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Specifications; Intended Use; Manufacturer's Information - Philips M8102A Instructions For Use Manual

Patient monitor.
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Intended Use

The monitor is intended to be used for monitoring and recording of, and to generate alarms for,
multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and
during patient transport inside and outside of the hospital environment. The monitor is intended for
use by health care professionals.
The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic
device.
Rx only: U.S. Federal Law restricts this device to sale by or on the order of a physician.
ST segment monitoring is intended for use with adult patients only and is not clinically validated for
use with neonatal and pediatric patients.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed
morphology of complex cardiac complexes (according to AAMI EC 11).
Hospital Environment
N O T E 1
The monitor is suitable for use in all medically used rooms which fulfil the requirements regarding
electrical installation according to IEC60364-7-710 "Requirements for special installations or locations
- Medical locations", or corresponding local regulations.
EMC Environment
N O T E 2
All measurements (except the sidestream CO
interfaces (except short range radio and wireless LAN) are, in addition, suitable for use in
establishments directly connected to the public low-voltage supply network that supplies buildings
used for domestic purposes (see table in "Electromagnetic Emissions" on page 267).
The monitor is indicated for use by health care professionals whenever there is a need for monitoring
the physiological parameters of patients.
The monitors are not intended for use in an MRI environment or in an oxygen-enriched environment
WARNING
(for example, hyperbaric chambers.

Manufacturer's Information

You can write to Philips at this address

Specifications

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measurement with M2741A sensor) and system
2
24
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