Indications For Use; Contraindications; Intended Use - Ossur DIRECT SOCKET TT Gebrauchsanweisung

Modular Spacer (L-661000)
• Icelock Clutch 4H 214 (L-214100)

INDICATIONS FOR USE

Trans-tibial amputation requiring a socket for residual limb to be used
with a prosthesis.
The product can be used by trans-tibial amputees regardless of age and
level of hand dexterity. Amputees shall be physically fit for using an
external prosthesis for load transfer while ambulating.
Direct Socket TT is a non-invasive, single patient, reusable prosthetic
device designed for everyday use of low to high active users. The device
has been tested and validated for exoskeletal prosthetic fittings of lower
limb amputees.

CONTRAINDICATIONS

None known.

INTENDED USE

This product is intended to be used for trans-tibial amputees (including
bilateral amputees) with a weight limit from 36 to 166 kg.
Direct Socket is not to be used by amputees with the following
conditions:
• Ultra-short trans-tibial with amputation performed directly under the
tuberosity of the tibia
• Long residual limb exceeding bladder length
• Liner size above size 34
GENERAL SAFETY INSTRUCTIONS
WARNING:
Do not reuse and dispose Casting Liner if used 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)
Do not use Direct Socket for amputees with the following conditions:
• Extreme residual limb volume fluctuations when using Seal-In liners
• Cognitive limitations to the extent that user is unable to follow
instructions for safe donning of device
Avoid direct contact with resin and inhalation of fiber dust.
CPO shall instruct user to inspect the residual limb each day, verifying
skin and limb are satisfactorily healthy enough for safe and continued
use of product.
9