User's Manual

This equipment complies with FCC/IC/EU RF radiation exposure limits set forth for an uncontrolled

environment. The highest SAR value for the MD-150 device is <1.562W/kg.

In order to maintain compliance as a Class 1 Medical device, the switches that are used in combination

with the MD-150 device must fulfill the isolation requirements of IEC/EN 60601-1 based on 15 VDC.

They must be electrically floating switches (switches that are not grounded).

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 MD-150 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.