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Idiomas disponibles
Idiomas disponibles
ENGLISH
Medical Device
DESCRIPTION
The device is a polycentric knee joint with geometric locking system.
Control of the swing phase is supported by an integrated hydraulic
system. Flexion and extension resistance can be adjusted separately by a
3-valve hydraulic swing control.
The axle geometry, and thus the pre-swing release of the four-bar locking
system, can be changed using an interchangeable Wedge (Fig. 6).
The device has a distal tube connector and is supplied with one of these
four proximal adapter options (Fig. 1). Only replace the adapter with one
of these adapter options:
– Pyramid Adapter (A)
– 36 mm Thread (B) for use with 3-Prong Adapter
– Loop Adapter (C)
– IKF Adapter (D)
INTENDED USE
The device is intended as a part of a prosthetic system that replaces knee
function of a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
Indications For Use and Target Patient Population
• Lower limb amputation and/or congenital deficiency
• No known contraindications
The device is for moderate to high impact use, e.g., walking and
occasional running.
The weight limit for the device is 136 kg.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Warning: If there is a change or loss in device functionality, or 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: Avoid placing hands or fingers near moving joints.
Caution: Do not adjust other screws than described in these instructions.
The device is for single patient use.
ASSEMBLY INSTRUCTIONS
Warning: Risk of structural failure. Components from other
manufacturers have not been tested and may cause excessive load on
the device.
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