Product Description; Contraindications; Intended Use; Required Components - Össur ICEROSS SEAL-IN X LOCKING Notice D'utilisation

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PRODUCT DESCRIPTION

The Iceross Seal-In X Locking liner is referred to as the "liner" in the
following document. This document provides important information on
the indications for use, fit and handling of the liner. This document is
intended for a certified prosthetist and the user of the liner.
Liner Description
The Iceross Seal-In X Locking liner is a silicone liner for trans-tibial users.
It is available with 3 and 6 mm profiles.
The liner is to be used with an Iceross Seal-In X Seal, Icelock 562 Hybrid,
and an airtight socket. Combining these components will result in the
residual limb being suspended by a mechanical distal attachment and
a distal vacuum chamber created below the seal.
INDICATIONS FOR USE
Lower limb amputation.
NOTE: Users should have an appropriate level of physical fitness to use
an external prosthesis for load transfer while ambulating.

CONTRAINDICATIONS

None known.

INTENDED USE

The Iceross Seal-In X Locking liner is a single patient, non-invasive and
reusable prosthetic device designed for daily use by trans-tibial amputees
with low to high impact levels.
The liner is only to be used for the exoprosthetic fitting of the residual
limb.
GENERAL SAFETY INSTRUCTIONS
Warnings: Misuse of the liner may result in loss of suspension.
Do not use for individuals with cognitive limitations not allowing for safe
use of the liner.
Precautions: In cases of functional change or loss, the user should
immediately cease using the liner and contact a health practitioner. This
may be the result of liner damage or changes in the residual limb.

REQUIRED COMPONENTS

Only use in combination with a suitable Iceross Seal-In X Seal, Icelock
562 Hybrid and an airtight socket.
Please refer to the "Instructions for Use" supplied with the Iceross Seal-In
X Seal and Icelock 562 Hybrid.
LINER SIZE SELECTION
Precautions: Selecting the correct liner size is essential. Selecting a size
which is too small/tight may result in pistoning, numbness, or blistering.
Selecting a size which is too large/loose, may result in increased
perspiration and movement of the limb inside the liner, which may lead
to blisters and rashes. If any of the above symptoms, or any other
indications of improper fit are experienced, the user should contact their
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