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Philips FM20/30 Instructions For Use Manual Page 283

Release j.3 with software revision j.3x.xx patient monitoring.
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Electromagnetic Compatibility (EMC)
The device and its accessories, listed in the accessories section, comply with the following EMC
standards:
IEC 60601-1-2:2007 / EN 60601-1-2:2007+AC:2010
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-003:2012. Cet appareil ISM est conforme à la norme
NMB-003 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.
WARNING
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.
WARNING
For paced patients: The radiated SRR power of the CL SpO
Measurement Devices, and other sources of radio-frequency energy, when used in very close proximity
of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects
of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However,
caution should be exercised when monitoring paced patients.
In order to minimize the possibility of interference, avoid positioning and wearing the Cableless
Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer
for information on the RF susceptibility of their products
28 Specifications and Standards Compliance
and CL NBP Maternal Cableless
2
283

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