VTech EzRay Air Portable - Standards and Regulations

1. General and Regulatory Information
10 EzRay Air Portable (Model: VEX-P300) User Manual
1.5 Standards and Regulations
Standards:
The device is designed and manufactured to meet the following standards:
 MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-2-
65(2012)
 ISO 13485
 21 CFR 1020.30 & 1020.31
This is Class IIb equipment and obtained CE marking in
April 2007 for regulation compliance by the revised
European Union’s MDD (Medical Devices Directive)
93/42 EEC.
This equipment received the UL certification mark in
accordance with ANSI/AAMI, CAN/CSA-C22.2 No.
60601-1 regulation.
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection against electric shock: Class II equipment,
Type B Applied Parts: Round Cover, Rectangular Cover, Rotating Rectangular Cover