Maintenance; Identification Of The Product By The Service Center; Legal Information; Liability - Otto Bock Genium 3B1-3 Instructions For Use Manual

14 Maintenance

Regular maintenance (service inspections) at 24-month intervals is mandatory in the interest of patient safety and in
order to maintain operating reliability and protect the warranty, maintain basic safety and the essential performance
characteristics, and ensure safety in regards to EMC.
When maintenance is due, this is indicated by feedback after disconnecting the battery charger (see the section
"Operating states/error signals", see Page 52). The manufacturer grants a grace period of no more than one
month before, or two months after, the due date.
Additional services such as repairs may be provided in the course of maintenance. These additional services may
be provided free of charge or can be billable according to an advance cost estimate, depending on the extent and
validity of the warranty.
The following components must always be sent in for maintenance and repairs:
The product with installed tube adapter, battery charger and power supply unit. The shipping container for the
loaner unit you receive must be reused for sending back the components requiring inspection.
Before shipping, the knee head of the prosthetic knee joint has to be extended. The knee head must not be flexed!

14.1 Identification of the product by the Service Center

The product may have been identified by an authorised Ottobock Service Center:
Factory setting
The patient-specific product settings have been reset to the state at delivery (factory setting).
User setting
The settings already configured using the adjustment software were not changed.
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.

15.3 CE conformity

Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with European require­
ments 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
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