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SAMSUNG CONFIDENTIAL

A35
Data Sheet
Version 3.01

Dec. 2014

Preliminary Version

Samsung Medison Bldg., 42, Teheran-ro 108-gil, Gangnam-gu, Seoul 135-851, Korea
TEL:(82)2-2194-1400 FAX:(82)2-556-9537
www.samsungmedison.com
Strategy Marketing Team
SAMSUNG CONFIDENTIAL

www.samsungmedison.com

Table of Contents

1 GENERAL SPECIFICATION -------------------------------------------------------------- 1


1.1 Physical Specification ------------------------------------------------------------------ 1

1.2 Electrical Power ------------------------------------------------------------------ 1

1.3 Console Design ------------------------------------------------------------------ 1

1.4 Control Panel ------------------------------------------------------------------ 1

1.5 Monitor ------------------------------------------------------------------ 1

1.6 Touch Screen ------------------------------------------------------------------ 2

1.7 PC ------------------------------------------------------------------ 2

2 System Specification -------------------------------------------------------------- 2


2.1 Application ------------------------------------------------------------------ 2

2.2 Transducer Types ------------------------------------------------------------------ 2

2.3 Operation Modes ------------------------------------------------------------------ 2

2.4 Display Modes ------------------------------------------------------------------ 3

2.5 System Standard Features ------------------------------------------------------------------ 3

2.6 System Options ------------------------------------------------------------------ 4

2.7 Peripheral Options ------------------------------------------------------------------ 4

2.8 Documentation Capability ------------------------------------------------------------------ 4

2.9 Peripheral Signals ------------------------------------------------------------------ 5

2.10 Operating Environment ------------------------------------------------------------------ 5

2.11 Acoustic Output Management ------------------------------------------------------------------ 5

2.12 Language ------------------------------------------------------------------ 5

2.13 Scan Mode ------------------------------------------------------------------ 5

2.14 Image Parameters ------------------------------------------------------------------ 6

3 Processing -------------------------------------------------------------- 6
3.1 Pre-Processing ------------------------------------------------------------------ 6

CONFIDENTIAL
THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION WHICH IS PROPRIETARY TO SAMSUNG MEDISON CO., Ltd. THE DOCUMENT AND ITS CONTENTS
(INFORAMTION) CANNOT BE COPIED OR DISCLOSED WITHOUT THE EXPRESSED WRITTEN CONSENT OF SAMSUNG MEDISON CO., Ltd.
SAMSUNG CONFIDENTIAL

www.samsungmedison.com

3.2 Post-Processing ------------------------------------------------------------------ 6

3.3 Image Processing ------------------------------------------------------------------ 6

3.4 Image Archive ------------------------------------------------------------------ 7

3.5 Cine Memory/Image Memory ------------------------------------------------------------------ 7

4 Connectivity -------------------------------------------------------------- 7
4.1 DICOM(Optional) ------------------------------------------------------------------ 7

5 Scanning Parameters -------------------------------------------------------------- 8


5.1 2D Mode ------------------------------------------------------------------ 8

5.2 M Mode ------------------------------------------------------------------ 8

5.3 Color Doppler Mode ------------------------------------------------------------------ 9

5.4 Power Doppler Mode ------------------------------------------------------------------ 10

5.5 PWD Mode ------------------------------------------------------------------ 11

5.6 CWD Mode ------------------------------------------------------------------ 12

5.7 Volume Mode ------------------------------------------------------------------ 13

5.8 Calipers & General Measurements ------------------------------------------------------------------ 14

5.9 Doppler General Measurements ------------------------------------------------------------------ 14

6 Probes -------------------------------------------------------------- 14
6.1 Linear Array ------------------------------------------------------------------ 14

6.2 Convex Array ------------------------------------------------------------------ 15

6.3 Endocavity Array ------------------------------------------------------------------ 16

6.4 Volume Probe ------------------------------------------------------------------ 17

6.5 Phased Array ------------------------------------------------------------------ 17

6.6 Continuous Wave Probe ------------------------------------------------------------------ 17

7 Measurement -------------------------------------------------------------- 18
7.1 OB Measurement ------------------------------------------------------------------ 18

7.2 OB Table Reference ------------------------------------------------------------------ 19

7.2 Gynecology Measurement ------------------------------------------------------------------ 20

7.3 Cardiac Measurement ------------------------------------------------------------------ 20

7.4 Carotid Measurement ------------------------------------------------------------------ 20

7.6 LE Artery Measurement ------------------------------------------------------------------ 21

CONFIDENTIAL
THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION WHICH IS PROPRIETARY TO SAMSUNG MEDISON CO., Ltd. THE DOCUMENT AND ITS CONTENTS
(INFORAMTION) CANNOT BE COPIED OR DISCLOSED WITHOUT THE EXPRESSED WRITTEN CONSENT OF SAMSUNG MEDISON CO., Ltd.
SAMSUNG CONFIDENTIAL

www.samsungmedison.com

7.7 UE Artery Measurement ------------------------------------------------------------------ 21

7.8 LE Vein Measurement ------------------------------------------------------------------ 21

7.9 UE Vein Measurement ------------------------------------------------------------------ 22

7.10 Fetal Echo Measurement ------------------------------------------------------------------ 22

7.11 Urology Measurement ------------------------------------------------------------------ 22

7.12 Abdomen Measurement ------------------------------------------------------------------ 23

7.13 Thyroid Measurement ------------------------------------------------------------------ 23

7.14 Breast Measurement ------------------------------------------------------------------ 23

7.15 Testicle Measurement ------------------------------------------------------------------ 23

7.16 Superficial Measurement ------------------------------------------------------------------ 23

7.17 TCD Measurement ------------------------------------------------------------------ 23

7.18 MSK Measurement ------------------------------------------------------------------ 24

7.19 Pediatric Hip Measurement ------------------------------------------------------------------ 24

8 Safety -------------------------------------------------------------- 24
8.1 Classifications ------------------------------------------------------------------ 24

8.2 Applicable Standard & Regulation ------------------------------------------------------------------ 24

CONFIDENTIAL
THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION WHICH IS PROPRIETARY TO SAMSUNG MEDISON CO., Ltd. THE DOCUMENT AND ITS CONTENTS
(INFORAMTION) CANNOT BE COPIED OR DISCLOSED WITHOUT THE EXPRESSED WRITTEN CONSENT OF SAMSUNG MEDISON CO., Ltd.
SAMSUNG CONFIDENTIAL

www.samsungmedison.com

GENERAL SPECIFICATION  Front Wheel Central Lock

 Front and rear handles


PHYSICAL SPECIFICATION
 Rear storage cover for peripheral connectors and

 Height: 1,415 ~ 1,760 mm cables

 Width: 549 mm  Integrated cable management

 Depth: 1,002 ~ 1,137 mm  Integrated high-fidelity stereo speakers

 Weight with monitor: approx. 115 kg (253.5lb.)  Prevention of noise of the system

 Easily removable air filter


ELECTRICAL POWER
 Integrated DVD Multi Recordable Driver
 Voltage: 100- 240 V AC

 Frequency: 50/60 Hz
CONTROL PANEL
 Power Consumption

786.5 VA with Peripherals • Height: adjustable 180 mm

636.5 VA without Peripherals • Rotation: adjustable +/- 30° from center

 Nominal Current: • Ergonomic hard key operations

110V: 8.93A • Hard key layout for General Imaging

220V: 4.47A • Functional grouping of keys

 Heat Dissipation: 3354.5 BTU/h • Interactive back-lighting

 Probe IPX: 7 • Functional grouping of keys on 9” Wide LED Touch

 Foot Switch IPX: 1 Panel (Resolution 800 x 480 x 24 bits)

 Safety Class • Integrated alphanumeric QWERTY backlit keyboard

Ultrasound system: B and Virtual Screen alphanumeric QWERTY

Transducer: BF (depend on transducer specification) keyboard on Touch Panel

• Integrated recording keys for remote control of


CONSOLE DESIGN
peripherals or DICOM devices
 5 active probe ports (include pencil probe) • Trackball
 Height/Rotate adjustable control panel • 8 TGC Slide Controls
 Height/Tilt/Rotate adjustable monitor
MONITOR
 On-board storage for peripherals

 6 probe holders • 23 inch Wide Color LED Flat Display

 1 gel holders • Resolution: 1,920 x 1,080 x 24 bits (Full HD)

 4 Swivel/Lock wheels (wheel diameter: 121 mm) • High-Resolution monitor Non Interlace Scan

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• Height: adjustable 1,415 ~ 1,760 mm  Muskuloskeletal

• Forth/Back: adjustable ~ 339.4 mm  Breast

• Tilt: adjustable +45° / - 15° from center  Cardiology

• Rotate: adjustable +/- 50° from center,  Pediatric

others +/- 130° from center High brightness &  Neonatal

contrast  TCD

• Digital brightness & contrast adjusent


TRANSDUCER TYPES
TOUCH SCREEN
 Convex Array

• 9” Wide LED Touch Screen Control C2-6IC, SC1-6, CA1-7A, CA2-8A

• Interactive dynamic soft key menu display  Volume Probes

• Display Resolution : 800 x 480 x 24bits - Convex Volume : V2-6, V4-8, CV1-8A

- Endocavity Volume : V5-9


PC
 Micro-Convex Array
• Operating System : Window 7 Embedded CF4-9
• CPU : Intel® Core i7-3635QM @ 2.4GHz  Linear Array
• RAM : DDR3 SDRAM 8GB L4-7, L5-13IS, L7-16IS, L5-13/50, LS6-15, LA3-14A,
• HDD : Integrated SATA HDD (500GB) LA3-16A

 Endocavity

EC4-9IS, VR5-9, EA2-11B


SYSTEM SPECIFICATION
 Phased Array
APPLICATIONS P2-4BA

 Pencil Probes
 General
CW4.0, CW6.0, DP2B
 Abdominal

 Gynecology
OPERATION MODES
 Obstetrical

 OB Early • 2D-Mode
 Renal • M-Mode
 Fetal Heart • Color Doppler Imaging
 Urology • Power Doppler Imaging
 Vascular • Pulsed Wave (PW) Spectral Doppler
 Small Parts • Continuous Wave (CW) Spectral Doppler

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• Tissue Doppler Imaging (TDI) • Tissue Harmonic Imaging

• Directional Power Doppler Imaging (DPDI) • Pulse Inversion Harmonic Imaging

• Color M-Mode • Trapezoidal Imaging

• Harmonic Imaging • Quick Scan (Automatic Optimization)

• Free Angle M-Mode (Arbitrary M mode) • DMR plus

• Single/Dual/Quad mode • Spatial Compounding Imaging

• Volume-mode(3D/4D) • Elastoscan

- L5-13IS (Small Parts>Breast, Thyroid(Except


DISPLAY MODES
North America))

• Simultaneous Capability: - L5-13/50 (Small Parts>Breast, Thyroid(Except


B+M, B+PW, B+C, B+PD, B+DPDI, B+TD(Tissue North America))
Doppler), B+C+PW, B+PD+PW, B+DPDI+PW, B+C+M - EC4-9IS (Urology>Prostate, Gynecology
• Selectable Alternative Modes: >General, Adnexa)
B+C, B+PW, B+CW, B+C+PW, B+PD+PW, - VR5-9 (Urology>Prostate, Gynecology
B+DPDI+PW, B+C+M, Dual Mode(Combine B, B+C, >General, Adnexa)
B+PD, B+PD), Quad Mode(Combine B, B+C, B+PD, - LA3-16A (Small Parts>Breast, Thyroid(Except
B+PD), B+C+CW, B+PD+CW, B+E(ElastoScan) North America))

• Colorized Image: - LA3-14A (Small Parts>Breast, Thyroid(Except


Colorized B, Colorized M, Colorized D, Colorized 3D North America))

• Time Line Display: • Panoramic Imaging


Format: Top/Bottom or Side/Side selectable • AutoIMT
Size: 1/2, 1/3, 2/3, Full • VolumeNT/IT
Timeline Method: Scrolling or Moving Bar • XI STIC
• Multi Image Split Screen: • VOCAL, XI VOCAL
Live and/or Frozen, B+B/C or PD, Independent Cine • 3D/4D
Playback) • Multi Slice View
Dual Mode (Combine B, B+C, B+PD, B+PD) • Oblique View
Quad Mode (Combine B, B+C, B+PD, B+PD) • Volume CT
• Zoom: Write / Read (Magnification) / Pan • OVIX, Multi-OVIX

• Volume Slice View


SYSTEM STANDARD FEATURES
• Mirror View
• Full Spectrum Imaging (3 bands) • Inversion 3D

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• FAD  3D MXI

• SFVI  Convex SCI*

• VSI * Countries which buy convex SCI as option is only

• Smooth cut applied

• FRV  CW Function

• Contrast Agent(Low MI)  Cardiac Measurement

• MagiCut  DICOM

• Raw Data Analysis  Spatial Compound Imaging (SCI)

• Post-image optimization  Strain

• Patient Information Database  StressEcho

• Image Archive integrated on CD/DVD and HDD  XI STIC

drive  Auto IMT

• Support for external USB 2.0 HDD drive  ElastoScan(ECI)

• Cine for 12,700(Max Condition) frames and Loop  Panoramic Imaging

Review for 8,192 lines  HDVI

• Auto Calc (Real-Time Automatic Doppler  VolumeNT

Calculation)  ADVR (Agile DVR)

• Doppler Auto Trace  FRV

• User Configurable Measurement Menu  Auto IMT+

• Customizable Measurement Menu


PERIPHERAL OPTIONS
• Customizable Body Maker

• Customizable User Keys • Integrated options for Digital B/W Printer, Digital

• Post-Measurement Color Printer, Digital Color Report Printer

• On-board electronic documentation • External USB Printer Connections

• Fully Digital Real Time Recording • DVI-I Output Available for compatible devices

• EZ exam • Digital ECG

• Screen Keyboard • Foot switch (USB type)

• 3D Stereo Cine
DOCUMENTATION CAPABILITY

SYSTEM OPTIONS
• ADVR

 4D • On-board printing device control

 3D XI • Selective printing on two connected printers

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• SonoView II (Image Filing Package) ACOUSTIC OUTPUT MANAGEMENT

• Export Media: CD/DVD+R/-R/RW, USB Flash,


 User selectable, transducer and scanning mode
External USB HDD
dependent
• Export Format: JPEG,BMP,TIFF,DICOM
 Dedicated Output Display on the system monitor
• Print Function
display of output acoustic power level, as well as
• Capacity:10BASE-T(Min.4000frame)
thermal and mechanical indices:
• Patient list and data search
 PWR – Output Power level. Range: From 10 % of
• Report save available
maximum output, output level is increased by 5%
• Post image processing available
in each step.
• Caliper measurement available
 Mechanical Index (MI): 0.1~3.0 Range
• DICOM 3.0
 Thermal Index (TI): 0.1~5.0 Range
Service: Storage/Printer/Worklist/PPS/SC
TIC – Thermal Index, Bone at Surface
DICOM SR Structured Reports
TIB – Thermal Index, Bone at Focus
PERIPHERAL SIGNALS TIS – Thermal Index, Soft Tissue

 Audio Right & Left I/O Port LANGUAGE


 LAN (I/O) : Ethernet, 100/10 BASE-T
 Display Language
 B/W Printer port (USB type) (O)
English, German, French, Spanish, Italian,
 Patient Monitor (DVI-I Connector) (O)
Russian, Chinese
 Patient Monitor Power (O)
 Input Language
 Video Output
English, German, French, Spanish, Italian,
- VHS, S-VHS : Each 1 Port
Russian, Korean, Chinese, Japanese
- DVI(for Full HD & RGB) : 2 Ports
 ECG AUX input (optional)
SCAN MODE
 USB port (I/O, USB 2.0) : 8 ports(front2 , rear6 )

 Microphone Input Port  Simultaneous Mode : 3 Type off, Allow B/PWD,

Allow B/C/PWD
OPERATING ENVIRONMENT
 Auto Unfreeze While Dual Operation

 Ambient temperature: 10°C–35°C (50°F–104°F)  Change Window at Dual Mode

 Relative humidity: Up to 75% non-condensing  2D/C Live Mode

 Pressure: 700~1060hPa Left/ Up, Right/ Down

 Audible noise: 70dB 2D/C Live left-Right Dual Only

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 Freeze Action : 4 Type PRE-PROCESSING


None
• 2D / M-Mode
Body Marker
Gain, TGC, Dynamic Range, Transmission Focus
Caliper
Position, Transmission Focus Number, Transmission
Measure
Frequency, Edge Enhancement, Sweep Speed for
 End Exam Action : End exam Only, End exam and
M-Mode
Patient
• Color-Mode

IMAGE PARAMETERS Gain, Velocity Range, Wall Filter, Ensemble,

Spatial Filter, Frame Averaging, Baseline Shift,


• 2D Gain 0 ~ 100 Smoothing Filter
• Power 10 ~ 100
• D-Mode
• Edge Enhance -3 ~ 3 Gain, Dynamic Range, Transmission Frequency,
• Frame Average 0 ~ 15 Velocity Scale/PRF, Wall Filter, Baseline Shift,
• 2D Filter Sweep Speed
• View area Control

• View area Steering POST-PROCESSING

• Dynamic Range 50~200 dB


 2D Quick Scan (Automatic Tissue Optimization)
(User selectable in 1 dB increments)
 Doppler Quick Scan (Automatic Spectrum
• Reject Level 1 ~ 32
Optimization)
• Gray map 13 types
 Gray Maps (2D Mode: 13 types / M-Mode: 13 types)
• Chroma map 15 types + 3 User types
 Chroma map (2D Mode : 18 types / M Mode : 18
• Trapezoidal Image
types)
• U/D Flip, L/R Flip
 Reject Function from 1 to 32 in 32 digit steps
• Line Density Low / Middle / High

• Max. Frame Rate 1,177Hz IMAGE PROCESSING


(L5-13IS, Triple-beam, Depth 2cm, Scan Area 40% )

• Frequency optimized setting: Pen(penetration) / • Digital Beamformer

Gen(general) / Res(resolution) • Imaging Depth 2 ~ 30 cm

• Dynamic Receive Focus

• Dynamic Receive Aperture


PROCESSING
• 688,128 System processing channel technology

• Tx Apodization

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• Tx Pulse Shaping CONNECTIVITY


• Adjustable Dynamic Range
DICOM (OPTIONAL)
• Adjustable Field of View

• Image Reverse: Left / Right, Up/Down  Ethernet Network Connection

• Transmission Focus:  Archiving Format:


1 ~ 8 Focal Points Selectable; Focus Position: 8  DICOM with ultrasound raw data
steps (probe independent)  Capture Area: pre-settable for each print key

• 256 shades of gray, 8 bits  Video Area

• 16,777,216 colors, 8 bits for each RGB component  Application Window

Whole Screen
IMAGE ARCHIVE
 Configurable Examination List Window, Patient

Information Window, and Search/Create Patient


• Archiving Format: DICOM
Window
• Possibly exported to other format
 Extended search dialog, auto search for patient in
• Archive Devices:
HDD Image Storage Search/Create Pts window

CD -RW Storage, DVD-RW Storage  Automatic generation of patient ID

USB Memory Stick  Request acknowledge of End Exam action

 Go directly screen from search


CINE MEMORY/IMAGE MEMORY  Verify DICOM directory on removable media

 Format removable media (rewritable DVD)


• CINE Gauge and Cine Image number display
 The currently selected dataflow
• CINE Review Loop
 All configured data flowstx
• Selectable CINE Sequence for CINE Review (by Start
 The network structure tree
Frame and End Frame)
 The configured buttons data flows
• Measurements/Calculations & Annotations on CINE
 AVI and JPEG Export : DICOM Support
• Available in all modes(include loop)
 DICOM Storage Commient Push Model User
• Imaging Cine, for real-time acquisition and review
 DICOM Modality Performed Procedure Step User
of 2-D
 DICOM Printer User
• After freezing immediate scrolling through Cine
 DICOM Store User
memory with the Track ball
 DICOM Modality Worklist User
• CINE memory: Max. 12700 frames
 DICOM Structured Report Cardiology, Vascular and
• Loop memory: Max. 8192 lines
OB/GY User

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SCANNING PARAMETERS  Gray Map 1 ~ 13 step

 View Angle -20° ~ 20°


2D MODE
 2D Image Size 50~100

 Max. Frame Rate: 1,177 Hz  Full Spectrum Image 1 ~ 3 step

 Frame Average 0 ~ 15 step  Store Method(Time, Manual) 2 Mode

 Dynamic Range 50 ~ 200 dB Store method time mode only 1~50 sec

 Reject Level 1 ~ 32 step Store method ECG Beat mode only 1~8 beat

 Edge Enhance -3 ~ +3 step  Zoom 120 ~ 400 %

 View area 40 ~ 100 %  Chroma Map

 Density(High, Middle, Low) 3 step - Type 1 ~ 15 step

 Tissue(1440~1620m/s) 10 step - User 1 ~ 3 step

 Trapezoidal (Linear)  Elastoscan

 Apex (U/D Flip)  Panoramic

 Direction (L/T Flip)  Body marker

 Frame Rate(Slow, Normal, Fast) 3 step  Quick-Scan

 Post Curve 1 ~ 13 step  Moving Line (M Line)

 Harmonic  Moving Line position(Up, Down, Left, Right)

 Pulse Inversion (Probe dependency)  ECG (Probe dependency)

 Time Gain Control 8 slide  Gamma(Hard, Medium, Weak, Off) 4 mode

 Gain 0 ~ 100 %
M MODE
 Power 10 ~ 100 %

 Depth (Probe dependency) 2 ~ 30 cm  M Line


 Focal point 8  Body marker
 Annotation  Annotation
 Single/Dual/Quad Control  Single/Dual/Quad Control
 Top-Bottom Dual  Top-Bottom Dual(Dual mode only)
 Frequency(Pen, Gen, Res) 3 mode  Dynamic range 50 ~ 200 dB
 SRF 3 index  Reject level 1 ~ 32 step
 DMR plus 5 index  Density(High, Middle, Low) 3 step
 Dual Live  Edge enhance -3 ~ 3 step
 Spatial Compound (High, Medium, low, Off)  Tissue(1440~1620m/s) 10 step
4 step  Chroma map

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- Type 1 ~ 13 step  Zoom 120 ~ 400%

- User 1 ~ 3 step  Quick Scan

 Gain control 0 ~ 100 %  ECG (Probe dependency)

 Time gain compensation 8 slice


COLOR DOPPLER MODE
 Depth (Probe dependency) 2 ~ 30 cm

 Frequency(Pen, Gen, Res) 3 step


 Color scale 256 colors
 Sweep speed 60, 120, 180, 240, 300, 360 Hz
 Frame average 0 ~ 9 step
 Post Curve
 Balance 1 ~ 16 Level
- Type 1 ~9 step  PRF 0.1 ~ 18.4KHz
- User 1 ~ 2 step  Velocity
 Frame Rate(Slow, Normal, Fast) 3 step
- Minimum 2.25cm/sec
 Gamma(Hard, Medium, Weak, Off) 4 mode
- Maximum 5.6 m/sec
 Display mode
 Wall filter 0 ~ 3 level (30 ~ 1,600 Hz)
Top/Bottom (30/70, 40/60, 50/50, 60/40, 70/30)
 Color gain 0 ~ 100%
Left/Right
 Frame rate 2 ~ 30Hz
 Power 10 ~ 100
 Read Zoom 120 ~400%
 Gray Map 1 ~ 13 step
 Dual mode(Top/Down, Left/Right)
 Store Method
 Quad mode
- Time (Store method time mode only) 1 ~50  Frequency(Pen, Gen)
sec
 Steer(Linear, convex)
- Manual  TDI
 Harmonic
 Color Invert
 Trapezoidal (Linear probe only)
 Single/Dual/Quad control
 Dual Live
 M Line
 SRF 1 ~ 3 Step
 M line position (Up/Down/Left/Right)
 Elastoscan
 M line Angle 0°~360°
 Up/Down Flip
 Frequency (Pen, Gen, Res)
 Left/Right Flip
 Steer(Left, Right, None)
 Frame Average 0 ~ 15 step
 Scale 0.20 ~ 12.00 KHz
 View Angle -20° ~ 20°
 Baseline 0 ~ 8 step
 Scan Area 40 ~ 100
 Display mode (Color + BW, BW only)
 Full Spectrum Imaging 1 ~ 3 step

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 Color mode (Velocity, Power, Variance, Velocity +  Minimum velocity 2.25cm/sec

Variance)  Maximum velocity 5.6m/s

 Color map 1 ~ 15 type  Wall filter 0 ~ 3 Level

 Sensitivity 2 ~ 31 step  Color gain 0 ~ 100%

 Density(High, Middle1, Middle2, Low)  Frame rate 2 ~ 30Hz

 Power 10 ~100%  Read zoom 120 ~ 400

 Harmonic  Dual mode Top/Down, Left/Right

 Trapezoidal  Quad mode

 SRF 1 ~ 3 Step  Frequency(Pen, Gen)

 Elastoscan  Steer (Linear, Convex)

 Up/Down, Left/Right  Single/Dual/Quad Control

 Dynamic Range 50 ~ 200 dB  M Line

 Reject level 1 ~ 32 step  M Line position (Up/Down/Left/Right)

 Gray Map 1 ~ 13 step  M Line Angle 0°~360°

 View Angle -20°~20°  Frequency (Pen, Gen, Res)

 Scan Area 40~100  Steer (Left, Right, None)

 2D Image Size 50 ~ 100  Filter 0 ~ 3 Step

 Full Spectrum Image 1 ~ 3 step  Scale 0.80 ~ 5.00 KHz

 Edge Enhance -3 ~ 3 step  Display mode

 Chroma Map - Top/Bottom 4:6, 6:4, 5:5

- Type 1 ~ 13 step - Side by Side

- User 1 ~ 3 step  PD mode (DPDI mode/PD mode)

 Tissue(1440 ~ 1620 m/s) 10 step  Color map 1 ~ 8 type

 Gain 0 ~ 100  Balance 1 ~ 16 level

 Zoom 120 ~ 400  Sensitivity 6 ~ 31 step

 Depth 2 ~ 30cm  Store Method(Time, Manual)

 Time Gain Control 1 ~ 8 Slide  Density (High, Middle1, Middle2, Low)

 Quick Scan  Frame Average 0 ~ 15 Step

 Power 10 ~ 100
POWER DOPPLER MODE
 Harmonic

 Trapezoidal (Linear probe only)


 Color scale 256 colors
 SRF 1 ~ 3 step
 PRF 0.1 ~ 18.4KHz

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 Elastoscan  D line update rate (120, 180, 240, 300, 360Hz)

 Up/Down, Left/Right  D mode display size (30/70, 40/60, 50/50, 60/40,

 Dynamic range 50~200dB 70/30)

 Reject level 1 ~ 32 Step  D mode display format(Top/Bottom, Side by Side)

 Gray map 1 ~ 13 Step  Loop Size 8192 loop

 View angle -20° ~ 20°  Steer

 Scan Area 40 ~ 100  Auto calculation

 2D Image Size 50 ~ 100  Multi frequency

 Full Spectrum Image 1 ~ 3 step  Tissue Doppler Imaging

 Edge Enhance -3 ~ 3  Doppler Invert

 Chroma Map  Simultaneous (B,C,D/B,D)

- Type 1 ~ 13 step  TDW

- User 1 ~ 3 step  Annotation

 Tissue (1,440 ~ 1,620m/s) 10 step  Single/Dual/Quad Control

 Gain 0 ~ 100%  M Line

 Zoom 120 ~ 400  M line position

 Depth 2 ~ 30cm  M Line Angle 0°~360°

 Time Gain Control 1 ~ 8 slide  AutoCalc (PSV, DEV, TAP, RI, PI, S/D)

 Quick scan  AutoCalc direction (All, Up, Down)

 Mean Trace
PWD MODE
 Sweep speed(60, 120, 180, 240, 300, 360Hz)

 Frequency (Pen, Gen, Rea)


 PRF 1 ~ 23 KHz
 Steer (Left, Right, None)
 Display height 9 step
 Filter 0 ~ 3 step
(70/30, 65/35, 60/40, 55/45, 50/50, 45/55, 40/60,
 Scale 0.6 ~ 14KHz
35/65, 30/70)
 Sound 0 ~ 100
 Sample Volume 0.5 ~ 15.0mm
 Baseline 0 ~ 8 step
 Wall filter 0 ~ 3 level (30 ~ 1,600 Hz)
 Sample volume 0.5 ~ 10mm
 Spectrum types(type1, type2 ,type3)
 Gray map 1 ~ 13 step
 Doppler average 0 ~ 6 level
 Spectrum Enhance 1 ~ 4 step
 Minimum velocity 5.0cm/sec
 Display Mode
 Maximum velocity 3.05m/sec
Top/Bottom 4:6, 6:4, 5:5
 Display : Sweep, Top/Down

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Side by Side CWD MODE


 Spectrum Type (Type1 ~ Type3)
 PRF 1 ~ 23KHz
 Dynamic range 50 ~ 200dB
 Sweep speed (60, 120, 180, 240, 300, 360Hz)
 Store Method (Time, Manual)
 Wall filter 0 ~ 3 (30 ~ 1,600 Hz)
 Chroma map
 Minimum velocity 19.25cm/sec
- Type 1 ~ 13 step
 Maximum velocity 8,2775 m/sec
- User 1 ~ 3 step
 Display size (30/70, 40/60, 50/50, 60/40, 70/30)
 Power 10 ~ 100
 Display : Sweep
 Harmonic
 Display format Left/Right, Side by Side
 Trapezoidal (Linear probe only)
 Loop size 8192 loop
 Dual live
 Quick scan
 SRF 1 ~ 3
 HPRF
 Elastoscan
 Doppler Invert
 Panoramic
 Single/Dual/Quad control
 Spatial Compound (High, Medium, Low, Off)
 M line angle 0°~360°
 Up/Down, Left/Right flip
 AutoCalc (PSV, EDV, TAP, RI, PI, S/D)
 Top-Bottom Dual(Dual mode only)
 AutoCalc direction (All, Up, Down)
 Frame Average 0 ~ 15 Step
 Mean Trace
 Reject level 1 ~ 32 step
 Sweep speed (60, 120, 180, 240, 300, 360 Hz)
 Gray map 1 ~ 13 step
 Scale 0.6 ~ 14KHz
 View angel -20°~20°
 Sound 0 ~ 100
 Scan area 40 ~ 100
 Baseline 0 ~ 8 Step
 Full Spectrum image 1 ~ 3 step
 Gray map 1 ~ 13 Step
 Line Density (High, Middle, Low)
 Spectrum Enhance 1 ~ 4 Step
 Edge Enhance -3 ~ 3
 Display mode
 Tissue (1440 ~ 1620m/s)
- Top/Bottom 4:6, 6:4 5:5
 Gain 0 ~ 100
- Side by Side
 Zoom 120 ~ 400
 Spectrum Type (Type1 ~ Type3)
 Depth 2 ~ 30 cm
 Dynamic Range 50 ~ 200dB
 Time gain control
 Store Method (Time, Manual)
 Quick scan
 Chroma map
 HPRF

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- Type 1 ~ 13 step  3DXI (3D eXtended Imaging)

- User 1 ~ 3 step - MSV (Multi-Slice View)


 Power 10 ~ 100 - Oblique View
 Harmonic  Static Line Oblique view

 Dual Live  Dynamic Line Oblique view

 SRF 1 ~ 3  Contour Oblique view

 Elastoscan - XI VOCAL
 Up/Down, Left/Right Flip - XI STIC
 Frequency (Pen, Gen, Res)  Multi Oblique View

 Frame Average 0 ~ 15 step OVIX (Oblique View eXtended Imaging)

 Reject level 1 ~ 32 step  Multi-OVIX

 View Angle 20°~20°  Volume CT (VCT)

 Scan Area 40 ~ 100  Cube Volume CT

 Full spectrum Image 1 ~ 3 Step  Cross Volume CT

 Line Density (High, Middle, Low)  3D-MXI (3D Multi-eXtended Imaging)

 Edge Enhance -3 ~ 3 - Multi-OVIX


 Tissue (1440 ~ 1620m/s) - Mirror View
 Gain 0 ~ 100 - Volume Slice
 Zoom 120 ~ 400  3D OH

 Depth 2 ~ 30cm  ROI single control

 Time Gain Control 8 slide  VOCAL(Virtual Organ Computer Aided anaLysis)

 Quick scan  SHELL Histogram

 Gray & Color STIC


VOLUME MODE  STIC + MSV

 Inversion 3D
 Max. Frame Rate : 40 Hz
 Face Auto Detection
 Live 3D, Static 3D
 Volume Shade Imaging
 MPR (Multi-Planar Rendering) mode
 Smart Filter Volume Imaging
 2D mode
 Smooth Cut
 Full 3D mode
 Volume NT/IT
 2D/3D mode
 Optimal volume resolution: Low, Mid, High
 ROI 3D mode

 3D Accept ROI mode

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 3D rendering mode: Surface, Surface Smooth, • A/B Ratio (Velocities/Frequency Ratio)


Maximum, Minimum, X-ray • Peak Systole/End Diastole (PS/ED Ratio)
 DMR plus • End Diastole/Peak Systole (ED/PS Ratio)
 HDVI (HD Volume Imaging) • Heart Rate
 Volume Contrast Enhancement(VCE) • AutoCalc : Auto Doppler Trace function with
 3D Compound Imaging (3D CI) automatic calculations

 SeeThru mode: gray + color Doppler mode • TAMAX (Time Average Maximum Velocity)
 MagiCut Plus: Available in both 3D and 4D • Volume Flow (TAMEAN and Vessel Area)
 Volume CINE (128MB) • PI (Pulsatility Index)
• RI (Resistivity Index)
CALIPERS & GENERAL MEASUREMENTS

• 4 pairs of 2-D calipers available. Screen display:


PROBES
Distance between calipers for each pair

Manual tracing in 2D distance LINEAR ARRAY

• Ellipse function: Up to 4 pairs of calipers


L5-13IS
Distance between calipers
 Linear Array
Ellipse circumference
 Center frequency : 8.0MHz
Ellipse area
 Radius of curvature : Flat
• Trace function. Displays:
 Field of view : 38.4mm
Trace circumference
 Number of elements : 192
Traced area
 Biopsy Guide : Available
• Minimum distance between calipers:
 Application : Vascular, Small Parts, MSK
Transducer type, depth and HRZ box setting
 Safety Class: BF
dependent

DOPPLER GENERAL MEASUREMENTS L5-13/50

 Linear Array
• Velocity
 Center frequency : 8.5MHz
• Frequency
 Radius of curvature : Flat
• Time
 Field of view : 49.6mm
• Acceleration
 Number of elements : 256
• Acceleration Time
 Biopsy Guide : Available
• Ratios
 Application : Vascular, Small Parts, MSK

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 Safety Class: BF LA3-14A

 Linear Array

L7-16IS  Center frequency : 7.2MHz

 Linear Array  Radius of curvature : Flat

 Center frequency : 12.0MHz  Field of view : 50mm

 Radius of curvature : Flat  Number of elements : 256

 Field of view : 38.4mm  Biopsy Guide : Available

 Number of elements : 192  Application : Vascular, Small Parts, MSK

 Biopsy Guide : Available  Safety Class: BF

 Application : Vascular, Small Parts, MSK

 Safety Class: BF LA3-16A

 Linear Array

L4-7  Center frequency : 8.7MHz

 Linear Array  Radius of curvature : Flat

 Center frequency : 5.15MHz  Field of view : 38.4mm

 Radius of curvature : Flat  Number of elements : 192

 Field of view : 44.16mm  Biopsy Guide : Available

 Number of elements : 192  Application : Vascular, Small Parts, MSK

 Biopsy Guide : Available  Safety Class: BF

 Application : Vascular, Small Parts, MSK, Abdomen

 Safety Class: BF
CONVEX ARRAY

LS6-15 C2-6IC

 Linear Array  Curved Linear Array

 Center frequency : 9MHz  Center frequency : 4.0MHz

 Radius of curvature : Flat  Radius of curvature : 60mm

 Field of view : 25.6mm  Field of view : 58.12°

 Number of elements : 128  Number of elements : 192

 Biopsy Guide : Not Available  Biopsy Guide : Available

 Application : MSK  Application : Abdomen, OB, Gynecology

 Safety Class: BF  Safety Class: BF

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SC1-6  Center frequency : 4.1MHz

 Curved Linear Array  Radius of curvature : 60.36mm

 Center frequency : 3.1MHz  Field of view : 58°

 Radius of curvature : 60mm  Number of elements : 192

 Field of view : 60.5°  Biopsy Guide : Available

 Number of elements : 192  Application : Abdomen, OB, Gynecology

 Biopsy Guide :  Safety Class: BF

 Application : Abdomen, OB, Gynecology, Contrast

 Safety Class: BF
ENDOCAVITY ARRAY

CF4-9 EC4-9IS

 Micro Curved Linear Array  Micro Curved Linear Array (Endo Cavity Type)

 Center frequency : 5.65MHz  Center frequency : 6.5MHz

 Radius of curvature : 14mm  Radius of curvature : 10mm

 Field of view : 92°  Field of view : 148.9°

 Number of elements : 128  Number of elements : 192

 Biopsy Guide : Not Available  Biopsy Guide : Available

 Application : Pediatric, Vascular  Application : Gynecology, OB, Urology

 Safety Class: BF  Safety Class: BF

CA1-7A VR5-9

 Curved Linear Array  Micro Curved Linear Array (Endo Cavity Type)

 Center frequency : 3.2MHz  Center frequency : 5.95MHz

 Radius of curvature : 45.69mm  Radius of curvature : 10mm

 Field of view : 70°  Field of view : 150.3°

 Number of elements : 160  Number of elements : 192

 Biopsy Guide : Available  Biopsy Guide : Available

 Application : Abdomen, OB, Gynecology, Contrast  Application : Gynecology, OB, Urology

 Safety Class: BF  Safety Class: BF

CA2-8A EA2-11B

 Curved Linear Array  Micro Curved Linear Array (Endo Cavity Type)

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 Center frequency : 6.4MHz  Center frequency : 6.5 MHz

 Radius of curvature : 10.1mm  Radius of curvature : 10.1 mm

 Field of view : 150.3°  Field of view : 150°

 Number of elements : 192  Number of elements : 192

 Biopsy Guide : Available  Biopsy Guide : Available

 Application : Gynecology, OB, Urology  Application : OB, Gynecology, Urology

 Safety Class: BF  Safety Class: BF

CV1-8A
VOLUME PROBE
 3D Curved Linear Array

 Center frequency : 4.0 MHz


V2-6
 Radius of curvature : 44.2 mm
 3D Curved Linear Array
 Field of view : 72°
 Center frequency : 3.15 MHz
 Number of elements : 192
 Radius of curvature : 39.1 mm
 Biopsy Guide : Available
 Field of view : 87°
 Application : Abdomen, OB, Gynecology
 Number of elements : 192
 Safety Class: BF
 Biopsy Guide : Available

 Application : Abdomen, Gynecology, OB

 Safety Class: BF PHASED ARRAY

P2-4BA
V4-8
 Phased Array
 3D Curved Linear Array
 Center frequency : 2.7MHz
 Center frequency : 4.4 MHz
 Radius of curvature : -
 Radius of curvature : 39.1 mm
 Field of view: 90°
 Field of view : 85°
 Number of elements : 80
 Number of elements : 192
 Biopsy Guide : Not Available
 Biopsy Guide : Available
 Application : Cardiac, Abdomen, TCD
 Application : Abdomen, OB, Gynecology

 Safety Class: BF

CONTINUOUS WAVE PROBE


V5-9
CW4.0
 3D Curved Linear Array (EC-straight type)

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 Pencil type  Abdomen Measurement

 Center frequency : 4.0MHz  TCD Measurement

 Biopsy Guide : Not Available  Thyroid Measurement

 Application : Cardiac  Testicle Measurement

 Safety Class: BF  Superficial Measurement

 Pediatric Hips Measurement

CW6.0  Musculoskeletal Measurement

 Pencil type

 Center frequency : 6.0MHz


OB MEASUREMENT
 Biopsy Guide : Not Available

 Application : Cardiac, Pediatric


 Fetal Biometry
 Safety Class: BF
 Fetal Long Bones

 Fetal Cranium
DP2B
 Fetal Others
 Pencil type
 AFI
 Center frequency : 2.0MHz
 Maternal others
 Biopsy Guide : Not Available
 CTAR
 Application : Cardiac
 PLI
 Safety Class: BF
 Umb. Artery

 MCA

 Lt. Uterine Artery


MEASUREMENT
 Rt. Uterine Artery
 OB Measurement  Plac. Artery
 Gynecology Measurement  Lt. Fetal Carotids
 Carotid Measurement  Rt. Fetal Carotids
 Cardiac Measurement  Fetal Aorta
 Urology Measurement  Ductus Venosus
 Fetal Echo Measurement  Rt Renal A
 LE Artery Measurement  Lt Renal A
 UE Artery Measurement  Volume Flow
 LE Vein Measurement  Fetal HR
 UE Vein Measurement  Fetal Description

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 Fetal Heart CLAV

 Fetal Brain Vertebral

 Fetal Abdomen  Fetal Cranium

 Biophysical Profile CEREB

 Maternal Survey OOD

 Comment IOD

CM
OB TABLE REFERENCE NF

NT
 Fetal Biometry
IT
GS
Lat Vent
CRL
NB
YS
HW
BPD
 Fetal Others
OFD
Foot
HC
Ear
APD
MP
TAD
Lt. Renal L
MAD
Rt. Renal L
AC
Lt. Renal AP
FTA
Rt. Renal AP
ThC
Pelvis
FL
EFW
SL
 Ratio Calculations
TTD
RL/BPD
APTD
FL/HC
APTD x TTD
FL/AC
 Fetal Long Bones
FL/Foot
HUM
CI(BPD/OFD0
ULNA
HC/AC
TIB
ThC/AC
RAD
Lat. Vent/HW
FIB

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 Fetal Doppler trend graph CARDIAC MEASUREMENTS


Mid Cerebral Artery
 Lt. Ventricle(2D)
Umbilical Artery
 Lt. Ventricle(M)
 Trend graph
 LV Vol.(Simpson)
AF Index
 LV Vol.(A/L)
HC/AC
 LV Vol.(Bullet)
FL/HC
 LV Mass
Lat.Vent/HW
 Rt. Ventricle(2D)

 Rt. Atrium

GYN MEASUREMENTS  LVOT

 RVOT
 Uterus
 Aortic Valve
 Cyst.
 Right Ventricle(M)
 Rt. / Lt. Ovary
 Mitral Valve(M)
 Rt. / Lt. Follicles
 Mitral Valve
 Mass 1
 Tricuspid Valve
 Mass 2
 Pulmonic Valve
 Mass 3
 Tei Index
 Rt. /Lt. Ovarian A
 Pulm. Veins
 Rt. / Lt. Uterine A
 Hepatic Veins
 Pericystic
 Tissue Doppler
 Endometrial
 Qpilm:Qsys
 Endo. Polyp
 HR
 Rt. / Lt. Ovarian Mass
 Aorta
 Uterine Tumor 1
 LA
 Uterine Tumor 2
 LA Vol. (Simpson)
 Uterine Tumor 3
 Shunt
 Cervical Tumor
 Comment
 Ectopic (Ectopic Pregnancy)

 Abnormalities of Uterus CAROTID MEASUREMENT


 Environment
 Rt. / Lt. Subclavian Artery
 Comment

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 Rt. / Lt. Proximal Common Carotid Artery  Digital Artery

 Rt. / Lt. Mid Commom Carotid Artery  General

 Rt. / Lt. Distal Common Carotid Artery  Volume Flow

 Rt. / Lt. Bulb  Heart Rate

 Rt. / Lt. Proximal Internal Carotid Artery  Comment

 Rt. / Lt. Mid Internal Carotid Artery


UE ARTERY MEASUREMENT
 Rt. / Lt. Distal Internal Carotid Artery

 Rt. / Lt. External Carotid Artery


 Rt. / Lt. Subclavian Artery
 Rt. / Lt. Vertebral Artery
 Rt. / Lt. Axillary Artery
 General
 Rt. / Lt. Brachial Artery
 Volume Flow
 Rt. Lt. Radial Artery
 HR
 Rt. / Lt. Ulnar Artery
 Vertebral Artery
 Rt. / Lt. Superficial Palmar Arches
 Rt. / Lt. ICA/CCA
 General
 Rt. / Lt. A/B
 Volume Flow
 Comment
 Heart Rate

 Comment
LE ARTERY MEASUREMENT

 Common Iliac Artery


LE VEIN MEASUREMENT

 Internal Iliac Artery


 Rt. / Lt. Comment Iliac Vein
 External Iliac Artery
 Rt. / Lt. Internal Iliac Vein
 Common Femoral Artery
 Rt. / Lt. External Iliac Vein
 Superficial Femoral Artery
 Rt. / Lt. Common Femoral Vein
 Deep Femoral Artery
 Rt. / Lt. PFV
 Popliteal Artery
 Rt. / Lt. Superficial Femoral Vein
 Anterior Tibial Artery
 Rt. / Lt. Great Saphenous Vein
 Posterior Tibial Artery
 Rt. / Lt. Popliteal Vein
 Peroneal Artery
 Rt. / Lt. LSV
 Dorsalis Pedis Artery
 Rt. / Lt. Anterior Tibial Vein
 Medial Plantar Artery
 Rt. / Lt. Posterior Tibial Vein
 Lateral plantar Artery
 Rt. / Lt. Peroneal V
 Metatarsal Artery
 Rt. / Lt. Metatarsal Vein

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 Rt. / Lt. Digital Vein  Tricuspid Inflow

 Volume Flow  Tricuspid Regurgitation

 General  Preload Index

 Comment  Tei Index

 Fetal Heart Rate


UE VEIN MEASUREMENT
 Environment

 Comment
 Rt. / Lt. Internal Jugular Vein

 Rt. / Lt. Innominate Vein


UROLOGY MEASUREMENT
 Rt. / Lt. Subclavian Vein

 Rt. / Lt. Axillary Vein  General

 Rt. / Lt. Brachial Vein Auto Trace

 Rt. / Lt. Cephalic Vein Limited Trace

 Rt. / Lt. Basilic Vein Manual Trace

 Rt. / Lt. Radial Vein PSV

 Rt. / Lt. Ulnar Vein EDV

 Volume Flow %StA

 General %StD

 Comment Vesl. Dist

Vesl.Area
FETAL ECHO MEASUREMENT  Bladder Volume

 Whole Gland prostate Volume


 LV Vol.(Simpson)
 Transitional Zone Volume
 2D Echo
 Residual Volume
 Cardio-Thorax Area Ratio
 Renal Volume
 Fetal M-mode
 Predicted PSA by WG
 Main Pulmonary Artery
 Prostate Specific Antigen
 Ductus Arteriosus
 Predicted PSA by T-Zone
 Inferior Vena Cava
 Digital Rectal Exam
 Ductus Venosus
 Transrectal US Prostate
 Ascending Aorta
 Transrectal US Seminal Vesicles
 Descending Aorta
 Comment
 Mitral Valve Inflow

 Mitral Valve Regurgitation

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ABDOMEN MEASUREMENTS  Rt. / Lt. Volume

 Rt. / Lt. Flow


 Gallbladder
 Rt. / Lt. Mass1~Mass5
 Pancreas
 Comment
 Bowel

 Liver BREAST MEASUREMENT


 Prox / Mid / Distal Aorta
 Rt. / Lt. Mass1~Mass10
 Celiac Artery
 Rt. / Lt. Flow
 Splenic Artery
 Comment
 Common / R / L Hepatic Artery

 Prox / Mid / Distal Superior Mesenteric Artery


TESTICLE MEASUREMENT
 Inferior Mesenteric Artery

 Prox / Mid /Distal Inferior Vena Cava  Rt. / Lt. Volume

 Kidney  Rt. / Lt. Flow

 Rt. / Lt. Renal Artery  Rt. / Lt. Mass1~Mass5

 Rt. / Lt. Arcuate Artery  Comment

 Rt. / Lt. Iliac Artery

 Rt. / Lt. Renal Volume


SUPERFICIAL MEASUREMENT

 Rt. / Lt. Portal Volume


 Rt. / Lt. Volume
 L / M / R Portal Volume
 Rt. / Lt. Flow
 L / M / R Hepatic Volume
 Rt. /Lt. Mass1~Mass5
 SMV
 Comment
 IMV

 Spleen TCD MEASUREMENT


 Splenic Volume
 Rt. / Lt. Anterior Cerebral Artery
 General
 Rt. / Lt. Mid Cerebral Artery
 HR
 Rt. / Lt. Posterior Cerebral Artery 1
 Renal Aortic Ratio
 Rt. / Lt. Posterior Cerebral Artery 2
 Indications
 Rt. / Lt. Distal Basilar Artery
 Comment
 Rt. / Lt. Mid Basilar Artery

THYROID MEASUREMENTS  Rt. / Lt. Proximal Basilar Artery

 Volume Flow

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 Comment use in the presence of a flammable anesthetic

mixture with air or with oxygen or nitrous oxide.


MUSCULOSKELTAL MEASUREMENT
 Mode of operation: Continuous operation

 EMC
 Rt. / Lt. Shoulder
RF Emission CISPR 11 : Class A
 Rt. / Lt. Wrist

 Rt. / Lt. Knee

 Rt. / Lt. Ankle APPLICABLE STANDARD & REGULATION


 Comment
FDA / USA: 21 Code of Federal Regulations 801.1

PEDIATRIC HIPS MEASUREMENT MDD 93/42/EEC: European Medical Device Directive

IEC (International Electrotechnical Commission)


 Rt. / Lt. Hips Angle
 Medical Electrical Equipment, Part 1: General
 Comment
Requirements for Basic Safety and Essential

Performance [IEC 60601-1:2005]

SAFTEY  Medical Electrical Equipment, Part 1-2: General

Requirements for Basic Safety and Essential


 RoHS (Restriction of Hazardous Substance) Performance- Collateral Standard: Electromagnetic
compliance Compatibility - Requirements and Tests [IEC 60601-
rd
 IHE 3 Edition 1-2:2007]

 Medical Electrical Equipment, Part 1-6: General

Requirements for Basic Safety and Essential


CLASSIFICATIONS
Performance- Collateral Standard: Usability [IEC
 Type of protection against electrical shock: Class I 60601-1-6:2010]
 Type of protection against electrical shock: Class I  Medical Electrical Equipment, Part 2-37: Particular
 Degree of protection against electrical shock Requirements for the Basic Safety and Essential
(Patient connection): Type BF equipment Performance of Ultrasonic Medical Diagnostic and
 Degree of protection against harmful ingress of Monitoring Equipment [IEC 60601-2-37:2007]
water: Ordinary equipment  Medical Electrical Equipment, Part 1: General
 Degree of safety of application in the presence of a Requirements for Safety [IEC 60601-1:1988 with
flammable anesthetic material with air or with A1:1991 and A2:1995]
oxygen or nitrous oxide: Equipment not suitable for  Medical Electrical Equipment, Part 1-1: General

Requirements for Safety - Collateral Standard:

A35 V3.01 Preliminary Version Written by Nick Kim


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safety Requirement for Medical Electrical Systems  ISO14971: 2007

[IEC 60601-1-1:2000] Medical devices – Application of risk management

 Medical Electrical Equipment, Part 1-2: General to medical devices

Requirements for Safety - Collateral Standard:

Electromagnetic Compatibility - Requirements and UL (Underwrites’ Laboratories, Inc.)

Test [IEC 60601-1-2:2001, A1:2004]  UL 60601-1

 Medical Electrical Equipment, Part 1-4 : General Medical electrical equipment

Requirements for Safety - Collateral Standard: Part 1: General requirements for safety

Programmable Electrical Medical Systems [IEC

60601-1-4:1996, A1:1999] CSA (Canadian Standards Association)

 Medical Electrical Equipment, Part 2-37: Particular  CAN/CSA 22.2, No.601-1 –M90: 1990, S-1:1994,

Requirements for Safety - Ultrasonic Medical B:1996

Diagnostic and Monitoring Equipment [IEC 60601- Medical electrical equipment

2-37: 2001 with A1:2004, A2:2005] Part 1: General requirements for safety

 Medical Devices – Application of Risk Management

to Medical Devices [ISO 14971:2007] EN (European Standard)

 Medical Electrical Equipment, Part 1: General  EN980: 2008

Requirements for Safety [UL 60601-1:2003] Graphical symbols for use in the labeling of medical

 Medical Electrical Equipment - Part 1: General devices

Requirements for Safety [CAN/CSA C22.2 No.  EN1041: 2008

601.1-M90:1990, with R2003, with R2005] Information supplied by the manufacturer with

 Biological Evaluation of Medical Devices, Part medical devices

1:Evaluation and Testing within a risk management

process [ISO 10993-1 : 2009] NEMA/AIUM

 Standard Means for the Reporting of the Acoustic  NEMA/AIUM UD-2: 2004

Output of Medical Diagnostic Ultrasonic Equipment Acoustic Output Display Standard for Diagnostic

[IEC 61157:2007] Ultrasound Equipment

 NEMA/AUIM UD-3: 2004

ISO (International Organization of Standards) Standard for Real Time Display of Thermal and

 EN/ISO 10993-1:2009 Mechanical Acoustic Output Indices on Diagnostic

Biological evaluation of medical devices Ultrasound Equipment

Part 1: Evaluation and testing

A35 V3.01 Preliminary Version Written by Nick Kim


19th Dec. 2014
<Page 25> in Marketing Group
SAMSUNG CONFIDENTIAL

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For more information, please don’t hesitate to contact

SAMSUNG MEDISON

Strategy Marketing Team

E-Mail : nick99.kim@samsungmedison.com

A35 V3.01 Preliminary Version Written by Nick Kim


19th Dec. 2014
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