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Service manual LIMAX
120
Service manual version 1.00
page 2
2
Safety Instructions
2.1
General Provisions
MPG (MDA)
Medizinproduktegesetz (German Medical Devices Act)
93/42/EEC
EC Directive 93/42/EEC concerning medical devices (MDD)
DIN EN 60825-1: 2008-05
Safety of laser products – Part 1: Equipment classification,
requirements and user’s guide
DIN EN 60601-1: 2007-07
Medical electrical equipment: General requirements (basic
standard)
DIN EN 60601-1-1: 2002-08
Medical electrical equipment – Part 1: General
requirements for safety
DIN EN 60601-1-2: 2007-12
Medical electrical equipment – Part 1–2: Electromagnetic
compatibility; Requirements and tests
DIN EN 60601-2-22 1996-12
Medical electrical equipment – Part 2–22: Particular
requirements for the safety of diagnostic and therapeutic
laser equipment
DIN EN 60601-1-4: 2001-04
collateral standard: Programmable electrical medical
devices
DIN EN 62304: 2007-03
Medical device software - Software life-cycle processes
DIN EN 62353: 2008-08
Medical electrical equipment - Recurrent test and test after
repair of medical electrical equipment
BGI 832
Betrieb von Lasereinrichtungen (Anwendung der
Unfallverhütungsvorschrift “Laserstrahlung” (BGV B2))
(Operation of laser devices – Application of the accident
prevention regulation concerning laser radiation)
Installation and initial start-up of the unit may only be carried out by Gebrüder Martin or an
authorized service partner.
Caution!
Any person who is in any way involved in the operation or maintenance of this unit
must be fully familiar with these Operating Instructions. Please note that improper
handling (i.e. any action not in compliance with the instructions given herein) can
result in personal injury and/or equipment damage!