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
C-46
Fecha de emisión/Date of issue: 2021-09
Fecha de revisión/Revision date: 2022-02 | v.02
Ref.: C-46
marca
®
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
⋅
As an orthopaedic positioning method for sprains, luxation, glenohumeral subluxation.
⋅
Capsular displacement.
⋅
As a conservative treatment for acute and chronic bursitis.
⋅
Rotator cuff repair surgery.
⋅
Shoulder endoprosthesis implantation.
⋅
Adhesive capsulitis.
⋅
Entrapment syndrome.
⋅
As a method of immobilisation after implantation of a prosthetic shoulder joint and after acromioplasty.
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
Adjustment by the technician:
The distance from the ball hand can be adjusted by the support plate to do this, remove the Velcro fastening, then
slide the plate along
the guide until it is in the correct position and then secure it with Velcro fasteners.
B
Patient fitting:
3 elements:
⋅ Ambidextrous 30° or 45° pad.
⋅ Splint with ball.
⋅ Forearm support.
Fit the cushion to the side of the affected arm. Each side of the cushion has an inclination of 30° or 45°. Select the
desired angle.
1. Secure it with the pelvic belt.
2-3. Attach the forearm support to the previously adjusted hand support and fasten with the hook. Position the
forearm and secure it with the forearm wrist and elbow strap.
4. Fit the shoulder and side straps joining them together through the loop.
5-6. Tighten the shoulder and side straps.
7. Attach the carabiner to the cushion ring.
8. Finally, check the tension and tighten all of the straps of the device to ensure a perfect fit.
The sling can be fitted to the right or left arm by inverting the shoulder and torso support straps so that the shoulder
strap becomes the side strap and vice versa. The fastening buckle, which can be closed from both sides, then has to be
turned over.
Both support straps have been colour coded on the closure system:
Left arm:
the shoulder strap is marked blue and the chest strap orange.
Right arm:
the shoulder strap is marked orange and the chest strap blue.
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
