Legal Information; Liability; Declaration Of Conformity - Otto Bock 701Z42-1-1 Operating Instructions Manual

18 Legal Information

18.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­
tions provided in this document (Operating Instructions). The manufacturer will not assume liability for damage
caused by disregard of this document.

18.2 Declaration of Conformity

EC Declaration of Conformity
in accordance with EC Machinery Directive 2006/42/EC, Annex II 1.A
Manufacturer
Ottobock Equipment B.V.
Mandenmaker 14
5253 RC Nieuwkuijk
Netherlands
Description and identification of the machine
Product
Type
Trade name
Function
This is to declare in express terms that the machine complies with all of the relevant provisions of the fol­
lowing EC directives.
2006/42/EC
2014/35/EU
2011/65/EU
Source of applied harmonised standards according to Article 7 paragraph 2
EN ISO 12100:2010-11
EN
60204-1:2006/A1:2009
Nieuwkuijk
Place
701Z42=1-1, 701Z42=1-4
Desinfection cabinet
701Z42=1-1, 701Z42=1-4
Desinfection cabinet
Desinfection cabinet for disinfecting medical products (e.g. prostheses and orthoses)
that may be treated with the machine's disinfectant
(Intended installation location: Orthopaedic workshop)
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006
on machinery and amending Directive 95/16/EC (amended version) (1)
Directive 2014/35/EU of the European Parliament and of the Council of 26 February
2014 on the harmonisation of the laws of the Member States relating to the making
available on the market of electrical equipment designed for use within certain
voltage limits
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and elec­
tronic equipment
Safety of machinery - General principles for design - Risk assessment and risk reduc­
tion (ISO 12100:2010)
Safety of machinery – Electrical equipment of machines – Part 1: General require­
ments
2020-12-22
Date
Person residing in the community and authorised
to compile the relevant technical documents
Ottobock Equipment B.V.
Manager R&D
Mandenmaker 14
5253 RC Nieuwkuijk
Netherlands
A.H.M. Boom + J.Boers
Managing director + Manager R&D
Legal Information
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