Planmeca ProOne User manual

technical manual
10016258_1
EN

TOC - i Planmeca ProOne
TABLE OF CONTENTS
Technical Manual
Chapter A GENERAL & TECHNICAL DATA
1 WARNINGS AND CAUTIONS .................................................................. A-1
2 MANUAL VERSIONS................................................................................ A-3
3 SYMBOLS ON PRODUCT LABELS ............................................................ A-3
4 TECHNICAL SPECIFICATIONS................................................................. A-4
4.1 Dimensions ................................................................................................. A-5
4.2 X-ray field area............................................................................................A-6
5 USER’S STATEMENT .................................................................................. A-7
6 HANDLING PRECAUTIONS FOR PCBs AND SOFTWARE CHIPS............ A-13
6.1 Handling printed circuit boards .................................................................A-13
6.2 Handling software flash memory chips .....................................................A-13
7 EMC INFORMATION ............................................................................. A-14
Chapter B PREVENTIVE MAINTENANCE
1 SYSTEM MAINTENANCE...........................................................................B-1
1.1 Cleaning......................................................................................................B-1
1.2 Operator’s checks .......................................................................................B-1
2 PREVENTIVE MAINTENANCE CHECKS ....................................................B-2
Chapter C C-ARM AND UPPER ARM
1 REMOVING COVERS ..............................................................................C-1
1.1 Removing the upper arm cover...................................................................C-1
1.2 Removing the sensor head cover ...............................................................C-2
1.3 Removing the tube head cover ...................................................................C-3
1.4 Removing the C-arm inner cover ................................................................C-4
2 ADJUSTING AND CALIBRATING X-RAY BEAM ......................................C-5
2.1 Radiation protection ....................................................................................C-5
2.2 Checking the X-ray unit adjustments ..........................................................C-6
2.3 Tools required .............................................................................................C-7
2.4 Step 1: Adjusting the X-ray beam position..................................................C-9
2.5 Step 2: Adjusting the patient support table in y-direction..........................C-13
2.6 Step 3: Adjusting the patient support table in x-direction..........................C-16
2.7 Step 4: Checking the symmetry ................................................................C-18
2.8 Step 5: Adjusting the positioning lights .....................................................C-20
2.9 Step 6: Calibrating the sensor...................................................................C-26
2.10 Step 7: Taking a ball phantom exposure ..................................................C-31

TOC - ii Planmeca ProOne
TABLE OF CONTENTS
Technical Manual
The manufacturer, assembler, and importer are responsible for the safety, reliability and
performance of the unit only if:
- installation, calibration, modification and repairs are carried out by qualified author-
ized personnel
- electrical installations are carried out according to the appropriate requirements such
as IEC364
- equipment is used according to the operating instructions
Planmeca pursues a policy of continual product development. Although every effort is
made to produce up-to-date product documentation this publication should not be re-
garded as an infallible guide to current specifications. We reserve the right to make
changes without prior notice.
COPYRIGHT PLANMECA 2007-10
PUBLICATION PART NUMBER 10016258 Revision 1
3 PARTS REPLACEMENT ........................................................................... C-33
3.1 Replacing the sensor head .......................................................................C-33
3.2 Replacing the tube head/PSU...................................................................C-35
3.3 Replacing the primary collimator...............................................................C-37
3.4 Replacing the layer light............................................................................C-38
3.5 Replacing the midsagittal plane positioning light ......................................C-39
Chapter D MOVING COLUMN
1 REMOVING COVERS...............................................................................D-1
1.1 Opening the front panel ..............................................................................D-1
2 PARTS REPLACEMENT ..............................................................................D-2
2.1 Replacing the Frankfort plane positioning light ...........................................D-2
2.2 Replacing the control panel ........................................................................D-3
2.3 Replacing the CPU PCB .............................................................................D-4
2.4 Replacing the lift motor ...............................................................................D-5
2.5 Replacing the lift motor steel cables .........................................................D-10
3 UPDATING SOFTWARE...........................................................................D-15
Chapter E DIAGRAMS

Planmeca ProOne A-1
Chapter
Technical Manual
AGENERAL & TECHNICAL DATA
1 WARNINGS AND CAUTIONS
WARNING
THE FOLLOWING WARNINGS, CAUTIONS AND NOTES MUST
ALWAYS BE CONSIDERED WHILE SERVICING THE X-RAY UNIT
IN ORDER TO AVOID PERSONAL INJURY OR DAMAGE TO THE
UNIT.
CAUTION RADIATION SAFETY RULES
Some procedures described in this manual produce X-ray radiation.
Always follow the rules for radiation protection.
Never attempt to open the TUBE HEAD. It does not contain any
serviceable parts, and radiation safety can no longer be guaranteed.
Never take exposures without the filter or the beam limiting device
(collimator) in place. Otherwise the radiation safety cannot be
guaranteed.
CAUTION ELECTRICAL SAFETY RULES
The X-ray unit contains hazardous voltages. While servicing internal
parts, always disconnect the unit from the mains (if possible) by
removing the plug from the wall outlet, and wait for 2 minutes before
touching any electrical parts.
Always replace the fuses with those of the same type and rating.
Otherwise patient, operator or equipment safety cannot be
guaranteed.
The circuit boards can be damaged due to static discharges and
require careful handling.
Do not connect a multiple portable socket outlet (MPSO) or an
extension cord to the system.
Do not connect items which are not specified as part of the system.
The X-ray unit must be connected to a dedicated, protectively
grounded power line (no other devices are connected to the same
power line).
If the X-ray unit is not connected to an Uninterruptible Power Supply
(UPS), disconnect the unit from mains during lightning storms.

CHAPTER A
GENERAL & TECHNICAL DATA
A-2 Planmeca ProOne
Technical Manual
WARNINGS AND CAUTIONS
CAUTION GENERAL SAFETY RULES
The X-ray unit must be serviced only by qualified personnel, trained
by PLANMECA. Repairs and parts replaced by unqualified personnel
carry no warranty.
The mains cord is a special part and always needs to be exchanged to
a part ordered especially from PLANMECA. The mains cord can only
be exchanged by a qualified authorized service technician trained by
PLANMECA.
Periodical maintenance as described in this manual must be
performed on a regular basis, to ensure the safety and image quality
of the X-ray unit.
Some procedures described in this manual could be dangerous if not
followed as stated.
NOTE The PC connected to the system must be:
- approved by local authorities: e.g. IEC-approved (CE marked), UL/CSA-approved
- located outside the patient area (more than 2m (79 in.) from the X-ray unit)
- protectively grounded.
NOTE External equipment intended for connection to signal input, signal output or other
connectors, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical electrical equipment). In addition, all such
combinations - systems - shall comply with the standard IEC 60601-1-1, Safety
requirements for medical electrical systems. Equipment not complying to IEC 60601
shall be kept outside the patient area (more than 2m (79 in.) from the X-ray unit).
Any person who connects external equipment to signal input, signal output or other
connectors has formed a system and is therefore responsible for the system to
comply with the requirements of IEC 60601-1-1.
NOTE EMC requirements have to be considered, and the equipment must be installed and
put into service according to the specific EMC information provided in section 7
"EMC INFORMATION" on page 14.
NOTE Portable and mobile RF communications equipment can affect the Planmeca ProOne
X-ray unit. For minimum distance between portable and mobile RF communications
equipment and the Planmeca ProOne X-ray unit, section 7 "EMC INFORMATION" on
page 14.
NOTE Never place or hang any objects on any part of the X-ray unit.
NOTE Make sure that you cannot get caught or hooked up on any part of the X-ray unit.
Keep loose items of clothing, hair and jewellery tucked away safely.
NOTE The display values shown in this manual are only examples and should not be
interpreted as recommended values unless otherwise stated.

Planmeca ProOne A-3
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
MANUAL VERSIONS
2 MANUAL VERSIONS
The installed software version determines the available functions and behaviour of the X-
ray unit. If the unit is reporting error or help messages not listed in this manual, please
refer to a newer revision of the manual.
NOTE This manual is valid for software version 1.0.0.r or later. If you find service modes
described in this manual that do not exist in the X-ray unit, update the unit software
to the latest version.
3 SYMBOLS ON PRODUCT LABELS
Type B applied part (Standard IEC 60601-1)
Alternating current (Standard IEC 60417)
Attention, consult accompanying documents
(Standard IEC 60601-1)
Warning: dangerous voltage
(Standard IEC 60417)
Electrostatic sensitive device (Standard IEC 60417)
Separate collection for electrical and electronic equipment
according to Directive 2002/96/EC (WEEE).

CHAPTER A
GENERAL & TECHNICAL DATA
A-4 Planmeca ProOne
Technical Manual
TECHNICAL SPECIFICATIONS
4 TECHNICAL SPECIFICATIONS
Original manufacturer
Planmeca Oy, Asentajankatu 6, FIN-00880, Helsinki, Finland
Phone: [phone], Fax: [phone], www.planmeca.com
Generator Constant potential, resonance mode
high frequency 60 - 80 kHz
according to IEC 60601-2-7: 1998
X-ray tube Toshiba D-058SB
Focal spot size 0.5 x 0.5 mm
according to IEC 60336:2005
Total filtration min. 2 mm Al
Anode voltage 60 - 70 kV ± 5%
Anode current 2 - 7 mA ±10%
Cooling period Automatically controlled
Exposure time 2 - 10 s as indicated ±10%
Duty cycle for height adjustment 1:10 or 2 min continuous use followed by
18 min not in use
SID 480 mm (19 in.)
Magnification 1.22 - 1.29 (panoramic exposures)
CCD pixel size 33 μm
Image pixel size 99/132 μm (selectable)
CCD active surface 9 x 136 mm (0.35 x 5.35 in.)
Line voltage 100 - 240 V~ / 50 - 60 Hz
Power input Continuous operation with intermittent
loading
800W intermittent: 1:20
(70 kV, 7 mA, 10 s exposure)
25W continuous
Line harmonics According to IEC 61000-3-2 class A
Max. permissible apparent
impedance of supply mains
0.5 Ω(100VAC)
Electrical classification Class I, type B applied part
Fuses 2 user replaceable fuses
F 8A H 250V
Weight 67 kg (148 lb)
Colour White, RAL 9016
Ambient temperature Operating +10°C to +40°C
storage ±0°C to +50°C
transport ±0°C to +50°C
Humidity 15% - 85%

Planmeca ProOne A-5
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
TECHNICAL SPECIFICATIONS
4.1 Dimensions
The numbers given below are nominal, physical measurements of the X-ray unit.
The minimum operational space requirements are given in the table below the figure.
Minimum operational space requirements
Width Depth Height
Planmeca ProOne X-ray unit 1300 mm
51 in.
1300 mm
51 in.
2250 mm
89 in.
2230 mm 87.8 in.
1751.5 mm 69 in. 1832 mm 72.1 in.
800 mm 230 mm 31.5 in. 9.1 in.
571mm
394 mm
22.5 in.
15.5 in.

CHAPTER A
GENERAL & TECHNICAL DATA
A-6 Planmeca ProOne
Technical Manual
TECHNICAL SPECIFICATIONS
4.2 X-ray field area
ProOne_017
C-arm
X-ray field area

Planmeca ProOne A-7
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
USER’S STATEMENT
5 USER’S STATEMENT
Radiation leakage technique factors
The maximum rated peak tube potential is 70 kV and the maximum rated continuous tube
current is 2 mA for the maximum rated peak tube voltage.
Filtration
The Radiation port contains additional filtration of at least 1.5 mm aluminium.
Total filtration min. 2 mm Al.
When the X-ray beam is attenuated with 1.5 mmAl the resulting dose is 0.5 - 0.7 times the
original.
Maximum attenuation equivalent of the front panel of the panoramic sensor
head
0.5 mmAl
Rated line voltage
100 - 240 V~
Maximum line current
Maximum 8 Amperes at 100 V~, 4A at 230 V~
Technique factors that constitute the maximum line current condition
70 kV / 7 mA at 100 V~
Generator rating and duty cycle
SW controlled at least 1:20 at 25°C ambient temperature with 70 kV, 7 mA, 10 s.
Maximum deviation of peak tube potential from indicated value
±5%
Maximum deviation of tube current from indicated value
±10%
Maximum deviation of exposure time from indicated value
±10%

CHAPTER A
GENERAL & TECHNICAL DATA
A-8 Planmeca ProOne
Technical Manual
USER’S STATEMENT
DEFINITION OF MEASUREMENT CRITERIA
Exposure time
The beginning and end points of the exposure time are defined at 70% of the peak
radiation waveform measured with a calibrated X-ray monitor.
Peak tube potential
Is defined as the maximum voltage difference over the X-ray tube. It is measured with a
calibrated non-invasive kVp meter.
The nominal X-ray voltage together with the highest X-ray tube current
obtainable from the high-voltage generator when operated at its nominal X-
ray tube voltage
70 kV 7 mA
The highest X-ray tube current together with the highest X-ray tube voltage
obtainable from the high-voltage generator when operated at its highest X-ray
tube current
7 mA 70 kV
The X-ray tube voltage and X-ray tube current which result in the highest
electric output power
70 kV 7 mA
Reference loading conditions
70 kV 7 mA 1260 mAs/h (duty cycle 1:20)
The nominal electric power for a load time of 2s and at the nominal X-ray tube
voltage
70 kV 7 mA - 800 W
The reference current time product
12 mAs
Irradiation time 2 s, X-ray tube current 6mA, X-ray tube voltage: whole range
Nominal anode input power of the X-ray tube
490 W
Maximum anode heat content of the X-ray tube
10 kJ

Planmeca ProOne A-9
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
USER’S STATEMENT
Anode heating/cooling curve of the X-ray tube
Single load rating of the X-ray tube
Target material of the X-ray tube
Tungsten anode
Reference axis to which the target angle and the focal spot characteristics of
the X-ray tube refer
90° with respect to the anode-cathode axis (pan)
Target angle with respect to the reference axis
12.5°
5
0
2
4
6
8
10
12
14
HEAT STORAGE (kJ)
TIME (min)
300W
200W
100W
10 234
HEATING
COOLING
TUBE CURRENT (mA)
EXPOSURE TIME (s)
0.1 1 10
0
2
4
6
8
10
12
14
16
50kV
60kV
70kV

CHAPTER A
GENERAL & TECHNICAL DATA
A-10 Planmeca ProOne
Technical Manual
USER’S STATEMENT
Filtration in terms of quality equivalent filtration of the X-ray tube
Inherent filtration at least 0.8 Al/50 kV according to IEC 522/1976
Emission and filament characteristics of the X-ray tube
Maximum X-ray tube assembly heat content
140 kJ
X-ray tube assembly heating/cooling curve
Maximum continuous heat dissipation of the X-ray tube assembly
4.3 kJ/min.
Ef
70kV
TUBE CURRENT (mA)
FILAMENT VOLTAGE (V)
0
2
4
6
8
10
12
14
1
1.5
2
2.5
3
3.5
4
4.5
2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0
FILAMENT CURRENT(A)
60kV
50kV
10000
30000
50000
70000
90000
110000
130000
150000
170000
0 15 30 45 60 75 90 105 120 135 150 165 180 195 210 225 240
TIME (min)
HEAT STORAGE (J)
Heating
curve
Cooling
curve
ProOne_Temp_Chart.eps

Planmeca ProOne A-11
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
USER’S STATEMENT
Reference axis to which the target angle and the focal spot characteristics of
the tube head assembly refer
Target angle with respect to the reference axis
12.5°
Dimensions of the tube head assembly
(WxHxD) 175 mm x 345 mm x 105 mm
Weight of the tube head assembly
7.4 kg
Values of loading factors concerning leakage radiation
70 kV, 7 mA
Tolerances of the focal spot on the reference axis
X= ±0.5 mm (sideways)
Y= ±0.5 mm (in depth)
Z= ±0.5 mm (in height)
ProO_Focus_Side.ai
7°
ProO_Focus_Top.ai
90°

CHAPTER A
GENERAL & TECHNICAL DATA
A-12 Planmeca ProOne
Technical Manual
USER’S STATEMENT
Indication of focal spot
ProO_Focus_Side.ai
Tube head
Focal spot
indication

Planmeca ProOne A-13
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
HANDLING PRECAUTIONS FOR PCBS
AND SOFTWARE CHIPS
6 HANDLING PRECAUTIONS FOR PCBs AND
SOFTWARE CHIPS
6.1 Handling printed circuit boards
The circuit boards are well protected against static discharges when they are in the X-ray
unit. However, some precautions are necessary when handling the boards since some
internal nodes on the PCBs can easily be damaged by static electricity. This is true
especially during low humidity conditions when there is evidently a potential risk of static
discharges.
WARNING
INPROPER HANDLING MIGHT CAUSE DISTRUCTIVE DAMAGE TO THE CIRCUIT
BOARDS. WARRANTY DOES NOT COVER SUCH DAMAGES.
Follow these rules when handling PCBs or software chips:
• Grounding wrist-straps are recommended but not necessarily required when handling
the boards, as long as you first always touch a grounded exposed metal part in the X-
ray unit before touching the PCB.
• Place the removed PCB immediately in an antistatic plastic bag without landing it any-
where else in between. PCBs for warranty replacement must be returned to the factory
properly packaged in antistatic plastic bags.
• Never place a removed PCB on any surface or hand it to another person without touch-
ing the surface or the person first.
6.2 Handling software flash memory chips
It is strongly recommended that the software is always upgraded electronically. In the
event that this is done the “old-fashioned” way (by replacing the software chips), you can
avoid static discharge problems by following the same rules that apply for PCBs (see
above).
Software flash memory chips must always be stored in their specific anti-static plastic
tubes which also protect them mechanically. A mechanically damaged chip might also
damage the mating socket on the CPU board.
Since the software chips are of PLCC-type (plastic leadless chip carrier), they must be
removed only by using a proper extracting tool (see spare part manual for details). Using
any other tool for removal can seriously damage the sockets on the CPU board.

CHAPTER A
GENERAL & TECHNICAL DATA
A-14 Planmeca ProOne
Technical Manual
EMC INFORMATION
7 EMC INFORMATION
WARNING
Use of any accessories and cables other than those specified in
Planmeca ProOne X-ray unit’s documentation, with the excep-
tion of cables sold by Planmeca as replacement parts for inter-
nal components, may result in increased emission or decreased
immunity of the X-ray unit.
WARNING
Planmeca ProOne X-ray unit should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is nec-
essary, the Planmeca ProOne X-ray unit should be observed to
verify normal operation in the configuration in which it is used.
Guidance and manufacturer’s declaration - electromagnetic emissions
Planmeca ProOne X-ray unit is intended for use in the electromagnetic environment specified
below. The customer or the user of the Planmeca ProOne X-ray unit should make sure that it is
used in such environment.
Emissions Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
Planmeca ProOne X-ray unit uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Planmeca ProOne X-ray unit 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
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

Planmeca ProOne A-15
Technical Manual
CHAPTER A
GENERAL & TECHNICAL DATA
EMC INFORMATION
Guidance and manufacturer’s declaration - electromagnetic immunity
Planmeca ProOne X-ray unit is intended for use in the electromagnetic environment specified below. The
customer or the user of Planmeca ProOne X-ray unit should make sure that it is used in such environment.
Immunity IEC 60601
level Compliance level Electromagnetic environment- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
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
±2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV line to earth
±1 kV line to line
±2 kV line to earth
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
<5 %
U
T
(>95 % dip in U
T)
for 0,5 cycle
40 %
U
T
(60 % dip in U
T)
for 5 cycles
70 %
U
T
(30 % dip in U
T)
for 25 cycles
<5 %
U
T
(>95 % dip in U
T)
for 5 s
<5 %
U
T
(>95 % dip in U
T)
for 0,5 cycle
40 %
U
T
(60 % dip in U
T)
for 5 cycles
70 %
U
T
(30 % dip in U
T)
for 25 cycles
<5 %
U
T
(>95 % dip in U
T)
for 5 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of Planmeca ProOne X-ray unit
requires continued operation
during power mains interruptions,
it is recommended that Planmeca
ProOne X-ray unit is powered
from an uninterruptible power
supply.
Power frequency(
50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment. The power
frequency magnetic field should
be measured in the intended
installation location to assure that
it is sufficiently low.
NOTE
U
Tis the a.c. mains voltage prior to application of the level.

CHAPTER A
GENERAL & TECHNICAL DATA
A-16 Planmeca ProOne
Technical Manual
EMC INFORMATION
Guidance and manufacturer’s declaration - electromagnetic immunity
Planmeca ProOne X-ray unit is intended for use in the electromagnetic environment specified below. The
customer or the user of Planmeca ProOne X-ray unit should make sure that it is used in such
environment.
Immunity IEC 60601
level
Compliance
level
Electromagnetic environment-
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Planmeca ProOne X-ray unit,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
where Pis the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and dis the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,ashould be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which Planmeca ProOne X-ray unit is used exceeds the
applicable RF compliance level above, Planmeca ProOne X-ray unit should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating Planmeca ProOne X-ray unit.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d1,2P=
d1,2P=80 MHz to 800 MHz
800 MHz to 2.5 GHz
d2,3P=