ELECTROMAGNETIC COMPATIBILITY (EMC)
ELECTROMAGNETIC COMPATIBILITY(EMC)
This product complies with EMC Standard EN60601-1-2:2015.
1. Precautions regarding EMC and compliance with accompanying documents
Medical electrical equipment requires special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in this booklet.
2. Effects of RF communication devices
Portable and mobile RF communication devices can affect medical electrical equipment.
3. Installation exclusion environment
Hospitals except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an
ME SYSTEM for magnetic resonance imaging,where the intensity of EM DISTURBANCES is high.
4. Electromagnetic emission declaration
73
Guidance and manufacturer’s declaration – electromagnetic immunity
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of the tbCOMPASS should ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Flooring should be wood, concrete, or ceramic
tiles. If the floor is 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
The 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
±1 kV differential mode
±2 kV common mode
The 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
0% UT
; 0.5 cycles
0°,45°,90°,135°,180°,
225°, 270° and 315°
0% UT
; 1cycle and
70% UT
; 25/30 cycles
at 0°, single phase
0%UT
; 250/300 cycles
0% UT
; 0.5 cycles
0°,45°,90°,135°,180°,
225°, 270° and 315°
0% UT
; 1cycle and
70% UT
; 25/30 cycles
at 0°, single phase
0%UT
; 250/300 cycles
The mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
tbCOMPASS requires continued
operation during mains power interruptions,
it is recommended that the
tbCOMPASS be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
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IEC 61000-4-8
30 A/m
30 A/m
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 the application of the test level.
Electromagnetic environment - guidance
Guidance and manufacturer’s declaration – electromagnetic emissions
The tbCOMPASS is intended for use in the electromagnetic environment specified below. The customer or user
of the tbCOMPASS should ensure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The tbCOMPASS only uses RF energy for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference with nearby electronic equipment.
RF emissions
CISPR 11
Class B
The tbCOMPASS 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.
Harmonic emissions
IEC 61000-3-2
Class A
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Flicker emissions
IEC 61000-3-3
Complies
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation.If such use is necessary,this equipment and the other equipment should be
observed to verify that they are operating normally.
WARNING
5. Electromagnetic immunity declaration 1
