Welch Allyn KleenSpec 800 Series Directions For Use Manual page 17

Directions for use
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
a
The 800 Series 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 2014/53/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.
The 800 Series is intended for use in the electromagnetic environment specified below. The customer or the user of the
800 Series 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
Electromagnetic emissions
Class B
The 800 Series is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low
voltage power supply network that supplies buildings used for domestic
purposes.
Class A
Complies
Electromagnetic immunity
IEC 60601 test level Compliance level
±8 kV contact ±8 kV
±15 kV air ±15 kV
±2 kV for power supply ±2 kV
lines
±1 kV for input/output ±1 kV
lines
±0.5 kV, ±1 kV ±1 kV
Line- to -line
±0.5 kV, ±1 kV, ±2 kV ±2 kV
Line-to-ground
0 % U ; 0.5 cycle 0 % U ; 0.5 cycle
T T
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % U ; 1 cycle 0 % U ; 1 cycle
T T
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
may be necessary to take mitigation measures, such
as re-orienting or relocating the 800 Series or
shielding the location.
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.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the 800 Series requires continued operation
during power mains interruptions, it is
recommended that the 800 Series be be
powered from an uninterruptible power supply
or a battery.
Appendices 13
a
. It