Sirona Orthophos 3 DS User Manual
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Sirona Dental Systems GmbH
Dear Customer Thank you for purchasing your new ORTHOPHOS 3 DS
X-ray unit for panorama planigraphy.
For this unit we have provided you with a set of techni-
cal literature: Operating Instructions, Installation
Instructions, Installation Report / Warranty Passport,
Wiring References, Pre-Installation, Dimensions, Technical Data. Keep this literature for quick and easy reference.
In order to protect your warranty rights, please fill out the
“Installation Report / Warranty Passport” provided
together with the technician immediately after installation of the unit.
Read the Operating Instructions to familiarize yourself
with the unit before taking radiographs on the patient.
Please observe the Radiation Protection Regulations
and Warning and Safety Notes.
These Operating Instructions assume a thorough familiarity with the SIDEXIS software.
Your
ORTHOPHOS Team
Maintenance To ensure the safety of the patient, the operators and
third parties, equipment inspections and maintenance
work must be carried out at specified intervals in order to
guarantee the operational safety and functional reliability
of your product.
It is the responsibility of the operator to ensure that the
inspections and maintenance work are carried out.
In the event that the operator fails to fulfil the obligation
to carry out inspections and maintenance work or
ignores error messages, Sirona Dental Systems GmbH
or their contracted dealer cannot assume liability for any
damage attributable to this.
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Sirona Dental Systems GmbH
List of Contents
1 Warning and Safety Notes........................................................................................................ 5
2 Technical Description ............................................................................................................... 8
2.1 Technical Data.................................................................................................. 8
3 Operating Controls and Displays........................................................................................... 12
3.1 Unit ................................................................................................................. 12
3.2 Multitimer ........................................................................................................ 13
4 Accessories ............................................................................................................................. 14
4.1 Rests and supports......................................................................................... 14
4.2 Hygienic Protective Covers............................................................................. 14
4.3 Service Tool.................................................................................................... 14
5 Exposure Programs ................................................................................................................ 15
5.1 P1 Program..................................................................................................... 15
5.2 P11 Program................................................................................................... 15
5.3 P6.1 / P6.2 Program ....................................................................................... 16
6 Operation.................................................................................................................................. 17
6.1 Preparing the Exposure .................................................................................. 17
6.2 Positioning the Patient.................................................................................... 20
6.3 Selecting Data at the Multitimer...................................................................... 25
6.4 Releasing the Exposure.................................................................................. 26
7 Programming ........................................................................................................................... 29
7.1 Programming Procedure................................................................................. 29
7.2 Adjustment of the Exposure............................................................................ 29
8 List of Help Messages H3/H4.................................................................................................. 30
9 Program Values ....................................................................................................................... 31
9.1 Program Values world-wide (except USA and Asia) ...................................... 31
9.2 Program Values USA...................................................................................... 32
9.3 Program Values Asia...................................................................................... 33
10 Care the surfaces .................................................................................................................... 34
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11 Error Messages........................................................................................................................ 35
12 Inspection and maintenance .................................................................................................. 36
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Sirona Dental Systems GmbH
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Sirona Dental Systems GmbH 1 Warning and Safety Notes
1 Warning and Safety Notes
Labeling of warning and safety information In order to prevent injury to persons and damage to the
equipment you must also read the warning and safety
notes given in these Operating Instructions. These are
emphasized with ATTENTION and CAUTION.
Intended use This unit has been designed for use in creating pano-
rama radiographic exposures.
This unit must not be used in areas where there is a risk
of explosion.
General safety information As manufacturers of electro-medical products, we can
assume responsibility for safety-related performance of
the equipment only if maintenance, repair and modifications are carried out only by us or agencies we have
authorized for this purpose, and if components affecting
safe operation of the unit that may be needed are
replaced with original parts.
We suggest that you request a certificate showing the
nature and extent of the work performed, from those who
carry out such work, and specify that the certificate show
any changes in rated parameters or working ranges, as
well as the date, the name of the firm, and a signature.
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For reasons of product safety, only original Sirona
accessories approved for this product, or accessories
from third parties which have been released by Sirona
may be used. It is the user's risk when using nonreleased accessories.
Exposures of patients may only be taken if the unit functions fault-free.
Never leave the patient unattended in the unit.
Instructions for avoiding, recognizing and correcting
unintended electromagnetic effects:
The ORTHOPHOS 3 DS X-ray System is a unit of class
A (classification according to CISPR 11, EN 60601-1-2:
1993 based off IEC 60601-1-2). This unit may be operated in a residential area, provided it is used under the
responsibility of a trained medical operator.
Safety measures during switch-on Following extreme temperature fluctuations, condensate
formation may occur; therefore please do not switch on
the device until normal room temperature has been
reached (see chapter "Technical Description").
When switching on the unit, there must not be a patient
positioned in the unit.
If a fault occurs which requires switching the unit off and
then back on again, the patient must be taken out of the
unit at the latest before switching it on again!
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1 Warning and Safety Notes Sirona Dental Systems GmbH
Interference with electromedical devices by radio
telephones
Malfunction of electronic units/devices which are
worn on the patient's body.
To guarantee the operational safety of electromedical
devices, it is recommended that the operation of mobile
radio telephones in the medical practice or hospital is
prohibited.
In order to prevent failure of electronic units and data
storage devices, e.g. radio-controlled watch and telephone card, etc., it is essential that these be removed
prior to X-ray exposure.
Radiation Protection Observe the applicable health physics regulations.The
radiation protection facilities should be used.
The operator should remain as far away from the X-ray
tube as the cable of the release button permits.
With the exception of the patient, no other persons
may remain in the room while the exposure is being
made.
Under exceptional circumstances a third person, however not belonging to the dental practice, may then
assist. Maintain visual contact with the patient and the
unit during the exposure.
In case of faulty operation, discontinue the exposure by
releasing the exposure button.
Disassembly and reinstallation For disassembly and reinstallation of the unit proceed as
described in the installation instructions for new installation to ensure perfect function of the unit and its stability.
Disposal It generally applies that any disposal of this product must
comply with the relevant national regulations. Please
observe the regulations applicable in your country.
Within the European Economic Community, Council
Directive 2002/96/EU (WEEE) requires environmentally
sound recycling/disposal of electrical and electronic
devices.
Your product is marked with the adjacent symbol. Disposal of your product with domestic
refuse is not compatible with the objectives of environmentally sound recycling/disposal.
The black bar underneath the "garbage can" symbol
means that it was put into circulation after Aug. 13, 2005.
(see EN 50419:2005)
Please note that this product is subject to Council Directive 2002/96/EU (WEEE) and the applicable national law
of your country and must be recycled or disposed of in
an environmentally sound manner.
The X-ray tube assembly of this product contains a
tube with a potential implosion hazard, a small amount
of beryllium, a lead lining and mineral oil.
Please contact your dealer if final disposal of your product is required.
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Sirona Dental Systems GmbH 1 Warning and Safety Notes
Laser light localizers used This product incorporates a laser of class 1.
The light localizers serve for the correct positioning of
the patient.
They must not be used for other purposes. A minimum
distance of 100mm must be maintained between the eye
and the laser. Do not look into the beam. Safety operation is described in Section 6.2.
The light localizers may be switched on only if they function fault-free. Repair work may be carried out only by
authorized personnel.
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2 Technical Description Sirona Dental Systems GmbH
2.1 Technical Data
2 Technical Description
2.1 Technical Data
Nominal line voltage: 208V / 230 V - 240 V~
Permissible line voltage fluctuation: ±10%
Nominal current: 9.7A
Nominal frequency: 50/60Hz
Power line resistance: max. 0.8 Ohm
Fuse at the distribution panel: 20A slow blow
Rating: 2.1kW
Tube voltage: 60 – 80 kV
Tube current: 6 – 11mA
Curve form of high voltage: high frequency
multipulse Residual ripple ≤ 4kV
Rotation time: see page 31
Exposure time: see page 31
Reproduction scale: With P1 program, medium mandibular arch (plane center) ca.
1:1,19. The image at the image receiver is approximately 19%
larger than the real proportions.
Focus size, according to IEC 336,
measured in central ray:
Focus marking:
Automatic exposure blockage (see page 27): The duration of the exposure blockage (cool-off period) depends on
Equipment of protective class I
Protection against electric shock:
Protection against penetration of water: Ordinary equipment (without protection)
0,5mm
the kV/mA step set and the actually triggered radiation time.
Depending on the tube load, pause times up to 200s are set automatically.
Example: For P1 program with exposure data 74kV/10mA and a
radiation time of 11.3s a pause of 200s results.
Type B equipment
Mode of operation: Continuous operation
Long time power rating: 64W
Target material: Tungsten
Loading factors concerning leakage radiation: 1.1mA / 80 kV
Leakage radiation: ≤ 1mGy/h
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Sirona Dental Systems GmbH 2 Technical Description
2.1 Technical Data
Source - Image receptor distance: 497mm
Transport and storing temperature: -40°C – +70° C (-40°F – 158°F)
Relative humidity: 10% – 95%
Permissible operating temperature: According to IEC 601-1 between +10°C and +40°C (50°F – 104°F)
Sensor (image receptor):
Type: Digital CCD-technology line sensor,
can be plugged to Panorama position.
External dimensions: 280mm x 120 mm x 35 mm
Active sensor surface: Panorama: 138mm x 5.9 mm
Resulting image format: Panorama: depends on selected program,
max. 138 x 288mm
Detail recognition: Panorama: 0.09mm pixel size
Minimum requirements for the PC systems:
Hard disk: > 2 GByte / database
> 50 MByte / SIDEXIS installation
RAM: at least 64 MB
Drives: CD-ROM
3.5" diskette (one per system / network)
MOD drive min. 640 MByte (one per system / network)
Operating system: Windows 98
Windows NT 4.0 / Service Pack >
Graphics system: Resolution at least 1024 x 768 pixels,
color depth at least 8 bit
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Network: 10 / 100 MBit Ethernet
Communication connection: RJ45 for LAN cable
Laser light localizer
Magnitude: 300mm long, 5mm wide
Max. radiant power: 350 J/m
Pulse duration: 100s
ORTHOPHOS 3 DS has been inspected by the VDE Testing and Certification Institute for compliance with EN 606011, EN 60601-2-28 and EN 60601-1-3 and has been found to comply with these regulations.
Original language: german
2
This product is provided with a CE marking in accordance with the regulations stated in the Directive 93/42/
EEC of June 14, 1993 concerning medical products.
0123
Reg. No.: China
SFDA (I) 20053301583
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2 Technical Description Sirona Dental Systems GmbH
2.1 Technical Data
Cooling curve for the tube housing:
HUx10
130
120
110
100
90
80
70
60
50
40
30
20
10
0 20 40 60 80 100 120 140 480 160 180 200 220
4
1HU = 1,35 Joule
Anode cooling caracteristic:
20
15
HUx10
3
1HU = 1,35 Joule
240
t
min
10
5
012 3 4 5 6
Heating curve for tube housing:
HUx10
1000
012 3 4 5 6
Reference axis:
3
1HU = 1,35 Joule
t
min
t
h
Reference axis
7°
10°
Anode angle
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Sirona Dental Systems GmbH 2 Technical Description
2.1 Technical Data
Radiation fields of the laser light localizers:
60°
°
32°
5
6
°
0
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3 Operating Controls and Displays Sirona Dental Systems GmbH
3.1 Unit
3 Operating Controls and Displays
3.1 Unit
43 2
9
10
1
1. Main switch
2. Patient positioning mirror
3. Head holder with adjusting knob for temple supports
4. Image receiver
5. Diaphragm
6. Diaphragm wheel
7. Height adjustment buttons
Additional function: key ↑ switches light localizer on
8. Knob for image receiver removal or insertion
9. Height adjustment
Light localizer horizontal light beam FH
10. Light localizer central light beam
11. Multitimer
58611 7
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