Alpinion Medical Systems E-CUBE 8 Diamond User manual

USER MANUAL
Rev. 6 (ENG)
70004854

Copyright and License
Reproducon, adaptaon, or translaon without prior wrien permission is prohibited, except as allowed under
the copyright laws.
The informaon contained herein is subject to change without noce.
The only warranes for ALPINION products and services are set forth in the express warranty statements
accompanying such products and services. Nothing herein should be construed as constung an addional
warranty. ALPINION shall not be liable for technical or editorial errors or omissions contained here in.
Prepared by:
ALPINION MEDICAL SYSTEMS Co., LTD.
4F, 15, Magokjungang 14-ro,
Gangseo-gu, Seoul, 07789, Republic of Korea
Telephone: [phone] Fax: [phone] www.alpinion.com
Copyright © ALPINION MEDICAL SYSTEMS Co., LTD, All rights reserved.
Revision Log
The following is a list of major changes and addions that have been made to this manual since it was rst
released.
Rev Date (YYYY/MM/DD) Descripon
Rev. 0 2019/01/22 User manual rst released
Rev. 1 2019/03/15 Updated for Rev. 1 release
Rev. 2 2019/08/27 Updated for Rev. 2 release
Rev. 3 2020/01/10 Updated for Rev. 3 release
Rev. 4 2021/12/15 Updated for Rev. 4 release
Rev. 5 2022/05/31 Updated for Rev. 5 release
Rev. 6 2022/10/14 Updated for Rev. 6 release

Table of Contents
1. System Basics............................................................................... 1-1
Introducon......................................................................................................... 1-2
System Components............................................................................................ 1-6
Peripherals and Accessories .............................................................................. 1-11
Image Display..................................................................................................... 1-17
Control Panel ..................................................................................................... 1-19
QWERTY Keyboard............................................................................................. 1-22
Touch Screen...................................................................................................... 1-23
Transducers........................................................................................................ 1-24
2. Geng Started ............................................................................ 2-1
Operang Requirements ..................................................................................... 2-2
Moving and transporng the system................................................................... 2-3
Powering On/O.................................................................................................. 2-6
Adjusng the Monitor and Touch Screen ............................................................ 2-8
Connecng/Disconnecng the Transducer ....................................................... 2-10
Acvang/Deacvang the Transducer ............................................................ 2-11
3. Starng a Study ........................................................................... 3-1
Paent Registraon ............................................................................................. 3-2
4. Imaging Modes............................................................................ 4-1
2D Mode.............................................................................................................. 4-2
M Mode ............................................................................................................. 4-18
Color Flow (CF) Mode ........................................................................................ 4-23
Power Doppler (PD) Mode................................................................................. 4-32
Pulsed Wave Doppler (PWD) Mode................................................................... 4-38
Connuous Wave Doppler (CWD) Mode........................................................... 4-47
Tissue Doppler Imaging (TDI) Mode .................................................................. 4-52
3D and 4D Modes .............................................................................................. 4-54

5. Imaging Funcons........................................................................ 5-1
Freezing Images ................................................................................................... 5-2
Zooming Images .................................................................................................. 5-3
Full Screen ........................................................................................................... 5-4
Screen Split .......................................................................................................... 5-5
CINE Images......................................................................................................... 5-6
Annotang Images............................................................................................... 5-7
Panoramic Imaging ............................................................................................ 5-13
Needle Vision™ Plus .......................................................................................... 5-17
Contrast Enhanced Imaging............................................................................... 5-19
Elastography ...................................................................................................... 5-22
Stress Echo......................................................................................................... 5-30
Cube Strain™...................................................................................................... 5-44
6. Managing Paent Informaon and Image .................................... 6-1
Clipboard ............................................................................................................. 6-2
Touch Clip ............................................................................................................ 6-4
E6-view ................................................................................................................ 6-5
DICOM Spooler .................................................................................................. 6-18
Printer................................................................................................................ 6-20
DVR .................................................................................................................... 6-21
7. Measurements and Reports......................................................... 7-1
Basics ................................................................................................................... 7-2
Abdomen ........................................................................................................... 7-34
Obstetrics........................................................................................................... 7-43
Gynecology ........................................................................................................ 7-82
Cardiology.......................................................................................................... 7-92
Vascular ........................................................................................................... 7-129
Urology ............................................................................................................ 7-142
Pediatrics ......................................................................................................... 7-149
Small Parts ....................................................................................................... 7-158
Breast............................................................................................................... 7-166
Musculoskeletal (MSK) .................................................................................... 7-173

Emergency Medicine (EM)............................................................................... 7-178
8. Transducer and Biopsy ................................................................. 8-1
Transducer ........................................................................................................... 8-2
Biopsy .................................................................................................................. 8-7
Transducer Accessories...................................................................................... 8-18
9. Preset ........................................................................................ 79-1
System Preset ...................................................................................................... 9-2
Image Preset...................................................................................................... 9-47
10. Care and Maintenance............................................................. 710-1
System Care and Maintenance .......................................................................... 10-2
Baery Care and Maintenance.......................................................................... 10-6
Transducer Care and Maintenance.................................................................... 10-7
11. Safety and Regulatory Informaon............................................. 11-1
Safety Summary................................................................................................. 11-2
Equipment Safety Informaon........................................................................... 11-3
Paent Safety Informaon................................................................................. 11-4
An11-Virus Program ........................................................................................ 11-5
Electrical Safety Informaon.............................................................................. 11-6
Transducer Safety Informaon .......................................................................... 11-7
Biopsy Safety Informaon.................................................................................. 11-9
System Symbols and Labels ............................................................................. 11-10
Regulatory Informaon.................................................................................... 11-14
Electromagnec Compability (EMC).............................................................. 11-17
Diagnosc Ultrasound Indicaons for Use Format.......................................... 11-22
Acousc Output............................................................................................... 11-43
12. Appendix ................................................................................... 12-1
Appendix A. Biopsy Guide.................................................................................. 12-2

1
Introducon........................................................................................................... 1-2
System Components.............................................................................................. 1-6
Peripherals and Accessories ................................................................................ 1-11
Image Display ...................................................................................................... 1-17
Control Panel....................................................................................................... 1-19
QWERTY Keyboard .............................................................................................. 1-22
Touch Screen ....................................................................................................... 1-23
Transducers ......................................................................................................... 1-24
This chapter describes the system overview and operator controls.
System Basics

1-2 System Basics
Introducon
System overview
The E-CUBE 8 ultrasound system provides excellent quality and reliability as well as these specic
features:
Table 1-1 System feature
Physical Dimensions
•Height: 1470/1560 mm
•Width: 532 mm
•Depth: 787 mm
•Weight: 55 kg (not including opons)
Clinical Applicaons
•Abdomen
•OB
•GYN
•Cardiology
•Small Parts
•MSK
•Vascular
•Urology
•EM
•TCD
•Breast
•Appendix
Available Imaging Modes
•2D mode
•Harmonic mode (HAR)
•M mode
•Color M mode
•Anatomical M mode (AMM)
•Color Flow Doppler (CF) mode
•Power Doppler (PD) mode
•Direconal PD mode
•Pulsed Wave Doppler (PWD) mode
•Connuous Wave Doppler (CWD) mode
•High PRF Doppler mode
•Tissue Doppler Imaging (TDI) mode
•3D/4D mode
Image Processing Technology
•Xpeed™
•Full SRI™
•Spaal Compounding Image (SCI)
•Panoramic
•Live HQ™
•Needle Vision™/Needle Vision™ Plus
•Contrast Enhanced Ultrasound (CEUS)
•ECG
•Elastography
•Filter Method Tissue Harmonic Image (FTHI)
•Pulse Inversion Tissue Harmonic Image (PTHI)
•Raw Data Processing
•Post Processing

Introducon 1-3
Operable Transducers
Pencil Doppler •CW2.0
•CW5.0
Linear Array •L3-12T
•L3-12H
•L3-12HWD
•L8-17H
•IO3-12
•IO8-17T
Sector Phased Array •SP3-8T
•P1-5CT
Convex Array •C1-6CT
•C5-8NT
•SC1-4H
•SC1-4HS
•SC1-6H
Endocavity •EV3-10T
•EC3-10T
•E3-10
Volume Convex •VC1-6T
Volume Endocavity •VE3-10H
Measurement Package
Including reports for:
•Abdomen
•OB
•GYN
•Cardiology
•Vascular
•Urology
•Pediatrics
•Small Parts
•Breast
•MSK
•EM
Basic Measurements
2D Mode •Distance, Ellipse, Trace
•Area, Circumference
•%Stenosis
•Volume
•Angle
•A/B Rao
•Volume Flow Area
Doppler Mode •Velocity
•Time
•PI
•Trace
•Acceleraon
•S/D Rao
•RI
•Auto Trace

1-4 System Basics
Basic Measurements (cont.)
M Mode •A/B Rao
•Distance
•Time
•Slope
•%Stenosis
•HR
Connecvity
•Vericaon
•DICOM storage
•DICOM print
•DICOM storage commitment
•DICOM media
•DICOM worklist
•DICOM MPPS
•DICOM Structured Report (OB-GYN)
•DICOM Structured Report (Echocardiography)
•DICOM Structured Report (Vascular)
•Cube View™
•Network Storage
•Wireless LAN (Opon)
User Interface
•English
•German
•French
•Spanish
•Italian
•Russian
•Portuguese
•Chinese

Introducon 1-5
Documentaon
CAUTION
Safety instrucons must be reviewed before operang the unit.
E-CUBE 8 documentaon consists of following manuals:
•The User Manual and Quick Guide (TRANSLATED) provides informaon needed by the user to operate
the system safely. It describes the basic funcons of the system, safety features, operang modes,
measurements/calculaons, transducers, and user care and maintenance.
•The Reference Manual (ENGLISH ONLY) contains data tables, such as Obstetric and Cardiology
references.
•The Service Manual (ENGLISH ONLY) supplies block diagrams, lists of spare parts, descripons,
adjustment instrucons or similar informaon which helps qualied technical personnel in repairing
those parts of the system which have been dened as repairable.
The E-CUBE 8 manuals are wrien for users who are familiar with basic ultrasound principles and
techniques. They do not include sonographic training or detailed clinical procedures.
NOTE
•The manuals are only provided in electronic format on the CD.
•The CD includes English and all translaons.
•The screen images in this manual are only for illustraonal purposes. Actual screen display may dier
slightly from that shown in this manual.
Contraindicaon
Using the system for certain purposes such as gender determinaon is severely restricted by law.
Do not operate the system for an ophthalmic purpose or any use aecng the paent’s eye by the
acousc beam.
Prescripon device
United States law restricts this device to sale or use by, or on the order of a physician.
Intended operator prole
The E-CUBE 8 is intended for use by a qualied and trained physician or sonographer with at least basic
ultrasound knowledge for ultrasound evaluaon.
The operator must have read and understood the user manual.

1-6 System Basics
System Components
Front view
There are the main components of your system:
2
4
8
9
10
1
3
5
6
7
Figure 1-1 Front view
No. Component No. Component
1Monitor (21.5-inch wide display) 6Control panel
2LED lamp 7Up/Down lever
3Gel warmer 8Handle
4Transducer holder 9Transducer cable holder
5Transducer holder 10 CW port

System Components 1-7
Rear view
1
43
5
2
Figure 1-2 Rear view
No. Component No. Component
1I/O panel 4ECG port
2AC outlet 5System on/o switch
3AC inlet
NOTE
When connecng an external monitor to your system, use the monitor with 1366 x 768 or higher resoluon.

1-8 System Basics
Side view
1
2
34
Figure 1-3 Side view
No. Component No. Component
1Monitor arm 3Caster lock
2Transducer port 4Caster
Peripheral area
In the middle of the system, you can place oponal peripherals such as black and white printer and color
printer.
CAUTION
The peripheral area is only for peripheral devices. Do not place transducers or the footswitch in the
peripheral area to prevent damaging them from accidentally falling o.

System Components 1-9
I/O panel
I/O panel located on the rear side of a system includes video input and output, audio input and output,
Ethernet, power and control connecons for a printer. See Figure 1-4 below for more details.
CAUTION
•Each outer (case) ground line of peripheral/accessory connectors are earth grounded. Signal ground lines
are not isolated.
•For compability reasons, use only ALPINION approved transducers, peripherals or accessories.
•Be sure to plug the power supply cable of the peripherals to the connector panel of the system to avoid
unexpected electrical shock.
•Do not connect any transducer or accessories without approval from ALPINION.
1211
9
8
10
1 2 3
4 5 6
7
Figure 1-4 I/O panel
No. Component No. Component
1B/W printer port 7VGA port
2Color printer port 8Audio in port (Reserved)
3S-Video input port (Rerserved) 9HDMI port
4Remote control port for a B/W printer 10 Audio out port
5 Remote control port for a color printer 11 USB ports (4 ports)
6S-Video output port 12 Ethernet port
NOTE
The external storage media such as USB HDD or DVD-RW should be connected with the system referring to
the following instrucons.
•If power consumpon of the external storage media corresponds to more than 0.5 A and less than 1 A, you
should use 3 or 4 port to get it acvated properly.
•If power consumpon of the external storage media exceeds 1A, you should use a Y-cable that makes the
external storage media receive power from two USB ports at the same me.

1-10 System Basics
CAUTION
•The connecon of equipment or transmission network other than as specied in these instrucons can
result in electric shock hazard.
•Connected peripherals must meet IEC standard (An equipment that processes data: IEC 60950/EN 60950,
a medical equipment: IEC 60601-1/EN 60601-1). For product conguraon, it must meet the safety
requirements of product standard IEC/EN 60601-1 or system standard IEC 60601-1-1/EN 60601-1-1.
•The operator shall not contact the parts (SIP/SOP) and the paent simultaneously.
•When connecng a cable to the ethernet (LAN) port, always use the oponal LAN isolator (EN-20G by
EMO system or any similar isolator complying with IEC/EN 60601-1) to protect your system from electrical
damage.

Peripherals and Accessories 1-11
Peripherals and Accessories
Before using the peripherals or accessories, you should consider the following requirements.
WARNING
Observe all warnings and cauons given in the operaon manual of peripheral device.
CAUTION
For compability reasons, use only ALPINION approved peripherals or accessories. DO NOT connect any
peripherals or accessories without approval by ALPINION.
Peripheral update for EU countries
The following is intended to provide the users in EU countries with updated informaon concerning the
connecon of the E-CUBE 8 to image recording and other devices or communicaon networks.
The E-CUBE 8 has been veried for overall safety, compability and compliance with the following on-
board image recording devices:
•Color Printer
Manufacturer: Sony Corporaon
Model: UP-D25MD, UP-25MD
•B/W Printer
Manufacturer: Sony Corporaon, Mitsubishi Electric Corporaon
Model: UP-D898MD, UP-X898MD, P95DE(P95DW)
•DVD-RW
Manufacturer: Hitachi-LG Data Storage, Inc
Model: GP50NW40
The E-CUBE 8 has also been veried for compability, and compliance for connecon to a local area
network (LAN) via the rear panel Ethernet connecon, provided the LAN components are IEC/EN 60950
compliant.
The E-CUBE 8 may also be used safely while connected to devices other than those recommended above
if the devices and their specicaons, installaon, and interconnecon with the system conform to the
requirements of IEC/EN 60601-1-1.

1-12 System Basics
Basic accessories
The E-CUBE 8 has the following basic accessories:
•E-CUBE 8 console •User Manual, Reference Manual (So copy)
•Sonic gel •Quick Guide (So copy)
Oponal supplies and accessories
The following tables show oponal supplies and accessories that have been veried to be compable
with the system.
Biopsy kit
•L3-12 Biopsy Starter Kit (for L3-12T, L3-12H)
•SC1-6 Biopsy Starter Kit (for C1-6CT, SC1-4H, SC1-6H)
•SC1-4HS Biopsy Starter Kit (for SC1-4HS)
•VE3-10H Disposable Needle Guide (for VE3-10H)
•VE3-10H Reusable Needle Guide (for VE3-10H)
•E3-10 Disposable Needle Guide (for E3-10)
•E3-10 Reusable Needle Guide (for E3-10)
•EN3-10 Disposable Needle Guide (for EV3-10T, EC3-10T)
•EN3-10 Reusable Needle Guide (for EV3-10T, EC3-10T)
Oponal funcon
•Full SRI •SRI •Elastography
•FTHI (Filtered Tissue Harmonic) •Auto IMT •Cube ViewTM
•Xpeed •CW •Needle Vision™
•Spaal compounding •Anatomical-M •Needle Vision™ Plus
•Value 3D/4D •Frequency Compounding •Auto NT
•CV M&R •Panoramic •Volume Advance
•DICOM 3.0 Connecvity •Tissue Doppler Image •Cube Note
•DICOM SR (OB) •Stress Echo •AutoEF
•DICOM SR (Adult Echo) •Cube StrainTM
•DICOM SR (Vascular) •Live HQTM
Console accessory
•Tri-pedal footswitch

Peripherals and Accessories 1-13
Footswitch (Opon)
The oponal tri-pedal footswitch that is connected with the rear panel of your system performs specic
funcons easily instead of pressing funcon keys on the control panel.
The each pedal of the footswitch may have dierent funcons depending on the assigned sengs such
as Freeze, P1, P2, P3, and Rec/Pause.
To assign the footswitch funcons, press the [System Preset] key and go to User Seng > Print/Foot
Switch.
Figure 1-5 Footswitch
CAUTION
Do not place or store the footswitch in the peripheral area on the system to prevent damaging the footswitch
from accidently falling o.
Wireless LAN (Opon)
A Wireless Network is available on the E-CUBE 8. For adjusng a wireless LAN connecon, see "Network"
on page 9-34.
Using unrecommended wireless LAN adapter may cause system malfuncon. To prevent system
malfuncon, only use wireless LAN adapters approved or recommended by ALPINION.
NOTE
Please contact your local agent to get the latest informaon on compable wireless LAN adapters.

1-14 System Basics
Baery (Opon)
This system uses lithium ion baeries. The lithium ion baery provides power if AC power is not
available.
NOTE
The baery is designed to work with E-CUBE 8 systems only. Use only the baeries authorized by Alpinion
Medical Systems.
The length of the me the system can run on the baery will vary, depending on the diagnosc mode
and the peripherals connected.
If the baery level runs low while using the system, connect it to an AC power source to recharge the
baery.
WARNING
•The baery has a safety device. Do not disassemble or alter the baery.
•Do not heat the baery or discard it in a re.
•Do not leave the baery in direct sunlight.
•Do not short-circuit the baery by directly connecng the negave terminals with metal objects.
•Do not subject baeries to mechanical shock.
•Do not use a damaged baery. If the baery emits an unusual odor or heat during use or recharging,
immediately stop using it and contact an authorized agent or an ALPINION MEDICAL service engineer.
CAUTION
•This system has an embedded baery. The baery used in the system must be replaced by an authorized
agent or an ALPINION MEDICAL service engineer.
•Ensure that water or liquids do not drip into the baery connecon area.