3
3 Indications for use and Contraindications
3.1 Indications for use
Intended for medical purposes for use on children from 3 to 18 months of age, with moderate-to-
severe non-synostotic positional plagiocephaly, including children with plagiocephalic, brachy
cephalic, and scaphocephalic shaped heads by applying mild pressure to prominent regions of a
child’s cranium in order to improve cranial symmetry and/or shape. These devices are also indic
ated for adjunctive use for children from 3 to 18 months of age whose synostosis has been surgic
ally corrected, but who still have moderate-to-severe cranial deformities including plagio
cephalic-, brachycephalic -, and scaphocephalic-shaped heads.
The orthosis must be used in accordance with the indications.
3.2 Contraindications
Not for use on children with pre-surgical craniosynostosis or hydrocephalus.
4 Safety
4.1 Explanation of warning symbols
WARNING
Warning regarding possible serious risks of accident or injury.
NOTICE
Warning regarding possible technical damage.
4.2 General safety instructions
WARNING!
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The product may be used only by the person it was made for.
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Observe the notices regarding intended use and the use of the product.
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Check the product for damage prior to each application.
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Evaluate the elastic band for damage and proper seating prior to each application to reduce
the potential for the elastic band to slip out of place which could create a choking hazard.
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Evaluate the structural integrity and fit of the orthosis to reduce the potential for the orthosis to
slip out of place which could cause asphyxiation or trauma to the child’s eyes or skin.
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Explain to the caregiver that they may not continue to use a damaged product and the O&P
professional needs to be contacted in this case.
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The expandable clasp is designed to accommodate the child’s growth; if the clasp reaches
maximum expansion during treatment, a new device may be required. Inform the caregiver to
discontinue use of a product that has reached maximum expansion, or if there are indications
that the child has outgrown the orthosis and to contact the O&P professional for a follow up
appointment.
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Evaluate the child’s skin at frequent intervals for signs of irritation or breakdown. Mild eryth
ema, edema and pressure sores, can be expected during the use of a cranial orthosis.
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Check the areas of skin that come into contact with the product before and after each use.
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Only use the product on intact skin.
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Note that using the product on a shaved head may cause ingrown hairs.
Potential adverse effects
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Skin irritation or breakdown.
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Potential adverse effects caused by extending treatment against medical advice. Extended
treatment can cause skin irritation, skin breakdown and may result in excessive pressure.
NOTICE!
