B - 2
• If the essential performance is lost or degraded, it may be necessary to take mitigation measures, 
such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location or 
stopping using the monitor and contact the service personnel.
• The device needs special precautions regarding EMC and needs to be installed and put into service 
according to the EMC information provided below. 
• Other devices may interfere with this device even though they meet the requirements of CISPR.
• When the inputted signal is below the minimum amplitude provided in technical specifications, 
erroneous measurements could result.
• The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals 
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally 
required) this device might not offer adequate protection to radio-frequency communication 
services. The user might need to take mitigation measures, such as relocating or re-orienting the 
device.
Guidance and Declaration - Electromagnetic Immunity 
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 IEC60601 test level  Compliance level Electromagnetic environment - guidance
Electrostatic 
discharge (ESD) IEC 
61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
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
±2 kV for power 
supply lines
±1 kV for input/
output lines
Mains power quality should be that of a 
typical commercial or hospital environment.
Surge IEC 61000-4-5 ±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Voltage dips and 
voltage interruptions
IEC 61000-4-11
0% U
T
 for 0.5 cycle: at 
0°, 45°, 90°, 135°, 180°, 
225°, 270° and 315°
0% U
T
 for 1 cycle and 
70% U
T
 for 25/30 
cycles: at 0°
0% U
T
 for 250/300 
cycle
0% U
T
 for 0.5 cycle: at 
0°, 45°, 90°, 135°, 180°, 
225°, 270° and 315°
0% U
T
 for 1 cycle and 
70% U
T
 for 25/30 
cycles: at 0°
0% U
T
 for 250/300 
cycle
Mains power quality should be that of a 
typical commercial or hospital environment. If 
the user of our product requires continued 
operation during power mains interruptions, 
it is recommended that our product be 
powered from an uninterruptible power 
supply or a battery.
RATED power 
frequency magnetic 
fields
IEC 61000-4-8
30 A/m
50 Hz/60 Hz
30 A/m
50 Hz/60 Hz
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 AC mains voltage prior to application of the test level.