Chapter 9: Compliance Declaration - NeoLight Skylife Service Manual

Chapter 9: Compliance Declaration

IEC 60601-1: 2005, 3 rd
ANSI/AAMI ED60601-1
IEC 60601-1-2: 2014, 4
Edition
IEC 60601-1-6: 2010, 3
Edition
IEC 60601-1-11:2015
IEC 60601-2-50: 2012, 2
Edition
IEC 60601-1-8: 2006
IEC 62304: 2006
Electromagnetic Compatibility (EMC)
The Skylife system is suitable for the electromagnetic environment of typical homes, commercial, or
hospital settings. During the immunity testing described below, the Skylife device delivered treatment at a
430-475 nm wavelength at an intensity between 25 to 72 µW/cm
Warnings
• Portable R.F. communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Skylife
device, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
•
The Skylife unit should not be used adjacent to or stacked with other equipment. However, if
adjacent or stacked use is necessary, the device should be observed to verify normal operation. If
the operation is not normal, the Skylife device or the other equipment should be relocated.
•
The use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity and result in improper operation.
© 2022 by NeoLight LLC.
All rights reserved.
Edition Medical Electrical Equipment- Part 1: General Requirements for basic
safety and essential performance
th Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
rd Medical electrical equipment – Part 1-6: General requirements for
safety – Collateral Standard: Usability
Medical electrical equipment – Part 1-11: Collateral Standard:
Requirements for medical electrical equipment and medical electrical
equipment used in the home healthcare environment
nd Medical electrical equipment – Part 2-50: Particular requirements for
the safety of infant phototherapy equipment
Medical electrical equipment – Part 1-8: General requirements for
basic safety and essential performance – Collateral standard: General
requirements, tests, and guidance for alarm systems in medical
electrical equipment and medical electrical systems
Medical device software – Software life cycle processes
2 /nm.
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