Shining a light on pulse oximetry
A pulse oximeter is a device that shines light through tissue to measure the oxygen content in the blood. This data can then inform care decisions and support outcomes. Pulse oximetry sensors detect the red and infrared LED light absorbance that shifts in the presence of oxygenated and deoxygenated hemoglobin. Melanin, the natural pigment that gives skin its color, can also impact light absorption — specifically the red LED light used in a pulse oximeter. This can lead to a higher incident of unrecognized hypoxemia in patients with darker skin pigmentation.†,1–4
To assess patient oxygen saturation, our Medtronic Nellcor™ technology uses a form of artificial intelligence called a pattern-matching neural network to recognize and track each patient’s unique pulse.5 We embed a digital memory chip in every sensor matched with individualized calibration curves to help enable higher accuracy and improved performance.6
Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2. Please consult the instructions for use and manual for full safety information.
Nellcor™ pulse oximetry performs better than market competitor for patients with dark skin tones‡,1
A leading hypoxia research laboratory independently tested pulse oximeters made by Medtronic and market competitor. The researchers evaluated devices for their ability to read blood oxygen in patients with dark skin pigmentation and low perfusion. The research showed that the Medtronic Nellcor™ system more frequently identified hypoxemia and more accurately measured oxygen saturation.
These findings show how different technologies perform across skin tones
- Nellcor™ technology missed 74% fewer hypoxemic events in subjects with dark skin and low perfusion.
- Nellcor™ pulse oximetry experienced only 10% as many data dropouts as market competitor pulse oximetry.
- Nellcor™ pulse oximetry had 31% greater precision in all dark skin readings than market competitor pulse oximetry.
Accuracy based on study, not funded by Medtronic, that enrolled 146 healthy subjects in the 92-96% saturation range and examined paired readings from Nellcor™ N-595 and market competitor pulse oximeters generated simultaneously. This study was not designed for head-to-head comparison of the respective devices.
Investing in inclusive clinical evidence
At the Medtronic Clinical Physiology Lab, we’re conducting pulse oximeter clinical studies incorporating the Monk Skin Tone (MST) Scale. The MST scale is a more inclusive 10-pigmentation scale designed to represent a broader range of patient populations. We’re using these new learnings to design the next generation of pulse oximetry technology.
By increasing representation in our research, we help ensure more equitable performance for all patients.
Can technology be blind to skin tone?
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The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.
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TM* Third–party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
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Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2. Please consult the instructions for use and manual for full safety information.
‡
The study enrolled 146 healthy subjects and examined the Nellcor™ N-595 and Masimo Radical-7™* pulse oximeters.
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Performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017). Performance data from healthy volunteers may not accurately represent performance in real world patient populations. The information displayed here shall not be construed as an endorsement by Open Oximetry.
