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ISO 80601-2-61:2017

98.8% SpO2 Correlation

CardioMood uses wearables from our technology partner Corsano Health, whose CE-MDR certified medical devices have been validated against CO-oximetry in induced hypoxia studies.

Validation Results

SpO2 validation conducted by Corsano Health at CMC Europe using induced hypoxia protocols.

98.8%
Correlation
vs. CO-oximetry
94,572
Measurements
Non-invasive comparison
2.34-3.06
Arms Accuracy
By SpO2 range
0-100%
Range
Full spectrum
Study Protocol

Induced Hypoxia Validation

SpO2 accuracy was validated at CMC Europe (Belgium) using controlled induced hypoxia protocols with 24 healthy volunteers, following ISO 80601-2-61:2017 standards.

  • Gold-standard CO-oximetry reference
  • N=300 measurements per ISO protocol
  • Induced hypoxia from 100% to 70% SpO2
  • Additional N=94,572 vs. Nellcor PM10
  • Multiple SpO2 ranges tested independently

Accuracy by SpO2 Range

90-100%
Normal range
2.34 Arms
80-90%
Mild hypoxemia
2.67 Arms
70-80%
Moderate hypoxemia
3.06 Arms
Meets FDA/CE accuracy requirements
Applications

What SpO2 Monitoring Enables

Sleep Apnea Screening

Detect nocturnal oxygen desaturations that indicate sleep-disordered breathing.

Altitude Training

Monitor acclimatization and oxygen levels during high-altitude activities.

Respiratory Health

Track oxygen levels for chronic respiratory conditions and recovery.

Exercise Monitoring

Ensure adequate oxygenation during intense physical activity.

Wellness Tracking

Daily SpO2 trends as part of comprehensive health monitoring.

Post-COVID Recovery

Monitor oxygen levels during respiratory recovery periods.

Clinically Validated SpO2 for Your Application

CardioMood uses Corsano Health's CE-MDR certified wearables, bringing clinically validated SpO2 monitoring to wellness and lifestyle applications.