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INSTRUCTIONS FOR USE
INTENDED USE
ATTENTION
The OPRA Axor™ II is a medical device designed to be used as part of the OPRA™ Implant System. The Axor
™ II
has
two functions:
i) It protects the OPRA™ Implant System from excessive loads via a release mechanism in both bending and rota-
tion. The function of the device is to limit rotational forces along the centre line of the implant and bending forces
when the prosthetic knee is flexed to its maximum position.
ii) It provides an interface between the OPRA™ Implant System and commercially available prosthetic components
via the 4-hole configuration which is commonly used for prosthetic components.
The Axor™ II is designed to be used for normal everyday activities.
EXTERNAL PROSTHETIC COMPONENTS
The external prosthetic connection device, Axor™ II, provides a standard connection to other prosthetic components
that would include the prosthetic knee and foot. A standard European 4 hole male/female mounting system is utilized in
the external prosthetic device. This allows the OPRA™ system to be connected to all prosthetic systems that utilize this
standardized connection method. The OPRA™ System is recommended for use with commercially available non-micro-
processor- controlled prosthetic knees and microprocessor controlled prosthetic knees that do not include powered
activation of flexion and extension of the prosthetic knee.
Prosthetic components with internal power supply attached to the Axor™ II must comply with the standard IEC60601
for medical electrical equipment.
[
The responsible physician must approve the use of the Axor
™ II
.
[
The Axor
™ II
is intended to be used together with the OPRA™ Implant System only and for above-knee ampu-
tees only.
[
The Axor
™ II
must be installed by a prosthetist certified by Integrum.
[
The Axor
™ II
is intended for single patient use only.
[
The Axor
™ II
is intended for patients with body weight equal or less than 100kg/220lb including prosthesis.
APPLICABLE FOR USA
CAUTION:
Federal (US) law restricts this device to sale by or on the order of a physician.
