Sirona ORTHOPHOS XG 5 User manual

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59 87 685 D 3352
D 3352.105.01.11.02
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 Customer data ............................................................................................................. 5
2Annual inspection performed by the system owner or other
authorized persons.....................................................................................6
2.1 Technical documents ................................................................................................... 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 Sensor functionality .................................................................................................... 12
2.10 Image quality .............................................................................................................. 12
2.11 Height adjustment functionality .................................................................................. 13
2.12 Documenting your yearly inspection .......................................................................... 14
3Safety-related checks by the service engineer in compliance with
standard IEC 62353...................................................................................15
3.1 General information for the service engineer ............................................................. 15
3.2 Intervals for safety-related checks ............................................................................. 16
3.3 Safety-related check .................................................................................................. 16
3.4 Documenting the safety-related check ....................................................................... 17
4Maintenance by the service engineer .....................................................18
4.1 General information for the service engineer ............................................................. 18
4.2 Maintenance interval .................................................................................................. 19
4.3 Checking the records ................................................................................................. 19
4.4 Labels on the system ................................................................................................. 20
4.5 Serial numbers of the system ..................................................................................... 21
4.6 Functional test ............................................................................................................ 22
4.7 Assessing X-ray exposures ........................................................................................ 23
4.8 Checking the tube data .............................................................................................. 23
4.9 Diaphragm check ....................................................................................................... 24
4.10 Checking the cables for damage ............................................................................... 24
4.11 Safety checks ............................................................................................................. 25
4.12 Final work ................................................................................................................... 25
4.13 Documenting maintenance work ................................................................................ 26

Sirona Dental Systems GmbH
59 87 685 D 3352
4D 3352.105.01.11.02

Sirona Dental Systems GmbH 1 General information
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1General 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 satisfactory
results, please contact your dental depot.
• 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 3 "Safety-related checks performed by the service engineer" should
be helpful here.
• In addition, your dental depot offers you maintenance of the system by specially trained engineers; see
Chapter 4 "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 Customer data
Customer
Last name:
First name:
Street:
Post code / city:
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 documents
Technical documents Answer questions with yes () or no (−)
Date (please enter month/year)
Operating Instructions available?
Installation Requirements availa-
ble?
Installation Report / Warranty
Passport available and com-
pletely filled out?
Declaration of Conformity by sys-
tem integrator available?
X-ray System Logbook available
(for Germany only)?
If no Order missing documents from your dealer.

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2.2 System accessories
System accessories (see Operating Instructions) Answer questions with yes () 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)
Needle phantom
available?
Test phantom
available?
(worldwide, incl.
Germany)
Test phantom
available?
(Germany, as from
07.2015)
Test phantom for
Ceph units availa-
ble?
Test phantom for
ORTHOPHOS XG
3 available?
Bite block, yellow/
blue available?
Contact segment,
yellow/blue availa-
ble?
Temporomandibu-
lar joint support 1
and 2 available?
Ear holders availa-
ble?
Forehead support,
temple supports
and Contact pads
available?
Chin rest comple-
tely available?
If no Order missing accessories from your dealer.

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 at X-ray
unit (Fig. 1)?
All screws on unit housing availa-
ble?
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 recommen-
ded cleaning agents
(see Operating Instructions).
If no Inform your dealer.
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 palpably/
visibly oil-free (Fig. 1)?
If no Inform your dealer.
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 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 imme-
diately switched off when the
emergency shutdown switch is
activated?
If no Immediately order repair by a service engineer.
Fig. 1:
Tube assembly housing
Fig. 1: Fig. 2:
Power cable
Control cable
Anti-kink
sleeve
2nd ground wire

2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH
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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?
Optical and acoustic signal pre-
sent when radiation is released?
Is the release button free of clean-
ing agent residues and freely
movable?
Exposure is immediately interrup-
ted when radiation button is
released prematurely?
Does rotational movement occur
without any atypical running noi-
ses?
If no Inform your dealer.
T
R
Prog.
S
kV
mA
E1 10 01
Radiation indication
Return key
kV/mA lights up
Exposuretime is
indicated
Radiation indicationno longer lights up.
Acoustic signal no longer sounding,
when radiation button is released prematurely
Error message
Fig. 2:
Temple supports
ORTHOPHOS XG 5 / Ceph,
ORTHOPHOS XG 3
Multipad

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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 Multipad
keys without cracks or holes?
All numbers and letters on the
Multipad show up completely?
Can the Multipad be positioned
reliably and does it remain in the
desired position?
If no Inform your dealer.
Light localizer Answer questions with yes () or no (−)
Date (please enter month/year)
Vertical and horizontal light beam
visible (Fig. 1)?
Position of horizontal light beam
can be changed and remains as
set?
If no Inform your dealer.
T
R
Prog.
S
kV
mA
E1 10 01
ORTHOPHOS XG 5 / Ceph,
ORTHOPHOS XG 3
Multipad
Fig. 1:
Vertical and
horizontal light beam

2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH
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2.9 Sensor functionality
2.10Image quality
Sensor Answer questions with yes () or no (−)
Date (please enter month/year)
Sensor can be removed and
insert up to stop easily (Fig. 1)?
Sensor fits snugly in the guide?
If no Inform your dealer.
Image quality Answer questions with yes () or no (−)
Date (please enter month/year)
Typical exposure parameters are
not adjusted in order to achieve a
constant image quality?
If no Inform your dealer.
Fig. 1:
To remove the sensor:
Press the pushbutton all the
way in and hold it down and
remove the sensor from its
holder by pulling it downward.

Sirona Dental Systems GmbH 2 Annual inspection performed by the system owner or other authorized persons
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2.11Height adjustment functionality
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, without slumping and wit-
hout 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?
No jerking at beginning of soft
start after key is pressed?
Soft start does not begin after key
is pressed?
No follow-up movement of height
adjustment after height adjust-
ment keys are released?
If no š Inform your dealer.

2 Annual inspection performed by the system owner or other authorized persons Sirona Dental Systems GmbH
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2.12Documenting 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 dealer 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 Safety-related checks by the service engineer in compliance with standard IEC 62353
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3 Safety-related checks by the
service engineer in compliance with
standard IEC 62353
3.1 General information for the service engineer
The Service Manual for ORTHOPHOS XG (order no. 59 38 399) is absolutely essential for performing safety-
related checks, as the protective ground wire and device leakage current tests are described in this document.
Measurements
Switch the power OFF at the main switch of the building installation.
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.

3 Safety-related checks by the service engineer in compliance with standard IEC 62353 Sirona Dental Systems GmbH
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3.2 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
3.3 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:

Sirona Dental Systems GmbH 3 Safety-related checks by the service engineer in compliance with standard IEC 62353
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3.4 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:

4 Maintenance by the service engineer Sirona Dental Systems GmbH
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4 Maintenance by the service engineer
4.1 General information for the service engineer
The Service Manual for ORTHOPHOS XG (order no. 59 38 399) is absolutely essential for performing mainte-
nance, as all of the maintenance required is described therein.
Furthermore, the operating instructions supplied with the unit 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 4.5‚ "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.

Sirona Dental Systems GmbH 4 Maintenance by the service engineer
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4.2 Maintenance interval
NOTE i
In addition to the annual inspections to be carried out by the system owner or authorized persons,
safety-related checks must be performed by the service engineer after 4, 7 and 10 years, and then
at two-year intervals.
4.3 Checking the records
In the chapter "Annual inspection performed by the system owner or other authorized persons" on page 6 and
in the chapter "Safety-related checks by the service engineer in compliance with standard IEC 62353" on page 15
Checking the records Answer questions with yes () or no (−)
Maintenance interval
(after years) 4 7 10 12 14
Date (enter month/year)
Annual inspection performed by
the system owner
(see Chapter 2)?
Records complete?
All questions answered with yes?
All work required due to a nega-
tive result during the checks has
been performed?
Have all safety-related checks
been carried out and did the mea-
sured values remain constant?
If no Perform annual inspection prior to maintenance.

4 Maintenance by the service engineer Sirona Dental Systems GmbH
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4.4 Labels on the system
Comparing labels on the system with
Installation Report / Warranty Passport Answer questions with yes () or no (−)
Maintenance interval
(after years) 4 7 10 12 14
Date (enter month/year)
All labels according to Installation
Report / Warranty Passport
affixed ?
All labels legible?
If no Replace missing and/or illegible labels.
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Kunde / Customer / Client / Cliente Händler /Dealer /Depositaire /Depositante
Adresse, Tel.:
Address, tel.:
Adresse, tel.:
Dirección, tel.:
Adresse, Tel.:
Address, tel.:
Adresse, tel.:
Dirección, tel.:
Kundennummer /Customer No.
No. du client / No. de cliente
Auftragsnummer /Order No.
No. de commande/No.de pedido
Seriennummern / Serial numbers/ Numérosde série / Numéros de serie Pos.Serial-No.
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Schockindikator ok JA
Shock watch ok YES
Indicateursde chocsintact OUI
Indicadorde golpes correcto SI
Kippindikator ok JA 
Tilt watch ok YES
Indicateursde basculementintact OUI 
Indicador devuelco correcto SI
XG Ceph
Inbetriebnahmegemäß ba useitiger Installati-
onsanleitung, Montageschablone und Instal-
lationsanleitungsowie bedarfsweiseländer-
spezifische sicherheitstechnische
Kontrollenfehlerfrei durchgeführt.
DasGerätincl. desZubehörsund aller Doku-
mente gemäß Gebrauchsanweisungwurde
in ordnungsgemäßenund funktionstüchti-
gen Zustand übergeben.
Der Unterzeichnende bestätigtdi e für die In-
betriebnahmeund Einweisungerforderliche
Sachkenntnisunddie Erfüllungund Einhal-
tungderzuvor aufgeführten Angaben.
Commissioning performed error-free according
to the pre-installation instructions,mounting
template and installationinstr uctionsas wellas
country-specific safetycontrolswhere required.
The unit, includingaccessor iesand alldocu-
mentsinaccordance with the Operating Instruc-
tions,was tur ned overto the the customer in
properand functioning condition.
USA only: The customer receivedhiscopy of
the FederalReport of Assembly FD 2579.
The person signing confirmshaving the re-
quired technical knowledge for performing com-
misioningand training and fulfill ing andcomply-
ing withthe requiremen tsoutline above.
Miseen service exécutée conformément aux
instructionsd’installationet aux instruc-
tionsde préinstallation,calibre de montage
etéventuelscontrôlesde sécurité spécifi-
quesau paysexécutéssansdétectionde
défauts.
L’appareily comprislesaccessoireset tous
lesdocuments, conformémentà la notice
d’utilisation,ont été remisdansl’état correct
etopérationnel mentionné ci-dessus.
Le sous-signé confirme disposer descon-
naissancestechniquesrequisespourla mi-
seen service et la prise en main et remplir et
respecterlesindicationsénoncéesci-des-
sus.
Puestaen funcionamiento según las instruccio-
nes de instalacióny de montaje, plantilla de
montajeasí como, si es necesario, de haber
efectuadocontroles técnicos de seguridad es-
pecíficosdel país exentos de defectos.
Launidad incluyendo los accesorios y todos los
documentosen correspondencia con las ins-
truccionesde uso ha sido entregada en el debi-
do estadoy en condiciones de funcionamiento
arriba indicados.
Elfirmante confirma los conocimientos técnicos
necesariospara la puesta en funcionamiento y
la instrucción inicial y el cumplimiento y obser-
vaciónde las indicaciones arriba mencionadas.
Name / Name / Nom /Apellido
Kunde/ Customer
Client /Cliente Unterwiesene Person / Trainedperson / Personne initiée / Persona instruida
Verkäu fer / Salesrep.
Vendeur/Vendedor
Techniker/ Technician
Technicien/ Tecnico
Unterschrift / Signature / Signature / Firma
Datum / Date
Date / Fecha:
Datum / Date
Date / Fecha:
Datum / Date
Date / Fecha:
Datum/ Date
Date/ Fe cha:
loqelmelp :
bitteankreuzen
please tickas appropriate
à cocher
marcarcon una cruz
udmäìë=ap=L=`ÉéÜ 
ud=R=L=`ÉéÜ 
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Wartun gsüberblick / Maintenance logbook
Journal de bord desinterventionsde maintenance / Libro de registro de mantenimiento
Datum/ Date
Date/Fecha
Händler /Dealer
Depositaire/Depositante
Techniker/Technician
Technicien/ Tecnico
Unterschrift /Signature
Signature / Firma
Fortsetzung, siehe Rückseite/ Continued, see rear / Suite, voir verso/ Continuación, ver dorso
Sirona Dental SystemsGmbH, Fabrikstraße 31, 64625 Bensheim, Germany Ä.-Nr: 11342959 38 357 D 3352.077.01.05.0912.2010
FÜR DEN KUNDEN FOR THE CUSTOMER POUR LE CLIENT PARA EL CLIENTE