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GALILEOS Operating Inst ructions for Comfort PL US
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Sirona Dental Systems GmbH Table of contents
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
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Table of contents
1
General information.................................................................................................. 6
1.1 Dear Customer,............................................................................................. 6
1.2 Contact information ....................................................................................... 6
1.3 General information about this operating manual ......................................... 7
1.4 Other valid documents .................................................................................. 7
1.5 Warranty and liability..................................................................................... 8
1.6 Obligation of system owner and personnel ................................................... 8
1.7 Intended use ................................................................................................. 9
1.8 Indication and contraindication...................................................................... 9
1.9 Structure of the document............................................................................. 10
1.9.1 Identification of the danger levels..................................................... 10
1.9.2 Formats and symbols used .............................................................. 10
2
Safety information .................................................................................................... 11
2.1 Information on the unit .................................................................................. 11
2.2 Ventilation slots ............................................................................................. 11
2.3 Condensation ................................................................................................ 11
2.4 Qualifications of operating personnel............................................................ 12
2.5 Switching the unit on ..................................................................................... 12
2.6 Radiation protection ...................................................................................... 12
2.7 Emergency Stop............................................................................................ 13
2.8 Laser light localizer ....................................................................................... 13
2.9 Hygiene ......................................................................................................... 13
2.10 Touchscreen ................................................................................................. 13
2.11 Trouble-free operation................................................................................... 14
2.12 Interference with electronic devices .............................................................. 14
2.13 Risks of electromagnetic fields...................................................................... 14
2.14 Combination with other equipment................................................................ 14
2.15 Modifications to the unit ................................................................................ 15
2.16 Structural alterations ..................................................................................... 15
2.17 Electromagnetic compatibility........................................................................ 15
2.18 Electrostatic charge....................................................................................... 16
2.18.1 ESD protective measures ................................................................ 16
2.18.2 About the physics of electrostatic charges....................................... 16
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Table of contents Sirona Dental Systems GmbH
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
3
Technical description............................................................................................... 18
3.1 Technical data .............................................................................................. 18
3.2 Diagrams ...................................................................................................... 21
3.3 Values of the secondary scattered radiation ................................................ 23
3.4 Certification and registration......................................................................... 24
4
Controls and functional elements ............................................................................ 25
4.1 Operating and display elements on the GALILEOS..................................... 25
4.2 Operating and display elements on the head fixation device....................... 26
4.3 Control and display elements on the Easypad with touchscreen................. 27
4.4 General touchscreen functions on the Easypad........................................... 28
4.4.1 Program settings (Level 2) .............................................................. 29
4.4.2 Service start settings (Level 4) ........................................................ 30
4.4.3 Service menu .................................................................................. 31
4.4.4 Touchscreen settings ...................................................................... 31
4.4.5 Closing menu cells .......................................................................... 31
4.4.6 Info screen....................................................................................... 32
5
Accessories ............................................................................................................. 33
5.1 Bite blocks, supports and fasteners ............................................................. 33
5.2 Accessories for head fixation device ............................................................ 34
5.3 Hygienic protective sleeves.......................................................................... 35
5.3.1 Hygienic protective sleeves for bite blocks, supports, and fasteners 35
5.3.2 Hygienic protective covers for head fixation device ........................ 36
5.4 Test phantom for acceptance/constancy test............................................... 37
6
Programs................................................................................................................. 38
6.1 VO5: standard volume program ................................................................... 38
6.1.1 HC mode: high contrast mode......................................................... 39
6.1.2 HD mode: high definition mode ....................................................... 39
6.2 VOG: volume program for template scan..................................................... 40
7
Operation................................................................................................................. 41
7.1 Preparing the exposure................................................................................ 41
7.1.1 Fitting the accessories..................................................................... 42
7.1.2 Inserting the head fixation device.................................................... 43
7.1.3 Switching the unit on ....................................................................... 45
7.1.4 Display on the Easypad touchscreen .............................................. 46
7.1.5 Switching SIDEXIS 4 to ready for exposure state........................... 47
7.1.6 Switch SIDEXIS to ready for exposure state................................... 47
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
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7.2 Selecting acquisition parameters (kV/mAs/dose values) ............................. 48
7.3 Setting high contrast..................................................................................... 50
7.4 Setting HD mode .......................................................................................... 51
7.5 Adjusting the mechanical diaphragm ........................................................... 52
7.6 Positioning the patient.................................................................................. 53
7.6.1 Positioning the patient - with bite block ........................................... 54
7.6.1.1 Aligning the patient - with standard bite block .................. 54
7.6.1.2 Aligning the patient - with chin rest, bite block, and contact
bar
55
7.6.2 Positioning the patient - with head fixation device (e.g. for
orthodontics)
56
7.6.3 Positioning patients - with spherical bite block ................................ 58
7.6.4 Display of midsagittal line................................................................ 59
7.7 Releasing the exposure................................................................................ 60
7.8 Remote control............................................................................................. 63
8
List of messages...................................................................................................... 64
8.1 List of help messages................................................................................... 64
8.2 Error message structure............................................................................... 65
8.2.1 Ex .................................................................................................... 65
8.2.2 yy..................................................................................................... 66
8.2.3 zz..................................................................................................... 66
8.3 Error message E1 10 07 .............................................................................. 67
9
Maintenance............................................................................................................ 68
9.1 Cleaning and care ........................................................................................ 68
9.1.1 Cleaning .......................................................................................... 68
9.1.2 Disinfecting...................................................................................... 68
9.1.3 Sterilization...................................................................................... 70
9.2 Inspection and maintenance ........................................................................ 71
10
Dismantling and disposal......................................................................................... 72
10.1 Dismantling and reinstallation ...................................................................... 72
10.2 Disposal........................................................................................................ 72
10.2.1 GALILEOS X-ray tube ..................................................................... 73
11
Dose information ..................................................................................................... 74
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1General information Sirona Dental Systems GmbH
1.1Dear Customer, Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
1
General information
1.1
Dear Customer,
We are pleased that you have equipped your practice with the GALILEOS
Comfort PLUS X-ray system from Sirona.
The GALILEOS system comprises an X-ray unit that uses a rotating X-ray
beam and an optics system. It prepares two-dimensional images and
three-dimensional reconstructions, and/or the surface of the head region
(including dentomaxilliofacial and ENT areas) for planning and
diagnostics.
The system also includes a package with software modules which
extends SIDEXIS to include the processing of 3D data. This includes 3D
reconstruction, storage, recall, display, and processing of 3D image data.
These Operating Instructions are designed to assist you prior to initial use
and whenever you require information later on.
We wish you every success with using your GALILEOS Comfort PLUS
system.
Your GALILEOS Team
1.2
Contact information
Worldwide customer service
Customer service center In the event of technical queries, please use our online contact form at
www.sirona.com. In the navigation bar, go to the menu commands
"CONTACT"
/
"Customer Service Center"
and then click the
"CONTACT
FORM FOR TECHNICAL QUESTIONS"
button.
Manufacturer's address (w orl dw i de )
Manufacturer's address Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Trademark
Phone: +49 (0) 6251/16-0
Fax: +49 (0) 6251/16-2591
e-mail: contact@sirona.com
www.sirona.com
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Sirona Dental Systems GmbH 1General information
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 1.3General information about this operating manual
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1.3
General information about this operating manual
Observe the Operating Instructions
Observe the Operating Instructions Please familiarize yourself with the unit by reading through these
Operating Instructions before putting it into operation. It is essential that
you comply with the specified warning and safety information.
Storage of documents, on line portal, help
Keep documents safe Always keep the Operating Instructions handy in case you or another
user require(s) information at a later point in time. Save the Operating
Instructions on the PC or print them out.
If you sell the unit, make sure that the Operating Instructions are included
with it either as a hard copy or on an electronic storage device so that the
new owner can familiarize himself with its functions and the specified
warning and safety information.
Online portal for technical documents We have set up an online portal for the Technical Documents at http://
www.sirona.com/manuals. From here, you can download these
Operating Instructions along with other documents. Please complete the
online form if you would like a hard copy of a particular document. We will
then be happy to send you a printed copy free of charge.
Help If you reach an impasse despite having thoroughly studied the operating
instructions, please contact your dental depot.
1.4
Other valid documents
The X-ray system includes other components, such as PC software,
which are detailed in other documents. Instructions and warning and
safety information provided in the following documents must be taken into
account:
Other relevant WW documents
● SIDEXIS Operator's Manual
● GALAXIS Operator's Manual
● Software Components Operating Instructions
● Facescan Operating Instructions
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1.5Warranty and liability Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
1.5
Warranty and liability
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.
As manufacturers of medical electrical equipment, we can assume
responsibility for the safety properties of the system only if maintenance
and repair work on the system is performed by ourselves or by agencies
expressly authorized by us, and if components affecting safe operation of
the system are replaced by original spare parts in case of failure.
Exclusion of liability 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.
Certificate of work We suggest that you request a certificate, showing the nature and extent
of the work performed, from those who carry out such work, and specify
that the certificate show any changes in rated parameters or working
ranges, as well as the date, the name of the firm and a signature.
1.6
Obligation of system owner and personnel
These operating instructions presuppose that you are familiar with the
use of SIDEXIS software.
Prior to the exposure, please ask women of a childbearing age as to
whether they are pregnant or not. If the patient is pregnant, a risk/benefit
analysis must be performed.
According to the X-ray Ordinance of Germany, owners of X-ray
equipment must perform constancy tests at regular intervals in order to
ensure the safety of operating staff and patients. Sirona recommends
monthly testing.
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 1.7Intended use
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1.7
Intended use
WW designated use
The GALILEOS system comprises an X-ray unit that uses a rotating X-ray
beam. It prepares two-dimensional images and three-dimensional
reconstructions of the head region (including dentomaxilliofacial and ENT
areas) for planning and diagnostics.
The system also includes a package with software modules which
extends SIDEXIS to include the processing of 3D data. This includes 3D
reconstruction, storage, recall, display, and processing of 3D image data.
This system must not be used in areas subject to explosion hazards.
1.8
Indication and contraindication
Canada indication GAX9
Indication in the sub-areas:
● Conservative dentistry
● Endodontics
● Periodontology
● Prosthodontics
● Functional diagnosis and treatment of craniomandibular dysfunctions
● Surgical dentistry
● Implantology
● Oral and maxillofacial surgery
● Orthodontics
● ENT (paranasal sinuses, analyzes of the respiratory passages and
treatment planning of midfacial fractures and fractures of the lower
jaw)
WW contraindication
Contraindications:
● Caries diagnosis, especially of proximal lesions
● Display of cartilage structures
● Display of soft tissue using X-ray
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1.9Structure of the document Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
1.9
Structure of the document
1.9.1 Identification of the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in the present operating
instructions. Such information is highlighted as follows:
Tip: Information on making work easier.
1.9.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily injury
or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the product
or an object in its environment.
IMPORTANT
Application instructions and other important information.
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢ Individual action step
Requests you to do something.
See "Formats and symbols
used [ → 10]"
Identifies a reference to another text
passage and specifies its page
number.
● List Designates a list.
"Command / menu item" Indicates commands, menu items or
quotations.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 2.1Information on the unit
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2
Safety information
2.1
Information on the unit
The following symbols are applied to the unit:
Accompanying document s
Accompanying documents
This symbol is affixed next to the unit rating plate.
Meaning: When operating the unit, observe the operating instructions.
This symbol is affixed on the unit rating plate.
Meaning: The accompanying documents are available on the homepage
of Sirona.
Electrostatic discharge (ESD)
Connector pins or sockets bearing ESD warning labels must not be
touched or interconnected without ESD protective measures. See also
"Electrostatic Discharge" and "Electromagnetic Compatibility".
Single use hygienic prote ctive sleeves
Identification of single use devices
Prior to each exposure, the hygienic protective sleeves (single use
devices) must be fitted.
Single use devices are identified with the symbol shown on the left. They
must be disposed of immediately after use. Do not use single use devices
more than once.
2.2
Ventilation slots
Ventilation slots
Under no circumstances may the ventilation slots on the unit be covered,
since otherwise the air circulation will be obstructed. This can cause the
unit to overheat.
Do not spray into the ventilation slots
Do not spray liquids such as disinfectants into the ventilation slots. This
may lead to malfunctions. Use wipe disinfection only in the vicinity of the
ventilation slots.
2.3
Condensation
Safety information for co ndensation: Customer
Extreme fluctuations of temperature may cause condensation inside the
unit. Do not switch the unit on before it has reached normal room
temperature. See the chapter on “Technical data”.
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2.4Qualifications of operating personnel Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
2.4
Qualifications of operating personnel
Operating personnel
The system may only be operated by skilled or properly trained
personnel.
Qualification
Personnel, who are to be trained, taught, instructed or are taking part in
a general training, may operate the device only under the supervision of
an experienced person.
To operate the unit, the operating personnel must:
● have read and understood the Operating Instructions
● be familiar with the fundamental structure and functions of the unit
● be able to recognize irregularities in the functioning of the unit and
implement the appropriate measures where necessary
2.5
Switching the unit on
Safety information for switching o n the unit: Customer
No patient may be positioned in the unit while it is booting up. The patient
could be injured in case of malfunction.
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 the unit is
switched back on.
2.6
Radiation protection
Safety information for radiation protection: Customer
The valid radiation protection regulations and measures must be
observed. The statutory radiation protection equipment must be used. In
order to reduce radiation exposure, Sirona recommends using bismuth or
lead shields or aprons, especially for pediatric patients.
During an exposure, the operator should move as far away from the X-ray
tube assembly as the coiled cable of the manual release permits.
With the exception of the patient, no other persons without radiation
protection are allowed to stay in the room during an exposure. In
exceptional cases, a third person may provide assistance, but not the
practice staff. Visual contact with the patient and the unit must be
maintained throughout the entire exposure.
In case of malfunctions, cancel the exposure immediately by letting go of
the exposure release button.
Information about radiation protection for Canada
NOTICE
3D imaging should not be used for screening examinations. 3D imaging
examinations must be clinically warranted and each exam must be
justified by demonstrating that the benefits outweigh the risks.
NOTICE
Where it is likely that evaluation of soft tissues will be required as part of
the patient's radiological assessment, the appropriate imaging should
be conventional medical CT or MR, rather than 3D imaging using Cone
Beam technology.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 2.7Emergency Stop
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2.7
Emergency Stop
Not included in the scope of supply
(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!
2.8
Laser light localizer
Safety information for light localizer: Customer
The system incorporates Class 1 laser products.
The light localizers are intended for correct patient positioning. They must
not be used for any other purposes.
A minimum distance of 10 cm (4") is required between the eye and the
laser. Do not stare into the beam.
The light localizers may be switched on only when functioning perfectly.
Repair work must be carried out by authorized staff only.
Do not use the system with any other lasers, and do not make any
changes to settings or processes that are not described in these
operating instructions. This may lead to a dangerous exposure to
radiation.
2.9
Hygiene
The protective sleeves must be exchanged and all auxiliary exposure
equipment must also be disinfected for each new patient in order to
prevent any possible transmission of infective agents which might cause
serious illnesses.
Suitable hygienic measures must be taken to prevent cross
contamination between patients, users and other persons.
The following chapters contain more information about sterilization and
hygienic protective sleeves: Hygienic protective sleeves [ → 35],
Preparing the exposure [ → 41], Sterilization [ → 70] .
2.10
Touchscreen
The Easypad monitor is equipped with touch-sensitive control
technology.
The touchscreen must not be operated with pointed objects such as ballpoint pens, pencils, etc. Such objects could damage or scratch its
surface. Always operate the touchscreen by pressing it gently with your
fingertip.
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2.11Trouble-free operation Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
2.11
Trouble-free operation
Generally valid
Use of this system is permissible only if it works properly without
malfunctions. If trouble-free operation cannot be ensured, the unit must
be taken out of service, checked by authorized technicians for
malfunctions and, if necessary, repaired.
Trouble-free operation
X-rays of patients may be taken only when the system is working troublefree.
Obstruction of unit mov ements
The movements of the unit must not be obstructed by physical
constitution, clothing, dressings, wheelchairs or hospital beds.
The travel range of the unit must be kept free from foreign matter.
Do not leave the patient at the unit unattended.
Unit cover
The device may only be operated with a complete cover and protective
hood.
2.12
Interference with electronic devices
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.
2.13
Risks of electromagnetic fields
The function of implanted systems (cardiac pacemakers or cochlear
implants, for example) can be affected by electromagnetic fields. Before
commencing treatment, ask if the patient has a cardiac pacemaker or any
other implanted system.
Any prevailing risks are listed in the documentation provided by the
equipment manufacturer.
2.14
Combination with other equipment
Any person, who assembles or modifies a medical electrical system
complying with the standard IEC 60601-1 (safety requirements for
medical electrical equipment) by combining it with other equipment is
responsible for ensuring that the requirements of this regulation are met
to their full extent for the safety of the patients, the operators and the
environment.
If any devices not approved by Sirona are connected, they must comply
with the applicable standards:
● IEC 60950-1 for information technology equipment and
● IEC 60601-1 for medical devices
See "Installation requirements" and the compatibility list/declaration of
conformity by the system integrator.
If in doubt, contact the manufacturer of the system components.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 2.15Modifications to the unit
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2.15
Modifications to the unit
Modifications to this unit which might affect the safety of the system
owner, patients or other persons are prohibited by law!
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 is responsible for any damage resulting from the use
of non-approved accessories.
2.16
Structural alterations
If structural changes are made in the vicinity of the X-ray unit which result
in the device being exposed to very high levels of vibration or even
impact, the device must be inspected by a service engineer and readjusted and re-calibrated if necessary.
2.17
Electromagnetic compatibility
EMC regarding high-volta ge, radio link and MRI sy stems
The GALILEOS Comfort PLUS X-ray unit complies with the requirements
of the standard IEC 60601-1-2.
Medical electrical equipment is subject to special EMC preventive
measures. It must be installed and operated as specified in the
“Installation Requirements” document.
If high-voltage systems, radio link systems or MRI systems are located
within 5 m of the unit, please observe the specifications stated in the
installation requirements.
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless
phones in medical office or hospital environments must be prohibited.
Please also observe the ESD protective measures described in the
section "Electrostatic Discharge".
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2.18Electrostatic charge Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
2.18
Electrostatic charge
2.18.1 ESD protective measures
ESD ESD stands for ElectroStatic Discharge.
ESD protective measures ESD protective measures include:
● Procedures for preventing electrostatic charge build-up (e.g. air
conditioning, air moistening, conductive floor coverings and nonsynthetic 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.
Training 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 USERS.
The content of this training is explained in the Chapter "About the physics
of electrostatic charges" [ → 16].
2.18.2 About the physics of electrostatic charges
What is an electrostatic charge? An electrostatic charge is a voltage field on and in an object (e.g. a human
body) which is protected against conductance to ground potential by a
nonconductive layer (e.g. a shoe sole).
Formation of an electrostatic charge
Electrostatic 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).
Amount of charge 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).
Electrostatic discharge must be preceded by electrostatic charging.
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.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 2.18Electrostatic charge
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Background Integrated circuits (logical circuits and microprocessors) are used to
implement a wide variety of functions in dental/X-ray/CAD/CAM 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. ESD stands for ElectroStatic Discharge.
Connector pins or sockets bearing ESD warning labels must not be
touched or interconnected without ESD protective measures.
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3Technical description Sirona Dental Systems GmbH
3.1Technical data Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
3
Technical description
3.1
Technical data
TD GALILEOS Comfort PLU S
Chassis: Model designation GALILEOS Comfort PLUS
Nominal voltage: 200 V – 240 V
Permissible fluctuation: ±10%
Permissible drop under load: 10%
Rated current: 6 A
Nominal power output: 0.6 kW at 98 kV/6mA
Current time product: 30 mAs
Nominal frequency: 50 Hz / 60 Hz
Internal line impedance: max. 0.8 ohms
Main building fuse: 25 A slow-blow (16 A for single line)
Power consumption: 0.9 kVA
X-ray tube assembly: Focal spot size acc. to IEC 60336,
measured in the central X-ray beam: 0.5 mm
kV: 98 kV
mA: 3 mA / 6 mA
Pulsed mode: 10 ms – 14 ms
min. permanent filtering:
min. half-value layer:
2.8 mm Al / 98 IEC 60522
3.9 mm Al
Integrated filter: 0.2mm Cu
Cone-beam angle: collimated to approx. 24°
High voltage generation frequency: 80 kHz – 100 kHz
Detector: Type: Image intensifier (I.I.), Siemens
Active input window size: 215 mm (8 1/2") diameter
Camera:
Pixels: 1000
2
FPS: 15 – 30
Dynamics: 12 bits,
(4096 brightness values), 63 dB
Geometry: Source-I.I. converter coating distance
(central X-ray beam)
590 mm (23 1/4")
Source-isocenter distance
(central X-ray beam)
413 mm (16 1/4")
Source-skin distance
(minimum distance)
approx. 300 mm (11 13/16")
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Sirona Dental Systems GmbH 3Technical description
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 3.1Technical data
bеЦдблЬ
Scanning process: Orbital angle 204°
Scan time approx. 14 s
Number of single exposures 200
HD-Modus 357
Reconstruction:
Marking of focal spot:
Automatic exposure blocking: 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, interval
times of 8 s to 300 s are automatically set
by the system.
Class I device
Degree of protection against electric
shock:
Type B device
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: 100 W
Anode material: Tungsten
Exposure parameters for determining
leakage radiation:
6mA / 98 kV
Continuing current for leakage radiation
measurements:
0.14 mA
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: between +10°C and +35°C (50°F – 95°F)
At a room temperature of > 35°C (> 95°F),
Sirona recommends using an air
conditioning system.
Operating altitude: ≤ 3000 m
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3Technical description Sirona Dental Systems GmbH
3.1Technical data Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
Minimum requirements for PC ww
X-ray tube: Siemens SR 120/15/60
Minimum requirements for
reconstruction PC (included
in the scope of supply):
Processor: QuadCore Intel i5
RAM: 8 GB RAM
Hard disks: 1 TByte
Operating system: Windows 7 64-bit (mandatory)
External drive: 1x DVD-ROM, dual-layer
Graphics card: explicit (not onboard),
at least 1 GB RAM
Minimum requirements for
SIDEXIS visualization PC
(not included in the scope of
supply):
see the SIDEXIS Operator’s Manual.
The system requirements are also
listed under www.sidexis.com
Network: Network: 100 MB Ethernet, 1 Gbit Ethernet
recommended
Communication interface: RJ45 for LAN cable
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Sirona Dental Systems GmbH 3Technical description
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 3.2Diagrams
bеЦдблЬ
3.2
Diagrams
Cooling curve of tube housing
Cooling curve of X-ray tube
Heating curve of tube housing
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3Technical description Sirona Dental Systems GmbH
3.2Diagrams Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
Central X-ray beam
Anode angle
10°
16°
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Sirona Dental Systems GmbH 3Technical description
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 3.3Values of the secondary scattered radiation
bеЦдблЬ
3.3
Values of the secondary scattered radiation
Values of the secondary scattered radiation
The following parameters were set for the scattered radiation
measurements:
Tube voltage 98 kV,
tube current 6 mA,
radiation time 5,1 s (corresponds to a current-time product of 30.6 mAs).
Angle
[°]
Measuring
point
Distance [m] Measured
dose [µSv]
Dose/mAs
[µSv]
0113.460.113
2 2 0.96 0.0314
3 1 (45° below) 2.91 0.0951
4 1 (45° above) 1.14 0.0372
45 5 1 4.09 0.114
6 2 1.16 0.0379
90 7 1 4.89 0.160
135 8 1 6.07 0.198
180 9 1 0.45 0.0148
225 10 1 5.64 0.184
270 11 1 4.81 0.157
315 12 1 3.92 0.128
315 13 2 1.09 0.0356
1. (3. + 4.)
2.
5.
6.
7.
8.
9.
10.
11.
12.
13.
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3Technical description Sirona Dental Systems GmbH
3.4Certification and registration Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
3.4
Certification and registration
The GALILEOS X-ray unit complies with IEC 60601-1
The GALILEOS X-ray unit complies with IEC 60601-1-3
The GALILEOS X-ray unit complies with IEC 60601-2-63
The GALILEOS D3437 dental X-ray unit for extra-oral radiography complies with IEC 60601-2-63
Original language: German
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.
0123
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 4.1Operating and display elements on the GALILEOS
bеЦдблЬ
4
Controls and functional elements
4.1
Operating and display elements on the
GALILEOS
1
If the system is installed with a remote control, the release button is
attached to the remote control.
A Main switch
B Forehead support
(contact upholstery detachable)
B1 Head fastening strap
C Bite block (sterilizable)
D Adjustment button for mechanical diaphragm adjustment
E
Release button
1
F Easypad (swiveling control panel)
G Light localizer, central light beam for face center
H Swivel arm for patient immobilization
I Handles for patient
J Rotary knob for bite-block locking device
K Rotary knob for swivel-arm lock and forehead support setting
K
J
I
H
GF
E
D
C
BAB1
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4Controls and functional elements Sirona Dental Systems GmbH
4.2Operating and display elements on the head fixation device Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
4.2
Operating and display elements on the head
fixation device
A Forehead pads for adult or child
B Forehead rest adjustment
C Head holder 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
I Locking buttons for head holder
J Ear olives
A
C
D
E
F
G
H
I
I
J
B
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 4.3Control and display elements on the Easypad with
bеЦдблЬ
4.3
Control and display elements on the Easypad
with touchscreen
L Light localizer ON/OFF
M "Unit down" key
N "Unit up" arrow key
O Touchscreen - touch-sensitive screen
Q Optical radiation indicator
R "R" key for return of the unit
S "Unit ON" LED display
T "T" key for test cycle without radiation
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4Controls and functional elements Sirona Dental Systems GmbH
4.4General touchscreen functions on the Easypad Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
4.4
General touchscreen functions on the Easypad
Touchscreen = touch-sensitive screen, i.e. different functions can be
triggered by touching the screen surface.
Color codes:
orange selected
white Default settings
light blue selectable
gray-white Help symbols
Touchscreen symbols
A Display of height setting value
B Display of the VO5 or VOG program
Depending on the option selected, the symbol contrast
changes.
C Submenu column (options)
D Blue arrows: Select submenu, close menu
E Red symbol for light localizer ON (is displayed as long as the
laser light of the light localizer is switched on)
F Patient symbol keys for selecting preset exposure parameters
G Comment line for help and error messages
H Display/setting of exposure parameters (kV/mAs)
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 4.4General touchscreen functions on the Easypad
bеЦдблЬ
4.4.1 Program settings (Level 2)
You can also display all of the program settings and select the settings in
a second program level.
To access the second program level, touch the blue arrow (D) in the
upper right corner of the touchscreen; the arrow will now point upward.
After making your selections, touch the blue arrow (D) again to return to
program level 1.
I When you touch the ? symbol, the help or info screen is
displayed
J Display/setting of high-contrast option
K Display/setting of HD mode (high definition mode)
Touchscreen symbols
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4Controls and functional elements Sirona Dental Systems GmbH
4.4General touchscreen functions on the Easypad Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
4.4.2 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.
GALILEOS GAX9
In order to access the fourth program level, you must select the third level
first.
To access the 3rd program level, touch the blue arrow in the upper right
corner of the touchscreen; the arrow will now point upward.
To access the fourth program level, touch the diskette symbol (N) in the
level three.
In Level 4, you can reprogram the starting or entry position (icon on left
as per factory setting) and the patient icon preference (3rd icon from left
as per factory setting).
Using this function, you can adapt the position where the patient enters
the device to the local space conditions.
The open segment of the ring in the icons indicates the direction of patient
entry. The patient entry position can be at the front, on the right-hand side,
or on the rear right.
To perform a particular change, touch the desired symbol; the icon will
turn orange and will also be displayed in the Submenu column (D).
The Memory symbol (M) will stay yellow until the new default setting has
been saved by touching the Memory icon (M).
This menu can only be closed by touching the blue double arrow (D) in
the upper right corner. The display will always return to the standard
menu (program level 1).
The icons framed with a broken line represent the factory settings.
If the programming settings have been changed, they remain saved until
they are changed again in this mode.
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Sirona Dental Systems GmbH 4Controls and functional elements
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 4.4General touchscreen functions on the Easypad
bеЦдблЬ
4.4.3 Service menu
The Service menu is exclusively intended for use by service engineers.
Service engineers can access the Service menu from the Basic Settings
menu (Level 3) via the wrench icon (O) and a special input algorithm.
For further information on accessing the Service menu and individual
service routines, please refer to the Service Manual.
4.4.4 Touchscreen settings
When you touch the question mark (i) in the lower right corner of the
touchscreen, a touchscreen setting menu appears starting in the first
level.
You can open two menu lines by touching the corresponding icons in
column (C).
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 the adjustment a reference value will
appear above the symbol in column (C).
To close the respective menu line, touch the blue arrow at the left end of
the corresponding line or the relevant symbol in column (C).
To return to the previous level, touch the blue arrow (D) at the top of
column (C).
4.4.5 Closing menu cells
● by touching the blue arrows
● by touching the corresponding symbol in the light blue area at the
right margin.
IMPORTANT
The unit must run 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).
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4Controls and functional elements Sirona Dental Systems GmbH
4.4General touchscreen functions on the Easypad Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
4.4.6 Info screen
Starting at level 2, the “GALILEOS configuration” info screen is displayed
when you touch the question mark (I) 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 (C) as well.
Checking the function activation
The page number and number of pages are displayed in a small black
field (P) 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 (D) at the top of
column (C).
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Sirona Dental Systems GmbH 5Accessories
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 5.1Bite blocks, supports and fasteners
bеЦдблЬ
5
Accessories
5.1
Bite blocks, supports and fasteners
A Forehead support
(contact upholstery can be removed for cleaning and
disinfection)
(1 pc) Order No. 61 34 931
B Rigid bite block
(can be removed for cleaning and sterilization by rotating the
locking knob)
(5 pcs) Order No. 61 34 949
C Head fastening strap
(2 pcs) Order No. 61 34 956
D Chin rest, complete
(1 pc) Order No. 59 81 472
E Mandibular bite block plate holder (with symbol for LJ)
(1 pc) Order No. 61 50 226
F Maxillary bite block plate holder (with symbol for UJ)
(1 pc) Order No. 61 50 218
G Spherical bite block plate
- For single use only (not sterilizable)
- Can be obtained from dental dealers.
A
B
C
D
E
F
G
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5Accessories Sirona Dental Systems GmbH
5.2Accessories for head fixation device Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
5.2
Accessories for head fixation device
J Ear olives
(10 pcs) Order No. 18 88 838
K Head holders (right and left)
The head holders 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 26 976
M Forehead pad
(contact pad can be removed for cleaning and disinfection)
(5 pcs) Order No. 62 27 057
N Forehead pad plus (child)
(contact pad can be removed for cleaning and disinfection)
(5 pcs) Order No. 62 27 065
J
K
L
M
N
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Sirona Dental Systems GmbH 5Accessories
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 5.3Hygienic protective sleeves
bеЦдблЬ
5.3
Hygienic protective sleeves
Single use hygienic prote ctive sleeves
Identification of single use devices
Prior to each exposure, the hygienic protective sleeves (single use
devices) must be fitted.
Single use devices are identified with the symbol shown on the left. They
must be disposed of immediately after use. Do not use single use devices
more than once.
5.3.1 Hygienic protective sleeves for bite blocks, supports, and
fasteners
H Hygienic protective sleeves for forehead support and head
fastening strap
(100 pcs) Order No. 61 84 894
I Hygienic protective sleeves for bite block
(500 pcs) Order No. 61 27 745
J Hygienic protective sleeves for handles
(500 pcs) Order No. 61 84 902
K Hygienic protective sleeves for chin rest support and bar
(100 pcs) Order No. 59 32 603
L Hygienic protective sleeves for chin rest support
(500 pcs) Order No. 33 14 072
H
I
K
L
K
J
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5Accessories Sirona Dental Systems GmbH
5.3Hygienic protective sleeves Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
5.3.2 Hygienic protective covers 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 head holders
(500 pcs) Order No. 62 34 400
Dimensions: 150 mm x 47 mm
O
P
O
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Sirona Dental Systems GmbH 5Accessories
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 5.4Test phantom for acceptance/constancy test
bеЦдблЬ
5.4
Test phantom for acceptance/constancy test
Constancy test phantom worldwide
Constancy test phantom worldwide
Constancy test phantom, replacement
(1 piece) Order No. 61 40 813
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6Programs Sirona Dental Systems GmbH
6.1VO5: standard volume program Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
6
Programs
6.1
VO5: standard volume program
High-resolution scan with the possibility of generating secondary
reconstructions (detail reco) with maximum resolution.
This program is used to create a volume data set of the patient with 616
x 616 x 616 volume elements (voxels).
The resolution in the volume (voxel size) equals 0.25 x 0.25 x 0.25 mm
3
.
Panoramic view
Radiological views
Scan time: 14 seconds
Effective radiation time: 2...5 seconds
Reconstruction time: approx. 2.5 minutes
Data volume: approx. 900 MB,
HD mode approx. 1230 MB
comprising:
Patient volume: approx. 430 MB
Panoramic slice: approx. 5 MB
Lateral cephalometric
image:
approx. 6 MB
Radiological views: approx. 6 MB
Detailed reconstruction: approx. 30 MB
Corrected raw data: approx. 420 MB
HD mode approx. 750 MB (can be deleted)
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Sirona Dental Systems GmbH 6Programs
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 6.1VO5: standard volume program
bеЦдблЬ
6.1.1 HC mode: high contrast mode
The VO5 HC (high contrast) program is selected on the touchscreen, via
the high contrast button. See the section "Selecting high contrast".
Compared to the standard settings, the high contrast setting VO5 HC is
effective for the display of hard structures such as bones and teeth. At the
same time, it can also impair the display of soft tissues and especially soft
tissue silhouettes.
The high contrast setting is therefore especially suitable in cases where
bone or tooth structures must be evaluated, e.g. after bone
augmentations, and a correct display of soft tissue silhouettes is not of
primary importance.
6.1.2 HD mode: high definition mode
Select the VO5 HD program (high definition) on the touchscreen with the
HD button. See section "Selecting HD mode".
HD mode (high-definition mode):
For improved visualization of structures.
In HD mode, 1 3/4 (HD mode: 357 partial images, standard: 200 partial
images) as many individual projections are created; these are used to
ensure a more refined reconstructed image quality. This can reduce
typical (CBCT) DVT/conebeam artifacts.
Please observe the maximum permissible patient dose, especially for
pediatric applications.
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6Programs Sirona Dental Systems GmbH
6.2VOG: volume program for template scan Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
6.2
VOG: volume program for template scan
The VOG program is suitable for scanning small objects. It is not suitable
for taking patient X-rays.
✔ In some implant planning procedures an X-ray template is required,
in which a second image is taken separately and must be exported.
1. A template holder without aluminum cylinders is needed to scan the
X-ray template.
Insert the template holder as follows:
ª Push the patient fixing system fully upward and remove the head
band or the entire patient fixing system, so that you have enough
space to position the template holder.
ª Insert the support plate (A) of the template holder up to the stop
and lock it using the control knob, as shown in the figure.
ª Position the foam support (B) on the cutout of the support plate.
ª Position the X-ray template (C) on the foam support, in line with
the position of the patient's jaw.
2. Now carry out the scan using the VOG program.
3. Export the data record using SIDEXIS.
Menu command: Image -> Export -> Volumes for third-party
manufacturers.
ª The scan is now in DICOM format, suitable for further processing.
A
B
C
A Support plate (included in delivery)
B Foam support (included in delivery)
C X-ray template, customized for each patient
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Sirona Dental Systems GmbH 7Operation
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.1Preparing the exposure
bеЦдблЬ
7
Operation
7.1
Preparing the exposure
Information about radiat ion protection for Canada
NOTICE
3D imaging should not be used for screening examinations. 3D imaging
examinations must be clinically warranted and each exam must be
justified by demonstrating that the benefits outweigh the risks.
NOTICE
Where it is likely that evaluation of soft tissues will be required as part of
the patient's radiological assessment, the appropriate imaging should
be conventional medical CT or MR, rather than 3D imaging using Cone
Beam technology.
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7Operation Sirona Dental Systems GmbH
7.1Preparing the exposure Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.1.1 Fitting the accessories
Using accessories worldwi de
● Insert the bite block (B) up to the stop and lock it with the rotary knob
(K).
● Insert the forehead support (A).
● Slide on the hygienic protective sleeves
or for creating a drilling template:
● Insert the mandibular bite block plate holder (E) or
● Maxillary bite block plate holder (F) up to the stop and lock it with the
rotary knob (K).
WARNING
Sterilizing and disinfecting accessories, hygienic protective sleeves
The bite block must be disinfected for each new patient.
The handles, head fastening strap (if used) and contact upholstery of
the forehead support must be disinfected for each new patient.
Use hygienic protective sleeves.
A
B
E
F
G
K
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Sirona Dental Systems GmbH 7Operation
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.1Preparing the exposure
bеЦдблЬ
● Position the spherical bite block plate (G) for the upper jaw or for the
lower jaw to the sphere of the corresponding bite block holder as
shown.
or for ENT exposures:
● Insert the bite block up to the stop and lock it with the rotary knob (K).
● Insert the forehead support (A).
● Slide on the hygienic protective sleeves
7.1.2 Inserting the head fixation device
Head fixation device
Inserting the head fixation device
● Insert the head fixation device until it easily snaps in place.
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.).
H
1.
2.
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7Operation Sirona Dental Systems GmbH
7.1Preparing the exposure Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
● Press the respective locking button (I) to remove or insert the head
holders.
Fitting the accessories
● Insert the volume control (L) as far as it will go and lock it with the
rotary knob (Q).
II
L
Q
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Sirona Dental Systems GmbH 7Operation
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.1Preparing the exposure
bеЦдблЬ
7.1.3 Switching the unit on
Temperature fluctuations, peri ods of disuse
Switching on the GAX 7
● Set main switch (A) to position I and wait approx. 1 minute.
● The LED (S) at the top of the Easypad lights up.
● The radiation indicator (Q) lights up for approx. one second for a
function test.
After the unit is switched off with the main switch, the touchscreen on the
Easypad remains illuminated for another 3 - 5 seconds.
Switching on and off
NOTICE
Extreme fluctuations of temperature may cause condensation. For this
reason, do not switch the unit on before it has reached normal room
temperature. See Technical description [ → 18] Section.
IMPORTANT
Following longer periods of disuse (> 200 hours), the X-ray detector
(sensor) requires a preparation time of up to ten minutes. Message S1
50 (Sensor being prepared) is displayed. If exposure readiness is
reached during this time, error message E1 10 07 appears. See Section
Error message E1 10 07 [ → 67].
CAUTION
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!
NOTICE
After switching the unit off with the main switch, you must wait for
approx. 2 minutes before switching it back on.
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7Operation Sirona Dental Systems GmbH
7.1Preparing the exposure Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.1.4 Display 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:
The preselected settings are represented in orange color.
● Briefly press return key R to bring the rotating element into position
for positioning.
A Bite block height adjustment value in mm (ranging from approx.
810 to 1815 mm) from the last patient set.
B The scan program
F The patient symbol which was last preselected with the
corresponding kV/mA combination
G Help messages in the comment line
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Sirona Dental Systems GmbH 7Operation
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.1Preparing the exposure
bеЦдблЬ
7.1.5 Switching SIDEXIS 4 to ready for exposure state
Refer to the SIDEXIS 4 User Manual
http://www.sirona.com/manuals
7.1.6 Switch SIDEXIS to ready for exposure state
● To make the SIDEXIS program on the PC ready for exposure, see
the SIDEXIS operator's manual.
● As long as no connection with SIDEXIS is established, the message
“Switch SIDEXIS to ready for exposure state” is displayed in the
comment line of the Easypad touchscreen.
Selecting Facescan on the PC
If you have a GALILEOS with Facescan, you can now select the exposure
type on a PC in SIDEXIS. The exposure dialog box looks different with
Facescan; see the Facescan Operating Instructions.
Once SIDEXIS is ready for exposure, the welcome screen with the
selected patient data from SIDEXIS appears on the Easypad
touchscreen.
It shows the first name, last name, date of birth, and the 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 will
turn yellow.
When you touch the screen, the welcome screen disappears and the
selection screen reappears.
TIP: If you wish to suppress this entire screen display or individual pieces
of information displayed here, your service engineer can disable the
corresponding data upon request.
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7.2Selecting acquisition parameters (kV/mAs/dose values) Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.2
Selecting acquisition parameters (kV/mAs/dose
values)
The preset exposure parameters are selected with the patient symbol
keys. These have been assigned preset kV/mA combinations, selected
according to the patient's size and weight. The symbols roughly
correspond to child, youth/woman, woman/man, hefty persons.
GALILEOS GAX9 DAP table
Standard mode: VO5 / VO5 HC
GALILEOS GAX9 HD mode DAP table
CAUTION
The larger the patient icon (according to the icons for child, youth/
woman, man/woman, strong people), the higher the dose for the patient.
HD mode further improves the image quality significantly. However, it
does increase the dose by a factor of 2 and more.
CAUTION
When X-raying children, be aware that, due to their physical
constitution, they react more sensitively to X-ray radiation.
Program: Child Youth/Woman Woman/Man Strong person
98 kV/3 mA 98 kV/4 mA 98 kV/5 mA 98 kV/6 mA
Set values: 6 mAs 8 mAs 10 mAs 12 mAs
Effective radiation time: 2 s 2 s 2 s 2 s
DAP:
222 mGycm
2
290 mGycm
2
356 mGycm
2
425 mGycm
2
DAP of LJ exposure*:
129 mGycm
2
168 mGycm
2
207 mGycm
2
247 mGycm
2
DAP of UJ exposure*:
171 mGycm
2
223 mGycm
2
274 mGycm
2
328 mGycm
2
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.2Selecting acquisition parameters (kV/mAs/dose values)
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HD mode: V05 HD / VO5 HD HC
Exposure method used:
FOV: Diameter 215 mm (8 1/2")
* Explanation
* LJ exposure: Lower jaw collimation
UJ exposure: Upper jaw collimation
Program: Child Youth/woman Woman/Man Strong person
98 kV/3 mA 98 kV/4 mA 98 kV/5 mA 98 kV/6 mA
Set values: 15 mAs 20 mAs 25 mAs 30 mAs
Effective radiation time: 5 s 5 s 5 s 5 s
DAP:
612 mGycm
2
780 mGycm
2
957 mGycm
2
1139 mGycm
2
DAP of LJ exposure*:
355 mGycm
2
452 mGycm
2
555 mGycm
2
660 mGycm
2
DAP of UJ exposure*:
471 mGycm
2
600 mGycm
2
737 mGycm
2
877 mGycm
2
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7.3Setting high contrast Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.3
Setting high contrast
See the program descriptions for further information on indications.
✔ You can choose between high contrast and normal contrast:
1. Touch the contrast symbol (J).
ª The submenu line for selecting the contrast level appears.
2. Select the contrast level by touching the corresponding symbol:
High-contrast
Normal contrast
3. Close the Contrast Level submenu line by touching the blue arrow
(L).
ª The currently selected contrast level and the corresponding
contrast symbol (J) are displayed on the right in the Submenu
column.
IMPORTANT
This setting is only temporarily valid for this exposure. It will then be
reset to the factory setting immediately afterwards. To change the
setting permanently, you have to edit the factory contrast setting.
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.4Setting HD mode
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7.4
Setting HD mode
See the program descriptions for further information on indications.
✔ You can choose between HD mode "ON" and "OFF":
1. Touch the HD symbol (K).
ª The submenu line for selecting the HD mode appears.
2. Select the HD mode by touching the corresponding symbol:
HD ON
HD OFF
3. Close the submenu line by touching the blue arrow (L).
ª The currently selected HD mode and the corresponding symbol
(K) are displayed on the right in the Submenu column.
IMPORTANT
This setting is only temporarily valid for this exposure. It will then be
reset to the factory setting immediately afterwards. To change the
setting permanently, you have to edit the factory contrast setting.
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7.5Adjusting the mechanical diaphragm Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.5
Adjusting the mechanical diaphragm
The mechanical diaphragm allows for three fixed settings.
The areas displayed in blue show the intended visible volume of the X-ray
exposure.
The collimation results in minimal radiation exposure to explore
diagnostic questions in the upper and lower jaw.
You can select the desired area by simply turning the switch on the X-ray
tube assembly.
1. Upper jaw collimation (UJ)
If the "Upper jaw" setting is selected, the X-ray image will only show
the area of the upper jaw. The height of the displayed volume is
approx. 8.5 cm. The region of the lower jaw will not be included in the
image.
2. Open diaphragm
When the "Open diaphragm" setting is selected, the full volume will
be displayed in the X-ray image. No collimation occurs in this case.
3. Lower jaw collimation (LJ)
If the "Lower jaw" setting is selected, the X-ray image will only show
the area of the lower jaw. The height of the displayed volume is
approx. 8.5 cm. The region of the upper jaw will not be included in the
image.
Tip: The open diaphragm is preferable for transverse wisdom teeth
because when the upper jaw is collimated it is not completely displayed
in some cases.
CAUTION
Check for the correct diaphragm setting prior to each exposure.
IMPORTANT
If the usual volume display shows considerable deviations with an
adjusted diaphragm setting, the diaphragm may be maladjusted.
In this event, contact your service engineer.
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.6Positioning the patient
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7.6
Positioning the patient
Information about radiat ion protection for Canada
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).
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.
● 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.
● 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 at the control panel.
NOTICE
3D imaging should not be used for screening examinations. 3D imaging
examinations must be clinically warranted and each exam must be
justified by demonstrating that the benefits outweigh the risks.
NOTICE
Where it is likely that evaluation of soft tissues will be required as part of
the patient's radiological assessment, the appropriate imaging should
be conventional medical CT or MR, rather than 3D imaging using Cone
Beam technology.
CAUTION
Parts of the dentist stool must not lie in the beam path and must not
affect the movement of the unit.
IMPORTANT
Note the diagnostic restrictions in the immediate vicinity of highly X-ray
absorbent objects, e.g. metal. These diagnostic restrictions apply
regardless of metallic artifact reduction sequence (MARS) and other
selected filter settings. For patients with metallic implants, bridges and
fillings, image quality can be affected, and thereby also the
establishment of a diagnosis.
IMPORTANT
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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7.6Positioning the patient Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.6.1 Positioning the patient - with bite block
● Press the R key to move the unit back to the entry position.
● The patient approaches 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 again.
7.6.1.1
Aligning the patient - with standard bite block
● Close the swivel arm (H) until it snaps in place.
● Using the "up" and "down" keys on the control panel, 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 patient then approaches the bite block and holds the handles (I)
firmly.
T
R
T
R
K
I
H
CAUTION
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.
IMPORTANT
The patient must stand upright with a straight back and relaxed
shoulders.
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.6Positioning the patient
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● Have the patient bite the spoon of the bite block.
7.6.1.2
Aligning the patient - with chin rest, bite block, and contact bar
Indications:
– Toothless patients
– Temporomandibular diagnosis
– Cephalometry
● The patient enters the unit.
● Using the "Up" or "Down" keys, 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.
● Ask the patient to place his chin on the chin rest (D) with closed
occlusion and to grasp the handles firmly.
● Swing in bite block (H).
● 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 contact bar (I) (arch
facing column).
● Please place the contact bar between the patient's chin and upper lip
and insert a cotton roll.
IMPORTANT
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.
D
H
CAUTION
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.
I
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7.6Positioning the patient Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.6.2 Positioning the patient - with head fixation device (e.g. for
orthodontics)
● Open the bands of the forehead support fully.
● Press the R key to move the unit back to the entry position.
● Attach the mandatory 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 again.
Aligning the patient - with head fixat ion device
Aligning the patient
● 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 auditory canals.
● Close the swivel arm (H) until it snaps in place.
● The patient should grasp the handles (I) relaxed but securely.
● 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 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.
CAUTION
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.
IMPORTANT
For an optimal exposure, the patient should stand up straight and let his
shoulders droop loosely.
R
S
T
IMPORTANT
The height of the X-ray unit must be set so that the occlusal plane is
perfectly horizontal following alignment.
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.6Positioning the patient
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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. This can be done by pushing the tip of the patient's nose and the
point of his chin out of the 3D volume.
● 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.
● The forehead rest can be returned to its zero position by pressing the
pushbutton (D).
NOTICE
The latch of the pins (B) is damaged by pushing back the forehead rest
by hand.
Always press the pushbutton (D) to unlatch the pins.
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7.6Positioning the patient Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.6.3 Positioning patients - with spherical bite block
Using the spherical bite block to create an implant drilling template
Select the bite block plate holder appropriate for a scan with the spherical
bite block. For exposures of the lower jaw, insert bite block plate holder
(E). For exposures of the upper jaw, insert bite block plate holder (G).
The spherical bite block plate (G) contains 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 plate
● Insert spherical bite block plate (G) 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 bite block plate holder
with his mouth open.
● Have the patient gently bite onto the bite block plate holder.
IMPORTANT
The spherical bite block plate may touch the bite block plate 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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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.6Positioning the patient
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7.6.4 Display of midsagittal line
● Switch on the light localizer with key (L) on the control panel. 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 Section General touchscreen
functions on the Easypad.
● Fix the patient's position by tightening the forehead support (A)
against the patient's forehead with the rotary knob (K).
● In some cases, it is also advisable to immobilize the patient's head
with a head fastening strap as well (see chapter Bite blocks, supports
and fasteners [ → 33]).
Concluding the preparations
● If the light localizer is still on, switch it off with key (L) on the control
panel.
A
K
L
CAUTION
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.
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7.7Releasing the exposure Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
7.7
Releasing the exposure
● Check the program and exposure parameters.
● To release an exposure, press the exposure release button (E)
directly on the X-ray unit or on the remote control.
The rotary movement of the selected exposure program is performed
automatically.
During radiation emission, the optical radiation indicator (Q) on the control
panel or on the remote control is illuminated. In addition, an acoustic
signal sounds throughout the entire radiation time.
CAUTION
Be sure to observe the radiation protection regulations in your country,
see also Radiation protection [ → 12].
IMPORTANT
No further help messages should appear in the comment line of the
touchscreen. Only the "Ready for exposure" message should be
displayed.
If the door of the X-ray room is not properly shut, the message "Close
the door" will appear in the touchscreen comment line and H321 as a
coded message on the remote control.
CAUTION
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.
Explain this particularly carefully to children.
CAUTION
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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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.7Releasing the exposure
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● The exposure is complete when ...
– The comment line displayed on the touchscreen switches from
"Exposure in progress" to "R button, confirm exposure data".
– The message "H 320" and the program number are alternately
displayed on the remote control.
– The actual mAs value is shown next to the program number at the
end of the exposure.
– A short, pulsed tone sequence can be heard at the end of the
exposure (this function can be deactivated by the service
engineer).
Display on the Sidexis monitor
The end of the exposure cycle can also be seen on the SIDEXIS monitor
when the progress bar indicates 100%.
Press the "R" key to confirm the exposure.
Then press the "R" key again to move the unit to the entry position.
The patient can now step out of the unit.
After completion of the exposure WW
After completion of the exposure
On 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.
Display
"Area dose product"
for SIDEXIS XG
Following the exposure, the
"Area dose product"
is displayed in the
"Describe image"
dialog box in SIDEXIS XG.
Open the dialog box via
"[A]nalysis" →"Findin[g]s"
or via an icon
displayed at the upper edge of the window.
The displayed dialog box shows the available image information for the
currently active X-ray.
CAUTION
Never switch off the X-ray unit during the transmission of an image. This
process takes approx. 2.5 minutes.
IMPORTANT
The operation of the visualization software is described in the attached
GALAXIS Operator's Manual.
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7.7Releasing the exposure Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
Display
"Area dose product"
for SIDEXIS 4
Following the exposure, the
"Area dose product"
is displayed in SIDEXIS
4 in the
"Examination"
work phase in the
"Tools"
docking window in the
"Info"
tool palette.
The displayed dialog box shows the available image information for the
currently active X-ray.
Canceling an exposure
If you let go of the exposure release button prematurely, the exposure is
canceled.
The message "R button, 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.
The Ready LED above the "R" button starts flashing.
● Press the "R" button on the control panel twice.
● After the rotating element has returned to its starting position, repeat
the exposure.
Automatic exposure blocking
(thermal protection of the tubes)
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 as "X".
Another exposure can be released only after the cooling period has
elapsed.
CAUTION
Please note that any program settings which may have been changed
must be preselected again before repeating the exposure.
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Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 7.8Remote control
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7.8
Remote control
Remote control 1
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 this purpose, the exposure release button (E) can be detached from
the unit and attached to the remote control (service engineer).
The exposure release button (E1) can be used if establishing visual
contact with the patient does not require a longer cable.
The remote control has an “R” key (R) for acknowledging the exposure
and resetting the unit to its starting position, an optical radiation indicator
(Q) and a "Unit ON" (S) LED display.
After the unit is switched on, the LED (S) lights up.
The radiation indicator (Q) lights up for a longer period of time for a
function test.
The three display fields on the display panel light up simultaneously.
Remote control 2.2
A progress bar appears after approx. 10 seconds. After the system starts,
the display switches to program VO5 with the corresponding values.
As long as plain-language help messages are displayed on the Easypad
touchscreen, they also appear in coded form on the "Prog." display,
continuously alternating with the program name.
Remote control 3
Once all help messages have been processed, the program name
“Prog.”, the “kV” and the “mAs” appear continuously on the display panel.
The exposure can be released now.
Q
S
R
E
E1
Y
GALILEOS
GALILEOS
IMPORTANT
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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8List of messages Sirona Dental Systems GmbH
8.1List of help messages Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
8
List of messages
8.1
List of help messages
A number of H3 help messages may appear on the control panel when
you attempt to release an exposure:
● Press the release button. CAUTION Observe radiation protection
measures..
The H3 / H4 .. message appears on the control panel.
● The list provided below explains how to proceed to make the system
ready for exposure.
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.
Help
message
Description Actions required
H3 01 The rotating element is not in the starting position. R button, move into starting position.
H3 20 The exposure data have not been acknowledged yet. R button, confirm exposure data.
H3 21 Check door contact of the X-ray room. Close the door.
H3 23 Open or close the swivel arm completely. Move the swivel arm into its end position.
H4 03 SIDEXIS is not ready for exposure. Switching SIDEXIS to ready for exposure state
H4 20 The image could not be transferred to SIDEXIS.
IMPORTANT!
To eliminate errors in the image database (rescue
management), see "Software component operating
instructions", REF 61 81 155.
CAUTION
Do not switch off the system before the rescue
management is successfully completed.
Call up existing exposure.
S1 50 The sensor is not yet ready for an exposure. Wait until the sensor is ready for an exposure.
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Sirona Dental Systems GmbH 8List of messages
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 8.2Error message structure
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8.2
Error message structure
The error messages are displayed in the form of an error code. They are
not provided in plain-text form.
The error message code has the following structure: Ex yy zz
All error messages of the system are grouped according to these criteria.
8.2.1 Ex
Digit (x) is intended to provide the user with quick help in deciding how to
deal with this error.
Ex Error type/"troubleshooting" classification for the user
yy Location; module; subsystem or logical function unit
zz Consecutive number with error identification
Ex Description Actions required Error group
1 System warning;
system message
Acknowledge the error message.
Contact your Customer Service.
Continued operation of the system is
ensured.
This error group includes all errors
that indicate still acceptable
tolerance variations, or messages
about states which do not directly
affect system operation.
2 Errors caused by
system overload
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 states that
indicate, for example, temporary
excess temperatures 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.
Switch the unit off and then on again;
if the error reoccurs inform customer
services.
NOTICE! After switching the unit off
with the main switch, you must wait
for approx. 2 minutes before
switching it back on again.
This error group includes all errors
that indicate invalid signal states of
keys and safety signals during
power-on.
4 Malfunction or
mechanical obstruction
of unit movements
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 problems with the
motor-controlled movements on the
outside of the unit.
5 Malfunction during the
exposure or during
exposure preparation.
Acknowledge the error message to
continue system operation. Repeat
the last procedure step or exposure.
If the error reoccurs, 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.
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8List of messages Sirona Dental Systems GmbH
8.2Error message structure Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
8.2.2 yy
The digits (yy) define the location or logical function unit where the error
has occurred.
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).
8.2.3 zz
Digits (zz) show a consecutive number with the error ID.
6 Error during system
self-test.
Acknowledge the error message to
continue system operation. If the
error occurs repeatedly, switch the
system off and back on; if the error
reoccurs, 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 selftests.
7 Unrecoverable system
error.
Switch off the system; contact your
Customer Service immediately.
This error group includes all errors
which may occur spontaneously and
without any related operator action.
They may be caused by system selftests. Further operation of the unit is
not allowed for safety reasons.
Ex Description Actions required Error group
10 Central control DX 11; system hardware
11 Central control DX 11; system software
12 Central control DX 11; central CAN bus error
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 X-ray tube assembly
7/71 User interface
89 Sensor
42 Remote
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Sirona Dental Systems GmbH 8List of messages
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 8.3Error message E1 10 07
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8.3
Error message E1 10 07
Explanation
The possible causes of this error and its correction are described here.
Case 1
Following longer periods of disuse (> 200 hours), the X-ray detector
(sensor) requires a preparation time of up to ten minutes. Message S1 50
(Sensor being prepared) is displayed.
During this time the unit is not ready for operation.
If exposure readiness is reached during this time, error message E1 10
07 appears.
Solution
Acknowledge this error message by pressing the R key and wait until the
error message goes out.
Case 2
If the error message E1 10 07 appears immediately after the unit is
switched on and the user has not established exposure readiness, please
inform the responsible service engineer.
IMPORTANT
Shortening the waiting time
Switching the unit off and on does not shorten the waiting time!
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9Maintenance Sirona Dental Systems GmbH
9.1Cleaning and care Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
9
Maintenance
9.1
Cleaning and care
9.1.1 Cleaning
Remove dirt, grime and disinfectant residue regularly using mild,
commercially available cleaning agents.
Cleaning the ventilatio n slots
9.1.2 Disinfecting
Only the external surfaces may be disinfected with approved chemical
disinfectants. Use only disinfectants that comply with the valid
requirements of the respective national regulatory body or whose
bactericidal, fungicidal and virucidal properties have been verifiably
tested and approved accordingly.
Cleaning and care agen ts
A continuously updated list of approved agents can be downloaded from
the Internet at:
"www.sirona.com"
/
"SERVICE"
/
"Care and cleaning"
/
"Care and
cleaning agents"
Orders WW
If you do not have any access to the Internet, you can order the list in one
of the following two ways:
● Order from your local dental depot
● Order from Sirona:
Tel: ++49 (0) 62 51 / 16-16 70
Fax: ++49 (0) 62 51 / 16-18 18
REF 59 70 905
NOTICE
During cleaning or disinfection, liquids may enter the manual release
button or unit via ventilation slots.
Electrical components of the system can be destroyed by liquids.
➢ Do not spray any liquids into the ventilation slots or manual release
button.
➢ First spray the liquid onto a cleaning cloth. Then wipe the ventilation
slots or manual release button with the cleaning cloth.
➢ Make sure that no liquids run along the surface and into the
ventilation slots or the manual release button.
CAUTION
Cleaning and care agents may contain aggressive ingredients.
Unsuitable cleaning and care agents are detrimental to health and
attack the surface of the unit.
➢ Do NOT use: Substances containing phenol, peracetic acid,
peroxide or any other oxygen-splitting agents, sodium hypochlorite
or iodine-splitting agents.
➢ Use only cleaning and disinfecting agents approved by Sirona!
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Sirona Dental Systems GmbH 9Maintenance
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 9.1Cleaning and care
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Sirona recommends the following disinfectants:
● MinutenSpray classic, by ALPRO®
● MinutenWipes, by ALPRO®
In the USA and Canada:
● CaviCide® or
● CaviWipes ™ .
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9Maintenance Sirona Dental Systems GmbH
9.1Cleaning and care Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
9.1.3 Sterilization
Sterilization of accessor ies
The following accessories can be sterilized:
In addition, also use the hygienic protective sleeves, see "Hygienic
protective sleeves" [ → 35].
Hygienic protective slee ves
WARNING
Infections can be transmitted from patient to patient.
Accessories that are not sterilized correctly can cause illness in patients.
➢ All accessories that are suitable for sterilization should only be
sterilized in an autoclave at 134 °C (273° F), with at least 3 minutes
holding time and at 2.1 bar (30.5 psi) overpressure.
134°C
273°F
WARNING
The hygienic protective sleeves single use devices.
Unsterile hygienic protective sleeves can cause illness in patients.
➢ Replace the hygienic protective sleeves after each patient.
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Sirona Dental Systems GmbH 9Maintenance
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 9.2Inspection and maintenance
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9.2
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.
Galileos inspection and maint enance document
The information provided in the document
"Inspection and maintenance
and safety-related checks"
REF 61 25 533 should be helpful here. The
document can be downloaded at http://www.sirona.com/manuals.
Inspection and maintena nce
Annual inspection
In order to ensure the operational safety and functional reliability of your
product, you as the system owner should check the equipment at regular
intervals (at least once a year) or commission your dental depot to do so.
Maintenance by the service engineer
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.
Digital image quality
Image quality check
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.
Assessment criteria
If, after taking into account the patient's anatomy and excluding possible
sources of error such as incorrect patient positioning, this criterion seems
to apply, immediately contact a service engineer to have potential system
faults repaired.
Country-specific requirements
Country-specific requirements
Observe any possible additional country-specific requirements.
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10Dismantling and disposal Sirona Dental Systems GmbH
10.1Dismantling and reinstallation Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
10
Dismantling and disposal
10.1
Dismantling and reinstallation
When dismantling and reinstalling the system, proceed 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.
10.2
Disposal
In accordance with Directive 2012/19/EU and national disposal
regulations regarding old electrical and electronic devices, please be
advised that such items must be disposed of in a special way within the
European Union (EU). These regulations require environmental friendly
usage/disposal of old electrical and electronic devices. Such items must
not be disposed of as domestic refuse. This has been expressed using
the icon of the “crossed out trash can” since March 24, 2006, amongst
other methods.
Disposal procedure
We feel responsible for our products from the first idea to their disposal.
For this reason, we give you an option to return our old electronic and
electrical devices.
If you wish to dispose of your devices, please proceed as follows:
In Germany
To initiate return of the electrical device, please send a disposal request
to enretec GmbH. You have the following options here:
● Use the “Returning an electrical device” button under the “eom” menu
item on the enretec GmbH homepage (www.enretec.de).
● Alternatively, you can also contact enretec GmbH directly.
enretec GmbH
Kanalstraße 17
16727 Velten
Tel.: +49 3304 3919-500
E-Mail: eom@enretec.de
In accordance with the national disposal regulations regarding old
electrical and electronic devices (ElektroG), as the manufacturer, we
assume the costs for disposing of the electrical and electronic devices in
question. Disassembly, transport and packaging costs shall be borne by
the owner/ operator.
Prior to disassembly / disposal of the product, it must be fully prepared
(cleaned / disinfected / sterilized).
If your unit is not permanently installed, it will be collected from the
practice. If it is permanently installed, it will be picked up curbside at your
address by appointment.
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Sirona Dental Systems GmbH 10Dismantling and disposal
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS 10.2Disposal
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Other countries
For country-specific information on disposal, contact your local dental
dealers.
10.2.1 GALILEOS X-ray tube
GALILEOS X-ray tube
The X-ray tube assembly for this product contains an X-ray tube with a
potential implosion hazard, a small amount of beryllium, a lead lining and
mineral oil.
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11Dose information Sirona Dental Systems GmbH
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
11
Dose information
GALILEOS GAX9 dose area product
Dose area product
The radiation exposure is indicated as the dose area product (DAP) of the
energy dose (Gy x cm²) per mAs of every selectable level and diaphragm.
To offset measurement errors and system and device variations, a
tolerance of 20% must be expected.
GALILEOS works with permanently set kV/mA combinations.
GALILEOS GAX9 DAP table
Standard mode: VO5 / VO5 HC
GALILEOS GAX9 HD mode DAP table
HD mode: V05 HD / VO5 HD HC
GALILEOS GAX9 template scan DAP table
Program: Child Youth/Woman Woman/Man Strong person
98 kV/3 mA 98 kV/4 mA 98 kV/5 mA 98 kV/6 mA
Set values: 6 mAs 8 mAs 10 mAs 12 mAs
Effective radiation time: 2 s 2 s 2 s 2 s
DAP:
222 mGycm
2
290 mGycm
2
356 mGycm
2
425 mGycm
2
DAP of LJ exposure*:
129 mGycm
2
168 mGycm
2
207 mGycm
2
247 mGycm
2
DAP of UJ exposure*:
171 mGycm
2
223 mGycm
2
274 mGycm
2
328 mGycm
2
Program: Child Youth/woman Woman/Man Strong person
98 kV/3 mA 98 kV/4 mA 98 kV/5 mA 98 kV/6 mA
Set values: 15 mAs 20 mAs 25 mAs 30 mAs
Effective radiation time: 5 s 5 s 5 s 5 s
DAP:
612 mGycm
2
780 mGycm
2
957 mGycm
2
1139 mGycm
2
DAP of LJ exposure*:
355 mGycm
2
452 mGycm
2
555 mGycm
2
660 mGycm
2
DAP of UJ exposure*:
471 mGycm
2
600 mGycm
2
737 mGycm
2
877 mGycm
2
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Sirona Dental Systems GmbH 11Dose information
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
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Template scan: VOG
* Explanation
* LJ exposure: Lower jaw collimation
UJ exposure: Upper jaw collimation
Effective dose values GAX9
Effective dose values
The radiation exposure can also be specified as effective dose value D
eff
(µSv).
To offset measurement errors and system and device variations, a
tolerance of 20% must be expected.
GALILEOS operates with fixed settings of 98 kV and 6 mA.
Dose values GAX9
This results in the following dose values for GALILEOS Comfort
PLUSStandard volume program:
Program:
98 kV/6 mA
Set values: 30 mAs
Effective radiation time 5 s
DAP
1139 mGycm
2
DAP of LJ exposure*
660 mGycm
2
DAP of UJ exposure*
877 mGycm
2
Program
Values 6 mAs 8 mAs 10 mAs 12 mAs
Full
Effective dose value D
eff
28 µSv 38 µSv 47 µSv 56 µSv
Maxillar
Effective dose value D
eff
20 µSv 27 µSv 34 µSv 41 µSv
Mandibular
Effective dose value D
eff
22 µSv 29 µSv 37 µSv 45 µSv
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11Dose information Sirona Dental Systems GmbH
Operating Instructions GALILEOS Comfort PLUS (CANADA) GALILEOS
This results in the following dose values for GALILEOS Comfort
PLUSStandard volume program:
Source
Study: “Comparative dosimetry of GALILEOS Dental CBCT imaging”,
Prof. Dr. John B. Ludlow, Department of Diagnostic Sciences and
General Dentistry, University of North Carolina School of Dentistry,
Chapel Hill, North Carolina, USA
Program
Values 15 mAs 20 mAs 25 mAs 30 mAs
Full
Effective dose value D
eff
78 µSv 106 µSv 130 µSv 154 µSv
Maxillar
Effective dose value D
eff
62 µSv 84 µSv 103 µSv 122 µSv
Mandibular
Effective dose value D
eff
68 µSv 92 µSv 113 µSv 133 µSv
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