background image

FONA XPan 3D Operating Instructions  

4/28

 

 

69 683 70110 

-

 150831

 

 

medical practice or hospital is prohibited. 

Malfunction of electronic units/ 

devices which are worn on the 
patient's body 

In order to prevent failure of electronic units and data storage 

devices, e.g. radio-controlled watch and telephone card, etc., it is 
essential that these be removed 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 distance of 100 mm must be maintained between the eye 

and the laser. Avoid unnecessary exposure of the eyes and pay 
attention that the beams are not intercepted by any optical device.  

Electrical safety 

Trained and qualified technicians only are authorized to remove 
covers and have access to power circuits. 
Power supply lines must comply with safety legislation and have 
ground terminals for protective earth connection. 

Mechanical safety 

Make sure that fingers or other parts of the patient or of the operator 

are not pinched during the movement of the unit. 

Explosion 

The equipment cannot be used in presence of flammable gases or 

vapours.  

Radiation protection guidelines 

 

 

 

X-ray equipment produces ionizing radiation that may be harmful if 
not properly controlled. It is therefore recommended that the 

equipment be operated by trained personnel only, in accordance with 
existing law.  
Observe the applicable health physics regulations. The radiation 
protection facilities should be used.  
The operator should remain as far away from the X-ray tube as the 
cable of the release button permits (in the designated significant zone 
of occupancy for the operator). 
With the exception of the patient, no other persons may remain in the 
room while the exposure is being made. Under exceptional 

circumstances a third person, however not belonging to the dental 
practice, may then assist.  
Maintain visual contact with the patient and the unit during the 

exposure and in case of faulty operation, immediately discontinue the 
exposure by releasing the X-ray button. 

Disassembly and reinstallation 

For disassembly and reinstallation of the unit proceed as described in 
the installation instructions for new installation to ensure perfect 
function of the unit and its stability. 

Disposal 

It generally applies that any disposal of this product must comply with 
the relevant national regulations. Please observe the regulations 
applicable in your country. 
Within the European Economic Community, Council Directive 

2012/19/EU (WEEE) requires environmentally sound recycling/disposal 
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 recycling/ disposal. The black bar underneath 

the garbage can symbol means that it was put into circulation after 
Aug. 13, 2005 (see EN 50419:2005). 
Please note that this product is subject to Council Directive 

2012/19/EU (WEEE) and the applicable national law of your country 
and must be recycled or disposed of in an environmentally sound 

manner. 
The X-ray tube assembly of this product contains a tube with a 

potential implosion hazard, a lead lining and mineral oil. 
Please contact your dealer if final disposal of your product is required. 

3 m 

10 foot 

DESIGNATED 

SIGNIFICANT ZONE 

OF OCCUPANCY FOR  

THE OPERATOR 

Summary of Contents for XPan 3D

Page 1: ...FONA XPan 3D Operating Instructions English...

Page 2: ...ontained in this user manual Keep the machine in perfect working condition following the maintenance instructions given by the manufacturer Failure to observe the instructions relieves the manufacture...

Page 3: ...e show any changes in rated parameters or working ranges as well as the date the name of the firm and a signature For safety reasons only use original accessories indicated in this Operating Instructi...

Page 4: ...le of the release button permits in the designated significant zone of occupancy for the operator With the exception of the patient no other persons may remain in the room while the exposure is being...

Page 5: ...to Medical Devices and subsequent amendments and integrations of which in the Directive 2007 47 EC of the European Parliament and of the Council Nominal line voltage 230 V 10 115 V 10 Nominal line fre...

Page 6: ...eal size vertical magnification on adult standard profile 1 27 1 approximately Centering References Bite block Chin Rest for edentulous Aiming lights Type Class I LASER beam Wavelength 650 nm Output P...

Page 7: ...s OFF disconnected from mains supply Inherent Filtration ON connected to mains supply Fragile Handle With Care Fuse Fear of Humidity Alternate Current Up Do Not Overturn Protective Earth Stacking Limi...

Page 8: ...150831 3 Operating Controls and Displays 3 1 Unit 1 Main switch 2 Patient positioning mirror 3 Bite block 4 Image receptor 5 Height adjustment buttons 6 Knob for Frankfurt plane adjustment 7 Control p...

Page 9: ...tion Orange Light ON Key 4 PROGRAM Selection Key 2L 2R INCREASE kV left side mA right side Key 2L 2R DECREASE kV left side mA right side Key 13 PATIENT build Small Medium Large Extra Large Key 6 LIGHT...

Page 10: ...to a complete stop START position System ready to start the exposure When the unit reaches the START position the green light of the READY indicator on the control panel is turned ON PATIENT EXIT pos...

Page 11: ...he OrisWin DG Suite User Manual A Starting On the PC connected to FONA XPan 3D with OrisWin DG Suite installed Start OrisWin DG Suite and select the Patient module with the relevant button B Selecting...

Page 12: ...ical magnification on dental arch Program duration time approx 16 s Program exposure time 14 2 s The image at receptor s plane is approximately 27 higher than real size the vertical magnification on a...

Page 13: ...Program Left hemi arch Program duration time approx 14 s Program exposure time 7 3 s 6 4 P4 Program Right hemi arch Program duration time approx 16 s Program exposure time 7 3 s 6 5 P5 Program Anterio...

Page 14: ...nder the nose Once taken the first set of two images return the unit A second set of two exposures can be taken immediately TMJ closed mouth Program duration time approx 16 s Program exposure time 2 2...

Page 15: ...ons 69 683 70110 150831 15 28 6 8 P8 Program Full Mouth 3D Program exposure time 12 3 s 6 9 P9 Program available soon 3D TMJ left Program exposure time 12 3 s 6 10 P10 Program available soon 3D TMJ ri...

Page 16: ...d Start of the reset function has to be performed ATTENTION When switching on the unit there must NOT be a patient positioned in the unit If a fault occurs which requires switching the unit off and th...

Page 17: ...READY light ON TEST mode can be activated to run the unit without radiation On the display are shown The selected program number The message Test Mode instead of values of kV and mA A green light is a...

Page 18: ...motor starts slowly and then increases its speed Press the height adjustment key until the unit has reached the desired height Standard exposure program Bring the carriage to have the bite block or t...

Page 19: ...ad inclination for the FH setting by briefly touching the UP or DOWN height adjustment key Verify side rotation of the head with reference to the Midsagittal light using the mirror from the back of th...

Page 20: ...SE or DECRESE keys on control panel on unit or on PC side Upon manual correction of the pre set technique factors the corresponding light on the patient build is turned OFF Setting tube voltage is don...

Page 21: ...the patient ready to immediately interrupt radiation if necessary Expose the patient The exposure is released by keeping the exposure key pressed till end of movement The rotation movement runs automa...

Page 22: ...data acquisition program has to be started first to make sure data acquisition will be performed during radiographic exposure Automatic Exposure Blockage ALARM RED LIGHT BLINKING This feature protects...

Page 23: ...onditions By pressing the PROGRAM key select the exposure program for ADULT panorama P1 P3 P4 P5 P6 P7 or for CHILD panorama P2 or for 3D exam P8 P9 P10 By pressing the PATIENT key select the patient...

Page 24: ...ted DO NOT use solvents or corrosive substances The bite block and the chin rest can be sterilized in autoclave at 134 C 11 Inspection and maintenance Inspection and maintenance work must be performed...

Page 25: ...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 the operator Call f...

Page 26: ...low The customer or the user of the FONA XPan 3D system should assure that it is used in such an environment Immunity test EN 60601 1 2 test level Compliance level Electromagnetic environment Electros...

Page 27: ...inity of equipment marked with the following symbol 13 4 Recommended safety distances for systems that are not life supporting The FONA XPan 3D system is intended for use in an electromagnetic environ...

Page 28: ...make any alterations which may be required due to clinical improvements FONA XPan 3D Operating Instructions English Edition 150831 FONA Dental s r o Stefanikova 7 SK 811 06 Bratislava Slovakia www fo...

Reviews: