Imaging System Overview - VATECH PaX-i PLUS Manual De Usuario

1.

Imaging System Overview

PaX-i Plus/ Insight (Model: PCH-30CS) is an advanced 2-in-1 digita X-ray imaging
system that incorporates PANO and CEPH (Optional) imaging capabilities into a single
system.
The PaX-i Plus/ Insight 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.
PaX-i Plus/ Insight 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
PaX-i Plus/ Insight (Model: PCH-30CS) is designed and developed to comply with
the following international standards and regulations:

IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63

CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09, CAN/CSA-
C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-63:15, CAN/CSA-IEC
62366:15

ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, A2:2010 / (R)2012
(Consolidated text - edition 3.1)

21 CFR 1020.30, 31, 33

NEMA Standard publication PS 3.1-3.18, 2008
Classifications (IEC 60601-1 6.1)

Degree of protection against water ingress: Ordinary Equipment: IPX0

Degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts: Temple Supports, Chinrests and Bites.
PaX-i Plus/ Insight User Manual
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.
This equipment received the CSA certification mark in
accordance with CAN/CSA C22.2 No.601.1 regulations.
1. Imaging System Overview
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