Држава: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
MASIMO ASIA PACIFIC PTE. LTD.
Class C medical device
Masimo Corporation
General Hospital
Indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors in patients in healthcare environments. The system is only to be used with Masimo O3 sensors. When used with the O3 Adult Sensor, the system is for measuring absolute and trending rSO2 on cerebral sites and trending rSO2 on non-cerebral sites in adults ≥40kg. When used with the O3 Pediatric Sensor, the system is for measuring absolute and trending rSO2 on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥5kg and <40kg. When used with the O3 Neonatal Sensor, the system is for measuring only trending rSO2 on cerebral sites and trending rSO2 on non-cerebral sites in neonates <10kg. It is also indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (ΔO2Hb), deoxygenated hemoglobin (ΔHHb), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.
Models: O3 Sensor - 3756, Masimo Root Kit - 9515, O3 Module - 9637, O3 Pediatric Sensor - 4235, O3 Infant and Neonatal Sensor - 4384
2015-12-23