Ce Conformity; Trademarks; Technical Data - Otto Bock C-Brace Instructions For Use Manual

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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
Joint module weight
Maximum flexion angle [°]
Minimum patient weight
Service life of the aligned leg prosthesis
Environmental conditions
Storage and transport in original packaging
Storage and transport without packaging
Operation
Charging the battery
Battery charger
Reference number
Storage and transport in original packaging
Storage and transport without packaging
C-Brace
17B300=L C-Brace (left)/17B300=R C-Brace (right)
approx. 1400 g/49.4 oz
120 (depending on the design)
approx. 45 kg/100 lbs
5 years
-10°C/+14°F to +60°C/+140°F
-10°C/+14°F to +60°C/+140°F
max. 80% relative humidity, non-condensing
-10°C/+14°F to +60°C/+140°F
max. 80% relative humidity, non-condensing
0°C/+32°F to +50°C/+122°F
4E50*
-25 °C/-13 °F to +70 °C/+158 °F
-25 °C/-13 °F to +70 °C/+158 °F
max. 93 % relative humidity, non-condensing
Technical data
79

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