Technical Information [Chapter 5]
37
English
Safety and Regulatory Compliance
EN/IEC
Capsule Neuron complies with EN/IEC 60601-1 and EN/IEC 60601-1-2.
• Data Integrity: Capsule Neuron does not compromise the data coming from the medical device.
This does not include data not being delivered or delays in data delivery.
• Medical Device Integrity: Capsule Neuron does not compromise the operation of the connected
medical devices.
Federal Communications Commission
Capsule Neuron complies with Part 15 of the FCC Rules. Operation is subject to two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential area is likely
to cause harmful interference in which case the user will be required to correct the interference
at his own expense.
Note: For operation within 5.15 ~ 5.25GHz / 5.47 ~5.725GHz frequency range, Capsule Neuron 2 is
restricted to indoor environment. The band from 5600-5650 MHz will be disabled by the
software during the manufacturing and cannot be changed by the end user. This device meets
all the other requirements specified in Part 15E, Section 15.407 of the FCC Rules.
Address of the legal representative for the European market
Caution: Capsule is not responsible for any radio or television interference caused by unauthorized
changes or modifications to this equipment. Unauthorized changes or modifications could
void the user’s authority to operate the equipment.
FCC Caution:
Any changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate this equipment.
This transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter.
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