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: [email protected] · Export mail: [email protected]
www.orliman.com
J002G
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
Ref.: J002G
Jewett
STERNOTECH
®
USE AND MAINTENANCE INSTRUCTIONS
ENGLISH
EN
The manufacturing date is included in the batch number which can be found on the packaging
label as
x
, in the following way: the second and third digits represent the year of manufacture and
the fourth and fifth digits represent the month.
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 due to crushing.
⋅
Vertebral pain caused by secondary metastasis.
⋅
Spondyloarthrosis associated or not with arthritic sclerosis.
⋅
Lumbalgia, lumbosciatica, and chronic dorsalgia.
⋅
Mid-term immobilisation after intervertebral disc surgery.
⋅
Stable vertebral fractures of the lower dorsal column and the lumbar column.
⋅
Mid-term immobilisation after intervertebral disc surgery.
⋅
Temporary orthosis care after surgery on fractures of unstable body of vertebrae.
⋅
Permanent orthosis care after surgery on tumours and metastasis of body of vertebrae.
⋅
Post-surgical care after spine surgery by decompression with or without internal attachment.
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
Adjusting the height of the sternal support: This support can be set to two different positions. When supplied, it is
always set to the lower position. To increase the height:
1-Remove the foam fabric padding to access the screws that connect the sternal pad to the hinges.
2-Remove these screws using the Allen key and invert the position of the pad keeping the Velcro pointed towards
the chest.
3-Reattach the sternal pad to the hinges using the screws.
B
Adjusting the position of the sternal support: The sternal pad can be repositioned by sliding it along its horizontal
grooves. To do so:
1-Remove the foam fabric padding to access the screws that connect the sternal pad to the hinges.
2-Loosen these screws using the Allen key and move the sternal pad to the required position.
3-Reattach the screws.
C
Adjusting the stability of the sternal piece: The lateral stability of the pad can be increased or decreased by chang-
ing the distance between the hinges. To do so:
1-Remove the foam fabric padding to access the screws that connect the sternal pad to the hinges.
2-Remove these screws using the Allen key, detach the sternal pad and remove the hinges and washers, leaving the
black axes accessible.
3-Remove these axes and change their position: moving them further apart produces less pad mobility and, there
-
fore, greater stability. Moving them closer together produces greater pad mobility and, therefore, less stability. The
position of the hinges must be symmetrical.
4-After fixing the black axes, reattach the hinges, washers and sternal pad, fastening the assembly with the screws.
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.
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 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
