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Ref.: LI1005
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The manufacturing date is included in the batch number which can be found on the packaging
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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
LI1005
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2021-09 | 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 de-
partment.
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 prod-
ucts, replacement parts or systems, make sure they are
compatible 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 regula-
tions 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 Orli-
man 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,
minimising the existing risks. Tests have been in accord-
ance with European Regulation UNE-EN ISO 22523 on
Prostheses and Orthoses.
INDICATIONS
Recommended for patients with tibial amputations.
FITTING INSTRUCTIONS
For best therapeutic results considering different pathol-
ogies and to extend the useful life of the product, it is es-
sential 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:
LI1001, LI1002, LI1003, LI1004:
A Selecting the size:
Selecting the size is of utmost importance because a
wrong size could cause perspiration problems and a lack
of precision in adjusting the prosthesis and while moving;
the stabilising matrix and the distal umbrella has to be fit-
ted to the stump exactly. This is why Orliman has a wide
range of sizes, in this way covering the needs of the differ-
ent morphologies of the tibial stumps (see table of sizes).
To select the right size take the measurement at the stump
of the patient 4 cm away from the distal end, and then
select the size below the measurement obtained, carrying
out a test on the patient so as to do a check prior to the
casting process. In the case of there being an amputee
who is having his first prosthetic device fitted, the swift
reduction in the girth of his stump may make it necessary
to select two sizes below the liner size.
(Never choose a size above the measurement or round it
upwards).
Example: Circumference measurement of the stump at
4cm: 24, you should choose the 23.5 cm size).
B Fitting:
To carry out the fitting of the liner on the stump, turn it
completely inside out as if it were a sock, keeping the tex-
tile surface on the inside and medical silicone on the out-
side, checking that it is clean and dry. Then place the distal
cup of the liner on the distal end of the stump, unrolling it
over the stump and making sure there are no wrinkles or
air pockets and that the fabrics are properly in place. The
distal umbrella has to be as close to the centre as possible,
enabling the fastening pin to be properly aligned. Then
fit the casing in place using the shuttle lock or any other
system of suspension that is selected, in this way obtain-
ing the proper and secure adaptation to the prothesis. Our
umbrella system make it possible to adapt any standard
pin on the market for use as it is compatible with all of
them.
Avoid tugging on the upper end while it is being fitted,
preventing tensions on the skin and soft tissue, and also
avoid using sharp objects or digging your nails in which
could damage the liner.
Remember that it is unnecessary to use talcum powder,
spray or any other additional substance in fitting this.
LI1005:
1-Firstly, measure the circumference of the patient's thigh
to find out the right size.
2-Once the size has been selected, fit the knee support
over the rigid socket of the prosthesis, fold down the top
so that the stump can be inserted into the socket and
then pull it up over the thigh.
3-The 10 cm proximal part of the knee support does not
have to touch the rigid edge of the socket.
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 establish-
ment.
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 rec-
ommend using some type of cotton fabric to separate
the skin from contact with the product material. For dis-
comfort 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 swell-
ing, 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 ferro-
magnetic components and, therefore, extreme pre-
caution 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 indica-
tions. 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 com-
munity.
RECOMMENDATIONS FOR STORAGE AND WASHING
The useful life of the liner will largely depend on the care
that we take and the hygiene that we provide to it, as well
as properly maintaining it. This is the direct responsibility
of the user, who must strictly follow the manufacturer's
instructions.
It is recommended that the liner is washed every day us-
ing a neutral soap. To facilitate this process, turn the liner
inside out, wash the silicon surface with soap, rinse it thor-
oughly with cold water and dry it with a cloth that is free
of fluff, and in the same way maintain continuous hygiene
on the stump every time the prosthesis is taken off.
Remember that skin hygiene is very important, and so
the skin has to be kept in the best condition, clean and
well-hydrated.
Many common bathing and care products, such as soaps,
deodorants, colognes, sprays, etc. may cause irritations to
the skin.
Check the condition of your liner periodically and report
any incident to your technician.
The liner must NEVER be washed in a washing machine.
t o y m U
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