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SONOLINE PrimaDigital Ultrasound System

OPERATING CONSOLE

The SONOLINE® Prima system employs aninnovative operating console ergonomicallydesigned to facilitate easy operation andshortened learning cycles.

Alphanumeric Keyboard• Full QWERTY keyboard supporting international

character sets for patient data entry, image annotationand system programming

Control Panel• Membrane control panel with two-level backlit

imaging controls and adjustable overhead lighting

Monitor• 12-inch (30-cm) high-resolution monochrome monitor

with tilt and swivel• Tilt and swivel lock to secure monitor during transit• Removable monitor for easy transit

Transducer Ports• Up to three transducers can be connected

simultaneously.• Two active curved or linear array ports• One active conventional sector port

Transducer Storage• On-board storage for specialty transducers and cable

management provides easy access and increasedsecurity.

• Four transducer holders integrated into console witha unique locking design to secure transducer andcables during transit

System Input/Output• Composite Video Input (BNC)• Composite Video Output (BNC)• RS-232C (25-pin female D-Sub) for report printer or

off-line analysis station• Footswitch• ECG (option)

Footswitch• Dual-pedal footswitch• Left pedal: freeze/unfreeze• Right pedal: user-programmable for print, M Mode,

endocavity transducer frequencies, or image planeson endorectal transducer

SONOLINE Prima Digital Ultrasound System

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SYSTEM ARCHITECTURE

SONOLINE Prima incorporates the latestadvances in wide bandwidth, multi-impedancematched transducer technology, 360-degreedigital scan converter and dual echoprocessing design to provide improvedresolution, exceptional tissue contrast andincreased clinical accuracy.

• Full field panoramic digital scan converter, 512x512x7bit memory, 355-degree display with circular scanningtransducers

• 32-channel dynamic receive beamformer• 256 shades of gray• Overall dynamic range: 140 dB• Dynamic receive focusing and dynamic aperture

control for improved resolution and signal/noise ratio• Adjustable persistence, edge enhancement and user-

editable gray maps

Image Display Modes• Single Imaging Modes

- B Modes (B. 2B, B+B.4B)- M Mode

• Mixed Modes- B+M Modes with various display formats:

Horizontal 50-50, 2/3-1/3: Vertical 40-60- A+B, A+M Mode

Image Screen Display• Display of all exam-related parameters: patient name:

patient ID: hospital name: operator name: referringphysician: date and time: transducer name andfrequency: transducer orientation: trackball status:exam type: DGC curve (if selected): ECG heart rate(with ECG option)

• On-screen display of all relevant imaging parameters:output power: receive gain: dynamic range:persistence: edge enhance: imaging angle / scanwidth: frame rate: line density: gray map type: graybar: depth scale including offset: focal zone markers:freeze indicator: mechanical index (MI): bone thermalindex (TIB) and soft tissue thermal index (TIS), asapplicable

• The display of on-screen imaging parameters can beturned off if desired.

• Magnification- Pan, read and write zoom in real-time and frozen

image• Image Orientation

- Left / right (horizontal) flip in B, 2B, B+B. and 4BMode and of the B image in B+M Mode

SONOLINE Prima Digital Ultrasound System

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- Up / down (vertical) flip in B, 2B, B+B, 4B, andB+M Mode for endocavity transducers throughtransducer preset menu

- 90-degree rotation (selectable steps: 0, 90, 180,270 degrees)

• Image Polarity- Negative (white on black)- Positive (black on white)

Pictograms• Up to 60 user-selectable standard and exam-specific

body symbols. Transducer position and orientationmay be indicated with a transducer marker in thepictogram.

• Orientation symbols for endocavity transducers

Annotation• Allows the user to annotate anywhere on image

screen, standardize views and label abbreviations.User can program word lists and sort by mostfrequently used words.

• A predefined annotation list ranging from 10 to 65terms, depending on application is available for theuser. Users can choose terms from a preprogrammedlibrary of common terms or define their own termsfor unlimited flexibility.

System Presets and User QuickSets• User-definable system set up through preset menus

or QuickSet function for customization of exam-specific transducer settings, canned text and phraselibrary, pictogram list, and user measurements,formulas and reports

• All presets and QuickSets can be stored on diskette.

IMAGING PARAMETERS

By continuously optimizing the receive delays,aperture size and frequency content,DYNAMIC RECEIVE FOCUS creates a moreperfect acoustic lens. The result is aremarkable improvement in axial and lateralresolution. DYNAMIC APERTURE CONTROLautomatically matches the precise number ofactive transducer elements to the focal zonerange, to keep the beam intensity constantand remove image arti facts due to unevenfocusing. MULTIIMPEDANCE MATCHEDTRANSDUCERS with 128 elementssignificantly increase the diagnosticinformation from returning signals.

• Transmit Power: displayed in decibals or percent

(user-selectable)• Receive Gain: overall system receive gain combined

with DGC totals 60 dB• DGC (Depth Gain Compensation) Control: eight DGC

slides controls to optimize receive gain, user-definablefor specific application

• Grayscale- B and M Mode: selectable 256, 128, 64, 32, 16,

8, 4, or 2 gray shades• Pre-processing

- Edge enhancement in four steps- Image persistence in four steps- Dynamic range 35 to 66 dB in 1 dB steps

• Post-processing- Six types of gray maps- Five of six gray maps user-editable

• Transmit Focus- Electronic arrays: one, two, or four user-

positionable focal zones- Conventional sector: fixed focus

• Dynamic Receive Focus- Image angle can be adjusted for curved array

and sector transducers. Selectable angles aretransducer-dependent.

- Image width can be adjusted for lineartransducers. Selectable widths are transducer-dependent.

TRANSDUCER TECHNOLOGY

HIGH FIDELITY transducer array technologyprovides high-density transducers with 128elements for optimal design performance.Multi-frequency transducers allow the userto shift the transmit frequency upward forhigh resolution and downward for morepenetration, increasing the versatility of eachtransducer at the push of a button.

Transducer Frequencies• 2.6, 3.5, 5.0, 6.0, 6.5, 7.5 MHz

Image Depth of View• Selectable in one-centimeter increments

- 2.6 MHz: 6 to 24 cm- 3.5 MHz: 6 to 24 cm- 5.0 MHz: 4 to 16 cm- 6.0 MHz: 4 to 16 cm- 6.5 MHz: 4 to 13 cm- 7.5 MHz: 3 to 12 cm

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M-MODE

M-mode display is a particularly useful wayof looking at motion within the heart.SONOLINE Prima heightens the clinical useof M Mode with simultaneous 2D split-screenimaging displays.

• Available on all imaging transducers• User-selectable display formats: 50-50, 2/3-1/3, or

40-60

Sweep speed and line density

PAL/CCIR: Speed 1 Speed 2 Speed 3 Speed 4Time for full screen sweep: 1.8 sec 3.6 sec 7.2 sec 14.4 secAcoustic Lines per second: 200 I/s 100 I/s 50 I/s 25 I/s

NTSC/EIA: Speed 1 Speed 2 Speed 3 Speed 4Time for full screen sweep: 1.5 sec 3.0 sec 6.0 sec 12.0 secAcoustic Lines per second: 240 I/s 120 I/s 60 I/s 30 I/s

MEASUREMENTS AND CALCULATIONS

• Support of general and exam-specific measurementson real-time, frozen, CINE or VCR-playback images

• B- and M-mode caliper: up to four distance or twoarea/circumference caliper measurements per image

• 2D Measurements- Distance/depth- Circumference (two-point ellipse or trace)- Area (two-point ellipse or trace)- One plane volume (W x H or two-point ellipse)- Ratio (A/B and (A-B)/A)

• Volume Measurements- Two plane volume (W x H x L. two-point ellipse,

trace or point-to-point)- Stepwise volume- Volume ratios

• M-mode Measurements- Distance- Time- Heart rate- Slope- Ratio (A/B and (A-B)/A)

EXAM-SPECIFIC MEASUREMENTS ANDREPORTS

Obstetrics (basic package)• Measurements: OFD: TAD: MSD: CRL: BPD: HC:

AC: APAD: FL: FHR: four user-defined measurementlabels

• Calculations: EFW: Clinical MA: US MA: Clinical EDC:US EDC: HC/AC: FL/AC: FL/BPD: Cl

• Reports: allows automatic visualization anddocumentation of measured and calculated data- Multi-measurement averaging- Multiple author selection- User-defined tables and formulas- Qualitative descriptions- User-defined phrase library- Pictogram display

Gynecology• Measurements

- Gyn and fertility protocol: uterus: ovary (L / R):multi-follicle measurement as distance, area orvolume (6L, 6R): cervix: endometrium

- User-defined measurement labels- Follicular averaging methods — up to three

distance averages• Reports: allows automatic visualization and

documentation of measured and calculated data- Qualitative description- User-defined phrase library

Urology• Measurements

- Prostate volume- Stepwise volume- Residual urine volume- Incremental volume for prostate brachytherapy

• Reports: allows automatic visualization anddocumentation of measured and calculated data- PSA/ PSAD entry and calculation- Qualitative description- User-defined phrase library- Pictogram display- Drawing function to indicate specific structures

of interest

Surgery• Measurements

- Endorectal volume- Residual urine volume- Stepwise volume

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• Reports: allows automatic visualization anddocumentation of measured and calculated data- Qualitative description- User-defined phrase library- Pictogram display- Drawing function to indicate specific structures

of interest

Orthopedics• Infant hip classification and graphical display according

to Dr. Graf• Hip angle measurement• Angle measurement• Qualitative description• User-defined phrase library• Pictogram display

Cardiology• Stroke volume• Ejection fraction• Fractional shortening• Qualitative description• User-defined phrase library

Small Parts and ENT• Thyroid volume

ENHANCED OBSTETRICAL CALCULATIONSAND REPORT PACKAGE (Standard)

Adds enhanced features to the basic obstetricalmeasurement package with:

• Additional Measurements and Calculations: humeruslength: ulnar length: clavicle length: binocular distance:tibia length: foot length: yolk sac diameter: nuchalthickness: cervical length: cistema magna distance:lateral ventricular width: hemispheric width:transcerebellar diameter: renal dimension: amnioticfluid index: BPD by TCD: TCD / AC ratio: LVW / HWratio: CorBPD (corrected BPD): two displays of EFW

• Other features include:- Twin gestational measurements and reports- Dedicated early gestational report- Additional user-defined tables and formulas (one

table/formula per parameter)- Four user-defined measurements- Fetal growth graphs and growth trend analysis

IMAGE REVIEW, DOCUMENTATION ANDSTORAGE

CINE Review• Up to 31 2D frames• Replay in continuous, variable speed or frame-by-

frame mode• Up to 546 seconds (EIA) or 656 seconds (CCIR) of

M-mode data storage and replay• Editing capability: The user is able to edit the CINE

loop from either the beginning or the end in orderto display selected frames.

3.5-inch Diskette Drive• Standard, high-density (1.44 MB) PC disk compatible• Allows storage and retrieval of:

- System software- User-defined presets- QuickSets- Images- Patient data and reports

• Images can be stored in "System" format forsubsequent evaluation on the Prima and "TIFF"(tagged image file format) for incorporation intocommon PC-based presentation and writingprograms.

Documentation Devices• B&W video printer (standard): SONY UP 890 MD• VCR option (external)

- SV0 9500 MD (NTSC/EIA)- SV0 9500 MDP (PAL/CCIR)

• Multi-format camera option (external)- CCM601 (EIA)- CCM 601 (CCIR)

SYSTEM SOFTWARE

• User-selectable operation in English, German, Frenchor Spanish

• Standard software includes complete operatingsystem with factory-defined system settings for allapplications.

SYSTEM ACCESSORIES

• 31-frame CINE Module Option- Allows storage of up to 31 2D images: replay in

continuous, variable or frame-by-frame mode- Allows up to 546 sec (EIA) or 656 sec (CCIR) of

M-mode data storage and replay• ECG Module Option

- Single / dual trigger in B Mode and B+B Mode- ECG trace display in B Mode and M Mode- Heart rate display

• Dual-pedal Footswitch- Left pedal: freeze / unfreeze- Right pedal: user-programmable for print, M

Mode, endocavity transducer frequencies, orimage planes on endorectal transducer

SYSTEM DIMENSION

• Width: 19" (483 mm)• Height

- 50.8" (1290mm)with VCR bay

- 46.3" (1176 mm)without VCR bay

• Depth: 23.6" (600mm)

• Weight (excludinginternaldocumentationdevices)- 190 lb (86 kg)

with VCR bay- 177 lb (80 kg)

without VCR bay

SONOLINE Prima Digital Ultrasound System

ELECTRICAL/VIDEO SPECIFICATION

• Power Connection- 115 V Version: 98-132 V: 3 A: 47-63 Hz- 230 V Version: 196-264 V: 1 .5 A: 47-63 Hz

• Power Consumption: maximum 345 VA (includinginternal documentation devices)

• Power Cable- 115 V Version: 1 1 '6" (3.5 m): SJT type with

hospital grade 3-pin plug- 230 V Version: 1 1 '6" (3.5 m): Harmonized type

with CEE 7-7 Schuko plug• TV Standards

- CCIR: 625 lines: 50 frames/sec- EIA: 525 lines: 60 frames/sec

• Temperature- Operating: +10° C to +40° C- Storage: -20° C to +60° C

• Humidity - Operation: 20 to 85%, non-condensing• Altitude - Operation: maximum 9800' (3000 m)• Heat dissipation - 1178 BTU/hr

SAFETY/REGULATORY REQUIREMENTS

• 115VVersion: UL2601-1: CSA22.2 No. 601.1:ANSI/AAMI ES1 (1985), FDA 510(K)

• 230 V Version: CE Mark certifying compliance with:- Medical Device Directive- EMC Directive- IEC 601-1- EN 29001- EN 46001- EN 55011 Class B- FDA 510(K)

Siemens Medical Systems, Inc.Ultrasound GroupP.O. Box 7002Issaquah, WA 98027-7002 U.S.A.Telephone: 1-800-477-6627

Siemens AktiengesellschaftMedical Engineering GroupHenkestrasse 127D-91052 Erlangen, GermanyTelephone: (+9131) 84 0

A91004-M2430-G060-03-4A00DA 0100

© 2000, Siemens Medical Systems, Inc.Printed in U.S.A.

USSiemens reserves the right to modify the design and specifications contained herein without prior notice. Please contact your local SiemensMedical Systems Sales Representative for the most current information.

From outside the U.S.A.call 1 -425-557-8704Europe: +49 9131 84 0E-mail: hotline@sqi.comwww.siemensultrasound.com

Dynamic Receive Focus

Dynamic Receive Focus automaticallyprovides a continuous receive focusthroughout the entire field of view. Bycontinuously optimizing receive delays,aperture size and frequency content,Dynamic Receive Focus creates a moreperfect acoustic lens. The result is aremarkable improvement in axial andlateral resolution.

Dual-echo Processing

Dual-echo Processing automaticallydoubles the number of available receivefocal zone positions at any display depth.Dual-echo Processing improves thesystem imaging by paralleling thesequential processes of 1) electronicallysetting the receive focal zone position,and 2) actually receiving the echo signals.While one portion of the systemelectronics is preparing the receive focusfor the next focal zone position, anotherpart is receiving the echo signals fromthe previous receive focal zone position.Dual-echo Processing effectivelyremoves uneven focusing artifacts whilemaintaining high image frame rates.

Wide Bandwidth Transducers

Wide Bandwidth Transducersautomatically improve resolution andpenetration simultaneously. Highly-damped transducers seek to improveimage quality and system resolution.Damping transducer vibration to improveaxial resolution changes the bandwidth,or the range of frequencies transmitted.The greater the damping, the wider therange of frequencies. Wide BandwidthTransducers typically transmit a rangeof higher and lower frequencies thatspans at least 60% of the centeroperating frequency (COF). As the body'stissues naturally absorb higher ultrasonicfrequencies faster than lowerfrequencies, Wide BandwidthTransducers automatically provide theoptimum frequency needed to image inboth the near and far fields.

Dynamic Aperture Control

Dynamic Aperture Control automaticallyfunctions on receive signals to removebeam focusing artifacts. Multi-elementfocusing forms a curved wave front tofocus the ultrasound beam. The diameterof this wave front is the effectivetransducer aperture. SONOLINEultrasound systems automatically matchthe precise number of workingtransducer elements to the focal zonerange to keep the beam intensityconstant. Dynamic Aperture Controlproduces a uniform beam regardless ofthe focal zone position, removing imageartifacts due to uneven focusing.

SONOLINE Prima Curved Linear Mechanical Specialty

Transducer 3.5C40S 5.0C40S 7.5L75S 7.5L45S 3.5SI15 3.5/5.0SI 5.0/7.5Micro 6.5EV13S Endo-V Endo-PII

Technology Curved Curved Linear Linear Mechanical Mechanical Mechanical Curved Mechanical MechanicalFrequency 2.6/3.5/5.0 MHz 5.0 MHz 5.0/7.5 MHz 5.0/7.5 MHz 3.5 MHz 3.5/5.0 MHz 5.0/6.0/7.5 MHz 5.0/6.5 MHz 5.0/6.0/7.5 MHz 5.0/6.0/7.5 MHzMultiple Frequencies yes no yes no no yes yes yes yes yesAperture 77mm 64mm 77mm 45mm 15mm 3.5MHz-15 mm 8mm 35mm 8mm 8mm

5.0 MHZ-10 mmFrame Rates 12-74 fps 15-93 fps 11-69 fps 11-69 fps 18-36 fps 6-24 fps 10-34 fps 11-69 fps 10-17 fps 10-17 fpsMax Sector Angle/Width 89° 60° 67mm 39mm 100° 100° 100° 133° 220° 355°Imaging Depths 60-240 mm 40-160 mm 30-120 mm 30-120 mm 30-240 mm 30-240 mm 40-160 mm 30-130 mm 40-160 mm 40-160 mElements 128 128 128 128 3 crystals 3 crystals 2 crystals 128 2 crystals 2 crystalBiopsy Guide yes no yes yes yes yes no yes yes yesWater Path no yes yes yes yes yes no no no yes

Abdominal l l l lObstetrics l l l mEndovaginal l lEndorectal lBreast l lThyroid l lTesticular l lPediatrics m lOrthopedic l mCardiac lIntraoperativeNeonatal m lEmergency Room l l m l l m l l

l Primary m Secondary

Revised 01/2000