d^ifiblp
fелйЙЕнбзе=~еЗ=г~бенЙе~еЕЙ
pбкзе~=aЙен~д=pулнЙгл=dгДe
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^=aЙен~д=pулнЙглK
61 25 533 D 3437
D 3437.105.01.03.02
Sirona Dental Systems GmbH
List of Contents
1 Yearly inspection by the system
owner....................................................5
1.1 Technical documents ............................... 5
1.2 System accessories ................................. 6
1.3 Surfaces of the unit .................................. 7
1.4 X-ray unit .................................................. 8
1.5 System safety .......................................... 8
1.6 Exposure safety ....................................... 9
1.7 Key functionality ..................................... 10
1.8 Light localizer functionality ..................... 10
1.9 Swivel arm/bite block/forehead
support functionality ............................... 11
1.10 Image quality .......................................... 11
1.11 Height adjustment functionality .............. 12
1.12 Documenting your yearly inspection ...... 12
ЗЙмнлЕЬЙеЦдблЬ
2 Yearly calibration by the service
engineer (for the USA refer to the
Maintenance Instructions)................13
2.1 Customer data ....................................... 13
2.2 Calibrating the X-ray unit ....................... 14
2.3 Documenting the yearly calibration ........ 15
3 Maintenance by the service
engineer .............................................16
3.1 Customer data ....................................... 16
3.2 Checking the records ............................. 17
3.3 Labels on the system ............................. 17
3.4 Serial numbers of the system ................ 18
3.5 Functional test ........................................ 19
3.6 Checking the tube data .......................... 20
3.7 Checking the cables for damage ........... 20
3.8 Safety checks ......................................... 21
3.9 Final work ............................................... 21
3.10 Documenting maintenance work ............ 22
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Sirona Dental Systems GmbH
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Sirona Dental Systems GmbH 1 Yearly inspection by the system owner
1 Yearly inspection by the system
owner
Inspection and maintenance must be performed at predetermined intervals to guarantee the health and safety
of all patients, users and third parties.
In order to guarantee the operational safety and reliability of your product, you as the system owner should
check your unit through at least once a year or commission your dental depot to do so.
In addition, your dental depot offers you maintenance of the system by specially trained engineers; see
two Chapter in this document.
All inspection and maintenance work performed by the system owner and/or service engineer must be
recorded in this document and kept near the unit!
If one or more checks to be performed do not lead to satisfactory results, please contact your dental depot.
1.1 Technical documents
Technical documents Answer questions with yes (9) or no (−)
Date
(please enter month/year)
Operating Instructions available?
Installation Instructions available?
Installation Requirements available?
Installation Report / Warranty
Passport available?
Declaration of Conformity by system integrator available?
X-ray System Logbook available
(for Germany only)?
If no Ö Order missing documents from your dental depot.
ЙеЦдблЬ
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1 Yearly inspection by the system owner Sirona Dental Systems GmbH
1.2 System accessories
System accessories (see Operating Instructions) Answer questions with yes (9) or no (−)
Not all accessories listed here may be included in
the scope of supply, cross out what does not apply.
Date (please enter month/year)
Test phantom available?
Forehead support
available?
Rigid bite block
available?
Head fastening
strap available?
Chin rest, complete
available?
Mandibular bite
plate holder available?
Maxillary bite plate
holder available?
If no Ö Order missing accessories from your dental depot.
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Sirona Dental Systems GmbH 1 Yearly inspection by the system owner
Fig. 1:
1.3 Surfaces of the unit
Cover parts Answer questions with yes (9) or no (−)
Date
(please enter month/year)
All cover parts attached at X-ray
unit (Fig. 1)?
All screws on unit housing available?
Cover parts and mirrors free of
damage (no surface damages,
e.g. scratches)?
All cover parts in clean condition?
Clean X-ray unit with the recommended cleaning agents
(see Operating Instructions).
If no Ö Inform your dental depot.
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1 Yearly inspection by the system owner Sirona Dental Systems GmbH
Fig. 1:
Tube assembly housing
Fig. 1: Fig. 2:
Power cable
Control cable
Anti-kink
sleeve
2nd ground wire
1.4 X-ray unit
X-ray tube assembly and stand condition Answer questions with yes (9) or no (−)
Date (please enter month/year)
Tube assembly housing palpably/
visibly oil-free (Fig. 1)?
If no Ö Inform your dental depot.
1.5 System safety
Safety Answer questions with yes (9) or no (−)
Date
(please enter month/year)
Coiled cable with strain relief and
anti-kink sleeve OK (Fig. 1)?
Power cable and 2nd ground wire
free of damage (Fig. 1)?
Control cable free of damage
(Fig. 1)?
All screws that fasten the X-ray
unit to the wall and the support
bracket tightly secured and/or unit
securely fastened to the stand
(Fig. 2)?
For Japan only: Is the unit immediately switched off when the
emergency shutdown switch is
activated?
If no Ö Immediately order repair by a service engineer.
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Sirona Dental Systems GmbH 1 Yearly inspection by the system owner
Error message
Radiation indication
kV/mAs lights
Fig. 1:
Radiation indicationno longer lights up.
Acoustic signal no longer sounding,
when radiation button is released prematurely
Return key
Light localizer
GALILEOS
Easypad
T
R
Prog.
kV
mAs
E1 10 07
Radiation indication
kV/mAs lights
Radiation indicationno longer lights up.
Acoustic signal no longer sounding,
when radiation button is released prematurely
Error message
Fig. 2:
GALILEOS
Multipad
Return key
Light localizer
1.6 Exposure safety
Exposure safety Answer questions with yes (9) or no (−)
Date
(please enter month/year)
No repeated occurrence of a certain error message (Fig. 1/2)?
Optical and acoustic signal
present when radiation is
released (Fig. 1/2)?
Exposure is immediately interrupted when radiation button is
released prematurely (Fig. 1/2)?
Does rotational movement occur
without any atypical running
noises?
If no Ö Inform your dental depot.
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1 Yearly inspection by the system owner Sirona Dental Systems GmbH
Fig. 1:
GALILEOS
Easypad
T
R
Prog.
kV
mAs
E1 10 07
GALILEOS
Multipad
Fig. 1:
Vertical light beam
1.7 Key functionality
Key functionality Answer questions with yes (9) or no (−)
Date
(please enter month/year)
Membrane foil of the Easypad/
Mutipad keys without cracks or
holes (Fig. 1)?
All numbers and letters on the
Easypad/Multipad show up completely?
Can the Easypad/Mutipad be
positioned reliably and does it
remain in the desired position?
If no Ö Inform your dental depot.
1.8 Light localizer functionality
Light localizer Answer questions with yes (9) or no (−)
Date (please enter month/year)
Vertical and horizontal light beam
visible (Fig. 1)?
If no Ö Inform your dental depot.
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Sirona Dental Systems GmbH 1 Yearly inspection by the system owner
Fig. 1:
1.9 Swivel arm/bite block/forehead support functionality
Swivel arm/bite block/forehead support Answer questions with yes (9) or no (−)
Date
(please enter month/year)
Can the swivel arm be easily
swiveled, 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
bit block work correctly?
Does the clamping device for the
forehead support work correctly?
If no Ö Inform your dental depot.
1.10 Image quality
Image quality Answer questions with yes (9) 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 Ö Inform your dental depot.
ЙеЦдблЬ
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1 Yearly inspection by the system owner Sirona Dental Systems GmbH
1.11Height adjustment functionality
Height adjustment Answer questions with yes (9) or no (−)
Date
(please enter month/year)
Acoustic signal sounds when
height is adjusted?
Height adjustment works without
jolting, without slumping and without atypical running noises (e.g.
clacking, scuffing)?
Does the height setting remain the
same even after the system has
been switched off for a longer
period of time?
If no Ö Inform your dental depot.
1.12Documenting your yearly 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.
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Sirona Dental Systems GmbH 2 Yearly calibration by the service engineer (for the USA refer to the Maintenance Instructions)
i
2 Yearly calibration by the service
engineer (for the USA refer to the Maintenance Instructions)
General information for the service engineer
The GALILEOS Service Manual (Order No. 61 25 665) 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 which have been supplied together with the unit are required.
In addition to the annual check by the system owner or other authorized persons, a yearly calibration
must also be performed by the service engineer.
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 3.4‚ “Serial numbers of the system”.
Discontinuation of spare part deliveries:
For each system, the spare part deliveries are discontinued after a certain period of time. The system owner will
be responsible for safety-relevant failures of systems which continue in operation after that time and can no
longer be serviced due to missing spare parts.
2.1 Customer data
Customer
Last name:
First name:
Street:
Post code / city:
Phone:
Space for practice stamp
ЙеЦдблЬ
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2 Yearly calibration by the service engineer (for the USA refer to the Maintenance Instructions) Sirona Dental Systems GmbH
2.2 Calibrating the X-ray unit
Assessing X-ray exposures Answer questions with yes (9) 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 Ö Correct fault.
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Sirona Dental Systems GmbH 2 Yearly calibration by the service engineer (for the USA refer to the Maintenance Instructions)
2.3 Documenting the yearly calibration
The undersigned confirms that he/she has checked the unit for the above criteria and that he/she has handed
over the unit in fully functional condition..
Year Date of
check:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Biometric
phantom
Serial No.:
Distorsion
phantom
Serial No.:
Name: Dealer: Signature:
ЙеЦдблЬ
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3 Maintenance by the service engineer Sirona Dental Systems GmbH
i
3 Maintenance by the service engineer
General information for the service engineer
For performing maintenance work, the Service Manual GALILEOS, (Order No. 61 25 665) is indispensable. All
measures which are required for maintenance are described there in Chapter “Maintenance”.
Furthermore, the Operating Instructions which have been supplied together with the unit are required.
In addition to the yearly inspection by the system owner or persons authorized by him/her, preventive
maintenance has to be performed after 4, 7, 10 years and afterwards every two years.
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 3.4‚ “Serial numbers of the system”.
Discontinuation of spare part deliveries:
For each system, the spare part deliveries are discontinued after a certain period of time. The system owner will
be responsible for safety-relevant failures of systems which continue in operation after that time and can no
longer be serviced due to missing spare parts.
3.1 Customer data
Customer
Last name:
First name:
Street:
Post code / city:
Phone:
Space for practice stamp
61 25 533 D 3437
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Sirona Dental Systems GmbH 3 Maintenance by the service engineer
Fig. 1:
fелн~дд~нбзе=oЙйзкн=L=t~кк~ену=m~ллйзкн
Customer Dealer
Address, tel.: Address, tel.:
Customer No.:Order No:
Serial numbers Pos. Serial-No.
n
o
p
q
r
s
t
u
v
n
o
s
r
q
p
Dongle
u
t
11
v
Software Hardware
GALILEOS V _ _ . _ _ _ _ _
GALILEOS
Implant
V _ _ . _ _
GALAXIS V _ _ . _ _
SIDEXIS V _ _ . _ _
RCU PC _ _ _
Information on installation:
Dispatch mode License file:
E-MAIL: .............................................................@..................................................... CD (dispatch by mail)
Visual inspection of packaging for possible damage. Remarks:
• Shockwatch OK? On the unit
On the X-ray detector
Yes
Yes
No
No
Confirmation of completeness of consignment (see installation instructions for scope of supply).
Dongle value explained to customer.
Installation of GALILEOS performed error-free, including RCU server and software modules.
•Patient management software: Manufacturer: Type: Version:
• Implantplaning software: Manufacturer: Type: Version:
•Installed products:
(X-ray/Treatment center)
SIRONA Competitors
Commissioning performed error-free according to the pre-installation instructions and installation instructions as well as country-specific safety controls where required.
The unit, including accessories and all documents in accordance with the Operating Instructions, was turned over to the the customer in proper and functioning condition.
USA only: The customer received his copy of the Federal Report of Assembly FD 2579.
The person signing confirms having the required technical knowledge for performing commisioning and training and fulfilling and complying with the requirements outline above.
Name
Customer: Trained person: Sales rep.: Technician:
Signature
Customer: Trained person: Sales rep.r: Technician:
Date: Date: Date: Date:
d^ifiblp
11
Maintenance overview: To ensure proper functioning, annual maintenanceand calibration must be performed by a specialized dental dealer. This must be documented in the "Inspection and Maintenance"
report.
Sirona Dental Systems GmbH, Fabrikstraße 31, 64625 Bensheim, Germany Ä.-Nr: 108 924 61 47 941 D3437.077.01.03.02 09.2007
FORTHE CUSTOMER
3.2 Checking the records
Checking the records of the Answer questions with yes (9) or no (−)
yearly inspection by the system owner
Maintenance interval
(after years)
Date (enter month/year)
Yearly inspection by the system
owner has been performed
(see Chapter 1)?
Yearly calibration has been performed by the service engineer
(see Chapter 2 or Maintenance
Instructions)?
Records are complete?
All questions answered with yes?
All work which has led to a negative result during the checks have
been performed?
4 7 10 12 14
ЙеЦдблЬ
If no Ö Perform yearly inspection prior to maintenance.
3.3 Labels on the system
Comparing labels on the system with
Installation Report / Warranty Passport Answer questions with yes (9) or no (−)
Maintenance interval
(after years)
Date (enter month/year)
All labels according to Installation
Report / Warranty Passport
affixed (Fig. 1)?
All labels legible?
4 7 10 12 14
If no Ö Replace missing and/or illegible labels.
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3 Maintenance by the service engineer Sirona Dental Systems GmbH
3.4 Serial numbers of the system
Please enter new Serial No. here when replacing a component:
X-ray unit Date Signature
Serial No. (at initial start-up)
Serial No.
Serial No.
X-ray tube assembly Date Signature
Serial No. (at initial start-up)
Serial No.
Serial No.
Serial No.
Serial No.
Tube Date Signature
Serial No. (at initial start-up)
Serial No.
Serial No.
Serial No.
Serial No.
Remote Date Signature
Serial No. (at initial start-up)
Serial No.
Serial No.
Serial No.
X-ray detector Date Signature
Serial No. (at initial start-up)
Serial No.
Serial No.
Test phantom Date Signature
Serial No. (at initial start-up)
Serial No.
Serial No.
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Sirona Dental Systems GmbH 3 Maintenance by the service engineer
3.5 Functional test
Prior to starting with maintenance work, a functional test must always be performed.
In doing so, it is helpful to read out the error messages, if present.
Refer to Chapter 5.2‚ “Selecting Service routines”.
Inform the customer or dental practice staff about any defects you have detected.
Checking the system functions
(observe Operating Instructions) Answer questions with yes (9) or no (−)
Maintenance interval
(after years)
Date (enter month/year)
Is there no visible abrasion on the
HA motor and threaded rod? See
Service Manual
No atypical running noises audible during height adjustment?
Jolt-free fine positioning possible
during height adjustment?
Does the height setting remain the
same even after the system has
been switched off for a longer
period of time?
Is the limit switch for height adjustment functional?
Acoustic signals audible during
height adjustment?
Clamping device for forehead support works correctly?
Clamping device for bite block
works correctly?
Can the swivel arm be easily
swiveled, is the locking mechanism OK, does the swivel arm lock
into position?
4 7 10 12 14
ЙеЦдблЬ
61 25 533 D 3437
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If no Ö Correct fault.
19
3 Maintenance by the service engineer Sirona Dental Systems GmbH
3.6 Checking the tube data
Checking the tube data Answer questions with yes (9) or no (−)
Maintenance interval
(after years)
Date (enter month/year)
Actual kV/mAs values OK?
Fan working?
See Service Manual.
Does the temperature sensor in
the tube assembly indicate a
value between ca. 18° and 65°C?
See Service Manual.
4 7 10 12 14
If no Ö Correct fault.
3.7 Checking the cables for damage
Checking the cables Answer questions with yes (9) or no (−)
Maintenance interval
(after years)
4 7 10 12 14
Date (enter month/year)
Power cable OK?
See Service Manual.
Protective ground wire OK?
Control cable OK?
Data transfer cable OK?
If no Ö Correct fault.
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Sirona Dental Systems GmbH 3 Maintenance by the service engineer
3.8 Safety checks
Move unit to working height. Switch power OFF at the main switch for the building installation or disconnect the
power plug. Remove covers from the unit.
Performing safety checks Answer questions with yes (9) or no (−)
Maintenance interval
(after years)
Date (enter month/year)
Idling roll free of damage? See
Service Manual.
Do grounding straps and cable
shields have complete and firm
contact?
Cable shielding OK?
Protective ground wire resistance
complies with specifications?
See Service Manual.
Protective ground wire connections properly attached?
Unit’s leakage current complies
with specifications?
See Service Manual.
3.9 Final work
4 7 10 12 14
ЙеЦдблЬ
If no Ö Correct fault.
Final work
(observe Operating Instructions) Answer questions with yes (9) or no (−)
Maintenance interval
(after years)
Date (enter month/year)
System cleaned?
61 25 533 D 3437
D 3437.105.01.03.02
4 7 10 12 14
If no Ö Clean system.
21
3 Maintenance by the service engineer Sirona Dental Systems GmbH
3.10Documenting maintenance work
The undersigned confirms that he/she has checked the unit for the above criteria and that he/she has handed
over the unit in fully functional condition.
Date of maintenance
Name of engineer Name of dealer Signature of engineer
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Sirona Dental Systems GmbH 3 Maintenance by the service engineer
Space for remarks
ЙеЦдблЬ
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3 Maintenance by the service engineer Sirona Dental Systems GmbH
61 25 533 D 3437
24 D 3437105.01.03.02
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