Masimo’s new rainbow parameter ORI secures CE Mark approval

8 October 2014 (Last Updated October 8th, 2014 18:30)

US-based Masimo has received CE Mark approval for its oxygen reserve index (ORI), which offers an insight into a patient's respiratory reserve when they are receiving the gas supplementally.

Masimo

US-based Masimo has received CE Mark approval for its oxygen reserve index (ORI), which offers an insight into a patient's respiratory reserve when they are receiving the gas supplementally.

With ORI, the company's rainbow SET Pulse CO-Oximeters that features MX-5 circuit board can measure around 11 parameters through its non-invasive optical rainbow sensor technology.

Pulse oximetry (SpO2) offers non-invasive 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 during supplemental oxygen administration.

According to the company, changes in PaO2 between invasive sampling cannot be evaluated, so unexpected hypoxia or unintended hyperoxia can occur.

"We believe ORI can help clinicians improve patient outcomes by keeping patients in the optimal oxygenation zone to help reduce risk for both hypoxia and hyperoxia."

Masimo founder and CEO Joe Kiani said: "ORI is another example of Masimo's commitment to take non-invasive 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."

The company said that ORI provides real-time visibility to oxygenation status in moderate hyperoxic range (PaO2 of approximately 100mmHg 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.

Masimo's ORI is expected to offer an advance warning of an impending hypoxic state, or an indication of an unintended hyperoxic state in patients who are receiving supplemental oxygen such as those in surgery, conscious sedation, or the intensive care unit.


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.