IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Product Description:
An electrically-powered lamp mounted on a headband or helmet frame and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack.
Technical specifications
Battery powered (AA batteries):
- rechargeable batteries(< 100 Wh)
- A separate battery pack is preferred
LED light with dim option and light intensity switch
- adjustable beam intensity: 100-1000 lumen
- minimal beam intensity: 1000 lumen
- beam distance: between 100-300 meters
Directional light: pivots within 90° angle
Low battery message system
Ergonomic: adjustable headset
Water and dust-resistant
SUPPLIED WITH
Instructions for assembly, use, and maintenance in English, French, and Spanish.
ESTIMATED LIFE SPAN
Five years.
WARRANTY
Two years from the shipping date.
Packaging & Labelling:
One (1) headlamp wrapped in a plastic film, with manufacturer's instruction for use, spare parts and accessories.
Symbols used according to ISO 15223
Information for particular storage conditions
(temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonized symbol).
Information for handling, if applicable (or equivalent harmonized symbol).
Labeling displays, at least: Product name, reference number, manufacturer's name and address, CE mark or similar, lot number or batch number, UDI (if MDR certified), use-by-date, symbol for Medical device
CE mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Safety & product Standards:
Must comply with following standards:
ISO 13845
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-2-41 Medical Electrical Equipment, Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis.
Environmental requirements:
LED technology
Low consumption
Rosh compliance
Product Description:
An electrically-powered lamp mounted on a headband or helmet frame and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack.
Technical specifications
Battery powered (AA batteries):
- rechargeable batteries(< 100 Wh)
- A separate battery pack is preferred
LED light with dim option and light intensity switch
- adjustable beam intensity: 100-1000 lumen
- minimal beam intensity: 1000 lumen
- beam distance: between 100-300 meters
Directional light: pivots within 90° angle
Low battery message system
Ergonomic: adjustable headset
Water and dust-resistant
SUPPLIED WITH
Instructions for assembly, use, and maintenance in English, French, and Spanish.
ESTIMATED LIFE SPAN
Five years.
WARRANTY
Two years from the shipping date.
Packaging & Labelling:
One (1) headlamp wrapped in a plastic film, with manufacturer's instruction for use, spare parts and accessories.
Symbols used according to ISO 15223
Information for particular storage conditions
(temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonized symbol).
Information for handling, if applicable (or equivalent harmonized symbol).
Labeling displays, at least: Product name, reference number, manufacturer's name and address, CE mark or similar, lot number or batch number, UDI (if MDR certified), use-by-date, symbol for Medical device
CE mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Safety & product Standards:
Must comply with following standards:
ISO 13845
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-2-41 Medical Electrical Equipment, Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis.
Environmental requirements:
LED technology
Low consumption
Rosh compliance
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $145.00 |