Otto Bock Paexo Shoulder 16ES100-2, Оригинальное руководство пользователя

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19.2 Declaration of Conformity
EC Declaration of Conformity
in accordance with EC Machinery Directive 2006/42/EC, Annex II 1.A
Manufacturer Person residing in the community and
authorised to compile the relevant technic­
al documents
Ottobock SE & Co. KGaA
Max-Näder-Straße 15
D – 37115 Duderstadt Ottobock SE & Co. KGaA
Dominik Schmidt
Max-Näder-Straße 15
D – 37115 Duderstadt
Description and identification of the machine
Product Paexo Shoulder
Product reference
number 16ES100=2
Function Passive exoskeleton to relieve strain on the arms and shoulder girdle
during overhead/above shoulder height work
This is to declare in express terms that the machine complies with all of the relevant pro­
visions of the following EC directives.
2006/42/EC 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)
Published in L 157/24 dated 9 June 2006
Source of applied harmonised standards according to Article 7 paragraph 2
EN ISO 13482:2014 Robots and robotic devices – Safety requirements for personal care
robots (ISO 13482:2014)
EN ISO
12100:2010-11 Safety of machinery – General principles for design – Risk assessment
and risk reduction (ISO 12100:2010)
DIN EN ISO
10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation
and skin sensitisation (ISO 10993-10:2010); German version EN ISO
10993-10:2013
DIN EN ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cyto­
toxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
Duderstadt, 30 April 2019 Dr Sönke Rössing Dominik Schmidt
Place, date Head of Ottobock Industrials Head of Regulatory Affairs