Description And Intended Purpose; Clinical Benefits - Blatchford Silcare Breathe Locking Liner Instructions D'utilisation

1 Description and Intended Purpose

These instructions are for the practitioner.
Please read these instructions carefully before fitting the device.
The term device is used throughout these instructions for use to refer to Silcare Breathe Locking
Liner.
Ensure that the user understands all instructions for use, drawing particular attention to the
maintenance and safety information.
Application
This device is an interface component for use only as a component of a lower limb prosthesis.
Intended for single user.
It is intended for moderate to high activity users with well covered residual limbs.
This device is a biocompatible, perforated locking liner that allows air and moisture to escape
through its perforations during stance. During the gait cycle, a silicone valve provides vacuum
suspension by controlling the airflow through the perforations on the distal cap. To optimize
comfort ensure that the user is instructed in the correct way to handle and don/doff the device.
See Donning the Device section.
Also ensure that they are made aware of how to maintain the device and to keep it clean for
maintaining hygiene as set out in these instructions. See Maintenance section.
Activity Level
Although this device is suitable for users of all Activity Levels, it is best suited to users who have
the potential to achieve Activity Level 3–4.
Contraindications
• Deep scars on the distal end of residual limbs can cause failure of the vacuum suspension. These
deep scars reduce skin contact with the silicone inside the device and make a less effective seal.
• Conical residual limbs can cause failure of the vacuum suspension. Conical residual limbs reduce
skin contact with the silicone inside the device and make a less effective seal.
• Short residual limbs can cause failure of the silicone side of the device. After donning, if the
unperforated fabric is on or above the patella tendon, the silicone is subject to more stress
during knee flexion.
• Users with poor hand or cognitive function might finds donning and cleaning difficult.
• Poor hygiene.

Clinical Benefits

• Provides cushioning for the residual limb in the socket
• Distributes in-socket pressure more evenly, compared other materials and alternative
cushioning solutions
• Improvements in residual limb health problems and wound healing, compared to non-
perforated liners
• Improved heat dissipation, compared to other temperature regulation solutions
• Removes sweat from skin interface
• Patients reported a preference for their perforated liners, compared to non-perforated liners
• Reduces the need to remove prosthesis throughout the day to dry residual limb, compared to
non-perforated liners
• The locking liner provides a means of suspension
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