Ossur FORMFIT TRACKER User manual

Instructions for Use
FORMFIT®TRACKER

FIGURES 3
EN | Instructions for Use 5
DE | Gebrauchsanweisung 8
FR | Notice d’utilisation 11
ES | Instrucciones para el uso 14
IT | Istruzioni per l’uso 17
NO | Bruksanvisning 20
DA | Brugsanvisning 23
SV | Bruksanvisning 26
EL | Οδηγίες Χρήσης 29
FI | Käyttöohjeet 32
NL | Gebruiksaanwijzing 35
PT | Instruções de Utilização 38
PL | Instrukcja użytkowania 41
CS | Návod k použití 44
TR | Kullanım Talimatları 47
RU | Инструкция по использованию 50
JA | 取扱説明書 53
ZH | 中文说明书 56
KO | 사용 설명서 59
SK | Návod na použitie 62
ET | Kasutusjuhend 65
RO | Indicaii pentru utilizare 68
HR | Upute za uporabu 71
AR |   74
IS | Notkunarleiðbeiningar 77
HU | Használati Útmutató 80

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d
b
c
e
f
g
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ab
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5mm
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ENGLISH
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 ):
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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Putting the brace on
. Hold the brace by the hinge pockets and pull it up over your knee
(Figure ).
. Make sure your kneecap is in the middle of the opening (Figure ).
. Use fingers to keep the buttress pushed against the side of your
kneecap (Figure ). Pull the bottom strap around the back of your
knee to tighten it first. Then fasten the bottom strap as the dots
show you.
CAUTION: Do not tighten too much. If you tighten too much, you
can cut off your blood flow.
. Repeat for the top strap (Figure ).
. The buttress is now in position and pushes tightly against the side of
your kneecap.
Taking the brace off
. Pull the strap ends off of the brace and fasten them to the strap
(Figure ). Fasten as the dots show you.
. Hold the brace by the hinge pockets. Then pull it down to take it off.
USING THE BUTTRESS
If necessary, you can bend and move the buttress to adjust it to your
patella (Figure ).
Moving the buttress
. Pull the buttress off of the loop material (Figure a).
. Put it in the correct position for your patella.
Bending the buttress
. Pull the strap ends off of the brace. Then fasten the strap ends as the
dots show you.
. Fully open the brace.
. Push the middle of the buttress down with your index finger (Figure b).
. Lift the end you want to adjust.
. Bend it to agree with the shape of your patella.
. Push the end back down again.
SHORTENING THE STRAPS
If the straps are too long, you can make them shorter.
NOTICE: Only shorten the strap in single steps of ,cm/ ¼”. If you cut
off too much, you may not be able to use the brace correctly.
. Fully remove the strap end from the strap.
. Then use scissors to cut off a short piece of the strap (Figure ).
. Put the brace on again to check how it fits. If the strap is too long,
repeat steps ) and ). If the strap length is good, move to step ).
. Put the strap end back on the strap again.
USING THE HINGES
Removing the hinges
If necessary, the hinges can be heated and bent by a certified prosthetist
orthotist (CPO) to agree with the shape of your leg. To remove the
hinges, do as follows:
. Pull the strap ends off of the brace and fasten them to the strap
(Figure ). Fasten as the dots show you.

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. Push the hinges out of the brace through the openings on the hinge
pockets (Figure ).
Putting the hinges back
To put the hinges back into the brace, do as follows:
. Pull the strap ends off of the brace and fasten them to the strap
(Figure ). Fasten as the dots show you.
. Push the hinges into the brace through the openings on the hinge
pockets (Figure ).
PRODUCT CARE
You can wash the brace without removing its components.
Wash on a delicate cycle at max  °C with a mild detergent. Leave to air
dry. Do not tumble dry.
NOTICE: Make sure to fasten the strap ends before washing. If you do
not fasten the strap ends, they can damage the brace materials.
REPORT A SERIOUS INCIDENT
Important notice to users and/or patients established in Europe:
The user and/or patient must report any serious incident that has occurred
in relation to the device to the manufacturer and the competent authority
of the Member State in which the user and/or patient is established.
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.