Appendix A: Specifications
SpO2 Specifications
A-6 Service Manual
The Masimo SpO
2
parameter 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 a %
transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or
minus, one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
Note: Because pulse oximeter equipment measurements are statistically distributed, only about two-
thirds of pulse oximeter equipment measurements can be expected to fall within ± Arms of the
value measured by a COOximeter.
Pulse Rate accuracy has been validated 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.
A.6.4.2 Specifications
Warmer Expected Service Life The product is designed to meet a life span of 8 years. However,
with proper maintenance and repairs, the service life can be
extended as long as service parts are available.
Measurement Range • SpO
2
: 1-100% SpO
2
• Pulse Rate: 25-240 bpm
Wavelengths
Red
Infrared
660 nm, nominal
905 nm, nominal
Maximum Optical Output Power
Radiant Power at 50 mA pulsed 0.13 mW, minimum
0.79 mW, maximum
Accuracy • SpO
2
: from 70-100% SpO
2
, +/- 3% SpO
2
for neonates
• Below 69%, unspecified
• Pulse rate, no motion: +/- 3 bpm
• Pulse rate, motion: +/- 5 bpm
Data Update Period At maximum averaging time, the data is updated in less than
thirty seconds; shorter averaging times reduce this update
period.
Alarms User selectable upper and lower limits for SpO
2
and pulse rates
Standards Designed to ISO 80601-2-61 with the exclusion to clause
201.15.3.5.101.1 with regard to shock and vibration.
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