VATECH Green 16 Mode D'emploi page 11

1. Imaging System Overview
Green16 (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.
Green16 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 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 (Model: PHT-65LHS) is designed and developed to comply with the
following international standards and regulations:
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IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63
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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
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ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, A2:2010 / (R)2012
(Consolidated text - edition 3.1)
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21 CFR 1020.30, 31, 33
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NEMA Standard publication PS 3.1-3.18, 2008
Classifications (IEC 60601-1 6.1)
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Degree of protection against water ingress: Ordinary Equipment: IPX0
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Degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts: Temple Supports, Chinrests and Bites.
Green16 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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