SONOLINE Prima Digital Ultrasound System

s SONOLINE Prima Digital Ultrasound System US

OPERATING CONSOLE The SONOLINE Prima system employs an innovative operating console ergonomically designed to facilitate easy operation and shortened learning cycles. Alphanumeric Keyboard Full QWERTY keyboard supporting international character sets for patient data entry, image annotation and 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 increased security. Four transducer holders integrated into console with a unique locking design to secure transducer and cables 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 planes on endorectal transducer SYSTEM ARCHITECTURE SONOLINE Prima incorporates the latest advances in wide bandwidth, multi-impedance matched transducer technology, 360-degree digital scan converter and dual echo processing design to provide improved resolution, exceptional tissue contrast and increased clinical accuracy. Full field panoramic digital scan converter, 512x512x7 bit memory, 355-degree display with circular scanning transducers 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 usereditable 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: referring physician: date and time: transducer name and frequency: 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 / scan width: frame rate: line density: gray map type: gray bar: depth scale including offset: focal zone markers: freeze indicator: mechanical index (MI): bone thermal index (TIB) and soft tissue thermal index (TIS), as applicable The display of on-screen imaging parameters can be turned 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 4B Mode and of the B image in B+M Mode 2

- Up / down (vertical) flip in B, 2B, B+B, 4B, and B+M Mode for endocavity transducers through transducer 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 orientation may be indicated with a transducer marker in the pictogram. 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 most frequently used words. A predefined annotation list ranging from 10 to 65 terms, depending on application is available for the user. Users can choose terms from a preprogrammed library of common terms or define their own terms for unlimited flexibility. System Presets and User QuickSets User-definable system set up through preset menus or QuickSet function for customization of examspecific transducer settings, canned text and phrase library, 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 more perfect acoustic lens. The result is a remarkable improvement in axial and lateral resolution. DYNAMIC APERTURE CONTROL automatically matches the precise number of active transducer elements to the focal zone range, to keep the beam intensity constant and remove image arti facts due to uneven focusing. MULTIIMPEDANCE MATCHED TRANSDUCERS with 128 elements significantly increase the diagnostic information from returning signals. (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-definable for 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 userpositionable focal zones - Conventional sector: fixed focus Dynamic Receive Focus - Image angle can be adjusted for curved array and sector transducers. Selectable angles are transducer-dependent. - Image width can be adjusted for linear transducers. Selectable widths are transducerdependent. TRANSDUCER TECHNOLOGY HIGH FIDELITY transducer array technology provides high-density transducers with 128 elements for optimal design performance. Multi-frequency transducers allow the user to shift the transmit frequency upward for high resolution and downward for more penetration, increasing the versatility of each transducer 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 Transmit Power: displayed in decibals or percent 3

M-MODE M-mode display is a particularly useful way of looking at motion within the heart. SONOLINE Prima heightens the clinical use of M Mode with simultaneous 2D split-screen imaging 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 4 Time for full screen sweep: 1.8 sec 3.6 sec 7.2 sec 14.4 sec Acoustic Lines per second: 200 I/s 100 I/s 50 I/s 25 I/s NTSC/EIA: Speed 1 Speed 2 Speed 3 Speed 4 Time for full screen sweep: 1.5 sec 3.0 sec 6.0 sec 12.0 sec Acoustic Lines per second: 240 I/s 120 I/s 60 I/s 30 I/s MEASUREMENTS AND CALCULATIONS Support of general and exam-specific measurements on real-time, frozen, CINE or VCR-playback images B- and M-mode caliper: up to four distance or two area/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 AND REPORTS Obstetrics (basic package) Measurements: OFD: TAD: MSD: CRL: BPD: HC: AC: APAD: FL: FHR: four user-defined measurement labels Calculations: EFW: Clinical MA: US MA: Clinical EDC: US EDC: HC/AC: FL/AC: FL/BPD: Cl - Multi-measurement averaging - Multiple author selection - User-defined tables and formulas - Qualitative descriptions - Pictogram display Gynecology Measurements - Gyn and fertility protocol: uterus: ovary (L / R): multi-follicle measurement as distance, area or volume (6L, 6R): cervix: endometrium - User-defined measurement labels - Follicular averaging methods up to three distance averages - Qualitative description Urology Measurements - Prostate volume - Stepwise volume - Residual urine volume - Incremental volume for prostate brachytherapy - PSA/ PSAD entry and calculation - Qualitative description - Pictogram display - Drawing function to indicate specific structures of interest Surgery Measurements - Endorectal volume - Residual urine volume - Stepwise volume 4

- Qualitative description - 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 CALCULATIONS AND REPORT PACKAGE (Standard) Adds enhanced features to the basic obstetrical measurement package with: Additional Measurements and Calculations: humerus length: ulnar length: clavicle length: binocular distance: tibia length: foot length: yolk sac diameter: nuchal thickness: cervical length: cistema magna distance: lateral ventricular width: hemispheric width: transcerebellar diameter: renal dimension: amniotic fluid index: BPD by TCD: TCD / AC ratio: LVW / HW ratio: 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 AND STORAGE CINE Review Up to 31 2D frames Replay in continuous, variable speed or frame-byframe 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 order to 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 for subsequent evaluation on the Prima and "TIFF" (tagged image file format) for incorporation into common PC-based presentation and writing programs. 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, French or Spanish Standard software includes complete operating system with factory-defined system settings for all applications. 5

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, or image 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" (600 mm) Weight (excluding internal documentation devices) - 190 lb (86 kg) with VCR bay - 177 lb (80 kg) without VCR bay 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 (including internal 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 reserves the right to modify the design and specifications contained herein without prior notice. Please contact your local Siemens Medical Systems Sales Representative for the most current information. Siemens Medical Systems, Inc. Ultrasound Group P.O. Box 7002 Issaquah, WA 98027-7002 U.S.A. Telephone: 1-800-477-6627 From outside the U.S.A. call 1-425-557-8704 Europe: +49 9131 84 0 E-mail: hotline@sqi.com www.siemensultrasound.com Siemens Aktiengesellschaft Medical Engineering Group Henkestrasse 127 D-91052 Erlangen, Germany Telephone: (+9131) 84 0 A91004-M2430-G060-03-4A00 DA 0100 US 2000, Siemens Medical Systems, Inc. Printed in U.S.A.

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 Mechanical Frequency 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 MHz Multiple Frequencies yes no yes no no yes yes yes yes yes Aperture 77mm 64mm 77mm 45mm 15mm 3.5MHz-15 mm 8mm 35mm 8mm 8mm 5.0 MHZ-10 mm Frame 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 fps Max 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 m Elements 128 128 128 128 3 crystals 3 crystals 2 crystals 128 2 crystals 2 crystal Biopsy Guide yes no yes yes yes yes no yes yes yes Water Path no yes yes yes yes yes no no no yes Abdominal Obstetrics Endovaginal Endorectal Breast Thyroid Testicular Pediatrics Orthopedic Cardiac Intraoperative Neonatal Emergency Room Primary Secondary Dynamic Receive Focus Dual-echo Processing Wide Bandwidth Transducers Dynamic Aperture Control Dynamic Receive Focus automatically provides a continuous receive focus throughout the entire field of view. By continuously optimizing receive delays, aperture size and frequency content, Dynamic Receive Focus creates a more perfect acoustic lens. The result is a remarkable improvement in axial and lateral resolution. Dual-echo Processing automatically doubles the number of available receive focal zone positions at any display depth. Dual-echo Processing improves the system imaging by paralleling the sequential processes of 1) electronically setting the receive focal zone position, and 2) actually receiving the echo signals. While one portion of the system electronics is preparing the receive focus for the next focal zone position, another part is receiving the echo signals from the previous receive focal zone position. Dual-echo Processing effectively removes uneven focusing artifacts while maintaining high image frame rates. Wide Bandwidth Transducers automatically improve resolution and penetration simultaneously. Highlydamped transducers seek to improve image quality and system resolution. Damping transducer vibration to improve axial resolution changes the bandwidth, or the range of frequencies transmitted. The greater the damping, the wider the range of frequencies. Wide Bandwidth Transducers typically transmit a range of higher and lower frequencies that spans at least 60% of the center operating frequency (COF). As the body's tissues naturally absorb higher ultrasonic frequencies faster than lower frequencies, Wide Bandwidth Transducers automatically provide the optimum frequency needed to image in both the near and far fields. Dynamic Aperture Control automatically functions on receive signals to remove beam focusing artifacts. Multi-element focusing forms a curved wave front to focus the ultrasound beam. The diameter of this wave front is the effective transducer aperture. SONOLINE ultrasound systems automatically match the precise number of working transducer elements to the focal zone range to keep the beam intensity constant. Dynamic Aperture Control produces a uniform beam regardless of the focal zone position, removing image artifacts due to uneven focusing. Revised 01/2000