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.

• Prudence, risque de choc électrique

  To avoid the risk of electric shock, this medical device must only be connected to power networks with protective earth. Use only the power supply approved from the manufacturer that are supplied with the device For the version Stand on Wheels, do not position the device in such a way that it is difficult to disconnect the power plug Do not use the device if there are damaged parts or enclosures. Do not use the device if there is any play or interruption between: - Head joint / Head bow - Fixed arm joint / Articulated arm joint The device must never be opened and/or used with wet hands and must not be put in contact with any liquid as this condition could cause danger for the patient and/or the operator.

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

  Due to its nature and intended use, the use of device is not indicated on all patients who: - are affected by a photosensitizing disease on skin or eye; - are under the effect of drugs, Medicinals or substances (also for topical use) that may have photosensitization as a side effect; if the User is or became aware that patient suffers of sensitization, the treatment shall be immediately stopped. This product emits possibly hazardous optical radiation. Do not stare at the light emitted from the surgical luminaire. Eye injury may occur. Use the Protective glasses supplied as accessory. The optical radiation emitted by this product complies with the exposure limits for reducing the risk of photobiological hazards in IEC 60601-2-41

• WARNING AGAINST CORROSION DUE TO THE RISK OF FALLING MASSES – CLEANING AND DISINFECTION For all metal or plastic parts, it is strictly forbidden to use substances that are - abrasive, - corrosive, - acids, - substances containing chlorine or chloride ions, phosphorus or phosphorous ions, - Trilene-based detergents, petrol, white spirit, ethylene, chlorine or similar. Do not use detergent-disinfectants containing the following substances: - Ammonium hydroxide - Sodium hydroxide - Hydrogen peroxide - Ammonium chloride - Methylene chloride - Methyl alcohol, Ethyl alcohol - Acids and corrosive substances of all kinds. The use of wet wipes without rinsing is forbidden. FARO has tested and recommends the use of the following disinfectants: - Durr FD366 Sensitive - Disinfectants based on water and alcohol with 70% isopropyl alcohol are suitable.

  AUTRE

• 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.

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

Dénomination commerciale

B75

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.

08054320512813

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.

805432051B75BE

Numéro de référence/catalogue

55U002000

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 intended to provide luminous energy to illuminate the patient body during dental, medical or surgical procedures. In particular the device is intended for: - illuminate the patient’s body locally during medical and/or surgical treatments when installed in medical or surgical areas; or - illuminate the oral cavity and oral structures of patients in dentistry, when installed in a dental practice. Patients can be of all ages. The device is not single fault safe for the Essential Performance and is not intended to be used in life supporting surgery. To have a single fault safe device, it is necessary to install a system composed by two luminaries connected independently to the mains and to an emergency power supply.

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.

• Z12010701FIXED SCIALYTIC LAMPS

• Dispositifs médicaux de Classe I dans EUDAMED

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