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

Maintenance

14 Maintenance
INFORMATION
This component was tested for three million load cycles in accordance with ISO 10328.
Depending on the activity level, this corresponds to a service life of three to five years.
The duration of use can be individually extended depending on the intensity of use by performing regular service
inspections.
Regular service inspections (maintenance) are mandatory in the interest of the patient's safety and in order to main­
tain operating reliability and protect the warranty. These service inspections include an inspection of the sensors
and replacement of wear and tear parts.
If maintenance is due, this is indicated after the service interval has expired by three brief beep and vibration sig­
nals after disconnecting the battery charger. Further information is available upon request by contacting the author­
ised Ottobock Service Center responsible for your country.
To have a service inspection carried out, please send the product with mounted tube adapter as well as the battery
charger and power supply unit to an authorised Ottobock Service Centre.
INFORMATION
Before shipping the knee joint, the top of the knee joint should be angled to avoid air getting into the hydraulic
system during transportation.

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

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 outlined in Annex IX of the directive. The
94 Genium 3B1-3/3B1-3=ST