Otto Bock C-Brace - CE Conformity and Trademarks; Technical Data

15.2 CE Conformity
Only applies to joint module "17B300=L C-Brace"/"17B300=R C-Brace"
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.
The product meets the requirements under the RoHS Directive 2011/65/EU of the European Parliament and of the
Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic
equipment.
Applies only to "O17CF2=1"/"17CF2=4"/"17CF2=HD" Spring Element
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.
The product meets the requirements under the RoHS Directive 2011/65/EU of the European Parliament and of the
Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic
equipment.
Applies only for 17AO1 Sensor Ankle
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.
The product meets the requirements under the RoHS Directive 2011/65/EU of the European Parliament and of the
Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic
equipment.
15.3 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.
16 Technical data
General information
Reference number 17B300=L C-Brace (left)/17B300=R C-Brace (right)
Joint module weight approx. 1400g/49.4oz
Maximum flexion angle [°] 120 (depending on the design)
Minimum patient weight approx. 45kg/100lbs
Service life of the aligned leg prosthesis 5years
Environmental conditions
Storage and transport in original packaging -10°C/+14°F to +60°C/+140°F
Storage and transport without packaging -10°C/+14°F to +60°C/+140°F
max. 80% relative humidity, non-condensing
Operation -10°C/+14°F to +60°C/+140°F
max. 80% relative humidity, non-condensing
Charging the battery 0°C/+32°F to +50°C/+122°F
Battery charger
Reference number 4E50*
Storage and transport in original packaging -25°C/-13°F to +70°C/+158°F
Storage and transport without packaging -25°C/-13°F to +70°C/+158°F
max. 93% relative humidity, non-condensing
79C-Brace
Technical data