Philips IntelliVue MX100 & X3 Patient Monitor - HSA Registration DE0502962
Access comprehensive regulatory information for Philips IntelliVue MX100 & X3 Patient Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502962 and owned by Philips Medizin Systeme Böblingen GmbH. The device was registered on April 03, 2019.
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For monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. For use during patient transport inside the hospital environment. ECG measurement is for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes. ST segment monitoring is for adult patients only and is not clinically validated for use with neonatal and pediatric patients. Integrated Pulmonary Index (IPI) is for adult and pediatric (1 to 12 years) patients only. IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. PPV measurement is validated only for adult patients. Modified version of the monitor with a subset of parameters is for use during patient transport outside the hospital environment (not including helicopters and aircrafts).