Legal Information - Ottobock 50R59 Dorso Direxa Posture Gebrauchsanweisung

6) Final check: The correct fit and proper positioning of the brace must be
checked during handover to the patient. The brace is seated correctly
when the lower edge of the brace extends just below the groin.
7) Instruct the patient: Explain to the patient how to don the brace and
ensure that it is seated correctly. Practice donning and doffing the brace
with the patient.
4.3 Cleaning
NOTICE
Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents
► Only clean the product with the approved cleaning agents.
Clean the brace regularly:
1) Close all hook-and-loop closures.
2) Recommendation: Use a laundry bag or net.
3) Wash the brace in warm water at 40 °C with standard mild detergent. Do
not use fabric softener. Rinse well.
4) Allow to air dry. Do not expose to direct heat sources (e.g. sunlight,
stove or radiator).
5 Disposal
Dispose of the product in accordance with national regulations.

6 Legal Information

All legal conditions are subject to the respective national law of the country
of use and may vary accordingly.
6.1 Liability
The manufacturer shall be liable in the event that the product is used in
accordance with the descriptions and instructions 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 unautho­
rized modification of the product.
6.2 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 manufacturer therefore drew up the declaration of conformity on its own
responsibility in accordance with Annex VII of the directive.
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