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MCO25plus Operating Instructions
2
Safety Instructions
The following provisions and recommendations are based on:
DIN EN 60825-1 (2003-10)
DIN EN 60601-1 (1996-03)
DIN EN 60601-1-2 (2002-10)
DIN EN 60601-1-4 (2001-04)
DIN EN 60601-2-22
BGI 832
MDA (MPG)
In addition to the above, all relevant local provisions and regulations – which may provide
otherwise – must be observed as well!
2.1
General Provisions
Installation and initial start-up of the unit must be carried out by qualified persons who have
been specially trained and authorized by Gebrüder Martin to perform such work.
Important notice!
All persons involved in the operation of this unit must be fully familiar with these
Operating Instructions. Note that improper handling (i.e. any action not in
compliance with the instructions given in this manual) may lead to injuries
and/or equipment damage.
Improper handling as well as modifications or repairs performed by non-
authorized persons shall void the manufacturer's warranty!
Please use the unit only after the following steps have been performed:
•
Handing over of the unit in perfect working order plus user training/instruction (to be
provided by Gebrüder Martin or an authorized agent);
•
acceptance of the unit by the purchasing department;
V 4.1
Safety of laser products – Part 1: Equipment classification,
requirements and user's guide
Medical electrical equipment – Part 1: General requirements
for safety
Medical electrical equipment – Part 1–2: Electromagnetic
compatibility; Requirements and tests
Medical electrical equipment – Part 1–4: Programmable
electrical medical systems
Medical electrical equipment – Part 2–22: Particular
requirements for the safety of diagnostic and therapeutic
laser equipment
"Betrieb von Lasereinrichtungen (Anwendung der
Unfallverhütungsvorschrift 'Laserstrahlung'" (BGV B2))
(Regulations for the prevention of accidents – laser
radiation)
German Medical Devices Act (see Medical Devices Directive
/ MDD)
7
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