Ce-Konformität; Intended Use; Relative Contraindications - Ottobock 50S19 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: 2020-05-25
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 prob­
►
lems.
Report each serious incident in connection with the product, in particular 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.
►
The instructions for use provide you with important information for adjusting and applying the
50S19 Infinity Air Walker high, 50S23 Infinity Air Walker low and 50S191 Infinity Achilles Walker
immobilisation orthoses.

2 Intended use

2.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the lower limbs and exclusively for
contact with intact skin.
The orthosis must be used in accordance with the indications.
2.2 Indications
50S19 Infinity Air Walker high
• Postoperative, conservative treatment of stable forefoot, metatarsal and/or ankle fractures
• Postoperative, conservative treatment of distal fibula fractures
• Soft tissue injuries of the foot
• Severe ankle sprains
50S23 Infinity Air Walker low
• Postoperative, conservative treatment of stable forefoot, metatarsal and/or ankle fractures
• Soft tissue injuries of the foot
• Exostosis treatment for hallux valgus
50S191 Infinity Achilles Walker
• Postoperative, conservative treatment of Achilles tendon ruptures
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; pronounced
varicose veins, especially with return flow impairment, lymphatic flow disorders, including unclear
soft tissue swelling distant to the body area to which the support will be applied; sensory and cir­
culatory disorders in the area of the lower leg and the foot, e.g. in case of diabetic neuropathy.
8
English