Philips M1351A, M1353A manual Spillage, Electromagnetic Compatibility, System, Characteristics

Spillage

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 SpO2 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.

Parameter

Sensor

Frequency Range

Immunity

Level

IUP

M1333A

26 MHz to 1000 MHz

0.5V/m

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.

Parameter

Sensor

Burst Immunity Level

Ultrasound

M1356A

600 V

System	The phenomena discussed above are not unique to the monitor but are characteristic of
Characteristics	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.

Appendix B Safety and Environment 173