Sirona Galileos User Manual

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General information Sirona Dental Systems GmbH Operating Instructions GALILEOS

General information

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
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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
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11

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
17
3 Controls and functional elements Sirona Dental Systems GmbH
NOTE
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)
d
)
e
*
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4
-
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3.2 General touchscreen functions on Easypad Operating Instructions GALILEOS
Setting the exposure parameters (kV/mAs values) (level 1)
The preset exposure parameters are selected with the patient symbol keys.
85kV/ 10mAs
If the default kV/mA combinations do not provide satis­factory results, you also can set two additional combina­tions (85 kV/10 mAs and 85 kV/42 mAs).
1. Select one of the outer
2. Touch the exposure parameter display in the sub-
3. Use the –/+ keys in the kV/mAs submenu line to se-
4. Close the kV/mAs submenu line by touching the
85kV/ 14mAs
patient symbol keys.
– Far left patient symbol key:
Sets to 85 kV/10 mAs
– Far right patient symbol key:
Sets to 85 kV/42 mAs
menu column.
The submenu line for selecting the exposure param­eters appears.
lect the exposure parameters:
– 85 kV/10 mAs
(left patient symbol key, then – key) or
– 85 kV/42 mAs
(right patient symbol key, then + key)
blue arrow (on the left in the line).
The currently selected exposure parameters are dis­played on the right in the submenu column.
85kV/ 21mAs
85kV/ 28mAs
85kV/ 35mAs
85kV/ 42mAs
This setting is only temporarily valid for this exposure. It will then be reset to the factory setting immediately after­wards. To permanently change the setting, you must edit the factory-adjusted exposure parameter settings (see
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page 19).
Program settings (Level 2)
You can also display all of the program settings and make the settings described above in a second program level.
To access the second program level, touch the blue arrow (4) in the upper right corner of the touchscreen; the arrow will point upward then.
After having made your selections, you can return to pro­gram level 1 only by touching the blue arrow (4) once again.
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Sirona Dental Systems GmbH 3 Controls and functional elements
NOTE
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20
21
43
Operating Instructions GALILEOS 3.2 General touchscreen functions on Easypad
Basic settings menu (Level 3)
In a third level, you can freely select and then program specific exposure parameters for the program.
To access the third program level, touch the arrow point­ing downward (4) at the top of the submenu column (3) in Level 1.
Level 2 is displayed.
Touch the blue arrow (20) on the left.
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Level 3 is displayed.
You can enter the new kV/mAs values for the respective preselected patient symbol here.
Programming is done by touching the memory symbol (21).
The respective patient symbol and the corresponding kV/mAs value are displayed on the right in the submenu column.
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This setting is now permanently stored. The original fac­tory setting has been overwritten.
Switch back to Level 1 by touching the blue double arrow (4) at the top of the submenu column on the right.
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3 Controls and functional elements Sirona Dental Systems GmbH
NOTE
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22
43
21
23
3.2 General touchscreen functions on Easypad Operating Instructions GALILEOS
Service start settings (Level 4)
Various factory preset start parameters can be repro­grammed in level 4. They will then become effective after each unit power-on resp. after each new exposure.
You can reach Level 4 by touching the disk icon (22) in the basic settings menu (Level 3).
In Level 4, you can reprogram the starting or entry posi­tion (icon on left as per factory setting) and the patient icon preference (2nd icon from left as per factory setting).
Using this function, you can adapt the patient entry posi­tion to the local space conditions. The open segment of the ring in the icons indicates the direction of patient entry.
To perform a particular change, touch the desired icon; the icon then turns orange and is also displayed in the submenu column (4).
The Memory icon (21) then turns and stays yellow until the new default setting has been saved by touching the Memory icon (21).
You can close this menu again only by touching the blue double arrow (4) in the upper right corner. The display always returns to the standard menu (program level 1).
The icons framed with a broken line represent the factory settings.
Service menu
The Service menu is intended only for the service engineer.
The service engineer can go to the Service menu from the Basic Settings menu (Level 3) via the wrench sym- bol (23) and a special input algorithm.
The service engineer can obtain more information on calling up the service menu and service routines by referring to the Service Manual.
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Sirona Dental Systems GmbH 3 Controls and functional elements
NOTE
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4
3
Operating Instructions GALILEOS 3.2 General touchscreen functions on Easypad
Touchscreen settings
When you touch the question mark (9) in the lower right
corner of the touchscreen, a touchscreen setting menu appears starting in the first level.
You can open two menu lines here by touching the cor­responding symbols in column (3).
In the upper menu line, you can switch off the clicking tone of the touchscreen by activating the crossed-out musical note symbol.
In the lower menu line, you can adjust the intensity of the touchscreen display with the –/+ keys. During this adjustment a reference value appears above the symbol in column (3).
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Switch the unit on for at least 10 minutes before adjusting the touchscreen intensity to ensure that the touchscreen has reached its full brightness. The contrast setting has been blocked until now (as denoted by an hour glass dis­played above the contrast symbol).
To close the respective menu line, touch the blue arrow at the left end of the corresponding line or the relevant symbol in column (3).
To return to the previous level, touch the blue arrow (4) at the top of column (3).
Closing menu lines
by touching the blue arrows
by touching the corresponding symbol in the light blue area at the right margin.
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3 Controls and functional elements Sirona Dental Systems GmbH
9
3
4
25
3.2 General touchscreen functions on Easypad Operating Instructions GALILEOS
Info screen
Starting at level 2, the “GALILEOS configuration“ info screen is displayed when you touch the question mark (9) in the lower right corner of the touchscreen.
System data which may be useful when contacting your service engineer are displayed here.
If this list is too long to be displayed all at once, a scroll bar for paging up or down appears on the right.
You can activate the “touchscreen click tone” and “touchscreen intensity setting” menu lines from the help screen in column (3) here as well.
Checking the function activation
The page number and number of pages are displayed in a small black field (25) located at the top right of the info screen.
Press this field to scroll through the pages until the “Active Keys” page appears.
Information on function activation is displayed here.
To return to the previous level, touch the blue arrow (4) at the top of column (3).
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NOTE
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10
1020

Operating Instructions GALILEOS 3.3 High contrast option

3.3 High contrast option
Setting up the high contrast option (Level 1)
To select the high contrast option, proceed as follows:
Additional information on the indication: See the descrip­tions of the programs.
1. Touch the contrast symbol (10).
The submenu line to select the contrast level will be displayed.
2. Select the desired contrast level by touching the cor­responding symbol:
High contrast:
Normal contrast:
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3. Close the submenu line Contrast Level by touching the blue arrow (20).
The currently selected contrast level is displayed with the corresponding contrast symbol (10) in the Submenu column on the right.
These settings only apply temporarily to the current ex­posure. After that, the settings return to the default val­ues. To change the settings permanently, you have to change the default values for the contrast.
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3 Controls and functional elements Sirona Dental Systems GmbH
CAUTION
12
3
4
22
3
4
Level 1
Level 2
Level 3
Level 4
3.3 High contrast option Operating Instructions GALILEOS
Changing the default setting for the high contrast option (Level 4)
Upon system delivery, the high contrast option will be disabled by default.
To generally activate the high contrast option, proceed as follows:
1. Touch the blue arrow (4) in the Submenu column (3).
Level 2 will be displayed.
2. Touch the blue arrow on the left (12).
Level 3 will be displayed.
3. To uc h τηε φλοππψ δισκ σψμβολ (22) in menu Basic Settings menu.
Level 4 will be displayed.
4. Select the desired contrast level in Level 4 by touch­ing the corresponding symbol:
High contrast:
Normal contrast:
5. Change back to Level 1 by touching the blue double
arrow (4) above the Submenu column (3).
The new default setting for the contrast level is dis­played with the corresponding contrast symbol in the Submenu column on the right.
This setting has now been saved as the permanent val­ue. The original factory default setting has been overwrit­ten.
If the high-contrast option is changed again, repeat the same procedure and select another contrast level.
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Sirona Dental Systems GmbH 4 Accessories

1
3
2
4
5
6
7
J
K
L
M
N

Operating Instructions GALILEOS 4.1 Bite blocks, supports and fasteners

4 Accessories
4.1 Bite blocks, supports and fasteners
The accessories can be removed for cleaning.
The bite block and the ear plugs can be sterilized.
Sterilize only in an autoclave at 134 °C (273 °F) and 2.1 bar for 3 min.
For reorders:
1 Forehead support
(contact upholstery can be removed for cleaning and disinfection) (1 pc) Order No. 61 34 931
2 Rigid bite block
(can be removed for cleaning and sterilization by ro­tating the locking knob) (5 pcs) Order No. 61 34 949
3 Head fastening strap
(2 pcs) Order No. 61 34 956
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4 Chin rest, complete
(1 pc) Order No. 59 81 472
5 Spherical mandibular bite block holder (with symbol
for lower LJ) (1 pc) Order No. 61 50 226
6 Spherical maxillary bite block holder (with symbol for
UJ) (1 pc) Order No. 61 50 218
7 Spherical bite block plate
- For single use only (not sterilizable)
- Available from a specialized dealer.
Accessories for head fixation device.
J Ear olives
(10 pcs) Order No. 18 88 838
K Headband (right and left)
The headbands can be removed for cleaning after pressing the corresponding locking button. (2 pcs) Order No. 62 27 040
L Volume control
(1 pc) Order No. 62 17 611
M Forehead pad
(contact pad can be removed for cleaning and disinfection) (5 pcs) Order No. 62 27 057
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N Forehead pad plus (child)
(contact pad can be removed for cleaning and disinfection) (5 pcs) Order No. 62 27 065
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4 Accessories Sirona Dental Systems GmbH
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8
9
11
1
12
O
P
O

4.2 Hygienic protective sleeves Operating Instructions GALILEOS

4.2 Hygienic protective sleeves
1 Hygienic protective sleeves for forehead support
and Head fastening strap (100 pcs) Order No. 61 84 894
2 Hygienic protective sleeves for bite block
(500 pcs) Order No. 61 27 745
3 Hygienic protective sleeves for handles
(500 pcs) Order No. 61 84 902
4 Hygienic protective sleeves for chin rest support and
bar (100 pcs) Order No. 59 32 603
5 Hygienic protective sleeves for bite block chin rest
(500 pcs) Order No. 33 14 072
for head fixation device
O Hygienic protective covers for forehead pads
(100 pcs) Order No. 62 34 392 Dimensions: 75 mm x 60 mm
P Hygienic protective covers for headbands
(500 pcs) Order No. 62 34 400 Dimensions: 150 mm x 47 mm
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10

Operating Instructions GALILEOS 4.3 Test phantom for acceptance/const ancy test

4.3 Test phantom for acceptance/constancy test
1 GALILEOS constancy test phantom replacement
(1 pc) Order No. 61 40 813
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5 Programs Sirona Dental Systems GmbH

NOTE
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NOTE
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Panoramic view
Radiological views

5.1 VO1: Volume 1 (High-resolution program) Operating Instructions GALILEOS

5 Programs
5.1 VO1: Volume 1 (High-resolution program)
High-resolution scan with the possibility of generating secondary reconstructions (detail reco) with maximum resolution.
Indication: Cases where maximum resolution is required. E.g. endodontic treatments, evaluations of the smallest structures.
This program is optimal for ordering drilling templates from GALILEOS:
This program is used to create a volume data set of the patient with 512 x 512 x 512 volume elements (voxels).
The resolution in the volume (voxel size) equals
0.3 x 0.3 x 0.3 mm
Scan time: 14 seconds Effective radiation time: 2...6 seconds
Reconstruction time: approx. 2.5 minutes
Data volume: up to 500 MB comprising: Patient volume: approx.180 MB Panoramic slice: approx. 4MB Lateral cephalometric image: approx. 5 MB Radiological views: approx. 5 MB Detailed reconstruction: approx. 30 MB Corrected raw data: approx. 220 MB (eras­able)
A high-resolution secondary reconstruction can be gen­erated via Galaxis diagnostic software only with this ex­posure. See Galaxis Operator’s Manual.
3
.
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Operating Instructions GALILEOS 5.2 VO1 HC: Volume 1 (High contrast option (HC))

5.2 VO1 HC: Volume 1 (High contrast option (HC))
The VO1 HC (high contrast) program is selected on the touchscreen, using the icon for the high contrast option (see also section "High contrast option" on page 22).
Compared to the standard settings, the high contrast setting VO1 HC is offers an improved display of hard structures such as bones and teeth.
The settings may result in an inferior display of the soft tissue, especially in terms of the soft tissue sil­houette.
The high contrast option is particularly suitable for the evaluation of bone and tooth structures, e.g. after bone augmentations, when the correct display of the soft tis­sue silhouette is negligible.
Additionally, the feature is particularly useful for the DICOM export function to other implant planning pro­grams (such as Nobel Guide or Simplant).
bеЦдблЬ
If the VO1 HC program is used for a DICOM export to a third-party implant planning software, always choose the setting value 42 mAs for optimal results.
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5 Programs Sirona Dental Systems GmbH
Panoramic view
Radiological views

5.3 VO2: Volume 2 (standard program) Operating Instructions GALILEOS

5.3 VO2: Volume 2 (standard program)
Standard scan for fast provision of views
Indication: for all exposures for which no detailed recon­struction is planned. E.g. implant planning, overview exposures and postoperative control exposures.
This program is used to create a volume data set of the patient with 512 x 512 x 512 volume elements (voxels).
The resolution in the volume (voxel size) equals
0.3 x 0.3 x 0.3 mm
Scan time: 14 seconds Effective radiation time: 2...6 seconds Reconstruction time: approx. 1:20 minutes Data volume: up to 500 MB Comprising: Patient volume: approx.180 MB Panoramic slice: approx. 4MB Lateral cephalometric image: approx. 5 MB Radiological views: approx. 5 MB Detailed reconstruction: approx. 30 MB Corrected raw data: approx. 60 MB (erasable)
3
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Operating Instructions GALILEOS 5.4 VO2 HC: Volume 2 (High contrast option (HC))

5.4 VO2 HC: Volume 2 (High contrast option (HC))
The VO2 HC (high contrast) program is selected on the touchscreen, using the icon for the high contrast option (see also section "High contrast option" on page 22).
Compared to the standard settings, the high contrast
setting VO2 HC is offers an improved display of hard
structures such as bones and teeth.
The settings may result in an inferior display of the soft tissue, especially in terms of the soft tissue sil­houette.
The high contrast option is particularly suitable for the evaluation of bone and tooth structures, e.g. after bone augmentations, when the correct display of the soft tis­sue silhouette is negligible.
Additionally, the feature is particularly useful for the DICOM export function to other implant planning pro­grams (such as Nobel Guide or Simplant).
bеЦдблЬ
If the VO2 HC program is used for a DICOM export to a
third-party implant planning software, always choose the setting value 42 mAs for optimal results.
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6 Operation Sirona Dental Systems GmbH

CAUTION
4
2
10
5
6
7

6.1 Preparing the exposure Operating Instructions GALILEOS

6 Operation
6.1 Preparing the exposure
Fitting the accessories to the bite block
For each new patient... ...the bite block should be sterilized. ...the handles, head fastening strap (if used) and contact upholstery of the forehead support must be disinfected.
Insert the bite block (4) up to the stop and lock it with the rotary knob (10).
Insert the forehead support (2).
Slide on the hygienic protective sleeves.
or for creating a drilling template:
Insert spherical mandibular bite block (5) or
spherical maxillary bite block (6) up to the stop and lock it with the rotary knob (10).
Clamp the spherical bite block plate (7) for the upper jaw or for the lower jaw to the sphere of the corre­sponding bite block as shown.
Inserting the accessories to the head fixation device
Insert the head fixation device until it easily snaps in place.
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H
1.
2.
I
I
L
Q
Operating Instructions GALILEOS 6.1 Preparing the exposure
Removing the head fixation device
To remove the head fixation device, press the lock­ing button (H) and push the head fixation device all the way to the rear (1.) past a pressure point; then pull it off straight down (2.).
Removing or inserting the head bar
Press the respective locking button (I) to remove or insert the headbands.
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Fitting the volume control
Insert the volume control (L) as far as it will go and lock it with the rotary knob (Q)
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CAUTION
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NOTE
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CAUTION
CAUTION
NOTE
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15
16
1
6.1 Preparing the exposure Operating Instructions GALILEOS
Switch the unit on
Following extreme temperature fluctuations, condensa­tion may occur; therefore please do not switch the sys­tem on until it has reached normal room temperature (see chapter 2 "Technical description").
Set main switch (1) to position I and wait approx. 1 minute.
In case of longer periods of disuse (> 200 hours), the X-ray detector (sensor) will require a preparation time of up to ten minutes. The system will display the message "Sensor preparation in progress." If the system is set to readiness for exposure during that time, the error mes­sage E1 10 07 will display. For further details, see "Error message E1 10 07" on page 44.
Due to the warm-up phase of the screen backlight, screen readability is poor for a few minutes after switch­ing on the system.
The LED (16) at the top of the Easypad lights up.
The radiation indicator (15) lights up for approx. one second for a function test.
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!
After switching the unit off with the main switch, you must wait for approx. 2 minutes before switching it back on.
After the unit is switched off with the main switch, the touchscreen on the Easypad remains illuminated for an­other 3 - 5 seconds.
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T
R
R
A
B
C
D
Operating Instructions GALILEOS 6.1 Preparing the exposure
Displays on the Easypad touchscreen
When you switch the system on, the start screen appears briefly and automatically disappears again after approx. 1 minute.
The clock symbol shows the current status of system power-up.
The selection screen appears.
The selection screen shows the following:
A – Bite block height adjustment value in mm (ranging
from 810 to 1815 mm) from the last patient set.
B – Exposure program VO1 or VO2
C – The patient symbol which was last preselected with
the related kV/mA combination
D – Help messages in the comment line
The preselected settings are represented in orange color.
Briefly press return key R to bring the rotating ele­ment into position for positioning.
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Switch SIDEXIS to ready for exposure state
Make the SIDEXIS program on the PC ready for exposure. (see SIDEXIS Operator’s Manual).
As long as no connection has been made to SIDEXIS, the message "Switch SIDEXIS to ready for exposure state" is displayed in the comment line of the Easypad touchscreen.
Once SIDEXIS is ready for exposure, the welcome screen with the selected patient’s data from SIDEXIS appears on the Easypad touchscreen.
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6 Operation Sirona Dental Systems GmbH
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James Thompson
24.11.1971 3836241-986
6.1 Preparing the exposure Operating Instructions GALILEOS
It shows the first name, last name, date of birth and card index number of the patient currently registered in SIDEXIS. The exposure data program, kV, mAs and a light blue radiation symbol are displayed in the upper right corner. When exposure readiness has been reached, the radia­tion symbol turns yellow.
When you touch the screen, the welcome screen disap­pears and the selection screen reappears.
If you wish to suppress this entire screen display or indi­vidual pieces of information displayed there, your service engineer can disable the corresponding data upon request.
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-
+
)
c
)
d
)
e
*
f
8 3

Operating Instructions GALILEOS 6.2 Selecting exposure parameters

6.2 Selecting exposure parameters
The preset exposure parameters are selected with the patient symbol keys.
bеЦдблЬ
85 kV/ 10mAs
If the default kV/mA combinations do not provide satis­factory results, you also can set two additional combina­tions (85 kV/10 mAs and 85 kV/42 mAs).
1. Select one of the outer
2. Touch the exposure parameter display in the sub-
3. Use the –/+ keys in the kV/mAs submenu line to se-
85 kV/ 14mAs
patient symbol keys.
– Far left patient symbol key:
Sets to 85 kV/10 mAs
– Far right patient symbol key:
Sets to 85 kV/42 mAs
menu column.
The submenu line for selecting the exposure param­eters appears.
lect the exposure parameters:
– 85 kV/10 mAs
(left patient symbol key, then – key) or
– 85 kV/42 mAs
(right patient symbol key, then + key)
85 kV/ 21mAs
85 kV/ 28mAs
85 kV/ 35mAs
85 kV/ 42mAs
4. Close the kV/mAs submenu line by touching the blue arrow (on the left in the line) or the kV/mAs symbol in the submenu column (3).
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The currently selected exposure parameters are dis­played on the right in the submenu column (8).
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6 Operation Sirona Dental Systems GmbH
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6.3 Positioning the patient Operating Instructions GALILEOS

6.3 Positioning the patient
In most cases, the X-ray exposure is performed on a standing patient. In special cases, you may also position a seated patient (using e.g. a dentist stool). You then must make sure that no parts of the dentist stool block the beam path or impair unit movements.
Preparations
Ask the patient to take off all metallic objects such as glasses and jewelry in the head and neck area as well as all removable dental prostheses.
For patients with metallic implants, bridges and fill­ings, image quality can be affected.
The movements of the unit must not be obstructed by physical constitution nor clothing, dressings, wheelchairs or hospital beds! Perform a test cycle with the T key (see also chapter 1.1 "General safety information").
Open the swivel arm of the unit completely.
Adjust the height of the unit roughly to the patient's height using the “up“ and “down“ keys on the Easypad.
When the R key is pressed, the unit begins moving only if the swivel arm is located in one of the two end positions.
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CAUTION
NOTE
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8
9
11
Operating Instructions GALILEOS 6.3 Positioning the patient
6.3.1 Positioning the patient to the bite block
Press the R key to move the unit back to the entry position.
The patient approaches the unit moving backwards from one side, depending on the default setting of the entry position in Level 4 (select start settings).
If the rotary ring was accidentally displaced while po­sitioning the patient, the entry position can be ap­proached again by pressing the “R“ key once again.
bеЦдблЬ
Aligning the patient to the standard bite block
Close the swivel arm (8) until it snaps in place.
Using the “up” and “down” keys on the Easypad, move the X-ray unit so that the bite block and the patient's front teeth are at the same height.
The motor movement is accompanied by an acoustic signal.
The height adjustment motor starts slowly and then in­creases its speed. Press and hold down the height adjustment key until the unit has reached the desired height.
The patient then approaches the bite block and holds the handles (9) firmly.
The patient must stand up with his back stretched per­fectly straight and let his shoulders hang loosely.
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NOTE
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NOTE
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A
B
C
6.3 Positioning the patient Operating Instructions GALILEOS
Have the patient bite the spoon of the bite block.
The height of the X-ray unit must be set so that the oc­clusal plane is perfectly horizontal after the patient bites the bite block.
Exposure with chin rest, bite block and contact bar
Indications: – Toothless patients
– Temporomandibular diagnosis – Cephalometry
The patient enters the unit-
Using the “upward movement” or “downward move­ment” key, adjust the height of the unit so that the pa­tient's chin and the chin rest are at the same height.
The motor movement is accompanied by an acous­tic signal.
The height adjustment motor starts slowly and then in­creases its speed. Press and hold down the height adjustment key until the unit has reached the desired height.
Have the patient place his chin on the chin rest with
closed occlusion (A) and grasp the handles firmly.
Swing in bite block (B).
Have the patient bite into the indentation of the bite block (upper anterior teeth into the indentation, low­er anterior teeth pushed forward as far as possible).
For patients with no anterior teeth, please insert con-
tact bar (C) (arch facing column).
Please place the contact bar between the patient's chin and upper lip and insert a cotton roll.
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CAUTION
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8
9
Operating Instructions GALILEOS 6.3 Positioning the patient
6.3.2 Positioning the patient to the head fixation device (e.g. for orthodontic
image series)
Open the bands of the forehead support fully.
Press the R key to move the unit back to the entry position.
Attach the statutory radiation protection equipment to the patient. Help the patient enter the unit moving backwards.
If the rotary ring was accidentally displaced while positioning the patient, the unit can be returned to the entry position by pressing the R key once again.
The height adjustment motor starts slowly and then in­creases its speed. Press and hold down the height ad­justment key until the unit has reached the desired height.
bеЦдблЬ
Aligning the patient to the head fixation device
Using the "up" and "down" keys on the control panel, move the X-ray unit until the centers of the
ear plugs are located at the same height as the patient's outer auditory canals.
The motor movement is accompanied by an acoustic signal.
Open the headband (C) of the head fixation device until the ear plugs contact the patient's outer audito-
ry canals.
Close the swivel arm (8) until it snaps in place.
The patient should grasp the handles (9) relaxed but securely.
For an optimal exposure, the patient should stand up straight and let his shoulders droop loosely.
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R
S
T
1
T
A
B
M
N
A
B
M
N
6.3 Positioning the patient Operating Instructions GALILEOS
Align the occlusal plane (S) of the patient's head par­allel to the marking line (R) via fine adjustment of the "up" and "down" keys.
The height of the X-ray unit must be set so that the oc­clusal plane is perfectly horizontal following alignment.
The correct position for the indication can be set by laterally fixing the position with the volume control and using the vertical and horizontal adjustment op­tions. The inner side (T) of the volume control should be re­garded as the volume boundary.
Example 1: The patient's nose and the point of his chin are within the volume, e.g. for optimal display of the sil­houette of a Ceph exposure.
Example 2: The horizontal adjustability makes it possible to push the rear of the skull region (e.g. the temporoman­dibular joints) further into the volume. The tip of the patient's nose and the point of his chin are pushed out of the 3D volume in return.
Finally, immobilize the patient's head by pushing the two pins (B) toward his forehead until the forehead rest (A) snugly fits against his head. Select the most suitable forehead pad, i.e. M or N.
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The forehead rest can be returned to its zero position by pressing the pushbutton (D).
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5
7
6
7
Operating Instructions GALILEOS 6.3 Positioning the patient
6.3.3 Positioning the patient to the spherical bite block
Using the spherical bite block to create an implant drilling template
Select the corresponding spherical bite block holder for the scan with the spherical bite block. For exposures of the lower jaw, insert spherical bite block holder (5). For exposures of the upper jaw, insert spherical bite block holder (6).
Spherical bite block plate (7) contains 6 radiopaque markers (spheres) which are used for orientation in the X-ray volume. Further applications can be set up on this spherical bite block plate.
Aligning the patient to the spherical bite block
bеЦдблЬ
Insert spherical bite block plate (7) with patient reg­istration at the patient.
Close swivel arm.
Adapt unit height until sphere and incisors are at the same height. The spherical bite block plate should be aligned horizontally.
Carefully lead the patient to the sphere of the spher­ical bite block holder with his mouth open.
Have the patient gently bite onto the spherical bite block holder.
The spherical bite block plate may touch the spherical bite block holder only via the sphere. If it has contact at the front, the patient's position or the unit height must be corrected.
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CAUTION
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12
11
2
6.3 Positioning the patient Operating Instructions GALILEOS
6.3.4 Display of the mid-sagittal plane
Switch on the light localizer with key (12) on the Easypad. It is used for correct patient positioning.
Align the patient so that the light beam strikes the center of the bite block and of the patient's face (mid­sagittal symmetry).
As long as the light localizer is switched on, a red light lo­calizer symbol is displayed on the touchscreen (see page 17).
Make sure that the light beam does not hit the patient’s eyes (laser light). The light localizer switches off auto­matically after approx. 100 seconds.
Fix the patient's position by tightening the forehead support (2) against the patient's forehead with the rotary knob (11).
In some cases, it is also advisable to immobilize the pa­tient's head with a head fastening strap as well (see chapter 4.1 "Bite blocks, supports and fasteners").
Concluding the preparations
If the light localizer is still on, switch it off with key (12) on the Easypad. The light localizer symbol on the touchscreen disappears.
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CAUTION
CAUTION
CAUTION
15
5

Operating Instructions GALILEOS 6.4 Releasing the exposure

6.4 Releasing the exposure
Be sure to observe the radiation protection regula­tions applicable in your country (see also chapter 1 "Warning and safety information")
Check the program and exposure parameters care­fully (see chapter 6.2 "Selecting exposure parame­ters").
No further help messages may be displayed in the com­ment line of the touchscreen. The message "Ready for exposure” must appear.
If e.g. the door of the X-ray room is not properly shut, the message "Close the door” appears in the touchscreen comment line; at the same time, the coded message H321 is displayed on the remote control.
bеЦдблЬ
Advise the patient not to move his/her head in any way during the exposure and check to make sure that this does not happen!
In order to attain optimal image quality, the patient should avoid any unnecessary breathing or swallowing during the exposure.
To release an exposure, press the exposure release button (5) directly on the X-ray unit or on the remote control.
The rotary movement of the selected exposure program is performed automatically.
While radiation is active, the optical radiation indicator (15) on the Easypad or on the remote control is illuminated.
In addition, an acoustic signal sounds throughout the entire radiation time.
Take care not to let go of the exposure release button prematurely. Wait until the unit has completed the expo­sure cycle. If the exposure is canceled prematurely, you will obtain a much poorer image quality, since not enough image data will be available for reconstruction of the volume.
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CAUTION
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6.4 Releasing the exposure Operating Instructions GALILEOS
The exposure cycle is complete when... ... the touchscreen comment line switches fromEx-
posure in progress” to “R key, confirm exposure data”.
... message “H 320“ appears alternately with the pro­gram number on the remote control display. … the actual mAs value is displayed under the pro­gram number at the end of the exposure (see image). ... a short pulsed tone sequence also can be heard at the end of the exposure (this function can be de­activated by your service engineer).
The end of the exposure cycle can also be seen on the SIDEXIS monitor when the progress bar indicates 100 %.
Confirm the exposure by pressing the “R“ key. Then press the “R“ key again to move the unit to the entry position. The patient can now leave the unit.
Never switch off the X-ray unit during transmission of an
image. The scanning process takes approx. 2.5 minutes.
After completion of the exposure
the image is reconstructed and displayed in the recon­struction software. Depending on the program selected and the PC system used, it may take from 2.5 to 5 min­utes to display all of the views on the screen.
The operation of the visualization software is described in the attached GALAXIS Operator's Manual.
Canceling an exposure
If you let go of the exposure release button prematurely, the exposure is canceled.
The message “R key, confirm exposure data” appears in the comment line and the actual mAs value flashes under the program number on the touchscreen as well as on the remote control.
Press the “R” key on the Easypad twice.
Please note that any program settings which may have been changed must be preselected again before repeat­ing the exposure.
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Sirona Dental Systems GmbH 6 Operation Operating Instructions GALILEOS 6.4 Releasing the exposure
After the rotating element has returned to its starting position, repeat the exposure.
Automatic exposure blocking
(thermal protection of the tube)
Premature release of a new exposure is prevented by the automatic exposure blocking function.
When you press the exposure release button, the mes­sage “Ready for exposure in "X" seconds“ appears in the comment line of the touchscreen.
The remaining cooling time is counted down and is dis­played under ‘x’.
Only after the cooling period has elapsed is it possible to release a new exposure.
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6 Operation Sirona Dental Systems GmbH
NOTE
i
GALILEOS
GALILEOS
A
5
18
15
16
B

6.5 Remote control Operating Instructions GALILEOS

6.5 Remote control
If the X-ray unit is located in an X-ray room which has a door and enables visual contact with the patient, you can use remote control to release the exposure.
For that purpose, the exposure release button (5) can be detached from the unit and attached to the remote control. The exposure release button (A) can be used if a longer cable is not required to maintain visual contact with the patient.
The remote control has an “R” key (18) for acknowledg­ing the exposure and resetting the unit to its starting position, an optical radiation indicator (15) and a "Unit ON" LED display (16).
After you switch on the system, the LED (16) lights up. The radiation indicator (15) lights up for a longer period of time for a function test. The three display fields on the display panel (B) light up. A progress bar appears after approx. 10 seconds. After the system starts, the display switches to program VO1 with the corresponding values.
As long as plain-text help messages are displayed on the Easypad touchscreen, they also appear in coded form on the "Prog." display field of the remote control, alternating with the program name.
Once all help messages have been processed, the pro- gram name “Prog.”, the “kV” and the “mAs” values are constantly displayed on the display panel (B). The exposure can be released.
If a row of dots ........ appears in the Prog. field, this
means that the system is currently in a preparatory phase (e.g. system movements, parameter changes, program loading times etc.). Just wait until the dots auto­matically disappear and the system signals that it is ready again.
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Sirona Dental Systems GmbH 7 List of messages

NOTE
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Operating Instructions GALILEOS 7.1 List of help messages

7 List of messages
7.1 List of help messages
A number of H3 help messages may appear on the Easypad while you attempt to release an exposure:
Press the exposure release button. ATTENTION Observe radiation protection measures. The message H3/H4 ... – Message appears on the Easypad.
See list below about how to proceed to make the system ready for exposure.
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Help
message
H3 01
H3 20
H3 21
H3 23
H4 03
H4 20
Actions required Description
R key, move into starting position. The rotating element is not in the starting position.
R key, confirm exposure data. The exposure data have not been acknowledged yet.
Close the door. Check door contact of the X-ray room.
Move the swivel arm into its end position. Open or close the swivel arm completely.
Switch SIDEXIS to ready for exposure state SIDEXIS is not ready for exposure.
Retrieve existing exposure. The image could not be transferred to SIDEXIS. See
SIDEXIS Operator’s Manual. ATTENTION Do not switch off the system until the help message has disappeared.
The above measures clear those help messages that result from operator errors.
If it is not possible to clear the help message by taking the appropriate measure, another type of error is the cause. To locate the error, proceed as described on the follow­ing pages.
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Separate operating instructions for troubleshooting in the image data path (Rescue Management) are attached to your documents. Order No. 61 81 114
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7 List of messages Sirona Dental Systems GmbH

7.2 Error message structure Operating Instructions GALILEOS

7.2 Error message structure
The error messages are displayed in the form of an error code. They are not provided in plain-text form.
13.2.1 The error message code has the following structure:
Ex yy zz
Ex
yy
zz
All error messages of the system are grouped according to these criteria.
Error type/“troubleshooting” classification for the user
Location; module; subsystem or logical function unit
Consecutive number with error ID
13.2.2 Ex
Digit (x) is intended to provide the user with quick help in deciding how to deal with this error.
Ex Description Actions required Error group
1
System warning; system message
2
Errors caused by system overload
Acknowledge the error message. Contact your Customer Service. Continued operation of the system is ensured.
Acknowledge the error message. Repeat the procedure step after a certain waiting time. If the error message reappears, prolong the waiting time. If the error state persists, contact your Customer Service.
This error group includes all errors that indicate still acceptable tolerance variations, or messages about states which do not directly affect system operation.
This error group includes states that indicate e.g. temporary overtemperatures or the like. The cause of the error disappears automatically after a certain waiting time.
3
The system detects that a key was pressed during power-on.
4
Malfunction or mechanical obstruction of unit movements
Switch the system off and back on; if the error reoccurs without any user intervention, contact your Customer Service.
CAUTION! After switching the unit off with the main switch, you must wait for approx. 2 minutes before switching it back on.
Acknowledge the error message; make sure that the movements of the unit are not obstructed. Repeat the last procedure step or exposure. If the error reoccurs without any identifiable cause -> contact your Customer Service
This error group includes all errors that indicate invalid signal states of keys and safety signals during power-on.
This error group includes all errors that indicate problems with the motor-controlled movements on the outside of the unit.
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Sirona Dental Systems GmbH 7 List of messages Operating Instructions GALILEOS 7.2 Error message structure
Ex Description Actions required Error group
5
Malfunction during the exposure or during exposure preparation.
6
Error during system self-test.
Acknowledge the error message to continue system operation. Repeat the last procedure step or exposure. If the error reoccurs -> contact your Customer Service.
Acknowledge the error message to con­tinue system operation. If the error occurs repeatedly, switch the system off and back on; if the error re-occurs -> contact your Customer Service.
This error group includes all errors resulting from a certain system action triggered by the user which could not be performed because a required (internal) partial function (SW or HW) is not ready or fails
This error group includes all errors which may occur spontaneously and without any related operator action. They may be caused by system self-tests.
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7
Unrecoverable system error.
Switch off the system; immediately contact your Customer Service.
This error group includes all errors which may occur spontaneously and without any related operator action. They may be caused by system self-tests. In this case it is absolutely certain that continued system operation is not possible.
13.2.3 yy
Digits (yy) define the location or logical function unit where the error has occurred.
10
Central control DX 11; system hardware
11
Central control DX 11; system software
12
Central control DX 11; central CAN bus errors
13
Central control DX 11; DX11, DX1 periphery (motor system of stand, sensor system of stand)
14
Central control DX 11; digital extension (HSI, network...)
15
Central control DX 11; configuration (wrong software, wrong module constellation, etc.)
06
Tube assembly
07
User interface (Easypad)
89
Sensor
41
Media interface card
42
Remote
The location may be a DX module number standing for an entire HW function unit, or a logical SW function unit on the DX11 (central control).
13.2.4 zz
Digits (zz) show a consecutive number with the error ID.
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7 List of messages Sirona Dental Systems GmbH
NOTE
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7.3 Error message E1 10 07 Operating Instructions GALILEOS

7.3 Error message E1 10 07
Explanation
This section describes the possible causes and the cor­rection of this error.
Case 1
In case of longer periods of disuse (> 200 hours), the X-ray detector (sensor) will require a preparation time of up to ten minutes.
The system will display the message "Sensor prepara­tion in progress."
During that time, the device is not ready for operation.
If the system is set to readiness for exposure during that time, error message E1 10 07 will display.
Solution
Acknowledge the error message with the (R) key and wait until the message "Sensor preparation in progress" is deactivated.
Decreasing the waiting time
Switching the unit on and off will not decrease the waiting time!
Case 2
If the error message E1 10 07 is displayed immediately after turning on the device without the user having estab­lished exposure readiness, please inform the responsi­ble service engineer.
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Sirona Dental Systems GmbH 8 Care of outer surfaces

CAUTION
Operating Instructions GALILEOS
8 Care of outer surfaces
Cleaning Remove dirt, grime and disinfectant residue regularly
using mild, commercially available cleaning agents.
Do not allow liquids to penetrate into the ventilation slots!
Wipe off any medicaments that may come into contact with the surface immediately.
Disinfecting Surfaces can be wiped with surface disinfectants.
Observe manufacturer’s instructions regarding restric­tions for use!
Use only disinfecting, cleaning and care agents which are approved by Sirona!
A continuously updated list of approved agents can be downloaded from the internet at: www.sirona.de /
SERVICE / Downloads / Care & cleaning agents
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If you do not have access to the internet, you can request a list in one of the following two ways:
Contact your dental depot.
Order the list from Sirona by phoning:++49 (0) 62 51/16-16 16 or sending a fax to:++49 (0) 62 51/16-18 18
REF 59 70 905
Disinfect only the outer surfaces with tested chemi­cal disinfectants. Use only disinfectants which com­ply which the laws and regulations applicable in your country or whose bactericidal, fungicidal and viru­cidal properties have been tested and certified accordingly.
Here are a few examples:
MinutenSpray classic from Alpro® or MinutenWipes from Alpro®.
In the USA and Canada:
CAVICIDE® or CAVIWIPES
Do not use:substances containing phenol, peracetic
acid, peroxide or any other oxygen-splitting agents, sodium hypochlorite or iodine-splitting agents.
Sterilizing The bite block should be sterilized for each new patient.
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Sterilize only in an autoclave at 134 °C (273 °F) and 2.1 bar.
53

9 Inspection and maintenance Sirona Dental Systems GmbH

Operating Instructions GALILEOS
9 Inspection and maintenance
Inspection and preventive maintenance must be per­formed at scheduled intervals to protect the health and safety of patients, users and other persons.
9.1 Annual check performed by the system owner or other
authorized persons
In order to ensure the operational safety and functional reliability of your product, you as the system owner must check the equipment at regular intervals (at least once a year) or commission your dental depot to do so.

9.2 Maintenance by the service engineer

9.3 Image quality check

In addition to the annual check to be carried out by the system owner or authorized persons, preventive mainte­nance must be performed after 4, 7 and 10 years, and then at two-year intervals.
The image quality should be assessed by the system owner at regular intervals, at least once a year.
On digital image receptor systems, the degree of post­processing (brightness or contrast adjustment) that is required in the image processing software (e.g. SIDEXIS) to produce satisfactory results is used as an assessment criterion.
If, after taking into account the patient’s anatomy and excluding possible sources of error such as incorrect patient positioning, this criterion can be regarded as given, you should immediately contact your Customer Service to have possible system faults rectified.
Observe any possible additional national requirements.
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