Prosthetics Lower Extremities - Kinetech Medical

Declaration of Conformity / Warranty
Declaration of Conformity
Otto Bock as manufacturer with sole responsibility declares that the intermediate
products/medical products specified in the catalog conform to the requirements
of the 93/42 EEC Guideline for medial products or, respectively, of the
Law for Medical Products (Medizinproduktegesetz, MPG), which represents the
national transfer of the EEC Guideline into German law.
To be able to fulfill your obligation of documentation (according to Annex VIII of
the 93/42 EEC Guideline “Declaration Concerning Products for Special Purposes”)
please take the bar-code labels from the respective packaging and stick
them into the Otto Bock confomity card, in order to document:
• the data necessary for identification of the concerned product;
• the assurance that the product is exclusively destined for a particular, named,
patient;
The confomity card will be kept with
the customer/patient documentation.
In case of complaints, this
measure makes it easier for you
to establish compliance with the
Otto Bock Mobility System MOBIS®
and the resulting 2-year warranty.
Please note that the confomity period
does not begin before the date
of the first trial fitting. For this reason
the date of the first use must be
documented on the warranty card
and a copy of it must be enclosed
with any possible complaints.
The confomity card is included in
the delivery of prosthetic feet and
tube adapters. Please refer to the
646P1 price list for our General
Terms of Business.
Otto Bock HealthCare GmbH | Prosthetics – Lower Extremities | www.ottobock.com
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