Össur OA EASE, Instructions For Use Manual

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4
ENGLISH
Medical Device
INTENDED USE
The device is intended for unicompartmental unloading of the knee
The device must be prescribed by a healthcare professional.
Indications for use
• Unicompartmental osteoarthritis of the knee.
• Other conditions that may benefit from unicompartmental unloading,
such as degenerative meniscal tears.
No known contraindications.
Warnings and Cautions:
• Regular healthcare professional supervision is recommended for
patients with peripheral vascular disease, neuropathy, and sensitive
skin.
• Make sure the device fits properly to minimize the possibility of skin
irritation. Increase usage time gradually as the skin adapts to the
device. If redness appears, temporarily decrease the usage time until
it has subsided.
• Care should be taken not to overtighten the device.
• Make sure the device fits properly to achieve effective pain relief.
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should stop using the device and contact a healthcare
professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, excessive pressure, or unusual reaction
occurs with the use of the device.
The device is for single patient – multiple use.
FITTING INSTRUCTIONS
While carrying out the following instructions, please refer to the overview
figure for locating components mentioned in the text
(Fig. 1) .
Device Application
1. Ask the patient to sit down on a chair and partially bend the knee with
the foot flat on the floor. Position the fully opened device on the leg
so that the Hinge (A) is on the affected side of the knee and the
Kneecap Opening (B) is positioned around the kneecap
(Fig. 2) .
Ensure proper alignment of the device on the leg (Fig. 3) .
• Height positioning: Lower edge of the Kneecap Opening should be
below the kneecap (3a) and align Össur logo on the Hinge with
upper edge of the kneecap (3b).
• Side positioning (3c): Front edge of the Hinge cap should be at
midline of leg.