MEDISON SONOACE 8000SE
Short Description
Descripción: ultrasound , MEDISON SONOACE 8000SE...
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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
Service Manual
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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SONOACE 8000SE
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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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SONOACE 8000SE
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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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SONOACE 8000SE
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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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SONOACE 8000SE
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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
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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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General Information
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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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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
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,
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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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 Patient’s ID and name are displayed here. The patient’s 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 perator’s 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
2-1
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
Chapter 2
2-2
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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Safety
Chapter 2
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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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2-5
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.
Service Manual
SONOACE 8000SE
Safety
Warning
Warning
Chapter 2
2-6
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.
Service Manual
SONOACE 8000SE
Safety
Caution
Chapter 2
2-7
■ 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.
Service Manual
SONOACE 8000SE
Safety
Chapter 2
2-8
EMC Test Reports Guidance and manufacturer’s declaration - electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment.
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.
95% dip in Uт) for 0.5cycle 40% Uт (60% dip in Uт ) for 5 cycle 70% Uт (30% dip in Uт) for 25 cycle
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