Local Legal Information - Ottobock Axon-Bus Prosthetic System Instrucciones De Uso

13.2 Trademarks
All denotations within this accompanying document are subject to the provisions of the respective
applicable trademark laws and the rights of the respective owners, with no restrictions.
All brands, trade names or company names may be registered trademarks and are subject to the
rights of the respective owners.
Should trademarks in this accompanying 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.
13.3 CE Conformity
The Axon-Bus components meet the requirements of directive 93/42/EEC for medical devices.
The Axon-Bus components have been classified as class I devices according to the classification
criteria for medical devices outlined in annex IX of the directive. The manufacturer therefore drew
up the declaration of conformity under its own responsibility according to annex VII of the direct­
ive.
The AxonMaster also meets the requirements of directive 1999/5/EC for radio equipment and
telecommunications terminal equipment. The declaration of conformity was created by the manu­
facturer according to annex IV of the directive. A copy of the declaration of conformity can be
requested from the manufacturer (see last page).

13.4 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 harmful inter­
ference 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:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Any changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
Caution: Exposure to Radio Frequency Radiation.
This device must not be co-located or operating in conjunction with any other antenna or transmit­
ter.
Responsible party:
Otto Bock Health Care, LP
40 | Ottobock