
DATOSPIR
· User’s Manual
EN 27
511-D00-MUM · Rev 1.01
Guidance and manufacturer’s declaration – electromagnetic immunity
DATOSPIR
is intended for use in the electromagnetic environment specified below. The costumer or the user of
DATOSPIR
should assure that it is used in such an environment.
Below mentioned tests are applicable to enclosure. Additionally, test EN-IEC 61000-4-2 is applicable to input/output signal and patient connections.
Immunity test
EN-IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge
(ESD)
EN-IEC 61000-4-2
±8 kV contact
±2, ±4, ±8, ±15 kV, air
±8 kV contact
±2, ±4, ±8, ±15
kV, air
Radiated RF
EN-IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
3 V/m
Proximity fields from RF
communications
EN-IEC 61000-4-3
(View following table).
Portable and mobile RF communications equipment should be used no closer than 30cm to any part of
DATOSPIR
, including cables. The distance is calculated according to:
where P is the output power rating of the transmitter in watts (W), d is the recommended separation in
meters (m) and E is the immunity level in V/m.
Power frequency (50 / 60
Hz) magnetic field
EN-IEC 61000-4-8
30 A/m
30 A/m
Only applicable to devices sensitive to magnetic fields.
Proximity fields EN-IEC 61000-4-3
Frecuency
(MHz)
Band
(MHz)
Modulation
Power
(W)
Distance
(m)
E
(V/m)
385
380-390
Pulso 18Hz
1.8
0.3
27
450
430-470
FM
D:+/-5kHz
1kHz sinus
2
0.3
28
710
745
780
704-787
Pulso 217Hz
0.2
0.3
9
810
870
930
800-960
Pulso 18Hz
2
0.3
28
1720
1845
1970
1700-1990
Pulso 217Hz
2
0.3
28
2450
2400-2570
Pulso 217Hz
2
0.3
28
5240
5500
5785
5100-5800
Pulso 217Hz
0.2
0.3
9