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
OCR300
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
Ref.: OCR300
Gonartec
®
Plus
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
⋅
Mild or moderate unicompartmental knee osteoarthritis (medial or lateral).
⋅
Genu valgum or varum associated with osteoarthritis.
⋅
Medial or lateral meniscus injury.
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:
A
Adjusting flexion and extension:
The brace is supplied with a set of stops to adjust flexion and extension. (It comes with a pre-installed 0° extension stop).
1-Select the desired stop and, using a screwdriver, remove the screws to enable the stop to be inserted.
2-After inserting the stop, tighten the screw to fasten the cover and the stop. Repeat this process to adjust both the
flexion and extension directions.
B
Fitting the brace:
1-Remove the buckles from their fixing point on the rigid structure to allow the brace to be fitted comfortably.
2-With the patient sitting on the edge of a chair and holding the knee at 45° of flexion, fit the brace to the knee, ensuring
that the mechanical axis of the joint coincides with the anatomical axis. Make sure that the knee brace does not rotate
around the leg.
3-Fasten the brace by inserting the buckles into their slots.
4-Then tighten the thigh and calf straps in number order from 1 to 4.
5-Check the straps for tightness and ask the patient to stand and walk around to make sure that it is correctly adjusted
and fastened. If the length of the straps needs to be shortened, do so by trimming the fastening end and never the
pulling end.
6-
Once the length of the straps is shortened, the knee brace can be fitted and removed by just using the buckle’s fas
-
tening/quick release.
C
Adjusting varus/valgus alignment:
1-Using a 3 mm Allen key, adjust the angle of the thigh piece with respect to the calf in the following directions:
2-Clockwise: valgus.
3-Anti-clockwise: varus.
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
