Otto Bock 24H1 MyCRO Band User manual

Instructions for use (user) ............................................................................................... 2
Instructions d'utilisation (Utilisateur) ................................................................................. 9
Instrucciones de uso (Usuario) ........................................................................................ 16
24H1 MyCRO (For prescription use only)

1 Product description English
INFORMATION
Date of last update: 2021-09-23
►Please read this document carefully before using the product and observe the safety
notices.
►Obtain instruction from the qualified personnel in the safe use of the product.
►Please contact the qualified personnel if you have questions about the product or in case of
problems.
►Report each serious incident in connection with the product, in particular a worsening of the
state of health, to the qualified personnel.
►Please keep this document for your records.
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 Warning regarding possible serious risks of accident or injury.
NOTICE Warning regarding possible technical damage.
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).
2

3
►The expandable clasp is designed to accommodate the infant’s growth; if the clasp reaches
maximum expansion during treatment, contact your O&P professional for a follow up appoint
ment.
►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.
►Observe the instructions for cleaning and care.
4 Scope of delivery
Quantity Designation Reference number
1Instructions for use (user) –
1MyCRO Band orthosis with lining –
1Spare lining (additional lining if ordered) –
2Spare elastic closure band 24Z2

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5 Handling
WARNING
Failure to comply with the examination intervals
Risk of injury due to improper use of the product
►Comply with the examination intervals established with your O&P professional in order to
ensure the safe use of the product.
INFORMATION
Wearing the orthosis in a child car seat is permissible. The child car seat must be adjusted so
the child can sit in it properly with the orthosis.
The child should progressively increase the time spent in their orthosis over a 5 day period to
allow for an acclimation period (see subsequent table). After 5 days, the orthosis should be worn
at least 23 hours/day to attain optimal treatment results. Activities that require the orthosis to be
removed (e.g. bathing) should be limited. The orthosis may cause increased perspiration during
the first 2-3 weeks of treatment, but this typically decreases over time.
If therapy for other conditions such as torticollis is needed during the MyCRO Band treatment,
the device can be removed for short durations as appropriate.
If the orthotic treatment is interrupted for an extended time period, the acclimation period may
need to be repeated.
CAUTION: If there is a problem with the orthosis make an appointment with your O&P
professional immediately . Do not wait until your next scheduled appointment. It is
important that the orthosis is worn consistently.
Day of use Daily duration of use
12hours
24hours
36hours (including naps)
48hours (including naps)
5+ Day and night (at least 23hours)
5.1 Application
WARNING
Wearing the orthosis in case of fever
Risk of injury due to overheating
►Stop using the orthosis in case of fever.
WARNING
Incorrect or excessively tight application of the product to the body
Risk of pressure points and constriction of blood vessels and nerves due to improper applica
tion
►Ensure that the product is applied properly and fits correctly.
►Do not continue to use the product if it fits incorrectly.
1) Check the following points before putting on the orthosis:
→The baby is in a stable position with no interfering objects or items near the head.
→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 without wrinkles and projects slightly beyond the hard
edge all around.

5
12) Open the elastic band of the closure (see
fig.1).
23) Carefully pull the orthosis apart at the clos
ure (see fig.2).

6
34) Align the orthosis and place it onto the
baby’s head (see fig.3).
5) Check the fit of the orthosis:
→The arrowhead on the front should
form a vertical line with the middle of
the nose.
→The orthosis has to leave the ears and
eyes exposed.
→The lining should project beyond the
edge of the orthosis all around and
protect the skin against contact with
the plastic.
6) If the orthosis fits correctly: Hold the
orthosis carefully so it cannot shift and
close the elastic band of the closure. A
gap in the closure is normal and no cause
for concern.
7) Make sure the elastic band fits properly in
the guide of the closure.
8) CAUTION! To avoid injuries, always
open the closure before positioning the
orthosis.
If the orthosis does not fit correctly or
has shifted: Repeat the previous steps.
5.2 Removal
INFORMATION
Redness of the skin after removing the orthosis is not unusual, and should go away within 2
hours. If the redness does not go away, or if pressure points develop, contact your O&P profes
sional.
>Prerequisite: The baby is in a stable position with no interfering objects or items near the
head.
1) Open the elastic band of the closure.
2) Carefully pull the orthosis apart at the closure.
3) Take the orthosis off the baby’s head.
TIP: Gently massage the baby's head with your fingertips after removing the orthosis in order
to promote self-perception.
4) Remove the padding from the orthosis and clean it (see page8). Insert the replacement pad
ding into the orthosis.
5.3 Changing the lining
The lining is attached to the orthosis with micro-hook. It has to fit inside the orthosis without
wrinkles and must be in contact with the orthosis over the entire surface area.
Removing the lining
1) Detach the folded lining in the neck area.
2) Starting at the closure, detach the lining all around the orthosis.

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Inserting the lining
41) Roll up the lining into a tight roll (see
fig.4).
52) Position the lining at the closure of the
orthosis. Carefully unroll the lining, press
ing it into the orthosis without wrinkles (see
fig.5).
3) Ensure that the lining projects slightly bey
ond the hard edge all around.

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64) In the neck area, fold over the lining to the
outside and press it into place (see fig.6).
5.4 Replacing the fastening strap
INFORMATION
The elasticity of the elastic band holding together the closure, which grows with the child,
decreases over time. To ensure that all supplied elastic bands stretch evenly, the elastic band is
changed every week.
►Change the elastic band every week and use all supplied elastic bands in rotation.
>Prerequisite: Take off the orthosis.
1) Take the elastic band out of the closure and put it aside for future use.
2) Insert a different elastic band into the guide of the closure. The loop in the band has to face to
the rear.
3) Make sure the new elastic band fits properly in the guide of the closure.
6 Cleaning
NOTICE
Improper cleaning
Damage to the product due to improper cleaning
►Only clean the product with the approved cleaning agents.
►Only clean the product by hand.
INFORMATION
Remove the lining from the orthosis before cleaning. Clean the lining and the shell of the orthos
is separately.
>Recommended cleaning agent: pH neutral soap
1) Clean the product by hand with clean water and a pH neutral soap.
2) Rinse the soap away with clean water.
3) Dry the product with a soft cloth.
4) Allow to air dry fully before donning.
7 Disposal
Return the product to the O&P professional for disposal.

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8 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
8.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.
8.2 Local Legal Information
Caution: Federal law restricts this device to sale by or on the order of a qualified orthotist or
physician or any other practitioners licensed by the law of the State in which that person practices
to use or order the use of the device.
1 Description du produit Français
INFORMATION
Date de la dernière mise à jour: 2021-09-23
►Lire attentivement l’intégralité de ce document avant d’utiliser le produit ainsi que respecter
les consignes de sécurité.
►Prière de demander au personnel spécialisé d’expliquer à l’utilisateur comment utiliser le
produit en toute sécurité.
►Prière de s’adresser au personnel spécialisé pour toute question concernant le produit ou
en cas de problème.
►Prière de signaler au personnel spécialisé tout incident grave survenu en rapport avec le
produit, notamment une aggravation de l’état de santé.
►Conserver ce document.
La bande MyCRO est une orthèse de correction de déformations crâniennes positionnelles.
L’orthèse a été confectionnée par Ottobock de manière individuelle pour l’enfant. L’orthèse
oriente la croissance de la tête par le biais de zones de contact et de zones de croissance. Les
zones de contact définissent en douceur des limites à la croissance et les zones de croissance li
bèrent de l’espace dans les régions où une croissance de la forme naturelle de la tête s’avère né
cessaire. La fermeture réglable permet d’adapter l’orthèse à la croissance du bébé. Le matériau
extérieur de l’orthèse se compose de résine thermoplastique et un rembourrage souple et lavable
se trouve à l’intérieur.
2 Usage prévu et contre-indications
2.1 Usage prévu
Destinée à des fins médicales dans le cadre d’un usage sur des bébés âgés de 3à18mois pré
sentant une plagiocéphalie positionnelle non synostotique, y compris des bébés affichant une tête
plagiocéphale, brachycéphale et scaphocéphale. La symétrie/forme crânienne est améliorée par
une légère pression sur des régions proéminentes du crâne d’un bébé. Ces orthèses sont par
ailleurs indiquées auprès de bébés âgés de 3à18mois chez lesquels une synostose corrigée
par voie chirurgicale est associée à des déformations crâniennes modérées à graves, dont une
plagiocéphalie, une brachycéphalie et une scaphocéphalie.
Il est impératif d’utiliser l’orthèse conformément aux indications.
2.2 Contre-indications
Non destinée à une utilisation sur des bébés présentant une craniosynostose préopératoire ou
une hydrocéphalie.

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3 Sécurité
3.1 Signification des symboles de mise en garde
AVERTISSEMENT Mise en garde contre les éventuels risques d’accidents et de blessures
graves.
AVIS Mise en garde contre les éventuels dommages techniques.
3.2 Consignes générales de sécurité
AVERTISSEMENT!
►Le produit ne doit être utilisé que par la personne pour laquelle il a été confectionné.
►Respecter les consignes relatives à une utilisation conforme et à l’usage du produit.
►Avant chaque utilisation, vérifier que le produit n’est pas endommagé.
►S’assurer de l’état irréprochable d’un point de vue structurel et de l’ajustement du casque
pour réduire le risque de glissement. Le glissement de l’orthèse est susceptible de provoquer
un étouffement du bébé ou l’apparition de lésions cutanées ou oculaires.
►Ne pas continuer à utiliser un produit endommagé et contacter l’orthoprothésiste compétent.
►La fermeture extensible a été développée pour s’adapter à la croissance du bébé. Si la ferme
ture atteint un degré d’extension maximal au cours du traitement, prière de contacter
l’orthoprothésiste compétent pour convenir d’un rendez-vous de contrôle.
►Vérifier la peau du bébé à intervalles réguliers afin de s’assurer de l’absence de signes
d’irritation ou de lésions.
►Contrôler les zones cutanées entrant en contact avec le produit avant et après chaque utilisa
tion du produit.
►Utiliser le produit uniquement sur une peau intacte.
►Prière de noter que le port du produit sur une tête rasée peut provoquer l’apparition de che
veux incarnés.
Éventuelles conséquences négatives
►Irritations ou lésions cutanées.
►Éventuels effets négatifs induits par une prolongation du traitement contre l’avis médical. Un
traitement prolongé peut se traduire par des irritations et des lésions cutanées et induire une
pression excessive.
AVIS!
Risque de détériorations du produit et de restrictions fonctionnelles
►Dans le cadre d’un usage normal, le produit ne saurait être exposé à des températures infé
rieures à -10°C et supérieures à +45°C.
►Nettoyer le produit lorsqu’il est entré en contact avec de l’eau salée ou contenant du chlore.
►Respecter les consignes de nettoyage et d’entretien.