This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment in a controlled desaturation study over a range between 80% and 100% peripheral oxygen saturation (SpO2). The study will be performed on a group of healthy volunteers in a controlled clinical setting.
This study is a post market clinical follow up study performed to confirm the performance of BrOxy M pulse oximeter in comparison with a reference, CE marked, pulse oximeter equipment (Nellcor™ Bedside Respiratory Patient Monitoring System model PM1000N, Covidien LLC, USA) in a controlled desaturation study over a range between 80% and 100% SpO2. The study will be performed on a group of healthy volunteers in a controlled clinical setting. Due to the use of a controlled desaturation protocol foreseen by the standard ISO 80601-2-61:2017, this study is classified as an interventional post-market clinical study in accordance with Annex I of EN ISO 14155:2020.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19
Measure of SpO2 and Heart Rate by BrOxy M device and reference device in a controlled desaturation study.
Ospedale "SS. Annunziata"
Chieti, Italy
Accuracy of SpO2 Measurement at 80-100% SpO2
Accuracy of SpO2 measurements obtained with BrOxy M in comparison with the reference pulse oximeter in paired observations over a range between 80% and 100% SpO2. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.
Time frame: The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.
Accuracy of Heart Rate Measurement at 80-100% SpO2
Accuracy of measurements obtained with BrOxy M with that obtained with the reference pulse oximeter in paired observations. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.
Time frame: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.
Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2
Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 94% SpO2 cut off. Cohen's kappa coefficient takes into account the possibility of agreement occurring by chance.
Time frame: Around 5 min after beginning of the test session
Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2
Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 90% SpO2 cut off
Time frame: After around 10 min after beginning of the test session
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