Sirona galileos comfort plus Operating Instructions Manual
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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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Sirona Dental Systems GmbH 1General information
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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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
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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
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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.
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