Durr Dental VistaScan Nano Easy Installation And Operating Instructions Manual

Durr Dental VistaScan Nano Easy Installation And Operating Instructions Manual

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VistaScan Nano Easy
EN
Installation and operating instructions
2160100227L02


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Summary of Contents for Durr Dental VistaScan Nano Easy

  • Page 1 VistaScan Nano Easy Installation and operating instructions 2160100227L02 ...
  • Page 3: Table Of Contents

    Contents Important information Assembly About this document                3 Requirements                     17 Warnings and symbols           3 Installation/setup room          17 Copyright information            4...
  • Page 4 Contents Troubleshooting 13 Tips for operators and service techni- cians                            35 131 Poor X-ray image              35 132 Software error                 39 133 Fault on the unit               40 Appendix...
  • Page 5: Important Information

    These symbols are used in the document and These operating instructions apply to the follow- on or in the unit: ing VistaScan Nano Easy units: Item number: Note, eg specific instructions regarding efficient and cost-effective use of the unit –...
  • Page 6: Copyright Information

    This way up / store and transport in an infection upright position 2.1 Intended purpose Keep dry VistaScan Nano Easy Stacking limits The unit is intended exclusively for use in dental applications for the scanning and processing of image data on an image plate...
  • Page 7: General Safety Information

    Important information VistaScan Nano Easy Replace any damaged cables or plugs imme- diately This unit is not suitable for monitoring patients over longer periods of time This unit must not be operated in operating theatres or similar Observe the EMC rules concerning medical...
  • Page 8: Essential Performance Character

    2.7 Essential performance charac- Do not expose the unit to any strong vibra- tions or shocks teristics The VistaScan Nano Easy unit does not pos- 2.11 Disposal sess any significant performance characteristics as set out in IEC 60601-1 (EN 60601-1) section An overview of the waste keys for Dürr...
  • Page 9: Product Description

    Product description Overview ba ck VistaScan Nano Easy image plate scanner Cartridge for image plates (S0 up to S2) IQ image plate Light protection cover Plus DBSWIN imaging software DVD VistaSoft imaging software DVD Network cable (3 m) Power supply unit with country-specific adapter...
  • Page 10: Scope Of Delivery

    VistaScan Nano Easy separately: image plate scanner ..2160110013 – VistaScan Nano Easy basic unit Cleaning and disinfection – Power supply unit Image plate cleaning wipes (10 pcs)   –...
  • Page 11: Wear Parts And Replacement

    Product description 3.5 Wear parts and replacement parts Image plates Image plate IQ, size 0 2 x 3 cm (2 pcs)               2130104050 Image plate IQ, size 1 2 x 4 cm (2 pcs)               2130104150 Image plate IQ, size 2 3 x 4 cm (4 pcs)               2130104250...
  • Page 12: Technical Data

    Product description Technical data 4.1 Image plate scanner Electrical data for the unit Rated voltage V DC Max current consumption Max power consumption < 12 Electrical data – power supply unit Nominal input voltage V AC 100 - 240 Frequency 50/60 Nominal output voltage V DC...
  • Page 13 Product description Classification Medical product class Laser class (unit) In accordance with IEC 60825-1:2014 Laser source Laser class In accordance with IEC 60825-1:2014 Wavelength l Output <10 Technical data for the RFID module Frequency 1356 Modulation Max power Electromagnetic compatibility (EMC) Interference emission measurements High-frequency emissions in accordance with CISPR 11 Group 1 Class B...
  • Page 14 Product description Immunity to interference table, near fields of wireless HF communication devices Radio service Frequency band Test level LTE band 13, 17 704 - 787 GSM 800/900 TETRA 800 iDEN 820 800 - 960 CDMA 850 LTE band 5 GSM 1800 CDMA 1900 GSM 1900...
  • Page 15: Image Plate

    Product description Electromagnetic compatibility (EMC) Interference immunity measurements SIP/SOP Immunity to interference, discharge of static electricity IEC 61000-4-2:2008 Compliant ± 8 kV contact ± 2kV, ± 4 kV, ± 8 kV, ± 15 kV air Immunity to interference, rapid transient bursts – I/O, SIP/SOP ports IEC 61000-4-4:2012 Compliant...
  • Page 16: Type Plate

    Dürr Dental herewith declares that the radio and transferred to the imaging software equipment "VistaScan Nano Easy" meets the After scanning, the image plate runs through the requirements of Directive 2014/53/EU erasure unit Image data still held on the image...
  • Page 17: Cartridges (S0-S2)

    Product description Operating elements Cartridge for S2 image plate is in the device Status LED flashing Connections The connections are located on the rear of the unit, underneath the cover 4 3 2 On / off switch Error display yellow Read display blue Green status LED Communication/standby display white...
  • Page 18: Image Plate

    Product description 5.3 Image plate The image plate stores X-ray energy, which is re-emitted in the form of light after excitation via the laser This light is then converted to image information in the image plate scanner The image plate has an active side and an inac- tive side The image plate must always be ex- posed on the active side When used properly, image plates can be ex-...
  • Page 19: Assembly

    Assembly Installation Only qualified specialists or employees trained by Dürr Dental are permitted to 7.1 Setting up the unit install, connect and start using the unit Requirements NOTICE Risk of damage to sensitive compo- 6.1 Installation/setup room nents in the unit as a result of shocks The room chosen for set up must fulfil the fol- or vibrations lowing requirements:...
  • Page 20: Electrical Connections

    Assembly 7.2 Electrical connections Remove the screw covers and screws from the bottom of the device Safety when making electrical connections The device must only be connected to a cor- rectly installed power outlet Do not place non-fixed multi-socket units on the floor Follow the requirements in sec- tion 16 of IEC 60601-1 (EN 60601-1) Do not operate any other systems using the...
  • Page 21: Connecting The Device To The Net

    Assembly Plug in the connecting plug of the power sup- network ply unit into the socket connection of the de- - Removing elements form the IT network vice - "Update" of devices that are connected to the IT network - "Upgrade" of devices that are connected to the IT network –...
  • Page 22: Commissioning

    Assembly Commissioning Connecting the unit via the network cable Remove the cover from the rear of the device Connect the supplied network cable to the NOTICE network connection of the device Short circuit due to the build up of condensation Do not switch on the unit until it has warmed up to room temperature and it is dry...
  • Page 23: Configuring The Unit In Vistasoft

    Assembly 8.2 Configuring the unit in VistaSoft 8.3 Configuring the appliance in DBSWIN Configuration is performed directly in VistaSoft > Select the unit Configuration is carried out using VistaNetCon- fig, which is automatically installed during instal- Mark the connected unit in the list lation of DBSWIN or VistaEasy Select Start >...
  • Page 24 Assembly Entering a fixed IP address (recommended) To reset the network settings, keep the unit reset key pressed for 15 - 20 sec- onds while switching on Deactivate DHCP Enter the IP address, subnet mask and gate- way Click on Apply The configuration is saved Testing the device You can scan in an X-ray image to check that...
  • Page 25: X-Ray Unit Settings

    Assembly 8.4 X-ray unit settings If 60 kV can be set on the X-ray unit, this setting is preferred The standard exposure values for F-speed film (e g Kodak Insight) can be used Intraoral X-ray units for an adult patient The following table shows the standard values for the exposure time and the dose area product of an image plate for an adult patient DC emitter, 7 mA Tube length 20 cm...
  • Page 26: Acceptance Tests

    Assembly DC emitter, 6 mA Tube length 30 cm Without X-ray field X-ray field limitation X-ray field limitation limitation 60 kV mGycm 60 kV mGycm 60 kV mGycm Incisors 010 s 010 s 010 s Premolars 013 s 118 013 s 013 s Molars 016 s 148...
  • Page 27: Usage

    Usage Correct use of image CAUTION plates Image plates are toxic Image plates that are not packed in a light protection cover can lead to poi- WARNING soning when placed in the mouth or Risk of cross contamination when swallowed not using the light protection cover or Only place image plates in the pa- when using the light protection cover...
  • Page 28: Operation

    Usage 10 Operation Do not scratch the image plates Do not sub- ject the image plates to pressure from hard or pointed objects CAUTION The image data on the image plate is not permanent. The image data is altered by light, natu- ral X-ray radiation and scattered X-ray radiation This will lead to a reduction in diagnostic information and clarity...
  • Page 29 Usage Check that the correct cartridge has been in- The green status LED flashes The green serted with the display (S0, S1, S2) cartridge display extinguishes If the incorrect cartridge has been inserted, Insert the appropriate cartridge it must be removed and the correct cartridge inserted Open the cover The green status LED lights up The green...
  • Page 30: 102 X-Ray

    Usage 10.2 X-ray Completely slide the image plate into the light protection cover The black (inactive) side of The procedure is described using a size the image plate must be visible 2 IQ image plate as an example Required accessories: –...
  • Page 31 Usage Taking the X-ray image In the event of heavy soiling, eg from blood, dry clean the light protection cover and pro- NOTICE tective gloves, eg wipe with a clean cellulose Damage to the image plate caused cloth by a sharp-edged holding system Disinfect the light protection cover and protec- Only use holding systems that will not tive gloves with a suitable disinfection wipe;...
  • Page 32: 103 Scanning The Image Data

    Usage 10.3 Scanning the image data faces down; the inactive (back) side of the im- age plate faces the operator Starting the image plate scanner and soft- The image plate must not be pulled out of the ware light protection cover before placement on the input unit There is the risk of image informa- The reading-out process is described us- tion being erased by ambient light (see "9...
  • Page 33: 104 Erasing The Image Plate

    Usage Remove the empty light protection cover Remove the image plate and prepare it for taking a new X-ray Once the image plate has been inserted into the unit, close the cover and leave it closed 10.4 Erasing the image plate throughout the entire scanning process The image data is automatically erased after scanning...
  • Page 34: Cleaning And Disinfection

    Usage 11 Cleaning and disinfection NOTICE Heat damages the cartridges When cleaning and disinfecting the unit and its Do not thermally disinfect or steam accessories, observe country-specific directives, sterilise the cartridges standards and specifications for medical prod- ucts as well as the specific specifications for Remove any soiling from the cartridge with a dental practices and clinics soft, lint-free cloth that has been dampened...
  • Page 35: 114 Storage Box With Image Plate

    Usage Soiling on both sides of the image plate should be cleaned off with a soft, lint-free wipe prior to every use Remove resistant or dried on dirt with the im- age plate cleaning wipe When doing this, ob- serve the instructions for use for the cleaning wipe Allow the image plate to completely dry before using it...
  • Page 36: Maintenance

    Usage 12 Maintenance 12.1 Recommended maintenance schedule Prior to working on the unit or in case of danger, disconnect it from the mains The recommended maintenance intervals are based on using the device for 25 intraoral images per day on 220 working days per year Maintenance Maintenance work interval...
  • Page 37: Troubleshooting

    Troubleshooting 13 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified personnel or our service Prior to working on the unit or in case of danger, disconnect it from the mains 13.1 Poor X-ray image Fault Probable cause...
  • Page 38 Troubleshooting Fault Probable cause Solution X-ray image only shadowy The X-ray dose on the image Increase X-ray dose plate was insufficient Amplification (HV value) is set too Increase amplification (HV value) low in the software Unsuitable scanning mode select- Select a suitable scanning mode Image plate exposed twice Only expose the image plate...
  • Page 39 Troubleshooting Fault Probable cause Solution Shadow on the X-ray im- Image plate removed from the Do not handle image plates light protection cover before without a light protection cover scanning Store the image plate in a light protection cover X-ray image cut off, part The metal part of the X-ray tube When taking an X-ray, make is in front of the X-ray beam...
  • Page 40 Troubleshooting Fault Probable cause Solution X-ray image has strips on Image plate has been pre-ex- If the image plate has been image posed, eg by natural radiation or stored for longer than one week, stray X-ray radiation erase the image plate prior to use Parts of image plate exposed to Do not expose used image...
  • Page 41: 132 Software Error

    Troubleshooting 13.2 Software error Fault Probable cause Solution "Too much ambient light" Unit exposed to too much light Darken the room Turn the unit so that no light can fall directly into the entry slot "Overtemperature" Laser or erasure unit too hot Switch off the unit and allow it to cool "Erasure unit fault"...
  • Page 42: 133 Fault On The Unit

    Troubleshooting 13.3 Fault on the unit Fault Probable cause Solution Unit not shown in the im- Network cable not installed Install the network cable aging software No DHCP server connected It may take some time for the imaging software to detect the unit Update the unit list Network configuration incorrect...
  • Page 43 Troubleshooting Fault Probable cause Solution Network connection has Connecting cable between device Check the connecting cable been disconnected and computer not correctly con- nected The IP address of the device is Check the network settings (IP being used by another unit address and subnet mask) and assign a unique IP address to every device...
  • Page 44: Appendix

    Appendix 14 Scanning times The scanning time corresponds to the time taken for complete scanning of image data and depends on image plate format and pixel size The time to image will depend largely on the computer system used and its work load Times stated are approximate For technical reasons, the surface of the largest size of image plate (size 2) is always scanned As a result, the scan times are the same for all sizes of image plate...
  • Page 45: File Sizes (Uncompressed)

    Appendix 15 File sizes (uncompressed) The actual file size will depend on the image plate format and the pixel size File sizes stated are ap- proximate and have been rounded upwards Suitable compression methods can considerably reduce the file size without loss of data Max.
  • Page 46: Handover Record

    Appendix 16 Handover record This document confirms that a qualified handover of the medical device has taken place and that ap- propriate instructions have been provided for it This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device Product name Order number (REF) Serial number (SN)
  • Page 48 Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...

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