Boston Scientific Rezum Manuel D'utilisation page 16

Table 10: Electromagnetic Immunity
Immunity Test Compliance
Level
Electrostatic ±8 kV contact
discharge (ESD) ±15 KV AIR
IEC 61000-4-2:2008
Electrical fast ±1 kV
transient/burst common
immunity mode; 5kHz
IEC 61000-4-4:2012 and 100KHZ
Surge immunity ±1 kV
IEC 61000-4-5:2014 differential
mode
±2 kV
common
mode
Power frequency 30 A/m, 50/60
magnetic field HZ
IEC 61000-4-8:2009
Voltage dips and Six dips each
interruptions at 100%, 60%,
immunity 30% voltage
61000-4-11:2004 reduction;
one interrupt
Three 100%
dips each at
phase angles
of 0, 45, 90,
135, 180, 225,
270, and 315;
one interrupt
Black (K) ∆E ≤5.0
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Rezūm™ Generator
requires continued operation during power
mains interruptions, it is recommended that
the Rezūm Generator be powered from an
uninterruptible power supply.
Table 11: Electromagnetic Immunity
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Rezūm Generator is intended for use in the electromagnetic environment
specified below. The customer or the user of the Rezūm Generator should assure
that it is used in such an environment.
Immunity Test Compliance
Conducted RF 3 Vrms
IEC 61000-4-6:2013 150 kHz to 80 MHz
Radiated RF 6 Vrms in ISM
IEC 61000-4-3:2010 bandsa
3 V/m
80 MHz to 2.7 GHz
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
a. The ISM (industrial, scientific and medical) 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; and 40.66 to 40.70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80
MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease
the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation
distance for transmitters in these frequency ranges.
c. 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 Rezūm Generator is used exceeds the applicable
RF compliance level above, the Rezūm Generator should be observed to verify
normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Rezūm Generator.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 1 V/m.
16
Electromagnetic Environment -
Guidance
Portable and mobile RF communications
equipment should be used no closer
to any part of the Rezūm Generator,
including power cord and delivery
device cable, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.57GHz
Where P is the maximum output power
rating of the transmitter in watts
(W) according to the transmitter
manufacturer and is the recommended
separation distance in meters (m) .
b
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey , should be
c
less than the compliance level in each
frequency range .
d
Interference may occur in the vicinity
of equipment marked with the following
symbol: