Masimo Rad-97 Operator's Manual

Rad-97 Chapter 11: Specifications
www.masimo.com 148 Masimo
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 1.4
80-90 1.6
90-100 1.1
70-100 1.4
The table below provides the upper 95% and lower 95% limits of agreement. The differences
between measurements by the two methods are used to calculate the mean and standard
deviation. The lower 95% limit of agreement is the mean minus 1.96 standard deviation and
the upper 95% limit of agreement is the mean plus 1.96 standard deviation. These limits are
expected to contain 95% of the differences between measurements between the two methods
in controlled environments.
Upper and Lower Limits of Agreement (LoA)*
Upper 95% LoA 3.15%
Lower 95% LoA -2.21%
* See Bland and Altman. Agreement between methods of measurement with multiple
observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp.
571-582.

Masimo Rad-97 Specifications

General

Display Size	7 inches
SpO2 Accuracy	±2% (70-100%)
Pulse Rate Accuracy	±3 bpm
Perfusion Index Range	0.02% to 20%
Pleth Variability Index Range	0% to 100%
SpO2 Range	0% to 100%
SpHb Range	0 to 25 g/dL
SpCO Range	0% to 40%
Battery Type	Rechargeable lithium-ion
Operating Temperature	5°C to 40°C (41°F to 104°F)
Storage Temperature	-20°C to 60°C (-4°F to 140°F)
Humidity Range	10% to 95% non-condensing
Display	Color touchscreen
Connectivity	Wi-Fi, Ethernet, Bluetooth
Power Supply	100–240 VAC, 50–60 Hz
Battery Life	Approximately 4 hours
Measurements	SpO2, Pulse Rate, Perfusion Index, Pleth Variability Index, SpHb, SpOC, SpMet, SpCO
Pulse Rate Range	25 to 240 bpm
HbCO Range	0-99%
MetHb Range	0-99%
SpMet Range	0-99%
Data Storage	Internal memory
Alarms	Audible and visual alarms for all parameters