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TABLE OF CONTENTS
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TABLE OF CONTENTS
ELECTRICAL/ENVIRONMENTAL
SPECIFICATIONS 17
STANDARDS COMPLIANCE 17
Quality Standards 17
Design Standards 17
Acoustic Output Standards 17
CE DECLARATION 18
EU AUTHORIZED REPRESENTATIVE
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ACUSON X300 Ultrasound System
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• Multi-directional articulating monitor arm to help • Monitor tilt of 10 degrees up, 65 degrees down
improve ergonomics and swivel of -80 to +80 degrees
-- Arm rotation: -90 to +90 degrees • Digital on-screen display of brightness and
-- FPD rotation: -80 to +80 degrees contrast controls
-- Tilt: -10 to +65 degrees • Energy Saving Display Power Management
-- Up: 125 mm • 4 levels of illumination intensity: Off, 1, 2, 3
-- Pull: 250 mm Audio Speakers
• Wheel-lock mechanism • High performance audio speakers are integrated
-- Front castor (2 ea): Bi-brake system in the monitor
(direction lock & total lock)
Physiological Interface
-- Rear castor (2 ea): total lock
• Standard 3-lead ECG interface
• Up to 32 QuickSet™ user-programmable system
• Continuous display in all real-time modes
parameters allows users to program system
• R-Wave single and dual trigger function
parameters for individual transducer/application
settings. QuickSet parameters combine all • Heart rate display
preferred imaging mode parameters, annotation • Adjustable gain and trace position on screen
text and measurements into one user preset • Selection for external ECG input
*The Instructions for Use in these languages are available upon request only. Allow 8 weeks minimum for
production.
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• Export of reports in readable format • Pulsed Wave spectral Doppler mode (PW)
• DICOM viewer for export of DICOM format to CD/ • Continuous Wave spectral Doppler mode (CW)
DVD only -- Auxiliary pencil transducer
Transducer Ports -- Steerable CW on selected phased array
• Up to three active universal transducer ports that transducers
support phased array, curved array and • ECG trace in all modes
• linear array transducers (third array port • Duplex mode
optional) • Triplex mode
• The two transducer port configuration has two • Flexible combination of imaging modes in side-
active ports and one transducer parking port by-side Dual and Dual Select in real-time, and
• Electronic transducer selection (instantaneous digital cine replay
switching between transducers) • Selectable split screen display formats in 2D or
• Industrial design provides easy access to the 2D/color with M-mode and/or spectral Doppler
transducer ports mode: top-bottom or side-by-side in real-time
and digital cine replay
Transducer Storage
• 4B mode
• Six configurable transducer holders support
• Virtual Format
all transducer designs and provide gel bottle
storage MultiHertz Multiple Frequency Imaging
• SuppleFlex™ transducer cables and integrated Siemens’ unique MultiHertz™ multiple frequency
cable management for protection during exams imaging is designed to combine the resolution and
and transport penetration of several transducers in one.
• Special transducer holder provides securestorage At the push of a button, the user can independently
and easy access to endocavity transducer change frequencies for 2D, THI (optional), color and
• Transducer holders can be removed for cleaning spectral Doppler to select the optimal combination
for image resolution, penetration and sensitivity.
Acoustic Output Management
• On-screen acoustic power indicator (AIUM/NEMA • Depending on the transducer, up to seven user-
output display standard) selectable transmit frequencies are available
-- Up to three 2D and M-mode frequencies
OPERATING/DISPLAY MODES -- Up to two THI frequencies
-- Up to two PW Doppler frequencies in color,
• 2D-mode imaging in fundamental and harmonic
modes (both phase inversion and filtered) -- power or pulsed wave modes
• DTI™ Doppler tissue imaging capability -- One frequency in SCW Doppler mode
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• Patented ASIC technology preserves signal
• integrity through precision up-sampling for
• better beam definition
• 2D-mode line density up to 256 lines
• Up to 11360 processing channels
• Total system dynamic range > 199 dB
Focusing
• Up to 4 transmit focal zones
• Digital dynamic receive focusing with dynamic
apodization
• MultiHertz multiple frequency imaging with -- Available on live and cine replay images
up to five user selectable transmit frequencies, -- At least 2.5x and up to 10x zoom (transducer
when optional THI is included dependent)
• Six levels Res/Speed selection: 0 – 5 • 4B-mode
• Five persistence levels: 0 – 4 2D Calipers – Generic Measurements and
• Four edge enhancement levels: 0 – 3 Calculations
• Display dynamic range: 30 to 70 dB in five- • Multiple cursor sets on frozen, live, dual screen
decibel increments and cine playback images
• Adjustable gain from 0 to 60 dB in one-decibel • Up to 8 distance measurements per screen
increments • Distance measurement
• Eight DGC controls for Depth Gain Compensation • Depth measurement from skin line
• Nine user-selectable gray maps • Angle measurement
• 16 user-selectable 2D colorization maps • Area and circumference: ellipse, trace
• Maximum Depth: 30 cm with CH5-2 & P4-2 • Compound Measurements
• Minimum Depth: 2 cm with VF13-5SP -- Volume: user-selectable preset by 1 distance, 2
2D Image Display distance, 3 distance; 1 ellipse and 1 distance,
thyroid, disk
• Full screen, Split, Quad and Dual Select screen
formats -- Flow volume: 1 velocity and 1 distance, or 1
velocity and 1 ellipse
• L/R flip and U/D flip for all formats in real-time
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-- Stenosis: user-selectable preset calculated by dependent
2 ellipse, or 2 distance measurements • 17 levels of baseline shift
Pulsed Wave Spectral Doppler • Spectral invert
• Available on all imaging array transducers • Autotrace function
• Up to two user-selectable transmit frequencies SCW and Spectral Doppler Display
per transducer • Full screen Doppler trace, 2D/Doppler mode,
• Five sweep speed selections: 1, 2, 3, 4, 5 triplex or update 2D/C/Doppler
• Eight selectable post processing gray maps • Imaging display: 4 formats
• 12 user-selectable Doppler colorization maps: -- Top-bottom: 1/3-2/3, 1/2-1/2, 2/3-1/3
0 – 11 -- Side-by-side: 40-60
• Adjustable gain from 0 to 90 dB in one-decibel
Spectral Doppler Calipers – Generic Measurements
increments
and Calculations
• PRF range: 100 to 19,500 Hz
• Multiple cursor sets on frozen and cine playback
• Velocity scale range is ± 1.5 ~ ± 350cm/sec with
images
0 degree angle correction
• Velocity/Frequency/Pressure Gradient
• Angle correction 0 - 89 degree in one degree
• Heart rate/Heart cycle/Time
increments
• Autotrace measurements in real-time and freeze
• Gate size: from 1.0 mm up to 20 mm
including calculations for PS, ED, TAMx, TAMn,
• Eight wall filter selections – transducer
PI, RI and S/D
dependent
• Resistive Index (RI)
• 17 levels of baseline shift
• Pulsatility Index (PI), including Peak-to-Peak
• Spectral invert
method
• Autotrace function
• Time Average Velocity max (TAV)
Steerable Continuous Wave (SCW) Doppler • Systolic/diastolic ratio (S/D)
• Available on all phased array transducers when • Velocity Time Integral (VTI)
• basic cardiac package is purchased • Acceleration/Deceleration
• One transmit frequency • Flow volume using combined velocity and
• Five sweep speed selections: 1, 2, 3, 4, 5 distance, or velocity and ellipse measurements
• Eight selectable post processing gray maps • Doppler angle correction after measurement
• 12 user-selectable Doppler colorization Color Doppler Velocity Imaging
• maps: 0 – 11 • Available on all imaging array transducers
• Adjustable gain from 0 dB to 90 dB in one- • MultiBeam Formation technology provides
• decibel increments parallel signal processing for color Doppler frame
• PRF range: 1.56kHz to 34.7kHz rates up to 85 fps– transducer dependent
• Velocity scale range is ±30 ~ ±650 cm/sec with • Left/right steer on all linear transducers
• 0 degree angle correction • Advanced processing in color mode resulting in
• Eight wall filter selections – transducer excellent spatial resolution and superior Flash
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suppression
• Up to two user-selectable transmit frequencies
per transducer
• Up to nine user-selectable color velocity maps
(seven velocity & two velocity/variance)
• Velocity scale range: ±0.6~±244.4 cm/sec
• PRF scale range: 100 Hz to 19,500 Hz —
transducer dependent
• Adjustable gain from -20 dB to 20 dB in one-
decibel increments
• Six color line density selections
measurement and annotation functions
• Four wall filter selections
• Retrospective clip capture during real-time
• Four levels of color smoothing imaging with a selectable duration of 1, 2, 3, or
• Five tissue/color priority selections 4 seconds or a selectable duration 1, 2, 3 or 4
• Five color persistence levels beat capture; ECG triggerable
• Color invert • Prospective clip capture during real-time imaging
• Velocity tag with a selectable duration of 1 to 120 seconds a
• Peak hold: Off, 1 sec, 2 sec, and 3 sec selectable duration 1 to 120 beat capture; ECG
triggerable
• AutoC
Post-Processing Features in Freeze Frame or Cine
FREEZE, CINE AND CINE • 2D-mode
POST-PROCESSING FUNCTIONS -- Zoom/pan
-- Gray map
Cine Review
-- Colorization map
Cine feature is standard and offers post-acquisition
-- Measurements/reports/annotations/pictograms
optimization of all real-time post-processing
funtions. • Color Doppler
-- Zoom/pan
• Frame-by-frame cine loop review and continuous
-- Color map
cine motion review, including control of
-- Color invert
playback rate
-- Measurements/reports/annotations/pictograms
• Independent cine review in mixed modes (2D/M,
2D/Doppler, 2D/C/Doppler) • Spectral Doppler
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-- M-mode colorization map • Abdominal
-- Measurements/reports/annotations/pictograms • Renal
• Obstetrics
TRANSDUCER TECHNOLOGY • Gynecology
The X300 system is designed to support most multi- • Menstrual Age parameter labels are MSD, CRL,
specialty imaging applications. Factory BPD, OFD, HC, AC, ATD, ASD, FL, HL, UL, TL, FT,
• Five user-defined labels are available in
supplied exam and transducer dependent imaging
2D-mode
presets have been carefully optimized for each
application to provide consistency, reliability, • Calculations include: EFW from the selected
and increased productivity. Selected applications reference, HC/AC, TCD/AC, LVW/HW, CorBPD,
include body markers, text and annotation labels, FL/AC, FL/BPD, CI, AFI, AXT, and Fetal Heart
worksheets and reports.
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Rate Stenosis measurements
• Growth Analysis Graphs with exam file linking • Cerebrovascular patient report
• Detailed Fetal Heart report page Peripheral Vascular
• Calculations for both Gestational Age (GA), • All general measurements and calculations
ultrasound menstrual age, and Estimated Date • CIA, EIA, CFA, PFA, SFA prox, SFA mid, SFA
of Confinement (EDC) dist, POP A, TRUNK ATA, PTA, PER A and DPA
• Early Obstetric patient report and Standard measurements
Obstetric patient report include a worksheet • Right and left extremity measurements
for viewing the progress of the report during • Peripheral vascular patient report
the exam process and to edit the report
Venous
• Multiple fetus reporting capabilities
• All general measurements and calculations
• Growth Analysis Graphs with exam file linking
• Right and left extremity measurements
• OB patient report and worksheet including
• Venous patient report
Fetal Heart report page
Thyroid
Gynecology
• All general measurements and calculations
• All general measurements and calculations
• Thyroid volume
• Micturated and residual volume calculation
• Uterus and right and left follicle ovary Urology
• Volume formulas for Left Ventricular function • All general measurements and calculations
digital images and dynamic clips with patient DICOM Vascular Structured Reporting (Option)
demographic data DICOM Structured Reporting (SR) provides a
• In-Progress Store during the exam standardized report architecture to allow for easy
• Image printing to DICOM color and transfer of Vascular measurements to offline PCs,
workstations and archiving systems. DICOM Vascular
grayscale printers
Structured Reporting will automatically populate
• DICOM Storage Commitment
Vascular measurements to their respective fields
• DICOM Exchange Media export to DVD-R/RW & in an external software package. (To send the
CD-R/RW Vascular SR data over the network the DICOM 3.0
• DICOM Region Calibration connectivity option is required.)
• DICOM interchange media viewer software
DICOM Cardiac Structured Reporting (Option)
SHOWCASE®
DICOM Structured reporting (SR) provides a
• Interchange media database that identifies
standardized report architecture to allow for easy
the CD to which the patient study has been
transfer of Cardiac measurements to offline PCs,
burned workstations and archiving systems. DICOM Cardiac
DICOM Modality Worklist (Option) Structured Reporting will automatically populate
Cardiac measurements to their respective fields in an
Enables query and direct download of the patient
external software package. (To send the Cardiac SR
worklist schedule from the Hospital/Radiology
data over the network the DICOM 3.0 connectivity
Information System (HIS/RIS) to the X300 system,
option is required.)
automatically populating the "New Patient" screen
with patient demographic information. (Requires
Tissue Grayscale Optimization (TGO) (Option)
DICOM 3.0 Connectivity option.)
TGO tissue grayscale optimization technology
DICOM MPPS–Modality Performed Procedure provides one-button image optimization. It
Step (Option) automatically adjusts image brightness to the tissue
type being imaged and equalizes the overall image
Enables automatic exchange of Modality Performed
gain. The user definable threshold accommodates
Procedure Step information with the Hospital/
different user preferences for gain settings and
Radiology Information System (HIS/RIS) (Requires
various room lighting conditions. TGO technology
DICOM 3.0 Connectivity option and DICOM Modality
improves the consistency and quality of ultrasound
Worklist option.)
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imaging to enhance productivity by removing • Auxiliary Continuous Wave Doppler module
time-consuming and operator dependent manual
adjustments. TGO technology can be used with Stress Echo Imaging (Option)
every transducer, for every exam type and at every The stress echo package provides tools for ECG-
imaging frequency, including THI. triggered acquisition, display, selection comparison,
evaluation and archiving of multiple cardiac loops
3-Scape real-time 3D (Option) during various stages of a stress echo examination.
3-Scape real-time 3D imaging provides real-time
• Standard acquisition protocols for treadmill,
reconstruction of 3D images during freehand
ergometric, and pharmacological stress
acquisition.
including:
• Functionality for Opacity and Surface Shading
- Multiple factory defaults stress echo
modes
protocols
• Acquisition in rocked and linear modes
- Customizable stress echo protocols
• Provides real-time feedback during freehand
- Prospective and retrospective capture
• 3D volume acquisition
available
• Available for CH5-2 and EV9-4 transducers
- Flexible combination of imaging modes
Third Array Port (Option)
while in stress echo package
The additional array port option adds a third array
- Ability for customized studies through
port to the X300 ultrasound system and allows
Protocol Editor, with up to 12 stages, six
the user to connect up to three linear, curved and
phased array transducers simultaneously. All linear, views per stage, 20 loops per view or 120
curved and phased array transducers offered on the second prospective clip capture
X300 system are compatible with the additional • Full screen or ROI (region of interest)
array port. acquisition
• Complete R-R capture with clip editing
• The third array port is required to connect the
VF8-3 and C8-5 transducers • Easy workflow throughout the exam protocol
• Stage Timer
Cardio-Vascular Package (Option) • Prospective Continuous Capture (up to 120
Contains the prerequisites to perform cardiac and seconds) or Retrospective labeled capture
certain vascular exams: • Reference image display during acquisition
• Physiological interface • Immediate review of acquired loops
- Standard 3-lead ECG interface • Flexibility to skip views or stages
- R-Wave single and dual trigger function • Flexibility to re-acquire and overwrite already
- Heart rate display acquired images
- Adjustable gain and trace position on • Indication of current view, acquired views and
screen skipped views in the workflow diagram
- Selection for external ECG input • Wall Motion Scoring, 17-segment model with
• Steerable Continuous Wave Doppler module graphical display and report printing
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• LV Volume Measurements with report printing • Enhances visualization of vascularity by reducing
• Factory default or user defined diagnostic text slice thickness and reverberation artifacts
selection for stress echo and LV volume report • Clarifies vascularity by reducing slice thickness
generation and reverberation artifacts
• Provides pixel-by-pixel, real-time, adaptive
Spectral and Color Doppler Tissue enhancement
Imaging (DTI) (Option)
• Selectively enhances macro and micro-
• Provides color DTI and spectral DTI exams with vascularity
quantification package
• Available on all curved and linear transducers.
• Spectral DTI with quantification package
Enables assessment of LV diastolic function SieScape Imaging (Option)
on the X300 system B/W panoramic imaging allows acquisition and
-- Requires the P4-2 or P8-4 transducer display of images up to 60 cm in length to a
maximum curvature of 360 degrees.
-- Spectral Doppler DTI capability utilizes real-
time Doppler shift information from moving • Available on all curved and linear transducers
tissue to better visualize and quantify • Can be displayed in full length or zoomed for
myocardial diastolic function detail viewing
-- The Spectral Doppler DTI calculation package
syngo® Arterial Health Package (Option)
provides guided velocity and acceleration
measurements and includes a measurement Semi-automatic Intima-Media Thickness (IMT)
report package measurement that color codes IMT relative to a
database of over 15,000 participants highlighting
-- Color DTI can be used for qualitative
at-risk areas.
evaluation of wall motion and displays
the relative change of velocities • Provides a calculation of vascular age and
Framingham Risk Assessment taking into
SieClear Compounding (Option) account the patients atherosclerotic burden in
• Multi-view spatial compounding determining the ten year risk assessment
• Speckle reduction increases contrast resolution • Noninvasive method to evaluate cardiovascular
and improves tissue differentiation of low risk since increased carotid IMT has been
contrast lesions directly associated with an increased risk for
• Tissue boundaries and interfaces appear sharper cardiovascular events (e.g., myocardial infarction
and more continuous and stroke)
• Accessible in THI and all mixed modes Axius EF (Option)
• Compatible with other advanced imaging Axius ejection fraction calculates left ventricle
options including SieScape, 3-Scape, TGO and volumes and ejection fractions quickly and reliably.
Clarify VE technology
• Enhances workflow by allowing the user to
Clarify VE Technology (Option)
indicate three boundary points for measurement
• Clarify technology uniquely utilizes energy instead of a manual trace of the ventricle
Doppler flow information to enhance 2D-mode
imaging
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• Utilizes the Simpson method for LV volume -- Mitsubishi P93W B/W Printer
calculations based on LV endocardial border -- Mitsubishi CP900UM Color Printer (NTSC)
trace -- Mitsubishi CP900E Color Printer (PAL)
Wireless Data Transfer (Option) -- USB Inkjet Printer
Utilizes USB dongle to enable wireless connectivity -- JVC DVD BD-X201MS Recorder (NTSC/PAL
between the ultrasound system and the facility’s switchable, 115V/230V)
LAN to provide functionality equivalent to a wired
network. SYSTEM INPUT/OUTPUT
The Wireless Option supports connectivity with:
Video Standard
• DICOM services - Modality worklist, print, storage
• PAL/CCIR: 625 lines, 50 Hz
commitment and store
• NTSC/EIA: 525 lines, 60 Hz
• Siemens Remote Service – Remote update
handling for storage distribution and NetViewer Video/Audio Input
for remote application support and remote • (1) Composite color Video in, BNC-type
trouble-shooting • (1) Y/C Video in, S-terminal (SVHS)
• Telexy Q-view* • (1) 2-Channel Audio in (Right/Left), RCA jack type
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• Peripherals The ACUSON X300 system meets the requirements
-- (2) Serial port RS-232C connector, D-SUB of the Medical Device Directive and carries the CE
(9-pin) Mark.
-- (2) USB 2.0 ports
Quality Standards
-- (2) AC Main Outlet
• ISO 9001:2000
Acoustic Output Management • ISO 13485:2003
• On-screen acoustic power indicator (AIUM/NEMA • EN46001:1996
output display standard)
Design Standards
SYSTEM DIMENSIONS • UL 60601-1
• CSA C22.2 No. 601-1
• Height: 137.9 cm (54.3 inches)
• EN 60601-1 and IEC 60601-1
• Width: 51.8 cm (20.4 inches)
• EN 60601-1-1 and IEC 60601-1-1
• Depth: 87.9 cm (34.6 inches)
• EN 60601-1-2 and IEC 60601-1-2
• Weight: 102 kg (225 lbs.)/98 kg without OEM’s
• EN 60601-2-37 and IEC60601-2-37
STANDARDS COMPLIANCE
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CE Declaration
The 230V/115 V version of the
ACUSON X300 system is provided
with a CE marking in accordance 0123
EU Authorized Representative
Siemens AG
Healthcare Sector
Henkestrasse 127
91052 Erlangen
Germany
phone: +49 9131 84 0
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3-Scape, ACUSON X300, Axius, Clarify, DTI,
microCase, MultiHertz, QuickSet, SieClear,
SieScape, SuppleFlex, SynAps and TGO are
trademarks of Siemens Medical Solutions
USA, Inc.,and syngo is a registered
trademark of Siemens AG.
www.siemens.com/healthcare