Thuasne ROM-R Manual Del Usuario página 4

HINGED KNEE IMMOBILISATION BRACE
Properties:
• Adjustable monocentric hinge (movement limitation and flexion/
extension block).
• Stabilisation of the knee joint ligaments.
• Hinge adjustment for flexion and extension.
• Total immobilisation at 0, 15, 30 and 45°.
• Totally open model, easy to fit and comfortable on all scars.
• 4 securing straps and detachable condyle inserts for knee comfort.
• Easy to use mount system with height adjustments.
Indications:
• Total or partial cruciate ligament tears (anterior / posterior) in pre/
post-operative or functional treatment.
• Medium or serious lateral ligament sprains (internal / external).
• Control and/or locking,
immobilisation/limitation of knee movement (patellar ligament,
articular cartilage, meniscus, fixed or stable fractures of the tibial
plateau, condyles, proximal tibia or distal femur.
Contraindications:
• Unstable fractures.
• Proximal femoral fractures.
• Distal tibia or fibula fractures.
• Patients with severe arterial failure arterial insufficiency.
• Allergy to any of the components.
Precautions for use:
• Do not apply the product in direct contact with broken skin.
• Venous thromboembolic risk assessment before any immobilisation.
Side effects:
No known side effects with correct use.
Preparation of the knee brace:
• In pre-operative care, it is recommended that the ROM-R post-
operative brace should be pre-adjusted on the patient before
surgery.
• The default setting of the ROM-R brace is in the total immobilisation
position at 0°. To change this setting, follow the instructions below.
Identical adjustments are to be made on both hinges.
• You can adjust the length of the straps. To do so, remove the self-
adhesive cap and cut the strap to adjust the brace to the patient's
morphology. Take care to cut it straight and to tightly attach the cap.
Once it is in position, pull on the end of the strap to test that it is
properly attached.
Height adjustments:
The ROM-R is a one-size-fits-all brace. The mounts on the brace
are initially set at 50 centimetres. The height of the orthosis can be
adapted to the subject's height by lengthening the femoral and/or
tibial mounts as follows:
1. Lift the grey lever located on the femoral and/or tibial section of the
mount (A).
2. Adjust the length of the mount to the patient's height using the scale
found on the mount extension (B).
3. Then lock in the setting by pushing the lever back down.
4. Perform the same adjustment on the other brace mounts.
Adjusting the hinge for total immobilisation:
Each hinge is equipped with a complete locking system. The brace can
be in the total immobilisation position at 0, 15, 30 and 45°. Locking
should be set in accordance with the physician's instructions and
adjusted during the patient's physical therapy. Make sure the hinges
have the same setting on both sides of the brace.
1. Position the latch on the upper part of the hinge on the arrow.
2. Set the hinge to the desired angle. The arrow indicates the desired
angle.
3. Then lock in the setting by pushing the latch down to the word "lock".
4. Perform the same adjustment on the other hinge on the brace.
Adjusting the hinge for flexion and extension limitation:
The extension and flexion limitations are located on a round plastic
support directly on the brace.
Extension limitations possible: 0, 15, 30, 45, 60, 75 and 90°.
post-traumatic and post-operative
Flexion limitations possible: 0, 15, 30, 45, 60, 75, 90, 105
and 120°.
1. Make sure that the dial located in the
middle of the hinge is positioned on "unlock (C).
2. Select the desired extension limitation by moving the blue cursor
to the desired angle, then select the desired flexion limitation by
moving the white cursor to the desired angle.
3. Lock in the settings and turn the dial to "lock" (D).
4. Perform a few flexions/extensions to make sure that the limitation
is properly locked in at the desired angles.
5. Then repeat all these actions on the other hinge.
Positioning the hinge/mount assembly:
For easier fitting, the straps have been pre-inserted into the mounts
and must not be removed. For heavy-set patients, the straps can be
loosened slightly to position the mounts properly on either side of the
leg.
The initial fitting should be carried out by a healthcare professional:
1. Lift the patient's leg.
2. Slide the brace under the leg, making sure that the straps are placed
under the thigh and under the dial, taking care to place the hinges
on the sides of the knee.
3. Then close the self-adhesive attachments on the top and bottom of
the brace.
Caution:
The flexion/extension settings must be defined and adjusted by your
healthcare professional. The same angle settings must be applied to
the right side and to the left side of the brace. Otherwise, the hinges
could be damaged.
Precautions:
Follow the advice of the healthcare professional who prescribed or
provided this product. Wearing this product, as for any compression
product, can lead to skin reactions (redness, erythema) in some
people. If need be, the product should be readjusted or removed
and the healthcare professional who provided the product should be
consulted.
Store at room temperature, preferably in the original packaging.
For hygiene and performance reasons, do not re-use this product on
another patient.
Washing instructions:
• Hand wash with mild soap, squeeze out excess water and dry in the
ambient air away from heat sources.
• Do not use detergents, fabric softeners or aggressive products
(products containing chlorine).
• Do not submerge the hinges when washing.
GB
Keep this instruction leaflet.