ORTHOPHOS 3 DS - Sirona - Technical Documentation
Contents
1. Ih Wh 24 Exposure of the Temporo mandibular Joint P6 Program with Head Positioner For these exposures insert the head positioner see page 17 Remove bite block Using the 1 and 1 buttos adjust unit height so that ear fixations and external auditory canals match up Position the patient s head in the head positioner Close the temple supports so that the ear fixations are inserted in the external auditory canals Swing out the mirror To set the correct position switch on the light localiz er by pressing the height adjsutment key 7 The horizontal light beam FH should go through the lower margins of the orbits and the upper mar gins of the external auditory orifices Frankfurt Hori zontal plane FH For this reason the FH localizer 9 can be adjusted man ually upwards and downwards Ensure that the spine is slightly tilted as described before Have the patient take a small step toward the col umn Close temple supports 3 with knob Insert contact spacer F see page 17 and slide down until it makes contact with the front Swing back the mirror 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH 6 Operation 6 3 Selecting Data at the Multitimer Selecting Data at the Multitimer a EUN a a pm O 32 P 00 0000 6000 bb Manual 9 SOF2. Switching ON the PC e Prepare SIDEXIS program on PC for ORTHO PHOS XP exposure stand by see SIDEXIS User s Manual Ready for Panoramic Ceph X ray Labl Station 208 Waiting for exposure EE Ce UE afi A 60 86 867 D 3285 18 D 3285 201 06 05 02 Sirona Dental Systems GmbH 6 Operation 6 1 Preparing the Exposure Exposure key At the Multitimer the program and exposure parameters employed with the last patient appear A shows you the exposure program sequentially and the respective maximum exposure time B gives you the kV mA matched value pair The LED over the respective patient symbol lights up C LED over the return key R blinks Move the rotating unit into place for patient positioning by tapping one of the return keys R e NOTE You can release a test rotation without radiation via the exposure button after having pressed the T button The LED over the R key at the Multitimer switches off to let you know that the unit is ready for the exposure Help Message C Should the LED over the R key go on blinking call up the help message H3 H4 to look for the reason List of Help Messages see page 30 Image receiver e The image receiver 7 must be pushed all the way to the stop turn the rotary knob 8 to the left i NOTE To remove the image receiver
3. 60 86 867 D 3285 D 3285 201 06 05 02 Select the Exposure Program e Select the Exposure Program by pressing the keys The exposure program selected e g P1 and the corre sponding maximum exposure time are alternatively shown on the digital display i NOTE When with preselection of the exposure program O 1 appears on the display instead of for example P 1 you have erroneously selected a mode provided for servic ing You can leave this mode by pressing the Memory button and then Program or by switching to another exposure program Select Exposure Data by tapping one of the four patient symbol keys The LED above the key will then light up and the respec tive kV mA matched pair will appear on the digital dis play Manually the exposure data can be modified with the keys The LED over the patient symbol key is then no longer illuminated The mA value is the same for all kV values See chapter Program Values The kV mA matched values for the patient symbol keys are factory programmed Should you need to modify these values see the chapter entitled Programming 25 6 Operation 6 4 Releasing the Exposure Sirona Dental Systems GmbH Releasing the Exposure 26 Aa TTENTION Operator Observe the radiation protection guidelines explaine
4. X RAY AA TTENTION Ww In case of unit failure the test key T on the Multitimer must be pressed first radiation protection measure o o e Press the X ray exposure key on Multitimer H3 H4 help message appears on the kV mA display e Read on the following list what is to be done to get the unit ready for the exposure e Before carrying out the corresponding indication press return key R on the Multitimer to acknowledge the help message Help Message H3 H3 01 Press one of the R buttons to return the rotation unit to the start position H3 20Press R key on Multitimer to confirm exposure data Help Message H4 H4 01Slide in the image receiver up to stop H4 03Set SIDEXIS operational on the PC H4 10lmage receptor not suitable for the set exposure H4 20Transfer exposure by SiRescue service program to the PC see SIDEXIS User Manual CAUTION Do not switch off the unit until the help mes sage goes out 60 86 867 D 3285 30 D 3285 201 06 05 02 Sirona Dental Systems GmbH Program Values 9 Program Values 9 1 Program Values world wide except USA and Asia Program Values world wide except USA and Asia Kennziffer 30 Program Program Exposure Factory programmed values Freely programmed values or duration time with an adjustment of the values with other adjustment of approx
5. with different values See chapter Program Values P O 1 Push buttons to select program number P1 to v 5b o Oe 2 be changed mA I 2 Push buttons to set desired kV value on the dig ital display Y 3 Push memory button The LED over the memory 4 button blinks RT b 4 Push the patient symbol button to be repro o QO grammed The LED above this button lights up l The LED above the memory button is switched off The new values are now stored S d Programming is complete l Please enter the new value in the Freely programmed values table The adjustment of the exposure is set to 03 at the fac tory If the degree of exposure is to be changed use the sup plied screwdriver as shown in the illustration During adjustment the corresponding switch position is briefly displayed example 04 Step switch set to lower dose noisy exposures Step switch set to higher dose low noise exposures i NOTE Changing the adjustment of the exposure automatically alters the programmed kV mA values Chapter Program Values see page 31 60 86 867 D 3285 D 3285 201 06 05 02 29 8 List of Help Messages H3 H4 Sirona Dental Systems GmbH List of Help Messages H3 H4 7 You want to release an exposure but the Ready LED on AP an Multitimer above the R key is still blinking
6. rona The Dental Company ORTHOPHOS 3 DS Operating Instructions Dear Customer Maintenance Sirona Dental Systems GmbH Thank you for purchasing yournew ORTHOPHOS 3 DS X ray unit for panorama planigraphy For this unit we have provided you with a set of techni cal literature Operating Instructions Installation Instructions Installation Report Warranty Passport Wiring References Pre Installation Dimensions Tech nical Data Keep this literature for quick and easy refer ence In order to protect your warranty rights please fill out the Installation Report Warranty Passport provided together with the technician immediately after installa tion of the unit Read the Operating Instructions to familiarize yourself with the unit before taking radiographs on the patient Please observe the Radiation Protection Regulations and Warning and Safety Notes These Operating Instructions assume a thorough famili arity with the SIDEXIS software Your ORTHOPHOS Team To ensure the safety of the patient the operators and third parties equipment inspections and maintenance work must be carried out at specified intervals in order to guarantee the operational safety and functional reliability of your product It is the responsibility of the operator to ensure that the inspections and maintenance work are carried out In the event that the operator fails to fulfil the obligation to carry out inspecti
7. exposure of 03 the exposure please enter here P1 21s 11 3s 66 10 70 10 74 10 78 10 P6 1 P6 2 21s 21s 7 8s 6840 72 0 76 10 80 10 P11 18s 11 3s 6610 70 10 74 10 78 10 These values serve only as user reference times Possible kV mA combinations can be selected manually 60 62 64 66 68 70 72 74 76 78 80 kV 10 10 10 10 10 10 10 10 10 10 10 mA 60 86 867 D 3285 D 3285 201 06 05 02 31 9 Program Values Sirona Dental Systems GmbH 9 2 Program Values USA Program Values USA Index 2A Program Program Exposure Factory programmed values Freely programmed values or duration time with an adjustment of the values with other adjustment of approx exposure of 03 the exposure please enter here P1 21s 11 3s 6610 70 10 74 10 78 10 P6 1 P6 2 21s 21s 7 8s 68 10 72 0 76 10 80 10 P11 18s 11 3s 66 10 70 10 74 10 78 10 These values serve only as user reference times By actuating one of the two smaller or one of the two larger patient symbols you can change between the two kv mA pair groups By actuating the kV mA keys you can select the individual values of the kV mA groups Possible kV mA value pairs manually selectable with the two smaller patient symbols 60 60 60 62 64 66 68 70 72 74 76 kV
8. 6 7 10 10 10 10 10 10 10 10 10 mA Possible kV mA value pairs manually selectable with the two larger patient symbols 60 62 64 66 68 70 72 74 76 78 80 kV 10 10 10 10 10 10 10 10 10 10 10 mA 60 86 867 D 3285 32 D 3285 201 06 05 02 Sirona Dental Systems GmbH 9 Program Values 9 3 Program Values Asia Program Values Asia Index 1A Program Program Exposure Factory programmed values Freely programmed values or duration time with an adjustment of the values with other adjustment of approx exposure of 03 the exposure please enter here P1 21s 11 3s 68 10 72 0 76 11 78 11 P6 1 P6 2 21s 21s 7 8s 70 10 74 10 78 11 80 11 P11 18s 11 3s 68 10 72 10 76 11 78 11 These values serve only as user reference times By actuating one of the two smaller or one of the two larger patient symbols you can change between the two kv mA pair groups By actuating the kV mA keys you can select the individual values of the kV mA groups Possible kV mA value pairs manually selectable with the two smaller patient symbols 60 62 64 66 68 70 72 74 76 78 80 kV 10 10 10 10 10 10 10 10 10 10 10 mA Possible kV mA value pairs manually selectable with the two larger patient symbols 60 62 64 66 68 70 72 74 76 78 80 kV 11 11 11
9. Multitimer cable damaged E235 Invalid data in data memory E309 Movement of height adjustment obstructed E401 Exposure interrupted by SIDEXIS Press R key on Multitimer to reset display Press R key on Multitimer to reset display Press R key on Multitimer to reset display Press R key on Multitimer to reset display Press R key on Multitimer to reset display Freely pro grammed values see page 31 are canceled sorry Please reprogram see page 29 Press R key on Multitimer to reset display Close x ray room door Press R key on Multitimer to reset display If error re appears poss break in cable Press R key on Multitimer to reset display Check that height adjustment can move freely Press R key on Multitimer to reset display WARNING If this fault message occurs repeatedly during the motor driven up and down movement of the rotary unit especially when no patient is positioned switch off the unit immediately and inform your service engineer without delay Press R key on Multitimer to reset display Check PC for readiness For error messages which are not contained in this list switch the unit off and back on if for an exposure the X ray image is displayed on the PC 60 86 867 D 3285 D 3285 201 06 05 02 A ATTENTION If an error is displayed again after switching the unit off and then on again please contact your service techni cian Aa TTENTION The turn off time must be at lea
10. Sirona Dental Systems GmbH 3 Operating Controls and Displays 3 2 Multitimer Multitimer di m sions y X RAY X ray oe o9 iti oo P1600 0090 66 690909 o 60 86 867 D 3285 D 3285 201 06 05 02 Unit ON LED Radiation present indicator Exposure key Digital display for exposure program exposure time with keys for exposure programs Digital display for kV mA paired values with keys for overriding kV values Patient symbol keys with programmed kV mA values Memory program key kV mA matched values Key with service function Rotation test key T without radiation Return key R The LED blinks when the system is not ready 13 4 Accessories Sirona Dental Systems GmbH 4 1 Rests and supports Accessories Rests and supports With marked accessories can be sterilized Sterilize only in an autoclave at 135 C 2 1 bar 135 C 275 F 275 F For reorders A Yellow bite block 5 pcs Order No 89 21 843 B Yellow contact segment for patient without front teeth 5 pcs Order No 89 31 545 C Head positioner complete incl 4x D Order No 18 88 770 D Ear fixation 10 pcs Order No 18 88 838 F Contact spacer Order No 33 10 336 disposable Before each exposure the hygienic protective covers should be attached For better illustration of the components the following figures are shown without
11. area provided it is used under the responsibility of a trained medical operator Following extreme temperature fluctuations condensate formation may occur therefore please do not switch on the device until normal room temperature has been reached see chapter Technical Description When switching on the unit there must not be a patient positioned in the unit If a fault occurs which requires switching the unit off and then back on again the patient must be taken out of the unit at the latest before switching it on again 1 Warning and Safety Notes Interference with electromedical devices by radio telephones Malfunction of electronic units devices which are worn on the patient s body Radiation Protection Disassembly and reinstallation Disposal Sirona Dental Systems GmbH To guarantee the operational safety of electromedical devices it is recommended that the operation of mobile radio telephones in the medical practice or hospital is prohibited In order to prevent failure of electronic units and data storage devices e g radio controlled watch and tele phone card etc it is essential that these be removed prior to X ray exposure Observe the applicable health physics regulations The radiation protection facilities should be used The operator should remain as far away from the X ray tube as the cable of the release button permits With the exception of the patient no other persons may remain in th
12. beryllium a lead lining and mineral oil Please contact your dealer if final disposal of your prod uct is required 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH Laser light localizers used LASER KLASSE 1 CLASS 1 LASER PRODUCT APPAREIL A LASER DE CLASSE 1 This product complies with 21 CFR Chapter 1 Subchapter J Sirona Dental Systems Fabrikstr 31 D 64625 Bensheim Germany Manufactured in Bensheim FH Model no 58 86 135 D3285 Serial no SAG Model no 58 86 143 D3285 Serial no 60 86 867 D 3285 D 3285 201 06 05 02 1 Warning and Safety Notes This product incorporates a laser of class 1 The light localizers serve for the correct positioning of the patient They must not be used for other purposes A minimum distance of 100mm must be maintained between the eye and the laser Do not look into the beam Safety opera tion is described in Section 6 2 The light localizers may be switched on only if they func tion fault free Repair work may be carried out only by authorized personnel 2 Technical Description 2 1 Technical Data Sirona Dental Systems GmbH Technical Description Technical Data Nominal line voltage Permissible line voltage fluctuation Nominal current Nominal frequency Power line resistance Fuse at the distribution panel Rating Tube voltage Tube current Curve form of high voltage Rotation time Exposure time Reproduction
13. country specific requirements Furthermore we would like to call your attention to our Quality Image Service For this please contact your dental dealer or the manufacturer directly 60 86 867 D 3285 D 3285 201 06 05 02 We reserve the right to make any alterations which may be due to technical improvements Sirona Dental Systems GmbH 2001 Sprache englisch Printed in Germany D 3285 201 06 05 02 03 2007 A Nr 108 523 Imprim en Allemagne pa J SSS EES ESS Ee Sirona Dental Systems GmbH in the USA in Canada FabrikstraBe 31 Sirona Dental Systems LLC Sirona Canada Order No 60 86 867 D 3285 64625 Bensheim 4835 Sirona Drive Suite 100 3250 Ridgeway Drive Unit 5 Germany Charlotte NC 28273 Mississauga Ontario L5L 5Y6 WWW sirona com USA Canada
14. order to prevent the saved image from being delet ed For operating the SiRescue service program please observe the corresponding software description in the SIDEXIS User Manual 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH 6 Operation 6 4 Releasing the Exposure The help message H4 20 is no longer displayed after the image has been transmitted by the SiRescue service program NOTE Only then may the units be switched off or put into the ready for exposure state After the exposure Acknowledge awareness of the exposure time actually required for the exposure by pressing the return key R Then bring the rotary unit in to the starting position by pressing the return key R once again After return travel to the start position the unit is automatically ready for another exposure See chapter Positioning the Patient 5 8 MH ol X RAY 0000 6090 t Interrupting the Exposure If the exposure key is prematurely released the expo sure is interrupted and terminated The kV mA value and the LED over key R blink at the Multitimer The exposure time passed until the interruption is shown Press the R key on the Multitimer twice Check patient positioning and repeat the exposure ins o kV m 0000 000 60 86 867 D 3285 D 3285 201 06 05 02 Automatic Exposure Blockag
15. scale Focus size according to IEC 336 measured in central ray Focus marking Automatic exposure blockage see page 27 Equipment of protective class Protection against electric shock Protection against penetration of water Mode of operation Long time power rating Target material Loading factors concerning leakage radiation Leakage radiation 208V 230V 240V 10 9 7A 50 60Hz max 0 8 Ohm 20A slow blow 2 1 kW 60 80kV 6 11mA high frequency multipulse Residual ripple x 4kV see page 31 see page 31 With P1 program medium mandibular arch plane center ca 1 1 19 The image at the image receiver is approximately 1996 larger than the real proportions 0 5mm The duration of the exposure blockage cool off period depends on the kV mA step set and the actually triggered radiation time Depending on the tube load pause times up to 200s are set auto matically Example For P1 program with exposure data 74kV 10mA and a radiation time of 11 3s a pause of 200s results Type B equipment h Ordinary equipment without protection Continuous operation 64W Tungsten 1 1mA 80 kV lt 1mGy h 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH Source Image receptor distance Transport and storing temperature Relative humidity Permissible operating temperature Sensor image receptor Type External dimensions Active sensor surface Resulti
16. the hygienic protective covers For orders G For temple supports and handles 500 pcs Order No 33 14 098 Dimensions 210 140 mm x 57mm H For bite block and contact segment 500 pcs Order No 33 14 080 Dimensions 80mm x 40mm Needle phantom Order No 33 11 235 60 86 867 D 3285 14 D 3285 201 06 05 02 Sirona Dental Systems GmbH 5 Exposure Programs 5 1 P1 Program Exposure Programs 5 1 P1 Program Complete standard exposure e Yellow bite block or contact segment with constant 1 25 fold magnification e g for implantology e Yellow bite block or contact segment 60 86 867 D 3285 D 3285 201 06 05 02 15 5 Exposure Programs Sirona Dental Systems GmbH 5 3 P6 1 P6 2 Program P6 1 P6 2 Program Lateral exposures of the temporoman dibular joints with closed and open mouth 4 exposures on one image e nsert head positioner see page 17 P6 1 Outer Image P6 1 Closed mouth e Actuate P6 1 After P6 1 is completed the unit automatically re turns to the initial position P6 2 Inner Image Open mouth Have the patient open his mouth and actuate P6 2 Head positioner P6 2 60 86 867 D 3285 16 D 3285 201 06 05 02 Sirona Dental Systems GmbH Operation 6 Operation 6 1 Preparing the Exposure Preparing the Exposure 60 86 867 D 3285 D 3285 201 06 05 02 Insert Contact Spacer F Appl
17. turn the rotary knob 8 to the right and pull the image receiver out Aa TTENTION Do not drop it a eo 0000 0000 60 86 867 D 3285 D 3285 201 06 05 02 19 6 Operation Sirona Dental Systems GmbH 6 2 Positioning the Patient Positioning the Patient e Have the patient remove all metallic objects such as glasses and jewelry from the head and neck re gions Have him take out removable dentures e Physical constitution clothing bandages etc must not interfere with the functioning of the unit Perform a test run with the T button see page 19 e Insert bite block contact segment or head position er see page 17 For selection see chapter Exposure Programs Standard Exposure Program P1 and P11 e Have the patient stand in front of the mirror Pressing the height adjustment key f automatically switches on the light localizer for 1minute o NOTE Please make sure that the light beam strikes the eyes of the patient only very briefly 60 86 867 D 3285 20 D 3285 201 06 05 02 Sirona Dental Systems GmbH 6 Operation 6 2 Positioning the Patient With Bite Block e Using the f and J buttons adjust unit height so that the bite block and the anterior teeth match up e Have the patient grip the handles e Have the patient bite the bite bloc
18. 11 11 11 11 11 11 11 11 mA 60 86 867 D 3285 D 3285 201 06 05 02 33 10 Care the surfaces Sirona Dental Systems GmbH Care the surfaces Cleaning Remove dirt and disinfectant residues regularly with a normal commercial cleaning medium Do not allow any liquid to enter the ventilating slots To avoid permanent staining quickly clean away any medicament that spills on the surface Do not clean the lens of the laser with alcohol Disinfecting Disinfecting is possible by wiping with surface disinfect ant Observe the directions of the manufacturer when using Use only tested and approved media Do not use agents containing the components phenol peracetic acid peroxide and other agents splitting up oxygen sodium hypochlroite and agents splitting off iodine 60 86 867 D 3285 34 D 3285 201 06 05 02 Sirona Dental Systems GmbH Error Messages 11 ErrorMessages E error messages Remedy E101 One of the keys on the Multitimer was pressed during start up of the unit E103 Faulty communication with the unit E201 Appears after pressing exposure key X ray head overheated Cool down periods ignored E203 Faulty communication with the Multitimer E204 Zero Power was re initialized E210 Max radiation time of program exceeded E220 Appears after pressing the exposure key e g if x ray room door contact not closed Exposure lead in
19. I swa DA ERU ERN DOO AD SER CR CUR 29 7 1 Programming Procedure eesseeeeneeen eene nennen 29 7 2 Adjustment of the Exposure nennen nennt 29 List ot Help Messages H3 HA anno eh eite cn tend ide 30 Program Vales cdi deawaias cx nde posta ER anade KR TRE UN C SaXREKIERI2XNRM RO nanim MAURIS SUR TE Raina Thina ESERE oip SaS 31 9 1 Program Values world wide except USA and Asia ssssss 31 9 2 Program Values USA neces ine ve tede etie ce erede ar reda Dus 32 9 3 Program Values Asia einen meet ihi triente anaiai aaa 33 Care the surfaces isi vic tiir recur daa dra i E tac rs dc ona adu Fn bro aa cada rav da Dea e CU aae da La n Po b RR 34 Error MeSSageS au sei nici en tni aa edi cr i DuC R2 SE Ei I rain Fwd Da TD Cu ER ERCDOD RD REC daa i Rn 35 Inspection and maintenance ona dmi rci randa di du cn rro dod S Staa dedi da rux ou c Der ilk dede Fore nnana 36 60 86 867 D 3285 D 3285 201 06 05 02 3 Sirona Dental Systems GmbH 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH 1 Warning and Safety Notes Warning and Safety Notes Labeling of warning and safety information Intended use General safety information Safety measures during switch on 60 86 867 D 3285 D 3285 201 06 05 02 In order to prevent injury to persons and damage to the equipment you must also read the warning and safety notes given in these Operating Instructions These are emph
20. Switch the light localizer on by pressing briefly on the height adjustment key f The light localizer serve for the correct positioning of the patient i NOTE Please make sure that the light beam strikes the eyes of the patient only very briefly i NOTE The light localizer switches off automatically after about 1 minute 60 86 867 D 3285 D 3285 201 06 05 02 The horizontal light beam FH should go through the lower margins of the orbits and the upper margin of the external auditory orifices Frankfurt Horizontal e For this reason the FH localizer 9 can be adjusted manually upwards and downwards e Finely adjust the head inclination for the FH line ad justment by tapping the buttons 7 or 4 for vertical unit movement The central light beam e should be directed onto the center of the anterior teeth or the middle of the face e Align the center of the anterior teeth or the middle of the face to the central light line e Close the temple supports with knob 3 e Insert contact spacer F see page 17 and slide down until it makes contact with the front e Swing back the mirror e Have the patient take a small step toward the col umn e Recheck the FH position 23 6 Operation 6 2 Positioning the Patient Sirona Dental Systems GmbH
21. a SFDA I 20053301583 60 86 867 D 3285 D 3285 201 06 05 02 9 2 Technical Description Sirona Dental Systems GmbH 2 1 Technical Data Cooling curve for the tube housing HUx10 1HU 1 35 Joule 0 20 40 60 80 100 120 140 480 160 180 200 220 240 min Anode cooling caracteristic HUx10 1HU 1 35 Joule 0 1 2 3 4 5 6 min Heating curve for tube housing HUx10 1HU 1 35 Joule 1000 Reference axis Reference axis Anode angle 7 v 60 86 867 D 3285 10 D 3285 201 06 05 02 Sirona Dental Systems GmbH 2 Technical Description 2 1 Technical Data Radiation fields of the laser light localizers 60 86 867 D 3285 D 3285 201 06 05 02 11 3 Operating Controls and Displays Sirona Dental Systems GmbH 3 1 Unit Operating Controls and Displays Unit 1 Main switch 2 Patient positioning mirror 3 Head holder with adjusting knob for temple supports 4 Image receiver 5 Diaphragm 6 Diaphragm wheel 7 Height adjustment buttons 1 Additional function key switches light localizer on 8 Knob for image receiver removal or insertion O 9 Height adjustment Light localizer horizontal light beam FH 10 Light localizer central light beam 11 Multitimer 60 86 867 D 3285 12 D 3285 201 06 05 02
22. asized with ATTENTION and CAUTION This unit has been designed for use in creating pano rama radiographic exposures This unit must not be used in areas where there is a risk of explosion As manufacturers of electro medical products we can assume responsibility for safety related performance of the equipment only if maintenance repair and modifica tions are carried out only by us or agencies we have authorized for this purpose and if components affecting safe operation of the unit that may be needed are replaced with original parts We suggest that you request a certificate showing the nature and extent of the work performed from those who carry out such work and specify that the certificate show any changes in rated parameters or working ranges as well as the date the name of the firm and a signature For reasons of product safety only original Sirona accessories approved for this product or accessories from third parties which have been released by Sirona may be used It is the user s risk when using non released accessories Exposures of patients may only be taken if the unit func tions fault free Never leave the patient unattended in the unit Instructions for avoiding recognizing and correcting unintended electromagnetic effects The ORTHOPHOS 3 DS X ray System is a unit of class A classification according to CISPR 11 EN 60601 1 2 1993 based off IEC 60601 1 2 This unit may be oper ated in a residential
23. d see page 6 Before releasing the exposure always check display for proper exposure data for the patient beeing radio graphed The exposure is released by keeping the expo sure key pressed The rotation movement runs automatically in accord ance with the exposure program selected For P6 program only The rotation unit returns back into the start position after having completed the program part P6 1 Then have the patient open his mouth wide and release the second pro gram part P6 2 During radiation the X ray radiation indicator lights up The radiation duration is additionally accompanied by an acoustic signal e The exposure ends when the LED over the R key flashes Rotation and radiation automatically switch off Open the temple supports and have the patient step out Interrupting the Exposure Automatic Exposure Blockage and Error Message see next page The program number e g P1 is indicated at the Multi timer After the end of the exposure the exposure time actually required for the exposure lights up and the exposure is displayed on the PC Q wore In case of disturbances of the data transmission to the PC the unit changes automatically into a safe mode which saves the acquired image until the image has been transmitted by a service program SiRescue The safe mode is indicated by the help message H4 20 ATTENTION In this condition the unit or the PC may not be switched off in
24. e Protection of X ray tube The automatic exposure blockage prevents premature triggering of a new exposure After the exposure key has been actuated the automatic cool off pause is indicated The LED over key R continues flashing until the cool off time has elapsed The exposure cannot be triggered until the LED over key R has gone out Example see page 8 27 6 Operation 6 4 Releasing the Exposure Sirona Dental Systems GmbH RENT eee ma Of 0000 6000 t 28 Error Message E Messages such as E2 01 in the kV mA field indicate errors The LED over the R key blinks All unit functions are blocked e Press the key R on the Multitimer to reset display poss more than once e Ifthe error message E continues to light up switch the unit off and back on if for an exposure the X ray image is displayed on the PC ANA TTENTION The turn off time must be at least 60s otherwise the unit will not function correctly If error message has disappeared all unit functions are normal again For List of Error Messages with remedy discription see page 35 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH 7 Programming 7 1 Programming Procedure Programming Programming Procedure a Ij Inthe factory kV mA values have been assigned to the 4 b four program buttons RT X RAY For free programming the buttons can be programmed
25. e room while the exposure is being made Under exceptional circumstances a third person how ever not belonging to the dental practice may then assist Maintain visual contact with the patient and the unit during the exposure In case of faulty operation discontinue the exposure by releasing the exposure button For disassembly and reinstallation of the unit proceed as described in the installation instructions for new installa tion to ensure perfect function of the unit and its stability It generally applies that any disposal of this product must comply with the relevant national regulations Please observe the regulations applicable in your country Within the European Economic Community Council Directive 2002 96 EU WEEE requires environmentally sound recycling disposal of electrical and electronic devices Your product is marked with the adjacent symbol Dis posal of your product with domestic refuse is not compatible with the objectives of environ mentally sound recycling disposal The black bar underneath the garbage can symbol means that it was put into circulation after Aug 13 2005 see EN 50419 2005 Please note that this product is subject to Council Direc tive 2002 96 EU WEEE and the applicable national law of your country and must be recycled or disposed of in an environmentally sound manner The X ray tube assembly of this product contains a tube with a potential implosion hazard a small amount of
26. ication For all exposure programs Always place the contact spacer where as a result of anatomical features with correct head positioning there is no contact with the forehead no 3 point fixing After positioning the head press the contact spacer onto the tube and push it down to the forehead contact Insert Head Positioner C Application Exposure program P6 Open temple supports with knob 3 remove rubber inserts Z and insert head positioner up to stop Insert Bite Block A or contact segment B Application Exposure programs P1 and P11 17 6 Operation Sirona Dental Systems GmbH 6 1 Preparing the Exposure Switching ON the Unit Aa TTENTION Following extreme temperature fluctuations condensate formation may occur therefore please do not switch on the device until normal room temperature has been reached see chapter Technical Description e Depress the main switch 1 into the I position and 1 allow one minute warm up time l The LED in the upper left corner of the Multitimer will O light up e The unit adjusts itself automatically e The rotating unit moves a little to the right and left Aa TTENTION f When switching on the unit there must not be a patient positioned in the unit If a fault occurs which requires switching the unit off and then back on again the patient must be taken out of the unit at the latest before switching it on again
27. k at the indenta tion The upper anterior teeth should be directly in the in dentation and the lower anterior teeth should be moved forward up to the stop With Contact Segment For patients without anterior teeth e Adgjustthe unit height so that contact segment and subnasals match up e The contact segment should be just under the pa tient s nose e Ensure that the upper and lower jaws are lined up with each other This is facilitated by a cotton roll Q wore The height adjustment motor starts up slowly and then picks up speed Motoric movement is accompanied by an acoustic signal 60 86 867 D 3285 D 3285 201 06 05 02 21 6 Operation Sirona Dental Systems GmbH 6 2 Positioning the Patient e Make certain the spine is tilted slightly as shown This moves the patient s cervical vertebrae into a more stretched out position The cervical vertebrae stretched out ensures that the area of the anterior teeth is not over exposed In special cases it is also possible to position for sitting patients CORRECT INCORRECT 60 86 867 D 3285 22 D 3285 201 06 05 02 Sirona Dental Systems GmbH O 0000 0000 6 Operation 6 2 Positioning the Patient e Swing out the mirror by pressing on A e Position the patient s head so that the bite plane is tilted slightly forward e
28. ng image format Detail recognition Minimum requirements for the PC systems Hard disk RAM Drives Operating system Graphics system Network Communication connection Laser light localizer Magnitude Max radiant power Pulse duration 2 Technical Description 2 1 Technical Data 497mm 40 C 70 C 40 F 158 F 10 95 According to IEC 601 1 between 10 C and 40 C 50 F 104 F Digital CCD technology line sensor can be plugged to Panorama position 280mm x 120mm x 35mm Panorama 138mm x 5 9mm Panorama depends on selected program max 138 x 288mm Panorama 0 09mm pixel size gt 2 GByte database gt 50 MByte SIDEXIS installation at least 64 MB CD ROM 3 5 diskette one per system network MOD drive min 640 MByte one per system network Windows 98 Windows NT 4 0 Service Pack gt 5 Resolution at least 1024 x 768 pixels color depth at least 8 bit 10 100 MBit Ethernet RJ45 for LAN cable 300mm long 5mm wide 350 J m 100s ORTHOPHOS 3 DS has been inspected by the VDE Testing and Certification Institute for compliance with EN 60601 1 EN 60601 2 28 and EN 60601 1 3 and has been found to comply with these regulations 0123 Original language german This product is provided with a CE marking in accord ance with the regulations stated in the Directive 93 42 EEC of June 14 1993 concerning medical products Reg No Chin
29. ons and maintenance work or ignores error messages Sirona Dental Systems GmbH or their contracted dealer cannot assume liability for any damage attributable to this 60 86 867 D 3285 D 3285 201 06 05 02 Sirona Dental Systems GmbH List of Contents Warning and Safety Notes deni Iac ied isa dot deat noueceevasseen ss decudaneucats 5 Technical D seriptioli uuo ei redde nanne annas end cett toda od eve sitae dione IM 8 2 1 Technical Data ende bbnp o e PURI RUE 8 Operating Controls and Displays eeeeeeee eese eeeeeee eene nnn nennt anna n nnn sanatus 12 3 1 Bot 12 3 2 M ltitimer uscite ertet eo rene rae cet tre deviance 13 ACCESSOS T 14 4 1 Rests and Supports s et E ERE EDREEEHAB RPUPU a RRREPERS dS 14 4 2 Hygienic Protective Covers essen nennen 14 A S Service Tools zu oe P UTERE ER P IIS 14 Expos re ipii T 15 5 1 P1 Program asu ie Reese uten n qe pice dti ins 15 5 2 Pt PrOQgEalTis ia dco ttt dot up t eth ded 15 5 3 P614 P6 2 Prograt cene ec Heec eaten 16 ODpGSration i oe oec ees uid LM ULL EI DE 17 6 1 Preparing tlie ExpoSure s oec eite toe ime s udi i TR e 17 6 2 Positioning the Patients irci neioii niidi ah e do 20 6 3 Selecting Data at the Multitimer eeee 25 6 4 Releasing the ExpOSure cccscccceseeeesseeeeeseeeeeneneeeeeeeeeseneeseenenesensesseneeseenes 26 Programimilig usiaseiccoa nisse aii aa Fe aaa aiaa OD rv Kaaa EX IC
30. st 60s otherwise the unit will not function correctly 35 12 Inspection and maintenance Sirona Dental Systems GmbH Inspection and maintenance Annual inspection performed by the operator or other authorized personnel Maintenance performed by the service technician Checking image quality 36 Inspection and maintenance work must be performed at regular intervals to protect the safety and health of patients users and third parties As the operator you should ensure the safety and relia bility of your system by performing maintenance on it at regular intervals at least once annually or having this work performed by your dental dealership In addition to the scheduled annual inspection by the user or persons contracted to perform this a mainte nance inspection must be performed after 4 7 10 and then every two years At regular intervals however at least once a year the user must evaluate the image quality For digital image receptors the increasing number of repeated image processing operations to be made with the brightness or contrast control in the image process ing software e g SIDEXIS is used as evaluation crite rion If this evaluation criterion is considered to be satisfied irrespective of the patient s anatomy or possible error Sources such as patient positioning a technician should be consulted immediately for elimination of possible sys tem defects In addition it is necessary to observe
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