APPENDIX II
User Manual
Appendix II-2
Guidance and manufacturer's declaration
–
electromagnetic immunity
The patient care monitors are intended for use in the electromagnetic environment specified below.
The customer or the user of the monitor should assure that they are 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
Complies
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
Complies
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
Complies
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
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Complies
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the monitor
requires continued operation, it is
recommended that the monitor be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Complies
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 test level.
