ENGLISH
1.
Intended Use
The Boston Hip Abduction Brace is a prefabricated orthosis used to aid in the orthotic treatment of Congenital Hip Dislocation /
Dysplasia in paediatric patients with respect to the indications outlined below.
2.
Indication / Contraindication
Indications:
Congenital Hip Dislocation, Hip Dysplasia and Cerebral Palsy
Contraindications:
None Known
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!
You have been prescribed this orthosis to treat a particular condition. Treatment can vary for each patient.
Your clinician will provide product specific information about:
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Applying your orthosis
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How to get used to wearing your orthosis to achieve optimum hours of daily wearing.
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Duration of use
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Acceptable and unacceptable activities
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If the patient wears a diaper, then the orthosis should be fitted over the orthosis.
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The orthosis can be worn over clothing such as hosiery, leggings, trousers, etc.
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 and ensure the skin is dried very well before application.
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pay attention to where the skin has become pink (where the most pressure is).
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 use rubbing alcohol to clean the orthosis.
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
