Masimo has secured CE mark for RD rainbow Lite SET sensors, which enable the monitoring of Masimo Oxygen Reserve Index (ORi) and RPVi.
RPVi is an improved PVi that allows clinicians to assess fluid responsiveness noninvasively and continuously1 at a fraction of the cost of invasive methods, and at a fraction of the cost of rainbow® sensors.
The 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.
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
Joe Kiani, Founder and CEO of Masimo, said, “rainbow Lite sensors allow clinicians, who depend on powerful SET® pulse oximetry technology, to augment their patient monitoring with ORi and newly introduced RPVi.
Given the positive reception of ORi in available markets, and feedback from clinicians who see great value in the benefits of ORi monitoring, we are excited to make ORi and RPVi accessible via the cost-effective solution represented by RD rainbow Lite SET. Hospitals that standardize on RD rainbow Lite SET will pay only nominally more per sensor than for SET®.”
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.