OSSUR OA Ease Knee Brace for Osteoarthritis from Ossur - INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE

Instructions for Use

OA EASE

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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

. 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 (a) and align Össur logo on the Hinge with
upper edge of the kneecap (b).

• Side positioning (c): Front edge of the Hinge cap should be at
midline of leg.

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. Attaching the Tabs (C, D, E, F).

• While keeping the device in place with one hand, affix the Tabs in
the order shown to the fastening locations on the device (Fig. 2: a,
b, c, d). The dot symbols on each Tab and fastening location
indicate the correct sequence and locations for attachment.

• • Make sure all the Tabs are tight but comfortable. If necessary,
adjust the Tabs again.

. Attaching the DFS Strap (G).

• Ask the patient to sit down on a chair and bend the knee with the
foot flat on the floor. Move the DFS Strap behind the leg and
thread it through the D-ring (H) (Fig. 4).

• Detach the Alligator Clip (I) (Fig. 5a) and fasten it to the “5”
position on the DFS Strap (b).

• While keeping the device in place with one hand, tighten the loose
end of the DFS Strap down over the Alligator Clip. When sufficiently
tight and sitting firmly against the leg, fold the DFS Strap into the
Alligator Clip.

. Have the patient stand up and take a few steps to verify correct

positioning of the device (Fig. 3) and tightness of the DFS Strap and
Tabs.

• Determine optimal DFS Strap tension based on patient’s pain relief
feedback.

• If patient requires more or less tension with the Alligator Clip at the
“5” position, adjust the length of the DFS Strap accordingly.

• Aim for final DFS Strap placement at the “5” position since this will
give patient the ability to adjust dosing during daily life activities.

. When final fit has been confirmed, trim the DFS Strap to the

appropriate length (c).

Device Removal

. Ask patient to sit down with the leg extended.
. Remove the DFS Strap from the D-ring.
. Unfasten the Tabs from the fastening locations on the device.

Accessories and Replacement Parts

Please refer to the Össur catalog for a list of available replacement parts
or accessories.

USAGE

Cleaning and care

Note: Secure the hook and loop fasteners before washing to avoid
damaging the textiles.

Washing Instructions

• Insert the entire device into a washbag, without removing soft goods.

• Machine-wash with a mild detergent at cold temperature (°C).

• Air dry.

Note: Do not tumble dry, iron, bleach, or wash with fabric softener.
Note: Avoid contact with salt water or chlorinated water. In case of

contact, rinse with fresh water and air dry.

DISPOSAL

The device and packaging must be disposed of in accordance with
respective local or national environmental regulations.

5PB

LIABILITY

Össur does not assume liability for the following:

• Device not maintained as instructed by the instructions for use.

• Device assembled with components from other manufacturers.

• Device used outside of recommended use condition, application, or
environment.

DEUTSCH

Medizinprodukt

VERWENDUNGSZWECK

Das Produkt ist zur unikompartimentellen Entlastung des Knies
vorgesehen
Das Produkt darf nur von einer orthopädietechnischen Fachkraft
verschrieben werden.

Indikationen

• Unikompartimentelle Gonarthrose.

• Andere Beschwerden, die von der unikompartimentellen Entlastung
profitieren können, wie degenerative Meniskusrisse.

Keine bekannten Kontraindikationen.

Warnungen und Vorsichtshinweise:

• Bei Patienten mit peripherer Verschlusskrankheit, Neuropathie und
empfindlicher Haut wird eine regelmäßige Überwachung durch
medizinisches Fachpersonal empfohlen.

• Achten Sie darauf, dass das Produkt richtig sitzt, um das Risiko von
Hautreizungen zu minimieren. Erhöhen Sie die Anwendungsdauer
schrittweise, während sich die Haut an das Produkt gewöhnt. Wenn
eine Rötung auftritt, verringern Sie vorübergehend die
Anwendungszeit, bis sie abgeklungen ist.

• Achten Sie darauf, dass das Produkt nicht zu fest angezogen wird.

• Stellen Sie sicher, dass das Produkt richtig sitzt, um eine wirksame
Schmerzlinderung zu erzielen.

• Die Verwendung des Produkts kann das Risiko einer tiefen
Venenthrombose und einer Lungenembolie erhöhen.

ALLGEMEINE SICHERHEITSHINWEISE

Die orthopädietechnische Fachkraft sollte den Patienten über alle in
diesem Dokument genannten Aspekte informieren, die für die sichere
Verwendung dieses Produkts erforderlich sind.
Jeder schwerwiegende Vorfall in Bezug auf das Produkt muss dem
Hersteller und den zuständigen Behörden gemeldet werden.
Der Patient sollte die Verwendung des Produkts einstellen und einen Arzt
aufsuchen:

• Wenn sich die Funktionalität des Produkts verändert oder verloren
geht oder wenn das Produkt Anzeichen von Beschädigung oder
Verschleiß aufweist, die seine normalen Funktionen beeinträchtigen.

• Wenn bei der Verwendung des Produkts Schmerzen, Hautreizungen,
übermäßiger Druck oder ungewöhnliche Reaktionen auftreten.

Dieses Produkt ist nur für die mehrfache Anwendung am einzelnen
Patienten bestimmt.

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