Össur TOTAL KNEE 2000 Instrucciones De Uso página 6

ENGLISH
Medical Device
DESCRIPTION
The device is a polycentric knee joint with a Geometric Locking System
and a 3-phase hydraulic swing control that accommodates changes in
walking speed.
Proximal adapter options are available, and the device has a Distal Tube
Connector.
Interchangeable Bumpers (Fig. 7A, 7B) allow for knee flexion to be
adjusted to suit the patient's preference and activity levels. The
adjustable Extension Promoter (7E) assists in limiting heel rise and
moving the device into a fully extended position.
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.
Total Knee 2000
The weight limit for the device is 100 kg.
Total Knee 2100
The weight limit for the device is 125 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.
Proximal Adapter Options
The following proximal adapter options are available for the device
(Fig. 1):
• 4-Prong Socket Adapter (1A),
• Female Pyramid Adapter (1B),
• Euro 4-Hole Adapter (1C), or
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