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Idiomas disponibles
Idiomas disponibles
Ref.: OP1170
marca
GUARANTEE 6 months since purchase date
EN
Reference
EN
lot no.
EN
Purchase date
EN
Stamp and signature of local
EN
stockist
To validate the warranty your local stockist should indicate the purchase
EN
date.
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
OP1170
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2024-02 | v.03
®
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 in-
structions and the packaging for future reference. If you have any questions or concerns, please contact your doctor, ortho-
paedic 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 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, minimising
the existing risks. Tests have been in accordance with European Regulation UNE-EN ISO 22523 on Prostheses and Orthoses.
INDICATIONS
⋅ Developmental dysplasia of the hip.
⋅ Congenital hip dislocation.
⋅ Congenital dislocable hip.
⋅ Congenital subluxating hip.
⋅ Acetabular dysplasia.
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 under-
stands how it works and should be used.
When fitting the product, you must adhere to the following instructions:
When placing the baby in the harness it is important that you are in a comfortable and relaxed environment. The harness
must be completely open on a flat and stable surface. The baby should have only one layer of clothing, preferably close to
the body and which does not include the legs.
1-Place the baby in the harness, making sure that the horizontal band of the bib is below the baby's armpits, at the level of
the nipples. The first thing to adjust is the horizontal band, putting one finger between the harness and the baby to avoid
interfering with respiratory movements.
2-Next, adjust the shoulder straps to prevent the horizontal band from sliding down. They must be placed symmetrically to
avoid damaging the baby's shoulders, and for this we will use the markings on these straps.
3-Now place the booties, which are indicated with different colours (orange and green), in order to place them correctly.
Open the booties. The coloured area of the bootie (orange and green) should be at the level of the baby's internal femoral
condyle (knee), making sure that the sole of the foot fits snugly into the bottom of the bootie. Adjust the fastening straps
of the bootie without over-tightening. Repeat the steps indicated on the other leg.
4-With the booties in place, first adjust the flexion of the hips in both legs with the front straps, so that they are symmetrical.
Place both straps on the same markers. Next, pull on them gently to check the position.
5-Next, place the back straps to prevent the baby from closing their legs and keep them in abduction, and place both straps
on the same markers so that they remain symmetrical. * The markers to which all the straps must be adjusted must be
indicated by the specialist.
6-Finally, place the protectors on the front leg straps or on the shoulders, if necessary, to avoid any unwanted rubbing
against the baby.
7-If the specialist requires it, place the regulating strap to limit the abduction (separation) of the legs, joining this strap to
the back leg straps.
PRECAUTIONS
p
Before each use, check that all product components are present as per the fitting process. Periodically check the condi-
tions 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.
The usage time of the Pavlik Harness will be progressive. At first, it will be worn for 24 hours until, under medical prescrip-
tion, it may be taken off during bathing time and used 23 hours a day.
If the baby is wearing the harness for 24 hours, wash the necessary areas by using a toothbrush and soap for babies. If it
can be taken off for 1 hour per day, wash it by hand with soap for babies.
Do not stop using the harness without prior authorisation from the doctor.
Every day of usage, check that the straps do not rub against the baby's skin, especially behind the knees and around the
neck area.
Do not place the product directly on the skin. Place the harness on top of a bodysuit or light garment, avoiding fabrics that
may move the product around, and use loose clothing over the harness. This prevents a build-up of clothing and nappy at
the level of the groin that may cause compression in the anterior part of the thigh It is essential that your doctor check the
placement of the harness. They will indicate the appropriate revisions according to your baby's needs.
The car seat must be approved. It may be helpful to place a small sheet under the knees to maintain the correct position.
The average total treatment time is about 3 months, and your doctor will provide more details on this. Do not stop using the
harness without prior authorisation from the doctor.
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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