26 Specifications and Standards Compliance
206
Electromagnetic Compatibility (EMC)
The device and its accessories, listed in the accessories section, comply with the following EMC
standards:
• EN/IEC 60601-1-2: 2001+A1:2004
Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical
equipment. You must operate your monitoring equipment according to the EMC information
provided in this book. Before using the device, assess the electromagnetic compatibility of the device
with surrounding equipment.
This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-
001 du Canada.
CAUTION
• FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth
conductor which is needed for EMC purposes.
• Always use the supplied power cord with the three-prong plug to connect the monitor to AC
mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet.
CAUTION
The use of accessories, transducers and cables other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the device.
WARNING
Do NOT use cordless/mobile phones or any other portable RF communication system within the
patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.
EMC Testing
CAUTION
Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals,
and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels
for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to
technological limitations. To ensure that external electromagnetic fields do not cause erroneous
measurements, it is recommended to avoid the use of electrically radiating equipment in close
proximity to these measurements.
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