Hologic MyoSure XL Notice D'utilisation page 6

Immunity test
Voltage dips, short interruptions and
voltage variations on power supply
input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated HF interference quantities
according to IEC 61000-4-3
Note *: UT is the AC mains voltage prior to application of the test level.
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 of 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 FLU-
ENT FLUID MANAGEMENT SYSTEM is used exceeds the applicable compliance level above, the FLUENT FLUID MANAGEMENT SYSTEM should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the changing orientation or the location of the FLUENT FLUID MANAGEMENT SYSTEM.
b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
4
MyoSure XL Tissue Removal Device for Fluent
®
IEC 60601 Compliance level
test level
0% UT (100% dip in the 0% UT (100% dip in the
UT) for ½ cycle at 0°, UT) for ½ cycle at 0°,
45°, 90°, 135°, 180°, 45°, 90°, 135°, 180°,
225°, 270°, and 315° 225°, 270°, and 315°
0% UT (100% dip in the 0% UT (100% dip in the
UT) for 1 cycle and 70% UT) for 1 cycle and 70%
(30% dip in the UT) UT (30% dip in the UT) UT
for 25/30 cycles at 0° for 25/30 cycles at 0°
0% UT (100% dip in the 0% UT (100% dip in the
UT) for 250/300 cycles UT) for 250/300 cycles
30 A/m 30 A/m
3 Vrms 3 Vrms
150 kHz to 80 MHz 150 kHz to 80 MHz
6 Vrms in ISM Bands 6 Vrms in ISM Bands
between 150 kHz and between 150 kHz and
80 MHz 80 MHz
3 V/m 3 V/m
80 MHz to 2.7 GHz 80 MHz to 2.7 GHz
Electromagnetic environment - guidance
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the /operator of FLUENT FLUID MAN-
AGEMENT SYSTEM requires continued operation
during power mains interruptions, it is recom-
mended that the FLUENT FLUID MANAGEMENT
SYSTEM be powered from an uninterruptible power
supply or battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
Portable and mobile RF communications equip-
ment used no closer to any part of the FLUENT
FLUID MANAGEMENT SYSTEM, including cables,
than the recommended separation distance calcu-
lated from the equation applicable to the frequency
of the transmitter.
Recommended safety distance:
d = 1.2√P for 150 KHz to 80 MHz
d = 1.2√P for 80 MHz to 800 MHz
d = 2.3√P for 800 MHz to 2.7 GHz
Where P is the maximum output power rating
of the transmitter in watts [W] according to
the transmitter manufacturer, and d is the
recommended separation distance in meters [m].
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
,
a
English