Professional Documents
Culture Documents
E-cube9 Sm Rev.1 고객지원팀 오효택 20111209
E-cube9 Sm Rev.1 고객지원팀 오효택 20111209
E-cube9 Sm Rev.1 고객지원팀 오효택 20111209
Rev. 1 (ENG)
Copyright and License
Prepared by:
ALPINION MEDICAL SYSTEMS Co., LTD.
7FL, Verdi Tower, 222-22
Guro-dong, Guro-gu, Seoul, 152-848
South Korea
Copyright © 2011 ALPINION MEDICAL SYSTEMS Co., LTD. All rights reserved.
70000359 Rev. 1
2
Revision log
The following is a list of major changes and additions that have been made to this manual
since it was first released.
See the accompanying Release Notes for specific changes to the software and hardware
between manual updates.
3
Table of Contents
PREFACE .................................................................................................................................................... 7
2-3 Unpacking....................................................................................................................................................................... 22
4
4-3 Main Functional Segments.......................................................................................................................................... 78
5
6-16 Probe (Transducer) ................................................................................................................................................ 2589
6
Preface
How to use this manual
This manual provides you with necessary information on installing and servicing the E-CUBE
9 ultrasound system.
l Chapter3, Checking Functions of Your System describes how to check major functions
of your system after the installation is finished.
l Chapter4, Components and Functions describes each component and function of your
system.
l Chapter7, Care and Maintenance provides how to care and maintain your system.
l Chapter8, Safety Information provides general safety precautions that must be observed
while operating and maintain the system.
7
Manual conventions
Before you start, be familiar with the following manual conventions that are commonly used
in this document:
Convention Meaning
Bold Qwerty keyboard keys, keys on the control panel, and
switches on the system
Buttons and dialog boxes on the user interface
windows
Italic Names of user interface windows
Document feedback
We have made every effort to ensure the accuracy and completeness of this document.
However, if you find an error or an omission, or you think that a topic needs further development,
we want to hear from you. Forward your feed back to:
www.alpinion.com
Provide the title and version number of this manual and as much detail as possible about your
comment, including the topic heading and page number and your suggestions for improvement.
8
Chapter 1. Preparing for Installation
This chapter describes necessary requirements to prepare for installing a new E-CUBE 9.
Before installing the system, you should consider all of the following requirements:
Ÿ Environmental Requirements
Ÿ Electrical Requirements
Ÿ EMI Limitations
Ÿ Facility Requirements
Ÿ Networking Requirements
9
1-1 Environmental Requirements
In an ultrasound room, check the following environmental requirements first to make the system
work properly.
Humidity 50 – 70%
10
1-1-3 Environmental requirements for transducer
Operation Storage
10 ~ 30 °C -10 ~ 60 °C
Temperature
50 ~ 104 °F 14 ~ 140 °F
NOTE:
Keep always your transducer in storage temperature. When the transducer is exposed to
large temperature differences, store the transducer in storage temperature for about 10
hours before using it.
11
1-2 Electrical Requirements
Ÿ Sites with a mains power system with defined neutral and live:
The dedicated line shall consist of one phase, a neutral (not shared with any other circuit), and a
full size ground wire from the distribution panel to the Ultrasound outlet.
NOTE:
Please note that image artifacts can occur, if at any time within the facility, the ground from the
main facility's incoming power source to the ultrasound unit is only a conduit.
To prevent the system from power outage or circuit overload, do not use the same
circuit with another machine.
12
1-2-3 Site power outlets
The AC power outlet should exist within reach of the system. Also, peripheral devices and all
other medical equipments should be placed within 1m (3.2 feet) of the system. Avoid using
extension cord to connect to the system.
Ÿ Power Transients (for all applications): Less than 25% of nominal peak voltage for
less than 1 millisecond for any type of transient, including line frequency, synchronous,
asynchronous, or aperiodic transients
13
1-3 EMI Limitations
The ultrasound system is sensitive to Electromagnetic Interference (EMI) from radio frequencies
(RF), magnetic fields, and transient in the air wiring. Before installing the system, consider
possible EMI sources from electrical and electronic machines nearby the ultrasound system. The
possible EMI sources are from: medical lasers, scanners, cauterizing guns, computers, monitors,
fans, gel warmers, microwave ovens, light dimmers, mobile phones.
The following descriptions are tips to prevent your system from unintentionally exposing EMI:
Ÿ Be aware of RF sources.
14
1-4 Facility Requirements
1-4-1 User requirements
A user (or a purchaser) needs to prepare required materials and pay additional costs (if
necessary) before an ultrasound system is delivered and installed.
NOTE:
The desire to use a non-listed or customer provided product or to place an approved product
further from the system than the interface kit allows presents challenges to the installation team.
To avoid delays during installation, such variances should be made known to the individuals or
group performing the installation at the earliest possible date (preferable prior to purchase).
15
1-5 Networking Requirements
1-5-1 Purpose of DICOM network function
The DICOM service provides clinically useful features for moving images and patient
information over a hospital network. The DICOM service includes the transfer of images
to workstations for viewing or transferring images to remote printers.
To configure the E-CUBE 9 to work with other network connections, the field’s network
administrator must provide some necessary information.
- A host name, local port number, AE title, IP address and subnet mask for the E-
CUBE 9
- The IP addresses for the default gateway and other routers at the site for routing
information
16
Figure 1-2 Storage
17
Figure 1-5 Worklist
18
Chapter 2. Installing Your System
This chapter introduces the basic install information and procedures when the new
equipment arrives at the site of a purchaser. Performing installation includes safety
considerations, unpacking and installing the system, and verifying hardware/software
specifications.
Ÿ Safety Information
Ÿ Unpacking
Ÿ Powering On/Off
Ÿ Specifications
19
2-1 Safety Information
The following note, cautions, and warnings describe safety information before or while
installing the system.
NOTE
Read the user manual carefully before operating the system. For quick reference, keep the
manual nearby the equipment.
Do not touch the equipment while testing the AC ground line with a test instrument.
The equipment weighs approximately 89.5kg (E-CUBE 9 PRO) and 83kg (E-
CUBE 9 STD) without any peripherals. To prevent injury from transporting and
unpacking the equipment, two people are required.
Adapt the equipment to room temperature first after transporting it. Turning on the
system may cause damage before adapting the equipment. The following table
shows the different adaptation time depending on the actual temperature of the
equipment after it is being transported. The maximum adaptation time is up to 24
hours.
hr 8 6 4 2 0 0 0 0 0 0 0 2 4 6 8 10 12 14 16 18 20
Connect the unit to a safely grounded power outlet to prevent any electrical shock.
Do not use a two to three prong adapter for safety grounding.
Make sure that all board covers and frame panels are securely in place before
operating the equipment. This may affect system performance and cooling.
Do not use a 20 Amp to 15 Amp adapter on the 120 Vac unit’s power cord. This unit
requires a dedicated 20A circuit and can have a 15A plug if the on board peripherals
do not cause the unit to draw more than 14.0 amps.
Although the ultrasound energy transmitted from your transducers is within FDA
limits, avoid unnecessary exposure. Ultrasound energy may produce heat and
mechanical damage.
21
2-3 Unpacking
When new equipment arrives, check all components are included in the package and they are
not damaged. If any component is damaged or excluded, contact your local agent.
1. Cut the plastic bands on the package by using your scissors or cutter.
22
3. Unscrew the plastic joints and remove them from the outer sleeve.
23
5. Remove the soft foam that covers up the monitor and option boxes.
7. Remove the plastic tapes on the palette and drop down the wooden board.
24
8. Release the front and rear caster locks, and then slide the equipment off the palette.
• Do not lift the equipment by holding the control panel or any cover.
The equipment may be damaged.
• While moving the equipment, be very carefully not to tilt the unit over.
To avoid injury from the tipping over, keep the monitor at the lowest position.
• Store all loose parts of the units in a separate place to prevent damage
before moving. For transducers, wrap them in soft cloth or foam.
25
2-4 Verifying the Customer Order
When you are finished with unpacking the equipment, you need to verify all items listed in the
delivery sheet. If any component is missing or damaged, contact your local agent.
2-4-1-1 Power on
Before powering the system on, make sure that the voltage setting is correct for the system.
Check the both voltage selectors for I/P and O/P on the rear of the system.
CAUTION:
Ÿ When connecting the AC power cable without its plug to the wall outlet, protective
earth should be taken.
Ÿ Make sure that the system power is supplied from a separate and properly rated
power outlet.
26
5. Press the System On/Off key on the control panel to turn on the system power.
The start-up screen is shown on the display and the system is initialized.
NOTE
To reboot the system, wait for a few seconds before powering on the system.
1. The start-up screen will be shown on the monitor when the system is powered on.
2. When the system boots, all keys on the control panel are lighted the default 2D mode screen
or patient screen is shown on the display.
27
2-4-1-3 Power off
1. Press the Power On/Off key on the control panel to turn the power off.
2. When the shutdown dialog box appears, select Shutdown by using Trackball.
NOTE: Depending on the power-off setting, you can activate Sleep mode or turn the
system off immediately. To change the power-off setting, press the System Preset key and
go to System > General > Power Off.
CAUTION: Do not unplug the power cord during the system operation. Do not turn off the
System On/Off switch before pressing the Power On/Off key. This may lead to data loss
or system software damage.
You can connect or disconnect the transducer to/from the transducer port regardless of
when the system is turned off or on. Make sure that you press the Freeze key on the
control panel before connecting or disconnecting the transducer.
28
To connect the transducer to the system, follow these steps:
CAUTION
Do not touch the patient when connecting or disconnecting a transducer.
NOTE: After connecting the transducer to the system, you need to activate the desired
transducer by selecting it from the screen.
29
You can disconnect the transducer from the transducer port when the system is powered off
or on. Make sure that you press the Freeze key on the control panel before disconnecting
the transducer.
30
2-5 Configuring the System Settings
Configure the system’s basic settings such as date, time, language, and basic user information.
2. From the General category, set the basic information such as the organization, hospital,
department, language, and date & time.
4. Click Exit.
31
2-6 Specifications
This section introduces specifications of the system and other peripheral devices.
1. Monitor
2. Professional arm
2-1. Standard arm
3. Rear handle
4. Body cover
5. Body base
6. Wheel and control pedal
32
2-6-1 Physical dimensions
2-6-1-1 E-CUBE 9 PRO
The following table shows the physical specifications of E-CUBE 9 PRO, with monitor and
peripherals.
33
2-6-1-2 E-CUBE 9 STD
The following table shows the physical specifications of E-CUBE 9 STD, with monitor and
peripherals.
34
2-6-2 Electrical specifications
Table 2-4 Electrical specifications
System Voltage Current Frequency
E-CUBE 9 110/220 VAC 5~7A 50~60 Hz
35
2-6-4 External I/O connector panel
I/O panel located on the rear side of the system includes video input and output connectors,
audio input and output, USB, power connector and control connections for VCR or DVD
recorder, and printer.
⑧ ② ④
① ⑥
⑤ ④ ⑤ ⑦
⑤
⑤ ⑤
⑨
⑤
No. Description
1 External USB Port : 4channel
2 Peripherals Remote Control Connector (printer shutter) : 2
channel (Left : B/W, Right : Color)
3 BNC Connector : Peripherals (Analog video) Y signal and
Composite signal (Left : B/W, Right : Color)
4 S-Video In/out Connector : (Top : Out, Bottom : In)
5 DVI out Connector
6 LAN Port
7 VGA out Connector
8 Audio In/out connector : (Top : Out, Bottom : In)
9 Outlet Power Connector 2 channel
Table 2-6 Signal description
36
2-6-5 External I/O pin outs
Table 2-7 Pin Assignments of USB
Pin Signal
1 VCC
2 Data-
3 Data+
4 GROUND
Composite (Color)
Pin Signal
1 COMPOSITE_OUT
2 GROUND
37
Table 2-9 Pin assignments of S-Video In/Out connector
S-Video
Pin Signal
A1 GROUND
A2 GROUND
A3 Y_OUT
A4 C_OUT
B1 GROUND
B2 GROUND
B3 Y_IN
B4 C_IN
38
VGA
Pin Signal
1 RED
2 GREEN
3 BLUE
4 NC
5 GROUND
6 GROUND
7 GROUND
8 GROUND
9 DDC_POWER
10 GROUND
11 NC
12 DDC_DAT
13 HSYNC
14 VSYNC
15 DDC_CLK
39
Table 2-11 Pin Assignments of DVI out Connector
DVI
Pin Signal Function
1 TMDS Data2-
2 TMDS Data2+
3 TMDS Data2/4 Shield GROUND
4 TMDS Data4- N/A
5 TMDS Data4+ N/A
6 DDC Clock [SCL]
7 DDC Data [SDA]
8 Analog vertical sync N/A
9 TMDS Data1-
10 TMDS Data1+
11 TMDS Data1/3 Shield GROUND
12 TMDS Data3- N/A
13 TMDS Data3+ N/A
14 +5 V Power
15 Ground (for +5 V) GROUND
16 Hot Plug Detect
17 TMDS Data0-
18 TMDS Data0+
19 TMDS Data0/5 Shield GROUND
20 TMDS Data5- NC
21 TMDS Data5+ NC
22 TMDS Clock Shield GROUND
23 TMDS Clock +
24 TMDS Clock -
C1 Analog Red N/A
C2 Analog Green N/A
C3 Analog Blue N/A
C4 Analog Horizontal Sync N/A
Analog GND Return: (analog R,
C5 N/A
G, B)
40
Table 2-12 Pin Assignments of LAN Port
LAN
41
Table 2-13 Pin assignments of Audio In/Out connector
AUDIO
Pin Signal
A1 GROUND
A2 LINE_IN_LEFT
A3 LINE_OUT_LEFT
B1 GROUND
B2 LINE_IN_RIGHT
B3 LINE_OUT_RIGHT
42
2-6-6 Connectivity installation worksheet
43
Figure 2-20 Commitment page
44
Figure 2-23 MPPS
45
Chapter3. Checking Functions of Your
System
This chapter introduces major functions of the system that you need to check after the
installation. By verifying the each part of the hardware and software functions, make sure
that your system works properly.
Ÿ Necessary Equipment
Ÿ Monitor Functions
Ÿ Mechanical Functions
Ÿ Board Functions
46
3-1 Necessary Equipment
Before the verification, check if the following equipments are available:
NOTE:
After turning off the system, wait for a while before turning it on again. If power is recycled too
fast, the system may not be able to boot up.
47
3-2-2 Control panel function checks
3 4 5
7
13
6
11 14
8 17
9
15
10 12 16
48
Table 3-1 Key description
No. Controls Description
Power on/off Use this control to turn on and off the system.
1
Use this control to select or adjust the functions in
the soft menu at the bottom of the display.
• Press to select the corresponding soft menu.
2 Soft keys
• Rotate to adjust the function of the
corresponding soft menu.
QWERTY keyboard Use this control to type numeric values and texts.
4
TGC slides Use these controls to adjust TGC values on images.
5
6 User (1~3) Use these controls to access user-defined functions.
Imaging mode Use these controls to activate 2D, PD, M, PW, CF, or
7 3D/4D modes.
Select Use this control to select the desired function from the
10 context menu on the screen.
Body Pattern Use this control to display the body pattern images.
Active mode Use this control to adjust parameters for each mode
in the duplex or triplex mode.
49
Harmonic Use this control to turn harmonic imaging on and off.
Image layout keys Use these controls to view an image in dual, single,
13 or quad screen.
50
3-2-3 Image display function checks
The image screen displays an image, application information, patient information, and
indicators.
1. Company logo
2. Hospital logo
3. Hospital name, current date, time
4. Patient ID, patient name
5. Operator ID, transducer name
6. Mechanical index, thermal index
7. Zoom reference window
8. Context menu (Submenu for mode control)
9. Depth scale bar
10. Focus mark
11. Image parameter
12. Gray scale bar
13. The location of transducer
14. Soft key menu (main menu for mode control)
15. Clipboard indicator
16. Clipboard area
17. Clipboard icons
(Recycle Bin, single layout format, dual layout format)
18. Caps lock, symbol lock, USB connection, network connection
19. Cine bar
51
3-2-4 Imaging modes checks
Verify function in each imaging mode of your system.
Focus You can tighten up the beam for a specific area by either
increasing the number of focal zones or moving the focal
zone(s). A graphic caret corresponding to the focal zone
position(s) appears on the right edge of the image.
Zoom Turn the Zoom key to activate Read Zoom and press the
Zoom key to activate Write Zoom. Use Read Zoom to get to
the area of Interest and then use Write Zoom to zoom in or
out.
Time Gain Compensation TGC amplifies returning signals to correct for the attenuation
(TGC) caused by tissues at increasing depths. TGC slide pots are
spaced proportionately to the depth. The area each pot
amplifies varies as well. A TGC curve may appear on the
display (if preset), matching the controls that you have set
(except during zoom). You can choose to deactivate the TGC
curve on the image.
Harmonic Harmonics enhances near field resolution for improved small
parts imaging as well as far field penetration by Digitally
Encoded Ultrasound (DEU). Harmonics reduces low frequency
high amplitude noise. Turning on this feature may be beneficial
when imaging isoechoic lesions in shallow-depth anatomy in
the breast, liver, and hard-to-visualize fetal anatomy.
Harmonics may improve 2D mode image quality without
introducing a contrast agent.
Frequency In multi frequency mode, you can change the frequency to the
transducer's next lower frequency or higher frequency.
Dynamic Range The ratio of the largest to smallest signals that an instrument
or a component of an instrument can respond to without
distortion.
In diagnostic ultrasound the dynamic range frequently is
expressed in decibel.
Dynamic Range is useful for optimizing tissue texture for
different anatomy. Dynamic Range should be adjusted so that
52
the highest amplitude edges appear as white while lowest
levels (such as blood) are just visible.
Rejection Elimination of low-amplitude signals from the display, also
known as noise rejection.
Up/Down Flips the image 180 degrees up/down.
Gray Map Press Gray Map to select a map. Gray maps gradually change
from least contrasty to most contrasty.
Edge Enhance Edge Enhance brings out subtle tissue differences and
boundaries by enhancing the gray scale differences
corresponding to the edges of structures. Adjustment to M
mode's edge enhancement affects M mode only.
Scan Area You can widen or narrow the size of the sector angle to
maximize the image's region of interest (ROI). Increase the
sector angle to see a wide field of view; decrease the sector
angle when you need to have a faster frame rate, as in fetal
heart.
Line Density Optimize 2D-mode frame rate or spatial resolution for the best
possible image. A lower line density is useful in fetal heart
beat, adult cardiac applications and in clinical Radiology
applications requiring significantly higher frame rates. A higher
line density is useful in obtaining very high resolution (e.g.
thyroid, testicles)
Dual and quad imaging Using dual imaging, you can position two images side-by side
on the display. Dual imaging is available in all 2D live imaging
Modes, M-mode, and Color Flow.
Sweep speed (M mode During M mode imaging, you can change the speed of the
only) sweeping display by turning Speed, a Soft Key display.
There are six sweep speeds: 0, 1, 2 , 3, 4, 5.
The sweep speed is displayed on the Soft menu window.
M-Mode Zoom (M mode When the system is in M mode, you can magnify a portion of
only) the reference image using M mode zoom function.
53
3-2-4-2 CF mode checks
Wall Filter It helps get rid of motion artifacts caused from breathing
and other patient motion by filtering out the low velocity
signals.
Color Map To select a specific color map, activate Color Flow first,
and then select Map from the Color Flow Top/Sub menu.
Invert (Color Invert) To reverse the color flow, press Invert (Color Invert).
54
3-2-4-3 PWD mode checks
1. On the control panel, press the Measure key on the control panel.
55
3-2-5-1 Distance
1. Press Distance on the Soft key menu. The start point is displayed.
3. To fix the point, press the Set key. The end point, overlapping the start point, appears.
4. Move the marker to the end point using Trackball, and then press the Set key.
3-2-5-2 Ellipse
1. Press Ellipse on the Soft key menu. The start point is displayed.
2. Move the marker to the start point using Trackball, and then press the Set key.
4. Move the marker to the second point using Trackball. The ellipse appears.
6. Move the marker to the second point using Trackball, and then press the Set key again.
56
3-2-5-3 Trace
1. Press Trace on the Soft key menu. The start point is displayed.
2. Move the marker to the start point using Trackball, and then press the Set key.
4. Move the end point gradually along the circumference of the target object using
Trackball.
6. The start point and the end point are connected with a line and they are automatically
close the trace.
3-2-5-4 Slope
1. Press Slope on the Soft key menu. The vertical line and the horizontal line are
displayed perpendicular to each other.
2. Use Trackball to move the point where they intersection point, and then press the Set
key.
4. Use Trackball to move the point, and then press the Set key again.
57
3-2-5-5 Time
1. Press Time on the Soft key menu. The vertical line and the horizontal line are displayed
perpendicular to each other.
2. Use Trackball to move the point where they intersection point, and then press the Set
key.
4. Use Trackball to move the point, and then press the Set key again.
3-2-5-6 Velocity
1. Press Velocity on the Soft key menu. The vertical line and the horizontal line are
displayed perpendicular to each other.
2. Use Trackball to move the point where they intersection point, and then press the Set
key.
To activate CINE,
1. Press Freeze.
2. Use Trackball to move through the Cinegate sequence frame-by-frame.
3. Select move first frame (Soft menu key) to take first frame.
4. Select move last frame (Soft menu key) to take last frame.
5. To exit the Cinegate, press the Freeze or 2D key on the control panel.
58
3-2-7 Transducer connectors function checks
5. Click Exit on the Transducer and Application Selection dialog box to save your
selections and exit the Transducer and Application Selection dialog box.
NOTE: If enabled “Exit window when transducer selected”, will exit the transducer
and application selection window when transducer selected.
NOTE: Before deactivating the transducer, press the Freeze key on the control panel.
An error may occur when you deactivate the transducer while running it.
59
3-2-8 DVR function checks
To select the DVR,
60
To record an image,
NOTE: Before recording, make sure that the DVD recorder power is on and the media is
played in the tray.
1. Insert a media into the recorder.
2. Press REC on the softkey menu.
To start recording again, press REC on the softkey menu on more time.
NOTE: You can use footswitch or the Print key on the control panel to record or pause.
For more detail configuration, go to System Preset > User Setting > Print / Foot switch.
Ÿ User Backup
Ÿ Image Backup
Ÿ Full Backup
Depending on the system, you can select a CD, DVD, or USB flash drive.
To perform the full backup, you can use an external USB type of hard disk drive. Depending
on the external USB memory, some types may not be supported.
61
3-2-9-1 User Backup
NOTE: A CD, DVD, and USB flash drive are available for user preset backup.
User preset allows you to back up the each preset data. To select all user-defined presets,
select the User Defined Configuration check box.
62
To back up the user preset data,
1. Select a media.
5. After the backup is completed, the last backup time and date appears next to the preset
category.
NOTE: Make sure that the software version of the data is the same as the system’s software
version. If NOT, you may not perform restoration.
63
3-2-9-2 Image Backup
NOTE: A CD, DVD, and USB hard disk are available for Image Archive.
CAUTION
Ÿ While restoring Image Archive data, some existing database may be overwritten on the
local hard disk and you may not be able to restore the old data. Make sure that you use
the appropriate media before the restoration proceeds.
Ÿ Before restoring Image Archive, make sure that the software version is the same or
compatible with. The system may not proceed restoring if the version is different.
Ÿ Do NOT turn the system off while backup is in progress. You may lose your image data.
Media
Ÿ Media: Select your media, CD or DVD.
Ÿ Media Capacity: Select the media capacity. The system calculates the number of
backup CDs before performing backup and informing you.
64
Backup, Export Setting
Ÿ Backup files older than in days: Specify the number of days to perform backup. When
you select Today, system back up all patient and image data.
Ÿ Image move after backup: Set to remove the backup image file after backup is
completed.
Ÿ Verification after the finalization (Backup): Verify all files after finalization when you
backup.
Ÿ Verification after the finalization (Export): Verify all files after finalization when you
export image data.
Ÿ Generate DICOM Dir file when export: Set the system generates a DICOM Dir file
when you export data.
NOTE: DICOM Dir is a DICOM file format which provides index and summary information
for all the DICOM files on media. If you want to save studies to CD or DVD and view them
on the PACS system, you should select this option.
4. The media formatting starts and the instructional message appears. You can view and
import backed up media via Patient Browser and Patient menu.
65
4-2-9-3 Full Backup
NOTE: Only the USB HDD is available for the full preset backup.
The full preset backup is only for service purpose. You can back up the system data such as
User preset, Image Archive, and Service configuration.
66
3-3 Monitor Functions
Verify the monitor functions by performing the following procedure.
2. From the Monitor category, check the resolution, gray bar, and color bar settings.
67
To configure on the monitor,
1. Press the Mode/Select button at the right side of the monitor once.
2. Adjust the contrast, brightness, or dim brightness value using the Up (∧) or Down (∨) button.
The value appears on the screen.
1. Up (∧) button
2. Mode/Select (◇)button
3. Down (∨) button
CAUTION: The LED lamp may overheat. Be careful not to directly touch it to avoid injury.
68
3-4 Mechanical Functions
3-4-1 Cover parts functions
The following list shows cover parts of the field-replaceable unit (FRU).
No Item
1 Body Cover Front
2 Body Cover Rear
3 Body Cover Right
4 Body Cover Left
5 Body Cover Top
6 Cable Holder
1. Check if the FRU parts are assembled tightly by naked eye and hands.
2. Check if there are dents, scratches or cracks on the FRU parts.
3. Check if all of the screws are in place.
69
3-4-3 Air filter function checks
Check if the air filter is installed securely.
.
Figure 3-9 Air filter function checks
70
TGC Knob (V1.0) TGC Knob (V2.0)
71
3-4-6 Transducer holder checks
Check if the transducer holder is not removed easily with your touch.
2. Check if the cover parts of the professional arm cannot be removed easily.
Folded
Default posture Tilt backward
Tilt forward
Panning
72
3-4-7 Standard arm function checks
2. Check if the cover parts of the standard arm cannot be removed easily.
Default posture
Left-side rotating Right-side rotating
73
3-5 Board Functions
WARNING: When Service Login for FRU Diagnostic, scan mode must be B-Mode. After
Diagnostic is completed the system should be rebooted. Diagnostic should be performed
with transducers.
5. When all items for the diagnostic test are successfully passed, shut down the system.
74
Chapter 4. Components and Functions
This chapter provides a system’s block diagram, main functional segments, and service
platform to describe main components and functions.
Ÿ General Information
Ÿ Block Diagram
Ÿ Service Platform
75
4-1 General Information
E-CUBE 9 is a medical ultrasound system that is used for the following modes:
- 2D mode
- M mode
- Color Flow(CF) mode
- Power Doppler mode
- Pulsed Wave(PW) Doppler mode with High PRF
- Static 3D and 4D mode
- Different combination of the above modes
The main functional segments of the E-CUBE 9 platform are listed and described as
follows:
76
4-2 Block Diagram
4-2-1 E-CUBE 9 functional block diagram
Figure4-1 describes a block diagram of E-CUBE 9. E-CUBE 9 consists of the main functional
segments as follows:
77
4-3 Main Functional Segments
4-3-1 Transducer Interface (TI) segment
The E-CUBE 9 Transducer Interface (TI) includes the following boards:
78
HV_MUX
M M
79
4-3-2 Front End (FE) segment
The E-CUBE 9 FE segment includes the following boards:
The Front End (FE) Segment utilizes the most advanced analog components and FPGA
technologies currently available. The following lists the main tasks performed by the FE
segment.
FE board
FE board performs the following functions:
FE board utilizes the most advanced analog components available. Figure 4-4 shows the
detailed block diagram.
Inputs are 64 transducer lines that have gone through aperture selection (HV MUX
control), performed in the TI board.
The signal in each channel is fed via a Limiter to a preamplifier (in VCA8500). The
Limiter limits the Pre-Amp input when high voltage transmits pulsed exist. The Pre-Amp
provides fixed gain for all transducers except for pencil transducers.
Thereafter, a Time Gain Compensation (TGC: in VCA8500) equalizes the signal strength
from the near-, mid-, and far-fields. The TGC low pass filters provide minimal gain
compensation to keep system noise within the dynamic range. (A low pass filter is an
anti-aliasing filter prior to signal sampling).
The CW Cross point is the first stage of the CW Doppler processor function. The rest of
the CW Doppler processor is located on the TI board.
80
T/R switch
Limiter:
- Limits pre-amp input level when high voltage transmits pulses exists.
- Standard 4 diode current limiting circuit
- Current per diode: 2.5mA
- Signal coupling: AC Coupling
-
Analog tuning
Inductor matching: Transducer Inductor Tuning
Additional Pre-Amplifier: N/A
Additional analog devices can be added for tuning.
Analog receiver
Analog receiver is composed of VCA8500 and limiter circuit. VCA8500 (TI) is an 8
channel gain variable amplifier.
VCA8500
Pre-Amplifier
- Input impedance: Input resistance 8k Ohm, Input Capacitance 30pF
- Input signal range: 250 mVpp
- LNA Gain: 20 dB
- Input referred noise: 0.8 nV/root Hz
TGC
- Gain range: 30dB
- Output signal range: 2Vpp
- Gain control signal: 47dB
Anti-aliasing LPF
- Filter spec: Two Pole Butterworth
- Cutoff frequency: 10MHz, 15MHz Selectable
DAC
DAC is used for controlling of a VCA8500
ADC
TI, TDS5277: 8 channel per 1chip
- Sample rate: Up to 65 MSPS
- Resolution: 10 bits
- Input range: 0 to 2.0V
- SNR: 61.7dB
- Interface: LVDS
81
Pulser
HV Bipolar pulser
- Pulse Type: Bipolar
- Pulse Voltage: 0 ~ ± 80 Vpp
- Transmit Apodization: disable
- Pulse Duration: variable
- Frequency: Up to 15MHz
- Damp/Clamp: enable
SCW Block
- Perform the analog beamforming receives an RF signal of the FE board
82
High Pass Filter
- High Pass Filtering in order to remove the Low Frequency Clutter
ADC Digitization
- ADC resolution : 16 bit
CWD FPGA
- Analog Gain Selection
83
4-3-4 Back End (BE) segment
The Back-End (BE) segment utilizes the most advanced DSPs and FPGAs technologies
currently available. The following lists the main tasks performed by the Back End Segment:
84
4-3-5 Back-End Processor (BEP)
Back End Processor (BEP) performs the following functions:
4-3-5-1 PC Interface
85
4-3-6 COM Express PC
COM Express PC performs the following functions:
- Real-time control of ultrasound imaging system hardware
- UI input interpretation and response
- Measurements and reports
- Control of OEM’s
- DICOM image storage, archival, retrieval and manipulation
- Keyboard and control panel interfaces
- External In/Out Interface for peripheral device
86
4-3-7 QWERTY keyboard and control panel
The control panel of the E-CUBE 9 consists of the QWERTY keyboard, Trackball, Encode 0,
soft keys, and USB Interface Module.
- Main board: QWERTY keyboard, Trackball, Encoder, Soft key and USB Interface
module
- Soft board: Encoder 1
87
The main board of the control panel includes the following boards:
Figure4-9 CP Assy
88
4-3-8 Monitor
The E-CUBE9 system has a 17 inch and 19 inch LCD monitor with DVI-HDMI interface. The
monitor also has a task lamp to light up the A/N key on CP assy.
Both monitor of E-CUBE 9 have completely same function and same hardware assembly.
AR coating is applied to the monitor filter.
HDMI POWER
HDMI POWER
Speaker R Speaker L
Speaker R Speaker L
89
Table 4-2 HDMI connector PIN MAP
PIN # PIN NAME IO BOARD Remarks
P1 DVI1_TX2+ DVI Video
P2 GND Shield
P3 DVI1_TX2- DVI Video
P4 DVI1_TX1+ DVI Video
P5 GND Shield
P6 DVI1_TX1- DVI Video
P7 DVI1_TX0+ DVI Video
P8 GND Shield
P9 DVI1 TX0- DVI Video
P10 DVI1 TXC+ DVI Video
P11 GND Shield
P12 DVI1 TXC- DVI Video
P13 RS232_RXD RS232_TXD
P14 RS232_TXD RS232_RXD
P15 DDC_CLK IO MONITOR DDC
Clock
P16 DDC_DATA IO MONITOR DDC
data
P17 Reserved NC
P18 D5V_DVI +5V
P19 DVI1_HTPLG Hot plug
90
4-3-9 I/O panel
E-CUBE 9 system has the I/O interface that is connected to the peripheral. The I/O panel is
included in connector for the peripheral. Y out and Composite out are analog video interface for
B/W printer and color printer. The printer shutter is an interface that controls the display and
print keys.
S-Video In/Out is an analog video interface that controls playback and recording of the DVD
recorder and analog color printer. Audio In/Out is an audio interface that controls audio
playback and audio recording of the DVD recorder. The I/O panel has four extended USB ports
for USB hub device. VGA and DVI signal is display interface for an external monitor.
91
Table 4-3 Input/Output signals for peripherals
Signal name Description Connection from/via/to
Ethernet Standard TCP/IP Syscon -> I/O penal ->
Ethernet LAN Connector
USB Port for Digital BW USB Port for Digital I/O panel (USB hub) ->
printer BW printer USB connector(A-type) -
> Digital BW printer
USB Port for Digital Color USB Port for Digital I/O panel (USB hub) ->
printer Color printer USB connector(A-type) -
> Digital Color printer
USB port for Foot Switch USB port for Foot Foot switch -> USB
Switch connector(A-type) ->
Syscon
USB port for Digital DVD USB port for Digital I/O panel (USB hub) ->
Recorder DVD Recorder USB connector(A-type) -
> Digital DVD recorder
printer
External VGA VGA signal output for Syscon -> I/O penal ->
external VGA monitor D-sub connector
External DVI DVI signal output for Syscon -> I/O penal ->
external DVI monitor DVI connector
S-video in for DVD S-video input signal for S-video connector -> I/O
Recorder and Analog Analog DVD Recorder penal -> Syscon
Color printer and Analog Color
printer
S-video in for DVD S-video output signal Syscon -> I/O penal ->
Recorder and Analog for Analog DVD S-video connector
Color printer Recorder and Analog
Color printer
Composite out for Analog Composite video signal Syscon -> I/O penal ->
Color printer output for Analog Color BNC
printer
Composite out for Analog Composite video signal Syscon -> I/O penal ->
BW printer output for Analog BW BNC
printer
Printer shutter(Analog Printer shutter of Syscon -> I/O penal ->
Color printer) Analog Color printer for Audio jack
printing screen of
system
Printer shutter(Analog BW Printer shutter of Syscon -> I/O penal ->
printer) Analog Color printer to Audio jack
printing screen of
system
Audio in for Analog DVD Audio input signal for RCA jack -> IO penal ->
recorder Analog DVD Recorder Syscon
Audio out for Analog DVD Audio output signal for Syscon -> I/O penal ->
recorder Analog DVD Recorder RCA jack
92
4-3-10 Power diagram
4-3-10-1 Overview
The AC power unit main task is supplying power to various internal subsystems (AC-
DC module, AC power fan, gel warmer, control panel, monitor, B/W printer, outlet). The
voltage to peripherals can be confederated to either 110 VAC or 220 VAC. To select
input voltage, move the control switches which are located on the rear of AC box to 110
VAC or 220 VAC.
4-3-10-2 AC power
93
Figure4-13-1 E-CUBE 9 AC Power signal(V2.0)
4-3-10-3 DC power
DC power is supplied by SMPS and source of all assys such as nest and nest fan. To turn on
the SMPS, the live power is needed as a standby power. This live power is generated from
SMPS when the SMPS receive the AC input from the AC power. When the live power is
supplied to the BE board and system momentary switch is pushed on, BE board switches
the PS_ON signal to low level to turn on the SMPS. After turning on the SMPS, AC power
assy changes the path itself to supply stable AC power.
94
Figure4-13-2 E-CUBE 9 DC Power signal(V1.0)
95
DC output capacity
SMPS supplies High-voltage power to activate high voltage transmit pulse and static supply
bias voltage on high voltage HVMUX. When BE Board makes the HV_STOP signal to low,
the SMPS generates the HV module in SMPS. The SMPS supplies +/-100V to the system
constantly and the VHVP and VHVN supplies 0~+/-80V individually.
BE Board controls the level of VHVP and VHVN through the IIC interface.
HV output capacity
96
4-3-10-4 AC power outlet for peripheral
The AC Power Outlet is for peripheral which interconnect external power with the E-CUBE 9
system. Both of the assemblies are the same except the circuit breaker’s current ratings
depending on voltage of the system power source.
The cable connection is separated by two groups, internal harness and external cable connection
for peripheral equipment.
97
SYSTEM CABLE HRARNESS TYPE
98
4-3-11-1 Peripherals and cable connection
A B/W printer, a color printer, and a DVD recorder may be pre-installed in the system at the
time of delivery. These devices are connected to the external I/O or control panel in the case
of B/W printer.
4) Digital BW printer
UP-D897, P95DW(E)
99
Ÿ Cable connection – color printer and DVD recorder (Rear)
3) DVD recorder
DVO-1000MD
100
Ÿ Cable connection – ECG Module Assy
The ECG module is will be interface between system through USB port. The power is uses
an internal power supply of the ECG module receives from USB port.
101
4-4 Service Platform
The Service platform contains a set of software modules for the diagnostic each modules.
4. The service login window for Service Platform appears on the display.
The service interface has different access and security account levels. Each account is only
permitted to access the tools that are authorized for their use. For an ALPINION field engineer,
changing the password may be required at regular intervals.
103
Figure 4-19 License management
4-4-5 Diagnostics
When you perform diagnostics for FRU, the default screen should be 2D mode.
NOTE: After finishing the diagnostic test, you must reboot the system.
4-4-5-1 Overall
104
Figure 4-21 Overall checklist
4-4-5-2 TI board
105
4-4-5-3 FE board
Ÿ DSP Memory: Check if the DSP memory normally loads the RTC table.
Ÿ BE FPGA Memory: Check whether a normally load the parameter of the signal
processing.
Ÿ FE Bus: Check if all devices of FE board work correctly.
Ÿ Network Interface Card: Check if the gateway and output NIC information are interacting.
Ÿ USB Drives: Check if the USB drives are accessible. Note that this test cannot detect
USB port problems.
106
4-4-5-5 Control panel
4-4-5-6 Monitor
107
4-4-5-7 Audio
4-4-6 Utility
2. Click I Accept.
108
3. Check the target drive and select Long Drive Self Test.
4. When the test is completed, the drive status (Pass or Failed) appears.
NOTE:
Ÿ Do not touch any button until the test is completed.
Ÿ Do not run the Advanced tests and System Tools.
109
4-4-6-2 Windows Services
Windows Services shows all service lists. You can view all services that are currently
activated and deactivated.
To refresh the list, click Update. To show details for the selected service, click Look into.
110
4-4-7 Log viewer
The log viewer consists three categories: with ECUBE Log, ECUBE Event Log, and Window
Event Log. You can view all scanner logs by using the log viewer. The service Interface supports
the transfer of these logs to local destinations such as CD/DVD and USB.
ECUBE Log consists six categories: Crash, Diagnostics, Control Panel, DICOM, Debug,
Overall. The log table has the following categories:
111
4-4-7-2 ECUBE Event Log
ECUBE Event Log shows the windows event logs generated by ECUBE software. The event
types are Error, Warning, and Report (information).
Window Event Log shows all event logs for Windows. The event types are Error, Warning,
and Report (information).
112
Chapter 5. Replacing Components
This chapter provides you with procedures about replacing the each hardware component,
installing and restoring the system software.
113
5-1 Disassembly and Reassembly
This section describes how to disassemble and reassemble for the replacing the component. Keep
in mind that the only qualified service personnel should perform this.
WARNING
Ÿ To avoid accidental contact, be familiar with all hazardous voltages and high current levels.
CAUTION
Turn off the system and unplug the power cord before disassembling the power supply unit. Do not
wear an ESD wrist strap during the disassembly a part of power supply. However, when you
disassemble a circuit board, always wear the strap to prevent electric shock after the system
power is off.
General preparations
Prepare the following requirements before performing disassembly and reassembly.
Ÿ Required tools
Ÿ Required manpower and time: Maximum of 2 persons and 2 hours for each component
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
NOTE: Depending on the component, the required tools, manpower, and time may be slightly
different.
114
5-1-1 AC Outlet Assy
Ÿ Required manpower and time: 1 person, approximately 15 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
Ÿ Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
115
5-1-2 AC Fan Assy
Ÿ Required manpower and time: 1 person, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
116
2. Remove 2 connectors from the Assy.
Ÿ Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
117
5-1-3 AC Fuse Assy
Ÿ Required manpower and time: 1 person, approximately 5 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
Ÿ Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
118
5-1-4 AC PSU Assy
Ÿ Required manpower and time: 2 persons, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Loosen 4 screws (Left 2 screws and Right 2 screws at the bottom of the equipment) to
remove the AC PSU Assy.
2. Slide down the AC PSU Assy and put it down on the floor carefully.
119
3. Loosen 2 screws to remove Cable Bracket(Ver2.0)
4. Remove all connectors except for 2 fan connectors inside of AC PSU Assy.
120
Figure 5-9-1 AC power harness connector configuration(Ver2.0)
Ÿ Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
121
Figure 5-11 Pull direction of Air Filter Cover
Ÿ Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
122
5-1-6 Control Panel (CP) Assy
Ÿ Required manpower and time: 1 person, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
123
2. Life up the top cover of the CP Assy.
124
3. Disconnect 2 cables from the CP Assy.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
125
5-1-7 AN Keyboard (QWERTY Keyboard) Assy
Ÿ Required manpower and time: 1 person, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Disconnect 2 cables.
126
3. Loosen 7 screws and remove the bracket.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
127
5-1-8 DGC Knob Set & DGC Key Assy
Ÿ Required manpower and time: 1 person, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
128
4. Loosen 4 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
129
5-1-9 Trackball Assy
Ÿ Required manpower and time: 1 person, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Loosen 4 screws.
130
4. Loosen 2 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
131
5-1-10 Single Knob Assy
Ÿ Required manpower and time: 1 person, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
132
5-1-11 Double Knob Assy
Ÿ Required manpower and time: 1 person, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
133
5-1-12 Main PCB Assy
Ÿ Required manpower and time: 1 person, approximately 40 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Remove the Single Knob Assy from the CP Assy. Refer to 5-1-10.
3. Remove the Double Knob Assy from the CP Assy. Refer to 5-1-11.
134
6. Loosen 38 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Remove the Single Knob Assy from the CP Assy. Refer to 5-1-10.
135
3. Remove 1 connector from the PCB.
4. Loosen 7 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
136
5-1-14 Left & Right body covers
Ÿ Required manpower and time: 1 person, approximately 10 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
137
5-1-15 Rear body cover
Ÿ Required manpower and time: 1 person, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right covers of the system body. Refer to 5-1-14 Left & Right
body covers.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
138
5-1-16 Front body cover
Ÿ Required manpower and time: 1 person, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right covers of the system body. Refer to 5-1-14 Left & Right
body covers.
2. Loosen 6 screws on the left and right side of the front cover.
139
4. Remove the front cover.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-14 Left & Right body covers.
140
4. Loosen 3 screws on the bottom rear of the top body cover.
5. Loosen 2 screws on the left and right side of the top body cover.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
141
5-1-18 CP Cover Assy
Ÿ Required manpower and time: 1 person, approximately 40 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Remove the DGC Knob Assy. Refer to 5-1-8 DGC Knob Set & DGC Key Assy.
3. Remove the Single Knob Assy. Refer to 5-1-10 Single Knob Assy.
4. Remove the Double Knob Assy. Refer to 5-1-11 Double Knob Assy.
7. Remove the Top PCB Assy. Refer to 5-1-13 Top PCB Assy.
8. Remove the Main PCB Assy. Refer to 5-1-12 Main PCB Assy.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
142
5-1-19 Cable Holder Assy
Ÿ Required manpower and time: 1 person, approximately 5 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
143
5-1-20 LC Arm Cover Set
Ÿ Required manpower and time: 1 person, approximately 10 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Loosen 1 screw, and push the knob and rotate it counter-clockwise to unlock the
standard arm.
144
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
145
3. Remove the bottom cover of the monitor.
146
5. Loosen 7 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
147
Figure 5-49-1 Unscrewing 6 screws
148
Figure 5-49-2 Open the Cover
149
4. Remove the OSD and LAMP cables
150
Figure 5-49-5 Open the Cover
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
151
2. Loosen 4 screws and remove the monitor arm cover.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
152
5-1-23 DC PSU Assy(V1.0)
Ÿ Required manpower and time: 1 person, approximately 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left body cover. Refer to 5-1-14 Left & Right body covers.
3. Loosen 9 screws.
153
Figure 5-55 Screws of DC PSU Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
4. Remove the left body cover. Refer to 5-1-14 Left & Right body covers.
154
Figure 5-55-1 Screws of DC Cable EMI Brkt
7. Loosen 9 screws.
155
Figure 5-55-3 Screws of DC PSU Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
156
Figure 5-56 Screws of EM cage cover
BE Board Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
157
5-1-25 FE Board Assy
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
FE Board Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
158
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
• Reassembly procedure
159
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Remove the FE Assy and BE Assy. Refer to 5-1-25 FE Board Assy and 5-1-24 BE
Board Assy.
3. Loosen 3 screws.
4. Loosen 4 screws.
160
Figure 5-62 Loosening 4 screws
6. Loosen 12 screws.
161
Figure 5-64 Loosening 12 screws
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
5-1-28 TI Assy
Ÿ Required manpower and time: 1 person, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
2. Loosen 3 screws.
162
Figure 5-65 Screws of the TI Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
164
5-1-30 MDC Board Assy
Ÿ Required manpower and time: 1 person, approximately 40 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
4. Loosen 4 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
165
5-1-31 TI Board Assy
Ÿ Required manpower and time: 1 person, approximately 40 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
4. Remove the DLP Board Assy. Refer to 5-1-29 DLP Board Assy.
5. Remove the MDC Board Assy. Refer to 5-1-30 MDC Board Assy.
6. Loosen 15 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
166
5-1-32 HDD Assy
Ÿ Required manpower and time: 1 person, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the air filter cover. Refer to 5-1-5 Air Filter Assy.
2. Loosen 4 screws.
3. Disconnect the SATA cable and SATA power cable from the backplane.
167
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
5-1-33 IO Assy
Ÿ Required manpower and time: 1 person, approximately 40 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-14 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-15 Rear body cover.
168
5. Loosen 4 screws and remove the HDD base bracket.
7. Loosen 4 screws.
169
Figure 5-75 Loosening 4 screws
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-14 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-15 Rear body cover.
170
3. Remove the HDD Assy. Refer to 5-1-32 HDD Assy.
4. Loosen 4 screws and remove the HDD base bracket. Refer to Figure 5-73 Screw of the
HDD base bracket.
6. Loosen 12 screws.
171
7. Loosen 2 screw nuts.
8. Loosen 1 screw and 2 screw nuts and remove the IO Assy bracket.
172
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-14 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-15 Rear body cover.
4. Loosen 4 screws and remove the HDD base bracket. Refer to Figure 5-73 Screw of the
HDD base bracket.
6. Remove the IO Sub Board Assy. Refer to 5-1-34 IO Sub Board Assy.
• Reassembly procedure
173
Change the new parts and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-14 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-15 Rear body cover.
3. Remove the front body cover. Refer to 5-1-16 Front body cover.
174
10. Loosen 8 screws on the left of the FEBE Assy. Refer to the Figure 5-81.
175
Figure 5-85 Removing the FEBE Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
176
5-1-37 Gel Warmer Assy
Ÿ Required manpower and time: 1 person, approximately 10 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
177
5-1-38 Monitor Assy(17 inch)
Ÿ Required manpower and time: 2 persons, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
178
3. Loosen 4 screws.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
179
5-1-38-1 Monitor Assy(19 inch)
Ÿ Required manpower and time: 2 persons, approximately 20 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
HDMI POWER
Speaker R
Speaker L
180
3. Loosen 4 screws.
181
Figure 5-91-5 Screwing 4 screws
Speaker R Speaker L
182
Figure 5-91-7 Screwing the EMI Brocket
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
3. Remove the Monitor Filter Assy. Refer to 5-1-43 Monitor Filter Assy.
5. Loosen 3 screws.
184
Figure 5-94 Removing the top cover
6. Loosen 7 screws.
185
Figure 5-96 Removing the LCD Open Frame Assy
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
2. Remove the Front monitor cover. Refer to 5-1-39 LCD Open Frame Assy.
186
Figure 5-97 Removing the LAMP Assy
4. Disconnect the lamp cable and loosen 2 screws of the lamp button module.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
187
1. Remove the Monitor Assy. Refer to 5-1-38 Monitor Assy.
2. Remove the front monitor cover. Refer to 5-1-39 LCD Open Frame Assy.
3. Loosen 2 screws.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
188
the bottom rear of the system.
Ÿ Disassembly procedure
2. Remove the front monitor cover. Refer to 5-1-39 LCD Open Frame Assy.
3. Disconnect the speaker cable on the left and right side of the speaker.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
189
5-1-43 Monitor Filter Assy
Ÿ Required manpower and time: 1 person, approximately 10 minutes
System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
CAUTION: Be careful not to damage the monitor when removing tapes on the edges of the
monitor filter.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
190
Figure 5-104 Loosening 4 screws
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
191
3. Loosen 4 screws and remove the monitor arm cover.
192
7. Loosen 2 screws.
193
Figure 5-112 Loosening 2 screws
CAUTION: Be careful not to drop down the arm during the disassembly.
194
Figure 5-114 Removing cables
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
Loosen 16 screws.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
195
5-1-47 Front & Rear Caster Assy
Ÿ Required manpower and time: 1 person, approximately 1 hour and 30 minutes
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
Loosen 16 screws.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
1. Loosen 4 screws.
196
Figure 5-117 Loosening 4 screws
2. Loosen 2 screws of the rear bracket cover and disconnect 2 cables (USB & DVD RW).
Ÿ Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Ÿ Disassembly procedure
197
Figure 5-119 Loosening 2 screws
4. Loosen 2 screws.
6. Loosen 4 screws.
198
Figure 5-122 Loosening 4 screws
Ÿ Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
199
Ÿ Disassembly procedure
1. Remove the right body cover. Refer to 5-1-14 Left & Right body covers.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
200
Screw
201
5-2 System Software Installation
5-2-1 Overview
This section describes the procedures how to install a new hard disk drive (Base system
software and Armstrong software) and update the software (application).
CAUTION:
Before starting the software loading, you must back up the patient image Data to the CD-R
or DVD.
[A] Load the base system software and DELETE ALL patient and application
data.
- This option recovers system software including operation system and ERASES
ALL the system completely.
[C] Exit
5-2-2 Requirements
Ÿ Base System Software DVD (OS)
Ÿ Blank DVDs, CD-Rs or USB (for patient image or preset data backup)
202
5-2-4 Preparations
Before installation, you need to set the connectivity options in the System Preset menu.
1. Press the System Preset key on the control panel and go to Connectivity > General.
- Computer Name, Device Name, Port No, IP Address, Subnet Mask, Default
Gateway, Network Speed
203
5-2-5 Installing the software
5-2-5-1 Installing the base system software
This section describes the procedures about the software installation such as Base
System and Armstrong.
WARNING:
This installation may result in user data loss including patient and Application Data loss.
Please back up patient and application data before performing the installation.
NOTE:
All digital peripherals, reporting systems connected via the USB ports should be either
power off or disconnected network and remove all transducers prior to the software
installation.
204
3. When the system asks for a password, enter “070427” and press the Enter key.
4. When the setup screen appears, use the Enter and arrow keys to set the
following options:
5. Insert the Base System Software Disk to the CD/DVD ROM drive.
205
6. From the Exit tab, select Save Changes > Exit and enter “OK.” The following
screen appears on the display.
7. After rebooting the system, the following screens appear as shown below.
206
Figure 5-130 Reboot screen
207
8. To start the installation, select one of the following options:
Ÿ [A] Load the base system software and DELETE ALL patient and
application data: Select this option to install a new HDD or format the
HDD. This option recovers the system software including operation
system and erases all the system completely.
Ÿ [B] Load the base system software only: Select this option to install
OS software only. This option recovers the system software including
operation system.
WARNING:
All patient and application data will be removed permanently.
NOTE:
Application software shall be installed after completion of this procedure.
208
9. After loading the base system software, the following screen appears.
10. Press any key to continue the installation. The following screen appears.
209
11. Press the C and Enter key. The following screen appears.
13. When a pop-up window appears, enter “Exit” and press the Enter key. Then,
close the opened windows by selecting X. The system automatically reboots.
210
5-2-5-2 Configuring the base system software
211
3. When the system asks for a password, enter “070427” and press the Enter key.
4. When the setup screen appears, use the Enter and arrow keys to set the
following options:
212
5. To exit the configuration, press the Help key. You can also select Save
Changes > Exit in the Exit menu.
6. After rebooting the system, the following screen appears and should be restart
again.
213
5-2-5-1 Installing the Armstrong software
214
4. Click Next.
215
7. Windows is shutting down and the system automatically reboots.
9. After completing the system reboot, the default 2D mode screen appears.
216
Figure 5-150 2D mode screen
217
5-3 Installing the Mechanical Options
This section describes the procedures about how to install the mechanical options.
Ÿ System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Ÿ Installation procedure
218
2. Install the B/W printer on the bracket and tighten 4 screws.
3. Loosen 2 screws and take out the B/W printer cables from DVD bracket on the rear
cover and assemble the DVD bracket.
219
4. Loosen 1 screw on the front side and tighten about 1 screw on the rear side.
220
5. Connect the printer cables.
221
5-3-1-2 Rear side installation
Ÿ System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Ÿ Installation procedure
222
3. Tighten 4 screws on the printer tray.
223
5. Install the cable cover and tighten 4 screws.
224
7. Connect the cables to the IO outlet.
225
5-3-2 DVD Recorder Fixture Installation
Ÿ System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Ÿ Installation procedure
226
3. Tighten 4 screws on the PERI DVD printer tray.
227
5. Put on the cable cover and tighten 4 screws on the left and right side.
228
7. Connect cables with IO outlet as below.
229
5-3-3 ECG Module Assy Installation
230
3. Insert ECG Module to ECG Holder and screwing 4 screws as below picture
4. Connect the USB Cable to the rear of the ECG Module as below picture
231
5. Connect the USB Cable of the ECG Module to the rear panel as below picture
Figure 5-176 Connecting the USB of the ECG Module to the Rear Panel
232
5-4 Finishing
1. After all peripherals have been installed, ensure that all cables are neatly and properly routed
to the system back and front panel. Use tie wraps, if necessary.
2. Properly store excess cable in the back panel cavity behind the door.
3. Fill out the proper customer information on the product locator card. Mail the installation card
“Product Locator” to the address corresponding to your region.
4. Properly dispose of any excess material in accordance with the system policy.
5. Once all peripherals have been installed, ensure that the operation of the system is verified
once again by performing the functional checks.
6. Ensure that each peripheral operates properly and then inform the customer of proper
peripheral operation.
7. Keep this documentation with this service manual for feature reference.
233
Chapter 6. Renewal Parts
This chapter provides you with renewal parts of E-CUBE 9.
• AC PSU • Cables
• Control Panel • IO
• Covers • Monitor
• DC PSU • TI
234
6-1 List of Renewal Parts
The following table shows a list of field replaceable units (FRU)
235
SVC00027 FRU-COMEXPRESS ASSY 1 1 O
237
6-2 AC Outlet
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
1 AC OUTLET ASSY SVC00001 1 Yes Yes
Table 6-2 AC outlet
238
6-3 AC PSU
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
2 AC FAN ASSY SVC00002 1 Yes
3 AC FUSE ASSY SVC00003 1 Yes
AC PSU ASSY SVC00004 1 Yes
4
AC PSU ASSY V2.0 SVC00082 1 Yes
Table 6-3 AC PSU
239
6-4 Air Filter
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
5 AIR FILTER ASSY SVC00005 1 Yes Yes
Table 6-4 Air filter
240
6-5 Control Panel
8
6
10
12
14
13
11
241
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
6 AN KEYBOARD ASSY SVC00006 1 Yes Yes
7 CP ASSY SVC00007 1 Yes Yes
8 DGC KEY ASSY SVC00009 1 Yes Yes
9 DGC KNOB ASSY SVC00010 1 Yes Yes
10 DOUBLE KNOB SET SVC00011 1 Yes Yes
11 MAIN PCB ASSY SVC00012 1 Yes Yes
12 SINGLE KNOB ASSY SVC00013 1 Yes Yes
13 TOP PCB ASSY SVC00014 1 Yes Yes
14 TRACKBALL ASSY SVC00015 1 Yes Yes
Table 6-5 Control panel
242
6-6 Covers
24 17 19 22
15
16
21 18 20
23
243
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
15 CP COVER ASSY SVC00008 1 Yes Yes
16 BODY FRONT COVER SVC00016 1 Yes Yes
17 BODY LEFT COVER SVC00017 1 Yes Yes
18 BODY REAR COVER SVC00018 1 Yes Yes
19 BODY RIGHT COVER SVC00019 1 Yes Yes
20 BODY TOP COVER SVC00020 1 Yes Yes
21 CABLE HOLDER ASSY SVC00021 1 Yes Yes
22 ARTICULATING ARM COVER SET SVC00031 1 Yes Yes
23 LC ARM COVER SET SVC00037 1 Yes Yes
MONITOR COVER SET SVC00051 1 Yes Yes
24
19 inch MONITOR COVER SET SVC00089 1 Yes
Table 6-6 Covers
244
6-7 DC PSU
25
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
DC PSU ASSY SVC00024 1 Yes
25
DC PSU ASSY V2.0 SVC00083 1 Yes
Table 6-7 DC PSU
245
6-8 FE/BE
29-1
30 29 26 27
28
246
Item Part name Part number Q’ty R1.0 R2.0
26 BE BOARD ASSY SVC00025 1 Yes Yes
27 BP BOARD ASSY SVC00026 1 Yes Yes
28 COMEXPRESS ASSY SVC00027 1 Yes Yes
29 FE BOARD ASSY SVC00028 1 Yes Yes
29-1 CWD BOARD ASSY SVC00094 1 Yes
30 FEBE ASSY SVC00029 1 Yes Yes
Table 6-8 FE/BE
6-9 Frame
37
31
32
32
34 33
36
247
35
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
31 ARTIDULATING ARM ASSY SVC00030 1 Yes Yes
32 BUMPER ASSY SVC00032 1 Yes Yes
33 CASTER FRONT ASSY SVC00033 1 Yes
4 CASTER REAR ASSY SVC00034 1 Yes Yes
35 DVD RW ASSY SVC00035 1 Yes Yes
36 LC ARM ASSY SVC00036 1 Yes Yes
37 PROBE CUP HOLDER SET SVC00038 1 Yes Yes
Table 6-9 Frame
248
6-10 Gel Warmer
38
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
38 GEL WARMER ASSY SVC00039 1 Yes Yes
Table 6-10 Gel warmer
249
6-11 Cables
39 42 40
41 42-1 42-2
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
39 AC TO DC CABLE ASSY SVC00040 1 Yes Yes
40 AC TO OUTLET CABLE ASSY SVC00041 1 Yes Yes
41 HDD CABLE ASSY SVC00042 1 Yes Yes
42 IO TO AC CABLE ASSY SVC00043 1 Yes Yes
42-1 AC TO DC CABLE ASSY V2.0 SVC00084 1 Yes
42-2 ECG TO IO CABLE ASSY SVC00085 1 Yes
Table 6-11 Cables
250
6-12 HDD
43
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
43 HDD ASSY SVC00044 1 Yes Yes
Table 6-12 HDD
251
6-13 IO 44
45 46
Figure 6-12 IO
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
44 IO ASSY SVC00045 1 Yes Yes
45 IO BOARD ASSY SVC00046 1 Yes Yes
46 IO SUB BOARD ASSY SVC00047 1 Yes Yes
Table 6-13 IO
252
6-14 Monitor
49
48
LCD OPEN FRAME Assy(17 inch) LCD OPEN FRAME Assy (19 inch)
51
253
52
47
50
254
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
LAMP ASSY SVC00048 1 Yes
47
19 inch LAMP ASSY SVC00086 1 Yes
LCD OPEN FRAME ASSY SVC00049 1 Yes
48
19 inch LCD OPEN FRAME ASSY SVC00087 1 Yes
MONITOR ASSY SVC00050 1 Yes
49
19 inch MONITOR ASSY SVC00088 1 Yes
50 MONITOR FILTER ASSY SVC00052 1 Yes
OSD BUTTON ASSY SVC00053 1 Yes
51
19 inch OSD BUTTON ASSY SVC00090 1 Yes
SPEAKER ASSY SVC00054 1 Yes
52
19 inch SPEAKER ASSY SVC00091 1 Yes
Table 6-14 Monitor
255
6-15 TI
53 56
55 54
Figure 6-14 TI
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
53 TI ASSY SVC00055 1 Yes Yes
54 DLP BOARD ASSY SVC00056 1 Yes Yes
55 MDC BOARD ASSY SVC00057 1 Yes Yes
56 TI BOARD ASSY SVC00058 1 Yes Yes
Table 6-15 TI
256
6-16 ECG Module Assy
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
58 SVC00092 ECG MODULE ASSY 1 Yes
Table 6-16 ECG Module
Item Part name Part number Q’ty Rev. 1.0 Rev. 2.0
59 SVC00095 ECG Cable(USA & KOR) 1 Yes
60 SVC00096 ECG Cable(EU) 1 Yes
Table 6-17 ECG Cable
257
6-18 Probe (Transducer)
1 2 3
4 5 6
7 8 9
258
Chapter 7. Care and Maintenance
This chapter introduces the followings:
259
7-1 System Care and Maintenance
It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic
operation on a daily basis. Each day, prior to using the system, perform each of the steps in
the daily checklist.
All exterior parts of the system, including the control panel, keyboard, and transducers,
should be cleaned and/or disinfected as necessary or between uses. Clean each component
to remove any surface particles. Disinfect components to kill vegetative organisms and
viruses.
The air filter on the ultrasound system must be cleaned regularly to maintain proper system
cooling. Remove and check the air filter weekly, and clean as needed.
CAUTION:
• The system does not contain any operator serviceable internal components. Ensure that
unauthorized personnel do not tamper with the unit.
• When defects or malfunctions occur, do not operate the system until the problems are
resolved. Contact your local service representative.
Ÿ Visually inspect all transducers. Do not use a transducer which has a cracked,
punctured, or discolored casing or frayed cable.
Ÿ Visually inspect all power codes. Do not turn on the power if a cord is frayed or split, or
shows signs of wear. If your system’s power cord is frayed or split, or shows signs of
wear, contact your ALPINION service representative for power cord replacement.
Ÿ Visually that the trackball and other controls on the control panel are clean and free
from gel or other contaminants.
Ÿ Visually inspect the ECG connector and cables. Do not use the ECG connector and
cables if they are damaged.
To avoid electrical shock, you must visually inspect a transducer prior to use. Do not
use a transducer that has a cracked, punctured, or discolored casing or a frayed
cable.
260
7-1-2 Monthly checklist
To inspect the system, examine the following on a monthly basis.
When the LED lamp needs to be replaced, contact the ALPINION service
representative.
To avoid electrical shock hazard, do not remove panels or covers from console.
This servicing must be performed by qualified service personnel. Failure to do so
could cause serious injury.
l Monitor
l Operator control panel
l Footswitch
- Turn off the system power. If possible, disconnect the power cord.
Do not spray any liquid directly into the unit when cleaning the system.
261
1. Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to
wipe the surface of the ultrasound system. Take particular care to clean the areas
near the trackball and the slide controls. Ensure these areas are free of gel and any
other visible residue.
Ensure that cleaning solution does not seep into the control panel, keyboard, or any
other openings.
3. After cleaning, reconnect the ultrasound system power code into the power outlet.
1. Use the tab to remove the liner from the transducer holder.
2. Clean the liner under running water, using a mild detergent and dry with a lint-free
cloth.
Do not drop or place foreign objects inside the trackball assembly. This may
affect the trackball’s operation and damage the system. Avoid other solvents
that may damage the mechanical parts of the trackball assembly.
3. Clean the trackball and the teflon ring with tissue and isopropyl alcohol.
4. Clean the inside of the trackball assembly with a cotton swab and isopropyl alcohol.
Use a soft, folded cloth and a glass cleaner solution. Apply the glass cleaner to the cloth.
Gently wipe the monitor face.
Do NOT use a glass cleaner that has a hydrocarbon base (such as Benzene, Methyl
262
Alcohol or Methyl Ethyl Ketone) on monitors with the filter (anti-glare shield). Prolonged
use of such cleaners will damage the filter (anti-glare shield). Hard rubbing will also
damage the filter.
When cleaning the monitor, make sure not to scratch the monitor.
Do not scrub, stretch, or bend the filter, or apply heat to the filter, as doing so
could damage the filter.
1. Power off and unplug the power code from the power outlet.
2. Grasp the air filter tray and pull it out of the system.
3. Remove the filter.
4. Rinse the air filter with running water and allow the filter to completely dry. To hasten
drying, you may gently shake the filter, or blot the filter with a clean, lint-free cloth.
5. Reinsert the filter into the filter tray.
6. Slide the air filter tray back into the ultrasound system.
7. Plug the power cord into the power outlet.
263
7-2 Transducer Care and Maintenance
It is the responsibility of the user to verify that the transducer is safe for diagnostic operation.
After each use, inspect the transducer's lens, cable, and casing. Look for any damage that
would allow liquid to enter the transducer. If any damage is found, do not use the transducer
until it has been inspected and repaired/replaced by ALPINION Service Representative.
264
product. Carefully follow the disinfectant manufacturer’s instructions. Do not
immerse for more than one hour.
Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient
by direct physical contact. Depending on the type of examination, this contact occurs with a
variety of tissues ranging from intact skin in a routine exam to recirculating blood in a
surgical procedure. The level of risk of infection varies greatly with the type of contact.
One of the most effective ways to prevent transmission between patients is with single use
or disposable devices. However, ultrasound transducers are complex and expensive devices
that must be reused between patients. It is very important, therefore, to minimize the risk of
disease transmission by using barriers and through proper processing between patients.
The following high-level disinfectant agents have been approved for use with all transducers:
Ÿ Cidex OPA
Ÿ Cidex Plus
Ÿ Gigasept FF
Ÿ Virkon
265
7-2-3 IPX8 immersion levels
To avoid damage to the transducer, observe the immersion levels indicated for
each transducer type. Transducers with the protection level IPX8 are indicated
by the presence of the “IPX8” symbol on the connector of the transducer.
Transducers meet Ingress Protection IPX8 of EN 60539 and IEC 60539 to the depth of the
immersion line shown in the illustration only for transducers with the “IPX8” symbol on the
connector of the transducer.
Connector
Strain relief
266
Chapter 8. Safety and Regulatory
Information
This chapter introduces the followings:
Ÿ Safety Summary
Ÿ Regulatory Information
Ÿ Acoustic Output
267
8-1 Safety Summary
You should make sure the following safety precautions during all phases of operation, service, and
repair of the E-CUBE 9 ultrasound system. If you fail to comply with these safety precautions or
specific warnings in this manual, you violate safety standards in terms of design, manufacture, and
intended use of this system. ALPINION MEDICAL SYSTEMS Co., LTD. does not have liability for
your failure to comply with these requirements.
268
8-2 Important Safety Warnings
Ÿ Installing the system yourself may cause damage to the system or electrical shock.
Ÿ To avoid damage to the system and avoid electrical shock, only qualified ALPINION
service engineer must install the system.
Ÿ Do not remove the covers of a system yourself to avoid damage to the system and
unexpected electrical shock. Only qualified ALPINION service engineer must repair or
replace components.
Ÿ Before cleaning up and disinfecting the system, always make sure you turn off the
system power and unplug the power cord from the power outlet.
Ÿ To avoid risk of electric shock, you must connect the system to the supply mains with the
protective earth.
Ÿ Do not allow water or liquids on or above the system. Dripping water or liquids into the
system may cause electrical shock and damage to the system.
Ÿ Always use peripherals and accessories approved by ALPINION. You must securely
connect peripherals and accessories to the system.
Ÿ Do not modify this system such as system components, or software. When you modify
the system, it may cause safety hazards. Only qualified ALPINION service engineer must
modify the system.
Ÿ Always use the system properly to avoid serious injury. Before using the system, you
must make sure the instructions and hazards involving ultrasound system. ALPINION
provides training assistance, if needed.
Ÿ You must follow safety precautions and avoid any situation that causes injury or damage.
Ÿ The system voltage may cause serious injury or damage to the system.
Ÿ When you observe that the system causes any malfunction, you must stop operating the
system and take proper action for patients. After that, contact ALPINION service engineer.
269
Ÿ You must make sure grounded integrity of the power outlet and system regularly.
Ÿ Always make sure that you do not use the system in an explosive atmosphere.
Ÿ For patient safety, you must locate the system to easily unplug the power cord from the
power outlet when a malfunction or an error occurs.
Ÿ Your ultrasound system is not intended for diagnosing and monitoring ECG. Do not use
the system for cardiac operation.
270
8-3 Patient Safety Information
Ÿ When you enter patient data, always make sure that you enter correct identification
with patient data.
Ÿ Do not use the system until you become familiar with the system operation.
Ÿ To avoid the transducer from overheating, you must freeze the system when not
imaging.
Ÿ Do not allow the system to transmit acoustic output when not using the transducer.
Otherwise, it could result in transducer overheating.
Ÿ When not using the system, you should freeze the image or turn off acoustic output.
Ÿ Do not use the system with defibrillator. The system does not include a defibrillation-
proof applied part for ECG.
Ÿ Do not allow the germicide to contact your patient. Contact to the patient’s skin or
mucous membrane may cause an inflammation.
271
8-4 Electrical Safety Information
Ÿ Do not clean or disinfect a system before turning off and unplug the system from
the power outlet. Otherwise, it could result in electrical shock and damage to the
system.
Ÿ Do not place water or liquids on the system. Dripping water or liquids into the
system may cause electrical shock and damage to the system.
Ÿ Do not remove the panels or covers of a system to prevent system damage and
electrical shock.
Ÿ The system voltage may cause serious injury or damage to the system. When you
observe that the system causes any malfunction, you must stop operating the
system and take proper action for patients. After that, contact ALPINION service
engineer.
Ÿ Do not modify the AC power connector plug of the system to prevent electrical
shock.
Ÿ You should use the ultrasound system after few hours when the system is in
humidity place.
Ÿ Using spray cleaners on the system drips cleaning fluid into the system. It
damages components in the system.
Ÿ Do not use aerosol spray cleaners on the monitor to prevent electrical shock and
damage to the system.
Ÿ While using the ECG function, keep ECG cables or patients away from any other
electrical conductor to prevent electrical shock.
272
8-5 Transducer Safety Information
Damaged transducers or improper use and manipulation of the transducer may result in
injury or increased risk of infection.
Never use excessive force when manipulating intracavity transducers. Become familiar with
all instructions and precautions provided with special purpose transducers.
The use of damaged transducers can result in injury or increased risk of infection. Inspect
transducer often for sharp, pointed, or rough surface damage that could cause injury or tear
protective barriers. Become familiar with all instructions and precautions provided with
special purpose transducers.
Ÿ Do not use damaged or defective transducer to prevent system damage and serious
patient injury.
Ÿ Make sure you do not bend or pull the transducer cable to prevent the damage to the
transducer.
Ÿ Use only approved coupling gels. Using unapproved gels may damage the
transducer and void the warranty.
Ÿ Do not drop the transducer. Always keep the transducer secure when you do not use
it.
Ÿ Do not allow the system to transmit acoustic output when not using the transducer.
Otherwise, it could result in transducer overheating.
Ÿ When not using the system, you should freeze the image or turn off acoustic output.
Ÿ To avoid serious patient injury, always inspect the transducer that you use has sharp
edges and rough surfaces.
Ÿ Proper cleaning and disinfecting the transducer prevent disease transmission. You
must follow infection control procedures.
273
Ÿ Make sure that you do not use an expired transducer sheath.
Ÿ Do not allow your eyes (or patient’s eyes) to contact the coupling gel. If there is gel
contact to the eyes, flush thoroughly with clean water.
274
8-6 System Symbols and Labels
The following are a list of system symbols and labels for a safety. There symbols and labels
are used on labels on the product and u in the documentation. They indicate that you must
refer to the manual for specific information to avoid personal injury or damage to the product.
On the system rating label for overseas, Patient applied part meets the
transducer label and ECG label isolation requirements for type BF
equipment
On the ECG port ECG triggered display
On the system rating label for overseas, This symbol indicates that when the
transducer label, and gel warmer label end-user wishes to discard this
product, it must be sent to separate
collection facilities for recovery and
recycling. By separating this product
from other household-type waste,
the volume of waste sent to
incinerators or land-fills will be
reduced and natural resources will
thus be conserved.
Please contact an authorized
representative of the manufacturer
for information concerning the
decommissioning of your
equipment.
On the system rating label for overseas, This system complies with
transducer label, and gel warmer label regulatory requirements of
European Directive 93/42/EEC
regarding medical device.
On the system front cover Consult instructions for use (or
consult operating instructions)
276
Safety Location Explanation
Symbols/Labels
Rear of the gel warmer
277
8-7 Peripherals and Accessories
8-7-1 Peripheral update for EC countries
The following is intended to provide the users in EC countries with updated information
concerning the connection of the E-CUBE 9 to image recording and other devices or
communication networks.
The E-CUBE 9 has been verified for overall safety, compatibility and
compliance with the following on-board image recording devices:
Ÿ Color Printer
Ÿ B/W Printer
Ÿ DVR
Ÿ DVD-RW
The E-CUBE 9 has also been verified for compatibility, and compliance for connection to a
local area network (LAN) via the rear panel Ethernet connection, provided the LAN
Connection may also be made to a CE Marked and IEC/EN 60950 compliant modem using
The E-CUBE 9 may also be used safely while connected to devices other than those
recommended above if the devices and their specifications, installation, and interconnection
278
with the system conform to the requirements of IEC/EN 60601-1-1.
Depending on the console type you purchase, the basic accessories provided with the console
may differ.
The following tables show optional supplies and accessories that have been verified to be
compatible with the system.
Console accessory
Tri-pedal footswitch
Transducer
SC1-6
C1-6
SP1-5
L3-12
E3-10
SVC1-6
VC1-6
L3-12H
L3-8
SP3-8
279
Disinfectant
Cidex OPA
Cidex Plus
Gigasept FF
Virkon
Biopsy kit
Software
Full SRI
Xpeed
Spatial compounding
DICOM
DICOM SR(OB)
Value 3D/4D
CV M&R Standard
CV M&R Professional
280
8-8 Regulatory Information
The E-CUBE 9 ultrasound system conforms to the following classifications, in accordance
with the IEC/EN 60601-1:6.8.1:
l EN 60601-1: 1990+A1:1993+A2:1995+A13:1995
(IEC 60601-1:1988+A1:1991+A2:1995)
l EN 60601-1-1 : 2001 (IEC 60601-1-1 : 2000)
l EN 60601-1-2:2001+A1:2006 (IEC 60601-1-2:2001+A1:2004)
l EN 60601-1-4:1996+A1:1999 (IEC 60601-1-4: 1996+A1:1999)
l EN60601-2-37:2001+A1:2005+A2:2005
(IEC 60601-2-37:2001+A1:2004+A2:2005)
l EN 55022:2006+A1:2007, Class B (CISPR 22:2005+A1:2005)
l EN 55011:2007+A2:2007, Group 1, Class B (CISPR 11:2003+A2:2006)
l EN 61000-4-2:1995+A2:2001(IEC61000-4-2:1995+A2:2000)
l EN 61000-4-3:2006 (IEC 61000-4-3:2006)
l EN 61000-4-4:2004 (IEC 61000-4-4:2004)
l EN 61000-4-5:2006 (IEC 61000-4-5:2005)
l EN 61000-4-6:2007 (IEC 61000-4-6:2003+A1:2004+A2:2006)
l EN 61000-4-8:1993+A1:2001(61000-4-8:1993+A1:2000)
l EN 61000-4-11:2004 (IEC 61000-4-11:2004)
l EN 61000-3-2:2006+A2:2009 (IEC 61000-3-2:2005+A2:2009)
l EN 61000-3-3:2008 (IEC 61000-3-3:2008)
l ISO 10993-1:2009
l NEMA/AIUM Acoustic Output Display Standard (NEMA US-3, 1998)
l EN 60601-1:2006 (IEC60601-1:2005)
l EN 60601-1-2:2007(IEC 60601-1-2:2007)
l EN 60601-2-37 :2008 (IEC 60601-2-37:2007)
l ISO13485:2003+AC:2009
l ISO14971:2007:AC2009
l ISO14155:2009
Authorized EU Representative
281
8-9 Electromagnetic Compatibility (EMC)
This equipment generates uses and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical and non-medical devices and radio
communications. To provide reasonable protection against such interference, this product
complies with emissions limits for a Group 1, Class Medical Devices Directive as stated in
EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular
installation.
If this equipment is found to cause interference (which may be determined by turning the
equipment on and off), the user (or qualified service personnel) should attempt to correct the
problem by one or more of the following measure(s):
l increase the separation between the equipment and the affected device
l power the equipment from a source different from that of the affected device
The manufacturer is not responsible for any interference caused by using other than
recommended interconnect cables or by unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the users’ authority to operate
the equipment.
Do not use devices which intentionally transmit RF Signals (cellular phones, transceivers, or
radio controlled products) in the vicinity of the equipment as it may cause performance
outside the published specifications. Keep the power to these type devices turned off when
near this equipment.
The medical staff in charge of this equipment is required to instruct technicians, patients, and
other people who maybe around this equipment to fully comply with the above requirement.
282
8-9-1 Recommended separation distances between portable and mobile RF
communications equipment and the E-CUBE 9
The E-CUBE 9 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the E-CUBE 9 can help Prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the E-CUBE 9 as recommended
below, according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Conducted RF
0.15 MHz to 80 MHz 3 Vrms 0.3 Vrms
IEC 61000-4-6
283
8-9-3 Immunity and compliance level for transducer
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 0.60 MHz, 19.08 MHz ~ 35.01 MHz and 44.89 MHz ~ 80.0 MHz the level
of
Immunity is 3 Vrms.
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 0.42 MHz, 24.71 MHz ~ 35.36 MHz and 43.57 MHz ~ 80.0 MHz the level of
Immunity is 3 Vrms.
284
▶ Transducer: SP1-5, 1 kHz, C mode
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the
system ambient background noise.
** Between 0.15 MHz ~ 0.50 MHz, 19.27 MHz ~ 36.43 MHz and 43.14 MHz ~ 80.0 MHz the
level of Immunity is 3 Vrms.
285
▶ Transducer: L3-12, 1 kHz, C mode
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 0.94 MHz and 47.66 MHz ~ 80.0 MHz the level of Immunity is 3 Vrms.
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 2.63 MHz, 49.10 MHz ~ 74.58 MHz and 76.08 MHz ~ 80.0 MHz the level
of Immunity is 3 Vrms.
286
▶ Transducer: SVC1-6, 1 kHz, C mode
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
287
▶ Transducer: C1-6, 1 kHz, C mode
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient
background noise.
** Between 0.15 MHz ~ 1.23 MHz, 17.10 MHz ~ 33.64 MHz and 46.25 MHz ~ 80.0 MHz the level of
Immunity is 3 Vrms.
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient
background noise.
** Between 0.15 MHz ~ 0.86 MHz, 29.56 MHz ~ 36.43 MHz and 44.01 MHz ~ 80.0 MHz the level of
Immunity is 3 Vrms.
288
▶ Transducer: E3-10, 1 kHz, C mode
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]
* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient
background noise.
** Between 0.15 MHz ~ 3.12 MHz and 47.18 MHz ~ 80.0 MHz the level of Immunity is 3 Vrms.
289
8-9-4 Guidance and manufacturer’s declaration –electromagnetic emissions
This system is suitable for use in the following environment. The user must assure that it is
used only in the electromagnetic environment as specified.
The E-CUBE 9 is intended for use in the electromagnetic environment specified below. The
customer or the user of the E-CUBE 9 should assure that it is used in such an environment.
Voltage fluctuations /
flicker emissions Complies
IEC 61000-3-3
290
8-9-5 Guidance and manufacturer’s declaration-electromagnetic immunity
The E-CUBE 9 is intended for use in the electromagnetic environment specified below.
The customer or the user of the E-CUBE 9 should assure that it is used in such an environment.
NOTE: Uт is the a.c. mains voltage prior to application of the test level.
291
8-9-6 Guidance and manufacturer’s declaration-electromagnetic immunity
3V/m
3V/m 80 MHz to 2.5
Radiated 80 MHz to 2.5 GHz
RF GHz
IEC
61000-4-3 80 MHz to 800 MHz
NOTE 1 ) At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the E-CUBE 9.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than [V1] V / m.
292
8-9-7 Diagnostic ultrasound indications for use format
System: E-CUBE 9
Transducer: SC1-6
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
293
System: E-CUBE 9
Transducer: C1-6
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
** Other: 3D, 4D
294
System: E-CUBE 9
Transducer: SVC1-6
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
** Other: 3D, 4D
295
System: E-CUBE 9
Transducer: L3-12
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
** Other: 3D, 4D
296
System: E-CUBE 9
Transducer: SP1-5
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
** Other: 3D, 4D
297
System: E-CUBE 9
Transducer: E3-10
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
298
System: E-CUBE 9
Transducer: VC1-6
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
299
System: E-CUBE 9
Transducer: L3-12H
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
300
System: E-CUBE 9
Transducer: L3-8
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
301
System: E-CUBE 9
Transducer: SP3-8
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
B M PWD CWD Color Power Harmonic Combined* Other**
Doppler Doppler Imaging (Specify) (Specify)
Ophthalmic
Fetal
Abdominal P P P P P P P P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P P P P
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)
N = new indication; P = previously cleared by FDA; E = added under this appendix
* Combined: B/C, B/D, B/C/D
** Other: 3D, 4D
AIUM/NEMA UD3 Standards for Real-time Display of Thermal and Mechanical Acoustic Output
302
Indices on Diagnostic Ultrasound equipment.
IEC 60601-2-37, Mechanical Electrical Equipment – Part2-37: Particular Requirements for the
Safety of Ultrasound Medical Diagnostic and Monitoring Equipment.
You should use the E-CUBE 9 ultrasound system at the lowest mechanical/thermal
index setting necessary to generate clinically acceptable images.
303
8-10-1 Acoustic output display (Mechanical/Thermal indices)
The E-CUBE 9 ultrasound system displays Mechanical index (MI) and Thermal index (TI) on
the upper right side of the screen as shown below.
One of the following TI values display on the screen based on the application and type of
tissue.
l Soft Tissue Thermal Index (TIS)
l Bone Thermal Index (TIB)
l Cranial Bone Thermal Index (TIC)
The TI and MI are displayed all the times. The MI and TI display start at a value of 0.4 and
increments in steps of 0.1 (values less than 0.4 are displayed as < 0.4).
Be sure to have read and understood control explanations for each mode used
before attempting to adjust the power control or any control that can affect Acoustic
Output.
To minimize exposure time and keep ultrasound levels low, operate your system by using the
ALARA (As Low As Reasonably Achievable) principle, increasing output only when needed to
obtain diagnostic image quality. It is recommended that all users receive ALARA training
program. The ALARA training program by ALPINION application specialists provides you with
basic ultrasound principles, possible biological effects, the derivation and meaning of the
indices, ALARA principles, and examples of specific applications of the ALARA principle.
304
8-10-3 Principle of ALARA
The principle of ALARA, which stands for As Low As Reasonably Achievable, is to keep the
radiation exposure at the minimum level necessary to obtain the diagnostic information. This
principle is widely practiced in medical x-ray protection where exposure at any level is potentially
harmful. Historically, ALARA was initiated as a cautious approach for dealing with uncertain
hazards but has since become the principle method for reducing the risk of injury from hazards
that do not have safe minimum threshold.
While no minimum thresholds for harmful bioeffects have been established with the use of
diagnostic ultrasound, the principle of ALARA can be readily implemented on equipment
incorporating an output display. As the operator adjusts the equipment to optimize the image
quality, the display interactively updates to indicate the effect on output.
Controls that have no noticeable impact on image quality should be set to minimize the output
while controls that improve the image quality and also increase acoustic output should be set no
higher than needed to achieve a diagnostic quality image.
305
8-10-4 Transducer / Mode combination summary
System : E-CUBE 9
N/A : Not Appliction
Mode of Operation
Transducer Color Combined Other
B M PWD CWD
Model Doppler (Specify) (Specify)
SC1-6 O O O N/A O O N/A
C1-6 O O O N/A O O N/A
SP1-5 O O O O O O N/A
SP3-8 O O O O O O N/A
L3-12 O O O N/A O O N/A
E3-10 O O O N/A O O N/A
SVC1-6 O O O N/A O O N/A
VC1-6 O O O N/A O O N/A
L3-12H O O O N/A O O N/A
L3-8 O O O N/A O O
306
SERVICE
Rev. 1(ENG)
307