MysonoU6 - Technical Specification - Rev02

MySono U6
Data Sheet
Version 1.00.00
November 10, 2011

Rev01
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
CONFIDENTIAL
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.
CONFIDENTIAL
GENERAL SPECIFICATION SYSTEM SPECIFICATION
PHYSICAL SPECIFICATION APPLICATION
Height: 75.4 mm Applications
Width: 360 mm Obstetrical
Depth: 291 mm Gynecological
Weight with Battery: approx. 5.6 kg (12.3 lb.) Abdominal
Cardiology
ELECTRICAL POWER
Musculoskeletal
Voltage: 100- 240 V AC Vascular
Frequency: 50/60 Hz Urological
Power: Max. 90 VA with Peripherals Small Parts

Pediatric
MONITOR Fetal Heart
15 inch High-Resolution Color LED Backlight

DIAGNOSIS MODES
Display size: 1024x768
Interactive Dynamic Software Menu B-Mode
Open Angle Adjustable 0 to 180° M-Mode
Integrated Speakers Free Angle M-mode
Brightness Adjustment Color Doppler Mode (CD)
Power Doppler Mode (PD)

CONSOLE DESIGN
Continuous Wave Doppler (CW, optional)
Laptop Style Pulse Wave Spectral Doppler (PW)
Live 3D Imaging (4D, optional)

Integrated HDD (500GB)
Color M mode(CMM)
Lithium-Ion Battery Pack (standard)
Harmonic Imaging
Wired, wireless LAN Support
Tissue Doppler Imaging (TDI)
For DICOM communication
Tissue Doppler Wave (TDW)
For Network Storage
SonoviewTM
(Image store to PC without DICOM system)
Simultaneous Capability
USB ECG (AHA / IEC) (Optional) Support
B/PW
CW Doppler (Optional) Support
B/CD or PD
Mechanical 3D (Optional) Support
B/M or Free Angle M
1 probe port with micro-connector
Dual B (B/B)
Rear handle
Dual B + CD or PD
B + CD (PD)/PW
MySonoU6 Datasheet rev01 Page 2

CONFIDENTIAL
B + CD (PD)/CW Urological Calcs
3D Mode Renal Calcs
4D Mode (optional) Report Package
Multi Image Split Screen SonoReport (Optional)
-Live and/or frozen

SYSTEM OPTIONS
-B + B/CD (= B/C Live Mode)
-Independent Cine playback 4D

Zoom: Read/Pan and from archive 3D XI
Time line Display Cardiac Measurement
-Independent Dual B/PW/CW Auto IMT
DMR+
DISPLAY MODES
SCI
Display Formats: DICOM
Top/ Bottom or Side/ Side selectable Format Size: 30~70% DOCOM SR
with B Mode SonoReport
format, switchable after freeze CW Function
Update mode: timed based on sweep ECG Function
TRANSDUCER TYPES
HARDWARE OPTIONS
Linear Array
Convex Array Battery Pack
Micro-Convex Array USB ECG
Phased Array 2 probe connector
Volume Probes
PERIPHERAL OPTIONS
- Convex Volume
- Endocavity Volume 2 pedal USB Foot Switch (Optional)

Pencil Probes Cart
SYSTEM STANDARD FEATURES Adjustable platform height
2 Probe port adapter option (Optional)

High Resolution 15 inch Color Backlight LED
-Height: 856~1006 mm
Max. 2,621 frames and 8,192 loop CINE/Loop depend on
-Depth: 560 mm
FOV, Scanning Lines etc.
-Width: 578 mm
500GB Hard Drive
-Weight : 18 kg
External DVD R/W storage
External USB DVD-RW (Optional)
Automatic Optimization
- DVD+-R
Quick-Scan B
- DVD+RW
Quick-Scan PW
- DVD-RW

CONFIDENTIAL
- CD-R - Indication
- CD-RW
USB thermal B&W printer, Sony™ UPD-897 & Mitsubishi LANGUAGE

P23DW & P95DW (optional) Display Language
USB thermal color printer, Sony UP-D25MD & UP-D23MD - English
& Mitsubishi CP30DW (optional) - German
Memory Stick (optional) - French
USB HDD (optional) - Spanish
- Seagate FreeAgent GoFlex 500GB - Italian
- Russian
DISPLAY ANNOTATION
- Mandarin Chinese
Institution Name Input Language
Date: 3 types selectable - English
- YYYY-MM-DD - German
- MM-DD-YYYY - French
- DD-MM-YYYY - Spanish
Time: 2 types selectable - Italian
- 24 hours - Russian
- 12 hours - Korean
Patient - Mandarin Chinese
Name: First, Last & Middle - Japanese
Patient Identification: 64 characters
Auto ID Creation
DISPLAY
Birhth
Age: YY-DD
Name + Age or Birthday
Gender : 2 Types Selectable – Female, Male
TGC Line On/Off
Accession
Image Information On/Off
Study Information
Display Blank Off/1~30 Min.
6 Types Categories : General, OB, Gynecology, Adult Echo,
Doppler Axis : Velocity, Frequency
Pediatric Echo, Fetal Heart, Vascular, TCD
LMP/GA/EDD Display
Search
Changeable Font Size & Colors both of
Exam View
Documents and Measure Result
Operator Identification
- Diag. Physician
- Ref. Physician
- Sonographer
- Description

CONFIDENTIAL
Boot up Caps Lock On

SCAN MODE
AutoText
Clear Annotation
Simultaneous Mode : 3 Type off, Allow B/PW, Allow
Programmable Autotext
B/C/PW
Autotext Dealy time (01.~5.0 Sec.)
Auto Unfreeze While Dual Operation
Power Output Readout
Change Window at Dula Mode
- MI: Mechanical Index
2D/C Live Mode
- TIS: Thermal Index Soft Tissue
- Left/ Up, Right/ Down
- TIC: Thermal Index Cranial (Bone)
- 2D/C Live left-Right Dual Only
- TIB: Thermal Index Bone
Freeze Action : 4 Type
Probe Orientation Marker
- None
Gray/Color Bar
- BodyMarker
Probe Type
- Caliper
Application Name
- Measure
Focal Zone Markers
EndExam Action : Endexam Only, Endexam and Patient
Body Pattern: 177 types
B Scale Marker
DISPLAY OPTION M Scale Markers: 2 types
Time/Depth, Time
Auto Freeze System Messages Display
HPRF Trackball Functionality Status: Scroll, Position, Size, Scan
Color Map Auto Invert Area Width and Tilt
M/PW Loop Side by Side Biopsy Guide Line and Zone
Wide Scale
lip Store Method : 3 types

SYSTEM PARAMETERS
- ECG Beat
- Time (1~50 Sec.)

System Setup
- Manual
Diagnostic Categories: 12 types, pre-settable
Cine Loop Period
OB, Gynecology, Abdomen, Neonatal, Pediatric, Cardiac,
- Retrospective, Prospective
Pediatric Cardiology, Small Parts, Vascular,
-Changeable Size Bodymarker : 3 Type
Musculoskeletal, TCD, Urology
(Small/Medium/Large)
User Programmable Preset Capability
-BodyMarker Auto Active
Factory Default Preset Data
-Programmable Bodymarker Table : 8 Groups
Languages setup: 6 Languages
-Text setup
English, German, French, Spanish, Italian, Russian
Quick Text
Languages for Manuals: 14 Languages
Auto Text Erase

CONFIDENTIAL
English, German, French, Spanish, Italian, Russian, Quick Scan
Korean, Brazilian Portuguese, Japanese, Czech, Polish, Audio Volume
Serbian, Ukrainian CW-Mode
Operation Error Beep - Gain
System Boot Up: 15 seconds - Velocity
Full maintenance Reboot: 110 sec - Doppler Frequency
Probe Change: 3-5 sec - Dynamic Range
- Audio Volume
Color Flow Mode

PRE-PROCESSING
- Gain
- ROI Position, Size

Acoustic Power Output
- PRF
B/M-Mode
- Color Line Density
- Gain
- Color Frequency
- Spatial Compound Imaging
- Packet Size
- Harmonic Imaging
- Threshold
- Quick Scan
- Frame Average
- TGC
- Focus Position
- Invert
3D Acquisition
- Depth
- Scan Distance
- Scan Area
- Scan Plane
- Dynamic Range
- Acquisition Mode
- Focus Number
- Focus Position
- Line Density POST-PROCESSING

- Frequency
- Frame Average Dynamic MR
- Edge Enhance Read Zoom
- Focus Width B/M-Mode
- M/D Cursor - Gain
- Sweep Speed for M-Mode - Image Reverse
PW-Mode - Image Rotation
- Gain - Gray Map
- Sample Volume Gate Position, Length - Rejection
- PRF - Sweep Speed for M-Mode
- Doppler Frequency PW-Mode
- Dynamic Range - Gain

CONFIDENTIAL
- Baseline Imaging Processing and Presentation
- Angle Correct Digital Beamformer
- Doppler Invert Displayed Imaging Depth: Minimum Depth of Field: 2 cm
- Display Format (Zoom and probe dependent); Maximum Depth of Field:
- Sweep Speed 30 cm (probe dependent)
- Full Timeline Transmission Focus
- Rejection - 1 – 8 Focus Points Selectable
- Dynamic Range (probe and application dependent)
- Auto Calcs - Focal Zone Position
CW-Mode Continuous Dynamic Receive Focus/Aperture
- Gain Multi-Frequency/Wideband Technology
- Baseline 256 Shades of Gray
- Angle Correct 200dB System Internal Dynamic Range
- Doppler Invert Adjustable Field of View (FOV)
- Display Format Image Reverse: Right/Left
- Sweep Speed Image Rotation: 2 steps
- Full Timeline Rotation: 0°, 180°
- Rejection CINE Memory/Image Memory
- Dynamic Range Over 2621 frames or over c CINE Memory depend on
- Auto Calcs FOV, Scanning Lines etc.
- Trace Sensitivity CINE Gauge and CINE Image Number Display
Color Flow Mode CINE Review:
- Gain Frame-by-frame, Loop
- Baseline Start and End Frame Selections for Loop Playback
- Color Invert Measurements, Calculations and Annotations on CINE
- Color Map Playback
- Threshold Scrolling Timeline Memory
- Frame Average (in loop images) Image Archive/Connectivity
3D Clipboard: displays thumbnail images of the acquired
- Threshold data for the current exam
- Rendering Previewing Clipboard Images: An
- Texture enlarged preview of the image
- Gray Surface Recalling Images from the Clipboard
- Scalpel Image Viewer: Archived images from past patient exams
- Auto Movie appear as well as images stored for the current exam
- Undo Previewing an Image
- Reset Analyzing Images

CONFIDENTIAL
Image Management  2D Mode
- Select All/Unselect All -Frame Average 0 ~ 15 Step
- Delete all the Temporary Images -Dynamic Range 50 ~ 200 dB
- Delete Selected Image -Reject Level 1 ~ 32 Step
- Analyze -Edge Enhance -3 ~ +3 Step
Ethernet Network Connection -View area 20 ~ 100 %
Archiving Format: -Density(High, Middle, Low) 3 Step
DICOM with ultrasound raw data -Tissue(Solid, Normal, Adipose, Cystic) 4 Step
DICOM -Trapezoidal (Linear)
Capture Area: pre-settable for each print key -Apex (U/D Flip)
Video Area -Direction (L/T Flip)
Application Window -Frame Rate(Slow, Normal, Fast) 3 Step
Whole Screen -Post Curve 1 ~ 9 Step
-Harmonic
Configurable Examination List Window, Patient Pulse Inversion (Probe dependancy)
Information Window, and Search/Create Patient Window -Time Gain Control 6 slide
Extended search dialog, auto search for patient in -Gain 0 ~ 100 %
Search/Create Pts window -Power 10 ~ 100 %
Automatic generation of patient ID -Depth (Probe dependancy) 2 ~ 30 cm
Request acknowledge of End Exam action Focus 8
Go directly screen from search Orientation Control
Tools Panning
Verify DICOM directory on removable media Frequency 3 mode
Format removable media (rewritable DVD) SRF 2 index
The currently selected dataflow DMR+ 3 index
All configured data flows TI Selection Control
The network structure tree Dual Control 2 mode
The configured buttons data flows Read Zoom 100 ~ 400 %
AVI and JPEG Export : DICOM Support Write Zom 100 ~ 400%
-Verify Biopsy
-Print Biopsy Guideline control
-Store Quick-Scan
-Modality Worklist Moving Line (M Line)
Moving Line position
ECG (Probe dependancy)

SCANNING PARAMETERS
M Mode
Dual Display

CONFIDENTIAL
Dynamic range 50 ~ 200 dB CDI box ROI position
Reject level 1 ~ 32 Step Filter
Density 3 Step Multi frequency
Edge enhance -3 ~ 3 Step PW Mode
Tissue 4 Step Dual Mode
Chroma map 1 ~ 13 Type Sweep speed
Gain control 0 ~ 100 % Sample volume position
Time gain compensation 6 Slice Sample volume size
Magnification [Probe dependancy] 2 ~ 30 cm Display size
Frequency 3 Step Loop format
Sweep speed 60, 120, 180, 240, 300, 360 Hz -Loop Size 6:4 / 5:5 / 4:6
Post map control -Dynamic Range 50 ~ 200 dB
Marker Angle correction -70° ~ 70° Angle
Loop Format Top/Bottom, Left/Right -Angle correction preset -60°, 0°, 60° Angle
M line Gain 0 ~ 100 %
Free Angle M Mode Line Baseline 0 ~ 8 Step
ECG [Probe dependancy] Chroma map 1 ~ 13 Step
Wall filter 0 ~ 3 Level
Audio volume 0 ~ 100 %

COLOR MODE
Invert
Multi Frequency 2 Step

Frame average 0 ~ 9 Level
Tissue Doppler
Balance 1 ~ 16 Level
Doppler axis
Velocity
AutoCalc
Velocity + Variance (None Display)
Mean Trace
Power Doppler Imaging
AutoCalc direction
Display : Color + B/W, Color Only, B/W Only
Simultaneous
Tissue Doppler [Probe dependancy]
Spectrum enhancement 1 ~ 4 Step
Color map 1 ~ 14 Type
Quick-Scan
Tag control
Scale 600 ~ 14K Hz
Steer Left, Right, None CW MODE

Baseline 0~8 Level
Sensitivity 8 ~ 31 Step Power 10 ~ 100 %
Invert Gain 0 ~ 100 %
Gain 0 ~ 100 % Baseline 0 ~ 8 Step
CDI box ROI size 5 ~ 100 % Spectral Invert Display

CONFIDENTIAL
Review Oblique View
Sweep Speed 6 Step Image Processing
Display Format ECG
Dynamic Range 1~4 level Step -ECG ON/OFF
Chroma 1 ~ 13 Step -Trigger ON/OFF
Wall Filter 0~3 level -Trigger Delay Time
Audio Volume 0~100 % -Size
Audio Volume Mute -Position
Scale 1.5 ~ 43 KHz -Sweep Speed
Invert -Auto Gain
AutoCalc
MEASUREMENTS
3D MODE
(Refer to FRS 3.3.3)
Static 3D, Live 3D OB Measurement
Open File: MVL, V00 Gynecology Measurement
Save File: Volume Data, Cine Data, Image Store Cardiac Measurement
Export AVI File Carotid Measurement
3D Rendering mode : Surface, Surface Smooth, Max, Min, UE Artery Measurement
X-ray, Light LE Artery Measurement
Plane Rendering mode UE Vein Measurement
Threshold LE Vein Measurement
Transparent Fetal Echo Measurement
Mix Urology Measurement
ABC(2D) mode Abdomen Measurement
ABC-3D mode (Volume) Thyroid Measurement
ROI-3D mode (Volume) Breast Measurement
Full 3D mode (Volume) Testicle Measurement
Reference Image mode Superficial Measurement
Reference Slice scroll TCD Measurement
Cine MSK Measurement
Init mode Pediatric Hops Measurement
Magicut
3D Measure
Multi Slice View

CONFIDENTIAL
•P2-4 Phased Array

PROBES
-Center frequency: 3.0MHz
-Radius of curvature: Flat

•C4-9 Micro Convex Array
-Field of view: 19.2°
-Number of elements: 64Elements
-Radius of curvature: 10.0mm
-Element pitch:0.3mm
-Elevation aperture: 13.0mm
-Number of elements: 128elements
-Geometric focus: 80.0mm
-Element pitch: 0.205mm
-Biopsy Guide: Not Available
-Application: Abdomen, Cardiac, TCD
-Geometric focus: 38.0mm

•C2-5 Curved Linear Array
-Application: Pediatric, Abdomen, Vascular
-Radius of curvature: 40mm

•EVN4-9 Endo Cavity Array
-Field of view: 75°
-Number of elements: 128 elements
-Radius of curvature: 10.073mm
-Elevation aperture: 13mm
-Geometric focus: 82mm
-Element pitch:0.205mm
-Biopsy Guide: Available
-Application: Abdomen, OB, Gynecology

•CW2.0 Pencil Type
-Application: Gynecology, OB, Urology
-Center frequency: 2.0 MHz
-Number of elements: 2 elements

•LN5-12 Linear Array
-Elevation aperture: 13.8 mm
-Center frequency: 8MHz
-Geometric focus: 55 mm
-Radius of curvature: Flat
-Field of view: 40mm
-Application: Cardiac

•C2-8 Curved Linear Array
-Center frequency: 4.6 MHz
-Radius of curvature: 51.071 mm
-Application: Musculoskeletal, Small Parts, Vascular
-Element pitch: 0.4785 mm
-Elevation aperture: 11.0 mm

CONFIDENTIAL
-Geometric focus: 70.0 mm Required for Canada. Medical Electrical Equipment:
-Biopsy Guide: Available General Requirements for Safety
-Application: Abdomen, OB, Gynecology IEC/EN 60601-1-2 Ed. 2.0:2001 :
Medical electrical equipment- Part 1-2: General
•3D2-6 3D-Curved Linear Array requirements for safety- Collateral standard:
-Center frequency: 3.8 MHz Electromagnetic compatibility-Requirements and tests
-Radius of curvature: 40 mm IEC60601-2-37: Ed. 1.0:2001 + A1:2005 :
-Field of view: 69° Medical Electrical Equipment – particular Requirements
-Number of elements: 128 elements for Safety: Ultrasonic Medical Diagnostic and
-Element pitch: 0.380 mm Monitoring Equipment
-Elevation aperture: 12.0 mm IEC 60601-1-1: Ed.2:2000 :
-Geometric focus: 60.0 mm Medical Electrical Equipment, Part 1-1: General
-Biopsy Guide: Available Requirements for Safety -Collateral Standard: Safety
-Application: Abdomen, Gynecology, OB Requirements for Medical Electrical System
IEC 60601-1-4:2000 Ed. 1.1 Consolidated Edition & ISO
•3D4-9 3D-Endocavity Array 14971:2001 :
-Center frequency: 6.5 MHz Medical Electrical Equipment, Part 1-4: General
-Radius of curvature: 10 mm Requirements for Safety -Collateral Standard:
-Field of view: 150° Programmable Electrical Medical Systems & Medical
-Number of elements: 128elements Devices – Application of Risk Management to Medical
-Element pitch: 0.205 mm Devices
-Elevation aperture: 8 mm IEC 61157:1992 :
-Geometric focus: 20 mm Requirements for the Declaration of the Acoustic Output
-Biopsy Guide: Available of Medical Diagnostic Ultrasonic Equipment
-Application: Urology, Gynecology, OB AIUM/NEMA UD-2: 2004 :
AIUM/NEMA Acoustic Output Measurement Standard for

APPICABLE STANDARD AND REGULATION Diagnostic Ultrasound Equipment
AIUM/NEMA UD-3: 2004 :

FDA / USA: 21 Code of Federal Regulations 801.1
AIUM/NEMA Standard for Real-Time Display of Thermal
MDD 93/42/EEC:
and Mechanical Acoustic Output Indices on Diagnostic
European Medical Device Directive
Ultrasound Equipment
EN 60601-1 (Ed. 2.0:1998 + A1:1991 + A2:1995 ) :
EN/ISO 10993-1 Ed. 3.0:2003 :
Medical electrical equipment – Part 1: General
Biological evaluation of medical devices – Part 1: Evaluation
requirements for safety
and testing
Safety of medical electrical equipment
CAN/CSA 22.2 NO.601.1-M90:1990, S-1:1994, B:1996 :

MysonoU6 - Technical Specification - Rev02

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MySono U6

November 10, 2011

GENERAL SPECIFICATION SYSTEM SPECIFICATION

PHYSICAL SPECIFICATION APPLICATION

Height: 75.4 mm Applications

Width: 360 mm Obstetrical

Depth: 291 mm Gynecological

Weight with Battery: approx. 5.6 kg (12.3 lb.) Abdominal

Voltage: 100- 240 V AC Vascular

Frequency: 50/60 Hz Urological

Power: Max. 90 VA with Peripherals Small Parts

15 inch High-Resolution Color LED Backlight

Interactive Dynamic Software Menu B-Mode

Open Angle Adjustable 0 to 180° M-Mode

Integrated Speakers Free Angle M-mode

Brightness Adjustment Color Doppler Mode (CD)

Power Doppler Mode (PD)

Laptop Style Pulse Wave Spectral Doppler (PW)

Live 3D Imaging (4D, optional)

MySonoU6 Datasheet rev01 Page 2

B + CD (PD)/CW Urological Calcs

3D Mode Renal Calcs

4D Mode (optional) Report Package

Multi Image Split Screen SonoReport (Optional)

-Live and/or frozen

-Independent Cine playback 4D

Top/ Bottom or Side/ Side selectable Format Size: 30~70% DOCOM SR

with B Mode SonoReport

format, switchable after freeze CW Function

Update mode: timed based on sweep ECG Function

Convex Array Battery Pack

Micro-Convex Array USB ECG

Phased Array 2 probe connector

- Endocavity Volume 2 pedal USB Foot Switch (Optional)

2 Probe port adapter option (Optional)

MySonoU6 Datasheet rev01 Page 3

USB thermal B&W printer, Sony™ UPD-897 & Mitsubishi LANGUAGE

Institution Name Input Language

Date: 3 types selectable - English

Time: 2 types selectable - Italian

Patient - Mandarin Chinese

Name: First, Last & Middle - Japanese

Patient Identification: 64 characters

MySonoU6 Datasheet rev01 Page 4

Boot up Caps Lock On

DISPLAY OPTION M Scale Markers: 2 types

Auto Freeze System Messages Display

HPRF Trackball Functionality Status: Scroll, Position, Size, Scan

Color Map Auto Invert Area Width and Tilt

M/PW Loop Side by Side Biopsy Guide Line and Zone

lip Store Method : 3 types

- Time (1~50 Sec.)

MySonoU6 Datasheet rev01 Page 5

English, German, French, Spanish, Italian, Russian, Quick Scan

Korean, Brazilian Portuguese, Japanese, Czech, Polish, Audio Volume

Serbian, Ukrainian CW-Mode

Operation Error Beep - Gain

System Boot Up: 15 seconds - Velocity

Full maintenance Reboot: 110 sec - Doppler Frequency

Probe Change: 3-5 sec - Dynamic Range

Color Flow Mode

- ROI Position, Size

- Line Density POST-PROCESSING