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 Ankle Stirrup is a medical device.
It is an ankle orthosis for stabilization in the
frontal plane.
Indications
• Post-operative protection after ligament suture
repair / reconstruction
• Pronation and / or supination trauma
• Conservative treatment of ankle sprains (all
levels of severity)
• Functional treatment of ligament ruptures
• Weber A fracture
• Chronic ligament instability
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
Ankle Stirrup, 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 leg due to
neurological abnormalities
• Circulatory disorders of the leg
(e.g. in cases of diabetes mellitus)
• Impaired lymphatic drainage and soft tissue
swelling of unknown origin
* 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 Ankle Stirrup
1. Place your foot on the heel strap and position
the two shells so that the gel cushions point
towards the ankle.
2. When putting on the lateral shells, make sure
they are parallel to one another and the ankle
protrusions are above the ankle joint.
3. Pull the straps tight in opposite directions
around the orthosis and the leg.
4. Start with the lower strap and bring it around
from the front.
TIP: Cool down the orthosis in the refrigerator
(not in the freezer) beforehand.
Cleaning instructions
To clean the plastic parts, use a moist cloth.
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. Adjust the heel width using the two
lateral straps with Velcro fastening so that
the lateral shells fit optimally. Shorten them if
required.
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 Ankle Stirrup
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
Polypropylene (PP), gel, PVC, nylon, metal (rivet)
– Medical Device
– DataMatrix Unique Device Identifier UDI
EN
2021-09
