Medical technology firm Masimo has secured CE mark approval for its single-patient-use adhesive rainbow SuperSensor.
Masimo has also announced the European commercial launch of rainbow SuperSensor, which can be used with both Masimo and third-party monitors with Masimo rainbow technology inside.
The multi-purpose SuperSensor uses 12 LEDs to simultaneously provide 12 blood constituent parameters noninvasively and continuously.
The parameters consist of SET oxygen saturation (SpO2), total haemoglobin, SpHb, carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen reserve index (ORi), PVi, RPVi, pulse rate (PR), respiration rate (RRp), perfusion index (Pi), fractional oxygen saturation (SpfO2), and oxygen content (SpOC).
Masimo’s SuperSensor will help evaluate the patient’s status continuously by allowing clinicians to noninvasively and continuously monitor different physiologic indicators simultaneously.
Masimo SET pulse oximetry, which is the core of the SuperSensor, supports care teams to enhance patient safety and outcomes.
As part of patient blood management programmes, continuous haemoglobin monitoring with SpHb will allow clinicians to improve outcomes in both high and low blood loss surgeries.
PVi is a measure of the dynamic changes in the perfusion index that occur during the respiratory cycle. It indicates fluid responsiveness.
ORi is a noninvasive and continuous trending index, which expands oxygen monitoring of patients receiving supplemental oxygen.
SpMet enables clinicians noninvasively and continuously monitor methemoglobin levels in the blood, while SpCO facilitates quick and noninvasive monitoring of carbon monoxide levels in the blood.
The SuperSensor provides a more complete picture of oxygenation in the presence of potential dyshaemoglobin interference by making SpMet, SpCO, and SpfO2 available on the same sensor.
Fractional oxygen saturation (FO2Hb) delivers a measure of the fraction of total haemoglobin that is currently oxygenated, as opposed to SpO2, functional oxygen saturation, which measures the fraction of haemoglobin that is oxygenated based on an estimation of the effective haemoglobin available.
Masimo founder and CEO Joe Kiani said: “The SuperSensor represents a key milestone in Masimo’s continued innovation journey, giving clinicians access to 12 breakthrough noninvasive measurements in a single, convenient, and comprehensive sensor as part of our RD rainbow SET sensor family – while easing concerns about cross-contamination because of being a single-patient-use, adhesive product. I am proud of our team for delivering this innovation to the medical community.”
ORi, RPVi and SpfO2 have not yet secured 510(k) clearance from the US Food and Drug Administration (FDA). They are not commercially available in the US.
