VATECH PaX-i PCH-2500 Mode D'emploi page 8

1. PaX-i Imaging System Overview
1. PaX-i Imaging System Overview
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The PaX-i is an advanced digital dental diagnostic system that incorporates
panoramic and cephalometric (optional) imaging capabilities into a single
system.
The PaX-i system is intended for use to take a panoramic and cephalometric
images of the oral and craniofacial anatomy to provide diagnostic information
for adult and pediatric patients.
The PaX-i system uses the advanced sensors to produce the higher quality of
image in 2D of the head region, including the dental/maxillofacial regions, for
planning and diagnostics.
The system includes the following software packages:
■ EasyDent for 2D viewing and patient management
■ Imaging software
The PaX-i 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. (The PaX-i may be used for ENT (Ear, Nose and Throat)
examination in countries requiring the CE marking.)
Standards and Regulations
The PaX-i3D Smart is designed and manufactured to meet the following standards:
IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63
21 CFR 1020.30, 31, 33
NEMA Standard publication PS 3.1-3.18, 2008
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.
CSA symbol grants this equipment compliance with the CSA mark
No.266436.
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
PaX-i (PCH-2500) User Manual