Product Description; Indications For Use; Intended Use - Össur BALANCE FOOT S Manual Del Usuario

ENGLISH
This document provides important information on the indications for use, and handling of the device.
It is intended for use by a certified prosthetist and the user of the device. It is necessary for the certified prosthetist
to instruct the user how to correctly use the device.
The device may only be fitted by a qualified practitioner.

PRODUCT DESCRIPTION

Balance Foot S is a prosthetic foot. Two versions are available. One version is the Balance Foot S, the other is the
Balance Foot S Torsion.
Balance Foot S (Figure 1)
1. Male Pyramid
2. Shim
3. Foot Blade
4. Heel Foam
5. Heel Clip
6. Toe Foam
7. Spectra Sock
8. FST Foot Cover
Spectra sock and foot cover
Balance Foot S and Balance Foot S Torsion are delivered with a Spectra sock and a foot cover.

INDICATIONS FOR USE

Lower limb absence.
CONTRAINDICATIONS
None known.

INTENDED USE

Balance Foot S and Balance Foot S Torsion are non-invasive, reusable prosthetic devices, designed for single
patient use.
The devices are to be used exclusively for the exoprosthetic fittings of people with lower-limb absence.
The devices only support low impact levels.
GENERAL SAFETY INSTRUCTIONS
WARNINGS:
– Össur products and components are designed and tested according to applicable official standards, or an
in-house defined standard where no official standard applies. Compatibility and compliance with these
standards are achieved only when Össur products are used with Össur components.
– The Balance Foot S and Balance Foot S Torsion should be used with Össur components. Durability cannot
be guaranteed if components from a different manufacturer are used.
– In cases of damage, malfunction, changes in alignment, or functional loss, the user should immediately
stop using the Balance Foot S and Balance Foot S Torsion. Noticeable functional loss may be the result of
reduced stiffness or loss of support. The user should return the foot to the certified prosthetist.
– Improper handling (including repetitive high loads) can cause device malfunction.
Balance Foot S Torsion (Figure 1)
1. Torsion Shock Module with Male Pyramid
2. Shim
3. Foot Blade
4. Heel Foam
5. Heel Clip
6. Toe Foam
7. Spectra Sock
8. FST Foot Cover
5