Table of Contents
Advertisement
Operating Instructions
Surgical Laser Unit Limax
3.2
Installation and Initial Start-Up
The installation and first start-up of the device may only be performed by
Gebrüder Martin GmbH & Co. KG or an authorized service partner.
CAUTION
Danger of injury!
Any person involved in any way in the handling of this device must be fully familiar with the
contents of these Operating Instructions. Improper handling (non-compliance) can lead to
bodily harm or equipment damage!
Prior to putting the device into service, the operator must ensure the following:
Acceptance of the unit by the purchasing department.
•
Formal appointment of a Laser Safety Officer by the operator of the unit (acc. to
•
section 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 labor safety matters (as 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.
•
Observance of the notices on electromagnetic compatibility provided in section 12.4
•
"Guidelines and Manufacturer's Declaration on Electromagnetic Compatibility", page 85.
Making sure that all operational procedures, including 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 neither the patient, nor the treating
physician, nor any other person present can 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.
V. 2.0
®
120
11
Advertisement
Table of Contents
