Operator's Manual

Rad-97 Chapter 15: Specifications
www.masimo.com 179 Masimo
Total Hemoglobin (SpHb) [8]
Range of 8 g/dL to 17 g/dL Adults, Pediatrics 1 g/dL
Respiratory Rate (RRa) [9]
Range of 4 to 70 bpm*** Adults, Pediatrics 1 bpm
Range of 4 to 120 bpm*** Infants, Neonates 1 bpm
Respiratory Rate (RRp)**** [10]
Range of 4 to 70 rpm Adults, Pediatrics 1 rpm
* A
RMS
accuracy is a statistical calculation of the difference between device measurements and
reference measurements. Approximately two-thirds of the device measurements fell within
+/- A
RMS
of the reference measurements in a controlled study.
** See Bland and Altman. Agreement between methods of measurement with multiple
observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp.
571-582.
*** Breaths per minute is denoted as rpm on device display.
****Parameter currently not available in the U.S.A. and territories relying on FDA market
clearance.
Note: A functional tester cannot be used to assess the accuracy of Rad-97.
SpO2 Performance Specifications
Accuracy testing for SpO
2
was performed on healthy adult subjects. The tables below provides
A
RMS
(Accuracy Root Mean Square) values measured using the Masimo Rainbow SET
Technology with Masimo RD SET disposable sensors in clinical studies under no motion
conditions. The Bland-Altman plots provided in the operator’s manual are for the sensors
identified in the respective plots. Bland-Altman plots for sensors not listed in the tables
below are available in the Directions for Use (DFU) for those sensors. See the sensor DFU for
the Bland-Altman plots for the respective compatible sensor.
Measurement A
RMS
Values for Disposable (RD SET Series) Sensors
SpO
2
Accuracy Range (%) A
RMS
(%)
70-80 0.83
80-90 1.11