Chapter 1: About This Manual; Indications For Use; Intended Users; Purpose - NeoLight Skylife Service Manual

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
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
provides an average intensity of 56.3 μW/cm
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
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All rights reserved.
2 /nm at Low, High, and Very High settings. Skylife at the Very High setting
2 /nm over the treatment area with a peak at 72.4
2 /nm to > 55 μW/cm 2 /nm, emitting light in
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