• Das Gel-Kondylenpolster kann mit Hilfe von Einschubkeilen zusätzlich an
die Knieanatomie angepasst werden, um die Kontaktfläche zur Korrektur
zu vergrößern. Dazu schieben Sie die beiliegenden Keile (3 und / oder 6 mm)
7
frontal ein, bis das Polster flächig am Knie anliegt
.
• Hinweis: sollte die Orthese trotz Anpassungen verstärkt rutschen
können zusätzlich 2 silikonisierte Gurtpolster bestellt und distal, knienah
ausgetauscht werden.
Anlegen der SecuTec OA (für den Patienten)
• Die Gurte und deren Längen wurden vom Fachpersonal eingestellt und
müssen daher nicht zwingend geöffnet werden. Zum Anlegen der Orthese
hängen Sie lediglich die 4 Schnellverschlüsse aus.
• Um die Orthese anzulegen, steigen Sie von hinten mit dem Fuß durch den
Rahmen und ziehen Sie diesen nach oben zum Knie
8
.
• Beugen Sie das Bein leicht (ca. 30°). Danach ertasten Sie die Position der
Kniescheibe. Die Mitte der Orthesengelenke wird etwa in Höhe der Knie-
scheiben mitte positioniert.
• Für die effektivste Reihenfolge beim Verschließen der Gurte ist unter den Griff en
des Schnellverschlusses auch eine Nummerierung (1 – 4) eingeprägt
• Klicken Sie alle Schnellverschlüsse an den Gurten in die Ösen ein; beginnend
vorn mit dem gelenknahen Verschluss (#1) am Unterschenkel, dann dem
am Oberschenkel (#2). Im Anschluss verschließen Sie die gelenkfernen
Verschlüsse, erst am Unter(#3)- dann am Oberschenkel(#4).
• Bei Bedarf können Sie an dieser Stelle die Gurte leicht nachspannen oder
lockern, wenn sie zu locker oder zu fest sind.
Achtung: Zu locker gespannte Gurte können zum Rutschen der Orthese
führen.
• Nachdem alle Gurte verschlossen sind, muss die Orthese bei angespannter
Muskulatur gleichmäßig anliegen.
• Nach erfolgter Anlage der Orthese kontrollieren Sie noch einmal die korrekte
Position 10.
Ablegen der SecuTec OA
• Lösen Sie zunächst die Schnellverschlüsse aus den Ösen hinten am Ober-
schenkelrahmen der Orthese.
• Danach die Schnellverschlüsse der Gurte vorn am Unterschenkelteil lösen.
• Der vordere, obere und der hintere untere Gurt kann geschlossen bleiben.
• Nach dem Lösen aller Schnellverschlüsse die Orthese Richtung Fuß schieben
und aus dem Rahmenaussteigen.
Reinigungshinweise
Die Orthese nie direkter Hitze (z. B. Heizung, Sonneneinstrahlung usw.)
aussetzen!
Die Aluminiumteile der Orthese sind beschichtet und können mit ph-neutraler
Seife gereinigt werden.
Wir empfehlen die Polster und Gurte bei 30 °C-Handwäsche zu reinigen.
Wir haben das Produkt im Rahmen unseres integrierten Qualitäts manage-
ment systems geprüft.
Sollten Sie trotzdem eine Beanstandung haben, setzen Sie sich bitte mit Ihrem
Sanitätsfachhandel vor Ort in Verbindung.
Einsatzort
Entsprechend den Indikationen (Knie). Siehe Zweckbestimmung.
Wartungshinweise
Bei richtiger Handhabung und Pflege ist das Produkt praktisch wartungsfrei.
Zusammenbau- und Montageanweisung
Die SecuTec OA wird in Standardgrößen montiert geliefert. Die Erstanlage mit
den Gelenkeinstellungen und die statische Anpassung müssen von geschultem
Fachpersonal erfolgen.
Technische Daten / Parameter
Die SecuTec OA ist eine Funktionsorthese für das Kniegelenk. Sie besteht aus
einem Rahmen, Gelenken, Scharnieren, Gurten, Schnellverschlüssen und
Polster.
Hinweise zum Wiedereinsatz
Die SecuTec OA ist zur einmaligen Versorgung für den Patienten vorgesehen.
Entsorgung
• Das Produkt kann entsprechend den nationalen Gesetzmäßigkeiten entsorgt
werden.
• Hinsichtlich bestehender Rückgabemöglichkeiten zur ordnungsgemäßen
Verwertung der Verpackung beachten Sie bitte die Hinweise der jeweiligen
Verkaufsstelle, in der Sie dieses Produkt erhalten haben.
Stand der Information: 2018-11
1
Orthese = orthopädisches Hilfsmittel zur Stabilisierung, Entlastung, Ruhigstellung,
Führung oder Korrektur von Gliedmaßen oder Rumpf
2
Fachpersonal ist jede Person, die nach den für Sie geltenden staatlichen Regelungen
zur Anpassung und Einweisung in den Gebrauch von Bandagen befugt ist.
en
english
These instructions for use can also be downloaded from:
www.bauerfeind.com/downloads
Dear Customer,
Thank you for choosing a product from Bauerfeind. The SecuTec OA knee
1
orthosis
is a high-quality medical and therapeutic product. Please read the
instructions for use carefully and if you have any questions contact your
physician, medical retailer, or our Technical Service department.
Intended purpose
The SecuTec OA orthosis is an approved therapeutic aid for supporting your
treatment. It secures and provides relief for your knee during therapy and can
be used in conjunction with physiotherapy to help reduce pain. By correcting
the leg alignment, targeted relief for the knee joint and its ligaments can be
achieved for the relevant indication.
9
.
The SecuTec OA must be individually adjusted for the patient by a trained
2
specialist
in order to ensure maximum effectiveness and optimum wearing
comfort.
Indications
• Medial or lateral osteoarthritis of the knee
• Postoperative stabilization and relief
Risks of using this product
Important information
• The SecuTec OA orthosis is a prescribed product that must be worn under
a physician's guidance. The product must be worn in accordance with these
instructions for use and for the listed indications.
• No product liability is accepted if the product is not used or adjusted correctly.
• No improper modifications may be made to the product. Failure to comply
with this requirement may adversely affect product performance, thereby
excluding any product liability.
• Should symptoms increase or should you notice any unusual changes, please
contact your physician without delay.
• Combining the orthosis with other products (e. g. compression stockings)
must be discussed beforehand with your physician.
• Do not allow the product to come into contact with ointments, lotions, or
substances containing grease or acids.
• If the orthosis is used in salt water or chlorinated water, it should be rinsed
with plain water afterwards.
• Should any problems with the fit of the orthosis arise, for instance if the
shape of your leg changes (e. g. due to an increase or reduction in muscle),
or should the product have a functional defect, please contact your medical
supply retailer immediately.
• Side effects involving the body as a whole have not been reported to date.
Correct usage / fitting is assumed. Any medical aids – supports and orthoses*
– applied externally to the body can, if tightened excessively, lead to local
pressure symptoms or, rarely, constrict blood vessels or nerves.
Contraindications
No clinically significant hypersensitivity reactions have been reported to date. If
you have any of the following conditions, the product should only be fitted and
worn after consultation with your physician:
1. Skin disorders / injuries in the relevant part of the body, particularly if
inflammation is present. Likewise, any raised scars with swelling, redness,
and excessive heat build-up.
2. Varicose veins (varicosis).
3. Impaired sensation and circulatory disorders of the legs / feet (e. g. diabetes
mellitus)
4. Impaired lymph drainage – including soft tissue swellings of uncertain origin
located away from the fitted aid.
Application instructions
Size calculation
The orthosis is selected and fitted by a specialist after measuring the patient.
You can refer to the size chart on the packaging for the correct size.
Procedure for the first fitting of the SecuTec OA knee orthosis
Adjustment options for the hinge (to be performed by a trained specialist
only)
The hinge cover can be opened via a screw fastening. This cover fastens the
movement-limiting wedges (extension – front / flexion – rear) and also protects
the hinge mechanism against dirt.
Wedges are pre-installed at the factory. They primarily provide fixed stop
absorption during extension and they do not limit the range of motion.
• Opening the screw fastening (quarter turn until the arrow points at the "open"
symbol
allows the hinge protection to be removed and the desired limiting
wedges to be changed (
1
a – c).
4
• The desired extension and flexion wedges are selected in pairs from the
enclosed frame and are inserted into the orthosis hinges on both sides. The
following limitations are possible:
Extension: 0°, 10°, 20°, 30°, 45°; flexion: 0°, 10°, 20°, 30°, 45°, 60°, 75°, 90°;
fixation: 0°, 10°, 20°, 30°, 45°.
• Make sure that the screw fastening is showing the
symbol and click the
cover back on to the hinge. When the wedges are flush with the surface of the
cover, the screw fastening can be turned back to
.
Adjustment (only by a trained specialist)
Preparation:
• The orthosis has special gel cushions on one side in order to ensure optimal
pressure distribution.
At the factory, the gel cushions for correcting a varus knee (bandy legs) or
medial osteoarthritis of the knee are attached to the lateral hinge of the
orthosis.
In order to correct a valgus knee (knock knees) or lateral osteoarthritis of
the knee, the gel cushions need to be exchanged.
• The oblong gel cushion on the lateral side of the orthosis frame below the
knee has a cut-out for the head of the fibula. Make sure that this is in the
correct position.
• Mark the compromise pivot axis of the knee joint (as defined by Nietert) on the
leg.
• The pivot point of the orthosis hinge lies in the center of the screw fastening
on the hinge cover.
• When fitting the orthosis for the first time, start by unclicking all four quick-fit
fasteners and loosening the two other straps.
• With the knee in a slightly flexed, unloaded position, put on the SecuTec OA
in such a way that the pivot point of the orthosis hinge corresponds to the
compromise pivot axis (as defined by Nietert).
• Check the fit of the shell parts when they are laid flat to make sure their
circumference and longitudinal direction are correct and reshape them
if necessary. A bending iron with protective caps should be used for any
extensive bending work.
• The calf shell is fitted to the anatomy of the lower leg by adjusting the slant.
• The position of the strap cushions can be altered as required.
• Now close the quick-fit fasteners that are close to the hinge (#1 and #2),
followed by the ones further away (#3 and #4)
9
, and tighten the straps using
the Velcro fastening
2
.
• Check once again that the orthosis hinges are in the correct position and
tighten the Velcro straps close to the hinge (without a quick-fit fastener).
• Adjust the hinges on the lower leg frame to the shape of the leg; a slight
correction position may be set here if required
3
.
• A 3 mm Allen key can be used for a valgus / varus setting of up to 25° in each
case. The direction of rotation is marked on the orthosis
4
.
Please note: Extreme settings cause the patient pain and often offer no
therapeutic benefit.
• Turn the screw on the hinge in the direction in which the lower part of the
frame should move. A scale and a groove in the screw will help to guide you
here. The distance between two marks corresponds to a correction of 2°.
• Make the same setting on the other side in order to ensure that the shift is
parallel; this results in an optimal application of force and ensures that the
hinges are parallel
5
(varus)
6
(valgus).
• The gel condylar cushion can also be adjusted to the anatomy of the knee by
using insertable wedges to increase the size of the contact surface for the
correction. To make this adjustment, insert the wedges supplied (3 and / or
6 mm) from the front until the cushion is lying flat against the knee
Putting on the SecuTec OA
• Since the straps and their length have been adjusted by the specialist, these
do not necessarily need to be undone. To put on the orthosis, just undo the
four quick-fit fasteners.
• Put on the orthosis by holding it in front of you, placing your foot down
8
through the frame, and then pulling the frame up to your knee
• Bend your leg slightly (approx. 30°). With your fingers, feel for the position of
the kneecap. The center of the orthosis hinges is positioned at approximately
the same height as the center of the kneecap.
• The grips of the quick-fit fasteners also have numbers (1 – 4) imprinted
underneath and these indicate the best order for doing up the straps
• Click all of the quick-fit fasteners on the straps into the eyelets, starting at the
front with the fastener on the lower leg close to the hinge (#1), followed by the
one on the thigh close to the hinge (#2). Next, close the fasteners further away
from the hinge, starting with the one on the lower leg first (#3), followed by
the one on the thigh (#4).
• If the straps are too loose or too tight, you can tighten or loosen them slightly
at this point.
Attention: Straps that are too loose may cause the orthosis to slip.
• After all the straps have been closed, the orthosis must lie evenly when the
muscles are tensed.
• Once the orthosis has been put on, check once more that it is in the correct
position 10.
Taking off the SecuTec OA
• Start by taking the quick-fit fasteners out of the eyelets on the back of the
thigh frame of the orthosis.
• Next, undo the quick-fit fasteners of the straps at the front on the lower leg
part.
• The front top strap and the rear bottom strap can remain closed.
• Once you have undone all of the quick-fit fasteners, push the orthosis down
toward your foot and step out of the frame.
Cleaning instructions
Never expose the orthosis to direct heat (e. g. heater, sunlight, etc.)!
The aluminum parts of the orthosis are coated and can be cleaned using
pH-neutral soap.
We recommend washing the cushions and straps by hand at 30 °C.
This product has been tested by our own quality control system.
However, should you have any complaints, please contact your local medical
supply retailer.
Where to apply the orthosis
In accordance with the indications (knee). Please see intended purpose.
Maintenance instructions
If handled and cared for correctly, the product is practically maintenance-free.
Assembly and fitting instructions
The SecuTec OA is supplied as a pre-assembled orthosis in standard sizes. The
first fitting, which includes the hinge adjustments and the static fitting, must be
carried out by a trained specialist.
Technical specifications / parameters
The SecuTec OA is a functional orthosis for the knee joint. It consists of
a frame, hinges, straps, quick-fit fasteners, and cushions.
Notes on reuse
The SecuTec OA is intended for the treatment of one patient only.
Disposal
• This product can be disposed of according to national laws.
• For information regarding the options available for returning the packaging to
ensure it is correctly recycled, please observe the instructions from the sales
outlet where you purchased this product.
Version: 2018-06
1
Orthosis = orthopedic aid used to stabilize, relieve, immobilize, control, or correct the
limbs or the torso
2
A specialist is any person who is authorized according to the state regulations for
fitting and instruction in the use of supports that are relevant to you.
fr
français
Cette notice d'utilisation peut également être téléchargée sur:
www.bauerfeind.com/downloads
7
.
Chère cliente,
cher client,
Nous vous remercions d'avoir acheté un produit Bauerfeind. Avec la
genouillère
1
SecuTec OA, vous bénéficiez d'un produit de haute qualité
technique, médicale et thérapeutique. Veuillez lire attentivement cette notice
.
d'utilisation. Pour de plus amples renseignements, n'hésitez pas à consulter
votre médecin, votre revendeur spécialisé ou nos services techniques.
Utilisation
L'orthèse SecuTec OA est une aide thérapeutique homologuée, renforçant votre
9
.
traitement. Elle immobilise et décharge votre genou pendant le traitement
et vous aide, en association avec la gymnastique médicale, à soulager vos
douleurs. La correction de la position de la jambe permet, dans les conditions
d'application correspondantes, de soulager de manière ciblée le genou et son
appareil ligamentaire.
SecuTec OA exige une adaptation au patient qualifiée et individuelle réalisée
2
par des professionnels formés
. Ce n'est qu'ainsi que la pleine efficacité de
cette orthèse et un confort de port optimal peuvent être garantis.
Indications
• Gonarthrose médiale ou latérale
• Stabilisation post-opératoire et soulagement
5