Use And Maintenance Instructions - Orliman TP-2100.1 Instrucciones De Uso Y Conservación

Ref.: TP-2100.1
marca
The manufacturing date is included in the batch number which can be found on the packaging
EN
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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-2100.1
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
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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
compatible and made by Orliman . It does not guarantee any products with altered characteristics due to im-
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proper 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
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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
The splint is suitable for: Post-operative care of the knee, hip and foot, where there is a need for control of the
rotation of the lower limb. (neutral position, internal rotation or external rotation).
A splint to control and position the lower end of patients that are confined to a bed for long periods of time. (In-
tensive care unit), as a system to prevent deformations in patients confined to a bed (prevention), hemiplegia,
paralysis of the lower limb. In cases of chronic pain of the plantar fascia (Plantar Fasciitis).
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:
Before fitting the orthesis on the patient, regulate the plantar or dorsal flexion by means of the medial and
lateral straps at a range of 75º, in 15º intervals. (following the specialist's instructions)
Subsequently regulate the internal and external rotation at the base of the triangle. (from 0º to 15º).
Place and insert the foot inside the splint.
Finally adjust the central pin, by tightening the forefoot and calf pin, and centralising the corresponding cush-
ions.
Ref.: TPA-2100.1
Remove the mid-side ankle adjustment strips and replace them with the continuous guide strips for active
rehabilitation.
Press the screws on the guide to enable them to slide, then fasten the Velcro strips (large size) at the base of the
foot as close as possible to the toes, and the 2 Velcro strips (small size) on the sides of the calf, positioning them
in the direction that the elastic strap is pulled.
Finally, attach the elastic strap to the base of the foot; pull the elastic as tightly as required, and attach with
the side Velcro strips.
PRECAUTIONS
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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 thera-
peutic 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.
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