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Page 6 of 43
500050 Rev A
Chapter 1: About this Manual
1.1 Indications for Use
Skylife is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide
phototherapy treatment from underneath the baby. Skylife must be used within a patient enclosure, such
as a bassinet, an open crib, a warming table, or an incubator. Skylife can be used in a clinical setting or in
the home.
1.2 Intended Users
This device should only be operated by health care providers or others designated by health care
providers* who are trained in its operation and familiar with the risks of this type of device.
1.3 Purpose
The service manual provides a complete guide on troubleshooting and maintaining the Skylife Infant
Phototherapy System.
1.4 Product Description
Skylife is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via
blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia.
Skylife is designed to provide phototherapy treatment from underneath the baby. The system must be
used within a patient enclosure, such as a bassinet, an open crib, a warming table, or an incubator.
Skylife utilizes blue LEDs to achieve intensities from 25
μW
/cm
2
/nm to
> 55 μW
/cm
2
/nm, emitting light in
a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of
light by bilirubin. SkylifeTM utilizes blue LEDs in this range to achieve peak intensities between 25 to 35,
35 to 55, and over 55
μW
/cm
2
/nm at Low, High, and Very High settings. Skylife at the Very High setting
provides an average intensity of 56.3
μW
/cm
2
/nm over the treatment area with a peak at 72.4
μW
/cm
2
/nm.
Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no
longer has jaundice as determined by the attending physician. Phototherapy treatment of neonatal
jaundice using Skylife can be applied at home or in a hospital.
* Such as those using the product through DME groups
