Liability; Trademarks; Ce Conformity; Local Legal Information - Ottobock Genium-Bionic Prosthetic System 3B1 Instrucciones De Uso

14.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descrip­
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.

14.2 Trademarks

All product names mentioned in this document are subject without restriction to the respective
applicable trademark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property of
the respective owners.
Should trademarks used in this document fail to be explicitly identified as such, this does not justi­
fy the conclusion that the denotation in question is free of third-party rights.

14.3 CE conformity

This product meets the requirements of the European Directive 93/42/EEC for medical devices.
This product has been classified as a class I device according to the classification criteria out­
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man­
ufacturer with sole responsibility according to Annex VII of the directive.
Only valid for the products 3B1/3B1=ST
This product meets the requirements of the European Directive 1999/5/EC for radio equipment
and telecommunications terminal equipment. The conformity assessment was drawn up by the
manufacturer in accordance with Annex IV of the directive.
Only valid for the products 3B1-2/3B1-2=ST
Hereby, Ottobock Healthcare Products GmbH declares that the product is in compliance with
Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following
internet address: www.ottobock.com/conformity
The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the
use of certain hazardous substances in electrical and electronic devices.

14.4 Local Legal Information

Legal information that applies exclusively to specific countries is written in the official language
of the respective country of use in this chapter.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
1) This device may not cause harmful interference, and
2) This device must accept any interference received, including interference that may cause
undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful inter­
ference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
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