Product Description; Contraindications; Intended Use - Ossur Direct Socket Tool Kit Gebrauchsanweisung

ENGLISH

PRODUCT DESCRIPTION

Direct Socket Tool Kit is a single chamber pressure casting system
providing pressure to shape soft tissue. The single chamber pressure
system is designed to optimally distribute pressure. The chamber is
reinforced with a matrix for durability, and to control elongation.
Direct Socket Tool Kit provides an effective and clinically validated option
for socket provision. It provides the prosthetist with tools to repeatedly
produce a reliable and well-fitting socket using the Direct Socket process.
Optimal axial and transverse stabilization can be obtained by using the
Iceross Casting Liner (I-09DCXX) in combination with the Direct Socket
Tool Kit.
Please refer to the Instructions for Use of the Direct Socket System for
handling of Resin Injection Tool, Distal Attachment, Taping Ring and
Molding Tube.
Direct Socket Tool Kit contents:
• Icecast Pump (D-040510)
• Icecast Bladder (D-040520)
• Resin Injection Tool (M-400201(200 ml) & 1950504 (400 ml))
• Distal Attachment for Direct Socket (Distal Attachment Pin and Distal
Attachment Nut; D-040532)
• Taping Ring (D-040552)
• Lanyard Cord (L-392018)
• Relief Pads (M-100001)
• Icecast Case
INDICATIONS FOR USE
The Direct Socket Tool Kit is for direct lamination using the Direct Socket
system, following trans-tibial amputation requiring a socket for a residual
limb to be used with a prosthesis.

CONTRAINDICATIONS

None known.

INTENDED USE

Direct Socket Tool Kit is used for direct lamination using the Direct
Socket system.
For lower limb application only.
Icecast Bladder is not to be used on 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
PRECAUTIONS:
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
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