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Masimo receives CE mark approval for new rainbow parameter ORI

US-based Masimo has received CE mark approval for its Oxygen Reserve Index (ORI), a parameter that offers insight into a patient's oxygen reserve when they are receiving supplemental oxygen.

Masimo

With ORI, the firm’s rainbow SET Pulse CO-Oximeters that features MX-5 circuit board, can measure around 11 parameters through its noninvasive optical rainbow sensor technology, said Masimo.

Masimo founder and CEO Joe Kiani said that ORI is another example of the firm’s commitment to take noninvasive patient monitoring to new sites and applications.

"We believe ORI will have significant applications during surgical procedures, intubation and procedural sedation, among others, and can help clinicians improve patient outcomes by keeping patients in the optimal oxygenation zone to help reduce risk for both hypoxia and hyperoxia," Kiani added.

Pulse oximetry (SpO2) offers noninvasive and continuous visibility to arterial blood oxygenation in hypoxia (less than normal oxygenation) and normoxia (normal oxygenation), and clinicians use the partial pressure of oxygen (PaO2) to monitor levels of hyperoxia.

ORI is said to provide visibility to oxygenation status in moderate hyperoxic range (PaO2 of approximately 100 to 200mmHg), and is intended to supplement SpO2 monitoring and PaO2 measurements.

ORI can be trended as an index parameter with a unit-less scale between 0.00 and 1.00, and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve.

It will offer an advance warning of an impending hypoxic state, or an indication of an unintended hyperoxic state in patients receiving supplemental oxygen such as those in surgery, conscious sedation, or the intensive care unit.

Currently, ORI is available in Europe, and is not yet available in the US.


Image: Masimo’s ORI parameter offers real-time visibility to oxygenation reserve in patients receiving supplemental oxygen, which may enable proactive interventions. Photo: courtesy of Masimo Corporation.