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Masimo recently announced that the RDrainbow LiteSET sensor has received the CE marking and is now available for sale. This innovative sensor enables clinicians to monitor two key parameters: the Masimo Oxygen Reserve Index (ORi) and the Revised Pulse Variability Index (RPVi), an enhanced version of PVi. These metrics allow for continuous, non-invasive assessment of a patient's hemodynamic status, offering valuable insights without the need for invasive procedures. Compared to traditional methods and even the standard Rainbow sensors, the RDrainbow LiteSET is more cost-effective and efficient.
The RDrainbow LiteSET uses twice as many light wavelengths as the standard SET sensor, which enhances its compatibility with Masimo’s SET™ technology. This allows it to work seamlessly with the Motion-Proof and Low Perfusion pulse oximeters, delivering accurate ORi and RPVi readings even in challenging conditions.
ORi is a groundbreaking, non-invasive parameter that provides real-time information about a patient’s oxygen reserve, particularly in the moderate hyperoxia range. When used alongside the SET pulse oximeter, ORi can alert clinicians to potential drops in oxygen saturation before they become apparent on SpO2 readings. In one study involving 25 children under general anesthesia, ORi detected changes 31.5 seconds earlier than SpO2. Another study with 106 adult patients showed a strong correlation between ORi and PaO2 levels during arterial catheterization. For patients receiving supplemental oxygen, ORi helps clinicians better understand oxygen reserves while adjusting oxygen delivery.
Joe Kiani, founder and CEO of Masimo, said, “With the RDrainbow LiteSET, clinicians who rely on our powerful SET technology can now access ORi and the newly introduced RPVi. We’ve seen positive responses from markets around the world, with many clinicians reporting significant benefits from using ORi monitoring. That’s why we’re offering these features through a cost-effective solution. The RDrainbow LiteSET is a great example—hospitals that adopt this sensor only pay slightly more per unit compared to the standard SET.â€
RPVi is an advanced version of the Pulse Variability Index (PVi), based on multi-wavelength technology. It aims to provide a more accurate assessment of fluid volume changes, building on the well-established value of PVi. Over 90 independent clinical studies have demonstrated that PVi is as effective as various invasive monitoring techniques.
With the introduction of the RDrainbow LiteSET, the RD sensor family now offers three distinct levels of functionality. The RDSET model features 2 wavelengths and works with the SET pulse oximeter. The RDrainbow LiteSET includes 4 wavelengths and provides ORi and RPVi measurements. The top-tier RDrainbowSET model boasts 7 or more wavelengths, enabling additional non-invasive parameters such as SpHb (total hemoglobin), SpCO (carboxyhemoglobin), SpMet (methemoglobin), and SpOC (oxygen content).
Designed with both patient comfort and clinician efficiency in mind, the RDrainbow LiteSET features a lightweight, flat, and soft cable with smooth edges, making it ideal for placement on hands and feet. The sensor-to-cable connection is intuitive, providing tactile and audible feedback for secure attachment. Both sides of the sensor are printed with application guides to simplify use.
It’s important to note that ORi and RPVi monitoring systems, along with the RDrainbow LiteSET sensor, have not been cleared by the FDA under 510(k) and are not currently available for sale in the United States.