Imaging System Overview - VATECH Green18 Handbuch

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Imaging System Overview

Green18 (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.
Green18 (PHT-65LHS), a digital radiographic imaging system, acquires and
processes multi-FOV diagnostic images for dentists and ENT specialists. Specifically
designed for dental radiography, Green18 (PHT-65LHS) is a complete digital X-ray
system equipped with imaging viewers, X-ray generator and a dedicated SSXI detector.
The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT
detector is used to capture 3D radiographic images of head, neck, oral surgery,
implant and orthodontic treatment.
Green18 (PHT-65LHS) can also acquire 2D diagnostic image data in conventional
panoramic and cephalometric modes.
Standards and Regulations
Green18 (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
Green18 (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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