Intended Use; General Safety Instructions - Ossur POWER KNEE PKA01 Gebrauchsanweisung

ENGLISH
DESCRIPTION
The device is a microprocessor-controlled, and motor-powered prosthetic knee. It enables patients to regain
mobility and perform activities of daily living.
The device consists of the following main components (Fig. 1):
1. Proximal pyramid adapter;
2. Motor;
3. Power button and status indicator;
4. Battery Release Clip;
5. Battery;
6. Charging port;
7. Battery indicator and battery button;
8. Distal pyramid Connector;
Device labels (Fig. 5) 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 or knee disarticulation amputation.
• Unilateral hip-disarticulation or hemipelvectomy amputation.
• Bilateral amputations that combine unilateral amputation listed above on one side with transfemoral level
amputation or any amputation below that level on the contralateral side.
• No known contraindications.
The device is for low to moderate impact use, e.g., walking.
The weight limit for the device is between 50 kg and 116 kg (110 lbs and 256 lbs).

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: In case of an unexpected power loss the device will stop moving and may not return to full extension.
Warning: Avoid placing hands or fingers near moving joints.
Warning: If the device gives a warning signal – sound or vibration, immediately stop walking and proceed with
caution.
Note that certain errors can cause the device to shut down. See Table 1 for more information.
Caution: The device is motor powered and can move on its own.
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 back and front of the device;
• Excessive shocks or vibrations;
• High-impact activities, sports, excessive loading, and heavy-duty use.
Note: Do not attempt to remove covers or modify device in any way.
The device is for single patient use.
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