Fetal/Maternal Monitor - India CDSCO Medical Device Registration

Product Information

The Philips Avalon FM20 (Avalon Fetal Monitor), FM30 (Avalon Fetal Monitor), FM40 (Avalon Fetal Monitor), and FM50 (Avalon Fetal Monitor) fetal/maternal monitors are intended for:• noninvasive monitoring of fetal heart rates and movements.• noninvasive monitoring of maternal heart rates, maternal pulse rates, uterine activity, maternalnoninvasive blood pressure, maternal oxygen saturation, and maternal temperature.• invasive monitoring of direct fetal heart rate, intrauterine pressure, and for displaying and recording of fetal and maternal electrocardiogram (Avalon Fetal Monitor) (Avalon Fetal Monitor).• displaying, storing, and recording patient data and parameter values, and for generating alarms fromfetal and maternal parameters.• transmitting patient data and parameter values to a patient information and surveillance system.• use by trained healthcare professionals.• use in antepartum testing areas, in labor and delivery rooms, and during postpartum recovery in thehospital environment. They are not intended for use in intensive care units or operating rooms.• monitoring in a bath or shower (Avalon Fetal Monitor).• transport situations in healthcare facilities, for healthcare facilities outside hospitals, such as doctors’offices, and for use in private households (Avalon Fetal Monitor). Avalon Fetal/Maternal Monitor FM20:Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.Avalon Fetal/Maternal Monitor FM30:Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parametersuterine activity, heart rate, electrocardiography (Avalon Fetal Monitor), oxygen saturation, non-invasive blood pressure, pulse rate and temperatureof pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testingareas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM40:Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parametersuterine activity, heart rate, oxygen saturation, non-invasive blood pressure, pulse rate and temperature of pregnant women and thefetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Avalon Fetal/Maternal Monitor FM50:Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parametersuterine activity, heart rate, electrocardiography (Avalon Fetal Monitor), oxygen saturation, non-invasive blood pressure, pulse rate and temperatureof pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.