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Risk Management Considerations - Philips IntelliVue MX40 Instructions For Use Manual

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Regulatory Information
The IntelliVue MX40 protects the patient from unacceptable immediate
clinical risk by generating specific Physiological Alarms when appropriate.
If the system cannot generate Physiological Alarms, then relevant Severe or
Hard-Level Technical Alarms (Inops) are created.

Risk Management Considerations

Warning
The MX40 operates exclusively via a wireless network connection,
therefore, it should not be used for primary monitoring in applications
where momentary loss of the ECG is unacceptable at the Information
Center. It sends ECG and optionally pulse oximetry data to the Information
Center, where the Information Center displays real-time patient data,
provides alarm annunciation, data storage and review applications. The
ECG waveform data, alarms and optionally SpO
can always be viewed on
2
the MX40 regardless of the connection to the Information Center.
Smart Hopping technology alleviates most of the problems associated with
legacy telemetry technologies. Reception problems are less frequent,
because Smart Hopping avoids interference and moves to a different access
point if the signal strength is too low. The level of radio frequency activity
is always fluctuating in the environment. If the level becomes high enough
to significantly interfere with transceiver operation, the system responds by
moving to another "cleaner" area where there is less activity.
Dropouts
Because the MX40 operates exclusively via a wireless network connection,
under certain frequency conditions dropouts can occur. Dropouts result
from a weak signal or RF interference, and appear on the waveform when
the signal "drops" to the bottom of the channel for a minimum of 200 ms. If
dropouts are frequent enough to affect the heart rate count, the "Cannot
Analyze ECG" or "Cannot Analyze ST" technical alarm occurs. If there are
enough dropouts to cause disassociation/reassociation with the Information
Center, events in the Clinical Review application can reflect loss of data for
up to 1 minute in the worst case.
Safety Standards & Specifications
15-5

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