Welch Allyn VSM 6000 series Directions For Use Manual page 112

106 Guidance and manufacturer's declaration
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
a
The monitor contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequency
hopping spread-spectrum transmitter for the purpose of wireless communication. The radio is operated
according to the requirements of various agencies, including FCC 47 CFR 15.247 and R&TTE Directive (1995/5/
EC). The transmitter is excluded from the EMC requirements of 60601-1-2:2007, but should be considered
when addressing possible interference issues between this and other devices.
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
Immunity test
Electromagnetic emissions
Complies
Electromagnetic immunity
IEC 60601 test Compliance level Electromagnetic environment -
level
±6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
±2 kV for power ±2 kV for power
supply lines supply lines
±1 kV for input/ ±1 kV for input/
output lines output lines
± 1 kV differential ± 1 kV differential
mode mode
± 2 kV common ± 2 kV common
mode mode
>95% dip in 0.5 cycle >95% dip in 0.5 cycle
60% dip in 5 cycles 60% dip in 5 cycles
30% dip for 25 cycles 30% dip for 25 cycles
>95% dip in 5 >95% dip in 5
seconds seconds
Electromagnetic immunity
IEC 60601 test Compliance level Electromagnetic environment -
level
Welch Allyn Vital Signs Monitor 6000 Series™
WARNING This equipment/system is intended
for use by healthcare professionals only. This
equipment/ system may cause radio
interference or may disrupt the operation of
a
nearby equipment . It may be necessary to take
mitigation measures, such as re-orienting or
relocating the monitor or shielding the location.
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.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the monitor
requires continued operation during power
mains interruptions, it is recommended
that the monitor be powered from an
uninterruptible power supply or a battery.
guidance