User's Manual

Radius-7 Chapter 7- Specifications
www.masimo.com 80 Masimo
Citations
[1] SpO
2
, SpCO, and SpMet accuracy was determined by testing on healthy adult male and
female volunteers in the range 60% to 100% SpO
2
, 0% to 40% SpCO, and 0% to 15% SpMet
against a laboratory CO-Oximeter. SpO
2
and SpMet accuracy was determined on 16 neonatal
NICU patients ranging in age from 7 days to 135 days old and weighing between 0.5 kg and
4.25 kg. Seventy-nine data samples were collected over a range of 70% to 100% SaO
2
and 0.5%
to 2.5% HbMet with a resultant accuracy of 2.9% SpO
2
and 0.9% SpMet. Contact Masimo for
testing specifications.
[2] The Masimo rainbow SET technology with Masimo sensors has been validated for no motion
accuracy in human blood studies on healthy adult male and female volunteers with light to
dark skin pigmentation in induced hypoxia studies in the range of 70%-100% SpO
2
against a
laboratory CO-Oximeter and ECG monitor. This variation equals ±1 standard deviation which
encompasses 68% of the population weight.
[3] The Masimo rainbow SET technology with Masimo sensors has been validated for motion
accuracy in human blood studies on healthy adult male and female volunteers with light to
dark skin pigmentation in induced hypoxia studies while performing rubbing and touching
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
2
against a laboratory CO-Oximeter and ECG monitor. This variation equals ±1 standard
deviation. Plus or minus one standard deviation encompasses 68% of the population.
[4] The Radius-7 has been validated for low perfusion accuracy in bench-top testing against a
Biotek Index 2TM* simulator and Masimo's simulator with signal strengths of greater than
0.02% and transmission of greater than 5% for saturations ranging from 70%-100%. This
variation equals ±1 standard deviation. Plus or minus one standard deviation encompasses
68% of the population.
[5] Masimo rainbow SET technology with Masimo sensors has been validated for pulse rate
accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator.
This variation equals ±1 standard deviation which encompasses 68% of the population.
[6] SpHb accuracy has been validated on healthy adult male and female volunteers and on
surgical patients with light to dark skin pigmentation in the range of 8 g/dL to 17 g/dL SpHb
against a laboratory CO-Oximeter. The variation equals ±1 standard deviation which
encompasses 68% of the population. The SpHb accuracy has not been validated with motion or
low perfusion.
[7] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and device has been
validated for the range of 4 to 70 breaths per minute in bench top testing. Clinical validation
for up to 30 breaths per minute was also performed with the Masimo Acoustic Respiration
Sensor and Instrument.
[8] Maximum sensitivity mode fixes perfusion limit to 0.02%.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington.