Test & Measurement

CE marking of respiration rate measurement on MightySat Rx

20th February 2017
Enaie Azambuja
0

Masimo announced the 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 maximised 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 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.

“MightySat Rx is our smallest, most compact pulse oximeter, and as such is particularly versatile, offering the convenience of portability,” stated 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 U.S.

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