SCANORA® 3D - thetechgods.net
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1. 64 8 Warnings and precautions 66 8 1 be observed during Uuse 66 8 2 General warnings APIS SUE EEUU UNE 69 Appendix A Technical Data A 1 A 1 Technical specifications A 1 A2 TIRE diinens Or uuu u A 9 Electromagnetic declaration A 10 vi User s Manual 202044 SCANORA 3D 1 Introduction 1 Introduction 1 1 The SCANORA 3D The SCANORA 3D is a cone beam computerized tomography x ray system intended to take digital images of the dento maxillo facial complex and the head and neck areas including the ear nose and throat ENT areas of the human skull The following 3D images can be taken 60x60 mm height x diameter small FOV Field Of View standard or high resolution 75x100 mm height x diameter medium FOV standard or high resolution 75x 145 mm height x diameter large FOV standard or high resolution OPTIONAL 130 x 145 mm height x diameter extra large FOV standard or high resolution Two large 3D images are auto2. 43 Informaliorrb li ii RE 44 Language u uuu RE M 44 5 2 Software settingS 44 ANCE ETT OT 45 6 1 The 3D QA procedure MUERE DUE ERES 45 Starting the QA procedure 45 Geometry calibration 49 CAID uuu uuu u 51 Quality XO EE 53 6 2 The Panoramic QA procedure OPTIONAL 57 7 Care maintenance and disposal T 61 7 1 Cleaning and disinfecting the unit 61 Unit surfaces and upholstery 61 FPOSHONNO HONE COV CLG uuu 61 Surfaces that the patient touches 61 7 2 Checking that the unit operates 62 General opseivations uu u u uuu u uu u asco a emu eee 62 Quality assurance curia via rU 62 Emergency Slop KNOD 62 B MANIC O u E 62 7 3 63 7 4 Symbols that appear on the unit
3. 4 2 THE SG INO 0 VEL TD cS 5 M in pans OC ONIONS RR ET 5 2 2 WNC COMM Ol pane 8 AIA E Em 8 Panoramic display OPTIONAL 8 ce Ol 9 2 4 Patient positioning lights 10 c S eee Su ee ee n nus 10 Panoramic OP TIONAL EAN 10 LOPOTT eaa E EE TS 11 SOPO E E u a as nun 11 COUTO EEE eee E EES 12 Panoramic programs OPTIONAL 19 FO SION CO VNC cc 14 3 1 4 611 11 u IILI iS 15 3 1 Preparing the system 15 3 2 Taking a 3D exposure 16 Taking a Panoramic exposure OPTIONAL 29 PIE 39 4 Messages and error codes J J 40 ISTE 1a tense REE En E E 40 ALENTO CO u 42 User s Manual 202044 V SCANORA 3D 5 uiu u 43 NT 43 Opening the Settings window 43 HO
4. Geometry calibration checks the rotation geom etry Pixel calibration checks the sensor and Quality check checks the density values and also allows you to check the positioning lights All the QA steps must be carried out and they must be carried out in the order in which they are listed above NOTE If the unit has the OPTIONAL panoramic sensor the panoramic QA procedure must also be carried out 6 1 The 3D QA procedure Starting the QA procedure 1 Push the forehead support locking lever up and remove the forehead support User s Manual 202044 45 6 Quality assurance 3D 2 Close the head support rotate it towards the chair and lock it in position with the head sup port locking lever 2 Rotate the head support adjusting knob until the head support is in the mid point of its travel There is a slight resistance when you reach this point O 3 Restart the system as described in section 3 1 Preparing the system IMPORTANT NOTE When the system is ready the head support will be in the mid point of its vertical travel During the QA test procedure DO NOT use the head support height adjusting keys on the remote control nor the head support adjusting knob to adjust the position of the QA phantoms 46 User s Manual 202044 3D gt Quality assurance User s Manual 202044 6 Quality assurance To adjust the position of the phantom
5. Always use the lowest suitable x ray dose to obtain the desired level of image quality Avoid taking x ray exposures of pregnant wom en When taking an x ray exposure of a child always use the lowest possible x ray dose the small est possible image area and the lowest possi ble resolution that will allow you to perform the required diagnostic task 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 before taking an exposure Always use disposable protective covers with the chin supports chin rests and bite pieces Disinfect all the surfaces that the patient is in contact with after every patient Crushing Danger The up down chair movement is only safe if the area around the chair is clear of foreign objects that could become trapped un der the edges of the chair Before using the unit remove all foreign objects for example drawers wheel chairs stools etc from around the chair to avoid damage to the unit or injury to people 8 Warnings and precautions SCANORA 3D If the patient moves during the exposure and or the imaging procedure is incorrect or incorrectly set up for the required examination and or the unit is not correctly maintained the accuracy of and measurement taken from the resulting im ages will be compromised The user must protect himself herself from x ray radiation when taking e
6. User s Manual 202044 51 6 Quality assurance SCANORA 3D Press the Return key to drive the unit to the ready position Touch the pixel calibration button to select the test Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button until the exposure is complete this will take about 15 seconds 6 After the exposure it will take approximately one and a half minutes for the image to be recon structed When reconstruction is complete the image will appear briefly on the unit display and then the PC The word PASSED should appear on the image This indicates that the unit has passed the pixel calibration test re FE mba eal 52 User s Manual 202044 3D 6 Quality assurance lf the word FAILED appears on the image the unit has failed the test Repeat the test If it fails a second time call service lt Touch the OK button to save the image and OK return to the QA window You must now carry out the quality check Quality Check 1 Place the QC phantom on the adjustable phan tom holder Make sure that the pin in the base of the quality assurance phantom goes into the middle hole in the adjustable phantom holder 2 Press the Return key to drive the unit to the ready position 3 Press the lights key to switch the patient posi tioning lights
7. 2 The 3D 2 5 Imaging programs User s Manual 202044 3D programs 60 x 60 mm diameter x height small FOV Standard resolution voxel size 0 20 mm or high resolution voxel size 0 133 mm 75 x 100 mm height x diameter medium FOV Standard resolution voxel size 0 30 mm or high resolution voxel size 0 20 mm 75 x 145 mm height x diameter large FOV Standard resolution voxel size 0 35 mm or high resolution voxel size 0 25 mm 130 x 145 mm height x diameter extra large FOV Standard resolution voxel size 0 35 mm or high resolution voxel size 0 25 mm 11 2 The 3D SCANORA 3D Scout programs 60 x 30 mm height x width scout projection image Allows the position of the 60 x 60 mm 3D small FOV to be verified The program takes a single lateral image of the front half of the 60 x 60 mm FOV program 75 x 50 mm height x width scout projection image Allows the position of the 75 x 100 mm 3D medium FOV to be verified The program takes a single lateral image of the front half of the 75 x 100 mm FOV program 75 x 72 5 mm height x width scout projection im age Allows the position of the 75 x 145 mm 3D large FOV to be verified The program takes a single lateral image of the front half of the 75 x 145 mm FOV program Also allows the position of the OPTIONAL 130 x 145 3D extra large FOV to be verified The program takes a single l
8. 3D If you are taking an extra large FOV image the rotating unit will rotate around the patient s head take the first half of the image and then stop The chair will then automatically descend and the rotating unit will then rotate around the patient s head in the opposite direction and take the second half of the image 27 When the audible signal stops and the exposure warning symbol disappears from the touch con trol panel the exposure has been taken It will take 1 to 5 minutes to process and transfer the 3D image to the PC After transfer open the image window and double click the 3D image to open it IMPORTANT NOTE extra large FOV If the patient moved between the first and sec ond exposure or if the boundary between the two large FOV images is not clearly defined e g too many metal artifacts the software may not be able to properly combine the two images into a single extra large FOV image If this is the case two separate large FOV images will be produced User s Manual 202044 3D User s Manual 202044 NN F 1 i i lt lt 29 30 3 Taking an exposure If the boundary between the two large FOV im ages is not clearly defined but the software is able to combine the two images the dimensional accuracy across the boundary area may be reduced NOTE If you took a scout image it will take 10 20 sec onds for the image a single h
9. SCANORA 3D Appendix A Technical Data 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 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 instructions Appendix A Technical Data 3D Tube housing assembly cooling heating characteristics TUBE HOUSING ASSEMBLY COOLING CHARACTERISTICS kHU HEAT UNITS Ep T L tA 120 150 180 TIME IN MINUTES Tube rating chart L gt z kJoule 1 kJ A 8 SCANORA 3D Appendix A Technical Data A 2 Unit dimensio
10. User s Manual 202044 53 6 Quality assurance 3D 4 Aswith the geometry calibration test use the seat height adjusting keys and the field of view positioning keys on the remote control to adjust the position of the QC phantom Position the patient positioning lights so that they coincide with the vertical and horizontal lines marked on the phantom 5 Touch the Quality Check button to select the test 6 Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button until the exposure is complete this will take about 15 seconds 7 After the exposure it will take approximately three minutes for the image to be reconstructed When reconstruction is complete the image will appear briefly on the unit display and then the PC 54 User s Manual 202044 3D User s Manual 202044 6 Quality assurance PC Open the 3D viewing software and then open the quality check image scroll through the quality check image the cylindrical 3D volume until you see the word PASSED This indicates that the unit has passed the Quality Check test Passed If the word FAILED appears on the image the unit has failed the test Recheck the position of the 3D phantom and reposition and relevel it if necessary NOTE You can check if the QC phantom is level by scrolling through the volume see step 9 next and che
11. Panoramic imaging 8 mA MAXIMUM ANODE OUTPUT POWER 774 W nominal nominal at 86 kV 9 mA MAXIMUM GENERATOR OUTPUT POWER 3D maximum 1 13 kW at 90 kVp 12 5 mA 3D maximum nominal 0 30 kW at 85 kVp 15 mA optional Panoramic maximum 0 65 kW at 81 kVp 8 mA optional Panoramic maximum nominal 0 65 kW at 81 kVp 8 mA REFERENCE CURRENT TIME PRODUCT 8 mAs at 81 8 mA 1 0 FILTRATION Collimator SBR3D Total filtration 60 x 60 3D 7 7 mm Al 75x 100 3D 7 7 mm Al 75x 145 3D 7 7 mmAl optional Panoramic 3 7 mm FILTRATION Collimator BLD SBR3D 2 Total filtration 60x 60 3D 6 6 mm Al equivalent filtration used 0 2 mm Cu 75 x 100 3D 6 6 mm Al equivalent filtration used 0 2 mm 75 x 145 3D 6 6 mm Al equivalent filtration used 0 2 mm Cu optional Panoramic 3 3 mm Al equivalent filtration used 0 1 mm Cu SCANORA 3D Appendix A Technical Data BEAM QUALITY HVL over 3 2 mm Al at 90 kV RADIATION LINEARITY lt 20 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 3D 34 pictures per hour OPTIONAL PANORAMIC 19 pictures per hour LEAKAGE TECHNIQUE FACTORS 3D 1920 mAs h at 90 kV FOV 60 x 60 mm high resolution OPTIONAL PANORAMIC 81 kV 2300 mAs h 81 kV 8 mA Power requirements INPUT VOLTAGE 230 240 VAC 10 50 60 Hz single phase grounded socket LINE CURRENT long term 1 A cont
12. 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 SBR3D is used exceeds the applicable RF compliance level above the SBR3D should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting of relocating the SBR3D Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A 12 3D Appendix A Technical Data Recommended separation distances between portable and mobile RF communications equipment and the SBR3D The SBR3D is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SBR3D can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SBR3D as recommended
13. 24 Arm rests User s Manual 202044 7 2 The 3D SCANORA 3D 2 2 The control panel 3D display amp 167761 7162 Smith John MJ AD Mode buttons a 8 FOV buttons Hesolution OJ k a scout buttons 12 5mA g jp MA buttons q T End study 7 7 button Settings button Information window Test exposure button Panoramic display OPTIONAL a 167 761 7167 Smith John MJ v c r Program buttons LY I3 jp kV buttons 6 3 jesus 5 mA buttons gt D 5 8 User s Manual 202044 3D 2 3 Remote control Rotating unit return key Backwards Field Of View positioning keys Forwards Up Head support height adjusting keys Down 2 The 3D Position lights on off key Chair height adjusting keys Down A User s Manual 202044 9 2 The SCANORA 3D 3D 2 4 Patient positioning lights 3D lights Lateral light Sagittal light Center of FOV Center of FOV Upper light Top of FOV 130mm XL FOV or 75 M and L FOV or 60 mm S FOV Lower light Bottom of FOV Panoramic lights OPTIONAL Focal trough light Midsagittal light Center of focal trough v Horizontal light Bottom of panoramic field 10 User s Manual 202044 3D
14. 4 Symbols that appear on the unit AN Radiation warning J Dangerous voltage On or enabled Off or disabled Connector tor remote control Exposure switch Connector for Ethernet RJ45 L i 4 Connector for exposure switch gt Connector for external exposure light AN Attention consult accompanying documents 64 User s Manual 202044 3D 7 Care maintenance and disposal L Ground Functional Protective ground CLASS 1 LASER PRODUCT aser 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 electrical and electronic equipment must not be disposed as unsorted municipal waste decommissioning of your equipment Type B equipment C CE 0537 symbol MDD 93 42 EEC 0537 ETL Classification C US User s Manual 202044 65 8 Warnings and precautions SCANORA 8 Warnings and precautions 8 1 To be observed during use The unit must only be used to take x ray im ages of the dento maxillo facial complex and the head and neck areas including the ear nose and throat ENT areas of the human skull 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 Only professionally
15. Federal law restricts this device to sale by or on the order of a dentist or other qualified profes sional 2 User s Manual 202044 SCANORA 3D 1 Introduction 1 3 About this manual This manual describes how to set up and use both versions of the SCANORA 3D x ray unit the 3D version and the 3D Panoramic version Please read this user s manual before operating the unit for the first time CAUTION It is important to read the warnings and precau tions listed in section 8 before operating the unit for the first time It is also important to observe these warnings and precautions whenever the unit is used NOTE Instructions in this user s manual starting with PC for example 1 PC Open a new or existing patient indicate that the task is carried out from the PC Instructions NOT starting with PC for example 3 Close the head supports indicate that the task is carried out from the UNIT NOTE Before you use the imaging system for the first time set the system to your requirements See section 5 System Settings User s Manual 202044 3 1 Introduction SCANORA 3D 1 4 Abbreviations used in this manual FOV Field Of View The cylindrical 3D volume that the unit will take an exposure of ROI Region Of Interest The anatomical area or region of the patient that you are interested to ex amine 1 5 Associated documentation The Scanora workstation software user s manual The user s
16. below according to the maximum output power of the communications equipment Rated maximum output power of 800 MHz to 2 5 GHz transmitter W 1 24P d 1 24P 2 3 0 23 0 73 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 applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A 13
17. date of manufacture Performance Standards and European Union Directive 93 42 EEC Medical De vices Directive EMC Class B 12 Safety according to IEC 60601 1 Protection against electric shock Class Degree of protection Type B applied with no conductive connection to the patient Protection against the ingress of liquids IP20 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 anaesthics nor flammable cleaning agents are present Mode of operation continuous operation intermittent loading Unit description A dental cone beam 3D x ray unit that generates 3D images and optional panoramic images The image receptors are a CMOS flat panel sensor for cone beam 3D images and an optional CCD sensor for panoramic images Appendix A Technical Data 3D X ray generator TADE PAN image OPX KL 5 or equivalent FOCAL SPOT optional 0 5 mm IEC 60336 1993 TARGET ANGLE 90 TARGET MATERIAL Tube 3D image Tungsten i OPERATING TUBE POTENTIAL 3D imaging 90 kV 5 kV optional Panoramic imaging 60 81 kV 5 kV OPERATING TUBE CURRENT AVERAGE 3D imaging 3 5 mA 0 5 optional Panoramic imaging 4 8 mA 1 mA NOMINAL ANODE INPUT POWER 668 W nominal at 81 kV 8 mA MAXIMUM TUBE CURRENT 3D imaging 12 5 mA 0 01 optional
18. instructions supplied with the 3D viewing software you are using 1 6 About cone beam 3D imaging During a 3D exposure the tubehead rotates around the patient s head taking a series of 2D images of the selected ROI 225 to 450 depending upon the 3D program and resolution selected The 3D imag ing software then reconstructs the separate 2D im ages to form a 3D model a volume of the ROI 4 User s Manual 202044 3D 2 The SCANORA 3D 2 The SCANORA 3D 2 1 Main parts and controls Tubehead assembly Rotating unit Detector head TW gt m d 10 Electronics cabinet On off switch Detector head electronics Tubehead 3D Panoramic Pan OPTIONAL cabinet assembly Remote control PC with Scanora Workstation software and 3D viewing sofware All software must conform to the MDD and the relevant legal requirements in the USA User s Manual 202044 5 2 The SCANORA 3D 3D Emergency stop knob Press to stop the unit Rotate to release Forehead support Temple supports knob Head support lever Head support 7 lt gt Sp Head support adjusting knob Forehead support locking lever 6 User s Manual 202044 3D 2 The SCANORA 3D Seat Back rest Chair Arm rests Leg rests pe I
19. name that will make it easily identifiable for example QA Test PC Click the Image Capture button Touch the Panoramic button to select the Pano ramic program mode select the adult panoramic program Select the minimum exposure factors 60kV and 4mA Push the temple supports towards the chair so that the panoramic sensor will not hit them dur ing the exposure 6 Quality assurance 3D 8 Place the adjustable phantom holder on the chin rest and then level the holder using the levelling screws on the under side There is a spirit level on top of the holder 9 Place the panoramic ball and pin phantom on to the adjustable phantom holder 10 Press the Return key to drive the unit to the ready position 11 Press the lights key to switch the patient posi 085 tioning lights on 12 Position the panoramic ball and pin phantom so that the midsagittal and focal trough light beams strike the middle of the metal ball in the phan tom The horizontal light must be positioned so that it strikes the lower edge of the phantom 58 User s Manual 202044 3D 6 Quality assurance 13 Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button The exposure will last about 15 seconds PC Click the Abort Capture button 15 PC A preview image of the panoramic ball pin phantom will appear on the unit display a
20. qualified dental and or medi cal personnel are allowed to operate the unit and carry out any diagnoses based on output from the unit 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 This unit complies with the EMC Electromag netic Compatibility according to IEC 60601 1 2 Radio transmitting equipment cellular phones etc shall not be used in close proximity of the unit as they could influence the performance of 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 doctor to decide if the x ray exposure is necessary The minimum height of patient that can be x rayed without the optional cushion is 140 cm 4 ft 7 and the maximum is 205 cm 6 9 in These heights only apply to patients with normal anatomy User s Manual 202044 3D User s Manual 202044 8 Warnings and precautions The unit chair can support a patient with a maxi mum weight of 150 kg When taking an x ray exposure of a patient with exceptional anatomy typically very tall or large use the test program no x rays first to make sure that patient can be positioned correctly in the unit
21. sup port knob to close the temple supports so that they grip the patient s head User s Manual 202044 3D 3 Taking an exposure 21 Press the seat height adjusting keys to position N the ROI within FOV you have selected The up per light beam indicates top of the FOV and the lower light beam the bottom of the FOV x If you are taking an extra large FOV image posi tion the lower light level with the bottom of the patient s chin For an adult patient with average size head this will place the boundary between the two large FOV images in an area away from the crowns 22 The sagittal light vertical front light indicates the center of the FOV in the sagittal direction Press the left right field of view positioning keys to position the sagittal light so that it is in the center of the ROI you wish to examine lt C gt User s Manual 202044 23 3 Taking an exposure SCANORA 3D 23 The lateral light vertical side light indicates the center of the FOV in the lateral direction Press the forwards backwards field of view positioning keys to position the patient so that the lateral light in the center of the ROI you wish to examine If you are taking a scout view the lateral light indicates the left hand edge of the scout view 24 Slide forehead support up or down until it is po sitioned in front of the patient s forehead Wrap the forehead support strap around the patient s head s
22. the front This will make it easier for the patient to enter the unit Ask the patient to remove or lower the armrest on the right hand side of the wheelchair Ask the patient to slide from the wheelchair onto the unit chair When the patient is in the unit chair lower the left hand chair armrest Remove the wheelchair from the unit environ After taking the exposure repeat above procedure in the reverse order to get the patient back into the wheelchair Carefully rotate the head support towards the patient until it stops Turn the head support lock ing lever to the right to lock the head support in position 3 Taking an exposure 17 9 19 SCANORA 3D Rotate the head support positioning knob to position the head support so that the patient can place their chin on the chin cup or bite the bite block 6 18 Press the light key to switch the patient position ing lights on NOTE If the patient positioning lights do not come on the rotating unit is not in the 3D ready position To switch the lights on press the return key to drive the unit to the 3D ready position and then press the light key to switch the patient position ing lights on Press the head support up down keys to level or adjust the angle of the patient s head 20 Push the temple supports towards the patient so that they are positioned on both sides of the patient s head Carefully rotate the temple
23. 230 240 VAC mains momentary 8 A 230 240 VAC mains MAXIMUM LINE RESISTANCE 1 ohm MINIMUM LINE FUSE 10 slow at 230 240 LINE SAFETY SWITCH when required Approved type min 10 A 250 VAC EARTH LEAKAGE CIRCUIT BREAKER when required Approved type min 16 A 250 VAC breaker activation leakage current in accordance with local regulations Mains fuses in the device F1 special 8 amp 250 V slow 6 3 x 32mm F2 special 8 amp 250 V slow 6 3 x 32mm External warning light fuse F3 special 2 amp 250 V slow 6 3 x 32mm Appendix A Technical Data 3D Mechanical parameters SOURCE TO IMAGE LAYER DISTANCE SID 3D 650 mm 10 mm optional Panoramic 550 mm 10 mm MAGNIFICATION FACTOR 3D 1 5 optional Panoramic 1 3 WEIGHT 308 6 kg 313 kg with optional Panoramic DIMENSIONS H x W x D 1963 x 1541 x 1100 mm PATIENT HEIGHT 140 205 cm PATIENT WEIGHT maximum 150 kg 3D image receptor TYPE CMOS Flat Panel PIXEL SIZE 200 microns ACTIVE SENSOR SURFACE 124 8 x 124 8 mm max OPTIONAL Panoramic image receptor TYPE CCD PIXEL SIZE 48 microns ACTIVE SENSOR SURFACE 146 x 6 mm X ray field size 3D 72 5 x 75 mm Maximum 30 x 60 mm Minimum OPTIONAL PANORAMIC Adult panoramic maximum size 15 cm x 30 cm SCANORA 3D Appendix A Technical Data Timer EXPOSURE TIMES 3D 4 5 sec maximum optional Panoramic 15 sec maximum SINGLE LOAD RATING 81 kV 8 1
24. 5 sec panoramic BACK UP TIMER 30 sec 15 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 PRIMARY SLIT 3D motorized variable Optional Panoramic 0 6 mm x 32 5 mm adult panoramic slit Child panoramic 0 6 mm x 25 mm The exposure time is also decreased to reduced the width Chair motor DUTY CYCLE Intermediate use 6 25 25s ON 400s OFF Environmental data OPERATING ambient temperature from 10 C to 30 C relative humidity O 85 no condensation SIORAGE TRANSPORTATION ambient temperature from 0 C to 50 C relative humidity 0 85 no condensation atmospheric pressure 700 1060 mbar Appendix A Technical Data 3D PC requirements The PC must meet the IEC 60950 standard minimum requirements Windows 7 Windows XP Professional with SP2 32 bit Windows XP Professional with SP3 32 bit or Windows Vista Business SP2 32 bit 2 to 4 GB RAM 500 GB HDD or larger Gigabit Ethernet copper one available PCI Express x16 bus slot for a GPU card full length dual slot 2 available USB ports hardware keylocks 19 LCD display 1280 x 1024 pixels 32 bit color 500 watt power supply 60950 230 VAC 230 VAC
25. ENGLISH 3D Cone Beam 3D Imaging System User s Manual 202044 rev 10 2010 11 SCANORA 3D Cone Beam 3D Imaging System User s Manual C 0537 Medical Device Directive 93 42 EEC Number 202044 rev 10 2010 11 Original approved English language version Manufactured by SOREDEX Nahkelantie 160 Tuusula P O BOX 148 04301 Tuusula Finland Tel 358 0 45 7882 2000 Fax 358 9 701 5261 SCANORA 3D 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 There fore this document should not be regarded as an infallible guide to current prod uct specifications Soredex maintains the right to make changes and alterations without prior notice IV User s Manual 202044 3D Contents 3ICINIII skasssasa 1 L MEP OCU CON u 1 12 THE SOARING RR cence 1 1 2 nn ee ee 2 1 3 About this Main c TEE 3 1 4 Abbreviations used in this manual 4 1 5 Associated documentation 4 1 6 About cone beam 3D imaging
26. alf lateral image to appear on the unit control panel If the patient is NOT positioned correctly touch the OK key reposition the patient and take an other scout image If the patient is positioned correctly touch the OK key and then select the resolution you re quire and take the 3D image After the 3D image appears on the PC display press the Return key to drive the rotating unit to the ready position Drive the chair to its lowest position open the head support and guide the patient out of the unit PC The 3D image can be examined using the 3D imaging software Refer to the documenta tion supplied with the 3D imaging software 3 Taking an exposure SCANORA 3D 31 PC Click the Abort Capture button when you have taken all the necessary images or 32 To finish the examination touch the End study button 28 User s Manual 202044 3D 3 Taking an exposure 3 3 Taking a Panoramic exposure OPTIONAL 1 PC Open a new or existing patient or select a patient from the work list Refer to the Scanora Workstation software users guide for information on how to do this 2 PC Click the Image Capture button 3 Touch the Panoramic button to select the Pano ramic program mode The button will change color 4 Select the panoramic program you wish to use adult panoramic 1 child panoramic 4 temporomandibular joints Y est possible kV 67kV rec
27. ateral image of the front lower half of the 130 x 145 mm FOV program User s Manual 202044 3D 2 The 3D Panoramic programs OPTIONAL Adult panoramic Magnification 1 25 M M M M M User s Manual 202044 13 2 The SCANORA 3D 3D 2 6 Positioning devices lt gt Chin cup Disposable cover lt Bite block Disposable cover Lip holder Disposable cover Lip support Disposable cover 14 User s Manual 202044 3D 3 Taking an exposure 3 Taking an exposure 3 1 Preparing the system 1 User s Manual 202044 PC Switch the PC on IMPORTANT NOTE Make sure that the hardware key dongle is connected to the PC If a hardware key has been removed the system will not work correctly Note that some systems have two hardware keys Switch the unit on The on off switch is on the under side of the electronics cabinet A message will appear on the control panel ask ing you to press and hold the chair down button to complete unit start up CAUTION Crushing Danger Before pressing the chair down button remove all objects for example drawers wheel chairs stools etc from around the chair to avoid dam age to the unit o
28. cking if the cross at the top and dot at the bottom appear within the white circles If they do not the QC phantom is not level Hepeat the test If it fails a second time call service PC Now check the position of the lights using the same image ocroll to the top of the quality check image A cross will appear The center of the cross should be within the white circle at the center of the crosshairs Now scroll to the bottom of the quality check image In the center of the image you will see a dot The dot should be within the white circle at the center of the crosshairs 6 Quality assurance SCANORA 3D If both the center of the cross and the dot are within the white circle at the center of the cross hairs the lights are correctly positioned If the center of the cross and the dot are not within the white circle the lights are not po sitioned correctly and must be adjusted Call service Touch the OK button to save the image and return to the QA window The QA test for 3D imaging is now complete Touch the arrow button to exit the QA mode and return to the main program window User s Manual 202044 3D 6 Quality assurance 6 2 The Panoramic QA procedure OPTIONAL 1 60kV 6 AmA User s Manual 202044 Start the system as described in section 3 1 Preparing the system PC Open a new patient card in which the QA images can be stored and give it a
29. d from an uninterruptible power supply ora battery Power frequency magnetic field should be at levels characteristic of a typical location ina typical commercial or hospital environment A 11 Appendix A Technical Data 3D Guidance and manufacturer s declaration electromagnetic immunity The SBR3D is intended for use the electromagnetic environment specified below The customer or the user of the SBR3D 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 SBR3D including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted Vrms d 1 2 P RF 150 kHz to d 1 24P 80 MHz 800 MHz d 2 34P 800 MHz to 2 5 GHz Radiated RF IEC 61000 4 3 where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is 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 n NOTE
30. d then press and hold the exposure button The unit will complete an exposure cycle without generating x rays Press the key button to drive the rotating unit to the 3D ready position 3 Taking an exposure SCANORA 3D 15 If necessary lift up the arm rests and then ask the patient to sit on the chair Make sure that the patient is sitting straight and in the middle of the chair with their back pushed against the back rest Also make sure that they are sitting in a position in which they feel comfortable If the patient is very large and cannot sit com pletely on the seat or is small and cannot sit back far enough adjust the forward backward position of the backrest with the knob at the rear of the chair Also with small patients and children use cush ions to position the patient at the right height User s Manual 202044 3D 16 User s Manual 202044 3 Taking an exposure Wheelchair patients Adjust the height of the unit chair so that the seat is level with the wheelchair seat or as near as possible at the same level Position the patient in the wheelchair as close as possible to the left hand side of the unit chair with the patient facing forwards Ask the patient to put the wheelchair s brake on so that wheelchair cannot move Make sure that the left hand arm rest of the unit chair is in the raised position Manually rotate the rotating unit so that the detector head is at
31. en the unit is not being used rotate the head support to the closed position and lock it in position with the head support locking lever User s Manual 202044 39 4 Messages and error codes SCANORA 3D 4 Messages and error codes 4 1 Messages Dental imaging program not open Open dental imaging program from PC The Scanora Workstation software in the PC has not been opened Open the program to clear the message NOTE If the unit is connected to the PC through a router this message indicates that the router is working but the PC may not be working No Ethernet link Check Eternet cable between unit and PC Either the Eternet cable between the unit and the PC is not connected or the PC has not been switched on Reconnect the Ethernet cable or switch the PC on to clear the message The exposure button was released during imag ing Check the image to see if it is sufficient for the diag nostic task If not take another image User s Manual 202044 3D 4 Messages and error codes Reconstruction of the 3D image failed See if the image can be retrieved using the Retrieve last image option If not take another image NOTE This message will also appear if the hardware key dongle used for software protection has been re moved from the PC s USB slot PC s driver failed Switch the system off and then on again If the mes sage reappears call service for help E
32. erruptions and voltage variations on power supply lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Ur is the AC mains voltage prior to application of the test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 Ut gt 95 96 dip in Ur for 0 5 cycle 40 96 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles 5 Ut gt 95 96 dip in Ur for 5 sec IEC 60601 test level Compliance level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 Ut 95 96 dip in Ur for 0 5 cycle 40 96 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ut gt 95 dip in for 5 sec Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If user of the SBR3D requires continued operation during power mains interruptions it is recommended that the SBR3D be powere
33. exposure of a child use the low est possible mA 8 10 mA recommended that will allow you to perform the required diagnostic task 7 Slide the forehead support into the two holes in the chin rest and then push the locking lever down to lock the forehead support in position User s Manual 202044 17 3 Taking an exposure SCANORA 3D Release the head strap 8 Rotate the temple supports knob to open the temple supports as far as they will go and then pull the temple supports away from the seat 9 Rotate the head support adjusting knob to move the head support to its mid point You will feel Slight click when you reach this position 4 10 Turn the head support lever to the left to release the head support and then rotate the head sup port away from the seat to the open position 18 User s Manual 202044 3D 11 x 12 13 e User s Manual 202044 3 Taking an exposure Insert the chin cup into the chin rest NOTE Use a new disposable cover for every patient Press the chair down key to drive the chair down so that it is low enough for the patient to enter unit Ask the patient to remove any spectacles den tures jewellery and hair clips and pins Place a protective lead apron on the patient NOTE If the patient is nervous or a child you can demonstrate how the unit works to reassure them Touch the T Test button an
34. from Soredex To maintain low EMC emissions that conform with the MDD it is mandatory to use a shielded CAT6 Ethernet cable between the unit and the network 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 the Medical Device Di rective 93 42 EEC and or relevant legal require ments in the USA Do not connect any equipment to the unit that has not been supplied with the unit or that is not recommended by SOREDEX The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system The aperture plate and tubehead housing are made of lead Pb which is a toxic material Do not touch these parts with your bare hands 8 Warnings and precautions 3D 70 User s Manual 202044 SCANORA 3D Appendix A Technical Data Appendix A Technical Data A 1 Technical specifications Type SBR3D Classification IEC 60601 1 1988 and A1 A2 IEC 60601 1 1 2000 IEC 60601 1 4 1996 and 1 IEC 60601 2 7 1998 IEC 60601 2 28 1993 IEC 60601 2 32 1994 IEC 60601 2 44 2001 and A1 IEC 60601 1 2 2001 and A1 IEC 60601 1 3 1994 UL 60601 1 2003 CAN CSA 22 2 No 601 1 90 and S1 A2 standards Complies with DHHS 21 CFR Chapter Subchapter J at the
35. he following tests will be carried out a kV mA test a check that the safety ground is connected a check that the positioning lights operate a check that oil is not leaking from the tube head a check 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 User s Manual 202044 3D 7 Care maintenance and disposal 7 3 Disposal User s Manual 202044 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 replacement 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 circuit boards TUBEHEAD OIL Inside tubehead CESIUM IODIDE Csl CMOS sensor CCD sensor 7 Care maintenance and disposal SCANORA 3D 7
36. lide the strap through the buckle and then gently pull the strap to tighten it around the patient s head Fold the strap backwards and then secure it in position D ig ma T Im 7 24 User s Manual 202044 3D User s Manual 202044 25 26 3 Taking an exposure Tell the patient not to move for the duration of the exposure If you are taking an extra large FOV 130 x 145 mm 3D image tell the patient that TWO images will be taken and that after the first image has been taken the chair will automatically descend and the unit take a second exposure The approximate exposure times are scout 5 seconds small medium and large FOV 3D 10 20 seconds extra large FOV 3D 20 26 second exposures Protect yourself from radiation by standing be hind a suitable x ray radiation shield 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 ex posure you will hear an audible signal and the exposure warning symbol will appear on the on the touch control panel If you are taking a scout image the rotating unit will not move and the image will be taken from the ready position If you are taking a small medium or large FOV 3D image the rotating unit will rotate around the patient s head once and then stop 3 Taking an exposure
37. matically taken and then combined to form a single image The following scout images a single image of the front lateral half of the 3D images can also be taken 60 x 30 mm height x width a front lateral im age of the 60 x 60 mm 3D small FOV 75 50 mm height x width a front lateral im age of the 75 x 100 mm 3D medium FOV 75x 72 5 mm height x width a front lateral im age of the 75 x 145 mm 3D large FOV Also the lower front part of the 130 x 145 mm 3D extra large FOV User s Manual 202044 1 Introduction SCANORA 3D With the OPTIONAL panoramic sensor the follow ing panoramic exposures can be taken adult panoramic child panoramic reduced width and height lateral TMJ left and right A CMOS flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images The unit is connected to a PC in which suitable dental imaging software and 3D imaging software have been installed All software must conform to the MDD and the relevant legal requirements in the USA 1 2 Intended use The unit must only be used and operated by quali fied healthcare professionals The unit must only be used to take 3D and OP TIONAL panoramic images of the dento maxillo facial complex and the head and neck areas in cluding the ear nose and throat ENT areas of the human skull It must not be used to take images of any other part of the human body USA only Caution
38. nd then the PC Use the measuring tools of the Scanora Work station software to check the image The ball in the center must be round no more that 1096 difference between the horizontal di ameter and the vertical diameter and the dis tances from the right hand pin and the left hand pin to the ball must be the same within 0 5mm If the ball is round and the distances are the same the unit has passed the panoramic Qual ity Check test User s Manual 202044 59 6 Quality assurance SCANORA 3D If the ball is not round and the dimensions are not the same the unit has failed the test Repeat the test and it fails a second time call service 16 Touch the Exit button to exit the test 60 User s Manual 202044 3D 7 Care maintenance and disposal 7 Care maintenance and disposal 7 1 Cleaning and disinfecting the unit User s Manual 202044 Warning Switch the unit off before cleaning it If you use a spray cleaner do not spray into any ventilation grills Unit surfaces and upholstery All surfaces can be wiped clean with a soft cloth dampened with a mild detergent DO NOT use abra sive cleaning agents or polishes on this equipment Positioning light covers The positioning light covers are made of clear plastic Use a soft cloth dampened with a mild de tergent NEVER use abrasive cleaning agents or polishes to clean the covers Surfaces that the patient touches All surfaces and
39. ns 1973 mm 1984 mm 1400 mm 1600 mm Appendix A Technical Data 3D A 3 Electromagnetic declaration Guidance and manufacturer s declaration electromagnetic emissions The SBR3D is intended for use in the electromagnetic environment specified below The customer or the user of the SBR3D should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance HF emissions Group 1 The SBRS3D 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 The SBR3D 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 3D Appendix A Technical Data Guidance and manufacturer s declaration electromagnetic immunity The SBR3D is intended for use in the electromagnetic environment specified below The customer or the user of the SBR3D should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transients bursts IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short int
40. ntal lines marked on the phantom Touch the geometric calibration button to select the test Protect yourself from radiation by standing be hind a suitable x ray radiation shield Press and hold down the exposure button until the exposure is complete this will take about 30 seconds After the exposure it will take approximately five minutes for the image to be reconstructed When reconstruction is complete the image will appear briefly on the unit display and then the PC User s Manual 202044 SCANORA 3D 6 Quality assurance The word PASSED should appear on the im age This indicates that the unit has passed the geometry calibration test A Tagus 0121912 ets zi5 3i mm 7 If the word FAILED appears on the image the unit has failed the test Recheck the position of the 3D phantom and reposition and relevel it if necessary Repeat the test If it fails a second time call service Touch the OK button to save the image and OK return to the QA window You must now carry out the pixel calibration test Pixel calibration 1 Remove the 3D phantom 2 CAUTION Crushing Danger Before pressing the chair down button remove all objects for example drawers wheel chairs stools etc from around the chair to avoid dam age to the unit or injury to people Press the seat height adjusting key to drive the chair down as far as it will go
41. ommended and mA 4 5 3mA recommended that will allow you to perform the required diagnostic task 73 4 Select the kV and mA 6 3 J CAUTION When taking an exposure of a child use the low lt User s Manual 202044 29 3 Taking an exposure SCANORA 3D 5 Pull the forehead support locking lever up and remove the forehead support 6 Rotate the temple supports knob to open the temple supports as far as they will go and then pull the temple supports away from the seat 7 Rotate the head support adjusting knob to move the head support to its mid point You will feel Slight click when you reach this position 1 30 User s Manual 202044 3D V m User s Manual 202044 a 3 Taking an exposure Turn the head support locking lever to the left to release the head support and then rotate the head support away from the seat Insert the required positioning device bite block lip rest or support into the head support Place the appropriate disposable cover on posi tioning device NOTE Use a new disposable cover for every patient Press the seat height adjusting keys to drive the chair down so that it is low enough for the pa tient Ask the patient to remove any spectacles den tures jewellery and hair clips and pins Place a protective lead apron on the patient NOTE If the pa
42. 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 instruc tions supplied with the disinfectant 7 Care maintenance and disposal SCANORA 3D 7 2 Checking that the unit operates correctly General observations 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 authorized serv ice 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 authorized 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 authorized service technician for help Quality assurance check The quality assurance QA check must be carried out at regular intervals to check the image quality oee section 6 Emergency stop knob When the emergency stop button has been pressed down make sure that the unit movements do not operate Yearly maintenance Once a year an authorized service technician must carry out a full inspection of the unit During the inspection t
43. patient to press their tongue against the roof of their mouth and remain still for the dura tion of the exposure 15 seconds If you are taking a temporomandibular joint exposure ask the patient to open or close their mouth depending on which exposure you wish to take Protect yourself from radiation by standing be hind a suitable x ray radiation shield 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 symbol on the touch control panel will appear The rotating unit will rotate around the patient s head and then stop When the rotating unit stops the exposure has been taken A preview image will appear on the unit control panel Touch the OK key After the image appears on the PC display press the Return key to drive the rotating unit to the ready position Drive the chair to its lowest position open the head support and guide the patient out of the unit User s Manual 202044 3D 3 Taking an exposure 30 PC The panoramic image can be examined us ing the Scanora workstation software Refer to the Scanora workstation software user s manual 31 PC Click the Abort Capture button when you have taken the necessary images or 32 Touch the End study button to finish the exami 2 7 nation 3 4 After use Wh
44. r injury to people Press and hold the chair down key until the unit stops moving A message will then appear asking you to select a patient and then start image capture The system is now ready to take an exposure 3 Taking an exposure SCANORA 3D 3 2 Taking a 3D exposure 1 2 K 4 PC Open a new or existing patient or select patient from the work list Refer to the user s guide supplied with the Scanora Workstation software for information on how to do this NOTE Do not open the 3D viewing software PC Click the Image Capture button The image capture window will open Touch the 3D button to select the 3D program mode select the Field Of View FOV 60 60 mm small FOV 75x 100 mm medium FOV N 75 x 145 mm large FOV A 130 x 145 mm extra large FOV NOTE For the 130 x 145 mm extra large FOV the unit will take two large FOV images and then combine them to form a single extra large FOV image User s Manual 202044 3D 3 Taking an exposure 5 Select the scout image or the 3D resolution Scout image Standard resolution 3D image QJ k D High resolution 3D image IMPORTANT NOTE Take a scout image before taking the 3D image if you wish to check that the Region Of Interest ROI is in the correct position within the FOV 15n4 9 6 Select the mA CAUTION When taking an
45. s ONLY use the Seat Height adjusting keys and the Field of View positioning keys on the remote control to adjust the position of the QA phan toms PC Open a new patient card in which the QA images can be stored and give it a name that will make it easy to identify for example QA Test NOTE Do not open the 3D viewing software PC Click the Image Capture button Touch the setting button at the bottom of the main window The settings window will appear Touch the Quality assurance button 6 Quality assurance 3D The QA window will appear 48 User s Manual 202044 SCANORA 3D 6 Quality assurance Geometry calibration 1 Place the adjustable phantom holder on the chin rest and then level the holder using the levelling screws on the under side There is a spirit level on the holder Place the 3D phantom on the adjustable phan tom holder Note that it can only be placed in one position because of the different size pins in the base ready position 4 Press the Lights key to switch the patient posi 085 tioning lights on 3 Press the Return key to drive the unit to the User s Manual 202044 49 6 Quality assurance SCANORA 3D 5 Use the seat height adjusting keys and the field of view positioning keys on the remote control to adjust the position of the 3D phantom Position the patient positioning lights so that they coin cide with the vertical and horizo
46. s on the unit control panel Display patient s name P PP p Display DAP value Allows you to select whether or not the DAP Dose Display DAP value Area Product appears on the unit control panel User s Manual 202044 43 5 System Settings Retrieve last image Quality assurance SCANORA 3D Retrieve last image If the image is not transferred to the PC or there is a problem with the PC or the PC unit connection this function can be used to retrieve the last image from the unit memory CAUTION If the unit is switched off the last image taken will be lost WARNING Before retrieving the last image MAKE SURE that the patient where the image must be stored is open If a different patient is open the retrieved im age will be stored with this the wrong patient Quality assurance oee section 6 Quality assurance Information button Displays the unit IP address and software versions M L mw Language button Displays the GUI language options Touch the language button to select the language _ you require isisa 5 2 Software settings Refer to the User s manuals supplied with the soft ware User s Manual 202044 3D 6 Quality assurance 6 Quality assurance The 3D quality assurance QA procedure must be carried out at regular intervals in accordance with local and national regulations There are three steps in the 3D quality assurance procedure
47. se the temple supports so that they grip the patients head 22 The focal trough light indicates the center of the focal trough which is approximately 10 mm wide at the front Press the forwards backwards positioning keys and position the focal trough light in the middle of the patient s upper canine I I I I I I I I I I I NS _ This position is used for both panoramic and temporomandibular joint exposures 36 User s Manual 202044 3D User s Manual 202044 3 Taking an exposure 23 If necessary readjust the tilt of the patient s head until the roots of the upper and lower front inci sors are within the focal trough Note that you may have to reposition the focal trough slightly 24 IMPORTANT NOTE When you press the exposure button to take a panoramic exposure the panoramic sensor will automatically rotate to the exposure position If before taking an exposure you want to check that the sensor will not touch the patient press the Return key to drive the sensor to the expo sure position and check its position in relation to the patient For safety reasons the chair cannot be driven up when the panoramic sensor is in the expo sure position If you wish to drive the chair up you must press the Return key to drive the panoramic sensor back to the non exposure position 3 Taking an exposure 25 26 SCANORA 3D Ask the
48. sition and then press the light key to switch the patient positioning lights on again The horizontal light indicates the bottom of the panoramic field However the light can also be used to position the Frankfort plane Press the up seat height adjusting key and position the patient so that the horizontal light is approximately level with the Frankfort plane AN w User s Manual 202044 3D User s Manual 202044 18 19 3 Taking an exposure Press the head support up down keys to adjust the tilt of the patient s head until the Frankfort plane is parallel to the horizontal light Now position the patient for the exposure you wish to take lf you are taking a panoramic exposure press the seat height adjusting keys and position the patient so that the horizontal light is under the patient s chin If you are taking a temporoman dibular joint exposure position the patient so that the light is under the lower lip AN 20 Check the position of the midsagittal light If it is not on the midsagittal plane of the patient press the left right field of view positioning keys to position the light correctly lt gt 3 Taking an exposure SCANORA 3D Make sure that the patient s head is not turned or tilted to one side 21 Push the temple supports towards the patient so that they are positioned on both sides of the patient s head Carefully rotate the temple sup port knob to clo
49. st of the unit chair is in the raised position Manually rotate the rotating unit so that the detector head is at the front This will make it easier for the patient to enter the unit Ask the patient to remove or lower the armrest on the right hand side of the wheelchair Ask the patient to slide from the wheelchair onto the unit chair When the patient is in the unit chair lower the left hand chair armrest Remove the wheelchair from the unit environ After taking the exposure repeat above procedure in the reverse order to get the patient back into the wheelchair Carefully rotate the head support towards the patient until it stops Turn the head support lock ing lever to the right to lock the head support in position 3 Taking an exposure 15 SCANORA 3D Rotate the head support positioning knob to position the head support so that the patient can place their chin on the chin rest and bite the bite block or press their lips against the lip holder or lip support O 17 If you are using the lip holder or lip support ask the patient to position their front teeth so that the front edges are touching Press the light key to switch the patient position Ing lights on NOTE If the patient positioning lights do not come on the rotating unit is not in the panoramic ready position To switch the lights on press the return key to drive the unit to the panoramic ready po
50. tient is nervous or a child you can dem onstrate how the unit works to reassure them Touch the T Test button and then press and hold the exposure button The unit will complete an exposure cycle without generating x rays 3 Taking an exposure E 13 SCANORA 3D Press the Return button to drive the rotating unit to the ready position If necessary lift up the arm rests and then ask the patient to sit on the chair Make sure that the patient is sitting straight and in the middle of the chair with their back pushed against the back rest Also make sure that they are sitting in a position in which they feel comfortable If the patient is very large and cannot sit com pletely on the seat or is small and cannot sit back far enough adjust the forward backward position of the backrest with the knob at the rear of the seat Also with small patients and children use cush ions to position the patient at the right height User s Manual 202044 3D User s Manual 202044 3 Taking an exposure Wheelchair patients Adjust the height of the unit chair so that the seat is level with the wheelchair seat or as near as possible at the same level Position the patient in the wheelchair as close as possible to the left hand side of the unit chair with the patient facing forwards Ask the patient to put the wheelchair s brake on so that wheelchair cannot move Make sure that the left hand arm re
51. xamination closed before preview image s could be shown The exit button was pressed before the images could be processed The preview image s can be retrieved from the imaging software PC s driver failed for unknown reason Switch the system off and then on again If the mes sage reappears call service for help User s Manual 202044 41 4 Messages and error codes SCANORA 3D Movement the rotating unit was blocked The movement of the rotating unit was interrupted during the exposure Determine and remove the reason for the interrup tion and then take another image Panoramic detector was moved its correct position The panoramic detector was moved during an expo sure Check the image to see if it is sufficient for the diagnostic task If not take another image 4 2 Error codes If an error code appears Error xx switch the unit and PC off and then restart the unit and PC If the error message reappears call service for help 42 User s Manual 202044 3D 5 System Settings 5 System Settings 5 1 Unit Settings Opening the Settings window Touch the settings button at the bottom of the main gt window The settings window will appear J Display patient s name 4 Retrieve last D Display DAF value Quality assu The Settings Display patient s name Allows you to select whether or not the name of the atient appear
52. xposures by standing behind a suitable x ray radiation shield The user must be able to see and hear the pa tient during an exposure The user must see the radiation warning light and or hear the audio warning signal during the exposure If the unit is installed in such a place where the warning light cannot be seen a sepa rate warning light should be used Please con tact the local service for help 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 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 The annual maintenance as described in this manual is mandatory for the correct and safe operation of the unit User s Manual 202044 3D 8 Warnings and precautions 8 2 General warnings User s Manual 202044 There should be at least 10 cm clear space around the installation place of the unit The place where the unit is to be installed and the position from where the user will take expo sures must be correctly shielded from the radia tion that is generated when the unit is operated The unit or its parts must not be changed or modified in any way without approval and in structions
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