Ossur DIRECT SOCKET TF Gebrauchsanweisung Seite 12

Liner Inspection
1. Check the liner for visible contamination and tears in the silicone layer.
2. Dispose liner if any tears are visible in the silicone layer.
3. If any contamination is visible, repeat manual cleaning and disinfection (see above).
WARNING:
Casting liner shall be disposed after use on amputees that have diagnostic open wound(s) with MRSA bacteria or
similar superbugs, e.g.:
• Streptococcus pneumoniae (S. pneumoniae)
• Clostridium difficile (C. diff.)
• Campylobacter
• Neisseria gonorrhoeae (gonorrhea)
• Salmonella
• Methicillin-resistant Staphylococcus aureus (MRSA)
WARNING:
For patients with open wounds on their amputated limb, all open wounds shall be covered before donning the
casting liner to prevent contamination. Thick bandages can affect the socket fit.
NOTE: The liner should not be exposed to glass, basalt, or carbon fibers or other foreign particles. Such
substances can become embedded in the silicone causing aggravation of the skin. Washing alone may not be
sufficient to eliminate the problem.
NOTE: Casting liners are for casting purpose only and should not be used as an everyday liner.
Direct Socket Tool kit
The Direct Socket tool kit includes the following parts. Some are also available seperately.
• Icecast Pump
• Icecast Bladder
• Resin Injection Tools (200ml and 400ml)
• Distal Attachment Tool
• Tape Ring Kits (Standard and Large)
• Lanyard Cord
• Relief Pads EVA
• Sheet straps
• Brim Tape
NOTE: Icecast Bladder is sensitive to puncturing, especially when inflated and inverted. It can be easily damaged
by improper handling of sharp objects such as scissors, knives and cured braids. Fingernails may also cause
damage during donning and doffing. Ensure Icecast Bladder is not inverted when not in use to minimize risk of
damage.
NOTE: Clean the Icecast Bladder with a damp cloth and a mild soap.
REPORT A SERIOUS INCIDENT
Important notice to users and/or patients established in Europe:
The user and/or patient must report any serious incident that has occurred in relation to the device to the
manufacturer and the competent authority of the Member State in which the user and/or patient is established.
DISPOSAL
The device and packaging must be disposed of in accordance with respective local or national environmental
regulations.
LIABILITY
Össur does not assume liability for the following:
• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or environment.
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