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ENGLISH

Digital intraoral imaging plate system

User Manual

208396 rev. 2

DIGORA

Optime

Содержание DIGORA Optime

Страница 1: ...ENGLISH Digital intraoral imaging plate system User Manual 208396 rev 2 DIGORA Optime ...

Страница 2: ......

Страница 3: ...d to any electronic medium or machine readable form in whole or part without the prior written permission of SOREDEX The original language of this manual is English SOREDEX reserves the right to make changes in specification and features shown herein or discontinue the product described at any time without notice or obligation Contact your SOREDEX representative for the most current information Ma...

Страница 4: ...DIGORA Optime ...

Страница 5: ...low 14 3 3 1 Readout start 14 3 3 2 Touchless operation 15 3 3 3 Plate eject mode 16 3 4 Power options 16 3 5 Comfort Occlusal projection imaging not included in delivery 17 3 6 Full Mouth Series FMS imaging 18 4 Accessories introduction 19 4 1 Hygiene accessories 19 4 2 Imaging plates 20 4 3 Imaging plate storage box 21 4 4 Holders 21 4 5 Occlusal projection imaging with Comfort Occlusal 4C start...

Страница 6: ...ccessories and imaging plates 39 7 1 2 Application errors 40 7 1 3 Imaging plate wearing 43 7 2 Error messages 44 8 Other information 45 8 1 Quality control 45 8 2 Device care 45 8 3 Device cleaning 45 8 4 Disinfecting the unit 46 8 5 Maintenance 46 8 6 Repair 46 8 7 Disposal 46 9 Technical specifications 47 9 1 Device 47 9 2 System requirements and connections 49 9 3 Imaging plate specifications ...

Страница 7: ...osed to the imaging plates from the intraoral complex of the skull 1 1 Unit with accessories 1 ON OFF key 2 START key 3 Control panel 4 Imaging plate collector 5 Plate slot and plate carrier 6 Power supply 7 Documentation and imaging application software media 8 Hygiene accessories 9 Imaging plates 10 Imaging plate cleaning wipe samples 11 Imaging plate storage box 1 2 3 5 6 7 8 9 10 4 11 ...

Страница 8: ...uthorized distributor See chapter Technical Specifications 3 Ethernet cable not included 4 Workstation WS computer not included 5 Optional local network switch not included 6 Optional workstations WS computers not included 7 Kensington security slot for securing unit in its place For more details of installing and setting up the system see chapters Installation and Technical specification ...

Страница 9: ...g up the unit Unit is NOT powered Unit is powered Light dim and brighten again in sequence Unit is in standby mode Press ON OFF or START key OR activate from imaging software Manual start selected Unit ready Insert imaging plate and press START to begin processing NOT LIT LIT BLINKING ON OFF key START key ...

Страница 10: ...atient selected Ready to process Insert imaging plate Unit in setup mode See chapter Advanced use Ready to Process Image goes to workstation 4 Insert imaging plate Blinking in sequence Imaging plate wrong way round Remove protective cover Error number Manual plate removal selected Remove plate Waiting for 2nd size 3 plate to make Comfort Occlusal 4C image Insert 2nd size 3 OR press START to cancel...

Страница 11: ...sing a new imaging plate for the very first time Imaging plate has been packed for over 24 hours Unpacked imaging plate has been stored in dark not exposed to ambient light for over 24 hours By doing this the erasing procedure will remove any fogging collected to the imaging plate due to natural background radiation ...

Страница 12: ...2 Basic use 6 SOREDEX 208396 rev 2 2 1 Imaging plate packing Note Do the packing before the patient enters the reception room but no more than 24 hours before ...

Страница 13: ...Taking and processing an image Power on the unit Launch the imaging application software Select a patient Make an exposure Check that the ready arrow is lit in the unit Unpack the imaging plate Note Ambient light harms the image information ...

Страница 14: ... from the cover You can place the plate with cover and leave it to the plate carrier Unit will not start the processing before removing the cover Remove the cover The image appears on the imaging application screen Note Process within one hour after exposure Processed imaging plate is ready to be packed and exposed again ...

Страница 15: ...e 208396 rev 2 SOREDEX 9 2 3 Exposure guidelines Recommended exposure values s for DC x ray units Exposure settings found good for F speed Insight film can be used for AC x ray units increase exposure time by 30 ...

Страница 16: ...2 Basic use 10 SOREDEX 208396 rev 2 ...

Страница 17: ... allow you to configure the DIGORA Optime to the user s clinical preferences From the imaging application software you are using select unit Setup Scanner page for more instruction on how to access setup page review application software manual 3 1 1 Status Shows the scanner type firmware version and unit serial number ...

Страница 18: ... the image Tooth numbers are as signed to the selected teeth The tools at the top of the window allow the image to be manipulated 3 Click OK to save the image and tooth numbers 3 1 4 Resolution Super gives a pixel size of 30 μm This results in images with better resolution but may require longer exposure time to compensate High recommended default gives a pixel size of 60 μm This results in images...

Страница 19: ...re established the last processed image is auto matically transferred to the PC 2 PC If the image is not automatically transferred to the PC select the Setup Scanner page from the imaging application software your are using 3 PC In the Last Image field click Retrieve now to re trieve the last processed image Note If required you can select different parameters e g resolution show image preview etc...

Страница 20: ...ically image plate processing The Start after options allow to select when the unit starts image plate processing After Plate insert processing starts automatically when it detects right way inserted imaging plate in the plate carrier After Cover removal after the imaging plate and protective cover have been inserted into the plate carrier processing starts automatically when the protec tive cover...

Страница 21: ...roximately 0 6 seconds Select Manual if you want processing to start only when the START key is pressed Note Processing starts even if the plate is Wrong way round Not detected Not inserted at all Note Unit turns off in manual mode if user is pressing ON OFF key regardless of imaging plate sensing in the plate carrier 3 3 2 Touchless operation Note This system does not support touchless operation ...

Страница 22: ...plate has been processed The Leave in plate carrier option is recommended for users who want to handle the imaging plates with more care and reduce wear and tear on them This option extends service life of the imaging plates and allows greater hygiene standards to be observed 3 4 Power options From the imaging application software you are using select unit Setup Power options page Standby after se...

Страница 23: ...switching itself off 3 5 Comfort Occlusal projection imaging not included in delivery To change Comfort Occlusal 4C projection imaging settings select from the imaging application software unit Setup Occlusal page Comfort Occlusal 4C projection image is formed from two sequential size 3 plates Image plates are processed separately and then stitched together to form a single Comfort Occlusal 4C pro...

Страница 24: ...ng application software Note When you are in the Occlusal 4C mode it is possible to temporarily override the mode and process a single size 3 imaging plate Insert the size 3 imaging plate into the unit so that it can be processed When the insert second plate symbol appears on the unit user interface press the start key This cancels the Occlusal 4C mode for this operation and produce a single size ...

Страница 25: ...Note USE ONLY GENUINE SOREDEX ACCESSORIES to ensure the optimum clinical results safe use of the system and long service life for the imaging plates Note Never use hygiene accessories more than once 4 1 Hygiene accessories Protective covers Hygiene bags ...

Страница 26: ...with all intraoral sizes equal to film 0 1 2 3 and Comfort Occlusal 4C all with film like usability IDOT imaging plates optional have individual identification marking that appear on the images Standard STD imaging plates has no identification mark on the sensitive side of the plate ...

Страница 27: ...n Fogging caused by background radiation which may decrease image quality Ultraviolet radiation which is harmful for the imag ing plates Base part of the storage box is autoclavable at 121 C 250 F or 134 C 272 F 4 4 Holders It is recommended to use imaging plate holders to ensure accurate patient positioning and consistently good image quality Problems caused by manually positioning the imaging pl...

Страница 28: ...Advanced use 4 6 Microfibre cloth Imaging plate microfibre cloth is used for dry cleaning of the imaging plates comparable to eyeglasses cleaning 4 7 Optiwipe imaging plate cleaning wipes Optiwipe cleans imaging plates efficiently and safely but does not damage the imaging plates Content Ethanol EtOH 82 Chlorhexidine Di gluconate 0 5 Chlorhexidine is a chemical anti septic used safely in many prod...

Страница 29: ...idually packed wipes 4 8 Imaging plate care Sensitive surface handle with care Use only original accessories Single use only You can bend Do not fold or bend excessively Touch the edges only Do not touch the sensitive surface Do not scratch Do not stab Avoid moist and water Do not sink ...

Страница 30: ...DEX 208396 rev 2 4 9 Imaging plate cleaning Allowed temperature Avoid dust Avoid direct sunlight and UV radiation Not household waste Use ONLY 70 Ethanol Do not apply Ethanol directly on the plate Apply Ethanol on lint free soft fabric ...

Страница 31: ...ccessories introduction 208396 rev 2 SOREDEX 25 Note Pack the imaging plates in advance but no longer than 24 hours before the exposure Wipe the plate gently Wipe dry or let dry for 1 minute Pack the plate ...

Страница 32: ...4 Accessories introduction 26 SOREDEX 208396 rev 2 ...

Страница 33: ...cclusion The support base material is black plastic On top of the base material is blueish photo stimulable layer does not contain any prosphor phosphorus On top of the blueish material is a top coat protective layer and the edges are closed with lacquer The phosphorescent side of the plate records and stores the image This side is sensitive and should be protected against dust and dirt Visible li...

Страница 34: ...t be held responsible for any problems caused by using acces sories from other manufacturers PROPER USE OF ORIG INAL HYGIENE ACCESSORIES ENSURES THE BEST IMAGE QUALITY AND MAXIMUM SERVICE LIFE OF THE IMAGING PLATES The packed imaging plate is positioned with a holder in the patient s mouth The exposure is made as with film The hygiene bag should be disinfected after exposure and disposed off after...

Страница 35: ...cted pixel by pixel line by line and measured with extremely sensitive photodetector 4 Digital image is formed from the measured light intensi ty variation After stimulating imaging plate is exposed to bright light which clears the remaining image information from the plate The imaging plate is dropped out of the unit X ray exposures and processing are not aging the imaging plate so it is re usabl...

Страница 36: ...ral back ground radiation which may cause fogging and lack of contrast on the image The X ray dose of single intraoral imaging is approximately the same as the dose one person gets from natural background radiation during one day Imaging plates may gather radiation also during transportation from the manufacturer Therefore it is recommended to perform initial erasing for the new plates This means ...

Страница 37: ...Light Ambient light is good when storing the imaging plates it keeps the plates clean from background radiation fogging Note Ambient light is harmful for the image information on the plate between the exposure and processing Note UV light is harmful for the imaging plates ...

Страница 38: ...5 Introduction to imaging plate technique 32 SOREDEX 208396 rev 2 ...

Страница 39: ...also be attached to a wall under or on a shelf with the optional mounting kit The unit must not be positioned so that it it touching other equipment It must not be placed on top of or under other equipment The unit can be positioned within the environment in which the patient is examined and treated patient environment 6 2 Positioning the PC network switch The PC network switch connected to the un...

Страница 40: ...d reconnect the unit using the imaging plate connection meth od 1 After positioning the unit connect it to the PC s in the local area network using the Ethernet cable not includ ed in delivery 2 Switch the unit on The imaging application software symbol appears in the unit user interface This indi cates that the unit is not communicating with the PC s in the network 3 PC Install the imaging applic...

Страница 41: ...ow the direct connection method to be used to connect the PC s connection can be done using an IP address 1 Follow steps 1 to 5 from the previous section Direct connection method uses the unit s n 2 PC From the Settings tab select IP based and then se lect the Enable changing IP address box Obtain an IP address for the unit from your network administrator and key it into the IP field in the Scanne...

Страница 42: ...ered into the field next to the work station identifier number Note If only one PC is connected to the unit do not select the Use Multiconnect check box The Scanner Autorelease timeout is the length of time that the unit remains reserved and unused by a PC before the PC automatically released the unit so that it can be used by another PC in the system the scanner can be reserved in advance from an...

Страница 43: ...that are not part of the supplied system not supplied by the manufacturer of the unit not recommended by the manufacturer of the unit The PC connected to the unit should not be used in the patient environment The minimum horizontal distance between the patient and the PC is 1 5 m 4 5 ft The minimum vertical distance between the patient and the PC is 2 5 m 6 5 ft ...

Страница 44: ...6 Installation of the imaging plate system 38 SOREDEX 208396 rev 2 ...

Страница 45: ...rotective cover misused or not used at all Hygiene bag not sealed properly Improper non genuine hygiene accessories use Improper storing of the imaging plates or exces sively high X ray dose used Imaging plate has been exposed to ultraviolet UV radiation Imaging plate has collected background radia tion because Plate has been stored near X ray unit Plate has been stored in the bag or in dark too l...

Страница 46: ...rk image Some areas showing uniform black Decreased diagnostic value Too long exposure time too high X ray dose Too light noisy image with decreased diagnostic value Showing only part of the image Showing wrong size of the image Image smaller than imaging plate Too short exposure time Too low X ray dose ...

Страница 47: ...sing leds are monitored during normal operation If leds are defected application SW shows warning Circular shape on the image Imaging plate has been exposed from the wrong side which shows the phantom of the metal disc on the rear side of the plate Cone cut X ray beam has exposed only part of the imaging plate surface Image may show on different smaller size than the imaging plate used Check expos...

Страница 48: ...ur intraoral X ray unit Use proper holders Too long exposure time may have been used Use shorter exposure time increase kV if neces sary to compensate effect of shorter exposure time Geometry distortion Improper patient positioning Use proper holders to avoid this Note Never do accurate measurements on intraoral im ages unless having known size of reference object in the imaging plane ...

Страница 49: ...nuine hy giene accessories are used Wearing of the imaging plate Scratches Clean the plate s Replace if cleaning does not help Pay attention on handling storing and maintenance Ensure that only the genuine hy giene accessories are used Spots dots white or gray or any visible pattern Most probably caused by wearing of the imaging plate Can be caused by moisture or improper cleaning Clean the plate ...

Страница 50: ...tor error imaging plate infor mation cannot be read due mirror not moving properly 12 K200 board not connected properly laser detection erasing move ment control 13 K300 board not connected properly imaging plate sensing detection 23 K200 error erase LED linear move ment detection sensor or laser syn chronization error 24 Plate carrier movement error 34 Plate sensor error imaging plate cannot be d...

Страница 51: ...wer supply before cleaning or disinfecting the unit Do not allow liquids to enter the unit 8 3 Device cleaning To clean the unit use a non abrasive cloth moistened with cool or lukewarm water soapy water mild detergent isopropyl alcohol or ethanol ethyl alcohol 70 96 Optiwipe CaviCide CaviWipes by Metrex FD322 by Dürr Dental Easydes by Kiilto After cleaning wipe the unit with a non abrasive cloth ...

Страница 52: ...national regulations and laws concerning such equipment and its location 8 5 Maintenance The unit does not require any maintenance 8 6 Repair The unit does not require any maintenance If the unit is damaged or malfunctions in any way it must only be repaired by service personnel authorized by the manufacturer of the unit 8 7 Disposal At the end of the useful working life of the unit and or its acc...

Страница 53: ...lantie 160 P O Box 20 FIN 04300 Tuusula FINLAND Quality system In accordance with ISO13485 and ISO9001 standard Environmental management system In accordance with ISO14001 standard Conformity to standards IEC 60601 1 1988 and A1 A2 IEC 60601 1 1 2000 IEC 60601 1 4 1996 and A1 IEC 60601 1 2 2001 IEC 60601 1 2005 EN 60825 1 2007 UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 and S1 A2 DHHS 21 CFR Chapte...

Страница 54: ...s than 30VA Pixel size selectable 30 μm Super resolution 60 μm High resolution Bit depth 16 bit Theoretical resolution 16 7 lp mm Firmware version 1 00 Interface connection Connection type RJ 45 Unshielded CAT 6 Ethernet cable Plastic materials Used materials are phthalate free containing 0 1 w w of DEHP and is not manufactured from raw materials containing or derived from Bisphenol A BPA Operatin...

Страница 55: ...ystem needs to be checked after changes are made When adding new devices to LAN make sure they all have unique IP address otherwise they may cause communication problems with existing LAN devices Place unit and PC with imaging applica tion software to same subnet in LAN NOTE Image is not transferred from unit to PC imaging application software in case of connection lost during image processing Ima...

Страница 56: ...timulable particles that exhibit the phe nomenom of phosphorescence uniformly coated on a support plastic material Shielded with a protective top coat layer on the sensitive surface and encapsulated with lacquer around the edg es Imaging plates do not not include phosphorous phosphorus P Use The typical service life for an imaging plate is several hundreds of cycles provided that the imaging plate...

Страница 57: ... 10993 5 Packaging Supplied in boxes Use For the best performance it is recommended the hygiene bags are used within two years from the date of manufacture The date of manufacture is printed on the bottom of the box containing the hygiene bags DDM MYYXX Extended storage time or exceeding the specified storage conditions may compromise the performance of the adhesive tape and or the plastic materia...

Страница 58: ...he DXR 60 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11E Group 1 The DXR 60 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The DXR 60 is suitable for use in all es...

Страница 59: ... Surge IEC 61000 4 5 1 kV differential mode line to line 1 kV differen tial mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrup tions and volt age variations on power sup ply lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in ...

Страница 60: ...by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 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 structures objects...

Страница 61: ...f transmit ter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the fr...

Страница 62: ...9 Technical specifications 56 SOREDEX 208396 rev 2 ...

Страница 63: ...details in operation instructions CLASS II equipment Double insulated electrical appliance UL symbol Indoor use Dangerous voltage Laser radiation Direct current power supply unit inlet Ethernet connector CE 0537 Symbol MDD 93 42 EEC This unit is marked according to the Medical Device Directive 93 42 EEC if the unit contains the CE mark ...

Страница 64: ... Please contact an author ized representative of the manufactur er for information concerning the decommissioning of your equipment DIGORA Optime This product complies with DHHS 21 CFR Chapter I Subchapter J at the date of manufacture Type DXR 60 01 Ser No SL1200001 3155129 CONFORMS TO UL STD 60601 1 CERTIFIED TO CSA STD C22 2 NO 601 1 209635r1 Manufactured August 2012 24 V 30 VA IEC 60601 1 Rx on...

Страница 65: ...unit when it is processing an imaging plate This unit must only be used to process image plates supplied by the manufacturer and must not be used for any other purpose NEVER use imaging plates protective covers or hygiene bags from other manufacturers This unit or its accessories must not be modified altered or remanufactured in any way Only the manufacturer s authorized service per sonnel are aut...

Страница 66: ...and any other external devices shall not be connected to an extension cable Multiple extension cables shall not be used If this device will be used with 3rd party imaging ap plication software not supplied by the manufactur er the 3rd party imaging application software must comply with all local laws on patient information software This includes for example the Medical Device Directive 93 42 EEC a...

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