Covidien Nellcor, Operator'S Manual

Page: 77 / 120

Performance Considerations
Operator’s Manual 67
6.3.4
Reducing EMI (Electromagnetic Interference)

WARNING:
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the monitoring system can cause inaccurate
measurement readings.

WARNING:
Any radio frequency transmitting equipment or other nearby sources of
electrical noise may result in disruption of the monitoring system.

WARNING:
Large equipment using a switching relay for its power on/off may affect
monitoring system operation. Do not operate the monitoring system in such
environments.

WARNING:
The monitoring system is designed for use in environments in which the
signal can be obscured by electromagnetic interference. During such
interference, measurements may seem inappropriate or the monitoring
system may not seem to operate correctly.

Caution:
This device has been tested and found to comply with the limits for medical
devices related to IEC 60601-1-2: 2007. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation.
Because of the proliferation of radio frequency transmitting equipment and
other sources of electrical noise in health care environments (for example, elec-
trosurgical units, cellular phones, mobile two-way radios, electrical appliances,
and high-definition television), it is possible that high levels of such interfer-
ence due to close proximity or strength of a source may result in disruption of
monitoring system performance.
Disruption may be evidenced by erratic readings, cessation of operation, or
other incorrect functioning. If this occurs, survey the site of use to determine
the source of this disruption, then take the appropriate actions to eliminate the
source.