36 Specifications
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36Specifications
The specifications in this section apply to the MX800 patient monitor.
The monitor is not user installable. It must be installed by qualified service personnel.
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 health care facilities. The
monitor is to be used by trained health care professionals.
The monitor is only for use on one patient at a time. It is 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.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with
adult patients only.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients
receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV
measurement has been validated only for adult patients.
The monitor is indicated for use by health care professionals whenever there is a need for monitoring
the physiological parameters of patients.
WARNING
The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment
(for example, hyperbaric chambers).
Manufacturer's Information
You can write to Philips at this address
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