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Содержание EAGLE 3D

Страница 1: ...US Mod SER del Eag S MA gle 3D ANUA AL...

Страница 2: ...1 THIS PAGE WAS INTENTIONALLY LEFT BLANK...

Страница 3: ...UIPMENT USE 10 3 6 3 WARNING AND OR CAUTION AFTER EQUIPMENT USE OPERATION 11 3 7 CAUTION IN CASE OF ABNORMAL EQUIPMENT FUNCTION 12 4 COMPUTERIZED TOMOGRAPHY SYSTEM OVERVIEW 13 4 1 DIGITAL PAN CBCT CON...

Страница 4: ...AND DOSE INFORMATION 50 10 CEPHALOMETRIC EXPOSURE 51 10 1 GETTING THE SOFTWARE READY 51 10 2 POSITIONING THE PATIENT 52 10 3 TAKING A CEPHALOMETRIC EXPOSURE 53 10 4 SETTINGS AND DOSE INFORMATION 54 11...

Страница 5: ...E MAINTENANCE 86 16 DISPOSAL OF THE UNIT 87 16 1 ENVIRONMENTAL CONTAMINATION 87 17 TECHNICAL SPECIFICATIONS 88 17 1 REGULATORY INFORMATION 88 17 2 GENERAL INFORMATION 88 17 3 RADIOLOGICAL INFORMATION...

Страница 6: ...5 17 9 ELECTROMAGNETIC IMMUNITY 100 18 IDENTIFICATION LABELS 104 18 1 PACKAGE 104 18 2 PRODUCT 105 19 EQUIPMENT DIMENSIONS 106 20 WARRANTY 107...

Страница 7: ...e 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 imperative that this equipment be installed...

Страница 8: ...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 9: ...t the equipment st any type of tion and storage p ackaging side hat it must be arrow pointing u piling ackaging side e maximum nu n be piled up d storage e limit ackaging side the temperatu the packa...

Страница 10: ...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 11: ...o may result in Safety Hazard Depending on local regulation the X Ray emission control may require installation outside the facility where the equipment is placed and the operator may need visual cont...

Страница 12: ...LL NOT HINE IS USE CH IT HAS B D TO THE E T AS A RES CE PROCE INSTRUCT PMENT OPE ON AFTER hine s mast ent clean for ective do n stance ipment part y achine must imilar devic nt clean and ause dama rem...

Страница 13: ...or any other type of abnormality check if the problem is related to any of the items listed in this manual If the problem cannot be solved turn off the equipment and call for Authorized Technical Assi...

Страница 14: ...ol Panel Handles y Tube Head Mov Mecha ED TOMO CT CONF hows the wh ing anism 13 OGRAP IGURATIO hole system PHY SYS ON without opt H STEM O tional Ceph Rotatin Pan S Sensor Head Holder Column C Se OVER...

Страница 15: ...nism L PAN CB ng image sh CT CEPH hows the wh 14 CONFIGU hole system CBC H Head Sup URATION with option Rotatin Base o CT Sensor Holder pport Column Pan S Hol nal Ceph arm ng Arm optional Second Colli...

Страница 16: ...SNAP O owing image HE SECON ON CONFIG e shows the D SENSOR H 15 GURATION whole syste R IS OPTION SNAP ON Ceph Head Support N em with opt NAL N Sensor halostat Arm tional Ceph Cep Base op Seconda Colli...

Страница 17: ...l P Pa X Ray Tu Head R M L FIXED C owing image n Panel tient Handles ube Rotating Arm Moving Mechanism CONFIGUR e shows the 16 RATION e whole syst tem No opt H tional ceph SNAP ON ead Support arm is a...

Страница 18: ...g Mechanism 5 ANALO The follo dles rm m G CONFIG owing image GURATION e shows the 17 N whole syste Film C Head Suppo em with opt m Holder Cephalostat Ar ort tional Ceph Base rm C arm mounte Cephalosta...

Страница 19: ...he equipme llation R SUPPLY ng image sh Standard TANDING ng image sho ent will be UNIT OPT hows the P BASE O ows the opt fixed to the 18 TIONS Power Supp PTIONAL ional Free S e base and ply Unit op St...

Страница 20: ...RIES 1 Bite G 2 Silicon 3 Chin re 4 Chin re 5 TMJ an 6 Chin re 7 Head H 8 Head H 19 Guide n chin rest c est for CT est for patie nd Sinus no est for patie Holder acryl Holder cover ent with teet ose s...

Страница 21: ...I RESPONSIB 1 2 S ACCESS MANUAL AR Y PARTS DED IN T BILITY 20 Nose Sup Carpus Su SORIES A RE FOR EX ACCESSO THIS OWN pport upport AND OPTIO XCLUSIVE U ORIES OR M NER S MA ONS DESC USE MATERIAL ANUAL I...

Страница 22: ...work ca stem automa s Contro 21 CATIONS puter system mended Com ows 7 Profes ows 8 Profes ows 8 1 Prof ows 10 Profe Core i7 r higher B xpress PCI it Ethernet d IA GEFORC MS with sup ctors PCI ex plate...

Страница 23: ...nt the compute ard follow t Network button on th Advanced ing is disabl Advanced ing is disabl Advanced 22 installed If er the procedu Internet and he connectio tab and sea led Change tab and sea led...

Страница 24: ...ect Internet P fine the IP ad ting is disab Power Man Protocol TC ddress 192 1 23 bled Chang nagement ta CP IP Versio 168 5 10 an ge the value ab and unch on Propr nd Subnet M e to 9014 by heck all i...

Страница 25: ...ay 1 Selec 2 Press 3 Read press NEXT WARE INST e accompan yed ct the langua NEXT carefully th T TALLATIO nying media age he EULA an 24 N a and execu nd if you agr ute the Setu ree select up exe The I...

Страница 26: ...ess 6 The so k on the Che INSTALL t oftware will eckbox if yo to start the i install all re 25 ou want crea installation equired soft ate a desktop tware pleas p icon and P se wait until Press NEXT l...

Страница 27: ...s 8 After ware Dental FINISH to installation l Imaging S close the se access Wi Software Th 26 etup indows Star he main soft rt Menu A tware windo All Programs ow should d s Dental Im display as fo ma...

Страница 28: ...NUAL W EATURES VERSION E WITH TEC FTWARE O CT OF PU WHERE TO 27 OF THE S CHNICAL C OPERATION RCHASE Y O FIND AL SOFTWARE CHARACTE N YOU WILL LL INFORM E USER MA ERISTICS A L RECEIVE MATION A ANUAL WI...

Страница 29: ...c This exposure has constant vertical magnification of the dental arch region optimal layer width and prioritizes homogeneous exposure during the entire imaging P2 Temporomandibular Joint This double...

Страница 30: ...on and lower dosage The patient 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 p...

Страница 31: ...am to b hogonal in dental arch Descrip Cephalom this profile xecute the s PA Po Anteri AP An Posteri 45 De Latera Carpal this profile i ust the expo 0 1 to 3 0 se ncrements al Cephalo this profile xe...

Страница 32: ...Program Description Tomography With this profile it is possible to select the interesting region and get 3D image and tomography cuts Fast Scout With this profile it is possible to make a fast lateral...

Страница 33: ...IN RE ADJUST y with six bu help the use mode is show e Selec Equipme rays If ex equipmen demonstr exposure Read Equipme Cooli Equipme counter r EST T FOC uttons and er operate th wn below S EXPLAN t X...

Страница 34: ...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 35: ...ge laye or front of t anoramic pr stment is m wing keys moves lay ack of denta moves lay owards fron rch ge and text i profile ction allows e equipment speeding up tion 34 s not user e indicated ge ro...

Страница 36: ...ELEC mA MODE The main creen TION CTION E n screen for EXP TIM r CBCT mo POSURE E 35 ode is shown CHIN RE ADJUST n below Sw EST T FO wap the fun OV ADJUST ctions by to T ouching INFO COLU ADJU LASER R...

Страница 37: ...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 38: ...osure t e small me ween adjust analog ce positioning ne column he lumn for 5 s tically when e column he lumn for 5 s tically when unctions on t time for a medium and age time for an edium and la table...

Страница 39: ...t in rest heigh ight limit est in rest heigh ight limit positioning ne column he lumn for 5 s tically when e column he lumn for 5 s tically when of the equipm ht The syst ht The sys g lasers Mi ight...

Страница 40: ...ill URE SWIT tch installed by state or c switch is a exposure sw connected to W 39 TING LIGH ng er of the sym also sound TCH OPTI d outside of country a dead man witch to wor o the equipm Wall remote...

Страница 41: ...HE it use the on tch is turned g screen wil configured ion and afte er can be h 40 EXPOS equired for e uired before T ON FIGURED HE TECHN ANNOT BE D ON THE CORRECT n off switch d on the ma ll be shown...

Страница 42: ...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 43: ...urfaces 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 Posterior...

Страница 44: ...ed sinus ormalities ment in kno e rologic find ent as to need RECOMMEN NT AND MA DENTIST S E AS LO THE PATIE hich radiogr dings ndodontic tr a l anomalies of healing ring vious impla Symptoms odontal...

Страница 45: ...Center 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 Adolesce...

Страница 46: ...cover The rt and a pla eth for only ted chin res Please see th 45 RES pts describe l size pano posed area w to use a ch below t for patient ent with teet second is u astic chin re y the Sinus a t int...

Страница 47: ...Pan en will be sh orm with the are will sta he patient c panoramic p t exposure TWARE RE are and mak hown e patient inf art a 150 s 46 completely o rofile from e paramete EADY ke sure the g formation...

Страница 48: ...g ut teeth use chin against to operate t ing The las button has b ning press ition the M he Frankfurt 47 nt of the ch f the contro to step forw ges of the m the specific it the patient p ser diodes w...

Страница 49: ...profiles you t needs to le AMIC EXPO se is show e their lips uth breathe a without lo 48 yer position een ON THE E E POWER VOID INTE E LASER B u need to us ean his her n OSURE wn on the d on the bite...

Страница 50: ...E S a cool down he machine e exposure 49 e button T h the exposu nce of x ray n like switch ation has co the arm wi ut of the ma ND VISUAL HOLE EXPO OPS DUR RELEASE E MACHINE m will rotate S A DOUB ON...

Страница 51: ...tory prog ge as well a a product D ase use the he values acc Ch Small M 65 kV 49 6 35 4 28 3 49 6 30 3 26 8 26 9 26 9 ion of equip FROM UNIT THUS AB grammed pa as the Dose DAP meter se factory p cordi...

Страница 52: ...z a 5 degrees Carpal BEFORE ST CHIN REST NG THE SO aging softwa Ceph en will be sh ETRIC E ionally use n needed duce a ceph axial TART OPE AND BITE OFTWARE are and mak hown 51 EXPOSU procedures alomet...

Страница 53: ...the pati he laser dio tton has bee key again n the Frankfu RS USED G THAT TH ACTICE AV YES TO TH 52 formation se ure The soft e NT nt of the cep control pane hold still w esired posit OR 45 DEGR pati...

Страница 54: ...witch e exposure he patient ou a cool down he machine e exposure 53 RIC EXPOS wn on the osing direct E CONTAC HANDS D S IS ESP AUTOMATIC P THE EXP button The ring this pe n like switch ation has co t...

Страница 55: ...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 56: ...55 Ch Small M 75 kV 7 27 3 16 5 18 2 10 9 ion of equip FROM UNIT THUS AB Dose Area P ildren Medium La 77 5 kV 80 28 8 3 17 5 1 19 2 2 11 5 1 pment cons T TO UNIT BOVE VAL Product mGy arge Small 0 kV 8...

Страница 57: ...GETTING T aging softwa D If you w en will be sh HY ionally use n needed duce tomogr rest support Chin rest f THE SOFTW are and mak ould like m hown 56 procedures raphic imag and head su for tomograp...

Страница 58: ...ference he patient in sition of the area selected E PATIEN e unit in fron own keys of ecessary use pter into the to usage of 57 nformation e FOV and p NT nt of the ch f the display e a head hol e hole...

Страница 59: ...he sc Use these im r he patient fu est his chin ing the tape cout image mages to po 58 ully open he against the Make sure the machin sition with p ead position e chin rest e that the pat ne will make...

Страница 60: ...OTH BCT THIS M IS A EDLY STOP he exposure posure Dur f x rays 59 ct If necess C EXPOSU wn on the osing direct E CONTAC HANDS D S IS ESP AUTOMATIC P THE EXP button The ring this pe sary adjust i RE dis...

Страница 61: ...duct DAP for the parameter combinations The dose area product DAP meter is a measure of dose in Gray multiplied by the area irradiated Please use these factory programmed parameters as a reference onl...

Страница 62: ...and variati ES VARY F OUTPUT ES 61 Dose Ar LD ST 16 5 20 1258 0 156 ion of equip FROM UNIT THUS AB rea Product m 85 kV 8 mA 6x8 TD HD 0 5 25 5 62 9 n a pment cons T TO UNIT BOVE VAL mGy cm A UHD 32 0...

Страница 63: ...G WA T AS IT CO NING DO N ORGANIC TS SUCH A 62 R REUSE ct clean the support sili is cloth produc ffect flotato on flammab ducts is not NIC SOLVEN CASE THE AN IT IMME contaminati THE MA E PROCEDU ATER...

Страница 64: ...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 65: ...mage i t positioning P re nd Head til Patient relation sagittal Hea He 64 ROBLEM1 is showed b g may gener Possible Cau lted patient position to to the plane ad tilted to the ad tilted to th below rate...

Страница 66: ...e Cau ient s head r position for n relation to d turned to th ad turned to t Possible Cau n of the r of the foca use rotated r posterior o the focal he right the left use arch is l plane Acti Check th...

Страница 67: ...re often cu age P Position posterio P nt rs re ut Patient s forward 66 Possible Cau n of the or of the foc Possible Cau s head d use arch is al plane use is tilted Acti Adjust the equipment the Canine...

Страница 68: ...Patient n Contras setting software 67 Possible Cau s head is tilt Possible Cau neck is not t and b is inco e use ted back use stretched brightness orrect in Acti Reposition relying o plane laser Acti...

Страница 69: ...in is chin res 68 Possible Cau r teeth be ane r teeth ahe ane eeth behind th eth ahead of t Possible Cau not leanin st use ehind the ead of the he focal plane the focal plan use ng against Acti Adjust...

Страница 70: ...ar in the mo ient wasn t y The patie n is oblique ayer was not aga f of palate did not re rtifacts use for the the t correct for the the t correct th molar olar plate placed ent s to the ainst emove t...

Страница 71: ...g Refer SSURAN ionally use n needed e quality of e 21CFR 10 ere designed or after a tion and com quality or a be validatin on The QA noramic equest e validating patial Resol etectability rmity rence M...

Страница 72: ...m for Sm d Order on r phantoms c an The proje PROCED aging softwa s QA Dia w below all FOV equest ontain two s ection imag URE are and mak agnosis 71 sections des ge of the pha ke sure the g QA Ph sig...

Страница 73: ...elect m press Repo THE SOFTW THE LAST be opened e informatio more than on rt to genera WARE WI DIAGNOS 72 on required ne diagnosis te a QA Rep ILL INDIC SIS PERFO d and select s Press Star port CATE T...

Страница 74: ...in fy if the bea GNOSIS F ure will pro POSITION re will indic e chin rest su eady press an exposure ng screen w am is visible FOR PANO oduce panor ate that the upport OK the so e will be show e in the...

Страница 75: ...ea metric form ate that the for Panoram QA OK the soft e asure in the m It will ind Calibr 74 calibration mic on chin Phantom for ftware will s image the dicate if the c ation Check f will be chec res...

Страница 76: ...ill displa e lines of the TRAST RE ate that the f the QA Ph s shown belo Re OK the soft e ay the follow Maximu e contrast el 75 ESOLUTIO maximum c hantom for P ow esolution Test ftware will s wing ima...

Страница 77: ...ing if the s FOR CEPH oduce cepha ate that the support ope he ear rods OK the so e will be show ate that the and lock at L OK the soft e The softw metal that phere is ins 76 HALOMETR alometric im beam...

Страница 78: ...n rest s and open th esolution T Calibrati TRAST RE ate that the support ope he ear rods est Phantom 77 ion Check for ESOLUTIO maximum c en the head m at carpal r Cephalomet ON contrast reso holder Ro...

Страница 79: ...ke solution Test P eady press O an exposure Phantom OK the soft e The softw Maximu 78 ftware will s ware will sho um Contrast R C start a 150 s ow a picture Resolution Carpal suppor second coun e belo...

Страница 80: ...rge FOV Q er cavity of e contrast el FOR TOMO AY UNIT oduce tomog D mode ate which p QA phantom hantom ll indicate to is ready to h the recons re six aspec mparing the r QA phantom the density 79 leme...

Страница 81: ...phantom on and the es measurem and SDs val water and a FORMITY he phantom els values w 80 Hounsfield terial densit has four ca fourth cavit ment in 5 lue of 5 mat Hounsfield v air in the ph m is an a...

Страница 82: ...to T SPATIAL Transfer Fun the contrast begins at olution equa er millimete 81 ise and Unifo formity and ctrum NPS xels and x P x y repre xel value in e deviation m sional NPS n e will use the art and...

Страница 83: ...o r is required at the tube 82 software w specifically e will use th with air The contrast software w n of the slan ansition of th d and all pix nse SFR L erivative of alculated P ABILITY LCD mea m it...

Страница 84: ...83 Access Tools Dose measurement Insert all values into the software to generate a report that can be saved to compare the results to previous or optimum values...

Страница 85: ...4 6 the re QA REP After dia esults to pre PORT agnosis the evious or op software wi timum valu 84 ill create a ues An exam QA report mple of this that can be report is sh saved to co hown below ompare...

Страница 86: ...al 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 with the standard results...

Страница 87: ...nnot be c Service Dep PEN THE TH THE AUTHOR OR PROD TY OF THE ded if origin 86 Operatio Operatio ral damages Perfo P Publicatio tem 14 re detected CE n to ensure a preventive partment ab NCE ent as in...

Страница 88: ...elow which upon completion of its useful life must be disposed of at the appropriate sites In particular the equipment contains the following materials and or components Tubehead non conductive oil le...

Страница 89: ...quency tion mption ut a cephalo a cephalosta Ray genera djustment sizes for inst SPECIF NFORMATI Alliage S A 55 16 3512 Abrao Asse Brazil CEP pe cording to F ss cording to st hock water e presence tur...

Страница 90: ...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 91: ...the gic protectio NBR IEC 60 GLE 3D NB ociated EAG ATION 90 High f 100 kH 85 kV See G 680 W 680 W 0 01 ft mitiga emiss 1 00 CLAS When emits Interm e manufactu on according 0601 2 7 19 BR IEC 6060 GLE...

Страница 92: ...tin ENTION X ray tube puted tomo 2 TUBE C TUBE ICATIONS on e y pacity and co nt nt current ure time er uous therm Toshiba D ography CHARACTE S ooling time al dissipatio D 054 mod ERIZATIO 91 TOSH D 05...

Страница 93: ...92...

Страница 94: ...14971 Medical devices application of risk management medical devices ISO 9687 1993 Dental equipment graphical symbols ISO 7494 Norma dental units ISO 13485 2 Quality systems medical devices ISO 780 P...

Страница 95: ...94...

Страница 96: ...95...

Страница 97: ...96...

Страница 98: ...7 7 MAXIMU 1 IRRADI AM PAN A 2 IRRADI UM SYMM IATED FIE ADULT AN IATED FIE ETRICAL ELD SIZE ND CHILD ELD SIZE 97 RADIATIO ANALOG D TMJ M DIGITAL ON FIELD G AND DIG MAXILLAR L CEPH EX GITAL PAN RY SINU...

Страница 99: ...17 7 17 7 3 IRRADI 4 IRRADI IATED FIE IATED FIE ELD SIZE ELD SIZE 98 ANALOG ANALOG G CEPH L G CEPH F LATERAL FRONTAL EXAM L EXAM...

Страница 100: ...17 7 5 IRRADI IATED FIE ELD SIZE 99 TOMOGR RAPHIC E EXAM...

Страница 101: ...romagnetic immunity The EAGLE 3D Computerized Tomography Machine has been designed for use in electromagnetic environments according to the specifications below The client or X Ray Machine operator mu...

Страница 102: ...C voltage prior to the application of the assay level Manufacturer s guidelines and declaration electromagnetic immunity The EAGLE 3D Computerized Tomography Machine has been designed for use in elect...

Страница 103: ...the maxim nce accordi 0 MHz 80 M MHz d 0 12 0 38 1 2 3 8 12 minal outp manufa recomm meters It is rec establi determ inspec than th frequen occur a the foll ency range n all situatio es objects a s s...

Страница 104: ...QUIP T BE FOLL OPERATIO PMENT FO RTS THE P MENTS TH ATIENT SH E EXPOSU TOR TO XPOSURE F THE M TOR OR PA CCESSORIE NENTS AN OVIDED B N INCREA IC IMMUN ers m ca requency s W ac n distance in all situat...

Страница 105: ...18 18 1 IDENT PACKA TIFICAT AGE TION LA 104 ABELS...

Страница 106: ...18 2 PRODU UCT 105...

Страница 107: ...19 Pow EQUIP wer supply u PMENT unit slim DIMENS 106 SIONS...

Страница 108: ...erve the operating and maintenance instructions Falls or knocks Improper storage Action of nature agents Installation and service performed by persons not authorized by Alliage Damage to the painted p...

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