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1 Foreword

English

INFORMATION

Date of last update: 2022-08-11

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 child.

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 child.

Caregiver is able to put the orthosis on the child´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

Ottobock

Creaform

Artec

Product name

iFab EasyScan

OMEGA Scanner 3D
M4DScan
Bodyscan
Peel 1/Peel 3D
HCP 

Eva
Eva Lite

2

Содержание 24H1 MyCRO Band

Страница 1: ...Instructions for use qualified personnel 2 24H1 MyCRO Band For prescription use only...

Страница 2: ...er 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 child Caregiver is able to put the orthosis...

Страница 3: ...r 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 Evaluate the structural integrity and fit of...

Страница 4: ...inders and heat may be used to make small adjust ments to the orthosis NOTICE Note that the heat during the flaring or grinding may cause permanent discoloration Prior to making adjustments the lining...

Страница 5: ...r bathing or treatment by a physiotherapist Wearing the orthosis can cause increased perspiration during the first two to three weeks This is normal and decreases over time If treatment is required fo...

Страница 6: ...g objects or items near the head Any lotions or creams being used have been absorbed by the skin The orthosis is in proper condition with no cracks or other damage The lining fits inside the orthosis...

Страница 7: ...s If the orthosis does not fit correctly or has shifted Repeat the previous steps 7 2 Removal INFORMATION Redness of the skin after removing the orthosis is not unusual and should go away within 2 hou...

Страница 8: ...mooth and securely fastened to the microhooks to avoid pressure points due to bunching of the lining Position the lining at the closure of the orthosis Carefully unroll the lining press ing it into th...

Страница 9: ...sure is intended to last the lifetime of the orthosis If the elast ic band needs to be replaced during treatment use the following instructions Prerequisite Orthosis is taken off 1 Remove the lining f...

Страница 10: ...a new elastic band through the opening 9 5 Inside the orthosis Push the new elastic band in place around the pin 10 6 Outside the orthosis Pull on the elastic band to test if it is secured properly 7...

Страница 11: ...ironment Observe the information provided by the responsible authorities in your country regarding return collection and disposal procedures 10 Legal information All legal conditions are subject to th...

Страница 12: ...Ottobock 647G1539 all_US 07 2208 Otto Bock HealthCare LP 3820 West Great Lakes Drive Salt Lake City UT 84120 USA T 1 800 328 4058 F 1 800 655 4963...

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