EN
OPERATOR'S MANUAL
7
Please pay particular attention to the sections in the manual where the following symbols appear:
Patient or operator safety-related warnings.
Important information on product use.
For 3D machines only.
In accordance with the privacy laws in force in several countries, all sensitive personal information must be
adequately protected. In addition, patients must sign a consent form before any personal information or
images are transmitted across networks. If required by the laws in force, dentists are obliged to protect data
using a protection password. Refer to the Microsoft® Window
s operating system manual for data access
protection methods by means of password.
It is recommended to regularly (at least once a week) make a backup copy of the databases. This will allow
restoring the data in the event of damage to the hard disc of the PC or the databases themselves.
1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT)
For proper functioning, the device requires connection to a personal computer (PC) and the relative software. For the
minimum requirements of the PC, refer to the paragraph TECHNICAL DATA.
The PC is not included with the device. It is recommended to only use a PC compliant to the IEC 60950-
1:2007 standards for information technology devices.
1.4. STANDARDS AND REGULATIONS
The system has been designed to meet the following standards:
- Directive 93/42/EEC and subsequent amendments and additions
(dir. 2007/47/EC) - Medical Devices Directive;
- Directive 2006/42/EEC - Machinery Directive.
Technical Standards:
IEC 60601-1:2005
IEC 60601-1-2:2014
IEC 60601-1-3:2008
IEC 60601-2-63:2012
IEC 60601-1-6:2010
IEC 62366-1:2015
IEC 62304:2006
The CE marking certifies compliance of the product as described herein with Medical Device Directive
93/42/EEC and subsequent amendments.
