Spo2 Specifications; Nellcor - GE PANDA Service Manual

Appendix A: Specifications

SpO2 Specifications

A.6 SpO Specifications
2
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
50 years old, comprised men and women of varied skin pigmentation, and were selected from local
population. Pulse oximeter SpO
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
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
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
Measurement Range
Accuracy
Wavelengths and Power
Data Update Period
Alarms
Standards
A-4
range(s) conducted by Covidien. The volunteers ranged in age from 18 to
2
readings were compared to SpO
2
) range.
RMS
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.
• SpO : 1-100% SpO
2
• Pulse Rate: 20-300 bpm
• SpO : from 70-100% SpO
2
• Below 69%, unspecified
• Pulse rate, no motion: +/- 3 bpm
Nominally 660 nm and 900 nm with total optical output power of
the sensor LEDs less than 15 mW
At maximum averaging time, the data is updated in less than thirty
seconds; shorter averaging times reduce this update period.
User selectable upper and lower limits for SpO
Designed to ISO 80601-2-61 with the exclusion to clause
201.15.3.5.101.1 with regard to shock and vibration.
values of drawn blood samples
2
and pulse rate values were
2
2
, +/- 3 digits for neonates
2
and pulse rates
2
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