CS-311

Dénomination commerciale

non renseigné

Code d'IUD-ID

+B195CS311

IUD-ID de base

++B195waveguard9J

Numéro de référence/catalogue

CS-311

Entité d'attribution

HIBCC

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

"waveguard EEG caps are intended for recording of electroencephalographic (EEG) signals, including event-related potentials (ERP) and evoked potentials (EP) on subjects or patients with intact scalp in combination with medical-grade EEG recording equipment (CE class IIa certified inside the European Union; class II device according to FDA regulations for USA). The cap must be dry and clean when used. The application of caps on subjects or patients should only be carried out by medically trained personnel (EEG technician). The technician must remain present during the entire recording session to prevent patient risks such as strangulation. Special infection control requirements may apply."

URL des informations complémentaires

https://academy.ant-neuro.com/knowledge-center/product-documents

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• N01010203EEG HEADSETS

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

• CW030

  The application of caps on subjects or patients should only be carried out by medically trained personnel (EEG technician). The technician must remain present during the entire recording session to prevent patient risks such as strangulation. Special infection control requirements may apply.
• CW010

  The caps should not be used on patients with skin injuries or problems such as blisters, burns, wounds from operation or other superficial wounds or transmissible diseases, such as – but not limited to – hepatitis, human immunodeficiency virus (HIV) or Creutzfeldt-Jacob disease. In the event of defibrillation, disconnect the cap and/or electrodes from the EEG recording equipment first.
• CW027

  Do not use the cap in a Magnetic Resonance Imaging (MRI) scanner or in any other high-intensity electromagnetic field radiation environment unless the type of the cap expressly states the compatibility with such a device.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.