Technical Data; General Conditions - Össur M.618.500 Manual Del Usuario

ENGLISH
The Össur 3-arm socket adapter is a component of leg prostheses and serves as the connecting element between
the socket, into which the adapter is laminated, and the pyramid system of modular components.

TECHNICAL DATA

Art. No Own weight
M.618.500 approx. 150 g
Note the following points when using the Össur 3-arm socket adapter:
• Before adapting (bending) the 3-arm socket adapter to the individual socket form screw either the pyramid
receiver, the pyramid or the adapter with an external thread into the internal thread or the 3-arm adapter
depending on use. Secure the locking screw with a torque of 10Nm.
• Adapt the 3-arm socket adapter to the shape of the socket.
• Loosen the M5 locking screw on the 3-arm socket adapter and remove the mounted adapter.
• Cover the internal thread of the 3-arm socket adapter with grease and screw in the dummy supplied. Tighten
the M5 locking screw of the 3-arm socket adapter again with a torque of 10Nm. Fill the slit in the 3-arm socket
adapter, the screw head and any free parts of the thread with Plastelin.
• Laminate the 3-arm socket adapter with sufficient carbon and glass fibre to suit the patient.
• After lamination loosen the M5 locking screw on the 3-arm socket adapter and remove the mounted dummy
and any resin and Plastelin residues.
• For final assembly screw the respective adapter (pyramid receiver, pyramid or adapter with external thread) into
the internal thread of the 3-arm socket adapter and align it to suit the individual patient.
• Tighten the M5 locking screw of the 3-arm socket adapter to a torque of 10Nm and secure with Loctite. Use
a torque wrench.
CAUTION: Any manipulation whatsoever leads to premature failure (fracture) of the adapter. Always observe the
respective maximum body weight for each adapter; the lowest maximum permissible weight is the limiting factor.
LIABILITY
In the event of a claim: Össur will only consider complaints submitted with a copy of the delivery note or invoice
from Össur and exact details of the reason for returning the joint. A manufacturer can only be held liable for the
failure of his own fittings. Any liability of the manufacturer in excess of this is only possible if his fittings are
demonstrably the cause of the damage or loss of function of fittings from other manufacturers.
CE MARK/COMPATIBILITY
All modular parts have been tested to EC Directive 93/42/EEC and bear the CE mark.

GENERAL CONDITIONS:

This product is recommended for use by one patient only. Product liability pursuant to the Medical Devices Act
becomes null and void if it is used for treating more than one patient.
The compatibility of Össur products with fittings from other manufacturers is guaranteed as long as the following
points are satisfied:
• The fittings are only used in compliance with their intended purpose (see Instructions for Use).
• If fittings with different max. weight limits are used, the maximum loading corresponds to that of the weakest
fitting.
• The use of tested individual components does not relieve the prosthetist from his duty to check by all possible
means the combination of fittings for their suitability, correct assembly and safety.
• If there are any indications that a certain combination of fittings does not guarantee the required level of safety,
then the fittings must not be combined.
• The prostheses must be built in accordance with the generally recognised professional rules of the orthopaedic
technical trade.
• If the patient's situation changes (e.g. body weight, degree of activity, etc.) the prosthesis must be checked
immediately.
Max. body weight Material
150 kg SS
3