Vatech Green 21 PCT-90LH, User Manual

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1. Introduction
6 Green21 (Model: PCT-90LH) Installation Manual
1.4 Standards and Regulations
Standards
Green 21 (Model: PCT-90LH) was designed and developed to comply with the
following international standards and regulations:
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH UL 60601-1, CAN/CSA-C22.2 No.60.1
This is Class IIb equipment and obtained CE marking in
April 2007 for regulations compliance in accordance with
the revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE
WITH UL 60601-1, CAN/CSA-C22.2 No.60.1
Classifications (IEC60601-1 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 (Chinrest, Bite and cover, Nasal Positioner and cover, Ear Rod and
cap, Carpus Plate)