Sirona C8+ Maintenance manual
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C8+ ___________
Model Serial number
Chair Supply box
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2 D 3417.102.01.04.02 02.2006
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Table of Contents
1 General information ............................................................... 5
1.1 Purpose of the Maintenance Manual ..............................5
1.2 Work to be performed .....................................................5
2 Installation Report /
Warranty Passport ................................................................. 6
2.1 Master data of the unit ....................................................6
2.2 Inspection and maintenance ...........................................6
3 Safety checks ........................................................................ 7
3.1 Visual inspection .............................................................9
3.2 Protective ground wire test............................................10
3.2.1 Protective ground wire test for C8+, C8+ Turn, C8+ Solo ...... 10
3.2.2 Protective ground wire test of the C8
3.3 Measurement of equivalent leakage currents ...............13
3.3.1 Equivalent unit leakage current ............................................ 16
3.3.2 Equivalent patient leakage current ....................................... 17
3.4 Safety check
(Initial test after initial start-up) ......................................18
3.5 Safety check
(re-tests) ........................................................................18
+
Stand-alone .............. 12
4 Remarks / particularities regarding the treatment center ..... 22
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1 General information
1.1 Purpose of the Maintenance Manual
In order to guarantee the operational safety and reliability of the system and
to protect the health of patients, users and other persons, inspection and
maintenance must be performed at predetermined intervals.
This includes:
z Inspection and maintenance (yearly)
to prevent damage due to natural wear
z Safety tests (every 2 years)
to ensure the technical safety of the system
This document describes the work to be performed by the service
engineer.
Its realization and the measurement results are documented by the service engineer.
This document must be stored near the treatment center.
1 General information
1.2 Work to be performed
By the service engineer: 1. Note the model and the serial number of the chair or stand-alone supply
box on the title page and the relevant pages (headers) of the Maintenance
Manual.
2. Complete the “Installation Report / Warranty Passport” and file it after
chapter 2.
3. Perform inspection and maintenance according to the Maintenance
Certificate.
Document their implementation in the “Installation Report / Warranty
Passpor t".
4. Conduct the safety tests in accordance with chapter 3. Document the
results.
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2 Installation Report / Warranty Passport
2 Installation Report /
Warranty Passport
2.1 Master data of the unit
Complete the document “Installation Report / Warranty Passport” and file
the “Customer Copy” after this page.
Unusual occurrences during installation can be noted down in addition on the
second page of the “Dealer Copy”.
2.2 Inspection and maintenance
To avoid damage due to natural wear, an inspection must be performed every
year.
The steps to be performed as well as the parts which must be replaced are
specified in the document “Maintenance Certificate”. Their realization is
documented there.
A separate Maintenance Certificate is produced for each maintenance event.
List the inspection and maintenance events also under the maintenance overview in the “Installation Report / Warranty Passport”.
Attachment: Installation Report / Warranty Passport
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3 Safety checks
Medical products 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 tests aimed particularly at
detecting electrical faults every 2 years. All inspections and measurements
are performed by the authorized service engineer. They are specified in the
following.
Safety tests are performed on the following occasions:
z Initial start-up (section 3.4)
z Regularly every 2 years
z After extensions/upgrades (conversion) of the treatment center
z After repair work
You must document the measured values in section 3.4 and/or 3.5.
CAUTION
When taking measurements, please observe that hazardous voltages might
be present on the system under test.
3 Safety checks
CAUTION
If the 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.
i
NOTE
The safety tests are in compliance with the standard VDE 0751-1:2001. It you
use an automatic tester, you can program it according to this standard.
z Type BF applied parts
z Permanently installed unit
z Protection class I
z The auxiliary measuring point (see 3.3) is treated like an applied part.
Sirona recommends using an automatic tester.
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3 Safety checks
Measurement according to IEC 60601-1: If you have no possibility of performing the measurements according to
VDE 0751-1:2001, you may also perform them according to IEC 60601-1.
For details on how to perform the measurements, please refer to the standard
IEC 60601-1 and the documents on your measuring device.
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NOTE
This type of measurement is not recommended by Sirona due to its
complexity.
When taking measurements, please observe the following:
Type B applied parts Micromotor
Highspeed handpiece
Ultrasound handpieces
Polylight
Type BF applied parts Sirocam 3
Protective ground wire resistance
Earth leakage current N.C. – 5mA
Patient leakage current N.C. – 0.1mA
During the measurements, the individual dental instruments must be operated one after the other.
Several measurements in succession may be required.
Make a note in Section 3.4 or 3.5 stating that you have performed the measurements according to IEC 60601-1 and correct the specified limiting values.
Document the highest measured values.
≤ 0.1Ω
S.F.C. – 10mA (permanent connection)
S.F.C. – 0.5mA
NC. – normal condition
S.F.C. – single fault condition
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