Table of Contents
Advertisement
•
formal appointment of a Laser Safety officer by the owner/operator of the unit (in acc. with
§ 6 BGV B2 (Germany) or equivalent local regulations concerning the prevention of
accidents);
•
appointment of a person who is responsible for the unit; providing user instruction to that
person as well as to other potential operators of the unit;
•
setting up a logbook for the medical device;
•
registration of the unit with the respective employers' liability insurance association and the
official body responsible for labor safety matters (if applicable);
•
carrying out all safety measures;
•
making sure that all operational procedures, as well as measures to be taken in case of
trouble/failure, are fully understood.
When using the unit in medical practice, all relevant regulations for the prevention of accidents
must be strictly observed. Such medical use includes all diagnostic, surgical or therapeutic
applications involving laser radiation (in the broadest sense). The owner/operator of the unit
and the Safety officers (e.g. the Laser Safety officer) are responsible for the proper
performance of all required safety measures, thus ensuring that the use of the laser will pose
no danger to the patient, the treating physician or any other person present during laser
operation.
Moreover, the following supplementary provisions should be observed:
•
The MCO25plus may be operated only by qualified and duly authorized personnel. These
persons must be fully familiar with the laser system and have a complete understanding of
all safety measures required. The names of these authorized persons must be recorded in
the medical device logbook.
•
Operating staff training should be repeated on an annual basis (refresher courses); all
participants in such training should confirm their participation in writing.
•
Whenever the unit is not in operation, it must be protected against unauthorized use (e.g.
by locking it and keeping the key in a safe place).
•
The unit must be operated and serviced in accordance with these Operating Instructions;
this also applies to the regular safety checks that are required.
The MCO25plus is a
classifies as a
and carries the
We recommend the owner/operator of the unit to maintain the following documents and keep
them accessible at any time:
•
medical device logbook or equipment ID card
•
Operating Instructions
8
Class IIb unit (acc. to the MDD),
Class IV laser (acc. to DIN EN 60825-1)
CE-mark in acc. with Directive 93/42/EEC.
MCO25plus Operating Instructions
V 4.1
Advertisement
Table of Contents
