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Intended Uses Of Mx40; Authorized Eu Representative; Patient Population - Philips IntelliVue MX40 Instructions For Use Manual

Wearable patient monitor.
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Intended Uses of MX40

The MX40 is to be used primarily as a traditional telemetry medical device.
It connects to the IntelliVue Information Center by way of a wireless
network. When the MX40 is connected the IntelliVue Information Center
the IntelliVue Information Center provides the primary patient monitoring
and alarming function. The MX40 does not automatically provide local
monitoring or alarming when connected to the Information Center.
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.
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.
13-4
Safety Standards & Specifications

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