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EXAMINATION LIGHT (LID Bella 17650DI), mobile, 110-230 V

https://msf.oodin.sh/cat/product/12798
STD EEMDLEXE2--

Valid Article

Former Code(s): EHOELAEX2--
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z12010702 - Mobile scialytic lamps
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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EXAMINATION LIGHT, mobile

US plug available on request

Definition

A mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.

Specifications

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Quality standards

EN IEC 60601-2-41, 2021, Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

Technical specifications

  • Flexible arrm (70 cm)
  • LED Lamp, 17 Watts
  • Longevity of LED : min 50.000 hours
  • Beam intensity: 1680 lumen
  • Dual intensity set-up: 50% or 100% switch on the top of the lamp
  • Illuminated field
    • distance 30 cm (210.000 Lux) Ø 10 cm
    • distance 100 cm (33.000 Lux) Ø 20 cm
  • White light similar to that of the day : 4500°K
  • Mobile trolley
    • adjustable in height (60 - 100 cm)
    • with 5 antistatic castors
  • Power cable lenght 3 meters
  • Power supply: 220-240 V AC
  • Protection against electric shocks
    • Class II
    • No applied parts
  • Warranty 5 years

Packaging & Labelling

Lamp delivered in one box, to be build up.

(Cf Introduction: Packaging and labelling)

Instructions for use

Lamp intended for basic hospital settings with small surgery, dermatology, gynecology, obstetrics, intensive care unit ...

Maintenance

Can be cleaned and disinfected with a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet the surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

MSF requirements

Operates on mains (220 V AC)

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