Infinium CLEO - EMC Information

User’s manual for CLEO Patient Monitor
- 54 -
EMC
The product is in radio-interference protection class A in accordance with EN55011. The
product complies with the requirements of standard EN60601-1-2:2007 “Electromagnetic
Compatibility - Medical Electrical Equipment”.
ELECTROMAGNETIC IMMUNITY
This section constitutes the guidance and CLEO Patient Monitor’s declaration regarding
electromagnetic immunity. The CLEO Patient Monitor is intended for use in the
electromagnetic environment specified below. The customer or the user of the CLEO
Patient Monitor should ensure 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 a ir
6 kV contact
8 kV a ir
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, th
e 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 c
ommercial or hospital
environment.
Surge
IEC 61000-4-5

1 kV
differential
Mode

2 kV
differential
Mode

1 kV
differential
Mode

2 kV
differential
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
<5 % UT
1
(>95 % dip in
UT) for 0.5
cycle
40 % UT
(60 % dip in
UT) for 5
cycles
70 % UT
(30 % dip in
UT) for 25
cycles
<5 % UT
(>95 % dip in
UT) for 5 sec
<5 % UT
2
(>95 % dip in
UT) for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT) for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the CLEO
Patient Monitor requires continued
operation during power mains
interruptions, then the CLEO
Patient
Monitor should
be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels typical in a commerc
ial or
hospital environment.
Note:
UT is the a. c. mains voltage prior to application of the test level.