GE BiliSoft - Chapter 1 Product Description; Intended Use; Description

M1110147 Rev. 5 © 2007 Datex-Ohmeda. All rights reserved 1-1
Chapter 1
Product Description
Intended Use
The BiliSoft LED Phototherapy System provides light therapy for the treatment of indirect
hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital or home setting.
Description
The BiliSoft LED Phototherapy System consists of a light box and a detachable fiberoptic light
pad with a long, flexible fiberoptic cable. The fiberoptic cable delivers light from a high
intensity LED module in the light box to the fiberoptic light pad. The flexible fiberoptic light
pad is placed in a soft BiliSoft Pad Cover or BiliSoft Nest that is then brought into contact with
the patient’s skin. The patient is exposed to light in the wavelength of 430-490 nanometer
range (peak 440-460 nanometer).
Units are available with two fiberoptic pad sizes: large (25cm x 30cm) and small (15cm x
30cm). The large pad’s nominal spectral irradiance is 35 µW•cm
-2
•nm
-1
through a typical
BiliSoft Pad Cover or BiliSoft Nest. The small pad’s nominal spectral irradiance is
50 µW•cm
-2
•nm
-1
through a typical BiliSoft Pad Cover or BiliSoft Nest.