Contraindications - Ossur DIRECT SOCKET TF Gebrauchsanweisung

ENGLISH
Medical Device
PRODUCT DESCRIPTION
The Direct Socket contains all necessary materials to fabricate a single Direct Socket for prosthetic use.
The Direct Socket TF consists of a Brim and a Material Kit with the following parts:
• Fiber braids with a distal attachment
• Silicone insulation sheets
• Silicone insulation caps
• Direct Socket resin with static mixer
• Plastic protection sheets
• Trimline strip
• Spacer for Icelock 600* (clear)
• Spacer for Icelock 562 Hybrid* (blue)
*Only supplied with 4" fiber braid version
INDICATIONS FOR USE
– Lower limb amputation.
– Lower limb deficiency.

CONTRAINDICATIONS

None known.
INTENDED USE
The device is a modular component for a lower limb prosthesis that replaces the function and aesthetics of
a missing limb. Suitability of this component for the prosthesis must be evaluated by a healthcare professional.
The Direct Socket TF is intended for creating a transfemoral socket (a device) using one of these suspension
methods:
• Seal-In
®
• Pin Locking
The device is for single patient use.
The device is designed for everyday use of low to high active users.
The device is not to be used by patients with the following conditions:
• Residual limb with extreme volume fluctuations when Seal-In liners are used.
• Össur does not recommend prescribing the device for patients that do not have sufficient hand strength to don
the device properly, and/ or do not have a caregiver to assist with donning.
GENERAL SAFETY INSTRUCTIONS
Inform the patient about everything in this document that is required for safe use of this device.
WARNING: If the device shows signs of damage or wear hindering its normal functions, the patient should stop
using the device and contact a healthcare professional.
WARNING: In cases of functional change or functional loss, the patient should stop using the device and contact
a healthcare professional.
REQUIRED COMPONENTS
For creating a socket the following is required:
Direct Socket Tool Kit
Casting Liner
Suspension components based on suspension type selected.
Bottom Seal (vacuum suspension only).
If using a 4" fiber braid and
Icelock 562: Put the blue spacer between the lock and distal attachement.
Icelock 600: Put the clear spacer between the lock and the modular spacer.
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