Estone MJ-80, User Manual, Page: 23 / 23

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FCC RF Radiation Exposure Statement:

This Transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.

This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled
environment. This device was tested for typical hand-held operations with the device contacted
directly to the human body to the sides of the device. To maintain compliance with FCC RF
exposure compliance requirements, avoid direct contact to the transmitting antenna during
transmitting.
B2 CE Statement
This equipment complies with the requirements relating to electromagnetic compatibility, the essential
protection requirement of Electromagnetic Compatibility (EMC) Directive 2014/30/EU on the
approximation of the laws of the Member States relating to electromagnetic compatibility and Radio
Equipment Directive (RED) 2014/53/EU to meet the regulation of the radio equipment and
telecommunications terminal equipment.
B3 Directives and Standards
The MJ-80 complies with the following directives:

Medical Device Regulation (MDR)

Low voltage Directive 2014/35/EU

Electromagnetic Compatibility (EMC) Directive 2014/30/EU

Radio Equipment Directive (RED) 2014/53/EU

RoHS2 Directive 2011/65/EU

WEEE Directive 2012/19/EU

Reach Directive 2006/121/EC, 1907/2006/EC Annex 17

Batteries Directive 2013/56/EU
The device has been tested to comply with FCC, IEC 60601-1, IATA/IEC62133, and other relevant
standards for the intended markets.