Regulatory Standards - GE BiliSoft Service Manual

Regulatory Standards

IEC Type B equipment.
IEC Class 1 (continuous operation)
FDA Class II
GE Healthcare has declared that this product conforms with the European Council Directive
93/42/EEC Medical Device Directive when it is used in accordance with the instructions
provided in the Operation and Maintenance Manual.
This symbol indicates that the waste of electrical and electronic equipment must not
be disposed as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
© 2007 by General Electric Company. All rights reserved.
Product certified to the following standards:
EN60601-1; EN60601-1-2; EN60601-2-50; ISO
10993-5; ISO 10993-10; UL 60601-1; CSA C22.2 No
601.1-M90; IEC 60601-1-8; BS EN 980; 16CFR Part
1632.6 (for BiliSoft Pad Covers and BiliSoft Nests)
M1110150 006
Chapter 8: Specifications
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