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ADJUSTABLE COMPRESSION DEVICE FOR THIGH AND KNEE
Description/Destination
The device comprises a number of adjustable and repositionable overlapping straps
which are closed with hook-and-loop fasteners.
Different models are available to fit various parts of the body: foot, calf, knee, thigh,
arm and hand.
The calf and thigh models have a tightening system used to control and reproduce the
desired level of pressure: low (minimum 20 mmHg), medium (minimum 30 mmHg)
and high (minimum 40 mmHg).
The device is intended only for the treatment of the indications listed and for patients
whose measurements correspond to the sizing table.
Composition
Components for the thigh model:
Textile components: polyamide - elastane - polyurethane - polyester.
Tightening system: polyamide - polyurethane.
Components for the knee model:
Polyamide - synthetic rubber (CR) - polyester.
Properties/Mode of action
The devices provide compression by applying pressure to the limb. They promote
venous and lymphatic circulation, help prevent the formation of edema and maintain
volume.
Inelastic short-stretch material (average pressure between 20 and 50 mmHg).
Indications
Management of edema (venous, lymphatic and caused by injury).
Chronic venous insufficiency (C3 to C6).
Symptomatic treatment of lipedema.
Contraindications
Do not use in case of major dermatological conditions on an affected limb.
Do not use in the event of known allergy to any of the components.
Do not use in case of lower limb peripheral arterial disease (PAD) with ankle-brachial
index (ABI) < 0.6.
Do not use in the event of decompensated heart failure.
Do not use in the event of advanced diabetic microangiopathy (for a compression
> 30 mmHg).
Do not use in case of severe peripheral neuropathy of the affected limb.
Do not use in the event of phlegmasia cerulea dolens (painful blue phlebitis with
arterial compression) of an affected limb.
Do not use in case of extra-anatomical bypass of the affected limb.
Do not use in the event of septic thrombosis.
Do not use on the upper limbs in the following cases:
• Do not use in case of brachial plexus condition.
• Do not use in case of vasculitis of the extremities.
Precautions
Strictly comply with your healthcare professional's prescription and recommendations
for use.
If the device seems to be too tight at the recommended tightness, remove it and see
a healthcare professional.
The risk/benefit ratio and the adequate level of pressure must be regularly re-assessed
by a healthcare professional in the event of:
• PAD with ABPI between 0.6 and 0.9
• Advanced peripheral neuropathy
• Weeping or eczematous dermatitis.
For hygiene, security and performance reasons, do not re-use the product for another
patient.
In the event of discomfort, significant restriction, pain, variation in limb volume,
deterioration of skin condition, infection, unusual sensations, change in the colour of
the extremities, or changes in the performance of the product, remove the product
and seek the advice of a healthcare professional.
Examine the shape of the leg; if there are any deformed or bony areas, use the
protective foam bandages or Varico pads to make the shape of the limb uniform.
In the event of a venous ulcer, a Doppler examination is necessary before using the
device in order to ensure there is no associated severe arterial disease.
In the event of lipedema, compression can be used to help relieve the symptoms.
Seek advice from a healthcare professional for compression and other solutions for
managing lipedema.
For some conditions (or situations) such as venous thrombosis, the device should
be used in combination with an anticoagulant treatment; consult a healthcare
professional for advice.
Do not use products on the skin (creams, ointments, oils, gels, patches...) before
applying the device, it could damage the product.
Do not apply the product directly to an open wound without a dressing.
Undesirable side-effect
This device can cause skin reactions (redness, itching, burns, blisters...) or wounds of
various degrees of severity or cutaneous dryness.
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Any serious device-related incidents occurring should be reported to the
manufacturer and to the competent authority of the Member State in which the user
and/or patient is resident.
Instructions for use/Application
Verify the product's integrity before every use.
Do not use the device if it is damaged.
Choose the appropriate size to fit the patient, referring to the size chart.
It is recommended that a healthcare professional supervises the first application.
Putting the thigh model on:
1. Before putting it on, ensure that the hook-and-loop fasteners are rolled up. ①
2. Pull the sleeve Ⓔ up to mid-thigh height. ②
3. Unroll the bottom strap Ⓐ , tighten the hook-and-loop fastener on the other part
of the strap (do not fasten to the sleeve) and tighten on the limb according to the
desired level of pressure. ③ⓐ
4. Take care not to pull on the adjuster.
5. Repeat with all the other straps from bottom to top ( Ⓑ , Ⓒ and Ⓓ ).④
6. To remove, undo the straps from top to bottom and roll the hook-and-loop
fasteners up again. ⑤
Using the pressure adjuster ⓐ :
The adjuster comes with 3 levels of pressure: L low (light blue line), M medium (blue
line) and H high (dark blue line).
Pressure is reached by pulling on the strap which slides the adjuster until it the outside
of the loop is over the desired level of pressure.
When putting it on and wearing it, ensure no large folds appear.
If necessary, the segment pressure can be adjusted by adjusting the loops from
bottom to top.
Putting the knee model on:
1. Before putting it on, ensure that the hook-and-loop fasteners are rolled up.①
2. Position the product on the knee.②
3. Unroll the middle strap Ⓑ and fasten on the other side while tightening it on the
limb.③
4. Position the bottom strap Ⓐ : hold the inner part against the skin, tighten the other
part over it and fasten with the hook-and-loop fastener. ④
5. Repeat with the top strap Ⓒ.⑤
6. To remove, undo the straps from top to bottom and roll the hook-and-loop
fasteners up again.⑥
Garment care
Compression devices are designed for daily use over a 6-month period (i.e. 90 washes).
After this time, garments should be replaced to ensure the treatment is effective and
technical performance is not affected. Close the hook-and-loop fasteners before
washing. Machine washable at 30°C (delicate program). If possible use a washing net.
Do not use detergents, fabric softeners or aggressive products (products containing
chlorine, etc.). Squeeze out excess water. Dry away from any direct heat source (radiator,
sun, etc.). Dry flat. If the device is exposed to seawater or chlorinated water, make sure
to rinse it in clear water and dry it.
Storage
Store at room temperature, preferably in the original packaging.
Disposal
Dispose of in accordance with local regulations.
Keep this instruction leaflet.
nl
VERSTELBAAR COMPRESSIEHULPMIDDEL VOOR DIJ EN
KNIE
Omschrijving/Gebruik
Het hulpmiddel bestaat uit verschillende verstelbare en herpositioneerbare
overlappende zwachtels die met klittenband worden vastgezet.
Er zijn verschillende modellen beschikbaar voor verschillende delen van het lichaam:
voet, kuit, knie, dij, arm en hand.
De kuit- en dijmodellen zijn uitgerust met een spansysteem om het gewenste
drukniveau te controleren en te reproduceren: laag (minimaal 20 mmHg), gemiddeld
(minimaal 30 mmHg) en hoog (minimaal 40 mmHg).
Het hulpmiddel is alleen bedoeld voor de behandeling van de genoemde indicaties en
voor patiënten van wie de maten overeenkomen met de maattabel.
Samenstelling
Componenten voor het dijmodel:
Textielcomponenten: polyamide - elastaan - polyurethaan - polyester.
Spansysteem: polyamide - polyurethaan.
Componenten voor het kniemodel:
Polyamide - synthetisch rubber (CR) - polyester.
Eigenschappen/Werking
De hulpmiddelen bieden compressie, oefenen druk uit op de ledemaat en bevorderen
zo de veneuze en lymfatische circulatie, helpen de vorming van oedeem te voorkomen
en het volume ervan onder controle te houden.
Niet-elastisch materiaal met korte rek (gemiddeld drukniveau tussen 20 en 50 mmHg).
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