Welch Allyn Spot VS100, Directions For Use Manual

Page: 51 / 64

Electromagnetic emissions
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 device or shielding
the location.
a
The device 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 Radio Equipment Directive 2015/53/EU. The
transmitter is excluded from the EMC requirements of 60601-1-2, but should be considered when addressing possible
interference issues between this and other devices.
Electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device 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
±8 kV contact
±15 kV air ±8 kV
±15 kV 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
±2 kV Mains power quality should be that of a typical
commercial or hospital environment.
±1 kV for input/output
lines
±1 kV
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
<0 % UT (>100 % dip
in UT) for 1 cycle 70 %
UT (30 % dip in UT) for
25/30 cycles
<0 % UT (>100 % drop
in UT) for 0.5 cycles@
0°, 45°, 90°, 135°,
180°, 225°, 270°, &
315° for 250/300
cycles
<0 % UT (>100 % dip
in
UT) for 1 cycle 70 %
UT (30 % dip in UT) for
25/30 cycles <0 % UT
(>100 % drop in UT) for
0.5 cycles@0°, 45°,
90°, 135°, 180°, 225°,
270°, & 315° for 250/
300 cycles
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the device requires continued operation
during power mains interruptions, it is
recommended that the device be be powered
from an uninterruptible power supply or a
battery.
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Note: U
T
is the a.c. mains voltage prior to application of the test level.
Directions For Use Specifications 47