Pulse Oximetry FAQ

This FAQ has been compiled by our team of experts. Please submit your questions at the bottom of this page!

Pulse Oximetry FAQ Causes of inaccuracies

What are common reasons for inaccurate pulse oximeters readings?

Pulse oximeter measurements can be influenced by many variables such as skin pigment, body temperature, nail polish, movement, and perfusion. If the waveform tracing is erratic and low amplitude, this might be due to a weak signal or due to the patient moving. This can make it difficult for the oximeter to interpret the oxygen saturation accurately. Common reasons for poor waveform can include poor perfusion, irregular heart rate, or poor probe placement. All of these factors can cause both underestimation and overestimation errors in oxygen saturation readings.

References: Lifebox Pulse Oximetry Learning Module

Keywords: waveform, perfusion, battery, error

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Healthy Human Performance Tests

To meet 2017 ISO standards (80601-2-61) or 2013 FDA guideline adherence for clinical use, pulse oximeter performance must be tested in healthy humans in a laboratory setting. Independent device testing for the Open Oximetry Project follows our protocol consistent with ISO and FDA. Only devices labeled as ‘verified’ or ‘failed’ have been independently tested by the Open Oximetry Project.
All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:

No Data

1 (red)

>4%

2 (red)

<4%

AND/OR Data suggesting Arms for dark skin color of >4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%

3 (yellow)

<4%

AND/OR Data suggesting Arms for dark skin color of 3-4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%

4 (green)

<3%

AND No data for or against performance problems in darker skin colors

AND No data for or against performance problems in low perfusion

5 (green)

<3%

AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023

* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark Lab) get labeled as ‘verified’