Annex 1. Electromagnetic Compatibility - Sibelmed DATOSPIR AIRA Manual De Uso

Annex 1. ELECTROMAGNETIC COMPATIBILITY

DATOSPIR is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment..
Emissions test
RF (Radiated) emissions
CISPR 11 (EN 55011)
RF (Conducted) emissions
CISPR 11 (EN 55011)
Harmonic emissions
EN-IEC 61000-3-2
Voltage fluctuations / Flicker emissions
EN-IEC 61000-3-3
DATOSPIR is intended for use in the electromagnetic environment specified below. The costumer or the user of
Tests EN-IEC 61000-4-4 y -4-5 are applicable to AC/DC power inputs, and input/output signal. Test EN-IEC 61000-4-6 additionally applies to patient connections. Test EN-IEC 61000-4-11
only applies to AC power inputs.
Immunity test EN-IEC 60601 test level
Electrical fast transient/burst
EN-IEC 61000-4-4
Surge
EN-IEC 61000-4-5
Conducted RF
EN-IEC 61000-4-6
Voltage dips, short interruptions 0% Ut ; 0.5 cycles:
and voltage variations on power
supply input lines
EN-IEC 61000-4-11
NOTE Ut is the a.c. mains voltage prior to application of the test level.
EN 26
Guidance and manufacturer's declaration – electromagnetic emissions
Compliance
Grupo 1
Clase B
Not applicable
Not applicable
Not applicable
Guidance and manufacturer's declaration – electromagnetic emissions
±2 kV for power supply lines and earth
±1 kV for input/output lines
Frecuency 100 kHz
±0.5, ±1 kV differential mode (Line to line).
±0.5, ±1, ±2 kV common mode (Line to
ground).
3 Vrms
de 150KHz a 80 MHz
6 Vrms in ISM bands
80% AM a 1kHz
0º, 45º, 90º, 135º, 180º,
225º, 270º y 315º.
0% Ut; 1 cycle
70% Ut; 25/30 cycles: 0º
0% Ut ; 250/300 cycles
(5 segundos)
DATOSPIR
Electromagnetic environment - Guidance
DATOSPIR
DATOSPIR
DATOSPIR
DATOSPIR
Compliance level
Not applicable
Not applicable
Not applicable
Not applicable
3 Vrms
Not applicable
· User's Manual
works with batteries.
works with batteries.
works with batteries.
should assure that it is used in such an environment.
Electromagnetic environment –Guidance
DATOSPIR works with batteries.
The input/output line cables are shorter than
3 meters long.
DATOSPIR
works with batteries.
DATOSPIR
works with batteries.
511-D00-MUM · Rev 1.01