CRANEX® Novus e - thetechgods.net
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1. 46 1A General WM MN r EE 46 7 2 User patient Warnings Lams kek kk ek kk k k k k kk kK 47 8 DIS OS AU vene 50 Appendix A Technical 4 04 A 1 User Manual 208898 V Contents CRANEX Novus e vi User Manual 208898 CRANEX Novus e 1 Introduction 1 Introduction 1 1 CRANEX Novus X ray unit The CRANEX Novus e the unit is a digital pano ramic dental x ray unit designed to take adult panoramic exposures child panoramic exposures reduced width bitewing optional not available in all countries and TMJ exposures The unit uses a CCD sensor as the image recep tor and a PC with suitable MDD compliant dental imaging software such as SCANORA or DIGORA for Windows not in USA for image acquisition and handling The unit can be used in single or multiple user con figurations With the single user configuration the unit is con nected to a single PC With the multiple user configuration Multiconnect activated the unit is connected to a network where up to eight PCs can be connected to the unit With the Multiconnect configuration only one PC ata time can reserve and use the unit IMPORTANT NOTE Before using the unit for the first time make sure that it is set up to your requirements See section 5 Unit Settings USA only Caution Federal law restrict2. Place the appropriate disposable covers on to the patient support you are using Press the appropriate panoramic program key to select the panoramic program you require adult or child The key color will change which indi cates that the program has been selected The magnification of all the programs is 1 25 A default kV value for the selected program will appear on the display User manual 208898 13 3 Taking an Exposure lt 730 CRANEX Novus If you consider that the default kV value for the program selected is not correct for the patient being examined select a different kV value based on the patient s size age and estimated bone density To change the kV value press the kV plus or minus key The recommended values are Large Adult 77 kV Adult 73 kV Juvenile or small adult 70 kV Child 63 or 66 kV Ask the patient to remove any spectacles den tures jewellery and hair clips and pins Place a protective lead apron around the pa tient s neck to protect the patient s thyroid gland from radiation NOTE If the patient is nervous you can reassure him her by demonstrating how the unit works before taking the exposure See section 4 Press the Up Down keys to adjust the height of the chin support so it is slightly higher than the patient s chin User manual 208898 CRANEX Novus e 8 3 Taking Exposure If the pat
3. ommended by SOREDEX The unit or its parts must not be changed or modified in any way without approval and in structions from SOREDEX The unit should not be used adjacent to or stacked with other equipment This unit can interfere with other devices due to its EMC characteristics and other devices can interfere with this unit due to their EMC charac teristics Refer to the EMC Declaration A4 in Appendix A for more information 46 User s manual 200409 Cranex Novus e 7 Warnings and precautions 7 2 User patient warnings The unit may be dangerous to the user and the patient if the safety regulations in this manual are ignored if the unit is not used in the way described in this manual and or if the user does not know how to use the unit Because the x ray limitations and safety regula tions change from time to time it is the respon sibility of the user to make sure that all the valid safety regulations are fulfilled It is the responsibility of the user to decide if the x ray exposure is necessary Always use the lowest suitable x ray dose to obtain the desired level of image quality Always use suitable hygienic barriers on parts of the unit that the patient has contact with Avoid taking x ray exposures of pregnant wom en If the patient is using a pacemaker consult the manufacturer of the pacemaker to confirm that the x ray unit will not interfere with the operation of the pacemaker b
4. The recommended values are Large Adult 77 kV Adult 73 Juvenile or small adult 70 KV Child 63 or 66 kV Ask the patient to remove any spectacles den tures jewellery and hair clips and pins Place a protective lead apron around the pa tient s neck to protect the patient s thyroid gland from radiation NOTE If the patient is nervous you can reassure him her by demonstrating how the unit works before taking the exposure See section 4 Press the Up Down keys to adjust the height of the chin support so it is slightly higher than the patient s chin User manual 208898 27 3 Taking an Exposure CRANEX Novus 8 Ask the patient to step into the unit grasp the patient handles place his her chin on the chin rest and bite the notches in the bite block 9 Press the mirror to open it so that you can see a reflection of the patient The patient positioning lights will automatically come on when the mirror is opened or when one of the Up Down keys is pressed They will remain on for two minutes or until the exposure button is pressed The Patient Positioning lights can also be switched on and off with the Lights key 10 Look at the reflection of the patient in the mir ror and position the midsagittal plane of the patient so that it coincides with the midsagittal plane light Make sure that the patient is looking straight ahead and that the patient s head is not tilted or tur
5. IEC 61000 3 2 Voltage Complies fluctuations flicker emissions IEC 61000 3 3 A 12 CRANEX Novus e CRA 2 Appendix A Technical Information Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 KV contact 8 KV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transients bursts 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a 30 dip in Ur for 25 cycles 30 dip in Ur for 25 cycles IEC 61000 4 4 1 kV for input output 1 kV for input output typical commercial or lines lines hospital environment Surge 1 kV differential 1 kV differential mode Mains power quality IEC 61000 4 5 mode 2 kV common mode should be that of a 2 kV common mode typical commercial or hospital environment Voltage dips lt 5 Ur lt 5 Ur Mains power quality short gt 95 dip in Ur gt 95 dip in Ur should be that of a interruption
6. Unit P ri SCANORA DED r r DK r MN 7 DIGORA for Windows not in 9 3 2 Taking EXPOS NSS EE EE 12 Panoramic Adult and Child 4 kk kk kk k 12 Temporomandibular Joint TMS kk kk k 20 Bitewing LE ee EE EE 26 4 Operating the unit without generating 32 GE JET gt EE ENE ER EN 33 ONS eee 33 5 2 Image Preview for Windows 37 6 Troubleshooting and 39 6 1 Error messages and SYMONS sanne 39 Error SG laya l dn ti ikand bana ce kaka veka dek nanan d la k d iin 40 User SIONS RE RM m 41 System FA OR a inin 41 6 2 Care and Maintenance 43 Cleaning and disinfecting the 2 2 43 Surfaces that the patient touches 43 Hin 0 EEE e ae iae mme 43 Positioning NT 43 SERN Cond pan yas n Ann nun dln a nekl dhe l n nin deir 43 Correct operation of the unit addo Fes kk kK KK 44 T dikk Has TT z kec nevne 45 7 Warnings and precautions 1 11
7. be carried out a kV mA test a beam alignment test check that the safety ground is connected check that the positioning lights operate check that no oil is leaking from the tube head check that the power lead is not damaged in any way check that all covers and mechanical parts are correctly secured and have not come loose check that any vents in the covers are not blocked with dust and that no dust has accumu lated inside the unit A full description of all the tests and checks is de scribed in the Service Manual User manual 208898 45 7 Warnings and precautions Cranex Novus e 7 Warnings and precautions 7 1 General warnings The unit must only be used to take the dental x ray exposures described in this manual The unit must NOT be used to take any other x ray exposures lt is not safe to use the unit to take an x ray ex posure that the unit is not designed to take The unit must only be used by personnel quali fied and experienced in the use and operation of digital panoramic dental x ray devices If this device will be used with 3rd party imaging application software not supplied by SOREDENX 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 and or FDA if applicable Do not connect any device to the unit that has not been supplied with the unit or that is not rec
8. nine sec onds Make sure that the unit status indicator is still GREEN indicating that the unit is ready to take an exposure If the indicator is not GREEN the unit reservation time may have expired Reserve the unit again see section 3 1 Prepar ing the unit Move at least two metres away from the unit and protect yourself from radiation Make sure that you can see and hear the patient during the exposure Press and hold down the exposure button for the duration of the exposure The exposure starts when you hear the exposure warning sig nal and the exposure warning indicator control panel and light side of the unit come on The rotating unit will rotate around the patient s head and take the exposure When the exposure warning signal and rotating unit stop the expo sure has been taken User manual 208898 CRANEX Novus e 3 Taking an Exposu 19 PC After the exposure has been taken a pro gress bar will appear This indicates that the image is being transferred to the PC Scanning the image Open Preview 20 Press the release button A at the top of the forehead support and then slide the forehead support away from the patient B support knob to the left C Guide the patient out of the unit Press the Return key to drive the unit to the P position NOTE After the exposure a timer indicating the tube head cooling time will appear on the display A re Open the te
9. taken until the counter reaches zero the exposure time reappears on the display and the unit status indicator turns green User manual 208898 25 3 Taking an Exposure CRANEX Novus Bitewing Optional 1 Slide the chin rest on to the support holder 2 Attach the bite block to the rod and insert the rod and bite block into hole 4 in the chin rest 4 lt 2 1234 4 TU IMPORTANT NOTE If the patient is exceptionally large or has unu sual skull anatomy a test exposure T should be taken to ensure that the rotating unit does not touch the patient s head during the exposure If the rotating unit touches the patient s head move the rod and bite block forward into hole 3 or 2 3 Place the appropriate disposable covers on to the patient support you are using 4 Press the bitewing key to select the bitewing program The key color will change which indi cates that the program has been selected The magnification of all the programs is 1 25 26 User manual 208898 CRANEX Novus e 734 O 730 5 3 Taking an Exposure A default kV value for the selected program will appear on the display If you consider that the default kV value for the program selected is not correct for the patient being examined select a different KV value based on the patient s size age and estimated bone density To change the kV value press the kV plus or minus key
10. to give a reduced length image PRIMARY SLIT SIZE 0 7 0 75 x 38 mm Z motor DUTY CYCLE Intermediate use 6 25 25s ON 400s OFF Environmental data OPERATING Ambient temperature from 10 C to 40 C Relative humidity 10 90 no condensation STORAGE TRANSPORTATION Ambient temperature from 20 C to 50 C Relative humidity 5 85 no condensation Atmospheric pressure 500 1080 mbar Appendix A Technical Information CRANEX Novus System requirements and connections The PC and any other external device s connected to the system must meet the IEC 60950 standard minimum requirements Devices that do not meet the IEC 60950 standard must not be connected to the system as they may pose a threat to operational safety The PC and any other external devices must be connected in accordance with IEC 60601 1 1 The x ray unit must be connected to it s own separate power supply The PC and any other external devices must NOT be connected to the same power supply as the x ray unit Position the PC and any other external device at least 1 85 m 73 from the x ray unit so that the patient cannot touch the PC or any other external device while being x rayed The PC and any other external devices shall not be connected to an extension cable Multiple extension cables shall not be used Do not position the PC where it could be splashed with liquids Clean the PC in accordance with the manufacturer s instructi
11. 8 mA 120 V 10 mA 220 240 V 10 mA X RAY TUBE CURRENT tolerance is 1 mA CRANEX Novus Appendix A Technical Information FILTRATION inherent filtration minimum 0 6 mm Al at 50 kV IEC 60522 1999 additional filtration minimum 2 mm Al patient support attenuation equivalent less than 0 2 mm Al attenuation equivalent of plastic cover approximately 0 25 mm Al total filtration minimum 2 6 mm Al at 77 BEAM QUALITY HVL over 2 77 mm Al at 73 kV DAP Dose Area Product accuracy of displayed value better than 25 PRIMARY PROTECTIVE SHIELDING minimum 0 5 mm Pb or equivalent OUTER SHELL TEMPERATURE 509 122 F maximum DUTY CYCLE 1 7 at maximum technique factors Example an 77 kV 10 mA 95 exposure will have a 65 s cool down period Power requirements OPERATING LINE VOLTAGE 100 120 V or 220 240 V 50 60Hz INPUT POWER Standby 26 W maximum 1100 W MAXIMUM LINE IMPEDANCE Apparent resistance of supply mains 0 5 ohm MAXIMUM LINE FUSING 100 120 V 16A 220 240 V 10A MAIN FUSE T 10A H 250V LINE SAFETY SWITCH when required 100 120 V Approved type min 16A 250 V 220 240 V Approved type min 10 A 250 V Appendix A Technical Information CRANEX Novus EARTH LEAKAGE CIRCUIT BREAKER when required 100 120 V Approved type min 16 A 250 V 220 240 V Approved type min 10 A 250 V breaker activation leakage current in accordance with local regulations Me
12. C or software fail ure the image can be retrieved from the unit memory IMPORTANT NOTE The last taken image can only be retrieved if the unit is left on after the last exposure was taken If the unit is switched off the image will be lost To retrieve the last image i Correct the problem that caused the network failure and then reopen the patient card ii The last taken image should automatically be transferred If it is not click the check box in the Retrieve Last Image field DIGORA for Windows or click the Retrieve now button to retrieve the last read image taken by the unit iii Click OK to close the Novus e Setup win dow The last image taken will appear on the patient card User manual 208898 35 5 Unit Setup Novus e Setup 4 CRANEX Novus e Device Serial Number field Device Settings Driver Info Device Serial Number j Add serial number to new images Click the Add serial number check box and the serial number of the unit will be added to all new images The serial number will appear in the top left hand corner and the bottom right hand corner of the image NOTE If you select Enable image marking in DfW General Setup Image Image marking do not select the left top or right bottom options as the image marking text will appear on top of the serial number 36 User manual 208898 CRANEX Novus e 5 Unit Setup 5 2
13. ENGLISH CRANEX Novus Digital Panoramic X ray Unit User Manual 208898 ver 2 2012 11 CRANEX Novus Digital Panoramic X ray Unit User Manual 0537 Medical Device Directive 93 42 EEC Number 208898 ver 2 2012 11 Original approved English language version Manufactured by SOREDEX PaloDEX Group Oy Nahkelantie 160 Tuusula P O BOX 148 04301 Tuusula Finland Tel 358 0 10 270 2000 Fax 358 9 701 5261 Contents CRANEX Novus e SOREDEX CRANEX SCANORA are registered trademarks of SOREDEX SOREDEX endeavours to produce product documentation that is accurate and up to date However our policy of continual product development may result in changes to products that are not reflected in the product documenta tion Therefore this document should not be regarded as an infallible guide to current product specifications SOREDEX maintains the right to make chang es and alterations without prior notice iv User Manual 208898 CRANEX Novus e Contents Contents AU ss Teri EE VERY EN DO Wa u Ee vaye e D ka ee Va Ya b uk bbe vet we 1 1 1 CRANEX Novus e X ray kk kK kk 1 1 2 About this 2 2 Unit d s me LN 3 PAIX rare AE 3 2 2 Control panels NAG Bua 5 2 PCO SSO MO EE ke KER XER Sene E 6 9 Using the Unit 7 3 1 Preparing the
14. Image Preview DIGORA for Windows only The Image Preview feature allows an image to be adjusted BEFORE it is saved The adjustments will be applied to the open image only or to ALL subse quent images CAUTION Adjustments made to images CANNOT be undone after the adjustments have been saved If you wish to undo the adjustments retrieve the original image click Retrieve Last Image 1 PC In the Novus e Setup window click the Show Image Preview check box Take an exposure PC The Image Preview window will automati cally appear To activate image adjustment click the Density Adjustment and Sharpen filter check boxes The Image Quality Controls will become active and the image can be adjusted CURRENT IMAGE ONLY Click OK to apply the adjustments to the image in the Image Preview window ONLY CURRENT AND ALL SUBSEQUENT IMAGES Click the Edit Quality Presets button The Set Image Quality Presets window will ap pear The Get from Preview window radio but ton will be active Click OK to accept the image adjustments you have made The Image Preview window will reappear Click OK to apply adjustments to the current image and ALL subsequent images User manual 208898 37 5 Unit Setup CRANEX Novus If you wish to have the factory default settings click the Factory defaults radio button The Marking field These tools allow you to add text and numbers to an image 38 User ma
15. LOW it indicates that the unit has been reserved by someone else Wait until the unit is free If you wish to know who has reserved the unit place the cursor on the Multiconnect icon while yellow and a message showing who has reserved the unit will appear NOTE If the multiconnect icon is GRAY it indicates that the unit has not been switched on or is just start ing up and is not yet ready for use Switch the unit on and or wait until the unit is ready for use Press the Return key to drive the rotating unit to the Patient In Out PIO position User manual 208898 11 3 Taking an Exposure CRANEX Novus 3 2 Taking Exposures Panoramic Adult and Child 1 Slide the chin rest on to the support holder 2 For dentate patients attach the bite block to the C22 rod and then insert the rod and bite block into the appropriate hole in the chin rest according to 4 the patient s occlusion For normal occlusion insert the rod and bite block into hole 2 99 070 Jt If the patient s teeth protrude angled outward insert the rod and bite block into hole 1 If the patient s teeth retrude angled inward insert the rod and bite block into hole 3 12 User manual 208898 CRANEX Novus e 4 r YY Adult Child 73 5 3 Taking an Exposure For edentulous patients use the lip holder and insert it into the round hole at the rear of the chin rest
16. PPARAT LUOKAN 1 LASERLAITE IEC 60825 1 1993 A1 1997 A2 2001 4 0537 TERTE CH01 6 Tr This symbol indicates that the waste of electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately Please contact an authorized represen tative of the manufacturer for information concern ing the decommissioning of your equipment Type B equipment CE 0537 symbol MDD 93 42 EEC ETL symbol GOST R symbol A 11 Appendix A Technical Information CRANEX Novus A 4 EMC declaration for CRANEX Novus 2 2 Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The device uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply Harmonic Class A network that supplies buildings used for domestic emissions purposes
17. acement parts and its accesso ries The device its spare parts its replacement parts and its accessories may include parts that are made of or include materials that are non environmentally friendly or hazardous These parts must be dis posed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materi als Hazardous materials and parts that are made of or contain these materials LEAD Tubehead housing collimator CCD sensor circuit boards TUBEHEAD OIL Inside tubehead CAESIUM IODIDE Csl CCD sensor For more information on these parts contact your dealer 50 User s manual 208898 CRANEX Novus Appendix A Technical Information Appendix A Technical Information A 1 Technical specifications Type CRA 2 Classification Complies with IEC 60601 1 IEC 60601 1 2 IEC 60601 1 3 IEC 60601 1 4 IEC 60601 2 7 IEC 60601 2 28 IEC 60601 2 32 UL 60601 1 Conforms with the regulations of DHHS Radiation Performance Standard 21CFR Subchapter J Safety according to IEC 60601 1 Protection against electric shock Class 1 Degree of protection Type B applied with no conductive connection to the patient Protection against the ingress of liquids IP 20 Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the chin rest disposable plastic covers for bite piece ch
18. ar of the column near the base The unit display will come on and the unit will carry out a self test Starting up Single user When the self test is complete the unit status indicator will turn GREEN and the text Status ready will appear The unit can now be used to take an exposure Go to step 6 to complete unit preparation El Status ready User manual 208898 3 Taking an Exposure E X NJ p CRANEX Novus e Multiple users When the self test is complete a question mark will appear next to the unit status indicator This indicates that you need to reserve the unit before you can take an exposure CEZ a NOTE If the no connection symbol X appears next to the unit status indictor it indicates that there is no connection between the unit and the PC See section Troubleshooting and Maintenance for more information PC To reserve the unit click the GREEN Multi connect icon which is in the bottom right hand corner of the PC display The Connect window will appear PC In the Connect window click the Reserve the device button to reserve scanner The Connect window will disappear and the GREEN Multiconnect icon will start to flash This indicates that you have now reserved the unit and it is now ready to take an exposure El Status ready User manual 208898 CRANEX Novus e 3 Taking an Exposure NOTE If the Multiconnect icon is YEL
19. chanical parameters PANORAMIC Source to Image layer Distance SID 500 mm 10 mm Magnification factor 1 25 Focus to skin distance minimum 154 mm WEIGHT 120 kg DIMENSIONS H x W x D 2316 x 865 x 1085 mm VERTICAL HEIGHT OF CHIN REST 950 1750 mm 10 mm Digital image receptor CCD PIXEL SIZE 96 microns ACTIVE SENSOR SURFACE 147 5 x 6 1mm Timer EXPOSURE TIMES Adult 90s Child 8s Bitewing 2537235 TMJ 1 9 1 95 for the displayed exposure times 15 SINGLE LOAD RATING 100 V 77 KV 8 mA 9 s panoramic 120 V 77 KV 10 mA 9 5 panoramic 220 240 V 77 KV 10 mA 9 s panoramic BACK UP TIMER 15 17 s 15 CRANEX Novus Appendix Technical Information Leakage technique factors PANORAMIC 100V 4564 mAs h exposure with maximum values 77 kV 8 mA 9 s according to the 1 5 duty cycle 120V 4713 mAs h exposure with maximum values 77 KV 10 mA 9 s according to the 1 7 duty cycle 220 240V 4713 mAs h exposure with maximum values 77 kV 10 mA 9 s according to the 1 7 duty cycle Measurement bases The kV is measured by monitoring differentially the current flowing through 450 Mohm 1 feedback resistor connected between the tube anode and ground The mA is measured by monitoring current in the HT return line which equals the tube current Collimator TYPE BLD M 1 PRIMARY SLIT Adult panoramic slit only For child panoramic the exposure time is reduced
20. cy of the transmitter Recommended separation distance Conducted 3 Vrms 3V RF 150 kHz to d 1 2 VP jS 61000 MHz d 1 2 VP 80 MHz to 800 MHz d 2 34 P 800 MHz to 2 5 GHz Radiated where P is the maximum output power rating BE 3 V m 3 V m of the transmitter in watts W according to the IEC 61000 90 MHz to transmitter manufacturer and d is the recom 4 3 2 5 GHz mended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz 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 and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operat
21. e patient is nervous you can reassure him her by demonstrating how the unit works before taking the exposure See section 4 Press the Up Down keys to adjust the height of the lip support so it is level with the patient s up per lip Ask the patient to step into the unit grasp the patient handles and press their top lip against the top of the lip support Press the mirror to open it so that you can see a reflection of the patient The patient positioning lights will automatically come on when the mirror is opened or when one of the Up Down keys is pressed They will remain on for two minutes User manual 208898 21 3 Taking an Exposure CRANEX Novus e The Patient Positioning lights can also be switched on and off with the Lights key Look at the reflection of the patient in the mir ror and position the midsagittal plane of the patient so that it coincides with the midsagittal plane light Make sure that the patient is looking straight ahead and that the patient s head is not tilted or turned to one side Press either Up Down key to adjust the tilt of the patient s head until the patient s Frankfort plane coincides with or is parallel to the hori zontal light If necessary use the light positioning knob to adjust the height of the light CAUTION When pressing the Up Down keys to adjust the tilt of the patient s head make small adjustments only so as not to cause the patient any dist
22. efore taking an exposure The user of the unit must stand at least two me ters away from the unit AND protect him herself from radiation when taking exposures It is recommended that a moveable radiation protection screen is used to protect the user The radiation protection screen should be lo cated so that the user is able to see the control panel and patient from behind the radiation protection screen the protected area or control zone User s manual 200409 47 7 Warnings and precautions a Cranex Novus e The radiation protection screen must be large enough to fully protect the user from radiation The radiation protection area must be at least 60 cm wide 60 cm deep and 200 cm high The radiation protection screen must include lead shielding with a minimum thickness 0 5 mm and the screen must conform to all national regulations concerning radiation shielding of dental medical devices qu 2 79 QO Ls The user must able to see and hear tient during an exposure The user must be positioned so that he she can see the exposure warning light indicator and hear the audio exposure warning signal during the exposure If the unit is installed in such a place where the exposure warning light indicator cannot be seen or the audio exposure warning signal cannot be heard then a separate expo sure warning light indicator device should be used Please con
23. er manual 208898 33 5 Unit Setup Novus e Setup CRANEX Novus e The Image Capturing field DIGORA for Windows only Device Settings Driver Info Image Capturing j Show Image Preview Novus e Setup The Show Image Preview check box see sec tion 5 2 Image Preview The Image Processing field DIGORAS for Windows only Device Settings Driver Info Image Processing Noise Filtering j Sharpen Filtering Automatic Density Adjustment The Noise Filtering check box should nor mally be selected Noise filtering make images smoother when they are taken at low doses The Automatic Density Adjustment check box should normally be selected Automatic density adjustment evens out the grayscale values The Sharpen Filtering check box should nor mally be selected When selected it adds default sharpening to all new images The default value can be changed by entering a new value into the Sharpen Matrix size edit box Values from 0 to 25 can be entered The factory set value is 7 34 User manual 208898 CRANEX Novus 5 Unit Setup The Retrieve Last Image field DIGORA for Windows Retrieve Last Image i Must be activated every time an image needs to be retrieved SCANORA Last Image Retrieve latest image from the device unit memory Retrieve now If the last image taken is not transferred to the PC because of a network P
24. ient is dentate ask the patient to step into the unit grasp the patient handles place his her chin on the chin rest and bite the notches in the bite block If the patient is edentulous ask the patient to step into the unit grasp the patient handles and press their top lip against the lip holder a Press the mirror to open it so that you can see a reflection of the patient The patient positioning lights will automatically come on when the mirror is opened or when one of the Up Down keys is pressed They will remain on for two minutes or until the exposure button is pressed The Patient Positioning lights can also be switched on and off with the Lights key User manual 208898 15 3 Taking an Exposure 11 10 12 CRANEX Novus e Look at the reflection of the patient in the mir ror and position the midsagittal plane of the patient so that it coincides with the midsagittal plane light Make sure that the patient is looking straight ahead and that the patient s head is not tilted or turned to one side Press either Up Down key to adjust the tilt of the patient s head until the patient s Frankfort plane coincides with or is parallel to the hori zontal light If necessary use the light positioning knob to adjust the height of the light CAUTION When pressing the Up Down keys to adjust the tilt of the patient s head make small adjustments only so as not to cause the patient any dist
25. in rest and lip support For use in environments where no flammable anaesthetics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading Unit description A dental panoramic x ray unit with a high frequency switching mode x ray generator The unit takes panoramic exposures The unit uses a CCD sensor as an image receptor Generator TUBE Toshiba D 052 SB or D 054 SB or CEI 105 5 TUBEHEAD HOUSING ASSEMBLY THA M X Where X is the version FOCAL SPOT 0 5 mm IEC 60336 2005 Appendix A Technical Information CRANEX Novus FOCAL SPOT ACCURACY The accuracy is 10 mm from the marking on the tubehead cover TARGET ANGLE 50 TARGET MATERIAL Tungsten Y NOMINAL X RAY TUBE VOLTAGE WITH THE HIGHEST X RAY TUBE CUR RENT 100 V 77 kV at 8 mA 120 V 77 kV at 10 mA 220 240 V 77 kV at 10 mA X RAY TUBE VOLTAGE tolerance is 4 kV HIGHEST X RAY TUBE CURRENT WITH THE HIGHEST X RAY TUBE VOLTAGE 100 V 8 mA at 77 kV 120 V 10 mA at 77 kV 220 240 V 10 mA at 77 kV X RAY TUBE CURRENT tolerance is 1 mA NOMINAL ANODE INPUT POWER AND NOMINAL ELECTRIC POWER 100 V 616 W at 77 kV 8mA 9s 120 V 770 W nominal at 77 kV 10 mA 9 s 220 240 V 770 W nominal at 77 kV 10 mA 9s X RAY TUBE VOLTAGE STEPS 100 V 63 66 70 73 and 77 kV 120 V 63 66 70 73 and 77 kV 220 240 V 63 66 70 73 and 77 kV X RAY TUBE VOLTAGE tolerance is 4 kV X RAY TUBE CURRENT 100 V
26. ion If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A 14 CRANEX Novus e CRA 2 Appendix A Technical Information Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter W 150 kHz to 80 MHz d 124P 80 MHz to 800 MHz d 124P 800 MHz to 2 5 GHz d 2 34P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 applies 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 frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the trans
27. mitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A 15
28. mple supports by sliding the temple lO new exposure cannot be taken until the counter reaches zero the exposure time reappears on the display and the unit status indicator turns green User manual 208898 19 3 Taking an Exposure CRANEX Novus e Temporomandibular Joint TMJ 1 Slide the lip support on to the support holder Use the slot nearest the mirror for patients with large skulls and the slot furthest away from the mirror for patient with small skulls Place the disposable cover on to the lip support Press the TMJ key to select TMJ program The key color will change which indicates that the program has been selected The magnification is 1 25 A default kV value for the selected program will appear on the display If you consider that the default kV value is not correct for the patient being examined select a different kV value based on the patient s size age and estimated bone density To change the kV value press the KV plus or minus key The recommended values are Large Adult 77 KV Adult 73 Juvenile or small adult 70 kV Child 63 or 66 kV 20 User manual 208898 CRANEX Novus e 3 Taking an Exposure Ask the patient to remove any spectacles den tures jewellery and hair clips and pins Place a protective lead apron around the pa tient s neck to protect the patient s thyroid gland from radiation NOTE If th
29. ndicating that the unit is ready to take an exposure If the indicator is not GREEN the unit reservation time may have expired Reserve the unit again see section 3 1 Prepar ing the unit Move at least two metres away from the unit and protect yourself from radiation Make sure that you can see and hear the patient during the exposure Press and hold down the exposure button for the duration of the exposure The exposure starts when you hear the exposure warning sig nal and the exposure warning indicator control panel and light side of the unit come on The rotating unit will rotate around the patient s head and take the exposure When the exposure warning signal and rotating unit stop the expo sure has been taken PC After the exposure has been taken a pro gress bar will appear This indicates that the image is being transferred to the PC Open Preview 30 User manual 208898 CRANEX Novus e 3 Taking an Exposure 19 Press the release button A at the top of the forehead support and then slide the forehead support away from the patient B Open the temple supports by sliding the temple support knob to the left C Guide the patient out of the unit Press the Return key to drive the unit to the PIO position NOTE After the exposure a timer indicating the tube head cooling time will appear on the display A new exposure cannot be taken until the counter reaches zero the exp
30. ned to one side 28 User manual 208898 CRANEX Novus e 11 14 3 Taking an Exposure Press either Up Down key to adjust the tilt of the patient s head until the patients Occlusal plane coincides with or is parallel to the hori zontal light If necessary use the light positioning knob to adjust the height of the light CAUTION When pressing the Up Down keys to adjust the tilt of the patient s head make small adjustments only so as not to cause the patient any distress or discomfort Close the temple supports by sliding the temple support knob to the right A Make sure that patient s neck is stretched and straight Adjust the height of the forehead support until it is level with the patient s forehead or nasion B Carefully push the forehead support in until it touches the patient s forehead or nasion C Check once more that the patient is positioned correctly and has not moved Close the mirror Ask the patient to press their lips together and press their tongue against the roof of their mouth Then ask the patient to look at a fixed point in the mirror and to remain still for the duration of the exposure The exposure takes approximately nine sec onds User manual 208898 29 3 Taking an Exposure El Status ready 16 18 Scanning the image 15 17 CRANEX Novus e Make sure that the unit status indicator is still GREEN i
31. nual 208898 CRANEX Novus e 6 Troubleshooting and Maintenance 6 Troubleshooting and Maintenance 6 1 Error messages and symbols If the unit is not used correctly or the unit malfunc tions an error message or symbol will appear on the unit display ERROR ER There are three groups of error message Error symbols The symbol will clear when the problem is cor rected H user errors E Error exposure errors these occur during exposure These appear on the error message display Touch the arrow key to clear the error message and return to the main display NOTE If the arrow does not appear on the error mes sage display you will have to wait for the error to clear automatically User manual 208898 39 6 Troubleshooting and Maintenance CRANEX Novus Error symbols E X N REASON i The PC connected to the unit is not on ii The dental imaging software in the PC is not open iii The cable connecting the unit to the PC is disconnected or damaged iv The IP address is not set correctly SOLUTION Switch ii Open the dental imaging software iii Reconnect the cable If damaged contact service iv Reconfigure the IP address REASON The emergency stop button is pressed down in the STOP position SOLUTION Rotate and release the emergency stop button The error symbol will clear 40 User manual 208898 CRANEX Novus 6 Tr
32. om the unit and pro tect yourself from radiation Make sure that you can see and hear the patient during the expo Sure Press and hold down the exposure button for the duration of the exposure The exposure starts when you hear the exposure warning sig nal and the exposure warning indicator control panel and light side of the unit come on The rotating unit will rotate around the patient s head and take the exposure When the exposure warning signal and rotating unit stop the expo sure has been taken PC After the exposure has been taken a pro gress bar will appear This indicates that the image is being transferred to the PC Open Preview e If you wish to take a second TMJ exposure press the Return key to drive the unit back to the PIO position and then reposition the patient for the second exposure step 13 Take the second exposure in the same way as described in steps 14 and 15 24 User manual 208898 CRANEX Novus e 3 Taking an Exposu 19 Press the release button A at the top of the forehead support and then slide the forehead support away from the patient B support knob to the left C Guide the patient out of the unit Press the Return key to drive the unit to the P position NOTE re Open the temple supports by sliding the temple IO After the exposure a timer indicating the tube head cooling time will appear on the display A new exposure cannot be
33. ons X ray system to IEC 60601 1 1 IEC 60950 gt 1 85m 73 CRANEX Novus Appendix Technical Information Tube housing assembly cooling heating characteristics TUBEHEAD THERMAL CHARASTERISTICS 140 000 120 000 Heat storage J 0 100 200 300 400 500 600 700 Time min Tube rating chart Toshiba D 052 SB Maximum Rating Charts Absolute maximum rating charts Focus Spot 0 5 mm TUBE CURRENT mA EXPOSURE TIME s Appendix A Technical Information CRANEX Novus Anode thermal characteristics Anode Thermal Characteristics HEAT STORAGE kJ are i CRANEX Novus Appendix A Technical Information A 2 Unit dimensions 92 in 950 1750 mm 27 in 80 in Appendix A Technical Information CRANEX Novus A 3 Symbols that appear on the unit Radiation warning Dangerous voltage On or enabled Off or disabled Exposure switch Connector for Ethernet RJ45 Connector for exposure switch Attention consult accompanying documents Electrostatic discharge ESD warning symbol O al E 2 gt Connector for external exposure light A 10 CRANEX Novus e L QD Appendix A Technical Information Ground functional Protective ground CLASS 1 LASERPRODUCT Laser class label APPAREIL A RAYONNEMENT Patient positioning lights LASER DE KLASSE 1 LASER KLASSE 1 KLASS 1 LASERA
34. ontrol panel Program keys adult pan child pan TMJ bitewing optional selection keys Exposure values Service key Test exposure key Unit status indicator Bz IU User manual 208898 5 2 Unit description CRANEX Novus 2 3 Accessories Chin rest Disposable cover iar Bite block SS AZ Disposable cover Rod long 72 5 mm Lip holder Disposable cover Lip support Disposable cover Rod short 62 5 mm 6 User manual 208898 CRANEX Novus e 3 Using the Unit 3 Taking an Exposure IMPORTANT NOTE If the unit is being used for the first time or if you are using the unit for the first time check that it is set up to your requirements See section 5 Unit Settings 3 1 Preparing the Unit SCANORA O 73 10 ma 9s 57 mGycm The preparation steps below are for SCANORA and DIGORA for Windows If you are using some other dental imaging software refer to the documen tation that is supplied with it 1 PC Switch on the PC that is connected to the unit 2 PC Open SCANORA and then open a patient card 3 Switch the unit on The on off switch is at the rear of the column near the base The unit display will come on and the unit will carry out a self test Starting up When the self test is complete a question mark will appear next to the unit status indicator This indicates that you need to reserve the unit before you can take an e
35. osure time reappears on the display and the unit status indicator turns green User manual 208898 31 4 Operating the unit without x rays CRANEX Novus 4 Operating the unit without generating x rays In some situations for example with nervous pa tients or patients with unusual anatomy you may wish to operate the unit without generating x rays before taking an exposure Press the T key Test The key will change color and the kV and mA values will become zero The exposure switch can now be pressed to dem onstrate how the unit operates without x rays being generated Press the T key a second time to return to the nor mal exposure mode NOTE After switching the unit off and then on again the unit returns to the normal exposure mode 32 User manual 208898 CRANEX Novus e 5 Unit Setup 5 1 Setup options Novus e Setup 4 5 Unit Setup Various set up options allow the unit to be custom ized to your requirements PC Open the dental imaging software you are using Select Options and then click Novus e Setup The Novus e Setup window will appear Status Device Version Device Settings Driver Info Novus e 0 02 exported Serial 501212345 Status field Device indicates whether the unit is connected to the PC Version shows the software version of the unit and Serial No the serial number of the unit Us
36. oubleshooting and Maintenance User errors H1 REASON The exposure button was released during an exposure SOLUTION Clear the error message and check if the attempted exposure is sufficient for the diagnostic task If it is not take a new exposure If the exposure failed while the exposure button was still being pressed check the exposure switch by taking a test exposure without patient to see if the exposure button is defective or not If the same problem occurs again contact service System errors E4 REASON Tubehead too hot or too cold SOLUTION When the error message automatically clears the tubehead has reached the cor rect operating temperature In normal conditions this will take about 30 minutes for the tubehead to reach the correct temperature If the error message does not disappear within a reasonable amount of time contact service E5 REASON Line voltage not within limits SOLUTION If the error message reappears it indicates that the voltage is not within limits The error message will automatically clear when the voltage returns to the correct level If the error message keeps on appearing or does not disappear within a reason able amount of time contact service User manual 208898 41 6 Troubleshooting and Maintenance CRANEX Novus E19 REASON Exposure switch stuck down during unit start SOLUTION Switch the unit off and check that the exposure switch is not stuck in the expos
37. ress or discomfort 22 User manual 208898 CRANEX Novus e 11 Status ready 14 3 Taking an Exposure Close the temple supports by sliding the temple support knob to the right A Make sure that patient s neck is stretched and straight Adjust the height of the forehead support until it is level with the patient s forehead or nasion B Carefully push the forehead support in until it touches the patient s forehead or nasion C Check once more that the patient is positioned correctly and has not moved Close the mirror If you wish to take TMJ exposure with the tients mouth closed ask the patient to clench their back teeth together look at a fixed point in the mirror and to remain still for the duration of the exposure If you wish to take a TMJ exposure with the pa tients mouth open ask the patient to open their mouth look at a fixed point in the mirror and to remain still for the duration of the exposure The exposure takes approximately nine sec onds Make sure that the unit status indicator is still GREEN indicating that the unit is ready to take an exposure If the indicator is not GREEN the unit reservation time may have expired Reserve the unit again see section 3 1 Prepar ing the unit User manual 208898 23 3 Taking an Exposure 15 17 Scanning the image 16 CRANEX Novus e Move at least two metres fr
38. ress or discomfort The focal trough light indicates the center of the focal trough which is 10 mm wide at the front Make sure that the roots of the front incisors are located within the focal trough and are on the same vertical plane User manual 208898 CRANEX Novus 3 Taking an Exposure If the roots of the front incisors are not on the same vertical plane adjust the tilt of the patient s head until they are If the roots of the front incisors are on the same vertical plane but not within the focal trough reposition the patient by moving the rod and bite block backwards or forwards 13 Close the temple supports by sliding the temple support knob to the right A Make sure that patient s neck is stretched and straight Adjust the height of the forehead support until it is level with the patient s forehead or nasion B Carefully push the forehead support in until it touches the patient s forehead or nasion C User manual 208898 17 3 Taking an Exposure 14 15 Status ready 17 16 18 CRANEX Novus e Check once more that the patient is positioned correctly and has not moved Close the mirror Ask the patient to press their lips together and press their tongue against the roof of their mouth Then ask the patient to look at a fixed point in the mirror and to remain still for the duration of the exposure The exposure takes approximately
39. s and for 0 5 cycle for 0 5 cycle typical commercial or voltage variations hospital environment If on power supply 40 Ur 40 Ur user of the device lines 60 dip in Ur 60 dip in Ur requires continued IEC 61000 4 11 for 5 cycles for 5 cycles operation during power mains interruptions it is 70 Ur 70 Ur recommended that the device be powered from an uninterruptible power supply or a battery lt 5 Ur 5 gt 95 dip in Ur gt 95 dip in for 5 sec for 5 sec Power frequency 3 A m 3 A m Power frequency 50 60 Hz magnetic field should be magnetic field at levels characteristic IEC 61000 4 8 of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level A 13 Appendix A Technical Information CRANEX Novus 2 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity IEC 60601 test Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequen
40. s this device to sale by or on the order of a dentist or other qualified professional User Manual 208898 1 1 Introduction CRANEX Novus e 1 2 About this manual This manual describes how to use and set up the unit Please read these instructions carefully before op erating the unit Also before operating the unit please read and observe the warnings and precautions that appear in section 7 Warnings and Precautions 2 User Manual 208898 CRANEX Novus 2 Unit description 2 Unit description 2 1 Main parts Exposure warning light 2 Emergency stop button Press to stop rotate to release Exposure switch On off switch rear of column Column Sensor U EP Dr 72 Tubehead Tubehead sensor Rotating unit 8 PC with MDD compliant imaging software User manual 208898 3 2 Unit description CRANEX Novus 9 Patient positioning mirror 10 Frankfort light 11 Midsaggital light 12 Focal trough light 13 Head support 14 Patient handles 15 Chin support A Chin rest and bite block B Chin rest and lip holder support 4 User manual 208898 CRANEX Novus 2 Unit description 2 2 Control panels and keys Status ready 16 Side control panel A Lights key switches the postioning lights on and off B Up down keys C Return key drives rotating unit to the patient in out position PIO 17 Main c
41. t cotton or other soft cloth Remove any drops of liquid from the control panel surface immediately Prolonged contact with liquid may cause the surface of the control panel to dis color or spots to appear User manual 208898 43 6 Troubleshooting and Maintenance CRANEX Novus Correct operation of the unit If any of the unit s controls displays or functions fail to operate or do not operate in the way described in this manual switch the unit off wait 30 seconds and then switch the unit on again If the unit still does not operate correctly contact your service technician for help If you hear the exposure warning tone but the expo sure warning light does not come on when an expo sure is taken stop using the unit and contact your service technician for help If you do not hear the exposure warning tone when an exposure is taken stop using the unit and con tact your service technician for help Every week check that the power supply cable is in good order not damaged in any way and that the unit operates correctly in accordance with the in structions in this manual Make sure that the unit cannot be driven up down when the emergency stop button has been pressed down 44 User manual 208898 CRANEX Novus e 6 Troubleshooting and Maintenance Yearly maintenance Once a year an authorized service technician must carry out a full inspection of the unit The following tests and checks must
42. tact your local service for help 48 User s manual 200409 Cranex Novus e 7 Warnings and precautions Disinfect all the surfaces that the patient is in contact with after every patient If the unit does not appear to be working cor rectly switch the unit off and release the patient Make sure that the unit operates correctly before you continue using it If you are not sure wheth er the unit is operating correctly please contact your local service for help If the unit will not be used for a long time switch the unit off in order to prevent unauthorized peo ple using the unit Do not use the unit if any of its covers parts or cables are damaged loose or have been re moved Contact a service person approved by SOREDEX and get them to repair or replace any damaged loose or removed covers parts or cables before reusing the unit When touching the patient do not touch any electrical or Ethernet connectors at the same time Do not touch or operate the unit if the unit is be ing serviced or if the covers have been removed for any reason User s manual 200409 49 CRANEX e Novus 8 Disposal 8 Disposal At the end of useful service life of the device its spare parts its replacement parts and its acces sories make sure that you follow all local national and international regulations regarding the correct and safe disposal and or recycling of the device its spare parts its repl
43. ure position Switch the unit on again If the message reappears contact service E21 REASON Patient positioning mirror is open SOLUTION Close the patient positioning mirror Exx all other E errors except E4 E5 E19 and E21 above SOLUTION Clear the error message and try to take an exposure without a patient If the error message reappears switch the unit off wait for half a minute and then switch the unit on again If the error message reappears contact service 42 User manual 208898 CRANEX Novus 6 Troubleshooting and Maintenance 6 2 Care and Maintenance Cleaning and disinfecting the unit Warning Switch the unit off before cleaning it Surfaces that the patient touches All surfaces and parts that the patient touches or comes into contact with must be disinfected after each patient Use a disinfectant that is formulated specifically for disinfecting dental equipment and use the disinfectant in accordance with the manu facturer s instructions Unit surfaces Use a soft cloth dampened with a mild detergent disinfectant to clean unit surface DO NOT use abrasive cleaning agents or polishes on the unit Positioning mirror The positioning mirror is made of glass Use a soft cloth dampened with a mild detergent to clean them DO NOT use abrasive cleaning agents or polishes on these parts Touch screen control panel If the surface of the control panel becomes soiled clean it with absorben
44. xposure Single user Multiple users u 7 8 a User manual 208898 3 Taking an Exposure CRANEX Novus If the no connection symbol X appears next to the unit status indictor it indicates that there is u no connection between the unit and the PC See section Troubleshooting and Maintenance for more information 4 PC Press the device icon to reserve the unit E gt vL enable image capture e gt NOTE a message appears stating that the unit is in use it indicates that the unit has been reserved by another user Wait until the unit is free INFORMATION The status of the unit available ready or busy can be seen in the status field at the bottom of the PC display Device status 5 When the unit status indicator turns GREEN and the text Status ready appears the unit is ready to take an exposure Single user El Status ready Multiple users El Status ready 2 8 User manual 208898 CRANEX Novus e 3 Taking an Exposure the Patient In Out PIO position 6 Press the Return key to drive the rotating unit to DIGORA for Windows not in USA 1 El Status ready PC Switch on the PC that is connected to the unit PC Open for Windows and then open a patient card Switch the unit on The on off switch is at the re
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