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
4406
Fecha de emisión/Date of issue: 2021-05
Fecha de revisión/Revision date: 2022-02 | v.02
Ref.: 4406
marca
®
USE AND MAINTENANCE INSTRUCTIONS
ENGLISH
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 manipulat
-
ed 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 characteris
-
tics due to improper use, defects or breakage of any kind. The statutory regulations of the country of pur
-
chase 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, 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. Sprains. Contusions and muscle pain. 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:
1-
Place the ankle in the brace so the heel is on the circular opening.
2-Close the Velcro straps in the proximal area of the brace.
3-Place the strap below the foot (with the Velcro upwards) so it is of the same length on each side of the
foot.
4-
Cross the outer strap over the instep around the back of the ankle.
5-While maintaining the tension, fold the strap forwards around the ankle over the Achilles Tendon.
6-
Secure the strap over itself at the instep.
7-
Repeat steps 4, 5 and 6 with the strap on the inner side.
8-
If the stabilisation provided by the straps is not necessary, they can be removed.
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
(Ref.: 4406) 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 deter
-
gent residue may irritate the skin and cause the product to deteriorate.
t o y m U
