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2170100001L29 2109V005

Assembly

EN

8.6 Acceptance tests

The required tests (eg acceptance tests) must
be carried out in accordance with local rules
and regulations

i

Find out which tests are required

i

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
possibly also the corresponding test
body holder

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
The consistency tests, which must be carried
out at regular intervals by the dental profes-
sional, are based on the results of the accept-
ance test

Electrical safety checks

i

Carry out the electrical safety check according
to the national law (eg in accordance with
IEC 62353)

i

Document the results

i

Carry out and document the instruction and
handover for the unit

A sample handover report is included in
the appendix

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Содержание VistaScan Ultra View

Страница 1: ...Installation and Operating Instructions VistaScan Ultra View 2109V005 2170100001L29 EN ...

Страница 2: ......

Страница 3: ...e data via a computer 36 11 4 Scanning image data via the touch screen on the unit 37 11 5 Erasing the image plate 39 11 6 Switching off the unit 39 Contents Important information 1 About this document 3 1 1 Warnings and symbols 3 1 2 Copyright information 5 2 Safety 6 2 1 Intended purpose 6 2 2 Intended use 6 2 3 Improper use 6 2 4 General safety information 6 2 5 Specialist personnel 6 2 6 Elect...

Страница 4: ...intenance schedule 42 Troubleshooting 14 Tips for operators and service techni cians 43 14 1 Poor X ray image 43 14 2 Software error 46 14 3 Fault on the unit 48 14 4 Error messages on the touch screen 49 Appendix 15 Scanning times 51 16 File sizes un compressed 51 17 Electromagnetic compatibility EMC compliance information 52 18 Manufacturer s Guidance and Declara tion Electromagnetic Emissions 5...

Страница 5: ... of the unit 1 1 Warnings and symbols Warnings The warnings in this document are intended to draw your attention to possible injury to persons or damage to machinery The following warning symbols are used General warning symbol Warning dangerous high voltage The warnings are structured as follows Signal word Description of type and source Here you will find the possible conse quences of ignoring t...

Страница 6: ...diation expo sure The laser is on only during an active scan i Alerts user that VistaScan Ultra View be comes a Class 3B device when opened Only a trained technician from an authorised dealer should remove a cover from the VistaScan Ultra View Direct eye contact with the output beam from the laser may cause serious damage and possible blindness EN ELECTRIC SHOCK RISK i The power line cord is the m...

Страница 7: ...ormation on handling i Equipment disposal Disposal of VistaScan Ultra View including internal electronic circuitry and image plates must be carried out only at the appropriate facilities for recovery and re cycling Make sure that such items are dis posed of in accordance with current federal national state and local government rules and regulations i Keep device dry Do not spray solvents or liquid...

Страница 8: ...vices i Keep a minimum distance of 30 cm between the unit and mobile radio devices 2 Safety The VistaScan Ultra View has been designed and constructed so that when used properly and for the intended purpose it does not pose any danger to people or property Nevertheless residual risks can remain You should therefore observe the following notes 2 1 Intended purpose VistaScan Ultra View The unit is i...

Страница 9: ...er patient is required to report to the manufacturer and the competent authority of the Member State in which the user and or patient is established any serious incident that has oc curred in relation to the device 2 9 Only use original parts i Only use Dürr Dental parts or accessories and optional articles specifically approved by Dürr Dental Only use original wear parts and re placement parts Dü...

Страница 10: ...rr Dental Further information can be found on our web site www dürrdental com i See section 6 for the supported operating sys tems and computer requirements EN 2 14 Protection from threats from the Internet The unit is to be connected to a computer that can be connected to the Internet Therefore the system needs to be protected from threats from the Internet i Use antivirus software and update it ...

Страница 11: ...guide intraoral 4 VistaScan Image Plate IQ 5 VistaScan Light Protection Cover Plus 6 SDHC memory card 7 DBSWIN imaging software data carrier 8 VistaSoft imaging software data carrier 9 Network cable 10 Country specific detachable mains cable 11 Power supply unit 12 Wireless network adapter 13 Plate guide storage rack 14 Image plate cleaning wipes not shown Product description EN ...

Страница 12: ... authorized dealer immediately so corrective ac tion can be taken Save all cartons and packing materials to protect VistaScan Ultra View in the event that it is to be transported or shipped in the future VistaScan Ultra View system includes the basic unit and associated accessory kit as listed below Verify that all listed items were received If any item is missing notify your dealer The following ...

Страница 13: ...2130106451 VistaScan IQ Pack S4 containing VistaScan Image Plate IQ S4 1 pc VistaScan Light Protection Cover Plus S4 100 pcs 3 5 Optional articles The following optional articles can be used with the unit Plate guide storage rack 2170103000 Wall bracket 2170100100 Storage box 2141 002 00 Bite protector size 4 100 pcs 2130 074 03 Image plate and film holder system set 2130 981 50 Image plate and fi...

Страница 14: ...6 Laser source Laser class IEC 60825 1 2014 3B Wavelength nm 635 Output mW 10 VistaScan Ultra View physical characteristics Dimensions W x H x D cm 25 1 X 39 1 X 29 2 in 9 9 X 15 4 X 11 5 Weight kg approx 8 0 lb approx 17 64 Noise levels Ready dB A 40 Scanning dB A 60 General values Laser class unit IEC 60825 1 2014 1 Medical appliance category I Maximum feeding width for image plates cm 5 7 in 2 ...

Страница 15: ...of cable CAT5 WLAN connection WLAN technology IEEE 802 11b g Encryption WPA WPA2 Memory card Type SDHC Maximum memory capacity GB 32 File system FAT32 Performance class Class 4 Ambient conditions during operation Temperature C 10 to 35 F 50 to 95 Air pressure hPa 750 to 1060 in Hg 22 15 to 31 30 Altitude m 2000 ft 6562 Humidity 20 to 80 Ambient conditions during storage and transport Temperature C...

Страница 16: ...ts cover Immunity to interference discharge of static electricity IEC61000 4 2 2008 8kV contact 2kV 4kV 8kV 15kV air Compliant Immunity to interference high frequency electromagnetic fields IEC61000 4 3 2006 A1 2007 A2 2010 3V m 80MHz 2 7GHz 80 AMat1kHz Compliant Immunity to interference near fields of wireless HF communication devices IEC61000 4 3 2006 A1 2007 A2 2010 See immunity to interference...

Страница 17: ...y bands 0 15 80 MHz 80 AM at 1kHz Compliant Immunity to interference due to voltage dips short interruptions and voltage variations IEC61000 4 11 2004 Compliant Electromagnetic compatibility EMC Interference immunity measurements SIP SOP Immunity to interference discharge of static electricity IEC61000 4 2 2008 8 kV contact 2 kV 4 kV 8 kV 15 kV air Compliant Immunity to interference rapid transien...

Страница 18: ...bient conditions during storage and transport Temperature C 33 F 91 Relative humidity 80 Dimensions of intraoral image plates Size 0 mm 22 x 35 in 0 87 x 1 38 Size 1 mm 24 x 40 in 0 94 x 1 57 Size 2 mm 31 x 41 in 1 22 x 1 61 Size 3 mm 27 x 54 in 1 06 x 2 13 Size 4 mm 57 x 76 in 2 24 x 2 99 4 3 Light protection cover Classification Medical device class I Product description EN ...

Страница 19: ...ad image data stored on the image plate The unit can be used in two different ways via the imaging software e g VistaSoft on 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 If a scanning job is started via the imaging s...

Страница 20: ... computers Make sure the different com puters used are given unique names so it is known which computer the X ray job is com ing from Connections The connections are located on the rear of the unit underneath the cover 2 3 1 1 USB connection for WLAN stick 2 Network connection use unshielded type Cat 5e cable only 3 Power supply unit connection 5 2 Image plate The term image plate is for reasons o...

Страница 21: ...arts listed in section 3 2 and 3 3 The light protection cover protects the image plate against light 5 4 Protection cover The protection cover protects the device against dust and dirt for example during extended periods in which it is not in use 5 5 Storage box Image plates packaged in light protection covers can be stored in the storage box until they are next used The storage box protects the i...

Страница 22: ...the room for set up e g strong magnetic field Any such disturbances can interfere with the operation of the VistaScan Ultra View In order to avoid problems when scan ning the image data VistaScan Ultra View should be set up so that it will not be subject to knocks vibration or similar 6 2 Counter top table set up Provide a stable flat counter top or table large enough for the scanner work area and...

Страница 23: ...he unit can be set up as a tabletop unit or mounted on a wall using the wall bracket The load bearing capacity of the table or wall must be suitable for the weight of the unit see 4 Technical data Setting the unit on a table i Place the unit on a firm horizontal surface Installing the unit with wall mounting bracket The unit can be mounted on a wall with the wall mounting bracket see 3 3 Optional ...

Страница 24: ... power outlet close to the unit observe the max mains cable length Easily accessible power outlet Mains voltage must match the rating shown on the power supply unit type plate Only the supplied power supply unit may be used i Remove the cover from the rear of the device i Attach the matching country specific mains cable to the power supply unit i Plug the connecting plug of the power supply unit i...

Страница 25: ...ge or harm to the surroundings 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 verify that the setup is safe i Observe the specifications of IEC 60601 1 EN 60601 1 when connecting the appliance with other appliances e g a PC system both in and outside the patient env...

Страница 26: ...ion When the unit is first connected to a computer it applies the language and time settings of the computer Assembly EN 8 2 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 configured Proper functioning is ...

Страница 27: ...g instal lation of DBSWIN or VistaEasy i Select Start All Programs Dürr Dental VistaConfig VistaNetConfig i Click The list of connected units is updated i Activate the connected unit in the Registered column You can also register multiple units The VistaNet device configuration window allows you to change the device name name manually enter an IP address or call up information EN Click i If necess...

Страница 28: ...on 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 Without X rayfield limitation X ray field limitation 2x3 X ray field limitation 3x4 60kV mGycm µGy 60 kV mGycm µGy 60 kV mGycm µGy Incisors 0 10 s 18 3 538 7 0 10 s 3 8 546 4 0 10 s 7 7 549 9 Premolars 0 14 s 25 6 766 8 0 1 s 5 4 766 2 0 14 s 10 8 768 9 M...

Страница 29: ...lars 0 20 s 20 0 881 0 0 20 s 3 8 781 1 0 20 s 7 7 781 9 Bite wing 0 20 s 20 0 881 6 0 20 s 3 8 781 1 0 20 s 7 7 781 9 DC emitter 70kV 6mA Tube Length 20cm Without X ray field limitation X ray field limitation 2x3 X ray field limitation 3x4 70 kV mGycm µGy 70 kV mGycm µGy 70 kV mGycm µGy Incisors 0 07 s 14 4 448 4 0 07 s 3 0 449 8 0 07 s 6 1 449 7 Premolars 0 10 s 20 6 642 3 0 10 s 4 3 643 1 0 10 ...

Страница 30: ...nd possibly also the corresponding test body holder 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 The consistency tests which must be carried out at regular intervals by the dental profes sional are based on the results of the accept ance test Electrical safety checks i Carry out the e...

Страница 31: ... the window cannot be com pletely displayed on the touch screen a scroll bar appears Touch hold and slide the bar up or down to move the displayed section in the win dow Scrolling may also be done by continuously pressing the arrow keys to move the displayed section up or down i Tap or to move the displayed sec tion of the window 9 2 Using menus The integrated menus within the main window contain ...

Страница 32: ...m settings can be viewed and edited via the touch screen icons listed below Language Select the output lan guage of the unit English German Date Time Edit the settings for date and time Network View the MAC address of the unit Edit the name of the net work and interface Activate or deactivate DHCP Edit IP address subnet mask and gateway Touch screen Set the brightness of the monitor Touch screen c...

Страница 33: ...e magnifying glass To magnify the image swipe across the X ray image from left to right The size ratio is dis played on the right next to the magnifying glass To reduce the image swipe across the X ray image from right to left Move the magnified image section Touch the magnifying glass symbol until the display disappears Touch the X ray image and move to the required image section Rotate the image...

Страница 34: ...amma value of the image To increase the gamma value move the controller to the right or touch the right arrow several times To reduce the gamma value move the controller to the left or touch the left arrow several times Switch between the pos itive and negative display of the image Vertically invert the image Horizontally invert the image Display help Save all changes Undo last change Cancel image...

Страница 35: ...ient s mouth rinse the mouth thoroughly with lots of wa ter Do not swallow the water in the process Image plates must only be read using an image plate scanner that is approved by Dürr Dental Image plates are flexible like X ray film How ever the image plates should not be bent i Do not scratch the image plates Do not sub ject the image plates to pressure from hard or pointed objects i Do not soil...

Страница 36: ...ssing 11 2 X ray The procedure is described using a size 2 VistaScan Image Plate IQ S2 as an ex ample Required accessories VistaScan Image Plate IQ VistaScan Light Protection Cover Plus of the same size as the image plate Plate guide and image plate are same size WARNING Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once i ...

Страница 37: ...light protec tion cover from the patient s mouth WARNING Contamination of the unit i Clean and disinfect the light protec tion cover before removing the image plate i Completely slide the image plate into the light protection cover The white inactive side of the image plate must be visible back IQ 2 E24721301042100 01234567F ba ck IQ 2 E24721301042100 01234567F i Pull off the adhesive strip fold d...

Страница 38: ...nly insert the image plate when the bar above the animated sequence has turned to green NOTICE VistaScan Ultra View only scans images using VistaScan Image Plate IQ made by Dürr Dental i Use only VistaScan Image Plate IQ i In the event of heavy soiling e g from blood dry clean the light protection cover and protective gloves e g wipe with a clean cellulose cloth i Disinfect the light protection co...

Страница 39: ... displayed on the touch screen After it has been scanned the image plate is erased and drops into the collection tray i Save the X ray image i Remove the image plate and prepare to take a new X ray 11 4 Scanning image data via the touch screen on the unit Starting the image plate scanner When scanning the image data via the touch screen there is no need for a PC connection The image data is stored...

Страница 40: ... into the device until the im age plate is automatically drawn in The light protection cover is held in place by the plate guide and is not transported into the unit Scanning progress is displayed on the touch screen The image data is automatically saved to the memory card The touch screen only shows a pre view which provides an initial impres sion of the X ray image For the pur pose of diagnosis ...

Страница 41: ...de ERASE i Scan the image plate see 11 4 Scanning im age data via the touch screen on the unit If you do not want the image data to be erased this function can be disabled for the current scanning process by selecting Disable erasing light on the touch screen of the unit 11 6 Switch off the unit Press the On Standby switch for 2 seconds As soon as the unit has shut down it switches off completely ...

Страница 42: ...aces using a disinfection wipe Alternatively use disinfectant on a soft lint free cloth 12 2 Light protection cover The surface of the unit must be cleaned and disinfected if it is contaminated or visibly soiled i Disinfect the light protection cover using a dis infectant before and after placement Dürr Dental recommends FD 333 forte wipes viru cidal FD 350 limited virucidal activity and FD 322 pr...

Страница 43: ... box and the image plate storage tray with a soft lint free cloth that has been dampened with cold tap water i Disinfect the storage box using a disinfection wipe Alternatively use disinfectant on a soft lint free cloth i Disinfect the image plate storage tray using a disinfection wipe Alternatively the image plate storage tray can also be treated in a thermal disinfector or steam sterilizer Do no...

Страница 44: ...ntervals are based on using the device for 15 intraoral images per day on 220 working days per year Maintenance interval Maintenance work Annually i Visually inspect the device i Check the image plates for signs of scratches and change if necessary i Check the belt drives transport belts and springs and replace if necessary i Remove dust and dirt from accessible parts i Carry out a system check Ev...

Страница 45: ...X ray image too dark X ray dose too high i Check X ray parameters Incorrect brightness contrast set tings in the software 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 Always scan the image data of the image plate as soon as possible X ray dose too low i Check X ray parameters Incorrect brightness contrast ...

Страница 46: ...lates without a light protection cover i Store the image plate in a light protection cover X ray image cut off part missing A metal part of the X ray tube is in front of the X ray beam i Recording an X ray image make sure there are no metal parts between the X ray tube and the patient i Check X ray tube Faulty edge masking in imaging software i Deactivate edge masking Software unable to combine th...

Страница 47: ...hour after the exposure Image plate dirty or scratched i Clean the image plate i Replace scratched image plate Bright stripes in the scanning window Too much incident ambient light during the scanning process i Darken the room i Turn the unit so that no light is directly in cident on the input unit Horizontal grey lines in the X ray image extending beyond the left and right image edge Transport sl...

Страница 48: ...operating instructions of the image plate and film retainer systems Imaging software displays two ac quisition images as one image Two image plates were fed into the unit simultaneously The status of the feeding indicator bar display was not regarded Only one Image plate can be fed into the unit when the feeding indicator bar display is green See section 11 3 and 11 4 14 2 Software error Problem P...

Страница 49: ...g and register the unit The IP address of the unit is being used by another unit i Check the network settings IP address and subnet mask and assign a unique IP address to each unit i Inform a service technician if the problem persists The unit appears in the VistaConfig selection list but no connection Subnet masks of the computer and the unit do not match i Check subnet masks adjust if necessary ...

Страница 50: ...secs after unit is turned on Radiation deflector defective i Contact technician Unit not responding The unit has not yet completed the startup procedure i Wait 20 30 seconds for the startup pro cedure to be completed Unit is blocked by the firewall i Enable unit ports in the firewall settings Unit is on touch screen does not display Touch screen initialization fault Screen brightness set too dark ...

Страница 51: ...anning modes to the fac tory settings via the unit interface or the Imaging Software Error code 1100 Permitted time for scan pro cess exceeded i Contact technician i Check the belt drive i Check for blockage remove image plate from unit Error code 1104 Erasure unit fault i Contact technician i Replace the erasure unit Error code 1153 Unit fault i Switch the unit off and on again i Update firmware ...

Страница 52: ...gain i Update the firmware Error code 78 Memory card full i Transmit image data to the computer i Insert an empty memory card Fault during memory cleanup i Press and hold the reset button while switching on the unit i Update firmware i Press and hold the reset button while switching on the unit Firmware not running Firmware update has been carried out i Switch the unit off and on again Internal co...

Страница 53: ...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 16 File size uncompressed The actual file size will depend on the image plate format and the pixel size File sizes stated are ap proximate and have been rounded upwards Suitable compression 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 ...

Страница 54: ... Ultra View is intended to be used within the electromagnetic environment specified be low The user of the VistaScan Ultra View should ensure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Guidance RF emissions ClSPR 11 Group 1 VistaScan Ultra View uses radio electric energy only for its internal subsystems It therefore emits very low energy and is not...

Страница 55: ...V line s to line s 2 kV line s to earth 1kV N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ur 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles 5 Ur 95 dip in Ur for 5 s 5 Ur 10ms 40 Ur 100ms 70 Ur 500ms 5 Ur 5 s Main...

Страница 56: ...gths a from fixed RF transmit ters as determined by an electromagnetic site survey should be less than the com pliance level in each frequency b Interference can occur nearby devic es bearing the following symbol Note 1 At 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from stru...

Страница 57: ... the transmitter W Separation distance as a function of the transmitter s frequency m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 16 P d 1 16 P d 2 33 P 0 01 0 116 0 116 0 233 0 1 0 366 0 366 0 736 1 1 16 1 16 2 33 10 3 66 3 66 7 36 100 11 6 11 6 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be establishe...

Страница 58: ...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...

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Страница 62: ...2 705 0 www duerrdental com info duerrdental com Air Techniques Inc 1295 Walt Whitman Road Melville New York USA 11747 3062 www airtechniques com Medical Device Safety Service Schiffgraben 41 30176 Hannover Germany Australian Sponsor Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia ...

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