Siemens X700 2 DATA Sheet Womens Imaging
Siemens X700 2 DATA Sheet Womens Imaging
Siemens X700 2 DATA Sheet Womens Imaging
ACUSON X700
Ultrasound System
Women's Imaging
Release 2.0
www.siemens.com/ultrasound
TABLE OF CONTENTS
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TABLE OF CONTENTS
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ACUSON X700 Ultrasound System
* At the time of publication, the U.S Food and Drug Administration has cleared ultrasound contrast agents only for use in LVO. Check
current regulations for the country in which you are using this system for contrast agent clearance.
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User Interface System
• On-screen text, control panel overlay and • Height-adjustable and swivel control panel
operating instructions are available in the • Control panel with lock lever
following languages: • Multi-directional articulating monitor arm to help
-- Chinese improve ergonomics
-- English -- Arm rotation: -90° to +90°
-- French -- FPD rotation: -80° to +80°
-- Italian -- Tilt: 15° to 90°
-- German -- Up: 125 mm
-- Spanish -- Pull: 250 mm
• Russian keyboard and operating instructions • Integrated high performance audio speakers
supported • Wheels
• Operating instructions are available in 17 -- Castor size: 125 mm
additional languages
-- Front castor (2 ea): Bi-brake system (direction
• Thumbnail menu provides on-screen thumbnail lock and total lock)
images and dynamic clips during exams
-- Rear castor (2 ea): Total lock
• On-screen acoustic power indicator (AIUM/NEMA
output display standard) Monitor
• Flat Panel Display (LED/LCD), 20-inch widescreen,
Control Panel
color, high resolution, and progressive scan
• Simple, intuitive user interface with Home Base (non-interlaced) with In Plane Switching (IPS)
design minimizes repetitive hand motions and technology
enables motor-memory learning
• Resolution: 1600 x 900 pixels
• A floating control panel allows for a wide range
• Total screen area: 1600 x 900 pixels
of adjustments for operator comfort in standing
• Recordable image area clips: 1024 x 768 pixels
and sitting positions
• Total screen capture: 1600 x 900 pixels
• Left/Right swivel articulation ± 90°
• Monitor tilt: 15° up, 90° down and swivel of ±80°
• Vertical adjustment: 10 cm
• Digital on-screen display of brightness control
• Backlit key illumination
• Energy saving display power management
• Variable key brightness indicates active functions
• (4) Illumination controls including menu,
• Multi-level task light: ON, 1, 2, 3, OFF
increase, decrease and light
• Customizable soft keys for easy and immediate
• Angle of view: 178°
viewing of on-screen menus
• Full-size QWERTY keyboard supports text entry,
function keys and system programming
• Wrist support to help reduce operator fatigue
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TRANSDUCER TECHNOLOGY Transducer Storage
• (6) Configurable transducer holders support
Ultra-sensitive wideband transducers, matched with
all transducer designs and provide gel bottle
user-selectable MultiHertz™ multiple frequency
storage
imaging, improve resolution and penetration. Up to
seven 2D and THI frequencies and up to two color • Special transducer holder provides secure
Doppler and spectral Doppler frequencies expand storage and easy access to endocavity transducer
the clinical versatility of a single transducer, thereby • Transducer holders can be removed for cleaning
maximizing transducer investment. Hard Drive
• Innovative ultra low-loss lens materials and • Internal 500 GB hard drive
microelectronic technologies for efficient • Allows storage of patient studies that include
performance and increased signal bandwidth images, clips, reports and measurements
• microCase™ transducer miniaturization • Image storage capacity up to 300,000 images
technology and SuppleFlex™ transducer cables with compression
• SuppleFlex cables and integrated cable • For more detailed information, please consult
management provide protection during exams the Digital Patient Study Storage and Archiving
and transport section on page 12
• Independent 2D and color frequencies for
optimal resolution and penetration OPERATING MODES
• Frequency range: 1.3 – 16.0 MHz
2D
• Hanafy lens acoustic technology
• Fundamental 2D
• Universal, stainless steel and disposable biopsy
• Phased THI
guides for specified linear and curved array
transducers • Filtered THI
• Alternating THI
Specialty Transducers
The ACUSON X700 system supports a range of Color Doppler
transducers and capabilities. For more detailed • Velocity-based color Doppler
transducer information, please consult the • Power Doppler
Transducer Flyer. • Directional power Doppler
• Color M-mode
Transducer Ports
• Color Doppler tissue imaging
• (3) Active transducer ports that support high
density phased array, curved array and linear Spectral Doppler
array transducers • Pulsed wave
• Electronic transducer selection (instantaneous • Spectral Doppler tissue imaging
switching between transducers) • Duplex and Triplex modes
• Supports 512 micro-pinless (MP) and DL (260)
M-mode
type connectors
• Color M-mode
• Industrial design provides easy access to the
transducer ports • Anatomical M-mode
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DISPLAY MODES MultiHertz Multiple Frequency Imaging
Siemens’ unique MultiHertz multiple frequency
• Selectable split screen display formats in 2D or
imaging is designed to combine the resolution and
2D/color with M-mode and/or spectral Doppler
penetration of several transducers into one. At the
mode: top-bottom or side-by-side in real-time
push of a button, the user can independently change
and digital cine replay
frequencies for 2D, THI, color and spectral Doppler to
• 4B-mode allowing simultaneous display of 4
select the optimal combination for image resolution,
static B-mode images
penetration and sensitivity.
• Virtual Format
• Dual from freeze • Transmit frequencies: Up to 7 user-selectable
frequencies
• Split/Zoom
-- 2D and M-mode: Up to 4 fundamental
Flexible combination of imaging modes in side-by- frequencies
side Dual and Dual Select in real-time, and digital -- THI: Up to 4 frequencies
cine replay. -- Color, power, or pulsed wave Doppler modes:
Up to 2 frequencies
2D-mode Image Processing
• All-digital parallel signal processing with frame Tissue Harmonic Imaging (THI)
rate up to 498 fps (transducer dependent) Selectable harmonic frequencies increase success
• MultiHertz imaging: Up to 7 user-selectable with difficult-to-image patients, improving
transmit frequencies diagnostic confidence, and dramatically improving
contrast and spatial resolution by reducing noise and
• Res/Speed selection: 6 levels
clutter in the image.
• Persistence: 5 levels
• Edge enhancement: 4 levels • MultiHertz imaging capability in THI
• Dynamic range selection: 30 – 90 dB in • Available on the 4C1, 6C2, EC9-4w, C6F2, C8F3,
3 or 5 dB increments, application dependent EV9F3, VF10-5, and VF12-4 transducers
• Gain: -30 to +30 dB in 1 dB increments Focusing
• DTO technology: 3 levels • Transmit focal zones: Up to 4 zones
• Dynamic TCE technology: 3 levels • Digital dynamic receive focusing with dynamic
• Depth/Gain compensation: 8 controls apodization
• User-selectable gain balance: 9 maps • Multi-position, user-selectable position
• User-selectable 2D colorization: 16 maps • Can use multiple focal zones simultaneously
• Maximum display depth: 30 cm 2D Image Display
• Minimum display depth: 1 cm • Full screen, Split, Quad and Dual Select screen
formats as well as Dual, Dual seamless, Dual
select and Dual from Freeze
• Curved Vector format
• L/R flip and U/D flip for all formats in real-time
and digital cine replay
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• Split/Zoom • Left/right steer on all linear transducers
• Image depth: 1 – 30 cm in 1.0 cm increments • Color Doppler invert
(transducer dependent) • Advanced processing in color Doppler mode
• Virtual Format Imaging (transducer dependent) resulting in excellent spatial resolution and
-- Left/right steer superior Flash suppression
-- Trapezoid Imaging • AutoColor flow state optimization with high,
• Digital read/write Zoom with image pan medium and low flow settings
-- Available on live and cine replay images • Color Doppler velocity maps: Up to 9 user-
selectable maps (7 velocity and 2 velocity/
-- At least 2.5x and up to 10x zoom (transducer
variance)
dependent)
• Velocity scale range: ±0.6 – ±244.4 cm/sec
• 4B-mode
• PRF scale range: 100 – 19,500 Hz (transducer
• 90° image rotation (all linear transducers)
dependent)
2D Calipers – Generic Measurements and • Gain: -20 – 20 dB in 1 dB increments
Calculations
• Color Doppler line density: 6 selections
• Multiple cursor sets on frozen, live, dual screen
• Wall filter: 4 selections
and cine playback images
• Color smoothing: 4 levels
• Distance measurements: Up to 8 measurements
• Tissue/color priority: 5 selections
per screen
• Color Doppler persistence: 5 levels
-- Distance measurement
• Velocity tag
-- Depth measurement from skin line
• Peak hold: Off, 1 sec, 2 sec and 3 sec
-- Angle measurement
-- Area and circumference: ellipse, trace Power Doppler Imaging/Directional Power Doppler
• Compound Measurements • Available on all imaging array transducers
-- Volume: user-selectable preset by 1 distance, 2 • Multi-beam formation technology provides quad
distance, 3 distance, or 1 ellipse and 1 signal processing for power Doppler frame rates
distance up to 195 fps (transducer dependent)
-- Flow volume: 1 velocity and 1 distance, or 1 • Left/right steer on all linear array transducers
velocity and 1 ellipse • Transmit frequencies: Up to 2 user-selectable
-- Stenosis: user-selectable preset calculated by 2 frequencies per transducer
ellipse or 2 distance measurements • Power Doppler maps: Up to 16 maps
(8 directional and 8 non-directional)
Color Doppler Velocity Imaging
• PRF scale range: 100 – 19,500 Hz (transducer
• Available on all imaging array transducers
dependent)
• Multi-beam formation technology provides quad
• Gain: -20 – 20 dB in 1 dB increments
signal processing for color Doppler frame rates
up to 177 fps (transducer dependent) • Power Doppler line density: 6 selections
• DTI capability available on select transducers • Flow volume using combined velocity and
distance, or velocity and ellipse measurements
• Sweep speed: 8 selections
• Doppler angle correction after measurement
• Post-processing gray maps: 8 maps
• Doppler colorization maps: 12 user-selectable M-mode
maps • Available on all imaging array transducers
• Gain: 0 – 90 dB in 1 dB increments • Anatomical M-mode – live, cineloop and DIMAQ
• PRF range: 100 – 19,500 Hz image review
• Velocity scale range: ±1.5 – ±350 cm/sec with 0° • Frequencies: Up to 5 user-selectable frequencies,
angle correction including fundamental and harmonics
• Angle correction: 0 – 89° in 1° increments • Edge enhancement: 4 selections
• Gate size: 0.2 – 20 mm • Display dynamic range: 30 – 70 dB in
• Wall filter: 25 – 3906 Hz, 8 steps 5 dB increments
(transducer dependent) • Gain: -30 – 30 dB in 1 dB increments
• Baseline shift: 17 levels • Gray maps: 9 maps
• Spectral invert • M-mode colorization maps: 16 maps
• Autotrace function • Sweep speed: 8 selections
Cine Review
The cine feature is standard and offers the ability to
• Spectral Doppler
review real-time acquired data. All real-time, post-
-- Gray map
acquisition optimization functions are available in
-- Doppler colorization map
cine review.
-- Angle correct
• Frame-by-frame cineloop review and continuous
-- Measurements/reports/annotations/pictograms
cine motion review, including control of
• M-mode
playback rate
-- Gray map
• Independent cine review in mixed modes (2D/M,
-- M-mode colorization map
2D/Doppler, 2D/C/Doppler)
-- Measurements/reports/annotations/pictograms
• Independent cine review in 2D Dual Select mode
with image align playback feature
• Standard cine memory: Up to 2729 frames
STUDY TYPES
• Acoustic clip capture from cine review The ACUSON X700 system is designed to support
• Anatomical M-mode available many women's healthcare imaging applications.
Factory-supplied exam and transducer dependent
Post-Processing Features in Freeze Frame or Cine
imaging presets have been carefully optimized
• 2D-mode for each application to provide consistency,
-- Zoom/pan reliability and increased productivity. All applications
-- Gray map include body markers, text and annotation
-- Colorization map labels. Selected applications support customized
worksheets and reports. The following study types
-- Measurements/reports/annotations/pictograms
are supported:
• Color Doppler
-- Zoom/pan • Abdominal
-- Color map • Renal
-- Color invert • Obstetrics
-- Measurements/reports/annotations/pictograms • Gynecology
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• Early Obstetrics • Calculations for both Gestational Age (GA) and
• Vascular (C-Vas, P-Vas, Venous) Estimated Date of Confinement (EDC)
• Small Parts (Breast, Testicle, Thyroid) • Early OB and Standard OB patient reports include
worksheets for viewing the progress of the
EXAM-SPECIFIC MEASUREMENTS report and editing during the exam process
AND REPORTS • Multiple fetus reporting capabilities
-- Maximum of 4
All measurement and report packages are available
• Growth Analysis Graphs with exam file linking
for use with all exam types.
• Detailed Fetal Heart report page
All exam specific measurement and reports support:
Gynecology
• All general measurements and calculations • Micturated and residual volume calculation
• Comprehensive, customizable, patient reports • Uterus, Right and Left Ovary, Right and
and worksheets Left Follicle, CRL, MSD, GS and Yolk Sac
• Customizable anatomy descriptions measurements
• Physician summary utility – supports on-system • Follicle Measurement supports up to 15 follicles
report generation including customizable • Follicles measurement methods supported
letterhead, patient data, results, graphs,
-- Distance
images, comments, recommendations and a
-- 2Dist + Avg
customizable signature line
-- 3Dist + Avg
The following Measurements and Reports packages -- 2Dist Avg
are available on the ACUSON X700 system:
-- 3Dist Avg
Abdomen -- Area
-- Volume
Obstetrics
-- Circumference
• Early Obstetrics Gestational Age (GA)
measurements are MSD, CRL, and Yolk Sac Cerebrovascular
• Gestational Age parameter labels are MSD, CRL, • CCA prox, CCA mid, CCA dist, ICA prox, ICA mid,
BPD, OFD, HC, AC, ATD, ASD, FL, HL, UL, TL, FT, ICA dist, ECA and VA measurements
FTA and BN • Area Percent Stenosis and Diameter Percent
• 20 user-defined measurement labels Stenosis measurements
• Calculations include: EFW from the selected Peripheral Vascular
reference, HC/AC, TCD/AC, LVW/HW, CorBPD, FL/ • CIA, EIA, CFA, PFA, SFA prox, SFA mid, SFA
AC, FL/BPD, CI, AFI, AXT dist, POP A, TRUNK ATA, PTA, PER A and DPA
• Comprehensive Fetal Heart measurements and measurements
calculations • Right and left extremity measurements
• Facial Angle
-- Nuchal Translucency and Nuchal Fold
measurements
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Venous • 300 GB (of the 500 GB internal hard drive)
• Right and left extremity measurements internal hard drive reserved for patient data
management
Thyroid
-- Patient database sorting by Name, ID and
• Rt. Lobe, Lt, Lobe Isthmus and nodule
Study Date
measurements
• Hard drive capacity:
• Supports measurement of up to 15 separate
-- Approximately 300,000 B/W and color images
nodules
• Storage and retrieval of static images
• Measurements can display all 3 measurements
plus volume calculation • Storage and retrieval of cine clips
-- Retrospective clip capture during real-time
The ACUSON X700 system supports customizable imaging with a selectable duration of 1, 2, or
labeled measurements (20 B-mode, 5 Doppler 4 seconds
and 5 M-mode) for the following exam types: -- Prospective clip capture during real-time
Abdomen, Breast, Thyroid, Venous, Renal, and imaging with a selectable duration of 1 to
Small Parts. Additionally, all reporting packages 120 seconds
support user-defined descriptors (up to 39). • Export of patient studies from hard drive
• Storage and retrieval of reports
DIGITAL PATIENT STUDY STORAGE
• Supports measurements and calculations on
AND ARCHIVING
archived study and on saved and retrieved
The DIMAQ-IP integrated workstation allows for images
digital acquisition, storage and review of complete • Acoustic clip capture from cine review
ultrasound studies, including static images, dynamic • M-mode still frame scroll and store
clips, measurements, calculations and reports.
• PW spectral Doppler still frame scroll and store
Studies can be reviewed and quantified on-board, • Export of patient studies from hard drive to
stored on the system hard drive and transferred to DVD-R/RW and CD-R/RW drive. Studies can be
the built-in DVD multi-drive (DVD-R/RW & CD-R/RW) individually selected or batched copied
or USB Flash drive for cost-effective archival. • The system supports the following data export
file formats: RTF, PDF, TIFF, AVI, JPG and DICOM.
Patient Study Management Connectivity to PACS, other off-line storage (such
Playback of digitally stored images in a selectable as USB flash drive) or EMR device is achieved via
1-up, 4-up, 9-up, 16-up or 25-up screen format. LAN or WLAN connection.
The patient study screen allows search, selection • Compatible with removable 650 MB, 700 MB
and deleting of studies or export to DVD multi-drive and 790 MB CD-R and 650 MB or 700 MB CD-RW
(DVD-R/RW and CD-R/RW). • Removable 4.7 GB single layer DVD and 8.5 GB
single side double layer DVD
• Supports export to USB Flash Drive
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ADVANCED TECHNOLOGIES
AND FEATURES
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• DICOM region calibration • Standby time: > 40 min
• DICOM interchange media viewer software • Full recharge: < 180 min
SHOWCASE®
Clarify Vascular Enhancement (VE) Technology
• Interchange media database that identifies the (Option)
CD to which the patient study has been burned
Clarify VE technology is a real-time, adaptive, pixel-
DICOM Modality Worklist by-pixel analysis implemented through a simple,
Enables query and direct download of the patient time-saving user interface that provides multiple
worklist schedule from the Hospital/Radiology levels of clarification to optimize tissue contrast
Information System (HIS/RIS) to the ACUSON X700 resolution and definition of both tissue and vessel
system, automatically populating the “New Patient” walls according to user preference. Clarify VE
screen with patient demographic information. technology is available on all curved and linear
transducers.
DICOM MPPS – Modality Performed
Procedure Step SieScape Panoramic Imaging
Enables automatic exchange of Modality Performed Grayscale panoramic imaging allows acquisition
Procedure Step information with the Hospital/ and display of images up to 60 cm in length to a
Radiology Information System (HIS/RIS). maximum curvature of 360°.
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• Advanced fourSight Technology • Area, Distance and Strain ratio measurement
-- Offers enhanced 3D/4D acquisition, data capability allow for quantitative comparison of
rendering and post-processing functionality two images
-- MultiSlice format allows the user to select • A quality factor indiciation provides feedback
range, slice spacing and format for viewing on the quality of acquisition and allows more
each slice. The MultiSlice format supports up acute selection of most appropriate frame(s) for
to 36 slices at once. assessment or measurement
-- Thick Slice Imaging (TSI) enables definition of syngo Auto OB Measurements (Option)
a view plane and creates a thick slice around The syngo Auto OB measurements option contains
the region of interest. TSI delivers improved an innovative algorithm which provides the ability
contrast resolution and provides more to automatically measure the most common fetal
information in a single image. structures required for fetal biometry: BPD, HC, AC,
-- Curved MPR enables real-time multiplanar FL and HL. This technology reduces user variance,
reformatting of images into any linear or providing consistency between operators and
curved plane. This permits the user to set reduces keystrokes. All measurement results are
points along a curved object in order to bring saved to the OB report.
all objects along this line into the same plane
for viewing, such as the fetal spine. syngo Velocity Vector Imaging (VVI) Technology
(Option)
syngo Auto Follicle Measurements (Option)
syngo VVI technology visualizes, measures and
The syngo® Auto Follicle measurement option is
displays global and regional myocardial motion
an automated measurement tecnique that enables
and mechanics from a 2D image and sophisticated
fast and acurate assessment of multiple follicles.
tracking algorithm. Using individual vectors to
It helps reduce exam time by allowing the user to
display direction and relative velocity (based on
automatically capture and record measurements.
length of the vectors) of frame-to-frame tissue
eSie Touch Elasticity Imaging (Option) movement, syngo VVI technology delivers motion
measurement at any point in the cardiac cycle.
eSieTouch elasticity imaging is a real-time
syngo VVI technology provides a unique graphical
quantitative imaging method that calculates and
presentation of the mechanics of myocardial
displays the relative stiffness of the tissue.
function.
eSieTouch elasticity imaging allows the user
• Algorithm processes ultrasound clips obtained in
to generate the elastogram by applying gentle
all views of the heart, as well as generic moving
sequential compression cycles during standard B
tissue (e.g. vessel wall)
mode imaging. This relative displacement of tissue
is displayed as an elastogram in a live dual image • Not limited by Doppler angle dependencies,
display of the grayscale or color image with the frame rate or mean velocities
standard B mode image. • ECG signal is not required, allowing use with
fetal echo
• Unique mapping options in grayscale and color
• Tracking algorithm incorporates multiple sources
further enhance the ease of interpreting an
of information, including speckle tracking
elastogram
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• Displays include: Barcode Reader (Option)
-- Visual assessment of wall motion and vector • Allows fast and accurate patient information
dynamics data input
-- Time curves of the selected velocity vector • Easy attachment to USB port
components • Supports 2D and 1D patient barcode
-- 3D representations of parametric color • Can scan up to 3 individual barcodes: patient,
M-mode physician and sonographer
-- Selected components of tissue velocity (tissue • Inputs the following patient identifying data:
strain and tissue strain rate) -- Patient Name (First and Last)
-- Time curves of global and segmental LV -- Patient ID
volumes and Ejection Fraction
-- Physician ID
-- Synchrony analysis including time-to-peak
-- Sonographer
• Compatible with standard acquisition frame rate
clips and acoustic clip capture (e.g. isovolumetric DICOM Structured Reporting (Option)
contraction and relaxation events) DICOM Structured Reporting (SR) provides a
standardized report architecture to allow for
Cadence Contrast Agent Imaging* (Option)
easy transfer of measurements to offline PCs,
Provides excellent detection of the responses from workstations and archiving systems. DICOM
contrast agent microbubbles, coupled with a high Structured Reporting will automatically populate
resolution display. The ability to simultaneously measurements to their respective fields in an
detect both the signals returning from the contrast external software package. This option is available
agent and the signals arising from tissue allows the for the following applications:
user to switch between a contrast-only display and a
tissue-only display for instantaneous confirmation of • OB/GYN
contrast presence and position, providing real-time • Vascular
flexibility and enhanced diagnostic confidence.
Wireless Data Transfer (Option)
• Optimized for 4C1 transducer for abdominal Utilizes USB dongle to enable wireless connectivity
applications between the ultrasound system and the facility’s
• MultiHertz imaging provides improved fine- LAN to provide functionality equivalent to a wired
tuning for low-MI contrast investigations network.
• Integrated burst/reflow control for destruction,
The Wireless Option supports connectivity with:
reperfusion investigations
• DICOM services – Modality worklist, print,
• On-screen stopwatch feature
storage commitment and store
• Frame rate triggering with extended clip capture
• Siemens Remote Service – Remote update
times of up to 20 minutes
handling for storage distribution and NetViewer
• Burst (bubble destruction) mode for remote application support and remote
* At the time of publication, the U.S Food and Drug Administration has cleared ultrasound contrast agents only for use in LVO.
Check current regulations for the country in which you are using this system for contrast agent clearance.
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troubleshooting • External audio out
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(525 – 795 mm Hg) or up to 3000 m (9,483 ft) STANDARDS COMPLIANCE
• Ambient temperature range (without OEM’s):
The ACUSON X700 system is in compliance with
10 – 40° C (50 – 104° F)
the following standards, including all applicable
• Humidity: 30 – 80%, non-condensing, during amendments at the time of product release.
operation
• Maximum heat output: 2150 BTU/hr Quality Standards
• Average noise level output: 46 – 47 dB • FDA QSR 21 CFR Part 820
• ISO 9001
INTEGRATING THE HEALTHCARE • ISO 13485
ENTERPRISE (IHE)
Design Standards
Having all relevant information at one’s fingertips • UL 60601-1
is a prerequisite for optimal and efficient patient
• CSA C22.2 No. 601-1
care. Seamless integration of the hospital’s IT
• EN 60601-1 and IEC 60601-1
and Imaging Systems and their capabilities to
exchange information without restriction are key • EN 60601-1-1 and IEC 60601-1-1
success factors for facilitating daily work. This is • EN 60601-1-2 and IEC 60601-1-2 (Class B)
why Siemens has been instrumental in launching • EN 60601-2-18 and IEC 60601-2-18
and advancing the IHE (Integrating the Healthcare • EN 60601-2-37 and IEC60601-2-37
Enterprise) Initiative. Our commitment and
• EN 60601-2-25 and IEC 60601-2-25
dedication enable us to provide clinicians with the
• EN 60601-1-4 and IEC 60601-1-4
ACUSON X700 system one of many innovative
• EN60601-1-6 and IEC 60601-1-6
products embedded with the building blocks
necessary in supporting clinicians’ need for seamless • ISO 14971
health information exchange. • EN 62304 and IEC 62304
For more information on the ACUSON X700 system Acoustic Output Standards
and the Siemens commitment to the IHE initiative, • IEC 61157 (Declaration of Acoustic Power)
please visit www.siemens.com/IHE. • IEC 62359 ed. 2 (Test Methods for the
Determination of TI and MI)
• AIUM/NEMA UD-2, Acoustic Output
Measurement Standard for Diagnostic
Ultrasound
• AIUM/NEMA UD-3, Standard for Real-time Display
of Thermal and Mechanical Acoustic Output
Indices on Diagnostic Ultrasound Equipment
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CE DECLARATION
This product is provided with a CE marking in
accordance with the regulations stated in Council
Directive 93/42/EEC of June 14, 1993
concerning Medical Devices. The CE
marking only applies to medical 0123
devices that have been put on the
market according to the above referenced Council
Directive. Unauthorized changes to this product are
not covered by the CE marking and the related
Declaration of Conformity.
EU AUTHORIZED REPRESENTATIVE
Siemens AG
Healthcare Sector
Henkestrasse 127
91052 Erlangen
Germany
phone: +49 9131 84 0
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The products/features mentioned in this
document may not be commercially
available in all countries. Due to regulatory
reasons their future availability cannot
beguaranteed. Please contact your local
Siemens organization for further details.
www.siemens.com/healthcare