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Gendex VisualiX

TM

eHD

8

User and Service Manual

Doc #4519 986 19041 - April 2005

9

User and Service Manual

Doc #4519 986 19041 - April 2005

3.2

Symbols appearing on the Intermediate
Electronics (IME) Control Unit plate

The symbol CE guarantees the
conformity of the product described
herein to the European Union Direc-
tive 93/42/EEC for Medical Devices.

This symbol guarantees the confor-
mity of the product described herein
to the standard UL 60601-1

Please refer to the written
instructions of this manual.

Class II device
(IEC 601.1 - 1988 and Amendments)

BF type device
(IEC 601.1 - 1988 and Amendments)

DC Current
(IEC 601.1 - 1988 and Amendments)

System serial number and sensor
type reference part number

0051

SN

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Summary of Contents for VisualiX eHD

Page 1: ...VisualiX eHD User and Service Manual Doc 4519 986 19041 April 2005 ...

Page 2: ...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: ...onics IME Control Unit plate 8 Product description 9 4 1 Unpacking the VisualiX system components 10 4 2 System Components 10 System configuration 13 5 1 Personal Computer requirements 13 5 2 Application software 15 5 3 Compatibility with radiographic generators 16 Installation 17 6 1 Installation of ActiveX software driver 20 Use 21 7 1 Acquisition of radiographic images 21 7 2 Status Icon 24 7 3...

Page 4: ...re registered trademarks of Microsoft Corporation This manual in English is the original version 8 9 Maintenance 27 Technical specifications 29 Diagnostics 31 Appendix 33 11 1 Printers 33 11 1 1 Thermal printers 33 11 1 2 Laser and ink jet printers 33 11 1 3 Sublimation printers 33 11 2 Software 34 11 3 Service 34 11 4 Components Code List for VisualiX 34 10 11 ...

Page 5: ...y before starting to use the device paying particular attention to warnings especially safety warnings 1 1 Conventions used in the manual This manual features three graphic styles Normal for information which must be read carefully before using the VisualiX system Detailed notes identified with the symbol Safety warnings identified with the symbol Gendexiscommittedtoongoingtechnicalimprovementofit...

Page 6: ...Gendex VisualiXTM eHD 4 User and Service Manual Doc 4519 986 19041 April 2005 ...

Page 7: ...allation Electrical safety The covers on the device may be removed only by qualified authorised technical personnel The product must be used only in rooms or areas which comply with all laws and regulationsapplicabletoelectricalsafetyinmedicalpremises suchasCEIstandards regarding use of an additional ground terminal for equipotential connections This device must always be disconnected from the pow...

Page 8: ...losion 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: ...tient and comply with the UL IEC EN 60950 standard and EC directive 89 336 In case other parts of the system are non medical devices further considerations should be done in accordance with IEC60601 1 1 under the responsibility of the installation technician Compulsory declaration under European Directive 93 42 regarding Medical Devices In ac cordancewiththerequirementsoftheCEmark theusermustnotif...

Page 10: ...herein to the European Union Direc tive 93 42 EEC for Medical Devices This symbol guarantees the confor mity of the product described herein to the standard UL 60601 1 Please refer to the written instructions of this manual Class II device IEC 601 1 1988 and Amendments BF type device IEC 601 1 1988 and Amendments DC Current IEC 601 1 1988 and Amendments System serial number and sensor type referen...

Page 11: ...ch is percep tible to the sensor Digital X ray images are quickly displayed on the screen Images can be optimized for viewing via imaging software stored as image files and printed out on a suitable printer if desired VixWin is one example of a dedicated software that employs a number of utilities for optimizing viewing and printing of images VisualiXmustbeconnectedtoaPCrunningonaMicrosoft Windows...

Page 12: ... components to the shipping company and any missing components to your dealer within 24 hours of receiving the shipment 4 2 System Components 1 X ray image sensor consisting of a special CCD sensor specifically constructed for use in radiography enclosed in a hermetically sealed ergonomic capsule the sensitive surface of which is covered by a thin layer of a scintillator through which X ray radiat...

Page 13: ...he 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: ... Electronics unit with a computer a b 6 Accessories a b IME wall mounting assembly Sensor wall mounting assembly 7 Software Pack a 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 contai...

Page 15: ... GB Display Setting 800x600 1024x768 at 32 bit true color Video memory 2 MB 8 MB Monitor S VGA with 0 28mm dot pitch S VGA with 0 25mm 0 26mm dot pitch Ports USB1 USB 2 0 Standards In compliance with the UL IEC EN 60950 standard In compliance with the UL IEC EN 60950 standard USB in compliance with the USB 1 1 USB2 standards In case of non conformity an add on USB port or an external active HUB ma...

Page 16: ...justed the contrast and brightness correctly Hard disk The choice of hard disk capacity depends on the number and size of images to be stored Intra oral images vary in size from 4 7 Mb uncompressed TIFF images with a type 2 sensor to 100 Kb JPEG JFIF with 50 compression A 20Gbharddiskisnormallycapableofsatisfyingtherequirementsoftheaverage user To guarantee data security however it is preferable t...

Page 17: ...dex Orthoralix 9200 DDE or colour images captured with an intra oral or extra oral video camera e g Gendex AcuCam IVFWT VixWinprovidesfunctionsforstorageofimagefilesonpermanentmemorydevices such as hard disks floppy disks and recordable cd roms whether local or shared with other workstations over a Local Area Network LAN The program complies with Microsoft Windows graphic interface standards Comma...

Page 18: ...ler exposure times than films thanks to the high sensitivity of the CCD This is why direct current X ray generators are recom mended DC high frequency or average frequency with electronic converter 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...

Page 19: ... 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 6 USB Port USB Cable IME ...

Page 20: ... information on installation of software programmes please refer to the soft ware manual supplied with the software installed Indicator status Colour IME status None Off or initialising Green Ready for image acquisition Red System is not functioning properly off on IME Intermediate Electronics may be installed externally to the PC wall mounted or on the dental assembly TheIntermediateElectronicsun...

Page 21: ...Gendex VisualiXTM eHD 19 User and Service Manual Doc 4519 986 19041 April 2005 Wall installation scheme Insertion IME on wall support Correct Not correct ...

Page 22: ...heVisualiX system containing the USB driversintheCD ROMdriveandfollowtheWindows GuidedInstallation instructions provided If nothing happens after 10 seconds then this means that the CD Rom auto run has been disabled in the computer it is necessary to manually launch the Setup file that can be found in the main directory of the ActiveX Driver CD ROM When you have completed the installation procedur...

Page 23: ...d 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 7 ...

Page 24: ...ng the source of the radia tion 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 A positioning device is supplied with the VisualiX system Green E...

Page 25: ...rallel to the tooth It may be best to position the sensor by hand in the small mouths of children Note however that image quality might be inferior with respect to the one attained using an aiming device 4 Position the X ray generator as usual for X ray film Use of the parallel technique is highly recommended with a rectangular cone if pos sible Correct Not correct 5 Acquire the image by pressing ...

Page 26: ...e VisualiX is not fully operational IME icon Indicates that one IME is acquiring information from the computer or is being updated HOURGLASS icon One IME is busy with transfer operations If no status icon appears CHECK THAT YOU HAVE INSTALLED THE SOFTWARE DRIVER CORRECTLY VisualiX cannot operate without the driver Click on the status icon to access a configuration panel containing information on t...

Page 27: ...ry cover for every different sensor usage and between different patients to prevent risk of cross infection Store disposable sanitary covers in a clean dry place not exposed to sunlight or UV rays Make sure that used sanitary covers are disposed of as infected waste which is potentially biologically hazardous Disinfect the image sensor whenever there is a risk of contamination Please follow the st...

Page 28: ...is Gluteraldehyde 2 2 2 6 Inert components 97 4 97 8 DO NOT Sterilize the sensor using an autoclave or a UV oven Immerse the sensor in bleach or alcohol solutions Clean the sensor using non appropriate tools The positioning device supplied with the VisualiX system may be sterilised in an auto clave standard method distilled water 134 C 3 bar 4 minutes or using cold chemical disinfectants refer to ...

Page 29: ...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 Be sure to use a video mode recom mended for use with VisualiX DonotsubjecttheX rayimagesensor IMEIntermediateElectronicsunitandcon nectorstostrongelectrostaticchargessuchasthosegeneratedonthesurfacesof the cathode tubes used in some...

Page 30: ...Gendex VisualiXTM eHD 28 User and Service Manual Doc 4519 986 19041 April 2005 ...

Page 31: ...it enhancement 8 16 bit applicat Maximum grey levels 4096 4096 8 bit image file size a 1 590 Kb 2 358 Kb 16 bit image file size b 3 180 Kb 4 715 Kb Saturation dose 250 μGy 20 250 μGy 20 PC Interface USB 1 1 and USB2 compliant USB Power Supply 5V DC max 500 mA IME Dimensions 150 x 85 x 40 cm System Weight 300 gr IME and sensor Sensor Cable Length 3 m USB Cable Length 4 5 m and 2 m supplied correspo...

Page 32: ...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 Storage and transportation environmental conditions eHD Universal Size eHD Large Area Temperature 20 to 70 C 20 to 70 C Relative Humidity 20 to 95 20 to 9...

Page 33: ...ea is aligned with the X ray beam c Make sure that the Intermediate Electronics unit is ready to acquire images green led on d If the Intermediate Electronics unit is installed at a distance check that its cable is properly connected to the USB port of the Personal Computer e Make sure that only one software program for capturing X ray images with VisualiX is running f Check that the sensor has no...

Page 34: ...Gendex VisualiXTM eHD 32 User and Service Manual Doc 4519 986 19041 April 2005 ...

Page 35: ...inters Thermal printers print in shades of grey with at least 64 levels Thermal printers use a special type of paper which guarantees a print life of about 3 years 11 1 2 Laser and ink jet printers May be used to print in colour or black and white We recommend a resolution of at least 600 dpi with pseudo random dithering Use of standard Microsoft Windows printer driverswillpermituseofthesameprinte...

Page 36: ... this tab the user can also see the last obtained image By pressing the NoXrayGrab button a sample image should be generated when the IME works properly Note that no exposure to X rays is necessary for the creation of this image 11 4 Components Code List forVisualiX Description Code 1 VisualiX eHD IME and X ray image sensor Universal size 4519 105 03601 2 VisualiX eHD IME and X ray image sensor La...

Page 37: ...Gendex VisualiXTM eHD 35 User and Service Manual Doc 4519 986 19041 April 2005 ...

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