Ce-Konformität; Intended Use; Instructions For Use - Ottobock 8354 Genu Therma Fit Instrucciones De Uso

6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro­
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Foreword
INFORMATION
Last update: 2017-06-02
► Please read this document carefully before using the product.
► Follow the safety instructions to avoid injuries and damage to the product.
► Instruct the user in the proper and safe use of the product.
► Please keep this document in a safe place.
These instructions for use provide important information on the application of the 8354 Genu
Therma Fit knee support.

2 Intended use

2.1 Indications for use
The support is intended exclusively for fittings of the lower limbs and exclusively for contact
with intact skin.
The support must be used according to the indication.
2.2 Indications
• Knee pain without ligament laxity or feeling of instability
• Irritation and swelling of the knee joint
• Tendomyopathy
• Insertional tendinosis
• Knee pain caused by strain
• Soft tissue irritation following injuries and/or surgeries
• Minor knee osteoarthritis
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries, inflamma­
tion, prominent scars that are swollen, reddening and hyperthermia of the fitted limb/body area;
lymphatic flow disorders, including unclear soft tissue swelling distant to the body area to which
the medical device will be applied; sensory and circulatory disorders in the leg area.
2.4 Effects
The support improves thermo-regulation, proprioreception and circulation, promotes the resorp­
tion of oedemas by compressing the soft tissues and can relieve pain.
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