61 93 556 D3509
171
D3509
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201.01.02
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02
19.09.2008
6 Maintenance by the service engineer
Sirona Dental Systems GmbH
Safety tests for systems with HF surgical equipment
Operating Instructions TENEO
6.3
Safety tests for systems with HF surgical
equipment
In Germany, medical equipment is subject to the provisions of the Ordinance
on the Installation, Operation and Use of Medical Equipment
(Medizinprodukte-Betreiberverordnung – MPBetreibV) of June 29, 1998.
z
According to Section 6, safety tests are required for systems with HF
surgical equipment.
z
According to Section 7, a “Medical Product Log” must be kept, in which
the measured values as well as the tests conducted must be documented.
These tests for systems with HF surgical equipment are identical to the safety
tests described in "Safety tests" [
.
The "Maintenance Manual" contains the "Medical Product Log". The system
owner is obliged to keep this Medical Product 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 surgical
equipment in Germany:
z
Performance of safety tests
z
Personnel who have been trained in the use of HF surgical equipment (§5
MPBetreibV)
z
Repair work on the HF module
z
Effects of malfunctions and repeated, similar operator errors
z
Reporting of incidents to authorities and manufacturers
The Medical Product Log must be kept in storage 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
purposes at any time.
6.4
Maintenance Manual
Keep this Maintenance Manual near your treatment center.
Any inspection and maintenance work as well as all safety tests are
documented by the service engineer in the Maintenance Manual. For systems
with HF surgical equipment, the consequences of malfunctions and reports to
the competent authorities must be documented by the user.
The "Maintenance Manual" contains the "Medical Product Log".
We recommend always keeping the documentation in the chapter "Reporting
of incidents to authorities / manufacturers" up to date, regardless of legal
requirements.
NOTE:
As a system user outside of Germany, you must observe the legal
requirements of your country.
