Villa Sistemi Medicali ROTOGRAPH-D User Manual Download Page 17

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USER'S MANUAL

Technical features

ROTOGRAPH-D (120V)

(Rev. 1)

Tubehead features

Type

MR05

Manufacturer

VILLA SISTEMI MEDICALI
Buccinasco (MI) Italy

Max peak tube potential

85 kV

Nominal power

0.630 kW (85kVp, 10mA)

Total filtration

≥ 2.8mm Al eq. at 85 kV

Insulation

Oil bath

Cooling

Ambient

Leakage radiation at 1 m

< 0.25 mGy/h
(85 kV, 10mA, 1:16 duty cycle)

Maximum power

85 kVp, 10mA

Type of circuit

Single-phase, self-rectifying

X-ray tube features

Manufacturer

CEI – Bologna Italy

Type

CEI OPX/105

Focus

0.5 IEC 336

Inherent filtration

0.5 mm Al eq.

Anode tilt

5°

Anode material

Tungsten

Nominal voltage

105 kVp

Filament maximum current

Filament maximum voltage

Anode thermal capacity

30 kJ

Laser centring device

2 laser beams are used for the patient positioning; beams align mid Sagittal and
Frankfurt planes (please refer to relevant paragraphs for detailed explanation).

Wave length

650 nm ± 10 nm

Divergence

< 2.0 mRad

Optical power

≤ 1 mW

Classification

Class 2 laser product according to IEC
Standard 60825-1:2007

Summary of Contents for ROTOGRAPH-D

Page 1: ...Release 15 July 2011 Rev 1 ROTOGRAPH ROTOGRAPH ROTOGRAPH ROTOGRAPH D D D D 120V version 120V version 120V version 120V version User s manual User s manual User s manual User s manual ...

Page 2: ...ision history Rev 1 ROTOGRAPH D 120V Revision history Revision history Revision history Revision history Rev Date Page s Modification description 0 26 10 05 Document approval 1 15 07 11 All Release version Restyle 2011 ...

Page 3: ...USER S MANUAL Revision history ROTOGRAPH D 120V Rev 1 THIS PAGE IS INTENTIONALLY LEFT BLANK ...

Page 4: ...ay examination 20 6 2 1 Preparing the equipment refer to Figure 6 and Figure 7 20 6 2 2 Programmed Manual exposure 21 6 2 2 1 Programmed exposure refer to Figure 7 21 6 2 2 2 Manual exposure refer to Figure 7 22 6 2 3 Preparing the patient refer to Figure 2 and Figure 3 23 6 2 4 Making the exposure refer to Figure 7 25 6 3 TMJ examination 27 6 3 1 Performing the TMJ1 examination 28 6 3 1 1 Prepari...

Page 5: ...nd Figure 7 40 6 6 Identification and correction of defects in dental radiographs exposure 42 6 6 1 Defects due to wrong patient positioning 42 6 6 2 Defects due to wrong setting of radiological data and dark room 43 7 MAINTENANCE 49 This publication can only be reproduced transmitted transcribed or translated into any human or computer language with the written consent of Villa Sistemi Medicali S...

Page 6: ...the instructions for proper and safe use of the appliance The appliance must be used strictly following the procedures described in this manual and never for activities other than those for which it was designed Before using the appliance we recommend to read carefully this manual Keep it in a safe place near the unit for future reference ROTOGRAPH D is an electromedical appliance and may be used ...

Page 7: ...D different from that for which it has been designed any damage to the equipment the operator or the patient caused either by incorrect installation and maintenance not compliant with the procedures contained in the relevant user s and installation manuals provided with the equipment or by incorrect operation techniques any mechanical and or electrical changes effected during or after installation...

Page 8: ...ed Although the appliance has been designed to have a reasonable degree of protection from electromagnetic interference it must be installed at a certain distance from electricity transformer rooms static continuity unit portable two way hand radios and cellular phones The latter may only be used at a distance of over 1 5 meters from all elements of the machine All instruments or equipment for pro...

Page 9: ...ow the safety procedures for both himself and the patient during an exposure We recommend that the X ray activation always be commanded from an X ray protected area via remote control If it is necessary to operate the exposure near the patient remain at the maximum distance allowed by the remote control cable in the direction opposite to the emission of the rays at a distance of at least 6 6 feet ...

Page 10: ...osed of at recovery centers established by the local health units The machine contains the following materials and or components Tubehead dielectric oil lead copper iron aluminum glass tungsten beryllium Control box and remote control iron copper glass resin non biodegradable plastic casings Column rotating arm extensions iron lead aluminum copper non biodegradable plastic materials glass resin NO...

Page 11: ...achine parts contain materials and liquids that upon completion of the machine s life cycle must be disposed of at recovery centers established by the local health units Alternating Current N Connection to neutral conductor L Connection to line conductor Protection ground Functional ground OFF equipment not connected to power line ON equipment connected to power line Warning read the documentation...

Page 12: ...ted surfaces the accessories and the connection cables using only a damp cloth and neutral detergents Take care to dry the parts with a dry cloth Do not use corrosive or abrasive solvents alcohol gasoline trielina The bite rod the centering bite and the ear centering pins must be replaced after each examination where they have been used In addition the bite must be disinfected by using a 2 Gluthar...

Page 13: ...NUAL Description ROTOGRAPH D 120V Rev 1 8 4 4 4 4 DESCRIPTION DESCRIPTION DESCRIPTION DESCRIPTION 4 1 4 1 4 1 4 1 Identification labels Identification labels Identification labels Identification labels 1 3 2 4 5 ...

Page 14: ...ion Rev 1 ROTOGRAPH D 120V 9 1a ROTOGRAPH D label 1b WARNING label 1c ETL certification label 2 Digital Sensor identification label 3 Tube head identification label 4 Remote control identification label 5 Laser WARNING label ...

Page 15: ...n the pseudo elliptic rotation system the original light beam luminous cross pattern centering system and most of all the small dimension of the focal spot in addition obvioulsy to the digital qualityof the solid state RX sensor This particular rotation system allows an orthogonal imaging of all teeth and wide image layer with an optimum focused zone of 10 mm for the incisors and 20 mm for the mol...

Page 16: ...r 1 15 kVA 108V Power fuse 10A T Command fuse 0 5A T Filament fuse 0 315A F Line voltage regulation 3 at 108V Compensation of the mains voltage fluctuation automatic Apparent line resistance 0 5 Ω max High voltage 60 85 kV 5 kV steps KV accuracy 10 nominal voltage 10 Anodic current 10 mA Anodic current accuracy 1 5 mA 120V 10 Exposure time Panoramic 17s adult 14s child Exposure time TMJ1 TMJ2 10 4...

Page 17: ...self rectifying X ray tube features Manufacturer CEI Bologna Italy Type CEI OPX 105 Focus 0 5 IEC 336 Inherent filtration 0 5 mm Al eq Anode tilt 5 Anode material Tungsten Nominal voltage 105 kVp Filament maximum current 4A Filament maximum voltage 8V Anode thermal capacity 30 kJ Laser centring device 2 laser beams are used for the patient positioning beams align mid Sagittal and Frankfurt planes ...

Page 18: ...nit net weight 62 lbs 28 kg Slider counterweights net weight 150 lbs 68 kg Environmental conditions Maximum operating temperature range 50 F 104 F 10 40 C Operating relative humidity range 30 75 Transportation and storage temperature range 4 F 158 F 20 70 C Maximum transportation and storage relative humidity 90 non condensing Minimum atmospheric pressure for transportation and storage 630 hPa ...

Page 19: ... Standards and regulation Standards and regulation The ROTOGRAPH D equipment is manufactured according to the following standards 21 CFR subchapter J General safety IEC 60601 1 IEC 60601 1 1 IEC 60601 2 7 IEC 60601 2 28 IEC 60601 2 32 UL 2601 Electromagnetic compatibility IEC 60601 1 2 Protection from radiation IEC 60601 1 3 ...

Page 20: ...D 120V 15 5 2 5 2 5 2 5 2 X X X X ray tubehead curves ray tubehead curves ray tubehead curves ray tubehead curves Tube CEI Tube CEI Tube CEI Tube CEI O O O OPX 105 0 5x0 5 PX 105 0 5x0 5 PX 105 0 5x0 5 PX 105 0 5x0 5 Loading chard Anode cooling chard ...

Page 21: ...USER S MANUAL Technical features ROTOGRAPH D 120V Rev 1 16 Cooling curve of tubehead 0 100 200 300 400 500 600 700 0 50 100 150 200 250 300 350 400 min E KJ ...

Page 22: ... X ray beam A direct measurement of the high voltage can only be carried out by specialized technicians in a suitable testing laboratory as it requires disassembling of the tubehead mA The output current is determined by measuring with a digital multimeter accuracy 0 5 by connecting the probes to the connectors of A1 PCB as indicated in the Service Manual digital multimeter set to VDC 20V 1V 1mA t...

Page 23: ...s ROTOGRAPH D 120V Rev 1 18 5 4 5 4 5 4 5 4 Overall dimension Overall dimension Overall dimension Overall dimension 1240 45 1170 46 1256 50 957 1791 37 7 70 5 774 30 5 2378 93 6 897 35 3 406 16 Figure 1 ROTOGRAPH D overall dimension ...

Page 24: ...ment 1 Push the button on the control panel to turn the equipment ON The CHECK function is so activated verified by the lighting up of the LED S on the remote control and the display pixels The software checks the enabled operating function with the corresponding LED signal on the hand control The system sets for a radiography PAN adult even if the digital sensor is not yet ready for the acquisiti...

Page 25: ... order to display the message concerning the interlock to be enabled on the sensor The messages that can be read during the Panoramic function setting and the relevant actions to perform are the following 1 Digital Sensor not Ready activate the QuickVision program and wait for the completion of the initial check 2 Select PAN TMJ1 it is necessary to select PAN with the dedicated button 13 positione...

Page 26: ... possibility to change the preset kV values 6 2 2 1 6 2 2 1 6 2 2 1 6 2 2 1 Programmed exposure Programmed exposure Programmed exposure Programmed exposure refer to Figure 8 Push button 33 for adult program or 34 for child s To check the new configuration depress push buttons Adult 33 and Child 34 there will only be a variation on kV and time pressing buttons Large Size 35 Medium Size 36 and Small...

Page 27: ...ons increase 41 or decrease 40 on the hand control selecting the desired kV value to be used After 2 seconds the function button LED stops blinking The unit is now ready for the next step NOTE The kV can vary from a minimum of 60kV to a maximum of 85kV with steps of 5kV If after having reached the minimum or maximum values of the kV range additional decrease or increase is requested the following ...

Page 28: ...ve of the bite piece 5 Press the laser centring device activation button 20 When this is done two crossed beams of light illuminate both the sagittal median line 45 and the horizontal line for the Frankfurt plane reference 46 The centring device stays illuminated for about 40 seconds if this time is insufficient to carry out the centring operations the activation button 20 may be pressed again 6 B...

Page 29: ...USER S MANUAL Operating instructions ROTOGRAPH D 120V Rev 1 24 1 9 18 20 24 45 46 Figure 2 Panoramic position 45 46 Legend of reference lines 45 Sagittal median line 46 Frankfurt plane line Figure 3 ...

Page 30: ... exposure data are correct paragraph 6 2 2 then press the X ray button 42 during the whole time of the exposure as the control is a dead man type checking the simultaneous operation of the rays signaling light 43 and the acoustic X ray signal NOTE The start of arm rotation and the emission of rays take place with a delay of four seconds after the activation of button 42 allowing preheating of the ...

Page 31: ...rn button 32 has to be pressed to bring the machine in the starting position The return end is evidenced by the message OK which will disappear when the button 32 is released It will then be necessary to ask the QuickVision program for the execution of a new radiography If for external reasons or incorrect operation the X ray emission times should exceed 17 seconds a backup security timer will com...

Page 32: ...ion phases between the different projections The TMJ functions allow to obtain 4 different images on the same image by means of two different programs The 4 images represent the right and left condyle of the temperomandibular joint TMJ both with closed TMJ1 or open TMJ2 mouth With TMJ1 projection the lateral portions of the image are generated while the centre part will be generated with the TMJ2 ...

Page 33: ... on the sensor The messages that can be read during the Panoramic function setting and the relevant actions to perform are the following 1 Digital Sensor not Ready activate the QuickVision program and wait for the completion of the initial check 2 Select PAN TMJ1 it is necessary to select TMJ1 with the dedicated button 14 positioned near the sensor NOTE THE SELECTION DONE ON THE HAND CONTROL MUST ...

Page 34: ...aring in mind that the kV and time parameters in the programmed exposure are indicatively the following numbers refer to Figure 8 Large Size 35 Medium Size 36 Small Size 37 TMJ1 and 2 Adult 33 80kV 5 20sec 70kV 5 20sec 65kV 5 20sec TMJ1 and 2 Child 34 65kV 4 70sec 60kV 4 70sec 60kV 4 70sec The times reported in the previous table are the sum of the exposure time for the right condyle with the one ...

Page 35: ...aligned with the patient s chin 4 Position the patient in the skull clamp with the chin resting on the appropriate support and against the vertical reference rod of the same Furthermore position the hands on the lateral knobs 5 Press the laser centring device activation button 20 In this way both reference lights mid sagittal 45 and Frankfurt planes 46 are lighted on adjust the patient s head in s...

Page 36: ...USER S MANUAL Operating instructions Rev 1 ROTOGRAPH D 120V 31 9 18 20 24 45 46 7 Figure 4 TMJ1 position ...

Page 37: ...nterrupted corresponding with the central middle part of the mouth As a consequence both acoustic and visual emission signals are interrupted in accordance with the emission X ray push button is a dead man type this means that the emission and arm s rotation are interrupted if the push button is released The push button must be held pressed also during the above emission interruption In case of pa...

Page 38: ...rning the interlock to be enabled on the sensor The messages that can be read during the Panoramic function setting and the relevant actions to perform are the following 3 Digital Sensor not Ready activate the QuickVision program and wait for the completion of the initial check 4 Select TMJ2 it is necessary to select TMJ2 with the dedicated button 15 positioned near the sensor NOTE THE SELECTION D...

Page 39: ... In this way both mid sagittal 45 and Frankfurt plane 46 will light on Adjust the patient s head in order to have the vertical light beam 45 to lean on the corresponding anatomical reference In order to check the patient s centring operator can tilt the mirror towards himself thus obtaining the a front view of the patient WARNING Do not align the patient to the Frankfurt plan in the case the patie...

Page 40: ...USER S MANUAL Operating instructions Rev 1 ROTOGRAPH D 120V 35 9 18 20 24 45 46 7 Figure 5 TMJ2 position ...

Page 41: ...emission On TMJ examination the X ray emission does not last for all the rotation but it is interrupted corresponding with the central middle part of the mouth As a consequence both acoustic and visual emission signals are interrupted in accordance with the emission X ray push button is a dead man type this means that the emission and arm s rotation are interrupted if the push button is released T...

Page 42: ...ssage OK that will disappear when the button 32 is released At this point the message Wait please will appear indicating that the automatic pause to allow anode cooling down procedure is acting At the end of this procedure the LED of the last examination performed will light on NOTE If for external reasons or incorrect operation the emission times should exceed 5 seconds a safety backup timer inte...

Page 43: ... the only difference between the Panoramic Exposure and the Sinus one is due to the different chin support used the chin support to be used in the Sinus examination is as follows numbers refer to Figure 7 at the end of this manual Chin support PANORAMIC 1 Chin support SINUS 21 ADULT NO YES SINUS CHILD NO YES 6 4 2 6 4 2 6 4 2 6 4 2 Programmed Manual exposure Programmed Manual exposure Programmed M...

Page 44: ...upport and against the vertical reference rod of the same and rest the hand on the side handles but instead of biting with the incisors the centring bit as in the Panoramic exposure the examination has to be carried out with a closed mouth 3 Proceed operating as for points 6 2 3 steps 5 6 7 and 8 9 18 20 24 45 46 7 Figure 6 SINUS position 6 4 4 6 4 4 6 4 4 6 4 4 Performing the exposure Performing ...

Page 45: ... and 6 3 2 3 X ray exposure has been performed Waiting time 4min for PAN or TMJ exposures Equipment not set 6 2 1 and 6 3 1 1 Not all interlocks are enabled Press a second time the function button to display the interlock to be enabled Digital Sensor Not ready 6 2 1 step 1 Digital sensor not enabled Request activation of digital sensor by the QuickVision program Select PAN TMJ1 NO reference Functi...

Page 46: ...eturn run is completed Release button RESET 32 TMJ modality not enabled NO reference TMJ examination has been requested on a unit not equipped with this feature Press the button of another examination NOT TMJ Memory data corrupted Call Technical Assistance NO reference Call Technical Assistance NO ANSWR NO reference Call Technical Assistance Out of Order N 1 Call Technical Assistance NO reference ...

Page 47: ...oo small and indistinct Incisor too small and indistinct Incisor too small and indistinct Incisor too small and indistinct The patient is positioned with an error opposite to point above Corrective action Refer to point above Radiograph with white central zone Radiograph with white central zone Radiograph with white central zone Radiograph with white central zone The patient s spinal column preven...

Page 48: ... exposed or over exposed image exposed image exposed image exposed image The number of kV set are not adequate for the patient s build more likely an error in development Corrective action Repeat the examination with a different value see paragraph 6 2 4 If the error happens again call the Technical Assistance Completely white image Completely white image Completely white image Completely white im...

Page 49: ...USER S MANUAL Operating instructions ROTOGRAPH D 120V Rev 1 44 THIS PAGE IS INTENTIONALLY LEFT BLANK ...

Page 50: ... 20 Laser centring device button 7 Skull Temple clamp support 21 Chin support TMJ SINUS Also used as an accessory to raise children s chin by sandwiching it with the standard Panoramic chin support 9 Skull Temple clamp control knob 22 Patient positioning handle and slider 10 Motor group unit 23 Support unit of the motor group 12 Slider 24 Brake release button 13 PAN selection button 25 Slot for Me...

Page 51: ... Selection 28 NOT ENABLED 37 Small Size Selection 29 TMJ1 mode Selection 38 kV Selection 30 TMJ2 mode Selection 39 Push button Multifunctional 31 Test mode dead man button 40 Decrease kV 32 RESET dead man button 41 Increase kV 33 Adult Selection 42 X rays push button dead man button 34 Child Selection 43 X rays emission pilot LED 35 Large Size Selection 44 Alphanumeric display ...

Page 52: ...l Type of check Daily check that the tubehead does not have oil leakage check that the cable of the remote control is not damaged check that the unit does not show damages that may affect the protection against radiation check that no metallic noise are generated by the column or the rotating assembly Once a week check that the metal ropes of the column are not damaged or broken the ropes can be s...

Page 53: ...r installation and after performing the preventive or corrective maintenance visits Installation Date Technician Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause ...

Page 54: ...ions Adult OPG Values T1 2 00 sec A2 Degrees A3 Degrees A4 Degrees A5 Degrees T2 18 sec 10 T3 17 sec 10 Adult TMJ1 T1 2 00 sec A1 Degrees A2 Degrees A5 Degrees A6 Degrees T2 16 sec 10 T3 5 20 sec 10 Adult TMJ2 T1 2 00 sec A1 Degrees A2 Degrees A5 Degrees A6 Degrees T2 16 sec 10 T3 5 20 sec 10 Child OPG T1 2 00 sec A2 Degrees A3 Degrees A4 Degrees A5 Degrees T2 16 sec 10 T3 14 sec 10 Child TMJ1 T1 ...

Page 55: ...USER S MANUAL ROTOGRAPH D 120V Rev 1 52 THIS PAGE IS INTENTIONALLY LEFT BLANK ...

Page 56: ...Cod 6908917700_Rev 1 VILLA SISTEMI MEDICALI S p a Via Delle Azalee 3 20090 Buccinasco MI ITALY Tel 39 02 48859 1 Fax 39 02 4881844 ...

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