User's Manual

Regulatory Information
15-4 Safety Standards & Specifications
The MX40 can provide time-limited local monitoring when it is not
connected to the wireless network.
Unlike a traditional bedside monitor which operates on AC power, the
MX40 is powered by battery and cannot provide continuous monitoring.
Authorized EU Representative
Philips Medizin Systeme Deutschland
Hewlett-Packard-Strasse 2
D 71034, Boeblingen
Germany
Patient Population
This device is not for use with infant or neonatal patients.
Clinical judgment must be used to determine when the MX40 should be
used on a specific pediatric patient, as it is not possible to assign a precise
weight or age to ECG performance.
Use of the device is restricted to one patient at a time.
The components/accessories which come into contact with the patient’s skin
are in compliance with the relevant requirements of EN ISO 10993-1 for
Biocompatibility. The device is not designed for direct contact with the
patient’s skin. The accompanying pouch is the appropriate means for
holding the device.
Rx
Federal Law restricts this device to sale by or on the order of a physician.
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 SpO2 and NBP Cableless Measurement
devices(Optional), IntelliVue Telemetry Network Infrastructure, and the
Information Center.