Indications For Use And Contraindications - Otto Bock 24H1 MyCRO Band Instructions For Use Manual

3 Indications for use and Contraindications

3.1 Indications for use
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-
severe non-synostotic positional plagiocephaly, including infants with plagiocephalic, brachy­
cephalic, and scaphocephalic shaped heads by applying mild pressure to prominent regions of
an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also
indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been
surgically 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 infants with pre-surgical craniosynostosis or hydrocephalus.
4 Safety
4.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible technical damage.
NOTICE
4.2 General safety instructions
WARNING!
► The product may be used only by the person it was made for.
► Observe the notices regarding intended use and the use of the product.
► Check the product for damage prior to each application.
► Evaluate the structural integrity and fit of the helmet to reduce the potential for the device to
slip out of place which could cause asphyxiation or trauma to the infant's eyes or skin.
► Tell the Caregiver not to continue to use a damaged product, and contact the orthotics and
prosthetics professional (O&P professional).
► The expandable clasp is designed to accommodate the infant'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 and to contact the O&P
professional for a follow up appointment.
► Evaluate the infant's skin at frequent intervals for signs of irritation or breakdown.
► Check the areas of skin that come into contact with the product before and after each use.
► Only use the product on intact skin.
► Note that using the product on a shaved head may cause ingrown hairs.
Potential adverse effects
► Skin irritation or breakdown.
► 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!
Risk of product damage and limited functionality
► During normal use, the product should not be exposed to temperatures lower than -10 °C
(14 °F) and higher than +45 °C (113 °F).
► Clean the product if it was in contact with salt water or water containing chlorine.
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