Gendex GXS-700, User Manual

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Gendex GXS-700 TM
English 7-6
Compatibility with Software
The GXS-700 requires the installation and use of GxPicture 3.0.1 or later software in
combination either with:
•
VixWin Platinum Software 2.0 or later, DEXIS 9.0.2 software or
later, or Dentrix Image 5.1 CU1 software or later.
or
•
Application software which has Dental IO Diagnostic Imaging
functionality; provided the software is released by the
manufacturer for usage with GxPicture software.
Important:
If the GXS-700 System is used with imaging software other than
VixWin Platinum, then the Intended Use of that software needs to
include
dental intra-oral x-ray
.
Declaration of Conformity
Manufacturer and Technical File Holder: Authorized EU Representative:
Gendex Dental Systems Kaltenbach & Voigt GmbH
1910 North Penn Road Bismarckring 39
Hatfield, PA 19440 D-88400 Biberach, Germany
Phone (215) 997-5666 Tel. +49 7351 56 0
Fax (215) 997-5665 Fax (215) 997-5665
E-mail: info@kavo.de
EC Declaration of Conformity
A. Name/Description of product:
Gendex GXS-700, Digital Intraoral Sensor
REF:
Models; GXS-700
Class:
IIa
B. A copy of the Technical File and relevant information for this equipment is available
to national authorities from the Authorized Representative listed above via mail or
email upon receipt of a written request.
C. Harmonized Standards (published in the Official Journal of the European Union)
under which conformity is declared:
•
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), 3rd Edition
‘General requirements for basic safety and essential performance’
•
IEC 60601-1-6:2006, 2nd Edition 'Collateral standard: Usability'
•
EN 60601-1-2:2007, 3rd Edition ‘Collateral standard: Electromagnetic
compatibility – Requirements and tests’
GXS-700.book Page 6 Wednesday, January 27, 2016 9:58 AM