Device Description; Indications For Use - Össur SEAL-IN X Instrucciones Para El Uso

ENGLISH
Iceross Seal-In X Seals 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 consists of a hypobaric membrane and textile donning aid.
The unique anti-friction coating makes donning and doffing a prosthetic
socket easier, without use of lubricant aids. When the device is correctly
positioned onto a donned Iceross Seal-In X Liner, it will be held in tension
against the silicone bands on the exterior surface of the liner, then
compressed against the interior surface of the prosthetic socket. This
creates a distal vacuum chamber that reliably suspends the residual limb
in the prosthesis.
The device is offered in 3 variants:
• Iceross Seal-In X Grip
• Iceross Seal-In X Volume
• Iceross Seal-In X Classic

INDICATIONS FOR USE

The device is a non-invasive, single patient, reusable prosthetic device
designed for daily use.
In combination with an Iceross Seal-In X Liner:
– Transtibial liner variant supports low to high impact levels.
– Transfemoral liner variant supports 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 individuals 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
Warning: A strong cautionary statement regarding possible dangers
related to the intended use or foreseeable misuse of a device.
Precaution: A cautionary statement requiring action to be taken in
advance of device use, or in the event of malfunction or change in device
performance. Intended to ensure safe and effective use of device, and to
protect the user against greater risk of harm and/or possible failure of
the device, when used as intended.
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