10.1 Haftung
Der Hersteller haftet, wenn das Produkt gemäß den Beschreibungen und Anweisungen in diesem
Dokument verwendet wird. Für Schäden, die durch Nichtbeachtung dieses Dokuments, insbe
sondere durch unsachgemäße Verwendung oder unerlaubte Veränderung des Produkts verur
sacht werden, haftet der Hersteller nicht.
1 Product description
INFORMATION
Last update: 2019-07-30
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Please read this document carefully before using the product.
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Follow the safety instructions to avoid injuries and damage to the product.
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Instruct the user in the proper and safe use of the product.
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Please keep this document in a safe place.
Ottobock fabricates this product as a contract manufacturer (referred to as "manufacturer" in the
following). Ottobock guarantees that the production process and technical data fulfil the require
ments of the European Directive for Medical Devices. The legal manufacturer is Ottobock's client.
1.1 Construction and Function
SiOCX inner sockets are made of HTV silicone and, depending on the version, also a carbon
prepreg outer socket with adapter. Depending on the version, additional silicone gel pads and
flexible socket sections can be integrated as options to provide pressure relief in sensitive or bony
areas. The inner sockets are individually fabricated according to the patient data. For the SiOCX-
TF with closed outer socket, a fitting step is integrated into the process for better adaptation to
the patient. For this purpose, the definitive inner socket is supplied with a ThermoLyn check sock
et without adapter. With the check socket, the shape and socket trim line can be changed and the
adapter position can be set.
1.2 Combination possibilities
This prosthetic component is part of the Ottobock modular system and can be combined with oth
er products of this modular system.
The SiOCX TF Prox 7T452=1 is suitable for various suspension systems such as shuttle locks
and KISS pull-in systems. The SiOCX TF Seal 7T452=2 is especially well suited for elevated
vacuum sockets in combination with the ProSeal SIL liner.
2 Intended use
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
2.2 Area of application
The product must be used in TF prostheses only.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or injury.
CAUTION
Warning regarding possible technical damage.
NOTICE
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