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 is a
medical device. It is a shoulder orthosis for
immobilization in a defined position.
Indications
• Post-operative immobilization
• Post-traumatic treatment
• Fractures, sprains and shoulder dislocation
• Acute injuries
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, only use it according to
your indication and any additional instructions
given by a medical specialist*. 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 neurologi-
cal 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)
* 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.
Application instructions
Putting on and taking off the
OrthoPrax Shoulder Immobilizer
1. Place the affected arm in the pocket, hold in
place with the hand if necessary.
2. Guide the upper strap over the head and
position on the non-affected shoulder.
3. Guide the hip strap around the body and fix it
in place.
4. Fix the shoulder in a slightly raised position
with bent elbow using the existing Velcro
fastenings.
Cleaning instructions
Wash the product by hand. Never expose your
product to direct heat / cold. Also observe the
washing symbols in the instructions for use.
Regular care guarantees optimum effectiveness
of the product.
General information for specialists
Make sure that all joints of the arm and shoulder
are positioned at the correct angle. Instruct the
patient how to put on the orthosis correctly. After
putting on the orthosis for the first time, shorten
the straps as needed to make it easier for the
patient to put on.
Notes on reuse
This product is intended to be fitted to one
patient 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 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 requi-
red 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
2021-10
