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Summary of Contents for Durr Dental VistaScan Ultra View
- Page 1 VistaScan Ultra View Installation and Operating Instructions 2170100001L29 ...
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Page 3: Table Of Contents
Contents Assembly Important information Requirements 20 About this document 3 Installation/setup room 20 Warnings and symbols 3 System requirements 20... - Page 4 12 Cleaning and disinfection 40 121 Image plate scanner 40 122 Light protection cover 40 123 Image plate 40 124 Plate guides 40 125 Storage box with image plate...
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Page 5: Important Information
VistaScan Ultra View Image Plate Scanner The manual forms an integral part of the device and Note, eg specific instructions regarding... - Page 6 ME EQUIPMENT Fragile, handle with care CAUTION Keep away from sunlight While the VistaScan Ultra View has been de- signed to minimise exposure of personnel to Knowledge of warnings and cautions. hazards, any use the device that is not com-...
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Page 7: Copyright Information
View meets the requirements of IEC 60825-1 Insert image plate only Avoid damage to the Ed 3 (2014) VistaScan Ultra View transport by making sure that the light protection cover does not EMC Compliance Requirements: get pulled into the transport along with the... -
Page 8: Safety
The use of the accessory in combination with Safety other than image plate scanners manufactured The VistaScan Ultra View has been designed by or branded with Dürr Dental and image plates and constructed so that, when used properly manufactured by or branded with Dürr Dental and for the intended purpose, it does not pose 2.4 General safety information... -
Page 9: 26 Electrical Safety
An overview of the waste keys for Dürr Dental teristics products can be found in the download area at wwwduerrdentalcom (document no The VistaScan Ultra View unit does not possess P007100155) any significant performance characteristics as set out in IEC 60601-1 (EN 60601-1) section 43... -
Page 10: 11 Disposal
Perform regular data backups Restrict access to units to trustworthy users, Only use VistaScan Ultra View with Dürr Den- eg via a user name and password tal VistaScan Image Plates IQ and VistaScan Light Protection Covers... -
Page 11: Product Description
Product description Overview b ac k VistaScan Ultra View Image Plate Scanner Image plate storage box Plate guide, intraoral VistaScan Image Plate IQ VistaScan Light Protection Cover Plus SDHC memory card DBSWIN imaging software data carrier VistaSoft imaging software data carrier... -
Page 12: Scope Of Delivery
Save all cartons and packing FD 333 forte wipes for quick materials to protect VistaScan Ultra View in the acting disinfection CDF33FW0150 event that it is to be transported or shipped in the... -
Page 13: Optional Articles
Product description VistaScan IQ Packs 2130106051 VistaScan IQ Pack S0, containing VistaScan Image Plate IQ S0 (2 pcs) + VistaScan Light Protection Cover Plus S0 (1000 pcs) 2130106151 VistaScan IQ Pack S1, containing VistaScan Image Plate IQ S1 (2 pcs) + VistaScan Light Protection Cover Plus S1 (1000 pcs) 2130106251 VistaScan IQ Pack S2, containing VistaScan Image Plate IQ S2 (2 pcs) + VistaScan... -
Page 14: Technical Data
Technical data 4.1 Image plate scanner Power unit electrical details Voltage V AC 100 - 240 Frequency 50/60 Electrical data for VistaScan Ultra View Voltage V DC Maximum current 165 Power consumption < 396 Laser source Laser class IEC 60825-1: 2014... - Page 15 Product description Technical data for the RFID module Frequency 1356 Modulation Maximum power Network connection LAN technology Ethernet Standard IEEE 8023u 100Base-TX Data rate Mbit/s Connector RJ45 Type of connection Auto MDI-X Type of cable ≥ CAT5 WLAN connection WLAN technology IEEE 80211b/g Encryption WPA /WPA2...
- Page 16 Product description Classification Laser class (unit) in accordance with EN60825-1:2014 Medical device class (MDD 93/42/EEC) Class I Medical device class (MDR 2017/745) Class I Electromagnetic compatibility (EMC) interference emission measurements High-frequency emissions in accordance with CISPR11 Group l Interference voltage at the power supply connection Class B CISPR11:2009+A1:2010 Electromagnetic interference radiation...
- Page 17 Product description Electromagnetic compatibility (EMC) interference immunity measurements supply input Immunity to interference, rapid transient bursts AC voltage grid IEC61000-4-4:2012 Compliant ±2k V 100 kHz repetition frequency Immunity to interference, surges IEC61000-4-5:2005 Compliant ±05 kV ,±1kV Immunity to interference, line-conducted disturbances induced by high-frequency fields –...
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Page 18: Image Plate
Product description 4.2 Image plate Classification Medical device class Ambient conditions during operation Temperature °C 18 to 45 °F 64 to 113 Relative humidity < 80 Ambient conditions during storage and transport Temperature °C < 33 °F < 91 Relative humidity <... -
Page 19: Type Plate
Product description 4.4 Type plate Operation The type plate is located on the back cover of the device 5.1 Image plate scanner REF Order number Serial number 4.5 Evaluation of conformity This device has been subjected to conformity acceptance testing in accordance with the cur- rent relevant European Union guidelines This User interface equipment conforms to all relevant require-... -
Page 20: Image Plate
Product description User interface Connections The connections are located on the rear of the unit, underneath the cover Touch screen On/Off switch The user interface to the unit consists of an On/ Off switch to control operating power and a touch screen The touch screen allows the unit to be operated when it is not connected to a com- puter Instructions can be entered on the touch... -
Page 21: Light Protection Cover
Product description 5.5 Storage box Inactive side Active side Image plates packaged in light protection covers can be stored in the storage box until they are next used The storage box protects the image plate and the light protection cover against con- tamination and dirt back White, printed with... -
Page 22: Assembly
– Do not arrange the unit so that it is im- mediately next to, or stacked with other – VistaScan Ultra View should be set up in a appliances However, if the unit is operated closed, dry and well-ventilated room immediately next to, or stacked with other –... -
Page 23: Installation
Assembly Installation For details of the installation refer to the installation instructions for the wall 7.1 Carrying the unit mounting NOTICE Risk of damage to sensitive compo- 7.3 Removing the protective film nents in the unit as a result of shocks Grasp one corner of the protective touch or vibrations screen film and peel it off carefully... -
Page 24: Software Installation
7.5 Software installation Plug the connecting plug of the power supply unit into the socket connection (item 3) of the VistaScan Ultra View is designed to be in- device stalled by your authorized dealer The user Plug the mains plug into the power outlet... - Page 25 Assembly - "Update" of devices that are connected to the IT network - "Upgrade" of devices that are connected to the IT network – The data connection utilises part of the band- width of the network Interactions with other medical devices cannot be completely ruled out Apply the IEC 80001-1 standard for risk assessment –...
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Page 26: Commissioning
Assembly Commissioning 8.2 Configuring WLAN on the unit If the unit is to be operated via WLAN, the WLAN NOTICE stick included in the scope of delivery must be Short circuit due to the build up of inserted into the USB connection on the back condensation of the unit (see "Connections") The connection to the unit then needs to be configured Proper... -
Page 27: 84 Configuring The Unit In Dbswin
Assembly Entering a fixed IP address (recommended) Click To reset the network settings, keep the unit reset key located near the SD card slot at the right side of the unit pressed using an office paper clip or similar for 15 - 20 seconds until the screen turns black while switching on Working under Connection, deactivate DHCP... -
Page 28: X-Ray Unit Settings
Assembly 8.5 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 (eg 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 The information dealing with the duration of X-ray exposition and the dose area product is only applicable when VistaIntra is used as X-ray device DC emitter 60kV/7mA Tube Length 20cm... - Page 29 Assembly DC emitter 70kV/6mA Tube Length 30cm Without X-ray field limitation X-ray field limitation 2x3 X-ray field limitation 3x4 70 kV mGycm² µGy 70 kV mGycm² µGy 70 kV mGycm² µGy Incisors 011 s 100 4334 011 s 4316 011 s 4327 Premolars 015 s...
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Page 30: Acceptance Tests
Assembly 8.6 Acceptance tests The required tests (eg acceptance tests) must be carried out in accordance with local rules and regulations Find out which tests are required Carry out testing in accordance with local rules and regulations (See article 9000-618-133) Acceptance test The Intra / Extra Digital test phantom is required for acceptance tests with the image plate and sensor as receivers, and... -
Page 31: Usage
Usage Operating the touch 9.2 Using menus screen The integrated menus within the main window contain additional commands that can be se- lected as required Touch to open the menu WARNING Damage to the touch screen due to incorrect handling Only operate the touch screen using the tip of a finger Do not use any sharp instrument (eg... -
Page 32: Calling Up Messages On The Screen
Usage 9.4 Calling up messages on the 9.5 System settings screen System settings can be viewed and edited via the touch screen icons listed below The Messages view shows a history of all previ- ous messages Messages are divided into the Select the output lan- following categories: Language... -
Page 33: Main Menu
Usage Editing settings for the touch screen To reduce the image, swipe across the X-ray image from right to left Touch Brightness Enter the values via the arrows Move the magnified image section Touch OK Touch the magnifying glass symbol Touch Calibrate touch screen until the display ±... - Page 34 Usage Edit the contrast of the image To increase the contrast, move the controller to the right or touch the right ar- row several times To reduce the gamma value, move the controller to the left or touch the left arrow several times Edit the gamma value of the image...
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Page 35: Correct Use Of Image Plates And Light
Usage 10 Correct use of image Image plates must only be read using an image plate scanner that is approved by Dürr Dental plates and light protection Image plates are flexible like X-ray film How- covers ever, the image plates should not be bent WARNING Risk of cross contamination when not using the light protection cover or... -
Page 36: Operation
Usage 11 Operation 11.2 X-ray 11.1 Changing the plate guide. VistaScan Ultra View can be used to scan im- age plates Size 0, Size 1, Size 2, Size 3 and Size 4 Each size of image plate requires the match-... - Page 37 Usage Completely slide the image plate into the light Taking the X-ray protection cover The white (inactive) side of NOTICE the image plate must be visible Damage to the image plate caused by a sharp-edged holding system Only use holding systems that will not damage the light protection cover or back the image plates in any way...
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Page 38: 113 Scanning Image Data Via A Computer 36
Tear off the light protection cover NOTICE VistaScan Ultra View only scans images using VistaScan Image Plate IQ made by Dürr Dental. Use only VistaScan Image Plate IQ 2170100001L29 2109V005... - Page 39 Usage After it has been scanned, the image plate is Scanning the image plate. erased and drops into the collection tray Place the light protection cover with the image Save the X-ray image plate centrally and straight into the plate Remove the image plate and prepare to take guide a new X-ray...
- Page 40 Usage Requirements: Scanning the image plate – Memory card (SDHC, max 32 GB) in the slot To avoid the risk of mixing up X-ray imag- on the unit es, only scan the X-ray images from the Press to switch on the unit selected patient Place the light protection cover with the image Start scanning:...
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Page 41: 115 Erasing The Image Plate
Usage 11.5 Erasing the image plate Pull the protection cover over the device so that it is completely covered Make sure that The image data is automatically erased after the markings are at the front scanning The special ERASE mode only activates the erasure unit of the image plate scanner No im- age data is read The image plate needs to be erased using the... -
Page 42: Cleaning And Disinfection
NOTICE Durr Dental recommends using the disinfectants Liquid can cause damage to the unit. FD 322, FD 333, FD 350, and FD 366 sensitive Do not spray the unit with cleaning... -
Page 43: 125 Storage Box With Image Plate
Usage 13 Maintenance Soiling on both sides of the image plate should be cleaned off with a soft, lint-free wipe prior to every use 13.1 Yearly scheduled maintenance Remove stubborn or dried-on dirt with the im- age plate cleaning wipe When doing this, ob- Like all precision products, the VistaScan Ultra serve the instructions for use for the cleaning View requires a certain amount of care on a reg-... -
Page 44: Schedule
Prior to working on the device or in case of danger, disconnect it from the mains (eg pull the mains plug) Only trained specialists or personnel trained by Durr Dental may service the unit The recommended maintenance intervals are based on using the device for 15 intraoral images per... -
Page 45: Troubleshooting
Troubleshooting 14 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified per- sonnel or our service Prior to working on the device or in case of danger, disconnect it from the mains (eg pull the mains plug) 14.1 Poor X-ray image Problem... - Page 46 Troubleshooting Problem Probable cause Solution Ghosting or dou- Image plate exposed twice Only expose the image plate once ble exposure Image plate not properly erased Check the erasure unit for proper func- on X-ray image tion Inform a service technician if the problem persists X-ray image mir- Image plate bent during X-ray ex-...
- Page 47 Troubleshooting Problem Probable cause Solution X-ray image has Image plate has been pre-exposed, If the image plate has been stored for strips on image eg by natural radiation or stray X- more than one week, erase the image ray radiation plate prior to use Parts of image plate exposed to Do not expose exposed image plates to...
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Page 48: 142 Software Error
Troubleshooting Problem Probable cause Solution X-ray image split Dirt in the laser slit (eg hair, dust Clean the laser slit vertically into two halves X-ray image with Micro scratches on the image plate Replace the image plate small bright spots or clouding Lamination of the Wrong retainer system used... - Page 49 Troubleshooting Problem Probable cause Solution Imaging software Unit not switched on Switch the device on fails to recognize the unit Cable between unit and computer Check the connecting cable not correctly connected Computer does not detect any Check the connecting cable connection to the unit Check the network settings (IP address and subnet mask)...
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Page 50: 143 Fault On The Unit
Troubleshooting 14.3 Fault on the unit. Problem Probable cause Solution Touch screen Image plates other than image Use only image plates IQ made by Dürr displays following plates IQ from Dürr Dental were Dental warning: RFID Tag used is missing, not valid or image plate size mismatch inserted Please use correct... -
Page 51: 144 Error Messages On The Touch
Troubleshooting 14.4 Error messages on the touch screen. Problem Probable cause Solution Error code 1008 Connection interrupted Update the firmware Error code Temperature of unit too high Allow the unit to cool down 1010 Contact technician Error code Subassembly not initialised Fault in software, update the software 1022 if required... - Page 52 Troubleshooting Problem Probable cause Solution Error code Unit is exposed to too much Darken the room 10000 light Turn the unit so that no light is directly incident into the entry slot Error code Internal communication error Update the firmware 10009 warning;...
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Page 53: Appendix
Appendix 15 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 Theoretical resolution (LP/mm) -
Page 54: Electromagnetic Compatibility (Emc)
IEC 60601-1-2 as shown below The user should ensure that the VistaScan Ultra View unit is indeed used within this environment to ensure that the system will perform as intended... - Page 55 Manufacturer’s Guidance and Declaration - Electromagnetic Immunity VistaScan Ultra View is intended to be used within the electromagnetic environment specified below The user of the VistaScan Ultra View should ensure that it is used in such an environment IEC 60601 Compliance...
- Page 56 Manufacturer’s Guidance and Declaration – Electromagnetic Immunity VistaScan Ultra View is intended to be used in the electromagnetic environment specified below. The user of the VistaScan Ultra View should ensure that it is used in such an environment. Immunity test...
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Page 57: Recommended Separation Distances
19 Recommended separation distances between equipment Distance between portable and mobile RF communications equipment VistaScan Ultra View is intended for use in an electromagnetic environment in which radiated RF inter- ferences are controlled The user of the VistaScan Ultra View unit can help prevent electromagnetic... -
Page 58: Handover Record
Appendix 20 Handover record This document confirms the qualified handover and provision of instructions for the medical device from Dürr Dental 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 62 Manufactured for / Distributed by: DÜRR DENTAL SE Höpfigheimer Str 17 74321 Bietigheim-Bissingen, Germany Fon: +49 7142 705-0 wwwduerrdentalcom info@duerrdentalcom Air Techniques, Inc 1295 Walt Whitman Road Melville, New York USA 11747- 3062 wwwairtechniquescom Medical Device Safety Service Schiffgraben 41 30176 Hannover, Germany Australian Sponsor: Emergo Australia...
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