Intended Use; General Safety Instructions; Fitting Instructions - Ossur AFO DYNAMIC Bedienungsanleitung

ENGLISH
Medical Device

INTENDED USE

The device is intended to support drop-foot.
The device must be fitted and adjusted by a healthcare professional.
Indications for use
Drop foot.
Contraindications
Loss of sensation, spasticity of the calf muscles, foot neuropathy
Warnings and Cautions:
• Customization beyond that specified in this IFU is not recommended.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should stop using the device and contact a healthcare
professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.

FITTING INSTRUCTIONS

To obtain the best effect of the device, proper footwear is critically
important to the overall success. Shoes should be well constructed to
include:
• Firm heel counter, for proper control of the rear foot.
• The foot and the device should be secured by the shoe.
• Rocker-type sole at toe end for smoother transition from 2nd to 3rd
rocker.
• Use shoes that allow for adjustable compressive support at mid-foot.
• Rubber sole, to minimize the chance of slipping on wet surfaces.
• Removable insole, to allow space for the footplate with modifications.
• Adequate height and adjustability to avoid pressure from the upper
leather on the upper side of the foot. The heel height should be
approximately 1,7 cm, wedges can be used as needed for adjustment.
Device Adjustments
Foot plate:
• If present remove the insole from the shoe and use as a template for
adjusting the footplate shape (A).
• The foot plate can be ground using a grinding machine to fit the shoe
shape. All edges should be smoothed so no sharp edges are left.
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