KARL KAPS SOM 22 LED, Инструкция по эксплуатации

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Instructions for use SOM 62/32/22 LED
SOM 62/32/22 LED EN 2017-03 6
4 Directives, laws and standards
The medical device described here conforms to the fundamental requirements laid down in
Directive 93/42/EEC for medical devices. A conformity assessment procedure to Appendix VII has
been conducted successfully. The following harmonised standards were applied for the conformity
assessment procedure:

EN 60601-1:2005 (ed.3)

EN 60601-1-2:2007 (ed.3)

EN 60601-1-6:2007

EN ISO 14971:2009-10

EN ISO 13485:2010-01

DIN EN 980: 2008-08

ISO 11884-1-2006

EN ISO 9001:2008

DIN EN 62471:2009-03

Directive 93/42/EEC
5 Delivery state
5.1 Deliverables
The product is delivered as described below (depending on device model).
5.1.1 Deliverables for SOM 62 LED
The device is delivered as four individual sub-assemblies:

Wheeled stand with four rollers

Column

Swivel and floating arms with electrical supply and lighting

Microscope head including attachment

Instruction manual
Fasteners for all components are included.
5.1.2 Deliverables for SOM 32 LED
The device is delivered as three individual sub-assemblies:

Ceiling bracket

Swivel and floating arms with electrical supply and lighting

Microscope head including attachment

Operating instructions
Fasteners for all components are included.