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88 

16.4.  X-RAY GENERATOR 

 

16.4.1. SPECIFICATIONS 

Generator type 

High-frequency constant potential generator 

Operating frequency 

100 kHz 

Maximum operation voltage  

85 kVp 

Heating and cooling curve  

See  Graphic on item 15.13  of this manual  

Output power 

680 W (85kV x 8mA) 

Output power during 0,1s 

680 W (85kV x 8mA) 

Total filtration 

0.01 ft Al eq. @ 85 kVp (This value takes all 
mitigating circumstances that exist from the 
emission source to the output of equipment) 

Radiation escape 

< 1.00mGy/h at 85kV / 8mA 

Equipment 

CLASS I - Type-B applied part 

 

When submitted in charge the equipment 
emits ionizing radiation. 
 

Operation mode 

Intermittent  

The X-Ray Generator is mounted by the manufacturer. 
X-Ray machine with radiologic protection according to NBR IEC 60601-1-3:2001.   
X-Ray generator  Eagle 3D NBR IEC 60601-2-7:1998  
X-Radiation-emitting set EAGLE 3D NBR IEC 60601-2-28:2001  
Radiological equipment associated EAGLE 3D NBRIEC60601-2-32:2001 

 

16.4.2. CHARACTERIZATION 

 

 

 
 

 

Содержание EAGLE 3D

Страница 1: ......

Страница 2: ...R EQUIPMENT USE OPERATION 10 3 7 PRECAUTIONS TO REDUCE ENVIRONMENTAL IMPACT 11 3 8 PRECAUTION IN CASE OF ABNORMAL EQUIPMENT FUNCTION 11 4 COMPUTERIZED TOMOGRAPHY SYSTEM OVERVIEW 12 4 1 DIGITAL PAN CBC...

Страница 3: ...TIENT 51 10 3 TAKING A CEPHALOMETRIC EXPOSURE 51 10 4 SETTINGS AND DOSE INFORMATION 53 11 TOMOGRAPHY 55 11 1 GETTING THE SOFTWARE READY 55 11 2 POSITIONING THE PATIENT 56 11 3 TAKING A TOMOGRAPHIC EXP...

Страница 4: ...ARRANTY 85 16 TECHNICAL SPECIFICATIONS 86 16 1 REGULATORY INFORMATION 86 16 2 GENERAL INFORMATION 86 16 3 RADIOLOGICAL INFORMATION 87 16 4 X RAY GENERATOR 88 16 4 1 SPECIFICATIONS 88 16 4 2 CHARACTERI...

Страница 5: ...ement Only personnel authorized by Alliage are qualified to install and service this equipment Any attempt to install or service this equipment by anyone not so authorized will void the warranty It is...

Страница 6: ...ioritizes image layer width constant vertical magnification and homogeneous exposure along the whole image Likewise the low dosage profile prioritizes the reduction of dosage time and anodic current T...

Страница 7: ...t walk or stand here Electrostatic Sensitive Devices ESD Recyclable Manufacturer Type B applied part Indicates that the product should be taken to a special waste disposal site at the end of its life...

Страница 8: ...from the main switch On power connect to the main switch Caution Emission of ionizing radiation General warning Warning High voltage Warning Crushing of hands Warning Ionizing radiation Warning Laser...

Страница 9: ...and storage 0 C to 55 C 32 F to 131 F Transportation and storage relative humidity range 30 to 75 non condensing Atmospheric pressure range 700 hPa to 1060 hPa 525 mmHg to 795 mmHg 3 3 OPERATIONAL EN...

Страница 10: ...do so may damage the equipment The equipment must be properly grounded Failure to do so may result in Safety Hazard Depending on local regulation the X Ray emission control may require installation ou...

Страница 11: ...R SHALL NOT BE LIABLE IN CASE THE X RAY MACHINE IS USED FOR PURPOSES OTHER THAN THOSE FOR WHICH IT HAS BEEN DESIGNED DAMAGE CAUSED TO THE EQUIPMENT THE OPERATOR AND OR PATIENT AS A RESULT OF IMPROPER...

Страница 12: ...covers and other consumables should follow the normal procedure for biomedical waste Biomedical waste shall include non acute materials which may cause diseases or suspicions of sheltering pathogenic...

Страница 13: ...AN CBCT CONFIGURATION The following image shows the whole system without optional Ceph arm mounted Control Panel Patient Handles X Ray Tube Head Rotating Arm Moving Mechanism Base optional Pan Sensor...

Страница 14: ...the whole system with optional Ceph arm mounted Control Panel Patient Handles X Ray Tube Head Rotating Arm Moving Mechanism Base optional CBCT Sensor Holder Head Support Ear Rods Column Cephalostat Ce...

Страница 15: ...optional Ceph arm mounted THE SECOND SENSOR IS OPTIONAL Control Panel Patient Handles Cephalostat Optional SNAP ON Sensor X Ray Tube Head Rotating Arm Moving Mechanism Base optional SNAP ON Sensor Ho...

Страница 16: ...ATION The following image shows the whole system No optional ceph arm is available in this configuration Control Panel Patient Handles SNAP ON Sensor X Ray Tube Head Rotating Arm Moving Mechanism Base...

Страница 17: ...hich are 100 recyclable materials DIMENSIONS Main unit 1896 x 682 x 1315mm gross approximately 240 Kg Cephalostat 1654 x 774 x 445 mm gross approximately 56 Kg Base 1162 x 1012 x 231 mm gross approxim...

Страница 18: ...ly Unit options that can be used in all configurations Standard Slim Order on request 4 7 FREE STANDING BASE OPTIONAL The following image shows the optional Free Standing Base The equipment will be fi...

Страница 19: ...ACCESSORIES 1 Bite Guide 2 Silicon chin rest cover 3 Chin rest for CT 4 Chin rest for patient with teeth 5 TMJ and Sinus nose support 6 Chin rest for patient without teeth 7 Head Holder acrylic bars...

Страница 20: ...rpus Support ALL PARTS ACCESSORIES AND OPTIONS DESCRIBED IN THIS OWNER S MANUAL ARE FOR EXCLUSIVE USE USE OF ANY PARTS ACCESSORIES OR MATERIAL NOT SPECIFIED OR PROVIDED IN THIS OWNER S MANUAL IS USER...

Страница 21: ...cated Video Card NVIDIA GEFORCE GTX 1060 6GB or higher Power Supply 400 RMS with supplementary power connectors PCI express compatible with video plate Monitor 21 5 Resolution 1920x1080 or higher AN E...

Страница 22: ...on on the connection DESKTOP Intel Gigabit CT and visit the properties 3 Go to Settings Advanced tab and search for item Receive Buffer 4 Initially this setting is disabled Change the value to 2048 an...

Страница 23: ...ll items 10 Select Internet Protocol TCP IP Version Proprieties 11 Define the IP address 192 168 5 10 and Subnet Mask 255 255 255 0 5 3 SOFTWARE INSTALLATION Insert the accompanying media and execute...

Страница 24: ...23 1 Select the language 2 Press NEXT 3 Read carefully the EULA and if you agree select I accept the agreement and press NEXT 4 Click on the Checkbox if you want create a desktop icon and Press NEXT...

Страница 25: ...24 5 Press INSTALL to start the installation 6 The software will install all required software please wait until if finish...

Страница 26: ...25 7 Press FINISH to close the setup 8 After installation access Windows Start Menu All Programs Dental Imaging Software Dental Imaging Software The main software window should display as follows...

Страница 27: ...HE SOFTWARE USER MANUAL WILL BE AVAILABLE WITH TECHNICAL CHARACTERISTICS AND GUIDELINES ON THE SOFTWARE OPERATION IN THE ACT OF PURCHASE YOU WILL RECEIVE A SOFTWARE MANUAL WHERE TO FIND ALL INFORMATIO...

Страница 28: ...vertical magnification of the dental arch region optimal layer width and prioritizes homogeneous exposure during the entire imaging P2 Temporomandibular Joint This double exposure fits the condyle in...

Страница 29: ...ent will receive less exposure so as a result the overall image quality is decreased P6 Child Panoramic This exposure has a 15 size reduction with respect to the standard panoramic profile P17 Bitewin...

Страница 30: ...cute the following images PA Posterior Anterior AP Anterior Posterior 45 Degrees Lateral Carpal With this profile it is possible to adjust the exposure time from 0 1 to 3 0 seconds in 0 1 step increme...

Страница 31: ...select the interesting region and get 3D image and tomography cuts Fast Scout With this profile it is possible to make a fast lateral image to position the patient before the tomography image Full Sc...

Страница 32: ...screen FUNCTION DESCRIPTION EXPLANATION INFO LINE Displays current status of the machine Select X ray Equipment is not ready to expose x rays If exposure switch is pressed the equipment will operate i...

Страница 33: ...patient biotype SMALL MEDIUM LARGE to pre select the kV Please be aware that the values of kV indicated are for reference only Size not selected Small patient selected Medium patient selected Large p...

Страница 34: ...GE LAYER POSITION This function allows the user to adjust the image layer towards the back or front of the dental arch in panoramic profiles The adjustment is made using the following keys moves layer...

Страница 35: ...main screen for CBCT mode is shown below Swap the functions by touching the screen CHIN REST ADJUST KV FOV SELECTION INFO COLUMN ADJUST EXAM SELECTION LASER RESTART POSITION mA EXPOSURE TIME FOV ADJUS...

Страница 36: ...nter reaches zero FOV Displays the selected FOV Example of FOV selection 8x8 kV Display the selected kV The value of kV is 85kV If the kV is left unchanged the equipment will be in demonstration mode...

Страница 37: ...position canine and radiography type Laser key Used to turn on off positioning lasers Mid Sagittal Frankfurt and Image layer Position Canine Key Up Used to increase the column height The equipment has...

Страница 38: ...Image layer Position Canine Key Up Used to increase the column height The equipment has a soft start system that ramps up the column for 5 seconds until it reaches its cruise speed The system stops a...

Страница 39: ...posure switch installed outside of the radiation exposure room is available upon request or as required by state or country The remote exposure switch is a dead man like switch and illuminates during...

Страница 40: ...NNOT BE DONE BY THE USER BEFORE TURNING ON THE UNIT MAKE SURE THE UNIT IS CONNECTED TO THE CORRECT VOLTAGE To turn on or off the unit use the on off switch on the base of the equipment When the main s...

Страница 41: ...n that the diagnostic yield will affect patient care The dentist must weigh the benefits of obtaining radiographs against the patient s risk of radiation exposure Because the effects of radiation expo...

Страница 42: ...mal surfaces cannot be examined visually or with a probe Posterior bitewing exam at 6 18 month intervals Not applicable Recall Patient with no clinical caries and not at increased risk for caries Post...

Страница 43: ...3 Familial history of dental anomalies 4 Postoperative evaluation of healing 5 Remineralization monitoring 6 Presence of implants previous implant related pathosis or evaluation for implant placement...

Страница 44: ...mber 20Center FIles Dental_Radiographic_Examinations _2012 ashx Accessed November 2 2015 2 The American Academy of Pediatric Dentistry Guideline on Prescribing Dental Radiographs for Infants Children...

Страница 45: ...ith teeth Chin rest for patient without teeth Chin rest for Sinus and TMJ The first one is used for a patient with teeth and it has three parts bite guide chin rest and a silicon chinrest cover The se...

Страница 46: ...rdance with the patient characteristics 9 1 GETTING THE SOFTWARE READY Open the Imaging software and make sure the green light is on before start Press New Pan A form screen will be shown Fill out the...

Страница 47: ...cific chin rest that doesn t have a bite guide Ask patient to lean his her chin against it Press the laser key to operate the patient positioning laser lights in order to assist with proper patient po...

Страница 48: ...nus and TMJ profiles you need to use a specific chin rest This chin rest has a nose support and the patient needs to lean his her nose against it 9 3 TAKING A PANORAMIC EXPOSURE When Ready to Expose i...

Страница 49: ...ou may guide the patient out of the machine MAINTAIN AUDIAL AND VISUAL CONTACT WITH THE PATIENT AND UNIT DURING THE WHOLE EXPOSURE PROCESS IF THE EXPOSURE OR MOVEMENT STOPS DURING THE PROCESS DUE TO A...

Страница 50: ...Children Adult Small Medium Large Small Medium Large 65 kV 70 kV 75 kV 70 kV 75 kV 80 kV Standard Panoramic 14 8 49 6 56 4 63 4 56 4 63 4 70 7 TMJ 10 8 35 4 40 3 45 3 40 3 45 3 50 5 Sinus 8 8 28 3 32...

Страница 51: ...will produce a cephalometric exposure as selected PA Waters PA AP Lateral Basal Hirtz axial 45 degrees Carpal BEFORE START OPEN THE HEAD POSITIONER AND REMOVE THE CHIN REST AND BITE GUIDE FROM THE PA...

Страница 52: ...tically switch off after a period of time or if the exposure button has been pressed If the laser diodes turn off during patient positioning press the light key again Use the laser to position the Fra...

Страница 53: ...e the exposure switch Upon completion of the exposure the arm will rotate to the patient exit position At this point you may guide the patient out of the machine The machine will enter a cool down pro...

Страница 54: ...38 1 0 7 8 27 1 31 2 35 5 44 4 39 9 44 5 0 8 8 31 0 35 7 40 6 50 8 45 6 50 9 0 9 8 34 9 40 2 45 6 57 1 51 3 57 2 1 0 8 38 7 44 6 50 7 63 4 57 0 63 6 1 1 8 42 6 49 1 55 8 69 8 62 7 69 9 1 2 8 46 5 53 5...

Страница 55: ...16 5 8 27 3 28 8 30 4 30 4 32 0 33 6 10 0 8 16 5 17 5 18 4 18 4 19 4 20 4 Digital Ceph Low Dosage 11 0 8 18 2 19 2 20 3 20 3 21 3 22 4 6 6 8 10 9 11 5 12 2 12 2 12 8 13 5 Due to measurement errors an...

Страница 56: ...cedure will produce tomographic images To do this use the chin rest support and head support Chin rest for tomography exposure 11 1 GETTING THE SOFTWARE READY Open the Imaging software and make sure t...

Страница 57: ...NG THE PATIENT Guide the patient to the unit in front of the chin rest If necessary adjust the height of the unit using the Up and Down keys of the display For this procedure is necessary use a head h...

Страница 58: ...hin rest Adjust the height of the head holder and secure firmly using the tape Make sure that the patient is immobilized If you selected the scout image the machine will make snapshots and show the po...

Страница 59: ...E PROCESS IN DIGITAL CBCT THIS IS ESPECIALLY IMPORTANT SINCE THE MECHANISM IS AUTOMATIC IF THE PATIENT BEHAVES UNEXPECTEDLY STOP THE EXPOSURE AT ONCE Press and hold down the exposure button The rotati...

Страница 60: ...ultiplied by the area irradiated Please use these factory programmed parameters as a reference only If necessary change the values according to your needs Dose Area Product mGy cm 85 kV 4 mA FOV 5x5 6...

Страница 61: ...0 5 25 5 32 0 16 5 20 5 25 5 32 0 16 5 20 5 25 5 32 0 DAP mGy cm 776 8 965 1 n a n a 1258 0 1562 9 n a n a 1486 1 1846 4 n a n a Due to measurement errors and variation of equipment consider a toleran...

Страница 62: ...ducts is not recommended as it may damage the equipment DO NOT USE ORGANIC SOLVENTS SUCH AS THINNER TO CLEAN THE EQUIPMENT IN CASE THE DEVELOPING SOLUTION IS SPILLED ON THE PANEL CLEAN IT IMMEDIATELY...

Страница 63: ...ged from wall socket Plug it into the wall socket Unit circuit breaker turned off Turn on unit circuit breaker Main ON OFF switch turned off Turn on main ON OFF switch Blown fuse Replace the fuse Digi...

Страница 64: ...amplified on one side and narrower on the other Head tilted patient Patient position to tune in relation to the median sagittal plane Check the position of the sagittal plane of the patient with the l...

Страница 65: ...Head turned to the right Head turned to the left Symptom Possible Cause Action required Incisors and canines narrow and unsharp Position of the arch is anterior of the focal plane Adjust the focal pla...

Страница 66: ...ng the Canine red laser on the tooth Canine tooth Symptom Possible Cause Action required A row of teeth is bent upwards The lower incisors are deformed TMJ joints are very high and are often cut off f...

Страница 67: ...Frankfurt plane laser Symptom Possible Cause Action required Central area of the image is very clear and deformed Shadow of the column Patient neck is not stretched Ask the patient to take a step forw...

Страница 68: ...lane by positioning the Canine red laser on Canine tooth Anterior teeth ahead of the focal plane Anterior teeth behind the focal plane Anterior teeth ahead of the focal plane Symptom Possible Cause Ac...

Страница 69: ...e equipment You cannot see the bottom edge of the jaw in the cortical cross sectional images The inclination of the patient s head is not correct Reposition the patient Patient without teeth molar pre...

Страница 70: ...will create a baseline performance data Make a periodic evaluation and compare with the baseline data If degradation in image quality or a change in QA values is noticed contact the Alliage Service De...

Страница 71: ...QA phantoms contain two sections design to measurement of all parameters with a single scan The projection image of the phantom with these sections is showed below 14 1 INITIAL PROCEDURE Open the Ima...

Страница 72: ...ation required and select the desired diagnosis to be performed You can select more than one diagnosis Press Start to start the procedures After finish press Report to generate a QA Report THE SOFTWAR...

Страница 73: ...M POSITION The software will indicate that the beam position will be checked Remove the chin rest support When it s ready press OK the software will start a 9 second countdown During the countdown tak...

Страница 74: ...ress OK the software will start a 150 second countdown During the countdown take an exposure The software will measure in the image the geometric distance between all spheres rotation and geometric fo...

Страница 75: ...on Test Phantom as shown below Resolution Test Phantom When it s ready press OK the software will start a 150 second countdown During the countdown take an exposure The software will display the follo...

Страница 76: ...ond countdown During the countdown take an exposure The following screen will be show 14 3 2 CALIBRATION The software will indicate that the calibration will be checked Rotate the cephalostat and lock...

Страница 77: ...will indicate that the maximum contrast resolution will be checked Remove the chin rest support open the head holder Rotate the cephalostat to lock at PA AP position and open the ear rods Place the Re...

Страница 78: ...ast Resolution Verify if the lines of the contrast element are visible 14 4 QA DIAGNOSIS FOR TOMOGRAPHY 14 4 1 PREPARING X RAY UNIT This procedure will produce tomographic images It will be necessary...

Страница 79: ...FOV QA phantom on chin rest support and level it Fill the water cavity of the density phantom Repeat the procedure above 14 4 2 CONTRAST SCALE CT numbers also called HU Hounsfield Units represent the...

Страница 80: ...lculation of the uniformity and using same flat field image slice the software evaluates the noise power spectrum NPS The NPS is defined as 2 where Nx and Ny are the number of pixels and x and y are t...

Страница 81: ...atially sampled capture devices For this evaluation the software will use the Section A area For the high contrast it will be used the conical through hole with air The air and acrylic will create a b...

Страница 82: ...ith the same size of these ROIs is set to 3 29 times the standard deviation to be distinguished from the background This analysis is repeated with different ROIs sizes and a contrast detail diagram is...

Страница 83: ...82 14 6 QA REPORT After diagnosis the software will create a QA report that can be saved to compare the results to previous or optimum values An example of this report is shown below...

Страница 84: ...ponents subject to normal wear and tear should be checked and if necessary replaced The manufacturer and the assembler installer are relieved from responsibility in those cases where noncompliance wit...

Страница 85: ...rmance a preventive maintenance in a maximum period of three 3 years Please contact Alliage Service Department about our periodic review and preventative maintenance program 15 4 CORRECTIVE MAINTENANC...

Страница 86: ...or its distributors are not responsible for improper disposal by the buyer 15 6 WARRANTY The Warranty Certificate should be completed by the Authorized Technical Alliage and one copy must be left wit...

Страница 87: ...equipment without protection against water penetration Application safety level in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Unsuitable equipment Operation mode O...

Страница 88: ...exposure 15 x 30 cm Mean magnification 1 1 22 Source to Image Distance SID 1 85 ft Information Specific for Cephalometric Profiles Analog cephalometric exposure time current 0 1 to 3s 8mA Complete dig...

Страница 89: ...ng circumstances that exist from the emission source to the output of equipment Radiation escape 1 00mGy h at 85kV 8mA Equipment CLASS I Type B applied part When submitted in charge the equipment emit...

Страница 90: ...A rectified by half or whole wave and 20mA constant potential Maximum filament current 3 5A 4 2V Frequency DC Maximum exposure time 20s Max anodic power 680kW Maximum continuous thermal dissipation 2...

Страница 91: ...90 16 5 1 TUBE CHARACTERIZATION...

Страница 92: ...ith reference axis 5 Reference axis angle between the target and the focal point of the x ray generator mounted measurements of x ray generator mounted 318mm x 440mm x 212mm weight of X ray generator...

Страница 93: ...92...

Страница 94: ...93...

Страница 95: ...94 16 6 MAXIMUM SYMMETRICAL RADIATION FIELD 16 6 1 ANALOG AND DIGITAL PANORAMIC EXAM PAN ADULT AND CHILD TMJ MAXILLARY SINUS 16 6 2 DIGITAL CEPH EXAM...

Страница 96: ...95 16 6 3 ANALOG CEPH LATERAL EXAM 16 6 4 ANALOG CEPH FRONTAL EXAM 16 6 5 TOMOGRAPHIC EXAM...

Страница 97: ...96...

Страница 98: ...95 IEC 61000 4 5 1995 IEC 61000 4 6 1996 IEC 61000 4 11 1996 IEC series 60601 1 Medical Electrical Equipment Part 1 General requirements for safety EN 980 2003 Ed 2 Graphical symbols for use in the la...

Страница 99: ...in electromagnetic environments according to the specifications below The client or X Ray Machine operator must ensure that the equipment is used in such type of environment Immunity Assays ABNT NBR I...

Страница 100: ...lectromagnetic environments according to the specifications below The client or X Ray Machine operator must ensure that the equipment is used in such type of environment Immunity Assays IEC 60601 Assa...

Страница 101: ...uency range of 150 kHz to 80 MHz Recommended separation distances between portable and mobile RF communication equipment and the EAGLE 3D CT Scanner The EAGLE 3D CT Scanner has been designed for use i...

Страница 102: ...PERFORM THE PATIENT SHOULD ALSO BE TOLD NOT TO MOVE DURING THE EXPOSURE IT IS THE RESPONSIBILITY OF THE OPERATOR TO WATCH THE PATIENT AND INTERRUPT THE EXPOSURE IN SUCH EVENTS IMPORTANT THE STRENGTH...

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