VistaScan Nano Easy EN 2160100227L02 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 1 2001V008 Installation and operating instructions 14.01.
160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 2 14.01.
Contents Important information Assembly 1 About this document . . . . . . . . . . . . . . . 3 1.1 Warnings and symbols . . . . . . . . . . 3 1.2 Copyright information . . . . . . . . . . . 4 6 2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.1 Intended purpose . . . . . . . . . . . . . . 4 2.2 Intended use . . . . . . . . . . . . . . . . . . 4 2.3 Improper use . . . . . . . . . . . . . . . . . 4 2.4 General safety information . . . . . . . . 5 2.5 Specialist personnel . . . . . . . .
Contents 13.1 Poor X-ray image . . . . . . . . . . . . . 35 13.2 Software error . . . . . . . . . . . . . . . . 39 13.3 Fault on the unit . . . . . . . . . . . . . . 40 EN Appendix 14 Scanning times. . . . . . . . . . . . . . . . . . . 42 15 File sizes (uncompressed) . . . . . . . . . . 43 16 Handover record . . . . . . . . . . . . . . . . . 44 2 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 2 2160100227L02 2001V008 14.01.
Important information 1 About this document These installation and operating instructions represent part of the unit. If the instructions and information in these installation and operating instructions are not followed, Dürr Dental will not be able to offer any warranty or assume any liability for the safe operation and the safe functioning of the unit. The German version of the installation and operating instructions is the original manual. All other languages are translation of the original manual.
Important information Non-ionizing electromagnetic radiation Warning – dangerous high voltage Warning - laser beam EN This way up / store and transport in an upright position Keep dry Stacking limits n xx % Lower and upper humidity limits 2 Safety Dürr Dental has designed and constructed this unit so that when used properly and for the intended purpose it does not pose any danger to people or property.
Important information 2.3 Intended use 2.5 General safety information VistaScan Nano Easy The unit may only be operated using accessories and optional articles manufactured by or branded with Dürr Dental. The unit may only be cleaned using the disinfectants and cleaning agents approved by and specified by the manufacturer. i Always comply with the specifications of all guidelines, laws, and other rules and regulations applicable at the site of operation for the operation of this unit.
Important information 2.7 Electrical safety i Comply with all the relevant electrical safety regulations when working on the unit. i Never touch the patient and unshielded plug connections or metallic parts of the device at the same time. i Replace any damaged cables or plugs immediately. Observe the EMC rules concerning medical devices i The unit is intended for use in professional healthcare facilities (in accordance with IEC 60601-1-2).
Important information i Consult the dealer or an experienced radio/TV technician for help. 2.9 Essential performance characteristics The VistaScan Nano Easy unit does not possess any significant performance characteristics as set out in IEC 60601-1 (EN 60601-1) section 4.3. The unit complies with the requirements according to IEC 60601-1-2:2014. EN 2.
Important information Dürr Dental accepts no liability for damages or injury resulting from the use of non-approved accessories or optional accessories, or from the use of non-original wear parts or replacement parts. The use of non-approved accessories, optional accessories or non-genuine wear parts / replacement parts (e.g. mains cable) can have a negative effect in terms of electrical safety and EMC. EN 2.12 Transport The original packaging provides optimum protection for the unit during transport.
Product description Overview 1 2 2bacIQ k *+E24721301042100/$+01234567F* 3 EN 3 4 6 5 7 8 1 2 3 4 5 6 7 8 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 2160100227L02 2001V008 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 9 9 14.01.
Product description 3.1 Scope of delivery The following items are included in the scope of delivery (possible variations due to country-specific requirements and/or import regulations): VistaScan Nano Easy image plate scanner . . . . . . . . . . 2160110001 EN VistaScan Nano Easy image plate scanner . . . . . . . . . . 2160110005 VistaScan Nano Easy image plate scanner . . . . . . . . . . 2160110011 VistaScan Nano Easy image plate scanner . . . . . . . . . .
Product description 3.5 Wear parts and replacement parts Image plates Image plate IQ, size 0 2 x 3 cm (2 pcs.) . . . . . . . . . . . . . . Image plate IQ, size 1 2 x 4 cm (2 pcs.) . . . . . . . . . . . . . . Image plate IQ, size 2 3 x 4 cm (4 pcs.) . . . . . . . . . . . . . . Image plate IQ, size 2 3 x 4 cm (12 pcs.) . . . . . . . . . . . . . 2130104050 EN 2130104150 2130104250 2130104255 Cartridges Cartridge for image plate S0 . . . . . 2160100246 Cartridge for image plate S1 . . . . .
Product description 4 Technical data 4.1 Image plate scanner EN Electrical data for the unit Rated voltage Max. current consumption Max. power consumption V DC A W 24 0.5 < 12 Electrical data – power supply unit Nominal input voltage Frequency Nominal output voltage Max. output current V AC Hz V DC A 100 - 240 50/60 24 0.5 mm 167 x 231 x 216 6.57 x 9.09 x 8.50 approx. 4 approx. 8.82 100 General technical data Dimensions (W x H x D) in Weight kg lb Duty cycle Max.
Product description Classification Medical product class Laser class (unit) In accordance with IEC 60825-1:2014 1 Laser source Laser class In accordance with IEC 60825-1:2014 Wavelength O Output 3B 635 <10 Technical data for the RFID module Frequency Modulation Max.
Product description EN Immunity to interference table, near fields of wireless HF communication devices Radio service Frequency band Test level MHz V/m LTE band 13, 17 704 - 787 9 GSM 800/900 TETRA 800 iDEN 820 800 - 960 28 CDMA 850 LTE band 5 GSM 1800 CDMA 1900 GSM 1900 1700 - 1990 28 DECT LTE band 1, 3, 4, 25 UMTS Bluetooth WLAN 802.11 b/g/n 2400 - 2570 28 RFID 2450 LTE band 7 WLAN 802.
Product description Electromagnetic compatibility (EMC) Interference immunity measurements SIP/SOP Immunity to interference, discharge of static electricity IEC 61000-4-2:2008 ± 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 ± 1 kV 100 kHz repetition frequency Immunity to interference, line-conducted disturbances induced by high-frequency fields – SIP/SOP ports IEC 61000-4-6:2013 3V 0.
Product description 4.4 Type plate 5 The type plate is located on the rear of the device. Operation 5.1 Image plate scanner 2 EN 3 1 4 REF Order number SN Serial number 4.5 Evaluation of conformity This device has been subjected to conformity acceptance testing in accordance with the current relevant European Union guidelines. This equipment conforms to all relevant requirements.
Product description Operating elements S2 Cartridge for S2 image plate is in the device Status LED flashing 8 7 6 1 5 4 3 2 1 2 3 4 5 6 7 8 On / off switch Error display yellow Read display blue Green status LED Communication/standby display white Display for cartridge S2 Display for cartridge S1 Display for cartridge S0 The status LEDs display the following status messages: Connections The connections are located on the rear of the unit, underneath the cover.
Product description 5.3 Image plate EN 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 inactive side. The image plate must always be exposed on the active side. When used properly, image plates can be exposed, read and erased several hundred times provided there is no mechanical damage.
Assembly Only qualified specialists or employees trained by Dürr Dental are permitted to install, connect and start using the unit. 6 Requirements 6.1 Installation/setup room The room chosen for set up must fulfil the following requirements: – Closed, dry, well-ventilated room – It should not be a room made for another purpose (e.g. boiler room or wet cell). – Max. light intensity 1000 Lux, no direct sunlight at the place of installation of the unit – There should be no large fields of interference (e.g.
Assembly 7.2 Electrical connections Safety when making electrical connections i The device must only be connected to a correctly installed power outlet. EN i Remove the screw covers and screws from the bottom of the device. i Do not place non-fixed multi-socket units on the floor. Follow the requirements in section 16 of IEC 60601-1 (EN 60601-1). i Do not operate any other systems using the same multiple socket.
Assembly i Plug in the connecting plug of the power supply unit into the socket connection of the device. network - Removing elements form the IT network - "Update" of devices that are connected to the IT network - "Upgrade" of devices that are connected to the IT network i Plug the mains plug into the power outlet. i Refit the cover. The cover on the rear must be properly intalled when the device is operated within the patient environment. 7.
Assembly i Connect the supplied network cable to the network connection of the device. 8 Commissioning NOTICE Short circuit due to the build up of condensation i Do not switch on the unit until it has warmed up to room temperature and it is dry. EN The unit supports the following imaging programs: – VistaSoft from Dürr Dental – DBSWIN from Dürr Dental – Third-party software on request The cover on the rear must be properly installed when the device is operated within the patient environment.
Assembly 8.2 Configuring the unit in VistaSoft Configuration is performed directly in VistaSoft. i > Select the unit. i Mark the connected unit in the list. 8.3 Configuring the appliance in DBSWIN Configuration is carried out using VistaNetConfig, which is automatically installed during installation of DBSWIN or VistaEasy. i Select Start > All Programs > Dürr Dental > VistaConfig > VistaNetConfig. EN i Click on Edit connection settings.
Assembly Entering a fixed IP address (recommended) To reset the network settings, keep the unit reset key pressed for 15 - 20 seconds while switching on. EN i Deactivate DHCP. i Enter the IP address, subnet mask and gateway. i Click on Apply. The configuration is saved. Testing the device You can scan in an X-ray image to check that the unit is properly connected. i Select the Test tab. i i i i i Select the unit from the Registered Units list. Select the mode class. Select the mode. Click on Scan Image.
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.
Assembly DC emitter, 6 mA Tube length 30 cm Without X-ray field limitation EN Incisors Premolars Molars Bite wing X-ray field limitation 2x3 X-ray field limitation 3x4 60 kV mGycm2 60 kV mGycm2 60 kV mGycm2 0.10 s 0.13 s 0.16 s 0.16 s 9.1 11.8 14.8 14.8 0.10 s 0.13 s 0.16 s 0.16 s 1.9 2.5 3.1 3.1 0.10 s 0.13 s 0.16 s 0.16 s 3.8 5.0 6.2 6.2 i Check and adjust the specific X-ray unit in accordance with the standard values. 8.5 Acceptance tests The required tests (e.g.
Usage 9 Correct use of image plates WARNING Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once i Do not use an image plate without a light protection cover. i Do not use the light protection cover more than once (disposable item). CAUTION The image data on the image plate is not permanent. The image data is altered by light, natural X-ray radiation and scattered X-ray radiation.
Usage i Do not scratch the image plates. Do not subject the image plates to pressure from hard or pointed objects. EN i Do not soil the image plates. i Protect the image plates against sunlight and ultraviolet light. Store image plates in a light protection cover or intraoral/extraoral foil cassette of the correct size. i Image plates will be pre-exposed on exposure to natural radiation and stray x-ray radiation. Protect erased and exposed image plates from X-ray interference.
Usage i Check that the correct cartridge has been inserted with the display (S0, S1, S2). If the incorrect cartridge has been inserted, it must be removed and the correct cartridge inserted. The green status LED flashes. The green cartridge display extinguishes. i Insert the appropriate cartridge. EN i Open the cover. The green status LED lights up. The green display for the corresponding cartridge lights up. The input unit is ready. i Remove cartridge.
Usage 10.2 X-ray The procedure is described using a size 2 IQ image plate as an example. i Completely slide the image plate into the light protection cover. The black (inactive) side of the image plate must be visible. WARNING Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once i Do not use an image plate without a light protection cover. i Do not use the light protection cover more than once (disposable item).
Usage i Place the image plate in the light protection cover into the patient's mouth. When doing this, make sure that the active side of the image plate points towards the X-ray tube. *+E247 213010 42100/ $+0123 4567F* IQ 2back EN ck Wear protective gloves. *+E24721301042100/$+01234567F* NOTICE Damage to the image plate caused by a sharp-edged holding system i Only use holding systems that will not damage the light protection cover or the image plates in any way.
Usage i Tear off the light protection cover. Scanning the image plate To avoid the mix up of X-ray images, only scan the X-ray images from the selected patient. i Open the cover. back 2 IQ *+E247 213010 42100/$ +01234 567F* ck 42100/$ +01234 567F* 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 32 213010 32 *+E247 i Press the on / off switch to switch on the device. i Switch on the computer and monitor. i Start VistaSoft. i Select the patient.
Usage i Slide the image plate out of the light protection cover downwards into the unit. The image plate must be inserted fully into the input unit. i Once the image plate has been inserted into the unit, close the cover and leave it closed throughout the entire scanning process. EN k 30104210 0/$+0123 2bacIQ *+E24721 4567F* Make sure that only the image plate, and not the light protection cover, is inserted into the unit. i Remove the empty light protection cover. The blue status LED lights up.
Usage EN – The first time the image plate is used, or if it is stored for longer than a week. – Due to an error, the image data on the image plate has not been erased (software error message). i Select the special ERASE mode in the software. i Insert the image plate (see "Scanning the image plate"). 10.5 Switch off the unit. i Press the on/off switch for 3 seconds. As soon as the unit has shut down it switches off completely. The LEDs go out.
Usage NOTICE Heat damages the cartridges i Do not thermally disinfect or steam sterilise the cartridges. i Remove any soiling from the cartridge with a soft, lint-free cloth that has been dampened with cold tap water. i Disinfect the cartridge using a disinfection wipe. Alternatively, use disinfectant on a soft, lint-free cloth. Comply with the operating instructions for the disinfectant when doing this.
Usage 12 Maintenance 12.1 Recommended maintenance schedule Prior to working on the unit or in case of danger, disconnect it from the mains. EN The recommended maintenance intervals are based on using the device for 25 intraoral images per day on 220 working days per year. Maintenance interval Maintenance work Annually i i i i i Every 3 years Visually inspect the device. Check the image plates for signs of scratches and change if necessary. Remove dust and dirt from accessible parts.
Troubleshooting 13 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified personnel or our service. EN Prior to working on the unit or in case of danger, disconnect it from the mains. 13.
Troubleshooting Fault Probable cause X-ray image only shadowy The X-ray dose on the image plate was insufficient Amplification (HV value) is set too low in the software Solution i Increase X-ray dose. i Increase amplification (HV value). Unsuitable scanning mode select- i Select a suitable scanning ed mode. EN Ghosting or double exposure on X-ray image Image plate exposed twice i Only expose the image plate once. Image plate not sufficiently erased i Check the erasure unit is working correctly.
Troubleshooting Fault Probable cause Solution Shadow on the X-ray image Image plate removed from the light protection cover before scanning i Do not handle image plates without a light protection cover. i Store the image plate in a light protection cover. EN X-ray image cut off, part missing The metal part of the X-ray tube is in front of the X-ray beam i When taking an X-ray, make sure there are no metal parts between the X-ray tube and the patient. i Check X-ray tube.
Troubleshooting Fault Probable cause Solution X-ray image has strips on image Image plate has been pre-exi If the image plate has been posed, e.g. 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 light during handling i Do not expose used image plates to bright light. i Scan image data within half an hour after the exposure. Image plate dirty or scratched i Clean the image plate.
Troubleshooting 13.2 Software error Fault Probable cause Solution "Too much ambient light" Unit exposed to too much light i Darken the room. i Turn the unit so that no light can fall directly into the entry slot. "Overtemperature" Laser or erasure unit too hot i Switch off the unit and allow it to cool. "Erasure unit fault" LED defective i Inform a Service Technician. EN Imaging software does not Unit not switched on i Switch on the unit.
Troubleshooting 13.3 Fault on the unit Fault Probable cause Solution Unit not shown in the imaging software Network cable not installed i Install the network cable. No DHCP server connected i It may take some time for the imaging software to detect the unit. i Update the unit list. Network configuration incorrect i Configure the network correctly. Unit does not switch on No mains voltage i Check the mains cable and plug connection and replace if necessary. EN i Check the power supply unit.
Troubleshooting Fault Probable cause Network connection has been disconnected Connecting cable between device i Check the connecting cable. and computer not correctly connected The IP address of the device is being used by another unit Unit ejects the image plate IQ image plate not used without the image data being transmitted to the imaging software. Error message: "Incorrect image plate type inserted" 2160100227L02 2001V008 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.
Appendix 14 Scanning times EN 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. Max.
Appendix 15 File sizes (uncompressed) The actual file size will depend on the image plate format and the pixel size. File sizes stated are approximate and have been rounded upwards. Suitable compression methods can considerably reduce the file size without loss of data. Max. theoretical resolution (LP/mm) Pixel size (μm) Intra Size 0 (2 x 3) Intra Size 1 (2 x 4) Intra Size 2 (3 x 4) 2160100227L02 2001V008 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 45 16.7 10 EN 30 50 1.8 MB 2.3 MB 3.
Appendix 16 Handover record This document confirms that a qualified handover of the medical device has taken place and that appropriate 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.
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Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com 2160100227L29_1910V008_US-EN_nur FCC-Zulassung_V2.indd 50 14.01.
