Ce Conformity; Local Legal Information - Otto Bock Genium 3B1-3 Instructions For Use Manual

14.3 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 hazardous 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

14.4 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.
This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Sci­
ence and Economic Development Canada's licence-exempt RSS(s)..
Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause undesired
operation of the device.
L'émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR
d'Innovation, Sciences et Développement économique Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisée aux deux conditions suivantes:
(1) L'appareil ne doit pas produire de brouillage;
(2) L'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est sus­
ceptible d'en compromettre le fonctionnement.
Caution: Exposure to Radio Frequency Radiation.
The installer of this radio equipment must ensure that the antenna is located or pointed such that
it does not emit RF field in excess of Health Canada limits for the general population.
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