A.R.C. Laser Nuvolas, User Manual

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User Manual NUVOLAS
April 2023
File: User Manual_NUVOLAS_rev3.docx 13
4 Safety Information
4.1 General
The NUVOLAS laser is a precision instrument for medical applications. The system has
been carefully developed and tested through intensive testing before shipping. In order
to offer you and the operating personnel all possible protection, we recommend that you
read this section of the operating instructions carefully.
The NUVOLAS falls under laser class 4 according to EN 60601-2-22, EN 60825-1
respectively.
Class 4 in the standard describes high-energy lasers and therefore special measures
must be taken before commissioning in order to ensure safe and trouble-free working with
the device. It is particularly important to protect the eyes and skin of the operator, the
patient and third parties. Laser safety glasses must be used for eye protection.
The following explanations are not exhaustive. All users of laser devices should enclose
applicable legal regulations and provisions with the device and inform the staff
accordingly.
If the device is operated outside Germany, provisions of the American National Standard
Office ANSI Z136.3-2018 "American National Standard for the Safe Use of Lasers in
Health Care Facilities" and ANSI Z136.1-2014 "American National Standard for the Use
of Lasers” must be respected.
This manual is limited to the operation, maintenance and control of the device. The
manual is not a guide for the treatment of diseases that can be remedied by laser.
With regard to the devices supplied, such as fibers or probes, the safety, operating and
maintenance instructions in the corresponding manuals must be observed.
A.R.C. Laser GmbH cannot be held responsible for damage or damage resulting from
improper use.
The warranty for the device expires if the laser has been opened (even partially), modified
or repaired by unqualified personnel.