Legal Information; Liability; Trademarks; Ce Conformity - Otto Bock Genium Series Instructions For Use Manual

Legal information

15 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

15.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­
tions provided in this document. 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.

15.2 Trademarks

All product names mentioned in this document are subject without restriction to the respective applicable trade­
mark 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 justify the conclusion
that the denotation in question is free of third-party rights.

15.3 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 outlined in Annex IX of the directive. The
declaration of conformity was therefore created by the manufacturer 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 telecommunic­
ations 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 haz­
ardous substances in electrical and electronic devices.

15.4 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 harm­
ful interference 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.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Any changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
Caution: Exposure to Radio Frequency Radiation.
This device must not be co-located or operating in conjunction with any other antenna or transmitter.
102