Masimo Announces CE Marking of O3 Regional Oximetry

Masimo has obtained CE Marking of its O₃ regional oximetry for the Root patient monitoring and connectivity platform.

O₃ regional oximetry is a new technology developed by Masimo and uses near-infrared spectroscopy in a Masimo Open Connect (MOC-9) module with up to two sensors per MOC-9 module. Each sensor contains four light-emitting diodes and two detectors to continuously and simultaneously measure both tissue oxygen saturation (rSO₂) and arterial blood oxygenation (SpO₂). Root allows either one or two O₃ MOC-9 modules to be connected, enabling monitoring with as few as one and as many as four sensors.

Regional oximetry, also referred to as tissue oximetry and cerebral oximetry, enables the continuous assessment of the oxygenation of the tissue beneath the sensor. O₃ helps clinicians detect regional hypoxemia that pulse oximetry alone can miss. In addition, the onboard pulse oximetry capability in O₃ sensors can automate the differential analysis of regional to central oxygen saturation. O₃ monitoring is as simple as applying O₃ regional oximetry sensors to the forehead and connecting the O₃ MOC-9 module to any Root through one of its three MOC-9 ports. Root offers multiple innovations including:

• Radical-7 with Masimo’s breakthrough rainbow and SET measurements;
• Instantly interpretable, high visibility, intuitive-navigation touchscreen display;
• MOC-9 flexible measurement expansion with SedLine EEG brain function monitoring and Phasein capnography, in addition to O₃ regional oximetry and future measurements;
• Iris for built-in connectivity gateway for standalone devices such as intravenous pumps, ventilators, hospital beds, and other patient monitors and
• MyView for automatic display of parameters, waveforms, and viewing configuration based on the clinician’s preference and presence.

In an abstract, Daniel Redford, M.D., from the University of Arizona evaluated cerebral oxygen saturation on 23 subjects and 202 paired measurements of rSO₂ from O₃ regional oximetry and reference arterial and venous blood samples (SavO₂).¹ Reference blood samples were taken from both an arterial cannula placed in the radial artery and a catheter placed in the internal jugular bulb vein, obtained at baseline and after a series of increasingly hypoxic states. O₃ regional oximetry had an absolute accuracy of 4 percent and a trend accuracy of 2.1 percent. 

“Masimo O₃ regional oximetry will have the unique ability to measure both rSO₂ and Masimo SET SpO₂ pulse oximetry simultaneously from the same forehead sensor,” said Michael Ramsay, M.D., chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas, Texas. “This may provide the anesthesiologist or perfusionist for the first time with a differential analysis of regional to central oxygen saturation monitoring that could help the clinician in maintaining brain oxygenation and safe cerebral perfusion during cardiac procedures.” 

O₃ regional oximetry currently is intended for use in subjects larger than 40 kg (88 lbs) and has not yet received U.S. Food and Drug Administration 510(k) clearance. 

Joe Kiani, CEO and Founder of Masimo, said, “O₃ regional oximetry delivers again on Masimo’s mission to improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications. We look forward to partnering with key hospitals around the world to demonstrate O₃‘s technical and clinical advantages.”

Based in Irvine, Calif., Masimo developed pulse co-oximetry and measure-through motion and low-perfusion pulse oximetry.

References:

1. Redford D, Paidy S, Kashif F, STA 2014; 46 (abstract).