Bauerfeind SofTec Lumbo Guia Del Usuario página 6

Notes on reuse
This product is intended for
your treatment only.
Warranty
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
SofTec Lumbo 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
Duty to report
Due to regional legal regulations, you are required to immediately report
any serious incident involving the use 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.
Version: 2019-08
1 Orthosis = orthopaedic appliance used to stabilize, relieve, immobilize, control
or correct the limbs or the torso
Orthopedic Technician:
Application instructions
Fitting and removing SofTec Lumbo
Despite its special design, SofTec Lumbo is always fitted and removed in
the same way at all stages.
Fitting:
• Place the support around the trunk so that the inserts for the CFR and
corset rods on the outer knitted section are positioned parallel to the
spine (Fig. 1).
• The shell is adjusted individually by the orthopaedic technician and must
be positioned uniformly over the iliac crests (Fig. 2).
• When the lower knitted section is being closed (if possible by the patient)
ensure that the support is correctly centered (Fig. 3).
• The individually adjusted shell with the precontoured pelvic indentations
must must sit loosely on the iliac crests. When fitting the support
without the shell, ensure that it is correctly positioned (labels at the top).
• For individual adaptation of the shell, the wedges can be cut into or cut
out and the shell adapted accordingly (Fig. 4).
• Place the fingers in the specially provided loops on the two halves of the
light grey fastener and pull evenly forward (Fig. 5).
• Press the left half of the fastener against the patient's stomach and
pull the right half over it to secure the Velcro fastening (Fig. 6). Ensure
that the pressure pad for the abdominal wall, if inserted, is positioned
correctly (this pressure pad should be fastened in the center of the left,
underlying Velcro fastening).
• When securing the Velcro fastening, remove the fingers from the left
loop first, followed by the right loop.
• Take hold of the two LPT (Low Power Tension) straps in both hands and
pull evenly forwards until the correct level of tension is reached (Fig. 7).
Secure both LPT straps onto the large fastening (Fig. 8). With the "long"
version, always fasten the distal (lower) straps first, followed by the
proximal (upper) straps. The plastic buckles on the LPT straps can be
shaped by thermoplastic formation (i. e. with the application of heat) if
necessary.
• Check, and if necessary correct, the optimal, individual fit.
• The CFR rods in the outer knitted section are made of shapable
thermoplastic material. To remove the rods (also when changing the
corset rods), open the inserts at the top. When re-inserting the CFR rods,
check the markings for correct orientation (top / bottom and left / right)
(Fig. 9).
• Correct fitting of the support should be practiced by the patient with the
help of the orthopaedic technician.
Removal:
• Undo the Velcro fastenings of the LPT straps on the outer knitted section
and pull back the straps to loosen the support and fasten the ends of the
straps to the retracted sections.
• Undo the two halves of the light grey fastener.
• Remove the support and reclose the light grey fastener.
Adapting SofTec Lumbo
• The shell must be adapted to the patient's individual anatomy. Pressure
points must be avoided at all costs. The plastic shell can be heated to
approx. 80 °C (176 °F) using a hot-air gun.
• The CFR rods can also be heated and reshaped.
Note: When SofTec Lumbo is used after stabilizing operations
(spondylodeses), the CFR rods must be shaped to match the nor-
mal spinal curvature (angle of anatomical lordosis) in order to avoid
the transfer of excessive straightening forces (lordosis flattening).
• When using SofTec Lumbo for bridging the lordosis, insert the straight
CFR rods as supplied with the convex side facing outwards (instead of
shaping them to match the body's contours as for stabilization of the
lordosis).
• If bending hooks are employed, only round bending hooks should be
used.
• Instructions for removing the shell and rods are provided under "Product
care".
• The ideal temperature for molding is between 170 °C and 190 °C or
338 °F and 374 °F. Heating at higher temperatures will damage the
material.
• When heating carbon / glass-fibres keep the material a minimum
distance of 1,97 inch from the heat source to avoid burning the surface.
• The carbon / glass-fibre should be heated evenly across the surface to
avoid damaging the material.
In that case Bauerfeind will not be liable
for the product.
• The material should only be bent gently and in large arches.
• The cooling process can be accelerated using cold water which will not
change the material's characteristics.
• The material can be heated and molded repeatedly.
• The heating process does not visually alter the surface of the material.
In order to find out the appropriate time for bending, test it during the
heating process.
• Check the fit of the support on the standing and sitting patient after each
modification.
• Local pressure points exerted on the skin or around the iliac crests must
be avoided at all costs.
fr français
Chère cliente, cher client,
merci d'avoir choisi un produit 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,
veuillez vous adresser à votre médecin ou à votre revendeur spécialisé.
Utilisation
SofTec Lumbo est un dispositif médical. Il s'agit d'une orthèse
d'immobilisation des vertèbres lombaires avec fonction de mobilisation
sur 3 niveaux.
Niveau 1 (phase d'immobilisation) :
Protection de la colonne vertébrale après une opération ou au
commencement d'un traitement non chirurgical via l'emploi d'une coque.
Niveau 2 (phase de mobilisation) :
Accompagnée d'un processus de guérison progressif, la coque est retirée
pour la mobilisation et est remplacée par des baleines en PRFC (baleines
en plastique renforcé de fibres de carbone) insérées dans le tricot.
Niveau 3 (phase d'activité) :
Lorsque l'activité augmente, les baleines en PRFC sont remplacées par
des baleines de corset afin de réduire l'effet de soutien externe.
Votre orthèse SofTec Lumbo demande une adaptation à votre
morphologie par un technicien ortho pédiste. Grâce à cela, vous
bénéficierez de l'efficacité totale et du confort optimal de votre
orthèse. Tout droit à la garantie expire en cas d'utilisation non
conforme du produit.
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