OCULUS BIOM 4 - Manufacturers and Service Addresses; 13 Declaration of Conformity

13 Declaration of Conformity
28 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
OCULUS shall not assume any liability if assembly, extensions, adjustments, changes or
repairs are carried out by unauthorised personnel, if the unit is maintained improperly or
if it is handled incorrectly.
12.3 Manufacturer’s and service addresses
Our service department or authorised representatives will furnish you with additional in-
formation.
Manufacturer - Service Addresses:
Germany:
OCULUS Optikgeräte GmbH
Münchholzhaeuser Str. 29
D - 35582 Wetzlar, Germany
Tel.: ++49 641/2005-0
Fax: ++49 641/2005-295
E-mail: sales@oculus.de
13 Declaration of Conformity
We declare under our sole responsibility that this product meets the fundamental re-
quirements of Annex 1 of Directive 93/42/EEC of 14th June, 1993 for medical products.
Following harmonized standards were employed to verify the above mentioned require-
ments:
-DIN EN ISO 15004
according to the regulations of MDD
Dipl.Ing. Rainer Kirchhübel
Management
OCULUS Optikgeräte GmbH