Appendix A: Specifications
SpO2 Specifications
A-4 Service Manual
A.6 SpO
2
Specifications
A.6.1 Nellcor
A.6.1.1 Technical Description, Specifications, and Accessories
Accuracy specifications are based on controlled hypoxia studies in healthy non-smoking adult volunteers
over the specified saturation SpO
2
range(s) conducted by Covidien. The volunteers ranged in age from 18 to
50 years old, comprised men and women of varied skin pigmentation, and were selected from local
population. Pulse oximeter SpO
2
readings were compared to SpO
2
values of drawn blood samples
measured by hemoximetery. All accuracies are expressed as ± “X” digits. Pulse oximeter equipment
measurements are statistically distributed. About two-thirds of pulse oximeter measurements can be
expected to fall in this accuracy (A
RMS
) range.
Pulse Rate reading accuracy in the presence of low perfusion (detected IR pulse modulation amplitude
0.03% - 1.5%) was validated using signals supplied by a patient simulator. SpO
2
and pulse rate values were
varied across the monitoring range over a range of weak signal conditions and compared to the known true
saturation and pulse rate of the input signals.
A.6.1.2 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: 20-300 bpm
Accuracy • SpO
2
: from 70-100% SpO
2
, +/- 3 digits for neonates
• Below 69%, unspecified
• Pulse rate, no motion: +/- 3 bpm
Wavelengths and Power Nominally 660 nm and 900 nm with total optical output power of
the sensor LEDs less than 15 mW
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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