Orliman TOB-500B Instrucciones De Uso página 2

REF.: TOB-500B | TOB-500N
English
INSTRUCTIONS FOR USE AND PRESERVATION
Dear customer,
Thank you for your trust in this Orliman product. You have acquired a quality product with a high
medicinal value. Please, read the instructions carefully. If you have any doubt, get in contact with
your doctor, your orthopaedist specialist or our customer service department. Orliman appreci-
ates your choice and wishes you a speedy recovery.
REGULATION
These products satisfy the European Medical Device Directive 93/42/CEE (RD. 1591/2009). A Risk
Analysis has been carried out (UNE EN ISO 14971) minimising all the existing risks. The trials have
been carried out in accordance with the European regulation UNE-EN ISO 22523 of Prosthesis and
Orthesis.
SUITABLE FOR
Ankle supports in general:
Minor sprains, tendinitis, post-operative care, relapses, prevention during sporting activities,
ligament instability.
FITTING INSTRUCTIONS
THE PRODUCT SHOULD BE ADJUSTED BY YOUR ORTHOPAEDIC TECHNICIAN OR IN ACCORDANCE
WITH DOCTOR'S ORDERS.
In order to obtain a greater degree of therapeutic effectiveness in the different pathologies and to
prolong the life and utility of the product, it is fundamental that the correct size adequate for each
patient or user is chosen (enclosed in the packet is a diagram with all the sizes and the equivalent
in centimetres). An excess compression can produce intolerance, therefore we recommend that
the compression be regulated to an optimum degree.
To fit observe the following aspects:
A-DEPENDING ON THE PRODUCT:
Ankle supports in general:
For correct fitting insert the foot into the ankle support placing the heel in its corresponding pos-
terior window, in the case of an open ankle support, tighten the velcros or zip according to the
model, located in the upper front side. Crossed dressings: if it incorporates elastic pins with an
inward direction or outward direction, secure one end of the pin to the base of the centre of the
foot, directing the pin towards an internal or external direction lifting it by the forefoot embracing
the opposite malleolus, and fixing the remaining end over the ankle support. Ensure the direction
of the pin is correctly placed according to whether it be a medial or lateral instability of the ankle.
B-STABILISING ANKLE SUPPORTS THAT INCORPORATE MALLEOLI PLATES:
Due to the design of this type of ankle support, we can choose between the following:
⋅ Conventional ankle support: the ankle support used without plates and without traction pins,
acts as an ankle support with compression.
⋅ Ankle support with pins: Adapting the traction pin either in the inward or outward sense would
grant a greater medial or lateral stabilisation.
⋅ Ankle support with pins and malleoli plates: Adapting the outward/inward pins and the thermo-
plastic malleoli to the ankle support would allow a complete stability of the medio lateral tibio
tarsal joint. Note: the plates can be placed medial, lateral or both ways according to the patients
needs.
Note-Caution: the ankle support, incorporates an internal and external plastic malleolus plate, it
is very important not to confuse them, as it could produce scratches and irritation. To enable this
difference the exterior plate has been marked with (EXT) and the interior (INT).
How do you fit the plates?
⋅ External malleolus plate: Carries an identification on the front that should be placed according to
whether the right foot or the left foot is being treated. It should be placed on the external part of
the ankle support inserting it into its corresponding pocket.
⋅ Internal malleolus plate: Carries an identification on the front that should be placed according to
whether the right foot or the left foot is being treated, place on the medial side of the ankle sup-
port, inserting it into its corresponding pocket.
C- TOB-500:
The dressing should be placed with a flexion of 90º and slight eversion (biomechanical resting
position).
Place the elastic sock (ankle support), making sure the dark area (area of greater compression)
meets the heel, avoiding undesired joint movement.
Tighten the traction pin over the velcro on the external side of the ankle, creating an inward trac-
tion movement.
Surround the ankle with the elastic clasp and close the external one allowing both to meet the
velcro on the other side.
Tension of the dressing: should not produce marks on the skin, painful points or changes in the
colour or temperature of the skin, if any of these are detected remove the dressing.
PRECAUTIONS
The constructive material is inflammable.
Do not expose these products to situations where they could ignite. If this were the case remove
them quickly and use the necessary measures to put it out. The material used is hypoallergenic,
however we cannot guarantee 100% that in some determined cases it will not produce allergies, if
this occurs, remove the product and see the doctor that prescribed it.
In case of minor irritations due to sweat, we recommend the use of a cotton sock, to separate
the skin from contact with the material. For small inconvenience caused by sweat, we recommend
using an interface to separate the skin from contact with the tissue. If rash, irritation or swell-
ing to remove the product and consult a doctor or prosthetist. Contraindicated in open scars with
swelling, redness and accumulation heat. The product contains natural rubber latex and may elicit
allergic responses in individuals who are sensitised to latex.
RECOMMENDATION-WARNINGS
These products are to be used only by those which have been medically prescribed to do so. Per-
sons unconnected to such prescriptions should not use them. When the product is not being used,
store in its original packaging. In order to dispose of the packaging and the product, strictly com-
ply with the legal norms of your community.
The use of the orthesis is conditioned to the recommendations of the prescribing doctor, therefore
it must not be used for any other means than those prescribed.
For the validity of the guarantee, the issuing establishment should comply with this sheet of in-
structions.
MANUFACTURE-CHARACTERISTICS
The material features used in production have been tested and approved and meet all the Euro-
pean quality requirements.
All the products are produced with high quality materials and offer an unbeatable comfort and
quality of use. All products offer restraint, stability and compression for the optimum treatment of
the pathologies for which they have been designed.
RECOMMENDATIONS FOR PRESERVATION AND CLEANING
Stick the velcros to each other (if the orthesis has any), wash periodically by hand with a damp
cloth and a neutral soap. To dry the orthesis, use a dry towel to absorb most of the dampness and
leave to dry at room temperature. Do not hang up or iron and do not expose to direct heat sources
such as stoves, heaters, radiators, direct sun light etc. During use or during washing do not use al-
cohols, ointments or dissolvent liquids. If the orthesis is not properly dried any detergent residues
could irritate the skin and deteriorate the product.
GUARANTEES
ORLIMAN, S.L.U. Guarantees all its products, as long as these have not been manipulated or al-
tered from their original state. Does not guarantee those products in which as a result of misuse,
deficiencies or breakage of any kind, its original state has been altered. If you observe any defi-
ciency or anomaly, communicate this immediately to the establishment from which it was obtained
in order for it to be changed.
ORLIMAN, S.L.U. Appreciates your choice and wishes you a speedy recovery.