624074/07 F-53
Footnotes:
1. SpO
2
, SpCO, and SpMet accuracy was determined by testing on healthy
adult volunteers in the range of 60-100% SpO
2
, 0-40% SpCO, and 0-15%
SpMet against a laboratory CO-oximeter. SpO
2
and SpMet accuracy was
determined on 16 neonatal NICU patients ranging in age from 7 - 135 days
old and weighing between 0.5 - 4.25 kg. Seventy-nine (79) data samples
were collected over a range of 70 - 100% SaO
2
and 0.5 - 2.5% MetHb with
a resultant accuracy of 2.9% SpO
2
and 0.9% SpMet.
2. The Masimo sensors have 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 plus or minus one standard deviation, which encompasses 68% of
the population.
3. The Masimo sensors have 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 in the range of 70-100%
SpO
2
against a laboratory CO-oximeter and ECG monitor. This variation
equals plus or minus one standard deviation, which encompasses 68% of
the population.
4. The Masimo SET technology has been validated for low-perfusion accuracy
in bench-top testing against 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%. This variation
equals plus or minus one standard deviation, which encompasses 68% of
the population.
5. The Masimo sensors have been validated for pulse-rate accuracy for the
range of 25-240 bpm in bench-top testing against a Biotek Index 2
Compliance
Type of protection
(battery power)
Internally powered
Degree of protection
(patient cable)
Type BF - applied part
Degree of protection
(Satshare cable)
Type CF - applied part
Degree of protection
(liquid ingress)
IPX1
Mode of operation Continuous
Table F-13. Masimo pulse oximeter specifications
Feature Specifications
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