Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Operation Manual page 109

Operation Manual
Guidance and manufacturer's declaration - electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure
that it is used in such an environment.
Immunity test IEC 60601 test Compliance level
Electrostatic discharge
±8 kV contact
(ESD)
±2, ±4, ±8, ±15 kV air
IEC 61000-4-2
Electrical/fast transient/
±2 kV for a.c. mains
burst
±1 kV for I/O ports
IEC 61000-4-4
Surge ± -0.5 kV, ± -1 kV, ± -2 kV line to ground
IEC 61000-4-5 ± -0.5 kV, ± -1 kV line to line
100% Vac for 0.5 cycles at 0°, 45°, 90°,135°,180°,
225°, 270°, 315°
100% Vac for 1.0 cycles at 0°
Voltage dips
IEC 61000-4-11
30% Vac for 30 cycles at 0°
100% Vac for 250 (50Hz) cycles or 300 (60Hz) cycles
at 0°
Voltage interruptions
0% a.c. 250(50 Hz) or 300(60 Hz) at 0°
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
30 A/m
field
IEC 61000-4-8
Guidance and manufacturer's declaration - electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure
that it is used in such an environment.
Immunity test IEC 60601 test Compliance level
3Vrms from 150kHz to 80 MHz at 80% AM 1kHz
6Vrm, 80% AM 1kHz at ISM frequencies listed below:
Frequency
(MHz-ISM List)
1.8 - 2.0
3.5 - 4.0
5.3 - 5.4
6.765 - 6.795
7.0 - 7.3
Conducted RF
10.1- 10.15
IEC-61000-4-6
13.553 - 13.567
14.0 - 14.2
18.07 - 18.17
21.0 - 21.4
24.89 - 24.99
26.957 - 27.283
28.0 - 29.7
40.66 - 40.70
50.0 - 54.0
Electromagnetic environment - guidance
Floors should be wood, concrete, or ceramic tile. If
floors are covered with a synthetic material, the
relative humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the system requires continuous operation during
power mains interruptions, it is recommended the
system be powered from an uninterruptible power
supply or battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Electromagnetic environment - guidance
Test Level
(Vrms)
6
6
WARNING: Portable RF communications equipment
6
(including peripherals such as antenna cables and
external antennas) should be used no closer than 30
6
cm (12 inches) to any part of the injection system
6
unless a greater separation distance is required as
6
indicated by the equation. Otherwise, degradation of
the performance of this equipment could result.
6
6
Recommended separation distance
6
d = 1.17 p
6
6
6
6
6
6
18 - 101