OFA Dynamics Hallux Valgus Instructions For Use Manual page 8

Do not use fabric softener!
Reporting obligation
In accordance with legal provisions
within the EU, patients and users are
obliged to report any serious incident
that occurs when using a medical
device to both the manufacturer and
the competent national authorities (in
Germany BfArM, Bundesinstitut für
Arzneimittel und Medizinprodukte, the
Federal Institute for Drugs and Medi-
cal Devices) immediately.
Indications
– Hallux Valgus (bunion)
– Formation of bony lumps
– Deformed big toe
– For stabilisation after bunion
surgery
Material composition
38% Acrylonitrile butadiene styrene
22% Polyurethane (foam)
20% Polyamide microfibre
18% Polyamide
2% Polyurethane
Side effects
There are currently no known side
effects for any part of the body if the
product is used correctly. However, if
the product is too tight it can cause
local pressure points or constrict
blood vessels and nerves.
Contraindications
Consult your doctor before using this
product in the following cases:
– Skin diseases or injuries in the area
where the product is used, particu-
larly if you experience any signs of
inflammation such as redness, an
increase in temperature or swelling
– Feeling of numbness and circulatory
problems in the area where the
product is used
– Problems with lymphatic drainage
and unexplained swelling
Disposal
Please dispose of the product
according to local regulations after
the end of use.
Guarantee
If used as intended and maintained
property, the product can be used for
six months. The product should be
handled carefully in line with these
instructions for use. Improper use or
improper changes to the product may
negatively impact the performance,
safety and functionality of the product
8