Legal Information - Ottobock C-Brace Instrucciones De Uso

10 Service
C-Brace® 17B300=*
INFORMATION
In the interest of user safety and in order to maintain reliability and protect the warranty, a ser­
vice inspection interval of 24 months must be observed. This service inspection includes an
inspection of the sensors and the replacement of wear parts.
The complete orthosis with the battery charger and power supply must be sent in to an author­
ised Ottobock Service centre for the service inspection.
17LA3=* system ankle joint
INFORMATION
The manufacturer requires at least a semi-annual inspection of the product by an authorised
O&P professional to verify functionality and check for wear.
11 Disposal
In some jurisdictions it is not permissible to dispose of these products with unsorted
household waste. Disposal that is not in accordance with the regulations of your country
may have a detrimental impact on health and the environment. Please observe the
instructions of your national authority pertaining to return and collection.

12 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
12.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip­
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregard of this document, particularly due to improper use or unauthorised
modification of the product.
12.2 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 out­
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man­
ufacturer 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 Par­
liament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous sub­
stances 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 out­
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man­
ufacturer 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 Par­
liament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous sub­
stances in electrical and electronic equipment.
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