80V,
which is sufficient
for operating the
probes.

HV Switch
4 : 1 Mux

Since the BFIC


operates at 3.3V,
the TX_out
signals do not
exceed 3.3V.

Amplifies the 3.3V


signals to 5V so
that the Pulser IC
can recognize the
signals properly.

Pulser
(32CH)
MHIC0201

Uses 4:1 Mux


in order to
operate all of
the 128
elements with
the 32 pulsers.

Limiter
(32CH)

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

Pulse
Signal
Buffers

TGC after
amplifying the
echo signals
to 50dB.

TGC
&
PreAmp
(32CH)

TX_out

BF IC
(32CH)
MCB014B

To
DSC

A/D
conversion.

LFP
&
ADC
(32CH)

Digital
Beamforming

TGC
Generates
TGC curve
TGC curve for
TGC.

TGC curve /reference generator & Buffer

[ Figure 6-7] Beamformer Functional Block Diagram

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System Organization

Chapter 6

6-10

Beamformer PCB

[ Figure 6-8] Beamformer PCB

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System Organization

Chapter 6

6-11

Digital Scan Converter (DSC)


The Digital Scan Converter PCB consists of three main parts: a Digital Signal Processing
(DSP) Part, a Digital Scan Converter (DSC) Part, and a Video Manager (VM) Part.

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

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.

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System Organization

Chapter 6

6-12

Digital Scan Converter(DSC) Functional Block Diagram


From
BF PCB
MGA016
Removes Clutter
Color Mapping

Produces color
box (combines the
existing 4 into 1)

PDSP

Basic
Doppler
datadata
process

DSP1

Real Time
auto
Performs
realtraceauto
trace

time

Color data scan


conversion

BW data scan
conversion

Produces 2D Image
Produces I and Q signals

Mid
Processor

PC Host Control
address mapping

CPLD

DSP
FPGA

Operates
1.2V
at
1.2V

DRAM

Removes Multi Beam


artifact

SDRAM

RAM for
Debugging
debugging
RAM

SDRAM

3D, Loop
Memory

SDRAM

CINE
Memory

SDRAM

CINE
Memory

DSP2

SSRAM

BW data scan
conversion

Combines
SA8000
SA8000
input, FM,
Iput,FM,Loop
loop CTR
into 1
3
CTR.
1

SSRAM

DSC
FPGA

DSC Control
VM Control
RTC Control

ADSP

SSRAM
Pixel Intp
Azimuth Intp
F.A
F.I
Read Zoom
E/E

SDRAM

ADC

I TO NI
SDRAM

To
PCC PCB

VM
FPGA
Post Map
Gray Bar
Color Keying
RGB conversion

Generates
Image
V-sync
H-Sync

Field Memory (B)

OSC

Field Memory (G)

Post Control
SDRAM

Converts
ECG

ECG signals
digital
into

signals

NI TO I
SDRAM

Header
Mapping

Field Memory (R)

Frame Memory

MGA015

Color
Doppler
Processor

Converts Image V-sync, H-Sync to


VGA V-Sync, H-Sync

[ Figure 6-9] DSC PCB Block Diagram

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SONOACE 8000SE

System Organization

Chapter 6

6-13

Digital Scan Converter (DSC) PCB

[ Figure 6-10] DSC PCB

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SONOACE 8000SE

System Organization

Chapter 6

6-14

PC Carrier (PCC) PCB


The PC Carrier (PCC) PCB consists of three main parts: a PC Part, a VM Part, and a Doppler
Sound Part.

PC Part Components and Functions


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

Video Manager Part Components and Functions


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

Audio Sound Part Components and Functions


The Audio Sound Part is the last device that processes Doppler Sound for the Spectral
Doppler.
The Audio Sound Part consists of the D/A converter (which converts digital signals into analog
signals), a filter (LPF) (which removes the noise from Doppler signals), and the Power Amp
(which amplifies the audio to sufficient output levels).
This part also includes a microphone that can be used for adding audio information when
recording the ultrasonographic scanner video.

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System Organization

Chapter 6

6-15

PC Carrier PCB Functional Block Diagram

PC Module
PC Interface
CPU : NS Geode GX1 300MHz
Memory : 128 MB
HDD : 80 GB (Seagate)

DSC

CPLD
PCI 9054

External VCR signal Input


I RGB data
DSC
NI RGB data

SAA7115
Decoder

Converts
(Y/UV)
(Y/UV)
signals
into
RGB
RGB
signals

SAA7129
Encoder

DSC

Converts I
signals into
I
Y/UV
VCR
signals for
Y/UV
VCR.

TDA
8775
DAC

Converts
Digital
digitaldata
data
Aalog

into
analog
data.

Converts
digital data into
analog data.
OP Amp

OP Amp

OP Amp

OP Amp
Main Monitor image signal output

BW Printer/Color Printer, external monitor image signal output


VCR image signal output (VHS Output)

Rear

VCR image signal input (VHS Input)

Doppler sound data


From
DSC

Mic input signal

DAC Block

Converts
Doppler sound
Into analog signals

VCR Sound Input


MIC Block

LPF

Doppler Noise Filter

To
Rear

Mux

Speaker R.L

Power Amp
Block

To
Rear

Final Doppler Sound amplification

[ Figure 6-11] PCC PCB Functional Block Diagram

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System Organization

Chapter 6

6-16

PC Carrier PCB

[ Figure 6-12] PC Carrier PCB

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System Organization

Chapter 6

6-17

Key Matrix PCB


Key Matrix Components and Functions
SEBYs K/M constitutes the Key Matrix that supports the UI (User Interface). When the user
clicks a function button, the associated command is sent to the system, so that the system can
perform the associated operation. It acts as a bridge between the user and the system.
SEBYs UI consists of a Key Matrix B/D (BD-340-KM) and a Alpha/Numeric Key Interface B/D
(BD-336-KI). The TGC VR Module (BD-336-TGC) is included in a separate Sub B/D.

[ Figure 6-13] Key Matrix PCB

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System Organization

Chapter 6

6-18

Key Matrix Functional Block Diagram

+3.3V

SR[8.. 15]

Key
control
CPLD

Key Matrix

SC[0..7]

XC 95144
TQ 144

DAT A[ 0..7]

BD- 336TGC

SD[0..7 ]

SA[0. .7]

Power Control Signal

MAX239

ADC
0808

SD[ 0..7]

Key
Power Control

uP
89c51

Foot s/w
Alpha Numeric
Key

+5VA

Connector

TTXA,B
Track
Ball

TTYA,B

PS2
Mouse
HT82 M39A

TBR,TBL
PS2
PORT

POWER
+5V , + 12V

ALPHA/ NUM
ERIC
PORT

[ Figure 6-14] Key Matrix Block Diagram

Service Manual

SONOACE 8000SE

C hapter 7
Setting up
Main Monitor Setting

7-1

Administration Mode

7-2

Network Setting

7-3

C-MOS Setting

7-4

System Upgrade

7-7

Service Manual

SONOACE 8000SE

Setting Up

Chapter 7

7-1

Setting Up
Main Monitor Setting
Brightness and Contrast Setting
1. Press the MENU button on the front of the monitor.
2. Press the + and buttons to set Brightness to 73% and Contrast to 65%.
3. Press the MENU button again to finish the screen adjustment.

CONTRAST

+ 50
Figure 7-1 Contrast Adjustment

BRIGHTNESS

+ 50
Figure 7-2 Brightness Adjustment

Other MENU Settings


1. Hold down the MENU button on the front of the monitor for about 10 seconds until
Main Menu is displayed.
2. Press the + and buttons to select an item to adjust and check or change the setting value.
3. Set Overall Image size to 270mm x 202mm.
4. Set Red, Green, and Blue levels to 83%.

MAIN MENU
EXIT
COLOR
SIZE / CENTER
GEOMETRY
UTILITY
ENTER : MENU SELECT : + / FH : 37.8 KHz FV : 60.3 Hz

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Setting Up

Chapter 7

7-2

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.

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Setting Up

Chapter 7

7-3

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.

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SONOACE 8000SE

Setting Up

Chapter 7

7-4

C-MOS Setting
ROM PCI/ISA BIOS

BIOS FEATURES SETUP

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SONOACE 8000SE

Setting Up

Chapter 7

7-5

CHIPSET FEATURE SETUP

POWER MANAGEMENT SETUP

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SONOACE 8000SE

Setting Up

Chapter 7

7-6

PNP/PCI CONFIGRATION

INTERGRATED PERIPHERALS

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SONOACE 8000SE

Setting Up

Chapter 7

7-7

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

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Setting Up

Chapter 7

7-8

4. Select the Upgrade Version.

5. The system will ask whether the file is correct. Hit y.

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SONOACE 8000SE

Setting Up

Chapter 7

7-9

6. When the upgrade is complete, the system will ask whether to update the image user
setting to factory setting.

7. Reboot the system to apply the upgrade.

Service Manual

SONOACE 8000SE

C hapter 8
Disassembly
Overview

8-1

Disassembly

8-2

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-1

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.

Warning

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

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-2

Disassembly
SA8000SE Front and Back

[ Figure 8-1] SA8000SE Front

[ Figure 8-2] SA8000SE Back

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-3

Opening Front Cover

Press the 2 hook locks with


thumbs and pull the cover out.

Unscrew the 2 screws and


disconnect the connector.
Push the Front Panel in the
direction of the arrow to release
the lock and then pull it out.

Unscrew the 5 screws.


Pull out the PSA PCB.

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-4

Opening PSA PCB

Unscrew the 5 screws.


Grab the top part of the PCB and
pull it out.

When detaching the shield case,


there is a plastic holder that
secures the internal boards.

Unscrew the 10 screws indicated


by the red circles.
Pull it out.

Installed components are, from the


left in order, CW, BF, DSC, PCC,
and Power Module.

Pull it out in a similar way.

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-5

Opening Back Panel

Press the 2 hooks indicated by the


red circles and pull the Rear
Bottom Cover out.

Fan power connector

Internal lock

Unscrew the 2 screws.


Push the cover down to release
the lock.
Pull the rear upper cover out.

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-6

Opening Rear Panel

Unscrew the 4 screws indicated by


the red circles.

Pull the panel out.

Opening Power Unit

Disconnect the power connectors


as illustrated in the picture on the
right.

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-7

Unscrew the 2 screws indicated by


the red circles.
Pull the power unit out in the
direction of the arrow.
(The picture above shows the
system without the power cover.)
Unscrew the 8 screws indicated by
the red circles.
Pull the power cover out in the
direction of the arrow.

The picture shows the power unit


that has been disassembled from
the system.

Service Manual

SONOACE 8000SE

Disassembly

Chapter 8

8-8

Changing Fuse

Press down the secure lever of the


fuse holder as the picture on the right
is shawing and then thpull the fuse
out.

The picture shows the fuse that has


been taken out of the power unit.

Service Manual

SONOACE 8000SE

C hapter 9
Auxiliaries
Auxiliary Cabling

9-1

Auxiliary Settings

9-4

Service Manual

SONOACE 8000SE

Auxiliaries

Chapter 9

9-1

Auxiliaries
Auxiliary Cabling
Connecting Auxiliary Cables
This chapter contains instructions for connecting auxiliaries with cables and information for
setting the devices.
Figures 9-1 through 9-4 are illustration images that show the auxiliary cabling organization.
They show the connection for color printer, B/W printer and VCR that are supported by the
Medison ultrasonographic image scanner.

Service Manual

SONOACE 8000SE

Auxiliaries

Chapter 9

9-2

Figure 9-1 Sony UP21MD Wiring Diagram

UP21MD cabling

Figure 9-2 Mitsubishi CP800 Wiring Diagram

CP800 cabling

Service Manual

SONOACE 8000SE

Auxiliaries

Chapter 9

9-3

Figure 9-3 Sony UP895 & Mitsubishi P91W Wiring Diagram

UP895MD cabling

Figure 9-4 Panasonic AG-MD835 Wiring Diagram

AG-MD835 cabling

Service Manual

SONOACE 8000SE

Auxiliaries

Chapter 9

9-4

Auxiliary Settings
The following setting values are factory setting values.

Sony UP895 Settings


On the DIP switch on the printer rear panel, only the first switch on the left (IMP) should be
switched up, and all other switches should be switched down.
Sharpness

Gamma

Paper

HD

Smoothing

OFF

Contrast

Brightness

[ Table 9-1] UP895 Printer Control Settings ]

Service Manual

SONOACE 8000SE

Auxiliaries

Chapter 9

9-5

Sony UP21-MD Settings


The following are default setting values for the Sony UP21-MD color printer.

COL:
Load Color:

CYN RED:

MAG RGB:

YEL BLU:

Dark:

Light:

Sharpness:

Interpol:

OFF

Save Color:

1 [EXEC]

LAY:

NTSC Settings

PAL Settings

Memory:

Frame

Frame

Multi Pix:

Separate:

*****

*****

H Start:

-24 Dots

40 Dots

V Start:

-8 Dots

20 Dots

H Width:

976 Dots

840 Dots

V Width:

480 Dots

496 Dots

Save

Press [EXEC]

Press [EXEC]

Caption:

OFF

OFF

Window:

[ Table 9-2] UP21- MD Printer Settings

Service Manual

SONOACE 8000SE

Auxiliaries

PRN:

Chapter 9

9-6

IN:

Print QLT:

INPUT SEL:

GAMMA:

Normal

Video:

N/A

PRN Speed:

Normal

S-Video:

N/A

Load User:

RGB

System Setup:

Hue:

*****

LCD. Center:

Color:

*****

Baud Rate:

4800

Gain:

Beep:

ON

Offset:

IRE.:

100

AGC:

ON

Save User:

Function:
Auto Live:

OFF

OUT:

Immed. Cap.:

OFF

Display:

OFF

RM2 Func.:

C&Print

RBN Remain:

OFF

Clear:

ALL

Source:

EE

Sync on G:

ON

Color Balance:
BAL X:

50

Moni C-R:

BAL Y:

50

Moni M-G:

BAL Step:

Moni Y-B

[ Table 9-3] UP21- MD Printer Settings

Service Manual

SONOACE 8000SE

Auxiliaries

Chapter 9

9-7

Mitsubishi CP800 Settings


Set the RGC and Sync switch on the printer rear panel to 75 OHM.

ACCUVIX Default Settings

Menus and Parameters


COLOR ADJ
BRT

7 or Users Preference

CONT

5 or Users Preference

R-SUB

G-SUB

B-SUB

CENTER

PUSH

ANALOG ADJ
BRT

CONT

R-SUB

B-SUB

CENTER

PUSH

INPUT
RGB
ADDITIONAL
MULTI

OFF

BUZZER

TONE1

PRINT
MODE

GRAD

NOMAL
[ Table 9-4] CP800 Main Menu Control Settings

Service Manual

SONOACE 8000SE

Auxiliaries

GAMMA ADJ

N/A

APT

NOMAL

COM

OFF

MIRROR

OFF

COMMENT

[>]

Chapter 9

9-8

SIZE/TIMMING
H-POSI

-2

H-START

FRONT

SIZE

USER

SAVE PRG

-6

SYSTEM SET
PAGE INC

ON

LIVE SELECT

DIGITAL

CONVERT

ON

REMAINING

OFF

REMOTE SET

N/A

PREVIOUS ERROR

N/A

[ Table 9-5] CP800 Main Menu Control Settings

Service Manual

SONOACE 8000SE

Auxiliaries

Menus and Parameters

Chapter 9

9-9

ACCUVIX Default Settings

KEY SET
KEY LOCK

OFF

MEM & PRN

ON

MEM & STOP

OFF

MEM & MONI

OFF

PRN & CLR

OFF

CLEAR KEY

PAGE

KEEP MONI

OFF

SIGNAL SET1
FIELD

NOMAL

AFC

OFF

SYNC

EXIT

R-SUB

B-SUB

SIGNAL SET2

N/A

SIGNAL SET
DIR

NOMAL

MARGIN CUT

OFF

AUTO CUT

ON

OP MODE

3P

[ Table 9-6] CP800 Main Menu Control Settings

Service Manual

SONOACE 8000SE

C hapter 10
Configuration
Overview

10 1

Verifying Main PCB Locations

10 - 1

PCB Names

10 - 3

Rear I/O Connector Panel PCB Detail

10 - 7

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-1

Configuration
Overview
This chapter contains instructions for verifying the main PCB locations for the SEBY system
and their functions.

Verifying Main PCB Locations


Figure 10-1 is a PCB illustration showing the locations of the primary system PCBs.

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-2

[Figure 10-1] Primary System PCB Locations in Card Cage

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-3

PCB Names

[Figure 10 2] Continuous Wave Doppler (CW) PCB

[Figure 10 3] Digital Beamformer (BF) PCB

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-4

[Figure 10 4] Digital Scan Converter (DSC) PCB

[Figure10 5] PC Carrier (PCC) PCB

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-5

[Figure10 6] Power Supply Unit PCB

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-6

[Figure 10-7] Motherboard (Back Plane) PCB

Service Manual

SONOACE 8000SE

Configuration

Chapter 10

10-7

Rear I/O Connector Panel PCB Detail


Auxiliary Connection A VCR, printer and other auxiliary devices can be connected here.
Rear Panel Input Connections
1. VHS and S-VHS VCR left and right audio Input
4. Keyboard

2. ECG

3. Microphone

5. VHS and SVHS VCR left and right audio Output

6. Patient monitor video and 9VDC power

7. B/W printer video and remote control

8. VGA monitor

10. LAN Port

9. Parallel port

1. VHS and S-VHS VCR


left and right audio Input

11. RS-232C Port

7. B/W printer video and


remote control Output

8. VGA monitor Output

2. ECG Out
9. Parallel port

5. VHS and S-VHS VCR


left and right audio Output

3. Microphone In

12. RS-232C Port

11. LAN Port

[Figure 10-8] Rear I/O Connector Panel

Service Manual

SONOACE 8000SE

C hapter 11
Parts
Ordering Parts

11-1

Part Numbers

11-2

Parts List

11-3

Service Manual

SONOACE 8000SE

Parts

Chapter 11

11-1

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.

Service Manual

SONOACE 8000SE

Parts

Chapter 11

11-2

Part Numbers
PART

Board

PART NAME

PART DESCRIPTION

BD-340-BF-0A

SEBY B/F B/D

BD-340-CW-00

SEBY CW B/D

BD-340-DSC-0A

SEBY DSC B/D

BD-340-PCC-0A

SEBY PCC B/D

BD-340-PSA-2P-0A

SEBY PSA 2PORT B/D

BD-336-KI-0B

SA8000 KEY INTERFACE B/D

BD-336-TGC-1A

SA8000 TGC B/D

BD-340-KM-0A

SEBY KEY/M B/D

BD-340-MTH-0A

SEBY MOTHER B/D

BD-340-RL-0A

SEBY REAR PANEL LEFT B/D

BD-340-RM-0A

SEBY REAR PANEL MIDDLE B/D

BD-340-RR-0A

SEBY REAR PANEL RIGHT B/D

BD-340-USB-0A

SEBY USB B/D

BD-336-RIL-0A

REAR PANNEL IF I LOWER BD

BD-336-RIU-0A

REAR PANNEL IF I UPPER BD

AY-340-PWR-ADM-00

SEBY POWER AY AC-DC MODULE

AY-340-PWR-DDM-00

SEBY POWER AY DC-DC MODULE

AY-FAN-336-BACK-00

SA8000 BACK FAN CABLE AY

AY-SPEAK-8000-00

SPEAKER SA8000 AY

AY-TB-B/58-UNIT-1-00

TRACK BALL BLACK UNIT 58MM

MNT-15-TOTOKU/SEBY-00

MONITOR 15 TOTOKU ASSY SEBY

Power

Electric
Track Ball
Monitor

Service Manual

SONOACE 8000SE

C hapter 12
PROBE
Specification

12-1

Information

12-2

Service Manual

SONOACE 8000SE

Probe

Chapter 12

12-1

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.

Probe

Application

Clinical Use

C3-7ED

Abdomen,OB,GYN,Fetal

Fetal,Abdomen

HL5-9ED

Vascular,Extremity

Small Parts,Peripheral-Vascular

EC4-9ED

OB,GYN,Urology

Trans-Vaginal,Trans-Rectal

Service Manual

SONOACE 8000SE

Probe

Chapter 12

12-2

Information
Probe Information
Probe Name

Element No.

Center Frequency

Doppler Frequency

C3-7ED

128

4.5 Mhz

Mhz

HL5-9ED

128

7.5 Mhz

Mhz

EC4-9ED

128

6.5 Mhz

Mhz

Service Manual

SONOACE 8000SE

Probe

Chapter 12

12-3

Probe Types, Capabilities, and Advantages


TYPE

HL5-9ED

C3-7ED

EC4-9ED

Capabilities

Advantages

2D Mode
C Mode
PWD Mode
M Mode

Dynamic receive focus for optimal lateral


resolution
Multiple transmit focal zones
Wide field of view (Trapezoidal)
High frame rate
Excellent tissue definition

2D Mode
C Mode
PWD Mode
M Mode
Freehand
3D Mode

Combines the advantages of phased array and


Linear
Array probes
Multiple transmit focal zones
Sector format with wide field of view at skin
surface
Good lateral resolution
Dynamic receive focus
Excellent resolution and detail
Design is lightweight and easy to use

Service Manual

SONOACE 8000SE

Probe

Chapter 12

12-4

C3-7ED
Probe Picture

Specification
Probe Type

Curved Linear Array

Center Frequency

4.5 Mhz

Radius of Curvature

50[mm]

Field of View

69,56

Number of Elements

128

Elements Pitch

0.474[mm]

Elevation Aperture

11[mm]

Geometric Focus

80[mm]

Application

Abdomen,OB,GYN,Fetal
Heart,Renal

Service Manual

SONOACE 8000SE

Probe

Chapter 12

12-5

HL5-9ED

Probe Picture

Specification
Probe Type

Center Frequency

Linear

7.5 Mhz

Radius of Curvature

Field of View

38.4[mm]

Number of Elements

128

Elements Pitch

0.30[mm]

Elevation Aperture

6[mm]

Geometric Focus

20[mm]

Application

Pediatric,Cardiac

Service Manual

SONOACE 8000SE

Probe

Chapter 12

12-6

EC4-9ED

Probe Picture

Specification
Probe Type

Endocavity

Center Frequency

6.5 Mhz

Radius of Curvature

10[mm]

Field of View

150.34

Number of Elements

128

Elements Pitch

0.205[mm]

Elevation Aperture

6[mm]

Elevation Focus Depth

38[mm]

Application

General,OB,GYN,Urology

Service Manual

SONOACE 8000SE

C hapter 13
Glossary
Acronyms and Abbreviations

13-1

Terms

13-3

Service Manual

SONOACE 8000SE

Glossary

Chapter 13

13-1

Glossary
Acronyms and Abbreviations
AC

Alternating Current

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

Service Manual

SONOACE 8000SE

Glossary

LED

Light Emitting Diode

LEP

List of Effective Pages

MUX

Multiplexer

NTSC

National Television Standards Committee

OEM

Original Equipment Manufacturer

PAL

Phased Alternating Line

PC

Personal Computer

PCB

Printed Circuit Board

PD

Phased Drive

PW

Pulsed-Wave

RF

Radio Frequency

RX

Receive, receiver

S-VHS

Super VHS, a VCR video format

TGC

Time Gain Compensation

TX

Transmit, transmitter

UIF

User Interface

VCR

Video Cassette Recorder

Service Manual

Chapter 13

13-2

SONOACE 8000SE

Glossary

Chapter 13

13-3

Terms
CAUTION:
Message containing caution information to protect the product.

Digital Imaging and Communication in Medicine Electromagnetic Interference (EMI):


A standard for network communication.
This system provides devices and network communication methods that comply with the
version 3.0 regulation standard for external signals and noise that may degrade the
performance of the electronic devices.

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.

National Television Standards Committee Non-Interlaced:


US broadcasting standard video signal (scanning at 525 line, 60Hz).

QWERTY Keyboard:
Keyboard with the top left keys laid out in the order of QWERTY. It is to the standard
computer keyboard type.

Phased Alternating Line:


It is the European video standard signal scanning: the 625 Line and 50Hz Composite Video
signal format.

WARNING:
Message containing caution information to protect the user and patient from possible risks
and dangers.

Service Manual

SONOACE 8000SE

www.medison.com

SONOACE 8000SE SERVICE MANUAL

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

Service Manual

SONOACE 8000SE