Legal Information - Ottobock 5065 Omo Neurexa Gebrauchsanweisung

colours (red and gold) to make correct application easier– one in the front (red) and one in the
back (golden) (fig.9, pos.1). Adjust the two straps carefully to achieve as much extension in the
elbow as possible and about 40° outward rotation in the shoulder joint.
7) Do final adjustments to make sure the brace is in a functional position concerning position
control and comfort.
8) Adjust the upper straps by slight pulling. The humerus head should be lifted ½-1 inch (fig. 10).
9) Optional: Put the muscle stimulation pad on desired spot (fig.11).
Correct application is reached if there are no wrinkles at the orthoses when the patient stand
relaxed after applying.
2.2 Instructions for use and care
NOTICE
Damage due to incorrect environmental conditions. The product is not flameproof; avoid
temperature above 120 °C/248 °F.
Material: Outlast®, silicone band. Pad in silicone.
The product should only be used for its original intended purpose. The acceptance and colla-
boration of the patient plays a major role. It is necessary to explain to the patient how to use the
product properly! Prior to every use, the product must be inspected for any wear and damage.
Do not use the product if any component is excessively worn or broken. The total duration of use
should be determined by medically trained personnel. If any changes to the skin are noticed a
physician should be consulted. Before washing (machine wash warm/40 °C/104 ºF) make sure
all hook and loop closures are closed. Mesh -laundry bag is recommended. Stretch product while
wet and let dry.
Disposal after use: Dispose of the product in accordance with national regulations.
3 Further usage restrictions
The product is designed to fit one patient only. The duration for using the product is determined
by the indication.

4 Legal information

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