Össur PROPRIO FOOT PSX02 Instrucciones Para El Uso página 4

ENGLISH
DESCRIPTION
This document is in regard to PROPRIO FOOT
The device is a microprocessor controlled prosthetic ankle and foot system.
The device consists of the following components (Fig. 1):
1. Charging port;
2. Actuator;
3. Pyramid connector;
4. Power button;
5. Status indicator;
6. Unit Serial Number;
7. Carbon blades.
This device must be used with a Foot Cover and a Spectra Sock.
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 the foot and ankle 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.
Healthcare professional must be authorized to fit the device by Össur after completing corresponding training.
Indications For Use and Target Patient Population
• Unilateral transtibial, transfemoral, and knee disarticulation amputation;
• Bilateral transtibial, 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 125 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: Avoid placing hands or fingers near moving joints.
Warning: Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Warning: In case of an unexpected power loss the device will behave like a mechanical foot. Note that the ankle
alignment may not be optimal.
Warning: Unexpected power loss increases the risk of falling.
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.
Note: Do not attempt to remove covers or modify device in any way.
Caution: Footwear that restricts movement of the ankle area e.g. due to height or stiffness of material will impair
device function.
The device is for single patient use.
REQUIRED COMPONENTS
The device is delivered with a power supply.
(PSX02).
®
4