Intended Use; General Safety Instructions - Ossur Rheo Knee Bedienungsanleitung

ENGLISH
DESCRIPTION
The device is a microprocessor-controlled prosthetic knee. It provides resistance to movement by means of a magneto-rheological actuator.
1. Proximal pyramid adapter;
2. Magnetorheologic actuator;
3. Mechanical lock;
4. Power button;
5. Status indicator;
6. Charging port;
7. Battery;
8. Distal pyramid adapter.
Device labels (Fig. 2) can be found at the rear of the device, on the power supply and on the internal face of the battery pack.
This document is for patients (intended device operator) and healthcare professionals.

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
• Unilateral transfemoral and knee disarticulation amputation;
• Bilateral transfemoral and knee disarticulation amputation.
No known contraindications.
The device is for low to moderate impact use, e.g., walking.
The weight limit for the device is 136 kg.

GENERAL SAFETY INSTRUCTIONS

Warning: Use of a lower limb prosthetic device carries an inherent risk of falling which may lead to injury.
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: Ensure the patient is able to recognize warning signals for power loss.
Warning: If device emits a warning signal, stop using device and refer to Table 1 for more information. Note that certain errors can cause the device to
shut down.
Warning: Avoid placing hands or fingers near moving joints.
Warning: A case of unexpected power failure or battery depletion during use will cause the device to stop functioning normally and may subject the
patient to the risk of falling.
Note: In case of power failure, malfunction, or warnings it is recommended to engage the mechanical lock. When locked, the device can support full
weight-bearing.
Warning: The device's misinterpretation of patient activity increases the risk of falling.
Note: High intensity uses or operation in high ambient temperature will cause the device actuator to heat up and become hot to the touch.
Note: Improper handling and/or adjustment of the device can cause malfunction. Patient should avoid:
• Direct impact to the device;
• Excessive shocks or vibrations;
• High-impact activities, sports, excessive loading, and heavy-duty use.
Warning: Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Note: Do not attempt to modify device in any way.
Warning: Risk of structural failure. Components from other manufacturers have not been tested and may cause excessive load on the device.
The device is for single patient use.
REQUIRED COMPONENTS
Össur Logic App
For the initial fitting, the healthcare professional must use the Össur Logic app. It is available on Apple App Store. See Össur Logic on the App Store for
5