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Dear customer,
please read through these instructions for use carefully.
If you have any questions, please contact your doctor or medical retailer.
Intended purpose
The OrthoPrax Shoulder Immobilizer 15 is a
medical device. It is a shoulder orthosis that
provides relief and immobilization in a 15°
abduction position.
Indications
• Pre-operative and post-operative
immobilization
• Acute irritation
• Post-traumatic, conservative care
• Soft tissue injuries in the shoulder region
• Treatment of chronic pain
Risks of using this product
• Please closely observe the specifications in
these instructions for use and the instructions
given by the specialist.
• Once you have been prescribed the OrthoPrax
Shoulder Immobilizer 15, only use it according
to your indication and any additional
instructions given by a medical specialist².
Please consult a specialist or your physician if
you want to use it together with other products.
Do not modify the product yourself in any way;
otherwise it may not help as expected or it may
be harmful to your health. In these cases, any
warranty or liability claims will be excluded.
• Avoid contact with ointments, lotions, or
substances containing grease or acids.
• Any aids applied externally to the body may, if
tightened excessively, lead to local pressure
points or, in rare cases, constrict the underlying
blood vessels or nerves.
• If you notice any changes or an increase in
symptoms while wearing the product, stop any
further use and contact your doctor.
Contraindications
Hypersensitive reactions harmful to health
have not been reported to date. In the following
conditions such aids should only be fitted and
applied after consultation with your medical
provider:
• Skin disorders / injuries in the relevant part of
the body, particularly if inflammation is present.
Likewise, any raised scans with swelling,
redness and excessive heat build-up.
• Varicose veins (varicosis)
• Impaired sensation in the arm due to
neurological abnormalities
• Circulatory disorders of the arm (e.g. in cases
of diabetes mellitus)
• Impaired lymphatic drainage and soft tissue
swelling of unknown origin
• Pacemaker (follow physician's instructions)
• Amputation of the breast (follow physician's
instructions)
Application instructions
Putting on and taking off the
OrthoPrax Shoulder Immobilizer 15
1. Guide the arm into the pocket and take hold of
the handle.
2. Place the cushion against the body with the
arched side facing forward.
3. The shoulder strap is guided over the head. If
required, the quick-fit fastener can be opened
to put it on.
* A specialist is any person who is authorized, according to their state's regulations,
to fit supports and orthoses and provide instructions on how to use them.
4. The waist strap is guided around the body and
closed with the quick-fit fastener.
5. To take off the support, proceed in the opposite
order.
Cleaning instructions
Before washing, remove the top cover of the
shoulder cushion. Please use mild detergent and
a mesh bag. Never expose your product to direct
heat / cold. Regular care guarantees optimum
effectiveness of the product.
General information for specialists
Instruct the patient how to put on the orthosis
correctly.
1. The length of the arm pocket and the position
of the handle can be adjusted for a correct
fit by folding back and adjusting the Velcro
fastenings. Position the handle and fix it in
place by adjusting the three Velcro fastenings
at the top and bottom of the handle.
2. Position the arm in the pocket and the cushion
on the waste and adjust the length of the
straps.
3. Place the shoulder strap over the uninjured
shoulder and fasten it to the buckle on the
handle (sling).
Notes on reuse
This product is intended to be fitted to one pa-
tient only.
Warranty
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.
The product must be cleaned before submitting
it in case of warranty claims. Warranty may be
limited or excluded if the instructions on how
to handle and care for the OrthoPrax Shoulder
Immobilizer 15 have not been observed.
Warranty is excluded if:
• The product was not used according to the
indication
• The instructions given by the specialist were
not observed
• The product was modified arbitrarily
Duty to report
Due to regional legal regulations, you are
required to immediately report any serious
incident involving the use of this medical device
to both the manufacturer and the responsible
authority. Our contact details can be found on the
back of this brochure.
Disposal
Once you have finished using the product, please
dispose of it according to local specifications.
Material content
Polyester (PES); PU foam;
Polyoxymethylene (POM); nylon
– Medical Device
– DataMatrix Unique Device Identifier UDI
EN
2021-09
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