GIBAUD 6392 Notice D'utilisation page 3

HEEL LIFT EVOLUTION
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 conditions that may benefit from use
of heel lifts, such as:
• Rehabilitation of Achilles tendon post-
surgical repair;
• Rehabilitation of Achilles tendon during
non-surgical treatment.
PERFORMANCE
The device provides increased plantar
flexion.
The device can be used in relation to
rehabilitation of Achilles tendon post-
surgical repair.
The device can be used in relation to
rehabilitation of Achilles tendon during
non-surgical treatment.
CONTRAINDICATION
None known.
WARNINGS • PRECAUTIONS OF USE
Under medical guidance, progressively
remove the layers, starting with the layer
in contact with the shoe (the darkest
colour).
The lightest heel lift should be removed
last (after the symptomatology has
disappeared).
Do not wear for extended periods
without medical follow-up.
The orthosis must not be used in direct
contact with a damaged skin.
The orthosis is a single patient use device.
Do not use for multiple patients.
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.
MEASUREMENT AND SIZE CHART
Size of the orthosis to choose according to the shoe size (UK).
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.
FEATURES OF THE DEVICE
27 mm heel lift, composed of 3 separable
9 mm layers.
Central depression for better heel
placement.
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
-Insert the heel lift in a suitable shoe: the
darkest colour is down and the lightest
colour is on the top.
-Under medical guidance, progressively
remove the layers, starting with the layer
in contact with the shoe (the darkest
colour).
-Important note: never remove the
lightest heel lift.
CARE INSTRUCTION, MAINTENANCE
AND DISPOSAL
Keep the device away from sources of
excessive heat.
Hand wash in warm soapy water
(maximum 40°C), rinse thoroughly.
Wring out gently; do not bleach; dry flat,
away from a source of excessive heat
(ex: radiators), 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.
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