Bauerfeind Spinova Osteo Manual De Instrucciones página 4

• Stable, osteoporotic vertebral body fractures
• Osteoporosis
• Painful hunched back
• Muscular insufficiency
Risks of using this product
Caution*
Your Spinova spine orthosis must only be used according to
the specifications in these instructions for use and for the
applications listed (intended use / part of the body this product
is used for). It is a prescribed product that should be applied
under a physician's guidance.
To ensure the best possible fit and optimal function, the
orthosis must be individually adjusted to you by a trained
2
specialist (adjusting the length of the straps and pads, fitting
the reclinator to the shape of your back).
Only a trained specialist may carry out the fitting of the
orthosis and provide instruction.
Contraindications
No side effects that affect the entire body have been reported
to date. This assumes the orthosis is used / fitted correctly. Do
not put the Spinova Osteo on too tightly as this could lead to
local pressure symptoms. In rare cases, constriction of blood
vessels and nerves may occur.
If you are wearing the orthosis after surgery, have the wound
checked regularly by a physician.
Combination with other medical products should be discussed
beforehand with the physician treating you.
Application instructions
Please refer to the care instructions on the sewn­in label. The
sewn­in label contains information on the size, manufacturer,
care instructions, and CE marking and is located on the inside
of the hip support.
The Spinova Osteo must be applied over a T­shirt or undershirt.
You can also wear the Spinova Osteo over your outer clothing.
Note: Never expose the product to direct heat (e. g. heaters,
sunlight, in your car, etc.)! This may damage the material,
which can impair the effectiveness of the orthosis.
Putting on the orthosis
+ Put the tensioning straps with the shoulder pads
1 2 F
over both shoulders in the same way as you would put on
G
a backpack. Make sure that the straps are not twisted. First
position the hip support on your pelvis so that the upper
B
edge is roughly level with your iliac crest. To do this, place
3
your fingers in the hand straps provided on the support's
fastening and pull the support outward in both directions
C 4
initially to stretch the material. Then fold both halves of the
5
fastening round to the front.
Fasten the hip support by positioning the right half of the
6
fastening on top of the left half so that it can be fastened to it.
The hip support should fit tightly but comfortably .
7
+ Now take hold of both tensioning straps by releasing
8 9
the blue finger pockets from the strap attachment point
J
Pull both strap ends forward, alternating from one to
10 J
the other, until you achieve the required straightening and
stabilization effect. + Now secure the blue strap ends
11 12
flush on the center of the support's fastening . Check
J C
the fit of the support and correct the position of the shoulder
pads if necessary . The tops of the pads must not touch
G
the reclinator under any circumstances , otherwise the
A 13
straightening function of the orthosis will be reduced. Have the
shoulder pads shortened by your orthotist if necessary.
G
Note: If the strap ends overlap at the front when you have put
the orthosis on, have the straps shortened by your orthotist.
Taking off the orthosis
Release the blue strap ends from the front of the support's
J
fastening and secure these to the strap attachment points
C
at the side again. Then loosen the tensioning straps
the orthosis off. Make sure to refasten the support's fastening
after taking it off to avoid damage.
C
Cleaning instructions
If necessary, you can wash the Spinova Osteo by hand with a
mild cleaning detergent. Let the orthosis air dry.
Please do not dismantle the orthosis for cleaning.
Part of the body this product is used for
In accordance with the indications. See Purpose.
Maintenance instructions
If handled and cared for correctly, the product is practically
maintenance­free.
Components
A – Reclinator pocket with reclinator
B – Hip support
C – Support fastening with hand straps
D – Lateral strap attachment points
E – Lateral strap crossing points
F – Tensioning strap system
G – Shoulder pads
H – Pocket for reclinator pocket
I – Dorsal buckles
J – Finger pockets
Assembly and fitting instructions
The Spinova Osteo is supplied as a pre­assembled orthosis in
five standard sizes. The reclinator, straps, and shoulder pads
must be individually adjusted by a trained specialist
For an extended sizing system, the Spinova Osteo also allows
customized combinations with a choice of six different hip
support sizes and three different reclinator lengths.
Technical specifications / parameters
The Spinova Osteo is an osteoporosis orthosis for active
relief and correction of the lumbar and thoracic spine using
biofeedback (reminder function) and movement restriction in
the sagittal plane.
It consists of a padded dorsal splint (reclinator)
a strap system running over the shoulders and around the
F
torso. The circular strap is an elastic hip support
a fastening with large hand straps and strap attachment
C
points at the sides . The reclinator is located in the
D A
reclinator pocket and linked to the strap system
tensioning straps have shoulder pads , lateral strap crossing
G
points , dorsal buckles , and finger pockets
E I
ends at the front.
Notes on reuse
This product is intended for your treatment only.
. Warranty
D
The statutory regulations of the country of purchase apply.
Please first contact the retailer from whom you obtained the
product directly in the event of a potential claim under the
warranty. The product must be cleaned before submitting it in
case of warranty claims. Warranty may be limited or excluded
if the instructions on how to handle and care for the Spinova
Osteo have not been observed.
Warranty is excluded if:
• The product was not used according to the indication
• The instructions given by the specialist were not observed
• The product was modified arbitrarily
4
Duty to report
Due to regional legal regulations, you are required to
D immediately report any serious incident involving the use
and take
F of this medical device to both the manufacturer and the
responsible authority. Our contact details can be found on the
back of this brochure.
Disposal
Once you have finished using the product, please dispose of it
according to local specifications.
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 orthoses which are
relevant to you.
* Note on the risk of personal injury (risk of injury, harm to health, and
accidents) or damage to property (damage to the product).
Information for specialists
Individual fitting / assembly
Tools required:
Scissors (not included in the delivery)
Adjusting the reclinator: Spinova Osteo orthoses are available
in five ready­made sizes. The shape of the reclinator must be
adjusted to the appropriate back shape when the patient is
standing .
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The reclinator does not necessarily need to be removed from
the reclinator pocket for reshaping
with rounded edges are to be used.
Adjusting the tensioning straps and shoulder pads:
2 . The length of the straps usually need adjusting. Both the front
and back strap ends can be adjusted
The shoulder pads can also be shortened in two places. To do
this, cut along the welded seam
Assembling partially assembled versions: The 18 partially
assembled versions of the Spinova Osteo (six different hip
supports and three reclinators) must first be put together. To do
this, slide the reclinator in the reclinator pocket into the dorsal
pocket on the hip support
in the eyelets of the reclinator
be attached at three different heights to optimize the position
fitted with
A
of the straps . The pocket for the reclinator has relevant
VII
markings .
VIII
that has
B
The reclinator shape, strap lengths, and shoulder pad lengths
are adjusted as described above in the ready­made versions.
. The
F Note: The top of the reclinator must not stick out above the
shoulders. Check the optimal fit of the orthosis after adjusting
on the strap
J
it for the patient. Without individual fitting, the function of the
orthosis may be limited!
Practice the process of putting on and taking off the orthosis
correctly with the patient. Ask the patient if the orthosis is
sufficiently stable and comfortable.
No improper modifications may be made to the product.
Failure to comply with this requirement may adversely affect
product performance, thereby canceling any product liability.
The Spinova Osteo is intended for treating one patient only.
Version: 2019­06
fr français
Chère Cliente, cher Client,
Merci d'avoir choisi un produit de Bauerfeind.
Tous les jours, nous travaillons à l'amélioration de l'efficacité
médicale de nos produits, car votre santé nous tient
particulièrement à cœur. Veuillez lire attentivement la notice
d'utilisation. Pour toutes questions, veuillez­vous adresser à
votre médecin ou à votre revendeur spécialisé.
Utilisation
Spinova Osteo est un dispositif médical. Il s'agit d'une orthèse
destinée à la stabilisation de la colonne vertébrale et au redres­
sement du haut du corps.
Indications
L'orthèse Spinova Osteo vous apporte une aide pour toutes
les indications nécessitant un redressement actif visant
le soulagement et la correction de la région lombaire et
2
thoracique de la colonne vertébrale ainsi qu'une restriction
dans les mouvements du torse.
• Fractures vertébrales ostéoporotiques, fractures stables
• Ostéoporose
• Douleur du dos rond
• Insuffisance musculaire
Risques d'utilisation
Attention*
Votre orthèse pour colonne vertébrale Spinova doit être
. If required, bending irons
I
portée conformément aux recommandations de cette notice
d'utilisation et dans le respect des indications données
(Utilisation / Position d'utilisation). Il s'agit d'un produit soumis
à la prescription et qui doit être porté sous contrôle médical.
+
.
II III
Pour garantir un positionnement et un fonctionnement
optimaux de l'orthèse, le produit doit être exactement ajusté
.
IV
à votre corps par un professionnel formé
la longueur des sangles et des coussinets, adaptation du
réclinateur à la forme du dos).
Seul un professionnel formé est habilité à procéder à
l'adaptation et à la mise en place.
, then secure the dorsal buckles
V
Contre-indications
. The dorsal strap ends can
VI
À ce jour, aucun effet secondaire affectant l'ensemble de l'or­
ganisme n'est connu. Il est cependant indispensable que ce
dispositif soit correctement mis en place et utilisé. L'orthèse
Spinova Osteo ne doit pas être portée trop serrée afin d'éviter
des pressions locales excessives. Une compression des vais­
seaux sanguins et des nerfs est possible dans de rares cas.
Dans le cas d'une orthèse portée suite à une opération, faites
contrôler régulièrement la cicatrice par un médecin.
Une combinaison avec d'autres produits médicaux doit
préalablement faire l'objet d'une discussion avec votre médecin
traitant.
Conseils d'utilisation
Veuillez tenir compte des conseils d'entretien sur l'étiquette
cousue. L'étiquette cousue comprenant des informations sur
la taille, le fabricant, les conseils d'entretien et le sigle CE se
trouve à l'intérieur du bandage de bassin.
Portez l'orthèse Spinova Osteo par­dessus un t­shirt ou un
maillot de corps. Spinova Osteo peut également être portée
par­dessus vos vêtements.
Remarque : N'exposez jamais le produit à la chaleur
directe (par ex. chauffage, soleil, dans une voiture) !
Des détériorations du matériau ne sont pas exclues.
Cela peut limiter l'efficacité de l'orthèse.
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1
2 (adaptation de