Soredex Novus User`s Manual
Contents
1. One Ethernet 10 100 Mbit s NIC 19 CRT or 17 TFT LCD min resolution 1024 x 768 pixels with DfW 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 A 4 CRANEX Novus CRANEX Novus Appendix A Technical Information Position the PC and any other external device at least 1 5 m 60 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 instructions X ray system to IEC 60601 1 1 IEC 60950 gt 1 5m 60 Ethernet oo ro r 4 lt fe 230 115 VAC 230 115 VAC Tube housing assembly cooling heating characteristics TUBEHEAD THERMAL CHARASTERISTICS 140 000 02. Cancel The 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 User s manual 200409 19 6 Unit Set up CRANEX Novus The Image Scanning field CRANEX Novus Setup xi Device Settings Driver Info Image Scanning M Show Image Preview Operation Normal C Calibrate The Show Image Preview check box see section 6 2 Image Preview The Operation radio buttons the Normal option is selected in normal use The Image Processing field CRANEX Novus Setup x Device Settings Driver Info Image Processing Noise Filtering The Noise Filtering check box should normally be selected Noise filtering make images smoother when they are taken at low doses The Retrieve Last Image field CRANEX Novus Setup Xi Device Settings Driver Info Retrieve Last Image 7 Must be activated every time an image needs to be retrieved If the last image read is not transferred to the PC because of a network PC or software failure the image can be retrieved 20 User s manual 200409 CRANEX Novus CRANEX Novus Setup x Device Settings Driver Info Device Serial Number Add serial number to new images 6 Unit Set up IMPORTANT NOTE The last read image can only be retrieved if the unit has been left connected to the power su
3. s Manual 200409 Contents CRANEX Novus iv User s Manual 200409 CRANEX Novus 1 Introduction 1 Introduction 1 1 CRANEX Novus X ray unit The CRANEX Novus is a digital panoramic dental x ray unit designed to take adult panoramic exposures child panoramic exposures reduced width and TMJ exposures The unit uses a CCD sensor as the image receptor and aPC with suitable MDD approved dental imaging software such as Digora for Windows not in USA for image acquisition and handling IMPORTANT NOTE Before using the unit for the first time make sure that itis set up to your requirements See section 6 Unit Set up 1 2 About this manual p T This manual describes how to use and set up the CRANEX Novus x ray unit Please read these instructions carefully before oper ating the unit Before operating this unit read and observe the warnings and precautions that appear in section 8 Warnings and Precautions The status of indicator lights is shown as follows Light on Light off User s Manual 200409 2 Unit description CRANEX Novus 2 Unit description 2 1 Main parts Column NOTE Tubehead CCD sensor Rotating Unit Upper shelf j aa a a IMIS Vertical carriage N j een a Head support Mirror ee Jah e Frankfort light i J T Tubehead gt i WS lt 4 Chin support Midsaggital light Patient handles Press to stop the unit
4. 100 200 300 400 500 600 700 Time min CRANEX Novus A 5 Appendix A Technical Information CRANEX Novus Tube rating chart KL40 0 5 70 Maximum Rating Charts Absolute maximum rating charts Focus Spot 0 5 mm TUBE CURRENT mA 0 1 0 2 03 0507 1 5 7 EXPOSURE TIME Anode thermal characteristics Anode Thermal Characteristics a of f V w KAT ITT TINT om KX 0 50 100 150 200 250 300 TIME s A 6 CRANEX Novus CRANEX Novus Appendix A Technical Information A 2 Unit dimensions 91 2 in 950 1750 mm 27 in 80 in CRANEX Novus A 7 Appendix A Technical Information CRANEX Novus A 3 Symbols that appear on the unit AN Radiation warning 4 Dangerous voltage On or enabled O Off or disabled Unlocked exposure switch O Locked exposure switch oil Exposure switch Connector for Ethernet RJ44 B Connector for exposure switch gt Connector for external exposure light N Attention consult accompanying documents A 8 CRANEX Novus CRANEX Novus Appendix A Technical Information L Ground Functional Protective ground CLASS 1 LASER PRODUCT Laser class label EN 60 825 1 A2 2001 Patient positioning lights and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the This symbol indicates that the waste of electr
5. 11 2006 for products with the UL Classification Mark and EN 55011 stand ards 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 IPX 0 Disinfection methods mild soapy water non abrasive non alcohol based disinfectant for the the chin rest disposable plastic covers for bite piece chin 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 Adental panoramic x ray units 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 KL40 0 5 70 or equivalent FOCAL SPOT gt 0 5 mm IEC 60336 1993 TARGET ANGLE 122 TARGET MATERIAL Tungsten y OPERATING TUBE POTENTIAL Panoramic imaging 60 and 70 kV 5 kV ix CRANEX Novus A 1 Appendix A Technical Information CRANEX Novus OPERATING TUBE CURRENT 7 mA 1 mA NOMINALANODE INPUT POWER 490 W nominal at 70 kV 7 mA MAXIMUM TUBE CURRENT 7 MA MAXIMUM ANODE OUTPUT POWER 600 W nominal nominal at 75 kV 8 mA 0 1 s REFERENCE TIME PRODUCT 7 mAs at 60 kV 7 mA 1 0 s FILT
6. REASON Control panel keys stuck down SOLUTION Switch the unit off press the keys and then switch the unit on again If the message reappears contact service E 18 REASON Display not connected SOLUTION Switch the unit off and then on again If the message reappears contact service E 19 REASON Exposure switch stuck down during unit start SOLUTION Switch the unit off and check that the exposure switch is not stuck in the exposure position Switch the unit on again If the message reappears contact service E 20 REASON Flash check error SOLUTION Switch the unit off and then on again If the message reappears contact service 28 User s manual 200409 CRANEX Novus 7 Troubleshooting and Maintenance 7 2 Care and Maintenance Cleaning and disinfecting the unit Surfaces Warning Switch the unit off before cleaning it All surfaces can be wiped clean with a soft cloth dampened with a mild detergent DO NOT use abrasive cleaning agents or polishes on this equip ment Positioning mirror and light lenses The positioning mirror and positioning light lenses are made of glass Use a soft cloth dampened with a mild detergent NEVER use abrasive cleaning agents or polishes on these parts 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
7. Rotate to release Ethernet cable a at a CSN On off switch PC with MDD approved rear of column dental imaging software 2 User s manual 200409 CRANEX Novus 2 Unit description 2 2 Display and keys OT Li oz bia Display and main control panel Display Exposure warning light Exposure ready light PC light Green system ready Yellow image transfer Red no connection Panoramic key Return key TMJ key User s manual 200409 3 2 Unit description CRANEX Novus 2 3 Accessories Chin rest 200682 Disposable cover 6801140 LY Bite block 200793 2 cw Disposable cover 6801120 Rod long 72 5 mm 6809710 Lip holder 6811870 Disposable cover 6801130 Lip support 6807870 Disposable cover 6801130 Rod short 62 5 mm 6809790 4 User s manual 200409 CRANEX Novus 3 Taking an Exposure 3 Using the Unit 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 6 Unit Set up 3 1 Preparing the Unit 1 PC Switch on the PC that is connected to the unit 2 Open the dental imaging software you are using for example Digora for Windows not in USA and then open a patient card Refer to the instructions supplied with the dental imaging software for information on how to do this 3 UNIT Switch the unit on The
8. for disinfecting dental equipment and use the disinfectant in accordance with the manufacturer s instructions 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 oper ate correctly contact your service technician for help If you hear the exposure warning tone but the expo sure warning light on the display does not come on when an exposure is taken stop using the unit and contact your service technician for help User s manual 200409 29 7 Troubleshooting and Maintenance CRANEX Novus If you do not hear the exposure warning tone when an exposure is taken stop using the unit and contact 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 instructions in this manual Make sure that the unit cannot be driven up down when the emergency stop button has been pressed down Yearly maintenance Once a year an authorized service technician must carry out a full inspection of the unit During the inspection the following tests will be carried out akV mA test abeam alignment test a ball pin test acheck that the safety ground is connected acheck that the positioning lig
9. iii The Set Image Quality Presets window will appear Grayscale control values Speed ContrastEnhancement User s manual 200409 23 6 Image Preview Unit Set up CRANEX Novus Click the Get from Preview window radio button to activate it and then click OK Set new control values i Get from Preview window 0 01 0 24 0 00 f Panoramic factory defaults 1 00 0 00 0 00 Cancel iv The Image Preview window will reappear Click OK to apply adjustments to the image in the Image Preview window and ALL subsequent images Retrieving the factory defaults If you made some grayscale adjustments but do not wish to save them click the Panoramic factory defaults radio button in the Set Image Quality Presets window to retrieve the factor settings fe Panoramic factory defaults 1 00 0 00 0 00 Pian 4 The Framing and Text tools in the top right hand ro corner allow the image to be rotated and amp Gls manipulated and text to be added to the image Text NOTE A In Framing and text changes are only saved with one image the image in the Image Preview window 24 User s manual 200409 CRANEX Novus 7 Troubleshooting and Maintenance 7 Troubleshooting and Maintenance 7 1 Information messages Information messages are grouped into two categories user errors these begin with the letter H and system errors these begin with the lett
10. indicator light will come on Child To 60 70 O The magnification is 1 25 5 Select the kV 70 kV for adults and 60kV for children User s manual 200409 7 3 Taking an Exposure g rk CRANEX Novus Ask the patient to remove any spectacles dentures jewellery and hair clips and pins Place a protective lead apron over the patient s shoulders NOTE If the patient is nervous you can reassure them 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 If the patient 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 d 9 Press the mirror to open it so that you can see a reflection of the patient User s manual 200409 CRANEX Novus 10 12 3 Taking an Exposure The patient positioning lights will automatically come on when one of the Up Down keys is pressed or the mirror is opened They will remain on for 30 seconds The Patient Positioning lights can also be switched on and off with the Lights key Look at the reflection of the patient in the mirror and position
11. magnification is 1 25 Select the kV 70 kV for adults and 60kV for children Ask the patient to remove any spectacles false teeth jewellery and hair clips and pins Place a protective lead apron over the patients shoulders NOTE If the patient is nervous you can reassure them by demonstrating how the unit works before taking the exposure See section 4 12 User s manual 200409 CRANEX Novus 3 Taking an Exposure 6 Press the Up Down keys to adjust the height of the lip support so it is level with the patient s upper lip 7 Askthe patient to step into the unit grasp the patient handles and press their top lip against the top of the lip support 8 Press the mirror to open it so that you can see a C d reflection of the patient Gal NOs 9 The patient positiong lights will automatically 6 come on when one of the Up Down keys is pressed or the mirror is opened They will remain on for 30 seconds The Patient Positioning lights can also be switched on and off with the Lights key User s manual 200409 13 3 Taking an Exposure CRANEX Novus 10 Look at the reflection of the patient in the mirror 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 ti
12. specified below The customer or the user of the CRA 1 should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 IEC 60601 test level 6 kV contact 8 kV air Compliance level environment guidance 6 kV contact 8 kV air Electromagnetic 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 2 kV for power supply 2 kV for power Mains power quality Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 3 A m transients bursts lines supply lines should be that of a IEC 61000 4 4 1 kV for input output 1 kV for typical commercial or lines input output lines hospital environment Surge 1 kV differential mode 1 kV differential Mains power quality IEC 61000 4 5 2 kV common mode mode should be that of a 2 kV common typical commercial or mode 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 interruptions 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 CRA 1 lines 60 dip in Ur 60 dip in Ur requires continued IEC 61000 4 11 for 5 cy
13. when the voltage stabilizes If the error does not clear within a reasonable time contact service E6 REASON Exposure timeout error exposure more than 10 seconds SOLUTION Switch the unit off and then on again If the message reappears contact service E7 REASON Optosensor failure SOLUTION Switch the unit off and then on again If the message reappears contact service 26 User s manual 200409 CRANEX Novus 7 Troubleshooting and Maintenance E8 REASON Z motor running timeout runs for more than 30 seconds SOLUTION Switch the unit off and then on again If the message reappears contact service E9 REASON Rotating motor running timeout runs for more than 30 seconds SOLUTION Switch the unit off and then on again If the message reappears contact service E 10 REASON CCD error configuration SOLUTION Switch the unit off and then on again If the message reappears contact service E 11 REASON CCD error power failure SOLUTION Switch the unit off and then on again If the message reappears contact service E 12 REASON CCD error line failure SOLUTION Switch the unit off and then on again If the message reappears contact service E 13 REASON CCD error DMA failure SOLUTION Switch the unit off and then on again If the message reappears contact service User s manual 200409 27 7 Troubleshooting and Maintenance CRANEX Novus E 16
14. CTIVE SENSOR SURFACE 147 5 x 6 1mm Timer EXPOSURE TIMES Normal 9 0 s 15 Child 7 5 s 415 TMJ 1 8 1 8 s 15 SINGLE LOAD RATING 70 kV 7 mA 9 s panoramic BACK UP TIMER 12 s 415 Leakage technique factors PANORAMIC 70 kV 1200 mAs h 70 kV 7 mA duty cycle 1 20 for example a normal exposure per 3 minutes cool down period 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 CRANEX Novus A 3 Appendix A Technical Information CRANEX Novus Collimator PRIMARY SLIT Adult panoramic slit only For child panoramic the exposure time is reduced to give a reduced length image PRIMARY SLIT SIZE 0 6 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 PC requirements The PC must meet the IEC 60950 standard minimum requirements Windows XP Professional SP1 or SP2 or Windows 2000 Professional SP4 512 MB RAM gt 20 GB HDD 32 MB Video RAM Pentium 4 or equivalent
15. Cranex Novus Digital Panoramic X ray Unit User s Manual Number 200409 ver 3 0702 CRANEX Novus Digital Panoramic X ray Unit User s Manual CE 0537 Medical Device Directive 93 42 EEC Number 200409 ver 3 0702 D500667 rev 3 Original approved English language version Manufactured by SOREDEX Nahkelantie 160 Tuusula P O BOX 148 Fl 04301 Tuusula Finland Tel 358 0 45 7882 2000 Fax 358 9 701 5261 Contents CRANEX Novus 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 documentation Therefore this document should not be regarded as an infallible guide to current product specifi cations Soredex maintains the right to make changes and alterations without prior notice ii User s Manual 200409 CRANEX Novus ok o 8 9 Appendix A Technical Information Contents Introduction 22 2 cceeceeceecceeceeeccneceeccecensceeceuseeeceusecnseeeeeesenees 1 1 CRANEX Novus X ray unit sssesssseeeesesenernnnnneserrrrrree 1 2 About this manual 0 ccccecceecceccecccecceccceeeceeceeeaeeeeeens Unit descripti n iiiisisnedcieiiccciceisancunvixdsenivenduiesewwdvseseauansnaeus aE Main CARS ce atest dos state te ice ee aeeenea aie tes vel seas 2 2 Display ANG KeyS ririri eee art BSC CCS OSS a ieee EEE EAA os I
16. RATION inherent filtration minimum 0 8 mm Al at 50 kV IEC 60522 1999 additional filtration 1 mm Al patient support attenuation equivalent less than 0 2 mm Al total filtration 2 mm Al at 70 kV BEAM QUALITY HVL over 2 0 mm Al at 70 kV PRIMARY PROTECTIVE SHIELDING minimum 0 5 mm Pb or equivalent OUTER SHELL TEMPERATURE 50 C 122 F maximum DUTY CYCLE controlled by the software of the unit Power requirements INPUT VOLTAGE 115 230 VAC 10 50 60 Hz single phase grounded socket LINE CURRENT 115 VAC long term 1 6 A cont at 70 kV 7 mA 115 VAC mains momentary 8 Aat 70 kV 7 mA 115 VAC mains 230 VAC long term 1 A cont at 70 kV 7 mA 230 VAC mains momentary 5A at 70 kV 7 mA 230 VAC mains MAXIMUM LINE RESISTANCE 1 ohm MAXIMUM LINE FUSING 10A 16A slow at 230 115 VAC main fuse 5 A 8 A slow in the device LINE SAFETY SWITCH when required Approved type min 10 A250 VAC EARTH LEAKAGE CIRCUIT BREAKER when required Approved type min 16 A250 VAC breaker activation leakage current in accordance with local regulations A 2 CRANEX Novus CRANEX Novus Appendix A Technical Information Mechanical parameters PANORAMIC Source to Image layer Distance SID 500 mm 10 mm Magnification factor 1 25 WEIGHT 100 kg DIMENSIONS H x W x D 2316 x 835 x 1070 mm VERTICAL HEIGHT OF CHIN REST 950 1750 mm 10 mm Digital image receptor CCD PIXEL SIZE 96 microns A
17. SHN TS Unit csinncasdeuns eat nse vanensienadauerenaiceannictiuandnatinastaabanus 3 1 Preparing the UIE csccescsetecvact et cecaderoecaccatetuonestensel tiieselss 3 2 Taking Exposures wricescnccentncectidepredindiaceniadcedeimtanstosetecetann Panoramic Adult or Child ssssnneneneeennnennneeeeeeeeren Temporomandibular Joint TMJ ceeceeeeeeeeeeeeeeeees Operating the unit without x rays ccccseesseeeeeeseeeeeeeees Exposure SWITCH LOCK a viscississsninasascsissninnctcnnendsesinoniininnnnacind 5 1 Unlocking the exposure SWItCN cccceeeeeeeeeeeeeeeeees 5 2 Locking the exposure SWItCN cccceeeeeeeeeeeeeeeeeeees A iige gl okerenre eee pererrerrpr ea reer rrr er Te er tren 6 1 Set up options yieee eee enn eee 6 2 Image Preview acces cess meen eenennentcsiennsies meen evansnensenanememawmmcean Troubleshooting and Maintenance ccccsssssseeeeeeeees 7 1 Information messages cccceeeeeeeeeeceeeeeeeeeeeeeeeeeeeeeees WS Gl SUNOS ean a E System GUNNS seio acit Sen E EA A 7 2 Care and Maintenance viciaciciciacassearaneuncecethedssinanandniedisinds Cleaning and disinfecting the unit eee Correct operation of the Unit cceeeeeeeeeeeeeeeeeeeeees Yearly Manat MANOS cccdscnnseceet ecehesanerd cee amecnmsnnmnseccennes Warnings and precautions ccccssseeeeeeeeeeeeeeeeeeeeeeeees BYES OSM esate a enn E a es mae ee enna cme an Contents User
18. cles for 5 cycles operation during power mains interruptions it is 70 Ur 70 Ur recommended that the 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 3 A m hospital environment NOTE Uzis the a c mains voltage prior to application of the test level CRA 1 be powered from an uninterruptible power supply or a battery Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or CRANEX Novus Appendix A Technical Information CRANEX Novus Guidance and manufacturer s declaration electromagnetic immunity The CRA 1 is intended for use in the electromagnetic environment specified below The customer or the user of the CRA 1 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 CRA 1 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms 3V d 1 2 4P RF 150 kHz to Ps 61000 80 MHz d 1 24 P 80 MHz to 800 MHz d 2 34 P_ 800 MHz to 2 5 GHz Padiaed sA SM where P is the maximum output power rating RF 80 MHz to re of the transmitter in watts W according to the IEC 61000 2 5 GHz 4 3 transmitter manu
19. ded by SOREDEX If the patient is using a pacemaker consult the manufactuer of the pacemaker to confirm that the x ray unit will not interfer with the operation of the pacemaker before taking an exposure 32 User s manual 200409 CRANEX Novus 9 Disposal 9 Disposal At the end of useful service life of the device its spare parts its replacement parts and its accessories 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 replacement parts and its accessories 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 disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials The locations of all parts that are made of or include materials that are non environmentally friendly or hazardous can be found in the device service manual and or installation manual User s manual 200409 33 CRANEX Novus Appendix A Technical Information Appendix A Technical Information A 1 Technical specifications Type CRA 1 Classification Complies with IEC 60601 1 1995 IEC 60601 2 7 1998 IEC 60601 2 28 1993 and IEC 60601 2 32 1994 IEC 878 UL 2601
20. e signal and the exposure warning light on the control panel will come on The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken 10 User s manual 200409 CRANEX Novus 3 Taking an Exposure 18 PC After the exposure has been taken a progress bar will appear This indicates that the image is being transfered to the PC CRANEX Novus Scanning the image Open Preview 19 UNIT Press the release button at the top of the forehead support and then slide the forehead support away from the patient Open the temple supports by sliding the temple support knob to the left 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 tubehead cooling time will appear on the display A new exposure cannot be taken until the counter reaches zero and the exposure time reappears on the display and the ready light comes on User s manual 200409 11 3 Taking an Exposure CRANEX Novus 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 indicator light will come on The
21. er E To clear an information message from the display press any key on the main control panel NOT the side control panel User errors H 1 flashes alternatively with the exposure time REASON The exposure button was released during an exposure SOLUTION Check if the attempted exposure is sufficient for the diagnostic task If itis 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 EO REASON Tube arcing SOLUTION Switch the unit off and then on again If the message reappears contact service E1 REASON Tube kV out of limits SOLUTION Switch the unit off and then on again If the message reappears contact service User s manual 200409 25 7 Troubleshooting and Maintenance CRANEX Novus E2 REASON Tube current mA out of limits SOLUTION Switch the unit off and then on again If the message reappears contact service E3 REASON Preheat failure SOLUTION Switch the unit off and then on again If the message reappears contact service E4 REASON Tubehead too hot or too cold SOLUTION Wait for the tubehead to reach the right temperature approximately 30 minutes E5 REASON Line voltage out of limits SOLUTION The error code will clear
22. facturer and dis the recommended 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 Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects 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 CRA 1 is used exceeds the applicable RF compliance level above the CRA 1 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting of relocating the CRA 1 P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A 12 CRANEX Novus CRANEX Novus Appendix A Technical Information Recommended separation distances between p
23. herself from radiation when taking exposures It is recommended that a moveable radiation protection screen be used The user must be able to see and hear the patient during an exposure User s manual 200409 31 8 Warnings and precautions CRANEX Novus The user must see the radiation warning light and or hear the audio warning signal during the expo sure If the unit is installed in such a place where the warning light cannot be seen a separate warning light should be used Please contact the local service for help If the unit does not appear to be working correctly 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 whether the unit is operating correctly please contact the local service If the unit will not be used for a long time switch the unit off and lock the exposure switch in order to prevent unauthorized people using the unit Disinfect all the surfaces that the patient is in contact with after every patient If this device will be used with 3rd party imaging application software not supplied by SOREDEX 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 appli cable Do not connect any device to the unit that has not been supplied with the unit or that is not recommen
24. hts operate a check that oil is not leaking from the tube head acheck that all covers and mechanical parts are correctly secured and have not come loose A full description of all the tests and checks is de scribed in the Service Manual 30 User s manual 200409 CRANEX Novus 8 Warnings and precautions 8 Warnings and precautions 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 It is not safe to use the unit to take an x ray expo sure that the unit is not designed to take The unit or its parts must not be changed or modi fied in any way without approval and instructions from Soredex 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 de scribed in this manual and or if the user does not know how to use the unit Always use the lowest suitable x ray dose to obtain the desired level of image quality Because the x ray limitations and safety regula tions change from time to time it is the responsi bility of the user to make sure that all the valid safety regulations are fulfilled It is the responsibility of the doctor to decide if the x ray exposure is necessary Avoid taking x ray exposures of pregnant women The user must stand at least two meters from the unit when taking exposures protect him
25. ical and electronic equipment must not be disposed as unsorted municipal waste decommissioning of your equipment Type B equipment CE 0537 symbol MDD 93 42 EEC i Q UL Classification and CSA classification CRANEX Novus A 9 Appendix A Technical Information A 4 Electromagnetic declaration Emissions test Compliance Guidance and manufacturer s declaration electromagnetic emissions The CRA 1 is intended for use in the electromagnetic environment specified below The customer or the user of the CRA 1 should assure that it is used in such an environment Electromagnetic environment guidance CRANEX Novus RF emissions CISPR 11 Group 1 The CRA 1 uses RF energy only for its internal function Therefore its RF emissions are not likely to cause any interference in nearby electronic equipment are very low and RF emissions Class B The CRA 1 is suitable for use in all establishments CISPR 11 including domestic establishments and those directly Harmonic Class A connected to the public low voltage power supply emissions network that supplies buildings used for domestic IEC 61000 3 2 purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 A 10 CRANEX Novus CRANEX Novus Appendix A Technical Information Guidance and manufacturer s declaration electromagnetic immunity The CRA 1 is intended for use in the electromagnetic environment
26. ing M Show Image Preview Operation Normal C Calibrate After taking an exposure the Image Preview window will appear Image Preview 2 In Grayscale Controls field at the bottom of the window the Speed Contrast and Enhancement slide controls allow the image to be adjusted Grayscale Controls Speed 0 98 pa fa Contrast 0 00 a Enhancement 0 00 22 User s manual 200409 CRANEX Novus Grayscale Controls Speed 0 98 Contrast 0 00 Enhancement 0 00 Grayscale Controls Speed 0 98 Contrast 0 00 Enhancement 0 00 Edit Quality Presets Set Image Quality Presets Preset properties 6 Unit Set up No adjustments i If you do not wish to make any grayscale adjustments DO NOT move any of the sliders just click the OK button NOTE If you moved the sliders and do not wish to save the new settings refer to Retrieving the factory defaults at the end of this section Adjust ONE image only i If you want to make grayscale adjustments to the image in the Image Preview window only use the grayscale sliders to adjust the image to your preference ii Click the OK button to apply adjustments to the image in the Image Preview window only Adjust ALL future images i If you want apply grayscale adjustments to ALL subsequent images use the grayscale sliders to adjust the image to you preference ii Click the Edit Quality Presets button
27. l panel will come on The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken User s manual 200409 15 3 Taking an Exposure CRANEX Novus 17 PC After the exposure has been taken a progress bar will appear This indicates that the image is being transfered to the PC CRANEX Novus Scanning the image Open Preview 18 UNIT If you wish to take a second TMJ exposure a press the Return key to drive the unit back to the PIO position reposition the patient step 13 and then take the second exposure steps 14 15 Press the release button at the top of the forehead support and then slide the forehead support away from the patient Open the temple supports by sliding the temple support knob to the left Guide the patient out of the unit Press the Return key to drive the unit to the PIO position 16 User s manual 200409 CRANEX Novus 4 Operating the unit without x rays 4 Operating the unit without x rays CE Ts In some situations for example with nervous patients or patients with unusual anatomy you may wish to operate the unit without x rays before taking an exposure Press the T key Test the indicator light will come on The exposure switch can now be pressed to demonstrate how the unit operates without x rays being generated Press the T key a second time to return to the normal exp
28. lt of the patient s head until the patient s Frankfort plane coincides with or is parallel to the horizontal light CAUTION When pressing the Up Down keys to adjust the tilt of the patient s head take care not to cause the patient any discomfort Close the temple supports by sliding the temple support knob to the right Make sure that patient s neck is stretched and straight Carefully push the forehead support in until it touches the patient s forehead or nasion 14 User s manual 200409 CRANEX Novus 13 3 Taking an Exposure Check once more that the patient is positioned correctly and has not moved Close the mirror Ifyou are taking a TMJ exposure with the patient s 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 are taking a TMJ exposure with the patient s 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 12 seconds Move at least two metres 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 During the exposure you will hear an audible signal and the exposure warning light on the contro
29. on off switch is at the base of the column at the rear The unit will carry out a self test When the PC light turns green and the READY light comes on the unit is ready to take an exposure NOTE If the PC light turns RED it indicates that there is no connection to the PC Press the Return key to drive the rotating unit to the Patient In Out PIO position User s manual 200409 5 3 Taking an Exposure CRANEX Novus 3 2 Taking Exposures Panoramic Adult or Child 1 Slide the chin rest on to the support holder G27 2 Fordentate patients attach the bite block to the rod and the insert the rod and bite block into the 4 appropriate hole in the chin rest for the patient s occlusion For normal occlusion insert the rod into the middle rectangular hole ia Ov FZ 5 If the patient s teeth protrude angled outward insert the rod into the rectangular hole nearest the column If the patient s teeth retrude angled inward insert the rod into the rectangular hole furthest away from the column 6 User s manual 200409 CRANEX Novus 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 3 Place the appropriate disposable covers on to the patient support you are using 4 Press the Panoramic program key to select the Adult O panoramic program you require adult or child O a The appropriate
30. ortable and mobile RF communications equipment and the CRA 1 Rated maximum output power of transmitter W 150 kHz to 80 MHz d 1 2 P The CRA 1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the CRA 1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CRA 1 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m 80 MHz to 800 MHz d 1 2 4P 800 MHz to 2 5 GHz d 2 3 P applies 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 For transmitters rated at a maximum output power not listed above the recommended separation distance din 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 transmitter 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 CRANEX Novus A 13
31. osure mode NOTE After switching the unit off and then on again the unit returns to the normal non test mode User s manual 200409 17 5 Exposure switch lock CRANEX Novus 5 Exposure switch lock The exposure switch locks the exposure switch so that unauthorized people cannot take exposures even if the unit is switched on The exposure switch lock is located at the rear of the unit near the base 5 1 Unlocking the exposure switch Insert the key and turn it clockwise to the horizontal A position to unlock the exposure switch O 5 2 Locking the exposure switch Turn the key anticlockwise to the vertical position and fo remove the key The exposure switch is locked 4 18 User s manual 200409 CRANEX Novus 6 Unit Set up 6 Unit Set up Various set up options allow the unit to be customized to your specific requirements 6 1 Set up options 1 PC Open DFW or the dental imaging software you are using 2 Select Options and then click CRANEX Novus Setup R Digora for Windows File Patient List Patient Card Image Options Window Help General Setup Print Setup DIGORSG Fix Scanner Setup DIGORA Optime Scanner Setup DIGORS PCT Scanner Setup CRANEX Excel D Basex D CRANEX Novus Setup 3 The CRANEX Novus Setup window will appear CRANEX Novus Setup xj Device Settings Driver Info Status Device Disconnected Version Serial No
32. pply If the unit has been disconnected 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 scanned image should automatically be transferred If itis not click the check box in the Retrieve Last Image field to retrieve the last read image iii Click OK to close the CRANEX Novus Setup window The last image taken will appear on the patient card Device Serial Number field 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 botton options as the image marking text will appear on top of the serial number User s manual 200409 21 6 Unit Set up CRANEX Novus 6 2 Image Preview The Image Preview feature allows grayscale adjustments to be made to an image BEFORE it is saved The adjustments can be applied to the open image only or ALL subsequent images CAUTION Grayscale adjustments made to images CANNOT be undone after the adjustments have been saved 1 Click the Show Image Preview check box if you want an image preview to appear CRANEX Novus Setup f EI Device Settings Driver Info r Image Scann
33. 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 horizontal light CAUTION When pressing the Up Down keys to adjust the tilt of the patient s head take care not to cause the patient any discomfort User s manual 200409 3 Taking an Exposure CRANEX Novus 13 Close the temple supports by sliding the temple support knob to the right Make sure that patient s neck is stretched and straight Carefully push the forehead support in until it touches the patient s forehead or nasion 14 Check once more that the patient is positioned correctly and has not moved Close the mirror 15 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 12 seconds 16 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 17 Press and hold down the exposure button for the duration of the exposure During the exposure you will hear an audibl
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