Device Dossier

Single-patient physiologic monitoring system

Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor Wiselink Group). ARTG…

Intended purpose

N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C;N10M/N10MA/N10MC/N12M/N12MA/N12MC/N15M/N15MA/N15MC;N10MPro/N10MAPro/N12MPro/N12MAPro/N15MPro/N15MAPro is a multi-parameter monitoring device for providing a reliable reference for clinical diagnosis so that doctors can take appropriate measures timely. This monitor is mainly used to monitor the patient’s ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis and Heart Rate (HR)),Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2),Masimo Rainbow SpO2, Oxygen (O2) and Anesthesia gas (AG), Bispectral Index (BIS), Impedance Cardiograph (ICG), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). It alarms when patient’s physiological parameters are overrange, and it can display, record and store each patient data and the corresponding waveforms. Usually it is used in general care (General), surgery/anesthesia care (OR), intensive care unit (ICU), neonatal care unit (Neo) and cardiac care unit (CCU). All the parameters can be monitored on single adult, pediatric and neonatal patients except for the following: - Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population. - ST segment analysis for adult only. - When using COMEN SpO2, the monitor is intended to be used on adult patient only. - PAWP is intended for adult and pediatric patients only. - C.O. measurement is intended for adult only. - BIS monitoring is intended for adult patients only. - RM is intended for adult and pediatric patients only. - NMT monitoring is intended for adult and pediatric patients only. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The monitors are not intended for helicopter transport, hospital ambulance, or home use.

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