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OVERHEAD INFANT PHOTOTHERAPY UNIT (ARDO Amelux), 230V

https://medicalguidelines.msf.org/en/node/2000
https://unicat.msf.org/cat/product/12849
NST EEMDPHOE1--

Outdated Article

Former Code(s): EHOEPHOT1--
Article is intended to be used with children (<12 years) ONLY.
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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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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OVERHEAD INFANT PHOTOTHERAPY UNIT (Ardo Amelux)

The Amelux is no longer produced by Ardo. It is replaced by the new Brilliance Pro phototherapy unit of Phoenix (see “replaced by” at bottom of the page).

Definition

A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia).

This device consists of an overhead lamp containing of several different fluorescent light bulbs: daylight, cool white, blue, or special fluorescent blue and a Plexiglas shield to be placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation.

Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally.

Specifications

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Quality standards

EN IEC 60601-2-50, 2021, Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Technical specifications

  • 4 blue light compact fluorescent lamps (CFLs) for the treatment of hyperbilirubinaemia
  • 2 white light CFLs emitting a pleasant mixed light for observation
  • 6 blue light CFLs can be used for more intensive treatment
  • Best possible focus from optimally positioned reflectors
  • Hours of operation timer to check total working hours
  • Operating life of the lamps at least 2‘000 hours
  • Power supply: 230V ± 10%
  • Consumption: 110 W
  • Mobile stand with 3 castors
  • Adjustable height

Instructions for use

See users' manual

The light tubes, white and blue, must be changed every 2000 hours.

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Precautions for Use

  • Eye protection of the neonate is mandatory (see accessories)
  • Increase breastfeeding. If the newborn is on intravenous fluids or extracted breast milk, increase the volume by 10%
  • This equipment is sensitive to variations in voltage:
    • Minimum requirements are: voltage regulation with over-voltage protection
    • In critical areas or places with frequent and/or long powercuts: double conversion UPS is recommended
    • Contact your biomedical referent for further information
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