Fona XDG: Service and Installation Manual
Fona XDG: Service and Installation Manual
Fona XDG: Service and Installation Manual
English
FONA XDG – Service & Installation Manual
Table of Contents
18
10 11 12
8
16
13 14 15
9 17
EXPOSURE INDEX
0.32 0.4 0.5 0.63 0.8 1.0 1.25 1.6 2.0 2.5 3.2 4.0
CDR XIOS F E D
SENSOR SENSOR FILM FILM FILM
CDR Sensor by Shick Technologies Inc., XIOS Sensor by Sirona Dental Systems GmbH
1. INTRODUCTION
1.1 Purpose
The FONA XDG X-ray Equipment is designed to fulfil the needs for high resolution intra-oral radiography in
the general dental practice. The systems can be configured for wall, mobile solutions.
The Operator’s Manual and the Service and Installation Manuals supplied with the system are integral part
of the product. The original language of the Operator’s Manual is English.
1.2 Equipment Classification
IEC: FONA XDG is a Class I, type B equipment
FDA: FONA XDG is a Class II medical device equipment (21 CFR 872-1800).
1.3 Applicable Standards
The FONA XDG system configurations 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
Particular requirements for the safety of high voltage generators of diagnostic
IEC 601-2-7
X-ray generators
Particular requirements for the safety of X-ray source assemblies and X-ray
IEC 601-2-28
tube assemblies for medical diagnosis
21 CFR 1020.30 Diagnostic x-ray systems and their major components
21 CFR 1020.31 Radiographic equipment
93/42/EEC European Directive concerning medical devices (1993)
1.4 Environmental Data
Applicable ranges of temperature, humidity, and atmospheric pressure are reported here below both for
operation and transport conditions.
Ambient Transport & Storage
Temperature from 10 to 40 °C from –20 to +50 °C
Relative Humidity from 30 to 75% 10 to 90%
Pressure from 700 to 1060 hPa from 500 to 1060 hPa
2. TECHNICAL DATA
2.1 System Supply
Line Voltage 110-120 V (from 99 V to 132 V in sub-ranges depending on THA mounted)
220-240 V (from 198 V to 264 V in sub-ranges depending on THA mounted)
Line Power 400 W
Line Voltage Range 108 - 132 V for type 93 256 01300, 207 - 253 V for type 93 256 01700,
216 - 264 V for type 93 256 01800
Line Fuse Slow Blow: 6.3 A at 110-120 V, 4 A at 220-240 V, second fuse for 2 phases or cord
Line Frequency 50/60 Hz 1 Hz
Line Resistance 0.4 Ohm at 110-120 V, 0.8 Ohm at 220-240 V
Voltage regulation for max. line current: 2.1% at 110-120 V, 1.4% V at 220-240 V
2.2 X-ray Head Assemblies
120 V for type 93 256 01300, 230 V for type 93 256 01700,
Nominal Line Voltage
240 V for type 93 256 01800
6 A at 120 V for type 93 256 01300, 4 A at 230 V for type 93 256 01700,
Nominal Line Current
4 A at 240 V for type 93 256 01800
70 kVp ± 8% at nominal line voltage
Anode Voltage
66 kVp ± 8% at nominal line voltage – 10%
(peak tube potential)
74 kVp ± 8% at nominal line voltage+ 10%
3.5 mA ± 10% at nominal line voltage
Anode Current
3.0 mA ± 10% at nominal line voltage – 10%
(tube current)
4.0 mA ± 10% at nominal line voltage + 10%
Nominal Power 0.2 kW at 70 kVp, 3.5 mA, 0.1 s
X-ray Insert CF4G070
Anode Tungsten, angle 16° to the tube axis
Focal Spot 0.4 (EN 60336:1995-04)
Focal spot mark Dot embossed on plastic covers of tube-head
Inherent Filtration > 2.5 mm Al/70kVp (EN 60522: 1999)
Duty Cycle 1/15
Radiation Leakage < 0.1 mGy/h a 1 m (< 11.5 mR/h a 1 m)
2.3 Beam Limiting Device
Focus skin distance 21 cm (8.27”)
Beam Limiting Circular radiation field 6 cm (2.35”) diameter /Rectangular 3.2x4.2 cm
Device (1.26”x1.65”)
Maximum 10% eccentricity
2.4 TipSet Timer
Supply Voltage 110-120 for type 93 354 60200, 220-240 for type 93 354 60100
Time-current in mAs: from 0.21 to 11.2 mAs
0.21 0.28 0.35 0.42 0.56 0.70
Exposure factor
0.88 1.12 1.40 1.75 2.20 2.80
3.50 4.40 5.60 7.00 8.75 11.2
Precision ± 0.04 mAs o 10% (whichever the greater) supplied at nominal line voltage
Automatic setting through tooth type selection and patient build, for use with
Exposure factors
traditional film or digital sensor, or manual setting with plus and minus keys.
Irradiation signal Yellow light on hand-switch and on control panel plus acoustic buzzer
Hand-switch Hand-switch with 3 m coiled cord, with remote mounting optional kit
Overall size Width: 15 cm /6”, Height: 24 cm /9”½, Depth: 9 cm /3”½
2.5 Mechanical Suspension System
Wall Adaptor 12 cm /4.7” width, 24 cm /9.4” height, 9 cm /3.5” depth
Short (S): 30 cm /11.8”, Medium (M): 60 cm /23.6”,
Arm Length
Long (L): 80 cm /31.5”, Extra Long (XL) 100 cm /39,4”
Useful Reach Arm S: 138 cm /54.3”, M: 168 cm /66.1”, L: 188 cm /74”, XL: 208 cm /81.9”
Mobile Stand Size 78 x 92 cm (30” ¾ x 36” ¼), Height: 186 cm /73” ¼” with scissor arm
2.6 Weights
Timer 1.7 kg / 3.7 lb Support Arm Arm S: 2.8 kg /6.2 lb , M: 4.0 kg /8.8
X-ray Head 6.6 kg / 14.5 lb lb, L: 4.8 kg /10.6 lb,
Circular BLD 0.1 kg / 0.22 lb XL: 5.4 kg /11,9 lb
Rectangular BLD 0.2 kg / 0.44 lb Wall Adaptor 1.3 kg / 2.9 lb
Scissor Arm 11.7 kg / 25.8 lb Mobile Stand 29.4 kg / 64.8 lb
INPUT
POWER X-RAY
LINE SWITCH HEAD
IN OUT
ELECTRONIC WALL
TIMER ADAPTOR
The cables (2 poles plus ground) to connect the power line to the timer and the timer to the wall adaptor
are not provided. Cables with large section conductors have minimum electrical resistance and voltage
drop.
The resistance between the ground provision in the connecting block of the timer and the metal body of
the tube housing assembly has not to exceed 0.1 Ohm. Proper section of the yellow green wire to be used
in case remote mounting of the timer.
The wall adaptor is provided with a common bolt for bonding and grounding blocked in place
with a nut which has not to be removed.
LOCK-WASHER
COMMON BOLT
FLAT WASHER
NUT
BONDING BONDING CONDUCTOR
CONDUCTOR OF OF SCISSOR ARM
SUPPORT ARM (IN CASE)
NUT FLAT WASHER
GROUND PROVISION
TO TIMER LOCK-WASHER
BLOCKING NUT DO FLAT WASHER
NOT REMOVE FLAT WASHER
A Light grease the shaft at the base of the arm and make sure
the ring spacer is in place; push back the cylinder of the
friction into the support arm not to interfere during the
insertion of the shaft.
B Secure the trailing rope to the end of the electrical cable of
the Scissor Arm.
C Pull the other end of the trailing rope to drive the electrical
cable of the Scissor Arm through the Support Arm out into
the Wall Adaptor.
D Hold the opening section of the Scissor Arm, carefully
remove the safety string and allow the arm to open slowly,
away from people.
E Perform final set-up complying with recommended sequence
of actions reported in the following.
MAINS LINE
INPUT TO
TIMER
SUPPLY CABLE
FROM TIMER
TO TUBE HEAD
YELLOW-GREEN
GROUND PROVISION
TO TIMER
YELLOW-GREEN YELLOW-GREEN
GROUND PROVISION GROUND PROVISION
FROM MAINS ON TIMER
A Pass the conductor of the grounding provision (already connected to the common bolt) into the timer
for connection to the central ground point in the connecting block (protective earthing).
B Connect the grounding provision of the extension arm to the common bolt on the wall plate (flat
washer, ground provision, lock-washer, nut).
C Pass through the supply cable of the arm into the timer for connection to the OUT positions (supply
cable output to X-ray head).
3.1.11 Connecting the Wall Adaptor with Timer remote
A In case the connection to the mains is done starting from the wall adaptor a 5 position connection
block has to be mounted. This approach is recommended allowing for a lower ground resistance.
a The ground wire of the mains has to be connected in first position on the common bolt and
blocked with a nut.
b The mains line goes to the remote timer and back through the connection block to the X-ray head.
c The other grounding provisions for support arm and of cable returning from the timer to be
connected to the common bolt and blocked with a second nut.
d The ground resistance to consider is actually the one of the cable in the scissor arm.
B In case the connection to the mains is done through the timer box, the ground resistance to consider
includes the wire from the timer to the wall adaptor.
a Prepare the terminations of the cable for remote connection of timer with tips to fit the connecting
blocks in timer and connecting blocks plus the common bolt for grounding in wall adaptor.
Make sure the copper section of the yellow green wire is large enough (see section 0,
Electrical Requirements, at page 7).
YELLOW-GREEN TO YELLOW-GREEN
COMMON BOLT ON
WALL ADAPTOR
WALL TIMER
ADAPTOR SIDE
SIDE
BOLT FOR
BONDING AND
GROUNDING
SUPPLY CABLE
FROM REMOTE
SUPPLY TIMER TO TUBE
CABLE HEAD
TO TUBE
HEAD
YELLOW-GREEN
BONDING CONDUCTOR
SUPPORT ARM YELLOW-GREEN
GROUND PROVISION
YELLOW-GREEN FROM/TO TIMER
BONDING CONDUCTOR
SCISSOR ARM
D Connect the cable for remote connection of the timer by placing the ground wire as first conductor on
the common bolt for bonding and grounding; block with washers and nut.
E Place the phase and neutral wires to the connecting block.
F Connect to the common bolt for bonding and grounding the bonding conductor of the extension arm
and the one of the cable of the arm.
G Connect the phase and neutral conductors of the supply cable in the arm to the connecting block.
See section 0,
H Electrical Requirements, at page 7 to determine cable length and maximum distance.
CONNECTING BLOCK
IN THE TIMER
GROUND
HAND-SWITCH
SOCKET TST2
IN
HAND-SWITCH
OUT SOCKET TST1
FUSE F1
A Turn-off the voltage supply line. Connect the three wires from the voltage supply to the terminal
block (IN on the left) but do not connect any outgoing wire (OUT on the right) to Wall Adaptor.
B Make sure that the “live” conductor is the “hot” one:
a Connect an AC voltmeter or a test light between the block terminal “live in” and “ground”.
b Turn line voltage supply “ON”. If full line voltage is measured (test lamp lights) the wiring is
correct. If not turn line voltage supply “OFF”, reverse “live in” and “neutral in” wires and repeat the
measurement; eventually the full line voltage should be read between “line” and “ground” (test
lamp lights).
c Make sure no voltage is read between “neutral in” and “ground”; if not check line voltage
distribution.
C Test the timer for full functionality keeping the output cables disconnected not to supply the load.
D Connect the load.
a Turn OFF the line voltage supply line,
b Connect the three wires of additional cable outgoing to the Wall Adaptor, Arm, Tube Housing
Assembly. Live and neutral wires to the arm (X-ray head) can be interchanged.
Fuses of FONA XDG Timer
Ref. 115 V 230 V and 240 V
F1 6.3 AT 5x20 4 AT 5x20
F2 6.3 AT 5x20 4 AT 5x20
F3 315 mAT 5x20 315 mAT 5x20
F4 80 mAT 5x20 50 mAT 5x20
3.1.13 Connecting the Hand-Switch
A The hand-switch is provided with a 3 m coiled cord to be plugged one side in the hand-switch, the
other side in the lower left corner of the timer’s board, either externally (connector TST1) or internally
to the timer (connector TST2). Internal connection is for remote hand-switch or for additional control
safety switches.
COUPLING
YOKE
DIP 4 DIP 8
ANODE CURRENT TECHNIQUE
FACTOR
DISPLAYED
DIP 1
TECHNIQUE DIPS 2-3 DIPS 5-6-7
FACTOR TUBE HEAD PRE HEATING
CORRECTION TYPE TIME
DIP 1 DIPS 5 – 6 – 7
Technique Factor Correction Pre Heating Time
Disabled 100 ms
Enabled 120 ms
DIPS 2- 3
140 ms
Tube Head Type
110 or 220
160 ms
VAC
115 or 230
180 ms
VAC
120 or 240
200 ms
VAC
127 or 250
220 ms
VAC
DIP 4
240 ms
Tube Head Anode Current
DIP 8
3.5 mA
Technique Factor Displayed
7 mA s
mAs
POWER
SUPPLY
SET-UP KEYBOARD 5 V LED
MICROSWITCHES CONNECTOR
BACK UP TIMER
TEST POINT & LED
MICROPROCESSOR
WATCH DOG LED
POWER
SUPPLY
24 V LED
5VA TRANSFORMER
PRIMARY 115/230 V
SECONDARY 18 V
FUSE 4
T50mA @230V
T80mA @115V
FUSE 3
T 315 mA
JUMPER HANDSWITCH
FUSE 2 JUMPERS
INPUT
MAINS LINE OUTPUT
NEUTRAL LINE TO MAINS
& LIVE TUBEHEAD SWITCH
HANDSWITCH
SOCKETS
4. MAINTENANCE
Here in the following the list of recommended maintenance actions to keep the FONA XDG system in
compliance with the Performance Standard.
It is the responsibility of the User to maintain the equipment in compliance with the standard. Failure of
the User to properly maintain the equipment may relieve the Manufacturer, or its Agent, from responsibility
for any injury, damage or non compliance which may result.
Maintenance for the FONA XDG system to be done regularly by a service technician at least once every 24
months, with regular checks performed by the operator every year.
Any defect or malfunction should be corrected immediately by qualified personnel with adequate training.
WARNING.
POSITION OF 21
DISK SPRINGS IN
FRICTION SCREW FRICTION
7 GROUPS OF 3 SCREW
POSITION OF 15 FRICTION
DISK SPRINGS IN SCREW
FRICTION SCREW
5 GROUPS OF 3
A Slide partially out the extension arm from wall mount, inspect for
wear of the joint and lubricate for smooth rotation.
B Check friction during rotation of Arm and adjust relevant screw if
needed.
C Verify that the technical label with identification data is in place and is readable.
FRICTION
POINT 2
SPRING FRICTION
TUNING POINT 4
POINT
ALLEN KEY
C Specifically for the arm, at least ALLEN KEY
every 24 months in case of
normal use or after every 5000
cycles performed, have the
service technician inspect for
wear of pins and levers.
a Remove plastic covers.
b Check for wearing out of pin and levers, starting from the joint at the
base of the arm.
c Make sure no part is loose and no vibrations are occurring during movements.
d Apply silicon spray lubricant if needed.
e Replace the worn out parts or the arm itself if they appear damaged.
D To replace defective pins or levers
a have the X-ray head disconnected with arm fully open to avoid injuries for sudden opening.
b Loosen completely the two springs of the arm before extracting pins or removing levers.
E Mount back the X-ray head if removed and secure it with the retaining fork.
F Slide partially out the Scissor Arm from the Support Arm, inspect for wear of the vertical joint and
lubricate for smooth rotation.
G Verify that the label with identification data is in place and is readable.
HOLDING
POSITION OF 8 SCREW
DISK SPRINGS IN
BLOCKED
FRICTION SCREW
4 GROUPS OF 2
A Inspect for damage/wear to the X-ray tube-
head and support system.
B Inspect for oil leakage. Replace tube-head if FRICTION
necessary. SCREWS
C Check for position stability. If necessary remove
the cap on the yoke side, tune the three friction
screws (with disk springs) to be moderately tight for smooth rotation.
The fourth one without disk springs must be blocked in place
D Check that electrical cables are correctly twisted and not damaged or worn down.
E Verify that the technical label with identification data is in place and is readable.
F Dismount the tube-head from the arm and lubricate the pin for smooth rotation.
Warning: remove the tube-head with the arm completely open to avoid the risk of injuries.
G Check the retaining clip and replace if worn down. Do not mount the tube-head until all checks of the
suspension system are completed.
4.5 Maintenance of Beam Limiting Device
A Verify that the collimator is properly mounted and firmly closed.
B Verify that the internal cone is not damaged. Replace the collimator if necessary.
C Verify that the technical label with identification data is in place and is readable.
4.6 Maintenance of Timer
A Inspect the panel for damages on the surface.
B Inspect the cable of the exposure switch for wear.
C Check that all lights (except the yellow one) are working when the system is switched on.
D Perform a functional check with verification of a) setting of dip switches, b) yellow light, c) buzzer,
d) alarm A07 for “Exposure push button pressed at power on”, e) alarm A08 for “Exposure stopped by
the operator”.
E Verify that the fuses mounted comply with those indicated on the label and listed below.
F Verify that the technical label with identification data is in place and is readable.
right for the least significant one. Press the sensor key to
exit (E).
5.
5. MEASUREMENTS
All measurements to be done with the equipment supplied at nominal line voltage with specified line
resistance. The tolerances on the measured values have to take into account the precision of each
measurement instrument. Measurements have to be done by trained personnel only to avoid the risk of
electrical shock.
5.1 Line Voltage
The Line voltage can be measured using a Volt Meter for Alternate Current within the proper range. A
service function can be activated on the timer to display the current line voltage in V and frequency in Hz
(see section 4.8 of this Manual).
5.2 Anode Voltage – KVp
The kVp level is the actual peak value of the Anode voltage which stabilizes once the preheating time of
the filament has elapsed (in about 0.2 s) and the high voltage transformer is actually loaded. The kVp level
can be measured with a non-invasive kVp meter placed in front of the BLD following the instructions in the
user manual of the instrument. A correct measure can be done with an exposure time of 500 ms or more
having introduced a delay of the reading instrument of about 300 ms to allow the voltage level to stabilize
after the pre-heating time has elapsed.
5.3 Anode Current – mA
WARNING. To prevent high voltage shock make sure
the system is disconnected from the power supply
when connections to the measurement points are
performed. Electric discharge might occur in case of improper
operation. A1
The Anode current in mA is the actual average value of the
tube current which raises when the filament has warmed-up,
after the pre-heating time has elapsed.
Remove the back cover of the tube-head, disconnect the
jumper A1-A2 and replace it with a resistor of 1000 Ohm.
The anode current can be read with a DC voltmeter connected A2
to points A1 and A2, with the 1 V corresponding to 1 mA.
After the measurement disconnect the 1000 Ohm resistor and
put back the jumper.
5.4 Exposure Time
Here below the timing indications in s (R10 scale) and line pulses at 50 and 60 Hz for each value of
exposure factor in mAs for tubehead at 3.5 mA.
mAs Pulses Pulses mAs Pulses Pulses
@3.5 mA s 50 Hz 60 Hz @3.5 mA s @50 Hz @60 Hz
0.21 0,06 3 4 1.75 0,50 25 30
0.28 0,08 4 5 2.20 0,63 31 38
0.35 0,10 5 6 2.80 0,80 40 48
0.42 0,12 6 7 3.50 1,00 50 60
0.56 0,16 8 10 4.40 1,25 62 75
0.70 0,20 10 12 5.60 1,60 80 96
0.88 0,25 12 15 7.00 2,00 100 120
1.12 0,32 16 19 8.75 2,50 125 150
1.40 0,40 20 24 11.2 3,20 160 192
The actual exposure (loading) time is “determined as the time interval between the instant when the tube
current first rises above the 25% of its maximum value and the instant when it finally falls below the same
value”.
In order to assure the requested exposure time (irradiation), the pre-heating time of the insert used, which
has been set-up at installation, is taken into consideration. The actual switch-on time (SOT) of the X-ray
head assembly is therefore the sum of the filament pre-heating time (PHT) and of the requested exposure
time (RET).
SOT = PHT + RET
The measurement of the exposure time can be done with kVp & Time meters with the ability to trigger at
75% of maximum kV level.
Appendix A
Systems and Components
FONA XDG Systems FONA XDG Systems FONA XDG Systems
at 230 V at 240 V at 120 V
Description Code Code Code
Wall Syst. Arm S 30 cm 97 586 62320 97 566 62320 97 546 62320
Wall Syst. Arm M 60 cm 97 586 62620 97 566 62620 97 546 62620
Wall Syst. Arm L 80 cm 97 586 62820 97 566 62820 97 546 62820
Wall Syst. Arm L 100 cm 97 586 62120 97 566 62120 97 546 62120
Mobile System 97 586 67820 97 566 67820 97 546 67830
C
G H
F
I
A
G
L
E J
D
K
Appendix B
Icons
Fragile,
Lower Molar
Handle With Care
Up
Digital Receptor
Do Not Overturn
Separate Collection,
Ionizing Radiation
Do Not Dispose
Appendix C
Exposure Table
Upper
Upper Canine/ Upper
Incisor Premolar Molar
Lower Lower
Large Lower Canine/ Molar or Small
Patient Incisor Premolar Bitewing Patient
Appendix D
Alarm Conditions
Appendix E
Identification Labels
Appendix F
Cooling Curves
kJ
Time (min)
Time (min)