ECUBE-5 Rev.0_Service Manual En

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SERVICE MANUAL

1
Copyright and License

Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under
the copyright laws.

The information contained herein is subject to change without notice.

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, Digtal-ro (St) 26-gil (Rd),
Guro-gu, Seoul, Republic of Korea
st
1316~1320 room, ACE HIGH-END Tower 1 ,
5, Digtal-ro (St) 26-gil (Rd),
Guro-gu, Seoul, Republic of Korea

T: +82 70 7465 2000 F: +82 2 851 5593 www.alpinion.com


Copyright © 2011 ALPINION MEDICAL SYSTEMS Co., LTD, All rights reserved.

2
Revision log
The following is a list of major changes and additions that have been made to this manual
since it was first released.

See the accompanying Release Notes for specific changes to the software and hardware
between manual updates.

Rev Date Description


Rev. 0 Sep 1, 2014 Service Manual first released

3
Table of Contents
PREFACE .................................................................................................................................................... 7

CHAPTER 1. PREPARING FOR INSTALLATION .................................................................................. 9

1-1 Environmental Requirements ..................................................................................................................................... 10

1-2 Electrical Requirements ............................................................................................................................................... 12

1-3 EMI Limitations ............................................................................................................................................................. 14

1-4 Facility Requirements ................................................................................................................................................... 15

1-5 Networking Requirements .......................................................................................................................................... 16

CHAPTER 2. INSTALLING YOUR SYSTEM ......................................................................................... 19

2-1 Safety Information ........................................................................................................................................................ 20

2-2 Average Installation Time ........................................................................................................................................... 21

2-3 Unpacking ...................................................................................................................................................................... 22

2-4 Verifying the Customer Order .................................................................................................................................... 26

2-5 Configuring the System Settings ............................................................................................................................... 30

2-6 Specifications ................................................................................................................................................................. 31

CHAPTER3. CHECKING FUNCTIONS OF YOUR SYSTEM ............................................................... 44

3-1 Necessary Equipment................................................................................................................................................... 45

3-2 General System Functions ........................................................................................................................................... 45

3-3 Monitor Functions ........................................................................................................................................................ 66

3-4 Mechanical Functions ................................................................................................................................................... 68

CHAPTER 4. COMPONENTS AND FUNCTIONS .............................................................................. 73

4-1 General Information ..................................................................................................................................................... 74

4-2 Block Diagram ............................................................................................................................................................... 75


4
4-3 Main Functional Segments.......................................................................................................................................... 76

4-4 Service Platform ............................................................................................................................................................ 90

CHAPTER 5. REPLACING COMPONENTS ......................................................................................... 95

5-1 Disassembly and Reassembly ..................................................................................................................................... 96

5-2 System Software Installation ....................................................................................................................................135

5-3 Installing the Mechanical Options ...........................................................................................................................151

5-4 Finishing .......................................................................................................................................................................155

CHAPTER 6. RENEWAL PARTS ......................................................................................................... 156

6-1 List of Renewal Parts ..................................................................................................................................................157

6-1 ATN PSU ASSY ............................................................................................................................................................. 159

6-2 Monitor ASSY .............................................................................................................................................................. 159

6-3 HDD ASSY ....................................................................................................................................................................160

6-4 FRAME ASSY ................................................................................................................................................................ 161

6-5 Board ASSY ..................................................................................................................................................................162

6-6 Control Panel ............................................................................................................................................................... 163

6-7 DVD RW ASSY ............................................................................................................................................................. 164

6-8 Cables ............................................................................................................................................................................164

6-9 Probe (Transducer) .....................................................................................................................................................165

CHAPTER 7. CARE AND MAINTENANCE ....................................................................................... 166

7-1 System Care and Maintenance .................................................................................................................................167

7-2 Transducer Care and Maintenance ..........................................................................................................................171

CHAPTER 8. SAFETY AND REGULATORY INFORMATION .......................................................... 174

8-1 Safety Summary ..........................................................................................................................................................175

5
8-2 Important Safety Warnings ......................................................................................................................................176

8-3 Patient Safety Information ........................................................................................................................................178

8-4 Electrical Safety Information ....................................................................................................................................179

8-5 Transducer Safety Information .................................................................................................................................180

8-6 System Symbols and Labels ......................................................................................................................................182

8-7 Peripherals and Accessories ......................................................................................................................................186

8-8 Regulatory Information .............................................................................................................................................189

8-9 Electromagnetic Compatibility (EMC) .....................................................................................................................191

8-10 Acoustic Output ........................................................................................................................................................206

6
Preface
How to use this manual
This manual provides you with necessary information on installing and servicing the E-CUBE
5 ultrasound system.

Who should use this manual


This manual is intended for authorized service representatives and hospital‟s service
personnel who are responsible for servicing the E-CUBE 5 ultrasound system.

How this manual is organized


This manual is organized as follows:

 Chapter1, Preparing for Installation describes preparations and requirements for


installing your system.

 Chapter2, Installing Your System describes how to install your system.

 Chapter3, Checking Functions of Your System describes how to check major functions
of your system after the installation is finished.

 Chapter4, Components and Functions describes each component and function of your
system.

 Chapter5, Replacing Components provides procedures for replaceable components.

 Chapter6, Renewal Parts provides lists of replaceable parts in each component.

 Chapter7, Care and Maintenance provides how to care and maintain your system.

 Chapter8, Safety and Regulatory Information provides general safety precautions that
must be observed while operating and maintain the system.

7
Manual conventions
Before you start, be familiar with the following manual conventions that are commonly used
in this document:

Convention Meaning
Bold Qwerty keyboard keys, keys on the control panel, and
switches on the system
Buttons and dialog boxes on the user interface
windows
Italic Names of user interface windows

> The order of menus you must select to perform a


specific function

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 feedback to:

www.alpinion.com

Provide the title and version number of this manual and as much detail as possible about your
comment, including the topic heading and page number and your suggestions for improvement.

8
Chapter 1. Preparing for Installation
This chapter describes necessary requirements to prepare for installing a new E-CUBE 5.
Before installing the system, you should consider all of the following requirements:

 Environmental Requirements

 Electrical Requirements

 EMI Limitations

 Facility Requirements

 Networking Requirements

9
1-1 Environmental Requirements
In an ultrasound room, check the following environmental requirements first to make the system
work properly.

WARNING :
Using the system in an inappropriate environment might cause unexpected problems

You should use this system in proper environment to prevent it from radio wave interference,
dust and gas. Make sure the area, which your system is installed, is well-ventilated, with a
temperature, humidity, and pressure requirements. If the system is exposed to inappropriate
temperature, humidity, or pressure, adapt your system to normal range of environment for a few
hours.

1-1-1 Environmental requirements for system

Temperature Humidity Pressure

Operation 10 ℃ ~ 35 ℃ 30 % ~ 75 % 700 ~ 1060 hPa


Storage -25 ℃ ~ 60 ℃ 20 % ~ 90 % 700~ 1060 hPa
Transportation -25 ℃ ~ 60 ℃ 20 % ~ 90 % 700~ 1060 hPa

CAUTION :
Before powering the system on, make sure that the system meets the operational conditions in
temperature and humidity.

10
1-1-2 Environmental requirements for ultrasound room
Item Values

Power source See Electrical Requirements.


Current rating 7.5A (100V-120V); 3.5A (220-240V)
Radiation Not required
shielding
Temperature 20 – 28 °C (68 – 79 °F)
Humidity 50 – 70%
Heat dissipation 2000 BTU/hr
Floor landing About 680 – 800 kg/m2 without accessories
Floor condition Gradient within 10 degrees
Cooling 2000 BTU/hr
Lighting Combination lighting (Dim and bright)

1-1-3 Environmental requirements for transducer


Operation Storage
10 ~ 30 °C -10 ~ 60 °C
Temperature
50 ~ 104 °F 14 ~ 140 °F

NOTE:
Keep always your transducer in storage temperature. When the transducer is exposed to
large temperature differences, store the transducer in storage temperature for about 10
hours before using it.

11
1-2 Electrical Requirements
 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.

 Sites with a mains power system without a defined neutral:


The dedicated line shall consist of one phase (two lines), 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.

1-2-1 Power requirements


Before installing the system, you need to check the following power requirements.

Parameter Area Limit


Voltage range 100 – 120V 100 – 120 VAC ± 10% (90-132 VAC)
220 – 240V 220 – 240 VAC ± 10% (198-264 VAC)
Power All applications MAX. 450 VA
Line frequency All applications 50/60 Hz (± 2Hz)
Power transients 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
Decaying All applications Less than 15% of peak voltage for less than 1
oscillation millisecond

1-2-2 Site circuit breaker


The branch circuit breaker is recommendable for the system.

CAUTION :

To prevent the system from power outage or circuit overload, do not use the same circuit with
another machine.

12
1-2-3 Site power outlets
The AC power outlet should exist within reach of the system. Also, peripheral devices and all
other medical equipments should be placed within 1m (3.2 feet) of the system. Avoid using
extension cord to connect to the system.

1-2-4 Unit power plug


When the system comes with the wrong plug, contact your local agent for replacement.

1-2-5 Power stability requirements


 Voltage drop-out: Max 10 ms

 Power Transients (for all applications): Less than 25% of nominal peak voltage for
less than 1 millisecond for any type of transient, including line frequency, synchronous,
asynchronous, or aperiodic transients

13
1-3 EMI Limitations
The ultrasound system is sensitive to Electromagnetic Interference (EMI) from radio frequencies
(RF), magnetic fields, and transient in the air wiring. Before installing the system, consider
possible EMI sources from electrical and electronic machines nearby the ultrasound system. The
possible EMI sources are from: medical lasers, scanners, cauterizing guns, computers, monitors,
fans, gel warmers, microwave ovens, light dimmers, mobile phones.
The following descriptions are tips to prevent your system from unintentionally exposing EMI:

 Be aware of RF sources.

 Ground the unit.

 Replace all screws, RF gaskets, covers, and cores.

 Replace broken RF gaskets.

 Do not place labels where RF gaskets touch metal.

 Use specified harnesses and peripheral machines.

 Take care with mobile phones.

 Properly dress peripheral cable.

14
1-4 Facility Requirements
1-4-1 User requirements
A user (or a purchaser) needs to prepare required materials and pay additional costs (if
necessary) before an ultrasound system is delivered and installed.

NOTE:
The desire to use a non-listed or customer provided product or to place an approved product
further from the system than the interface kit allows presents challenges to the installation team.
To avoid delays during installation, such variances should be made known to the individuals or
group performing the installation at the earliest possible date (preferable prior to purchase).

1-4-2 Feature requirements


 Dedicated single branch power outlet of adequate amperage meeting all local and national
codes which is located less than 2.5 m (8 feet) from the unit‟s proposed location
 Door opening is at least 76 cm (30 inch) wide
 Proposed location for unit is at least 0.3 m (1 foot) from the wall for cooling
 Power outlet and place for any external peripheral are within 2 m (6.5 feet) of each other
with peripheral within 1 m of the unit to connect cables.

1-4-3 Additional recommendations


The following facility features are additionally desirable for better performance of your system.

 Door is at least 92 cm (3 feet) wide

 Circuit breaker for dedicated power outlet is easily accessible

 Sink with hot and cold water

 Receptacle for bio-hazardous waste, like used transducer sheaths

 Emergency oxygen supply

 Storage for linens and equipment

 Nearby waiting room, lavatory, and dressing room

 Dual level lighting (bright and dim)

 Lockable cabinet for the system software and proprietary manuals

15
1-5 Networking Requirements
1-5-1 Purpose of DICOM network function

The DICOM service provides clinically useful features for moving images and patient
information over a hospital network. The DICOM service includes the transfer of images
to workstations for viewing or transferring images to remote printers.

1-5-2 Pre-installation Requirements

To configure the E-CUBE 5 to work with other network connections, the field‟s network
administrator must provide some necessary information.

Information must include:

- A host name, local port number, AE title, IP address and subnet mask for the E-
CUBE 5

- The IP addresses for the default gateway and other routers at the site for routing
information

Figure 1-1 General

16
Figure 1-2 Storage

Figure 1-3 Commitment

Figure 1-4 Print

17
Figure 1-5 Worklist

Figure 1-5-1 MPPS

18
Chapter 2. Installing Your System
This chapter introduces the basic install information and procedures when the new
equipment arrives at the site of a purchaser. Performing installation includes safety
considerations, unpacking and installing the system, and verifying hardware/software
specifications.

 Safety Information

 Average Installation Time

 Unpacking

 Verifying the Customer Order

 Powering On/Off

 Configuring the System Settings

 Specifications

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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 50kg (E-CUBE 5) 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.

Table 2-1 Acclimation time


°C 60 55 50 45 40 35 30 25 20 15 10 5 0 -5 -10 -15 -20 -25 -30 -35 -40

°F 140 131 122 113 104 96 86 77 68 59 50 41 32 23 14 5 -4 -13 -22 -31 -40

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 unitrequires 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.

20
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.

Table 2-2 Average installation time


Category Average time Comment
Unpacking the system 20 minutes
System installation with 20 minutes Dependant on the required configuration
no options
Network options 30 minutes Dependant on the required configuration

WARNING :

Do not remove any covers or panels, to prevent shock. If it problems or malfunctions occur,
unplug the power cord from the outlet.

21
2-3 Unpacking
When new equipment arrives, check all components are included in the package and they are
not damaged. If any component is damaged or excluded, contact your local agent.

To unpack the equipment,

1. Cut the plastic bands on the package by using your scissors or cutter.

Figure 2-1 Cutting the plastic bands

2. Lift the top cover up.

Figure 2-2 Removing the top cover

22
3. Unscrew the plastic joints and remove them from the outer sleeve.

Figure 2-3 Removing Plastic Joints

4. Remove the outer sleeve.

Figure 2-4 Removing sleeves

23
5. Remove the soft foam that covers up the monitor and option boxes.

Picture 2-5 Removing soft foam

6. Remove the plastic bag that surrounds the equipment.

7. Remove the plastic tapes on the palette and drop down the wooden board.

Figure 2-6 Moving the system from the crate

24
8. Release the front and rear caster locks, and then slide the equipment off the palette.

9. Slowly move the equipment to its position in the ultrasound room.

CAUTION :

1. Do not lift the equipment by holding the control panel or any cover. The equipment may be
damaged.

2. 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.

3. Store all loose parts of the units in a separate place to prevent damage before moving.
For transducers, wrap them in soft cloth or foam.

25
2-4 Verifying the Customer Order
When you are finished with unpacking the equipment, you need to verify all items listed in the
delivery sheet. If any component is missing or damaged, contact your local agent.

2-4-1 Power on/off


2-4-1-1 Power on

1. Make sure that the power code is plugged into the power outlet.

CAUTION:
Make sure that the system power is supplied from a separate and properly rated power
outlet.

2. Turn on the System On/Off switch on the rear of the system

Figure 2-7 Circuit breaker

3. Press the Power On/Off key on the control panel to turn on the system power.

CAUTION:

Do not unplug the power cord during the system operation. Do not push the System On/Off
switch before pressing the Power On/Off key. This may lead to data loss or system
software damage.

26
Figure 2-8 Power on/off key

NOTE
To reboot the system, wait for a few seconds before powering on the system.

2-4-1-2 Power-up screen sequence

1. The start-up screen will be shown on the monitor when the system is powered on.

Figure 2-9 Start-up screen display

2. When the system boots, all keys on the control panel are lighted the default 2D mode screen
or patient screen is shown on the display.

27
2-4-1-3 Power off

1. Press the Power On/Off key on the control panel to turn the power off.
2. When the shutdown dialog box appears, select Shutdown by using Trackball.
NOTE: Depending on the power-off setting, you can activate Sleep mode or turn the
system off immediately. To change the power-off setting, press the System Preset key and
go to System > General > Power Off.

CAUTION:
Do not unplug the power cord during the system operation. Do not turn off the System
On/Off switch before pressing the Power On/Off key. This may lead to data loss or system
software damage.

Figure 2-10 Shutdown dialog box

2-4-1-4 Connecting/Disconnecting the transducer


You can connect the transducer to the transducer port when the system is powered off
or on. Make sure that you press the Freeze key on the control panel before connecting
the transducer.

CAUTION
Do not touch the patient when connecting or disconnecting a transducer.

1. Check if you press Freeze key on the control panel.


2. Insert the transducer connector into the transducer port.

CAUTION
Do not forcibly insert the transducer connector to the system. Improper connection may
cause damages to the system and transducer.

28
3. Flip the knob to the lock position.

Figure 2-11 Connecting the transducer

NOTE
After connecting the transducer to the system, you need to activate the desired transducer by
selecting it from the screen.
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.

CAUTION
Do not touch the exposed surface of the transducer connector when the transducer is removed.

1. Check if you press Freeze key on the control panel.


2. Flip the knob to the unlock position.
3. Pull out the transducer connector from the transducer port.

29
2-5 Configuring the System Settings
Configure the system‟s basic settings such as date, time, language, and basic user information.

1. Press the System Preset key on the control panel.

2. From the General category, set the basic information such as the organization, hospital,
department, language, and date & time.

3. Click Save to save the settings.

4. Click Exit.

Figure 2-12 System preset screen

30
2-6 Specifications
This section introduces specifications of the system and other peripheral devices.

Figure 2-13 E-CUBE 5

1. Monitor arm
2. Transducer port
3. Caster lock
4. Caster

31
2-6-1 Physical dimensions
2-6-1-1 E-CUBE 5
The following table shows the physical specifications of E-CUBE 5, with monitor and
peripherals.

Table 2-3 Physical dimensions

Height Width Depth Unit


1295 540 660 mm
50.98 21.25 25.98 inch

WEIGHT: 50 kg (lbs) including Monitor

NOTE: Length is in mm Variation: +/-10%

Figure 2-14 System dimensions

32
2-6-2 Electrical specifications
Table 2-4 Electrical specifications
System Voltage Current Frequency
E-CUBE 5 110/220 VAC 5~7A 50~60 Hz

2-6-3 Optional peripherals


The following table shows the list of optional recording devices. Refer to the each
manufacturer‟s manual for installation and connection procedures.

Table 2-5 List of optional peripherals

Device Manufacturer Model Signal type Video signal


B/W Printer SONY UP-897MD Analog BNC Interface
B/W Printer SONY UP-D897 Digital USB Interface
Color Printer SONY UP-D25MD Digital USB Interface
Color Printer SONY UP-25MD Analog BNC Interface
DVR SONY DVO-1000MD Digital/Analog RS232 & S-Video
Interface

NOTE: There is only one power outlet on the system, so that you should connect one of the
Peripherals to wall outlet in case that you would like to utilize 2 peripherals at the
same time.

33
2-6-4 External I/O connector panel
I/O panel located on the rear side of the system includes video output connectors, audio input
and output, USB, power connector and control connections for VCR or DVD recorder, and
printer.

1 2 3
7 9 10 11

4 5 6

Figure 2-15 I/O panel

34
Table 2-6 Signal description

No. Description
1 B/W printer port (Analog type)
2 Color printer port (Analog type)
3 S-Video input port for a DVD-RW
4 Remote control port for a B/W printer
5 Remote control port for a color printer
6 S-Video output port for a DVD-RW
7 VGA port
8 Audio in/out port
9 DVI port
10 USB ports (4 ports)
11 Ethernet port

35
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

Signal Pin Description I/O


VCC 1 +5V power supply P 5V
-DATA 2 Universal Serial Bus I/O USB
Data, negative
different signal
+DATA 3 Universal Serial Bus I/O USB
Data, positive different
signal
GND 4 Ground

Table 2-8 Pin assignments of peripherals y signal and composite signal


Y (BW)
Pin Signal
1 Y_OUT
2 GROUND

Composite (Color)
Pin Signal
1 COMPOSITE_OUT
2 GROUND

36
Table 2-9 Pin assignments of S-Video In/Out connector

S-Video

Pin Signal
A1 GROUND
A2 GROUND
A3 Y_OUT
A4 C_OUT
B1 GROUND
B2 GROUND
B3 Y_IN
B4 C_IN

Table 2-10 Pin Assignments of VGA out Connector

VGA

Pin Signal
1 RED
2 GREEN
3 BLUE
4 NC
5 GROUND
6 GROUND
7 GROUND
8 GROUND
9 DDC_POWER
10 GROUND
11 NC
12 37
DDC_DAT
13 HSYNC
14 VSYNC
15 DDC_CLK
Table 2-11 Pin Assignments of DVI out Connector

DVI
Pin Signal Function
1 TMDS Data2-
2 TMDS Data2+
3 TMDS Data2/4 Shield GROUND
4 TMDS Data4- N/A
5 TMDS Data4+ N/A
6 DDC Clock [SCL]
7 DDC Data [SDA]
8 Analog vertical sync N/A
9 TMDS Data1-
10 TMDS Data1+
11 TMDS Data1/3 Shield GROUND
12 TMDS Data3- N/A
13 TMDS Data3+ N/A
14 +5 V Power
15 Ground (for +5 V) GROUND
16 Hot Plug Detect
17 TMDS Data0-
18 TMDS Data0+
19 TMDS Data0/5 Shield GROUND
20 TMDS Data5- NC
21 TMDS Data5+ NC
22 TMDS Clock Shield GROUND
23 TMDS Clock +
24 TMDS Clock -
C1 Analog Red N/A
C2 Analog Green N/A
C3 Analog Blue N/A
C4 Analog Horizontal Sync N/A
Analog GND Return:
C5 N/A
(analog R, G, B)

38
Table 2-12 Pin Assignment 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-

39
Table 2-13 Pin assignments of Audio In/Out connector

AUDIO
Pin Signal
A1 GROUND
A2 LINE_IN_LEFT
A3 LINE_OUT_LEFT
B1 GROUND
B2 LINE_IN_RIGHT
B3 LINE_OUT_RIGHT

40
2-6-6 Connectivity installation worksheet

Figure 2-16 General page

Figure 2-17 Storage page

41
Figure 2-18 Commitment page

Figure 2-19 Print page

Figure 2-20 Worklist page

42
Figure 2-21 MPPS

43
Chapter3. Checking Functions of Your System
This chapter introduces major functions of the system that you need to check after the
installation. By verifying the each part of the hardware and software functions, make sure
that your system works properly.

 Necessary Equipment

 General System Functions

 Monitor Functions

 Mechanical Functions

 Board Functions

44
3-1 Necessary Equipment
Before the verification, check if the following equipments are available:

 At least one transducer

3-2 General System Functions


This section provides you with the basic functions of the equipment. Check the functions and
features by the following sequences.

3-2-1 Power on/off function checks


The power is distributed to the ATN PSU Assy and power control.
When you press the Power On/Off key, the ATN PSU Assy is enabled and feed each DC
power to board assemblies and system run the software.
For power on/off procedures, see Power on/off in chapter 2.

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.

45
3-2-2 Control panel function checks

Figure 3-1 Control panel layout

46
Table 3-1 Key description
No. Controls Description
Power on/off Use this control to turn on and off the system.
1
Use this control to type numeric values and texts.
2 QWERTY keyboard
Patient Use this control to display the Patient Registration
screen. You can enter patient data.
Transducer Use this control to select the desired transducer,
application, and preset.
3 Report Use this control to create a report based on the exam
result and edit it

E-view Use this control to activate image management with


end of study options.
Soft keys Use this control to select or adjust the functions in
the soft menu at the bottom of the display.
• Press to select the corresponding soft menu.
4
• Rotate to adjust the function of the
corresponding soft menu.

5 TGC slides Use these controls to adjust TGC values on images.


Gain Use this control to adjust the gain function of the
6
current image.
Imaging mode Use these controls to activate 2D, CF, PW, or M
7
mode.
Image layout Use these controls to view an image in single, or dual
8
screen.
Depth Use this control to adjust the scanning depth of an
image.
Focus Use this control to focus on the area of interest.
Zoom Use this control to turn Zoom mode on.
9
• Rotate to activate Read zoom.
• Press to activate Write zoom in Read zoom
mode.

10 User (1~2) Use these controls to access user‐ defined functions.


Exit Use this control to exit current screen (mode) and
11
return to the previous screen (mode).
Select Use this control to select the desired function from the
12
context menu on the screen.
Body Pattern Use this control to display the body pattern images.
Arrow Use this control to display an arrow pointer on the
13 screen.
Text Use this control to annotate images.
Clear Use this control to delete the arrow, comment, and
47
measurement.
PD Use this control to activate Power doppler mode.
Active Mode Use this control to adjust parameters for each mode
in Duplex or Triplex mode.
THI Use this control to turn harmonic imaging on and off.
Xpeed Use this control to automatically optimize image
parameters on the live screen.
Set/Cur Use this control to show the cursor on the screen.
You can select a menu on the screen using this
cursor.
Use this control to set the current function.
Measure Use this control to perform measurement.
Priority Use this control to adjust the priority of Trackball.
14 • In 2D mode, press to select the priority
between the width and tilt functions.
• In Duplex or Triplex mode, press to select the
priority between ROIs of the activated imaging
modes.

Update Use this control to update a 2D image in real time


based on the specified time or freeze a 2D image.
Trackball Use this control to scroll through menus or options on
15 the
screen by moving the cursor.
16 Freeze Use this control to start and stop scanning.
17 Print Use this control to print out.

48
3-2-3 Image display function checks
The image display consists of an US image, application information, patient information,
and indicators.

19
8
17

Figure 3-2 Image display

1. Company logo
2. Hospital logo
3. Hospital name, current date, time
4. Patient ID, patient name
5. Operator ID, transducer name
6. Mechanical index, thermal index
7. Zoom reference window
8. Context menu (Submenu for mode control)
9. Depth scale bar
10. Focus mark
11. Image parameter
12. Gray scale bar
13. The location of transducer
14. Soft key menu (main menu for mode control)
15. Clipboard indicator
16. Clipboard area
17. Clipboard icons (Recycle bin, Single layout format, Dual layout format)
18. Symbol lock, caps lock, USB connection, network connection
19. Cine bar

49
3-2-4 Imaging modes checks
Verify function in each imaging mode of your system.

3-2-4-1 2D mode and M mode checks

Table 3-2 2D mode and M mode functions


Image optimization Functions
controls
Gain Increase or decrease the amount of echo information
displayed in an image. It may have the effect of brightening or
darkening the image if sufficient echo information is generated.
With the Gain control, you can adjust the brightness of M
mode image. The adjustment of the Gain control determines
the amount of amplification applied to the received echoes. All
received echoes are amplified with the same gain value
regardless of the scan depth. The M Gain function influences
the M trace only.

Depth Increasing the depth enables the deeper structures to be


visualized. You can decrease the depth if you do not need the
bottom portion of the display.

Focus Curved array, linear array, and phased array transducers


support multiple transmit focus zones, which you can select in
2D-mode images. Focal zone markers display on the left
side of the image screen.

Harmonic Tissue Harmonic Imaging (THI) is a system feature that can


enhance the contrast resolution with fine tissue differentiation,
benefiting patients with poor images. THI creates images from
received signals using the harmonics of the transmitted
frequency.

For certain applications, Filtered THI (FTHI) can be used to


optimize temporal resolution. The frame rate of FTHI is higher
than THI between similar images. To use the FTHI function,
you need an additional request to your local agent.
XpeedTM is an auto‐ optimizing technology that enables you
to easily adjust an image‟s the contrast resolution and
brightness uniformity. For using this feature, you need an
additional request to your local agent.

Time Gain Compensation To compensate for weak signals or over‐ bright signals at
(TGC) various depths, you can adjust Time Gain Compensation
(TGC) using the TGC slide controls. The 2D control adjusts
the overall receiver gain and compensates for the brightness
of the image.

Dual imaging Using dual imaging, you can position two images side by side
on the display. Dual imaging is available in all 2D live imaging
50
modes, M mode, Color flow mode, and Doppler mode.

Panoramic Panoramic is an optional imaging function that provides you


with a wider 2D image over a long tissue. By connecting
successive 2D images, you can view them as a single image
on the screen. This feature is especially helpful when you
study vascular structures such as blood vessel.

Priority Priority function has the following two options : Width, Tilt

Angle steer In 2D mode, you can tilt an image left or right by using a linear
transducer.

Frequency You can adjust the operating frequency of the transducer. The
selected frequency is displayed in the Image Parameter.

Dynamic range Dynamic range is useful for optimizing tissue texture in


different anatomy. Dynamic range should be adjusted so that
the highest amplitude edges appear as white while lowest
levels (such as blood) are just visible.

Rejection Low echo information will not be displayed on the screen


below the adjusted rejection level. The rejection function
determines the amplitude level below which echoes are
suppressed (rejected). Rejection set to high leads to bad
tissue display.

Virtual convex On linear transducers, virtual convex provides a larger field of


view in the far field.

Up/Down To flip the image vertically, select Up/Down

Gray map The Gray map provides you with the system maps for 2D, M,
and Doppler modes.

Colorize Colorize is the colorization of a conventional 2D mode image


or Doppler Spectrum to enhance the user's ability to discern
2D mode, M mode, and Doppler mode intensity valuations.

Persist Persistence provides a visible smoothing effect to the 2D-


mode image by persisting lines of image data for each frame
of imaging.

SRI Speckle Reduction Imaging (SRI) is a smart solution that


enables you to reduce unnecessary elements of your image
such as speckles and image noises. SRI is useful when
unnecessary elements interfere with the desired image detail.
After applying SRI, you can view your image more smoothly.

Full SRI Full SRI is a more powerful SRI feature that allows you to
adjust the SRI level according to your image condition or

51
imaging mode. For using this feature, you need an additional
request to your local agent.

Spatial compounding Spatial compound allows you to combine different steering


frames to form a single frame at real‐ time frame rates.

Line density Line density optimizes 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).

Frequency compound Frequency compound allows your system to compound


images on between high and low frequencies. By using each
imaging feature on different frequencies, you can obtain a
better image of enhanced resolution and penetration.

TGC slider controls In M mode, the TGC slide controls have the same functions in
2D mode.

CINE In M mode, image trace information can be recalled. When


freezing an image, a certain time frame (M information of the
last examination sequence) is stored in the loop memory. The
sequence can be reviewed second by second.

Sweep speed During M mode imaging, you can adjust the sweep speed of
the display.

Full timeline Expand the display to full timeline display.

M mode zoom When the system is in M mode, you can magnify a portion of
the reference image using M mode zoom function.

Anatomical M mode Anatomical M mode allows you to move or rotate an M line


and review an image on the desired region. For using this
feature, you need an additional request to your local agent.

52
3-2-4-2 CF mode checks

Table 3-3 Color flow (CF) mode


Imaging optimization Functions
controls
Gain Gain amplifies the overall strength of echoes processed in
the Color Flow window or spectral Doppler timeline.

Pulse Repetition Increase or decrease the PRF on the color bar. The PRF is
Frequency (PRF) established by the depth of the color ROI. Before a pulse is
transmitted, the pulse transmitter must wait until the
echoes from the previously transmitted pulse return from the
color ROI.

Threshold Threshold assigns the gray scale level at which color


information stops.

Baseline Change the Color Flow or Doppler spectrum baseline to


accommodate higher velocity blood flow. Minimize aliasing by
displaying a greater range of the forward flow with respect to
the reverse flow, or vice versa.

Wall Filter Wall filter allows you to filter out clutter signals caused from
vessel movement.

Invert (Color Invert) Invert allows you to view blood flow from a different
perspective, e.g., red away (negative velocities) and blue
toward (positive velocities). You can invert a real‐ time or
frozen image.

53
3-2-4-3 PWD mode checks

Table 3-4 Pulsed wave doppler (PWD) mode


Imaging optimization Functions
controls
Doppler Sample Size the sample volume gate.
Volume Length
PRF Adjust the velocity scale to accommodate faster/slower
blood flow velocities. Velocity scale determines the pulse
repetition frequency. If the sample volume gate range
exceeds single gate PRF capability, the system
automatically switches to the high PRF mode. When
multiple gates appear, HPRF is indicated on the display.

Baseline Adjust the baseline to accommodate faster or slower


blood flows to eliminate aliasing.

Update (B pause) In simultaneous mode of 2D and Doppler modes, you can


pause a doppler image and move the image to the 2D
live screen by adjusting the doppler gate.

Wall filter Wall filter allows you to filter out clutter signals caused
from vessel movement.

Angle correct Estimate the flow velocity in a direction at an angle to the


Doppler vector by computing the angle between the
Doppler vector and the flow to be measured.

Invert Vertically invert the spectral trace without affecting the


baseline position.

Full timeline Full timeline allows you to expand the display in full
timeline.

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.

2. Use Trackball to move the point.

3. Press the Set key to fix the point.

54
3-2-5-1 Distance

1. Press Distance on the Soft key menu. The start point is displayed.

2. Move the marker to the start point using Trackball.

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.

5. The measure value is fixed.

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.

3. The first point is fixed and the second point appears.

4. Move the marker to the second point using Trackball. The ellipse appears.

5. Press the Set key. The end point appears.

6. Move the marker to the second point using Trackball, and then press the Set key again.

7. The measure value is fixed.

55
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.

3. The end point appears.

4. Move the end point gradually along the circumference of the target object using
Trackball.

5. Press the Set key. The end point appears.

6. The start point and the end point are connected with a line and they are automatically
close the trace.

7. The measure value is fixed.

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.

3. The start point is fixed and the end point appears.

4. Use Trackball to move the point, and then press the Set key again.

5. The oblique line is displayed and the slope is calculated.

56
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.

3. The start point is fixed and the end point appears.

4. Use Trackball to move the point, and then press the Set key again.

5. The time interval between the two points is displayed.

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.

3. The measure value is fixed.

3-2-6 CINE Imaging Function Checks


Cinegate image review is the storage and review of a sequence of images in system memory.
Cinegate review is available by pressing the Freeze key. Moving Trackball left to right
moves through the Cinegate sequence. Image from a Cinegate sequences can be measured
and annotated.

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.

57
3-2-7 Transducer connectors function checks
3-2-7-1 Activating the transducer

Use the following procedure to activate the transducer and application.

1. On the control panel, press the Transducer key.


2. The dialog box for transducer and application selection appears
3. Move the cursor to select the desired transducer, application and preset using
Trackball on the control panel. Press the Set key on the control panel

4. Click Exit to exit and save your selections.

3-2-7-2 Deactivating the transducer

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.

Use the following procedure to deactivate the transducer.

1. Press the Freeze key on the control panel.


2. Clean the gel from the transducer.
3. Gently wipe the excess gel on the transducer face.
4. Place the transducer in its holder.

58
3-2-8 DVR function checks
To select the DVR,

1. Select the System preset > System > Peripherals.


2. Select the DVR recorder from the dropdown list.
3. Click Save and Exit.
4. Press the DVR key on the control panel. Soft key menu for DVR control appears.

Figure 3-3 Peripheral

59
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 pause recording, you press PAUSE on the softkey menu.

To start recording again, press REC on the softkey menu on more time.

To stop recording, press STOP on the softkey menu.

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.

3-2-9 Backup and restore function checks


The Backup/Restore preset allows you to back up and restore the user data. The following
submenus are available:

 User Backup
 Image Backup
 Full Backup

3-2-9-1 User Backup

NOTE: USB flash drives are available for user preset backup.

60
Figure 3-4 User 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.

 Image Preset: Set to back up or restore the Image preset only.


 Service: Set to back up or restore the Service preset only.
 Measurement: Set to back up or restore the Measurement preset only.
 Annotation: Set to back up or restore the Text and Body Pattern preset only.
 Connectivity: Set to back up or restore the Connectivity preset only.
 Others: Set to back up or restore other presets such as System and User settings.

To back up the user preset data,

1. Select a media.

2. Insert a blank media properly on your system.

3. Select the user preset you want to back up.

4. Click Backup to start backup. The backup procedure begins.

5. After the backup is completed, the last backup time and date appears next to the preset
category.

To restore the user preset data,

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.

61
1. Insert a media on your system.

2. Select the user preset(s) you want to restore.

3. Click Restore to start restoring. The restore procedure begins.

62
3-2-9-2 Image Backup

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.

NOTE: Use Import on Patient Browser to restore image data.

Figure 3-5 Image Backup

Media
 Media: Select your media
 Media Capacity: Select the media capacity. The system calculates the number of
backup CDs before performing backup and informing you.

63
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.

To back up Image Archive,

1. Configure Image Archive.

2. Prepare unformatted CD(s).

3. Click Backup to start backup Image archive.

4. The media formatting starts and the instructional message appears. You can view and
import backed up media via Patient Browser and Patient menu.

To view the backup images,

1. Insert your media.

2. Go to Patient or Patient browser.

3. Change the source to CD or DVD from the local hard disk.

4. View the backup images of the study you want.

64
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.

Figure 3-6 Full Backup

65
3-3 Monitor Functions
Verify the monitor functions by performing the following procedure.

To configure in the System Preset menu,

1. Press the System Preset key on the control panel.

2. From the Monitor category, check the resolution, gray bar, and color bar settings.

Figure 3-7 Monitor function checks

66
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.

Monitor OSD

Figure 3-8 Monitor function checks

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.

67
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 ATN Caster
2 ATN Base cover
3 ATN Body front cover
4 ATN Body top cover
5 ATN Body top cover dummy
6 ATN Body cover R
7 ATN Body cover L
8 ATN Probe lock knob
9 ATN IO BRKT

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.

68
3-4-2 Air filter function checks
Check if the air filter is installed securely.

.
Figure 3-9 Air filter function checks

69
3-4-3 Knob function checks
1. Check if the each button operates properly.

2. Check if encoder knobs are in the center.

3. Check if the keycap set cannot be removed easily.

Figure 3-10 Button and knob function checks

70
3-4-4 Front & Rear 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.

Figure 3-11 Caster checks

71
3-4-5 Transducer holder checks
Check if the transducer holder is not removed easily with your touch.

Figure 3-12 Transducer holder checks

3-4-6 Monitor arm function checks


1. Check if the arm operates properly (rotation, and tilting).

135° 135°

Figure 3-13 Arm function checks

72
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

 Main Functional Segments

 Service Platform

73
4-1 General Information
E-CUBE 5 is a medical ultrasound system that is used for the following modes:

- 2D mode
- M mode
- Color Flow(CF) mode
- Power Doppler mode
- Pulsed Wave(PW) Doppler mode with High PRF
- Different combination of the above modes

The main functional segments of the E-CUBE 5 platform are listed and described as
follows:

- USP(Transducer Interface, Front End) segment


- IO(Back End, COM Express PC) Segment
- Power Supply Unit (PSU) Segment
- Keyboard and Control Panel Segment
- Peripherals

74
4-2 Block Diagram
4-2-1 E-CUBE 5 functional block diagram
Figure4-1 describes a block diagram of E-CUBE 5. E-CUBE 5 consists of the main functional
segments as follows:

- USP(Transducer Interface, Front End) segment


- IO Segment
- Power Supply Unit (PSU) Segment
- Keyboard and Control Panel Segment
- Peripherals

Figure4-1 E-CUBE 5 Functional block diagram

75
4-3 Main Functional Segments
4-3-1 Ultrasound Processing (USP) Segment
The E-CUBE 5 USP board performs the Transducer interface and Front-end function.
- Enables acquisition of signals from and to probes
- 64Channel High-voltage transmits Pulse generation
- 64Channel Transmit/Receive Switching
- Receive analog signal, gain control
- Receive signal digitization
- Receive Beamforming
- Transducer and Board Connecting
- Port Selection
- Real time Control RTC

Figure 4-2 E-CUBE 5 USP board block diagram

The E-CUBE 5 USP includes the following boards:

USP board performs the following functions:


- Transmit/Receive switching
- Operating transducer interface
- Receive beam forming
- High-voltage transmits signal generation
- Receive analog signal gain control
- Signal digitization

76
T/R switch
Limiter:
- Limits pre-amp input level when high voltage transmits pulses exists.
- Standard 4 diode current limiting circuit
- Current per diode: 2.5mA
- Signal coupling: AC Coupling
-
Analog tuning
Inductor matching: Transducer Inductor Tuning
Additional Pre-Amplifier: N/A
Additional analog devices can be added for tuning.

Analog receiver
Analog receiver is composed of VCA8500 and limiter circuit. VCA8500 (TI) is an 8
channel gain variable amplifier.

VCA8500
Pre-Amplifier
- Input impedance: Input resistance 8k Ohm, Input Capacitance 30pF
- Input signal range: 250 mVpp
- LNA Gain: 20 dB
- Input referred noise: 0.8 nV/root Hz

TGC
- Gain range: 30dB
- Output signal range: 2Vpp
- Gain control signal: 47dB

Anti-aliasing LPF
- Filter spec: Two Pole Butterworth
- Cutoff frequency: 10MHz, 15MHz Selectable

DAC
DAC is used for controlling of a VCA8500

ADC
TI, TDS5277: 8 channel per 1chip
- Sample rate: Up to 65 MSPS
- Resolution: 10 bits
- Input range: 0 to 2.0V
- SNR: 61.7dB
- Interface: LVDS

Additional anti-aliasing low-pass filter: N/A

Pulser
HV Bipolar pulser
- Pulse Type: Bipolar
- Pulse Voltage: 0 ~ ± 80 Vpp
- Transmit Apodization: disable
- Pulse Duration: variable
77
- Frequency: Up to 15MHz
- Damp/Clamp: enable

78
4-3-2 IO(COM express PC, Back End (BE)) segment

IN/OUTPUT(IO) Segment

The E-CUBE 5 IO includes the following Modules.


- PC Interface(S/W Application support)
- PC Peripheral Interface(SATA, USB, Digital/Analog Display, LAN)
- PCI express Interface(DMA)

IO board

DVI

LAN

SATA
HDD

PC VGA
(Com-express)

Analog Video
(S-Video)

USB

PCIe
Audio
CODEC

I2C

IDPROM

Figure 4-3 IO Block Diagram

The main functional segments of IO board are as follow.


- IQ Data DMA Receive(PCI express)
- PC based Application processing, external In/Out Interface
- DVI : 2Port, VGA : 1Port, SATA : 2Port, USB : 8Port, LAN, Audio

79
4-3-3 COM Express PC Segment
COM Express PC performs the following functions. .
- Real time control of ultrasound imaging system hardware
- UI input interpretation and response
- Measurements and reports
- DICOM image storage, archival, retrieval and manipulation
- Keyboard and control panel interfaces
- External in/out Interface for peripheral Device
COM Express Module‟s main specification is as following.
- Processor : Intel Celeron 1020E 2.2GHz
- Memory : 2 sockets(DDR3 1600MHz, 4GBx1)
- Chipset
 Graphics and Memory Controller Hub IntelQM77
Connector

PC Base Module
SATA
HDD/DVD-RW
USB
Peripheral
Ethernet
Transformer RJ45 Con

DVI ch.1
Main Monitor
HDMI LEVEL DVI DVI DVI ch.2
Display Output 1 Sub Monitor
Shiftter Splitter
DVI ch.3
Y(B/W)
Digital RGB
DVI TO
TO S-Video, S-Video(Y,C)
Digital RGB
Composit
Composite
Control Signal (I2C)

VGA(RGB)
Display Output 2 Sub Monitor

Audio Out Audio


Audio Signals D-SUB Con
AMP
Audio
Codec RCA Jack
PCI express Bus
(To USP B’D)

Figure 4-4 COM express and IO Block Diagram

80
4-3-4 QWERTY keyboard and control panel
- Number of CP keys: < 50 keys (except A/N keyboard, TGC slide, Trackball)
- A/N Keyboard: 85 keys below
- TGC slide control: 8EA
- Trackball: Dia. 2 inch (50.8mm)
- Multi language
- Standard: English
- Optional: French, Italian, German, Brazil, Spanish
- Interface : USB
- Input Voltage Range : 12V, DC / 5V, DC
-
The main board of the control panel includes the following boards:

- USB connector : System Interface


- Power connector : Power

4-3-5 Monitor

General Information

- LCD Panel : LP156WHA (LG Display)


(Panel size : 15.6 inch / Backlight : LED)
- Input Resolution : 1366 X 768 @ 60Hz
- Input Interface : DVI
- Input Voltage Range : 12V, DC
- Color temperature :
1) 7,200K : X = 0.311 ± 0.008 , y = 0.325 ± 0.008 , cd=160/m2
2) 9,700K : X = 0.286 ± 0.008 , y = 0.311 ± 0.008 , cd=150/m2

81
The E-CUBE5 system has a 15 inch LCD monitor with DVI interface

15 inch Monitor

Figure4-5 E-CUBE 5 monitor

4-3-5-1 Monitor signal I/O


The Monitor Assy has two main I/O connectors: One is for DVI connection to scan and show
an image, two is for power supply

Monitor signal I/O(15 inch)

Figure4-6 E-CUBE 5 Monitor signal I/O

82
Table 4-1 DVI 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
4-3-6 I/O panel

E-CUBE 5 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.

Figure 4-7 E-CUBE 5 I/O panel signal

General Information

E-CUBE 5 supports the following peripheral.


- Digital BW printer
- Digital Color printer
- Analog BW printer
- Analog Color printer
- DVD recorder
- DVD R/W
- Foot switch
- External Monitor(DVI, VGA)

E-CUBE 5 consists of IO interface that can connect peripheral. IO Board includes connectors as
follows.
- Ethernet
 10/100 Mbps
- USB Port
 USB2.0, 8 EA, Digital BW printer, Digital color printer, DVD R/W, DVD recorder, Foot
S/W, Control Panel
- VGA
 External VGA monitor
- DVI
 Main DVI monitor, External DVI monitor
- S-video out
 DVD recorder video signal
- Composite out
 Analog color printer 1 EA

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- Y out
 Analog BW printer 2 EA
- Printer shutter
 Analog printer shutter input
- Audio
 Main speaker, DVD recorder audio signal support

E-CUBE5 system provides you with 5 unit of USB port which has each specified capability with
regard to electric power supply.
In accordance with above figures,
- On CP(Control Panel) side, 1 unit : applicable for power supply up to 0.5A

- On rear side, USB 1/2, 2 unit : applicable for power supply up to 0.5A for each port.

- On rear side, USB 3/4, 2 unit : applicable for power supply up to 1A for each port. (in detail,
indication printed as „1A/1A‟ is corresponded to this explication.)

Figure 4-8 E-CUBE 5 USB Ports

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In compliance with which peripherals user wants to connect to E-CUBE5 system, dedicated
engineer authorized by ALPINION has to make sure whether power specification of it is
applicable for the system or not precisely before getting started to installation.
1) USB Memory Stick, Foot Switch, external mouse/keyboard (Generally possible regardless of
certain USB ports)
2) In case printers having individual power supplies are connected to E-CUBE5 system, it‟s possible
for those to be operated with the system on account that USB is not utilized as main power generally.
3) In case external device for storage such as external USB HDD or DVD-RW, it should be connected
with the system referring to the following instruction.
- If power consumption of it is corresponded to more than 0.5A and less than 1A, you should utilize 3
or 4 port to get it activated properly.
- If power consumption of it exceeds 1A, you should utilize specialized tool that make USB applied on
requiring power with 2 USB cables.

(for reference, in case the external USB HDD or DVD-RW which is utilizing its own adapter for
power supply, you are able to connect USB cable regardless of port position.

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Table 4-2 Input/Output signals for peripherals
Signal name Description Connection from/via/to
Ethernet Standard TCP/IP Syscon -> I/O penal ->
Ethernet LAN Connector
USB Port for Digital BW USB Port for Digital I/O panel (USB hub) ->
printer BW printer USB connector(A-type) -
> Digital BW printer
USB Port for Digital Color USB Port for Digital I/O panel (USB hub) ->
printer Color printer USB connector(A-type) -
> Digital Color printer
USB port for Foot Switch USB port for Foot Foot switch -> USB
Switch connector(A-type) ->
Syscon
USB port for Digital DVD USB port for Digital I/O panel (USB hub) ->
Recorder DVD Recorder USB connector(A-type) -
> Digital DVD recorder
printer
External VGA VGA signal output for Syscon -> I/O penal ->
external VGA monitor D-sub connector
External DVI DVI signal output for Syscon -> I/O penal ->
external DVI monitor DVI connector
S-video in for DVD S-video input signal for S-video connector -> I/O
Recorder and Analog Analog DVD Recorder penal -> Syscon
Color printer and Analog Color
printer
S-video in for DVD S-video output signal Syscon -> I/O penal ->
Recorder and Analog for Analog DVD S-video connector
Color printer Recorder and Analog
Color printer
Composite out for Analog Composite video signal Syscon -> I/O penal ->
Color printer output for Analog Color BNC
printer
Composite out for Analog Composite video signal Syscon -> I/O penal ->
BW printer output for Analog BW BNC
printer
Printer shutter(Analog Printer shutter of Syscon -> I/O penal ->
Color printer) Analog Color printer for Audio jack
printing screen of
system
Printer shutter(Analog BW Printer shutter of Syscon -> I/O penal ->
printer) Analog Color printer to Audio jack
printing screen of
system
Audio in for Analog DVD Audio input signal for RCA jack -> IO penal ->
recorder Analog DVD Recorder Syscon
Audio out for Analog DVD Audio output signal for Syscon -> I/O penal ->
recorder Analog DVD Recorder RCA jack

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4-3-7 Power diagram

4-3-7-1 Overview

The ATN power unit main task is supplying power to various internal subsystems (AC-
DC module, power fan, control panel, monitor, B/W printer, outlet). The voltage to
peripherals can be confederated to either 110 VAC or 220 VAC.

DC output capacity

- A4.5VP, 8.5A rms


- A7VP, 1.5A rms
- A5VN, 1A rms
- A12VP, 3.5A rms
- A12VN, 3A rms
- D3.3VP, 10A rms
- D5VP, 5A rms
- D12VP, 6A rms
- D12P_AMP, 1A rms
- D12VN, 0.6A rms
- P5D_STB, 0.6A rms

SMPS supplies High-voltage power to activate high voltage transmit pulse and static supply
bias voltage on high voltage HVMUX. When IO segment 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.

IO segment controls the level of VHVP and VHVN through the IIC interface.

HV output capacity

- FHVP, 0.01A rms


- FHVN, 0.01A rms
- VHVP1, 0.5A rms
- VHVN1, 0.5A rms
- VHVP2, 0.5A rms
- VHVN2, 0.5A rms

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4-3-7-2 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.

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4-4 Service Platform
The Service platform contains a set of software modules for the diagnostic each modules.

4-4-1 Service login


1. Press the System Preset key on the control panel.
2. Click Administration.
3. Click Service Station on the Service tab.

Figure 4-8 Service Station

4. The service login window for Service Platform appears on the display.

Figure 4-9 Login screen

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.

To log in as each account,

 Operator: User account; the password is “.”


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 Partner: Dealer account; the password will be changed every 3 month.

 Engineer: Engineer account; the password will be changed every 3 month.

 Admin: Manufacturer account; the password will be changed every 3 month.

4-4-3 Service homepage


When the Service station starts, the service homepage appears.
The homepage contains the software revision along with the hardware inventory and the results
of the latest system information.

Figure 4-10 Service homepage

 Top menu: Top-level category

 Tree menu: the context menu of a top menu

 Main window: interaction area for the context menu

 Exit button: Exit the service station.

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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.

Figure 4-11 License management

The available option status is as follows:


- Trial: 3-month-trial license is activated.
- Invalid: No license is available.
- Demo: The license is activated for a specified period.
- Permanent: The license is activated permanently.

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4-4-5 Log viewer
The log viewer consists three categories: with ECUBE Log, ECUBE Event Log, and Window
Event Log. You can view all scanner logs by using the log viewer. The service Interface supports
the transfer of these logs to local destinations such as CD/DVD and USB.

Figure 4-12 Log viewer page

4-4-5-1 ECUBE Log

ECUBE Log consists six categories: Crash, Diagnostics, Control Panel, DICOM, Debug,
Overall. The log table has the following categories:

 Crash : Crash dump files

 Diagnostics: Diagnostics logs

 Control Panel: Key logs

 DICOM: DICOM logs

 Debug: Programmer‟s logs

 Overall: All logs

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4-4-5-2 ECUBE Event Log

ECUBE Event Log shows the windows event logs generated by ECUBE software. The event
types are Error, Warning, and Report (information).

4-4-5-3 Window Event Log

Window Event Log shows all event logs for Windows. The event types are Error, Warning,
and Report (information).

4-4-6 Partner Tools


Users are able to confirm Host ID which can configure display setting, nation, language and
information for issuing FSRI option license key. Furthermore, Partner tool offers remote service
and some tools for dealing with service issue.

No. items Description


Control Desktop Display properties
1
Region Option Setting nation and language
2
Full SRI Full SRI Host ID confirmation
3

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Chapter 5. Replacing Components
This chapter provides you with procedures about replacing the each hardware component,
installing and restoring the system software.

 Disassembly and Reassembly

 System Software Loading Procedure

 Installing the Mechanical Options

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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.

Do not disassemble any parts under the specified FRU unit.

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

- Common screwdrivers: Flat tip, cross tip


- Milli wrench

 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.

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5-1-1 ATN BASE COVER
 Required manpower and time: 1 person, approximately 10minutes

 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. Unscrew 2 screws located on front side as shown below.

Figure 5-1 ATN BASE COVER front fixing screws

2. Unscrews 4 screws (Left 2 screws and Right 2 screws at the bottom of the equipment)
to remove ATN BASE COVER.

Figure 5-2 ATN BASE COVER outer fixing screws

3. Unscrew 4 screws which are located on inside of ATN BASE COVER as shown below
Figure.

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Figure 5-3 ATN BASE COVER inner fixing screws

4. Remove ATN BASE COVER.

Figure 5-4 ATN BASE COVER removal

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-2 ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY
 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

1. Unscrew 2 screws on ATN BODY TOP COVER DUMMY.

Figure 5-5 ATN BODY TOP COVER DUMMY

2. Remove ATN BODY TOP COVER DUMMY.

3. Unscrew 4 screws on ATN BODY TOP COVER.

Figure 5-6 ATN BODY TOP COVER DUMMY

4. Remove ATN BODY TOP COVER.

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-3 ATN BODY FRONT COVER
 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

1. Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

2. Pull ATN BODY FRONT COVER forward.

Figure 5-7 ATN BODY FRONT COVER

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-4 ATN BODY COVER L
 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

1. Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

2. Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3

3. Unscrew 2 screws on the rear side of ATN BODY COVER L

Figure 5-8 ATN BODY COVER L

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4. Unscrew 4 screws on ATN BODY COVER L outer.

Figure 5-9 ATN BODY COVER L

5. Remove ATN BODY COVER L.

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-5 ATN BODY COVER R
 Required manpower and time: 1 persons, 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

1. Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

2. Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3

3. Unscrew 2 screws on the rear side of ATN BODY COVER R..

Figure 5-10 ATN BODY COVER R

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4. Unscrew 4 screws on ATN BODY COVER R outer.

Figure 5-11 ATN BODY COVER R

5. Adjust probe fixing lever as shown below.

Figure 5-12 Probe fixing lever

6. Remove ATN BODY COVER L.

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-6 Air Filter Assy
 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

1. Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

2. Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3

3. Pull out the air filter.

Figure 5-13 Pull Direction of Air Filter Assy

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-7 HDD Assy
 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

 Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

 Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3

 Unscrew 4 screws on HDD BRKT.

Figure 5-14 HDD BRKT

 Remove HDD SATA cable from HDD.

Figure 5-15 HDD SATA Cable

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• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

5-1-8 PSU 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 ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

2. Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3.

3. Remove the ATN BODY COVER L from the system. Refer to 5-1-4.

4. Unscrew 6 screws on PSU.

Figure 5-16 PSU

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5. Disconnect 4 cables.

Figure 5-17 Disconnecting 4 cables

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

108
5-1-9 USP BOARD 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

1. Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from the
system. Refer to 5-1-2

2. Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3.

3. Remove the ATN BODY COVER L from the system. Refer to 5-1-4.

4. Remove the ATN BODY COVER R from the system. Refer to 5-1-5

5. Unscrew 12 screws to remove ATN IO BRKT.

Figure 5-18 Removing the ATN IO BRKT

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6. Disconnect CABLE IO BOARD TO PRNT REMOTE from IO board when removing
ATN IO BRKT.

Figure 5-19 CABLE IO BOARD TO PRNT REMOTE

7. Unscrew 8 screws to remove ATN PPOBE CONN BRKT.

Figure 5-20 ATN PROBE CONN BRKT

110
8. Unscrew 8 screws to remove ATN TIFE TOP BRKT.

Figure 5-21 ATN TIFE TOP BRKT

9. Disconnect 2 cables from USP board.

Figure 5-22 Disconnecting 2 cables

111
10. Disconnect 7 cables from IO ASSY.

Figure 5-23 Disconnecting IO ASSY cables

11. Disconnect FAN PWR cable from IO board.

Figure 5-24 Disconnecting FAN PWR cable

112
12. Remove EM BRKT referring to Figure 5-25.

Figure 5-25 removing EM BRKT

13. Disconnect CABLE IO SATA TO USP SATA.

Figure 5-26 CABLE IO SATA TO USP SATA

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14. Unscrew 14 screws and remove USP board.

Figure 5-27 USP Board ASSY

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

114
5-1-10 IO Board 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

1. Remove the ATN BODY TOP COVER & ATN BODY TOP COVER DUMMY from
the system. Refer to 5-1-2

2. Remove the ATN BODY FRONT COVER from the system. Refer to 5-1-3.

3. Remove the ATN BODY COVER L from the system. Refer to 5-1-4.

4. Remove the ATN BODY COVER R from the system. Refer to 5-1-5

5. Unscrew 12 screws to remove ATN IO BRKT.

Figure 5-28 Removing the ATN IO BRKT

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6. Disconnect CABLE IO BOARD TO PRNT REMOTE from IO board when
removing ATN IO BRKT.

Figure 5-29 CABLE IO BOARD TO PRNT REMOTE

7. Unscrew 8 screws to remove ATN PROBE CONN BRKT.

Figure 5-30 ATN PROBE CONN BRKT

116
8. Unscrew 8 screws to remove ATN TIFE TOP BRKT.

Figure 5-31 ATN TIFE TOP BRKT

9. Disconnect 2 cables from USP board.

Figure 5-32 Disconnecting 2 cables

117
10. Disconnect 7 cables from IO ASSY.

Figure 5-33 Disconnecting IO ASSY cables

11. Disconnect FAN PWR cable from IO board.

Figure 5-34 Disconnecting FAN PWR cable

118
12. Remove EM BRKT referring to Figure 5-35.

Figure 5-35 removing EM BRKT

13. Disconnect CABLE IO SATA TO USP SATA.

Figure 5-36 CABLE IO SATA TO USP SATA

119
14. Unscrew 5 screws to remove IO board from EM BRKT.

Figure 5-37 IO Board ASSY

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

120
5-1-11 ATN COM EXPRESS BOARD ASSY
 Required manpower and time: 1 person, approximately 50 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 IO ASSY from the system. Refer to 5-1-10

2. Unscrew 4 screws on rear side of IO board.

Figure 5-38 ATN COM EXPRESS BOARD ASSY

3. Disconnect ATN COM EXPRESS BOARD ASSY from IO board.

Figure 5-39 ATN COM EXPRESS BOARD ASSY

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-12 CP 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. Unscrew 3 screws on ATN CP COVER DUMMY referring to Figure 5-40.

Figure 5-40 ATN CP COVER DUMMY

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2. Unscrew 10 screws on the bottom side of Control panel referring to Figure 5-41.

Figure 5-41 Control panel screw

3. Disconnect 3 cables from CP ASSY referring to Figure 5-42.

Figure 5-42 Control panel cables

123
4. Remove CP ASSY referring to Figure 5-43.

Figure 5-43 Control panel

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

124
5-1-13 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

1. Remove the CP Assy. Refer to 5-1-12 CP Assy.

2. Remove all Knob Assy from the CP Assy.

Figure 5-44 knob ASSY

3. Disconnect 4 cables from CP Main PCB Assy.

Figure 5-45 CP Main PCB ASSY

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4. Unscrew 26 screws and remove Main PCB ASSY.

Figure 5-46 CP Main PCB ASSY SCREW

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

126
5-1-14 ATN KEYBOARD 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 CP Assy. Refer to 5-1-12 CP Assy.

2. Disconnect 1 cable as shown Figure 5-47.

Figure 5-47 Connector for keyboard Assy

127
3. Unscrew 7 screws and remove the bracket.

Figure 5-48 keyboard screw

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

128
5-1-15 ATN_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

1. Remove the CP Assy. Refer to 5-1-12 CP Assy.

2. Remove plastic cable tie fixing speaker cables.

Figure 5-49 Plastic cable tie fixing Speaker cables

3. Unscrew 6 screws on ATN_SPEAKER ASSY.

Figure 5-50 ATN_SPEAKER ASSY

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-16 ATN_PCB DGC 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 CP Assy. Refer to 5-1-12 CP Assy.

2. Remove DGC Knob as shown Figure 5-51.

Figure 5-51 DGC KNOB

3. Disconnect the cable lifting black-colored cover up.

Figure 5-52 DGC cable

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4. Unscrew 4 screws on DGC PCB.

Figure 5-53 ATN_PCB DGC ASSY

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

131
5-1-17 TRACKBALL 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 CP Assy. Refer to 5-1-12 CP Assy

2. Unscrew 2 screws on Trackball.

Figure 5-54 Screws for TRACKBALL ASSY

3. Disconnect 2 cables from Main PCB and

Figure 5-55 TRACKBALL ASSY

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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5-1-18 156 LCD Monitor 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. Unscrew 2 screws and remove the rear cover.

Figure 5-56 Unscrewing 2 screws

2. Release cable tie and disconnect 2 cables referring to Figure 5-57.

Figure 5-57 Monitor Cables

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3. Unscrew 6 screws and disconnect the monitor from the monitor arm.

Figure 5-58 Unscrewing 6 screws from the neck

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

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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.

To start installation, select one of the following options:

[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.

WARNING: All patient and application data will be removed permanently.


NOTE: Application software shall be installed after completion of this procedure.

[B] Load the base system software only.


- This option recovers the system software including operation system.

NOTE: Application software shall be installed after completing this procedure.

[C] Exit

5-2-2 Requirements
 Base System Software DVD (OS)

 Armstrong Software DVD (Application)

 Blank DVDs, CD-Rs or USB (for patient image or preset data backup)

5-2-3 Average installation time


The installation procedures may take about 1 hour. Make sure that this is based on an
experienced service engineer.

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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.

2. Set the following connectivity options:

- Computer Name, Device Name, Port No, IP Address, Subnet Mask, Default
Gateway, Network Speed

Figure 5-59 Connectivity options

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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.

1. Power the system on.

Figure 5-60 Startup screen

2. Press the DEL key until the following screen appears.

Figure 5-61 Boot-up screen

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3. When the system asks for a password, enter “070427” and press the Enter key.

Figure 5-62 Password screen

4. When the setup screen appears, use the Enter and arrow keys to set the
following options:

 Boot Priority Selection: Typed Based


 1st Boot Device: USB CDROM

Figure 5-63 Boot Device Priority

5. Insert the Base System Software Disk to the CD/DVD ROM drive.

138
6. From the Exit tab, select Save Changes > Exit and enter “OK.” The following
screen appears on the display.

Figure 5-64 Exiting configuration screen

7. After rebooting the system, the following screens appear as shown below.

139
Figure 5-65 Reboot screen

140
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.

 [C] Exit: Cancel the installation.

Figure 5-66 Base system software

WARNING:
All patient and application data will be removed permanently.

NOTE:
Application software shall be installed after completion of this procedure.

141
9. After loading the base system software, the following screen appears.

Figure 5-67 Loading Base system software

10. Press any key to continue the installation. The following screen appears.

Figure 5-68 Finish loading the base system software

142
11. Press the C and Enter key. The following screen appears.

Figure 5-69 Select C & Enter

12. Eject the disk from the CD/DVD ROM drive.

Figure 5-70 Eject disk

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.

143
5-2-5-2 Configuring the base system software

1. Power the system on.

Figure 5-71 Startup screen

2. Press the DEL key until the following screen appears.

Figure 5-72 Boot-up screen

144
3. When the system asks for a password, enter “070427” and press the Enter key.

Figure 5-73 Password screen

4. When the setup screen appears, use the Enter and arrow keys to set the
following options:

 Boot Priority Selection: Typed Based


 1st Boot Device: Primary Master
 2nd Boot Device: USB CDROM

Figure 5-74 Boot Device Priority

145
5. To exit the configuration, press the Help key. You can also select Save
Changes > Exit in the Exit menu.

Figure 5-75 Save Changes and Exit

6. After rebooting the system, the following screen appears and should be restart
again.

Figure 5-76 Startup screen

146
5-2-5-3 Installing the Armstrong software

1. Reboot the system. The desktop screen will be shown as below.

Figure 5-77 Desktop screen

2. Insert Armstrong CD and double-click the CD RAM DRIVE from My Computer.

Figure 5-78 CD RAM drive

3. Double-click the Armstrong installation icon.

Figure 5-79 Armstrong installation icon

147
4. Click Next.

Figure 5-80 Wizard Setup

5. Install the Armstrong software.

Figure 5-81 Installing the Armstrong

148
6. Select Yes, restart the computer now and click Finish.

Figure 5-82 Finish the installation

7. Windows is shutting down and the system automatically reboots.

Figure 5-83 Shutdown screen

149
8. The system automatically reboots.

Figure 5-84 System boot-up

9. After completing the system reboot, the default 2D mode screen appears.

Figure 5-85 2D mode screen

150
5-3 Installing the Mechanical Options
This section describes the procedures about how to install the mechanical options.

5-3-1 B/W printer fixture installation


5-3-1-1 Front side installation

 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.

 Installation procedure

1. Install the B/W printer on the bracket and tighten 4 screws.

Figure 5-86 Installing the B/W printer on the bracket

151
2. Install Brkt on the system top body and tighten 4 screws.

3. Install on Hook and tighten 2 screws.

152
4. Connect cables on print and cover brkt and tighten 4 screws.

153
5. Connect Power, USB cable

154
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.

155
Chapter 6. Renewal Parts
This chapter provides you with renewal parts of E-CUBE 5.

• List of Renewal Parts • CONTROL PANEL

• PSU • DVD RW

• MONITOR • CABLES

• HDD • Probe (Transducer)

• BOARD

156
6-1 List of Renewal Parts
The following table shows a list of field replaceable units (FRU)

Table 6-1 List of renewal parts


Section Part Number Part description Q’ty FRU

PSU 20003656 ATN PSU ASSY 1 1


MONITOR 20003650 156 LCD Monitor ASSY 1 1
HDD 20001708 HDD_500GB_ST3500312CS_Seagate 1 1
20003519 ATN AIR FILTER 1 1
20003487 ATN BODY FRONT COVER 1 1

20003484 ATN BASE COVER 1 1


20003485 ATN BODY COVER R 1 1
Frame
20003486 ATN BODY COVER L 1 1
20003488 ATN BODY TOP COVER 1 1
20003521 ATN PROBE CUP 1 1
20000010 CASTER_REAR 1 1
20003694 E-CUBE 5 IO SMT BOARD 1 1
Board 20003695 E-CUBE 5 PC Module ASSY 1 1
20003702 ATHENA 2PORT USP BOARD ASSY 1 1
20003649 ATN_CP_ASSY 1 1
20003523 ATN KEYBOARD ASSY 1 1
20003635 ATN_SPEAKER ASSY 1 1
Control Panel
20003637 ATN_PCB DGC ASSY 1 1
20003636 ATN_PCB MAIN ASSY 1 1
20000270 TRACKBALL ASSY 1 1
DVD RW 20003748 DVD_RW_SE-208 1 1
20003560 CABLE_12R AC TO IO PWR_ATN 1 1
Cable 20003561 CABLE_20R AC TO DIGITAL USP PWR_ATN 1 1
20003563 CABLE_22R AC TO ANALOG USP PWR_ATN 1 1

157
Section Part Number Part description Q’ty FRU

10001299 PB_C1-6T 1 1

10001300 PB_EC3-10T 1 1
Probe
10001301 PB_EV3-10T 1 1

10001302 PB_L3-12T 1 1

158
6-1 ATN PSU ASSY

Figure 6-1 ATN PSU ASSY

Item Part name Part number Q’ty


1 ATN PSU ASSY 20003656 1
Table 6-2 ATN PSU ASSY

6-2 Monitor ASSY


1

Figure 6-2 15.6 LCD Monitor Assy

Item Part name Part number Q’ty


2 15.6 LCD Monitor Assy 20003650 1
Table 6-3 15.6 LCD Monitor Assy

159
6-3 HDD ASSY

Figure 6-3 HDD ASSY

Item Part name Part number Q’ty


3 HDD_500GB_ST3500312CS_Seagate 20001708 1
Table 6-4 HDD ASSY

160
6-4 FRAME ASSY

Figure 6-4 Air Filter ASSY

5 6
7
8

11

Figure 6-5 Covers


Item Part name Part number Q’ty
4 ATN AIR FILTER 20003519 1
5 ATN BASE COVER 20003484 1
6 ATN BODY FRONT COVER 20003487 1
7 ATN BODY COVER R 20003485 1
8 ATN BODY COVER L 20003486 1
9 ATN BODY TOP COVER 20003488 1
10 ATN PROBE CUP 20003521 1
11 CASTER_REAR 20000010 1
Table 6-5 FRAME
161
6-5 Board ASSY

12 14
13

Figure 6-6 IO Board ASSY & USP Board ASSY

Item Part name Part number Q’ty


12 E-CUBE 5 IO SMT BOARD 20003694 1
13 E-CUBE 5 PC Module Assy 20003695 1
14 ATHENA 2PORT USP BOARD ASSY 20003702 1
Table 6-6 IO Board ASSY & USP Board ASSY

162
6-6 Control Panel

16
15 17

CP ASSY Keyboard Assy Speaker Assy


18
19 20

Figure 6-7 CP ASSY

Item Part name Part number Q’ty


15 ATN_CP_ASSY 20003649 1
16 ATN KEYBOARD ASSY 20003523 1
17 ATN_SPEAKER ASSY 20003635 1
18 ATN_PCB DGC ASSY 20003637 1
19 ATN_PCB MAIN ASSY 20003636 1
20 TRACKBALL ASSY 20000270 1
Table 6-7 Control panel

163
6-7 DVD RW ASSY

21

Figure 6-8 DVD RW ASSY

Item Part name Part number Q’ty


21 DVD_RW_SE-208 20003748 1
Table 6-8 DVD RW ASSY

6-8 Cables
22 23 24

Figure 6-9 Cables


Item Part name Part number Q’ty
22 CABLE_12R AC TO IO PWR_ATN 20003560 1
23 CABLE_20R AC TO DIGITAL USP PWR_ATN 20003561 1
24 CABLE_22R AC TO ANALOG USP PWR_ATN 20003563 1

Table 6-9 Cables

164
6-9 Probe (Transducer)
1 2

3 4

Figure 6-10 Probe

Item Part name Part number Q’ty


25 PB_C1-6T 10001299 1
26 PB_EC3-10T 10001300 1
27 PB_EV3-10T 10001301 1
28 PB_L3-12T 10001302 1

Table 6-10 Probe

165
Chapter 7. Care and Maintenance
This chapter introduces the followings:

 System Care and Maintenance

 Transducer Care and Maintenance

166
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.

7-1-1 Daily checklist


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.

167
7-1-2 Monthly checklist
To inspect the system, examine the following on a monthly basis.

 Connectors on cables for any mechanical defects

 Entire length of electrical and power cables for cuts or abrasions

 Control panel and keyboard for defects

 Casters for proper locking operation

NOTE
When the LED lamp needs to be replaced, contact the ALPINION service
representative.

WARNING

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.

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.

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

Failure to perform required maintenance may result in unnecessary service calls.

7-1-4 Cleaning the system


Prior to cleaning any part of the system:

- Turn off the system power. If possible, disconnect the power cord.

168
7-1-4-1 Cleaning the surface of the ultrasound system
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.

2. After cleaning, use a clean, lint-free cloth to dry the surface.

3. After cleaning, reconnect the ultrasound system power code into the power outlet.

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.

3. Reinsert the liner into the transducer holder.

7-1-4-3 Cleaning the trackball


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.

1. Remove the front panel bezel by rotating the bezel counterclockwise.

2. Remove the trackball and the teflon ring.

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.

5. Allow the assembly parts to completely dry before reassembly.

6. Replace the trackball and front panel bezel.


169
7-1-4-4 Cleaning the monitor face

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.

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.

170
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 :

 Always place a sterile, non-pyrogenic transducer sheath on a


transducer used in procedures requiring sterility.
 To minimize the risk of cross-contamination and infectious diseases,
intraoperative transducers must be cleaned and high-level disinfected after
each use. A sterile, non-pyrogenic transducer sheath must be in place during
procedures requiring sterility.
 There have been reports of severe allergic reactions to medical devices
containing latex (natural robber). Health care professionals are advised to
identify latex-sensitive patients and to be prepared to treat allergic reactions
promptly.
 During neurosurgical procedures, if a transducer becomes contaminated with
tissue or fluids of a patient known to have Creutzfeld-Jacob disease, the
transducer should be destroyed, as it cannot be sterilized.
 When using an endocavity or intraoperative transducer with a CF type applied
part, the patient leakage currents may be additive.
 To avoid electrical shock and damage to the system, disconnect the transducer
prior to cleaning or disinfecting.
 The list of disinfectants and cleaning methods are recommended by ALPINION
for the compatibility with product materials, not for the biological effectiveness.
Refer to disinfectant label instructions for the guidance on disinfection efficacy
and appropriate clinical uses.

CAUTION :

 Transducers are sensitive instruments – irreparable damage may occur if they


are dropped, knocked against other objects, cut, or punctured. Do not attempt
to repair to alter any part of a transducer.
 To avoid cable damage, do not roll the system over transducer cables.
 To avoid damage to the transducer, do not use transducer sheaths containing
on oil-based coating or petroleum-or mineral oil-based ultrasound coupling
agents. Use only a water-based ultrasound coupling agent.
 DO NOT place or store the transducer in the side pocket or the storage area on
the system to prevent damaging it from accidently falling off.
 To avoid damage to the transducer, observe the immersion levels indicated for
each transducer type. Do not immerse or allow the cable or connector of a
transducer to become wet.
 The transducer have been designed and tested to be able to withstand high-
level disinfection as recommended by the manufacturer of the disinfectant
product. Carefully follow the disinfectant manufacturer‟s instructions. Do not
immerse for more than one hour.

171
7-2-1 Transducer handling and infection control
This information is intended to increase user awareness of the risks of disease transmission
associated with using this equipment and provide guidance in making decisions directly
affecting the safety of the patient as well as the equipment user.

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.

7-2-2 Cleaning and disinfecting transducers


To clean a transducer,

1. Disconnect the transducer from the system.


2. Moisten a clean gauze pad with water and wipe the transducer to remove any gel or
particles remaining on the transducer. If water is not effective, then you can use an
approved pre-cleaner or low-level disinfectant.
3. Carefully wipe the entire transducer, including the cable and connector.
4. After cleaning or disinfecting, use a clean cloth to dry the transducer.

To disinfect or high-level disinfect a transducer,

1. Disconnect the transducer from the system.


2. Thoroughly clean, rinse, and dry the transducer.
3. Take care to keep the cable strain relief and connector of the transducer dry while
immersing the transducer in an approved disinfectant to the level indicated in the following
illustration.
4. Carefully follow the disinfectant manufacturer‟s instructions for disinfection or high-level
disinfection.
5. After disinfecting or high-level disinfecting, use a clean cloth to dry the transducer.

The following high-level disinfectant agents have been approved for use with all transducers:

 Cidex OPA
 Cidex Plus

172
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

Figure 7-1 IPX8 immersion level

7-2-4 Cable handling


Take the following precautions with transducer cables:

 Keep free from wheels


 Do not bend the cable acutely
 Avoid crossing cables between transducers

7-2-5 Planned maintenance


The following maintenance schedule is suggested for the transducer to ensure optimum
operation and safety.

 Daily: inspect transducers


 After each use: clean transducers
 After each use: disinfect transducers

173
Chapter 8. Safety and Regulatory Information

This chapter introduces the followings:

 Safety Summary

 Important Safety Warnings

 Patient Safety Information

 Electrical Safety Information

 Transducer Safety Information

 System Symbols and Labels

 Regulatory Information

 Electromagnetic Compatibility (EMC)

 Peripheral Update for EC Countries

 Acoustic Output

174
8-1 Safety Summary
You should make sure the following safety precautions during all phases of operation, service, and
repair of the E-CUBE 5 ultrasound system. If you fail to comply with these safety precautions or
specific warnings in this manual, you violate safety standards in terms of design, manufacture, and
intended use of this system. ALPINION MEDICAL SYSTEMS Co., LTD. does not have liability for
your failure to comply with these requirements.

8-1-1 Safety notice


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.

8-1-2 Service document


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.

175
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.

 Connecting electrical equipment to Multiple Socket 10Outlet (MSO) effectively leads to


creating the system, and can result in a reduced level of safety.

 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.

 Always use transducers approved or recommended by ALPINION.

 Always use approved ECG cables and recommended electrodes by ALPINION.

 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.
176
 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.

177
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.

178
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.

 Do not use extension cords, adaptors or converters, which are a three-prong to


two-prong type, to connect with a power plug.

 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.

 Do not connect, disconnect, or replace any part of a system during scanning a


patient at the same time.

 Do not replace a fuse or power cord by yourself. An ALPINION MEDICAL service


engineer or an authorized agent must perform the replacement. Replacing the
fuse or power cord by yourself will avoid your warranty.

 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.

179
8-5 Transducer Safety Information
Damaged transducers or improper use and manipulation of the transducer may result in
injury or increased risk of infection.

Never use excessive force when manipulating intracavity transducers. Become familiar with
all instructions and precautions provided with special purpose transducers.

The use of damaged transducers can result in injury or increased risk of infection. Inspect
transducer often for sharp, pointed, or rough surface damage that could cause injury or tear
protective barriers. Become familiar with all instructions and precautions provided with
special purpose transducers.

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.

 Using damaged or defective transducer causes unexpected electric shock. Make


sure the use and care of the transducer.

 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.

 Make sure that you do not use an expired transducer sheath.

 Using pre-lubricated condoms as a sheath might damage the transducer.

 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.

180
8-5-1 Transducer surface temperature limits

Maximum Temperature(°C)
Transducer
Tissue Mimicking Material(TMM) Still Air
C1-6T 33.5 43
EC3-10T 30.5 41.1
EV3-10T 30.5 40.8
L3-12T 30.1 40.6

181
8-6 System Symbols and Labels
The following are a list of system symbols and labels for a safety. There symbols and labels
are used on labels on the product and u in the documentation. They indicate that you must
refer to the manual for specific information to avoid personal injury or damage to the product.

Safety Location Explanation


symbols/
Labels
On the power button of the control panel System on/off/stand-by

On the system rating label for overseas, Patient applied part meets the
transducer label and ECG label isolation requirements for type BF
equipment
On the transducer label This symbol indicates that the
transducer meets immersion
requirement. Depending on the
transducer model, the immersion
label may differ

On the Multi-caution labeland This symbol indicates that when the


transducer label end-user wishes to discard this
product, it must be sent to separate
collection facilities for recovery and
recycling. By separating this product
from other household-type waste,
the volume of waste sent to
incinerators or land-fills will be
reduced and natural resources will
thus be conserved.
Please contact an authorized
representative of the manufacturer
for information concerning the
decommissioning of your
equipment.
On the system rating label for overseas, This system complies with
transducer label, and gel warmer label regulatory requirements of
European Directive 93/42/EEC
regarding medical device.
Rear of the system body Consult instructions for use (or
consult operating instructions)

Various locations on labels Attention (Caution) – consult


accompanying documents if
complete information cannot be
provided on the label
On the rating label for overseas : Alternating current in accordance
Adjacent to the AC Power with IEC60878-01-14

182
Safety Location Explanation
Symbols/Labels
Adjacent to the AC power outlet Push-push button

Adjacent to the AC power Equipotentiality

On the control panel cover Universal Serial Bus

On the system rating label for Date of manufacture


overseas and transducer label See ISO 8601 for date format

On the system rating label for Symbol for manufacturer


overseas and transducer label This symbol shall be accompanied
by the name and the address of
the manufacturer
On the system rating label for Serial Number
overseas and transducer label

To ensure safety of user, moving


Rear of the system body and delivering system shall be
performed by at least 2 persons.

• Rear of the LCD monitor Do not forcibly push the monitor or


the system when the casters are
locked.
• Rear of the system body

Rear of the LCD monitor Do not press or place loads on the


monitor when folded. Otherwise,
monitor and (or) professional arm
could be damaged.
Rear of the LCD monitor Be very careful not to injure
yourself or damage the system
when rotating the monitor arm

Rear of the system body Do not use mobile transmitter


such as mobile phone, radio
receiver, broadband power line,
etc.
Rear of the LCD monitor Caution label

183
Safety Location Explanation
Symbols/Labels
Rear side of LCD monitor Care against pinch shall be taken.
(In accordance with IEC60878)

Bottom rear of System Neck Multi-caution label

Left cover No gender detection label

IO BRKT System rating label for overseas

IO BRKT System rating label for domestics

In the middle of the rear side of Option(BW print, DVD)


System Neck Restriction for live load

Transducer Name of transducer


Manufacturer,
Authorized EU Representative,
Safety, WEEE symbol, indicating
separate collection, Certification
mark

184
Transducer Transducer name, Serial, IPX
Rating Caution mark

185
8-7 Peripherals and Accessories
8-7-1 Peripheral update for EC countries

The following is intended to provide the users in EU countries with updated information
concerning the connection of the E-CUBE 5 to image recording and other devices or
communication networks.

The E-CUBE 5 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, 

 B/W Printer

Manufacturer: Sony Corporation, Mitsubishi Electric Corporation

Model: Sony Digital UP-D897, Sony Analog UP-897MD,

 DVR

Manufacturer: Sony Corporation

Model: Sony Digital DVO-1000MD

 DVD-RW

Manufacturer: Samsung Electronics

Model: Samsung Digital SE-208

The E-CUBE 5 has 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.

186
8-7-2 Basic accessories

Depending on the console type you purchase, the basic accessories provided with the console
may differ.

E-CUBE 5
E-CUBE 5 consol
User Manual CD/hard copy (English)
Quick guide(English hard copy)
Sonic gel

8-7-3 Optional supplies and accessories

The following tables show optional supplies and accessories that have been verified to be
compatible with the system.

Console accessory
Tri-pedal footswitch

Transducer
•C1-6T
• EC3-10T
• EV3-10T
• L3-12T

187
Disinfectant
•Cidex OPA
• Cidex Plus

Biopsy kit
SC1-6 Biopsy starter kit ( for C1-6, C1-
6T, and SC1-6)

L3-12 Biopsy Starter Kit (for L3-8, L3-12,


L3-12T, and L3-12H)

EC/EV3-10T and EN3-10 Disposable


Needle Guide

EC/EV3-10T and EN3-10 Reusable Needle


Guide

Software
Full SRI
Xpeed
Spatial compounding
Frequency compounding
FTHI(Filtered Tissue Harmonic)
DICOM 3.0 Connectivity
DICOM SR (OB)
CV M&R Standard
CV M&R Professional
Panoramic
Auto IMT Measurement
Anatomical-M
Compact 3D/4D

188
8-8 Regulatory Information
The E-CUBE 5 ultrasound system conforms to the following classifications, in accordance
with the IEC/EN 60601-1:6.8.1:

Classifications:

 Type of protection against electrical shock: Class I


 Degree of protection against electrical shock (Patient connection): Type BF equipment
 Degree of protection against harmful ingress of water: Ordinary equipment and all of
applied parts (IPX7, IPX8) except ECG meet ingress protection level according to IEC
60529
 Degree of safety of application in the presence of a flammable anesthetic material with
air or with oxygen or nitrous oxide : Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide
 Mode of operation : Continuous operation

The E-CUBE 5 ultrasound system conforms to the following standards:


• EN 60601‐1:1988+A1:1991+A2:1995 (IEC60601‐1:1988+A1:1991+A2:1995)
• EN 60601‐1:2006 (IEC60601‐1:2005)
• EN 60601‐1‐2:2007 (IEC 60601‐1‐2:2007)
• EN 60601‐1‐4:2000 (IEC 60601‐1‐4:2000)
• EN 60601‐1‐6:2010 (IEC 60601‐1‐6:2010‐Ed.3.0)
• EN 60601‐2‐37: 2008 (IEC 60601‐2‐37:2007)
• EN 55022:2010, Class B (CISPR 22:2008, modified)
• EN55011:2009+A1:2010, Group 1, Class B
• EN 61000‐4‐2:2009 (IEC 61000‐4‐2:2008)
• EN 61000‐4‐3:2006+A1:2008+A2:2010 (IEC 61000‐4‐3:2006+A1:2007+A2:2010)
• EN 61000‐4‐4:2004+A1:2010 (IEC 61000‐4‐4:2004+A1:2010)
• EN 61000‐4‐5:2006 (IEC 61000‐4‐5:2005)
• EN 61000‐4‐6:2009 (IEC 61000‐4‐6:2008)
• EN 61000‐4‐8:2010 (IEC 61000‐4‐8:2009)
• EN 61000‐4‐11:2004 (IEC 61000‐4‐11:2004)
• EN 61000‐3‐2:2006+A1:2009+A2:2009 (IEC 61000‐3‐2:2005+A1:2009+A2:2009)
• EN 61000‐3‐3:2008 (IEC 61000‐3‐3:2008)
• EN 62304:2006 (IEC 62304:2004/AC2008)
• EN 62366:2008 (IEC 62366:2007)
• ISO 14971:2007

189
• ISO 10993‐1:2003
• ISO 10993‐5:2009
• ISO 10993‐10:2002
• AIUM/NEMA UD 2:2004 (R2009)
• AIUM/NEMA UD 3:2004
• MDD 93/42/EEC
• CANADA *Regulation+ SOR‐98‐282
• 의료기기법 , 시행령 , 시행규칙

Authorized EU Representative:

Name: IL Ryong Kim


Address: Lilienthalstrasse 17a, 85399 Hallbergmoos, Germany
Phone: +49 (0) 811 99 82 86 0

Authorized US Representative:
Name: Julian Lee
Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States
Phone: +1 425 949 1059

Authorized Brazil Representative:


Name: Júlia Zema
Address: CNPJ: 04.967.408/0001‐98
SIA Trecho 3, Lotes 2010/2020 1º. Andar, Ed. Myrian ‐ Bairro: Zona Industrial
Brasília – DF ‐ CEP 71200‐030
Phone: +55 61 3386 3166

190
8-9 Electromagnetic Compatibility (EMC)
This equipment generates uses and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical and non-medical devices and radio
communications. To provide reasonable protection against such interference, this product
complies with emissions limits for a Group 1, Class Medical Devices Directive as stated in
EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular
installation.

If this equipment is found to cause interference (which may be determined by turning the
equipment on and off), the user (or qualified service personnel) should attempt to correct the
problem by one or more of the following measure(s):

 reorient or relocate the affected device(s)

 increase the separation between the equipment and the affected device

 power the equipment from a source different from that of the affected device

 consult the point of purchase or service representative for further suggestions

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.

191
8-9-1 Recommended separation distances between portable and mobile RF
communications equipment and the E-CUBE 5
The E-CUBE 5 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the E-CUBE 5 can help Prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the E-CUBE 5 as recommended
below, according to the maximum output power of the communications equipment.

8-9-2 Immunity and compliance level for system

Frequency of Interest Actual Immunity


Immunity test Compliance Level
[MHz] Level

Conducted RF
0.15 MHz to 80 MHz 3 Vrms 0.3 Vrms
IEC 61000-4-6

80 MHz to 800 MHz 3V/m 1V/m


Radiated RF
IEC 61000-4-3
800 MHz to 2.5 GHz 3V/m 3V/m

192
8-9-3 Immunity and compliance level for transducer

193
194
195
196
8-9-4 Guidance and manufacturer’s declaration –electromagnetic emissions

This system is suitable for use in the following environment. The user must assure that it is
used only in the electromagnetic environment as specified.

197
8-9-5 Guidance and manufacturer’s declaration-electromagnetic immunity

The E‐CUBE 5 is intended for use in the electromagnetic environment specified below.
The customer or the user of the E‐CUBE 5 should assure that it is used in such an
environment.
IEC 60601 Electromagnetic
Immunity test Compliance level
Test level environment ‐guidance
Electrostatic ±6 kV Contact ±6 kV Contact Floors should be wood,
discharge (ESD) concrete or ceramic tile. If
±8 kV air ±8 kV air floors 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 power Mains power quality should
transient/burst supply lines supply lines be that of a typical
±1 kV for input/ ±1 kV for input/ commercial or hospital
IEC 61000‐4‐4 output lines output lines environment.
Surge ±1 kV line(s) to ±1 kV line(s) to Mains power quality should
line(s) line(s) be that of a typical
IEC 61000‐4‐5 ±2 kV line(s) to ±2 kV line(s) to commercial or hospital
earth earth environment.
Voltage dips, < 5 % Uт < 5 % Uт Mains power quality should
short (> 95 % dip in Uт) (> 95 % dip in Uт) be that of a typical
interruptions and for 0.5cycle for 0.5cycle commercial or hospital
voltage variations environment. If the user of
on power supply 40 % Uт 40 % Uт the E‐CUBE 5 image
input lines (60 % dip in Uт ) (60 % dip in Uт ) intensifier requires
for 5 cycle, 6 cycle for 5 cycle, 6 cycle continued operation during
IEC 61000‐4‐11 power mains interruptions,
70 % Uт 70 % Uт it is recommended that the
(30 % dip in Uт) (30 % dip in Uт) E‐CUBE 5 image intensifier
for 25 cycle, 30 for 25 cycle, 30 be powered from an
cycle cycle uninterruptible power
supply.
<5 % Uт <5 % Uт
(> 95 % dip in Uт ) (> 95 % dip in Uт )
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
location in a typical
IEC 61000‐4‐8 commercial or hospital
environment.

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

198
8-9-6 Guidance and manufacturer’s declaration-electromagnetic immunity

IEC 60601 test Compliance


Immunity test Electromagnetic environment - guidance
level level
Portable mobile RF communications
Conducted RF 3 Vrms 3V/m equipment should be used no closer to
IEC 61000‐4‐6 150 kHz to any part of the E‐CUBE 5, including
80 MHz cables, than the recommended
Radiated separation distance calculated from the
RF IEC 61000‐ equation applicable to the frequency of
4‐3 3V/m the transmitter.
3V/m Recommended separation distance
80 MHz to
2.5 GHz
80 MHz to 800 MHz

800 MHz to 2.5 GHz

where P is the maximum output power


rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).

Field strengths from fixed RF


transmitters, as deter‐mined by an
electromagnetic site survey, a
should be less than the compliance
level in each frequency range. b
Interference may occur in the
vicinity of equipment marked with
the 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.

199
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the EUT is used exceeds
the applicable RF compliance level above, the EUT should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as re‐orienting or relocating the E‐CUBE 5.

b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.

200
8-9-7 Diagnostic ultrasound indications for use format

E-CUBE 5 Ultrasound System


Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic (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 N N N N N N N
Small Organ
N N N N N N N
(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
N N N N N N N
(Conventional)
Musculo-skeletal
N N N N N N N
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel N N N N N N N
Urology (including prostate) N N N N N N N

N = new indication; P = previously cleared by FDA ; E = added under appendix


* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

201
E-CUBE 5 with C1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic (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 N N N N N N N
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

N = new indication; P = previously cleared by FDA; E = added under appendix


* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

202
E-CUBE 5 with EC3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic (Specify) (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
Trans-vaginal 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) N N N N N N

N = new indication; P = previously cleared by FDA; E = added under appendix


* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

203
E-CUBE 5 with EV3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic (Specify) (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
Trans-vaginal 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) N N N N N N

N = new indication; P = previously cleared by FDA; E = added under appendix


* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

204
E-CUBE 5 with L3-12T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic (Specify) (Specify)
Imaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N N N N
Small Organ
N 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 N
(Conventional)
Musculo-skeletal
N N N N N N N
(Superficial)
Intravascular
Cardiac Adult

Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel N N N N N N N
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under appendix


* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

205
8-10 Acoustic Output
The E‐CUBE 5 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.
Two standards for the acoustic output display are as follows:
AIUM/NEMA UD3 Standards for Real‐time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound equipment.
IEC 60601‐2‐37, Mechanical Electrical Equipment – Part2‐37: Particular Requirements
for the Safety of Ultrasound Medical Diagnostic and Monitoring Equipment.

WARNING :
You should use the E-CUBE 5 ultrasound system at the lowest mechanical/thermal index
setting necessary to generate clinically acceptable images.

206
8-10-1 Acoustic output display (Mechanical/Thermal indices)
The E-CUBE 5 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:


 Mechanical Index (MI)
 Thermal Index (TI)
 Acoustic Output (AO) 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)
 Bone Thermal Index (TIB)
 Cranial Bone Thermal Index (TIC)

The TI and MI are displayed all the times. The MI and TI display start at a value of 0.4 and
increments in steps of 0.1 (values less than 0.4 are displayed as < 0.4).

Be sure to have read and understood control explanations for each mode used before
attempting to adjust the power control or any control that can affect Acoustic Output.

8-10-2 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 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.

207
8-10-3 Principle of ALARA
The principle of ALARA, which stands for As Low As Reasonably Achievable, is to keep the
radiation exposure at the minimum level necessary to obtain the diagnostic information. This
principle is widely practiced in medical x-ray protection where exposure at any level is potentially
harmful. Historically, ALARA was initiated as a cautious approach for dealing with uncertain
hazards but has since become the principle method for reducing the risk of injury from hazards
that do not have safe minimum threshold.

While no minimum thresholds for harmful bioeffects have been established with the use of
diagnostic ultrasound, the principle of ALARA can be readily implemented on equipment
incorporating an output display. As the operator adjusts the equipment to optimize the image
quality, the display interactively updates to indicate the effect on output.

Controls that have no noticeable impact on image quality should be set to minimize the output
while controls that improve the image quality and also increase acoustic output should be set no
higher than needed to achieve a diagnostic quality image.

208
8-10-4 Transducer / Mode combination summary
System : E-CUBE 5
N/A : Not Applicable

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)
Default Displayed MI and TI Values by Transducer
(Per transducer/mode that exceeds default MI or TI value of 0.4)
General Imaging

209
Output range summary format
Transducer Model: C1‐6T
System: E‐CUBE 5

210
Transducer Model: EC3‐10T
System: E‐CUBE 5

211
Transducer Model: EV3‐10T
System: E‐CUBE 5

212
Transducer Model: L3‐12T
System: E‐CUBE 5

213
Acoustic output reporting table
Transducer Model: C1‐6T
Operating Mode: B Mode
System: E‐CUBE 5

214
Transducer Model: C1‐6T
Operating Mode: THI Mode
System: E‐CUBE 5

215
Transducer Model: C1‐6T
Operating Mode: BC, BCD Mode
System: E‐CUBE 5

216
Transducer Model: C1‐6T
Operating Mode: BD Mode
System: E‐CUBE 5

217
Transducer Model: C1‐6T
Operating Mode: D, M Mode
System: E‐CUBE 5

218
Transducer Model: EC3‐10T
Operating Mode: B Mode
System: E‐CUBE 5

219
Transducer Model: EC3‐10T
Operating Mode: THI Mode
System: E‐CUBE 5

220
Transducer Model:EC3‐10T
Operating Mode: BC, BCD Mode
System: E‐CUBE 5

221
Transducer Model: EC3‐10T
Operating Mode: BD Mode
System: E‐CUBE 5

222
Transducer Model: EC3‐10T
Operating Mode: D, M Mode
System: E‐CUBE 5

223
Transducer Model: EV3‐10T
Operating Mode: B Mode
System: E‐CUBE 5

224
Transducer Model: EV3‐10T
Operating Mode: THI Mode
System: E‐CUBE 5

225
Transducer Model: EV3‐10T
Operating Mode: BC, BCD Mode
System: E‐CUBE 5

226
Transducer Model: EV3‐10T
Operating Mode: BD Mode
System: E‐CUBE 5

227
Transducer Model: EV3‐10T
Operating Mode: D, M Mode
System: E‐CUBE 5

228
Transducer Model: L3‐12T
Operating Mode: B Mode
System: E‐CUBE 5

229
Transducer Model: L3‐12T
Operating Mode: THI Mode
System: E‐CUBE 5

230
Transducer Model: L3‐12T
Operating Mode: BC, BCD Mode
System: E‐CUBE 5

231
Transducer Model: L3‐12T
Operating Mode: BD Mode
System: E‐CUBE 5

232
Transducer Model: L3‐12T
Operating Mode: D, M Mode
System: E‐CUBE 5

233
SERVICE MANUAL

Rev. 1(ENG)

234

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