Model note · Phototherapy Unit
GE HealthCare BiliSoft 2.0 Phototherapy System
BiliSoft 2.0 is a fibre optic blanket phototherapy system: an LED light box sends blue light through a flexible cable into a woven light pad placed under or around the baby. It is used in hospitals and, under professional instruction, at home, often alongside overhead lights. A magnetic pad connector, hour meter and front panel indicators for overheating and LED failure are the main serviceable features.
The model
Maker, model and type.
- Maker
- GE HealthCare (made with Lumitex, Inc.)
- Model
- BiliSoft 2.0 Phototherapy System
- Device type
- Phototherapy Unit
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Peak wavelength | 445 to 470 nm | Source |
| Spectral irradiance as shipped (bare pad) | Large pad 49 uW/cm2/nm plus or minus 25% (9 point check); small pad 70 uW/cm2/nm plus or minus 25% (6 point check) | Source |
| Irradiance through pad cover or nest | About 35 uW/cm2/nm (large) and 50 uW/cm2/nm (small) | Source |
| Pad sizes and cable | Small 20 x 25 cm, large 25 x 30 cm light emitting area; cable 137 cm; pad under 0.5 kg; X-ray compatible | Source |
| Light box | 16.5 x 21 x 17.5 cm; under 1.7 kg; sound under 44 dB(A) at 1 m | Source |
| Electrical | 100 to 240 V, 50/60 Hz, 0.25 to 0.75 A; Class II double insulated; type BF pad; touch current under 100 uA normal, 500 uA single fault | Source |
| Ingress and environment | Light box IP21, pad IPX4; operating 5 to 35 C, 15 to 90% RH, 70 to 106 kPa | Source |
| Service life | Light box 7 years; light pad 3.5 years; LED module over 50,000 hours to a 25% drop | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Infants need eye protection, and nearby babies' eyes should be shielded too; never look straight at the light. Source
- Staff watching blue light for long periods may get headache, nausea or mild vertigo. Source
- Monitor bilirubin during therapy; listed risks include apnoea, bronze baby syndrome, skin blistering and patent ductus arteriosus. Source
- Use only manufacturer specified replacement parts. Source
Sources
Where this note comes from.
- GE BiliSoft 2.0 Phototherapy System Operation and Maintenance Manual (2017, reseller copy)
- openFDA 510(k) search, BiliSoft
- openFDA MAUDE problem counts, BiliSoft brand
Not covered: The only 510(k) found is K053568 for the original Lumitex BiliSoft; no BiliSoft 2.0 specific summary was opened. The manual's troubleshooting table swaps the replacement thresholds (small under 27, large under 39) compared with its own note and output table (large 27, small 39); the note's values are used here and the discrepancy should be checked. No FDA recall names BiliSoft and MAUDE has only two reports.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Phototherapy Unit
Other models of this device.
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