My main issue is that the Mindray user manual states that a PI of 0.3 to 1 is acceptable and above 1 is optimal. I'm only seeing accurate results, albeit with not the best probe placement possible, with a PI of 3.
I want to be sure that this is a result due to my method of testing and cannot be replicated in a clinical environment on a patient.
Repeating the exact same test on a Masimo Radical 7 I get no issues and all readings are within 2% tolerance of the simulator.
This issue only arose due to our ICU staff reporting higher than expected SpO2 readings compared to the SaO2 blood gas reading.
It would be interesting to see how the manufacturer actually tests SpO2 to achieve ISO 80601-2-61 to get a device on the market. Would it be under perfect lab conditions or do they take into account slight patient movement can happen and how do they measure outside these perfect conditions.
