Imaging System Overview - VATECH Green16 Handbuch

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Imaging System Overview

Green16 (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.
Green16 (PHT-65LHS) is a dental 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.
Green16 (PHT-65LHS) 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
Green16 (PHT-65LHS) is designed and developed to comply with the following
international standards and regulations:
MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-2-63
(2012)
21 CFR 1020.30, 31, 33

NEMA Standard publication PS 3.1-3.18, 2008

Green16 (PHT-65LHS) 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 UL certification mark in accordance with
CAN/CSA C22.2 No.601.1 regulations.
1. Imaging System Overview
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