Identification Of The Product By The Service Center; Legal Information; Liability; Trademarks - Otto Bock Kenevo 3C60 Instructions For Use Manual

Legal information

Regular maintenance (service inspections) is mandatory in the interest of patient safety and in order to maintain
operating reliability and fulfil the conditions of the warranty. This maintenance includes an inspection of the sensors
and replacement of wear and tear parts.
If maintenance is due, this is indicated after the service interval has expired by three brief beep signals after dis­
connecting the battery charger. Further information is available upon request by contacting the authorised
Ottobock Service Centre responsible for your country.
To have a service inspection carried out, please send the product with mounted tube adapter as well as the battery
charger and power supply unit to an authorised Ottobock Service Centre.

11.1 Identification of the product by the Service Center

The product may have been identified by an authorised Ottobock Service Center:
Factory setting
The patient-specific product settings have been reset to the state at delivery (factory setting).
User setting
The settings already configured using the adjustment software were not changed.
CAUTION
Use of the prosthesis with incorrect setting data
Falling due to unexpected prosthesis behaviour caused by triggering the swing phase at the wrong time.
► The prosthesis settings (parameters) have to be checked using the corresponding adjustment software and
changed as needed.
12 Legal information

12.1 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.

12.2 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.

12.3 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.
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.

12.4 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.
32 Kenevo 3C60/3C60=ST