Intended Use; General Safety Instructions - Ossur MAUCH KNEE Gebrauchsanweisung

ENGLISH
Medical Device
DESCRIPTION
The Mauch Knees are single axis hydraulic knee systems with swing and
stance control (SNS). The devices are designed to provide variable
hydraulic resistance to flexion and extension during the swing phase
based on changes in the patient's walking speed and yielding stance
control. A mode selector switch allows for manual locking and free swing
functions.
Mauch Knee
The device has integrated proximal and distal Male Pyramid Adapters.
Mauch Knee Plus
The device has either threaded or through hole proximal and distal
4-Hole Connectors.

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.
Mauch Knee
The weight limit for the device is 136kg.
Mauch Knee Plus
The weight limit for the device is 166 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
Adapter Options
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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