97050543
Rev. 17
2018-12
hyperi
on
X9
EN
Page 1: ...97050543 Rev 17 2018 12 hyperion X9 EN...
Page 2: ...2 OPERATOR S MANUAL EN ITALIANO...
Page 3: ...E MACHINE 24 4 2 PUSHBUTTON PANEL ON TELE X RAY ARM 24 4 3 X RAY EMISSION REMOTE CONTROL 25 4 4 PERFORM A SIMULATION DUMMY RUN 25 5 PERFORMING A 2D X RAY EXAMINATION 26 5 1 STARTING THE SYSTEM 26 5 2...
Page 4: ...OSE INDEX MEASUREMENTS 60 10 7 CBCT DETECTOR CHARACTERISTICS 62 10 8 PANORAMIC SENSOR CHARACTERISTICS PAN 62 10 9 TELERADIOGRAPHIC CEPH SENSOR CHARACTERISTICS CEPH 62 10 10 LASER CHARACTERISTICS 62 10...
Page 5: ...The image is acquired by means of an X ray detector and a constant potential X ray source powered by a high voltage and high frequency generator Then the image is sent to a computer in real time 2D or...
Page 6: ...cludes also the optional tomography function the user must have a Personal Computer with a suitable software for capturing and saving images further information about its installation and use is inclu...
Page 7: ...ing the data in the event of damage to the hard disc of the PC or the databases themselves 1 3 REQUIREMENTS NOT PROVIDED WITH THE PRODUCT For proper functioning the device requires connection to a per...
Page 8: ...on SN Product serial number Date of manufacture month year Manufacturer Symbol Possible hazard Read the user manual Patient or operator safety related warnings Consult the enclosed documentation befor...
Page 9: ...by a technician authorised by the Manufacturer under supervision of a Qualified Expert The room where the system is installed must exclusively be for medical use and designed by an expert in protectio...
Page 10: ...tance If the operator has to remain in the exam room he she must wear a leaded apron with thyroid collar f Inform the patient about the risks associated with the exam acquire his her informed consent...
Page 11: ...device or its parts to the Manufacturer or a Technical Service centre disinfect all the external parts of the device using a specific product see the paragraph Cleaning and disinfection and preferably...
Page 12: ...ed to use the specific medium level disinfectant STER 1 PLUS CEFLA S C which is compatible with the painted surfaces plastic parts and unpainted metal surfaces Alternatively it is recommended to use p...
Page 13: ...is suitable in size and is legally marketed in Canada According to Health Canada bite block covers are Class I devices and are distributed by authorized establishments only as listed in the MDEL data...
Page 14: ...movements in the vicinity of the patient and the operator During the execution of the X rays the operator controls the movements by holding down dedicated buttons The reset procedure must be carried...
Page 15: ...ection indicated by the arrow to resume normal operation 1 8 5 CONDENSATE FORMATION Following strong temperature oscillations condensate may form in the X ray device Activate the X ray device only aft...
Page 16: ...erating normally Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased...
Page 17: ...ity test IEC 60601 1 2 Test level Level of conformity Electromagnetic Environment Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air IEC 60601 1 2 Test level Floors must be made of wood...
Page 18: ...pment with the following symbol interferences can be caused Recommended distance between the RF portable and mobile communication devices and hyperion X9 hyperion X9 is intended for use in electromagn...
Page 19: ...sed Authorised personnel must always be present outside the room until the projection is completed Pay attention not to release the emission button too soon Please note that during an exposure cycle r...
Page 20: ...diations 0 5 m 40 Gy h 1 0 m 13 Gy h 2 0 m 3 Gy h 3 0 m 1 5 Gy h 2 Standard panoramic examination leaked radiations measured at the current average usage percentage or based on 4 examinations per hour...
Page 21: ...sition The X ray device can feature a tele X ray arm fitted on the column support The arm houses a cephalostat which keeps the patient position during the exam and the image detector which translates...
Page 22: ...etector Optional standard stand Optional easy access stand Remote X ray button USB Pen Drive including Instruction Manual Drivers and Software for image display The multiple workstation hardware key a...
Page 23: ...tency tests optional Phantom for 2D quality checks optional Phantom for 3D quality checks optional 22 24 medical monitor for image displaying optional 2D or 3D image acquisition workstation optional M...
Page 24: ...ioning The control panel features 3 LED lights which indicate the state of the system If the X ray device is on the Green LED on the left is on If the X ray device is in pause mode Standby the Green L...
Page 25: ...hus avoiding subjecting the patient to a further dose of radiation In order to comply with the operator safety regulations on ionising radiation for clarifications see the paragraph on radiation safet...
Page 26: ...ATION FROM THE CONTROL CONSOLE 5 2 1 2D EXAMINATIONS AVAILABLE Panoramic examinations PAN Preview Name Description HD Scanning time 13 s High definition projection that shows the view of the entire de...
Page 27: ...ntition only with enhanced focal trough to improve root exposure Magnification 1 23 RH HALF ARCH Scanning time 6 1 s Like DENTITION limited to the right half arch only and with improved orthogonality...
Page 28: ...right joint only executes three sections at a different angle to achieve better anatomic visibility Magnification 1 50 FRONTAL L3 Scanning time 9 6 s Posteroanterior projection of the left joint only...
Page 29: ...Scans the carpus length 18 cm with the aid of a special support for the hand Magnification 1 03 5 2 2 SELECTING AN EXAMINATION The HOME screen is displayed after switch on and shows the list of favour...
Page 30: ...ed by tapping on the icon again 5 2 4 SETTING A CURRENT EXAMINATION AS FAVOURITE To set the CURRENT examination as favourite tap the icon The FAVOURITES home page will be displayed where you can inser...
Page 31: ...mic X rays you can choose between HD and QUICK PAN HD PAN QUICK The DTS function is not available for the PAN QUICK protocol DENT For the dentition examinations you can choose between STANDARD and BIT...
Page 32: ...as shown option enabled option disabled For a CEPH examination turning the cephalostat from frontal to lateral position and vice versa also determines the setting shown on the display of the control...
Page 33: ...nal image while minimising the amount of X rays received by the patient PRESET sets the parameters following the default values for man woman and child For each of the adults presets three different b...
Page 34: ...phalostat Remember to change the single use protections before positioning each new patient Before each X ray examination make sure that the patient has taken all metal objects off such as glasses rem...
Page 35: ...The sensor locking system contains both electronic parts and a mechanical lock During operation the sensor is mechanically locked and cannot be removed Do not attempt to remove the sensor if this fun...
Page 36: ...he operator Both conditions are indicated on the control console by the green LED being on or flashing if an INTERLOCK connection is open When pressing the CONFIRM button wait for a few seconds for th...
Page 37: ...e of edentulous patients in PAN DENT SIN DTS or CBCT examinations which require the bite block use the supplied disposable soft insert as follows 1 remove the soft bite from the matrix Fig 1 2 apply t...
Page 38: ...line running from the upper edge of the auditory meatus to the lower edge of the orbit Sagittal vertical trace 2 it ensures the symmetry of the patient head with respect to the sagittal midline While...
Page 39: ...ight locking position in order to centre it and lock it in place In order to remover it remember to move lever 5 to the locking position and slide it out from its seat The upper part is composed of a...
Page 40: ...er to stretch and straighten the neck 2 Make sure that the bite piece is turned sideways to leave room for the patient Fit the single use bite piece protection 3 Guide the patient towards the unit so...
Page 41: ...d extended 9 After having reached the correct positioning lock the craniostat as explained in paragraph 5 4 2 A Push the front support forward until resting it against the patient s forehead The foreh...
Page 42: ...der nose support as in the figure 4 Check the symmetry of the patient s head using the sagittal vertical trace as a guide check the correct positioning of the Frankfurt plane by overlapping the upper...
Page 43: ...but it is not strictly necessary 7 Press the CONFIRMATION button and immediately before leaving the room to press the X ray emission button ask the patient to close his her eyes and remain still 5 4 5...
Page 44: ...must stand with his or her back straight and staring at the horizon 5 Close the earpieces in such a way that they slip slightly into the auditory meatuses being careful not to cause discomfort 6 For L...
Page 45: ...positioned as shown in figure 3 The horizontal laser must pass through the auditory meatus and the base of the nose so that it is parallel with the mandible plane whereas the vertical laser must alwa...
Page 46: ...he area exposed to radiation and where required stand behind the special protection Press the X ray button on the remote control and hold it down for the entire duration of the examination The examina...
Page 47: ...therwise there would be an area not exposed to the X ray 6 1 SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE 3D Examination can be performed only if the X ray device is connected to a PC on which i...
Page 48: ...ses In particular the fields of view available with the Extended View software license are more than those available with the base license only A field of view of Extended View type features the autom...
Page 49: ...nstructed A red circle will highlight the selected area The choice of the reconstruction centre is just a preliminary operation at the end of the patient positioning the anatomical region involved in...
Page 50: ...he lower limit of the area radiated 5 Arrange the patient s head using as guide the vertical laser trace that identifies the sagittal plane 6 After having reached the correct positioning lock the cran...
Page 51: ...nternal memory until the device is turned off or the projection is overwritten when performing a new examination If an image is available in the internal memory the icon is active on the home page and...
Page 52: ...of a colour touch screen The user interacts with the display by tapping graphic icons with selection button functions The intuitive operator interface makes it easy for the operator to select the set...
Page 53: ...EL action cancellation performed The display shows the previous screen Parking positioning mechanical axes position to minimise the overall dimensions 2D sensor unhook positioning removable detector s...
Page 54: ...the preset values for man woman and child For adults it is possible to select three different sizes high medium low CUSTOM sets parameters manually with a precision of 1 kV or 1 mA Technique Factor S...
Page 55: ...tion enabled for side Ceph examinations Press to disable patient shoulder anti collision option For 3D Examinations only High resolution CBCT acquisition mode Maximum resolution CBCT acquisition mode...
Page 56: ...s can be distinguished Artifacts In the image there must be no artifacts such as visible horizontal lines or halftones Frequency of the check Yearly Use the optional phantom available upon request wit...
Page 57: ...de 0 2mm Half value layer HVL 2D PAN CEPH HVL 3 6mm 85kV 3D CBCT mode HVL 5 0mm 90kV with additional automatic filter Dispersed radiation 0 88mGy h at 1 metre from focus at 90KV 10mA duty cycle 1 20 M...
Page 58: ...ions Generator voltage at maximum current 90kV 10mA Load factors for the maximum output power 90kV 10mA Maximum output rated power value averaged with T 4s 810VA 90kV 10mA 20 25 duty cycle Exposure ti...
Page 59: ...EN OPERATOR S MANUAL 59 10 4 ISODOSE CURVES FOR CBCT EXAMINATIONS 10 5 ISODOSE CURVES FOR 2D EXAMINATIONS...
Page 60: ...y set by the machine for this dosimetric phantom for CTDI is reasonably similar to that of an average patient The table indicates the X ray load used typically suggested by the X ray device Type of ex...
Page 61: ...40 14 40 14 40 14 40 CTDI100 mGy 1 780 1 266 1 266 1 266 1 266 8x5 HiRes kV 90 90 90 90 90 mA 6 00 6 00 6 00 6 00 6 00 exposure time s 9 0 9 0 9 0 9 0 9 0 mAs 54 00 54 00 54 00 54 00 54 00 CTDI100 mG...
Page 62: ...CS PAN Pixel size 48 x 48 m Sensitive area dimensions 6 x 146 mm Resolution 5 2 LP mm Primary screen 0 5 mm Pb 10 9 TELERADIOGRAPHIC CEPH SENSOR CHARACTERISTICS CEPH Pixel size 48 x 48 m Sensitive are...
Page 63: ...alometric unit installed 1519 x 1829 mm Height Min 1590 mm Max 2380 mm 10 12 ENVIRONMENT CHARACTERISTICS Operating conditions Temperature 10 40 C max 30 C during the acquisition operations Relative hu...
Page 64: ...NTEL GIGABIT CT OTHER PERIPHERAL DEVICES MONITOR MINIMUM RESOLUTION 1280X1024 64 MILLION COLOURS OR HIGHER DVD BURNER Notes 1 The use of a 7200 RPM hard disk implies considerably reduced performance 2...
Page 65: ...GB GDDR5 500W Sapphire Radeon HD 7850 1GB 2GB GDDR5 500W Sapphire Radeon HD 7770 GHZ Ed OC VaporX 1GB GDDR5 500W Sapphire Radeon HD 7750 GHZ Ed OC VaporX 1GB GDDR5 400W Sapphire Radeon HD 6970 VaporX...
Page 66: ...Windows 8 1 Professional 32 64 bit Update 3 Windows 7 Professional 32 64 bit SP1 Processor Intel Core i3 or next Hard Disk 100 Gb 7200RPM System memory 4 GB Video card 3D VideoCard 1 GB physical RAM M...
Page 67: ...2 Laser danger and warning nameplates 3 CBCT sensor nameplate 4 Generator nameplate 5 CEPH arm nameplate 6 CEPH sensor identification nameplate 7 DHHS and WARNING nameplate 8 Main nameplate 9 Mark nam...
Page 68: ...Turn off the unit check CAN bus connections wait 30sec and turn it back on If the problem persists contact tech support 0 6 CONVERTER Circuit Board unable to communicate with MAIN Board Turn off the...
Page 69: ...ment transfer to PC or USB before proceeding New exposure requested while previous has not been downloaded yet 0 24 Please wait for confirmation before press The xray button was pressed before startin...
Page 70: ...r therefore expressly accepts that the Software may contain errors To this end the User agrees in his own interest to make back up copies of the files data and images regularly and diligently in order...
Page 71: ...lied in its original state and the Author does not offer and shall not acknowledge any guarantee for original defects or defects which might subsequently arise and shall not make any guarantee of qual...
Page 72: ...mains understood that should any inconsistencies arise regarding interpretation the Italian version shall prevail 12 1 9 SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE If the Author declares compli...
Page 73: ...for units with Cephalometric arm and removable detector Section Sensor positioning 10 Perform a movement test running the Dummy panoramic procedure making sure the movement on the 3 axes X Y R rotatio...
Page 74: ...R rotation and translation simultaneously is smooth and without noise See figure 1 next page To perform a dummy cycle namely the simulation of an examination without the emission of X rays select any...
Page 75: ...EN OPERATOR S MANUAL 75 Figure 1 Figure 2...
