Legal Information; Liability; Ce Conformity; Service Life - Ottobock Avantgarde XXL 2 Gebrauchsanweisung

General information
• Joint contractures/damage
• Muscle and nerve disorders
• Disorders such as cardiac or circulatory insufficiency, balance disorders or cachexia as well
as geriatric patients who still have usable residual strength in the upper limbs.
The Avantgarde was specially designed for individuals who are normally able to move in a
wheelchair independently.
The following points should also be considered for custom fittings:
• Body height and weight (maximum load is 180 kg)
• Physical and mental condition
• Age of the user
• Living conditions and
• Environment

1.4 Legal information

All legal conditions are subject to the respective national laws of the country of use and may
vary accordingly.

1.4.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descrip-
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregard of this document, particularly due to improper use or unauthorised
modification of the product.

1.4.2 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 out-
lined 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.

1.4.3 Service life

Expected service life: 4 years.
The design, manufacturing and requirements for the intended use of the product are based on
the expected service life. These also include the requirements for maintenance, ensuring effec-
tiveness and the safety of the product.
Using the product beyond the specified expected service life leads to increased residual risk
and should only take place subject to the due diligence and deliberations of qualified personnel.
If the service life is reached, the user or a responsible attendant should contact the qualified
personnel who fitted the product or the manufacturer's service (see inside rear cover or back
page for address). Here the user can obtain information about known risks and the current op-
tions for refurbishing the product.

1.4.4 Trademarks

All product names mentioned in this document are subject without restriction to the respective
applicable trademark laws and are the property of their respective owners.
Avantgarde XXL 2 Ottobock | 47