Pax-I3D Green Imaging System Overview - VATECH Pax-i3D Manual Del Usuario

1 PaX-i3D Green Imaging System Overview

0543
PaX-i3D Green (PHT-60CFO) User Manual
The PaX-i3D Green is an advanced digital dental diagnostic system that
incorporates Panoramic (PANO), Cephalometric (CEPH), and 3D CT imaging
capabilities into a single system.
The PaX-i3D Green system is intended for use to take a panoramic,
cephalometric and CT image of the oral and craniofacial anatomy to provide
diagnostic information for adult and pediatric patients.
The PaX-i3D Green may only be used by dentists, X-Ray technicians and other
professionals who are licensed to perform X-Rays by the law of the region in
which it is being used.
Standards and Regulations
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 [HDG-07B10T2] 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
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment: IPX0
Protection against electric shock: Class 1 equipment, Type B Applied Parts
1 PaX-i3D Green Imaging System Overview
07