Ce-Konformität; Explanation Of Warning Symbols; Instructions For Use - Ottobock 8156 Genu Combi Stable Instrucciones De Uso

sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur­
sacht werden, haftet der Hersteller nicht.
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: 2015-09-24
► 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 fitting and application of the 8156
Genu Combi Stable knee joint brace.
2 Application
2.1 Indications for use
The brace is intended exclusively for orthotic fittings of the lower limbs and exclusively for con­
tact with intact skin.
The brace must be used in accordance with the indications.
2.2 Indications
• Knee pain with mild to moderate ligament laxity and/or mild to moderate feeling of instability
The indication must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
None 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 Mechanism of Action
The brace relieves and stabilises the knee joint.
3 Safety

3.1 Explanation of warning symbols

Warning regarding possible risks of accident or injury.
CAUTION
Warning regarding possible technical damage.
NOTICE
English
Ottobock | 7