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Operating Instructions

 

 

 

 

 

   

 

 

42 

 
 

 

14. ELECTROMAGNETIC COMPATIBILITY 

14.1.  ELECTROMAGNETIC EMISSION 

 
The FONA XPan 3D Plus system is suitable for use in the electromagnetic environment specified below. The customer 
or the user of FONA XPan 3D Plus system should assure that it is used in such an environment. 

 
 

Emission test 

Compliance 

Electromagnetic environment 

Radiated and conducted RF emissions  
CISPR 11 

Group 1 

This FONA XPan 3D Plus uses RF energy only for its 
internal  function.  Therefore.  the  RF  emission  is  very 
low and not likely to cause any interference in nearby 
electronic equipment.  

Class B 

This  FONA  XPan  3D  Plus  is  suitable  for  use  in  all 
establishments.  including  domestic  establishments 
and those directly connected to the public low-voltage 
power supply network that supplies buildings used for 
domestic purposes  

Harmonic Emissions EN 61000-3-2 

Not applicable 

Voltage  fluctuations/  flicker  emissions 
61000-3-3 

Complies 

 
 

 
14.2.  ELECTROMAGNETIC IMMUNITY 

 
The  FONA  XPan  3D  Plus  system  is  intended  for  use  in  the  electromagnetic  environment  specified  below.  The 
customer or the user of the FONA XPan 3D Plus system should assure that it is used in such an environment.  
 

Immunity test 

EN 60601-1-2 test level 

Compliance level 

Electromagnetic environment 

Electrostatic discharge (ESD)  
IEC 61000-4-2  

6 kV contact  
8 kV air  

IEC 60601-1-2  
Test level  

Floors should be wood. concrete 
or  ceramic  tile.  If  floors  are 
covered  with  synthetic  material. 
the  relative  humidity  should  be 
at least 30%.  

Electrical fast  
transient/burst  
IEC 61000-4-4  

2 kV for power  
supply lines  
1 kV for input/output  
lines > 3 m  

IEC 60601-1-2  
Test level  

Mains  power  quality  should  be 
that  of  a  typical  commercial  or 
hospital environment.  

Surge  
IEC 61000-4-5  

1 kV differential mode  
2 kV common mode  

IEC 60601-1-2  
Test level  

Mains  power  quality  should  be 
that  of  a  typical  commercial  or 
hospital environment.  

Voltage dips. short interruptions  
and voltage  variations  on  power 
supply input lines  
IEC 61000-4-11  

0% Un for 0.5 cycles  
40 % Un for 5 cycles  
70 % Un for 25 cycles  
0 % Un for 5 s  

IEC 60601-1-2  
Test level  

Mains  power  quality  should  be 
that  of  a  typical  commercial  or 
hospital environment. If the user 
of  the  FONA  XPan  3D  Plus 
requires  continued  operation 
during 

power 

mains 

interruptions. it is recommended 
that the FONA XPan 3D Plus be 
powered  from  an  uninterruptible 
power supply or a battery.  

Power  frequency  (50/60  Hz) 
magnetic field  
IEC 61000-4-8  

3 A/m  

IEC 60601-1-2  
Test level  

Power frequency magnetic fields 
should be at levels characteristic 
of  a  typical  location  in  a  typical 
commercial 

or 

hospital 

environment.  

 
 

Summary of Contents for XPan 3D Plus

Page 1: ...OPERATING INSTRUCTIONS FONA XPan 3D Plus_ English...

Page 2: ...left 3D volume 18 6 10 P10 PROGRAM TMJ right 3D volume 18 6 11 P11 PROGRAM Latero lateral cephalometric image 19 6 12 P12 PROGRAM Antero posterior cephalometric image 19 6 13 P13 PROGRAM Carpus image...

Page 3: ...1 WARNING MESSAGES 37 11 2 ERROR MESSAGES 37 12 INSPECTION AND MAINTENANCE 38 13 TECHNICAL DESCRIPTION 39 14 ELECTROMAGNETIC COMPATIBILITY 42 14 1 ELECTROMAGNETIC EMISSION 42 14 2 ELECTROMAGNETIC IMM...

Page 4: ...ure x Operating Instructions x Installation manual x Service manual x Maintenance manual x Warranty conditions Keep this literature for easy and quick reference Read the Operating Instructions to beco...

Page 5: ...stem following the instructions and recommendations contained in this user manual x Keep the machine in perfect working condition following the maintenance instructions given by the manufacturer Failu...

Page 6: ...prior to X ray exposure Laser light localizers used This product incorporates Class 1 lasers as light localizers for the positioning of the patient They must not be used for other purposes A minimum...

Page 7: ...of electrical and electronic devices Your product is marked with the adjacent symbol Disposal of your product with domestic refuse is not compatible with the objectives of environmentally sound recycl...

Page 8: ...me and secures your investment Innovative sensor technology acquires the cephalometric image in less than 1 second thus preventing patient movement and increasing image quality Setting of exposure was...

Page 9: ...nables visual contact with the patient An optional kit is available for remote mounting of the hand switch Order code 93 190 00155 1 X Ray button 2 Patient positioning mirror 3 3D Panoramic Image Mirr...

Page 10: ...ray Radiation Orange Light ON PROGRAM Selection INCREASE kV left side mA right side DECREASE kV left side mA right side PATIENT build Small Medium Large Extra Large LIGHT for alignment ON for 60 s RE...

Page 11: ...n the unit reaches the START position the green light of the READY indicator on the control panel is turned ON x PATIENT EXIT position Control panel and X ray source on the left of the patient and the...

Page 12: ...for TMJ and sinus exams 2 Chin rest with support for edentulous 6 Nasal support for TMJ and sinus exams 3 Bite block 7 Chin rest with support for 3D TMJ exams left and right Optional 4 Nasal support f...

Page 13: ...reatment planning The software OrisWin DG Suite allows the acquisition of panoramic and cephalometric X ray images and X Ray images for 3D reconstruction managing also the associated patient data reco...

Page 14: ...to acquire o Green system ready to acquire o Blue system acquiring X Ray ON x Click on P button 2 to select the program and on Size button 3 to select proper patient size x If needed it is possible to...

Page 15: ...standard panoramic image x Program duration time approx 16 s x Program exposure time 14 2 s x Positioning tool 1 2 3 4 see 4 Positioning tools 6 2 P2 PROGRAM Children panoramic image x Program duratio...

Page 16: ...rogram duration time approx 16 s x Program exposure time 7 3 s x Positioning tool 1 2 3 4 see 4 Positioning tools 6 5 P5 PROGRAM Anterior teeth panoramic image x Program duration time approx 16 s x Pr...

Page 17: ...n the unit A second set of two exposures can be taken immediately TMJ closed mouth x Program duration time approx 16 s x Program exposure time 4 4 s 2 x 2 2 s x Positioning tool 5 6 see 4 Positioning...

Page 18: ...s x Program exposure time 12 3 s x Positioning tool 1 2 3 4 see 4 Positioning tools 6 9 P9 PROGRAM TMJ left 3D volume x Program exposure time 12 3 s x Positioning tool 7 available on request 6 10 P10...

Page 19: ...djustable 6 12 P12 PROGRAM Antero posterior cephalometric image x Positioning tool 8 without nasion see 4 Positioning tools x Program duration time 1 6 s adjustable Program exposure time 1 6 s adjusta...

Page 20: ...to press the Return button in order to initialize the device as indicated on side figure By pressing the RETURN Arm Movement key the rotation arm locates the reference points and moves to the PATIENT...

Page 21: ...e current can be set from 4 to 10 mA 4 0 5 0 6 3 8 0 10 F TEST Mode without Radiation optional READY GREEN LIGHT ON Press RETURN Arm Movement to move the arm from PATIENT ENTRY position to START posit...

Page 22: ...OTE The height adjustment motor starts slowly and then increases its speed Press the height adjustment key until the unit has reached the desired height 7 3 POSITIONING THE PATIENT 7 3 1 Panoramic and...

Page 23: ...ion holding firmly the handles With bite block x Have the patient bite into the indentation in the tip of the bite block Mouth is closed but teeth are not superimposed With nasal support x Instruct th...

Page 24: ...een the upper edge of the external auditory meatus and the lower edge of the infra orbital rim x The height of the FH horizontal beam can be adjusted with a dedicated knob 7 on the right side of the t...

Page 25: ...move the carriage with the FORWARD BACKWARD buttons until the lateral light beam is on the canine to have the roots of the incisors within the layer in focus the movement in mm is shown on the contro...

Page 26: ...sition in the following Run the acquisition program on PC to receive the radiographic image being created as described in section 5 Application Software on page 11 Go to the area designated for the op...

Page 27: ...ue of the dose by area product DAP in mGy cm2 is indicated on display after a panoramic exposure Do acknowledge the DAP value with RETURN or EXPOSURE key to proceed DAP computations can be enabled or...

Page 28: ...rn button in order to initialize the device as indicated on side figure By pressing the RETURN Arm Movement key the rotation arm locates the reference points and moves to the PATIENT ENTRY position Wh...

Page 29: ...l The mAs level can be selected from 2 to 40 2 0 4 0 8 0 16 32 2 5 5 10 20 40 3 2 6 3 12 25 Press the Return button to bring the carriage from Patient Entry Position to Cefalometric Exams position The...

Page 30: ...neously outwards as far as they will go Insert the protective caps for ear plug Bring the unit the proper height using UP or DOWN keys NOTE The height adjustment motor starts slowly and then increases...

Page 31: ...outwards as far as they will go Insert the protective caps for ear plug Bring the unit the proper height using UP or DOWN keys NOTE The height adjustment motor starts slowly and then increases its spe...

Page 32: ...ot to lose the washer Grasp the holders at the very top with both hands Push the holders simultaneously outwards as far as they will go Guide the patient sideways into the unit Instruct the patient to...

Page 33: ...patient has been partially exposed Part of the radiograph is being available Examination may have to be repeated 8 5 AFTER THE EXPOSURE At the end of the X Ray exposure grasp the holders at the very t...

Page 34: ...OTE Keep pressed the TEST key to reset all values to default factory conditions Select the exposure program by pressing the program key Select the patient build by pressing the PATIENT key Small Mediu...

Page 35: ...values kV mAs Program P1 P3 P4 P5 P6 P7 61 6 3 67 6 3 73 6 3 79 6 3 P2 61 5 0 67 5 0 73 5 0 79 5 0 P8 P9 P10 61 6 3 67 6 3 73 6 3 79 6 3 Factory programmed values kV mAs Freely programmed values kV m...

Page 36: ...being careful not to let liquid substances penetrate the machine The plastic covers can be cleaned with a soft cloth and a mild detergent Disinfecting The parts that come into contact with the patient...

Page 37: ...failure Switch the unit off Report to technical service 10 Tube head temperature exceeding limit Wait for tube cool down 11 Exposure aborted during irradiation Restart if termination was requested by...

Page 38: ...our system by performing maintenance on it at regular intervals at least once annually or having this work performed by your dental dealership In addition to the scheduled annual inspection by the use...

Page 39: ...oducts Diagnostic X ray Systems and their major Components US FDA 21CFR1020 31 Performance Standards for Ionizing Radiation Emitting Products Radiographic Equipment US FDA 21CFR1040 10 Performance Sta...

Page 40: ...at receptor s plane is approximately 27 higher than real size vertical magnification on adult standard profile 1 27 1 approximately Cephalometric images at receptor s plane is approximately 10 higher...

Page 41: ...ve Tube housing assembly Reference axis Used Icons OFF disconnected from mains supply Inherent Filtration ON connected to mains supply Fragile Handle With Care Fuse Fear of Humidity Alternate Current...

Page 42: ...601 1 2 test level Compliance level Electromagnetic environment Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air IEC 60601 1 2 Test level Floors should be wood concrete or ceramic tile...

Page 43: ...arked with the following symbol 14 4 RECOMMENDED SAFETY DISTANCES FOR SYSTEMS THAT ARE NOT LIFE SUPPORTING The FONA XPan 3D Plus system is intended for use in an electromagnetic environment in which r...

Page 44: ...6968380110 11 2016...

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