Orliman GONARTEC 6121D Instrucciones De Uso página 2

REF.: 6121D | 6121I | GONARTEC®
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
Arthrosis of the tibio-femoral compartments, arthrotic valgus and varus, meniscal injuries, gonar-
throsis.
Function: When inflating the cushion, increase the medial or lateral compression for knee valgus
or varus, in order to obtain an opening in the other tibio-femoral compartment, minimising condy-
lar loads on the superior extremity of the tibia.
The polycentric articulation, along with the inflatable cushion will contribute to an improved align-
ment.
Open the tibio-femoral compartment in meniscal injuries.
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:
1-Open the knee brace fully, both the femur and tibia straps, as well as the velcro closures at the
front of the thigh and the back of the calf.
2-Introduce the foot into the knee support, sliding it upwards until the infrapatellar donut matches
the lower edge of the kneecap.
3-Adjust calf and femur closures.
4-Adjust the straps for knee varus or valgus
5-Next adjust thigh and calf straps.
6-Proceed to inflate the internal air cushion to desired compression.
Note:
The polycentric atriculation shells must be adjusted to the morphology of the patient, keeping in
mind whether it is to be used to correct knee varus or valgus, or if it is to be fitted on the medial or
external portion of the knee.
Keep in mind:
Right-handed version: right knee varus or left knee valgus.
Left-handed version: left knee varus or right knee valgus.
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 swelling
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
alcohols, ointments or dissolvent liquids. If the orthesis is not properly dried any detergent resi-
dues could irritate the skin and deteriorate the product.
Instructions on removing and placing the lateral reinforcements inserted in the kneepad, to en-
able cleaning. Pull from both ends of the kneepad until the joints or springs appear through the
upper opening. Once the cleansing has been carried out and when the kneepad is completely dry,
reinsert the reinforcements
Precautions: To ensure the therapeutic effectiveness during normal use of the kneepads, the
reinforcements should never be handled or removed from their home, other than for cleaning
purposes or under strict recommendation by the prescribing doctor or orthopaedic tecnician.
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 de-
ficiency or anomaly, communicate this immediately to the establishment from which it was ob-
tained in order for it to be changed.
ORLIMAN, S.L.U. Appreciates your choice and wishes you a speedy recovery.