Otto Bock 28U11, Инструкция по эксплуатации

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9.3 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 English
INFORMATION
Date of last update: 2021-02-11
►
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 related to the product to the manufacturer and to the relevant
authority in your country. This is particularly important when there is a decline in the health
state.
► Please keep this document for your records.
These instructions for use provide important information on the fitting and application of the
28U11 WalkOn, 28U22 WalkOn Flex/WalkOn Flex Junior, 28U23 WalkOn Trimable and 28U33
WalkOn Lateral/WalkOn Lateral Junior ankle-foot orthoses.
2 Product overview
(see fig. 1)
Item
Designation Item Designation
1 Lower leg shell 4 Calf strap with padding
2 Orthosis 5 Sole
3 Y-hook-and-loop
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.
Ottobock recommends wearing the product with a stocking and not directly on the skin. A thin
stocking made of a washable, moisture-absorbent material is suitable to wear under the product.
To avoid pressure points, make sure that the stocking is free of wrinkles.
The orthosis must be used in accordance with the indications.
3.2 Indications
• Drop foot, without or with mild spasticity
Caused for example by:
○ Peroneal paralysis
○ Stroke
○ Traumatic brain injury
○
Multiple sclerosis
○
Neuromuscular atrophy
Indications must be determined by the physician.