Sirona Orthophos Plus User Manual
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Sirona Dental Systems GmbH
Dear Customer Thank you for purchasing your new ORTHOPHOS Plus
X-ray unit for panorama planigraphy.
Standard radiographs (jaw region), sinus radiographs
(maxillary sinuses) and temporomandibular joint radiographs in digital exposure technique are possible.
For this unit we have provided you with a set of techni-
cal literature. Keep this literature for quick and easy
reference.
In order to protect your rights under Sirona warranty, the
purchaser must register the unit by filling out the War-
ranty 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 Notes.
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. (IEC 601-1 / DIN EN 60601-1, etc.).
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
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List of Contents
1 Warning and Safety Notes........................................................................................................ 5
2 Technical Description ............................................................................................................... 8
3 Operating Controls and Displays........................................................................................... 12
3.1 Unit ................................................................................................................. 12
3.2 Control Panel A............................................................................................... 12
3.3 Help LED-displays .......................................................................................... 13
3.4 Multitimer ........................................................................................................ 13
4 Accessories ............................................................................................................................. 14
4.1 Rests and supports......................................................................................... 14
4.2 Hygienic Protective Covers............................................................................. 15
4.3 Service Tools.................................................................................................. 15
5 Exposure Programs ................................................................................................................ 16
5.1 P 1 Program.................................................................................................... 16
5.2 P 2 Program.................................................................................................... 16
5.3 P3 Program..................................................................................................... 17
5.4 P4 Program..................................................................................................... 17
5.5 P5 Program..................................................................................................... 18
5.6 P6.1 / P6.2 Program ....................................................................................... 18
5.7 P7.1 / P7.2 Program ....................................................................................... 19
5.8 P8 Program..................................................................................................... 19
5.9 P9 Program..................................................................................................... 20
5.10 P10 Program................................................................................................... 20
5.11 P11 Program................................................................................................... 21
5.12 P12 Program................................................................................................... 21
5.13 P13 Program................................................................................................... 22
5.14 P14 Program................................................................................................... 22
5.15 P15 Program................................................................................................... 23
5.16 P16 Program................................................................................................... 23
6 Operating.................................................................................................................................. 24
6.1 Preparing the Exposure.................................................................................. 24
Loading the Film Cassette ....................................... 24
Insert Accessories.................................................... 24
Contact Spacer and Head Positioner....................... 24
Switching ON the Unit.............................................. 25
Primary Diaphragm .................................................. 25
Digital Displays......................................................... 25
6.2 Positioning the Patient .................................................................................... 27
Preparations............................................................. 27
Exposure with Chin Rest and Bite Block.................. 27
The Frankfurt horizontal FH ..................................... 29
Digital displays ......................................................... 29
Exposure with Chin Rest and Bar ............................ 30
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List of Contents Sirona Dental Systems GmbH
Exposure with Bite Block or Contact Segment without
Chin Support ............................................................ 31
. . . with Bite Block.................................................... 31
. . . with Contact Segment ........................................ 31
The Frankfurt Horizontal FH..................................... 32
Digital displays ......................................................... 32
Exposures of the Temporomandibular Joint, P4 – P9
Programs with Head Positioner................................ 33
6.3 Final Preparations........................................................................................... 34
Selecting the Exposure Program.............................. 34
Automatic Exposure Selection AES (ABV)............... 35
Select Exposure Data............................................... 35
Anomaly Button A..................................................... 36
6.4 Releasing the Exposure.................................................................................. 37
Interrupting the Exposure ......................................... 38
Automatic Exposure Blockage ................................. 38
Error Message E... ................................................... 38
7 Programming ........................................................................................................................... 39
Programming Procedure .......................................... 39
Adjustment of the Exposure ..................................... 40
8 Help Messages H3................................................................................................................... 41
9 Program Values ....................................................................................................................... 42
9.1 Program Values .............................................................................................. 42
10 Care the surfaces .................................................................................................................... 43
11 List of Error Messages............................................................................................................ 44
12 Inspection and Maintenance .................................................................................................. 46
12.1 Annual inspection performed by the operator or other authorized personnel . 46
12.2 Maintenance performed by the service technician.......................................... 46
12.3 Checking image quality................................................................................... 46
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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 CAUTION and 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.
The system may only be operated by skilled or properly trained personnel.
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1 Warning and Safety Notes Sirona Dental Systems GmbH
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.
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
Plus 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, condensation 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 poweron.
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 (XRay) 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.
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.
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Sirona Dental Systems GmbH 1 Warning and Safety Notes
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 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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2 Technical Description Sirona Dental Systems GmbH
2 Technical Description
Nominal line voltage: 208V / 230V AC
Permissible fluctuation with 230 V:
with 208 V:
Nominal current: 12A
Nominal frequency: 50/60Hz
Power line resistance: max. 0,8Ohm
Fuse at the distribution panel: 16A slow blow
Rating: 2,8kVA
Tube voltage: 60 – 90kV
Tube current: 9 –16mA
Curve form of high voltage: High frequency, multipulse
Program duration: see page 42
Exposure time: see page 42
Reproduction scale:
Focus size, according to IEC 336,
measured in central ray:
+6, –10%
±10%
Residual ripple ≤ 4kV
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.
0,5mm
Focus marking:
Automatic exposure blockage (see page 38): The duration of the exposure blockage (cool-off period) depends
on the kV/mA step set and the actually triggered radiation time.
Depending on the tube load, pause times between 8s and 300s
are set automatically.
Example: For P1 program with exposure data 80kV/14mA and a
radiation time of 14.1s a pause of 255s results.
Equipment of protective class I
Protection against electric shock:
Protection against penetration of water: Ordinary equipment (without protection)
Type B equipment
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Sirona Dental Systems GmbH 2 Technical Desc ription
Year of manufacture (on the name plate)
Mode of operation: Continuous operation
Long time power rating 60W
Ta r ge t ma t er ia l Wo l fr a m
Loading factors concerning leakage radiation 0,57mA / 90 kV
Source - Image receptor distance 497 mm
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)
ORTHOPHOS Plus is in compliance with EN 60 601-2-7 / 1998
ORTHOPHOS Plus is in compliance with IEC 601-2-28 / 1993
ORTHOPHOS Plus is in compliance with IEC 601-1-3 / 1994
Original language: german
0123
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.
Reg. No.: China
SFDA (I) 20053301583
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2 Technical Description Sirona Dental Systems GmbH
Cooling curve for the tube housing:
4
HUx10
1HU = 1,35 Joule
130
120
110
100
90
80
70
60
50
40
30
20
10
t
0 60 120 180 240 300 360 420 480 540 600 660 720
Anode cooling caracteristic:
25
HUx10
3
1HU = 1,35 Joule
20
15
10
5
t
012 3 4 5 6
3
HUx10
1HU = 1,35 Joule
min
Heating curve for tube housing:
1350
min
t
012 3 4 5 6
h
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Sirona Dental Systems GmbH 2 Technical Desc ription
Reference axis
Reference axis
7°
10°
Anode angle
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3 Operating Controls and Displays Sirona Dental Systems GmbH
3 Operating Controls and Displays
3.1 Unit
234 5 6781 9 10
11 12 13 14
A
1 Main switch
2 Patient positioning mirror
3 Height adjustment for the FH light line
4 Adjusting knob for temple supports
5 Forehead support
6 Temple supports
7 Cassette holder
8 Cassette carriage
9 Film cassette
10 Film cassette stop
11 Button for removing bite block
12 Diaphragm wheel
13 Locking button
14 Diaphragm
Multitimer
3.2 Control Panel A
Return button R
Light localizer ON / OFF
Anomaly button A + – with LED display
Height adjustment display in mm
Height adjustment
Forehead support adjustment display in mm
Forehead support adjustment
← towards column / away from column →
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Sirona Dental Systems GmbH 3 Operating Controls and Displays
3.3 Help LED-displays
See the inside of the door for a list of appropriate H3 help
messages (see page 41).
13
14
15
3.4 Multitimer
16
17
18
19
13 Cassette holder not in position
14 Forehead support position
15 Exposed film inserted
16 X-ray tube position
17 Cool-down interval
18 Diaphragm adjustment
19 Height adjustment
”Unit ON” LED
PI
62
I6
PI
I4.I
62
I6
X-ray ON indicator
Exposure button
Digital display for exposure program / exposure time
with – + buttons for exposure programs
Digital display for kV/mA values
with – + buttons for kV/mA matched values
Patient symbols
programmed kV/mA values
Memory program button
kV/mA matched values
AES button (Automatic Exposure Selection)
Rotation test button T
without radiation
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Return button R
The LED blinks when the system is not ready (ReadyLED).
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4 Accessories Sirona Dental Systems GmbH
4 Accessories
4.1 Rests and supports
The receptacles behind the door are for the storage of
accessories and hygienic protective covers.
Press
shortly
to open.
Handles and * marked accessories can be sterilized.
Sterilize only in an autoclave at 135°C, 2.1 bar
(275°F, 30PSI).
Untightened handles can be removed for sterilization as
shown.
For tightened handles, please use the hygienic protective covers shown on the next page.
For reorders:
A* Forehead support strip
(5 pcs) Order No. 89 21 835
E*
F
135° C
275° F
A*
C*
D*
H*
B*
L
G*
B* Chin rest complete,
incl. 5xE, 1xF, C, D, R, S
Order No. 18 88 762
C* Bar for chin rest
Order No. 59 61 461
D* Intermediate piece
Order No. 14 49 227
E* Bite block
(10 pcs) Order No. 18 88 887
F Stick for bite block
(5 pcs) Order No. 18 88 895
G* Standard yellow bite block
(5 pcs) Order No. 89 21 843
H* Standard yellow contact segment
for subnasals
(5 pcs) Order No. 89 31 545
J Head positioner complete,
incl. 4xK
Order No. 18 88 770
K* Ear fixation
(10 pcs) Order No. 18 88 838
L Contact spacer
Order No. 33 10 336
M* Bite block blue, for sinus exposures
(5 pcs) Order No. 89 21 850
J
N*
M*
N* Contact segment, blue,
for subnasals with sinus and paranasal
tomographic exposures
(5 pcs) Order No. 89 31 552
K*
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Sirona Dental Systems GmbH 4 Accessories
4.2 Hygienic Protective Covers
Before each exposure, the hygienic protective covers
(disposable) should be attached.
For better illustration of the components, the following
figures are shown without the hygienic protective covers.
For orders:
P For forehead support and handles
(500 pcs) Order No. 33 14 098
P
S
R
Dimensions:
210mm (140 mm) x 57 mm
R For chin rest
(100 pcs) Order No. 59 32 603
Dimensions: 75mm x 60mm
S For bite block
(500 pcs) Order No. 33 14 072
Dimensions: 43mm x 21mm
T For bite block and contact segment
(500 pcs) Order No. 33 14 080
Dimensions: 80mm x 40mm
4.3 Service Tools
1
T
4
3
Tools supplied with the unit and needed for the maintenance and/or service must remain with the unit.
(Adjustment set).
1 Special wrench
Order No. 52 43 605
2 Needle phantom
Order No. 89 31 925
3 Te s t b lo c k
2
Certified component of the unit.
4 Beam alignment tool
Order No. 89 31 800
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