the femoral shell of the brace to increase the corrective 3-point force
and offload the compromised (degenerated, compressed) medial or
lateral compartment of the knee. ❻
Both uprights ② are set during fabrication in a neutral position at mid-
height.
The best way to adjust the correction is to increase the length of the
upright on the affected side. This produces more leverage force.
If the patient is short, you can also increase correction by shortening the
length of the upright on the unaffected side.
For severe OA and/or severe varus or valgus deformities, you may need
to adjust both uprights.
To adjust the Loadshifter ② , lift the plastic Snap Lock lever located
above the hinge, on the side requiring adjustment, lengthen or shorten
the upright and close the lever. ❼
Tip: if opening of the Snap Lock seems difficult, do a quick
back and forth movement with both hands on the upright to
unlock the mechanism. ❼
Medial Compartment Femoro-Tibial Osteoarthritis of the Knee: this
brace is effective for the treatment of unicompartment internal/medial
femoral-tibial osteoarthritis of the knee.
A thicker condylar pad should be positioned on the external/lateral
hinge (on the side opposite the affected compartment).
To increase corrective force, the internal/medial upright (affected side)
can be lengthened compared with the external/lateral upright, or the
external/lateral upright can be shortened compared to the internal/
medial upright.
Lateral Compartment Femoro-Tibial Osteoarthritis of the Knee: this
brace is also effective for the treatment of unicompartment external/
lateral compartment femoral-tibial osteoarthritis of the knee.
The thicker condylar pad should be positioned on the internal/medial
hinge (on the side opposite the affected compartment). To increase
corrective force, the internal/medial upright (affected side) can be
lengthened compared with the external/lateral upright, or the external/
lateral upright can be shortened compared to the internal/medial
upright.
• Step 6: Evaluation of pain after adjusting the corrective force
After adjusting the offloading of the brace:
- Ask the patient to walk again and assess his/her pain level.
- Repeat the operation, increasing or reducing the correction until the
proper amount of offloading is achieved for the patient.
- If the patient feels any discomfort, reduce the angle of the thigh shell
which will reduce the corrective force.
- Once the adjustment of the knee brace is finalized, it is possible to
trim any excess padding at the lower end of the pads, just above both
hinges.
For conservative treatment, start with a small amount of correction and
let the patient wear the knee brace for one or two weeks.
If it is necessary to increase the correction, see the patient again.
A bag containing an additional set of condylar pads is provided in the
box with the brace.
If necessary, use the set of thicker pads to increase the compression on
the sides of the knee.
Lines and numbers are printed on the uprights of the knee brace. There
is no correlation between these graduations and specific degrees of
correction. You can record in the patient's chart the initial setting of
the Loadshifter.
Flexion/extension control:
The brace's default extension setting is 0°.
To change this setting, please follow the following instructions, to be
repeated with the same limitation on both hinges.
The extension and flexion limitations are situated on plastic pieces
contained in the box ❽ ❾ .
Extension can be limited to 0°, 5°, 10°, 15°, 20°, 30° and 40°.
Flexion can be limited to 0°, 30°, 45°, 60°, 75° and 90°.
• Adjusting the extension limitation:
1. Choose the desired extension limitation on the corresponding plastic
piece ❽ .
2. Open the hinge cap by using the latch located at the back: push the
latch inwards and then lift the cap.
3. Flex the hinge slightly and remove the existing extension limitation.
Take care to note the direction this limitation is facing.
4. Insert the new extension limitation. Take care to check that the shape
of this part follows the contours of the cap.
Straighten the hinge to full extension to confirm the extension
limitation is correctly positioned.
5. Close the cap.
Do a few flexions/extensions to make sure that the limitation is properly
locked at the desired angle.
• Adjusting the flexion limitation:
1. Choose the desired flexion limitation on the corresponding plastic
piece ❾
.
2. Open the hinge cap by using the latch located at the back: push the
latch inwards and then lift the cap.
3. Straighten the hinge to full extension and insert the desired flexion
limitation (the flexion limitations should be placed behind the hinge).
Ensure the hole in the flexion limitation is aligned with the hole in
the hinge (metal part).
4. Close the cap.
Do a few flexions/extensions to make sure that the limitation is properly
locked at the desired angle.
• Definitive locking of the hinge cap (to prevent from being opened by
the patient):
1. Remove from its support, the plastic piece which locks the cap ❾ⓐ .
2. When the cap is closed, position the locking piece so that it fits into
the cap notch.
Then push the locking piece until it comes into abutment.
Warning:
The adjustment of the flexion/extension must be decided and
performed by the healthcare professional, not by the patient.
Both hinges MUST be adjusted to the same angle. There can be damage
to the hinges, and compromises (including injury) to the patient, if the
settings are not the same on both hinges.
6
PATIENT INSTRUCTIONS GUIDE:
The healthcare professional who performed the
initial fitting of your brace should have made all
the necessary modifications to the corrective force
applied by the knee brace, selected the appropriate
hinge pads, and adjusted the length of the straps. The
healthcare professional should have also explained
how to put on your brace.
Fitting the orthosis:
• Step 1: Sit on the edge of a chair and slightly bend your leg (30° to 60°).
• Step 2: Open the 4 buckles on the posterior straps ( Ⓐ, Ⓒ, Ⓓ, Ⓔ ) and
place the brace on the leg. ❷
The condylar pads attached to the inside of the hinges should press
against the sides of your knee.
The middle of the pads should line up between the middle and the
upper third of your knee cap (bone at the front of the knee joint) and
should also be centered on the side of your leg ❷ .
NOTE: It is always better to put your brace on a little too high than too
low.
• Step 3: First close the Synergy Suspension Strap Ⓐ above the calf
using the buckle ❸ .
This strap should be tightened in the flexion fold behind the knee.
It is the most important strap for preventing the brace from slipping
down your leg.
By tightening the synergistic suspension strap Ⓐ above the calf muscle
in the flexion fold behind the knee you will ensure that the hinges are at
the correct level on the leg.
• Step 4: Next fasten and tighten the lower strap Ⓒ , then the two straps
behind the thigh Ⓓ and Ⓔ .
If you feel the need to tighten the straps during an activity, make sure
you tighten them following the steps indicated in the fitting instructions.
It should not normally be necessary to readjust the front straps Ⓑ and Ⓕ .
Do not change the position of the self-gripping clamps used to attach
the straps to the rigid frame of the brace. They are intended for strap
changes when necessary. This operation must be performed by a
healthcare professional.
It may take several weeks to feel comfortable with the brace on your leg.
It is recommended to initially wear the brace for only a few hours a day.
Adjusting the correction:
During the initial fitting, the healthcare professional should make
all necessary adjustments to obtain a base level of corrective force,
according to the medical indication.
If you feel the need for additional correction in the future, or if you are
feeling any discomfort, or are experiencing any other issue with the fit,
function or suspension of the brace, stop wearing your brace until you
can see your physician or the healthcare professional who fit the brace.
Thuasne cannot be held responsible for undesirable effects or injuries
resulting from any unsupervised or inadapted adjustments.
Care/Maintenance
Close the self-fastening tabs before washing. Hand wash. Do not use
detergents, fabric softeners or aggressive products (products containing
chlorine). Squeeze out excess water. Dry away from any direct heat source
(radiator, sun, etc.). If the device is exposed to seawater or chlorinated water,
make sure to rinse it in clear water and dry it.
Hinges ① :
The hinges on the brace are pre-lubricated in the factory. If sand, dirt or
water gets inside the hinges, they may require lubricating again. If you notice
the hinges not gliding smoothly, a few drops of a synthetic lubricant can be
applied. Wipe off any excess lubricant before wearing the brace to prevent
stains on clothing.
Straps:
After prolonged use, if the fibers on your strap do not adhere as well to the
self-fastening tab, cut the strap shorter so the self-fastening tab adheres to
a section of the strap that has fresher fibers. If this is not possible, you should
contact the medical provider who fit your brace.
Pads:
The brace is lined with padding that provides a comfortable interface
between the leg and the shells. The straps also have pads. Do not remove
these pads from the brace or straps. Wipe the pads after each use to remove
any moisture and let the pads air dry. You can also clean the pads with a mild
anti-bacterial soap and rinse them off with fresh water. Do not wash the pads
in a machine and do not dry in a tumble dryer.
Storage
Store at room temperature, preferably in the original packaging.
Disposal
Dispose of in accordance with local regulations.
COMMERCIAL WARRANTY AGREEMENT AND WARRANTY
LIMITATIONS
Thuasne offers a free, limited commercial warranty to the user, in the territory
where the device was purchased, against defects in manufacturing and
workmanship for a period of:
- six months for the textile components;
- one year for the rigid components.
The limited warranty is effective from the date of purchase of the product
by the end-user.
The limited commercial warranty does not apply to any defects in
manufacturing and workmanship in case of:
- misuse of the product or any damage occurred by a usage outside the
normal and intended use of the product as mentioned in the instructions
for use,
- damages occurred as part of attempts to modify the product.
Any deterioration or improper trimming of the product during its modification
or adjustment process by the healthcare professional when fitting device is
expressly excluded from this warranty.
Any claim for this commercial warranty must be sent by the user to the
entity where the product was purchased, which will forward this claim to the
corresponding Thuasne entity.
Any warranty claim will first be reviewed by Thuasne to determine if the
conditions of the limited warranty are fulfilled and do not fall into one of the
cases of exclusion of the commercial warranty.
To benefit from the warranty, the buyer must mandatorily provide an original
and dated proof of purchase of the product.
If the conditions of the limited warranty are fulfilled and the claim is made by
the user or its legal representative (parents, guardian...) within the warranty
delays indicated above, the buyer will get a new substitution product.
It is expressly agreed that this commercial warranty is in addition to the
legal warranties binding the entity which sold the product to the user, in
accordance with the applicable local legislation in the country of purchase
of the product.
Keep this instruction leaflet.
de
STARRE KNIESTÜTZE
Beschreibung/Zweckbestimmung
Das Produkt ist ausschließlich für die Behandlung der aufgeführten
Indikationen und für Patienten vorgesehen, deren Körpermaße der
Größentabelle entsprechen.
Lateralisiertes Produkt (linke Ausführung, rechte Ausführung).
Erhältlich in 6 Standardgrößen und 9 angepassten Größen.
Eine Größe wird als „angepasst" bezeichnet, wenn der Waden- und der
Oberschenkelumfang keiner Standardgröße entsprechen. In diesem
Fall kann eine an die abweichenden Oberschenkel- und Wadenmaße
angepasste Orthesengröße verwendet werden.
Das Produkt besteht aus:
- einem Rahmen, der die Steife der Orthese gewährleistet,
- dem Gelenk TM5+ ① mit Schutzabdeckung zur Unterstützung der
natürlichen Bewegung des Kniegelenks,
- einem (werkzeuglosen) Loadshifter-Mechanismus ② zur Verlängerung
der Orthesenschienen,
- 2 Kondylenpolster,
- 4 Halbgurten hinten ( Ⓐ , Ⓒ, Ⓓ, Ⓔ ) (davon ein synergistischer
Suspensionsgurt Ⓐ ) und 2 Halbgurten vorne ( Ⓑ , Ⓕ ) ❶
- 4 Schnellschnallen, um das Öffnen und Schließen der hinteren Gurte zu
erleichtern ( Ⓐ , Ⓒ, Ⓓ, Ⓔ ) , ❸ ❹
Die Einstellung des Beuge- und Streckwinkels erfolgt werkzeuglos.
Zusätzliche Kondylenpolster der Flexions- und Extensionsstopps sowie
zusätzliche Klettverschlüsse befinden sich in einem in der Schachtel der
Orthese enthaltenen Plastikbeutel.
Je nach Verkaufsland können Zubehör/zusätzliche Ersatzteile erhältlich sein.
Zusammensetzung
Textilkomponenten: Elastan - Polyamid - Ethylen-Vinylacetat - Silikon -
Polymethylmethacrylat - Polyethylen.
Feste Komponenten: Aluminium - Edelstahl - Polyoxymethylen - Vinyl -
Polypropylen - Polyamid - Epoxidharz - Messing.
Eigenschaften/Wirkweise
®
Die Rebel Reliever
Orthese dient in erster Linie dazu, mit Hilfe eines
3-Punkt-Entlastungssystems korrigierende Kräfte auszuüben und die
Ausrichtung des Beins zu unterstützen.
Diese korrigierenden Kräfte tragen dazu bei, die Varus- oder Valgusstellung
sowie extreme Belastung auf den geschädigten Teil des Knies zu mindern.
Durch die Unterstützung der normalen Ausrichtung des Beins trägt die
Orthese zur Verminderung der Belastung und damit des Drucks und der
Entzündung bei.
Diese verringerte Belastung der verletzten Seite trägt generell zur
Schmerzlinderung bei und hemmt den Knorpelabbau.
Die korrigierenden Eigenschaften der Rebel Reliever
Korrektur der Varus- oder Valgusstellung (+/- 9°) gedacht.
In neutraler Position, ohne Winkelkorrektur, kann die Rebel Reliever®
Orthese auch zur spezifischen Ruhigstellung mit Einstellung der Beuge-/
Streckbegrenzung des Knies zur konservativen Behandlung von
Bandverletzungen oder zur postoperativen Ruhigstellung verwendet werden.
- Einstellung der möglichen Streckbegrenzung auf 0°, 5°, 10°, 15°, 20°, 30°
und 40°.
- Einstellung der möglichen Beugebegrenzung auf 0°, 30°, 45°, 60°, 75°
und 90°.
Für einen guten Sitz der Knieorthese am Bein sorgen:
- ein synergistischer Suspensionsgurt Ⓐ ,
- die Form der Schienbeinschale (abgerundeter Seitenteil und flacher
Mittelteil), die das Drehen der Kniestütze am Bein des Patienten verhindert,
- das Kompressions-/Suspensions-Package, das eine zusätzliche Stütze
am Oberschenkel ermöglicht.
Indikationen
Symptomatische unikompartimentelle femorotibiale Osteoarthritis
(mittelschwer bis schwer).
Entlastung des Knies bei posttraumatischen, postoperativen oder
degenerativen Verletzungen.
Gelenkinstabilität/-laxität.
Alternative zu einer Osteotomie oder Beinumstellungsoperation.
Konservative Behandlung von Kniebandverletzungen und/oder -rissen
(Kreuz- und/oder Seitenbänder).
Gegenanzeigen
Verwenden Sie das Produkt nicht bei einer unsicheren Diagnose.
Das Produkt bei einer bekannten Allergie gegen einen der Bestandteile nicht
anwenden.
Das Produkt nicht ohne eine geeignete Wundauflage auf geschädigter Haut
oder offenen Wunden anwenden.
Nicht anwenden bei starken Krampfadern (die das regelmäßige Tragen einer
Kniestütze verhindern).
Nicht anwenden bei Genu recurvatum.
Nicht anwenden bei ausgeprägtem Genu varum oder Genu valgum.
Nicht anwenden, wenn in der Vorgeschichte eine schwere venöse
Thromboembolie ohne Thromboseprophylaxe aufgetreten ist.
Vorsichtsmaßnahmen
Vor jeder Verwendung die Unversehrtheit des Produkts überprüfen.
Das Produkt nicht verwenden, wenn es beschädigt ist.
Die für den Patienten geeignete Größe anhand der Größentabelle
auswählen.
Es wird empfohlen, die erste Anwendung unter der Aufsicht einer
medizinischen Fachkraft durchzuführen.
Die von der medizinischen Fachkraft empfohlenen Verordnungen
und Empfehlungen sind strikt einzuhalten.
Dieses Produkt ist für die Behandlung einer bestimmten Erkrankung
bestimmt, daher ist die Verwendungsdauer auf diese Behandlung
beschränkt.
Das Produkt darf aus hygienischen und leistungsbezogenen Gründen nicht
für einen anderen Patienten wiederverwendet werden.
Es wird empfohlen, das Produkt in angemessener Weise festzuziehen, um
einen Halt/eine Immobilisation ohne Beeinträchtigung des Blutkreislaufes
zu gewährleisten.
Bei venösen oder lymphatischen Störungen in der Vorgeschichte ist eine
medizinische Fachkraft zu Rate zu ziehen.
Bei Unwohlsein, übermäßigen Beschwerden, Schmerzen, einer Änderung
des Volumens der Gliedmaßen, ungewöhnlichen Empfindungen oder einer
Verfärbung der Extremitäten das Produkt abnehmen und eine medizinische
Fachkraft um Rat fragen.
Wenn sich die Leistung des Produkts ändert, entfernen Sie es und wenden
Sie sich an einen Fachmann.
Vor jeder sportlichen Aktivität die Verträglichkeit der Anwendung dieses
®
Orthese sind für die
