VistaScan Mini View Installation and Operating Manual

Contents Important information 1

Documentation��������������������������������������� 3 1.1 Warnings and symbols ��������������������� 3 1.2 Notes on copyright ��������������������������� 3

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Safety ����������������������������������������������������� 4 2.1 Correct use��������������������������������������� 4 2.2 Incorrect use������������������������������������� 4 2.3 General safety notes������������������������� 4 2.4 Qualified personnel ��������������������������� 4 2.5 Protection against electrical current��� 4 2.6 Only use original parts����������������������� 4 2.7 Transport������������������������������������������� 5 2.8 Disposal ������������������������������������������� 5

6.1 Area of installation��������������������������� 16 6.2 System requirements����������������������� 16 6.3 Monitor������������������������������������������� 16 7

Installation ������������������������������������������� 16 7.1 Carrying the appliance��������������������� 16 7.2 Setting up the appliance ����������������� 16 7.3 Remove the touchscreen protective foil��������������������������������������������������� 17 7.4 Applying stylus ������������������������������� 17 7.5 Insert memory card������������������������� 17 7.6 Electrical connection����������������������� 17 7.7 Connecting the appliance to a network����������������������������������������������� 18

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Operation ��������������������������������������������� 19 8.1 Installing and configuring the appliance����������������������������������������������� 19 8.2 X-ray appliance settings ����������������� 21 8.3 Tests for start-up����������������������������� 21

Product description 3

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Overview������������������������������������������������� 6 3.1 Delivery Contents ����������������������������� 7 3.2 Accessories��������������������������������������� 7 3.3 Special accessories��������������������������� 7 3.4 Disposable materials������������������������� 7 3.5 Working parts and spare parts����������� 8 Technical data ��������������������������������������� 9 4.1 Image plate scanner ������������������������� 9 4.2 Image plate������������������������������������� 10 4.3 Light protection cover��������������������� 12 4.4 Model identification plate����������������� 12 4.5 Note on Conformity������������������������� 12 Function ����������������������������������������������� 12 5.1 Image plate scanner ����������������������� 12 5.2 Image plate������������������������������������� 14 5.3 Light protection cover��������������������� 14 5.4 Stylus pen for touch screen������������� 14 5.5 Protective cover ����������������������������� 15 5.6 Storage box ����������������������������������� 15 5.7 Bite protector (optional)������������������� 15

Mounting 6

Prerequisites����������������������������������������� 16

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Usage 9

Using the touch screen ����������������������� 22 9.1 Navigation��������������������������������������� 22 9.2 Using the menu������������������������������� 22 9.3 Enter text into relevant field������������� 22 9.4 Calling up information on the touch screen��������������������������������������������� 23

10 Use image plates correctly ����������������� 23 11 Instructions for use ����������������������������� 24 11.1 Taking an X-ray������������������������������� 24 11.2 Reading the image data using the computer ��������������������������������������� 26 11.3 Scanning image data using the unit touch screen����������������������������������� 27 11.4 Erasing the image plate������������������� 29 11.5 Switching off the appliance ������������� 29 12 Cleaning and disinfecting ������������������� 30 12.1 Image plate scanner ����������������������� 30 12.2 Light protection cover��������������������� 31 12.3 Image plate������������������������������������� 32 12.4 Stylus pen for touch screen������������� 32 13 Maintenance����������������������������������������� 33 13.1 Recommended maintenance schedule����������������������������������������� 33 1

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Contents

Trouble-shooting

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14 Tips for Operators and Technicians ��� 34 14.1 Defective radiograph����������������������� 34 14.2 Software error��������������������������������� 38 14.3 Error on the appliance��������������������� 39 14.4 Error message on touch screen������� 39

Annex 15 Menu layout settings��������������������������� 41 16 Scan times ������������������������������������������� 44 17 File size (uncompressed)��������������������� 45 18 Information on EMC according to EN 60601-1-2 ��������������������������������������� 46 18.1 General notes��������������������������������� 46 18.2 Abbreviations ��������������������������������� 46 18.3 Guidelines and manufacturer's information����������������������������������������� 46 18.4 Table of calculation ������������������������� 50

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Important information 1

Documentation

These Installation and Operating Instructions form an integral part of the unit. They conform to the relevant version of the equipment and the status of technology valid at the time of first operation. Dürr Dental cannot guarantee smooth operation and safe function of the unit and will not accept any liability where the instructions and notes contained in these installation and operating instructions are not strictly observed. This translation has been carried out in all good faith. The original German version is decisive. Dürr Dental accepts no liability for incorrect translation.

1.1 Warnings and symbols Warnings The warnings in this document are there to point out possible injury to persons or damage to machinery. The following warning symbols are used: General warning symbol

The signal word differentiates between differentlevels of danger: –– DANGER High risk of danger of serious injury or death –– WARNING Possible risk of danger of serious injury or death –– CAUTION Risk of danger of minor injuries –– NOTICE Risk of serious damage Further symbols These symbols are used within the documentation and on the unit itself: Notes, e.g. special instructions concerning economical use of the unit. Observe the accompanying documentation. CE-labeling Date of manufacture

Warning - dangerous electrical voltage

Dispose of product correctly and in accordance with EU directive (2002/96/ EG-WEEE).

Warning - laser beam

Only use once.

The warnings are structured as follows: SIGNAL WORD Description of type and sourceof danger Possible consequences of ignoringthe safety warning here • Measures to be taken to avoidany possible danger.

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Wear protective gloves Unplug at the mains and remove all power.

1.2 Notes on copyright All circuits, processes, names, software and appliances quoted are protected under industrial property rights. Any reprinting of the technical documentation, in whole or in part, is subject to prior approval of Dürr Dental being given in writing.

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Important information

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Safety

Dürr Dental has designed and constructed this appliance so that when used correctly there is no danger to people or property. Nevertheless, there are residual risks. Please follow the instructions below carefully.

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2.1 Correct use The appliance is intended exclusively for the scanning and processing of image data on an image plate under dentistry conditions.

2.2 Incorrect use Any use of the appliance above and beyond that laid down here s considered to be imroper use of the equipment. Any resulting damage thus caused is the sole liability of the user. The manufacturer cannot be held responsible for damage caused by improper use. WARNING Risk of explosion due to inflammation of combustible materials • Do not use the appliance in rooms in which combustible mixtures may be present, e.g. in operating theatres.

2.4 Qualified personnel Instructions for use Persons who operate the appliance must, on the basis of their training and knowledge, ensure safe and correct handling of the appliance. • Ensure personnel are trained in the correct usage of the appliance. Installation and repair • Installation, resetting, alterations, extensions and repairs must be carried out by Dürr Dental or by qualified personnel specifically approved and authorized by Dürr Dental.

2.5 Protection against electrical current • When working on and with the appliance always observe the local electrical safety procedures. • Never come into contact with patients and open plug-in connections on the appliance at the same time. • Damaged supply lines and connections must be replaced immediately.

This appliance is not suitable for monitoring patients over longer periods of time. The preview of the x-ray as seen on the touch screen is not suitable for using in diagnosis.

Observe guidelines for electro-magnetic compatibility for medical devices • Heed special precautionary measures with regard to electromagnetic comparability (EMC) for medical products, see "18 Information on EMC according to EN 60601-1-2".

2.3 General safety notes

2.6 Only use original parts

• Before using the appliance observe any and all guidelines, laws, regulations and other restrictions which may apply to the appliance. • Before each use check the function and condition of the appliance. • Do not convert or change the appliance in any way. • Observe the Installation and Operating Instructions precisely. • Keep the Installation and Operating Instructions in an accessible place so that the operator has instant access to them.

• Only Dürr Dental parts or accessories and special accessories specifically approved by Dürr Dental may be used. • Only use original working parts and spare parts.

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Dürr Dental cannot accept any liability for damage caused by the use of accessories and special accessories not specifically approved by Dürr Dental or not using original working parts and spare parts.

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Important information

2.7 Transport The original packaging offers the optimum protection for the appliance during transport. If required, the original packaging for the unit can be ordered at Dürr Dental. Dürr Dental cannot accept any liability for damage caused during transport by the use of unsuitable packaging, this is also valid during the warranty term.

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• Only transport the appliance in its original packaging whenever possible. • Keep the packing materials out of the reach of children. • Do not expose the appliance to any strong shocks.

2.8 Disposal Appliance Dispose of the appliance correctly. Within the European Union dispose of the appliance according to EU directive 2002/96/EG (WEEE). • If you have any questions concerning correct disposal, please contact Dürr Dental or your usual dental supplier. Image plate The image plate contains barium compounds. • Dispose of the image plate properly in accordance with the locally applicable regulations. • In Europe, dispose of the image plate in accordance with general unspecified waste, code 090199. Disposal with general house waste is not permitted.

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Product description 3

Overview 1

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EN 3

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VistaScan Mini View Image plate scanner Stylus Image plate intraoral Light protection cover intraoral Storage box Memory card SDHC DBSWIN imaging software DVD Power unit with country adapter Network cable

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Product description

3.1 Delivery Contents The following articles are included in the scope of delivery (possible variations due to countryspecific conditions and/or import regulations): VistaScan Mini View Image plate scanner ������������������������ 2142-01 –– VistaScan Mini View Base unit –– Power unit –– Network cable –– Memory card SDHC (4 GB) –– Stylus –– DBSWIN imaging software DVD –– Plus image plate: -- Size 0 (2 pcs.) -- Size 2 (4 pcs.) –– Light protection covers: -- Size 0 (100 pcs.) -- Size 2 (300 pcs.) –– Storage box –– Protective cover –– Image plate cleaning cloth (10 pcs.) –– Installation and Operating Instructions –– Quick start instructions

3.2 Accessories The following items are required for operating the appliance, depending on the application: SDHC memory card��������������������� 9000-134-18 Image plates Plus image plate Size 0 2 x 3 cm (2 pcs.)��������������������������� 2130-040-50 Image plate Plus Size 1 2x 4 cm (2 pcs.) ��������������������������� 2130-041-50 Plus image plate Size 2 3 x 4 cm (4 pcs.)��������������������������� 2130-042-50 Plus image plate Size 2 3 x 4 cm (12 pcs.)������������������������� 2130-042-55 Image plate Plus Size 3 2.7 x 5.4 cm (2 pcs.)��������������������� 2130-043-50 Plus image plate Size 45.7 x 7.6 cm (1 )��������������������������������� 2130-044-50 Plus ID image plate Size 0 2 x 3 cm (2 pcs.)��������������������������� 2130-040-60 Plus ID image plate Size 2 3 x 4 cm (4 pcs.)��������������������������� 2130-042-60

light protection cover Light protection cover Size 0 2 x 3 cm (100 pcs.)����������������������� 2130-070-00 Light protection cover Size 1 2 x 4 cm (100 pcs.)����������������������� 2130-071-00 Light protection cover Size 2 3 x 4 cm (300 pcs.)����������������������� 2130-072-00 Light protection cover Size 2 3 x 4 cm (1000 pcs.)��������������������� 2130-072-55 Light protection cover Size 3 2.7 x 5.4 cm (100 pcs.)����������������� 2130-073-00 Light protection cover Size 4 5.7 x 7.6 cm (100 pcs.)����������������� 2130-074-00 Light protection cover white Size 0 2 x 3 cm (100 pcs.)����������������������� 2130-070-50 Light protection cover white Size 2 3 x 4 cm (300 pcs.)����������������������� 2130-072-50

3.3 Special accessories The following items can be optionally used with the appliance: Wall mounting bracket������������������ 2141-001-00 Storage box��������������������������������� 2141-002-00 Bite protector Size 4 (100 pcs.)����� 2130-074-03 Image plate and film handling system set ����������������������������������������������� 2130-981-50 Image plate and film handling upgrade set for endo-exposures����������������� 2130-981-51 Copper dot set, self-adhesive������� 2130-006-00 Mobile Connect (for using apps for mobile appliances, e. g. Dürr Dental Imaging iPad App)���������������������2100-725-12FC Commissioning and intraoral constancy checks Test specimen Intra / Extra Digital� 2121-060-54

3.4 Disposable materials The following materials are used during operation of the appliance and must be re-ordered: Cleaning and disinfecting Image plate cleaning cloth (10 pcs.) ��� CCB351B1001 FD 350 Classic disinfectant wipes������� CDF35CA0140 FD 333 surface disinfectant�������� CDF333C6150 FD 322 surface disinfectant�������� CDF322C6150 light protection cover see "3.2 Accessories"

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Product description

3.5 Working parts and spare parts Image plates see "3.2 Accessories" Information concerning spare parts can be found in the spare parts catalogue under: www.duerr.de/etk.

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Product description

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Technical data

4.1 Image plate scanner Electrical data of the unit Voltage Max. supply voltage fluctuation Max. current consumption Output Fuse type Electrical data power supply unit Voltage Max. supply voltage fluctuation Frequency Protection class Fuse type Overvoltage category Output Max. current consumption

V DC % A W

24 ± 10 1.25 < 30 IP20

V AC % Hz

100 - 240 ± 10 50 - 60 II IP20 II < 40 0.8

W A

Classification Medical devices directive (93/42/EU) Laser class (appliance) according to EN 60825-1:1994-03 + A1:2002-07 + A2:2001-03

Class I

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Electromagnetic compatibility (EMC)* HF transmissions according to CISPR 11

Veff

Group 1 Class B Not applicable Not applicable 3

V/m

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Laser source Laser class according to EN 60825-1:1994-03 + A1:2002-07 + A2:2001-03 Wavelengthl Output

nm mW

3B 635 10

Sound pressure level Standby Ready to scan During readout

dB(A) dB(A) dB(A)

0 approx. 37 approx. 55

Harmonic limits according to IEC 61000-3-2 Voltage fluctuations/flicker according to IEC 61000-3-3 Directed HF interference V1 acc. to IEC 61000-4-6 Transmitted HF interference E1 according to IEC 61000-4-3

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*see also "18 Information on EMC according to EN 60601-1-2"

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Product description

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General technical data Dimensions (W x H x D) Weight Heat output Duty cycle S2 (acc. to VDE 0530-1) Duty cycle S6 (according to VDE 0530-1) Pixel size (selectable) Max. resolution (depending on image plate) Memory card Model Maximum memory capacity File system

mm kg W min % μm Line pairs/mm (Lp/mm)

226 x 275 x 243 approx. 7 < 40 25 25 12.5 - 50 approx. 40

GB

SDHC 32 FAT32

Ambient conditions for operation Temperature Relative humidity Air pressure Height above sea level

°C % hPa m

+10 up to +35 20 - 80 750 - 1060 < 2000

Ambient conditions for storage and transport Temperature Relative humidity Air pressure Height above sea level

°C % hPa m

-20 up to + 60 10 - 95 750 - 1060 < 16000

4.2 Image plate Classification Medical devices directive (93/42/EU)

Class IIa

Ambient conditions for operation Temperature Relative humidity

°C %

18 - 45 <80

Ambient conditions for storage and transport Temperature Relative humidity

°C %

<33 <80

Dimensions of intraoral image plates Size 0 Size 1 Size 2 Size 3 Size 4

mm mm mm mm mm

22 x 35 24 x 40 31 x 41 27 x 54 57 x 76

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Product description

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Product description

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4.3 Light protection cover

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Function

Classification Medical devices directive (93/42/EU)

5.1 Image plate scanner Class I

4.4 Model identification plate The model identification plate is located on the rear side of the appliance.

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5 REF Order number SN

Serial number

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4.5 Note on Conformity This appliance has been tested according to the relevant directive of the European Union and the required conformity acceptance procedure. This appliance meets all the necessary requirements.

1 Operating panels 2 Input unit 3 Stylus 4 Unlocking button 5 Collection tray 6 Memory card slot The image plate scanner is used to scan the image information on the image plate. The appliance can be used in two different ways: using the imaging software (e. g. DBSWIN) on a PC or directly on the appliance via the touch screen. The transport mechanism guides the image plate through the appliance. In the scanner unit a laser scans the image plate. The scanned data is converted into a digital image. When the scan task is started via the imaging software the image is automatically transmitted to the computer. When the scan task is started via the touch screen the image is first stored on the memory card and must be transmitted to the computer later. 12

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Product description After scanning, the image plate runs through the erasure unit. Image data still held on the image plate will be erased using intense light. The image plate is then ejected to be used again.

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Operating panels

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1 Touchscreen 2 Press the on/off switch The touch screen can be used to operate the device even when a computer is not connected. The touch screen can be operated either by using one's finger tips or by using the stylus.

Figure 1: Start menu on the touch screen Touching the field Help opens a help page relevant to the current page. Touching the field News opens a page with current information. Connections The connections are on the rear side of the appliance under the cover.

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Connection for power unit Reset button AUX connection for diagnostic appliances Status displays network connection Network connection

Exposure recognition When the exposure recognition is switched on, then the unit will detect whether an image plate is exposed or not on insertion. When an exposed image plate is scanned then an x-ray image will be displayed. When an unexposed image plate is scanned then an empty image plate will be displayed. A preview will not be displayed on the touchscreen. When the exposure recognition is switched off and an unexposed image plate is scanned then the unit will not display anything on the touchscreen or in the software. ScanManager When the ScanManager is enabled, then more than one x-ray job can be transmitted to the unit from different computers simultaneously. The unit administers the jobs by placing them in a waiting list, from which the required job can be selected via the touch screen and then executed. Without ScanManager the unit processes one xray job at a time and is blocked until this job has been completed. During this time no further xray jobs can be transmitted to the unit from other computers. The ScanManager can be enabled using Settings > System Settings> Operating Mode.

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Product description

5.2 Image plate

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The image plate stores X-ray energy which is reemitted in the form of light due to excitation with a laser. This light is converted into image information in the image plate scanner. The image plate has an active and an inactive side. Exposure of the image plates must take place on the active side. When used properly, the image plate can be exposed, read and erased several hundred times provided there is no mechanical damage. The image plate must be replaced if there are any signs of damage (e.g. protective layer is damaged or visible scratches) which could interfere with diagnosis. Intraoral

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1 Marker visible as a shadow The exposure can be corrected by mirroring in the software. If it is not possible to diagnose in the area of the marker, the exposure must be repeated. Image plates can be retrofitted with a marker using the copper dot set (see "3.3 Special accessories").

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Inactive side:

black, printed with "back", size and manufacturer information

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Active side:

light blue, with positioning aid

Unique assignment of image plate and image (Plus ID image plate only) In addition to the marker, a hexadecimal code which is visible on the X-ray image is applied on the Plus ID image plate. This code ensures a unique correlation between image plate and X-ray image.

The positioning aid is visible on the X-ray image and makes orientation easier during diagnosis. Exposure on the wrong side A marker is placed on the inactive side of the Plus ID image plate.

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Hexadecimal code

5.3 Light protection cover 1

1 Marker If the image plate has been exposed on the wrong side, the marker is visible as a shadow on the X-ray image.

The light protection cover provides several protection functions for the intraoral image plate: –– Protection against sunlight and UV light and hence against unwanted erasure –– Protection from physical damage –– Protection from contamination and soiling The light protection cover is a disposable item.

5.4 Stylus pen for touch screen The stylus can be used with the touch screen as an alternative to using one's finger tips.

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Product description

5.5 Protective cover The protective cover protects the appliance against dust and dirt, e. g. if not used for some time.

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5.6 Storage box

Image plates packed in light protection covers can be placed in the storage box until the next use. The storage box protects the image plate and light protection cover from contamination and soiling.

5.7 Bite protector (optional)

The bite protector protects the image plate Plus Size 4, additionally to the light protection cover, from severe mechanical damage, e. g. too intense biting pressure during x-ray exposure.

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Mounting Only fully-qualified or from Dürr Dental trained personnel may set-up, install or operate this appliance.

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Prerequisites

6.1 Area of installation The installation room must fulfil the following requirements: –– Closed, dry, well-ventilated room –– No purpose-built room (e. g. boiler room or wet room) –– Max. illuminance 1000 Lux, no direct sunlight where the appliance is installed –– No large interference fields (e. g. strong magnetic fields) present which can interfere with the functioning of the appliance. –– Corresponding ambient conditions"4 Technical data".

6.2 System requirements System requirements for computer systems for imaging see leaflet (order number 9000-618-148).

6.3 Monitor The monitor must comply with the requirements for digital X-ray with higher light intensity and high contrast range. Strong ambient light, sunlight falling directly onto the monitor and reflections can reduce the diagnosability of the X-ray images.

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Installation

7.1 Carrying the appliance NOTICE Damage to sensitive appliance components from shocks • Do not expose the appliance to any strong shocks. • Do not move the appliance during operation.

7.2 Setting up the appliance Portable and mobile HF communication appliances can interfere with the effectiveness of electrical medical appliances. • Do not stack the appliance next to or with other appliances. • If the appliance is to be used stacked next to or used with other appliances, monitor the appliance in this configuration to ensure normal operation. The appliance can be installed as a tabletop appliance or mounted on the wall with the wall mounting bracket. The load-bearing capacity of the table or the wall must be suitable for the weight of the appliance (see "4 Technical data"). Place the appliance on a table To prevent errors when scanning the image data, install the appliance so it is not exposed to vibrations. • Place the appliance on a firm, horizontal surface.

7 kg

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Mounting Attaching the appliance with the wall mounting bracket The appliance can be mounted on a wall with the wall mounting bracket (see "3.3 Special accessories").

7.5 Insert memory card • Place the memory card in the appropriate slot (see also "4.1 Image plate scanner").

For installation, see installation instructions for the wall mounting bracket (order number 9000-618-162)

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7.3 Remove the touchscreen protective foil • Take hold of the touchscreen protective foil in one corner and peel off carefully.

7.6 Electrical connection

7.4 Applying stylus • The stylus is held on the unit by a magnet. Place the stylus in the recess provided.

Safety for the electrical connection • The appliance may only be connected to a correctly installed electrical socket outlet. • Do not lay multi-socket units on the floor. Specifications of EN 60601-1-1 apply. • Other systems should not be plugged into the same multi-socket unit. • All cables, etc. must be laid so that no mechanical tension is exerted on them. • Before start-up or first use, check the mains voltage against the voltage indicated on the model identification plate (see also "4. Technical Data"). Connecting the appliance to the power supply The appliance has no main power switch. The appliance must, therefore, be installed so that the socket outlet is easily accessible and can be unplugged if necessary. Requirements: 99 Properly installed socket outlet close to the appliance (max. mains cable length 1.8 m) 99 Easily accessible socket outlet 99 Supply voltage matches the details on the model identification plate of the power unit

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Mounting • Insert the matching country adapter in the power unit.

7.7 Connecting the appliance to a network The unit can be connected via network cable or WLAN to a network. For informationen on connecting via WLAN see "8.1 Installing and configuring the appliance".

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• Remove the cover from the rear side of the appliance.

• Insert the connecting plug of the power unit in the socket of the appliance. • Secure the cable with a cable clip.

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Safe connection of appliance Connecting appliances together or to parts of other units can cause danger to arise (e.g. leakage current). • Only connect units together where it is certain that there will be no danger to operator or to patient. • Only connect units together where it is certain that there will be no danger to the environment. • Where the possible risk of danger cannot be ruled out and is not clear from the appliance data then technical advice from an expert (e.g. manufacturer) should be called to ensure safe connection of units. • When connecting the appliance to other appliances, e.g. a computer system, the respective provisions of IEC 60601‑1‑1 (EN 60601‑1‑1) must be heeded both inside and outside the vicinity of the patients. • Only connect additional appliances (e.g. computer, monitor, printer) which at least comply with the IEC 60950‑1 (EN 60950‑1) standard. A template for the system manufacturer's declaration as per Article 12 of Directive 93/42/EU (order number 9000461-264) can be found in the download area at www.duerr.de. Connecting up the appliance with network cable • Remove the cover from the rear side of the appliance.

• Plug the power plug into the mains supply socket outlet. • Replace the cover. When operating the appliance in the vicinity of the patients, the rear cover must be in place.

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Mounting • Insert the network cable supplied into the network socket of the appliance.

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Operation NOTICE Short circuit due to build up of condensation • The appliance can only be put into operation once it has warmed up to room temperature and it is dry.

8.1 Installing and configuring the appliance The appliance can be operated with the following imaging programs: • Replace the cover. When operating the appliance in the vicinity of the patients, the rear cover must be in place.

–– DBSWIN from Dürr Dental –– VistaEasy from Dürr Dental –– Third-party software on request Setting up the network • Switch on the network appliances (router, PC, and switch). • Check that TCP port 2006 and UDP port 514 are released in the firewall that is used; if not, release them. If you are using the Windows firewall, it is not necessary to check the ports since you are asked if you want to release them during the driver installation process. On connecting to a computer for the first time the unit adapts to the language and the time currently on the computer. Configuring the appliance Configuration is carried out with VistaNetConfig which is automatically installed during the installation of DBSWIN or VistaEasy. • Click Start > All Programs > Dürr Dental > VistaConfig > VistaNetConfig.

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EN