6.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745 über
Medizinprodukte. Die CE-Konformitätserklärung kann auf der Website des
Herstellers heruntergeladen werden.
1 Foreword
INFORMATION
Date of last update: 2020-04-01
► Please read this document carefully before using the product and
observe the safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the
product or in case of problems.
► Report each serious incident in connection with the product, in particu
lar a worsening of the state of health, to the manufacturer and to the
relevant authority in your country.
► Please keep this document for your records.
These instructions for use provide important information on the fitting and
application of the 50K15 Genu Sensa 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
•
Feeling of instability
•
Irritation (postoperative, posttraumatic and chronic)
•
Knee pain due to stress (tendomyopathy, insertion ligamentosis)
•
Joint effusion
•
Swelling
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.
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