Boston Scientific Precision Novi Manual Del Usuario página 16

Information for Prescribers
Guidance and manufacturer's declaration – electromagnetic immunity
The Precision Novi System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Precision Novi System should assure that it is used in such an
environment.
Immunity Test IEC 60601
Test Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
(ETS only) 80 MHz
Radiated RF 10 V/m
80 MHz to
IEC 61000-4-3
2,7 GHz
NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Precision Novi is used exceeds the applicable RF compliance level above, the
Precision Novi should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Precision Novi System.
Precision Novi™ System Information for Prescribers
90962628-03 12 of 445
Compliance Electromagnetic Environment - guidance
Level
3 Vrms Professional healthcare facility environment
and home healthcare environment.
150 kHz to 80
MHz
6 Vrms in ISM
and amateur
radio bands
between 150
kHz and 80
MHz
10 V/m Professional healthcare facility environment
80 MHz to 2,7 and home healthcare environment.
GHz
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range. Interference may occur
in the vicinity of equipment marked with the
symbol shown below:
a