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2142100002L02 1908V007

Product description

4.2 Image plate

Classification

Medical devices class

IIa

Ambient conditions during operation

Temperature

°C

18 - 45

°F

64 - 113

Relative humidity

< 80

Ambient conditions during storage and transport

Temperature

°C

< 33

°F

< 91

Relative humidity

< 80

Dimensions of intraoral image plates

Size 0

22 x 35

Size 1

24 x 40

Size 2

31 x 41

Size 3

27 x 54

Size 4

57 x 76

4.3 Light protection cover

Classification

Medical product class

Содержание VistaScan Mini View

Страница 1: ...EN 1908V007 2142100002L02 Installation and operating instructions VistaScan Mini View ...

Страница 2: ......

Страница 3: ...ch screen on the unit 36 11 4 Erasing the image plate 38 11 5 Switch off the unit 39 12 Cleaning and disinfection 40 12 1 Image plate scanner 40 EN Contents Important information 1 About this document 3 1 1 Warnings and symbols 3 1 2 Copyright information 4 2 Safety 4 2 1 Intended purpose 4 2 2 Intended use 4 2 3 Improper use 5 2 4 General safety information 5 2 5 Specialist personnel 5 2 6 Electr...

Страница 4: ... Stylus 42 13 Maintenance 43 13 1 Recommended maintenance schedule 43 Troubleshooting 14 Tips for operators and service techni cians 44 14 1 Poor X ray image 44 14 2 Software error 50 14 3 Fault on the unit 51 14 4 Error messages on the touch screen 53 Appendix 15 Settings menu layout 55 16 Scanning times 58 17 File sizes uncompressed 59 18 Handover protocol 60 EN ...

Страница 5: ...tions are not followed Dürr Dental will not be able to offer any warranty or as sume any liability for the safe operation and the safe functioning of the unit The German version of the installation and oper ating instructions is the original manual All other languages are translation of the original manual These operating instructions apply to the follow ing VistaScan Mini View units Item number 2...

Страница 6: ...otect against cross contamination Bite protector The bite protector protects the image plate against mechanical damage 2 2 Intended use VistaScan Mini View The unit may only be operated using accesso ries and optional articles manufactured by or branded with Dürr Dental The unit may only be cleaned using the disin fectants and cleaning agents approved by and specified by the manufacturer Light pro...

Страница 7: ...unit hav ing reduced electromagnetic immuni ty leading to an erroneous operation mode Bite protector The bite protector is a disposable item The bite protector is intended solely for use with Dürr Dental image plates and Dürr Dental light protection covers in dental applications 2 3 Improper use Any other usage or usage beyond this scope is deemed to be improper The manufacturer ac cepts no liabil...

Страница 8: ...ompounds i i Dispose of the image plate properly in accord ance with the locally applicable regulations i i In Europe dispose of the image plate in ac cordance with waste code 090199 Wastes not otherwise specified Disposal as domes tic waste is possible NOTICE Erroneous operation mode due to use immediately adjacent to other devices or with other stacked de vices i i Do not stack the unit together...

Страница 9: ...rnet i i Use antivirus software and update it regularly Look for evidence of possible virus infection and if applicable check with the antivirus software and remove the virus i i Perform regular data backups i i Restrict access to units to trustworthy users e g via a user name and password i i Make sure that only trustworthy content is downloaded Only install software and firmware updates that hav...

Страница 10: ...8 2142100002L02 1908V007 3 Overview 1 3 4 5 9 2 6 7 10 11 8 Product description EN ...

Страница 11: ...te scanner 2 Stylus 3 Image plate intraoral 4 Light protection cover intraoral 5 Storage box 6 SDHC memory card fitted in the unit 7 DBSWIN imaging software DVD 8 VistaSoft imaging software DVD 9 Power supply unit with country specific adapter 10 Network cable 11 WLAN stick EN ...

Страница 12: ...cs CCB351B1001 FD 350 Classic disinfection wipes CDF35CA0140 FD 333 rapid surface disinfection CDF333C6150 FD 322 rapid surface disinfection CDF322C6150 FD 366 sensitive rapid surface disin fection CDF366C6150 3 1 Scope of delivery VistaScan Mini View image plate scanner 2142 01 VistaScan Mini View image plate scanner 2142 05 VistaScan Mini View image plate scanner 2142 07 VistaScan Mini View imag...

Страница 13: ...white 2 x 3 cm 100 pcs 2130 080 50 Light Protection Cover Plus size 2 white 3 x 4 cm 300 pcs 2130 082 50 3 5 Wear parts and replacement parts Image plates Plus image plate size 0 2 x 3 cm 2 pcs 2130 040 50 Plus image plate size 1 2 x 4 cm 2 pc 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 Plus image plate size 3 2 7 x 5 4 cm 2 pc...

Страница 14: ...er class unit In accordance with IEC 60825 1 1 Laser source Laser class In accordance with IEC 60825 1 3B Wavelength l nm 635 Output mW 10 General technical data Dimensions W x H x D mm 226 x 275 x 243 in 8 9 x 10 8 x 9 6 Weight kg approx 7 lb approx 15 4 Duty cycle S2 in accordance with IEC 60034 1 min 25 Duty cycle S6 in accordance with IEC 60034 1 25 Pixel size selectable μm 12 5 50 Max theoret...

Страница 15: ...onditions during storage and transport Temperature C 20 to 60 F 4 to 140 Relative humidity 10 95 Air pressure hPa 750 1060 Height above sea level m 16000 ft 52493 Electromagnetic compatibility EMC Interference emission measurements High frequency emissions in accordance with CISPR 11 Group 1 Class B Interference voltage at the power supply connection CISPR 11 2009 A1 2010 Compliant Electromagnetic...

Страница 16: ...rence table near fields of wireless HF communication devices Radio service Frequency band MHz Test level V m TETRA 400 380 390 27 GMRS 460 FRS 460 430 470 28 LTE band 13 17 704 787 9 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 800 960 28 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS 1700 1990 28 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 2400 2570 28 WLAN 802 11 a n 5100 580...

Страница 17: ...nterference due to voltage dips short inter ruptions and voltage variations IEC 61000 4 11 2004 Compliant 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 Compliant Immunity to interference rapid transient bursts I O SIP SOP ports IEC 61000 4 4 2012 1 kV 100 ...

Страница 18: ...n Temperature C 18 45 F 64 113 Relative humidity 80 Ambient conditions during storage and transport Temperature C 33 F 91 Relative humidity 80 Dimensions of intraoral image plates Size 0 mm 22 x 35 Size 1 mm 24 x 40 Size 2 mm 31 x 41 Size 3 mm 27 x 54 Size 4 mm 57 x 76 4 3 Light protection cover Classification Medical product class I EN ...

Страница 19: ...n a PC or directly via the touch screen on the unit The transport mechanism guides the image plate through the device The image plate is read using a laser inside the scanner unit The scanned data is converted into a digital image 4 4 Type plate The type plate is located on the rear of the de vice REF Order number SN Serial number 4 5 Evaluation of conformity This device has been subjected to conf...

Страница 20: ... ray jobs can be transmitted to the unit from oth er computers ScanManager can be enabled via Set tings System Settings Operating Mode If a scanning job is started via the imaging soft ware the image is automatically transmitted to the computer If a scanning job is started via the touch screen the image is saved to the memory card and then needs to be transferred to the computer After scanning the...

Страница 21: ... 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 posed 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 if the protective layer is damaged or there...

Страница 22: ... there is also a hexa decimal code on the image plate in addition to the marker This code can be seen in the X ray image This code allows you to clearly assign the cor rect image plate to the X ray image 1 1 Hexadecimal code 5 3 Light protection cover The light protection cover protects the image plate against light 5 4 Stylus The touch screen can be operated using the stylus as an alternative to ...

Страница 23: ...ct description 5 7 Bite protector optional The bite protector protects the image plate size 4 as well as the light protection cover against heavy mechanical damage e g if the patient bites down too hard during the X ray ex posure EN ...

Страница 24: ...ations i i Place the unit on a firm horizontal surface 7 kg 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 fol lowing requirements Closed dry well ventilated room It should not be a room made for another purpose e g boiler room or wet cell ...

Страница 25: ...t the unit is be set up in such a way that the plug can be easily accessed and unplugged if re quired Requirements Properly installed power outlet close to the unit observe the max mains cable length Easily accessible power outlet Installing the unit with the wall mounting bracket The unit can be mounted on a wall with the wall mounting bracket see 3 3 Optional items For installation refer to the ...

Страница 26: ...er some of the functions are not available in this case Incorrect manual configuration can lead to significant network problems The expert knowledge of a network administrator is required for configuration 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 The d...

Страница 27: ... vary depending on the config uration When the unit is first connected to a computer it applies the language and time settings of the computer i i If it is not 100 clear from the unit data sheet that such connections can be safely made or if you are in any doubt always get a suitably qualified person e g the manufacturer to ver ify that the setup is safe i i Observe the specifications of IEC 60601...

Страница 28: ...its is updated Configuring WLAN on the unit If the unit is to be operated via WLAN the WLAN stick included in the scope of delivery must be inserted into the USB connection on the back of the unit see Connections The connection to the unit then needs to be config ured Proper functioning is only ensured if the WLAN stick supplied by Dürr Dental is used In order to establish a secure WLAN con nectio...

Страница 29: ...the connected unit in the Registered column You can also register multiple units The VistaNet device configuration window al lows you to change the device name name manually enter an IP address or call up informa tion i i Click i i If necessary change the name i i Click Apply to save the configuration Entering a fixed IP address recommended To reset the network settings keep the unit reset key pre...

Страница 30: ... 14 DC emitter 6 mA Tube length 30 cm Without X ray field limitation X ray field limitation 2x3 X ray field limitation 3x4 70 kV mGycm2 70 kV mGycm2 70 kV mGycm2 Incisors 0 13 s 11 8 0 13 s 2 5 0 13 s 5 0 Premolars 0 18 s 16 4 0 18 s 3 4 0 18 s 6 9 Molars 0 25 s 22 8 0 25 s 4 8 0 25 s 9 6 Bite wing 0 27 s 24 6 0 27 s 5 2 0 27 s 10 4 i i Check and adjust the specific X ray unit in accordance with t...

Страница 31: ...ut testing in accordance with local rules and regulations Acceptance test The Intra Extra Digital test body is required for acceptance tests with the image plate and sensor as receivers and possibly also the corresponding test body holder i i Before the unit is started up and used for the first time the acceptance test of the X ray system must be carried out in accordance with national regulations...

Страница 32: ...touch screen due to incorrect handling i i Only operate the touch screen using your fingertips or the stylus i i Do not use a sharp instrument e g ballpoint pen to operate the touch screen i i Protect the touch screen against wa ter i i Operate the touch screen by tapping it with a fingertip or the stylus to select a menu or input field i i For further information about any window tap on the Help ...

Страница 33: ...g about the current status of the device The unit continues to op erate Information Information for the opera tor The unit continues to op erate Normal operation i i Tap on Messages The message is displayed If there are sever al messages the most current with the high est priority is displayed first i i For more information about the message touch Help 9 3 Entering text in the field i i If an inpu...

Страница 34: ... plate if there are any signs of damage e g protective layer is damaged or visible scratches that could interfere with the diagnosis i i Image plates that have a production or pack aging defect will be replaced by Dürr Dental in the same quantity Claims can only be ac cepted within 7 working days after receipt of the goods i i Clean image plates properly see 12 3 Image plate 10 Correct use of imag...

Страница 35: ...eduction in diagnostic information and clarity i i Read the image data within 30 min utes of exposure i i Never handle exposed image plates without the light protection cover i i Do not subject an exposed image plate to X ray radiation before or after the scanning process i i Do not X ray during the scanning process if the unit is in the same room as the X ray tube 11 1 X ray The procedure is desc...

Страница 36: ...h the image plate on the disinfection wipe i i Allow the light protection cover to fully dry i i Pull off the protective gloves disinfect and clean the hands 12 2 Light protection cover i i Allow the light protection cover to fully dry i i In the case of image plates Plus size 4 place the bite protector around the light protection cover with image plate if necessary Taking the X ray image NOTICE D...

Страница 37: ...e powder from your hands before handling the image plate i i Tear off the light protection cover 11 2 Scanning the image data via a computer Starting the image plate scanner and soft ware The reading out process is described us ing the VistaSoft imaging software For further information on using the imag ing software refer to the relevant manual i i Press the on off switch to switch on the device i...

Страница 38: ...e and time and no addi tional information Use Help on the touch screen for further information on operating the unit via the touch screen Requirements Memory card SDHC max 32 GB in the slot on the unit i i Press to switch on the unit Start scanning i i On the touch screen tap on Scan i i Enter the patient data i i Select the image settings and scanning mode i i Slide the image plate out of its lig...

Страница 39: ...only scan the X ray images from the selected patient i i Place the light protection cover with the image plate centrally and straight onto the input unit The opened side of the light protection cover The touch screen will display an animated visual symbol requesting insertion of the im age plate Only insert the image plate when the bar above the animated sequence has turned to green Figure 3 Examp...

Страница 40: ...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 special mode in the following cases The first time the image plate is used or if it is stored for longer than a week faces down the inactive side of the image plate faces the operator The fixing mechanism moves forwards auto matically and takes hold ...

Страница 41: ...omputer Erasing the image plate via the touch screen i i On the touch screen tap on Rapid scan i i Select the scanning mode ERASE i i Scan the image plate see 11 3 Scanning im age data via the touch screen on the unit 11 5 Switch off the unit i i Press the on off switch for 3 seconds As soon as the unit has shut down it switch es off completely The touch screen is off After you switch off the unit...

Страница 42: ...asing compounds strong organic acids or ox ygen releasing compounds as they may damage the materials i i Dürr Dental recommends using disin fectants from the Dürr Dental product range Only the products specified in these instructions have been subject ed to material compatibility testing by Dürr Dental i i Read the operating instructions for the disinfectants Wear protective gloves 12 1 Image plat...

Страница 43: ...orage box FD 366 sensitive Dürr Dental recommends the following disinfect ants for the image plate storage tray FD 350 and FD 366 sensitive i i Clean the surface of the storage box and the image plate storage tray with a soft lint free cloth that has been dampened with cold tap water i i Disinfect the storage box using a disinfection wipe Alternatively use disinfectant on a soft lint free cloth i ...

Страница 44: ...a disinfection wipe Alternatively the image plate storage tray can also be treated in a thermal disinfector or steam steriliser Do not exceed a temperature of 134 C when doing this 12 6 Stylus The stylus can can be cleaned in the same way as the unit see 12 1 Image plate scanner EN ...

Страница 45: ...d on using the device for 15 intraoral images per day on 220 working days per year Maintenance interval Maintenance work Annually i i Visually inspect the device i i Check the image plates for signs of scratches and change if necessary i i Check the belt drives transport belts and springs and replace if necessary i i Remove dust and dirt from accessible parts i i Carry out a system check Every 3 y...

Страница 46: ... plate not exposed i i Expose the image plate X ray unit is faulty i i Inform a Service Technician X ray image too dark X ray dose too high i i Check X ray parameters Incorrect brightness contrast set tings in the software i i Adjust the brightness of the X ray image in the software X ray image too bright Exposed image plate has been exposed to ambient light i i Always scan the image data of the i...

Страница 47: ...nsert the image plate correctly in the light protection cover i i Position the image plate cor rectly Round shadow on the X ray image Plus ID image plate with marker exposed on the wrong side i i When taking an X ray make sure that the active side faces towards the X ray tube Ghosting or double expo sure on X ray image Image plate exposed twice i i Only expose the image plate once Image plate not ...

Страница 48: ...ht protection cover before scanning i i Do not handle image plates without a light protection cover i i Store the image plate in a light protection cover X ray image cut off part missing The metal part of the X ray tube is in front of the X ray beam i i When taking an X ray make sure there are no metal parts between the X ray tube and the patient i i Check X ray tube Faulty edge masking in imaging...

Страница 49: ... ray radiation i i If the image plate has been stored for longer than one week erase the image plate prior to use Parts of image plate exposed to light during handling i i Do not expose used image plates to bright light i i Scan image data within half an hour after the exposure Image plate dirty or scratched i i Clean the image plate i i Replace scratched image plates Light strips in the scan ning...

Страница 50: ...rizontal stripes Incorrect light protection cover or image plate used i i Only use original accessories X ray image split vertically into two halves Dirt in the laser slit e g hair dust i i Clean the laser slit X ray image with small bright spots or clouding Micro scratches on the image plate i i Replace the image plate EN ...

Страница 51: ... image plate becoming detached at the edge Incorrect retainer system used i i Only use original image plates and film retainer systems Image plate handled incorrectly i i Use the image plate correctly i i Observe the operating instruc tions for the image plates and film retainer systems EN ...

Страница 52: ... The IP address of the device is being used by another unit i i Check the network settings IP address and subnet mask and assign a unique IP address to every device i i Inform a service technician if the problem persists The unit does not appear in the options list in Vista Config Unit is connected behind a router i i Configure the IP address without an intermediate router on the unit i i Reconnec...

Страница 53: ...e fault i i Inform a Service Technician Mains supply voltage too low i i Check the mains voltage Unit is on but there is no display on the touch screen Touch screen initialisation fault i i Switch the unit off and back on again Touch screen brightness set too dark i i Update the firmware i i Increase the brightness of the touch screen Touch screen defective i i Inform a Service Technician Loud ope...

Страница 54: ...ick i i Set up the unit closer to the WLAN router Another WLAN network is affect ing the operation of the unit s WLAN network i i Change the frequency range of the WLAN network Connecting cable between device and computer not correctly con nected i i Check the connection cable The IP address of the device is being used by another unit i i Check the network settings IP address and subnet mask and a...

Страница 55: ...the scanning modes to the factory settings via the unit interface or the Imaging Software Error code 1100 Permitted time for scan process exceeded i i Inform a Service Technician i i Check the belt drive i i Check for blockage remove image plate from unit Error code 1104 Erasure unit fault i i Inform a Service Technician i i Replace the erasure unit Error code 1116 Drive feed blocked i i Remove th...

Страница 56: ... fed in off centre i i Insert the image plate centrally Error code 10017 Unit shutting down i i Wait until the unit has shut down completely Error code 2 System error during startup of the unit i i Switch the unit off and back on again i i Update the firmware Error code 78 Memory card full i i Transfer the image data to the computer i i Insert an empty memory card Fault during memory cleanup i i P...

Страница 57: ...2142100002L02 1908V007 55 15 Settings menu layout Device Information1 Unit data Dealer information Report Access level1 Operator Administrator Service technician Factory technician Appendix EN ...

Страница 58: ...ettings Patient ID Surname First name Date of birth Male female Pregnancy Comment X ray station X ray parameters Acquisition type INTRA Child X ray stations Room 1 Room 2 Touch screen Brightness Touch screen calibra tion Device settings Standby Standby time Fade out time menu Autom rotation Query radiation dose Patient ID scheme Service information Service interval Operating mode ScanManager EN ...

Страница 59: ...y error counters Manipulation Transport Insert Erasure unit Pentaprism PMT Query sensor values Sensors Temperatures Internal device voltages Oscilloscope Check touch screen Display test images Factory settings Reset scanning modes 1 Visible from access level Operator or higher 2 Visible from access level Administrator or higher 3 Visible from access level Service Technician or higher EN ...

Страница 60: ...e The time to image will depend largely on the computer system used and its work load Times stated are approximate Theoretical resolution LP mm 40 25 20 10 Pixel size μm 12 5 20 25 50 Intra Size 0 2 x 3 26 s 16 s 13 s 6 s Intra Size 1 2 x 4 32 s 20 s 16 s 8 s Intra Size 2 3 x 4 32 s 20 s 16 s 8 s Intra Size 3 2 7 x 5 4 40 s 25 s 20 s 10 s Intra Size 4 5 7 x 7 6 53 s 33 s 27 s 14 s EN ...

Страница 61: ...mpression methods can considerably reduce the file size without loss of data Theoretical resolution LP mm 40 25 20 10 Pixel size μm 12 5 20 25 50 Intra Size 0 2 x 3 9 86 MB 3 85 MB 2 46 MB 0 62 MB Intra Size 1 2 x 4 12 29 MB 4 80 MB 3 07 MB 0 77 MB Intra Size 2 3 x 4 16 27 MB 6 36 MB 4 07 MB 1 02 MB Intra Size 3 2 7 x 5 4 19 01 MB 7 43 MB 4 75 MB 1 19 MB Intra Size 4 5 7 x 7 6 55 45 MB 21 66 MB 13...

Страница 62: ...device Product name Order number REF Serial number SN o Visual inspection of the packaging for any damage o Unpacking the medical device and checking for damage o Confirmation of the completeness of the delivery o Instruction in the proper handling and operation of the medical device based on the operating instructions Notes Name of person receiving instruction Signature Name and address of the qu...

Страница 63: ......

Страница 64: ...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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