Sirona Orthophos 3 User Manual
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General information Sirona Dental Systems GmbH
Operating Instructions ORTHOPHOS 3
General information
Dear customer, Thank you for purchasing your new Sirona X-ray unit
ORTHOPHOS
For this unit we have provided you with a set of technical 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.
Your
ORTHOPHOS-Team
®
3 for panorama planigraphy.
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
Operating Instructions ORTHOPHOS 3
List of Contents
1 Warning and Safety Notes............................................................................................. 5
2 Technical Description .................................................................................................... 9
2.1 Technical Data.................................................................................................................................... 9
3 Operating Controls and Displays ............................................................................... 13
3.1 Unit ................................................................................................................................................... 13
3.2 Multitimer .......................................................................................................................................... 14
4 Accessories .................................................................................................................. 15
4.1 Rests and supports........................................................................................................................... 15
4.2 Hygienic Protective Covers............................................................................................................... 15
4.3 Service Tool...................................................................................................................................... 15
5 Exposure Programs ..................................................................................................... 16
5.1 Program P 1...................................................................................................................................... 16
5.2 Program P 11.................................................................................................................................... 16
5.3 Program P 6.1 / P 6.2 ....................................................................................................................... 17
6 Operation ...................................................................................................................... 18
6.1 Preparing the Exposure.................................................................................................................... 18
6.2 Positioning the Patient ...................................................................................................................... 20
6.3 Selecting Data at the Multitimer........................................................................................................ 25
6.4 Releasing the Exposure.................................................................................................................... 26
7 Programming ................................................................................................................ 28
8 List of Help Messages H3............................................................................................ 29
9 Program Values ............................................................................................................ 30
9.1 Program Values world-wide (except USA and Asia) ........................................................................ 30
9.2 Program Values USA........................................................................................................................ 31
9.3 Program Values Asia........................................................................................................................ 32
10 Care the surfaces ......................................................................................................... 33
11 List of Error Messages................................................................................................. 34
11.1 Error Messages ................................................................................................................................ 34
12 Inspection and Maintenance ....................................................................................... 35
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List of Contents Sirona Dental Systems GmbH
Operating Instructions ORTHOPHOS 3
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Sirona Dental Systems GmbH 1 Warning and Safety Notes
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Operating Instructions ORTHOPHOS 3
1 Warning and Safety Notes
Labeling of warning and safety information To prevent any personal injury or material damage,
please observe the warning and safety information provided in the present operating instructions. They are
highlighted by the caption
NOTE, CAUTION or WARNING.
Symbols used Observe accompanying documents
(on name plate)
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.
Maintenance and repair As manufacturers of electromedical equipment we can
assume responsibility for safety-related performance of
the equipment only if maintenance and repair are carried out only by us or agencies we have authorized for
this purpose, and if components affecting safe operation
of the unit are replaced with original spare parts.
We suggest that you request a certificate showing the
nature and extent of the work performed from those who
carry out such work; it must contain any changes in rated
parameters or working ranges (if applicable), as well as
the date, the name of the company and a signature.
Modifications to the system Modifications to this system which could impair the
safety of operators, patients or third persons are prohibited by legal provisions!
For reasons of product safety, this product may be
operated only with original Sirona accessories or accessories manufactured by third parties expressly approved
by Sirona. The user is responsible for dangers resulting
from the use of non-approved accessories.
If any devices not approved by Sirona are connected,
they must comply with the applicable standards:
IEC 60950 for information technology equipment (e.g.
PCs), and IEC60601-1 for medical electrical equipment.
Ventilation slots Under no circumstances may the ventilation slots on the
unit be covered, since otherwise the air circulation will be
obstructed.
Do not spray disinfectants or other similar products into
the ventilation slots.
X-rays of patients X-rays of patients must be taken only when the system
works without errors.
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1 Warning and Safety Notes Sirona Dental Systems GmbH
The system may only be operated by skilled or properly trained personnel.
The movements of the unit must not be obstructed by
physical constitution nor clothing, dressings, wheelchairs or hospital beds!
Do not leave the patient unattended in the unit.
Operating Instructions ORTHOPHOS 3
Electromagnetic compatibility (EMC) Medical electrical devices are subject to special precau-
tionary measures regarding EMC. They must be
installed and operated as specified in the document
"Installation Requirements".
Information on avoiding, recognizing and eliminating
unintended electromagnetic effects:
The ORTHOPHOS 3 acquisition unit is a Class B device
(classified according to CISPR 11, EN 60601-1-2: 2001
based on IEC 60601-1-2).
This system may be operated in a residential area.Portable and mobile HF communication devices can influence medical electrical equipment. The use of mobile
telephones in the practice or hospital area therefore
must be prohibited.
Precautionary measures when switching on the unit Following extreme temperature fluctuations, condensa-
tion may occur; therefore please do not switch on the
system until it has reached normal room temperature
(see chapter “Technical Description”).
No patient may be positioned in the unit during
power-on.
In case of an error that requires switching off and subsequent switching on of the unit, the patient must be
removed from the unit before switching it on again at the
latest!
Emergency Stop If parts of the unit contact the patient during the rotational
movement , let go of the exposure release button
(X-Ray) immediately and stop the unit by actuating the
unit main switch or an Emergency Stop switch!
Disturbance of electronic devices worn on the
patient’s body.
To prevent the malfunctioning of electronic devices and
data storage devices, e.g. radio-controlled watches, telephone cards, etc., these objects must be removed prior
to X-raying.
Radiation protection The valid radiation protection regulations must be
observed.
The operator should move as far away from the X-ray
tube assembly as allowed by the coiled cable of the
exposure release button.
The statutory radiation protection equipment must be
used.
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Sirona Dental Systems GmbH 1 Warning and Safety Notes
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Operating Instructions ORTHOPHOS 3
With the exception of the patient, no other persons
without radiation protection are allowed to stay in the
room. In exceptional cases, a third person may provide
assistance, but not the practice staff. During the whole
exposure, visual contact with the patient and the unit
must be maintained.
In case of malfunctions, interrupt the exposure immediately by releasing the exposure release button.
Hygiene information The protective covers must be exchanged for each new
patient and the sterilizable accessories must be sterilized to prevent any transmission of infective agents
which might cause serious illnesses.
Suitable hygienic measures must be taken to prevent
cross contamination among patients, users and other
persons.
Dismantling and reassembly For dismantling and reassembly of the device, proceed
according to the Installation Instructions for new installation in order to guarantee the operability and stability of
the system.
Disposal It applies generally that the national regulations have to
be complied with when disposing of this product. Please
observe the regulations applying in your country.
Within the European Economic Community the directive
2002/96/EEC (WEEE) for electrical and electronic
devices requires environmentally compatible recycling /
disposal.
Your product is marked with the adjacent symbol. With
the goal of environmentally compatible recycling / disposal, your product must not be disposed of with the
domestic refuse.
The black bar under the "refuse bin" symbol means that
it has been put onto the market after 13.08.2005. (See
EN 50419:2005)
Please note that this product is subject to the directive
2002/96/EEC (WEEE) and laws applicable in your country and must be sent for environmentally compatible
recycling / disposal.
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 your product should be
finally disposed of.
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1 Warning and Safety Notes Sirona Dental Systems GmbH
Operating Instructions ORTHOPHOS 3
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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Sirona Dental Systems GmbH 2 Technical Description
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Operating Instructions ORTHOPHOS 3
2 Technical Description
2.1 Technical Data
Nominal line voltage: 208V / 230V - 240V
Permissible line voltage fluctuation: ±10%
Nominal current: max 9.7A
Nominal frequency: 50/60Hz
Power line resistance: max. 0.8Ohm
Fuse at the distribution panel: 20A slow blow
Rating: 2.1kW
Tube voltage: 60 – 80kV
Tube current: 6 –11mA
Curve form of high voltage: high frequency
Multipuls Residual ripple ≤ 4kV
Rotation time: see page 30
Exposure time: see page 30
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)
Equipment of protective class I
Protection against electric shock:
0.5mm
depends on 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
Protection against penetration of water: Ordinary equipment (without protection)
Year of manufacture (on the name plate)
Mode of operation: Continuous operation
Long time power rating: 64W
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2 Technical Description Sirona Dental Systems GmbH
Target material: Tungsten
Loading factors concerning leakage radiation: 1.1mA / 80 kV
Leakage radiation: ≤ 1mGy/h
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)
Source - Image receptor distance: Panorama 497mm
Cassette format:
Panorama
15cm x 30cm (6" x 12")
Operating Instructions ORTHOPHOS 3
USA/CANADA
Korea
Laser light localizer
Magnitude: 300mm long, 5mm wide
Max. radiant power: 350J/m
Pulse duration: 100s
8 x 10in.
10 x 8in.
2
ORTHOPHOS 3 has been inspected by the VDE Testing and Certification Institute for compliance with
EN 60 601-1, / 1998
EN 60 601-2-7 / 1998
EN 60 601-2-28 / 1998,
EN 60 601-1-3 / 1998,
and has been found to comply with these regulations.
Original language: german
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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Sirona Dental Systems GmbH 2 Technical Desc ription
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Operating Instructions ORTHOPHOS 3
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 characteristic:
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°
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10°
Anode angle
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2 Technical Description Sirona Dental Systems GmbH
Radiation fields of the laser light localizers:
Operating Instructions ORTHOPHOS 3
60°
°
32°
5
°
0
6
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