Intended Use; General Safety Instructions - Ossur VARI-FLEX JUNIOR Gebrauchsanweisung

ENGLISH
Medical Device
DESCRIPTION
The device is a prosthetic foot. It is composed of a base foot, with
a composite heel and keel, and male pyramid.
The device consists of the following components (Fig. 1):
A. Foot Blade
B. Heel
C. Male Pyramid
This device must be used with a Foot Cover and a Spectra Sock.

INTENDED USE

The device is intended as a part of a prosthetic system that replaces the
foot and ankle function of a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
Indications For Use and Target Patient Population
• Lower limb loss, amputation, or deficiency
• No known contraindications
The device is intended for children and adolescent patients.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Warning: The device may break or delaminate if sudden high impact side
bending and/or twisting occurs.
Warning: If there is a change or loss in device functionality, or if the
device shows signs of damage or wear hindering its normal functions, the
patient should stop using the device and contact a healthcare
professional.
The device is for single patient use.
DEVICE SELECTION
Verify that selected variant of the device is suitable for the weight limit
according to the following table.
Warning: Do not exceed weight limit. Risk of device failure.
Incorrect category selection may also result in poor device function.
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