HyperHero

Dénomination commerciale

HyperHero

04270005384405

42700053844MD-HYPERHEROKT

Numéro de référence/catalogue

HyperHero v1.x.x

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

HyperHero is a digital application intended for adjunctive use alongside standard care in children aged 8 to 13 diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). The software is based on an interactive, game-like concept and is used with commercially available Virtual Reality (VR) headsets. The application aims to improve ADHD-related deficits, especially in the area of organizational skills. It is also intended to reduce core ADHD symptoms such as impulsivity, hyperactivity, and attention deficits, as well as oppositional behaviour. In addition, the app supports psychosocial functioning, family well-being, and overall health. The therapy is supported by a caregiver through a separate app, which helps with the setup and operation of the VR devices and tracks the progress of the therapy. Additionally, the software includes psychoeducational content that provides basic information about ADHD to both the caregivers and the patients. The application is not intended to provide information for diagnostic or therapeutic decisions. Direct involvement of doctors, psychotherapists, or other medical professionals during use is not foreseen.

URL des informations complémentaires

https://www.brainjo.de/hyperhero/gebrauchsanweisung

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

8 avertissements enregistrés — faire défiler le panneau pour tout voir.

• HyperHero is contraindicated in patients with photosensitive epilepsy. In cases of uncertainty, legal guardians (e.g., parents) should consult a healthcare provider before use.

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• Session duration: Avoid using the device for longer than 30 minutes. Therapy sessions must be limited in duration, frequency, and breaks in accordance with the software’s specifications and the VR headset manufacturer’s guidelines to prevent fatigue or overstimulation.

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• Environmental hazards: Do not use the software near stairs, balconies, windows, or sharp objects. Ensure that the area is free of tripping hazards and sudden drops.

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• Allergic reactions/skin contact: VR headsets may contain materials (e.g., foam, rubber, synthetic fabrics) that can cause allergic reactions. If necessary, use protective covers or hypoallergenic alternatives. Consult a doctor before first use to ensure there are no relevant allergies.

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• Post-VR Disorientation: Users may experience temporary disorientation after removing the headset. Allow them time to readjust before performing tasks such as walking, driving, or operating machinery.