Shining 3D Aoralscan 3 - Compliance; FCC Compliance Statement; Electrical Safety; Electrical

Aoralscan 3_Manual_V1.0.0.30 - 11 -
Indicates correct upright position of the transport package.
Indicates that the material shall be recycled.
Indicates the manufacturer information.
Indicates the product serial number information.
Indicates CE-related certification information.
Class II equipment.
Indicates laser information.
Indicates Shining 3D’s representative information.
Indicates that for more information, see use 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.
2.5.1. Electrical
⚫ IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for