(restyle 2011) Anatomic programs

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1 Product Data Panoramic X-Ray System with CCD sensor (restyle 2011) Examination programs Panoramic - adult - child - child with deceleration ramp for spine compensation TMJ - open/close mouth (4 views on the same image: left/right, open/close) Sinus Studies Anatomic programs Patient type Patient size 2 choices: adult, child 3 choices: small, medium, large Image Magnification Panoramic 1:1.2 average as geometric magnification (1:1 magnification after software correction) Open/close mouth TMJ 1:1.2 average as geometric magnification (1:1 magnification after software correction) Note: The declared image magnification value for digital images depends on the calibration of the specific SW used and is therefore valid after proper software calibration. Generator Automatic line voltage compensation High voltage: 60 85kV p step 5kV Current: 10mA Exposure times: 17 s panoramic adult 14 s panoramic child 10.4 s TMJ adult 9.4 s TMJ child X-ray tube Focal Spot size: Heat storage capacity: Total filtration: Duty cycle: 0.5 (IEC336) 30kJ (40kHU) 2.5mm Al eq. 1 exposure every 4 minutes User Interface Hand-held keyboard with LED display with extensible cable Each operation is guided by messages shown on the display The user can choose one of five available languages: English, Italian, French, Spanish, German Product data Rotograph-D (restyle 2011) Rev. 3 Page 1 of 5

2 Patient positioning Through 2 laser references (mid-sagittal plane; Frankfurt plane) Allows access to patients on wheelchairs Digital Acquisition System CCD Sensor Technology: CCD sensor with Cesium Iodide (CsI) scintillator screen Pixel size: 48 µm (96 µm in binning modality) Image matrix: 1536 x 2805 pixels in binning modality (standard panoramic) Sensor resolution: 10.4 lp/mm maximum theoretical 5.2 lp/mm with CTF 60% real (in binning modality) Gray levels: 4096 (12 bits) in acquisition (A/D converter) 256 (8 bits) in viewing Image Acquisition Rotograph-D allows to acquire digital images in two different modalities: 1. Direct acquisition through a USB 2.0 connection: the images and the exposure parameters are transferred from Rotograph-D to the PC via a high speed USB 2.0 connection (480 Mb/s). The images are seen forming on-screen in real time during the exposure. 2. Acquisition on memory card Compact Flash (XSDi extended Storage for Dental images) Rotograph-D is equipped with a slot for memory cards Compact Flash type I with 16MB to 1GB capacity, where the images and the exposure parameters can be stored also without a direct connection to a PC. The typical capacity of a 128MB memory card is 7 images. Images stored on the card can be transferred to any PC at any time after the acquisition using an appropriate cardreader by the QuickVision software. Use of fast Compact Flash cards is recommended. Images are stored on the cards in a proprietary format that must be read using the QuickVision software. The system automatically recognizes where the image can be stored: - On PC when Rotograph-D is connected to a PC via USB 2.0 connection - On Compact Flash when the card is in the slot and there is no USB connection - On both PC and card when a card is in the slot and USB connection is available The exposure is inhibited when there is no USB connection and no card in the slot. Product data Rotograph-D (restyle 2011) Rev. 3 Page 2 of 5

3 QuickVision Software Rotograph-D is supplied with the QuickVision software for image acquisition, storage and processing. The QuickVision software is available in 9 languages (English, Italian, French, German, Spanish, Portuguese, Russian, Polish and Chinese) with the following functions: Patient and Image Archive Various archives are created including the main patients data and the exams for each patient. Image processing The QuickVision software allows to employ the following functions: - Image contrast adjustment - Image brightness adjustment - Gamma factor adjustment - Filter for edge enhancement, with possibility to adjust the filter level - Gray scale equalization to improve the image definition - Hi contrast - Embossed view - 3-D view - Image rotation (90 and 180 ) - Image horizontal inversion - Pseudo-colors - Gray scale inversion (Negative/Positive) - Magnification (up to X32) - Distance measurement - Drawing and annotation - Image hardcopy. Images can be printed on any Windows compatible printer (image quality may differ according to the printer model). Dicom Connectivity (option) - If the system is equipped with the optional QuickPrint Dicom Gateway package for QuickVision, images can be printed on any Dicom 3 printer. Images are printed with the following parameters: - Name of the practice/hospital - Patient data - Exposure parameters - Examination date - If equipped with the optional Dental Studio SW with related Dicom package, the system guarantees a full connectivity with PACS networks. It includes: - PRINT class (for printing on Dicom 3 imagers); - STORE class (for image transfer to PACS networks); - WORKLIST class (for automatic retrieval of patients list from RIS/HIS) Twain Driver Offered as standard, it allows other imaging programs to import images acquired with Rotograph-D. Image Import/export The software permits import/export of images in jpeg and tiff format. Image Scan The software also allows for the storage of images scanned with a compliant scanner. Product data Rotograph-D (restyle 2011) Rev. 3 Page 3 of 5

4 Minimum Requirements for the PC Hardware CPU: Intel Pentium 4 with Intel Chipset RAM: 256 MB or more Operating system: Windows XP with Service Pack 2, Windows Vista 32 bit, Windows 7 32 bit Windows 7 64 bit Video: 1024x768, 16 Million colors or more USB port: compatible with USB 2.0 specification Compact Flash cards: Rotograph-D is compatible with Compact Flash Type I cards from 16MB to 1GB. No dedicated PC board is required. Standard Accessories Byte stick support Chin rest Hand-held keyboard with LED display with extensible cable 5 bites with sticks Mechanical characteristics Source to image distance Vertical column movement Weight: Operating surface: Type of installation Electrical characteristics Power supply voltage: Frequency: Current rating: Power rating: 500 mm 834 mm (32.8 ), manual balanced 236kg (520 lb) 1170x1140mm wall mount or floor mount. Choice at order 120/220/230/240 Vac (±10%) single phase (specify at order) 50 Hz 5 A 1.15 kva Environmental characteristics Operative temperature range: +10 C +40 C (50 F 104 F) Operative relative humidity: 30% 75% Standards and Regulations 0051 CE symbol grants the product compliance to the European Directive for Medical Devices 93/42/EEC and its revised versions as a class IIB device (Only for 220/230/240 V versions) c-etl-us approval means that the product meets the requirements of the applicable US and Canadian standards FDA approval grants the product compliance to US Code of Federal Regulation title 21 subchapter j Health Canada Licence grants the product compliance to the Canadian Medical Device Regulations SOR/ Product data Rotograph-D (restyle 2011) Rev. 3 Page 4 of 5

5 Dimensions (indicated in mm) 406 (16") 897 (35.3") 1256 (50") 1240 (45") (37.7" 70.5") 2378 (93.6") 774 (30.5") 1170 (46") Note: Products are continuously under review in the light of technical advancement. The actual specification may therefore be subject to improvement or modification without notice. VILLA SISTEMI MEDICALI s.p.a BUCCINASCO (MI) ITALY Via delle Azalee, 3 Tel , Fax Company with Quality System certified by ISO 9001:2008 I S O : Product data Rotograph-D (restyle 2011) Rev. 3 Page 5 of 5