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34Installation and Specifications
The specifications in this section apply to the MP20, MP30, MP40, MP50, MP60, MP70, MP80 and
MP90 patient monitors, unless otherwise stated.
The monitors are not user installable. They must be installed by qualified service personnel.
Intended Use
The monitors are intended to be used for monitoring, recording, and alarming of multiple
physiological parameters of adults, pediatrics, and neonates in health care facilities. The devices are to
be used by trained health care professionals.
All the monitors are intended for use in health care facilities; the MP20/MP30/MP40/MP50 monitors
are additionally intended for use in transport situations within the hospital setting.
The monitors are only for use on one patient at a time. They are not intended for home use. Rx only:
U.S. Federal Law restricts this device to sale by or on the order of a physician. Not a therapeutic device.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
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).
BIS is intended for use under the direct supervision of a licensed health care practitioner or by
personnel trained in its proper use. It is intended for use on adult and pediatric patients within a
hospital or medical facility providing patient care to monitor the state of the brain by data acquisition
of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of
the incidence of awareness with recall in adults during general anesthesia and sedation.
Indication for Use
The monitor is indicated for use by health care professionals whenever there is a need for monitoring
the physiological parameters of patients.