Imaging System Overview; Standards And Regulations - VATECH Green16 PHT-65LHS Handbuch

1.

Imaging System Overview

Green 16 (Model: PHT-65LHS) is an advanced 4-in-1 digital X-ray imaging system
that incorporates PANO, CEPH (Optional), CBCT and 3D MODEL Scan imaging
capabilities into a single system.
Green 16 is a computed tomography X-ray system intended to produce panoramic,
cephalometric or cross-sectional images of the oral anatomy by computer
reconstruction of x-ray image data from the same axial plane taken at different angles.
It provides diagnostic details of the maxillofacial areas for dental treatments in adult
and pediatric dentistry. The system also utilizes carpal images for orthodontic
treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
The Green 16 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

Green 16 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.
Green 16 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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