Restrictions For Use; Legal Information - Ottobock 28R14 Gebrauchsanweisung

7 Instructions for use and care
NOTICE
Contact with salt water or water containing chlorine/soap as well as abrasive substances
(e. g. sand)
Damage and premature product wear
„ Following any contact with the substances identified above, promptly clean the product.
„ Inform the patient.
To ensure the effectiveness of this relatively lightweight device, the orthosis must always be applied
with adequate pressure. Patient acceptance and cooperation play key roles in the effectiveness
along with proper application, periodic examination and orthosis adjustment. Patients must consci-
entiously follow physician guidelines.
The orthosis is fully waterproof to allow the patient to shower or bathe without removing the orthosis.
The orthosis can be cleaned with a damp piece of cloth and neutral soap.

8 Restrictions for use

The 28R14 Hyperextension Orthosis is designed for use on one patient. This orthosis is designed
for contact with intact skin only. Parts that are shaped for a particular patient and those parts that
come into contact with the skin may represent functional or hygienic risks when used by another
person. Functional risks are for example:
„ formation of cracks in the material (invisible to the eye if the paint is undamaged),
„ material fatigue due to alternating loading, and
„ reduced elongation at rupture (strain hardening) after the components have been cold-formed
several times.
The medical indication determines the period of application and the daily duration of use.
9 Disposal
Dispose of the product in accordance with national regulations.

10 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
10.1 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.
10.2 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 outlined
in Annex IX of the directive. The declaration of conformity was therefore created by the manufac-
turer with sole responsibility according to Annex VII of the directive.
10 | Ottobock 28R14