Use And Maintenance Instructions - orliman oneplus OPL480 Gebrauchs- Und Pflegeanleitung

Ref.: OPL480
marca
The manufacturing date is included in the batch number which can be found on the packaging
EN
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label as , in the following way: the second and third digits represent the year of manufacture and
the fourth and fifth digits represent the month.
ORLIMAN S. L. U.
C/ Ausias March, 3 - Pol. Ind. La Pobla-L´Eliana
Apdo. de correos 49 · C.P.: 46185
La Pobla de Vallbona Valencia - España (Spain)
Tel.: +34 96 272 57 04 - Fax: +34 96 275 87 00
Tel. Exportación: +34 96 274 23 33
E-mail: orto@orliman.com · Export mail: export@orliman.com
www.orliman.com
OPL480
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
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USE AND MAINTENANCE INSTRUCTIONS

INSTRUCTIONS FOR USE, STORAGE AND WARRANTY
Dear Customer,
Thank you very much for placing your trust in an Orliman product. Please read the instructions carefully. Keep these
instructions and the packaging for future reference. If you have any questions or concerns, please contact your doctor,
orthopaedic specialist or our customer service department.
ORLIMAN S.L.U. guarantees all its products as long as the original configuration has not been manipulated or altered
except for the intended use as described in these instructions.
If the products are used in combination with other products, replacement parts or systems, make sure they are compat-
ible and made by Orliman . It does not guarantee any products with altered characteristics due to improper use, defects
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or breakage of any kind. 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. If any serious incidents
related to the product occur, notify Orliman S.L.U. and the corresponding competent authority in your country.
Orliman would like to thank you for choosing this product and hopes you a speedy recovery.
REGULATIONS
d
This article is defined as a class I medical device. A Risk Analysis (UNE EN ISO 14971) has been carried out, min-
imising the existing risks. Tests have been in accordance with European Regulation UNE-EN ISO 22523 on Prostheses
and Orthoses.
INDICATIONS
⋅ Osteoarthritis and arthritis.
⋅ Capsuloligamentous contusions.
⋅ Chronic osteoarticular instability.
⋅ Post-surgical and post-traumatic treatment.
⋅ Lateral instabilities of the knee varus or valgus (using the rigid polycentric joint).
FITTING INSTRUCTIONS
For best therapeutic results considering different pathologies and to extend the useful life of the product, it is essential
to choose the correct size for each patient or user. Excessive compression may be intolerable; adjusting the compression
to be firm yet comfortable is recommended.
If the product must be adapted, any such adjustments must be done by an orthopaedic specialist or healthcare profes-
sional legally certified to do so who must make sure the end user or person responsible for fitting the product properly
understands how it works and should be used.
When fitting the product, you must adhere to the following instructions:
1-Open the straps located at the front and back of the brace, unfastening their Velcros.
2-Open the 2 wraparound thigh and calf bands, unfastening their Velcros.
3-Fit the brace to the front of the knee so that the patella pad surrounds the outer edges of the patella. The joints must
be parallel to each other and the mechanical axis must coincide with the axis of the anatomical joint.
4-Close the thigh and calf bands, attaching their Velcros to the corresponding contralateral areas.
5-Close the 2 straps at the back, passing them through the respective loops in the bands. Then close the two front straps.
To adjust the length of the straps, unfasten the tongue with Velcro/velour and trim the fabric to the required size.
When it is necessary to fit the joint splints to the morphology of the patient:
1-Remove the joints from the brace following the instructions below for each model:
A. OPL480/OPL481 models:
A1. Remove the brace from the patient and extract the joints through the upper area of the cover.
B. OPL482/OPL483 models:
B1. Remove the brace from the patient and adjust the joint's permitted degrees by moving the pins responsible for
flexion to the "FULL RANGE" position.
B2. Articulate the brace in the direction of flexion to enable the joint to be removed (including the splints).
2-Make the modifications and adjust its shape until it comes into maximum possible contact with the limb. Make sure
that the axis of the mechanical joint coincides with that of the anatomical joint.
NOTE: Ensure that the morphology of the femoral condyles is respected: prevent the upper and lower ends of the splints
from exerting pressure on the thigh and calf. Carry out this operation on both the internal and external joints, keeping
their anatomical differences in mind.
p PRECAUTIONS
Before each use, check that all product components are present as per the fitting process. Periodically check the
conditions of the product. If you observe any defect or anomaly, immediately report it to the issuing establishment.
This product is made of inflammable material. Do not expose the products to situations that could set them on fire. In
the event of a fire, quickly get them off your body and use the proper resources to extinguish the fire.
To avoid minor discomfort caused by sweating, we recommend using some type of cotton fabric to separate the skin
from contact with the product material. For discomfort such as chafing, irritation and swelling, remove the product
and see a doctor or orthopaedic specialist. The product should only be used on healthy skin. It is not recommended
for use over open scars with swelling, redness or hotspots.
l
Products marked with the symbol contain natural rubber latex and can cause allergic reactions in people sensitive
to latex.
o
Products marked with the symbol contain ferromagnetic components and, therefore, extreme precaution must be
taken if you undergo an MRI scan or are exposed to radiation associated with diagnostic or therapeutic procedures.
RECOMMENDATIONS-WARNINGS
The use of these products is conditioned by the indications. Although the product is not defined as a single-use device,
using it on a single patient only is recommended and only for the intended purposes as described in these instructions
or by a healthcare professional.
When disposing of the product and its packaging, you must strictly adhere to the legal regulations in your community.
RECOMMENDATIONS FOR STORAGE AND WASHING
When not using the product, store it in the original packaging in a dry place at room temperature. Stick the Velcro to each
other (if the orthotic device has them), frequently wash by hand with warm water (30º C max.) and mild soap. To dry the
product, use a dry towel to absorb as much moisture as possible and let it dry at room temperature. Do not hang it up or
iron the product and do not expose it to direct heat sources such as stoves, dryers, direct sun exposure, etc. When using
or cleaning the product, do not use abrasive or corrosive substances, alcohol, ointments or liquid solvents. If not dried off
properly, the detergent residue may irritate the skin and cause the product to deteriorate.
t o y m U
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