Ce-Konformität; Intended Use; Relative Contraindications - Ottobock 50A8 Instrucciones De Uso

7.3 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: 2020-06-02
Please read this document carefully before using the product and observe the safety
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notices.
Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the product or in case of prob­
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lems.
Report each serious incident in connection with the product, in particular a worsening of the
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state of health, to the manufacturer and to the relevant authority in your country.
Please keep this document for your records.
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These instructions for use provide you with important information on the fitting and application of
the 50A8 Omo Immobil Sling and 50A9 Omo Immobil Sling abduction shoulder orthosis.

2 Intended use

2.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the shoulder and exclusively for con­
tact with intact skin.
The orthosis must be used in accordance with the indications.
2.2 Indications
Indications must be determined by the physician.
50A8 Omo Immobil Sling
• Acute or chronic shoulder pain
• Irritation in the shoulder region
• Frozen shoulder
• Acromioclavicular separation
• Osteoarthritis of the shoulder
• Subcapital humerus fracture
• Anterior shoulder dislocation
• Bankart lesion
50A9 Omo Immobil Sling, abduction
• Acute or chronic shoulder pain
• Irritation in the shoulder region
• Biceps tendon and muscle injuries
• Posterior shoulder dislocation
2.3 Contraindications
2.3.1 Absolute Contraindications
Not known.

2.3.2 Relative Contraindications

The following complaints require consultation with a physician: skin diseases/injuries, inflamma­
tion, prominent scars that are swollen, reddening and hyperthermia in the area treated; lymphatic
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