Intended Use; Fitting Instructions - Ossur UNLOADER ONE SMARTDOSING Bedienungsanleitung

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
• Mild to severe unicompartmental knee osteoarthritis
• Degenerative meniscal tears
• Other unicompartmental knee conditions that may benefit from
unloading such as:
– Articular cartilage defect repair
– Avascular necrosis
– Tibial plateau fracture
– Bone marrow lesions (bone bruises)
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.
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.
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 Upper (A) and Lower (B) Buckles. Ask patient to sit down and
extend leg while fitting the device. Ensure that the Upper (C) and Lower
(D) SmartDosing
the patient's leg with the Hinge (E) on the affected side of the knee.
Ensure proper alignment of the device on the leg (fig. 2).
Dials are set to the "0" position. Place the device on
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