Sirona C1+ Notice D'utilisation page 183

Sirona Dental Systems GmbH
Safety checks for devices with HF surgery equipment:
59 06 446 D 3386
D 3386.201.01.08.02
The check includes a visual inspection as well as
measurements of the protective ground wire
connections and the equivalent leakage currents.
The inspections and measurements to be performed are
specified in the "Maintenance Manual". The measured
values must be documented there by the service
engineer.
Safety tests must also be performed and documented
during initial start-up, after extensions/upgrades
(conversion) of your treatment center and after repair
work.
i
NOTE
The treatment center must not be operated if it has failed
to pass the safety tests!
In Germany, medical products are subject to the Ordi-
nance on the Installation, Operation and Use of Medical
Devices (MPBetreibV) from 06/29/1998.
According to Sec. 6, safety checks for devices with HF
surgery equipment must be performed.
According to Sec. 7, a "Medical Product Log" must be
kept in which the measurement values and the perfor-
mance of the tests is documented.
These checks for devices with HF surgery equipment
are identical with the checks as described above.
The "Maintenace Manual" is therefore at the same time
the "Medical Product Log".
The operator is obligated to maintain this medical pro-
duct log.
In order to comply with the provisions of the Ordinance
on the Installation, Operation and Use of Medical
Devices (MPBetreibV), the following documentation
must be maintained for treatment centers with HF sur-
gery equipment in Germany:
• Realization of safety tests
• Personnel trained in the use of the
HF surgery device (Sec. 5 of MPBetreibV)
• Repair work on the HF module
• Effects of malfunctions and repeated, similar opera-
tor errors
• Reporting of incidents to authorities and manufactur-
ers
The Medical Product Log must be safekept for a period
of at least 5 years after putting the system out of service.
Upon request, the Medical Product Log must be made
available to the competent authority for inspection pur-
poses at any time.
22 Maintenance
22.3 Safety tests
87