Vibe 12+

Nom de l'organisation

Jabbla

SRN

BE-MF-000049893

Statut du fabricant

Actif

Marché principal en Belgique ; disponible dans 1 pays au total.

Dénomination commerciale

Vibe 12+

Code d'UDI-DI

54300002668330

Basic UDI-DI

5430000266SGDVP

Numéro de référence/catalogue

VP-2979

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Vibe 12+ is a dedicated, portable, battery-operated Speech Generating Device (SGD) specifically designed for individuals who rely on augmentative and alternative communication (AAC), including but not limited to individuals with amyotrophic lateral sclerosis (ALS), cerebral palsy, aphasia, and non-verbal autism. The device enables users to create messages using symbol-based or text-based page sets, which are converted into audible speech through integrated text-to-speech technology. Internal amplified speakers ensures that generated messages are output clearly and at sufficient volume. Easily accessible physical volume controls allow the user to adjust output levels as needed. Message selection is performed via direct touch using a finger or capacitive stylus on the 13” touch-screen. The Vibe 12+ also supports alternative access methods, including one and two switch scanning. The dimensions of the Vibe 12+ are 310 x 275 x 25 – 50 mm. The Vibe 12+ weighs 1.6 kg.

URL des informations complémentaires

https://url.jabbla.com/Vibe12%E2%81%BAmanualEN

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Y214212VOICE GENERATORS

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel