Product Description - Otto Bock 24H1 MyCRO Band Instructions For Use Manual

1 Foreword
INFORMATION
Date of last update: 2021-10-25
Please read this document carefully before using the product and observe the safety
►
notices.
Instruct the user in the safe use of the product.
►
Please contact the manufacturer if you have questions about the product or in case of prob­
►
lems.
Report each serious incident related to the product to the manufacturer and to the relevant
►
authority in your country. This is particularly important when there is a decline in the health
state.
Please keep this document for your records.
►
The initial fitting and application of the product must be carried out by the O&P professional.
Please ensure the following points, before handing the product and the instructions for use to the
patient:
• The orthosis is the correct one for the infant.
• The UDI on the orthosis matches the UDI from the order number.
• The shipping latch is securely in place when the orthosis is received.
• The scope of delivery is complete.
• The orthosis is not damaged.
• The orthosis fits the infant.
• Caregiver is able to put the orthosis on the infant´s head.
• Schedule examination intervals with the caregiver in order to ensure the safe use of the
product.

2 Product description

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.
The orthosis was made based on a 3D-scan. The following scanners are compatible:
Manufacturer
Product name
2
Ottobock
iFab EasyScan
Creaform
OMEGA Scanner 3D
M4DScan
Bodyscan
Peel 1/Peel 3D
HCP
English
Artec
Eva
Eva Lite