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: [email protected] · Export mail: [email protected]
www.orliman.com
4404
Fecha de emisión/Date of issue: 2021-06
Fecha de revisión/Revision date: 2021-06 | v.01
Ref.: 4404
USE AND MAINTENANCE INSTRUCTIONS
ENGLISH
EN
GUARANTEE 6 months since purchase date
EN
Reference
EN
lot no.
EN
Purchase date
EN
Stamp and signature of local
stockist
EN
To validate the warranty your local stockist should indicate the purchase
date.
EN
The manufacturing date is included in the batch number which can be found on the packaging
label as
x
, in the following way: the second and third digits represent the year of manufacture and
the fourth and fifth digits represent the month.
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 compatible and made by Orliman
®
. It does not guarantee any products with altered characteristics due to
improper use, defects or breakage of any kind. To use the warranty, go to the place where you bought the prod
-
uct as they must complete the warranty information table on this instructions sheet. 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,
minimising the existing risks. Tests have been in accordance with European Regulation UNE-EN ISO 22523 on
Prostheses and Orthoses.
INDICATIONS
Arthrosis and arthritis. Tendinitis and bursitis. Progressive treatment of second degree sprains and prevention
of relapses. Instability and joint stiffness. Support and protection for sports. Post-surgical and post-trauma
treatment.
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
professional 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:
A
FITTING THE THERMOPLASTIC PLATES:
1-External/lateral malleolar plate: It is identified by (EXT) on the side where it must be fitted. Depending
on whether it is being used with the right or left foot, it shall be placed on the outside of the ankle in the
corresponding pocket.
2-Inner/medial malleolar plate: It is identified by (INT) on the side where it must be fitted. Depending on
whether it is being used with the right or left foot, it shall be placed on the inside of the ankle in the corres
-
ponding pocket.
B
ADJUSTING THE ANKLE BRACE:
1-Loosen the straps on the front of the brace by pulling up the Velcro.
2-Place the foot in the ankle brace with the heel properly inside the corresponding back gap. Adjust the tension
of the straps and tighten for a firm and comfortable fit.
C
FITTING THE SEMI-RIGID PLATE:
1-Place one end of the strap on the base of the middle of the foot. Make sure the direction of the strap is correct
based on whether medial or lateral ankle instability needs to be supported. Wrap the strap (to the inside or
outside), raising it over the back of the foot. Then, wrap around the edge of the ankle on the back above the
malleolus and secure the Velcro on the end over the same strap.
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.
Products marked with the
l
symbol contain natural rubber latex and can cause allergic reactions in people
sensitive to latex.
Products marked with the
o
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 thera
-
peutic 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 substanc
-
es, 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
