Durr Dental VistaScan Nano Easy Скачать руководство пользователя страница 15 | Manualshive

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Durr Dental VistaScan Nano Easy Скачать руководство пользователя страница 15

2160100227L02 1910V008

13

Product description

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 kHz repetition frequency

Compliant

Immunity to interference, line-conducted disturbances
induced by high-frequency fields – SIP/SOP ports
IEC 61000-4-6:2013
3 V
015 - 80 MHz
6 V
ISM frequency bands
015 - 80 MHz
80 % AM at 1 kHz

Compliant

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

mm

22 x 35

inches

087 x 138

Size 1

mm

24 x 40

inches

094 x 157

Size 2

mm

31 x 41

inches

122 x 161

4.3 Light protection cover

Classification

Medical product class

I

EN

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Содержание VistaScan Nano Easy

Страница 1: ...EN 1910V008 2160100227L02 Installation and operating instructions VistaScan Nano Easy ...

Страница 2: ......

Страница 3: ...box with image plate storage tray 33 12 Maintenance 34 12 1 Recommended maintenance schedule 34 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 4 2 4 General safety information 5 2 5 Specialist personnel 5 2 6 Electrical safety 5 2 7 Essential performance character...

Страница 4: ...tents Troubleshooting 13 Tips for operators and service techni cians 35 13 1 Poor X ray image 35 13 2 Software error 39 13 3 Fault on the unit 40 Appendix 14 Scanning times 42 15 File sizes uncompressed 43 16 Handover record 44 EN ...

Страница 5: ...t These installation and operating instructions represent part of the unit If the instructions and information in these installation and operating instruc 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 man...

Страница 6: ...nit may only be cleaned using the disin fectants and cleaning agents approved by and specified by the manufacturer Light protection cover The Light Protection Cover is a disposable item The Light Protection Cover is designed exclu sively for use with image plate scanners manu factured by or branded with Dürr Dental and im age plates manufactured by or branded with Dürr Dental 2 3 Improper use Any ...

Страница 7: ...Nano Easy This unit is not suitable for monitoring patients over longer periods of time This unit must not be operated in operating theatres or similar rooms in which dangers may arise from the combustion of flammable materials Light protection covers Especially The multiple use of this accessory and reprocessing contrary to the instructions of the manufacturer The use of the accessory in combinat...

Страница 8: ...icat ed by the manufacturer 2 7 Essential performance charac teristics The VistaScan Nano Easy unit does not pos sess any significant performance characteristics as set out in IEC 60601 1 EN 60601 1 section 4 3 The unit complies with the requirements accord ing to IEC 60601 1 2 2014 2 8 Notification requirement of seri ous incidents The operator patient is required to report any serious incident t...

Страница 9: ...6 1 VistaScan Nano Easy image plate scanner 2 Cartridge for image plates S0 up to S2 3 IQ image plate 4 Light protection cover Plus 5 DBSWIN imaging software DVD 6 VistaSoft imaging software DVD 7 Network cable 3 m 8 Power supply unit with country specific adapter Product description EN ...

Страница 10: ...size 2 3 x 4 cm 1000 pcs 2130 082 55 Light Protection Cover Plus size 0 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 1 Scope of delivery The following items are included in the scope of delivery possible variations due to country spe cific requirements and or import regulations VistaScan Nano Easy image plate scanner 2160110001 VistaSca...

Страница 11: ...cm 2 pcs 2130104150 Image plate IQ size 2 3 x 4 cm 4 pcs 2130104250 Image plate IQ size 2 3 x 4 cm 12 pcs 2130104255 Cartridges Cartridge for image plate S0 2160100246 Cartridge for image plate S1 2160100247 Cartridge for image plate S2 2160100248 Information about replacement parts is available from the portal for authorised specialist dealers at www duerrdental net EN ...

Страница 12: ... x 9 09 x 8 50 Weight kg approx 4 lb approx 8 82 Duty cycle 100 Max theoretical resolution Line pairs mm Lp mm approx 16 7 Noise level During scanning dB A approx 45 Network connection LAN technology Ethernet Standard IEEE 802 3u Data rate Mbit s 100 Connector RJ45 Type of connection Auto MDI X Cable type CAT5 Ambient conditions during operation Temperature C 10 to 35 F 50 to 95 Relative humidity ...

Страница 13: ...ce radiation CISPR 11 2009 A1 2010 Compliant Electromagnetic compatibility EMC Interference immunity measurements cover Immunity to interference discharge of static electricity IEC 61000 4 2 2008 8 kV contact 2 kV 4 kV 8 kV 15 kV air Compliant Immunity to interference high frequency electromagnet ic fields IEC 61000 4 3 2006 A1 2007 A2 2010 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Compliant Immunity to...

Страница 14: ...00 5800 9 Electromagnetic compatibility EMC Interference immunity measurements supply input Immunity to interference rapid transient bursts AC voltage grid IEC 61000 4 4 2012 2 kV 100 kHz repetition frequency Compliant Immunity to interference surges IEC 61000 4 5 2005 0 5 kV 1 kV Compliant Immunity to interference line conducted disturbances induced by high frequency fields AC voltage grid IEC 61...

Страница 15: ...cted disturbances induced by high frequency fields SIP SOP ports IEC 61000 4 6 2013 3 V 0 15 80 MHz 6 V ISM frequency bands 0 15 80 MHz 80 AM at 1 kHz Compliant 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 Dimen...

Страница 16: ...are After scanning the image plate runs through the erasure unit Image data still held on the image plate is erased with the aid of bright light The image plate is then ejected for re use 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 conformity acceptance testing in accordance wit...

Страница 17: ...e that is currently in the device is indicated via the LEDs on the device Operating elements 8 5 1 4 3 2 7 6 1 On off switch 2 Error display yellow 3 Read display blue 4 Green status LED 5 Communication standby display white 6 Display for cartridge S2 7 Display for cartridge S1 8 Display for cartridge S0 The status LEDs display the following status messages Device starts Communication display Stan...

Страница 18: ...al 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 are visible scratches that could interfere with the diagnosis Intraoral Inactive side Active side back IQ 2 E24721301042100 01234567F White printed with the word back and the size and manu facturer s information Light blue with po...

Страница 19: ...it with the wall mounting bracket The unit can be mounted on a wall with the wall mounting bracket see 3 3 Optional items 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 b...

Страница 20: ...eading to the unit are under any mechanical tension i i Before initial start up check that the mains supply voltage and the voltage stated on the type plate match see also 4 Technical data Connecting the unit to the mains supply The unit has no main power switch For this reason it is important that the unit is be set up in such a way that the plug can be easily accessed and unplugged if re quired ...

Страница 21: ...ts such as com puters monitors or printers that conform at least to the requirements set out in IEC 60950 1 EN 60950 1 i i The connected computer must conform to EN 55032 class B and EN 55024 i i Plug in the connecting plug of the power sup ply unit into the socket connection of the de vice i i Plug the mains plug into the power outlet i i Refit the cover The cover on the rear must be properly int...

Страница 22: ...omatic configuration via Auto IP for direct connection of unit and computer Manual configuration i i Configure the network settings of the unit us ing the software or if applicable the touch screen i i Check the firewall and release the ports if ap plicable Network protocols and ports Port Purpose Serv ice 45123 UDP 45124 UDP Unit recognition and configuration 2006 TCP Unit data 5141 UDP Event pro...

Страница 23: ...ct the unit i i Mark the connected unit in the list i i Click on Edit connection settings i i The unit name designation can be changed and information queried working under Gen eral i i An IP address can be entered manually and DHCP can be activated deactivated working under Connection Entering a fixed IP address recommended To reset the network settings keep the unit reset key pressed for 15 20 s...

Страница 24: ... i i Enter the IP address subnet mask and gate way i i Click on Apply The configuration is saved Testing the device You can scan in an X ray image to check that the unit is properly connected i i Select the Test tab i i Select the unit from the Registered Units list i i Select the mode class i i Select the mode i i Click on Scan Image i i Scan an image plate see 10 3 Scanning the image data EN ...

Страница 25: ...emitter 6 mA Tube length 30 cm Without X ray field limitation X ray field limitation 2x3 X ray field limitation 3x4 60 kV mGycm2 60 kV mGycm2 60 kV mGycm2 Incisors 0 15 s 13 7 0 15 s 4 9 0 15 s 5 8 Premolars 0 20 s 18 2 0 20 s 3 8 0 20 s 7 7 Molars 0 27 s 24 6 0 27 s 5 2 0 27 s 10 4 Bite wing 0 28 s 25 5 0 29 s 5 6 0 28 s 10 8 i i Check and adjust the specific X ray unit in accordance with the sta...

Страница 26: ...out 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 regulation...

Страница 27: ...flexible like X ray film How ever the image plates should not be bent 9 Correct use of image plates WARNING Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once i i Do not use an image plate without a light protection cover i i Do not use the light protection cover more than once disposable item CAUTION The image data on the ...

Страница 28: ...image plates Do not sub ject the image plates to pressure from hard or pointed objects i i Do not soil the image plates i i Protect the image plates against sunlight and ultraviolet light Store image plates in a light protection cover or intraoral extraoral foil cassette of the cor rect size i i Image plates will be pre exposed on exposure to natural radiation and stray x ray radiation Protect era...

Страница 29: ... The green status LED lights up The green display for the corresponding cartridge lights up The input unit is ready i i Check that the correct cartridge has been in serted with the display S0 S1 S2 If the incorrect cartridge has been inserted it must be removed and the correct cartridge inserted i i Open the cover i i Remove cartridge EN ...

Страница 30: ...y The procedure is described using a size 2 IQ image plate as an example Required accessories Image plate Light protection cover the same size as the image plate WARNING Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once i i Do not use an image plate without a light protection cover i i Do not use the light protection cover...

Страница 31: ...o the image plate caused by a sharp edged holding system i i Only use holding systems that will not damage the light protection cover or the image plates in any way i i Do not use holding systems with sharp edges Wear protective gloves i i Place the image plate in the light protection cover into the patient s mouth When doing this make sure that the active side of the image plate points towards th...

Страница 32: ... the unit 10 3 Scanning the image data 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 i Switch on the computer and monitor i i Start VistaSoft i i Select the patient i i Select the corres...

Страница 33: ...the special ERASE mode in the soft ware i i Insert the image plate see Scanning the im age plate 10 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 LEDs go out i i Remove the empty light protection cover i i Once the image plate has been inserted into the unit close the cover and leave it closed throughout the entire...

Страница 34: ... Heat or humidity will damage the im age plate i i Do not steam sterilise the image plate i i Do not immersion disinfect the image plate i i Only use cleaning agents that are compatible with the materials 11 Cleaning and disinfection When cleaning and disinfecting the unit and its accessories observe country specific directives standards and specifications for medical prod ucts as well as the spec...

Страница 35: ...ation or visible soiling Dürr Dental recommends the following disinfect ant for the storage 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...

Страница 36: ...intenance intervals are based on using the device for 25 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 Remove dust and dirt from accessible parts i i Carry out a system check Every 3 years i i Exchange the cartridges EN ...

Страница 37: ...e data on image plate image plate not exposed or not sufficiently exposed i i X ray tubes check unit settings i i Expose the image plate X ray unit is faulty i i Inform a Service Technician Incorrect cartridge light protec tion cover was also pushed into the unit i i Use the correct cartridge for the size of image plate being used Image plate falls out of the unit and no image appears on the monit...

Страница 38: ...fication HV value Unsuitable scanning mode select ed i i Select a suitable scanning mode Ghosting or double expo sure on X ray image Image plate exposed twice i i Only expose the image plate once Image plate not sufficiently erased i i Check the erasure unit is work ing correctly i i Inform a service technician if the problem persists X ray image mirrored in one corner Image plate bent during X ra...

Страница 39: ...ay 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 software i i Deactivate edge masking Software unable to com bine the data to make a complete image The X ray dose on the image plate was insufficient i i Increase X ray dose Amplification HV value is set too low in the software i i Increase ...

Страница 40: ...ess Light strips in the scan ning window Too much incident ambient light during the scanning process i i Darken the room i i Turn the unit so that the light does not fall directly onto the input unit X ray image with small bright spots or clouding Micro scratches on the image plate i i Replace the image plate Lamination of the image plate becoming detached at the edge Incorrect retainer system use...

Страница 41: ...ice Technician 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 Error message E2490 The connection to the unit was interrupted while the software was still attempting to communi cate with the unit i i Restore the connection to th...

Страница 42: ...g not inserted correctly i i Check the mains cable and plug connections Hardware fault i i Inform a Service Technician Mains supply voltage too low i i Check the mains voltage Unit is on but none of the indicator LEDs are lit up status error or operating LEDs Display defective i i Inform a Service Technician Unit not responding The unit has not yet completed the startup procedure i i After switchi...

Страница 43: ...P address and subnet mask and assign a unique IP address to every device i i Inform a service technician if the problem persists Unit ejects the image plate without the image data being transmitted to the imaging software Error message Incorrect image plate type inserted IQ image plate not used i i Only use Dürr Dental IQ image plates i i The ejected image plate can be imported on a suitable image...

Страница 44: ...o image will depend largely on the computer system used and its work load Times stated are approximate For technical reasons the surface of the largest size of image plate size 2 is always scanned As a result the scan times are the same for all sizes of image plate Max theoretical resolution LP mm 16 7 10 Pixel size μm 30 50 Intra Size 0 2 x 3 to Intra Size 2 3 x 4 20 s 13 s Appendix EN ...

Страница 45: ...e 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 Max theoretical resolution LP mm 16 7 10 Pixel size μm 30 50 Intra Size 0 2 x 3 1 8 MB 1 1 MB Intra Size 1 2 x 4 2 3 MB 1 4 MB Intra Size 2 3 x 4 3 0 MB 1 8 MB EN ...

Страница 46: ... of the medical 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 a...

Страница 47: ......

Страница 48: ...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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