VATECH Smart Plus PHT-35LHS Mode D'emploi page 9

1. Imaging System Overview
Smart Plus (Model: PHT-35LHS) 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.
Smart Plus 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. With Auto Pano function, it also reconstructs the 3D CT data
and produces 2D panoramic images without an additional scan. The system also
utilizes carpal images for orthodontic treatment. The device is to be operated by
physicians, dentists, and x-ray technicians.
The Smart Plus 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
Smart Plus 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.
Smart Plus 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 certific_171127ation mark in
accordance with CAN/CSA C22.2 No.601.1 regulations.
1. Imaging System Overview
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