Comparing pulse oximeter performance using a common functional tester versus controlled desaturation studies on...

Area of Science:

• Biomedical Engineering
• Medical Device Technology
• Clinical Diagnostics

Background:

• Pulse oximeters are critical for monitoring oxygen saturation.
• Functional testers are used to evaluate oximeter performance.
• Misuse of testers for accuracy validation may provide false reassurance.

Purpose of the Study:

• To evaluate if the Fluke ProSim8 (FPS8) can accurately predict oximeter performance during human desaturation studies.
• To assess the FPS8's ability to identify performance differences under low signal conditions.

Main Methods:

• 12 oximeters were tested using two FPS8 protocols: 'SpO₂ plateau' and 'signal space'.
• Devices were also tested during controlled human desaturation studies.
• Performance was evaluated based on SpO₂ accuracy (ARMS) and reading generation under varying signal conditions.

Main Results:

• Oximeter performance on the FPS8 did not correlate with human performance (R² = 0.08 and R² = 0.01).
• Devices that passed FPS8 protocols often failed human testing.
• Many oximeters overestimated SpO₂ at low saturations and failed under low signal conditions.

Conclusions:

• The FPS8 does not reliably predict oximeter accuracy in human studies or under low signal conditions.
• Current functional tester protocols are limited in predicting real-world oximeter performance.
• Further development of functional testers is needed to ensure accurate real-world device assessment.