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
94240
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
Ref.: 94240
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 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
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
Instability of the knee, post operative and post-traumatic knee rehabilitation and relative immobilisation of the knee
joint in situations that require a perfect control. To obtain a range of mobility of the operated knee (crossed ligament
surgery).
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:
Instructions on tightening the mechanical joint:
1-With the mechanical joints slightly in flexion, open the lid of the mechanical joint, change the locks to the desired
positions and close the lid. To avoid any damage to the mechanical joints, both lock flexions should be placed in
identical positions.
2-Place the patient in decubitus supine (lying face up) wrap the leg firmly in the rubber foam cushions of the calf and
thigh and secure them to the front of the leg.
3-The joint/articulation bars can be folded in order to follow the inner or outer outline, above and below the mechanical
joint. With the leg as fully extended as possible, adapt the medial and lateral bar to the morphology of the patient
ensuring the mechanical shaft meets the anatomical shaft. Secure them over the rubber foam cushion ensuring they
meet the central line of the leg. The lateral malleolus and the greater trocanter are good reference points for the
alignment.
4-Repeat the same procedure with the medial bar ensuring the height of the medial and lateral mechanical joints are
the same. Insert the velcro fasteners through the slides, firstly adjusting those closest to the knee, then adjusting the
remaining fasteners.
In order to remove the orthesis in one piece, firstly loosen the velcro fasteners and then open the rubber foam cushions,
this way the orthesis can be removed as one piece.
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 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
