Sirona Galileos User Manual
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General information Sirona Dental Systems GmbH
Operating Instructions GALILEOS
General information
Dear Customer, Thank you for purchasing your GALILEOS X-ray device.
The GALILEOS system consists of an X-ray device that
uses a cone beam with a rotational sequence to provide
two dimensional images and three dimensional volume
reconstructions of the head area, including both the ENT
and the dentomaxillofacial areas, for use in planning and
diagnostic support.
The system also includes a package of PC software
modules (GALAXIS, REKO Software) which extend the
capabilities of SIDEXIS to include the handling of 3D
data. This includes the 3D reconstruction, storage,
retrieval, viewing and processing of 3D image data.
The technical documentation supplied is also part of
the product. Keep these documents handy at all times.
To safeguard your warranty claims, please complete the
attached “Installation Report/Warranty Passport”
together with the service engineer immediately after the
installation of your unit.
Please familiarize yourself with the unit by reading
through these Operating Instructions before taking
any X-rays of patients. Always observe the valid radia-
tion protection regulations and warnings.
These operating instructions presuppose that you are
familiar with the use of the SIDEXIS software.
SIRONA requires regular constancy tests to ensure the
image quality.
Your GALILEOS Team
Maintenance In the interest of the safety and health of patients, users
and other persons, inspection and preventive maintenance must be performed at scheduled intervals to
ensure the operational reliability and functional safety of
your product (IEC 60601-1 / DIN EN 60601-1 etc.).
The system owner must ensure that all inspections and
maintenance events take place.
If the system owner fails to fulfill the obligation to have
inspections and maintenance work performed or ignores
error messages, Sirona Dental Systems GmbH and its
authorized dealers cannot assume any liability for resulting damage.
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Sirona Dental Systems GmbH Contents
Operating Instructions GALILEOS
Contents
1 Warning and safety information ................................................................................ 5
1.1 General safety information................................................................................................................ 5
1.2 ESD protective measures ................................................................................................................. 9
1.3 About the physics of electrostatic charges ....................................................................................... 10
2 Technical description ................................................................................................. 11
3 Controls and functional elements ............................................................................. 15
3.1 Operating and Display Elements ...................................................................................................... 15
3.2 General touchscreen functions on Easypad ..................................................................................... 17
3.3 High contrast option.......................................................................................................................... 23
4 Accessories ................................................................................................................. 25
4.1 Bite blocks, supports and fasteners.................................................................................................. 25
4.2 Hygienic protective sleeves .............................................................................................................. 26
4.3 Test phantom for acceptance/constancy test ................................................................................... 27
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5 Programs...................................................................................................................... 28
5.1 VO1: Volume 1 (High-resolution program) ....................................................................................... 28
5.2 VO1 HC: Volume 1 (High contrast option (HC)) ............................................................................... 29
5.3 VO2: Volume 2 (standard program).................................................................................................. 30
5.4 VO2 HC: Volume 2 (High contrast option (HC)) ............................................................................... 31
6 Operation ..................................................................................................................... 32
6.1 Preparing the exposure .................................................................................................................... 32
6.2 Selecting exposure parameters ........................................................................................................ 37
6.3 Positioning the patient ...................................................................................................................... 38
6.4 Releasing the exposure .................................................................................................................... 45
6.5 Remote control ................................................................................................................................. 48
7 List of messages ......................................................................................................... 49
7.1 List of help messages....................................................................................................................... 49
7.2 Error message structure ................................................................................................................... 50
7.3 Error message E1 10 07................................................................................................................... 52
8 Care of outer surfaces ................................................................................................ 53
9 Inspection and maintenance ...................................................................................... 54
9.1 Annual check performed by the system owner or other authorized persons.................................... 54
9.2 Maintenance by the service engineer ............................................................................................... 54
9.3 Image quality check.......................................................................................................................... 54
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Contents Sirona Dental Systems GmbH
Operating Instructions GALILEOS
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Sirona Dental Systems GmbH 1 W arning and safety information
Operating Instructions GALILEOS 1.1 General safety information
1 Warning and safety information
1.1 General safety information
Identification 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. All such information is highlighted by the signal words NOTE,
CAUTION or WARNING.
Symbols used Observe accompanying documents
(on rating plate)
Intended use The GALILEOS system consists of an X-ray device that
uses a cone beam with a rotational sequence to provide
two dimensional images and three dimensional volume
reconstructions of the head area, including both the ENT
and the dentomaxillofacial areas, for use in planning and
diagnostic support.
The system also includes a package of PC software
modules (GALAXIS, REKO Software) which extend the
capabilities of SIDEXIS to include the handling of 3D
data. This includes the 3D reconstruction, storage,
retrieval, viewing and processing of 3D image data.
This system must not be used in areas subject to explosion hazards.
With room temperatures > 35 °C (> 95 °F) Sirona recommends the use of an air conditioning system.
Recommended operating temperature: < 35 °C (< 95 °F)
Caution:
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Federal Law (USA) restricts sale of this device to or on
the order of a physician, dentist or licensed practitioner.
Maintenance and repair As manufacturers of medical electrical equipment we
can assume responsibility for the safety-related features
of the equipment only if maintenance and repair are
carried out only by ourselves or agencies expressly
authorized by us, and if components affecting safe operation of the system are replaced with original spare
parts upon failure.
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 might affect the safety
of the system owner, patients or other persons are prohibited by law!
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1 Warning and safety information Sirona Dental Systems GmbH
1.1 General safety information Operating Instructions GALILEOS
For reasons of product safety, this product may be
operated only with original Sirona accessories or
third-party accessories expressly approved by Sirona.
The user assumes the risk of using non-approved
accessories.
Combination with other equipment Permissible combinations are specified in the Declara-
tion of Conformity and confirmed by the system integrator (service engineer).
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-raying 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.
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) The GALILEOS X-ray unit complies with the require-
ments of IEC 60601-1-2: 2001.
Medical electrical equipment is subject to special precautionary measures regarding EMC. It must be
installed and operated as specified in the document
“Installation Requirements”.
If high-voltage systems, radio link systems or MRI systems are located within 5 m of the unit, please observe
the guidelines the installation requirements.
Portable and mobile RF communications equipment
may interfere with medical electrical equipment. Therefore, the use of mobile wireless phones in practice or
hospital environments must be prohibited.
Please also observe the ESD protective measures in
Chapter 1.2.
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 the unit off and
back on again, the patient must be removed from the
unit, at the latest before switching the unit on again!
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Sirona Dental Systems GmbH 1 W arning and safety information
Operating Instructions GALILEOS 1.1 General safety information
Emergency stop (not included in the scope of supply) If any parts of the unit touch the patient during the rotary
movement, let go of the exposure release button
(X-Ray) immediately or stop the unit at once 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.
In case of malfunctions, cancel the exposure immediately by letting go of the exposure release button.
Hygiene information The bite block should be resterilized for each new
patient to prevent any possible transmission of infective
agents which might under certain circumstances cause
serious illnesses.
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Also be sure to use hygienic protective sleeves.
Suitable hygienic measures must be taken to prevent
cross contamination among patients, users and other
persons.
Structural alterations If structural alterations are made in the immediate vicin-
ity of the unit, a technical check must be made by the
service engineer.
Dismantling and reassembly When dismantling and reassembling the system, pro-
ceed according to the installation instructions for new
installation in order to guarantee its proper functioning
and stability.
The X-ray unit must be recalibrated whenever structural
alterations in the area surrounding the X-ray room or
new installations have been performed.
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.
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1 Warning and safety information Sirona Dental Systems GmbH
CAUTION
1.1 General safety information Operating Instructions GALILEOS
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.
Laser light
localizer used
The system incorporates Class 1 laser products.
The light localizer is used for correct patient positioning.
It must not be used for any other purposes.
A minimum distance of 100mm (4“) between the eye and
the laser is required. Do not stare into the beam. Its safe
operation is described in chapter 6.3 "Positioning the
patient".
The light localizer may be switched on only if it is functioning properly and faultlessly. Repair work must be
carried out by authorized staff only.
Do not look directly into the beam.
Do not use any other lasers and avoid changing any settings or processes not described in these instructions, as
such actions could result in hazardous radiation exposure.
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Sirona Dental Systems GmbH 1 W arning and safety information
CAUTION
Operating Instructions GALILEOS 1.2 ESD protective measures
1.2 ESD protective measures
ESD stands for ElectroStatic Discharge.
Connector pins or sockets bearing ESD warning labels
must not be touched or interconnected without ESD
protective measures.
ESD protective measures include:
• Procedures for preventing electrostatic charge
build-up (e.g. air conditioning, air moistening, conductive floor coverings and non-synthetic clothing)
• Discharging the electrostatic charges of your own
body on the frame of the unit, the protective ground
wire or large metallic objects
• Connecting yourself to ground using a wrist band.
We therefore recommend that all persons working with
this system be instructed on the significance of this
warning label. Furthermore, they also should receive
training in the physics of electrostatic discharges which
can occur in the practice and the destruction of electronic components which may result if such components
are touched by electrostatically charged
The content of this training is explained in Chapter 1.3.
USERS.
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1 Warning and safety information Sirona Dental Systems GmbH
1 nanosecond = 1/1,000,000,000 second =
1 billionth of a second
1.3 About the physics of electrostatic charges Operating Instructions GALILEOS
1.3 About the physics of electrostatic charges
ESD stands for ElectroStatic Discharge. Electrostatic
discharge must be preceded by electrostatic charging.
Static electric charges generally build up whenever two
bodies are rubbed against each other, e.g. when walking
(shoe soles against the floor) or driving a vehicle (tires
against the street pavement). The amount of charge
depends on several factors:
Thus the charge is higher in an environment with low air
humidity than in one with high air humidity; it is also
higher with synthetic materials than with natural materials (clothing, floor coverings).
The following rule of thumb can be applied to assess the
transient voltages resulting from an electrostatic discharge.
An electrostatic discharge is:
• perceptible at 3,000 V or higher
• audible at 5,000 V or higher (cracking, crackling)
• visible at 10,000 V or higher (arc-over)
The transient currents resulting from these discharges
have a magnitude of 10 amperes. They are not hazardous for humans because they last for only several nanoseconds.
Voltage differentials exceeding 30,000 volts per centimeter may lead to a charge transfer (electrostatic discharge, lightning, arc-over).
Integrated circuits (logical circuits and microprocessors)
are used in order to implement a wide variety of functions in dental/X-ray/CEREC systems. The circuits must
be miniaturized to a very high degree in order to include
as many functions as possible on these chips. This leads
to structure thicknesses as low as a few ten thousandths
of a millimeter.
It is obvious that integrated circuits which are connected
to plugs leading outside of the unit via cables are sensitive to electrostatic discharge. Even voltages which are
imperceptible to the user can cause breakdown of the
structures, thus leading to a discharge current which
melts the chip in the affected areas. Damage to individual integrated circuits may cause malfunction or failure
of the system.
To prevent this from happening, the ESD warning label
next to the plug warns of this hazard.
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Sirona Dental Systems GmbH 2 T echnical description
Operating Instructions GALILEOS
2 Technical description
Chassis: Model designation GALILEOS
Nominal voltage: 200 – 240V
Permissible deviation: ±10%
Permissible drop under load: 10%
Rated current: 6A
Nominal power output X-ray tube: 0.6kW at 85kV/7mA
Current time product X-ray tube: 42mAs
Nominal frequency: 50/60 Hz
Internal line impedance: max. 0.8Ohm
Main building fuse: 25A slow-blow (16A for standalone connection)
Power consumption: 0.9kVA
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X-ray tube assembly: Focal spot size acc. to IEC 60336,
measured in the central X-ray beam: 0.5
kV: 85 kV
mA: 5/7 mA
Pulsed mode: 10 ms – 30 ms
Total filtration of X-ray tube assembly > 2.5 Al/90 IEC 522
Cone-beam angle: collimated to approx. 24°
Detector: Type: Image intensifier (I.I.), Thales
Active input window size: 215 mm (8 1/2“) diameter
Camera: Pixels: 1000
Geometry: Source-I.I. converter coating distance
(central X-ray beam)
Source-isocenter distance
(central X-ray beam)
Source-skin distance
(minimum distance)
2
FPS: 15 – 30
Dynamics: 12 bits, (4096 brightness values), 60 dB
510 mm (20 1/16“)
333 mm (13 1/8“)
approx. 220 mm (8 5/8“)
Scanning operation: Orbital angle 204°
Scan time approx. 14 s
Number of single exposures 200
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2 Technical description Sirona Dental Systems GmbH
Operating Instructions GALILEOS
Reconstruction: Filtered backprojection
Marking of focal spot:
Automatic exposure blocking (see
page 46):
The duration of automatic exposure blocking (cooling period) depends on the set kV/mA level and
the actual exposure time. Depending on the tube
load, a pause duration of 8 s to 300 s is automatically set by the system.
Class I equipment
Type B equipment
Degree of protection against electric
shock:
Degree of protection against ingress of
water:
Ordinary equipment
(without protection against ingress of water)
Year of manufacture (on the rating plate)
Mode of operation: Continuous operation
Long-term power output: 100W
Anode material: Tungsten
Exposure parameters for determining
7mA/85 kV
leakage radiation:
Long time current for leackage radia-
0,14 mA
tion measurement:
Transport and storage temperature:
Basic unit -40°C – +70°C (-40°F – 158°F)
Detector -30°C – +55 °C (-22 °F – 131 °F)
Air humidity: 10% – 95% without condensation
Admissible operating temperature: from +10 °C to +35 °C (50 °F – 95 °F)
X-ray tube: DF-151R – from Toshiba
Minimum requirements for reconstruction PC
(included in the scope of supply):
Processor: 2x 3.0 GHz, alternatively dual-core
RAM: 2 GB RAM
Hard disks: > 200 GB
Operating system: Windows XP Professional Service Pack 2 or newer
External drive: 1x DVD writer, dual-layer
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Sirona Dental Systems GmbH 2 T echnical description
0123
Operating Instructions GALILEOS
Minimum requirements for
SIDEXIS visualization PC
(included in the scope of supply): See SIDEXIS XG Operator’s Manual.
Network:
Network: 100 MB Ethernet, 1 Gbit Ethernet recommended
Communication interface: RJ45 for LAN cable
The GALILEOS X-ray unit complies with IEC 60601-2-28/1993
The GALILEOS X-ray unit complies with IEC 60601-1-3/1994
The GALILEOS X-ray unit complies with IEC 60601-2-7/1998
The GALILEOS X-ray unit complies with AS / NZS 3200.1.0
Original language: German
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This product bears the CE mark in accordance with the
provisions of the Council Directive 93/42/EEC of
June 14, 1993 concerning medical devices.
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2 Technical description Sirona Dental Systems GmbH
0 60 120 180 240 300 360 420 480 540 600 660 720
10
20
30
40
50
60
70
80
90
100
110
120
130
HUx10
4
t
min
1 HU = 1.35 Joule
min
HUx10
3
1 HU = 1.35 Joule
35
30
25
012 3 4 5 6
5
10
15
20
t
7 8 910
012 3 4 5 6
130
h
t
HUx10
4
1 HU = 1.35 Joule
16°
10°
Anode angle
Central X-ray beam
Operating Instructions GALILEOS
Cooling curve of tube housing
Cooling curve of X-ray tube
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Heating curve of tube housing
Central X-ray beam/anode angle
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Sirona Dental Systems GmbH 3 Controls and functional elements
NOTE
i
1
2
4
68 117
109
5
3
A
C
D
E
F
G
H
I
I
J
B
Operating Instructions GALILEOS 3.1 Operating and Display Elements
3 Controls and functional elements
3.1 Operating and Display Elements
on the GALILEOS
1 Main switch
2 Forehead support
(contact upholstery detachable and sterilizable)
3 Head fastening strap
4 Bite block (sterilizable)
5 Release button
If the system is installed with a remote control, the release button is attached to the remote control.
6 Easypad (swivelable control panel)
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7 Light localizer, central light beam for face center
8 Swivel arm for patient immobilization
9 Handles for patient
10 Rotary knob for bite-block locking device
11 Rotary knob for swivel-arm lock and forehead sup-
port setting
on the head fixation device
A Forehead rest (in two versions)
B Forehead rest adjustment
C Headband adjustment
D Pushbutton for resetting forehead rest
E Lock for vertical adjustment
F Scale for vertical adjustment
(adjustment range +/- 10 mm)
G Scale for horizontal adjustment
(adjustment range +16 mm /-20 mm)
H Locking button for horizontal adjustment and
unlocking head fixation device for removal
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I Locking buttons for headband
J Ear plugs
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3 Controls and functional elements Sirona Dental Systems GmbH
CAUTION
T
R
12 13
14
15
16
17
18
19
3.1 Operating and Display Elements Operating Instructions GALILEOS
Controls and displays on the Easypad with
touchscreen
12 Light localizer ON/OFF
13 “Unit up” arrow key
14 “Unit down” arrow key
15 Optical radiation indicator
16 “Unit ON” LED
17 “T“ key for test cycle without radiation
18 “R“ key for unit return
19 Touchscreen – touch-sensitive screen
Never touch the touchscreen with sharp or pointed objects (ball-point pens, pencils, etc.)!
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Sirona Dental Systems GmbH 3 Controls and functional elements
1 2 3
4
5
789
6
10
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Operating Instructions GALILEOS 3.2 General touchscreen functions on Easypad
3.2 General touchscreen functions on Easypad
Touchscreen = touch-sensitive screen, i.e. different
functions can be triggered by touching the screen
surface.
Color codes:
orange – selected
white – presettings
light blue – selectable
gray and white – auxiliary symbols
Touchscreen symbols
1 Display of height setting value
2 Display of program VO1, VO1 HC (with high contrast
option) or VO2, VO2 HC (with high contrast option).
The grid contrast shows the corresponding contrast
option.
Normal contrast (without high contrast option):
High contrast (high contrast option (HC)):
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3 Submenu column (options)
4 Blue arrows: Select submenu, close menu
5 Red symbol for light localizer ON (is displayed as
long as the laser light of the light localizer is switched
on)
6 Patient symbol keys for selecting preset exposure
parameters
7 Comment line for help and error messages
8 Display/setting of exposure parameters
(kV/mAs)
9 When you touch the
screen is displayed
10 Display/settings of the high contrast option
11 Program selection keys –/+
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? symbol, the help or info
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