FDA Clears RRp®, Respiration Rate from Pleth, on MightySat™ Rx Fingertip Pulse Ox

Masimo recently announced FDA clearance of the measurement of respiration rate from the pleth (RRp^®) on the MightySat™ Rx spot-check fingertip pulse oximeter, as well as its indication for use in the home environment. The addition of RRp to MightySat Rx, which also measures functional oxygen saturation (SpO₂), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi^®), makes it a more thorough and versatile spot-check solution.

Respiration rate, or the number of breaths taken per minute, typically requires manually counting breaths with a timer and then converting to a rate per minute, or being fitted with chest leads or straps that can be inconvenient. With RRp, respiration rate can conveniently be measured using the same optical sensor that measures SpO₂, PR, Pi, and PVi. RRp is provided 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.

With the introduction of RRp to the U.S., Masimo now offers clinicians more ways to accurately measure breathing rate than ever, helping to ensure they have the right tools for each patient scenario. RRp on MightySat Rx offers a convenient, fast, and portable option, adding to the portfolio of respiratory solutions from Masimo that includes continuous, acoustic respiration rate monitoring using RRa^® and capnography-based solutions using NomoLine^®.

Alongside RRp, PVi, PR, and Pi, MightySat Rx features the same Measure-through Motion and Low Perfusion™ SET^® pulse oximetry available in a variety of bedside Masimo and OEM monitors. SET^® has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies,¹ is estimated to be used on more than 100 million patients a year,² and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.³ The benefits of SET^® are maximized by choosing the correct sensor type for each use scenario: adhesive sensors for continuous monitoring, reusable sensors for short-term monitoring, and MightySat Rx fingertip oximeters for spot-check measurements.

MightySat Rx is small and light, weighing less than 100 grams (with batteries), but also durable and long-lasting, with an IP23 ingress rating (protected from water spraying from up to 60 degrees from vertical) and providing approximately 1,800 spot-checks with each set of 2 AAA batteries. Available in both black and white, MightySat offers a high-resolution color display, including display of plethysmographic waveforms, as well as a Bluetooth^® wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Estimate: Masimo data on file.
3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
4. 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.
5. 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;Jan 8;338.
6. 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.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8. 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.