The specifications in this section apply to the MX 400/MX450, MX500/MX550, MX600, MX700 and
MX800 patient monitors.
The monitors are not user installable. They must be installed by qualified service personnel.
Indications for Use
The monitors are indicated for use by health care professionals whenever there is a need for
monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for,
multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for
use by trained healthcare professionals in a hospital environment.
The MX400/MX450/MX500/MX550 monitors are additionally intended for use in transport
situations within hospital environments.
The monitors are only for use on one patient at a time. They are not intended for home use. Not
therapeutic devices. The monitors are for prescription use only.
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).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for
use with neonatal and pediatric patients.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
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 Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years)
patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
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.