OSSUR Rebound Dual Knee Brace with Adjustable Range of Motion from Ossur - INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE
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Instructions for Use
REBOUND® DUAL
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Hinge Center
Knee Center
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ENGLISH
Medical Device
INTENDED USE
The device is intended for external support or stabilization of the knee.
The device must be fitted and adjusted by a healthcare professional.
Indications for use
• ACL, MCL, LCL, PCL and combined instabilities.
• Conditions requiring unicompartmental load control (Acculign slider
configuration).
No known contraindications.
Warnings and Cautions:
• 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, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.
This device is a supportive brace only and is not intended or guaranteed to
prevent injury.
FITTING INSTRUCTIONS
While carrying out the following instructions, please refer to the overview
figure for locating components mentioned in the text (Fig. ).
Device Application
. Unfasten all straps on the posterior side of the device (Fig. ).
. Bend the knee at a ° angle with the foot flat on the floor and place
the device on the leg such that the patella is centered between the
Condyle Pads (A) (Fig. ).
Ensure proper alignment of the device on the leg:
• Height positioning: Align the center of the Hinge (B) slightly above
the middle of the patella (Fig. ).
. The device is pre-assembled with medium Condyle Pads. There are
also thin and thick Condyle Pads, as well as a hook-and-loop, shim
included with the device. Use any combination of the Condyle Pads
and shim to widen or narrow the width of the device at the knee.
. The supplied tibial wedge pads can be placed between the liner and
device frame to adjust the fit around the tibia. They can also be used
to position the hinge center forward slightly or removed to position
the hinge further back.
Fasten the straps in the following order. All straps can be adjusted and/or
trimmed to length.
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. Fit the Lower Cruciate Strap (C) first, located directly below the knee
(Fig. ). This strap is located above the calf muscle and aids in the
correct positioning of the device as it helps create the device-to-bone
contact required to help keep the device in place.
. Next, snugly fasten the Bottom Strap (D) by inserting it through the
D-Ring.
. Continue with the Upper Cruciate Strap (E), located just above the
knee and then fasten the Top Strap (F).
Note: Overtightening the top two straps can cause the device to migrate.
. Last, snugly fasten the Anterior Tibial Strap (G) (Fig. ).
• If the device frame is too far anterior, loosen the Anterior Tibial Strap
and tighten the Lower and Bottom Straps.
• If the device frame is too far posterior, loosen the Lower and Bottom
Straps and tighten Anterior Tibial Strap.
Device Adjustments
Adjusting the Device Contouring
The device can be adjusted to individual anatomies. Use bending irons to
cold form the aircraft-grade aluminum frame to fit different thigh and calf
shapes.
How to Replace or Move the Field-Serviceable D-Rings
D-Rings can be moved from the interior to the exterior or replaced if broken.
Moving a D-Ring from the interior to the exterior:
. Remove strap from D-Ring.
. Bend D-Ring mounted on the device interior, push it inwards to
release it from the keyhole lock and remove it from the rivet (Fig. ).
. Attach D-Ring to the device exterior by pushing down onto the rivet
through the keyhole lock. Slide and click D-Ring into place. Place
keyhole lock with indented side facing up (Fig. ).
. Replace strap. If needed, repeat steps for other D-Rings.
Adjusting the Height of the Device
The device can be adjusted for individual height requirements:
. Loosen the screws on both sides of the Upper Frame (H) and pull the
frame up with a steady force (Fig. ). Ensure the device is properly
aligned by checking that both hinge arms are located at the same
position on the medial and lateral Hinge Arm (I).
. Retighten the screws until snug.
Adjusting the Varus / Valgus angle of the Device
The device can be adjusted for individual varus or valgus angles and to
create an offloading force to either the medial or lateral compartment.
. Loosen the screws on the desired side of the device and slide the
Upper Frame (H) to the desired position with a steady force.
. Adjust the medial Hinge Arm (I) to offload the medial compartment or
adjust the lateral Hinge Arm to offload the lateral compartment. The
slide bar has a lettered scale and may be moved to increase or decrease
the amount of varus or valgus force on the leg (Fig. ). The lettered scale
does not relate to degrees of offloading and should be used as a guide.
. Retighten the screws until snug (recommended torque value of in-lb
/ . Nm).
. All adjustments should be determined by a healthcare professional, in
accordance with the patient’s comfort level. Each time the device is
adjusted, the healthcare professional should note the letter for
a record of progression.
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Range of Motion (ROM) Adjustment
The device has ° extension stops attached to the hinges. If needed, the
range of motion can be adjusted using the extension and flexion stop kits.
. Lift and turn tab ° (Fig. ).
. Remove existing stop if necessary, by pulling on the lower edge of the
installed stop (Fig. ).
. Insert desired flexion/extension stop with the number facing the
opposite direction of leg (Fig. ).
. Return tab to initial position and press downward to lock in place
(Fig. ).
. Follow the same procedure to change any additional stops and repeat
on the opposite hinge.
PCL Strap Attachment
The PCL kit is designed to counteract posterior subluxation of the tibia.
Trim and adjust the PCL strap for proper fit.
Attaching PCL Strap:
. Note height position on medial and lateral Hinge Arms (H).
. Remove hook-and-loop fastener to access connection area.
. Remove Acculign Hinge Screws (J) and Acculign Hinge D-Ring.
. Position PCL Acculign Hinge D-Ring and position PCL Acculign Hinge
Inserts with raised portion into the recessed pocket.
. Return frame to initial positions on Hinge Arms.
. Tighten Acculign Hinge Screws and re-apply hook-and-loop fastener.
. Attach PCL strap.
Device Removal
. Sit down and bend the knee at an ° angle with the foot flat on the
floor.
. Unfasten all posterior straps of the device and attach the straps back
to themselves. This will make it easier to put the device on next time
and will also prolong the life of the straps.
Accessories and Replacement Parts
Please refer to the Össur catalog for a list of available replacement parts
or accessories.
USAGE
Cleaning and care
Washing Instructions
Washing the device with the soft goods detached allows for more
thorough cleaning.
• Hand-wash using mild detergent and rinse thoroughly.
• Air dry.
Note: Do not machine-wash, 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.
Hinge
• Remove foreign materials (e. g., dirt or grass) and clean using fresh
water.
• Do not disassemble the hinge.
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DISPOSAL
The device and packaging must be disposed of in accordance with
respective local or national environmental regulations.
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 äußeren Unterstützung oder Stabilisierung des Knies
vorgesehen
Das Produkt darf nur von einer orthopädietechnischen Fachkraft angelegt
und angepasst werden.
Indikationen
• Vorderes Kreuzband, Innenband, Außenband, hinteres Kreuzband und
kombinierte Instabilitäten.
• Erkrankungen, die eine unikompartimentelle Lastverteilung erfordern
(Acculign-Gleiter-Konfiguration).
Keine bekannten Kontraindikationen.
Warnungen und Vorsichtshinweise:
• 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
oder ungewöhnliche Reaktionen auftreten.
Dieses Produkt ist nur für die mehrfache Anwendung am einzelnen
Patienten bestimmt.
Dieses Produkt ist nur eine unterstützende Orthese und ist nicht dazu
bestimmt oder garantiert, Verletzungen zu verhindern.
ANWEISUNGEN ZUM ANLEGEN
Bitte beachten Sie bei der Ausführung der folgenden Anweisungen die
Übersichtsabbildung zur Lokalisierung der im Text erwähnten
Komponenten (Abb.).
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