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Ref.: TP-6400
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
TP-6400
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
Fractures of the humeral diaphysis, whether by direct or indirect trauma, pathological fractures, surgical treatment of
fractures. As an aid to the treatment of upper arm fractures associated with the elbow joint.
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:
Because it is a brace made of thermoplastic, the use of an interface between the patient and brace is recommended
(included in the package).
Because the arm is injured, it is recommended not to make any sudden movements with the upper arm when fitting the
patient with the brace.
1-Completely open all the brace straps, separating the thermoplastic sections, until there is sufficient room to comforta-
bly insert the arm. Position it so that the mechanical axis is aligned with the anatomical axis, then using a screwdriver
unscrew the guides and adjust the brace for the arm and forearm to the length of the patient's arm.
2-After checking that the size is correct, fasten the straps beginning with those nearest to the elbow joint. Then do the
same with the wrist and shoulder straps.
3-Next, pull the chest strap across to the other side, adjust and insert the traction pin until the desired tension is achieved.
4-With a permanent marker, mark the excess thermoplastic, with particular emphasis on the underarm and elbow areas,
to enable the required bending. Finally, perform the same operation at the height of the wrist so that it is not too tight
and to prevent grazes. After taking the brace off, remove the surplus thermoplastic.
E Modifying the elbow joint:
1-Open the protective cover of the elbow hinge to gain access to the screws.
2-Using the key provided, undo the screws and put them in the hinge holes provided to control the mobility of the
flex-extension length as required.
F Modifying the shoulder strap (arm / forearm support):
1-Once the articulated brace is adjusted to the upper arm, place one end of the arm support strap in the side area/
back of the humerus brace, then position it across the back towards the opposite shoulder. Pull it over the shoulder,
with the other end of the strap touching the forearm at wrist level.
2-Adjust the strap by lifting the arm to the desired level.
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
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