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
4109
Fecha de emisión/Date of issue: 2021-06
Fecha de revisión/Revision date: 2021-06 | v.01
Ref.: 4109
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
Anterior cruciate ligament injury. Posterior cruciate ligament injury. 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
PUTTING ON THE KNEE BRACE:
1-Hold the knee brace with the thumb on the inside of the stabilisers and put the knee brace on the leg.
2-Make sure the patellar hole coincides with the kneecap so the patellar donut surrounds the outer edges of
the kneecap.
3-The lateral stabilisers must be parallel in the middle and at the side of the knee.
4- Adjust the fastening straps based on the injured cruciate ligament:
B
FITTING FOR AN ANTERIOR CRUCIATE LIGAMENT INJURY:
1-Wrap the upper (proximal) strap around the back of the thigh. Then, insert it into the buckle, close the strap
over itself using the Velcro. If necessary, cut the strap to fit after removing the pin. Once cut to fit, re-insert
the pin.
2-Cross each lower (distal) strap over the front counter-lateral buckle and secure one strap over the other using
the Velcro. If necessary, cut the strap to fit after removing the pin. Once cut to fit, re-insert the pin.
C
FITTING FOR A POSTERIOR CRUCIATE LIGAMENT INJURY:
1-Wrap the upper (proximal) strap around the front of the thigh. Then, insert it into the buckle, close the strap
over itself using the Velcro. If necessary, cut the strap to fit after removing the pin. Once cut to fit, re-insert
the pin.
2-Cross each lower (distal) strap over the back counter-lateral buckle and secure one strap over the other using
the Velcro. If necessary, cut the strap to fit after removing the pin. Once cut to fit, re-insert the pin.
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.: 4109) symbol contain ferromagnetic components and, therefore, ex
-
treme 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 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
