Masimo Announces CE Marking of Respiration Rate Measurement on MightySat Rx

Masimo has received CE marking of the measurement of respiration rate from the pleth (RRpTM) on the MightySat Rx fingertip pulse oximeter. MightySat Rx is a noninvasive device that measures and displays functional oxygen saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI) with the option to add Pleth Variability Index (PVi) and now, RRp.
 
Respiration rate, or the number of breaths taken per minute, typically requires manually counting breaths with a timer and then converting to a per minute rate, or being fitted with chest leads or straps that can be inconvenient. With the addition of RRp to MightySat Rx, respiration rate can conveniently be measured using the same fingertip sensor that measures SpO2, PR, PI, and PVi (a measurement of the dynamic changes in PI that occur during the respiratory cycle). RRp is measured only when the respiratory movement-induced signal is present in the pulsatile waveform and may not be available during certain conditions, such as very irregular breathing and excessive movement.
 
MightySat Rx is indicated for use with both adult and pediatric patients during both no motion and motion conditions, who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments. It offers a Bluetooth wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements. MightySat Rx features the same Measure-through Motion and Low Perfusion SET pulse oximetry available in a variety of bedside Masimo and OEM monitors. Masimo SET addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Infection control issues aside, Masimo SET performance benefits are maximized by choosing the correct sensor type for the applicable use scenario: adhesive sensors for continuous monitoring, reusable cabled sensors for short-term monitoring and MightySat Rx fingertip oximeters for spot-checks on those who are not moving excessively and do not have very poor perfusion. Masimo SET helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year¹ and is the primary pulse oximetry at top hospitals, including nine of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.²
 
“MightySat Rx is our smallest, most compact pulse oximeter, and as such is particularly versatile, offering the convenience of portability,” said Joe Kiani, chairman and CEO of Masimo. “We are happy to be able to increase its capability with the addition of RRp, and to continue innovating in the field of mobile monitoring devices for the professional caregiver market.”
 
RRp does not have 510(k) clearance and is not available in the United States.

References:
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview
 
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 helps clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring 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. 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), and more recently, Pleth Variability Index (PVi) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion,^6,7 and when used with PVi, reductions in length of hospital stay⁸ and 30- and 90-day mortality.⁹ 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 role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2 pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter.
 
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. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.