Masimo RD SET Serie Manual página 8

SPECIFICATIONS
When used with Masimo SET pulse oximetry monitors, or with licensed Masimo SET pulse oximetry modules the RD SET
Sensors have the following specifications:
RD Sensor used with
Masimo Device
Body Weight
Application Site
SpO Accuracy,
2
No Motion (70–100%)
1,5
SpO Accuracy,
2
Motion (70–100%)
2,5
SpO Accuracy,
2
Low Perfusion (70–100%)
3
Pulse Rate Accuracy,
No Motion (25–240 bpm)
1
Pulse Rate Accuracy,
Motion (25–240 bpm)
4
Pulse Rate Accuracy,
Low Perfusion (25–240 bpm)
NOTE: A accuracy is a statistical calculation of the difference between device measurements and reference measurements.
rms
Approximately two-thirds of the device measurements fell within ± A
Specification represents clinical study results using Masimo SET Technology under no motion conditions in human blood studies
1
on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70–100%
SpO against a laboratory co-oximeter.
2
The Masimo SET Technology has been validated for motion accuracy in human blood studies on healthy adult male and female
2
volunteers with light to dark pigmented skin in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz
at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies
in the range of 70–100% SpO
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator
3
and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging
from 70% to 100%.
The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25–240 bpm in bench top testing against
4
a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than
5% for saturations ranging from 70% to 100%. Pulse rate accuracy under motion was verified by bench top testing in the range of
45-180 bpm against a Biotek simulator using the motion preset setting.
Specification reflects use with the following Masimo technology boards and software versions and higher: MS-2000 SB version
5
V5.1, MSX-1 version V5.3, MX-5 version V7.12. For SpO
refer to individual device operator's manual.
Specification represents clinical study results using Masimo SET Technology under no motion conditions in human blood studies
6
on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70–100%
SpO against a laboratory co-oximeter. Form, Fit, and Function on neonates was verified using 70 convenience arterial blood
2
samples collected on 42 hospitalized sick neonate patients ranging in age from 1 to 31 days old and weighing <4.5 kg. The SpO
was found to have a 3.19 A
* See Bland and Altman. Agreement between methods of measurement with multiple observations per individual Journal of
Biopharmaceutical Statistics (2007) vol. 17 pp. 571–582.
RD SET Adt RD SET Pdt
> 30 kg 10–50 kg
Finger or Toe Finger or Toe
1.5% 1.5%
1.5% 1.5%
2% 2%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
3
SpO Upper and Lower Limits of Agreement (LoA)*
2
Upper 95% LoA
Lower 95% LoA
against a laboratory co-oximeter.
2
over a saturation range of 70-100% SaO
rms
RD SET Inf
3–10 kg 10–20 kg
Thumb or
Finger or Toe
Great Toe
1.5% 1.5%
1.5% 1.5%
2% 2%
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
No Motion
2.3%
-2.3%
of the reference measurements in a controlled study.
rms
accuracy specifications with older versions of Masimo technology boards,
2
.
2
8
RD SET Neo
< 3 kg > 40 kg
Hand or Foot Finger or Toe
1.5% 1.5%
6
1.5% 1.5%
6
2% 2%
6
3 bpm 3 bpm
5 bpm 5 bpm
3 bpm 3 bpm
Motion
2.9%
-2.2%
RD SET NeoPt/
NeoPt-500
< 1 kg
Hand or Foot
1.5%
6
1.5%
6
2%
6
3 bpm
5 bpm
3 bpm
2
10497A-eIFU-1220