Sirona Heliodent plus User manual

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HELIODENT
PLUS
PLUS
7mA DC
70kV 60kV
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00
8
.
HELIODENT
PLUS
7mA DC
70kV 60kV
S
00
8
.

Sirona Dental Systems GmbH
62 14 923 D 3507
D 3507.105.01.10.02
Dear Customer,
You are no doubt eagerly looking forward to using your Sirona
X-ray unit for some time to come.
Safety and reliability are essential in order to achieve this.
Your dental depot offers you service by specially trained
engineers for this purpose.
This maintenance service will ensure that your product is
always safe and ready to use. All components which are
subject to normal wear and tear are checked and, if necessary,
replaced.
Maintenance work may be performed by the system owner
only if this has been described by Sirona Dental
Systems GmbH; in all other cases, only authorized service
engineers of Sirona Dental Systems GmbH or of its authorized
dealers may be commissioned to perform such work.
If you have not concluded a service agreement, please contact
the customer service department of your dental depot.
All maintenance work performed must be recorded in this
document and kept near the unit.
We wish you much success and pleasure with this quality
product from pfolk^=aÉåí~ä=póëíÉãëK

Sirona Dental Systems GmbH Table of contents
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Table 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 ................................................................... 6
2.3 Labels on the system ................................................................. 7
2.4 Surfaces of the unit .................................................................... 8
2.5 System functions ........................................................................ 9
2.6 Documenting your yearly inspection ........................................ 10
3Safety-related checks performed by the service
engineer .........................................................................11
3.1 General information for the service engineer ........................... 11
3.2 Interval for safety-related checks ............................................. 12
3.3 Safety-related check ................................................................ 12
3.4 Documenting the safety-related check ..................................... 13
4Maintenance by the service engineer .........................14
4.1 General information for the service engineer ........................... 14
4.2 Maintenance interval ................................................................ 15
4.3 Checking the records ............................................................... 15
4.4 Maintenance of wall adapter/remote timer ............................... 16
4.5 Maintenance of arm/tube assembly ......................................... 17
4.6 Maintenance Ceiling Model ...................................................... 18
4.7 Mobile stand maintenance ....................................................... 18
4.8 Maintenance Unit model .......................................................... 19
4.9 Final steps ................................................................................ 20
4.10 Documenting maintenance work .............................................. 20

Table of contents Sirona Dental Systems GmbH
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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 Please fill in the required general information
*Information for the service engineer: Please update the serial no. when replacing a component.
Customer
Last name:
First name:
Street:
City/State/Postal (ZIP) code:
Phone:
System data*
Serial no. of system:
Serial no. of tube assembly:
Serial no. of test phantom:

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2Annual inspection performed by the
system owner or other authorized
persons
2.1 Technical documentation
2.2 System accessories
Technical documents Answer questions with yes () or no (−)
Date (please enter month/year)
Operating Instructions available?
Installation requirements
available?
X-ray system logbook regularly
updated (Germany/Austria/
Switzerland)?
Accessories (see Operating Instructions) Answer questions with yes () or no (−)
Not all of the accessories listed here are included
in the scope of supply, cross out if not applicable.
Date (please enter month/year)
Conventional test phantom
available?
Digital test phantom available?
300 mm (12") cone available?
300 mm (12") square cone
available?
Radiation field limiter
blue 3x4 cm present?
Radiation field limiter
black 2x3 cm present?

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2.3 Labels on the system
Labels on system Answer questions with yes () or no (−)
Date (please enter month/year)
All all labels affixed?
Are all labels legible?
Please enter changes here:
X-ray tube unit Date Signature
Serial no.
Serial no.
Serial no.
Tube
Serial no.
Serial no.
Serial no.
Radiation field limiter
blue 3x4 cm
Serial no.
Serial no.
Serial no.
Radiation field limiter
black 2x3 cm
Serial no.
Serial no.
Serial no.
300 mm (12") cone
Serial no.
Serial no.
Serial no.
300 mm (12") square cone
Serial no.
Serial no.
Serial no.
Wall adapter/Ceiling model
Serial no.
Serial no.
Serial no.

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2.4 Surfaces of the unit
Cover parts Answer questions with yes () or no (−)
Date (please enter month/year)
Are all cover parts present?
Are the cover parts free of
damage?
Do the cover parts fit properly?
Do the cover on the wall adapter
for the ceiling model fit properly
and is firmly glued?
Are the cover parts clean?
Are all screws present and tightly
screwed in? (See arrows.)
Is the scale on the tube assembly
legible?
30
60
6060
90

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2.5 System functions
Condition of tube assembly/arm/
remote control/remote timer Answer questions with () or no (−)
Date (please enter month/year)
Loss of oil noticeable on tube
assembly (outside of tube
assembly housing)?
Coiled cable and anti-kink
sleeve OK?
Power connection with strain
relief OK (for surface
installation)?
Can scissor arm be moved
without jolting?
System functions Answer questions with yes () or no (−)
Date (please enter month/year)
Is the wall fastening in safe
condition?
Main switch functioning?
Is the exposure canceled if you
let go of the exposure release
button prematurely (dead man's
control)?
Are the optical (X-ray lit) and
acoustic signals present during
radiation?
Is the release button free of
cleaning agent residues and
freely movable?
Are all buttons and indicators
functioning?
Are all system functions
executable based on the
operating instructions?
Is the image quality always
constant?

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2.6 Documenting your yearly inspection
The undersigned confirms that he/she has checked the unit for the above criteria.
NOTE: If one of the questions is answered with NO or an error message occurs repeatedly, please contact your
service engineer.
Inspection date: Name: Signature:
Inspection date: Name: Signature:
Inspection date: Name: Signature:
Inspection date: Name: Signature:
Inspection date: Name: Signature:
Inspection date: Name: Signature:
Inspection date: Name: Signature:
Inspection date: Name: Signature:

Sirona Dental Systems GmbH 3 Safety-related checks performed by the service engineer
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3Safety-related checks performed by
the service engineer
3.1 General information for the service engineer
The Service Manual for HELIODENTPLUS (order no. 62 15 102) is absolutely essential for performing safety-
related checks, as the protective ground wire and device leakage current tests are described in this document.
Measurements
ATTENTION
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 performed by the service engineer Sirona Dental Systems GmbH
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3.2 Interval for safety-related checks
It is essential to perform safety-related 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, measured
value less than 0.2 ohms?
Enter measured values.
Wall Model
Unit leakage current test OK,
measured value less than 2 mA?
Enter measured values.
Ceiling Model
Unit leakage current test OK,
measured value less
than2mA?
Enter measured values.
Mobile stand
Unit leakage current test OK,
measured value less
than2mA?
Enter measured values.
Unit Model
Unit leakage current test OK,
measured value less
than2mA?
Enter measured values.

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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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4Maintenance by the service engineer
4.1 General information for the service engineer
The Service Manual for HELIODENTPLUS (order no. 62 15 102) is absolutely essential for performing mainte-
nance, as all of the maintenance required is described therein.
Furthermore, the Operating Instructions are also required.
Measurements
ATTENTION
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, the consent of the cus-
tomer or dental practice staff must be obtained first.
ATTENTION 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.

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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 performed by the service engineer” on page 11
Checking the records Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (please enter month/year)
Annual inspection performed by
the system owner?
Records complete?
Were all questions answered
with yes?
Has all work which led to a
negative result during the checks
been performed?
Have all safety-related checks
been carried out and did the
measured values remain
constant?

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4.4 Maintenance of wall adapter/remote timer
(see Service Manual, chapter on Maintenance)
Equipment safety Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (please enter month/year)
Is the wall fastening in safe
condition?
Are the cover parts present and
free of damage?
Are all EMC plates available over
the DX1?
Are all shielded connections
tight?
Are all protective ground
connections tightly fitted?
Damage-free, tight and proper
seating of power cable.
Exposure times and high
voltage OK?
Release button OK?
Is front panel OK?

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4.5 Maintenance of arm/tube assembly
(see Service Manual, chapter on Maintenance)
Equipment safety Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (please enter month/year)
Round/angular support arm OK?
Can the round/angular support
arm system be moved smoothly,
without jolting, easily and without
running noises?
Is the support arm in an upright
position.
Round support arm system: are
the stopper buffers exactly oppo-
site each other?
Angular support arm system: are
the scissor arms parallel?
Are the moving support arm
parts and cast parts free from
mechanical damage?
Is tube assembly joint OK?
Tube assembly without oil loss?
Are all protective ground
connections in the tube
assembly tight?
Is the grounding strap for the
protective conductor OK
(light damage with no more
than 20% cross-section loss is
acceptable)?
Is tube current OK?

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4.6 Maintenance Ceiling Model
4.7 Mobile stand maintenance
Equipment safety Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (Enter month/year)
Is the mounting on the ceiling in
a safe condition?
Are all cover parts available and
free of damage?
Are all protective ground wire
connections made firmly?
Are the cables connected at ter-
minal K10 connected free of
damage, firmly and according to
regulations.
Equipment safety Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (please enter month/year)
Is the wall module fastening on
the mobile stand in a safe
condition?
Are all protective ground
connections tightly fitted?
Is the power cable with strain
relief and bend protection on the
mobile stand in order?
Is the insulation resistance on
the power supply cord of the
mobile stand in order?
Damage-free, tight and proper
seating of the cables on clamp
X100.
Are the cover parts present and
free of damage?
Are the rollers of the mobile
stand, including brakes, in order
and free from contamination?

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4.8 Maintenance Unit model
Equipment safety Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (please enter month/year)
Is the fastening on the treatment
center in a safe condition?
Are all protective ground
connections tightly fitted?
Is the power cable with strain
relief and bend protection in
order?
Damage-free, tight and proper
seating of the cables on clamp
X100.
Are the cover parts present and
free of damage?

4 Maintenance by the service engineer Sirona Dental Systems GmbH
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4.9 Final steps
4.10 Documenting maintenance work
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.
Equipment safety Answer questions with yes () or no (−)
Maintenance interval
after X years 4 710 12 14
Date (please enter month/year)
Complete functional test
performed? (see Operating
Instructions)
System cleaned?
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature:
Date of maintenance: Engineer's name: Signature: