Electromagnetic Emissions - Welch Allyn CP 50 Directions For Use Manual

48 Guidance and manufacturer's declarations
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic
environment specified below. The customer or the user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph 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
Powerfrequency (50/60
Hz) magnetic field
IEC 61000-4-8
Note

Electromagnetic emissions

voltage power supply network that supplies buildings used for domestic
Class A
purposes.
Complies
Electromagnetic immunity
IEC 60601 test level Compliance level
±6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
±2 kV for power supply ±2 kV for power supply
lines lines
±1 kV for input/output ±1 kV for input/output
lines lines
± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth ± 2 kV line(s) to earth
<5 % U (>95 % dip in <5 % U
T
U ) for 0.5 cycle U
T T
40 % U (60 % dip in 40 % U
T
U ) for 5 cycles U
T T
70 % U (30 % dip in 70 % U
T
U ) for 25 cycles U
T T
<5 % U (>95 % dip in <5 % U
T
U ) for 5 s U
T T
3 A/m 3 A/m
NOTE U is the a.c. mains voltage prior to application of the test level.
T
CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph
WARNING The Welch AllynCP 50™ and CP 50
Plus™ 12-lead resting electrocardiograph should not
be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the
Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph should be observed to verify
normal operation in the configuration in which it will
be used.
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
(>95 % dip in
T
commercial or hospital environment. If the user
) for 0.5 cycle
of the Welch AllynCP 50™ and CP 50 Plus™ 12-
(60 % dip in
lead resting electrocardiograph requires
T
) for 5 cycles continued operation during power mains
interruptions, it is recommended that the
(30 % dip in
T
Welch AllynCP 50™ and CP 50 Plus™ 12-lead
) for 25 cycles
resting electrocardiograph be powered from an
uninterruptible power supply or a battery.
(>95 % dip in
T
) for 5 s
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commerical or hospital environment.