Nom de l'organisation

F.A.R.O. Fabbrica Apparecchiature Razionali Odontoiatriche Società per Azioni

SRN

IT-MF-000029670

Statut du fabricant

Actif

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

• Risques biologiques

  The physician is required to use disposable covers on the handles of the lamps or to disinfect or sterilize them after each patient. For surface disinfection, use appropriate disinfectants. The handles cannot be disinfected by thermodisinfection.

• Prudence, risque de choc électrique

  Do not use the lamp if its components are damaged. The supply voltage must always be disconnected during installation. Check the mainplate before installation. Check that the supply voltage indicated on the mainplate corresponds to the mains voltage. The dental lamp must be installed on a control and power supply device (e.g. dental units), or with an electrical system that complies with IEC 60364-1 and the "National rules for the installation of electrical systems in medical premises". The device must be installed with an omnipolar mains disconnecting device in accordance with IEC 61058-1, approved for a transient mains voltage of 4KV. Installation and maintenance of the device in accordance with IEC 60601-1 is the responsibility of the installer or the device manufacturer. Do not carry out any maintenance on the lamp when the power supply is on: disconnect the power cable from the mains before carrying out any work. Rotating the head and arms beyond the stops can damage the conductor insulation. Do not spra

• Consulter la notice d’utilisation
• Avertissement; Rayonnement optique

  do not stare into light beam The dental lamp is classified according to IEC 62471 as class 1 for blue retinal risk. Do not look at or direct the light beam directly into the patient's eyes, especially for patients with an increased risk of eye damage (e.g. children, elderly patients with eye diseases). In this case, always use appropriate protection and precautions. However, it cannot be excluded that patients who are particularly photosensitive or who have taken photosensitising medication may experience erythema or allergic reactions to light. In this case, discontinue the treatment and use very low levels of illumination

• BREAKAGE OF MECHANICAL PARTS AND FALLING MASSES Failure to comply with this paragraph may result in: a risk of wear or corrosion of plastic or metal parts leading to mechanical failure. Do not use detergents or disinfectants containing: ammonium hydroxide/hydrogen peroxide/ammonium chloride/methylene chloride/methyl alcohol. It is also forbidden to use: abrasives/corrosives/acids/chloride or chloride ions/phosphorous ions/cleaners based on trilene, petroleum, white spirit or similar. Do not spray chemical agents directly onto the lamp. Do not use wet wipes without squeezing them to remove excess liquid. Do not exceed the prescribed maximum loads during operation. Do not overload the mechanical limit switches of the arms and head. Do not place the lamp head directly on the patient's or user's head. When installing, always maintain the correct clearance between the patient and the lamp in all positions.

  AUTRE

Marché principal en Italie ; disponible dans 32 pays au total.

Dénomination commerciale

MAIA

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

08034028395352

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

803402839MAIA9H

Numéro de référence/catalogue

322090355

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque MDR

Les classes de risque du MDR classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The device is used in the dental office and is intended to illuminate the oral cavity and oral structures of dental patients. In normal use, the device is positioned at a distance of 700 mm from the operating area, the distance for which the lighting features were designed. Patients can be of all ages with typical dental pathologies

URL des informations complémentaires

https://faro.it/en/download-area/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

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

• Z12110180INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES

• Dispositifs médicaux de Classe I dans EUDAMED

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