Regulatory Information
10-6 Safety Standards & Specifications
Essential Performance
The IntelliVue MX40 provides Essential Performance (EP) under normal
operating conditions (includes EMC exposure) only as a complete Medical
Electrical System, consisting of the MX40, MPx companion monitor
(Optional), IntelliVue CL SpO
2 and NBP Cableless Measurement
devices(Optional), IntelliVue Telemetry Network Infrastructure, and the
Information Center.
The System achieves its Essential Performance exclusively through alarm
generation at the IntelliVue Information Center and locally at the MX40,
based on configuration.
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 and respiration 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
2 and Resp can always be
viewed on 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.
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