938461PK2/2-0822
3
These instructions are for use by 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 Walk
Cushion and Silcare Breathe Walk Locking Liner unless otherwise stated.
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 part of a lower limb prosthesis.
Intended for single user.
The device is manufactured from biocompatible materials. The cushion liner provides a perforated
cushioned socket interface which allows moisture to pass through the perforations keeping the
skin dry. In addition to this, the locking liner’s silicone valve provides vacuum suspension during the
gait cycle 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 Section 11
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 Section 5
.
Activity Level
The device is best suited for low to moderate activity users. If used on more active users device
life may be compromised.
Contraindications - Cushion Liner
• Conical residual limbs:
• This device may not be optimally contoured to fit conical residual limbs.
• Users whose suspension sleeve causes a bulk around their knee may be better suited with
an alternative type liner.
• Users with poor hand or cognitive function might finds donning and cleaning difficult.
• Poor hygiene.
Contraindications - Locking Liner
• Conical residual limbs:
• Can cause failure of the vacuum suspension.
• Reduce skin contact with the silicone inside the device and make a less effective seal.
• Deep scars distally:
• Can cause failure of the vacuum suspension.
• Reduce skin contact with the silicone inside the device and make a less effective seal.
• Short residual limbs: These 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.
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Description and Intended Purpose
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