Service manual LIMAX
120
Service manual version 1.00
page 3
Before putting the unit into operation, the following steps must have been carried out:
•
Acceptance of the unit by the purchasing department
•
Formal appointment of a Laser Safety Officer by the operator of the unit (see § 6 BGV
B2 (Germany) or equivalent national regulations concerning the prevention of
accidents)
•
Appointment of a person specifically responsible for the unit; familiarization of that
person and the staff with the unit
•
Setting up the medical device logbook supplied with the product
•
Registration of the unit with the respective employers' liability insurance association
and the official body responsible for laboratories safety matters (if applicable)
•
Handing over of the unit in a ready-for-use condition with appropriate user instruction,
either by Gebrüder Martin or an authorized representative
•
Observance of all safety instructions
•
Making sure that all operational procedures, as well as measures to be taken in case of
trouble/failure, are fully understood. Please note that 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 widest sense). The operator of the unit and the Safety
Officers (specifically, the Laser Safety Officer) are responsible for the proper
performance of all required safety measures, thus ensuring that the patient, the
treating physician or any other person present cannot be endangered during laser
operation.
Moreover, the following supplementary provisions must be observed:
•
The LIMAX
®
120 laser may be operated only by qualified and duly authorized personnel.
These users 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 must be repeated on an annual basis (refresher courses); all
participants in such training must confirm their participation in writing.
•
When the unit is not in use, it must be protected against unauthorized access (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 includes periodic safety checks as specified.
•
The operator of the unit is required to maintain the following documents and keep them
accessible at all times:
•
medical device logbook or equipment ID card
•
Operating Instructions (regarding the unit itself as well as accessories used)
In case of accidents or damage involving personal injuries, such incidents must be reported to
the appropriate body immediately.
