Rad-67
Chapter 8: Specifications
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76
Masimo
Total Hemoglobin (SpHb) [5]
Range of 8 g/dL to 17 g/dL Adults**
Upper 95% LoA
2.07
Lower 95% LoA
-1.82
* A
RMS
accuracy is a statistical calculation of the difference between device measurements
and reference measurements. Approximately two-thirds of the device measurements fell
/- A
RMS
of the reference measurements in a controlled study.
** For SpHb measurements, an Adult is defined as a person 18 years of age or older.
Note:
A functional tester cannot be used to assess the accuracy of Rad-67.
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 rainbow DCI-mini 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 Reusable (rainbow DCI-mini) Sensors
SpO
2
Accuracy Range (%)
A
RMS
(%)
70-80
1.9
80-90
1.7
90-100
1.2
70-100
1.6
