Intended Use; General Safety Instructions - Ossur BALANCE KNEE OFM1 Gebrauchsanweisung

ENGLISH
Medical Device
DESCRIPTION
The device is a four-bar polycentric mechanical knee. It is designed to
facilitate single cadence ambulation on level ground and small slopes.
The device offers a manual locking for improved security which can be
activated optionally, aimed for users that require a manual locking feature
during rehabilitation.
Extension of the knee is aided by a spring, which is compressed during
knee flexion.
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 low impact use, e.g., gentle walking.
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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