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Spillage
Appendix B Safety and Environment 173
Spillage
If liquid enters the monitor, you must cease using it immediately. Contact an authorized
engineer for a safety inspection.
Electromagnetic Compatibility
The electromagnetic compatibility (EMC) validation includes testing performed according
to the international standard for EMC with medical devices. See the Manufacturer’s
Declaration for details.
EMC Testing During the test program the monitor was subjected to international standard and Philips
proprietary EMC tests. During most of the testing no anomalies were observed. Some
reduced performance was observed with the IEC 801-3 Radiated Immunity and IEC 801-
4 Fast Transient/Bursts Immunity tests.
IEC 801-3 specifies that the product must be subjected to a field of 3V/m over a frequency
range of 26 to 1000 MHz with no degradation of performance. At many of the test
frequencies over the specified range no anomalies were observed. However increased jitter
of SpO
2
values and DECG derived fetal heartrate values was observed at a number of test
points. For these test points the radiated field was reduced to the level at which the trace
returned to normal. These reduced levels are shown in the table below.
IEC 801-4 specified that the product is subjected to high speed pulses up to 1000 V
applied to the power cord and all I/O cables. During and after most of the test pulses, no
anomalies were observed. However in rare cases the ultrasound channel had been triggered.
System
Characteristics
The phenomena discussed above are not unique to the monitor but are characteristic of
patient monitors in use today. This performance is due to very sensitive high gain front
end amplifiers used to process the physiological signals from the patient. Among the many
similarly performing monitors already in use by customers, interference from
electromagnetic sources is rarely a problem.
Parameter Sensor Frequency Range
Immunity
Level
IUP M1333A 26 MHz to 1000 MHz 0.5V/m
Parameter Sensor
Burst Immunity Level
Ultrasound M1356A 600 V