Users Manual

 Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

 Consult the dealer or an experienced radio/TV technician for help.

Any changes or modifications not expressly approved by the manufacturer could void the user’s

authority to operate the equipment . Modifications not expressly approved by Device

Manufacturer could void the user’s authority to operate the equipment under FCC rules.

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 de- vice. To maintain compliance with FCC RF

exposure compliance requirements, avoid direct contact to the transmitting antenna during

transmitting.

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

environment. The highest SAR value for the MD-100 device is <0.88W/kg.

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

with the MD-100 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-100 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.