Product Manual

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 SpO2 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 SpO2 sensor. To verify the accuracy, clinical tests are
required.
Test Method 2
Tool required:
 SpO
2
simulator, Index-2 recommended
Test procedure:
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 [Neonatal] respectively. Observe
the monitor and make sure the displayed SpO
2
and Pulse Rate 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