Device Description; Indication For Use; Intended Use - Össur ICEFORM S Instrucciones Para El Uso

ENGLISH
The ICEFORM Liner is referred to as the device in the following
document. This document provides important information on the
indications for use, fit, and handling of the device. This document is
intended for a certified prosthetist and the user of the device.

DEVICE DESCRIPTION

The device is a liner made of Thermoplastic Elastomer (TPE) material
and covered with durable textile. The unique thermo-formability of the
TPE material allows the device to adapt to residual limb shape, providing
optimal comfort for daily use.
The device is available in the following variants:
• Suspension: Locking or Cushion
• Anterior Thickness: 3,6 or 9mm
• Posterior Thickness: 3mm
The cushion liners should be paired with a suitable suspension sleeve.
Össur recommends the use of the ICEFORM Sleeve.

INDICATION FOR USE

Lower limb amputation
CONTRAINDICATION FOR USE:
None known

INTENDED USE:

The device is a non-invasive, reusable prosthetic device, designed for
single patient use.
The device is to be used exclusively for the exo-prosthetic fitting of
amputations of the lower limb.
The device supports low to moderate impact levels.
SIZING
Precaution: Selecting the correct device 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 device, which may lead
to blisters and rashes. If any of the above symptoms, or any other
indication of improper fit are experienced, the user should contact their
practitioner immediately.
To determine the correct device size:
1. Measure the circumference of the residual limb at 4 and 30 cm from
the distal end (Figure 1).
2. Choose the device size, which corresponds to the measurement, or
the one which is immediately below (Figure 2).
3. Never choose a device size, which exceeds the measurement, or
round up.
Example: If the residual limb measures 26cm at the indicated distal
location and more than 36cm at the indicated proximal location, than
choose device size M+.
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