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VisualiX® eHD
User and Service Manual
Doc# 4519 986 19041 - April 2005

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Summary of Contents for Gendex VisualiX eHD

  • Page 1 VisualiX® eHD User and Service Manual Doc# 4519 986 19041 - April 2005...
  • Page 2 No part of this publication may be reproduced, transmitted, transcribed or translated into any spoken or computer language without prior written consent from Gendex Dental Systems. The content of this manual is subject to modification without prior notification.
  • Page 3: Table Of Contents

    Gendex VisualiX Table of contents Introduction 1.1 Conventions used in the manual.................... 3 Safety procedures Standards and regulations 3.1 Compliance with regulations ....................7 3.2 Symbols appearing on the Intermediate Electronics (IME) Control Unit plate..8 Product description 4.1 Unpacking the VisualiX system components..............10 4.2 System Components.........................10...
  • Page 4 11.2 Software ............................34 11.3 Service............................34 11.4 Components Code List for VisualiX..................34 VisualiX and VixWin are Trademarks of Gendex Corporation. Microsoft® and Windows® are registered trademarks of Microsoft® Corporation. This manual in English is the original version. User and Service Manual...
  • Page 5: Introduction

    Detailed notes, identified with the symbol Safety warnings, identified with the symbol Gendex is committed to ongoing technical improvement of its products. The information and figures contained in this User and Service Manual are subject to change without prior notification.
  • Page 6 Gendex VisualiX User and Service Manual Doc #4519 986 19041 - April 2005...
  • Page 7: Safety Procedures

    Modifications and/or additions to the device must be made exclusively by Gendex personnel or by parties expressly authorized for the purpose by Gendex. Any modifica- tions or additions must always comply with standards and generally recognised rules of good workmanship.
  • Page 8 Gendex VisualiX Explosion safety: This device is not recommended for use in the presence of flammable gases or va- pours. Some disinfectants evaporate and form explosive or flammable mixtures. If disinfectants of this kind are used, it is important to let the vapours disperse before using the device again.
  • Page 9: Standards And Regulations

    Standards and regulations Compliance with regulations The VisualiX system complies with the European Community Directive 93/42/EEC re- garding medical devices and with the following standards: • IEC 601.1 (1988), Amendment Nr. 1 (1991), Amendment Nr. 2 (1995) • IEC 601.1.1 (2000) •...
  • Page 10: Symbols Appearing On The Intermediate Electronics (Ime) Control Unit Plate

    Gendex VisualiX Symbols appearing on the Intermediate Electronics (IME) Control Unit plate The symbol CE guarantees the conformity of the product described 0051 herein to the European Union Direc- tive 93/42/EEC for Medical Devices. This symbol guarantees the confor- mity of the product described herein...
  • Page 11: Product Description

    Product description VisualiX is a direct (filmless) digital X-ray imaging system, conceived specifically for dental radiography in the oral cavity. The system captures X-ray images and makes them available for display on a Personal Computer (PC) screen. An X-ray image sensor (CCD) is positioned in the patient’s mouth just like intra-oral film. The sensor may be inserted in a special positioning device to facilitate positioning and alignment with the X-ray beam.
  • Page 12: Unpacking The Visualix System Components

    Gendex VisualiX Unpacking the VisualiX system components The Visualix system is carefully inspected and packaged prior to shipment. If the Visualix system was shipped to you, please remove the contents of the shipping container and be sure to identify and directly locate each of the system components shown below.
  • Page 13 Gendex VisualiX 2) Intermediate Electronics unit (IME) providing: • power for the sensor • timing and synchronisation of sensor signals • signal pre-amplification • analogue/digital signal conversion • USB port interface Indicator status (led) Sensor cable USB Port 3) RINN intra-oral positioning device Specifically designed to support the sensor and align it with the X-ray beam and with the teeth of the upper and lower jaws.
  • Page 14 VixWin Software (not in all system configurations; its use is optional) containing: VixWin installation CD-Rom and utilities, User’s Manual in 5 languages (also refer to section 5.2). VisualiX eHD does not require the use of VixWin soft- ware. b. ActiveX Driver Disk: CD-Rom containing the software driver for the IME...
  • Page 15: System Configuration

    System configuration Personal Computer requirements Minimum System Requirements Recommended Operating Microsoft Windows 98SE Microsoft Windows XP-PRO System Processor Pentium II - 300 MHz Pentium 4 - 1 GHz or higher Memory 128 MB 512 MB Hard Disk 20 GB 60+ GB Display Setting 800x600 1024x768 at 32 bit...
  • Page 16 Gendex VisualiX Video board: Good viewing of the radiography image requires a video mode of at least 800x600 pixels x 16 million colours, corresponding to a scale of 256 shades of grey. This requires a S-VGA video board with at least 2 MB RAM, requiring instal- lation and use of video software drivers supplied with the video board installed or supplied by Microsoft ®...
  • Page 17: Application Software

    (panoramic and other types) acquired with a backlit scanner, phosphorous plates acquired using Gendex DenOptix, digital Panoramic or Cephalometric images using Gendex Orthoralix 9200 DDE or colour images captured with an intra-oral or extra-oral video camera (e.g. Gendex AcuCam IV...
  • Page 18: Compatibility With Radiographic Generators

    These generators can normally provide stabilised tube voltage (kV) and reproducible exposure doses even with very short exposure times. Gendex is committed to the reduction of the exposure dose in order to safeguard both the patients and the practice personnel. VisualiX eHD has been designed with the objective of providing optimum quality images at low doses.
  • Page 19: Installation

    Installation VisualiX is normally connected up with a Personal Computer (PC) by a professional system integrator or a software house. We advise against non-professional installation and configuration of VisualiX. The PC’s power supply must be a mains socket with an earth contact. USB Port USB Cable User and Service Manual...
  • Page 20 Gendex VisualiX VisualiX is supplied with two USB cables, 2 m and 4.5 m long. The USB cables have different connectors at each end. The Type A connector is The Type B connector is connected to the PC connected to the IME The VisualiX system may be connected and disconnected while the computer is on, unless the PC presents particular limitations.
  • Page 21 Gendex VisualiX Wall installation scheme: Insertion IME on wall support Correct Not correct User and Service Manual Doc #4519 986 19041 - April 2005...
  • Page 22: Installation Of Activex Software Driver

    Gendex VisualiX Installation of ActiveX software driver Before connecting the USB cable, carefully follow the procedure described below. 1) Install the diagnostic imaging software (such as VixWin) in the Personal Computer following the installation and configuration procedures contained in the software Operator Manual.
  • Page 23: Use

    Acquisition of radiographic images Turn on the PC on which the VisualiX is installed and launch the application software, such as VixWin (please refer to the Software Manual for information on the software program). 1) Set the required technical settings (exposure time, etc.) on the X-ray generator. 2) Apply a new disposable cover to the image sensor, making sure that it covers the portion of the cable which may come into contact with the patient.
  • Page 24 The extent of the sensitive area is delineated by the white dotted line and the border of the “Gendex Imaging” logo on the front side of the sensor. Use of a sensor positioning device is recommended to guarantee that the sensor is positioned at right angles to the radiation beam and parallel to the tooth.
  • Page 25 Gendex VisualiX The sensor may alternatively be positioned by hand, held in place by the patient with one finger just like conventional X-ray film. If the positioning device is not used, a wad of cotton wool may be useful for aligning the sensor parallel to the tooth. It may be best to position the sensor by hand in the small mouths of children.
  • Page 26: Status Icon

    Gendex VisualiX Status Icon In the Windows® System Tray (portion of the “application bar” next to the “system clock”, available in all releases of Microsoft® Windows® operating systems) an ICON appears representing the status of the IME Electronics unit and the sensor. Each icon identifies a different status, as listed below.
  • Page 27: Portability

    Gendex VisualiX Portability VisualiX can be easily moved from one dental chair to another. The Intermediate Elec- tronics, once disconnected from the USB port of the computer, may be positioned near a second dental chair and connected to the USB port present nearby (also refer to section 6).
  • Page 28 Gendex VisualiX Recommended disinfecting solutions: As a standard recommendation do not use aggressive products as they may damage the sensor. You can use the “CIDEX. ” disinfecting solution whose composition is: · Gluteraldehyde 2.2-2.6 % · Inert components 97.4-97.8 % DO NOT: ·...
  • Page 29: Maintenance

    Maintenance VisualiX does not require any special maintenance other than regular cleaning and disinfection. The Intermediate Electronics unit (IME) may be cleaned with a soft cloth and a non- abrasive water-based detergent. Clean the monitor screen, mouse and keyboard frequently. Set monitor brightness and contrast properly.
  • Page 30 Gendex VisualiX User and Service Manual Doc #4519 986 19041 - April 2005...
  • Page 31: Technical Specifications

    Technical specifications Available Sensors: eHD Universal Size eHD Large Area Overall dimensions (mm) 37.5 x 25.5 x 7 40.5 x 33 x 7 Active surface (mm) 31 x 20 34 x 27 Pixel size 19.5 x 19.5 µm 19.5 x 19.5 µm Image matrix (pixels) 1590 x 1024 1744 x 1384...
  • Page 32 500 to 1060 hPa 500 to 1060 hPa The Visualix eHD device complies with the standard IEC/EN60601-1-2 (2001). It is therefore suitable for use in an appropriate electromagnetic environment where interference from other devices are below the limit of the said standard.
  • Page 33: Diagnostics

    Diagnostics This section supplies information on some simple tests which the user may perform in the event of malfunctioning. Refer to the PC manual and the software manual for information on other types of malfunctions. The system does not acquire X-ray images: a) Make sure that X-rays have been emitted.
  • Page 34 Gendex VisualiX User and Service Manual Doc #4519 986 19041 - April 2005...
  • Page 35: Appendix

    Appendix 11.1 Printers As VisualiX may be interfaced with a variety of software programs and printer technol- ogy is evolving constantly, a definitive choice of printer cannot be made, but we can provide a series of technical considerations to be taken into account in the choice of a printer.
  • Page 36: Software

    11.4 Components Code List for VisualiX Description Code VisualiX eHD IME and X-ray image sensor (Universal size) 4519 105 03601 VisualiX eHD IME and X-ray image sensor (Large area) 4519 105 03611 Intraoral aiming device...
  • Page 37 Gendex VisualiX User and Service Manual Doc #4519 986 19041 - April 2005...

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