GIBAUD 6911 Notice D'utilisation page 3

STANDARD LIGHT 0°/20° SPLINT
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 orthopedic consultant for
advice.
INDICATIONS
For conditions that may benefit from knee
immobilization, such as:
• Traumatic knee injuries.
• Emergency immobilization.
• Pre-/post-op knee immobilization.
PERFORMANCE
The device provides motion restriction of
the knee joint or relative immobilization.
CONTRAINDICATIONS
None known.
WARNINGS • PRECAUTIONS OF USE
The splint should not be used when the
patient's condition requires absolute
immobilization or a surgical procedure.
Do not wear for extended periods without
medical follow-up.
The splint must not be used in direct contact
with a damaged skin.
The splint is a single patient use device. Do
not use for multiple patients.
When adjusting the straps, tighten them
so that the hold is firm but comfortable.
If any problems occur while using the splint,
e.g. pain or appearance of local signs, remove
the device and contact your healthcare
professional.
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
Pairs of removable lateral metal stays (0°
or 20° flexion).
2 dorsal stays (1 for size T0).
1 pre-positioning strap.
4 semicircular straps.
MEASUREMENT AND SIZE CHART
The size of the orthosis is to be chosen according to :
- the length from the upper 1/3 of the thigh to the lower 1/3 of the calf of the leg to be
immobilized (in cm). (B)
- the circumference of the thigh at 20 cm from the kneecap (in cm). (A)
B
A
T0
A 30
B 30-40
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.
The device can be worn on or under
trousers.
1-Opening the splint:
Release the straps, including the pre-
positioning strap inside the device, and
pull the the hook and loop fastener part
over the straps.
2- Adjusting the stays:
The product comes with 0° lateral and
dorsal stays.
Two lateral stays with 20° flexion are
supplied with the device and, depending
on the prescription of the healthcare
professional, can be used instead of the
0° lateral stays.
Where applicable, please refer to the
illustrative drawings for the replacement
of 0° lateral stays with 20° stays. During
testing the fitter must shape the dorsal stays
of the brace at 20° to adjust it to your form.
3- Securing the straps:
Attach the pre-positioning strap just above
the kneecap. Tighten in such a way that the
hold is firm but comfortable.
Attach and tighten, without compressing, the
two straps near the kneecap (lower followed
by upper) and then the two straps further
from the kneecap (upper followed by lower).
Tighten the straps in such a way that the
hold is firm but comfortable.
CARE INSTRUCTION, MAINTENANCE AND
DISPOSAL
Store the splint away from excessive heat.
After removing the stays from the splint
(see illustrative drawing), hand wash the
splint in warm soapy water (maximum 40°C),
rinse thoroughly; wring out gently; do not
bleach; dry flat away from excessive heat
(e.g. radiator); do not tumble dry; do not
iron; do not dry clean.
The device and packaging must be disposed
of in accordance with local or national
environmental regulations.
T1 T2
50 50
45-55 55-65
T3 T4
60 60
45-55 55-65