Introduction - NeoLight SKYLIFE User Manual

1. INTRODUCTION

The Skylife Phototherapy System is a portable phototherapy device that delivers a narrow band of high-intensity
light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The
Skylife system is designed to provide phototherapy treatment from underneath the baby minimizing interference
with other ongoing treatments. The Skylife device must be used within a patient bed, such as a bassinet, an open
crib, a warming table, or incubator and may be used in either hospital or home settings.
The terms "neonatal" and "neonate" refer to a baby from birth through the first 28 days of life. The Skylife device is
intended for use with all neonatal subpopulations.
The system utilizes blue LEDs to achieve intensities from 25 µW/cm
narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by
bilirubin, and is thus considered to be the most effective for treatment
this range to achieve peak intensities between 25 to 35, 35 to 55, and over 55 μw/cm²/nm* at low, high, and very
high settings.
The Skylife device greatly minimizes the risk of UV exposure typically seen with phototherapy treatment through
the use of Blue LEDs, as this light source does not emit significant energy in the ultraviolet (UV) spectrum.
However, as with all phototherapy treatment, protective eye masks must be used to protect the baby's eyes from
blue light exposure.
Treatment times can range from hours to weeks and should only be performed under the supervision of a licensed
practitioner. Treatment exposures may be applied continuously 24 hours a day or as prescribed by the treating
physician. The Skylife device may be contraindicated for babies with rapidly rising bilirubin levels. Babies with
rapidly rising bilirubin levels must be monitored frequently and may require a more intensive therapy.
Read this User Manual carefully before using the device. Please pay careful attention to the Safety
Information and Warnings throughout the manual.
Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the
law of the State in which he/she practices to use or order the use of the device.
This product is covered by one or more U.S. Patents.
*
Very High setting provides an average intensity of 56.3 μw/cm
1. Vreman, Hendrik J., et al. "Light-emitting diodes: a novel light source for phototherapy." Pediatric research 44.5 (1998): 804-809.
2. Lee, Kwang-Sun, and Lawrence M. Gartner. "Spectrophotometric characteristics of bilirubin." Pediatric research 10.9 (1976): 782-788.
3. Dixon, J. M., M. Taniguchi and J. S. Lindsey (2005), "PhotochemCAD 2. A Refined Program with Accompanying Spectral Databases for
Photochemical Calculations, Photochem. Photobiol., 81, 212-213.
/nm to >55 µW/cm²/nm*, emitting light in a
2
2
/nm over the treatment area with peak intensity at 72.4 μw/cm
. The Skylife system utilizes blue LEDs in
1,2, 3
2
/nm.
500007, Rev P, Pg 2