Össur REBOUND POST-OP KNEE Full Foam Mode D'emploi page 5

ENGLISH
Medical Device
INTENDED USE
The device is intended to immobilize the knee
The device must be fitted and adjusted by a healthcare professional.
Indications for use
Indications requiring knee immobilization and restrictions to knee range
of motion. These indications may include:
• ACL, PCL, MCL, LCL repairs/injuries
• Meniscal repairs
• Tibial plateau fractures
• Patellar tendon repairs
• Osteochondral repairs
• Condylar fractures
• Sprains/strains of the knee
• HTOs (High Tibial Osteotomy)
No known contraindications.
Warnings and Cautions:
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.
• Care should be taken not to overtighten the device.
• Regular healthcare professional supervision is recommended for
patients with peripheral vascular disease, neuropathy, and sensitive
skin.
• The device is not designed nor intended to prevent injury or withstand
substantial loads during impacts such as falling or jumping.
• Make sure to apply the stop locks over the flexion and extension
buttons to secure the desired ROM setting. Not using the stop locks
may result in an unintentional change to both flexion and extension
angles.
• Any adjustments to the device should be performed by a healthcare
professional.
• Proper rehabilitation and activity modification are also essential parts
of a safe treatment program.
• Prolonged immobilization may result in decreased strength and
decreased range of motion around immobilized joint.
• Open wounds or damaged skin should be covered with a bandage or
other appropriate covering to prevent direct contact between the
wound and device.
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 immediately 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.
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