Sirona galileos User manual

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61 25 533 D 3437
D 3437.105.01.10.02
Dear customer
You would like to have and will have many years of satisfaction
with your páêçå~ X-ray unit.
Safety and reliability are necessary to ensure this.
Your dental dealership offers you service by specially trained
engineers for this purpose.
The maintenance should ensure that your product is
permanently safe and operational. All components subject to
normal wear and tear are checked and, if necessary, replaced.
Maintenance work may be performed by the operator only if
this is described on the part of Sirona Dental Systems GmbH,
otherwise only authorized service engineers of Sirona Dental
Systems GmbH or its authorized dealers may be entrusted
with the work.
In case you have not concluded a maintenance contract,
please contact the customer service department of your dental
dealership.
The performed maintenance must be documented in this
document, which must be kept with the unit.
We wish you much success and pleasure with your quality
product
from pfolk^=aÉåí~ä=póëíÉãëK

Sirona Dental Systems GmbH
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List of Contents
1General information........................................................5
1.1 Inspection and maintenance and safety-related checks ............ 5
1.2 Please fill in the required general information ............................ 5
2Annual inspection performed by the system owner or
other authorized persons...............................................6
2.1 Technical documentation ........................................................... 6
2.2 System accessories .................................... .............................. 7
2.3 Surfaces of the unit ..................................... .............................. 8
2.4 X-ray unit ..................................................... .............................. 9
2.5 System safety ............................................................................ 9
2.6 Exposure safety .......................................... ............................ 10
2.7 Key functionality ....................................................................... 11
2.8 Light localizer functionality ....................................................... 11
2.9 Swivel arm/bite block/forehead support functionality ............... 12
2.10 Image quality ............................................................................ 12
2.11 Height adjustment functionality ................................................ 13
2.12 Facescan functionality (option) ................................................ 13
2.13 Documenting your annual inspection ....................................... 14
3Yearly calibration by the
service engineer
(for the USA, see the Maintenance Instructions) .......15
3.1 General information for the service engineer ........................... 15
3.2 Calibrating the X-ray unit ............................ ............................ 15
3.3 Documenting the yearly calibration ............. ............................ 16
4Safety-related checks by the service engineer in
compliance with standard IEC 62353..........................17
4.1 General information for the service engineer ........................... 17
4.2 Intervals for safety-related checks ........................................... 18
4.3 Safety-related check ................................................................ 18
4.4 Documenting the safety-related check ..................................... 19
5Maintenance by the service engineer .........................20
5.1 General information for the service engineer ........................... 20
5.2 Maintenance interval ................................................................ 21
5.3 Checking the records .................................. ............................ 21
5.4 Labels on the system ............................................................... 22
5.5 Serial numbers of the system ..................... ............................ 23
5.6 Functional test ............................................. ............................ 24
5.7 Checking the tube data ............................... ............................ 25
5.8 Checking the cables for damage ............................................. 25
5.9 Safety-related check ................................... ............................ 26
5.10 Final steps ................................................................................ 26
5.11 Documenting maintenance work ................. ............................ 27

Sirona Dental Systems GmbH
61 25 533 D 3437
4D 3437.105.01.10.02

Sirona Dental Systems GmbH 1 General information
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1 General information
1.1 Inspection and maintenance and safety-related checks
Inspections, preventive maintenance and safety-related checks must be performed at scheduled intervals
to protect the health and safety of patients, users and other persons.
• In order to ensure the operational safety and functional reliability of your product, you as the system owner
should inspect the equipment at least once a year or commission your dental depot to do so.
The information provided in Chapter 2 "Annual inspection performed by the system owner or other
authorized persons" should be helpful here. If one or more checks to be performed do not lead to satisfac-
tory results, please contact your dental depot.
• In addition to the yearly inspection performed by the system owner, a yearly calibration is to be performed
by the service engineer.
The information provided in Chapter 3 "Yearly calibration by the service engineer (for the USA, see the
Maintenance Instructions)" should be helpful here.
• Medical devices are designed in such a way that the first occurrence of a fault does not create a hazard to the
safety of the patient, the user or other persons. Hence it is important to detect such faults before a second
fault occurs, which might then lead to safety hazards. For that reason it is essential to perform safety checks
aimed particularly at detecting electrical faults every 2 years.
The information provided in Chapter 4 "Safety-related checks by the service engineer in compliance
with standard IEC 62353" should be helpful here.
• In addition, your dental depot offers you maintenance of the system by specially trained engineers; see
Chapter 5 "Maintenance by the service engineer".
All inspection and maintenance work and safety-related checks performed by the system owner or ser-
vice engineer must be recorded in this document and kept near the unit.
1.2 Please fill in the required general information
Space for practice stamp
Customer
Last name:
First name:
Street:
City/State/Postal (ZIP) code:
Phone:

2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH
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2 Annual inspection performed by the
system owner or other authorized
persons
2.1 Technical documentation
Technical documents Answer questions with yes () or no (−)
Date (please enter month/year)
Operating Instructions available?
Installation requirements
available?
Installation Report/Warranty
Passport available and comple-
tely filled out?
Declaration of Conformity by
system integrator available?
X-ray System Logbook available
(for Germany only)?
If no Order missing documents from your dental depot.

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2.2 System accessories
System accessories (see operating instructions)
Not all of the accessories listed here are included
in the scope of supply, cross out what does not apply. Answer questions with yes () or no (−)
Date (please enter month/year)
Test phantom avail-
able?
(worldwide, incl.
Germany)
Test phantom
available?
(Germany, as from
07.2015)
Geometry phan-
tom available?
Forehead support
available?
Rigid bite block
available?
Head fastening
strap available?
Complete chin rest
available?
Mandibular bite
plate holder
available?
Maxillary bite plate
holder available?
If no Order missing accessories from your dental depot.

2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH
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2.3 Surfaces of the unit
Cover parts Answer questions with yes () or no (−)
Date (please enter month/year)
All cover parts attached to the
X-ray unit (Fig. 1)?
All screws on unit housing
available?
Cover parts and mirrors free of
damage (no surface damage,
e.g. scratches)?
All cover parts in clean condition?
Clean X-ray unit with the recom-
mended cleaning agents
(See operating instructions).
If no Inform your dental depot.
Fig. 1:

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2.4 X-ray unit
2.5 System safety
X-ray tube assembly and stand condition Answer questions with yes () or no (−)
Date (please enter month/year)
Tube assembly housing percepti-
bly/visibly oil-free (Fig. 1)?
If no Inform your dental depot.
Safety Answer questions with yes () or no (−)
Date (please enter month/year)
Coiled cable with strain relief and
anti-kink sleeve OK (Fig. 1)?
Power cable and 2nd protective
ground wire free of damage
(Fig. 1)?
Power cable free of damage
(Fig. 1)?
Are all of the screws for fastening
the X-ray unit to the wall and
mounting bracket and/or for
fastening the unit securely to the
floor stand securely tightened
(Fig. 2)?
Only for Japan: Is the unit
switched off when the Emergency
Stop switch is pressed?
If no Order repair by a service engineer immediately.
Fig. 1:
Tube assembly
housing
Fig. 1: 2nd protective
ground wire
Power cable
Control cable
Anti-kink
sleeve
Fig. 2:

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2.6 Exposure safety
Exposure safety Answer questions with yes () or no (−)
Date (please enter month/year)
No repeated occurrence of a cer-
tain error message (Fig. 1/2)?
Optical and acoustic signal pres-
ent when radiation is released
(Fig. 1/2)?
Is the release button free of clean-
ing agent residues and freely
movable?
Exposure is interrupted immedi-
ately when release button is
released prematurely (Fig. 1/2)?
Does the rotary movement occur
without any atypical running
noises?
If no Inform your dental depot.
Radiation indicator
Return key kV/mAs lights up
Radiation indicator no longer lights up.
Acoustic signal no longer sounds after
you let go of the release button
Error message
Fig. 1:
Light localizer
GALILEOS
Easypad
T
R
Prog.
kV
mAs
E1 10 07
Radiation indicator
kV/mAs lights up
Radiation indicator no longer lights up.
Acoustic signal no longer sounds after
you let go of the release button
Error message
Fig. 2:
GALILEOS
Multipad
Return key
Light localizer

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2.7 Key functionality
2.8 Light localizer functionality
Key functionality Answer questions with yes () or no (−)
Date (please enter month/year)
Membrane foil of the Easypad/
Multipad keys without cracks or
holes (Fig. 1)?
All numbers and letters on the
Easypad/Multipad are displayed
completely?
Can the Easypad/Multipad be
positioned reliably and does it
remain in the desired position?
If no Inform your dental depot.
Light localizer Answer questions with yes () or no (−)
Date (please enter month/year)
Vertical light beam is centered on
the bite block (Fig. 1)?
If no Inform your dental depot.
Fig. 1:
GALILEOS
Easypad
T
R
Prog.
kV
mAs
E1 10 07
GALILEOS
Multipad
Vertical light beam
Fig. 1:

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2.9 Swivel arm/bite block/forehead support functionality
2.10Image quality
Swivel arm/bite block/forehead support Answer questions with yes () or no (−)
Date (please enter month/year)
Can the swivel arm be easily swiv-
eled, is the locking mechanism
OK, does the swivel arm lock into
position (Fig. 1)?
When swiveled out, is return
movement not possible?
Does the clamping device for the
bite block work correctly?
Does the clamping device for the
forehead support work correctly?
If no Inform your dental depot.
Image quality Answer questions with yes () or no (−)
Date (please enter month/year)
Typical exposure parameters e.g.
mAs are not adjusted in order to
achieve a constant image quality?
No recurring deterioration of the
image sharpness or contrast?
If no Inform your dental depot.
Fig. 1:

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2.11 Height adjustment functionality
2.12 Facescan functionality (option)
Height adjustment Answer questions with yes () or no (−)
Date (please enter month/year)
Acoustic signal sounds when
height is adjusted?
Height adjustment works without
jolting and without atypical
running noises (e.g. clacking,
scuffing)?
Does the set height remain
unchanged even when the unit is
switched off for longer periods of
time?
No jerking at beginning of soft
start after key is pressed?
Soft start does begin after key is
pressed?
No follow-up movement of height
adjustment after height adjust-
ment keys are released?
If no Inform your dental depot.
Facescan Answer questions with yes () or no (−)
Date (please enter month/year)
Are all Backlight LEDs illumi-
nated?
Are the glass panes fog-free,
clean and without scratches?
If no Inform your dental depot..

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2.13Documenting your annual inspection
The undersigned confirms that he/she has checked the unit for the above criteria and that he/she has informed
the competent dental depot in case of any defects.
Year Inspection date: Name: Signature:
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Sirona Dental Systems GmbH 3 Yearly calibration by the service engineer (for the USA, see the Maintenance Instructions)
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3 Yearly calibration by the
service engineer
(for the USA, see the Maintenance Instructions)
3.1 General information for the service engineer
The Service Manual for GALILEOS (order No. 61 25 665 and 64 26 345) is indispensable for performing the
calibration. All of the measures required for the calibration are described there in the Chapter "Calibrating the
unit".
Furthermore, the operating instructions are required.
Should it be necessary to replace defective components along with parts subject to wear, this must be agreed
previously with the customer or dental practice staff.
If components bearing a serial number are replaced, the new serial number must be recorded in the table in
Chapter 5.5, "Serial numbers of the system".
Discontinuation of spare part deliveries:
Deliveries of spare parts are discontinued after a certain period of time for every system. The system owner will
be responsible for safety-relevant failures of systems which continue in operation after that time and can no lon-
ger be serviced due to missing spare parts.
3.2 Calibrating the X-ray unit
Assessing X-ray exposures Answer questions with yes () or no (−)
Date (enter month/year)
Mechanical unit adjustment OK?
See service manual
Diaphram exposure OK?
See service manual
Beam field OK?
See service manual
Dosimetry OK?
See service manual
Sensor calibration OK?
See service manual
Iris calibration OK?
See service manual
Shading calibration OK?
See service manual
Distorsion calibration OK? See
service manual
Geometric calibration OK? See
service manual
Calibration of touchscreen OK?
See service manual
If no Correct fault.

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3.3 Documenting the yearly calibration
The undersigned confirms that he/she has checked the unit for the above criteria and that he/she has informed
the competent dental depot in case of any defects.
Year Date of
check:
Geometry
phantom
serial No.:
Distorsion
phantom
serial No.:
Name: Dealer: Signature:
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Sirona Dental Systems GmbH 4 Safety-related checks by the service engineer in compliance with standard IEC 62353
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4 Safety-related checks by the service
engineer in compliance with
standard IEC 62353
4.1 General information for the service engineer
The Service Manual for GALILEOS (order No. 61 25 665 and 64 26 345) is absolutely essential for performing
safety-related checks, as the protective ground wire and device leakage current tests are described in this doc-
ument.
Measurements
Switch the power OFF at the main switch of the building installation, see Service Manual.
Select the correct current/voltage type and adjust the measuring range to match the expected readings.
Perform continuity tests only on units which are switched off.
ATTENTION
When opening the unit:
Please observe the usual precautionary measures for handling printed circuit boards (ESD).
Touch a ground point to discharge static electricity before handling any components.
ATTENTION
If the dental treatment center does not pass the safety tests, it must not be operated any longer!
You must advise the user of this fact in your capacity as service engineer. Corresponding repair work by
an authorized service engineer is required before putting the system into service again.
NOTE i
The safety checks correspond to the standard IEC 62353:2007
(DIN EN 62353/VDE 0751-1:2008).
If you use an automatic tester, you can program it according to these standards.
– Application components Type B
– Permanently attached unit
– Protection Class I
The measurements to be performed are complex and time-consuming.
Sirona therefore explicitly recommends using an automatic tester.

4 Safety-related checks by the service engineer in compliance with standard IEC 62353 Sirona Dental Systems GmbH
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4.2 Intervals for safety-related checks
It is essential to perform safety checks aimed particularly at detecting electrical faults during initial startup and
then every 2 years. All inspections and measurements are performed by the authorized service engineer. They
are specified in the following.
Safety-related checks are performed on the following occasions:
• Initial startup
• Regularly every 2 years
• After extensions/upgrades (conversion)
• After repair work
4.3 Safety-related check
(see Service Manual, chapter on Maintenance)
Equipment safety Answer questions with yes () or no (−)
Enter measured values
Maintenance interval
after X years
Initial
startup 2 4 6 8 10 12 14
Date (please enter month/year)
Ground wire test OK?
Enter measured values:
Aand B(GNYE wire)
Measured value less than
0.1 ohms
Aand C(2nd ground wire)
Measured value less than
0.1 ohms
Aand D(housing DX32)
Measured value less than
0.2 ohms
Aand E(tube assembly
housing)
Measured value less than
0.2 ohms
Unit leakage current test OK,
measured value less than 2 mA?
Enter measured values:
Facescan (option)
Ground wire test OK? Enter
measured values:
Aand F(housing POE)
Measured value less than
0.2 ohms
Aand G(stand arm)
Measured value less than
0.2 ohms
Aand H(image intensifier chas-
sis) Measured value less than
0.2 ohms

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4.4 Documenting the safety-related check
The undersigned confirms that he/she has checked the unit for the above criteria.
If any question is answered with No, the fault must be eliminated.
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:
Date: Engineer's name: Signature:

5 Maintenance by the service engineer Sirona Dental Systems GmbH
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5 Maintenance by the service engineer
5.1 General information for the service engineer
The Service Manual for GALILEOS (order No. 61 25 665 and 64 26 345) is indispensable for performing main-
tenance. All of the maintenance measures required are described there in the Chapter entitled "Maintenance".
Furthermore, the operating instructions are required.
Measurements
Always switch the unit OFF before connecting the measuring instruments.
Select the correct current/voltage type and adjust the measuring range to match the expected readings.
Perform continuity tests only on units which are switched off.
If several exposures with radiation must be taken to check a measurement, make sure that the prescribed cool-
down intervals are observed.
ATTENTION
Observe the radiation protection guidelines before releasing radiation.
ATTENTION
When opening the unit:
Please observe the usual precautionary measures for handling printed circuit boards (ESD).
Touch a ground point to discharge static electricity before handling any components.
Before starting maintenance work, always perform a functional test and advise the customer or dental practice
staff about any defects found.
Should it be necessary to replace defective components along with parts subject to wear, this must be agreed
previously with the customer or dental practice staff.
If components bearing a serial number are replaced, the new serial number must be recorded in the table in
Chapter 5.5, "Serial numbers of the system".
Discontinuation of spare part deliveries:
Deliveries of spare parts are discontinued after a certain period of time for every system. The system owner will
be responsible for safety-relevant failures of systems which continue in operation after that time and can no lon-
ger be serviced due to missing spare parts.