FONA XPan Operator Manual GB
FONA XPan Operator Manual GB
FONA XPan Operator Manual GB
Operating Instructions
FONA XPan – Operating Instructions
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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FONA XPan – Operating Instructions
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
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.
1.3 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.
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
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
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)
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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FONA XPan – Operating Instructions
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
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.
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
Maxillary Sinus 12 s
WARNING.
Only use the accessories indicated in this Operating Instructions.
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
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.
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.
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
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
Appendix B
Icons
Compliance to Compliance to
IEC Type B Equipment European Commu- North American
nity Requirements Safety Requirements
X-ray indicator
ON (connected
The unit is READY (ionizing radiation
to mains supply)
emission)
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
Decrease parameter
kV level Half Panoramic Left Fuse
mA or mAs level
Entity of carriage
TMJ Open and
displacement Inherent Filtration
Closed Mouth
in mm
Patient alignment
Ceph
laser beams Fear of Humidity
Antero Posterior
(15 s ON)
Size Adult/Child:
Alarm Reset small, medium, Stacking Limit Number
large extra-large
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
Appendix D
Labels
Appendix E
Cooling Curves
20
18
16
14
12
10
0
0 1 2 3 4 5 6
Time (min)
kJ
120
100
80
60
40
20
0
0 15 30 45 60 75 90 105 120 135 150 165 180
Time (min)
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 F 501
MIRROR PLASTIC
COVER IS FIXED
WITH 4 ALLEN
SCREWS
ON THE BACK