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Philips FM20/30 Instructions For Use Manual Page 285

Release j.3 with software revision j.3x.xx patient monitoring.
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System Characteristics
The phenomena discussed above are not unique to this system, but are characteristic of fetal patient
monitoring equipment in use today. This performance is due to very sensitive high gain front end
amplifiers required to process the small physiological signals from the patient. Among the various
monitoring systems already in clinical use, interference from electromagnetic sources is rarely a
Electromagnetic Emissions and Immunity
The EMC standards state that manufacturers of patient-coupled equipment must specify immunity
levels for their systems. See Tables 1 to 4 for this detailed immunity information. See Table 5 for
recommended minimum separation distances between portable and mobile communications
equipment and the product.
Immunity is defined in the standard as the ability of a system to perform without degradation in the
presence of an electromagnetic disturbance.
Caution should be exercised in comparing immunity levels between different devices. The criteria used
for degradation are not always specified by the standard, and can therefore vary with the manufacturer.
In the table below, the term "device" refers to the Avalon FM20/30/40/50 fetal monitor together with
its accessories. The table gives details of the electromagnetic emissions, and how these are classified,
for the device, and the electromagnetic environments in which the device is specified to technically
Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions
Emissions Test
Radiofrequency (RF) emissions
Harmonic emissions IEC 61000-3-2
Voltage fluctuations and flicker IEC 61000-3-3 complies
RF emissions CISPR 11
For the Avalon FM20/30 fetal monitor with all
accessories except the IUP/ECG patient
module M2738A.
28 Specifications and Standards Compliance
Avoiding Electromagnetic Interference
Group 1
The device 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
Class B
The device is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage supply network that
supplies buildings used for domestic purposes


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