file - Sirona - Technical Documentation
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1. Temple supports can be adjusted easily and symmetrically Rotating element No abrasion or hardened grease visible in the vicinity of the two actuators and the axis unit Sensor Pan Sensor can be moved in and out easily and fits snugly in its guide See Service Manual Bite block contact segment chin rest in the bite block holder secu rely mounted Light localizer adjustable Sensor Ceph Sensor can be moved in and out easily and fits snugly in its guide Ceph light localizer OK See Service Manual If no gt Correct fault 59 87 685 D 3352 22 D 3352105 01 11 02 Sirona Dental Systems GmbH 4 Maintenance by the service engineer Assessing X ray exposures Ask to be shown the most recent X ray exposures taken by the dentist Assessing X ray exposures Answer questions with yes v or no Maintenance interval after years E wy E I Date enter month year Unexposed surrounding border present See Service Manual Exposure sharp Density of X ray image OK If no gt Correct fault Checking the tube data Checking the tube data Answer questions with yes v or no Maintenance interval after years 1 4 w ds 1d Date enter month year Actual kV mA values OK See Service Manual Fan working Does the temperature sensor in the tube asse2. Is the unit imme diately switched off when the emergency shutdown switch is activated If no gt Immediately order repair by a service engineer Dee B Anti kink sleeve Control cable Fig 1 r Fig 2 r 3 T 2nd ground wire i 1 peg 4 prc 59 87 685 D 3352 D 3352 105 01 11 02 9 2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH Exposure safety Exposure safety Answer questions with yes v or no Date please enter month year No repeated occurrence of a cer tain error message Optical and acoustic signal pre sent when radiation is released Is the release button free of clean ing agent residues and freely movable Exposure is immediately interrup ted when radiation button is released prematurely Does rotational movement occur without any atypical running noi ses If no gt Inform your dealer Radiation indication Radiation indicationno longer lights up ORTHOPHOS XG 5 Ceph Acoustic signal no longer sounding ORTHOPHOS XG 3 when radiation button is released prematurely Multipad Error message kV mA lights up Exposuretime is Return key indicated Fig 2 59 87 685 D 3352 10 D 3352 105 01 11 02 Sirona Denta
3. The system owner will be responsible for safety relevant failures of systems which continue in operation after that time and can no lon ger be serviced due to missing spare parts 59 87 685 D 3352 18 D 3352 105 01 11 02 Sirona Dental Systems GmbH 4 Maintenance by the service engineer Maintenance interval NOTE l In addition to the annual inspections to be carried out by the system owner or authorized persons safety related checks must be performed by the service engineer after 4 7 and 10 years and then at two year intervals Checking the records In the chapter Annual inspection performed by the system owner or other authorized persons on page 6 and in the chapter Safety related checks by the service engineer in compliance with standard IEC 62353 on page 15 Checking the records Answer questions with yes v or no Maintenance interval 4 after years 4 1o a ue Date enter month year Annual inspection performed by the system owner see Chapter 2 Records complete All questions answered with yes All work required due to a nega tive result during the checks has been performed Have all safety related checks been carried out and did the mea sured values remain constant If no gt Perform annual inspection prior to maintenance 59 87 685 D 3352 D 3352 105 01 11 02 19 4 Maintenance by the service engineer Si
4. no gt Inform your dealer To remove the sensor Press the pushbutton all the way in and hold it down and remove the sensor from its holder by pulling it downward Fig 1 2 10 Image quality Image quality Answer questions with yes v or no Date please enter month year Typical exposure parameters are not adjusted in order to achieve a constant image quality If no gt Inform your dealer 59 87 685 D 3352 12 D 3352 105 01 11 02 Sirona Dental Systems GmbH 2 Annual inspection performed by the system owner or other authorized persons Height adjustment functionality Height adjustment Answer questions with yes v or no Date please enter month year Acoustic signal sounds when height is adjusted Height adjustment works without jolting without slumping and wit hout atypical running noises e g clacking scuffing Does the height setting remain the same even after the system has been switched off for a longer period of time No jerking at beginning of soft start after key is pressed Soft start does not begin after key is pressed No follow up movement of height adjustment after height adjust ment keys are released If no Inform your dealer 59 87 685 D 3352 D 3352 105 01 11 02 13 2 Annual inspect
5. 59 87 685 D 3352 Sirona Dental Systems GmbH Dear customer You would like to have and will have many years of satisfaction with your Sirona X ray unit Safety and reliability are necessary to ensure this Your dental dealership offers you service by specially trained engineers for this purpose The maintenance should ensure that your product is permanently safe and operational All components subject to normal wear and tear are checked and if necessary replaced Maintenance work may be performed by the operator only if this is described on the part of Sirona Dental Systems GmbH otherwise only authorized service engineers of Sirona Dental Systems GmbH or its authorized dealers may be entrusted with the work In case you have not concluded a maintenance contract please contact the customer service department of your dental dealership The performed maintenance must be documented in this document which must be kept with the unit We wish you much success and pleasure with your quality product from SIRONA Dental Systems D 3352 105 01 11 02 Sirona Dental Systems GmbH List of Contents 59 87 685 D 3352 D 3352 105 01 11 02 General information am rteesec niei drea dats chat curtes ia feu Ed eS 5 1 1 Inspection and maintenance and safety related checks sseeeess 5 1 2 Customer data css a i era aee dies dere dina cue ed ect Yee edu debe ou so Deu 5 Annual inspection performed by the system own
6. Cover parts Answer questions with yes v or no Date please enter month year All cover parts attached at X ray unit Fig 1 All screws on unit housing availa ble Cover parts and mirrors free of damage no surface damages e g scratches All cover parts in clean condition Clean X ray unit with the recommen ded cleaning agents see Operating Instructions If no gt Inform your dealer Fig 1 59 87 685 D 3352 D 3352 105 01 11 02 Sirona Dental Systems GmbH 2 Annual inspection performed by the system owner or other authorized persons X ray unit X ray tube assembly and stand condition Answer questions with yes v or no Date please enter month year Tube assembly housing palpably visibly oil free Fig 1 If no gt Inform your dealer Tube assembly housing Fig 1 System safety Safet Answer questions with yes v or no y Date please enter month year Coiled cable with strain relief and anti kink sleeve OK Fig 1 Power cable and 2nd ground wire free of damage Fig 1 Control cable free of damage Fig 1 All screws that fasten the X ray unit to the wall and the support bracket tightly secured and or unit securely fastened to the stand Fig 2 For Japan only
7. Enter measured values Maintenance interval Initial after X years startup E 6 8 10 Je 14 Date please enter month year Ground wire test OK Enter measured values A and B GNYE wire Measured value less than 0 1 ohms A and C 2nd ground wire Measured value less than 0 1 ohms A and D housing DX32 Measured value less than 0 2 ohms A and E tube assembly housing Measured value less than 0 2 ohms Unit leakage current test OK measured value less than 2 mA Enter measured values 59 87 685 D 3352 16 D 3352 105 01 11 02 Sirona Dental Systems GmbH 3 Safety related checks by the service engineer in compliance with standard IEC 62353 Documenting the safety related check The undersigned confirms that he she has checked the unit for the above criteria If any question is answered with No the fault must be eliminated Engineer s name Signature Engineer s name Signature Engineer s name Signature Engineer s name Signature Engineer s name Signature Engineer s name Signature Engineer s name Signature Engineer s name Signature 59 87 685 D 3352 D 3352 105 01 11 02 17 4 Maintenance by the service engineer Sirona Dental Systems GmbH Maintenance by the service engineer General information for the service engineer The Service Manual for ORTHOPHOS XG order no 59 38 399 is absolutely essential for performing m
8. ainte nance as all of the maintenance required is described therein Furthermore the operating instructions supplied with the unit are required Measurements Always switch the unit OFF before connecting the measuring instruments Select the correct current voltage type and adjust the measuring range to match the expected readings Perform continuity tests only on units which are switched off If several exposures with radiation must be taken to check a measurement make sure that the prescribed cool down intervals are observed ATTENTION A Observe the radiation protection guidelines before releasing radiation ATTENTION A When opening the unit y Please observe the usual precautionary measures for handling printed circuit boards ESD Touch a ground point to discharge static electricity before handling any components fa Before starting maintenance work always perform a functional test and advise the customer or dental practice staff about any defects found Should it be necessary to replace defective components along with parts subject to wear this must be agreed previously with the customer or dental practice staff If components bearing a serial number are replaced the new serial number must be recorded in the table in Chapter 4 5 Serial numbers of the system Discontinuation of spare part deliveries Deliveries of spare parts are discontinued after a certain period of time for every system
9. alometer sensor Datum Unterschrift Serial No at initial start up Serial No Serial No Signature Serial No at initial start up Serial No Serial No 59 87 685 D 3352 D 3352 105 01 11 02 21 4 Maintenance by the service engineer Sirona Dental Systems GmbH Functional test Prior to starting with maintenance work a functional test must always be performed In doing so it is helpful to read out the error messages if present Refer to Chapter 5 1 Selecting Service routines Inform the customer or dental practice staff about any defects you have detected Checking the system functions observe Operating Instructions Answer questions with yes v or no Maintenance interval after years 4 ue de is Date enter month year No visible signs of abrasion or hardened grease on HV motor and threaded rod See Service Manual No atypical running noises audi ble during height adjustment Jolt free fine positioning possible during height adjustment Is there still enough lubricant bet ween the sliding surfaces Does the height setting remain the same even after the system has been switched off for a longer period of time Is the limit switch for height adjust ment functional Acoustic signals audible during height adjustment Forehead support can be moved easily and without jolting through the entire range See Service Manual
10. any D 3352 105 01 11 02 10 2015 Nr 121125 Imprim en Allemagne Sirona Dental Systems GmbH in the USA FabrikstraBe 31 Sirona Dental Systems LLC D 64625 Bensheim 4835 Sirona Drive Suite 100 Order No 59 87 685 D 3352 Germany Charlotte NC 28273 www sirona de USA
11. eckirig the records ucro ep Hd seri gut Re ie E bere eens 19 4 4 Labels on the System tecti cubic EC SE OE GU eee abe 20 4 5 Serial numbers of the system sssssssssssseseeeeeeeeen eene rnm 21 4 6 F nctlonalitest sr ee date etes 22 4 7 Assessing X ray exposures eesssesessseeeeeeneee innen nennen entrent entere 23 4 8 Checking the tube data 4 9 Diaphragm check 4 10 Checking the cables for damage 4 11 Safety checks 4 12 Final work eeeenne 4 13 Documenting maintenance work Sirona Dental Systems GmbH 59 87 685 D 3352 D 3352 105 01 11 02 Sirona Dental Systems GmbH 1 General information General information Inspection and maintenance and safety related checks Inspections preventive maintenance and safety related checks must be performed at scheduled intervals to protect the health and safety of patients users and other persons e In order to ensure the operational safety and functional reliability of your product you as the system owner should inspect the equipment at least once a year or commission your dental depot to do so The information provided in Chapter 2 Annual inspection performed by the system owner or other authorized persons should be helpful here If one or more checks to be performed do not lead to satisfactory results please contact your dental depot Medical devices are designed in such a way that the first occurrence
12. er or other authorized DerSOLHSs aiio isets Ert en nsu ceri Roa casar niini D n SE DEFUI DS AE RAE 6 2 1 Technical documents 2 nee ea ea Ebor ae ee 6 2 2 System accessories nite aa socis akon evened ene cud erent 7 2 3 Surfaces ofthe nib 3 2 iR db cat A HT t de eM D o ee SERE RES 8 2 4 X ray unit s 2 5 System safety 2 6 Exposure safety cte Ee a eU CERE ONERE e 10 2 7 Key functionality ine ede xit ee ee 11 2 8 Light localizer functionality s siti ns in pai ein idea emen 11 2 9 Sensor functionality x iate teta dede edet Lane ce ddl ensia 12 2 10 Image quality 5 2 5 1 ted ree dc rrt eae Ebo etre tete Potete 12 2 11 Height adjustment functionality sess 13 2 12 Documenting your yearly inspection sessseenn een 14 Safety related checks by the service engineer in compliance with standard IEC 62359 odierna ei era Co eic ee vae cp erai vete eet cess 3 1 General information for the service engineer 3 2 Intervals for safety related checks 3 3 Safety related check i ne ee IR EHE DIE ARRe RUE 3 4 Documenting the safety related check sssseeemeee Maintenance by the service engineer eeeeeeneennee 18 4 1 General information for the service engineer sseee 18 4 2 Maintenance interval 2 eene re HERI EREMO REN 19 4 3 Ch
13. ervice Manual Do grounding straps and cable shields have complete and firm contact See Service Manual Cable shielding OK See Service Manual Protective ground wire connec tions properly attached See Service Manual If no gt Correct fault Final work Final work observe Operating Instructions Answer questions with yes v or no Maintenance interval after years 12 14 Date enter month year System cleaned If no gt Clean system 59 87 685 D 3352 D 3352 105 01 11 02 25 4 Maintenance by the service engineer Sirona Dental Systems GmbH Documenting maintenance work The undersigned confirms that he she has checked the unit for the above criteria and that he she has handed over the unit in fully functional condition Date of maintenance Name of engineer Signature of engineer 26 59 87 685 D 3352 D 3352105 01 11 02 Sirona Dental Systems GmbH Space for remarks 59 87 685 D 3352 D 3352 105 01 11 02 4 Maintenance by the service engineer 27 4 Maintenance by the service engineer Sirona Dental Systems GmbH 59 87 685 D 3352 28 D 3352105 01 11 02 We reserve the right to make any alterations which may be required due to technical improvements Sirona Dental Systems GmbH 2015 Sprache englisch Printed in Germ
14. he dental treatment center does not pass the safety tests it must not be operated any longer You must advise the user of this fact in your capacity as service engineer Corresponding repair work by an authorized service engineer is required before putting the system into service again mie NOTE The safety checks correspond to the standard IEC 62353 2007 DIN EN 62353 VDE 0751 1 2008 If you use an automatic tester you can program it according to these standards Application components Type B Permanently attached unit Protection Class The measurements to be performed are complex and time consuming Sirona therefore explicitly recommends using an automatic tester 59 87 685 D 3352 D 3352 105 01 11 02 15 3 Safety related checks by the service engineer in compliance with standard IEC 62353 Sirona Dental Systems GmbH Intervals for safety related checks It is essential to perform safety checks aimed particularly at detecting electrical faults during initial startup and then every 2 years All inspections and measurements are performed by the authorized service engineer They are specified in the following Safety related checks are performed on the following occasions e initial startup e Regularly every 2 years After extensions upgrades conversion e After repair work Safety related check see Service Manual chapter on Maintenance Equipment safety Answer questions with yes v or no
15. ion performed by the system owner or other authorized persons Sirona Dental Systems GmbH Documenting your yearly inspection The undersigned confirms that he she has checked the unit for the above criteria and that he she has informed the competent dealer in case of any defects Year 1 Inspection date Name Signature 2 10 11 12 13 14 14 59 87 685 D 3352 D 3352 105 01 11 02 Sirona Dental Systems GmbH 3 Safety related checks by the service engineer in compliance with standard IEC 62353 Safety related checks by the service engineer in compliance with standard IEC 62353 General information for the service engineer The Service Manual for ORTHOPHOS XG order no 59 38 399 is absolutely essential for performing safety related checks as the protective ground wire and device leakage current tests are described in this document Measurements Switch the power OFF at the main switch of the building installation Select the correct current voltage type and adjust the measuring range to match the expected readings Perform continuity tests only on units which are switched off ATTENTION A When opening the unit Please observe the usual precautionary measures for handling printed circuit boards ESD Touch a ground point to discharge static electricity before handling any components ATTENTION A If t
16. l Systems GmbH 2 Annual inspection performed by the system owner or other authorized persons Key functionality Key functionality Answer questions with yes v or no Date please enter month year Membrane foil of the Multipad keys without cracks or holes All numbers and letters on the Multipad show up completely Can the Multipad be positioned reliably and does it remain in the desired position If no gt Inform your dealer ORTHOPHOS XG 5 Ceph ORTHOPHOS XG 3 Multipad 4 4 sirona S moe Light localizer functionality Light localizer Answer questions with yes or no Date please enter month year Vertical and horizontal light beam visible Fig 1 Position of horizontal light beam can be changed and remains as set If no gt Inform your dealer Vertical and horizontal light beam Fig 1 59 87 685 D 3352 D 3352 105 01 11 02 11 2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH Sensor functionality Sensor Answer questions with yes v or no Date please enter month year Sensor can be removed and insert up to stop easily Fig 1 Sensor fits snugly in the guide If
17. mbly indicate a value between ca 18 and 65 C If no gt Correct fault 59 87 685 D 3352 D 3352 105 01 11 02 23 4 Maintenance by the service engineer Sirona Dental Systems GmbH Diaphragm check Perform diaphragm check also with Cephalometer if present Performing diaphragm check Answer questions with yes v or no Maintenance interval after years 12 14 Date enter month year Test phantom exposure needle phantom exposure correct See Service Manual If no gt Correct fault Checking the cables for damage Checking the cables Answer questions with yes v or no Maintenance interval after years 12 14 Date enter month year Power cable OK See Service Manual Protective ground wire OK Control cable OK Data transfer cable OK If no gt Correct fault 24 59 87 685 D 3352 D 3352105 01 11 02 Sirona Dental Systems GmbH 4 Maintenance by the service engineer Safety checks Move unit to working height Switch power OFF at the main switch for the building installation Remove covers from the unit Performing safety checks Answer questions with yes v or no Maintenance interval after years 12 14 Date enter month year Idling roll free of damage See S
18. of a fault does not create a hazard to the safety of the patient the user or other persons Hence it is important to detect such faults before a second fault occurs which might then lead to safety hazards For that reason it is essential to perform safety checks aimed particularly at detecting electrical faults every 2 years The information provided in Chapter 3 Safety related checks performed by the service engineer should be helpful here n addition your dental depot offers you maintenance of the system by specially trained engineers see Chapter 4 Maintenance by the service engineer All inspection and maintenance work and safety related checks performed by the system owner or ser vice engineer must be recorded in this document and kept near the unit Customer data Customer Last name First name Street Post code city Phone 59 87 685 D 3352 D 3352 105 01 11 02 5 2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH Annual inspection performed by the system owner or other authorized persons Technical documents Technical documents Answer questions with yes v or no Date please enter month year Operating Instructions available Installation Requirements availa ble Installation Report Warranty Passport available and com pletely filled out Declaration of Conformity by s
19. rona Dental Systems GmbH Labels on the system Comparing labels on the system with Installation Report Warranty Passport Answer questions with yes v or no Maintenance interval after years 4 7 10 12 14 Date enter month year All labels according to Installation Report Warranty Passport affixed All labels legible If no gt Replace missing and or illegible labels ORTHOPHOS X 20 59 87 685 D 3352 D 3352 105 01 11 02 Sirona Dental Systems GmbH 4 Maintenance by the service engineer Serial numbers of the system Please enter new Serial No here when replacing a component X ray unit Date Signature Serial No at initial start up Serial No Serial No X ray tube assembly Signature Serial No at initial start up Serial No Serial No Serial No Serial No Signature Serial No at initial start up Serial No Serial No Serial No Serial No Remote Date Signature Serial No at initial start up Serial No Serial No Serial No Ceph Date Signature Serial No at initial start up Serial No Serial No Sensor Date Signature Serial No at initial start up Serial No Serial No Ceph
20. ys tem integrator available X ray System Logbook available for Germany only If no gt Order missing documents from your dealer 59 87 685 D 3352 D 3352 105 01 11 02 Sirona Dental Systems GmbH 2 Annual inspection performed by the system owner or other authorized persons System accessories System accessories see Operating Instructions Answer questions with yes v or no Not all accessories listed here may be included in the scope of supply cross out what does not apply Date please enter month year Needle phantom available Test phantom available worldwide incl Germany SR Var Test phantom available Germany as from 07 2015 Test phantom for Ceph units availa ble 5 g SSE Test phantom for ORTHOPHOS XG 3 available Bite block yellow eS ee blue available fff Contact segment yellow blue availa ble Temporomandibu lar joint support 1 and 2 available Ear holders availa ble Forehead support temple supports and Contact pads available Chin rest comple tely available 59 87 685 D 3352 D 3352 105 01 11 02 If no gt Order missing accessories from your dealer 2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH Surfaces of the unit
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