THERANICA Nerivio, Руководство пользователя, Страница: 33 / 39

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The Nerivio
™ device should 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 IEC60601-1-2 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.
The Nerivio
™ medical device conforms with the IEC60601-1-2:2014 standard for both
immunity and emissions.
The Nerivio
™ device requires special precautions regarding EMC and needs to be
installed and used according to the EMC information provided in this manual:
•
Do not use any unspecified accessories with the Nerivio
™ device. This may result
in increased emissions or decreased immunity of the device.
•
The Nerivio
™ device should not be used adjacent to or stacked with other
equipment. In case adjacent or stacked use is necessary, the Nerivio
™ device
should be monitored to verify normal operation in the configuration in which it is
used.
•
Do not use devices which generate strong electrical or electromagnetic fields in
proximity to the Nerivio
™ device. This may result in incorrect operation of the device
and create a potentially unsafe situation. In order to reduce the risk of EM
interference, it is recommended to keep a minimum distance of 30 cm (12 inches)
between the device and other electromagnetically radiating devices. Verify correct
operation of the device if the distance is shorter.
The Nerivio
™ device complies with immunity tests described below.
14.1. ELECTROMAGNETIC TEST RESULT SUMMARY
Test Standard Class /
Severity level Test
result
Emission
Radiated emission
Frequency range:
30-1000 MHz IEC 60601-1-2 section 7.1 /
CISPR 11 Group 1 Class B Complies
ETSI EN 301 489-1 section 8.2;
ETSI EN 301 489-17 section
7.1/EN 55032 Class B Complies
Radiated emission
Frequency range:
1.0 GHz-6.0 GHz ETSI EN 301 489-1 section 8.2;
ETSI EN 301 489-17 section 7.1
EN 55032 Class B Complies
Immunity
Immunity from
Electrostatic
discharge (ESD) IEC 60601-1-2 section 8, Table
4 /
IEC 61000-4-2 8 kV contact &
15 kV air discharges Complies
ETSI EN 301 489-1 section 9.3;
ETSI EN 301 489-17 section 7.2/
EN 61000-4-2 4 kV contact &
8 kV air discharges Complies