0% found this document useful (0 votes)
63 views25 pages

Acclarix AX3 Series Datasheet

Uploaded by

commercialhir
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
63 views25 pages

Acclarix AX3 Series Datasheet

Uploaded by

commercialhir
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 25

Acclarix AX3 Series

Diagnostic Ultrasound
Version 1.9

Product Description
The remarkable Acclarix AX3 series Compact Ultrasound System delivers
a powerhouse combination of features to meet the demands of
point-of-care and general imaging applications. The Acclarix AX3 series
has been designed from the ground up with a relentless focus on
delivering unexpected levels of innovation and performance at a price
point that is equally surprising. Dual active transducer ports design
enables switching transducer seamlessly at a finger tip. Dual batteries
extend the imaging scanning. Extremely light body embodied with brand
new EIS operating system empowerssmooth system operation and fast
system response.

Advanced Technique and Features


TAI-Tissue Adaptive Imaging 3D/4D Imaging
eSRI- Adaptive Speckle Reduction Needle Visualization
Imaging eLearn Instruction software
Frequency Compounding Imaging ECG synchronization
Adaptive Spatial Compounding Imaging Color M mode
Harmonic Imaging Elastography mode
Digital Multi-Beam forming Panorama
Trapezoid Imaging B mode one-key Optimization
Adaptive Doppler imaging PW mode one-key Optimization
Spectrum Enhancement Color mode one-key Optimization
Digital Zoom Auto IMT
Full Screen Zoom Auto OB
Auto Doppler trace Auto NT
Anatomic M mode Auto vessel diam*
TDI mode-Tissue Doppler Imaging

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Battery
System Overview
System Architecture
- Rechargeable Li-ion Battery

Physical Channels 64
- Max. two batteries configurable (two batteries
with 6800mAh*2 capacity)
Digital Channels ≤1105920
Gray Scale 256
- For 6800mAh capacity battery
- Approximately 1.5 hour of typical
Beam Forming Eight beam
ultrasound exam use for one fully
Processor ARM
charged battery.
Memory 2 GB
- Approximately 3 hours of typical
Hard Drive 120GB/512GB/1TB
ultrasound exam use for two fully
SSD
charged batteries.
Operating System Android
- One battery fully charged in about 3.5
System Boot-up About 30s
hours
Boot-up from sleep 6s(Sleep mode)
- Two batteries fully charged in about 6.5
10s(Deep Sleep mode)
hours.
Shutdown 3s
- Removable

Dimensions and Weight


- Battery indicator on the console near the
handle.
Main unit 395 mm×385 mm×64mm
dimensions (without cushion)
- Battery level icon displayed on the main
screen.
Weight ≤4.5kg
( without battery and any other
- Up to 18 hours Standby time (two fully
charged batteries) in Deep Sleep mode.
accessory)

AC Power Requirements
Monitor
Voltage 100 -240 V~
- 15.6’’ high resolution LCD monitor
Frequency 50 Hz/60 Hz
- Resolution: 1920 x 1080
Environment Requirements
- Image Size: 1040*780
Operating Environment
- Open angle:0°-180°
Ambient temperature 0° to 40°C
- Magnetic latch closure
Relative Humidity 15%~95% (no
- Built-in stereo speaker
condensing)
- Brightness and Contrast adjustable
Atmospheric pressure 86kPa-106kPa
- Color temperature adjustable
Storage Environment
Ambient temperature -20° to 55°C
Transducer Ports
Relative Humidity 15%~95% (no
- Dual active transducer ports
condensing)
- Single or Dual transducer ports configurable
Atmospheric pressure 70kPa-106kPa
- One MTC module is supported, and maximum
four transducers can be connected
simultaneously.

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Language Supported - Suitcase
- English - MTC module
- Chinese - ECG module
- German - External DVD drive
- French
- Italian System Ergonomic Design
- Spanish Dual Transducer Ports
- Russian Dual active transducer ports design enables
- Portuguese switching transducer seamlessly at a finger tip,
- Polish and reduces the workload of
disconnecting/connecting transducers during an
I/O Ports exam.
- S-Video
- USB 3.0 Handle
- USB 2.0(two) Provides wrist support during imaging.
- HDMI
- Ethernet Magnesium alloy body
Extremely light weight realizes the true portability.
Options
- Transducers User Interface
- Needle Guide Bracket Kits Control Panel

- Printers  Interactive back-lighting


- Battery  Hard Keys provides tactile feedback
- 512GB/1TB SSD  User-defined keys
- WIFI  Physical trackball
- Footswitch
- Single button/Double buttons Touch Screen
- User-defined Functions(Freeze, Save,  10.1’’ Touch screen
Print)  Gesture-control
- Simple Cart: MT-808  Virtual TGC sliders
- Height Variable (0~200±10mm)  Support visual Chinese, English QWERTY
- Length 602±5mm, width 600±5mm and keyboard, German QWERTZ keyboardand
height (849~1049)±5mm French AZERTY keyboard for text input
- A drawer for glossary storage  Brightness adjustable
- A shelf for Video printer
- 4transducer holders and 2 gel holders Main Screen Display
with removable silicon cover Information Field
- Cable manager - EDAN logo
- Drawer height and position adjustable - Hospital name

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
- Date - The active function of user-defined key F1 and
- Time F2.
- Patient ID - PIP display
- Patient Name
- Patient Gender Status Bar
- Patient Age - Utility Icon(access to Utilities function)
- Transducer model - Image Store Icon
- Exam Preset - USB Icon
- LMP/BBT, GA, EDD - Printer Icon
- User Name - WIFI Icon
- Network Transfer Status Icon
Image Field - Hard Drive Icon
- Mechanical Index (MI) - Battery Icon
- Thermal Index (TI) - DVD icon
- Imaging parameters
- Gray Scale bar User Login Management
- Depth Scale - Supports User Login at boot up and at exiting
- Center Mark the sleep mode.
- Measured result window - Supports user type of Administrator and
- TGC curve Operator
- Supports switching users without powering
Measurements Menu Field off the system.
- Available generic and application - Support Emergency login for emergency use.
measurements for current exam preset.
- Pre-categorized measurement groups.
- Consistent with the display on Measurement Other Features
Touch Screen (10.1-inch).  eLearn instruction tool for basic scanning and
nerve blocks.
Thumbnail Field - Support instructions for OB&GYN, Nerve
- All captured static images and cine clips block, and GI (ABD, Cardiac, etc.)
- Quick preview of thumbnails in image area scanning.
- Shortcut keys for selecting, viewing, deleting, - Provides descriptions of Transducer
exporting images. position, Scan technique, Standard
- Display of catheter size reference. ultrasound image, Anatomy, Needle
guide, tips, etc.
User Feedback Field - The illustration pictures can be enlarged
- Illustration of trackball and trackball keys to full touch screen display by pressing it.
- Cine bar  One-key full screen zoom(3 levels) by
- Exit icon for exiting RawData review status. user-defined key F1 or F2.

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Exam Preset
 System pre-defined exam presets include
- Neonatal Abdomen
(Transducer specific) :
- Neonatal Head
- ABD
- TCD
- ABD Difficult
- Needle-SMP
- EM ABD
- Aorta  User customizable presets: Copy, Delete,
Save as and rename
- FAST
- Early OB  Exam presets are configurable in Set-up.

- OB  Supports a second page, up to 30 presets per


transducer.
- EM OB
- Fetal Echo  Each preset can share comment, body mark,
and measure presets.
- GYN
- IVF  The display order of the exam presets of each
transducer can be adjusted per user's needs.
- Urology
- Prostate
Annotations
- Thyroid
Comments
- Breast
- Testis
- User-programmable home position

- Carotid
- Arrow with user controlled orientation

- Up Ext A (Upper Extremity Artery)


- Five language soft keyboard: Chinese, English,
French, German, Russian.
- Up Ext V (Upper Extremity Vein)
- Low Ext A (Lower Extremity Artery)
- Block move and delete for separate blocks of
text
- Low Ext V (Lower Extremity Vein)
- Vascular
- Smart text replacement for predefined text
(e.g., Long replaces Trans with one keystroke)
- Vascular Access
- EM VAS
- 545 pre-defined comments

- Spine
- User customizable

- MSK
- English Comments Library is supported when
the system language is not in English.
- Sup MSK (Superficial MSK)
- EM MSK
Body Mark
- Nerve
- Sup Nerve (Superficial Nerve)
- Up to 143 Body Mark graphics in library

- Shoulder
- Support separate body mark in Dual/Quad
mode.
- HIP
- Adult Cardiac
- Pediatric Cardiac
- EM Adult Card
- Pediatric Abdomen

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Imaging
Imaging Modes
Imaging Mode Combinations
B-mode
M-mode
- B+M

- M-mode
- B/C (PDI or DPDI), Single

- Linear Anatomic M mode


- B/C(PDI or DPDI), Dual

- Curved Anatomic M mode


- B/C(PDI or DPDI), Quad

- Color M mode
- B+B/C(PDI or DPDI),Dual live

Color Doppler
- B+Color (PDI or DPDI) +M

- Velocity-based color Doppler


- B+PW (Duplex)

- PDI
- B+PW (Update)

- DPDI
- HPRF

PW Doppler
- B/C(PDI or DPDI)+PW (Triplex)

CW Doppler
- B/C(PDI or DPDI)+PW (Update)

TDI mode
- B+CW (Update)

- TVI
- B/C(PDI or DPDI)+CW (Update)

- TEI
- B+TVI

- TVD
- B+TVI+TEI

- TVM
- B+TVI+TVD(Update)

3D/4D mode
- B+TVI+TVD(Triplex)

Elastography Mode
- B+TVM(Update)

Display Modes
- B+E
Imaging Parameters
Dual Imaging
B- mode(Live imaging)
- Available for B and Color(PDI/DPDI) mode.
Image Type Detail/General/Penetration
- Displays two image side-by-side, two frozen
Auto(one-key TGC, Gain
or one active/one frozen.
optimization)
- Allows to switch between two images.
Digital Zoom x0.8-x2.0
- Measurements and calculations are
supported on each image and across the dual Display Depth 1-45cm

images. Frequency 1-17MHz


Max. 5 fundamental + 5
- Annotations are supported on both images.
Quad Imaging harmonic(depends on
transducer)
- Available for B and Color (PDI/DPDI) mode.
- Displays images in four quadrants, four frozen Frequency display Bandwith, Frequency points

or one active/three frozen. eSRI Off, Low, Med, High

- Allows to switch between four images. FOV Small, Med, Large, Full

- Measurements and calculations are Steer 0°, ±10°


supported on each image. Gain 0-100dB, 1dB/step

- Annotations are supported on each image. TGC 8 segments

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
LGC 8 segments - Zoom
Dynamic Range 40-96dB, 2dB/step - Dynamic range
Line Density Low, Med, High - eSRI
≥512 lines - Colorize
Frame Rate Linear Transducer: Max. - Map
532f/s, depends on - Up/Down Flip
transducer; - Left/Right Flip
Convex Transducer: Max. - Quick Rotation
48f/sat 18cm depth and Full
FOV; M- mode(Live imaging)
Phased transducer: Max. Sweep Speed Fast/High/Med/Low/ Slow
77f/s at 18cm depth and Corresponds to sweep time of
Full FOV. 1s, 2s, 4s, 8s and 12s per

Map 11 Types screen respectively.

Persistence Off, Low, Med, High Line Persist Off, Low, Med, High

Focus Position Max. 16 positions, Map 11 Types

adjustable Colorize On, off

Focus Number 1-3, adjustable Tint 5 Types

Colorize On, off Gain 0-100dB, 1dB/step

Tint 5 Types Frequency 1-17MHz

Up/Down Flip Max. 5 fundamental + 5

Left/Right Flip harmonic (depends on

Spatial On/ off ,max 3angles() transducer)

Compounding Dynamic Range 40-96 dB, 2dB/Step

Trapezoid 8,12,20, off Strip size Full, large, Med., small

(Linear transducer) Side-by-side On(Left/Right)

Max. 10° Off(Up/Down)

left/right extended angle Acoustic Power 10%-100%, 10%/step

Acoustic Power 10%-100%, 10%/step Linear Anatomic On, off

Quick Rotation 0°,90°,180°,270° M Mode Up to 3 linear sample lines

Panorama On, Off Adjustable angle of each

Real-time speed indicator sample line

360° rotation of Curved Anatomic On, off

Panoramic image M Mode Free-hand drawing of sample

B- mode(Post-processing & retrospective) line; Sample line supports

- Gain edition and deletion.

- TGC M-mode(Post-processing & retrospective)

- LGC - Gain
- TGC

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
- Dynamic range Max.PRF 0.1-21.7 kHz
- Colorize (L12-5HQ, Vasc Acc)
- Map Baseline 25 levels
- Stripe Size (Not available for PDI mode)
- Side-by-side Threshold 0-100
Invert On, off
Color/PDI/DPDI Mode(Live imaging) (Not available for PDI mode)
Image Type HighFlow/MidFlow/LowFlow Acoustic Power 10%-100%, 10%/step
Dual Live Color Hide On, off
ROI Adjustable Panorama On, Off
size/position Real-time speed indicator
Frequency Max. 5 levels (depends on 360 ° rotation of Panoramic
transducer) image
Gain 0-100dB, 1dB/step Auto(one-key Gain
Line Density Low, Med, High optimization)
Dynamic Range 10-70 dB, 5dB/step Color/PDI/DPDI Mode
Not available for Color mode (Post-Processing & Retrospective)
Frame Rate Linear Transducer: Max. 350f/s, - Zoom
depends on transducer; - Color map
Convex Transducer: Max. 8f/s - Invert(Not available for PDI mode)
at 18cm depth, Full FOV and - Baseline
biggest ROI; - Color Hide
Phased transducer: Max. 14f/s - VelDistr
at 18cm depth, Full FOV and
biggest ROI. PW mode(Live imaging)
Persistence Off, Low, Med, High Image Type High Flow/Mid Flow/Low Flow
Smooth Off, Low, Med, High HPRF Automatic invocation to
Wall Filter Low, Med, High maintain gate location/scale
Color Map 8 Types Auto Trace
Steer Angle 0°,±15°, ±30° Trace Side Up, down, both
(L12-5Q,Thyroid) Duplex Max. FR: 43f/s, depends on
0°,±10°,±20° transducer
(L12-5Q,Low Ext V) Triplex Max. FR: 11f/s, depends on
0°,±10°, ±15° transducer
(L12-5Q,Up Ext A) Frequency 2 levels
0°,±5°,±10° PRF 0.9- 14.7kHz
(L17-7SQ,MSK) Max.PRF 0.34–27.9kHz
PRF 0.6- 11.4kHz (L12-5HQ, Vasc Acc)

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Gain 0-100dB, 1dB/step PW Mode (Post-Processing & Retrospective)
Dynamic Range 10-70 dB, 5dB/step - Gain
Wall Filter Low, Med, High - Dynamic Range
Sweep Speed Fast/High/Med/Low/ Slow - Colorize
Corresponds to sweep time of - Map
2s, 3s, 4s, 6s and 8s per screen - Baseline
respectively. - Angle Correction
Baseline 9 levels - Invert
Angle -80° to 80° - Strip size
Correction - Auto trace

Quick Angle -60 ° /-45 ° /-30 ° /-15 ° /0 ° - Trace side

/15°/30°/45°/60 ° - Quick Angle

Steer 0°,±15°, ±30° - Side-by-side

(L12-5Q,Thyroid)
0°,±10°,±20° CW mode(Live imaging)

(L12-5Q,Low Ext V) Image Type HighFlow/MidFlow/LowFlow

0°,±10°, ±15° PRF 1- 100kHz

(L12-5Q,Up Ext A) Gain 0-100dB, 1dB/step

0°,±5°,±10° Dynamic Range 10-70 dB, 5dB/step

(L17-7SQ,MSK) Wall Filter Low, Med, High

Invert Sweep Speed Fast/High/Med/Low/ Slow

Volume 0-99 Corresponds to sweep time of

Map 11 Types 2s, 3s, 4s, 6s and 8s per screen

Colorize On, off respectively.

Tint 5 Types Baseline 9 levels

Gate Size 0.5-40 mm Angle Correction -80° to 80°

Strip size Full, large, Med., small Quick Angle -60 ° /-45 ° /-30 ° /-15 ° /0 °

Auto Gain, DR or Scale/Baseline, /15°/30°/45°/60 °

(One-key user configurable Invert

Optimization) Volume 0-99

Acoustic Power 10%-100%, 10%/step Map 11 Types

PW velocity Max. 4.5m/s (correct angle Colorize On, off

60°); Tint 5 Types

Max. 13m/s (correct angle 80°) Strip size Full, large, Med., small

Min. 2mm/s (Non-noise signal) Acoustic Power 10%-100%, 10%/step

Side-by-side On(Left/Right) CW velocity Max. 72m/s


Off(Up/Down) Min. 1cm/s
Auto Trace

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Trace Side Up, down, both ROI size/position Adjustable
Side-by-side On(Left/Right)
Off(Up/Down) TVI Mode (Post-Processing & Retrospective)
CW Mode (Post-Processing & Retrospective) - Zoom
- Gain - Baseline
- Dynamic Range - Color map
- Colorize - Invert
- Map - Color Hide
- Baseline
- Angle Correction TVD(PW-TDI) mode(Live imaging)

- Invert Image Type HighFlow/MidFlow/LowFlow

- Strip size Triplex B+TVI+TVD

- Auto trace PRF 0.9- 5.9kHz

- Trace side Frequency 2 levels


- Quick Angle Gain 0-100dB, 1dB/step
- Side-by-side Dynamic Range 10-70 dB, 5dB/step
Wall Filter Low, Med, High
TVI Mode(Live imaging) Sweep Speed Fast/High/Med/Low/ Slow
Image Type High Flow /Mid Flow /Low (Corresponds to sweep time of
Flow 2s, 3s, 4s, 6s and 8s per screen
Dual Live B+ TVI respectively.)
ROI size/position Adjustable Baseline 9 levels
Frequency 2 levels Angle -80° to 80°
Gain 0-100dB, 1dB/step Correction
Line density Low, Med, High Quick Angle -60°/-45°/-30°/-15°/0°/15°/30°/
Persistence Off, Low, Med, High 45°/60 °
Smooth Off, Low, Med, High Invert On, Off
Wall Filter Low, Med, High Volume 0-99
Color Map 8 types Map 11 types
PRF 0.6- 3.5kHz Colorize On, off
Baseline 25 levels Tint 5 Types
Threshold 0-100 Gate Size 0.5-40 mm
Invert On, off Strip size Full, large, Med., small
Acoustic Power 10%-100%,10%/step Acoustic Power 10%-100%, 10%/step
Color Hide On, off Auto Trace
Image Type High Flow /Mid Flow /Low Trace Side Up, down, both
Flow Side-by-side On(Left/Right)
Dual Live B+ TVI Off(Up/Down)

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
TVD (Post-Processing & Retrospective) Map 0-6
- Gain DR 0-6
- Dynamic Range Invert On, Off
- Colorize Elastography Mode
- Map (Post-Processing & Retrospective)
- Baseline - Opacity
- Angle - Map
- Quick Angle - DR
- Invert - Invert
- Auto trace
- Trace side Review and Post-Processing functions
- Gate Size Cine Review
- Side-by-side - Frame by frame manual review
- Auto playback with 6-level speed adjustable
3D/4Dmode(Live imaging) - Start frame and end frame are selectable for
Acquisition modes 3D, 4D cine loop review.
Visualization Volume rendering, Multi-Slice - Independent cine review in Dual/Quad mode.
modes - Maximum cine memory depends on
Multi-Slice Max. 21 slices can be displayed transducers and image parameters:
on the same screen; - 100000 frames for B mode
Distance between each slice is - 30000 frames for Color mode
0.5-10.0mm - 180s for M mode
VOI size/Position Adjustable - 240s for PW/CW Doppler mode
Render modes Surface, Max.
3D clip Post-Processing Features
Cut tools Trace, Box, Eraser All the image/cine is stored in Raw Data format in

Cut functions Undo, Undo all, Redo local disk. The following Post-Processing features

Display formats Single 3D, Dual(A-plane + 3D), are available when in image/cine review of current

Quad(A/B/C Planes + 3D) exam or the stored exam.

3D parameters Threshold, Smooth, Brightness, - Adjusting imaging parameters

Contrast, Tint - Measurements

eFace EDAN auto show face - Annotations

4D frame rate Max. 6vps - Storing static image/ cine loop

Elastography mode(Live imaging)


Opacity 1, 2, 3, 4 levels
Smooth Off, Low, Med., High
Persistence Off, Low, Med, High

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Transducers and Biopsy Guide
Transducer Applications

Transducer Applications Transducer Applications


C5-2Q Abdomen E8-4Q Fetal / Obstetrics
Fetal / Obstetrics Gyncecology
Urology Trans-vaginal
Gynecology Trans-rectal
Musculoskeletal Urology

L12-5Q Small parts P5-1Q Adult Cardiac


Peripheral Vascular Abdomen
Abdomen Pediatric Cardiac
Musculoskeletal Adult Cephalic

L17-7HQ Small Parts L17-7SQ Intra-operative


Peripheral Vascular Musculoskeletal
Musculoskeletal Peripheral Vascular

C5-1Q Abdomen C6-2MQ Fetal / Obstetrics


Fetal / Obstetrics Abdomen
Urology Gynecology
Gynecology
Musculoskeletal
MC8-4Q Pediatric MC9-3TQ Pediatric
Abdomen Abdomen
Neonatal Cephalic Neonatal Cephalic
Musculoskeletal Musculoskeletal
PeripheralVascular Peripheral Vascular

E10-3BQ Fetal / Obstetrics E10-3HQ Fetal / Obstetrics


Gyncecology Gyncecology
Trans-vaginal Trans-vaginal
Trans-rectal Trans-rectal
Urology Urology
P7-3Q Adult Cardiac L12-5HQ Small Parts (Breast,
Pediatric Testes, Thyroid)
Abdomen Peripheral Vascular
Pediatric Cardiac
Musculoskeletal
Neonatal cephalic
Abdominal

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Transducer Specifications

Transducer C5-2Q P5-1Q L12-5Q L17-7HQ E8-4Q

Transducer Type Convex Phased Linear Linear Intra-cavity

Bandwidth@ -6dB 2-5MHz 1-5MHz 5-11MHz 7-15MHz 4-8MHz

Centeral Frequency 3.5MHz 2.7MHz 8.0MHz 12.0MHz 6.2MHz

B Harmonic H2~4/H3~5 H9~13/ H5~6/H5~8/H5~


H2~4/H3~5 H6~10/H7~12
Frequencies(MHz) / H2~5/ H3~4* H10-17 10/H6~11

B Fundamental 7~11/8~13/9~1
2~4/3~5/2~5 1~3/2~4/2~5 5~8/6~10/7~11 4~6/4~7/5~8
Frequencies(MHz) 5
Spectrum Doppler
2.3/3.0 2.0/2.2 4.7/5.7 6.7/8.0 3.6/5.0
Frequencies(MHz)
Color Doppler
2.2/2.7/3.2 2.0/2.5 5.2/5.9 6.7/8.0 3.6/4.7
Frequencies(MHz)

Elements 128 64 128 192 128

Footprint NA 16 mm 38mm 38mm NA

Convex Radius 60mm NA NA NA 10mm

FOV 60° 90° NA NA 150°

Display Depth 45cm 30cm 11cm 11cm 14cm

Biopsy Guide Yes Yes Yes Yes Yes

Cable Length 2.0m 2.0m 2.0m 2.0m 2.0m

Transducer C5-1Q P7-3Q L17-7SQ MC8-4Q MC9-3TQ


Transducer Type Convex Phased Linear Micro Convex Micro Convex

Bandwidth@ -6dB 2-5MHz 3-7MHz 7-15MHz 4-9MHz 3-9MHz

Central Frequency 3.25MHz 5.0MHz 12.0MHz 6.2MHz 6.4MHz


H2~4/H3~5/H2~ H4~7/H5~7/H5~
B Harmonic H9~13/
5/ H5~7/H6~8 8/ H5~8/H6~9
Frequencies(MHz) H10-17
H3~6 H5~10/H6~10
B Fundamental 3~5/4~6/ 7~11/8~13/ 4~5/4~6/4~7/
2~4/3~5/2~5 3~6/4~7/5~9
Frequencies(MHz) 5~7 9~15 5~8/6~9
Spectrum Doppler
2.3/3.0 2.7/3.8 6.7/8.0 4.2/5.0 3.6/4.5
Frequencies(MHz)

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Color Doppler
2.9/3.2/3.5 2.5/3.0 6.7/8.0 4.2/5.0 3.6/4.5
Frequencies(MHz)

Elements 160 96 128 128 128

Footprint NA 15 mm 26mm NA NA

Convex Radius 50mm NA NA 15mm 10mm

FOV 64° 90° NA 100° 150°

Display Depth 45cm 18cm 11cm 15cm 15cm

Biopsy Guide Yes No No Yes Yes

Cable Length 2.0m 2.0m 2.0m 2.0m 2.0m

Transducer C6-2MQ E10-3BQ E10-3HQ L12-5HQ


Transducer Type Wobbler Intra-cavity Intra-cavity Linear

Bandwidth@ -6dB 2-5MHz 4-8MHz 4-8MHz 5-11MHz

Centeral Frequency 3.9MHz 6.5MHz 6.5MHz 8.0MHz


H5~6/H5~8/ H5~6/H5~8/H5~ H6~10/H7~12/H
B Harmonic H2~4/H3~5/
H5~10/H6~11/ 10/H6~11/ 8~10/ H8~11/
Frequencies(MHz) H2~5
H6~13 H6~13* H8~12
B Fundamental 5~8/6~10/7~11/
2~4/3~5/2~5 4~6/4~7/5~8 4~6/4~7/5~8
Frequencies(MHz) 8~10
Spectrum Doppler
2.6/3.0 3.6/4.8 3.6/4.8 4.7/5.2
Frequencies(MHz)
Color Doppler 5.2/5.9/7.2/7.5/
2.6/3.0/3.3 4.0/4.5/5.0 4.0/4.5/5.0
Frequencies(MHz) 7.9

Elements 128 192 192 192

Footprint NA NA NA 38mm

Convex Radius 40mm 10mm 10mm NA

FOV 64° 190° 190° NA

Display Depth 30cm 14cm 14cm 11cm

Biopsy Guide No Yes Yes Yes

Cable Length 2.0m 2.0m 2.0m 2.0m

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
NOTE: The asterisk "*" indicates that the frequency type is related to the transducer version. Among them:
optimized C5-2Q probe (02.01.212622015) add harmonic frequency type H3~4 and optimized E10-3HQ
probe (02.01.214791011) add harmonic frequency type H6~13.

Biopsy Guide

 Needle Guide
- Supports guide lines of multiple angles.
- Supports single and parallel guide line.
- Supports depth and length mark on guide line.
- Support guide line calibration.

 Need Visualization
- Supports three needle inserted angles for linear transducers

 Center Line
- Center Line is a vertical dotted line displayed at the middle of the image field, representing the
middle of ultrasound beam.It helps to locate the position and depth of a target disease focus for
out-of-plane biopsy, lithotripsy and etc.

 Supported Needle Guided Brackets

Model Type Angle/Depth Description

For use with the E8-4Q,


BGK-CR10UA In-plane 2°
Supports: 16G-18G

For use with the


BGK-002 In-plane 38°, 46°, 58° L12-5Q/L17-7HQ/L12-5HQ,
Supports: 14G-23G
For use with the
0.5cm, 1.0cm, 1.5 cm,
BGK-003 Out-of-plane L12-5Q/L17-7HQ/L12-5HQ,
2.5 cm, 3.5 cm
Supports: 21G-22G
For use with the MC9-3TQ,
BGK-004 In-plane 12°, 20°
Supports: 14G-23G

For use with the E10-3BQ,


BGK-005 In-plane 0°
Supports: 16G-18G

For use with the E10-3HQ,


BGK-006 In-plane 1°
Supports: 16G-18G

For use with the C5-2Q,


BGK-007 In-plane 18°, 25°, 35°
Supports: 14G-23G

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
For use with the P5-1Q
BGK-008 In-plane 12° , 22°
Supports: 14G-23G

For use with the C5-1Q


BGK-009 In-plane 14°, 20°, 32°
Supports: 14G-23G

For use with the MC8-4Q,


BGK-012 In-plane 11°, 20°, 37°
Supports: 14G-23G

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Measurements
 Default measurement unit options
 Tei index: COT, ET
- Distance: mm, or cm
Doppler mode
- Area: mm2, or cm2
 PS
- Volume: mm3, or cm3
 ED
 Caliper Size: switch automatically according
 RI
to the distance (3 sizes)
 PI
 Dynamic display of measurement results
 PS,ED,RI,S/D
 Reposition caliper
 Time
 Pre-categorized measurement groups based
 HR
on clinical applications; Configurable in
Measure Preset. Measured results of each
 Manual Trace

measurement are configurable in Measure  Spline Trace

Preset.  Auto Trace(Max. 15 measured results are


configurable)
 Measurements displayed on main screen and
touch screen are consistent.  Velocity
 PGMax

General Measurements  PGMean

B-mode  Volume Flow

 Distance (2-point,Ratio D1/D2)  Tei index: COT, ET

 Circumference/Area (Ellipse, Trace,  dp/dt


Spline,Ratio A1/A2) Elastography mode

 Angle(3-point)  Eratio(Ellipse, Trace)

 Volume(3-distance, Ellipse+ 1 distance)


 Stenosis Application Measurements/calculations

- %Dist Stenosis(Distance) Abdomen

- % Area Stenosis (Ellipse, Trace, Spline) B-mode:

 Vessel  Liver

- Vessel Diameter (2-point, Ellipse) - Length, Width, Height

- Volume flow area - Volume(calculation)

- IMT - Portal Vein Diameter

M-mode - Common Hepatic Duct

 Distance(2-point method)  Gallbladder


 Ratio D1/D2(2-point method) - Length, Height
 Time - Gallbladder Wall Thickness
 Slope
- Common Bile Duct
 HR

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
 Pancreas - Uterus body
- Head, Body, Tail, Duct - Uterus volume

 Spleen - UT Cavity
- Length, Height - UT-L/CX-L(calculation)

 Renal  Cervix
- Length, Width, Height - Length, Width, Height
- Volume(calculation) - UT-L/CX-L(calculation)
- Renal Cortex Thickness  Ovary
 Aorta Diameter - Length, Width, Height

 Bladder - Ovary volume


- Pre-void bladder (Length, Width, Height)  Follicle
- Post-void bladder Length, Width, Height)  Cyst
- Micturated Volume  Fluid POD
- Pre-void bladder volume  Pelvic Floor
- Post-void bladder volume - BSD(R)
PW mode: - BSD(S)

 Abdominal Aorta PW mode:

 Superior Mesenteric Artery  Uterine Artery


 Inferior Mesenteric Artery  Ovary Artery
 Hepatic Artery
 Splenic Artery Obstetrics

 Renal Artery B-mode:

 Portal Vein BPD, HC, AC, FL, HUM,


 Inferior Vena Cava  Fetal Biometry CER, OFD, NF, TAD, APAD,

 Main Portal Vein THD, APTD, TTD, FTA

 Hepatic Vein CRL, BPD, FL, HUM, NT,


 Early Gest
 Middle Hepatic Vein GS, YS, AF

 Splenic Vein HUM, ULNA, RAD, TIB, FIB,


 Long Bones
 Superior Mesenteric Vein Foot

 Inferior Mesenteric Vein CER, NT, NF, LVW, CM,


 Fetal Cranium
NB,PNT, BOD
Gynecology  AFI Q1, Q2,Q3,Q4
B-mode:
 Ovary Ovary L, Ovary W, Ovary H
 Uterus
LV Diam, LA Diam, RV
- Length, Width, Height  Chamber
Diam, RA Diam
- Endometrium Thickness

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
LVOT Diam, Ao Asc, Ao  LVOT Diam LVOT Diam
 LVOT/AO
Arch, Ao Isthmus, Desc Ao  PV PV Diam
RVOT Diam, MPA Diam,  RVDs RVDs
 RVOT/PA
Ductus A
RA length, RA Width, LA length,
 CTAR Area 1, Area 2  LA/RA
LA width
PW mode:
 LVM(A-L)
 MCA (Left LVAd Sax Epi, LVAd Sax Endo,
 Umb. A Ventricular LVAd Apical
 Planenta A Mass)

 Ovary A  LVM (T-E)


 Ut. A (Left LVAd Sax Epi, LVAd Sax Endo,
 Fetal Ao Ventricular a, d

 Desc Aorta Mass)

 SMA  LVM
 IVC (Cube)(Left
LVSTd, LVIDd, LVPWd
 Ductus V Ventricular

 FHR Mass)

 MV  MVA
 TV  AVA
 MPV M-mode:
 Ductus A
LVSTd, LVIDd, LVPWd, IVSTs,
M-mode:  LV Study
LVIDs, LVPWs
 FHR
 LV/RV LVIDd, LVIDs,RVAWd, RVIDd

 Time LVET, LV PEP, RV PEP


Cardiac
MV D-E Exc, MV D-E Slope, E-F
B-mode:
 Mitral Valve Slope, EPSS, MV E-E Sep, MV
 LV A4C Dias., A4C Sys., A2C Dias.,
A-C Interval, MAPSE
Simpson A2C Sys.
 TAPSE TAPSE
LVSTd, LVIDd, LVPWd, IVSTs,
 LV Study LA, AoR Diam, RVOT Diam,
LVIDs, LVPWs  LA/Ao
ACS
 LV/RV LVIDd, LVIDs,RVAWd, RVIDd
 HR HR
 LA/Ao LA,AoD
 LVM
 Aorta Ao Asc, AoD
(Cube)(Left
LVSTd, LVIDd, LVPWd
 RVOT Ventricular
RVOT Diam
Diam Mass)

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
 IVC-CI IVCmax, IVCmin, , IVC-CI(cal)  Renal
- Length, Width, Height
PW mode:
- Renal Cortex Thickness
E/A, MV PHT, MV VTI, IVRT,
MV A Duration, MV DecT,  Bladder
 Mitral Valve - Pre-void Bladder (Length, Width, Height,
MR Vmax, MR VTI, MV E
Duration,MV HR volume)

TV VTI, TV Vmax, TV E/A,


- Post-void Bladder (Length, Width, Height,
 Tricuspid Valve volume)
TV HR
- Micturated Volume
LVOT VTI, LVOT Vmax, AV
 Prostate
VTI, AV HR, AV Vmax, AV
- Length, Width, Height
Accel Time, AV Decel Time,
 AV  Seminal
AR VTI, AR Vmax, AR Accel
Time, AR PHT, AR Decel - Length, Width, Height

Time  Testis

PV VTI, PV Vmax, PR Vmax, - Length, Width, Height


 PV
PW mode:
PV Accel Time,PV HR

PVein S Vel, PVein D Vel, PV  Renal Artery


 PV Vein
A Vel, PV A Dur  Arcuate Artery

Hep S Vel, Hep D Vel, Hep  Segmental Artery


 Hep Veins
A Vel, Hep A Dur  Interlobar Artery

 RVSP TR Vmax ,RA Pressure


Small Parts
 AVA(VTI) LVOT VTI,AV VTI
B-mode:
Sa Medial, Ea Medial, Aa
 Thyroid
 TDI Medial, Sa Lateral, Ea
- Length, Width, Height
Lateral, Aa Lateral
- Thyroid Isthmus
MR Trace, AR Trace, TR
 PISA  Breast
Trace, PR Trace
- Lesion1, Lesion2, Lesion3, Lesion4,
 Qp/Qs LVOT VTI,RVOT VTI
Lesion5
C- mode:
 Testis
MR Rad,MR Als. Vel,AR Rad,AR
- Length, Width, Height
 PISA Als. Vel, TR Rad, TR Als. Vel, PR
PW mode:
Rad, PR Als. Vel
 Superior Thyroid Artery
 Inferior Thyroid Artery
Urology
B-mode:

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Vascular PW mode:

B-mode: Common Femoral Vein, Deep


Femoral Vein, Superficial
Common Carotid Artery
Femoral Vein, Common Iliac
Intima-Media Thickness,  Lower
Vein, External Iliac Vein, Internal
Internal Carotid Artery Extremity
Iliac Vein,Great Saphenous
Intima-Media Thickness, Vein
Vein, Popliteal Vein, Peroneal
Carotid Artery Bifurcation
Vein, Posterior Tibial Vein,
 Carotid Intima-Media Thickness
Anterior Tibial Vein, Small
PW mode:
Saphenous Vein,Volume Flow
Common Carotid Artery,
B mode:
External Carotid Artery, Internal
Carotid Artery, Vert Artery, Stenosis% Distance
 Stenosis%
Subclavian Artery, HR, Volume Stenosis% Area (Ellipse, Trace,

Flow Spline)

 Volume B mode:
PW mode:
Flow Volume Flow Area
 Upper Subclavian Artery, Axillary
PW mode:
Extremity Artery, Brachial Artery, Ulnar
Anterior Cerebral Artery, Middle
Artery Artery, Radial Artery,
Cerebral Artery, Posterior
HR,Volume Flow
Cerebral Artery, Anterior
 Cephalic
Communicating Artery,
PW mode:
Posterior Communicating
Subclavian Vein, AxillaryVein,
 Upper Artery, Basilar Artery, Vertebral
Brachial Vein, Cephalic Vein,
Extremity Artery, Internal Carotid Artery
Basilic Vein, Ulnar Vein, Radial
Vein
Vein, Median Cubital  Vessel
B mode: Vessel Diam
Diam
Vein,Volume Flow

PW mode:
Pediatrics
Common Femoral Artery, Deep
B-mode:
Femoral Artery, Superficial
 Left lateral ventricle
Femoral Artery, Common Iliac
 Lower  Right lateral ventricle
Artery, External Iliac Artery,
Extremity  left trigone
Internal Iliac Artery, Popliteal
Artery  right trigone
Artery, Peroneal Artery,
Posterior Tibial Artery, Anterior  Hip joint(with dislocation type)

Tibial Artery, Dorsalis Pedis - HIP Angle

Artery, HR,Volume Flow - HIP d/D

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
Image Storage & Exam Archiving
Emergency Image Storage
 EM Abdpackage  Static image/Cine clip is stored in local disk in
 EM OB package RawData format.
 EM Card package  Two dedicated hard keys on the console for
capturing static image and cine clips
respectively.
Reports
 Editable worksheet  Cine clips supports prospective and
retrospective storing.
 Report type: ABD, GYN, OB, URO, VAS, SMP,
FETAL, CARD, PED, Nerve, MSK  The length of cine clip is configurable.

 Comments/Findings section  Prospective storing: max. 2 min length of clip


can be stored in real-time scanning.
 Support fetal growth curve and grow bar
display; supports data display of max. 4 fetus  Retrospective storing: all the clip data in the
cine buffer can be stored in cine review mode,
 Support Fetus Score *;support add Fetus
max.2 min.
Score to the report

 Support data of multiple fetus


 Supports up to 30,000(for 120GB hard disk)or
150,000(for 512GB hard disk) or350,000(for
 User-imported Report Header
ITB hard disk) lossless single frames
 User-defined hospital logo
 Supports cine clips exported:
 Multiple number of selected images
- Up to 100000 frames for B mode
 Multiple layouts of image in report.
- Up to 30000 frames for Color mode
 Support select all images to add into the
report
- Up to 180s for M
- Up to 240s for PW/CW mode
 Report Layout supports auto adjust.
.
 Support zoom in preview
Exam Database
 Support Export as PDF format
Support exam storage without patient information
 Support print by report printer.
Support exam query
 Support custom report information
Support review current exam or prior exam
 Support display BMI and BSA
Support review images of an exam
 Some information supports to adjust its
Support review report of an exam
display order in the report
Support export images as BMP,JPEG, TIFF, Raw
 (Measurements/Growth Curve/Image/Fetus
Data or DICOM format
Score Result/Findings/Comment)
Support export cine clip as AVI, MP4, WMV, Raw
 Support display the time of system’s first use
Data or DICOM format
displayed in the report
Support export Report as PDF format
Support export exams (including patient
.

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
information, images) OB, GYN, Cardiac and Vascular.
Support compare images  DICOM Modality Worklist
- Enables query of the patient worklist
Exam Archiving schedule from hospital information

All Clips and Static images stored on the system system to the ultrasound system via

are stored internally in Raw Data format. They can DICOM network connection.

be archived to other storage device for long-term - Query of worklist on demand or on start
storage as described below. of exam.

- Archived to DICOM server. - Populates the Patient Information screen

- Archived to FTP server. with patient demographic information

- Archived to USB device. automatically when one patient is


selected.
Note: If a clip length exceeds 3s, when
selecting to export in DICOM format to a - Displays/hides the ended exams in the

DICOM server or USB stick, only the last 3s of worklist

the clip will be exported for this release. - Query conditions can be configured to

- Burned to DVD disk quickly filter exam information.

- Sent to mobile devices.  MPPS


- The MPPS service automatically sends
the exam status to the MPPS server at
Connectivity the start and the end of the ultrasound
Network
exam.
 Wired network connection - Displays Additional Materials item on
 Wi-Fi connection patient information page.

 Storage Commitment
DICOM 3.0 Service - Supports using the port information of
 DICOM Storage the storage commitment server to
- Connectivity to DICOM server for storage receive storage commitment information
of all static images or cine clips with - Supports the establishment of a new
patient information. association for receiving storage
- Manual-Transfer in background on commitment information
Demand.  DICOM Query/Retrieve
- Auto-Transfer when store or at exam - Supports entering key words for query
end. prior exams from DICOM server.
- Transfer management UI for viewing - Supports download a queried exam to
transfer task status, retransferring a task local disk for reviewing.
or deleting a transfer task.
 DICOM Print
- Transfer process encrypted. - Prints the images remotely via a DICOM
- Supports Structured Report transferring: printer which connects to a DICOM

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
server. - HP Deskjet Ink Advantage 2010
Multiple parameters for printing are - HP Deskjet 1010
configurable. - HP Deskjet 1510
FTP Network Store Service - HP LaserJet 400 M401d
- Supports to transfer exams to FTP - HP DeskJet Ink Advantage Ultra 2029
servers for storage in the background. - HP DeskJet 1112
- Transfer management UI for viewing - Canon E518
transfer task status, retransferring a task
- Canon iP2780
or deleting a transfer task.
- HP LaserJet Pro MFP M126nw
- A PDF report can be sent to FTP server
- EPSON L310
together with the exam.
- HP DeskJet 1050
Cloud Share
- HP DeskJet 2050
- Supports sending image/clips to mobile
- HP LaserJet M252n
devices by scanning the QR code on
- EPSON L130
main screen when CloudShare icon is
clicked.
- HP Color LaserJet Pro M254nw

-
- HP Color Laser 150a

Time Synchronization
- HP Color Laser 150nw

- Sets the system time to synchronize with


- HP Laser 103a
- EPSONL3118
the network time
 Photo printer
- Cannon CP1300
Supported Peripherals
 Network report printer
Printers
The system supports the connection of Video
Mini PC
printers and report printers. The report can be
connected locally via USB connector or remotely
Safety and Regulatory
via network connection. Printer drivers can be
The Acclarix AX3 series Diagnostic Ultrasound
imported to the system for the support of more
System have been designed, manufactured and
report printers.
tested to comply with the following internationally
 Video printers
recognized standards:
- SONY UP-X898MD
- IIEC 60601-1: Medical Equipment Safety
- SONY UP-D25MD
- IEC 60601-1: Medical Equipment Safety
- SONY UP-25MD
- IEC 60601-1-2: Medical Device
 Local report printers
Electromagnetic Safety
- HP Officejet Pro 251dw
- IEC 60601-2-37: Ultrasonic Medical
- HP LaserJet Pro 200 color M251n Equipment Safety
- HP LaserJet CP1525n Color - IEC 62133: Battery Safety

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.
- IEC 62304: Medical Device Software - EN ISO 14971: Medical Device Risk
Life-cycle Process Management
- IEC 62366: Medical Device Usability - ISO 10993-1 Biological evaluation of medical
Engineering devices — Part 1:Evaluation and testing within
a risk management process sheet

Revision History
Version Revisions Date
1.0 Updated for R1.02 release. 2019-5-24
1.1 Updated for R1.1 release. See the changes highlighted with blue color. 2019-9-12
1.2 Updated for R1.2 release. See the changes highlighted with blue color. 2020-02-09
1.3 Updated for R1.21 release: Updated the DICOM store function. 2020-03-26
1.4 Updated for R1.40 release. See the changes highlighted with blue color. 2020-09-17
1.5 Updated for R1.41 release. See the changes highlighted with blue color. 2020-11-25
1.6 Updated for R1.50 release. See the changes highlighted with blue color. 2021-02-20
1.7 Updated for R2.00 release. See the changes highlighted with blue color. 2021-11-15
1.8 Updated for R2.10 release. See the changes highlighted with blue color. 2022-04-10
1.9 Updated for R2.20 release. See the changes highlighted with blue 2022-08-29
color.

This datasheet applies to Acclarix AX3 series Diagnostic Ultrasound Systems, including Acclarix AX3,
Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp,
Acclarix AX2 Super, Acclarix AX15 and Acclarix AX18 models. The configuration difference between each
model is listed in the following table.
Configuration Difference
Models Feature 1 Feature 2 Feature 3 Feature 4
Seminal Vesicle Meas. Testis Meas. Fluid POD 3D/4D

Acclarix AX3 √ √ √ √

Acclarix AX3 Exp √ X √ √

Acclarix AX3 Super X X √ √

Acclarix AX25 X √ √ √

Acclarix AX28 √ X X √

Acclarix AX2 √ √ √ X

Acclarix AX2 Exp √ X √ X

Acclarix AX2 Super X X √ X

Acclarix AX15 X √ √ X

Acclarix AX18 √ X X X

*Feature is subject to regulatory approval, and may not be available for sale in specific countries.

Features and specifications are subject to change without prior notice. No reproduction, copy or transmission may be
made without written permission. Not all products or features are available in all countries, contact Edan for local availability.

You might also like