BMB MEDICAL – CLAVIA 5 / 1VCLVE092020
100
EMISSIONS
Conducted and radiated RF emissions:
CISPR11 Group 1 Class A
Harmonic distortions IEC 61000-3-2:
Class A
Voltage fluctuations and Flicker IEC 61000-3-3:
Compliant
Immunity test
Test level IEC 60601
Compliance level
Electrostatic discharges (ESD)
IEC 61000-4-2
± 8 kV in contact
± 2/4/8/15 kV in air
± 8 kV in contact
± 2/4/8/15 kV in air
RF radiated electromagnetic
fields
IEC 61000-4-3
3 V/m (professional healthcare
establishment)
80MHz-2.7GHz
80% AM at 1 kHz
3V/m
80MHz-2.7GHz
80% AM at 1 kHz
Proximity fields emitted by wireless RF
communication devices
IEC 61000-4-3
Frequency (MHz)
Modulation
Required level
(V/m)
Compliance level
(V/m)
385
Pulsed modulation: 18 Hz
27
27
450
Pulsed modulation: 18 Hz
28
28
710-745-780
Pulsed modulation: 217 Hz
9
9
810-870-930
Pulsed modulation: 18 Hz
28
28
1720-1845-1970
Pulsed modulation: 217 Hz
28
28
2450
Pulsed modulation: 217 Hz
28
28
5240-5500-5785
Pulsed modulation: 217 Hz
9
9
Rapid / burst electrical spikes
IEC 61000-4-4
Power supply: ± 2 kV
Input/output lines: ± 1 kV
Repeat frequency: 100 kHz
Power supply: ± 2 kV
Input/output lines: ± 1 kV
Repeat frequency: 100 kHz
Shock waves
IEC 61000-4-5
Between phases:
± 0.5 kV, ± 1 kV
Between earth and phases
± 0.5 kV, ± 1 kV, ± 2 kV
Between phases:
± 0.5 kV, ± 1 kV
Between earth and phases
± 0.5 kV, ± 1 kV, ± 2 kV
Conducted interference, induced by RF
fields
IEC 61000-4-6
3 V 0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz
80 % AM at 1 kHz
3 V 0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz
80 % AM at 1 kHz
Power frequency magnetic fields
IEC 61000-4-8
30A/m
30A/m
Voltage Dips and Interruptions:
IEC 61000-4-11
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 1 cycle at 0°
70% UT; 25/30 cycles at 0°
0% UT; 250/300 cycles
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% UT; 1 cycle at 0°
70% UT; 25/30 cycles at 0°
0% UT; 250/300 cycles
NB: There is no deviation from the requirements of IEC 60601-1-2 ed. 4
NB: There are no other known measures for maintaining basic safety with respect to EMC
phenomena.
4.2
TRANSPORT
AND
STORAGE
Storage and transport conditions:
Ambient conditions
Operation
Ambient temperature
-10 to +30 °C
Relative humidity
20 to 90% at 30 °C - no condensation
Atmospheric pressure
700 to 1060 ha