Shining3D Aoralscan 2, User Manual, Page: 13 / 108

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Intraoral Scanner User Manual
Compliance
Anyone creating or changing a medical electrical system through a combination with
other devices in accordance with standard EN 60601-1-1:2001 based on 60601-1-
1:2000 (specification for the safety of medical electrical systems)/UL 60601-1 Part 1:
first edition 2003 is responsible for ensuring that the requirements of these standards
are met to the full extent in order to ensure the safety of patients, operators and the
environment.
FCC compliance statement
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
Electrical safety
Only trained medical personnel should operate this scanner. The product complies
with the following standards:
Electrical
• IEC 60601-1-2:2014
• IEC 60601-1:2015/A1:2012 (ed 3.1)
• IEC 60601-1-6: 2013.Con Ed 3.1 Rev. October 29. 2013.
• IEC 62366-1:2015
• IEC 62304:2006/AMD1:2015
Classification
• Type of protection against electric shock: Class II
• The degree of protection against electric shock: Type BF
• The mode of operation: Continuous operation
• Pollution degree 2
For maximum safety, observe the following guidelines strictly:
WARNINGS
• Shock hazards exist if the power adapter is damaged or is not properly
grounded. Use only the supplied medical grade power adapter.
• To avoid the risk of electric shock, connect the scanner only to properly
grounded wall outlets.
• Only authorized service labs can make internal replacements of the
scanner and modify the software.