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OVERHEAD INFANT PHOTOTHERAPY UNIT (Brilliance Pro), 230V

https://medicalguidelines.msf.org/en/node/2000
https://unicat.msf.org/cat/product/80777
STD EEMDPHOE2--

Valid Article

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.
Z12080401 - Paediatric phototherapy equipment
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.
IIa
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 (Brilliance Pro)

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 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.

This new phototherapy unit Brillance Pro, is replacing the Ardo Amelux which is no longer produced

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

Components

  • Light unit head
  • Mobile stand and base with 3 castors
  • Power cord
  • User manual
  • Bag of assembly parts (screws and tilt lock lever)

Technical specifications

  • Illumination source: blue LED
  • Observation light: white LED
  • LED lifetime: >100,000 hours
  • Peak spectral irradiance: 40 μW/cm2/nm (±15%) at 45 cm
  • Peak wavelength: 451 nm
  • Emission spectrum: 445-470 nm (bounds of FWHM range)
  • Effective surface area: 500 mm x 250 mm at recommended treatment distance
  • Irradiance ratio: > 0.4 (min/max irradiance)
  • Light intensity: high or low
  • Pedestal with L-pipe: epoxy coated
  • Mobile stand: 3 castors of which 2 are lockable
  • Height adjustment range: 118 cm – 165 cm approx.(distance between bottom surface and ground)
  • Recommended treatment distance: 45 cm
  • Lamp unit tilting: up to 90° continuously adjustable
  • Time totalizers:
    • machine run time totalizer
    • therapy time totalizer
  • Power supply mains
    • Voltage: 100-240V
    • Current: 0.8A maximum
    • Frequency: 50/60 Hz, single phase
    • Power consumption: 42W maximum
  • Protection against electric shock: class 1
  • Operating conditions
    • temperature: 10°-35°C
    • relative humidity 0% to 90% non condensing
    • atmospheric pressure: 70 kPa to 106 kPa

Dimensions

  • Overall dimensions: Height x Width x Depth: 123 x 69 x 64 cm
  • Head assembly dimensions: Length x Width x Depth: 55 cm x 30 cm x 5 cm
  • Weight: 12 kg

To be Ordered Separately

Light meter for irradiation distribution checking (one per project recommended)

Instructions for use

See users' manual

Irradiation distribution checking: Check the irradiance distribution of the light on the infant surface by using the light meter. Distribution should be 40% over the bed surface. Plug the light meter into the socket provided at the rear side of the light unit. Now the LCD display on the light unit shows the irradiance level of the light meter. Place the light meter over the bed surface and measure the irradiance output.

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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

MSF requirements

For the treatment of severe jaundice:

  • any jaundice occuring in the first 24 hours after birth
  • feature of severe clinical jaundice or identified risk factors
  • elevated serum bilirubin level for weight and age
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