Instructions For Use; Product Description; Contraindications - Ossur Direct Socket TF Gebrauchsanweisung

ENGLISH
IFU – INSTRUCTIONS FOR USE
This document provides important information on the indications for use, fit, and handling of the device. It is
intended for a certified prosthetist and the user of the device.

PRODUCT DESCRIPTION

The Direct Socket TF system is offered with different suspension variants for transfemoral amputees. The systems
consist of the following components:
– Transfemoral locking liner
– Material kit (including fiber braids and resin)
– Össur brim
– Direct Socket Tool Kit
Recommended Combinations
For comfort and suspension, pair the Direct Socket TF with one of the options listed below.
Also pair with a male or female 4-hole adapter to connect to a pylon and/or a knee, depending on the level and/or
the function required.
For Seal-In suspension:
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• Iceross Seal-In Transfemoral or Iceross
® ®
• Passive vacuum:
Icelock Expulsion Valve (L-551002) and Bottom Seal for Direct Socket (M-400206)
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Icelock 544 Plate Expulsion (L-544521) and Icelock
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• Active vacuum:
Icelock 544 Plate Unity (L-544511) and Icelock
®
For locking suspension:
• Iceross Transfemoral Locking liner
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• Icelock ® Lanyard 631 Adaption Kit (L-631100), including the 600-Modular spacer (L-661000)
• Icelock Ratchet 621 Adaption Kit (L-621100), including the 600-Modular spacer (L-661000)
®
• Icelock Smooth 651 Adaption Kit (L-651100), including the 600-Modular spacer (L-661000)
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• Icelock Clutch 4H 214 (L-214100)
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INDICATIONS FOR USE
Lower limb absence.

CONTRAINDICATIONS

None known.
INTENDED USE
This product is intended to be used for transfemoral amputees (including bilateral amputees) with a weight limit
from 36 kg to 166 kg.
The Direct Socket is not to be used for patients with the following conditions:
• Residual limb with extreme volume fluctuations when Seal In liners are used.
• Cognitive limitations to the extent that the patient is unable to follow instructions on the safe donning of the
device.
The product can be used by persons from the aforementioned group regardless of age and level of hand dexterity.
Patients shall be physically fit for using an external prosthesis for load transfer while ambulating.
The device is a non-invasive, single patient, reusable prosthetic device designed for everyday use of low to high
active users. The device is tested and validated for exoskeletal prosthetic fittings of lower limb amputees.
Seal-In X5 TF liners
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544 Direct Socket adapter (L-544050)
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544 Direct Socket adapter (L-544050)
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