Device Description; Indications For Use - Össur ICEROSS SEAL-IN X LINERS Instrucciones De Uso

ENGLISH
Iceross Seal-In X Liners are 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 silicone liner available in two variants:
• Transtibial, 3 mm / 6 mm profiles;
• Transfemoral, standard / conical.
The device should be paired with a suitable Iceross Seal-In X Seal.
Together they form a suspension system where a distal vacuum chamber
is created below the level of the seal that reliably suspends the residual
limb in the prosthesis.

INDICATIONS FOR USE

The device is a non-invasive, single patient, reusable prosthetic device
designed for daily use.
• Transtibial: Low to high impact levels.
• Transfemoral: Low to extreme impact levels.
The device is to be used exclusively for the exoprosthetic fitting of
amputations of the lower limb, for example due to:
• Trauma
• Vascular Disease
• Cancer
• Congenital Defects
The device can be used by persons from the aforementioned groups
regardless of age and level of hand dexterity.
NB: Users should have an appropriate level of physical fitness to use an
external prosthesis for load transfer while ambulating.
CONTRAINDICATIONS
Not known.
SAFETY
Warnings
• Misuse of the device may result in potential loss of suspension.
• The device should not be used by individuals with the following
conditions:
– Extremely short residual limb (refer to tables 1 and 2).
– Extreme residual limb volume fluctuations.
– Cognitive limitations hindering safe device usage.
Residual limb length is measured as follows;
• Transtibial: From mid-patella tendon to distal end.
• Transfemoral: From perineum to distal end, with the tissue
hanging down.
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