Vatech Green 16, Руководство по установке

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1. Introduction
Green 16/18 Installation Manual 11
En
glis
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1.5 Standards and Regulations
Standards
Green16/18 (PHT-65LHS) is designed and developed to comply with the following
international standards and regulations:

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)

21 CFR 1020.30, 31, 33

NEMA Standard publication PS 3.1-3.18, 2008
This is Class IIb equipment and obtained CE marking
in April 2007 for regulations compliance following the
revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.
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)
Classifications (IEC 60601-1 6.1)

The degree of protection against water ingress: Ordinary Equipment: IPX0

The degree of protection against electric shock: Class 1 equipment, Type B
Applied Parts (Temple Supports, Chinrests and cover, Nasal Positional and
cover, Ear Rod and cap, Carpus Plate)