Posted in | Medical Sensor

Masimo Launches CE-Marked Oxygen Reserve Index™ rainbow Lite Sensors

Masimo recently announced the launch and CE marking of RD rainbow Lite SET™ sensors, which make it possible to monitor Masimo Oxygen Reserve Index™ (ORi™) and RPVi™.

RPVi is an enhanced PVi® that enables clinicians to evaluate fluid responsiveness in a continuous and noninvasive manner1 – all at a fraction of the cost of rainbow® sensors and invasive techniques. Similar to SET® sensors, rainbow Lite sensors use twice as many wavelengths of light, enabling them to provide RPVi and ORi together with Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry.

Masimo RD rainbow Lite SET™ Sensor (Photo credit: Masimo)

As the first continuous and noninvasive parameter, ORi provides a better insight about a patient’s oxygen reserve in the moderate hyperoxic range. Together with SET® pulse oximetry, ORi may also provide state-of-the-art warning of imminent desaturation, which could enable clinicians to intervene sooner.

For instance, in a study of 25 pediatric patients who were undergoing general anesthesia with orotracheal intubation, scientists noted that ORi allows clinicians to detect imminent desaturation a median of 31.5 seconds before the occurrence of perceptible changes in oxygen saturation (SpO2).2

In a new study that involved 106 adult patients scheduled for surgery with intraoperative blood gases analyses and arterial catheterization, researchers observed a major association between change in ORi and change in PaO2.3 ORi may also provide a better insight into oxygen reserve when titrating patients who are getting supplemental oxygen.4

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®

Joe Kiani, Founder and CEO of Masimo

A multi-wavelength version of Pleth Variability Index (PVi), Masimo RPVi is specifically designed to offer improved assessment of changes in fluid volume as opposed to PVi5, which has been demonstrated in more than 90 independent clinical studies to be as effective as invasive monitoring techniques.6

With the inclusion of RD rainbow Lite SET, the RD series of sensors now comes in three levels of capability such as RD SET, which uses two wavelengths (2 LED) and features SET® pulse oximetry; RD rainbow Lite SET, which uses four wavelengths (4 LED) and enables the measurement of RPVi and ORi; and RD rainbow SET, which uses more than seven wavelengths (7+ LED) and provides the ability to measure additional advanced noninvasive parameters such as SpOC™ (oxygen content), SpMet® (methemoglobin), SpCO® (carboxyhemoglobin), and SpHb® (total hemoglobin).

Similar to RD SET sensors, RD rainbow Lite SET sensors are particularly designed to optimize clinician workflow and maximize patient comfort. The lightweight sensors have a soft, flat cable with smooth edges, which allows the sensors to lie comfortably on the hand or foot of a patient. The sensors are integrated with an intuitive sensor-to-cable connection, with audible and tactile audible feedback to guarantee a proper connection. Graphics are also printed on both sides of the sensors to aid with application.

However, RD rainbow Lite SET sensors and devices with RPVi and ORi measurements are yet to receive FDA 510(k) clearance and are not available for sale in the US.

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 can be found at www.masimo.com/en-GB/home/clinical-evidence/pleth-variability-index-pvi/.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Tell Us What You Think

Do you have a review, update or anything you would like to add to this news story?

Leave your feedback
Submit