Orliman 3-TEX ADVANCE 7117D Manual De Instrucciones página 2

REF.: 7117D | 7117I | 3-TEX® ADVANCE
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 and arthritic pain and inflammation of the joints, tendinitis, minor instabilities. Con-
genital or acquired instabilities. As post-surgical treatment of the knee, rehabilitation processes.
Ref.: 7117:
External or internal hyperpressure syndromes and patellar subluxations.
Prevention of recurring injuries (e.g. patellar luxation).
Post-surgical treatment of the lateral or medial section of the retinaculum.
Ref.: 6121:
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:
A-Kneepads with lateral springs.
Insert kneepad ensuring it meets the triangular bone (patella) window with the kneecap placed
so that the patella surrounds the external outline of the kneecap. The lateral springs should be
parallel, placed on the medial and lateral line of the knee.
B-Kneepad with polycentric / joint.
The joints should be parallel to each other, and the mechanical shaft must meet the anatomic
shaft exactly.
C-Flexo-extension kneepad.
The joints should remain parallel to each other, the mechanical shaft should exactly meet the ana-
tomical shaft. In order to regulate the range of mobility of flexo-extension, before adapting regu-
late the degrees of flexion and extension desired, which will lift the lid of the joint. Blockage takes
place at an extension of 0°, the flexo-extension can be regulated at intervals of 0-15-30-60-90
degrees, by inserting the lock in the different corresponding orifices represented on the mobility
scale of the joint (close the lid). If a kneepad has been chosen that incorporates velcro pins, these
must be the last to be tightened.
Instructions for the orthopaedic technician:
If it is necessary to adapt the mediolateral metallic splints to the patient's anatomy:
1 – Take the orthosis off the patient and alter the joint's permitted degrees by moving the pins
responsible for flexion movement to the "FULL RANGE" position.
2 – Move the orthosis in the direction of flexion to remove the joint (including the splints).
3 – Make the modifications and place the orthosis on the patient's leg, perfecting its shape until
it comes into maximum contact with the limb. Make sure the axis of the mechanical joint coincides
with that of the anatomical joint.
NOTE: Exercise care with the anatomy of the femoral condyles: ensure the upper and lower ends
of the splints do not squeeze the thigh or calf. Carry out this operation on both the internal and
external joints, keeping their anatomical differences in mind.
Ref.: 6121
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 irrita-
tions 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 ac-
cumulation 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 sunlight etc. During use or during washing do not use
alcohols, ointments or solvents. If the orthesis is not properly dried any detergent residues could
irritate the skin and deteriorate the product.
Instructions for removing and inserting the lateral reinforcements in the knee support to facilita-
te its washing (if there are any).
Polycentric joints: Open the lid to the joint housing and remove the joint. Once washing is com-
plete and the knee support is totally dry, reinsert the joint. Ensure the housing lid is closed.
Polycentric joints with flexo-extension adjustment: open the joint lid and free the flexion pins,
this will allow removal of the joint. Once replaced, return the flexion pins to their previous posi-
tions and close the joint lid.
Precautions:
To ensure therapeutic effectiveness during normal use of the knee supports, the reinforcements
must never be manipulated or removed from their housing except by express recommendation
from the prescriber or orthopaedic technician, or if washing is required.
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.