OMRON battery-operated Electronic Nerve Stimulator (ENS), model E4 (HV-F128-E) Information for accompanying documents in the scope of IEC60601-1-2:2007 Important information regarding Electro Magnetic Compatibility (EMC) With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. Medical devices manufactured by OMRON Healthcare conform to this EN60601-1-2:2007 standard for both immunity and emissions. Nevertheless, special precautions need to be observed: • The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device. • The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used. • Refer to further guidance below regarding the EMC environment in which the device should be used.

_Guidance and manufacturer’s declaration - electromagnetic immunity OMRON battery-operated E4 (HV-F128-E) ENS devices are intended for use in the electromagnetic environment specified below. The customers or the users of these ENS devices should assure that it is used in such environment. Immunity test Test level level Electromagnetic environment -guidance Portable and mobile RF communications equipment should be used no closer to any part of the OMRON E4 (HV-F128-E) ENS devices including cables, than the recommended separation distance calculated from the equation appropriate to the frequency...

Note: EMC tests conducted including attached electrode cord of 1 m length