Business Wire01.23.18
Masimo has announced the CE marking and release of RD rainbow Lite SET sensors, which enable the monitoring of Masimo Oxygen Reserve Index (ORi) and RPVi, 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. 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 U.S. Food and Drug Administration (FDA) 510(k) clearance and are not available for sale in the United States.
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 http://www.masimo.com/en-GB/home/clinical-evidence/pleth-variability-index-pvi/.
Masimo develops noninvasive monitoring technologies. In 1995, the company debuted Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET is estimated to be used on more than 100 million patients in hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet), Pleth Variability Index (PVi), and more recently, Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2 pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. 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.
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 U.S. Food and Drug Administration (FDA) 510(k) clearance and are not available for sale in the United States.
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 http://www.masimo.com/en-GB/home/clinical-evidence/pleth-variability-index-pvi/.
Masimo develops noninvasive monitoring technologies. In 1995, the company debuted Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET is estimated to be used on more than 100 million patients in hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet), Pleth Variability Index (PVi), and more recently, Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2 pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. 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.