ACCUVIX - A30 Especificaciones Tecnicas

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ACCUVIX A30

Data Sheet
Version 1.00.00

January, 2012

Rev 01

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

Product Management Group


www.samsungmedison.com
CONFIDENTIAL

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

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 ------------------------------------------------------------------ 4

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

3.2 Post-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.
www.samsungmedison.com
CONFIDENTIAL

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 -------------------------------------------------------------- 7


5.1 2D Mode ------------------------------------------------------------------ 7

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 -------------------------------------------------------------- 15
6.1 Linear Array ------------------------------------------------------------------ 15

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

6.3 Endocavity Array ------------------------------------------------------------------ 15

6.4 Volume Probe ------------------------------------------------------------------ 16

6.5 Phased Array ------------------------------------------------------------------ 16

6.6 Continuous Wave Probe ------------------------------------------------------------------ 16

7 Measurement -------------------------------------------------------------- 17
7.1 OB Measurement ------------------------------------------------------------------ 17

7.2 OB Table Reference ------------------------------------------------------------------ 18

7.2 Gynecology Measurement ------------------------------------------------------------------ 19

7.3 Cardiac Measurement ------------------------------------------------------------------ 19

7.4 Carotid Measurement ------------------------------------------------------------------ 19

7.6 LE Artery Measurement ------------------------------------------------------------------ 20

7.7 UE Artery Measurement ------------------------------------------------------------------ 20

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.
www.samsungmedison.com
CONFIDENTIAL

7.8 LE Vein Measurement ------------------------------------------------------------------ 20

7.9 UE Vein Measurement ------------------------------------------------------------------ 21

7.10 Fetal Echo Measurement ------------------------------------------------------------------ 21

7.11 Urology Measurement ------------------------------------------------------------------ 21

7.12 Abdomen Measurement ------------------------------------------------------------------ 22

7.13 Thyroid Measurement ------------------------------------------------------------------ 22

7.14 Breast Measurement ------------------------------------------------------------------ 22

7.15 Testicle Measurement ------------------------------------------------------------------ 22

7.16 Superficial Measurement ------------------------------------------------------------------ 22

7.17 TCD Measurement ------------------------------------------------------------------ 22

7.18 MSK Measurement ------------------------------------------------------------------ 23

7.19 Pediatric Hip Measurement ------------------------------------------------------------------ 23

8 Safety -------------------------------------------------------------- 23
8.1 Classifications ------------------------------------------------------------------ 23

8.2 Applicable Standard & Regulation ------------------------------------------------------------------ 23

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.
www.samsungmedison.com
CONFIDENTIAL

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. 111 kg (244.7 lb.)  Prevention of noise of the system

 Easily removable air filter


ELECTRICAL POWER
 Integrated SATA HDD (500GB)
 Voltage: 100- 240 V AC  Integrated DVD Multi Recordable Driver
 Frequency: 50/60 Hz  EMC Class B
 Power Consumption
CONTROL PANEL
786.5 VA with Peripherals

636.5 VA without Peripherals • Height: adjustable 180 mm

 Nominal Current: • Rotation: adjustable +/- 30° from center

110V: 8.93A • Ergonomic hard key operations

220V: 4.47A • Hard key layout for General Imaging

 Heat Dissipation: 3354.5 BTU/h • Functional grouping of keys

 Probe IPX: 7 • Interactive back-lighting

 Foot Switch IPX: 1 • Functional grouping of keys on 9” Wide LED Touch

 Safety Class Panel (Resolution 800 x 480 x 24 bits)

Ultrasound system: B • Integrated alphanumeric QWERTY backlit keyboard

Transducer: BF (depend on transducer specification) and Virtual Screen alphanumeric QWERTY

keyboard on Touch Panel


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

 1 gel holders • 21.5 inch Wide Color LED Flat Display

 4 Swivel/Lock wheels (wheel diameter: 121 mm) • Resolution: 1920 x 1080 x 24 bits

ACCUVIX A30 Datasheet rev01 Page 1


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CONFIDENTIAL

• High-Resolution monitor Non Interlace Scan  TCD

• Height: adjustable 1,415 ~ 1,760 mm


TRANSDUCER TYPES
• Forth/Back: adjustable ~ 339.4 mm

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

• Rotate: adjustable +/- 50° from center, C2-6IC

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

contrast Convex Volume

• Digital brightness & contrast adjustment V2-6, V4-8

Endocavity Volume
TOUCH SCREEN
V5-9

• 9” Wide LED Touch Screen Control  Micro-Convex Array

• Interactive dynamic soft key menu display C5-8

• Display Resolution : 800 x 480 x 24bits  Linear Array

L4-7, L5-13IS, L7-16IS

 Endocavity
SYSTEM SPECIFICATION
EC4-9IS, VR5-9

APPLICATIONS  Phased Array

P2-4BA
 General
 Pencil Probes
 Abdominal
CW2.0, CW4.0, CW6.0
 Gynecology

 Obstetrical
OPERATION MODES
 OB Early

 Renal • 2D-Mode

 Fetal Heart • M-Mode

 Urology • Color Doppler Imaging

 Vascular • Power Doppler Imaging

 Small Parts • Pulsed Wave (PW) Spectral Doppler

 Muskuloskeletal • Continuous Wave (CW) Spectral Doppler

 Breast • Tissue Doppler Imaging (TDI)

 Cardiology • Directional Power Doppler Imaging (DPDI)

 Pediatric • Color M-Mode

 Neonatal • Harmonic Imaging


ACCUVIX A30 Datasheet rev01 Page 2
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CONFIDENTIAL

• Free Angle M-Mode (Arbitrary M mode) • Quick Scan™ (Automatic Optimization)

• •
TM
Single/Dual/Quad mode DMR plus

• •
TM
Volume-mode(3D/4D) Spatial Compounding Imaging

• Elastoscan
DISPLAY MODES
L5-13IS: SmallParts, Breast, Thyroid

• Simultaneous Capability: L7-16IS: SmallParts, Breast


B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, EC4-9IS: Gyn.-adnexa, uterus/ Urology-prostate
B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, •
TM
Panoramic Imaging
B+TD+PW, B+C+M, Dual B, Dual B+C, Dual B+PD, •
TM
AutoIMT
B+E •
TM
VolumeNT
• Selectable Alternative Modes: • XI STIC
TM

B/M, B/PW, B/CW, B+C/PW, B+PD/PW, B+DPD/PW, •


TM TM
VOCAL , XI VOCAL
B+TD/PW, B+C/M, B+C/CW, B+PD/CW • 3D/4D
• Colorized Image: • Multi Slice View
TM

Colorized B, Colorized M, Colorized D, Colorized 3D •


TM
Oblique View
• Time Line Display: • Volume CT
TM

Format: Top/Bottom or Side/Side selectable •


TM TM
OVIX , Multi-OVIX
Size: 1/2, 1/3, 2/3, Full •
TM
Volume Slice View
Timeline Method: Scrolling or Moving Bar •
TM
Mirror View
• Multi Image Split Screen: • Inversion 3D
Live and/or Frozen, B+B/C or PD, Independent Cine •
TM
FAD
Playback) •
TM
SFVI
Dual (B, B/C, B/PD, B/TD, B/PPI, B/PD) •
TM
VSI
Quad (B, B/C, B/PD, B/TD, B/PPI, B/PD) •
TM
Smooth cut
• Zoom: Write / Read (Magnification) / Pan • MagiCut

• Raw Data Analysis


SYSTEM STANDARD FEATURES
• Post-image optimization
• Full Spectrum Imaging (3 bands) • Patient Information Database
• Tissue Harmonic Imaging • Image Archive integrated on CD/DVD and HDD
• Pulse Inversion Harmonic Imaging drive
• Power Pulse Inversion Harmonic Imaging • Support for external USB 2.0 HDD drive
• Trapezoidal Imaging

ACCUVIX A30 Datasheet rev01 Page 3


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CONFIDENTIAL

• Cine for 12,700(Max Condition) frames and Loop PERIPHERAL OPTIONS


Review for 8,192 lines
• Integrated options for Digital B/W Printer, Digital
• Auto Calc (Real-Time Automatic Doppler
Color Printer, Digital Color Report Printer
Calculation)
• External USB Printer Connections
• Doppler Auto Trace
• DVI-I Output Available for compatible devices
• User Configurable Measurement Menu
• Digital ECG
• Customizable Measurement Menu
• Foot switch (USB type)
• Customizable Body Maker

• Customizable User Keys DOCUMENTATION CAPABILITY

• Post-Measurement

TM
ADVR
• On-board electronic documentation
• On-board printing device control
• Fully Digital Real Time Recording
• Selective printing on two connected printers

TM
EZ exam
• SonoView II (Image Filing Package)
• Screen Keyboard
• Export Media: CD/DVD+R/-R/RW, USB Flash,

SYSTEM OPTIONS External USB HDD

• Export Format: JPEG,BMP,TIFF,DICOM


 4D
• Print Function
 3D XI™
• Capacity:10BASE-T(Min.4000frame)
 3D MXI™
• Patient list and data search
 CW Function
• Report save available
 Cardiac Measurement
• Post image processing available
 DICOM
• Caliper measurement available
 Spatial Compound Imaging™ (SCI™)
• DICOM 3.0
 XI STIC
Service: Storage/Printer/Worklist/PPS/SC
 Auto IMT™
DICOM SR Structured Reports
 ElastoScan

 Panoramic Imaging PERIPHERAL SIGNALS


TM
 HDVI
 Audio port (I/O)
TM
 VolumeNT
 LAN (I/O) : Ethernet, 100/10 BASE-T
TM
 ADVR (Agile DVR)
 B/W Printer port (USB type) (O)

 Patient Monitor (DVI-I Connector) (O)

 Patient Monitor Power (O)


ACCUVIX A30 Datasheet rev01 Page 4
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CONFIDENTIAL

 DVI port (O) for digital signals to the monitor Spanish

 ECG AUX input (optional) Italian

 Foot switch port (USB type) Russian

 USB port (I/O, USB 2.0) : 4 ports(front2 , rear2 ) Chinese

 Microphone  Input Language

English
OPERATING ENVIRONMENT
German

 Ambient temperature: 10°C–35°C (50°F–104°F) French

 Relative humidity: Up to 75% non-condensing Spanish

 Pressure: 700~1060hPa Italian

 Audible noise: 70dB Russian

Korean
ACOUSTIC OUTPUT MANAGEMENT
Chinese

 User selectable, transducer and scanning mode Japanese

dependent
SCAN MODE
 Dedicated Output Display on the system monitor

display of output acoustic power level, as well as  Simultaneous Mode : 3 Type off, Allow B/PWD,
thermal and mechanical indices: Allow B/C/PWD
 PWR – Output Power level. Range: From 10 % of  Auto Unfreeze While Dual Operation
maximum output, output level is increased by 5%  Change Window at Dual Mode
in each step.  2D/C Live Mode
 Mechanical Index (MI): 0.1~3.0 Range Left/ Up, Right/ Down
 Thermal Index (TI): 0.1~5.0 Range 2D/C Live left-Right Dual Only
TIC – Thermal Index, Bone at Surface  Freeze Action : 4 Type
TIB – Thermal Index, Bone at Focus None
TIS – Thermal Index, Soft Tissue Body Marker

Caliper
LANGUAGE
Measure
 Display Language
 End Exam Action : End exam Only, End exam and
English
Patient
German

French

ACCUVIX A30 Datasheet rev01 Page 5


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CONFIDENTIAL

IMAGE PARAMETERS • D-Mode


Gain, Dynamic Range, Transmission Frequency,
• 2D Gain: 0 ~ 100
Velocity Scale/PRF, Wall Filter, Baseline Shift,
• Power: 10 ~ 100
Sweep Speed
• Edge Enhance: -3 ~ 3

• Frame Average: 0 ~ 15 POST-PROCESSING


• 2D Filter
 2D Quick Scan (Automatic Tissue Optimization)
• View area Control
 Doppler Quick Scan (Automatic Spectrum
• View area Steering
Optimization)
• Dynamic Range: 50~200 dB, User selectable in 1 dB
 Gray Maps (2D Mode: 13 types / M-Mode: 13 types)
increments
 Chroma map (2D Mode : 16 types / M Mode : 16
• Reject Level: 1 ~ 32
types)
• Gray map: 13 types
 Reject Function from 1 to 32 in 32 digit steps
• Chroma map: 13 types + 3 User types

• Trapezoidal Image
IMAGE PROCESSING
• U/D Flip, L/R Flip

• Frame Rate: Slow / Normal / Fast • Digital Beamformer

• Frequency optimized setting: Pen(penetration) / • Imaging Depth: 2 ~ 30 cm


Gen(general) / Res(resolution) • Dynamic Receive Focus

• Dynamic Receive Aperture

• Tx Apodization
PROCESSING
• Tx Pulse Shaping

• Adjustable Dynamic Range


PRE-PROCESSING
• Adjustable Field of View
• 2D / M-Mode • Image Reverse: Left / Right, Up/Down
Gain, TGC, Dynamic Range, Transmission Focus • Transmission Focus:
Position, Transmission Focus Number, Transmission 1 ~ 8 Focal Points Selectable; Focus Position: 8
Frequency, Edge Enhancement, Sweep Speed for steps (probe independent)
M-Mode • 256 shades of gray, 8 bits
• Color-Mode • 16,777,216 colors, 8 bits for each RGB component
Gain, Velocity Range, Wall Filter, Ensemble,

Spatial Filter, Frame Averaging, Baseline Shift,

Smoothing Filter
ACCUVIX A30 Datasheet rev01 Page 6
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CONFIDENTIAL

IMAGE ARCHIVE Whole Screen

 Configurable Examination List Window, Patient


• Archiving Format: DICOM
Information Window, and Search/Create Patient
• Possibly exported to other format
Window
• Archive Devices:
 Extended search dialog, auto search for patient in
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
• CINE Gauge and Cine Image number display  Format removable media (rewritable DVD)
• CINE Review Loop  The currently selected dataflow
• Selectable CINE Sequence for CINE Review (by Start  All configured data flows
Frame and End Frame)  The network structure tree
• Measurements/Calculations & Annotations on CINE  The configured buttons data flows
• Available in all modes(include loop)  AVI and JPEG Export : DICOM Support
• Imaging Cine, for real-time acquisition and review  DICOM Storage Commitment Push Model User
of 2-D  DICOM Modality Performed Procedure Step User
• After freezing immediate scrolling through Cine  DICOM Printer User
memory with the Track ball  DICOM Store User
• CINE memory: Max. 12700 frames  DICOM Modality Worklist User
• Loop memory: Max. 8192 lines  DICOM Structured Report Cardiology, Vascular and

OB/GY User

CONNECTIVITY

SCANNING PARAMETERS
DICOM (OPTIONAL)

2D MODE
 Ethernet Network Connection

 Archiving Format:  Frame Average 0 ~ 15 step


 DICOM with ultrasound raw data  Dynamic Range 50 ~ 200 dB
 Capture Area: pre-settable for each print key  Reject Level 1 ~ 32 step
 Video Area  Edge Enhance -3 ~ +3 step
 Application Window  View area 40 ~ 100 %
ACCUVIX A30 Datasheet rev01 Page 7
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CONFIDENTIAL

 Density(High, Middle, Low) 3 step Type 1 ~ 13 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 %

 Power 10 ~ 100 %
M MODE

 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
 Gray Map 1 ~ 13 step
Type 1 ~ 13 step
 View Angle -20° ~ 20°
User 1 ~ 3 step
 2D Image Size 50~100
 Gain control 0 ~ 100 %
 Full Spectrum Image 1 ~ 3 step
 Time gain compensation 8 slice
 Store Method(Time, Manual) 2 Mode
 Depth (Probe dependency) 2 ~ 30 cm
Store method time mode only 1~50 sec
 Frequency(Pen, Gen, Res) 3 step
Store method ECG Beat mode only 1~8 beat
 Sweep speed 60, 120, 180, 240, 300, 360 Hz
 Zoom 120 ~ 400 %
 Post Curve
 Chroma Map
Type 1 ~9 step
ACCUVIX A30 Datasheet rev01 Page 8
www.samsungmedison.com
CONFIDENTIAL

User 1 ~ 2 step Minimum 2.25cm/sec

 Frame Rate(Slow, Normal, Fast) 3 step Maximum 5.6 m/sec

 Gamma(Hard, Medium, Weak, Off) 4 mode  Wall filter 0 ~ 3 level

 Display mode  Color gain 0 ~ 100%

Top/Bottom (30/70, 40/60, 50/50, 60/40, 70/30)  Frame rate 2 ~ 30HZ

Left/Right  Read Zoom 120 ~400%

 Power 10 ~ 100  Dual mode(Top/Down, Left/Right)

 Gray Map 1 ~ 13 step  Quad mode

 Store Method  Frequency(Pen, Gen)

Time (Store method time mode only) 1 ~50 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  Filter 0~3

 View Angle -20° ~ 20°  Scale 0.20 ~ 12.00 KHz

 Scan Area 40 ~ 100  Baseline 0 ~ 8 step

 Full Spectrum Imaging 1 ~ 3 step  Display mode (Color + BW, BW only)

 Zoom 120 ~ 400%  Color mode (Velocity, Power, Variance, Velocity +

 Quick Scan Variance)

 ECG (Probe dependency)  Color map 1 ~ 15 type

 Sensitivity 2 ~ 31 step
COLOR DOPPLER MODE  Density(High, Middle1, Middle2, Low)

 Power 10 ~100%
 Color scale 256 colors
 Harmonic
 Frame average 0 ~ 15 step
 Trapezoidal
 Balance 1 ~ 16 Level
 SRF 1 ~ 3 Step
 PRF 0.1 ~ 18.4KHz
 Elastoscan
 Velocity
ACCUVIX A30 Datasheet rev01 Page 9
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CONFIDENTIAL

 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
 Elastoscan
 Minimum velocity 2.25cm/sec
 Up/Down, Left/Right
 Maximum velocity 5.6m/s
 Dynamic range 50~200dB
 Wall filter 0 ~ 3 Level
 Reject level 1 ~ 32 Step
 Color gain 0 ~ 100%
 Gray map 1 ~ 13 Step
 Frame rate 2 ~ 30Hz
 View angle -20° ~ 20°
 Read zoom 120 ~ 400
 Scan Area 40 ~ 100
 Dual mode Top/Down, Left/Right
 2D Image Size 50 ~ 100
 Quad mode
 Full Spectrum Image 1 ~ 3 step
 Frequency(Pen, Gen)
 Edge Enhance -3 ~ 3
 Steer (Linear, Convex)
ACCUVIX A30 Datasheet rev01 Page 10
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CONFIDENTIAL

 Chroma Map  Doppler Invert

Type 1 ~ 13 step  Simultaneous (B,C,D/B,D)

User 1 ~ 3 step  TDW

 Tissue (1440 ~ 1620m/s) 10 step  Annotation

 Gain 0 ~ 100%  Single/Dual/Quad Control

 Zoom 120 ~ 400  M Line

 Depth 2 ~ 30cm  M line position

 Time Gain Control 1 ~ 8 slide  M Line Angle 0°~360°

 Quick scan  AutoCalc (PSV, DEV, TAP, RI, PI, S/D)

 AutoCalc direction (All, Up, Down)


PWD MODE  Mean Trace

 Sweep speed(60, 120, 180, 240, 300, 360Hz)


 PRF 1 ~ 23 KHz
 Frequency (Pen, Gen, Rea)
 Display height 9 step
 Steer (Left, Right, None)
(70/30, 65/35, 60/40, 55/45, 50/50, 45/55, 40/60,
 Filter 0 ~ 3 step
35/65, 30/70)
 Scale 0.6 ~ 14KHz
 Sample Volume 0.5 ~ 15.0mm
 Sound 0 ~ 100
 Wall filter 0 ~ 3 level
 Baseline 0 ~ 8 step
 Spectrum types(type1, type2 ,type3)
 Sample volume 0.5 ~ 10mm
 Wall filter 0 ~ 3 step
 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
Side by Side
 D line update rate (120, 180, 240, 300, 360Hz)
 Spectrum Type (Type1 ~ Type3)
 D mode display size (30/70, 40/60, 50/50, 60/40,
 Dynamic range 50 ~ 200dB
70/30)
 Store Method (Time, Manual)
 D mode display format(Top/Bottom, Side by Side)
 Chroma map
 Loop Size 8192 loop
Type 1 ~ 13 step
 Steer
User 1 ~ 3 step
 Auto calculation
 Power 10 ~ 100
 Multi frequency
 Harmonic
 Tissue Doppler Imaging
ACCUVIX A30 Datasheet rev01 Page 11
www.samsungmedison.com
CONFIDENTIAL

 Trapezoidal (Linear probe only)  Display format Left/Right, Side by Side

 Dual live  Loop size 8192 loop

 SRF 1 ~ 3  Quick scan

 Elastoscan  HPRF

 Panoramic  Doppler Invert

 Spatial Compound (High, Medium, Low, Off)  Single/Dual/Quad control

 Up/Down, Left/Right flip  M line angle 0°~360°

 Top-Bottom Dual(Dual mode only)  AutoCalc (PSV, EDV, TAP, RI, PI, S/D)

 Frame Average 0 ~ 15 step  AutoCalc direction (All, Up, Down)

 Reject level 1 ~ 32 step  Mean Trace

 Gray map 1 ~ 13 step  Sweep speed (60, 120, 180, 240, 300, 360 Hz)

 View angel -20°~20°  Filter 0 ~ 3

 Scan area 40 ~ 100  Scale 0.6 ~ 14KHz

 Full Spectrum image 1 ~ 3 step  Sound 0 ~ 100

 Line Density (High, Middle, Low)  Baseline 0 ~ 8 Step

 Edge Enhance -3 ~ 3  Gray map 1 ~ 13 Step

 Tissue (1440 ~ 1620m/s)  Spectrum Enhance 1 ~ 4 Step

 Gain 0 ~ 100  Display mode

 Zoom 120 ~ 400 Top/Bottom 4:6, 6:4 5:5

 Depth 2 ~ 30 cm Side by Side

 Time gain control  Spectrum Type (Type1 ~ Type3)

 Quick scan  Dynamic Range 50 ~ 200dB

 HPRF  Store Method (Time, Manual)

 Chroma map
CWD MODE Type 1 ~ 13 step

User 1 ~ 3 step
 PRF 1 ~ 23KHz
 Power 10 ~ 100
 Sweep speed (60, 120, 180, 240, 300, 360Hz)
 Harmonic
 Wall filter 0 ~ 3
 Dual Live
 Minimum velocity 19.25cm/sec
 SRF 1 ~ 3
 Maximum velocity 8,2775 m/sec
 Elastoscan
 Display size (30/70, 40/60, 50/50, 60/40, 70/30)
 Up/Down, Left/Right Flip
 Display : Sweep
ACCUVIX A30 Datasheet rev01 Page 12
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CONFIDENTIAL

TM
 Frequency (Pen, Gen, Res)  Multi-OVIX
TM
 Frame Average 0 ~ 15 step  Volume CT (VCT)

 Reject level 1 ~ 32 step  Cube Volume CT

 View Angle 20°~20°  Cross Volume CT


TM
 Scan Area 40 ~ 100  3D-MXI (3D Multi-eXtended Imaging)
TM
 Full spectrum Image 1 ~ 3 Step  Volume Slice
TM
 Line Density (High, Middle, Low)  Mirror View

 Edge Enhance -3 ~ 3  3D OH

 Tissue (1440 ~ 1620m/s)  ROI single control


TM
 Gain 0 ~ 100  VOCAL

 Zoom 120 ~ 400  SHELL Histogram


TM
 Depth 2 ~ 30cm  XI VOCAL
TM
 Time Gain Control 8 slide  XI STIC

 Quick scan  Gray & Color STIC

 STIC + MSV
VOLUME MODE  Inversion 3D
TM
 Face Auto Detection
 Live 3D, Static 3D
TM
 Volume Shade Imaging
 MPR (Multi-Planar Rendering) mode
TM
 Smart Filter Volume Imaging
 2D mode
TM
 Smooth Cut
 Full 3D mode
TM
 Volume NT/IT
 2D/3D mode
 Optimal volume resolution: Low, Mid, High
 ROI 3D mode
 3D rendering mode: Surface, Surface Smooth,
 3D Accept ROI mode
TM Maximum, Minimum, X-ray
 3DXI (3D eXtended Imaging)
TM
 DMR plus
 MSV (Multi-Slice View)TM display
TM
TM  HDVI (HD Volume Imaging)
 Oblique View
TM
 Volume Contrast Enhancement(VCE)
 Static Line Oblique view
 3D Compound Imaging (3D CI)
 Dynamic Line Oblique view
 SeeThru mode: gray + color Doppler mode
 Contour Oblique view
 MagiCut Plus: Available in both 3D and 4D
 Multi Oblique View
TM  Volume CINE (128MB)
 OVIX

(Oblique View eXtended Imaging)


ACCUVIX A30 Datasheet rev01 Page 13
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CONFIDENTIAL

CALIPERS & GENERAL MEASUREMENTS • RI (Resistivity Index)

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


Distance between calipers for each pair

Manual tracing in 2D distance

• Ellipse function: Up to 4 pairs of calipers


Distance between calipers

Ellipse circumference

Ellipse area

• Trace function. Displays:


Trace circumference

Traced area

• Minimum distance between calipers:


Transducer type, depth and HRZ box setting

dependent

DOPPLER GENERAL MEASUREMENTS

• Velocity

• Frequency

• Time

• Acceleration

• Acceleration Time

• Ratios

• A/B Ratio (Velocities/Frequency Ratio)

• Peak Systole/End Diastole (PS/ED Ratio)

• End Diastole/Peak Systole (ED/PS Ratio)

• Heart Rate

• AutoCalc
Auto Doppler Trace function with automatic

calculations

• TAMAX (Time Average Maximum Velocity)

• Volume Flow (TAMEAN and Vessel Area)

• PI (Pulsatility Index)
ACCUVIX A30 Datasheet rev01 Page 14
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CONFIDENTIAL

PROBES  Safety Class: BF

LINEAR ARRAY CONVEX ARRAY

L5-13IS C2-6IC

 Linear Array  Curved Linear Array

 Center frequency : 8.0MHz  Center frequency : 4.0MHz

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

 Field of view : 38.4mm  Field of view : 58.12°

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

 Biopsy Guide : Available  Biopsy Guide : Available

 Application : Musculoskeletal, Small Parts, Vascular  Application : Abdomen, OB, Gynecology

 Safety Class: BF  Safety Class: BF

L7-16IS C5-8

 Linear Array  Micro Curved Linear Array

 Center frequency : 12.0MHz  Center frequency : 56.5MHz

 Radius of curvature : Flat  Radius of curvature : 14mm

 Field of view : 38.4mm  Field of view : 92°

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

 Biopsy Guide : Available  Biopsy Guide : Not Available

 Application : Musculoskeletal, Small Parts, Vascular  Application : Pediatric, Vascular

 Safety Class: BF  Safety Class: BF

ENDOCAVITY ARRAY
L4-7

 Linear Array EC4-9IS

 Micro Curved Linear Array (Endo Cavity Type)


 Center frequency : 5.15MHz
 Center frequency : 6.5MHz
 Radius of curvature : Flat
 Radius of curvature : 10mm
 Field of view : 44.16mm
 Field of view : 148.9°
 Number of elements : 192
 Number of elements : 192
 Biopsy Guide : Available
 Biopsy Guide : Available
 Application : Musculoskeletal, Small Parts,
 Application : Gynecology, OB, Urology
Vascular, Abdomen

ACCUVIX A30 Datasheet rev01 Page 15


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CONFIDENTIAL

 Safety Class: BF

V5-9

VR5-9  3D Curved Linear Array (EC-straight type)

 Micro Curved Linear Array (Endo Cavity Type)  Center frequency : 6.5 MHz

 Center frequency : 5.95MHz  Radius of curvature : 10.1 mm

 Radius of curvature : 10mm  Field of view : 150°

 Field of view : 150.3°  Number of elements : 192

 Number of elements : 192  Biopsy Guide : Available

 Biopsy Guide : Available  Application : OB, Gynecology, Urology

 Application : Gynecology, OB, Urology  Safety Class: BF

 Safety Class: BF
PHASED ARRAY

VOLUME PROBE P2-4BA

 Phased Array
V2-6
 Center frequency : 2.7MHz
 3D Curved Linear Array
 Radius of curvature : -
 Center frequency : 3.15 MHz
 Field of view: 90°
 Radius of curvature : 39.1 mm
 Number of elements : 80
 Field of view : 87°
 Biopsy Guide : Not Available
 Number of elements : 192
 Application : Cardiac, Abdomen, TCD
 Biopsy Guide : Available

 Application : Abdomen, Gynecology, OB CONTINUOUS WAVE PROBE


 Safety Class: BF
CW2.0

 Pencil type
V4-8
 Center frequency : 2.0MHz
 3D Curved Linear Array
 Biopsy Guide : Not Available
 Center frequency : 4.4 MHz
 Application : Cardiac
 Radius of curvature : 39.1 mm
 Safety Class: BF
 Field of view : 85°

 Number of elements : 192


CW4.0
 Biopsy Guide : Available
 Pencil type
 Application : Abdomen, OB, Gynecology
 Center frequency : 4.0MHz
 Safety Class: BF
ACCUVIX A30 Datasheet rev01 Page 16
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CONFIDENTIAL

 Biopsy Guide : Not Available OB MEASUREMENT


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

 Fetal Cranium
CW6.0
 Fetal Others
 Pencil type
 AFI
 Center frequency : 6.0MHz
 Maternal others
 Biopsy Guide : Not Available
 CTAR
 Application : Cardiac, Pediatric
 PLI
 Safety Class: BF
 Umb. Artery

 MCA

MEASUREMENT  Lt. Uterine Artery

 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
 Abdomen Measurement
 Fetal Heart
 TCD Measurement
 Fetal Brain
 Thyroid Measurement
 Fetal Abdomen
 Testicle Measurement
 Biophysical Profile
 Superficial Measurement
 Maternal Survey
 Pediatric Hips Measurement
 Comment
 Musculoskeletal Measurement

ACCUVIX A30 Datasheet rev01 Page 17


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CONFIDENTIAL

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
 Fetal Doppler trend graph
CLAV
Mid Cerebral Artery
Vertebral
Umbilical Artery
 Fetal Cranium
 Trend graph
CEREB
AF Index
OOD
HC/AC
IOD
FL/HC
CM
ACCUVIX A30 Datasheet rev01 Page 18
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CONFIDENTIAL

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

 Comment  Rt. / Lt. Subclavian Artery

 Rt. / Lt. Proximal Common Carotid Artery


CARDIAC MEASUREMENTS  Rt. / Lt. Mid Commom Carotid Artery

 Rt. / Lt. Distal Common Carotid Artery


 Lt. Ventricle(2D)
 Rt. / Lt. Bulb
 Lt. Ventricle(M)
 Rt. / Lt. Proximal Internal Carotid Artery
 LV Vol.(Simpson)
 Rt. / Lt. Mid Internal Carotid Artery
 LV Vol.(A/L)
 Rt. / Lt. Distal Internal Carotid Artery
 LV Vol.(Bullet)
 Rt. / Lt. External Carotid Artery
 LV Mass
ACCUVIX A30 Datasheet rev01 Page 19
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CONFIDENTIAL

 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
LE VEIN MEASUREMENT
 Common Iliac Artery

 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

 Digital Artery  Rt. / Lt. Digital Vein

 General  Volume Flow

 Volume Flow  General

 Heart Rate  Comment

 Comment
UE VEIN MEASUREMENT
UE ARTERY MEASUREMENT
 Rt. / Lt. Internal Jugular Vein

 Rt. / Lt. Subclavian Artery  Rt. / Lt. Innominate Vein


ACCUVIX A30 Datasheet rev01 Page 20
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CONFIDENTIAL

 Rt. / Lt. Subclavian Vein UROLOGY MEASUREMENT


 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

FETAL ECHO MEASUREMENT Vesl.Area

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

 Tricuspid Inflow ABDOMEN MEASUREMENTS


 Tricuspid Regurgitation
 Gallbladder
 Preload Index
 Pancreas
 Tei Index
 Bowel
 Fetal Heart Rate
 Liver
 Environment
 Prox / Mid / Distal Aorta
 Comment
 Celiac Artery

ACCUVIX A30 Datasheet rev01 Page 21


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CONFIDENTIAL

 Splenic Artery  Comment

 Common / R / L Hepatic Artery

 Prox / Mid / Distal Superior Mesenteric Artery


TESTICLE MEASUREMENT

 Inferior Mesenteric Artery


 Rt. / Lt. Volume
 Prox / Mid /Distal Inferior Vena Cava
 Rt. / Lt. Flow
 Kidney
 Rt. / Lt. Mass1~Mass5
 Rt. / Lt. Renal Artery
 Comment
 Rt. / Lt. Arcuate Artery

 Rt. / Lt. Iliac Artery SUPERFICIAL MEASUREMENT


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

 IMV
TCD MEASUREMENT
 Spleen

 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

 Rt. / Lt. Proximal Basilar Artery


THYROID MEASUREMENTS  Volume Flow

 Comment
 Rt. / Lt. Volume

 Rt. / Lt. Flow


MUSCULOSKELTAL MEASUREMENT
 Rt. / Lt. Mass1~Mass5

 Comment  Rt. / Lt. Shoulder

 Rt. / Lt. Wrist


BREAST MEASUREMENT  Rt. / Lt. Knee

 Rt. / Lt. Ankle


 Rt. / Lt. Mass1~Mass10
 Comment
 Rt. / Lt. Flow
ACCUVIX A30 Datasheet rev01 Page 22
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CONFIDENTIAL

PEDIATRIC HIPS MEASUREMENT  IEC/EN 60601-1 : Ed. 2.0:1998 + A1:1991 +

A2:1995 ) :
 Rt. / Lt. Hips Angle
Medical electrical equipment
 Comment
Part 1: General requirements for safety

 IEC/EN60601-1-1: Ed. 1.0:2000

SAFTEY Medical electrical equipment

Part 1-1: General requirements for safety –


 RoHS (Restriction of Hazardous Substance) Collateral Standard: Safety requirements for
compliance medical electrical systems
rd
 IHE 3 Edition  IEC/EN60601-1-2: Ed. 2.0:2001

Medical electrical equipment

Part 1: General requirements for safety – 2.


CLASSIFICATIONS
Collateral Standard: Electromagnetic compatibility
 Type of protection against electrical shock: Class I – Requirements and tests
 Type of protection against electrical shock: Class I  IEC/EN60601-1-4:Ed. 1.1:1996 + A1:1999
 Degree of protection against electrical shock Medical electrical equipment
(Patient connection): Type BF equipment Part 1-4: General requirements for safety –
 Degree of protection against harmful ingress of Collateral standard: Programmable electrical
water: Ordinary equipment medical systems
 Degree of safety of application in the presence of a  IEC/EN60601-1-6: Ed. 2.0:2006
flammable anesthetic material with air or with Medical electrical equipment
oxygen or nitrous oxide: Equipment not suitable for Part1-56: General requirements for basic safety
use in the presence of a flammable anesthetic and essential performance – Collateral standard:
mixture with air or with oxygen or nitrous oxide. Usability
 Mode of operation: Continuous operation  IEC/EN60601-2-37:Ed. 1.0:2001 + A1:2004 +

A2:2005

Medical electrical equipment


APPLICABLE STANDARD & REGULATION
Part 2-37: Particular requirements for the safety of
FDA / USA: 21 Code of Federal Regulations 801.1 ultrasonic medical diagnostic and monitoring
MDD 93/42/EEC: European Medical Device Directive equipment
IEC (International Electrotechnical Commission)  IEC/EN61157: Ed. 1.0:1992

ACCUVIX A30 Datasheet rev01 Page 23


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CONFIDENTIAL

Requirements for the declaration of the acoustic  EN1041: 2008

output of medical diagnostic ultrasound equipment Information supplied by the manufacturer with

 IEC/EN62304: Ed. 1.0:2006 medical devices

Medical device software – Software life cycle

processes NEMA/AIUM

 IEC/EN62366: Ed. 1.0:2007  NEMA/AIUM UD-2: 2004

Medical devices – Application of usability Acoustic Output Display Standard for Diagnostic

engineering to medical devices 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

 ISO14971: 2007

Medical devices – Application of risk management

to medical devices

For more information, please don’t hesitate to contact

UL (Underwrites’ Laboratories, Inc.) SAMSUNG MEDISON Product Management Part.

 UL 60601-1 E-Mail : hj.ellie.kim@samsungmedison.com

Medical electrical equipment

Part 1: General requirements for safety

CSA (Canadian Standards Association)

 CAN/CSA 22.2, No.601-1 –M90: 1990, S-1:1994,

B:1996

Medical electrical equipment

Part 1: General requirements for safety

EN (European Standard)

 EN980: 2008

Graphical symbols for use in the labeling of medical

devices

ACCUVIX A30 Datasheet rev01 Page 24

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