ENGLISH
1.
Intended Use
The Boston Scoliosis Night Brace is a prefabricated modular spinal orthosis used at night-time in the non-operative and conservative
treatment of Idiopathic Scoliosis primarily used for adolescent and young females.
2.
Indication / Contraindication
Indication: Adolescent Idiopathic Scoliosis (AIS)
Contraindications: Thoracic Lordosis; Severe Obesity
3.
General Safety Instruction
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This orthosis is for single patient multiple use
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Only appropriately trained and qualified Clinicians should fit your orthosis with specific reference to the Technical Manual available to view
and download at www.allarduk.co.uk
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Patients should contact their Clinician in event of any persistent skin irritation
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In the event of incorrect use product liability is excluded
4.
Application Information
Your Clinicians instruction will always supersede the information given in this instruction!
How to put on your Boston Scoliosis Night Brace:
The orthosis is more effective when put on in a laying down position as it is easier to tighten the straps!
Put on the orthosis while sitting down or standing up and hold it against the body. Then lay on your back. Ensure that the waist (the pads located at the
centre on the inside of the orthosis) fits above the hip bone and under the ribs.
Begin to tighten the middle strap on the front of the orthosis. If there are only two straps begin with the lower strap. Then tighten the top strap and finally
the lower. Adjust all straps so they are evenly tightened. Always pull the straps as tight as possible to avoid the orthosis sliding and reduce the risk of skin
irritation. Roll over onto your side and let your legs hang over the edge towards the floor. Use the lower arm and the elbow and the opposite hand to lift
the body to a sitting position.
Getting use to your Boston Scoliosis Night Brace:
It can take up to a week to get used to wearing the orthosis. The first few nights you may wake up several times during the night. If this happens remove
the orthosis and sleep the rest of the night without the orthosis on. Repeat this process each night and try to build up wearing time so that you eventually
sleep through the whole night wearing the orthosis. If several weeks past and you are still not able to sleep through the night wearing the orthosis, please
contact the clinician who fitted the orthosis.
5.
Side Effects
The skin under the orthosis should be checked regularly for irritation. Due the normal pressure of the orthosis on your skin while wearing for extended
lengths of time your skin will need to adjust. We recommend that you:
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shower or bathe daily;
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apply / massage rubbing alcohol to your skin wear the brace touches your body, this may help to toughen the skin. Pay attention to where the skin has
become pink (where the most pressure is);
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wear a seamless, tight-fitting vest under the orthosis which covers the body under the orthosis.
Contact your clinician if any irritation that occurs does not heal.
6.
Maintenance and Cleaning
It is important to clean the orthosis daily. Use a damp cloth and soapy water to wipe it clean. Dry thoroughly. For best results, clean the orthosis in the
morning and allow to dry during the day.
7.
CE Conformity
The product satisfies the requirement regulation (EU) 2017/745 of the European Parliament and of the Council (MDR) and bears a CE mark. Any serious
incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the
user and / or patient is established.
8.
Warranty and Guarantee
We recommend that the orthosis is renewed / changed if it no longer fits or is damaged.
Warranty is provided under the terms of sale and supply of Allard Support UK Ltd provided that the above conditions are met.
9.
Storage and Disposal
When not in use store your orthosis safely to avoid accidental damage. Refer to your local disposal regulations with reference to the material content as
per the material content symbol on your orthosis.
