Vatech PaX-i3D User Manual

PaX-i3D Green (PHT-60CFO) User Manual
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3 PaX-i3D Green Imaging System Overview
3.1.4 Standards and Regulations
Standards:
The PaX-i3D Green is designed and manufactured to meet the following
standards:
IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2, IEC/EN 60601-1-
3, IEC/EN 60601-2-7, IEC/EN 60601-2-28, IEC/EN 60601-2-32, IEC/EN 60601-
2-44, ISO 9001, ISO 13485
NEMA standard publication PS 3.1-3.18, 2008
X-ray source assembly [DG-07C11T2 / DG-07C11C1] IEC 60601-2-28 (1993)
The CE symbol grants this equipment compliance with the European
Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a
class IIb device.
UL symbol grants this equipment compliance with the UL 60601-1 / CAN/
CSA C22.2 No.601.1
Classications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment: IPX0
Protection against electric shock: Class 1 equipment, Type B Applied Parts
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Vatech PaX-i3D Specifications

General

Brand	Vatech
Model	PaX-i3D
Category	Medical Equipment
Language	English