Barco MDSC-1119 Owner's manual

MANUFACTURERS

EU DECLARATION OF CONFORMITY

www.barco.com

Barco NV

President Kennedypark 35

8500 Kortrijk, B

elgium

CE declaration Medical Devices EN 60601 Template

Issue 0

; Release Date:

March 2010

–

07/47/EC added

Kortrijk, 16 June 2010

Manufacturer Identification:

Legal Name : Barco NV

Address : President Kennedypark 35

B-8500 Kortrijk

Belgium

Representative : Jan Willem Brands

Function : Chief Technology Officer

Product Identification:

Product : Medical Display

Brand : BARCO

Model : MDSC-1119

Declaration:

Provided that it is installed, maintained and used in the application for which it is made,

with respect of the professional practices, relevant installation codes and manufacturer’s

instructions:

We hereby declare that the above referenced product comply with the essential

requirements of Council Directives

2004/108/EC (EMC) and 93/42/EC, amended by 2007/47/EC (Medical Devices)

The notified body involved in the above specified procedures is SGS holding the

registration number 0120

The procedures of Annex II have been applied to mark the product with the CE-label.

European harmonised standards applied:

EMC : EN 60601-1-2 Ed.3 (2007)

Product safety : EN 60601-1 Ed.2 (1988) + A1 (1991) + A2 (1995)

Signature of manufacturer representative: