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Authorized Eu Representative; Patient Population; Essential Performance - Philips IntelliVue MX40 Instructions For Use Manual

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Regulatory Information

Authorized EU Representative

Patient Population

Rx

Essential Performance

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.
Philips Medizin Systeme Deutschland
Hewlett-Packard-Strasse 2
D 71034, Boeblingen
Germany
This device is not for use with infant or neonatal patients.
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.
Federal Law restricts this device to sale by or on the order of a physician.
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
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.
and NBP Cableless Measurement
2

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