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The Lenire device is intended for use in the home healthcare and professional
healthcare environments only. The performance of the Lenire in environments
with high electromagnetic disturbances, e.g. near magnetic resonance
imaging (MRI) or high frequency surgical equipment has not been evaluated
and the Lenire device should not be used in such environments.
Radio communications equipment (such as WIFI router, mobile phones etc)
may interfere with the performance of Lenire (including cables as specified by
Neuromod Devices Limited) and should be kept at least 2m away from it when
in use. Otherwise, degradation of the performance of this equipment could
result.
The Lenire device should not be used adjacent to or stacked with other
electrical equipment because it could result in improper operation.
Use of accessories and cables other than those specified for use for the
Lenire device (and as provided by Neuromod Devices Limited) could result in
increased electromagnetic emissions or decreased electromagnetic immunity
of this equipment and result in improper operation.
The Lenire device has been tested for electromagnetic emissions and complies with CISPR
11 Group 1 Class B and is therefore unlikely to interfere with the operation of other electrical
equipment.
Chapter 26 - Materials in Direct Contact with Human Tissue
The Lenire device does not contain phthalates, latex, human blood derivatives or cells or tissues
of human or animal origin.
The electrodes of the Tonguetip contain nickel.
Note: For a complete list of materials in contact with human tissue, contact Neuromod
Devices Limited.
Chapter 27 - Declaration of Conformity Radio Equipment Directive 2014/53/EU
Hereby Neuromod Devices Limited declares that the radio equipment type are Wideband Data
Transmission Equipment in the 2.4 GHz ISM band (operating in the frequency range 2.4 GHz to
2.4835 GHz) per ETSI 300 328 v.2.1.1. and is in compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
www.neuromoddevices.com.
Disturbances higher than these limits are unlikely to be encountered in the home healthcare or
professional healthcare environments.
