Welch Allyn Connex Vital Signs Monitor 6000 Series, Directions For Use Manual

Page: 112 / 143

Electromagnetic emissions
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
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
nearby equipment
a
. It may be necessary to take
mitigation measures, such as re-orienting or
relocating the monitor or shielding the location.
Complies
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.
Electromagnetic immunity
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 IEC 60601 test
level
Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
± 8 kV air ± 6 kV contact
± 8 kV air Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5 ± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip for 25 cycles
>95% dip in 5
seconds
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip for 25 cycles
>95% dip in 5
seconds
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.
Electromagnetic immunity
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 IEC 60601 test
level
Compliance level Electromagnetic environment -
guidance
106 Guidance and manufacturer's declaration Welch Allyn Vital Signs Monitor 6000 Series™