Bayer HealthCare MEDRAD 800 Module Operation & Installation Manual page 27

THE SYSTEM REQUIRES SPECIAL PRECAUTIONS REGARDING EMC. Install and put into service according to the
EMC information provided below:
Guidance and manufacturer's declaration - electromagnetic emissions
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.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations / flicker emissions
IEC 61000-3-3
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 ±8 kV contact
discharge (ESD) ±2, ±4, ±8, ±15 kV air
IEC 61000-4-2
Electrical fast ±2 kV for a.c. mains
transient/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
Voltage dips 100% Vac for 0.5 cycles at 0°, 45°, 90°,135°,180°,
IEC 61000-4-11 225°, 270°, 315
100% Vac for 1.0 cycles at 0°
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 30 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
MEDRAD
Compliance Electromagnetic environment - guidance
Group 1 The System uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
Class A The emission characteristics of this system make it
suitable for use in industrial areas and hospitals (CISPR
11 Class A). If the system is used in a residential
environment (for which CISPR 11 Class B is normally
Not applicable
required), this equipment might not offer adequate
protection to radio-frequency communication services.
The user might need to take mitigation measures, such
Not applicable
as relocating or reorienting the equipment.
®
Stellant ISI 800 Module Operation Man-
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.
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