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Ref.: C-45
marca
The manufacturing date is included in the batch number which can be found on the packaging
EN
x
label as
, in the following way: the second and third digits represent the year of manufacture and
the fourth and fifth digits represent the month.
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: orto@orliman.com · Export mail: export@orliman.com
www.orliman.com
C-45
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
®
USE AND MAINTENANCE INSTRUCTIONS
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
⋅ As an orthopaedic positioning method for sprains, luxation, glenohumeral subluxation.
⋅ Capsular displacement.
⋅ As a conservative treatment for acute and chronic bursitis.
⋅ Rotator cuff repair surgery.
⋅ Shoulder endoprosthesis implantation.
⋅ Adhesive capsulitis.
⋅ Entrapment syndrome.
⋅ After arthroscopic treatment of Bankhart lesions.
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 Adjustment by the technician:
The distance from the ball hand can be adjusted by the support plate to do this, remove the Velcro fastening, then
slide the plate along the guide until it is in the correct position and then secure it with Velcro fasteners.
Place the abductor pad on the side of the affected arm at the height of the forearm with the elbow flexed at 90°,
fasten it to the waist by means of the strap, adjust its length so that it is tight and fasten it with the closure system.
The position of the hand exercise ball can be adjusted with the support splint. To do so, undo the Velcro, slide the
splint along the guide until it reaches the correct position and then fasten with the Velcro.
Place the forearm into the sling, secure it to the abductor pad with the Velcro and position the stabilising and limiting
straps using the following steps* (If 30º of abduction is required, add the other 15° wedge to the first abductor pad
and fasten it with the Velcro - see picture C).
B Patient fitting:
3 elements:
Pad - bilateral (with Velcro and adjustment system for the splint with ball).
Splint with ball.
Sling.
*The sling can be adapted for use with the right or left arm. Por that the shoulder straps and fastening trunk must be
reversed, so that the shoulder strap to be passed to the girth of the side and vice versa.
To do so, the fastening straps have different colours:
Left arm: the shoulder strap is marked blue
Right arm: the shoulder strap is marked orange
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.
l
Products marked with the
symbol contain natural rubber latex and can cause allergic reactions in people sensitive
to latex.
o
Products marked with the
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
and the chest strap orange
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and the chest strap blue
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