Bayer HealthCare Certegra, Operation Manual

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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 Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 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 inter-
ference in nearby electronic equipment.
RF emissions
CISPR 11 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 required), this equipment might not offer adequate protec-
tion to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or reorienting
the equipment.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuations / flicker emissions
IEC 61000-3-3 Not applicable
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 Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2 ±8 kV contact
±2, ±4, ±8, ±15 kV air Floors should be wood, concrete or ceramic tile. If floors
are covered with a synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4 ±2 kV for a.c. mains
±1 kV for I/O ports Mains power quality should be that of a typical commercial
or hospital environment.
Surge
IEC 61000-4-5 ± -0.5 kV, ± -1 kV, ± -2 kV line to ground
± -0.5 kV, ± -1 kV line to line Mains power quality should be that of a typical commercial
or hospital environment.
Voltage dips
IEC 61000-4-11 100% Vac for 0.5 cycles at 0°, 45°, 90°,135°,180°, 225°,
270°, 315 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 uninterrupt-
ible power supply or battery.
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
IEC 61000-4-11 0% a.c. 250(50 Hz) or 300(60 Hz) at 0°
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8 30 A/m Power frequency magnetic fields should be at levels char-
acteristic of a typical location in a typical commercial or
hospital environment.