Sutter CURIS 36 0 00-01, Инструкция по эксплуатации

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CURIS
®
Instructions for Use
33
Guidelines and manufacturer declaration according to IEC 60601-1-2:2014, section 8.9:
Electromagnetic interference resistance
The CURIS
®
is intended for operation in an electromagnetic environment as specified below. The
customer or user of the CURIS
®
must ensure that it is operated in such an environment.
Radio equipment, mobile telephones or other transmitters operated in the immediate vicinity may
impair the functioning of the device.
Interference
resistance
tests
Test level
according to IEC
60601
Compliance level Electromagnetic environment – guidelines
Conducted HF
interference
according to
IEC 61000-4-6
3 V
eff
150 kHz to
80 MHz
6 V
effa
in ISM
frequency bands
150 kHz to
80 MHz
3 V
eff
150 kHz to
80 MHz
6 V
effa
in ISM
frequency bands
150 kHz to
80 MHz
Portable and mobile radio devices should not
be used closer to the CURIS
®
(including
cables) than the recommended separation
distance of 30 cm.
The field strength of stationary radio
transmitters for all frequencies should be
lower than the compliance level
b
according to
on-site testing.
b
.
Interference may occur in the vicinity of
equipment marked with the following symbol.
Radiated HF
interference
according to
IEC 61000-4-3
3 V/m
80 MHz to
2.7 GHz 3 V/m
80 MHz to
2.7 GHz
NOTE These guidelines may not be applicable in all cases. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a
The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;
26.957 MHz to 27.283 MHz; 40.66 MHz to 40.70 MHz
b
The field strength of stationary transmitters such as base stations of mobile telephones and mobile radio
devices, amateur radios, AM and FM radio and TV transmitters cannot be theoretically determined exactly
in advance. In order to determine the electromagnetic environment in regards to the stationary transmitters,
a site survey should be considered. If the measured field strength at the location where the CURIS
®
I is used
exceeds the aforementioned compliance level, the device should be monitored to ensure it is functioning
properly. Should unusual performance characteristics be observed, additional measures may be required,
such as changing the alignment or location of the CURIS
®
.