Durr Dental VistaScan Mini Installation And Operating Instructions Manual
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Summary of Contents for Durr Dental VistaScan Mini
- Page 1 VistaScan Mini, VistaScan Mini Plus Installation and operating instructions...
- Page 3 Contents Contents Image plate ....Light protection cover ..Protection cover ... . . Important information Storage box .
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Page 4: Table Of Contents
Contents 12.1 Recommended maintenance schedule ....Troubleshooting 13 Tips for operators and service techni- cians ......13.1 Poor X-ray image . -
Page 5: About This Document
All other languages are translations of the original manual. These operating instructions apply to: Order number VistaScan Mini, item number: 2141-000-50 and VistaScan Mini Plus, item number: Serial number – 2141-000-80 – 2141-000-81 Medical device –... -
Page 6: Copyright Information
– Personal injury due to lack of hygiene, e.g. infection DC current Intended purpose This way up / store and transport in an VistaScan Mini, VistaScan Mini Plus upright position The unit is intended exclusively for use in dental applications for the scanning and processing of Keep dry image data on an image plate. -
Page 7: Specialist Personnel
The operator will be held liable and authorised by the manufacturer perform bears all risks. mounting, new installations, modifications, VistaScan Mini, VistaScan Mini Plus expansions and repairs. This unit is not suitable for monitoring patients Electrical safety over longer periods of time. - Page 8 Essential performance char- – Do not expose the unit to any strong vibrations acteristics or shocks. The VistaScan Mini unit or VistaScan Mini Plus unit does not possess any significant perform- 2.11 Disposal ance characteristics as set out in IEC 60601-1 An overview of the waste keys for Dürr...
- Page 9 Important information Image plate The image plate contains barium compounds. – Dispose of the image plate properly in accord- ance with the locally applicable regulations. – In Europe, dispose of the image plate in accordance with waste code 20 03 01 "Mixed municipal waste".
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Page 10: Product Description
Product description Product description Overview 1 VistaScan Mini Plus image plate scanner 2 Image plate intraoral 3 Light protection cover intraoral 4 Storage box 5 Power supply unit with country-specific adapter 6 Data cable (USB network cable) 2141100009L02 2412V005... -
Page 11: Scope Of Delivery
Protection cover ....2141-003-01 – VistaScan Mini / Mini Plus basic unit Stylus ..... . . 9000-623-02 –... - Page 12 Product description Light protection covers VistaScan light protection cover Plus S0 (100x) ..... . . 2130-080-00 VistaScan light protection cover Plus S1 (100x) .
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Page 13: Technical Data
Product description Technical data Image plate scanner Electrical data for the device Voltage V DC Max. current consumption 1.25 Output < 30 Type of protection IP20 Electrical data – power supply unit Rated voltage V AC 100 - 240 Frequency 50/60 Classification Medical Device Class (MDR) - Page 14 Product description Network connection Standard IEEE 802.3u Data rate Mbit/s Connector RJ45 Type of connection Auto MDI-X ³ CAT5 Cable type Ambient conditions during operation Temperature °C +10 to +35 °F +50 to +95 Relative humidity 20 - 80 Air pressure 750 - 1060 Height above sea level <...
- Page 15 Product description Immunity to interference table, near fields of wireless HF communication devices Radio service Frequency band Test level TETRA 400 380 - 390 GMRS 460 430 - 470 FRS 460 LTE band 13, 17 704 - 787 GSM 800/900 TETRA 800 iDEN 820 800 - 960...
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Page 16: Image Plate
Product description Electromagnetic compatibility (EMC) Interference immunity measurements supply input Immunity to interference, rapid transient bursts – AC volt- age grid IEC 61000-4-4:2012 Compliant ± 2 kV 100 kHz repetition frequency Immunity to interference, surges IEC 61000-4-5:2005 Compliant ± 0.5 kV, ± 1 kV Immunity to interference, line-conducted disturbances induced by high-frequency fields –... - Page 17 Product description Dimensions of intraoral image plates 57 x 76 2.24 x 2.99 Light protection cover Classification Medical Device Class (MDR) 2141100009L02 2412V005...
- Page 18 Product description Function Type plate Image plate scanner The type plate is located on the rear of the device. 1 Input unit 2 Operating elements 3 Release key REF Order number 4 Collection tray Serial number The image plate scanner is used to read image data stored on an image plate and to transfer the data to the imaging software (e.g.
- Page 19 Status LED flashing Status LED off Connections The connections are located on the rear of the unit, underneath the cover. 1 Display (VistaScan Mini Plus only) 2 Green operating LED 3 Blue communication indicator 4 Cleaning display yellow 5 Cleaning button...
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Page 20: Protection Cover
Product description When used properly, image plates can be The image can be corrected by mirroring it in the exposed, read and erased several hundred times software. If a diagnosis is not possible in the area provided there is no mechanical damage. The of the marker then the image will need to be image plate must be replaced if there are any acquired again. -
Page 21: Storage Box
Product description Storage box Image plates packed in light protection covers can be stored in the image plate storage box until the next use. The image plate storage box protects the image plate and the light protection cover against contamination and dirt. Bite protector (optional) The bite protector protects the image plate S4 as well as the light protection cover against heavy... -
Page 22: Installation
Assembly Installation Assembly Carrying the unit Only qualified specialists or employees NOTICE trained by Dürr Dental are permitted to Risk of damage to sensitive compo- install, connect and start using the unit. nents in the unit as a result of shocks or vibrations Requirements Do not expose the unit to any strong... -
Page 23: Electrical Connections
Assembly Installing the unit with the wall mounting Attach the matching country-specific bracket adapter to the power supply unit. The unit can be mounted on a wall with the wall mounting bracket (see "3.3 Optional items"). For installation refer to the installation instructions for the wall mounting (order number 9000-618-162) Electrical connections... -
Page 24: Connecting The Unit
Assembly Connecting the unit Only connect peripheral units (e. g. com- puter, monitor, printer) that conform at least The device can be connected either via the USB to the requirements set out in IEC 60950‑1 port or via the network connection. If you are or IEC 62368‑1. - Page 25 Assembly Commissioning Connecting the unit via the network cable Purpose of the network connection The network connection is used to exchange NOTICE information or control signals between the unit Short circuit due to the build up of and a software installed on a computer, in order condensation to, e.
- Page 26 Assembly The port may vary depending on the configura- Configuring the unit in tion. VistaSoft When the unit is first connected to a com- Configuration is performed directly in VistaSoft. puter, it applies the language and time Select > Devices. settings of the computer.
- Page 27 Assembly X-ray unit settings Intraoral X-ray units 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. The following table shows the standard values for the exposure time and the dose area product of an image plate for an adult patient.
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Page 28: Acceptance Tests
Assembly DC emitter, 6 mA Tube length 30 cm Without X-ray field X-ray field limitation X-ray field limitation limitation 70 kV 70 kV 70 kV mGycm mGycm mGycm Incisors 0.08 s 0.08 s 0.08 s Premolars 0.11 s 10.0 0.11 s 0.11 s Molars 0.14 s... - Page 29 Usage Do not scratch the image plates. Do not Usage subject the image plates to pressure from hard or pointed objects. Correct use of image plates CAUTION Image plates are toxic Image plates that are not packed in a light protection cover can lead to poi- soning when placed in the mouth or swallowed.
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Page 30: Operation
Usage 10 Operation Preparing the X-ray ü The image plate has been cleaned. ü The image plate is not damaged. CAUTION ü The marker (if present) is stuck in the correct The image data on the image plate is position on the image plate. If the marker peels not permanent. - Page 31 Usage The light protection cover must be disinfec- Preparing for scanning ted using a disinfection wipe immediately before positioning it inside the patient's CAUTION mouth (see "11.2 Light protection cover"). Light erases the image data on the image plate Never handle exposed image plates ❯...
- Page 32 Usage Scanning the image plate NOTICE To avoid the mix up of X-ray images, only Powder from the protective gloves on scan the X-ray images from the selected the image plate can damage the unit patient. during scanning Place the light protection cover with the Completely clean all traces of the pro- ❯...
- Page 33 Usage When the green and yellow status LEDs light 10.4 Switch off the unit. Press the on/off switch for 3 seconds. Remove the empty light protection cover. While the unit is shutting down the operating When the green status LED lights up: and communication LEDs flash.
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Page 34: Cleaning And Disinfection
Usage 11 Cleaning and disinfection Input unit The input unit must be cleaned and disinfected if When cleaning and disinfecting the unit and its there are indications of contamination or visible accessories, observe country-specific directives, dirt. standards and specifications for medical prod- ucts as well as the specific specifications for Use the following cleaning and disinfecting dental practices and clinics. - Page 35 Usage Remove the fixing mechanism by moving it 11.2 Light protection cover upwards. The surface of the unit must be cleaned and dis- infected if it is contaminated or visibly soiled. Disinfect the light protection cover using a disinfectant before and after placement. Dürr Dental recommends FD 333 forte wipes (virucidal), FD 350 (limited virucidal activity) and FD 322 premium wipes (limited virucidal...
- Page 36 Usage Only fit the protective cover to a unit that has been cleaned and disinfected. 11.5 Storage box with image plate storage tray Clean and disinfect the surface of the image plate storage box and the internal image plate storage tray in the event of contamination or visible soil- ing.
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Page 37: Recommended Maintenance Schedule
Usage 12 Maintenance 12.1 Recommended maintenance schedule Only trained specialists or personnel trained by Dürr Dental may service the device. Prior to working on the unit or in case of danger, disconnect it from the mains. Maintenance Maintenance work interval Annually Visually inspect the device. -
Page 38: Troubleshooting
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 Error... - Page 39 Troubleshooting Error Possible cause Remedy Top or bottom bulge in the X- Image plate fed in off-centre and Check the error code on the ❯ at an angle touch screen. ray image Insert the image plate cen- ❯ trally and straight. X-ray image is mirror-inverted Image plate exposed on the Insert the image plate cor-...
- Page 40 Troubleshooting Error Possible cause Remedy Shadow on the X-ray image Image plate removed from the Do not handle image plates ❯ light protection cover before without a light protection scanning cover. Store the image plate in a light ❯ protection cover. X-ray image cut off, part miss- The metal part of the X-ray tube When taking an X-ray, make...
- Page 41 Troubleshooting Error Possible cause Remedy Horizontal, grey lines on the Transport slipping Clean the transport mecha- ❯ nism, replace the transport X-ray image, extending beyond the left and right belts if necessary. image edge X-ray image is stretched Incorrect light protection cover Only use original accessories.
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Page 42: Software Error
Troubleshooting Error Possible cause Remedy Lamination of the image plate Incorrect retainer system used Only use original image plates ❯ and film retainer systems. becoming detached at the edge Image plate handled incorrectly. Use the image plate correctly. ❯ Observe the operating ❯... -
Page 43: Fault On The Unit
Troubleshooting Error Possible cause Remedy The unit does not appear in Unit is connected behind a Configure the IP address with- ❯ router out an intermediate router on the options list in VistaConfig the unit. Reconnect the router. ❯ Manually enter the IP address ❯... -
Page 44: Error Message On Display
Troubleshooting Error Possible cause Remedy Loud operating noises after Radiation deflector defective Inform a Service Technician. ❯ switching on lasting more than 30 seconds Unit not responding The unit has not yet completed After switching on, wait 20 - ❯ the startup procedure 30 seconds until the startup procedure has finished. - Page 45 Troubleshooting Error Possible cause Remedy Error code 1104 Erasure unit fault Inform a Service Technician. ❯ Replace the erasure unit. ❯ Error code 1116 Drive feed blocked Remove the blockage. ❯ Inform a Service Technician. ❯ Error code 1117 Feed position error Inform a Service Technician.
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Page 46: Appendix
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. -
Page 47: 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 approx- imate and have been rounded upwards. Suitable compression methods can considerably reduce the file size without loss of data. Theoretical resolution (LP/mm) Pixel size (μm) -
Page 48: Handover Record
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. Product name Order number (REF) Serial number (SN) -
Page 49: Country Representatives
Appendix 17 Country representatives Country Address UK Responsible Person: Duerr Dental (Products) UK Ltd. 14 Linnell Way Telford Way Industrial Estate Kettering, Northants NN 16 8PS Уповноважений представник в Україні: Приватне підприємство “Галіт” вул. 15 квітня, 6Є, с. Байківці, Тернопільський р-н, 47711, Україна... - Page 52 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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