SDU-1200Pro. Diagnostic Ultrasound System GENERAL DESCRIPTION

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PD579-012A Diagnostic Ultrasound System SDU-1200Pro GENERAL DESCRIPTION The Shimadzu SDU-1200Pro platform is the latest addition to the Shimadzu family of ultrasound platforms designed to produce outstanding clinical performance at an excellent value. Its powerful propriety digital architecture enables clinicians to optimize image quality simply and quickly. The SDU-1200Pro platform offers advances in all system operations and performance modes including imaging quality, digital preserved exams including dynamic clips with calculations, and color doppler. Exam data is stored in JPEG-compressed DICOM format for fast and easy access. The platform supports a full range of high performance wide bandwidth imaging probes for all clinical requirements. Shimadzu s legendary reliability and imaging performance makes the SDU-1200Pro platform a proven long-term investment in ultrasound to explore and expand clinical capabilities while establishing new levels in value and diagnostic confidence.

Features (1) All advantages of digital technology plus proprietary LSI. (2) Dual receive technology produces faster processing and higher frame rates for true time in all modes (3) Technology levels to satisfy the most sophisticated user. (4) User convenience for the new user with Application Specific Imaging and Optimize. (5) Small size plus user convenience allows this Color Imager to break the barrier and go where this technology has not gone before! (6) Digital movie archive and replay system with MPEG format. Configuration (1) Standard Constitution 1) SDU-1200Pro version Main unit: 1 2) Accessories: a) AC Power Cable: 1 b) Probe Holder (Right, Left): 1 c) Probe Cable Hanger: 1 d) Rubber Mat: 1 e) Gel: 1 f) Gel Cap: 1 g) Fuse: 1 h) Instruction Manual: 1 (2) Options 1) Probes 2) Foot Switch 3) Physiological Unit 4) Sector Upgrade Kit 5) CWD Unit* 1 6) External Image Archiving Unit 7) CD-R Kit 8) Video Cine Kit 9) Digital Movie Archive Kit 10) DICOM Package 11) 3D Display for OB/GYN 12) 3D Display for General Imaging 13) IMT Measurement Software 14) Cine Expansion Memory* 2 15) On-line option (W.I.P.) 16) Clear Cover 17) Video Printer (Black and White) 18) Color Video Printer 19) VCR * 1 Sector upgrade kit is needed. * 2 Cine Standard Memory is mounted. System General Data Applications Scan Method Imaging Mode Beamforming Processor Processing Channel Aperture Frequency Range View Angle Abdominal, Obstetrics, Gynecology, Pediatrics, Urology, Breast, Small parts, Peripheral, Vascular, Cardiology Convex, Linear and Sector scanning (option) B-Mode, M-Mode, Pulsed Doppler, Color Doppler, Doppler Power Imaging, Continuous Wave Doppler(option) Broadband Digital beamforming Parallel digital signal processing method, maximum 2 lines 384ch Dynamic 1.5 to15 MHz Variable to 190 degrees, depends on probe Probe Connector System Upgradability System Dynamic Range Resolution System General Data Selectable 3 active probes, 1 passive, Software/Hardware upgrade 167dB Transmit Focus Zone Up to 16 Receive Focus Zone Continuous/Dynamic Apodization Lines Per Images/Frame Up to 512 Display Mode (1) General 1) B, B/B Mode 2) M, B/M Mode 3) PWD, B/PWD Mode 4) CFM(B), CFM(B)/PWD 5) B/CFM(B), B/CFM(B, power) 6) CFM(B)/CFM(M), CFM(M) (2) B-mode Gray Shade Depth STC Display Dynamic Range Edge Enhance Persistence Post Process 2D filter Tissue Harmonic Imaging Chromatic Image Mode Frame Rate Gain Range (3) M-mode Display Method Sweep Edge Enhance Post Process 256 gray shades 2 to 25 cm, depends on combination probe and frequency 8 slide pot controls 30-80dB 4 levels selectable 6 levels selectable 10 curves selectable Dedicated spatial filter ON/OFF Maximum 400 images/sec 60dB Scrolling Selectable sweeping rates, 1.25, 2.5, 5 and 10 s/screen 4 levels selectable 10 curves selectable (4) Pulsed Doppler mode Velocity Range Adjustable 20 mm/sec to +/-3.0m/sec Sample Volume Sweep Wall Filters Auto Trace Auto calculation Audio Reference Frequency Chromatic Image mode Adjustable from 1mm to 20mm. 1mm increments Selectable sweeping rates Selectable filtering of low frequency signals with 6 increments, Mean & Peak, or Mode HR, Vmax, Vmin, RI, PI Stereo 2.0 to 7.5 MHz (5) Continuous Wave Doppler mode (Option) Phased Array Sector Probe only Steerable Through Velocity Range Auto Trace Auto calculation Audio 90 degree Max +/- 9.6 m/sec, Mean, Peak, or Mode HR, Vmax, Vmin, RI, PI Stereo

(6) CFM mode Color Doppler Color Power Directional color power Maps Wall Filter Reference Frequency User Interface Pan Zoom Scroll FOV Frequency M-Line ASI function Quick Set Keys Control Panel Display function Velocity, Variance 20 selectable 4 levels 2.0 to 7.5 MHz Continuous 1) Zoom with Pan 2) Write Zoom:Up to 2cm, dependent on probes 3) Read Zoom: Zoom after freeze and Zoom from cine, up to 2cm, dependent on probes, 5mm increments Selectable View Angle and View Steering Transmit & receive range ON/OFF 50 types can be set. 8 types of image optimizing can be set for each ASI 5 presets, user-programmable 1) Backlit tactile keyboard a) Bright=active, b) Dimm=key is available, but not active. c) Off=key is not available in current mode 2) Alpha-numeric, specialized defined key, trackball, STC, Gain volume 3) Easy to learn graphical user interface 1) Orientation: a) Top-bottom and right-left reverse orientation b) Image rotation: 0, 90, 180, 270 2) Display information a) Hospital name, Doctor name b) Patient information (Patient ID, Patient name, Sex, Age) c) ASI name d) Acoustic power information Real-time display of Mechanical Index (MI) Real-time display of Thermal Index (Tlb, Tls) e) Imaging parameters: Including Probe type, Frequency, Frame rate, Dynamic range, Gain, Postprocess, Enhance, Persistence 3) Annotation: a) Body markers:, Anatomical Icons- Probe location b) Text c) Annotation library: Pre-registered annotation terms, User-programmable User Interface Display function Cine memory Internal Image Storage Print Language High Mobility Cart Basic Measurement (1) B-mode Distance Circumference Area Volume Angle Area Reduction Histogram (2) M-mode Distance Velocity Heart Rate (3) D-mode Velocity Acceleration PI (Pulsatility Index) RI (Resistivity Index) Trace Heart Rate (4) CFM-mode Velocity Application Program Obstetrics 4) Monitor: a) Monitor size: A single 15 inch b) High resolution, Non-interlace flicker free, SVGA color monitor c) Tilt and Swivel:, 180 degree rotation 1) Frame No.: Maximum 6,200, images in B/B mode. The number of storable images depends on probe type, scanning mode, scanning size, and other conditions. 2) Function: Search, Scroll, Store, Review a) Hard disk capacity: 80GB b) Storage image capacity: Approximately more than 50,000 images c) Storage image file format: Original d) Store, Recall e) Export Image file format: JPG, BMP 3 keys, User assigned English Low rolling resistance 4-wheel swivel casters, 8 channels, Trace & Ellipse, Trace & Ellipse, Distance & Ellipse, 4 channels, 2 channels, 4 channels, 2 channels, 2 channels, Auto & Manual, 2 channels, 2 channels, Auto & Manual, 2 channels 1) B-mode measurement a) GS, CRL, BPD, OFD, TTD, APTD, FL, HL, LV, BD b) HC, AC c) FTA d) AFI

Application Program Obstetrics 2) M-mode measurement: Fetal heart 3) D-mode: a) Velocity b) Acceleration c) PI d) RI e) Trace f) Fetal HR 4) Report 5) OB Graph 6) BPP Report 7) Anatomy Report Gynecology 1) Uterus, Ovary: 2) Follicle: 3) Ratio:, up to 6 channels 4) Other (Volume):, up to 6 channels 5) Report Vascular 1) Carotid: CCA, ICA, ECA, VertA, ICA/CCA 2) Labeling function is available 3) Measurement a) %Stenosis b) Velocity c) Systolic/Diastolic Ratio d) Velocity Ratio e) PI f) RI g) Trace h) Flow Volume I) Report Cardiology 1) B-mode measurement a) LV b) LV A-L c) LV Simpson s Rule d) Ao/LA e) MVA f) AVA g) Report 2) M-mode measurement a) Ao/LA b) MV c) LV d) Report 3) D-mode measurement a) AV b) MV c) PV d) TV e) Report Urology 1) Prostate:, Stepper volume and 3D method 2) Bladder, Testicle: 3) Report function Application Program Others 1) Pediatric Hip measurement 2) Thyroid measurement 3) VCR measurement Input/output Interface CD-RW Image archive (Option) DVD-RAM Image archive (Option) LAN port External connectors Two USB ports BNC for video out Options Probes Foot Switch Two pedals, Freeze and Print User definable print output device Physiological Unit One 3-lead ECG input Two Physio. input channels (Pulse-phone input, Respiration input) Sector Upgrade Kit Sector scanning is available CWD Unit Sector upgrade kit is needed External Image Storage Method: DVD-RAM Archiving Unit Storage Media type: 4.7GB/single-sided type 9.4GB/double-sided type CD-R Kit Storage Method: CD-R Video Cine Kit Simultaneous replay of left and right images Digital movie archive kit Digital dynamic image recording and replaying function DICOM Package 1) DICOM 3.0 store service class user 2) DICOM 3.0 print service class 3) DICOM 3.0 worklist service class 4) Fully integrated user interface 5) 10/100 Base-T Ethernet output 6) Site configurable IP address 3D Display for 1) Qualitative freehand acquisition OB/GYN supported on all probes 2) Volume display with surface rendering 3) Easy to use 3D editing tools 4) Animation function 3D Display for General 1) Qualitative freehand acquisition Imaging supported on all probes 2) 3D tomographic reconstruction 2) Intended as a general purpose digital 3D ultrasound image processing tool for radiology, urology, obstetrics and gynecology IMT measurement 1) Auto trace or manual trace for IMT analysis 2) Summary report including IMT-Evaluation software On-line option 1) System performance analysis 2) Application support (W.I.P.) 3) Image analysis 4) Downloads for software upgrades Cine Expansion Memory Frame No.: Maximum 12,400, dependent on scanning size Clear Cover

Recommended Peripherals (Options) Video Printer Mitsubishi P-93W Thermal Printer (Black and White) (for 100-120VAC, 200-240VAC) Color Digital Video Mitsubishi CP900DW (USB interface) Printer (for 100-120VAC, 200-240VAC) VCR Mitsubishi HS-MD3000E (Pal in/out, S-VHS) Mitsubishi HS-MD3000U (NTSC in/out, S-VHS) Mitsubishi Remote Controller R-3001 Note: Remote Controller is needed to use HS-MD3000E/U Safety and Regulatory Requirements Electromechanical 1) JIS T0601-1:1999, Japanese Standard for Standards Met Medical Electrical Equipment 2) JIS T0601-1-2:2002, Japanese Standard for Medical Electrical Equipment 3) IEC60601-2-37:2001, European Norm, Safety of Medical Electrical Equipment 4) IEC60601-1-2, European Norm, Collateral Standard: Electromagnetic compatibility Agency Approvals 1) CE Mark 2) Tested TUV Rheinland North America (ctuvus label) 3) Japanese Ministry of Health, Labor and Welfare Operating Conditions Atmospheric Pressure 700 to 1060 hpa Range Ambient Temperature +10 degrees centigrade to +40 degrees centigrade Relative Humidity 30 to 85%, non-condensing Physical Dimensions and Weight Width 500 mm/19.6 inches Depth 800 mm/31.5 inches Height 1350 mm/53.1 inches Weight 140 kg/308 lbs. Electrical Power Requirement 100V-120V/50 Hz and 60 Hz 200V-240V/50 Hz and 60 Hz Power Consumption 550 watts to 1350 watts, depending on peripherals

DIMENSIONS AND WEIGHT unit: mm (inch) Remarks * Every value in this Product Data Sheet is a standard value, and it may vary a little from the actual at each site. * The appearances and specifications are subject to change for reasons of improvement without notice. * Certain configurations may not be available pending regulatory clearance. Contact your Shimadzu representative for information on specific configurations. SHIMADZU CORPORATION. International Marketing Division 3. Kanda-Nishikicho 1-chome, Chiyoda-ku, Tokyo 101-8448, Japan Phone: 81(3)3219-5641 Fax: 81(3)3219-5710 URL http://www.shimadzu.com Shimadzu Corporation Medical Systems Group has been certified by TUV Rheinland as a manufacturer of medical equipment and systems in compliance with ISO9001: 2000 Quality Management Systems and EN ISO13485: 2003 Medical Equipment Quality Management Systems.