FONA XPan

Operating Instructions
 FONA XPan – Operating Instructions

FONA XPan Operating Instructions

English Edition

Version 111104 November 2011

Code 69 682 70110

Manufactured by FONA S.r.l.

Via Idiomi 1/8-33 - 20090 Assago (MI) Italy

Distributed by FONA Dental s.r.o.

Stefanikova 7 SK-811 06 Bratislava, Slovakia
www.fonadental.com

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Table of Contents

1. INTRODUCTION .....................................................................................5
1.1 Destination of Use.............................................................................5
1.2 Warning for the User.........................................................................5
1.3 Caution .............................................................................................6
1.4 Safety ................................................................................................6
2. GENERAL ................................................................................................7
2.1 Indications for Use ............................................................................7
2.2 Operation ..........................................................................................8
2.3 Control panel ..................................................................................10
2.4 Functions ........................................................................................11
2.5 Cassette Preparation ........................................................................13
2.6 Panoramic Magnification Factor .....................................................13
2.7 Ceph Magnification Factor..............................................................13
2.8 Provisions for safety........................................................................14
3. PANORAMIC RADIOLOGY.................................................................14
3.1 Panoramic Programs .......................................................................14
3.2 Trial Session ...................................................................................14
3.3 Technique Factors ...........................................................................15
3.4 Positioning Accessories ..................................................................15
3.5 Collimator for Panoramic ................................................................16
3.6 The Aiming Lights ..........................................................................16
3.7 Resetting Carriage in Patient Entry Position ...................................16
3.8 Patient Positioning ..........................................................................17
3.9 TMJ projections ..............................................................................19
3.10 Maxillary Sinuses............................................................................19
3.11 Panoramic Exposure .......................................................................20
4. CEPHALOMETRIC RADIOLOGY .......................................................21
4.1 Cephalometric Programs .................................................................21
4.2 Technique Factors ...........................................................................21
4.3 Collimator for Cephalometric .........................................................22
4.4 Film Formats and Cassette Placement .............................................23
4.5 Cephalometric Exposure .................................................................23
5. MAINTENANCE....................................................................................24
5.1 Cleaning ..........................................................................................24
5.2 Disinfection.....................................................................................24
5.3 Technical maintenance ....................................................................24
5.4 Disposing of Obsolete Equipment ...................................................25
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6. CLASSIFICATION.................................................................................25
Appendix A Alarm Messages ..........................................................................26
Appendix B Icons ............................................................................................27
Appendix C Technical Data .............................................................................28
Appendix D Labels ..........................................................................................29
Appendix E Cooling Curves ............................................................................30
Appendix F Fuse Table ...................................................................................31

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1. INTRODUCTION
FONA XPan /Ceph are high quality panoramic and cephalometric dental X-ray
systems based on latest technologies, featuring software driven multi-projection
capabilities, for optimal diagnostic result in the day to day routine.
Units are is manufactured under a Quality Control System that grants full com-
pliance to specifications.
The Operating Instructions and the Service and Installation Manual supplied
with the system are integral part of the product.
The original language of the Operating Instructions is English.

1.1 Destination of Use

The family of FONA XPan /Ceph products includes traditional systems
equipped with cassette for use of films
 either for chemical processing
 or phosphor plates for laser scanning and digital acquisition.
Two versions are available
 Panoramic Solo (Pan Solo) and
 Panoramic and Cephalometric (Pan Ceph) with arm for teleradiography.
Each system can be equipped with temporo mandibular resting bars, on request.
A panoramic cassette holder for 24x30 cm cassette is optionally available.

1.2 Warning for the User

The user has the following responsibilities:
 Use the system following the instructions and recommendations contained
in this user manual.
 Keep the machine in perfect working condition following the main-
tenance instructions given by the manufacturer. Failure to observe
the instructions relieves the manufacturer or his agent from any re-
sponsibility for injury, damage or non-conformities that may derive there
from.
 Promptly notify the competent Health Authority and the manufacturer in the
event of an accident involving this medical device and/or operations that
may cause death or put the patient and/or the user at risk. The type and serial
numbers of the components involved, indicated on the external labels, are to
be communicated to the manufacturer.

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1.3 Caution
X-ray equipment produces ionizing radiation that may be harmful if
not properly controlled. It is therefore recommended that the equip-
ment be operated by trained personnel only, in accordance with exist-
ing law.
Even if compliant to specifications of electromagnetic compatibility, it is rec-
ommended not to use the equipment in presence of external electromagnetic
fields, such as those generated by cellular phones, which might interfere with
the electronic circuits of the system.

1.4 Safety
 Electrical.
 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.
 Switch the equipment off and possibly disconnect it from mains (room
switch) before cleaning or disinfecting the unit.
 Mechanical.
 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 va-
pours.
 Radiation.
 Trained and qualified personnel only are authorized to operate the
equipment always complying with existing law for Radiation Protection.
 Safety distance. The operator is invited to stay 3 meters from the column
(in the designated significant zone of occupancy) or exit the room, always
keeping an eye to the patient, ready to terminate the exposure in case of
need.
 Make sure that the equipment is not left unattended.
 Environmental.
 The machine contains components that cannot be disposed of in the envi-
ronment and it must be disposed of in accordance with the laws in force.

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2. GENERAL
2.1 Indications for Use
The family of FONA XPan /Ceph imaging systems includes diagnostic X-ray
equipment to produce panoramic and cephalometric radiographs of the dento-
maxillofacial area for diagnostic examination in any dental practice.
Panoramic imaging in dental
X-ray is considered a routine 4 2 4
procedure with which to per-
form a complete examination of 1
the dental arch (1), of the maxil-
lary (2) and mandibular (3) re-
gions, and that of the Temporo
Mandibular Joints (TMJ) (4). 3

Available panoramic examina-

tions include:
 Panoramic for adults.
 Panoramic for children with reduced ex-
posure.
 Left side of dentition.
 Right side of dentition.
 Anterior part of dentition.
 TMJ, habitual occlusion and open at
maximum extent (placed on same film
for analog systems).
 Frontal view of nasal (maxillary) sinuses

Extraoral radiology is completed with tele-

radiograpfhy for cephalometric applica-
tions. Cephalometric projections include:
 Latero Lateral (LL) radiograph of the
skull with soft tissue filter for adult and
child.
 Antero Posterior (AP) or Postero Ante-
rior (PA) radiograph of the skull.
 Wrist radiograph.

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2.2 Operation
A vertical carriage (A) , to which the
power supply cord and the exposure
hand-switch (L) are connected, can be G
moved vertically on the column (B) . B
A rotating unit (C) comprising the tube-
head generator(D), cassette holder (E)
and control panel (F) is connected to the A

C
I
F

D
E
J

vertical carriage. The stand is fixed to a

wall with a wall holder (G) . Alterna-
tively an optional self-standing base
(H) fixed to the floor can be used.
The arm carrying the cephalostat (I)
with the Ceph cassette holder (J) is
fixed to the vertical car-
riage.
SAFE ZONE OF
The diagnostic equipment OCCUPANCY
can be raised or lowered FOR OPERATOR
with the up and down
keys to activate the motor 3m
(K). 10 foot
Panoramic picture of the
dentition is performed by
H
means of a narrow X-ray
L
beam scanning the patient
from left to right.
The cassette with the film
moves at a variable speed
with regard to the radiation beam dur-
ing the exposure.

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In order to have the roots of
teeth falling into the “in-focus
layer” adjustments of the car-
riage either backward or for-
ward may be needed.
A shift of the carriage is
M
usually not required for pa-
tients with normal occlusion,
but in case of overjet for class
II or class II malocclusion, in
order to have the roots of
teeth falling into the “in-focus
layer” adjustments of the car-
riage can be done using the
displacement key (M) on con- O
trol panel, with the help of the
lateral light beam (N) P

Midsagittal light (P) is avail-

able to check for side rotation
of head. N
Frankfurt plane can be ad-
justed (P) to verify backward
or forward tilting of the head.
Adaptation of the system to
teleradiography is done by ro-
tating the tube-head (D) in fa-
vour of the cephalostat and
selecting the proper beam col-
limating window by rotating D
the disk below the tube-head
(Q).
The use of cassettes equipped
with rare earth intensifying
screens and light sensitive Q
films reduce to minimum the
radiation dose necessary for
this type of application .

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2.3 Control panel

12 13 14 15
1 16
3
2
6 6
17

7 8 9 10 11

BACKWORD Shift
System ON
1 11 (referred to patient)
2 11 FORWORD Shift (re-
System READY
ferred to patient)
PROGRAM number
3 X-ray emission 12 1-7 for PAN
8-10 for CEPH
SHIFT rotating arm
4 PROGRAM Selection 13 in mm
PATIENT build: small,
COLLIMATOR: PAN
5 medium, large, very 14 A, PAN B, CEPH
large
INCREASE/ ALARM or ERROR:
6 DECREASE: kV (left), 15 consult documenta-
mA (right) tion
X-ray Indicator (Ioniz-
MOVEMENT in se-
7 16 ing Radiation Emis-
quence/initialization
sion)
LIGHT: LASER beams
8 17 X-RAY control button
on (30 s)

9 TEST without radiation 18 UP movement

10 BACK to patient en- 19

trance position/Alarm DOWN movement
reset

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2.4 Functions
A Switching Unit ON
Pressing the General Switch placed below the chin-rest, the unit is supplied
and the green Led turns ON. Then the INIT function is started and after 7 s
the message “RESET” appears.

B Reset Function
By pressing the ARM MOVEMENT key the rotation arm, and, in case, the
cassette carriage, automatically locate the reference points and terminate in
“PATIENT ENTRY” position (rotating carriage at 90°, with tube-head placed
to the right of the patient, cassette holder to the left).
C Panoramic- Cephalometric Mode of Operation
This function is applicable for units with cephalometric capabilities.
The X-ray beam opening on the tube house assembly has to be directed towards
the cassette holder (or digital sensor) for panoramic examinations and towards
the cephalostat for cephalometric ones.
In case of panoramic selection the applicable kV and
mA values appears on the display. This last is replaced
by mAs in case of cephalometry.
For “analog” systems the panoramic or ceph cassette
properly loaded has to be placed on the cassette holder
paying attention to the applicable field.
The set of programs from 1 to 7 are available in pano-
ramic mode and those from 8 to 10 in cephalometric
mode.
UP
D Raising or lowering the system KEY
The unit is equipped with a motor to raise or lower the
carriage and fit the patient height by activating the UP
or DOWN keys on the sides. DOWN
KEY
E Examination Selection
By pressing key of program selection the desired examination can be acti-
vated, with the relevant code reported on the display.
Patient size can be selected with the PATIENT key .
The applicable technique factors are thus selected. Should them be corrected
manually, the plus and minus keys can be used to increase or decrease
the proposed values. To step back to the automatically proposed values, the
PATIENT key can be pressed.
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F High Voltage Setting
In case the proposed value of kV level has to be corrected, it can be done with
the plus and minus keys on the left side of the display.
The anode voltage can be set from 61 to 85 kV in steps of 3 kV.
61 64 64 67 70 73 76 79 82 85

G Anode Current Setting

In case the proposed value of mA level has to be corrected, it can be done with
the plus and minus keys on the right side of the display.
The anodic current can be set from 4 to 10 mA.
4.0 5.0 6.3 8.0 10

H Time-Current Product Setting

In Ceph mode the time-current product in mAs is used (at 10 mA fixed).
In case the proposed value of mAs has to be corrected, it can be done with the
plus and minus keys on the right side of the display.
The mAs ranges from 2 to 40.
2.0 4.0 8.0 16 32
2.5 5.0 10 20 40
3.2 6.3 12 25

I Collimator Selection
In case of cephalometric units, the proper collimating window can
YELLOW
be selected by rotation of the disk on the tube-house assembly. LIGHT
The code of the selected collimator therefore appears on the dis-
play under the COLLIMATOR mark . In case of incongruent
selection the mark appears blinking.
J Exposure control
The control unit takes care of both rotation and translation move- EXPOSURE
ments of the carriage and of film cassette together with X-ray PUSH-
BUTTON
generation during irradiation. A yellow light is emitted during ir-
radiation and a sound buzzer is activated. EXPOSURE
HAND-
SWITCH
K Error Handling CABLE

The ERROR number is shown on the display with the red light
ON (blinking).
To reset the error condition, the RETURN key has to be pressed.

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2.5 Cassette Preparation

A Use of film with intensifying screens
Make sure that the intensifying screens are clean.
Be sure that the dark room is light proof and in case equipped with proper safe-
ty lights (please note that panoramic films are much more sensitive to light than
intra-oral films and therefore safety lights good for intra-oral film processing
may be not adequate).
Always work with dry and clean hands.
Insert the film into the cassette and close it firmly. As a general rule to avoid
mistakes, unloaded cassettes are kept unlocked.
Combination with speed 400 is recommended.
Speed Screen type Film Type Light Color Manufacturer
250 Lanex Medium T Mat G GREEN Kodak
250 Curix Ortho Medium Dentus ST8G GREEN Agfa
400 Lanex Regular T Mat G GREEN Kodak
400 Curix Ortho Regular Dentus ST8G GREEN Agfa
400 Ektavision Ektavision GREEN Kodak

B Use of Storage Phosphor Plates

Cassettes to be used are without intensifying screens which are not compatible
with storage phosphor plates.
Make sure the plates are properly erased before loading them into the cassette.

2.6 Panoramic Magnification Factor

The shown size of the teeth in the radiograph is different than actual size.
The distance focus–film is of 513 mm, the one focus–object is of 404 mm.
The magnification factor of panoramic radiography (MFpan) can be computed
as follows:
MFpan = 513 / 404 which is about 1.27, i.e. 27% magnification.
Magnification in panoramic is referred to the vertical size of incisor teeth with
patient properly positioned.

2.7 Ceph Magnification Factor

The shown size of the skull in the radiograph picture is different than actual
size.
Distance focus–film is 1650 mm, the one focus–object is 1500 mm
The magnification factor of Cephalometric radiography (MFceph) can be com-
puted as follows:
MF ceph = 1650 / 1500 which is 1.10, i.e. 10% magnification.

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2.8 Provisions for safety

 Correct status of the unit and proper adjustment of movable parts are indi-
cated by the READY light . If system is not in the READY condition,
press the ARM MOVEMENT key to initialize the system.
 After each exposure the unit enters a waiting period to cool down.
 During the waiting time the READY indicator blinks and exposures can-
not be made. Count down register is displayed.
 If a failure happens when system is switched ON or during exposure, the
ERROR indicator will light up. This indicator is also lit for incorrect op-
erations (e.g. push-button released during exposure).
The number displayed represents the error code (see appendix A).
Press the ALARM RESET key to acknowledge and cancel the error in-
dication.

3. PANORAMIC RADIOLOGY
3.1 Panoramic Programs
Icon Program Exposure time
Standard panoramic on adult
14 s
constant vertical magnification
Child projection,
13 s
with reduced exposure
Half Panoramic Left 7s

Half panoramic Right 7s

Frontal Dentition 4.9 s

TMJ Lateral Projections 2 x 1.75 s

Maxillary Sinus 12 s

3.2 Trial Session

 A trial session without irradiation can be started by pressing the TEST
key push-button (9).
 By pressing the exposure hand-switch under the TEST condition the unit
performs normally, but X-rays are not generated.

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 To exit the TEST mode press again the TEST key.

 After the execution of a trial exposure without radiation, the rotating car-
riage moves to the “patient entry” position, and exits from “test mode”.

3.3 Technique Factors

Default values are reported in the tables below for film-screen combination of
speed 400. In case of use of receptors with different sensitivity, the technique
factors have to be changed accordingly.
 Increase of technique factors lead to darker radiographs.
 Decrease of technique factors lead to lighter radiographs.
Technique Factors Patient Size
Adult
Anodic Vol- Anodic Cur- Child Adult
Panoramic &
tage (kV) rent (mA) Panoramic TMJ & Sinus
partial views
61 6.3 Small
64 6.3 Medium
67 6.3 Large
70 6.3 Extra large Small
73 6.3 Medium Small
76 6.3 Large Medium
79 6.3 Extra large Large
82 6.3 Extra large
85 6.3
Values of kV and mA are automatically set and indicated on the display upon
selection of type of examination and patient size. In case a change is needed the
relevant parameter can be corrected on the control panel by using the PLUS
or MINUS keys on the right for mA and on the left for kV. The kV level is
related to penetration of X-ray, i.e. the ability to go through the anatomical
structures and build the image: the bigger the patient the higher the kV level.

3.4 Positioning Accessories

A bite block and a chin
rest for edentulous pa-
tients are available as
positioning devices.
Temporal resting bars
can be added as an op- Bite Chin
tion. Block Rest Temporal Bars

WARNING.
Only use the accessories indicated in this Operating Instructions.

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3.5 Collimator for Panoramic

A single collimator slit is available on Pan Solo units for a standard image
height of 13.5 cm on receptor. In Pan Ceph units with revolving collimator the
Child projection uses a dedicated slit to further reduce the exposure dose.

3.6 The Aiming Lights

The unit is equipped with a set
of LASER lights for the three
alignment planes:
Median Sagittal. It divides the
head of the patient in left and
right side. Check to be done
for the light beam to fall in
the middle of the face.
Frankfurt Horizontal Plane.
This beam source can be
moved up and down to align
just above the ear hole and
allow the operator to check
for correct orientation of the head (forward or backward tilting of the head).
Lateral Vertical Plane. It defines the center of the focal trough for the frontal
teeth (incisors), i.e. the correct position of the carriage (backward or forward
displacement of the rotating carriage) to have the teeth structures falling into
the focal trough.
The laser beams are activated with ALIGNMENT LIGHTS key on the con-
trol panel and stay on for 30 s.
The laser aiming system is a Class I laser product.
WARNING. Avoid unnecessary exposure of the eyes of the patient or of
the operator to the laser radiation and pay attention that the laser beams
are not intercepted by any optical device.

3.7 Resetting Carriage in Patient Entry Position

 The carriage is in “PATIENT ENTRY” position when the tube housing as-
sembly is on the right. The laser lights can be switched on and the alignment
of patient performed. In case of different position:
 Push briefly the X-ray pushbutton or the ARM MOVEMENT key on
the control panel to rotate forward.
 Keep pressed the RETURN key until starts for backward rotation,
from the READY position to PATIENT ENTRY position.

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3.8 Patient Positioning

 Remove from the patient any metal
item such as provisional denture, ear-
rings, necklaces, which might cause
ghost images on the radiograph (side
picture).
 In case a protective apron is used leave
the neck free not to interfere with the
X-ray beam (radiation enters from
sides and from rear of the patient).
 With the carriage in “entry” position, place the patient facing the mirror and
make sure he is holding firmly the handles.
 The patient must stay with lowered shoulders with advanced feet (almost
close to the column) to stretch the spine at cervical level for a better beam
penetration.
 Start with the unit slightly higher. Ask the patient to
tilt the head backward and bite the reference block.
Then press the DOWN key and lower the unit at
the same time asking the patient to tilt the head for-
ward following the lowering of the carriage.
Stop when the Frankfurt plane is horizontal.
Same procedure in case the chin rest is used.
UP
 Use the angled mirror to see the face of the patient KEY
and correct any side rotation of the head.
 Ask patient to open the lips and teeth are visible. By
biting the thin block, mouth is closed and teeth are DOWN
not superimposed. Use of cotton roll allows for same KEY
condition is in case the chin rest is used instead.
 Switch the positioning lights ON to properly lo-
cate the in-focus layer on frontal teeth by press-
ing the alignment lights key.
 Correction of the side position of the carriage is
not required for patients with normal occlusion
 In case of patient with overjet for class II or
class III malocclusion, using the the relevant
displacement key left or right, the rotat-
ing carriage is shifted forward or backward until the lateral light beam falls
over the canine (the corresponding shift in mm is displayed). In this position
the roots of the frontal teeth are positioned into the in-focus layer.

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 Ask the patient to swallow and keep the tongue lightly pressed to the palate,
then recommend to stay calm and firm, avoiding movements, till the end of
the exposure.

a) Correct position, Frankfurt plane is horizontal

b) Wrong position, head tilted forward, V shaped dental arch

c) Wrong position; head tilted backward, flat dental arch

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3.9 TMJ projections

 Two exposures are usually
taken with closed (habitual
occlusion) and open mouth.
 The full set of 4 images is
placed on one film.
2 4 3 1
.

 Patient is positioned with bite block under the nose.

 The lateral light is set on canine as for standard panoramic.
 Once taken the first set of two images, return the unit.
 A second set of two exposures (open mouth) can be taken immediately.

3.10 Maxillary Sinuses

 Patient is positioned with
bite block under the nose.
 The lateral light is set on
canine as for standard pano-
ramic.

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3.11 Panoramic Exposure

 In case of digital panoramic imaging activate OrisWin Pan program on
computer and start the procedure for a new image acquisition (File/New Im-
age).
 The operator is invited to stay behind the patient, three meters from the col-
umn, always keeping an eye to the patient, ready to terminate the exposure
in case of need, at any time (section 2.2, Operation, at page 8).
 Press the exposure hand-switch and hold it down during the whole cycle
until the acoustical and optical alarms are terminated and the rotating car-
riage and the cassette holder stop.
 Press the hand switch or the ARM MOVEMENT key. The rotating
unit performs the first part of return function to make it easier for the patient
to exit.
 Remove the exposed cassette and process the film immediately (for analog
systems only).
 Press the hand switch or the ARM MOVEMENT key to return to the
initial position for patient entry.
Last used data are stored and appear on the display: Program number, pa-
tient size, carriage shift, used collimator, kV level, mA value.
 Press the hand switch to have the rotating arm moving to the START po-
sition.
In case the patient is not properly positioned, the rotating arm can be
brought to the “entry” position by pressing for few second the ALARM RE-
SET key.
 Error messages to be handled by the operator:
 11 - Exposure Aborted During Irradiation. The film in the cassette has to
be changed to take a new radiograph, because exposed.
 12 - Exposure Aborted Before Irradiation. The film in the cassette was
not exposed and can be used for next rradiograph.
 20 - Exposure aborted after irradiation. The film in the cassette was cor-
rectly exposed and can be processed.

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4. CEPHALOMETRIC RADIOLOGY
4.1 Cephalometric Programs
Icon Program Format Notes
Latero-Lateral with A1 for Adult
soft tissue filter A2 for Child
Antero Posterior or S
Postero-Anterior
S
Wrist

4.2 Technique Factors

The X-ray tube current in the Ceph mode is automatically set to the value of 10
mA. The available mAs values are reported in the table below.
2 4 8 16 32
2.5 5 10 20 40
3.2 6.3 12 25
Values are reported in the tables below for film-screen combination of speed
400. In case of used of receptors with different sensitivity, the technique factors
have to be changed accordingly.
 Increase of technique factors lead to darker radiographs.
 Decrease of technique factors lead to lighter radiographs.
Ceph Exposures
LL Adult LL Child AP Wrist
Patient Size kV mAs kV mAs kV mAs kV mAs
1 Small 73 12 70 12 70 12 61 5
2 Medium 76 12 70 12 76 12 61 5
3 Large 79 12 73 12 79 12 61 5
4 Extra large 82 12 73 12 82 12 61 5

Values of kV and mAs are automatically set and indicated on the display upon
selection of type of examination and patient size.
In case a change is needed the relevant parameter can be corrected by acting on
the keys on the control panel.
The kV level is related to penetration of X-ray, i.e. the ability to go through the
anatomical structures and build the image information: the bigger the patient
the higher the kV level has to be.

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4.3 Collimator for Cephalometric

On Pan Ceph units 2 of the 6 collimator positions on the revolving disk are
available for the panoramic projections of adult and child.

Beam collimation for panoramic on Panoramic & Cephalometric

Units
Imaging
Display Program Projection
Size cm
Standard panoramic and partial
PAN A 1-3-4-5-6-7 15x30
views
PAN B 2 12x24 Child panoramic

4 positions on the revolving disk are reserved for teleradiography in metric or

inch formats as reported in the following.

Film Unit - Ceph Metric Format

Imaging
Display Program Projection
Size cm
18x24 S 9 - 10 18x24 Antero Posterior (vertical symmetric)
Latero Lateral Adult
18x24 A1 8 18x24
(vertical asymm.)
Latero Lateral Child
18x24 A2 8 18x24
(vertical asymm.)
24x30 S 9 - 10 24x30 Carpus (vertical symmetric)

Film Unit - Ceph Inch Format

Imaging
Display Program Projection
Size inch
8X10 S 9 - 10 8x10 Antero Posterior (vertical symmetric)
Latero Lateral Adult (horiz. asymme-
10X8 A1 8 10x8
tric)
Latero Lateral Child (horiz. asymme-
10X8 A2 8 10x8
tric)
10X10 S 9 - 10 10x10 Carpus (vertical symmetric)

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4.4 Film Formats and Cassette Placement

 Symmetric Format.
 Patient is placed facing the X-ray generator.
 Used for Antero-Posterior (AP, frontal) views and wrist.
 Cassette is aligned on cassette holder with mark “S”.
 Unit comes configured either for 18x24 cm or 8x10” format.
 Asymmetric Format.
 Patient is placed with the X-ray beam entering the left side.
 Used for Latero-Lateral (LL, side) views.
 Soft tissue filter A1 for adult or A2 for child.
 Ear plugs are aligned to the X-ray beam direction.
 Cassette is aligned on cassette holder with mark “A”.
 Unit comes configured for 18x24 cm, 8x10”, or 10x10” format.

4.5 Cephalometric Exposure

 The operator is invited to stay in front of the column, three meters from it,
always keeping an eye to the patient, ready to provide assistance in case of
need, at any time(section 2.2, Operation, at page 8).
 Press the exposure hand-switch and hold it down during the whole expo-
sure time until the acoustical and optical alarms are terminated. The longest
exposure tiem in ceph mode is of 4 seconds.
 Remove the exposed cassette and process the film immediately.

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5. MAINTENANCE
5.1 Cleaning
WARNING. Always disconnect the system from the mains (main
switch in the room) before cleaning it.
Use a mild soap to remove fingerprints or other traces of dirt being careful not
to let liquid substances penetrate the machine.
The plastic covers can be cleaned with a soft cloth and a mild detergent.

5.2 Disinfection
The parts that come into contact with the patient must be cleaned after each use
with a detergent (for example, a 2% ammonia solution) and then disinfected.
DO NOT use solvents or corrosive substances.
The bite block can be sterilized in autoclave at 121°C.

5.3 Technical maintenance

The user is responsible for keeping the system in normal efficiency conditions.
Failure to observe the instructions relieves the manufacturer or his agent from
any responsibility for injury, damage or non-conformities that may
consequently occur.
The integrity of every part of the machine and the fluidity of movements must
be checked regularly by the user.
WARNING. Any fault or malfunction must immediately be corrected
by qualified and trained personnel. Any defective part that may
compromise safe use of the machine must be repaired or replaced.
Machine maintenance must be carried out at least once a year by qualified
personnel according to indications provided by the manufacturer. The
following activities must be carried out:
 Complete check of system operation (kV, mA, s)
 Check all the mechanical and electrical safety functions.

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5.4 Disposing of Obsolete Equipment

A radiological system is made of different materials which include
many kinds of metals (iron, aluminum, lead, copper and others), plas-
tic materials, electronic components and dielectric oil in the tank of
the X-ray tube. The "crossed-out wheeled bin" symbol on the product
indicates that the product at the end of its useful life must not be dis-
posed of as unsorted municipal waste but has to be collected separately and de-
livered to specialized operators for recycling or disposal of waste of electrical
and electronic equipment (WAEE), in compliance with existing laws.
By doing in this way possible negative effects on human health and environ-
ment are prevented, and recycling of the component materials is promoted. Pe-
nalties are applicable to illicit disposal.
FONA and its local Dealers commit to fulfill obligations related to the man-
agement of WAEE of professional nature, according to the provisions of the
European directives 2002/96/EC and 2003/108/EC.

6. CLASSIFICATION
FONA XPan /Ceph are classified as follows:
 CE: the systems are listed in class IIb, with accessories in class I
 FDA: Class II equipment, including Class I lasers.
 IEC: Class I, type B equipment with Class I lasers (IEC 60825-1).
FONA XPan /Ceph comply with the following standards.
IEC 601-1 General requirements for safety
IEC 601-1-2 Electromagnetic compatibility
IEC 601-1-3 General requirements for radiation protection in diagnostic
X-ray equipment
EN 60601-1-4 Programmable Electrical Medical Systems
IEC 601-2-7 Particular requirements for the safety of high voltage gene-
rators of diagnostic X-ray generators
IEC 601-2-28 Particular requirements for the safety of X-ray source as-
semblies and X-ray tube assemblies for medical diagnosis
21CFR1020.30 Performance Standards for Ionizing Radiation Emitting
Products: Diagnostic X-ray Systems and their major Com-
ponents
21CFR1020.31 Performance Standards for Ionizing Radiation Emitting
Products: Radiographic Equipment
21CFR1040.10 Performance Standard for Light Emitting Products:
Laser products
IEC 60825-1 Safety of laser products. Part 1: Equipment classification,
requirements and user’s guide

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Appendix A
Alarm Messages

Warning Messages
A Low Battery
B X-ray generator hot
C CAM init
D Adjust Arm Position
E Wait for PC ready

Num Error Messages

1 kV reference signal out of range
2 mA reference signal out of range
3 Carriage rotation encoder failure
4 Carriage displacement encoder failure
5 Carriage rotation sensor failure
6 Carriage displacement sensor failure
7 Cassette displacement sensor failure
9 Tube-head temperature exceeding limit
11 Exposure aborted during irradiation
12 Exposure aborted before irradiation
13 38 V DC supply out of range
14 24 V DC supply out of range
15 15 V DC supply out of range
16 5 V DC supply out of range
17 High voltage failure
19 Exposure time exceeded
20 Exposure aborted after irradiation
21 No tube current
23 Filament current out of range
25 Thermal Sensor Failure
26 Battery fault (low voltage)
32 Control unit fault

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Appendix B
Icons
Compliance to Compliance to
IEC Type B Equipment European Commu- North American
nity Requirements Safety Requirements

The unit is ON OFF (disconnected See the Annexed

from mains supply) Documentation

X-ray indicator
ON (connected
The unit is READY (ionizing radiation
to mains supply)
emission)

Radiation Emission Radiography Digital Detector

Light Push Button indicator (green light)

Program selected
Program selection
1 through 7 for Pan, USB Interface
panoramic and cepha-
8 through 10 for (orange light)
lometric
Ceph
Patient size selection:
Standard panoram- UP
small, medium, large
ic carriage movement
extralarge

Increase parameter DOWN

kV level Child Panoramic
Carriage movement
mA or mAs level

Decrease parameter
kV level Half Panoramic Left Fuse
mA or mAs level

Carriage shift right

for patient positioning
Half Panoramic
Right ~ Alternate Current

Carriage shift left

Anterior Dentition Protective Earth
for patient positioning

Entity of carriage
TMJ Open and
displacement Inherent Filtration
Closed Mouth
in mm

Type of collimator Dispose properly

selected (Pan, Child, Maxillary Sinus Do not abandon in the
AP, LLA, LLB, APXL) environment

Arm Sequential Ceph Fragile, Handle With

Movement Latero Lateral Care

Patient alignment
Ceph
laser beams Fear of Humidity
Antero Posterior
(15 s ON)

Test mode without rad- Wrist Up, Do Not Overturn

iation emission

Size Adult/Child:
Alarm Reset small, medium, Stacking Limit Number
large extra-large

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Appendix C
Technical Data
EXTRAORAL RADIOGRAPHIC SYSTEM
FDA Classification Class II (21CFR872-1800, 21CFR892.1650)
IEC Classification: Class I, type B
Power Supply: 230 V ± 10%, 50/60 Hz, 8 A, slow fuse
115 V ± 10%, 50/60 Hz, 16 A, slow fuse
Mains Resistance: < 0.8 ohm at 230 V, < 0.4 ohm at 115 V
X-ray generator: Multipulse at 40-80 kHz
Anode Voltage: 61 - 85 kV ± 5%, constant potential
Anode Current: 4 - 10 mA ± 10%, direct current (DC)
Focus size: 0.5 IEC 336
Inherent Filtration > 3.0 mm Al @ 85 kV
Leakage Radiation < 50 mR/h (0.43 mGy/h) @ 100 cm, 85 kV, 10 mA
Column Heigth 220 cm/87”
Maximum height 225 cm/88.7”
Displacement 92 cm/36.2”, from 90 to 182 cm (35 to 71.7”)
Vertical Movement Motorized displacement
Patient Positioning Motorized horizontal displacement
Centering Light 3 lasers: Lateral, Median sagittal, Frankfurt
Centering Reference Bite block and chin rest for edentulous, tunable
temporal resting bars (option)
Source Image Distance Pan 51.3 cm/20.2”, Ceph 165 cm/65”
Vertical Magnification Pan 27%, Ceph 10%
Panoramic Projections: Adult standard with constant vertical magnification
on dental arch(14 s), Child at reduced dose (13 s),
Half Dentition Left (7 s), Half Dentition Right (7 s),
Anterior Teeth (4.9 s), TMJ habitual occlusion or
opened at maximum extent (3.5 s), Maxillary
Sinuses (12 s)
Ceph projections Antero Posterior, Latero Lateral Adult,
Latero Lateral Child, Carpus
Cool down pause: Variable pause depending on requested tube load
Weight: Pan Solo 100 kg/220 lb, Pan Ceph 120 kg/264 lb

LASER LIGHTS
FDA Classification Class I
Wavelength 650 nm
Output Power < 0.11 mW at 100 mm

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Appendix D
Labels

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Appendix E
Cooling Curves

COOLING CURVE OF X-RAY TUBE

kJ

20

18

16

14

12

10

0
0 1 2 3 4 5 6

Time (min)

COOLING CURVE OF TUBE HOUSING ASSEMBLY

kJ
120

100

80

60

40

20

0
0 15 30 45 60 75 90 105 120 135 150 165 180

Time (min)

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Appendix F
Fuse Table
FU 303
CONFIGURATION 230 V 115 V
CONNECTOR PLUG
T8A T 16 A
F 501
5x20 6.3x32
T 1.6 A T 3.15 A
FU 303
5x20 5x20
FU 304 FU 305 F 6.3 A F 6.3 A
FU 304
5x20 5x20
F 6.3 A F 6.3 A
FU 305
5x20 5x20

F MOT T4A T4A

5x20 5x20
POWER SUPPLY UNIT IS
AT TOP OF VERTICAL
CARRIAGE

TO ACCESS REMOVE TOP PLASTIC COVER FIXED WITH

TOP PLASTIC COVER 2 ALLEN SCREWS ON TOP
AND TOP METAL COVER 2 ALLEN SCREWS ON THE BACK

TOP METAL COVER FIXED WITH

2 PHILLIPS SCREWS ON TOP

FUSE MOT IS ON FUSE F 501 IS ON

THE LEFT SIDE THE RIGHT SIDE
BEHIND MIRROR BEHIND MIRROR
PLASTIC COVER PLASTIC COVER

F MOT F 501

MIRROR PLASTIC
COVER IS FIXED
WITH 4 ALLEN
SCREWS
ON THE BACK

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FONA Dental s.r.o.

Stefanikova 7 SK-811 06
Bratislava, Slovakia
www.fonadental.com