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Product Description; Indications For Use; General Safety Instructions - Ossur FORMFIT TRACKER Gebrauchsanweisung

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Medical Device

PRODUCT DESCRIPTION

Formfit Tracker is a brace that provides lateral support to your kneecap
(patella). The strap tightly fastens the buttress next to your kneecap. The
buttress can be adjusted to the shape of your kneecap.
You can also find two thermoformable hinges on each side. A CPO can
remove the two hinges if necessary.
Overview (Figure 1):
a. PowerLock™ strap
b. Hook and loop surfaces
c. Strap ends
d. ReflexWing™ buttress
e. Kneecap opening
f. CustomFit™ hinges
g. Hinge pocket

INDICATIONS FOR USE

For knee conditions that may benefit from realignment of the patella
and/or patients that would benefit from an added lateral support of the
patella, such as:
• lateral patellar subluxation or dislocation
• lateral maltracking
CONTRAINDICATIONS
None known.
INTENDED USE
Formfit Tracker is intended to be used for lateral support of the kneecap
during everyday activities of all activity levels.

GENERAL SAFETY INSTRUCTIONS

WARNINGS:
– This product is designed and tested based on single patient use.
Do not use for multiple patients.
– In cases of functional change or functional loss, the patient should
stop using the device and contact a healthcare professional.
– 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.
USING THE BRACE
Fastening dots
Dots show you where to fasten the strap ends.
Fasten parts of the brace with two vertical dots in the same area. Fasten
parts with single dots in the same area.
NOTICE: Make sure to fasten the strap ends when the brace is not in
use. If you do not fasten the strap ends, they can damage the brace.
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