ECUBE-15 Rev.0_Manual Service EN
ECUBE-15 Rev.0_Manual Service EN
Rev. 0 (ENG)
Copyright and license
Reproduction, adaptation, or translation without prior written permission is prohibited,
except as allowed under the copyright laws.
The only warranties for ALPINION products and services are set forth in the express
warranty statements accompanying such products and services. Nothing herein should be
construed as constituting an additional warranty. ALPINION shall not be liable for technical
or editorial errors or omissions contained here in.
Prepared by:
ALPINION MEDICAL SYSTEMS Co., LTD.
1FL and 6FL, Verdi Tower,
72, Digital-ro (St) 26-gil (Rd),
Guro-gu, Seoul, Republic of Korea
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.
1
Table of Contents
PREFACE .................................................................................................................................................. 5
2
4-4 Service Platform .................................................................................................................... 95
3
CHAPTER 8. SAFETY AND REGULATORY INFORMATION ....................................................... 238
4
Preface
How to use this manual
This manual provides you with necessary information on installing and servicing the E-
CUBE 15 ultrasound system.
Chapter7, Care and Maintenance provides how to care and maintain your system.
5
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.
6
Chapter 1. Preparing for Installation
This chapter describes necessary requirements to prepare for installing a new E-
CUBE 15. Before installing the system, you should consider all of the following
requirements:
Environmental Requirements
Electrical Requirements
EMI Limitations
Facility Requirements
Networking Requirements
7
1-1 Environmental Requirements
In an ultrasound room, check the following environmental requirements first to make the
system work properly.
Item Values
Power
See Electrical Requirements.
source
Current
7.5A (100V-120V); 3.5A (200-240V)
rating
Radiation
Not required
shielding
Temperature 10 – 35 °C (50 – 95 °F)
Humidity 30 – 75%
Heat
2000 BTU/hr
dissipation
Floor About 680 – 800 kg/m2 without
landing accessories
Floor
Gradient within 10 degrees
condition
Cooling 2000 BTU/hr
8
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.
9
1-2 Electrical Requirements
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.
CAUTION:
To prevent the system from power outage or circuit overload, do not use the same circuit
with another machine.
10
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.
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
11
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:
Be aware of RF sources.
12
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).
13
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 15 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 15
- The IP addresses for the default gateway and other routers at the site for routing
information
14
Figure 1-2 Storage
15
Figure 1-5 Worklist
16
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.
Safety Information
Unpacking
Powering On/Off
Specifications
17
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.
WARNING
Do not touch the equipment while testing the AC ground line with a test instrument. The
equipment weighs approximately 105kg (E-CUBE 15 ) without any peripherals. To prevent
injury from transporting and unpacking the equipment, two people are required.
CAUTION
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
CAUTION
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.
CAUTION
Make sure that all board covers and frame panels are securely in place before operating
the equipment. This may affect system performance and cooling.
CAUTION
Do not wear an ESD wrist strap while working on live circuits.
CAUTION
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.
CAUTION
Although the ultrasound energy transmitted from your transducers is within FDA limits,
avoid unnecessary exposure. Ultrasound energy may produce heat and mechanical
damage.
18
2-2 Average Installation Time
The average installation time for an experienced service engineer is about 2 hours.
The following table shows the average installation time by an experienced service engineer.
Note that this is based on the original equipment and the time may take longer depending on
the optional equipment.
WARNING
Do not remove any covers or panels, to prevent shock. If it problems or malfunctions occur,
unplug the power cord from the outlet.
19
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.
20
3. Unscrew the plastic joints and remove them from the outer sleeve.
sleeve
Figure
ure 2-4 Removing sleeves
21
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.
22
8. Release the front and rear caster locks, and then slide the equipment off the palette.
CAUTION
• 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.
23
2-4 Verifying the Customer
C 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.
CAUTION:
When connecting the AC power cable
cabl without its plug to the wall outlet, protective earth
should be taken.
Make sure that the system power is supplied from a separate and properly rated power
outlet.
AC PSU ASSY
24
5. Press the System On/Off key on the control panel to turn on the system power.
The start-up
up screen is shown on the display and the system is initialized.
Figure
ure 2-8 Power on/off key
NOTE
To reboot the system, wait for a few seconds before powering on the system.
creen sequence
2-4-1-2 Power-up screen
up screen will be shown on the monitor when the system is powered on.
The start-up
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.
25
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.
26
2-4-1-4 Connecting/Disconnecting the transducer
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.
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.
27
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.
28
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.
29
2-6 Specifications
This section introduces specifications of the system and other peripheral devices.
1. Monitor Arm
2. Rear handle
3. Body cover
4. Body base
5. Caster lock
6. Caster
30
2-6-1 Physical dimensions
2-6-1-1 E-CUBE 15
Table 2-3
2 Physical dimensions
Fig
Figure 2-15 System dimensions
31
2-6-2 Electrical specifications
Table 2-4 Electrical specifications
System Voltage Current Frequency
E-CUBE 110/220 VAC 5~7A 50~60 Hz
15
32
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.
⑨⑧ ⑦ ⑤ ①
⑩ ④ ② ③
No. Description
1 External USB Port : 6channel
2 DVI out Connector
3 LAN Port
4 HDMI out Connector
5 Audio In/out Connector : (Top : Out, Bottom : In)
6 Outlet Power Connector 2 channel
7 S-Video in/out Connector : (Top : Out, Bottom : In)
8 BNC Connector(Composite)
9 BNC Connector(Y signal)
10 VGA out Connector
Table 2-6 Signal description
33
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
34
Table 2-9 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
Analog Horizontal
C4 N/A
Sync
Analog GND Return:
C5 N/A
(analog R, G, B)
35
Table 2-10 Pin Assignments of LAN Port
LAN
Pin Signal Function
1 TD+
2 TD-
3 CT0 N/A
4 CHS GROUND
5 CHS GROUND
6 CT1
7 RD+
8 RD-
36
Table 2-11 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
37
2-6-6 Connectivity installation worksheet
Necessary Equipment
Monitor Functions
Mechanical Functions
Board Functions
40
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.
41
3-2-2 Control panel function
unction checks
42
Table 3-1 Key description
No Controls Description
.
Power on/off Use this control to turn on and off the system.
1
Select Use this control to select the desired function from the
7
context menu on the screen.
Soft keys Use this control to select or adjust the functions in the s
oft
menu at the bottom of the display.
Press to select the corresponding soft menu.
8
Rotate to adjust the function of the corresponding so
ft
menu.
Body Pattern Use this control to display the body pattern images.
43
CW Use this control to activate Continuous Wave(CW)
Doppler mode. This control is optional.
Update Use this control to update a 2D image in real time based
on the specified time or freeze a 2D image.
44
3-2-3 Image display function
unction checks
The image screen displays an image,
mage, application information, patient information, and
indicators.
45
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 TGC amplifies returning signals to correct for the
Compensation (TGC) attenuation 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.
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 Using dual imaging, you can position two images side-by
imaging side on the display. Dual imaging is available in all 2D live
imaging Modes, M-mode, and Color Flow.
Sweep speed (M During M mode imaging, you can change the speed of the
mode 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 When the system is in M mode, you can magnify a portion
mode only) of the reference image using M mode zoom function.
47
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).
48
3-2-4-3 PWD mode checks
49
3-2-5 Basic measurements function checks
To begin the measurement, follow these steps:
1. On the control panel, press the Measure key on the control panel.
50
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.
51
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.
52
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.
53
3-2-7 Transducer connectors function checks
3-2-7-1 Activating the transducer
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.
54
3-2-8 DVR function checks
To select the DVR,
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.
55
3-2-9 Backup and restore function checks
The Back up/Restore preset allows you to back up and restore the user data. The following
submenus are available:
User Backup
Image Backup
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.
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.
56
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.
57
3-2-9-2 Image Backup
NOTE: A CD, DVD, and USB hard disk are available for Image Archive.
CAUTION
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.
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.
Do NOT turn the system off while backup is in progress. You may lose your image data.
Media
Media: Select your media, CD or DVD.
Media Capacity: Select the media capacity. The system calculates the number of backup
CDs before performing backup and informing you.
58
Backup, Export Setting
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.
Image move after backup: Set to remove the backup image file after backup is
completed.
Verification after the finalization (Backup): Verify all files after finalization when you
backup.
Verification after the finalization (Export): Verify all files after finalization when you
export image data.
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.
59
3-2-9-3 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.
60
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.
61
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.
62
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 3 Port Front Cover
1-1 4 Port Front Cover
2 Left Cover
3 Main Base Cover
4 Main Base Rear Cover
5 Rear Cover
6 Rear Top Cover
7 Right Cover
8 Top Cover
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.
.
Figure 3-9 Air filter function checks
63
3-4-3 Knob function checks
1. Check if the each button operates properly.
TGC Knob
Figure 3-10
3 Button and knob function checks
64
3-4-4 caster function checks
1. For the bi break caster, check all caster locks and caster swivel locks for proper
operation.
2. Check if the front caster locks operates properly.
3. Check if the rear caster operates properly.
4. Check if all screws are in place.
65
3-4-6 Monitor arm function
unction checks
1. Check if the Monitor arm operates properly (Up/down, rotation, and tilting).
2. Check if the cover parts of the Monitor arm cannot be removed easily.
Move up (Height
adjust)
Fold
ed Default
posture Tilt backward
Tilt
forwa Pannin
g
Figure 3-13 Monitor arm function checks
hecks
66
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.
67
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.
General Information
Block Diagram
Service Platform
- 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 15 platform are listed and described as
follows:
68
4-2 Block Diagram
4-2-1 E-CUBE 15 functional block diagram
Figure4-1 describes a block diagram of E-CUBE 15. E-CUBE 15 consists of the main
functional segments as follows:
69
4-3 Main Functional Segments
4-3-1 Transducer Interface (TI) segment
The E-CUBE 15 Transducer Interface (TI) includes the following boards:
70
HV_MUX
0 0
M M
63 63
64
M
128
129
M
192
HV MUX
Figure4-3 E-CUBE 15 HV MUX control
71
4-3-2 Front End (FE) segment
The E-CUBE 15 FE segment includes the following boards:
FE_BUS
Pulser control FE_BUS
64
FE
64 PLS_OUT[63:0] Pulser
Pulser Controller
Pulser BF0_OUT
TIFE_DL[63:0] FETI BF 0
connector (Beam Former) LVDS/MGT
32
CSA FE_BUS
PDA
VGA (8EA) RSTA
LIM_IN CLK
DIN
Limiter & LPF 64
Limiter & LPF LIM_OUT LNA Attneuatio PGA LPF BF 1 BF1_IN
(64EA)& LPF
Limiter FEBE
(64EA) n
64 ((Beam Former))
(64EA) ADC (8EA) AD_BF[31:0]
LVDS/MGT connector
CW
Switch
AD_BF[63:32]
32
TGC control
I2C
From BE
IDPROM
TGC control
10
signals
control
Power
Bus
The Front End (FE) Segment utilizes the most advanced analog components and
Digital technologies currently available. The following lists the main tasks performed
by the FE segment.
72
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. 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 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.
73
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 Variable Gain Amplifier and limiter circuit.
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
ADC
- Sample rate : Up to 40MSPS
- Resolution : 12 bits
- Input range : 2.03 Vpp
- SNR : 70.5 dB
- Interface : LVDS
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
74
4-3-3 Continuous Wave Doppler (CWD) segment
The E-CUBE 15 CWD Board Functional Description the following :
75
SCW Power Block
- Support the SCW mode power to pulse of the FE board
- Out put Power Range : +/- 6.5 voltage ~ 0 voltage
SCW Block
- Perform the analog beamforming receives an RF signal of the FE board
ADC Digitization
- ADC resolution : 16 bit
CWD FPGA
- Analog Gain Selection
76
4-3-4 Back End (BE) segment
The Back-End (BE) segment utilizes the most advanced DSPs and digital technologies
currently available. The following lists the main tasks performed by the Back End
Segment:
77
4-3-5 Back-End Processor (BEP)
Back End Processor (BEP) performs the following functions:
4-3-5-1 PC Interface
78
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
MUX
MUX
De-
79
4-3-7
7 QWERTY keyboard and control panel and Touch Module
Figure4-5 shows the detailed block diagram of the control panel & Touch Module:
The main board of the control panel includes the following boards:
80
Figure4-9 CP Assy
TM Power Connector
PIN Pin
# name
1 +12V
2 Null
3 GND
81
4-3-8 Monitor
The E-CUBE15 system has a 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 15 have completely same function and same hardware assembly.
HDMI POWER
Speaker R Speaker L
82
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
83
4-3-9 I/O panel
E-CUBE 15 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.
84
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 USB Port for I/O panel (USB hub)
BW printer Digital BW printer -> USB
connector(A-type) -
> Digital BW printer
USB Port for Digital USB Port for I/O panel (USB hub)
Color printer Digital Color -> USB
printer connector(A-type) -
> Digital Color
printer
USB port for Foot USB port for Foot Foot switch -> USB
Switch Switch connector(A-type) -
> Syscon
USB port for Digital USB port for I/O panel (USB hub)
DVD Recorder Digital DVD -> USB
Recorder connector(A-type) -
> Digital DVD
recorder printer
External VGA VGA signal output Syscon -> I/O penal
for external VGA -> D-sub connector
monitor
External DVI DVI signal output Syscon -> I/O penal
for external DVI -> DVI connector
monitor
S-video in for DVD S-video input S-video connector -
Recorder and Analog signal for Analog > I/O penal ->
Color printer DVD Recorder Syscon
and Analog Color
printer
S-video in for DVD S-video output Syscon -> I/O penal
Recorder and Analog signal for Analog -> S-video
Color printer DVD Recorder connector
and Analog Color
printer
Composite out for Composite video Syscon -> I/O penal
Analog Color printer signal output for -> BNC
Analog Color
printer
Composite out for Composite video Syscon -> I/O penal
Analog BW printer signal output for -> BNC
Analog BW printer
Printer Printer shutter of Syscon -> I/O penal
shutter(Analog Color Analog Color -> Audio jack
printer) printer for printing
screen of system
85
Printer Printer shutter of Syscon -> I/O penal
shutter(Analog BW Analog Color -> Audio jack
printer) printer to printing
screen of system
Audio in for Analog Audio input signal RCA jack -> IO
DVD recorder for Analog DVD penal -> Syscon
Recorder
Audio out for Analog Audio output Syscon -> I/O penal
DVD recorder signal for Analog -> RCA jack
DVD Recorder
86
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.
87
4-3-10-2 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.
88
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
89
4-3-10-3 AC power outlet for peripheral
The AC Power Outlet is for peripheral which interconnect external power with the E-CUBE
15 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.
90
SYSTEM CABLE HRARNESS TYPE
91
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.
1) Digital BW printer
UP-D897, P95DW(E)
92
Cable connection – color printer and DVD recorder
5) DVD recorder
DVO-1000MD
93
4-3-12 ECG Module
The ECG(Electrocardiogram) is used measures that the heart’s action or determination of
cardiac lesions.
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.
94
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.
95
4-4-2 Access & Security
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.
96
4-4-4 License management
License Management shows the status of licenses for optional features.
If you add a key for another system, it does not work even if the option related to the key is
not invalid.
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.
97
4-4-5-1 Overall
4-4-5-2 TI board
98
4-4-5-3 FE board
DSP Memory: Check if the DSP memory normally loads the RTC table.
BE FPGA Memory: Check whether a normally load the parameter of the signal processing.
FE Bus: Check if all devices of FE board work correctly.
Network Interface Card: Check if the gateway and output NIC information are interacting.
USB Drives: Check if the USB drives are accessible. Note that this test cannot detect USB
port problems.
99
4-4-5-5 Control panel
Figure 4-27
4 Control panel test page
4-4-5-6 Monitor
Figure 4-28
4 Monitor test page
100
4-4-5-7 Audio
4-4-6 Utility
4-4-6-1 Disk surface scan
2. Click I Accept.
101
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:
Do not touch any button until the test is completed.
Do not run the Advanced tests and System Tools.
102
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.
103
4-4-7-1 ECUBE Log
ECUBE Log consists six categories: Crash, Diagnostics, Control Panel, DICOM, Debug,
Overall. The log table has the following categories:
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).
104
Chapter 5. Replacing Components
This chapter provides you with procedures about replacing the each hardware
component, installing and restoring the system software.
105
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
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.
Required tools
Required manpower and time: Maximum of 2 persons and 2 hours for each component
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.
106
5-1-1 AC Outlet Assy
Required manpower and time: 1 person, approximately 15 minutes
System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Disassembly procedure
Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
107
5-1-2 AC Fuse Assy
time 1 person, approximately 5 minutes
Required manpower and time:
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
Figure
ure 5-3 Fuse on the AC Outlet Assy
Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
108
5-1-3 AC PSU Assy
time 2 persons, approximately 20 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Loosen 2 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.
109
3. Remove all connectors inside of AC PSU Assy.
ssy
Figure 5-6 Push direction of AC PSU Assy
Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
110
5-1-4 Air Filter Assy
time 1 person, approximately 5 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
Figure 5-8
5 Pull Direction of Air Filter Assy
Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
111
5-1-5 Control Panel (CP) Assy
A
time 1 person, approximately 20 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
112
2. Life up the top cover of the CP Assy.
Assy
Figure
ure 5-10
5 Lifting up the top cover
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
113
5-1-6 Touch Module Assy
time: 1 person, approximately 30 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove 4 Screws.
Figure 5-12
5 Touch module screws
Figure 5-13
5 Removing the Touch module.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
114
5-1-7 AN Keyboard Assy
time: 1 person, approximately 30 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
Fig
Figure 5-14 Screws of the latch
Figure 5-15
5 Keyboard Assy’s slide rail
115
4. Loosen 7 screws and remove
re Keyboard ASSY Top Cover.
Figure 5-16
5 Screws and bracket of AN Keyboard
oard Assy
116
6. Remove 2 connector
Figure 5-18
5 Disconnecting the AN Keyboard cables
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
117
5-1-8 DGC Knob Set & DGC Key Assy
time: 1 person, approximately 30 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
DGC Knob
Figure 5-19
5 Removing the DGC knobs
6. Remove 1 connector
onnector from the PCB.
PCB
Fig
Figure 5-20 DGC key connector
118
7. Loosen 4 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
119
5-1-9 Trackball Assy
time: 1 person, approximately 30 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Loosen 4 screws.
Figure 5-23
5 Screws for Trackball bracket
4. Loosen 2 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
120
5-1-10 Single Knob Assy
time 1 person, approximately 10
Required manpower and time: 0 minutes
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
Figure 5-25
5 Single knobs in CP Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
121
5-1-11 Double Knob Assy
time 1 person, approximately 10
Required manpower and time: 0 minutes
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
122
5-1-12 CP Main PCB Assy
Required manpower and time: 1 person, approximately 40 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
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.
123
6. Loosen 38 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
124
5-1-13 Left & Right body covers
c
time 1 person, approximately 5 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
125
5-1-14 Rear body cover
time 1 person, approximately 20
Required manpower and time: 0 minutes
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
126
5-1-15 Front body cover
time 1 person, approximately 20
Required manpower and time: 0 minutes
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Loosen 6 screws on the left and right side of the front cover.
Figure 5-31
5 Screws on the front cover
127
3. Remove the front cover.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
128
5-1-16 Top body cover
Required manpower and time: 1 person, approximately 20 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
129
5-1-17 Top Rear cover
time 1 person, approximately 25 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove TOP covers of the system body. Refer to 5-1-16 TOP body covers.
covers
130
5-1-18 Bottom Rear Cover Assy
time 1 person, approximately 5 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Loosen 2 screws on the Bottom rear cover and remove the Top Rear Cover.
131
5-1-19 Bottom Cover Assy
time 1 person, approximately 30 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove the rear body cover Assy. Refer to 5-1-14 rear body cover Assy.
Assy
Figure 5-37
5 Screws of Bottom body cover
132
5-1-20 Cable Holder Assy
Required manpower and time: 1 person, approximately 5 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
133
5-1-21 Monitor cover set(19 inch)
Required manpower and time: 1 person, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
134
Figure 5-39-2 Open the Cover
135
Figure 5-39-3 Remove the cables
136
5. Open the cover
137
5-1-22 Arm cover set
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.
Disassembly procedure
138
4. Loosen 4 screws and remove the base arm cover.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
139
5-1-23 DC PSU Assy
time 1 person, approximately 20
Required manpower and time: 0 minutes
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the left body cover. Refer to 5-1-13 Left & Right body covers.
covers
140
4. Loosen 7 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
141
5-1-24 FEBE Fan Assy
Required manpower and time: 2 person, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.
Disassembly procedure
Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
142
5-1-25 BE Board Assy
time 1 person, approximately 15 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
143
3. Loosen 12 screws and remove
r the EM Cage Cover
BE Board Assy
Figure 5-52
5 BE board in FEBE Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
144
5-1-26 BE Board Battery
Required manpower and time: 1 person, approximately 20 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the right body cover. Refer to 5-1-13 Left & Right body covers.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
145
5-1-27 FE Board Assy
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the right body cover. Refer to 5-1-13 Left & Right body covers.
FE Board Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
146
5-1-28 COM Express Board Assy
time 1 person, approximately 20 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
8. Remove the BE
E Board Assy. Refer to Figure 5-52.
147
10. Loosen 6 screws on the rear of the BE board.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
148
5-1-29 CWD Board Assy
time 1 person, approximately 15 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the right body cover. Refer to 5-1-13 Left & Right body covers.
covers
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
149
5-1-30 BP Board Assy
Required manpower and time: 1 person, approximately 1 hour
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove the FE Assy and BE Assy. Refer to 5-1-53 FE Board Assy and 5-1-52 BE
Board Assy.
3. Loosen 3 screws.
150
4. Loosen 4 screws.
151
6. Loosen 12 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
152
5-1-31 TI Assy
time 1 person, approximately 15 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Loosen 2 screws.
153
3. Remove the TI Assy.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
154
5-1-32 DLP Board Assy
Required manpower and time: 1 person, approximately 25 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the right body cover. Refer to 5-1-13 Left & Right body covers.
3. Loosen 18 screws.
155
5. Loosen 6 screws.
Figure 5-65
5 Screws of the DLP Board Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
156
5-1-33 TI Board Assy
time 1 person, approximately 30 minutes
Required manpower and time:
System preparation:: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove
e the TI Assy. Refer to 5-1-29 TI Assy.
5. Loosen 15 screws.
Fig
Figure 5-66 Screws of the TI Board Assy
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
157
5-1-34 HDD Assy
Required manpower and time: 1 person, approximately 20 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the left & Right Body Cover. Refer to 5-1-13 left & Right Body Cover
2. Remove the Rear Body Cover. Refer to 5-1-14 Rear Body Cover
3. Loosen 4 screws.
4. Disconnect the SATA cable and SATA power cable from the backplane.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
158
5-1-35 IO Assy
Required manpower and time: 1 person, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-13 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-14 Rear body cover.
159
5. Loosen 4 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
160
5-1-36 IO Sub Board Assy
Required manpower and time: 1 person, approximately 45 hour
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-13 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-14 Rear body cover.
4. Loosen 4 screws and remove the HDD base bracket. Refer to Figure 5-69 Screw of
the HDD base bracket.
6. Loosen 15 screws.
161
7. Loosen 1 screw and 2 screw nuts and remove the IO Assy bracket
racket.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
162
5-1-37 IO Board Assy
Required manpower and time: 1 person, approximately 1 hour
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
1. Remove the left and right body covers. Refer to 5-1-13 Left & Right body covers.
2. Remove the rear body cover. Refer to 5-1-14 Rear body cover.
4. Loosen 4 screws and remove the HDD base bracket. Refer to Figure 5-69 Screw of
the HDD base bracket.
6. Remove the IO Sub Board Assy. Refer to 5-1-34 IO Sub Board Assy.
7. Loosen 6 screws.
• Reassembly procedure
Change the new parts and reassemble them in reverse order of disassembly.
163
5-1-38 Gel Warmer Assy
Required manpower and time: 1 person, approximately 5 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
164
5-1-39 Monitor Assy
Required manpower and time: 2 persons, approximately 20 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
HDMI POWER
Speaker R
Speaker L
165
3. Loosen 4 screws.
166
5. Assembly the 19 inch Monitor Assy.
HDMI POWER
Speaker R Speaker L
167
7. Assembling the EMI Brocket and Cable Clamp
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
168
5-1-40 LCD Open Frame Assy
Required manpower and time: 2 persons, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Loosen 6 screws.
169
4. Loosen 8 screws and remove the Monitor front Cover.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
170
5-1-41 Lamp Assy
Required manpower and time: 2 person, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove the Rear monitor cover. Refer to 5-1-38 LCD Open Frame Assy.
171
4. Loosen 1 screws of the lamp button module.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
172
5-1-42 OSD Button Assy
Required manpower and time: 1 person, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove the Rear monitor cover. Refer to 5-1-38 LCD Open Frame Assy.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
173
5-1-43 Speaker Assy
Required manpower and time: 1 person, approximately 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
2. Remove the Rear monitor cover. Refer to 5-1-38 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.
174
5-1-44 Monitor Arm Assy
Required manpower and time: 1 person, approximately 1 hour and 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
175
5. Loosen 2 screws and remove the mid joint cover.
7. Loosen 2 screws.
176
8. Remove the cables.
177
10. Loosen 4 screws.
CAUTION: Be careful not to drop down the arm during the disassembly.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
178
5-1-45 Front & Rear Caster Assy
Required manpower and time: 2 person, 30 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
Loosen 16 screws.
• Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
179
5-1-46 DVD RW Assy
Required manpower and time: 1 person, approximately 20 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
4. Loosen 4 screws.
Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
180
5-1-47 ECG Board Assy
Required manpower and time: 1 person, approximately 20 minutes
System preparation: When the system power is off, turn off the System On/Off switch
on the bottom rear of the system.
Disassembly procedure
Reassembly procedure
Change the new part and reassemble them in reverse order of disassembly.
181
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
Base System Software DVD (OS)
Blank DVDs, CD-Rs or USB (for patient image or preset data backup)
182
5-2-4 Preparations
5-2-4-1 Configuring the connectivity options
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
183
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.
184
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:
185
5. Insert the Base System Software Disk to the CD/DVD ROM drive.
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.
186
Figure 5-106 Reboot screen
187
8. To start the installation, select one of the following options:
[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.
[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.
188
9. After loading the base system software, the following screen appears.
10. Press any key to continue the installation. The following screen appears.
189
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.
190
5-2-5-2 Configuring the base system software
191
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:
192
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.
193
5-2-5-1 Installing the Armstrong software
196
9. After completing the system reboot, the default 2D mode screen appears.
197
5-3 Installing the Mechanical Options
This section describes the procedures about how to install the mechanical options.
System preparation: When the system power is off, turn off the System On/Off
switch on the bottom rear of the system.
Installation procedure
199
Figure 5-130 Assembling B/W printer Bottom BRKT / Tightening screws
200
7. Install the cable cover and tighten 2 screws.
201
5-3-2 Color printer fixture installation
5-3-2-1 Front side installation
System preparation: When the system power is off, turn off the System On/Off
switch on the bottom rear of the system.
Installation procedure
202
10. Insert the screw’s stud
203
12. Assemble BRKT and tighten 2 screw.
204
14. Install the cable cover and tighten 2 screws.
205
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.
206
Chapter 6. Renewal Parts
This chapter provides you with renewal parts of E-CUBE 15.
• AC Outlet • Cables
• AC PSU • HDD
• Control Panel • IO
• Covers • Monitor
• DC PSU • TI
207
6-1 List of Renewal Parts
The following table shows a list of field replaceable units (FRU)
20002182 BATTERY_CR2450 1 1 O
208
SVC00030 FRU-ARTICULATING ARM ASSY 1 1 O
FRU-ARTICULATING ARM O
SVC00031 1 1
COVER SET
20002208 DVD RW ASSY for E-CUBE 15 1 1 O
209
6-2 AC Outlet
Part Rev.
Item Part name Q’ty
number 1.0
1 AC Outlet for E-CUBE 15 20001807 1 Yes
Table 6-2 AC outlet
210
6-3 AC PSU 2
Part Rev.
Item Part name Q’ty
number 1.0
AIR FILTER ASSY for E-
2 20002009 1 Yes
CUBE 15
AC PSU ASSY for E-CUBE
3 SVC00098 1 Yes
15
Table 6-3 AC PSU
211
6-4 Control Panel
9
Part Rev.
Item Part name Q’ty
number 1.0
4 CP ASSY for E-CUBE 15 20001864 1 Yes
Trackball ASSY for E-
5 SVC00100 1 Yes
CUBE 15
6 FRU-DGC KEY ASSY SVC00009 1 Yes
TGC Knob ASSY for E-
7 20001666 1 Yes
CUBE 15
CP Cover ASSY for E-
8 SVC00117 1 Yes
CUBE 15
9 TOUCH SCREEN ASSY 20001859 1 Yes
Table 6-5 Control panel
212
6-5 Covers
17 15 18
16
14 18
17 12
11
213
Part Rev.
Item Part name Q’ty
number 1.0
Body Bottom Cover
10 20001645 1 Yes
ASSY for E-CUBE 15
Body Bottom Rear Cover
11 20001646 1 Yes
ASSY for E-CUBE15
Body Rear Top Cover
12 20001644 1 Yes
ASSY for E-CUBE 15
Body 3Port Front Cover
13 20001868 1 Yes
ASSY for E-CUBE15
Body Left Cover ASSY
14 20001640 1 Yes
for E-CUBE 15
Body Rear Cover ASSY
15 20001869 1 Yes
for E-CUBE 15
Body Right Cover ASSY
16 20001641 1 Yes
for E-CUBE 15
Body Top Cover ASSY
17 20001643 1 Yes
for E-CUBE 15
FRU-ARTICULATING
18 SVC00031 1 Yes
ARM COVER SET
214
6-6 DC PSU
19
DC PSU ASSY
Part Rev.
Item Part name Q’ty
number 1.0
DC PSU ASSY for E-
E
19 SVC00099 1 Yes
CUBE 15
Table 6-7 DC PSU
215
6-7 FE/BE
23
21
24
25
20
22
26
216
Part
Item Part name Q’ty R1.0
number
COMEXPRESS Board
20 SVC00116 1 Yes
ASSY for E-CUBE 15
BE Board ASSY for E-
21 SVC00102 1 Yes
CUBE 15
BP Board ASSY for E-
22 SVC00103 1 Yes
CUBE 15
CW Board ASSY for E-
23 SVC00104 1 Yes
CUBE 15
FE Board ASSY for E-
24 SVC00115 1 Yes
CUBE 15
Fan ASSY for E-CUBE
25 SVC00116 1 Yes
15
26 BATTERY_CR2450 20002182 1 Yes
217
6-8 Frame
30
27
29
31
31
28 32
218
Part Rev.
Item Part name Q’ty
number 1.0
ARTIDULATING ARM
27 SVC00030 1 Yes
ASSY
DVD RW ASSY for E-
28 20002208 1 Yes
CUBE 15
29 AN KEYBOARD ASSY SVC00006 1 Yes
AN Keyboard Module for
30 SVC00101 1 Yes
E-CUBE 15
FRU-CASTER REAR
31 SVC00034 1 Yes
ASSY
ECG Module Assy for E-
32 20002027 1 Yes
CUBE 15
219
6-9 Gel Warmer
33
Part Rev.
Item Part name Q’ty
number 1.0
33 GEL WARMER ASSY SVC00039 1 Yes
220
6-10 Cables
34 35 36
37 38 39
Part Rev.
Item Part name Q’ty
number 1.0
IO to AC Cable ASSY for
34 20000293 1 Yes
E-CUBE 15
AC to Outlet Cable
35 20000299 1 Yes
ASSY for E-CUBE 15
BE to DVD-RW Cable
36 20001994 1 Yes
ASSY for E-CUBE 15
BE to HDD Cable ASSY
37 20001995 1 Yes
for E-CUBE 15
AC to DC Cable ASSY
38 20001707 1 Yes
for E-CUBE 15
ECG to IO Cable ASSY
39 20001996 1 Yes
for E-CUBE 15
Table 6-11 Cables
221
6-11 HDD
40
Part Rev.
Item Part name Q’ty
number 1.0
HDD ASSY for E-CUBE
40 20001708 1 Yes
15
Table 6-12 HDD
222
6-12 IO
41
Part Rev.
Item Part name Q’ty
number 1.0
IO Board ASSY for E-
41 SVC00124 1 Yes
CUBE 15
Table 6-13 IO
223
6-13 Monitor
42
Monitor Assy
43 45
LCD OPEN FRAME Assy (19 inch) SPEAKER Assy (19 inch)
46
44
224
Part Rev.
Item Part name Q’ty
number 1.0
42 19 inch MONITOR ASSY SVC00088 1 Yes
19 inch LCD OPEN
43 SVC00087 1 Yes
FRAME ASSY
19 inch OSD BUTTON
44 SVC00090 1 Yes
ASSY
45 19 inch SPEAKER ASSY SVC00091 1 Yes
46 19 inch LAMP ASSY SVC00086 1 Yes
Table 6-14 Monitor
225
6-14 TI
48 Figure 6-14 TI 49
Part Rev.
Item Part name Q’ty
number 1.0
3 Port DLP Board ASSY
47 SVC00118 1 Yes
for E-CUBE
CUBE 15
4 Port DLP Board ASSY
48 SVC00119 1 Yes
for E-CUBE
CUBE 15
TI Board ASSY for E-
E
49 SVC00120 1 Yes
CUBE 15
Table 6-15 TI
226
6-15 ECG Cable
Part Rev.
Item Part name Q’ty
number 1.0
50 ECG Cable(USA & KOR) SVC00095 1 Yes
51 ECG Cable(EU) SVC00096 1 Yes
Table 6-16 ECG Cable
227
6-16 Probe (Transducer)
1 2 3
4 5 6
Part Rev.
Item Part name Q’ty
number 1.0
1 SC1-4H PROBE 10000627 1 Yes
2 SC1-6H PROBE 10000570 1 Yes
3 SP1-5X PROBE 10000628 1 Yes
4 E3-10H PROBE 10000630 1 Yes
5 L8-17X PROBE 10000629 1 Yes
6 L3-12H PROBE 10000275 1 Yes
228
Chapter 7. Care and Maintenance
This chapter introduces the followings:
229
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.
Perform the following each day before using the ultrasound system:
Visually inspect all transducers. Do not use a transducer which has a cracked,
punctured, or discolored casing or frayed cable.
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.
Visually that the trackball and other controls on the control panel are clean and free
from gel or other contaminants.
Visually inspect the ECG connector and cables. Do not use the ECG connector and
cables if they are damaged.
WARNING
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.
230
7-1-2 Monthly checklist
NOTE
To maintain the safety and functionality of the ultrasound system, maintenance must be
performed every 12 months. Electrical safety tests must also be performed at regular
intervals as specified by local safety regulations. Refer to the service manual for the
electrical leakage test.
WARNING
When the LED lamp needs to be replaced, contact the ALPINION service representative.
CAUTION:
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.
231
7-1-3 Weekly maintenance
The system requires weekly care and maintenance to function safely and properly. Clean
the following:
Monitor
Operator control panel
Footswitch
- Turn off the system power. If possible, disconnect the power cord.
CAUTION
Do not spray any liquid directly into the unit when cleaning the system.
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.
232
7-1-4-2 Cleaning the liners of the transducer holders
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.
CAUTION
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
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.
CAUTION
When cleaning the monitor, make sure not to scratch the monitor.
233
7-1-4-5 Removing and cleaning the air filter
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
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.
234
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.
WARNING
CAUTION
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:
Cidex OPA
Cidex Plus
236
7-2-3 IPX8 immersion levels
CAUTION
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
237
Chapter 8. Safety and Regulatory
Information
This chapter introduces the followings:
Safety Summary
Regulatory Information
238
8-1 Safety Summary
You should make sure the following safety precautions during all phases of operation, service,
and repair of the E‐CUBE 15 ultrasound system. If you fail to comply with these safety
precautions or specific warnings in this manual, you violate safety standards in terms of desig
n,
manufacture, and intended use of this system. ALPINION MEDICAL SYSTEMS Co., LTD. do
es not have liability for your failure to comply with these requirements.
WARNING
A WARNING notice indicates a hazard. You need to observe an operating procedure,
practice, or the like that. If you do not correctly perform this notice, it could result in personal
injury or death.
CAUTION
A CAUTION notice indicates a hazard. You need to observe an operating procedure,
practice, or the like that. If you do not correctly perform this notice, it could result in damage
to the system or loss of important data.
The Service Manual supplies block diagrams, lists of spare parts, descriptions, adjustment
instructions or similar information which help adequately qualified technical personnel in
repairing those parts of the instrument which have been defined repairable by the
manufacturer.
239
8-2 Important Safety Warnings
WARNING
Installing the system yourself may cause damage to the system or electrical shock.
To avoid damage to the system and avoid electrical shock, only qualified ALPINION
service engineer must install the system.
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.
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.
To avoid risk of electric shock, you must connect the system to the supply mains with
the protective earth.
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.
Always use peripherals and accessories approved by ALPINION. You must securely
connect peripherals and accessories to the system.
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.
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.
You must follow safety precautions and avoid any situation that causes injury or
damage.
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.
240
You must make sure grounded integrity of the power outlet and system regularly.
Always make sure that you do not use the system in an explosive atmosphere.
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.
Your ultrasound system is not intended for diagnosing and monitoring ECG. Do not
use the system for cardiac operation.
241
8-3 Patient Safety Information
WARNING
When you enter patient data, always make sure that you enter correct identification
with patient data.
Do not use the system until you become familiar with the system operation.
To avoid the transducer from overheating, you must freeze the system when not
imaging.
CAUTION
Do not allow the system to transmit acoustic output when not using the transducer.
Otherwise, it could result in transducer overheating.
When not using the system, you should freeze the image or turn off acoustic output.
Do not use the system with defibrillator. The system does not include a defibrillation-proof
applied part for ECG.
Do not allow the germicide to contact your patient. Contact to the patient’s skin or mucous
membrane may cause an inflammation.
242
8-4 Electrical Safety Information
WARNING
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.
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.
Do not remove the panels or covers of a system to prevent system damage and
electrical shock.
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.
Do not modify the AC power connector plug of the system to prevent electrical
shock.
You should use the ultrasound system after few hours when the system is in
humidity place.
Using spray cleaners on the system drips cleaning fluid into the system. It
damages components in the system.
Do not use aerosol spray cleaners on the monitor to prevent electrical shock
and damage to the system.
While using the ECG function, keep ECG cables or patients away from any
other electrical conductor to prevent electrical shock.
243
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.
WARNING
Do not use damaged or defective transducer to prevent system damage and serious
patient injury.
Make sure you do not bend or pull the transducer cable to prevent the damage to the
transducer.
Use only approved coupling gels. Using unapproved gels may damage the transducer
and void the warranty.
CAUTION
Do not drop the transducer. Always keep the transducer secure when you do not
use it.
Do not allow the system to transmit acoustic output when not using the transducer.
Otherwise, it could result in transducer overheating.
When not using the system, you should freeze the image or turn off acoustic output.
To avoid serious patient injury, always inspect the transducer that you use has
sharp edges and rough surfaces.
Proper cleaning and disinfecting the transducer prevent disease transmission. You
must follow infection control procedures.
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.
244
8-5-1 Transducer surface temperature limits
245
8-6 System Symbols and Labels
The following is a list of system symbols and labels for safety. They indicate that you must refer
to the manual for specific information to avoid personal injury or damage to the product.
Safety
symbols/ Location Explanation
Labels
On the power button of the control
System on/off/stand-by
on/off/stand
panel
On the system rating label for Patient applied part meets the
overseas, transducer label and isolation requirements for type
ECG label BF equipment
246
Safety Location Explanation
Symbols/Label
s
On the rating label for overseas: Alternating current in
Adjacent to the AC power and accordance with IEC60878-
IEC60878
the AC power outlet 01-14
247
Safety Location Explanation
Symbols/Labels
248
Safety Location Explanation
Symbols/Labels
Name of transducer
manufacturer, Authorized EU
249
8-7 Regulatory Information
The E-CUBE 15 ultrasound system conforms to the following classifications, in accordance
with the IEC/EN 60601-1:6.8.1:
Classifications::
EN 60601-1: 1990+A1:1993+A2:1995+A13:1995
(IEC 60601-1:1988+A1:1991+A2:1995)
EN 60601-1-1 : 2001 (IEC 60601-1-1 : 2000)
EN 60601-1-2:2001+A1:2006 (IEC 60601-1-2:2001+A1:2004)
EN 60601-1-4:1996+A1:1999 (IEC 60601-1-4: 1996+A1:1999)
EN60601-2-37:2001+A1:2005+A2:2005
(IEC 60601-2-37:2001+A1:2004+A2:2005)
EN 55022:2006+A1:2007, Class B (CISPR 22:2005+A1:2005)
EN 55011:2007+A2:2007, Group 1, Class B (CISPR 11:2003+A2:2006)
EN 61000-4-2:1995+A2:2001(IEC61000-4-2:1995+A2:2000)
EN 61000-4-3:2006 (IEC 61000-4-3:2006)
EN 61000-4-4:2004 (IEC 61000-4-4:2004)
EN 61000-4-5:2006 (IEC 61000-4-5:2005)
EN 61000-4-6:2007 (IEC 61000-4-6:2003+A1:2004+A2:2006)
EN 61000-4-8:1993+A1:2001(61000-4-8:1993+A1:2000)
EN 61000-4-11:2004 (IEC 61000-4-11:2004)
EN 61000-3-2:2006+A2:2009 (IEC 61000-3-2:2005+A2:2009)
EN 61000-3-3:2008 (IEC 61000-3-3:2008)
ISO 10993-1:2009
NEMA/AIUM Acoustic Output Display Standard (NEMA US-3, 1998)
EN 60601-1:2006 (IEC60601-1:2005)
EN 60601-1-2:2007(IEC 60601-1-2:2007)
EN 60601-2-37 :2008 (IEC 60601-2-37:2007)
ISO13485:2003+AC:2009
ISO14971:2007:AC2009
ISO14155:2009
Authorized EU Representative
European registered place of business:
250
8-8 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):
increase the separation between the equipment and the affected device
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.
251
8-8-1 Recommended separation distances between portable and mobile
RF communications equipment and the E-CUBE
E 15
The E-CUBE 15 is intended for use in an electromagnetic environment in which
whi radiated RF
disturbances are controlled. The customer or the user of the E-CUBE
E CUBE 15 can help Prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the E-CUBE
E CUBE 15 as recommended
below, according to the maximum output power of the communications equipment.
252
8-8-2 Immunity and compliance level for system
Frequency of Actual
Immunity Compliance
Interest Immunity
test Level
[MHz] Level
Conducted
RF 0.15 MHz to 80
3 Vrms 0.3 Vrms
IEC 61000- MHz
4-6
80 MHz to 800
Radiated RF 3V/m 1V/m
MHz
IEC 61000-
4-3 800 MHz to 2.5
3V/m 3V/m
GHz
253
8-8-3 Immunity and compliance level for transducer
▶ Transducer: E3-10H,
10H, 2 Hz, C mode
Frequency of
Image at Frequency of Actual
Interest**
Interest Immunity Level
[MHz]
2.20 MHz to 37.91
3 Vrms
MHz
42.72 MHz to
3 Vrms
54.24 MHz
2.31 MHz to 37.16
1 Vrms
MHz
43.14 MHz to
1 Vrms
53.70 MHz
Conducted RF 2.58 MHz to 36.79
0.3 Vrms*
IEC 61000-4-6 MHz
43.57 MHz to
0.3 Vrms*
53.17 MHz
* Voltage Level at which the RF Induced Noise is No Longer
Discernable from the system ambient background noise.
** Between 0.15 MHz ~2.18 MHz, 38.29 MHz ~ 42.29 MHz and
54.78 MHz ~ 80.00 MHz the level of Immunity is 3 Vrms. .
254
▶ Transducer: L3-12H, 2 Hz, C mode
Frequency of Actual
Image at Frequency of
Interest** Immunity
Interest
[MHz] Level
1.89 MHz to
3 Vrms
36.07 MHz
45.34 MHz to
3 Vrms
46.72 MHz
2.43 MHz to
1 Vrms
35.36 MHz
45.34 MHz to
1 Vrms
46.72 MHz
Conducted RF
IEC 61000-4-6 3.62 MHz to
0.3 Vrms*
34.66 MHz
* Voltage Level at which the RF Induced Noise is No Longer
Discernable from the system ambient background noise.
** Between 0.15 MHz ~ 1.87 MHz, 36.43 MHz ~ 44.89 MHz and
47.18 MHz ~ 80.00 MHz the level of Immunity is 3 Vrms..
Vrm
255
▶ Transducer: L8-17X,
17X, 2 Hz, C mode
Frequency of
Image at Frequency of Actual Immunity
Interest**
Interest Level
[MHz]
1.31 MHz to
3 Vrms
37.91 MHz
44.45 MHz to
3 Vrms
50.09 MHz
69.56 MHz to
3 Vrms
76.84 MHz
1.65 MHz to
1 Vrms
36.07 MHz
46.72 MHz to
1 Vrms
47.18 MHz
Conducted RF 71.67 MHz to
1 Vrms
IEC 61000-4-6 74.58 MHz
1.97 MHz to
0.3 Vrms*
35.01 MHz
73.11 MHz to
0.3 Vrms*
74.58 MHz
* Voltage Level at which the RF Induced Noise is No Longer
Discernable from the system ambient background noise.
** Between 0.15 MHz ~ 1.30 MHz, 38.29 MHz ~ 44.01 MHz, 50.59
MHz ~ 68.87 MHz and 77.60 MHz ~ 80.00 MHz the level of Immunity
is 3 Vrms.
256
▶ Transducer: SC1-4H,
4H, 2 Hz, C mode
Frequency of Actual
Image at Frequency of
Interest** Immunity
Interest
[MHz] Level
1.21 MHz to
3 Vrms
20.25 MHz
37.16 MHz to
3 Vrms
42.29 MHz
1.23 MHz to
1 Vrms
10.19 MHz
257
▶ Transducer: SC1-6H,
6H, 2 Hz, C mode
Frequency of Actual
Image at Frequency of
Interest** Immunity
Interest
[MHz] Level
1.58 MHz to
3 Vrms
14.44 MHz
1.61 MHz to
1 Vrms
13.46 MHz
1.93 MHz to
Conducted RF 0.3 Vrms*
10.50 MHz
IEC 61000-4-6
* Voltage Level at which the RF Induced Noise is No Longer
Discernable from the system ambient background noise.
** Between 0.15 MHz ~ 1.57 MHz and 14.58 MHz ~ 80.00 MHz
the level of Immunity is 3 Vrms.
258
▶ Transducer: SP1-5X,
5X, 2 Hz, C mode
Frequency of Actual
Image at Frequency of
Interest** Immunity
Interest
[MHz] Level
0.80 MHz to 28.98
3 Vrms
MHz
30.15 MHz to
3 Vrms
46.25 MHz
1.09 MHz to 20.86
1 Vrms
MHz
31.69 MHz to
1 Vrms
44.89 MHz
Conducted RF 1.50 MHz to 19.65
0.3 Vrms*
IEC 61000-4-6 MHz
35.01 MHz to
0.3 Vrms*
43.14 MHz
* Voltage Level at which the RF Induced Noise is No Longer
Discernable from the system ambient background noise.
** Between 0.15 MHz ~ 0.79 MHz, 29.27 MHz ~ 29.85 MHz and
46.72 MHz ~ 80.00 MHz the level of Immunity is 3 Vrms.
259
8-8-4 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.
260
8-8-5 Guidance and manufacturer’s declaration-electromagnetic immunity
The E-CUBE 15 is intended for use in the electromagnetic environment specified
below.
The customer or the user of the E-CUBE 15 should assure that it is used in such an
environment.
Electromagnetic
IEC 60601 Compliance
Immunity test environment -
Test level level
guidance
Electrostatic ±6 kV Contact ±6 kV Floors should be
discharge Contact wood, concrete or
(ESD) ±8 kV air ceramic tile. If floors
±8 kV air are covered with
IEC 61000-4-2 synthetic material,
the relative humidity
should be at least
30 %.
Electrical fast ±2 kV for power ±2 kV for Mains power quality
transient/burst supply lines power should be that of a
±1 kV for supply lines typical commercial or
IEC 61000-4-4 input/output ±1 kV for hospital environment.
lines input/output
lines
261
Power 3A/m 3A/m Power frequency
frequency magnetic
(50/60 Hz) fields should be at
magnetic field levels
characteristic of a
IEC 61000-4-8 typical
location in a typical
commercial or
hospital
environment.
NOTE: Uт is the a.c. mains voltage prior to application of the test level.
262
8-8-6 Guidance and manufacturer’s declaration-electromagnetic
electromagnetic immunity
IEC
Immunity 60601 Compliance Electromagnetic
test test level environment - guidance
level
Portable mobile RF
Conducted 3 Vrms Please see communications equipment
RF 150 kHz the page 91 should be used no closer to
IEC to 80 to 97 any part of the
61000-4-6 MHz E-CUBE 15,, including cables,
than the recommended
separation distance calculated
from the equation applicable
to the frequency of the
transmitter.
Radiated 3V/m
RF 3V/m 80 MHz to Recommended separation
IEC 80 MHz 2.5 GHz distance
61000-4-3 to 2.5
GHz
80 MHz to 800
MHz
263
following symbol :
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.
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,
necessary, such as re-re
orienting or relocating the E-CUBE
E 15.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less
than [V1] V / m.
264
8-8-7 Diagnostic ultrasound indications for use format
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Tissue Combined* Other**
Clinical Application Color Power
B M PWD CWD Harmonic
Doppler Doppler
Imaging (Specify) (Specify)
Ophthalmic
Fetal N N N N N N N
Abdominal N N N N N N N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Neonatal Cephalic
Adult Cephalic
Trans-rectal N N N N N N N
Trans-vaginal N N N N N N N
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
N N N N N N N
(Conventional)
Musculo-skeletal (Superficial) N N N N N N N
Intravascular
Other (Specify) N N N N N N N N
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel N N N N N N N
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Tissue
Clinical Application Color Power Combined*
B M PWD CWD Harmonic Other** (Specify)
Doppler Doppler (Specify)
Imaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal N N N N N N N
Trans-vaginal N N N N N N N
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)
266
E-CUBE 15 with L3-12H Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Tissue
Clinical Application Color Power Combined* Other**
B M PWD CWD Harmonic
Doppler Doppler (Specify) (Specify)
Imaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
N N N N N N
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
N N N N N N
(Conventional)
Musculo-skeletal (Superficial) N N N N N N
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel N N N N N N
Urology (including prostate)
267
E-CUBE 15 with L8-17X Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Tissue
Clinical Application Color Power Combined* Other**
B M PWD CWD Harmonic
Doppler Doppler (Specify) (Specify)
Imaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
N N N N N N
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
N N N N N N
(Conventional)
Musculo-skeletal (Superficial) N N N N N N
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel N N N N N N
Urology (including prostate)
268
E-CUBE 15 with SC1-4H Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Tissue
Clinical Application Color Power Combined* Other**
B M PWD CWD Harmonic
Doppler Doppler (Specify) (Specify)
Imaging
Ophthalmic
Fetal N N N N N N N
Abdominal N N N N N N N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate) N N N N N N N
269
E-CUBE 15 with SC1-6H Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
270
E-CUBE 15 with SP1-5X Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Tissue
Clinical Application Color Power Combined* Other**
B M PWD CWD Harmonic
Doppler Doppler (Specify) (Specify)
Imaging
Ophthalmic
Fetal
Abdominal N N N N N N N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Cardiac Adult N N N N N N N N
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)
271
Acoustic Output
The E-CUBE
CUBE 15 ultrasound system shows the acoustic output display (e.g. Mechanical Index
(MI), Thermal Index (TI)) on the upper right side of the screen. This acoustic output display
allows you to monitor the acoustic levels generated by the system.
AIUM / NEMA UD3 Standards for Real time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound equipment.
WARNING
You should use the E-CUBE
CUBE 15 ultrasound system at the lowest mechanical/thermal index
setting necessary to generate clinically acceptable images.
272
Acoustic output display (Mechanical/Thermal indices)
The E-CUBE 15 ultrasound system displays Mechanical index (MI) and Thermal index (TI) on the
upper right side of the screen as shown below.
The acoustic output display has three values as follows:
• Power value
MI is used as an indicator of the mechanical bio effect such as cavitation in the tissue. TI
represents the ratio of total power to the power required to raise tissue by 1°C. The power value
informs you of where the system is operating within the range of available output power.
One of the following TI values display on the screen based on the application and type of tissue.
• Soft Tissue Thermal Index (TIS)
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).
WARNING
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.
273
Controls affecting acoustic output
The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be
influenced by certain controls. The power control has the most significant effect on Acoustic
Output Indirect effects may occur when adjusting controls.
Controls that can influence MI and TI are detailed under the bioeffects portion of each control
in the Image chapter. Always observe the acoustic output display for possible effects.
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 you
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.
274
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.
275
Transducer/Mode Combination Summary
System: E-CUBE 15
Mode of Operation
Transducer Model Color Combined Other
B M PWD CWD
Doppler (Specify) (Specify)
SC1-6H O O O NA O O NA
L8-17X O O O NA O O NA
L3-12H O O O NA O O NA
SP1-5X O O O O O O NA
SC1-4H O O O NA O O NA
E3-10H O O O NA O O NA
276
Display resolution and measurement accuracy
When a transducer is capable of exceeding a mechanical or thermal index of 1.0,
the ultrasound imaging system displays indices starting from 0.4 in increments of
0.1 for all displayed values.
A number of factors contribute to the estimation error for the displayed index.
Variation among transducers and systems, approximation for real‐time index
calculations, and measurement errors contribute to the index display error.
Measurement precision for ultrasonic intensities, pressure, center frequency, &
power is within 10%, 6%, 7% and 10% respectively. The total estimated display
accuracy is +/‐15% for MI and +/‐30% for TI. Definitions for these parameters can
be found in the AIUM/NEMA document entitled Standard for Real‐Time Display of
Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment (also known as the Output Display Standard)
General Imaging
277
Output Range Summary Format
System: E-CUBE 15
Mode of Operation
278
Transducer Model: L8-17X
System: E-CUBE 15
Mode of Operation
279
Transducer Model: L3-12H
System: E-CUBE 15
Mode of Operation
280
Transducer Model: SP1-5X
System: E-CUBE 15
Mode of Operation
281
Transducer Model: SC1-4H
System: E-CUBE 15
Mode of Operation
282
Transducer Model: E3-10H
System: E-CUBE 15
Mode of Operation
283
8-11 Acoustic Output Reporting Table
Transducer Model: SC1-6H
Operating Mode: B Mode
System: E-CUBE 15
TIS TIB
P W0 mW 119 - - 142
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.26 - - - 1.56
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.39
Mode Type B B - - - B
284
Transducer Model: SC1-6H
Operating Mode: THI Mode
System: E-CUBE 15
TIS TIB
P W0 mW 85.6 - - 100
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.26 - - - 1.56
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.46
285
Transducer Model: SC1-6H
Operating Mode: D, M Mode
System: E-CUBE 15
TIS TIB
P W0 mW - - 367 367
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] 81.0
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm 3.10
zb zsp cm 0.80
td PD µsec 3.01
286
Transducer Model: SC1-6H
Operating Mode: BC, BCD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 352 - - 455
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.36 - - - 2.04
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 1.08
Mode Type BC BC - - - BC
287
Transducer Model: SC1-6H
Operating Mode: BD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 207 - - 207
[Pα(zs),Ita.α(zs)] ITA.3(z1))
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.37 - - - 0.37
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.40
Mode Type BD BD - - - BD
288
Transducer Model: L8-17X
Operating Mode: B Mode
System: E-CUBE 15
TIS TIB
P W0 mW 106 - - 106
[Pα(zs),Ita.α(zs)] ITA.3(z1))
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.84 - - - 0.84
Dim of Aaprt
Y cm 0.40 - - - 0.40
td PD µsec 0.15
Mode Type B B - - - B
289
Transducer Model: L8-17X
Operating Mode: THI Mode
System: E-CUBE 15
TIS TIB
Index Label
MI non-scan TIC
scan non-scan
Aaprt≤1 Aaprt>1
P W0 mW 67.2 - - 68.4
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.84 - - - 0.84
Dim of Aaprt
Y cm 0.40 - - - 0.40
td PD µsec 0.16
290
Transducer Model: L8-17X
Operating Mode: D, M Mode
System: E-CUBE 15
TIS TIB
zs z1 cm -
zbp zbp cm -
zb zsp cm 0.60
td PD µsec 0.85
291
Transducer Model: L8-17X
Operating Mode: BC, BCD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 108 - - 132
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.65 - - - 0.84
Dim of Aaprt
Y cm 0.40 - - - 0.40
td PD µsec 0.42
Mode Type BC BC - - - BC
292
Transducer Model: L8-17X
Operating Mode: BD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 45.1 - - 41.8
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.30 - - - 0.30
Dim of Aaprt
Y cm 0.40 - - - 0.40
td PD µsec 0.84
Mode Type BD BD - - - BD
293
Transducer Model: L3-12H
Operating Mode: B Mode
System: E-CUBE 15
TIS TIB
P W0 mW 155 - - 157
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.90 - - - 0.90
Dim of Aaprt
Y cm 0.50 - - - 0.50
td PD µsec 0.24
Mode Type B B - - - B
294
Transducer Model: L3-12H
Operating Mode: THI Mode
System: E-CUBE 15
TIS TIB
P W0 mW 31.7 - - 34.0
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.06 - - - 0.06
Dim of Aaprt
Y cm 0.50 - - - 0.50
td PD µsec 0.25
295
Transducer Model: L3-12H
Operating Mode: D, M Mode
System: E-CUBE 15
TIS TIB
zs z1 cm -
zbp zbp cm -
zb zsp cm 1.70
td PD µsec 1.22
296
Transducer Model: L3-12H
Operating Mode: BC, BCD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 93.8 - - 93.8
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.98 - - - 0.98
Dim of Aaprt
Y cm 0.50 - - - 0.50
td PD µsec 0.70
Mode Type BC BC - - - BC
297
Transducer Model: L3-12H
Operating Mode: BD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 77.7 - - 77.7
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.46 - - - 0.46
Dim of Aaprt
Y cm 0.50 - - - 0.50
td PD µsec 1.24
Mode Type BD BD - - - BD
298
Transducer Model: SP1-5X
Operating Mode: B Mode
System: E-CUBE 15
TIS TIB
P W0 mW 168 - - 168
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.92 - - - 1.92
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.40
Mode Type B B - - - B
299
Transducer Model: SP1-5X
Operating Mode: THI Mode
System: E-CUBE 15
TIS TIB
P W0 mW 101 - - 101
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.92 - - - 1.92
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.52
300
Transducer Model: SP1-5X
Operating Mode: D, M Mode
System: E-CUBE 15
TIS TIB
P W0 mW - - 127 286
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] 82.4
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm 2.80
zb zsp cm 1.30
td PD µsec 2.98
301
Transducer Model: SP1-5X
Operating Mode: CWD Mode
System: E-CUBE 15
TIS TIB
P W0 mW - - 179 179
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] 135
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm 2.00
zb zsp cm 4.70
td PD µsec 5.02
prr PRF Hz
Other Information
302
Transducer Model: SP1-5X
Operating Mode: BC, BCD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 328 - - 390
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.92 - - - 1.92
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 1.28
Mode Type BC BC - - - BC
303
Transducer Model: SP1-5X
Operating Mode: BD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 156 - - 156
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.92 - - - 1.92
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 2.51
Mode Type BD BD - - - BD
304
Transducer Model: SC1-4H
Operating Mode: B Mode
System: E-CUBE 15
TIS TIB
P W0 mW 131 - - 77.0
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.56 - - - 0.14
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.66
Mode Type B B - - - B
305
Transducer Model: SC1-4H
Operating Mode: THI Mode
System: E-CUBE 15
TIS TIB
P W0 mW 117 - - 117
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.56 - - - 1.56
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 1.03
306
Transducer Model: SC1-4H
Operating Mode: D, M Mode
System: E-CUBE 15
TIS TIB
P W0 mW - - 116 116
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] 95.9
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm 5.70
zb zsp cm 1.10
td PD µsec 2.53
307
Transducer Model: SC1-4H
Operating Mode: BC, BCD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 254 - - 223
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 1.36 - - - 0.78
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 0.91
Mode Type BC BC - - - BC
308
Transducer Model: SC1-4H
Operating Mode: BD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 177 - - 102
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.75 - - - 0.14
Dim of Aaprt
Y cm 1.35 - - - 1.35
td PD µsec 3.01
Mode Type BD BD - - - BD
309
Transducer Model: E3-10H
Operating Mode: B Mode
System: E-CUBE 15
TIS TIB
P W0 mW 28.6 - - 28.6
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.12 - - - 0.12
Dim of Aaprt
Y cm 0.59 - - - 0.59
td PD µsec 0.28
Mode Type B B - - - B
310
Transducer Model: E3-10H
Operating Mode: THI Mode
System: E-CUBE 15
TIS TIB
P W0 mW 39.2 - - 25.7
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.78 - - - 0.12
Dim of Aaprt
Y cm 0.59 - - - 0.59
td PD µsec 0.30
311
Transducer Model: E3-10H
Operating Mode: D, M Mode
System: E-CUBE 15
TIS TIB
zs z1 cm -
zbp zbp cm -
zb zsp cm 2.30
td PD µsec 1.45
312
Transducer Model: E3-10H
Operating Mode: BC, BCD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 76.4 - - 76.4
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.26 - - - 0.26
Dim of Aaprt
Y cm 0.59 - - - 0.59
td PD µsec 0.53
Mode Type BC BC - - - BC
313
Transducer Model: E3-10H
Operating Mode: BD Mode
System: E-CUBE 15
TIS TIB
P W0 mW 122 - - 118
min of [(W.3(Z1),
min of [Pα(zs),Ita.α(zs)] -
ITA.3(z1))
Associated Acoustic Parameter
zs z1 cm -
zbp zbp cm -
zb zsp cm -
deq(zb) deq(zsp) cm -
X cm 0.43 - - - 0.26
Dim of Aaprt
Y cm 0.59 - - - 0.59
td PD µsec 1.61
Mode Type BD BD - - - BD
314
8-9 Peripherals and Accessories
The following is intended to provide the users in EU countries with updated information
concerning the connection of the E‐CUBE 15 to image recording and other devices or
communication networks.
·
The E‐CUBE 15 has been verified for overall safety, compatibility and compliance with the
following on‐board image recording devices:
· Color Printer
Manufacturer: Sony Corporation, Mitsubishi Electric Corporation
Model: Sony Digital UP‐D25MD, Sony Analog UP‐25MD, Mitsubishi CP30DW
· B/W Printer
Manufacturer: Sony Corporation, Mitsubishi Electric Corporation
Model: Sony Digital UP‐D897, Sony Analog UP‐897MD, Mitsubishi P95DW(E)
· DVR
Manufacturer: Sony Corporation
Model: Sony Digital DVO‐1000MD
· DVD‐RW
Manufacturer: Samsung Electronics
Model: Samsung Digital SE‐T084
The E‐CUBE 15 may also be used safely while connected to devices other than those
recommended above if the devices and their specifications, installation, and
interconnection with the system conform to the requirements of IEC/EN 60601‐1‐1.
315
8-9-1 Basic accessories
Depending on the console type you purchase, the basic accessories provided with the console
may differ.
E-CUBE 15
E-CUBE 15 console
User manual CD/hard copy (English)
Quick guide (English hard copy)
Sonic gel
The following table list shows optional supplies and accessories that have been verified to be
compatible with the system.
Console accessory
Tri-pedal footswitch
Transducer
E3-10H
L3-12H
L8-17X
SC1-4H
SC1-6H
SP1-5X
316
Disinfectant
Cidex OPA
Cidex Plus
Biopsy kit
Software
Full SRI
Xpeed
Spatial compounding
DICOM
DICOM SR(OB)
CV M&R Standard
CV M&R Professional
317
1
SERVICE MANUAL
Rev. 0 (ENG)