Compliance Declaration; Stabilization Time - NeoLight SKYLIFE User Manual

7.4 COMPLIANCE DECLARATION

IEC 60601-1: 2005, 3
rd
ANSI/AAMI ES60601-1
IEC 60601-1-2: 2014, 4
IEC 60601-1-6: 2010, 3
IEC 60601-1-11: 2015
IEC 60601-2-50: 2012, 2
IEC 60601-1-8: 2006
IEC 62304: 2006

7.5 STABILIZATION TIME

The Skylife Phototherapy System does not require a pre-aging time. It is ready for use immediately after it is
turned on the initial time.
The Skylife Phototherapy System does not require a stabilization period. It is ready for use immediately after it is
powered ON.
Edition Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
Edition Medical electrical equipment - Part 1-2: General requirements
th
for basic safety and essential performance - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
Edition Medical electrical equipment - Part 1-6: General requirements
rd
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
Edition Medical electrical equipment - Part 2-50: Particular requirements
nd
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
500007, Rev P, Pg 16