User's Manual

Radical-7 Chapter 8: Specifications
www.masimo.com 125 Masimo
Citations
[1] SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in
the range 60% to 100% SpO2, 0% to 40% SpCO, and 0% to 15% SpMet against a laboratory
CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients
ranging in age from 7 days to 135 days old and weighting between 0.5 kgs and 4.25 kgs.
Seventy-nine (79) data samples were collected over a range of 70% to 100% SaO2 and 0.5%
to 2.5% HbMet with a resultant accuracy of 2.9% SpO2 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% SpO2
against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one
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 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% SpO2
against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one
standard deviation. Plus or minus one standard deviation encompasses 68% of the
population.
[4] The Radical-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 plus or minus one 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 plus or minus one 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 plus or minus one standard deviation
which encompasses 68% of the population. The SpHb accuracy has not been validated with
motion or low perfusion.
[7] This represents approximate run time at the lowest indicator brightness and pulse tone
turned off using a fully charged battery.
[8] If the batteries are to be stored for extended periods of time, it is recommended that they
be stored between -20°C to +30°C, and at a relative humidity less than 85%. If stored for a
prolonged period at environmental conditions beyond these limits, overall battery capacity
may be diminished, and lifetime of the batteries may be shortened.
[9] With FastSat the averaging time is dependent on the input signal. For the 2 and 4 second
settings the averaging time may range from 2-4 and 4-6 seconds, respectively.
[10] Maximum sensitivity mode fixes perfusion limit to 0.02%.
[11] Respiration rate accuracy for the Masimo Acoustic Respiration Sensor and Instrument 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.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington.