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Electromagnetic Emissions and Immunity
Cervella has been designed and tested in accordance to IEC60601-1-2:2014
electromagnetic compatibility (EMC) safety regulations. Cervella is suitable for use
in Home Healthcare and Professional Healthcare establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes. Cervella can be used in
medical facilities except for near active high-frequency surgical equipment and RF
shielded rooms for magnetic resonance imaging equipment, or anywhere where the
intensity of electromagnetics disturbances is high.
The essential performance of the Cervella system is that the device will provide
stimulation according to parameters listed in the Technical Specifications section of
the User’s Manual. The specifications can be lost or degraded due to
electromagnetic disturbances including loss of device-to-app connection,
unresponsive device, or inoperative device that may result in ineffective or
incomplete treatment.
Cervella must only be used with the headset with integrated electrodes, headset-to-
device connecting cable, AC/DC charger, and charger-to-device cable provided with
the Cervella system as shown on Page 6 of this document.
WARNING
1
. Use of the Cervella device adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
2
. Use of accessories (e.g. headset), electrodes, chargers and cables other than
those specified or provided by the manufacturer of Cervella could result in
increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation. For replacement accessories,
please contact us at
.
3
. Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of Cervella, including cables included with the device.
Otherwise, degradation of the performance of this equipment could result in
ineffective or incomplete treatment or device malfunction.
