Organization name

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

SRN

IT-MF-000029670

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• Biological risks

  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.

• Caution, risk of electric shock

  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.

• Consult instructions for use
• Warning; Optical radiation

  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. 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.

  OTHER

Primary placement in Italy; available across 32 countries total.

Trade name

B75

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08054320512608

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

805432051B75BE

Reference / catalog number

55U000000

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12010701FIXED SCIALYTIC LAMPS

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.