Air Techniques ScanX Edge Series, Installation And Operating Instructions Manual

Page 1: ...EN US ScanX Edge Installation and Operating Instructions 2160100287L41 2160100287L41 G8302 1911V006 ...

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Page 3: ...y assessment 16 5 Function 16 5 1 Imaging plate scanner 16 5 2 Cartridges S0 S2 17 5 3 Phosphor storage plate 18 5 4 Barrier envelope 18 Installation 6 Requirements 19 6 1 Installation setup room 19 6 2 System requirements 20 6 3 Monitor 21 7 Installation 21 7 1 Setting up the unit 21 7 2 Electrical connection 22 7 3 Connecting the unit to the net work 23 8 Commissioning and first start up 24 8 1 ...

Page 4: ...erators and service techni cians 39 13 1 Poor X ray image 39 13 2 Software error 42 13 3 Fault on the unit 43 Appendix 14 Scanning times 45 15 File sizes uncompressed 46 16 Handover record 47 Contents 2 2160100287L41 1911V006 EN US ...

Page 5: ... 1 Warnings and symbols Warnings The warning notes in this document highlight possible injury to persons or damage to machin ery They are marked with the following warning sym bols General warning symbol The warnings are structured as follows SIGNAL WORD Description of type and source of danger Here you will find the possible conse quences of ignoring the warning Follow these measures to avoid the...

Page 6: ...us electric volt ages Warning laser beams Damage to components due to electro static discharges ESD This way up store and transport in an upright position Keep dry n Stacking limits no condensation XX YY Lower and upper humidity limits XX YY Lower and upper temperature limits XX YY Lower and upper atmospheric pressure limits Fragile handle with care Keep away from sunlight during storage 1 2 Copyr...

Page 7: ...it must not be operated in operating theatres or similar rooms in which dangers may arise from the combustion of flammable materials Barrier envelope Intended purpose CE Disposable Barrier Envelope are intended to be used as a disposable barrier for the Air Tech niques Phosphor Storage Plates The device is non sterile and intended for single patient use only Indication for use Disposable Barrier E...

Page 8: ...s concerning medi cal devices The unit is intended for use in professional healthcare facilities in accordance with IEC 60601 1 2 If the unit is operated in any other environment potential effects on the electro magnetic compatibility must be taken into account Do not use the device near HF surgical devices and MRI equipment Keep a minimum distance of 30 cm between the device and other electronica...

Page 9: ...are and replacement parts Air Techniques accepts no liability for damage resulting from the use of non approved accessories special acces sories or any parts other than original spare and wear parts The use of non approved accessories special accessories or non genuine work ing parts spare parts e g mains cable can have a negative effect on the electri cal safety and EMC 2 11 Transport Only the or...

Page 10: ...an be connected to the Internet Therefore the system needs to be protected from threats from the Internet Use antivirus software and update it regularly Look for evidence of possible virus infection and if applicable check with the antivirus soft ware and remove the virus Perform regular data backups Provide access to units only to trustworthy users e g by means of user name and pass word Make sur...

Page 11: ...r storage plate scanner 2 Cartridge for phosphor storage plates S0 to S2 3 Phosphor storage plate IDX 4 Barrier envelope 5 VisionX imaging software DVD 6 DBSWIN imaging software DVD 7 Network cable 3 m 8 Power supply unit with country specific adapter Product description 2160100287L41 1911V006 9 EN US ...

Page 12: ... plate IDX Size 2 Barrier envelopes Barrier envelope Size 0 Barrier envelope Size 1 Barrier envelope Size 2 3 3 Optional items The following optional items can be used with the device Wall mount G8321 Commissioning and intraoral constancy tests 2D X ray test phantom G8795 3 4 Consumables The following materials are consumed during operation of the device and must be re ordered Cleaning and disinfe...

Page 13: ...m 167 x 231 x 216 in 6 57 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 Type of cable CAT5 Ambient conditions during operation Temperature C 10 to 35 F...

Page 14: ...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 Conforms Electromagnetic interference radiation CISPR 11 2009 A1 2010 Conforms Electromagnetic compatibility EMC Interference immunity measurements on cover Immunity to interference by discharge of static...

Page 15: ... 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 bands 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 5800 9 Electromagnetic compatibility EMC Interference immunity measurements on supply input Immunity to interference...

Page 16: ...munity to interference by discharge of static electricity IEC 61000 4 2 2008 8 kV contact 2 kV 4 kV 8 kV 15 kV air Conforms Immunity to electrical fast transients bursts I O SIP SOP ports IEC 61000 4 4 2012 1 kV 100 kHz repetition frequency Conforms Immunity to conducted disturbances induced by radio frequency fields SIP SOP ports IEC 61000 4 6 2013 3 V 0 15 80 MHz 6 V ISM frequency bands 0 15 80 ...

Page 17: ...of intraoral phosphor storage plates Size 0 mm 22 x 35 inch 0 86 x 1 38 Size 1 mm 24 x 40 inch 0 94 x 1 57 Size 2 mm 31 x 41 inch 1 22 x 1 61 4 3 Barrier envelope Classification Medical Devices Directive Class I FDA classification CFR Title 21 Class II Product description 2160100287L41 1911V006 15 EN US ...

Page 18: ...n 5 1 Imaging plate scanner 2 3 4 1 1 Input unit 2 Cover open 3 User interface 4 Collection tray The phosphor storage plate scanner is used to read image data stored on a phosphorus storage plate and to transfer the data to an imaging soft ware e g VisionX on a computer The transport mechanism guides the PSP through the unit A laser in the scanner unit scans the PSP The scanned data is converted i...

Page 19: ...ge is displayed in the soft ware S0 Cartridge for PSP S0 is inside the device S1 Cartridge for PSP S1 is inside the device S2 Cartridge for PSP S2 is inside the device Status LED flashes Connections The connections are located on the rear of the unit underneath the cover 1 2 3 1 Network connection 2 Reset button 3 Connection for power supply unit 5 2 Cartridges S0 S2 Depending on the PSP used the ...

Page 20: ...layer is damaged or there are vis ible scratches that could interfere with the diag nostics Inactive side Active side back IDX 2 E247G36120 01234567L a a White with back size and manufac turer s information printed on it Light blue with posi tioning aid a Positioning aid a is visible on the x ray image and makes orientation easier during diagnosis Only use phosphor storage plate IDX with the unit ...

Page 21: ...osed dry well ventilated room It should not be a room made for another pur pose e g boiler room or wet cell Max light intensity 1000 Lux no direct sun light at the place of installation of the unit There should be no major fields of interference e g strong magnetic fields present that can interfere with the proper operation of the unit Ambient conditions correspond to 4 Techni cal data Installatio...

Page 22: ...itional system requirements must also be met Interface Ethernet 100 Mbit Diagnostic moni tor In accordance with DIN 6868 157 room category 5 or 6 depending on the requirements Software DBSWIN version 5 16 or higher order number E7200A VistaEasy Image Bridge VisionX version 2 4 or higher order number E7300 For the system requirements of the computer systems visit the download area at www airtech ni...

Page 23: ...l medical devices Do not stack the unit next to or together with other appliances If however this unit is operated next to other units or stacked with other units monitor the unit carefully in the configuration selected in order to ensure normal operation The 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 sui...

Page 24: ...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 to set up the unit properly such that the plug can be easily accessed and unplugged if required Requirements ü Properly installed power outlet close to the unit observe the max length of the power cord ü Easily accessible power outlet ü Mains voltage matches the infor...

Page 25: ...of devices that are connected to the IT network Upgrade of devices that are connected to the IT network The data connection utilizes part of the band width of the network Interactions with other medical devices cannot be completely excluded Apply the IEC 80001 1 standard for risk assessment The device is not suitable to be connected directly to the public internet Take care when connecting units t...

Page 26: ...the commissioning of the device Check the version of the enclosed imaging program versus the ver sions available at www airtech niques com 8 1 Configuring the network Network configuration Various options are available for network configu ration ü Automatic configuration via DHCP ü Automatic configuration via Auto IP for direct connection of device and computer ü Manual configuration Configure the...

Page 27: ...or close Flyout using This saves the configuration Testing the device You can scan an X ray image to check if the unit is properly connected Open VisionX Create an X ray station for the connected unit Log in the demo patient patient ID DEMO0001 Select the acquisition type e g Intraoral To scan a PSP see 10 3 Scanning the image data 8 3 Configuring the unit in DBSWIN The configuration is done with ...

Page 28: ...nd gate way Click on Apply This saves the configuration Testing the device You can scan an X ray image to check if the unit is properly connected Select the Test tab Select the unit from the Registered Devices selection list Select the mode class Select the mode Click on Scan Image For the scanning of an image plate see 10 3 Scanning the image data Installation 26 2160100287L41 1911V006 EN US ...

Page 29: ...X ray field limitation X ray field limitation 2x3 X ray field limitation 3x4 60 kV mGycm2 60 kV mGycm2 60 kV mGycm2 Incisor 0 15 s 13 7 0 15 s 4 9 0 15 s 5 8 Premolar 0 20 s 18 2 0 20 s 3 8 0 20 s 7 7 Molar 0 27 s 24 6 0 27 s 5 2 0 27 s 10 4 Bitewings 0 28 s 25 5 0 29 s 5 6 0 28 s 10 8 Check and adjust the specific X ray unit in accordance with the standard values Intraoral X ray units for a pedia...

Page 30: ...dance with local rules and regulations Acceptance check The 2D X ray test phantom is required for acceptance tests with the PSP and sensor as receivers and possibly also the corresponding test phantom holder Before commissioning the unit the acceptance test of the X ray system must be carried out in accor dance with national regulations The consistency tests which must be carried out at regular in...

Page 31: ...same room as the X ray tube CAUTION Phosphor storage plates PSP are toxic PSPs that are not used with a barrier envelope can lead to poisoning when placed in the mouth or swallowed Only place PSPs in the patient s mouth in a barrier envelope Do not swallow the PSP or parts of it If the PSP or parts of it have been swallowed consult a specialist doctor immediately and remove the PSP If the barrier ...

Page 32: ...ll be replaced by Air Techniques in the same quantity Claims can only be accepted within 7 working days after receipt of the goods Clean phosphor storage plates properly see 11 Cleaning and disinfection 10 Operation CAUTION Image data on the phosphor storage plate PSP is not permanent The image data is altered by light natu ral X ray radiation and scattered X ray radiation This impairs the diagnos...

Page 33: ...ge The green status LED flashes The green car tridge display extinguishes Insert the appropriate cartridge The green status LED lights up The green dis play for the corresponding cartridge lights up The input unit is ready 10 2 X ray The procedure is described using a size 2 PSP as an example Required accessories PSP Barrier envelope of the same size as the PSP Usage 2160100287L41 1911V006 31 EN U...

Page 34: ...e lope The white inactive side of the PSP must be visible back IDX 2 E247G36120 01234567L a back IDX 2 E247G36120 01234567L a Pull off the adhesive strip and close the barrier envelope tightly by pressing together firmly back IDX 2 E247G36120 01234567L a back IDX 2 E247G36120 01234567L a 1 2 Taking the X ray image NOTICE Damage to the phosphor storage plate PSP caused by a sharp edged holding syst...

Page 35: ...our hands NOTICE Powder from the protective gloves on the PSP damages the unit during scanning Completely clean all traces of the pro tective glove powder from your hands before handling the PSP Tear off the barrier envelope back IDX 2 E247G36120 01234567L a 10 3 Scanning the image data Starting the imaging plate scanner and soft ware The scanning process is described for the VisionX imaging softw...

Page 36: ...sk of image information being erased by ambient light see 9 Correct use of phosphor storage plates bac k 2 E2 4721 3010 4210 0 0123 4567 F IDX b a c k 2 E 247 213 010 421 00 01 234 567 F ID X Slide the phosphor storage plate out of the barrier envelope downwards into the unit The phosphor storage plate must be inserted fully into the input unit bac k 2 E2 4721 3010 4210 0 0123 4567 F IDX Make sure...

Page 37: ... imaging plate The image data is erased automatically after scanning The special ERASE mode only activates the era sure unit of the image plate scanner No image data is scanned The phosphor storage plate needs to be erased using the special mode in the following cases The first time the phosphor storage plate is used or if it is stored for more than one week Due to an error the image data on the p...

Page 38: ...car tridge with a dampened soft lint free cloth Disinfect the cartridge with a disinfection wipe Alternatively use a spray disinfectant on a soft lint free cloth Comply with the operating instructions of the disinfectant Allow the cartridge to completely dry before use 11 2 Barrier envelope Clean the Barrier Envelope after being removed from the patient s mouth with a disinfectant wipe such as Air...

Page 39: ...leaning and disinfection and the image quality of the PSP and X ray system need to be checked Inspection inter val Work Daily before each use Clean the PSP if necessary Check the PSP for scratches If there are scratches on the surface take a homogeneous test image see Check the PSP with a homogeneous test image replace the PSP if applicable Keep an eye on the image quality with each X ray image ta...

Page 40: ...e 8 4 X ray unit settings Scan the PSP with the PSP scanner at high resolution Check the image for homogeneity No scratches visible in the image PSP can still be used Scratch is visible in the image discard the PSP Check X ray system To check the X ray system take an X ray image with the 2D X ray test phantom refer to 3 3 Optional items This can be used to check the image produced with the X ray s...

Page 41: ... check settings of the unit Expose the PSP X ray unit is faulty Contact technician Incorrect cartridge barrier enve lope was also pushed into the unit Use the correct cartridge for the size of phosphor storage plate being used Phosphor storage plate falls out of the unit and no image appears on the monitor IDX phosphor storage plate was not used Only use Air Techniques IDX phosphor storage plates ...

Page 42: ...not handle PSPs without a barrier envelope Store the PSP in a barrier envelope X ray image cut off part miss ing A metal part of the X ray tube is in front of the X ray beam Recording an X ray image make sure there are no metal parts between the X ray tube and the patient Check X ray tube Faulty edge masking in imaging software Deactivate edge masking Software unable to combine the data to make a ...

Page 43: ...ate Replace scratched phosphor storage plate Unit was shaken by impact or cover of the input unit closed during scanning process Set up the unit so that it can not be shaken Prevent the unit from being touched during the scanning process Bright stripes in the scanning window Too much incident ambient light during the scanning process Darken the room Turn the unit such that no light is directly inc...

Page 44: ...r erasure unit too hot Switch the unit off and allow it to cool Erasure unit fault LED defective Contact technician Imaging software fails to rec ognize the unit Unit not switched on Switch the device on Connecting cable between unit and computer not correctly con nected Check the connecting cable Computer does not detect any connection to the unit Check the connecting cable Check the network sett...

Page 45: ...ible cause Remedy Unit not shown in the imaging software Network cable not plugged in Plug in the network cable No DHCP server connected It may take some time for the imaging software to detect the unit Update the unit list Faulty network configuration Configure the network cor rectly Unit does not switch on No mains voltage Check the mains cable and plug connection and replace if necessary Check ...

Page 46: ...ed correctly Insert the cartridge correctly Network connection has been disconnected Connecting cable between unit and computer not correctly con nected Check the connecting cable The IP address of the unit is in use by another unit Check the network settings IP address and subnet mask and assign a unique IP address to each unit Inform a service technician if the problem persists Unit ejects the p...

Page 47: ...ystem used and its work load Times stated are approximate For technical reasons the surface of the largest size of phosphor storage plate size 2 is always scanned As a result the scan times are the same for all sizes of phosphor storage 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 2160100287L41 1911V006 45 EN US ...

Page 48: ...e 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 Appendix 46 2160100287L41 1911V006 EN US ...

Page 49: ...rder 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 qualified adviser for t...

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