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Device Lab 57

Phototherapy Unit

Phototherapy Unit in the BMEssentia 3D Device Lab

Forty-eight royal-blue emitters on a metal-core board behind a diffuser and a polycarbonate window, in a slim head on an arm over an open cot. Almost everything it radiates falls inside the absorption band, the whole light-facing aspect of the infant is treated at once, and the irradiance at the skin is set by how far above the mattress somebody left the head, which is a number on a scale nobody records and which the geometry of the room keeps changing.

Also called: Bili Light. Arabic: وحدة العلاج الضوئي. Device Lab 57 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Overhead LED array

Forty-eight royal-blue emitters on a metal-core board behind a diffuser and a polycarbonate window, in a slim head on an arm over an open cot. Almost everything it radiates falls inside the absorption band, the whole light-facing aspect of the infant is treated at once, and the irradiance at the skin is set by how far above the mattress somebody left the head, which is a number on a scale nobody records and which the geometry of the room keeps changing.

Fibre-optic biliblanket

A 220 watt quartz-halogen lamp in a box on a low cart, a dichroic band-pass filter, a fibre bundle, and a woven fibre-optic pad laid against the skin. The filter and the bundle between them throw away more than ninety per cent of the lamp’s radiant power and multiply the spectral overlap more than twentyfold, which is the entire reason an incandescent source can be pressed against a baby at all. The distance is zero and stays zero.

How it works: the main parts

What each part does, from the Phototherapy Unit lessons in the 3D Device Lab.

Mains inlet, fuse and protective earth
An appliance inlet, a fuse drawer, a rocker switch with a neon leg in it and an earth stud, all on one recessed plate at the back of whichever enclosure the configuration has. The neon is the only thing on either machine that tells you a supply has arrived.
Constant-current driver and output stage
A chassis tray with one populated board in it: reservoir capacitors, a switching transformer, an output stage on a small heatsink, a sense resistor, a connector out to the source, and a screwdriver-slot trimmer that nobody thinks about. That trimmer sets the radiant output of the whole machine.
Heatsink, fan and cooling airway
A finned aluminium block clamped to the source through a thermal pad, a fan in a guarded housing, an intake grille and a set of exhaust louvres somewhere else. On the configuration that hangs over the cot the block is in the head and the fan is not, it is down in the column enclosure, cooling the driver instead.
Control fascia and irradiance selector
A raked panel with a small display window, five membrane keys, a rotary drive selector and printed legends beside all of them. Read it from end to end and the significant thing is what is not on it: there is no irradiance anywhere, and there is a greyed line of text saying so.
Treatment timer and source-hours counter
Two counters behind the same fascia, and the difference between them is the point. One is a digital window that counts this treatment and is reset by a key.
Thermal cut-out and source-fail detection
Two small, unglamorous circuits that between them are the only automatic protections on the machine. A bimetal disc clamped to the source’s thermal path with a relay in series with the source, and a comparator watching the driver’s sense shunt for a source that has gone open circuit.
Hand-held spectral irradiance meter
A moulded hand-held box with a small display, two keys, a band-select switch, and a sensor head on a lead. It is not part of either machine, it is the only thing in the system that knows the dose, and on most units it lives in a drawer.
Distance-irradiance chart and rating plate
A printed label on the back of the enclosure with a short table on it: a distance in one column and an irradiance in the other, a waveband, and the words "new source". Beside it a rating plate giving the source type and the electrical classification.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Overheating of Device421
Melted419
Device Issue83
Device Operational Issue47
Low Test Results45
Output Problem19

Raw counts of adverse event reports for this device type (FDA product code LBI), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Standards engineers test against

IEC 60601-2-50: infant phototherapy equipment

The particular standard for neonatal phototherapy.

Recent FDA recalls

RecallProduct and reason
Z-0923-2020
2019-12-11
Lumitex Inc: Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958,
There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. Root cause: Device Design.
Z-1924-2017
2017-04-14
Natus Medical Incorporated: Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top
The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used. Root cause: Component change control.
Z-0769-2017
2016-12-15
Natus Medical Incorporated: Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used
The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. Root cause: Device Design.
Z-1503-2017
2016-11-18
Ohmeda Medical: Giraffe Spot PT
Certain power cords could overheat. Root cause: Under Investigation by firm.
Z-0770-2017
2016-10-28
Natus Medical Incorporated: Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal
neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box. Root cause: Device Design.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 14 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

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