Product Description; Indications For Use And Contraindications - Otto Bock 24H1 MyCRO Instructions For Use Manual

1 Product description

INFORMATION
Date of last update: 2021-09-23
Please read this document carefully before using the product and observe the safety
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notices.
Obtain instruction from the qualified personnel in the safe use of the product.
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Please contact the qualified personnel if you have questions about the product or in case of
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problems.
Report each serious incident in connection with the product, in particular a worsening of the
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state of health, to the qualified personnel.
Please keep this document for your records.
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The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head
shape caused by positioning. The orthosis uses contact and growth zones to guide the growth of
the head. The contact zones define gentle limits for growth, while the growth zones leave space in
areas required for forming the natural head shape. An adaptable closure allows for adjustability
as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on
the interior.

2 Indications for use and Contraindications

2.1 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.
2.2 Contraindications
Not for use on infants with pre-surgical craniosynostosis or hydrocephalus.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible technical damage.
NOTICE
3.2 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.
► Do not continue to use a damaged product, and contact your orthotics and prosthetics profes­
sional (O&P professional).
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