Otto Bock 170K1-80 FreeWalk Instructions For Use Manual page 8

9.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen und Anweisungen in diesem
Dokument verwendet wird. Für Schäden, die durch Nichtbeachtung dieses Dokuments, insbe­
sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur­
sacht werden, haftet der Hersteller nicht.
9.2 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: 2021-09-16
Please read this document carefully before using the product and observe the safety
►
notices.
Obtain instruction from the qualified personnel in the safe use of the product.
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Please contact the qualified personnel if you have questions about the product or in case of
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problems.
Report each serious incident related to the product to the manufacturer and to the relevant
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authority in your country. This is particularly important when there is a decline in the health
state.
Please keep this document for your records.
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These instructions for use provide you with important information on the use of the 170K1=80 and
170K1=120 Free Walk orthosis system.
2 Product description
2.1 Design
The Ottobock FreeWalk orthoses include an orthotic knee joint with lock. Three modes can be
selected on the orthotic knee joint:
FreeWalk mode: The orthotic knee joint locks in the stance phase and unlocks in the swing
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phase.
Permanent lock: The orthotic knee joint is permanently locked.
•
Free motion mode: The orthotic knee joint is permanently unlocked.
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3 Intended use
3.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the lower limbs and exclusively for
contact with intact skin.
Reuse of the product on other persons is not permitted.
3.2 Indications
• Partial or total paralysis of the leg muscles
• Orthopaedic diseases of the lower limbs
Indications must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications
• Ankle movement < 10°
• Knee flexion contractures > 10°
8
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