Oxygen Sensors Get The CE Mark Of Approval

Masimo announces both the CE marking and release of RD rainbow Lite SET sensors. The components enable monitoring of the company’s Oxygen Reserve Index (ORi) and RPVi, described as an improved PVi that allows clinicians to assess fluid responsiveness noninvasively and continuously1 at a fraction of the cost of invasive methods and rainbow sensors. Rainbow Lite sensors utilize twice as many wavelengths of light as SET sensors, allowing rainbow Lite sensors to provide ORi and RPVi along with Masimo SET Measure-through Motion and Low Perfusion pulse oximetry.

 

Reportedly, ORi is the first noninvasive and continuous parameter to provide insight into a patient’s oxygen reserve in the moderate hyperoxic range. In conjunction with SET pulse oximetry, ORi may provide advanced warning of impending desaturation, which may allow clinicians to intervene sooner. For example, in a study of 25 pediatric patients undergoing general anesthesia with orotracheal intubation, researchers found that ORi helped clinicians identify impending desaturation a median of 31.5 seconds before noticeable changes in oxygen saturation (SpO2) occurred.2 In another recent study of 106 adult patients scheduled for surgery with arterial catheterization and intraoperative blood gases analyses, researchers found a significant relationship between change in PaO2 and change in ORi.3 In addition, ORi may provide insight into oxygen reserve when titrating patients who are receiving supplemental oxygen.4

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Masimo RPVi is a multi-wavelength version of Pleth Variability Index (PVi). RPVi is designed to provide enhanced assessment of changes in fluid volume compared to PVi5, which has been shown in over 90 independent clinical studies to be as effective as invasive monitoring methods.6 With the addition of RD rainbow Lite SET, the RD family of sensors is now available in three levels of capability: RD SET, utilizing two wavelengths (2 LED) and featuring SET® pulse oximetry; RD rainbow Lite SET, which utilizes four wavelengths (4 LED) and adds the ability to measure ORi and RPVi; and RD rainbow SET, which utilizes over seven wavelengths (7+ LED) and enables the measurement of additional advanced noninvasive parameters such as SpHb (total hemoglobin), SpCO (carboxyhemoglobin), SpMet (methemoglobin), and SpOC (oxygen content).

 

Like RD SET sensors, RD rainbow Lite SET sensors are designed to maximize patient comfort and optimize clinician workflow. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot. The sensors feature an intuitive sensor-to-cable connection, with tactile and audible feedback to ensure a proper connection, and have graphics printed on both sides to assist with application.

 

Devices with ORi and RPVi measurements and RD rainbow Lite SET sensors have not received FDA 510(k) clearance and are not available for sale in the United States. Pay a visit to Masimo for more scintillating details.

 

References

1. Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010 Oct; 111(4):910-4.

2. Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, and Ezri T. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.

3. Applegate R, Dorotta I, Wells B, Juma D, and Applegate P. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep; 123(3); 626-633.

4. Scheeren TWL, Belda FJ and Perel A. The oxygen reserve index (ORi): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2017. doi:10.1007/s10877-017-0049-4.

5. Masimo data on file.

6. Published clinical studies on PVi are available.

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