Legal Information; Liability; Trademarks; Ce Conformity - Otto Bock C-Leg 3C98-3 Instructions For Use Manual

Legal information

User setting
The settings already configured using the adjustment software were not changed.
CAUTION
Using the prosthesis in the delivery state (factory settings)
Falling due to unexpected behaviour of the prosthesis because the knee joint locks in the flexion direction
► After receiving the knee joint, it needs to be adjusted with the C-Soft Plus adjustment software, version 1.10
or higher.
► Using the knee joint on the patient without prior adjustment with the adjustment software is not permitted.
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.
15 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

15.1 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.

15.2 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.
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

15.3 CE conformity

Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European
requirements for medical devices.
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.
This product meets the requirements of the 2014/53/EU directive.
The full text of the regulations and requirements is available at the following Internet address:
http://www.ottobock.com/conformity

15.4 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.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) This device may not cause harmful interference, and
2) This device must accept any interference received, including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harm­
ful interference to radio or television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
46 C-Leg 3C98-3/3C88-3