Maintenance; Legal Information - Otto Bock 1B1-2 Meridium Instructions For Use Manual

Maintenance

12 Maintenance
INFORMATION
The foot shell for the prosthetic foot has an expected working life of approx. one year when professionally moun­
ted and properly used. Damaged foot shells must be replaced immediately, before the prosthetic foot is used
again.
Regular service inspections (maintenance) are mandatory in the interest of patient safety and in order to maintain
operating reliability and protect the warranty. These service inspections include inspecting the sensors and repla­
cing wear and tear parts.
When maintenance (a service inspection) is due, this is indicated after the service interval has expired by three
brief beeps after disconnecting the battery charger. Further information is available upon request by contacting the
authorised Ottobock Service Centre responsible for your country.
To have a service inspection carried out, please send the product as well as the battery charger and power supply
unit to an authorised Ottobock Service Centre.
12.1 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.

13 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
13.1 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.
13.2 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.
13.3 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
declaration of conformity was therefore created by the manufacturer with sole responsibility according to Annex VII
of the directive.
Hereby, Ottobock Healthcare Products GmbH declares that the product is in compliance with Directive
2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:
www.ottobock.com/conformity
30 1B1-2=* Meridium