Ce Conformity; Trademarks - Otto Bock 17KO1 Series Instructions For Use Manual

Legal information
3820 West Great Lakes Drive
Salt Lake City, Utah 84120-7205 USA
Phone + 1-801-956-2400
Fax + 1-801-956-2401
This device complies with RSS 210 of Industry Canada.
Operation is subject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired operation of this
device.
L' utilisation de ce dispositif est autorisée seulement aux conditions suivantes:
(1) il ne doit pas produire d'interference et
(2) l' utilisateur du dispositif doit étre prêt à accepter toute interference radioélectrique reçu, même si celle-ci est
susceptible de compromettre le fonctionnement du dispositif.
Caution: Exposure to Radio Frequency Radiation.
The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit
RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from
Health Canada's website
http://www.hc-sc.gc.ca/rpb.
Responsible party:
Otto Bock Healthcare Canada Ltd.
5470 Harvester Road
L7L 5N5 Burlington, Ontario
Canada
Phone + 1-800-665-3327
Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the
State in which he/she practices to use or order the use of the device.

15.3 CE conformity

Only applicable for "17KO1=L C-Brace joint unit"/"17KO1=R C-Brace joint unit"
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.
Valid only for the 560X17-ANDR=V* and 560X17-IOS=V* C-Brace Setup adjustment app
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.

15.4 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.
48 C-Brace joint unit 17KO1=*