Intended Use; General Safety Instructions; Fitting Instructions - Ossur UNLOADER ONE X Gebrauchsanweisung

ENGLISH
Medical Device

INTENDED USE

The device is intended for unicompartmental unloading of the knee
The device must be fitted and adjusted by a healthcare professional.
Indications for use
For knee conditions that may benefit from unicompartmental load
reduction, such as:
• Mild to severe unicompartmental knee osteoarthritis
• Degenerative meniscal tears
• Articular cartilage defect repair
• Meniscal repair
• Avascular necrosis
• Condylar bone marrow lesions (bone bruises)
• Tibial plateau fractures
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.
• If any pain or excessive pressure occurs with the use of the device,
the patient should stop using the device and contact a healthcare
professional.
• Care should be taken not to overtighten the device.
• Make sure the device fits properly to achieve effective pain relief.

GENERAL SAFETY INSTRUCTIONS

Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
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.
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. Open Lower (A) and Upper (B) Buckle. Ask patient to sit down and
extend leg while fitting the device. Place the device on patient's leg
with the Hinge (C) on the affected side of the knee.
Ensure proper alignment of the device on the leg (Fig. 2).
• Height positioning (2a): Align Össur logo on the Hinge with upper
edge of the patella.
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