4-3
Measurement validation
The SpO
2
accuracy has been validated in human studies against arterial blood sample
reference measured with a CO-oximeter. Pulse oximeter measurements are statistically
distributed, and only about two-thirds of the measurements can be expected to fall within
the specified accuracy compared to CO-oximeter measurements.
NOTE
The SpO
2
simulator can only be used to verify that the pulse oximeter
operates properly. It cannot be used to verify the accuracy of the pulse
oximeter or the SpO
2
sensor. To verify the accuracy, clinical tests are required.
Test Method 2
Required Tool:
SpO
2
simulator, Index-2 recommended
Test Procedures:
1. Connect the SpO
2
sensor to the SpO
2
simulator.
2. Selected the model and manufacturer of the SpO
2
module to be tested on the
simulator, and set the simulator as follows: SpO
2
to 96% and Pulse Rate to 80
bmp.
3. Set the patient type to adult, pediatric and neonate respectively. Observe the
monitor and make sure the displayed SpO
2
and PR value fall in the following
range.
Manufacturer SpO
2
Pulse Rate
Nellcor
96% ± 2% (Adult, Pediatric)
96% ± 3% (Neonate)
80 ± 3 bpm
Masimo
96% ± 2% (Adult, Pediatric)
96% ± 3% (Neonate)
80 ± 3 bpm