GIBAUD 6800 Notice D'utilisation page 4

HALLUX VALGUS CORRECTOR
EN
If you have any doubts regarding the
applications and use of this medical
device, do not hesitate to ask your
doctor and / or fitter, pharmacist,
orthotist, or orthopaedic consultant for
advice.
INDICATIONS
For foot conditions that may benefit from
realignment of the big toe, such as:
• Reducible hallux valgus.
PERFORMANCE
Realignment of the big toe.
CONTRAINDICATIONS
Fixed deformation (irreducible hallux
valgus).
Diabetes.
Deformations associated with a trauma
injury (metatarsal, sesamoid or cuneiform
fractures).
Arteritis.
WARNINGS • PRECAUTIONS OF USE
The device should be worn during the
night or during inactivity.
Do not wear for extended periods
without medical follow-up.
The orthosis must not be used in direct
contact with a damaged skin.
If any problems occur with the use of the
orthosis, e.g. pain or appearance of local
signs, remove the orthosis and contact
your healthcare professional.
The orthosis is a single patient use device.
Do not use for multiple patients.
The user and/or patient must report any
serious incident that has occurred in
relation to the device to the manufacturer
and the competent authority of the
Member State in which the user and/or
patient is established.
MEASUREMENT AND SIZE CHART
Unique size. Choose the left (figure 2) and / or right (figure 3) model.
FEATURES OF THE DEVICE
- 1 elastic mesh (at 1 in figure 1).
- 2 hook-and-loop fasteners (at 2 in
figure 1).
- 3 plastic retaining stays (at 3 in figure 1).
- A removable foam padd (at 4 in figure 1).
SET UP AND OPERATION
The first application must be carried out
by a qualified healthcare professional to
understand the correct fitting and how to
put the device on properly. Subsequently,
the product should be put on the patient
in the same way by the user or a family
member or a friend.
1- Position the orthosis in front of your
foot as shown in figure 2 (for left model)
or in figure 3 (if for the right). Pull the
orthosis on like a sock, passing the foot
underneath the elastic mesh (figure 4).
2- Position the foam cushion on the
hallux valgus (figure 5). The cushion can
be removed and adjusts to fit.
3- Close the orthosis on the medial side,
using the two hook-and-loop fasteners.
The large strip goes around the foot and
the other around the big toe (figure 6).
Adjust so that it is tight but comfortable.
CARE INSTRUCTION, MAINTENANCE
AND DISPOSAL
The device must be stored in a dry, cool
place out of direct sunlight.
Hand wash in warm soapy water
(maximum 30°C); rinse thoroughly. Wring
out gently; do not bleach; dry flat, do not
tumble dry; do not iron; do not dry clean.
The device and packaging must
be disposed of in accordance with
respective local or national environmental
regulations.